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As filed with the Securities and Exchange Commission on
January 19, 2010
Registration 333-163911
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Amendment No. 1
to
Form S-4
REGISTRATION
STATEMENT
UNDER
THE SECURITIES
ACT OF 1933
LA JOLLA PHARMACEUTICAL
COMPANY
(Exact name of registrant as
specified in its charter)
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Delaware
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2836
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33-0361285
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(State or other jurisdiction of
incorporation or organization)
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(Primary Standard Industrial
Classification Code Number)
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(I.R.S. Employer
Identification Number)
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4365 Executive Drive, Suite 300
San Diego, CA 92121
(858) 452-6600
(Address, including zip code,
and telephone number, including area code, of registrants
principal executive offices)
Deirdre Y. Gillespie, M.D.
La Jolla Pharmaceutical Company
4365 Executive Drive, Suite 300
San Diego, CA 92121
(858) 452-6600
(Name, address, including zip
code, and telephone number, including area code, of agent for
service)
Copies to:
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Ryan A. Murr, Esq.
Goodwin Procter LLP
4365 Executive Drive, Suite 300
San Diego, CA 92121
(858) 202-2700
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C. Kevin Kelso, Esq.
Weintraub Genshlea Chediak
400 Capitol Mall, Eleventh Floor
Sacramento, California 95814
(916) 558-6000
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Dennis J. Carlo, Ph.D.
President and Chief Executive Officer
Adamis Pharmaceuticals Corporation
2658 Del Mar Heights Road, #555
Del Mar, CA 92014
(858) 401-3984
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Approximate date of commencement of proposed sale to the
public: As soon as practicable after this
Registration Statement becomes effective.
If the securities being registered on this Form are being
offered in connection with the formation of a holding company
and there is compliance with General Instruction G, check the
following
box. o
If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act, check
the following box and list the Securities Act registration
statement number of the earlier effective registration statement
for the same
offering. o
If this Form is a post-effective amendment filed pursuant to
Rule 462(d) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering. o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of
large accelerated filer, accelerated
filer and smaller reporting company in Rule
12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o
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(Do not check if a smaller reporting company)
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*If applicable, place an X in the box to designate the
appropriate rule provision relied upon in conducting this
transaction:
Exchange Act Rule 13e-4(i) (Cross-Border Issuer Tender
Offer) o
Exchange Act Rule 14d-1(d) (Cross-Border Third-Party Tender
Offer) o
CALCULATION OF REGISTRATION
FEE
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Title of Each Class of
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Amount to be
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Proposed Maximum
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Proposed Maximum
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Amount of
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Securities to be Registered
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Registered(1)
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offering Price per Share
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Aggregate Offering Price(2)
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Registration Fee(2)
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Common Stock, $0.01 par value per share
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50,387,881
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N/A
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$11,841,153
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$844.27
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(1)
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Relates to common stock,
$0.01 par value per share, of La Jolla Pharmaceutical
Company, or La Jolla, issuable to holders of common stock,
$0.0001 par value per share, of Adamis Pharmaceuticals
Corporation, or Adamis, in the proposed merger of Jewel Merger
Sub, Inc., a wholly-owned subsidiary of La Jolla, with and
into Adamis. The amount of La Jolla common stock to be
registered is based on the estimated maximum number of shares of
La Jolla common stock that may be issued pursuant to the
merger, assuming an exchange ratio of one share of La Jolla
common stock for each outstanding share of Adamis common stock,
after giving effect to the reverse stock split described in the
next sentence. La Jolla anticipates that before the
completion of the distribution of the securities covered by this
registration statement, all outstanding shares of La Jolla
common stock will be combined by a reverse stock split into a
lesser number of shares of La Jolla common stock. The
number of shares covered by this registration statement reflects
post-reverse stock split shares, although historical disclosures
for La Jolla are on a pre-split basis. The actual number of
shares issued pursuant to the merger transaction may be less
than the number of shares being registered.
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(2)
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Computed pursuant to Securities Act
Rules 457(c) and 457(f), and estimated solely for purposes
of calculating the registration fee, the proposed maximum
aggregate offering price is $11,841,153, which is (a) the
product of (i) the average high and low prices of
Adamis common stock of $0.235, as reported on the OTC
Bulletin Board as of December 17, 2009 (which was within 5
business days of the initial filing date of the registration
statement), and (ii) the maximum total number of shares of
Adamis common stock (50,387,881) to be cancelled in the merger.
$810.76 was paid previously, in connection with the initial
filing of the
S-4 on
December 22, 2009.
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The Registrant hereby amends this Registration Statement on
such date or dates as may be necessary to delay its effective
date until the Registrant shall file a further amendment which
specifically states that this Registration Statement shall
thereafter become effective in accordance with Section 8(a)
of the Securities Act of 1933 or until this Registration
Statement shall become effective on such date as the Securities
and Exchange Commission, acting pursuant to said
Section 8(a), may determine.
The
information in this joint proxy statement/prospectus is not
complete and may be changed. These securities will not be sold
until the registration statement filed with the Securities and
Exchange Commission is effective. This joint proxy
statement/prospectus is not an offer to sell these securities
and it is not soliciting an offer to buy these securities in any
state where the offer or sale is not permitted.
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SUBJECT TO COMPLETION, DATED
JANUARY 19, 2010
To the stockholders of La Jolla Pharmaceutical Company and
Adamis Pharmaceuticals Corporation:
The boards of directors of La Jolla Pharmaceutical Company,
referred to herein as La Jolla, and Adamis Pharmaceuticals
Corporation, referred to herein as Adamis, have each unanimously
approved a proposed merger involving La Jolla and Adamis
pursuant to a merger agreement between La Jolla, Adamis
and Jewel Merger Sub, Inc., referred to herein as Merger Sub, a
direct wholly-owned subsidiary of La Jolla. If approved by
the stockholders of La Jolla and Adamis, Merger Sub will merge
with and into Adamis and Adamis will survive the merger as a
wholly-owned subsidiary of La Jolla, with the Adamis
stockholders receiving a controlling interest in La Jolla.
The merger is intended to qualify for U.S. federal income
tax purposes as a reorganization under Section 368(a) of
the Internal Revenue Code of 1986, as amended.
If the merger is consummated, each Adamis stockholder will be
entitled to receive, in exchange for each share of Adamis common
stock held by such stockholder immediately before the closing of
the merger, one post-reverse split share of La Jolla common
stock. Before the closing of the merger, there will be a reverse
split of the outstanding La Jolla common stock so that
La Jolla stockholders would, immediately after the closing
of the merger, have a total number of shares that takes into
account the amount of La Jollas adjusted net cash at
the closing date of the transaction, plus $750,000, divided by a
price based on Adamis weighted average stock price over a
defined period of time, subject to a variable discount, which in
no event will yield a stock price that is less than $0.20 or
greater than $1.50. This reverse split ratio is expected to be
within a range of 1:3 to 1:30 and will affect only the
La Jolla stockholders; Adamis stockholders will be entitled
to receive one share of post-reverse split La Jolla common stock
in the merger regardless of the reverse split ratio affecting
the holders of La Jolla common stock.
The stockholders of La Jolla are being asked to approve the
issuance of La Jolla common stock pursuant to the merger
agreement, as well as the resulting change in control and
approve amendments to La Jollas restated certificate
of incorporation effecting a reverse stock split of
La Jolla common stock at a ratio to be determined in
accordance with the merger agreement and changing the corporate
name of La Jolla to Adamis Pharmaceuticals
Corporation, each as described in the accompanying joint
proxy statement/prospectus. The stockholders of Adamis are being
asked to approve and adopt the merger agreement, as described in
the accompanying joint proxy statement/prospectus. If the merger
is consummated, existing La Jolla stockholders are expected
to own between 5% and 30% of the combined company.
In connection with the merger, each outstanding stock option,
warrant, convertible security and other right to purchase or
acquire the capital stock of Adamis will be assumed by
La Jolla and will be converted into an option, warrant,
convertible security or other right to purchase or acquire
shares of common stock of La Jolla.
La Jolla common stock is currently listed on the Nasdaq
Capital Market. On January 14, 2010, the last trading day
before the date of this joint proxy statement/prospectus, the
closing price of the La Jolla common stock was $0.22 per
share. Adamis common stock is quoted on the
Over-The-Counter
Bulletin Board. On January 14, 2010, the last trading
day before the date of this joint proxy statement/prospectus,
the closing price of the Adamis common stock was $0.47 per share.
This joint proxy statement/prospectus provides you with detailed
information concerning La Jolla, Adamis and the merger
transaction. Please give all the information contained in this
joint proxy statement/prospectus your careful attention. In
particular, you should carefully consider the discussion in the
section entitled Risk Factors beginning on
page 11 of this joint proxy statement/prospectus.
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Deirdre Y. Gillespie, M.D.
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Dennis J. Carlo, Ph.D.
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President and Chief Executive Officer
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President and Chief Executive Officer
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La Jolla Pharmaceutical Company
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Adamis Pharmaceuticals Corporation
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Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of the shares
to be issued under this proxy statement/prospectus or passed
upon the adequacy or accuracy of this proxy
statement/prospectus. Any representation to the contrary is a
criminal offense.
This joint proxy statement/prospectus is dated
[ ],
2010 and was first mailed to stockholders of La Jolla and
Adamis on or about
[ ],
2010.
La Jolla
Pharmaceutical Company
4365 Executive Drive,
Suite 300
San Diego, CA 92121
(858) 452-6600
NOTICE OF SPECIAL MEETING OF
STOCKHOLDERS
TO BE HELD ON
[ ],
2010
TO THE LA
JOLLA STOCKHOLDERS:
NOTICE IS HEREBY GIVEN that La Jolla Pharmaceutical Company
will hold a special meeting of its stockholders on
[ ],
2010, at 10:00 a.m., Pacific Time, at
[ ]
for the following purposes:
1. To consider and vote upon a proposal to approve the
issuance of La Jolla common stock to the stockholders of
Adamis Pharmaceuticals Corporation pursuant to the Agreement and
Plan of Reorganization dated as of December 4, 2009, by and
among La Jolla, Jewel Merger Sub, Inc., or Merger Sub, and
Adamis Pharmaceuticals Corporation, a copy of which is attached
as Annex A to the accompanying joint proxy
statement/prospectus, pursuant to which Merger Sub will merge
with and into Adamis, with Adamis surviving the merger as a
wholly-owned subsidiary of La Jolla, and pursuant to which
La Jolla would issue post-reverse split shares of common
stock to the stockholders of Adamis, resulting in a change of
control of La Jolla.
2. To consider and act upon a proposal to approve an
amendment to La Jollas restated certificate of
incorporation to effect a reverse split of the issued and
outstanding shares of La Jolla common stock, to occur
immediately before the closing of the proposed merger
transaction with Adamis, at a ratio based on the formula
described in the merger agreement, expected to be within a range
of 1:3 to 1:30, with the final ratio to be determined before the
merger as provided in the merger agreement, as described in the
accompanying joint proxy
statement/prospectus.
3. To consider and act upon a proposal to approve an
amendment, which would become effective in connection with or
immediately following the closing of the proposed merger
transaction with Adamis, to La Jollas restated
certificate of incorporation to change La Jollas name
from La Jolla Pharmaceutical Company to
Adamis Pharmaceuticals Corporation, as described in
the accompanying joint proxy statement/prospectus.
4. To consider and act upon a proposal to approve, if
necessary, an adjournment of the La Jolla special meeting
to solicit additional proxies in favor of the foregoing
proposals.
5. To consider and act upon such other business and matters
or proposals as may properly come before the special meeting or
any adjournments or postponements thereof.
The board of directors of La Jolla has fixed
[ ],
2010 as the record date (the La Jolla Record
Date) for determining which stockholders have the
right to receive notice of and to vote at the La Jolla
special meeting or any adjournments or postponements thereof.
Only holders of record of shares of La Jolla common stock
at the close of business on the La Jolla Record Date have
the right to receive notice of and to vote at the La Jolla
special meeting. At the close of business on the La Jolla
Record Date, La Jolla had
[ ] shares
of common stock outstanding and entitled to vote. A quorum of
stockholders is necessary to hold a valid meeting. The presence,
in person or represented by proxy, at the La Jolla special
meeting of the holders of a majority of the shares of
La Jolla common stock issued and outstanding and entitled
to vote at the La Jolla special meeting is necessary to
constitute a quorum at the meeting. If a quorum is not present
at the La Jolla special meeting, La Jolla expects that
the meeting will be adjourned or postponed to solicit additional
proxies.
Your vote is important. The affirmative vote of the holders of a
majority of the outstanding shares of La Jolla common stock
having voting power on the La Jolla Record Date for the
La Jolla special meeting is required for approval of
La Jolla Proposal Nos. 2 and 3. The affirmative vote
of the holders of a majority of the shares of La Jolla
common stock having voting power present in person or
represented by proxy at the La Jolla special meeting is
required for approval of La Jolla Proposal Nos. 1, 4
and 5.
Whether or not you plan to attend the La Jolla special
meeting, please complete, sign and date the enclosed proxy and
return it promptly in the enclosed postage-paid return envelope
or vote via the telephone or the Internet as instructed in the
materials you will receive. You may revoke the proxy at any time
before its exercise in the manner described in the accompanying
joint proxy statement/prospectus. Any stockholder present at the
La Jolla special meeting, including any adjournment or
postponement thereof, may revoke such stockholders proxy
and vote personally on the matters to be considered at the
La Jolla special meeting. Executed proxies with no
instructions indicated thereon will be voted FOR
each of the proposals outlined above.
Please do not send in any La Jolla stock certificates at this
time. If La Jolla Proposal Nos. 2 and 3 are approved, you
will receive written instructions from La Jollas transfer
agent regarding exchanging your stock certificates.
THE LA JOLLA BOARD OF DIRECTORS HAS DETERMINED THAT EACH OF
THE PROPOSALS OUTLINED ABOVE IS ADVISABLE TO AND IN THE
BEST INTERESTS OF LA JOLLA AND ITS STOCKHOLDERS AND HAS APPROVED
EACH SUCH PROPOSAL. THE LA JOLLA BOARD OF DIRECTORS UNANIMOUSLY
RECOMMENDS THAT LA JOLLA STOCKHOLDERS VOTE FOR EACH
SUCH PROPOSAL.
BY ORDER OF THE BOARD OF DIRECTORS
Corporate Secretary
San Diego, California
[ ],
2010
Adamis
Pharmaceuticals Corporation
2658 Del Mar Heights Rd., #555
Del Mar, California 92014
NOTICE OF
SPECIAL MEETING OF STOCKHOLDERS
TO BE HELD ON
[ ],
2010
TO THE
ADAMIS STOCKHOLDERS:
NOTICE IS HEREBY GIVEN that Adamis Pharmaceuticals Corporation
will hold a special meeting of its stockholders on
[ ],
2010, at 10:00 a.m., Pacific Time, at
[ ],
for the following purposes:
1. To consider and vote upon a proposal to approve and
adopt the Agreement and Plan of Reorganization, dated as of
December 4, 2009, by and among La Jolla Pharmaceutical
Company, Jewel Merger Sub, Inc., or Merger Sub, and Adamis, a
copy of which is attached as Annex A to the
accompanying joint proxy statement/prospectus, pursuant to which
Merger Sub will merge with and into Adamis, with Adamis
surviving the merger as a wholly-owned subsidiary of
La Jolla.
2. To consider and act upon a proposal to approve, if
necessary, an adjournment of the Adamis special meeting to
solicit additional proxies in favor of the foregoing proposal.
3. To consider and act upon such other business and matters
or proposals as may properly come before the special meeting or
any adjournments or postponements thereof.
The board of directors of Adamis has fixed the close of business
on
[ ],
2010 as the record date (the Adamis Record
Date) for determining which stockholders have the
right to receive notice of and to vote at the Adamis special
meeting or any adjournments or postponements thereof. Only
holders of record of shares of Adamis common stock at the close
of business on the Adamis Record Date have the right to receive
notice of and to vote at the Adamis special meeting. At the
close of business on the Adamis Record Date, Adamis had
[ ] shares
of common stock outstanding and entitled to vote.
Your vote is important. The affirmative vote of the holders of a
majority of the outstanding shares of Adamis common stock on the
Adamis Record Date for the Adamis special meeting is required
for approval of Adamis Proposal No. 1. The affirmative
vote of the holders of a majority of the outstanding shares of
Adamis common stock having voting power present in person or
represented by proxy at the Adamis special meeting is required
for approval of Adamis Proposal Nos. 2 and 3.
Under the General Corporation Law of the State of Delaware,
which is referred to in the accompanying joint proxy
statement/prospectus
as the DGCL, holders of Adamis common stock who do not vote in
favor of the adoption of the merger agreement will have the
right to seek appraisal of the fair value of their shares as
determined by the Delaware Court of Chancery if the merger is
completed, but only if they submit a written demand for an
appraisal before they vote on the adoption of the merger
agreement and they comply with the other procedures under the
DGCL explained in the accompanying joint proxy
statement/prospectus. Please see the section entitled The
Merger Appraisal Rights in the accompanying
joint proxy statement/prospectus.
Whether or not you plan to attend the Adamis special meeting,
please complete, sign and date the enclosed proxy and return it
promptly in the enclosed postage-paid return envelope. You may
revoke the proxy at any time before its exercise in the manner
described in the accompanying joint proxy statement/prospectus.
Any stockholder present at the Adamis special meeting, including
any adjournment or postponement thereof, may revoke such
stockholders proxy and vote personally on the matters to
be considered at the Adamis special meeting. Executed proxies
with no instructions indicated thereon will be voted
FOR the proposals outlined above.
THE ADAMIS BOARD OF DIRECTORS HAS DETERMINED THAT EACH OF THE
PROPOSALS OUTLINED ABOVE IS ADVISABLE TO AND IN THE BEST
INTERESTS OF ADAMIS AND ITS STOCKHOLDERS AND HAS APPROVED EACH
SUCH PROPOSAL. THE ADAMIS BOARD OF DIRECTORS UNANIMOUSLY
RECOMMENDS THAT ADAMIS STOCKHOLDERS VOTE FOR EACH
SUCH PROPOSAL.
BY ORDER OF THE BOARD OF DIRECTORS
Dennis J. Carlo,
President and Chief Executive Officer
Del Mar, California
,
2010
REFERENCES
TO ADDITIONAL INFORMATION
You may obtain documents related to La Jolla and Adamis,
without charge, by requesting them in writing or by telephone
from the appropriate company.
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Requests for documents relating to La Jolla should be
directed to:
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Requests for documents relating to Adamis should be directed to:
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Gail A. Sloan
Vice President of Finance
La Jolla Pharmaceutical Company
4365 Executive Drive, Suite 300
San Diego, CA 92121
(858) 452-6600
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Dennis J. Carlo, Ph.D.
President and Chief Executive Officer
Adamis Pharmaceuticals Corporation
2658 Del Mar Heights Road, #555
Del Mar, CA 92014
Phone: (858) 401-3984
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To receive timely delivery of requested documents in advance
of the stockholder meetings, Adamis stockholders should make
their requests no later than
[ ],
2010 and La Jolla stockholders should make their requests
no later than
[ ]
2010.
TABLE OF
CONTENTS
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Page
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Agreement and Plan of Reorganization dated as of
December 4, 2009, as amended
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A-1
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Section 262 of Delaware General Corporation Law
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B-1
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Proposed Certificate of Amendment of La Jollas
Restated Certificate of Incorporation Regarding Reverse Stock
Split
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C-1
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Proposed Certificate of Amendment of La Jollas
Restated Certificate of Incorporation Regarding Change of
Corporate Name
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D-1
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EX-5.1 |
EX-8.1 |
EX-23.1 |
EX-23.2 |
QUESTIONS
AND ANSWERS ABOUT THE MERGER
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Q: |
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What is the transaction? |
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A: |
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The transaction is the merger of La Jollas
wholly-owned subsidiary, or Merger Sub, with and into Adamis,
with Adamis surviving the merger as a wholly-owned subsidiary of
La Jolla. As a result, Adamis stockholders will be entitled
to have their shares of Adamis common stock converted into
shares of La Jolla common stock and will obtain a
controlling stake in La Jolla after the closing of the merger. |
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Q: |
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Why are the two companies proposing to merge? |
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A: |
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The combined company resulting from the merger will be a
specialty pharmaceutical company that has recently launched its
first significant product, has several product candidates in
late stage development and will be led by an experienced senior
management team from Adamis. The merger provides La Jolla
with a product pipeline and provides Adamis with the anticipated
net cash from La Jolla to strengthen Adamis balance
sheet and support Adamis commercialization and drug
development activities. |
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Q: |
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On what market are the combined companys shares
expected to trade? |
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A: |
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Although La Jolla common stock is currently traded on the
Nasdaq Capital Market, it is expected that the combined
companys shares will be quoted on the Over-the-Counter
Bulletin Board. |
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Q: |
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What is the reverse stock split and why is it necessary? |
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A: |
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The reverse stock split is the combination of the outstanding
shares of La Jolla common stock into a lesser number of
shares immediately prior to the effective time of the merger.
For example, the reverse stock split is expected to range
between
one-for-three
and
one-for-thirty.
If the reverse stock split ratio is
one-for-three,
this means that every three shares of La Jolla common stock
outstanding prior to the reverse split will be combined into one
share of La Jolla common stock outstanding post-split; if
the reverse stock split ratio is
one-for-thirty,
this means that every thirty shares of La Jolla common
stock outstanding prior to the reverse split will be combined
into one share of La Jolla common stock outstanding
post-split. The precise reverse stock split ratio will be
determined based on the amount of La Jollas net cash
as of the closing date of the merger, plus $750,000, divided by
a price based on Adamis weighted average stock price over
a defined period of time, subject to a variable discount, which
in no event will yield a stock price that is less than $0.20 or
greater than $1.50. The reverse stock split only affects the
La Jolla stockholders and is necessary to adjust the number
of shares owned by La Jolla stockholders so that they
represent an agreed-upon percentage of the combined company,
after giving effect to the fair value of the net assets that
La Jolla is contributing to the combined company. At the
effective time of the merger, existing La Jolla
stockholders are expected to own between 5% and 30% of the
combined company. |
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Q: |
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How many shares of common stock of the combined company would
I own assuming that I currently own 100 shares of
La Jolla common stock? |
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A: |
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As a result of the proposed reverse stock split, immediately
prior to the effective time of the merger, your 100 shares
of La Jolla common stock would be reduced to a range
expected to be between 3 and 33 shares of common stock of
the combined company (depending on the reverse split ratio,
which is expected to range between
one-for-three
and
one-for-thirty).
After your shares are subject to this reverse stock split,
La Jolla will then issue new post-reverse split shares of
La Jolla common stock to holders of Adamis common stock on
a fixed
one-for-one
basis in connection with the merger. |
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Q: |
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How many shares of common stock of the combined company would
I own assuming that I currently own 100 shares of Adamis
common stock? |
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A: |
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As a result of the merger, immediately after the effective time
of the merger, your 100 shares of Adamis common stock will
be converted into 100 shares of La Jolla common stock
(post-reverse stock split). The reverse stock split will have no
impact on Adamis stockholders. |
ii
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Q: |
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What will happen to any options or warrants to acquire Adamis
common stock in the merger? |
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A: |
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In connection with the merger, Adamis warrant holders and option
holders will have their Adamis warrants and options converted
into warrants and options to purchase La Jolla common stock. |
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Q: |
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Who will be the directors and executive officers of the
combined company immediately following the merger? |
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A: |
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Immediately following the merger, the board of directors of the
combined company is expected to be composed solely of the
members of the Adamis board of directors prior to the merger:
(i) Dennis J. Carlo, Ph.D., (ii) David J.
Marguglio and (iii) Richard L. Aloi. Immediately following
the merger, the executive management team of the combined
company is expected to be composed solely of the members of the
Adamis executive management team prior to the merger: |
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Name
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Position
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Dennis J. Carlo, Ph.D.
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President, Chief Executive Officer, and Director
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Richard L. Aloi
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President, Adamis Laboratories, and Director
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Robert O. Hopkins
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Vice President, Finance and Chief Financial Officer
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David J. Marguglio
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Vice President of Business Development and Investor Relations,
Director
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Q: |
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What happens to La Jolla if the merger is not ultimately
completed? |
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A: |
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La Jolla will have limited cash resources, and if the
merger with Adamis does not close, the La Jolla board of
directors may elect to, among other things, attempt to complete
another strategic transaction or wind down the business in a
voluntary dissolution under Delaware law. |
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Q: |
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When do La Jolla and Adamis expect to complete the
merger? |
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A: |
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La Jolla and Adamis are working to complete the merger
during the first quarter of calendar year 2010, or as soon
thereafter as reasonably possible. We must first obtain the
necessary approvals, including, but not limited to, the approval
of each companys stockholders, and satisfy the closing
conditions described in the merger agreement. We cannot assure
you as to if or whether all the conditions to the merger will be
met nor can we predict the exact timing of the closing of the
merger or whether the merger will be completed at all. |
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Q: |
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What do I need to do now? |
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A: |
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La Jolla and Adamis urge you to read this joint
proxy/registration statement carefully, including its annexes,
and to consider how the merger affects you. After you have
carefully read and considered this joint proxy
statement/prospectus, please indicate on your proxy card how you
want your shares to be voted, then sign, date and mail the proxy
card in the enclosed prepaid return envelope as soon as possible
so that your shares may be represented and voted at the
La Jolla special meeting or the Adamis special meeting.
La Jolla stockholders may also attend the La Jolla
special meeting and Adamis stockholders may also attend the
Adamis special meeting and, in either case, vote in person.
La Jolla stockholders may also vote via the telephone or
the Internet as instructed in the materials you will receive. |
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Q: |
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If my shares are held in street name by my
broker, will my broker vote my shares for me? |
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A: |
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If your shares are held in street name, you should instruct your
broker as to how to vote your shares, following the instructions
contained in the voting instructions card that your broker
provides to you. Without instructions, your shares will not be
voted with respect to certain of the proposals, which will have
the same effect as if you voted against approval of the merger
and any related proposals. Brokers can vote for certain
proposals. While brokers can vote for certain proposals, unless
your broker has discretionary authority to vote on certain
matters, your broker will not be able to vote your shares of
common stock without instructions from you. To make sure that
your vote is counted, you should instruct your broker to vote
your shares, following the procedure provided by your broker. |
iii
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Q: |
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What happens if I do not return a proxy card or otherwise
provide proxy instructions? |
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A: |
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If you are a La Jolla stockholder, the failure to return
your proxy card or otherwise vote via the telephone or Internet
will have the same effect as voting against the proposals
outlined in your special meeting notice and your shares will not
be counted for purposes of determining whether a quorum is
present at the La Jolla special meeting. Executed proxies
without instructions will be voted for the proposals outlined in
your special meeting notice. If you are an Adamis stockholder,
the failure to return your proxy card will have the same effect
as voting against the proposals outlined in your special meeting
notice and your shares will not be counted for purposes of
determining whether a quorum is present at the Adamis special
meeting. Executed proxies without instructions will be voted for
the proposals outlined in your special meeting notice. |
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Q: |
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May I change my vote after I have mailed my signed proxy card
or otherwise voted? |
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A: |
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Yes. If you have not voted through your broker, there are three
ways for you to revoke your proxy and change your vote. First,
you may send a written notice to the corporate secretary of your
company stating that you would like to revoke your proxy.
Second, you may complete and submit a new proxy card, but it
must bear a later date than the original proxy, or if you are a
La Jolla stockholder, you may also submit new proxy instructions
via the telephone or the Internet. Third, you may vote in person
at your companys stockholder meeting. If you have
instructed a broker to vote your shares, you must follow the
directions you receive from your broker to change your vote.
Your last vote will be the vote that is counted. |
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Q: |
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Should I send in my stock certificates now? |
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A: |
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No. If you are an Adamis stockholder, if Adamis Proposal
No. 1 is approved and the merger is consummated, you will
receive written instructions from the exchange agent for
exchanging your certificates representing shares of Adamis
common stock for certificates representing shares of
La Jolla common stock. If La Jolla
Proposal Nos. 2 and 3 are approved and the reverse
stock split of La Jolla common stock and corporate name
change of La Jolla are effected, record owners of La Jolla
common stock will receive written instructions from
La Jollas transfer agent for exchanging their
certificates representing pre-reverse stock split shares of
La Jolla common stock. |
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Q: |
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What stockholder approvals are needed for the merger? |
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A: |
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The issuance of La Jolla common stock to Adamis
stockholders in connection with the merger must be approved by
an affirmative vote of the holders of a majority of the shares
of La Jolla common stock having voting power present in
person or represented by proxy at the La Jolla special
meeting. The merger is also subject to approval by the Adamis
stockholders by an affirmative vote of the holders of a majority
of the shares of Adamis common stock entitled to vote at the
Adamis special meeting. |
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Q: |
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Where can I find more information? |
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A: |
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You may obtain more information from various sources, as set
forth under the section entitled Where You Can Find More
Information in this joint proxy statement/prospectus. If
you are a La Jolla stockholder and have any questions about
the merger, or would like copies of any of the documents we
refer to in this information statement/prospectus, please call
La Jolla at
(858) 452-6600.
If you are an Adamis stockholder and have any questions about
the merger, or would like copies of any of the documents we
refer to in this information statement/prospectus, please call
Adamis at
(858) 401-3984. |
iv
SUMMARY
The following summary highlights selected information from
this joint proxy statement/prospectus and may not contain all of
the information that is important to you. To better understand
the merger and the other proposals being considered at the
La Jolla special meeting and the Adamis special meeting,
respectively, you should carefully read this entire joint proxy
statement/prospectus, including the merger agreement attached
hereto as Annex A, and incorporated herein by reference,
and the other documents to which you are referred in this joint
proxy statement/prospectus. For purposes of this joint proxy
statement/prospectus, the term merger agreement will
refer to the Agreement and Plan of Reorganization, dated as of
December 4, 2009, by and among La Jolla Pharmaceutical
Company, Jewel Merger Sub, Inc. and Adamis Pharmaceuticals
Corporation, as amended.
The
Companies
La Jolla Pharmaceutical Company
4365 Executive Drive, Suite 300
San Diego, CA 92121
(858) 452-6600
La Jolla was incorporated in 1989 as a biopharmaceutical
company and had historically focused substantially all of its
research, development and clinical efforts and financial
resources toward the development of its
Riquent®
(abetimus sodium) product candidate as a treatment for patients
with lupus. In February 2009, La Jolla announced that an
independent monitoring board for the Riquent Phase 3 study had
completed its review of the first interim efficacy analysis and
determined that continuing the study was futile. La Jolla
subsequently took steps to significantly reduce its operating
costs and ceased all Riquent development, manufacturing and
regulatory activities, and had commenced steps to wind down its
operations before signing the merger agreement with Adamis.
La Jollas common stock is currently listed on the
Nasdaq Capital Market under the symbol LJPC.
Adamis Pharmaceuticals Corporation
2658 Del Mar Heights Road, #555
Del Mar, California 92014
(858) 401-3984
Adamis was founded in June 2006. Adamis is a specialty
pharmaceuticals company that is engaged in the research,
development and commercialization of products for the treatment
of allergic conditions and the prevention and treatment of viral
infections. Adamis has three wholly-owned subsidiaries: Cellegy
Holdings, Inc., Adamis Corporation and Biosyn, Inc. Adamis
Corporation has two wholly-owned subsidiaries: Adamis
Laboratories, Inc. (specialty pharmaceuticals), or Adamis Labs;
and Adamis Viral Therapies, Inc. (biotechnology), or Adamis
Viral.
Adamis Labs is a specialty pharmaceutical company that Adamis
acquired in April 2007. Adamis Labs has a line of prescription
products in the allergy and respiratory field that are sold
through its own sales force. These products generated net
revenues to Adamis of approximately $659,500 for Adamis
fiscal year ended March 31, 2009. Adamis pre-filled
Epinephrine Injection USP 1:1000 (0.3mg Pre-Filled Single Dose
Syringe), or the PFS Syringe product, for use in the emergency
treatment of extreme acute allergic reactions, or anaphylactic
shock, was launched in July 2009. An additional product
candidate in its product pipeline is a generic inhaled nasal
steroid for the treatment of seasonal and perennial allergic
rhinitis. Adamis goal is to commence commercial sales of
the nasal steroid product in the first quarter of 2012, assuming
adequate funding and no unexpected delays. Based on Adamis
knowledge of a previously marketed pre-filled syringe indicated
for anaphylaxis, the anticipated lower price of the PFS Syringe
product relative to the leading syringe products currently
marketed and the ease of use of its product, Adamis believes
that its PFS Syringe product has the potential to compete
successfully, although there can be no assurance that this will
be the case.
Adamis Viral is focused on developing patented preventative and
therapeutic vaccines for a variety of viral diseases such as
influenza and hepatitis. The first target indication will be
avian influenza. Adamis believes that avian flu is a good
initial clinical application because there is a large potential
demand for a vaccine or other
1
therapeutic product. However, there are no assurances concerning
whether such a product will be developed or launched. Adamis
hopes to initiate an initial clinical trial in the third quarter
of 2010, and if the results are successful to initiate clinical
trials in the United States in 2011, assuming no unexpected
delays and adequate funding. Future potential disease targets
might include therapeutic vaccines for Hepatitis C and Human
Papillomavirus.
Adamis general business strategy is to attempt to increase
sales of existing and proposed products and services from its
Adamis Labs operations in order to generate cash flow to help
support the vaccine product development efforts of Adamis Viral.
Jewel Merger Sub, Inc.
4365 Executive Drive, Suite 300
San Diego, CA 92121
(858) 452-6600
Merger Sub is a Delaware corporation and a direct wholly-owned
subsidiary of La Jolla. Merger Sub does not conduct any
business. In the merger, Merger Sub will merge with and into
Adamis, with Adamis surviving the merger as a wholly-owned
subsidiary of La Jolla.
The
Merger
A copy of the merger agreement is attached hereto as
Annex A. La Jolla and Adamis encourage you to read the
entire merger agreement carefully because it is the principal
document governing the merger.
Consideration
to be Received in the Merger by Adamis Stockholders (see
page 53)
If the merger is completed, Merger Sub will merge with and into
Adamis, and Adamis will survive the merger as a wholly-owned
subsidiary of La Jolla. Each Adamis stockholder will be
entitled to receive one post-reverse split share of
La Jolla common stock in exchange for each share of Adamis
common stock held by such stockholder immediately before the
closing of the merger. Immediately before the effective time of
the merger, La Jolla will effect a reverse stock split of
its outstanding shares of common stock pursuant to a ratio set
forth in the merger agreement (the Reverse Stock
Split Ratio). The Reverse Stock Split Ratio takes
into account the amount of La Jollas cash and cash
equivalents and current amounts receivable as of the date of
closing of the merger (the Closing
Date), plus $750,000, and less all cash
liabilities and obligations, including severance, as of the
Closing Date and divides such amount by a price based on
Adamis weighted average stock price over a defined period
of time, subject to a variable discount (which in no event will
yield a stock price that is less than $0.20 or greater than
$1.50.) The parties expect that La Jollas adjusted
net cash, taking into account amounts receivable and
liabilities, will be between approximately $2.5 million and
$3.0 million if the merger closes during the first quarter
of 2010. The actual amount of adjusted net cash could be higher
or lower than this range. Assuming net cash within this range,
and using the high and low Adamis stock prices that are provided
for in the merger agreement, La Jolla is expected to effect
a reverse stock split in the range of 1:3 to 1:30; using the
current Adamis share price of $0.25 per share and assuming
$2.7 million net cash at the closing of the merger, the
reverse stock split ratio would be approximately 1:3.81.
Assuming a split in the range of 1:3 to 1:30, the current
La Jolla stockholders are expected to own between
approximately 5% and 30% of the outstanding shares of the
combined company immediately after the merger, without taking
into account any outstanding La Jolla or Adamis options,
warrants, convertible securities or other rights to acquire
shares of common stock, or any increase in the number of
outstanding Adamis shares between the date of this joint proxy
statement/prospectus and the closing of the merger. The actual
ownership percentage by La Jolla stockholders may be higher
or lower than these estimates.
For a more complete description of the merger consideration to
be issued by La Jolla, please see the section entitled
The Merger Agreement beginning on page 53.
Treatment
of Adamis Options, Warrants and Convertible Securities (see
page 55)
As of December 22, 2009 there were outstanding options to
purchase 463,439 shares, and outstanding warrants or other
rights to purchase 1,952,139 shares, of Adamis common
stock. In connection with the merger, each outstanding stock
option, warrant, convertible security and other right to
purchase or acquire the capital stock of
2
Adamis will be assumed by La Jolla and will become an
option, warrant, convertible security or other right to purchase
or acquire shares of common stock of La Jolla.
Reasons
for the Merger (see page 41)
The combined company resulting from the merger will be a
specialty pharmaceutical company with several existing products
and product candidates. La Jolla and Adamis believe that
the combined company will have the following potential
advantages:
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Existing Sales and Product Line. The combined
company will have an existing line of prescription products,
primarily the PFS Syringe product, that are promoted and sold to
physicians who specialize in allergy, respiratory disease and
pediatric medicine.
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Additional Product Candidates. The combined
company will have a number of additional product candidates in
the allergy and respiratory field, including the nasal steroid
product candidate.
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Intellectual Property Rights for Additional Product
Candidates. The combined company will have a
portfolio of intellectual property rights that may lead to
product candidates targeted at prevention and treatment of
certain viral diseases, which, if successfully developed, are
expected to address significant markets.
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Management Team. The combined company will be
led by the experienced senior management from Adamis.
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Stronger Balance Sheet. The anticipated net
cash from La Jolla will strengthen the balance sheet of
Adamis and support the commercialization and drug development
activities of Adamis.
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For a more complete description of the principal factors on
which the La Jolla Board based its decision to approve the
issuance of La Jolla common stock to Adamis stockholders in
connection with the merger and the other La Jolla proposals
discussed in this joint proxy statement/prospectus, please see
the section entitled The Merger
La Jollas Reasons for the Merger. For a more
complete description of the principal factors on which the
Adamis board of directors based its decision to approve the
merger and the other Adamis proposals discussed herein, please
see the section entitled The Merger
Adamis Reasons for the Merger.
Overview
of the Merger Agreement
Conditions
to Completion of the Merger (see page 60)
La Jolla and Adamis are required to complete the merger
only if certain conditions are satisfied or waived, including:
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approval of La Jolla Proposal Nos. 1, 2 and 3 by the
La Jolla stockholders and Adamis Proposal No. 1
by the Adamis stockholders;
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accuracy of the respective representations and warranties of
La Jolla and Adamis, subject to exceptions that would not
have a material adverse effect on the business of La Jolla
or Adamis, as applicable; and
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compliance in all material respects by La Jolla and Adamis
with their respective covenants and obligations in the merger
agreement, except where noncompliance would not have a material
adverse effect.
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Other than the conditions regarding effectiveness of the
registration statement of which this joint proxy
statement/prospectus is a part, the condition regarding having
obtained required stockholder approvals for the proposals
described herein, and the conditions regarding having obtained
any required governmental authorization and no restraining order
or injunction having been issued or government proceeding
pending preventing the consummation of the merger, satisfaction
of each of the conditions to the merger is permitted by law to
be waived in the discretion of the board of directors of
La Jolla or Adamis, as applicable. Many of the other
closing conditions, such as the representations and warranties
of the parties to the merger agreement being true and correct as
of the closing of the merger and the parties having performed
all obligations under the merger agreement that they are
required to perform, are qualified by the requirement that the
failure of the condition must have a material adverse
3
effect. The failure of certain other closing conditions to be
true, such as the requirement that La Jolla have taken
required actions to cause the board of directors and officers of
the combined company to be as described in this joint proxy
statement/prospectus or the requirement that La Jolla have
timely filed with the SEC all reports or other documents
required to be filed under the Securities Act or the Securities
Exchange Act of 1934, might or might not have a material adverse
effect.
Termination
of the Merger Agreement (see page 63)
The merger agreement may be terminated at any time before the
completion of the merger by the mutual consent of La Jolla
and Adamis. Under certain circumstances specified in the merger
agreement, either La Jolla or Adamis may terminate the
merger agreement, including if:
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the merger is not completed on or before March 31, 2010,
unless the failure is due to the party seeking to terminate the
merger;
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the Adamis stockholders fail to approve the merger and the
merger agreement;
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the La Jolla stockholders fail to approve the issuance of
shares of La Jolla common stock to Adamis stockholders in the
merger and related proposals;
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either party breaches its representations, warranties, covenants
or agreements contained in the merger agreement and the breach
could reasonably be expected to have a material adverse effect;
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the La Jolla board of directors has withdrawn or changed
its recommendation of the merger or recommended or entered into
an agreement with respect to an alternative acquisition proposal
with another party; or
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the Adamis board of directors has withdrawn or changed its
recommendation of the merger or recommended or entered into an
agreement with respect to an alternative acquisition proposal
with another party.
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In addition, Adamis may terminate the merger agreement if
La Jollas net cash at closing is less than
$2.3 million, in which case Adamis would owe La Jolla
a termination fee of $150,000. La Jolla may terminate the
merger agreement if the discounted weighted average Adamis stock
price, determined as provided in the merger agreement, is less
then $0.20 at closing and one of the following events has
occurred: (i) material manufacturing or supply problems
with Adamis epinephrine PFS product (including API and
syringe), or any regulatory actions taken by the Food and Drug
Administration, or FDA, that result in or would reasonably be
expected to result in a commercial interruption in sales of such
product; (ii) any litigation filed against Adamis, its
directors or officers asserting claims that could reasonably be
expected to result in the occurrence of a material adverse
effect; or (iii) the loss of services of Dennis J. Carlo as
an officer, director or full-time employee of Adamis for any
reason. If La Jolla terminates the merger agreement
pursuant to the preceding sentence, La Jolla would owe
Adamis a termination fee of $150,000.
Voting
Agreements (see page 64)
Dennis J. Carlo, David J. Marguglio, Richard L. Aloi and Robert
O. Hopkins, each of whom is an officer of Adamis and all of whom
will sometimes be referred to collectively herein as the
Principal Adamis Stockholders, have entered into voting
agreements with La Jolla pursuant to which, among other
things, each such stockholder agreed, solely in his capacity as
an Adamis stockholder, to vote all of the shares of Adamis
common stock held by him in favor of the approval of the merger
and against any matter that would result in a breach of the
merger agreement by Adamis and any proposal made in opposition
to, or in competition with, the consummation of the merger and
the other transactions contemplated by the merger agreement. As
of December 4, 2009, such Principal Adamis Stockholders
beneficially owned an aggregate of 16,271,693 shares of
Adamis common stock, representing approximately 35% of the
outstanding shares of Adamis common stock.
Management
of the Combined Company Following the Merger (see
page 55)
Effective as of the closing of the merger, the combined
companys officers are expected to include Dennis J.
Carlo, Ph.D., as president and chief executive officer,
Robert O. Hopkins as chief financial officer, Richard L. Aloi,
who is president of Adamis Labs, and David J. Marguglio as vice
president of business development and investor
4
relations, each of whom currently holds the same position at
Adamis. The board of directors of the combined company will
consist of the three persons who are directors of Adamis
immediately before the closing of the merger: Dr. Carlo and
Messrs. Aloi and Marguglio.
Interests
of Certain Persons in the Merger (see pages 45-47)
In considering the recommendation of the La Jolla board of
directors (the La Jolla Board)
with respect to approving the issuance of shares of
La Jolla common stock to Adamis stockholders in connection
with the merger and the other matters to be acted upon by
La Jolla stockholders at the La Jolla special meeting,
La Jolla stockholders should be aware that Deirdre Y.
Gillespie, M.D. and Gail A. Sloan, the President and Chief
Executive Officer and Vice President of Finance and Secretary
respectively, of La Jolla, have interests in the merger
that may be different from, or in addition to, interests they
have as La Jolla stockholders.
Pursuant to the Retention and Separation Agreement and General
Release of All Claims, dated as of December 4, 2009, by and
between La Jolla and Dr. Gillespie (the
Gillespie Retention Agreement), which
supersedes the severance provisions of Dr. Gillespies
existing employment agreement, as amended, Dr. Gillespie
received a retention bonus in the amount of $202,800 and is
entitled to receive a severance payment in the amount of
$405,600. Dr. Gillespie is entitled to both payments so
long as she does not resign her employment with La Jolla
prior to the earlier of (a) the closing of the merger with
Adamis and (b) March 31, 2010. If, however,
Dr. Gillespie voluntarily resigns her employment with
La Jolla prior to the earlier to occur of (a) the
closing of the merger and (b) March 31, 2010, she must
immediately repay her retention bonus to La Jolla and will
not receive a severance payment of $405,600 payable under the
Gillespie Retention Agreement.
Pursuant to the Retention and Separation Agreement and Release
of All Claims, dated as of December 4, 2009, by and between
La Jolla and Ms. Sloan (the Sloan
Retention Agreement), which supersedes the
severance provisions of Ms. Sloans existing
employment agreement, as amended, Ms. Sloan received a
retention bonus in the amount of $66,183.53 and is entitled to
receive a severance payment in the amount of $132,367.06.
Ms. Sloan is entitled to both payments so long as she does
not resign her employment with La Jolla prior to the
earlier of (a) the closing of the merger with Adamis and
(b) March 31, 2010. If, however, Ms. Sloan
voluntarily resigns her employment with La Jolla prior to
the earlier to occur of (a) the closing of the merger and
(b) March 31, 2010, she must immediately repay her
retention bonus to La Jolla and will not receive a
severance payment of $132,367.06 payable under the Sloan
Retention Agreement.
Moreover, on December 3, 2009, the La Jolla
Compensation Committee approved grants of restricted stock units
to each of Dr. Gillespie and Ms. Sloan with a
grant-date fair value of no more than $223,080 and $76,442 for
Dr. Gillespie and Ms. Sloan, respectively. The
restricted stock units of each of Dr. Gillespie and
Ms. Sloan will only vest upon the closing of the merger.
La Jollas directors, executive officers and their
affiliates hold less than 1% of the shares of La Jolla
common stock that are outstanding on the date of this joint
proxy statement/prospectus.
In considering the recommendation of the Adamis board of
directors (the Adamis Board) with
respect to approving the merger, Adamis stockholders should be
aware that certain members of the board of directors and
executive officers of Adamis have interests in the merger that
may be different from, or in addition to, interests they have as
Adamis stockholders. Following the consummation of the merger,
the persons who currently constitute the Adamis board of
directors will continue to serve on the board of directors of
the combined company and the existing executive officers of
Adamis will continue to serve in their respective positions with
the combined company. Adamis directors, executive officers
and their affiliates hold approximately 35% of the shares of
Adamis common stock that are outstanding on the date of this
joint proxy statement/prospectus.
Regulatory
Approvals (see page 47)
As of the date of this joint proxy statement/prospectus, neither
La Jolla nor Adamis is required to make filings or to
obtain approvals or clearances from any antitrust regulatory
authorities in the United States or other countries to
consummate the merger. La Jolla must comply with applicable
federal and state securities laws in connection with the
issuance of shares of La Jolla common stock to Adamis
stockholders and the filing of this joint proxy
5
statement/prospectus with the Securities and Exchange
Commission, or the SEC. As of the date hereof, the registration
statement of which this joint proxy statement/prospectus is a
part has not become effective.
Accounting
Treatment (see page 50)
Adamis stockholders are expected to own, after the merger,
between approximately 70% and 95% of the outstanding shares of
the combined company. Further, Adamis directors will initially
constitute the entirety of the combined companys board of
directors, and all members of the executive management of the
combined company will be from Adamis. Therefore, Adamis will be
deemed to be the acquiring company for accounting purposes, and
the merger will be accounted for as a reverse merger and a
recapitalization.
The unaudited pro forma combined condensed consolidated
financial statements included herein have been prepared to give
effect to the proposed merger of Adamis and La Jolla as a
reverse acquisition of assets and a recapitalization in
accordance with accounting principles generally accepted in the
United States. For accounting purposes, Adamis is considered to
be acquiring La Jolla in the merger and it is assumed that
La Jolla does not meet the definition of a business in
accordance with The Accounting Standards Codification Topic
of Business Combinations because of La Jollas
current efforts to sell or otherwise dispose of its operating
assets and liabilities.
Material
U.S. Federal Income Tax Considerations with Respect to the
Merger (see page 47)
The merger is intended to qualify as a reorganization within the
meaning of Section 368(a) of the Internal Revenue Code of
1986, as amended, sometimes referred to herein as the Code or
the IRC. Consistent with such treatment, Adamis stockholders
generally would not recognize gain or loss for United States
federal income tax purposes upon the exchange of shares of
Adamis common stock for shares of La Jolla common stock,
except for Adamis stockholders who exercise their appraisal
rights with respect to the merger and other than with respect to
cash received in lieu of fractional shares. Tax matters are
very complicated, and the tax consequences of the merger to a
particular stockholder will depend in part on such
stockholders circumstances. Accordingly, you are urged to
consult your own tax advisor for a full understanding of the tax
consequences of the merger to you, including the applicability
and effect of United States federal, state, local and foreign
income and other tax laws. For more information on the federal
income tax effect of the merger, see the section entitled
Material Federal Income Tax Considerations with Respect to
the Merger.
Comparison
of Stockholder Rights (see page 122)
If La Jolla and Adamis successfully complete the merger,
holders of Adamis common stock will become La Jolla
stockholders, and their rights as stockholders will be governed
by La Jollas restated certificate of incorporation
and bylaws, as amended. There are differences between the
certificates of incorporation and bylaws of La Jolla and
Adamis. Because Adamis and La Jolla are both Delaware
corporations, the rights of Adamis stockholders will continue to
be governed by Delaware law after the completion of the merger.
See Comparison of Rights of Holders of La Jolla Stock
and Adamis Stock for more information.
Appraisal
Rights in Connection with the Merger (see
page 50)
Under Delaware law, Adamis stockholders are entitled to
appraisal rights in connection with the merger. Holders of
La Jolla common stock are not entitled to appraisal rights
in connection with the merger. For more information about
appraisal rights, see the provisions of Section 262 of the
General Corporation Law of the State of Delaware, or the DGCL,
attached hereto as Annex B, and the section herein
entitled The Merger Appraisal Rights.
6
Risks
Associated with the Merger (see page 11)
Both La Jolla and Adamis are subject to various risks
associated with their businesses and industries. In addition,
the merger poses a number of risks to each company and its
respective stockholders, including, but not limited to, the
following:
|
|
|
|
|
failure to complete the merger may result in La Jolla or
Adamis paying a termination fee or expenses to the other party
and could harm La Jollas and Adamis future
business and operations;
|
|
|
|
the combined company will need to raise additional capital after
the merger and may not be able to obtain required financing
after the closing of the merger;
|
|
|
|
the market price of Adamis or the combined companys
common stock may decline before the closing of the merger or as
a result of the merger and, because of the floor on the Adamis
price for determining the reverse stock split ratio, the
La Jolla stockholders may receive fewer post-reverse split
shares than they otherwise would receive in the event of a low
Adamis price;
|
|
|
|
La Jolla and Adamis stockholders may not realize a benefit
from the merger commensurate with the ownership dilution they
will experience in connection with the merger;
|
|
|
|
during the pendency of the merger, La Jolla and Adamis may
not be able to enter into a business combination with another
party at a favorable price because of restrictions in the merger
agreement, which could adversely affect their respective
businesses; and
|
|
|
|
certain provisions of the merger agreement may discourage third
parties from submitting alternative takeover proposals,
including proposals that may be superior to the arrangements
contemplated by the merger agreement.
|
These risks are discussed in greater detail under the section
entitled Risk Factors. La Jolla and Adamis
encourage you to read and consider all of these risks carefully.
7
LA
JOLLAS SELECTED HISTORICAL CONDENSED FINANCIAL
DATA
The following selected financial data for the five years ended
December 31, 2008 are derived from the audited consolidated
financial statements of La Jolla. The financial data for
the nine-month periods ended September 30, 2009 and 2008
are derived from unaudited financial statements. The unaudited
financial statements include all adjustments, consisting of
normal recurring accruals, that La Jolla considers
necessary for a fair presentation of the financial position and
the results of operations for these periods. Operating results
for the nine months ended September 30, 2009 are not
necessarily indicative of the results that may be expected for
the entire year ending December 31, 2009.
You should read the following financial information together
with the information under the sections entitled,
La Jollas Managements Discussion and
Analysis of Financial Condition and Results of Operations
and La Jollas Business and
La Jollas financial statements and the related notes
to these financial statements appearing elsewhere in this joint
proxy statement/prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
|
|
|
|
|
|
|
September 30
|
|
|
Years Ended December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands, except per share data)
|
|
|
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
8,125
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
9,567
|
|
|
|
38,170
|
|
|
|
51,025
|
|
|
|
46,635
|
|
|
|
32,834
|
|
|
|
22,598
|
|
|
|
33,169
|
|
General and administrative
|
|
|
5,602
|
|
|
|
6,766
|
|
|
|
9,702
|
|
|
|
9,058
|
|
|
|
9,287
|
|
|
|
5,405
|
|
|
|
7,568
|
|
Asset impairments
|
|
|
|
|
|
|
|
|
|
|
2,810
|
|
|
|
|
|
|
|
104
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
15,169
|
|
|
|
44,936
|
|
|
|
63,537
|
|
|
|
55,693
|
|
|
|
42,225
|
|
|
|
28,003
|
|
|
|
40,737
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(7,044
|
)
|
|
|
(44,936
|
)
|
|
|
(63,537
|
)
|
|
|
(55,693
|
)
|
|
|
(42,225
|
)
|
|
|
(28,003
|
)
|
|
|
(40,737
|
)
|
Other income (expense), net
|
|
|
51
|
|
|
|
(770
|
)
|
|
|
683
|
|
|
|
2,617
|
|
|
|
2,780
|
|
|
|
640
|
|
|
|
193
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(6,993
|
)
|
|
$
|
(45,706
|
)
|
|
$
|
(62,854
|
)
|
|
$
|
(53,076
|
)
|
|
$
|
(39,445
|
)
|
|
$
|
(27,363
|
)
|
|
$
|
(40,544
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.11
|
)
|
|
$
|
(0.96
|
)
|
|
$
|
(1.26
|
)
|
|
$
|
(1.40
|
)
|
|
$
|
(1.21
|
)
|
|
$
|
(1.77
|
)
|
|
$
|
(3.40
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share(1)
|
|
|
62,555
|
|
|
|
47,764
|
|
|
|
49,689
|
|
|
|
37,818
|
|
|
|
32,588
|
|
|
|
15,446
|
|
|
|
11,941
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
On December 21, 2005, La Jolla effected a one-for-five
reverse stock split, which has been applied retroactively to all
periods presented. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
As of December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands)
|
|
|
Selected Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
5,830
|
|
|
$
|
9,447
|
|
|
$
|
4,373
|
|
|
$
|
3,829
|
|
|
$
|
6,411
|
|
|
$
|
2,861
|
|
Working capital
|
|
|
5,551
|
|
|
|
2,996
|
|
|
|
29,881
|
|
|
|
37,673
|
|
|
|
70,124
|
|
|
|
17,539
|
|
Total assets
|
|
|
6,576
|
|
|
|
20,839
|
|
|
|
44,405
|
|
|
|
49,525
|
|
|
|
80,928
|
|
|
|
33,026
|
|
Noncurrent obligations, net of current portion
|
|
|
|
|
|
|
213
|
|
|
|
388
|
|
|
|
196
|
|
|
|
142
|
|
|
|
716
|
|
Accumulated deficit
|
|
|
(422,680
|
)
|
|
|
(415,687
|
)
|
|
|
(352,833
|
)
|
|
|
(299,757
|
)
|
|
|
(260,312
|
)
|
|
|
(232,949
|
)
|
Total stockholders equity
|
|
|
5,551
|
|
|
|
3,390
|
|
|
|
33,521
|
|
|
|
43,089
|
|
|
|
77,130
|
|
|
|
26,001
|
|
8
MARKET
PRICE DATA AND DIVIDEND INFORMATION
La Jollas common stock currently trades on the Nasdaq
Capital Market under the symbol LJPC. The following
table sets forth the range of high and low sales prices for the
common stock as reported on the Nasdaq Capital Market for the
periods indicated below.
|
|
|
|
|
|
|
|
|
|
|
High
|
|
|
Low
|
|
|
2007
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
8.57
|
|
|
$
|
2.80
|
|
Second Quarter
|
|
$
|
8.68
|
|
|
$
|
4.35
|
|
Third Quarter
|
|
$
|
5.59
|
|
|
$
|
3.15
|
|
Fourth Quarter
|
|
$
|
4.50
|
|
|
$
|
3.15
|
|
2008
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
4.25
|
|
|
$
|
1.45
|
|
Second Quarter
|
|
$
|
2.35
|
|
|
$
|
1.59
|
|
Third Quarter
|
|
$
|
2.50
|
|
|
$
|
1.01
|
|
Fourth Quarter
|
|
$
|
1.20
|
|
|
$
|
0.43
|
|
2009
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
3.20
|
|
|
$
|
0.04
|
|
Second Quarter
|
|
$
|
0.64
|
|
|
$
|
0.13
|
|
Third Quarter
|
|
$
|
0.36
|
|
|
$
|
0.14
|
|
Fourth Quarter
|
|
$
|
0.32
|
|
|
$
|
0.06
|
|
On December 4, 2009, the last full trading day immediately
preceding the public announcement of the signing of the merger
agreement and on January 14, 2010, the last sales price
reported on the Nasdaq Capital Market for La Jolla common
stock was $0.06 per share and $0.22 per share, respectively. As
of the La Jolla Record Date, there were approximately
[ ] shares
of La Jolla common stock outstanding and approximately
[ ]
holders of record of La Jolla common stock.
Adamis common stock currently trades on the OTC
Bulletin Board, sometimes referred to as the OTCBB, under
the symbol ADMP. The following table sets forth the
range of high and low sales prices for the common stock as
reported on the OTCBB for the periods indicated below. The
quotations below reflect inter-dealer prices, without retail
mark-up,
markdown or commission, and may not represent actual
transactions.
|
|
|
|
|
|
|
|
|
|
|
High
|
|
|
Low
|
|
|
2007
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
0.10
|
|
|
$
|
0.03
|
|
Second Quarter
|
|
$
|
0.11
|
|
|
$
|
0.09
|
|
Third Quarter
|
|
$
|
0.09
|
|
|
$
|
0.06
|
|
Fourth Quarter
|
|
$
|
0.08
|
|
|
$
|
0.04
|
|
2008
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
0.10
|
|
|
$
|
0.02
|
|
Second Quarter
|
|
$
|
0.10
|
|
|
$
|
0.04
|
|
Third Quarter
|
|
$
|
0.09
|
|
|
$
|
0.04
|
|
Fourth Quarter
|
|
$
|
0.06
|
|
|
$
|
0.02
|
|
2009
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
0.07
|
|
|
$
|
0.02
|
|
Second Quarter
|
|
$
|
1.15
|
|
|
$
|
0.04
|
|
Third Quarter
|
|
$
|
0.40
|
|
|
$
|
0.15
|
|
Fourth Quarter
|
|
$
|
0.32
|
|
|
$
|
0.19
|
|
9
On December 4, 2009, the last full trading day immediately
preceding the public announcement of the signing of the merger
agreement and on January 14, 2010, the last sales price
reported on the OTC Bulletin Board for Adamis common stock
was $0.25 per share and $0.47 per share, respectively. As of the
Adamis Record Date, there were approximately
[ ] shares
of Adamis common stock outstanding and approximately
[ ]
holders of record of Adamis common stock.
Neither La Jolla nor Adamis has ever declared or paid any
cash dividends on their common stock nor do they intend to do so
in the foreseeable future. Accordingly, the stockholders of the
combined company will not receive a return on their investment
unless the value of the combined companys shares
increases, which may or may not occur. Any future determination
to pay cash dividends will be at the discretion of the board of
directors of the combined company and will depend upon the
combined companys financial condition, operating results,
capital requirements, any applicable contractual restrictions
and such other factors as the board of directors of the combined
company deems relevant.
For detailed information regarding the beneficial ownership of
certain stockholders upon consummation of the merger, see
Beneficial Ownership Information on page 118.
10
RISK
FACTORS
La Jolla and Adamis stockholders should carefully
consider the following factors, in addition to the other
information contained in this joint proxy statement/prospectus,
before deciding how to vote their shares of capital stock. The
risk factors relating to Adamis will also apply to the combined
company going forward because the business of the combined
company will be Adamis business.
Risks
Related to the Merger
The
number of shares that La Jolla stockholders will hold upon
the closing of the merger will depend in part upon the amount of
La Jollas net cash at closing and the market price of
the Adamis common stock.
The number of shares of La Jolla common stock that La Jolla
stockholders hold immediately before closing of the merger
depends on the Reverse Stock Split Ratio to be determined in
accordance with the merger agreement. Under the terms of the
merger agreement, the shares of La Jolla common stock
issued and outstanding immediately before the closing of the
merger will be subject to a reverse stock split, with each share
thereafter representing a fractional share equal to the Reverse
Stock Split Ratio. Under the merger agreement, the Reverse
Stock Split Ratio is a function of the amount of
La Jolla net cash at closing, plus $750,000, and the Adamis
stock price. Adamis and La Jolla expect that
La Jollas adjusted net cash, taking into account
amounts receivable and liabilities, will be between
approximately $2.5 million and $3.0 million as of the
time that the parties expect the merger to be completed. The
actual amount of adjusted net cash could be higher or lower than
this range. The amount of La Jollas net cash at the
closing date of the merger will depend primarily on when the
La Jolla and Adamis stockholder meetings are held and how
long it takes to satisfy the other closing conditions in the
merger agreement, the extent of La Jollas working
capital needs until the closing and the extent of unexpected
expenses or cash needs that may arise before the closing.
The Adamis stock price that is used for calculating the Reverse
Stock Split Ratio is determined with reference to the volume
weighted average closing price of the Adamis common stock (as
reported on the OTC Bulletin Board or other market or
quotation system on which the Adamis common stock is quoted or
traded) commencing on the first business day after the date of
the merger agreement (which was December 7, 2009), and
ending two trading days before the closing date of the merger
(the Adamis Average Share Price),
discounted by an amount set forth in the following table:
|
|
|
Adamis Weighted Average Share Price
|
|
% Discount
|
|
Less than $0.25
|
|
10% (not to go below $0.20 per share)
|
$0.25 to $2.00
|
|
25% (not to go below $0.20 per share)
|
Greater than $2.00
|
|
$1.50 (fixed price)
|
11
The following table sets forth the approximate percentage
ownership of the outstanding shares of common stock of the
combined company that Adamis stockholders and current
La Jolla stockholders would be expected to hold immediately
following the closing of the merger, based on an assumed
45,972,303 outstanding Adamis shares and 65,722,648 outstanding
La Jolla shares at the closing date of the merger, and
reflecting the assumed high and low amounts of La Jolla Net
Cash ($3.0 million (high) and $2.5 million (low),
respectively) and different Adamis Weighted Average Share Prices
and related Adamis Discounted Share Prices.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Adamis
|
|
|
|
|
|
|
|
|
Total La Jolla
|
|
|
|
Stockholders
|
|
|
|
|
|
|
|
|
Stockholders
|
|
|
|
Approximate
|
|
|
|
|
|
|
|
|
Approximate
|
|
|
|
Ownership in
|
|
|
|
|
|
|
|
|
Ownership in
|
|
|
|
the Combined
|
|
|
Adamis
|
|
|
|
La Jolla
|
|
the Combined
|
|
Adamis
|
|
Company after
|
|
|
Weighted
|
|
Adamis
|
|
Stockholders
|
|
Company after Closing
|
|
Stockholders
|
|
Closing
|
La Jolla Net
|
|
Average
|
|
Discounted
|
|
Reverse Stock
|
|
Share
|
|
|
|
Exchange
|
|
Share
|
|
|
Cash Plus $750,000
|
|
Share Price
|
|
Share Price
|
|
Split Ratio
|
|
Amount
|
|
%
|
|
Ratio
|
|
Amount
|
|
%
|
|
$3,750,000
|
|
$
|
2.00
|
|
|
$
|
1.50
|
|
|
|
1: 26.3
|
|
|
|
2,500,000
|
|
|
|
5
|
|
|
|
1 : 1
|
|
|
|
45,972,303
|
|
|
|
95
|
|
(high)
|
|
$
|
1.00
|
|
|
$
|
0.75
|
|
|
|
1: 13.1
|
|
|
|
5,000,000
|
|
|
|
10
|
|
|
|
1 : 1
|
|
|
|
45,972,303
|
|
|
|
90
|
|
|
|
$
|
0.50
|
|
|
$
|
0.38
|
|
|
|
1: 6.6
|
|
|
|
10,000,000
|
|
|
|
18
|
|
|
|
1 : 1
|
|
|
|
45,972,303
|
|
|
|
82
|
|
|
|
$
|
0.25
|
|
|
$
|
0.20
|
|
|
|
1: 3.5
|
|
|
|
18,750,000
|
|
|
|
29
|
|
|
|
1 : 1
|
|
|
|
45,972,303
|
|
|
|
71
|
|
$3,250,000
|
|
$
|
2.00
|
|
|
$
|
1.50
|
|
|
|
1: 30.3
|
|
|
|
2,166,667
|
|
|
|
5
|
|
|
|
1 : 1
|
|
|
|
45,972,303
|
|
|
|
95
|
|
(low)
|
|
$
|
1.00
|
|
|
$
|
0.75
|
|
|
|
1: 15.2
|
|
|
|
4,333,333
|
|
|
|
9
|
|
|
|
1 : 1
|
|
|
|
45,972,303
|
|
|
|
91
|
|
|
|
$
|
0.50
|
|
|
$
|
0.38
|
|
|
|
1: 7.6
|
|
|
|
8,666,667
|
|
|
|
16
|
|
|
|
1 : 1
|
|
|
|
45,972,303
|
|
|
|
84
|
|
|
|
$
|
0.25
|
|
|
$
|
0.20
|
|
|
|
1: 4
|
|
|
|
16,250,000
|
|
|
|
26
|
|
|
|
1 : 1
|
|
|
|
45,972,303
|
|
|
|
74
|
|
The
Adamis Discounted Share Price has a floor of $0.20, which may
result in La Jolla stockholders receiving less value than
anticipated in the merger.
In calculating the Reverse Stock Split Ratio, the Adamis
Discounted Share Price may not go below $0.20, even if the
actual Adamis share price is below this level. As a result, if
the weighted average Adamis stock price drops below $0.20 per
share, the value of Adamis in the merger will be lower than the
value that is ascribed to Adamis in the merger agreement than if
there were no floor price.
The
Adamis exchange ratio is fixed in the merger agreement, which
means that additional issuances by Adamis prior to closing will
dilute the La Jolla stockholders at closing.
The merger agreement provides for a fixed 1:1 exchange ratio for
the Adamis common stock to La Jolla common stock, without regard
to the reverse split ratio for the La Jolla stockholders. As a
result, if Adamis issues any additional shares of Adamis common
stock prior to closing, there will be a larger number of
outstanding shares of Adamis common stock before the closing and
the La Jolla stockholders would own a correspondingly lower
percentage of the outstanding shares of the combined company.
The illustrations of the relative ownership of the combined
entity by La Jolla and Adamis after the merger assume that
there are no additional issuances of Adamis common stock by
Adamis prior to closing. However, if there are additional
issuances, the actual proportionate ownership in the combined
entity by the La Jolla stockholders could be significantly
lower than as set forth herein.
Some
of La Jollas and Adamis officers and directors
may have conflicts of interests in recommending that you vote in
favor of the proposals that may influence them to support or
approve the proposals without regard to your
interests.
Certain officers and directors of La Jolla and Adamis
participate in arrangements that provide them with interests in
the merger that are different from other stockholders of
La Jolla and Adamis, including the continued service as an
officer or director of the combined company. These interests may
influence the officers and directors of La Jolla and Adamis
to support or approve the merger.
The current directors of Adamis are expected to continue to
serve on the board of directors of the combined company
following the consummation of the merger. Following the merger,
they will be eligible to receive compensation pursuant to the
combined companys director compensation policies.
Similarly, following the
12
consummation of the merger, the executive officers of Adamis
will continue to serve in their respective positions with the
combined company. Adamis directors, executive officers and
their affiliates hold approximately 35% of the shares of Adamis
common stock that are outstanding on the date of this joint
proxy statement/prospectus.
Deirdre Y. Gillespie, M.D., the President and Chief
Executive Officer of La Jolla, will, pursuant to the
Gillespie Retention Agreement, retain the retention bonus in the
amount of $202,800 and receive a severance payment in the amount
of $405,600 so long as she does not resign her employment with
La Jolla prior to the earlier of (a) the closing of the merger
with Adamis and (b) March 31, 2010.
Gail A. Sloan, the Vice President of Finance and Secretary of
La Jolla, will, pursuant to the Sloan Retention Agreement,
retain the retention bonus in the amount of $66,183.53 and
receive a severance payment in the amount of $132,367.06 so long
as she does not resign her employment with La Jolla prior to the
earlier of (a) the closing of the merger with Adamis and (b)
March 31, 2010.
Moreover, on December 3, 2009, the La Jolla
Compensation Committee approved grants of restricted stock units
to each of Dr. Gillespie and Ms. Sloan with a
grant-date fair value of no more than $223,080 and $76,442 for
Dr. Gillespie and Ms. Sloan, respectively. The
restricted stock units of each of Dr. Gillespie and
Ms. Sloan will only vest upon the closing of the merger.
Failure
to complete the merger may result in La Jolla or Adamis
paying a termination fee to the other party and could harm
La Jollas and Adamis future business and
operations.
If the merger is not completed, La Jolla and Adamis may be
required to pay a termination fee of $150,000 in certain
circumstances. This amount represents a significant sum to each
company, based on their limited available capital resources and
the need to pay this termination fee may adversely affect the
paying companys stock price. Additionally, each company
will bear significant transaction-related expenses in connection
with pursuing the merger.
In addition, if the merger agreement is terminated and
La Jollas and Adamis boards of directors
determine to seek another business combination, there can be no
assurance that they will be able to find a partner willing to
provide equivalent or more attractive consideration than the
consideration to be provided by each party in the merger.
Moreover, La Jolla would have limited funds to continue
operations, and if La Jolla is unable to complete another
strategic transaction, it would likely have to liquidate in a
voluntary dissolution under Delaware law.
The
market price of the combined companys common stock may
decline as a result of the merger.
The market price of the combined companys common stock may
decline as a result of the merger for a number of reasons,
including the following:
|
|
|
|
|
the combined company does not achieve the perceived benefits of
the merger as rapidly or to the extent anticipated by
La Jolla, Adamis or financial or industry analysts;
|
|
|
|
the combined company is unable to obtain required financing;
|
|
|
|
the effect of the merger on the combined companys business
and prospects is not consistent with the expectations of
La Jolla, Adamis or financial or industry analysts;
|
|
|
|
revenues and net income from sales of Adamis products are
less than investors expectations; or
|
|
|
|
Adamis product research and development efforts do not
meet investors expectations.
|
La Jolla
and Adamis stockholders may not realize a benefit from the
merger commensurate with the ownership dilution they will
experience in connection with the merger.
If the combined company is unable to realize the strategic and
financial benefits currently anticipated from the merger,
La Jolla stockholders will have experienced an anticipated
approximately 70% to 95% dilution of their ownership interests
in La Jolla, and Adamis stockholders will have experienced
an estimated approximately 5% to 30% dilution of their ownership
interests in Adamis, without receiving a commensurate benefit.
13
During
the pendency of the merger, La Jolla and Adamis may not be
able to enter into certain transactions with another party
because of restrictions in the merger agreement, which could
adversely affect their respective businesses.
Covenants in the merger agreement impede the ability of
La Jolla and Adamis to complete certain transactions that
are not in the ordinary course of business, such as the sale or
licensing of capital assets or any transaction inconsistent with
the merger, pending completion of the merger. As a result, if
the merger is not completed, the parties may be at a
disadvantage to their competitors because the parties will have
been prevented from entering into arrangements with possible
financial and or other benefits to them. In addition, any such
transactions could be favorable to such partys
stockholders.
Certain
provisions of the merger agreement may discourage third parties
from submitting alternative takeover proposals, including
proposals that may be superior to the arrangements contemplated
by the merger agreement.
The terms of the merger agreement prohibit each of La Jolla
and Adamis from soliciting alternative takeover proposals or
cooperating with persons making unsolicited takeover proposals,
except in limited circumstances when the La Jolla Board or
the Adamis Board, as applicable, determines in good faith after
consultation with outside counsel that an unsolicited
alternative takeover proposal is or is reasonably likely to lead
to a superior takeover proposal and that failure to cooperate
with the proponent of the proposal would result in a breach of
such boards fiduciary duties. In addition, under certain
circumstances, La Jolla or Adamis would be required to pay
a termination fee of $150,000 to the other party, including upon
termination of the merger agreement by such partys board
of directors if such board decides to recommend an alternative
proposal. This termination fee may discourage third parties from
submitting alternative takeover proposals to both La Jolla
and Adamis and their respective stockholders, and may cause the
respective boards of directors to be less likely to recommend an
alternative proposal.
Because
of the lack of an active trading market for the stock of Adamis,
the stockholders of Adamis and La Jolla may receive
consideration in the merger that is greater than or less than
the fair market value of their shares.
Although the Adamis common stock is publicly traded, the lack of
an active public market for the Adamis common stock makes it
challenging to determine the fair market value of Adamis.
Because the exchange ratios of the merger and the reverse stock
split were determined based on negotiations between the parties,
it is possible that the value to Adamis stockholders of the
La Jolla common stock to be issued in connection with the
merger will be greater than the fair market value of Adamis, and
that the market value represented by the number of post-reverse
split shares that the La Jolla stockholders will hold after
the merger will be less in the aggregate than the current
aggregate market value of all outstanding La Jolla shares.
Alternatively, it is possible that the value of the shares of
La Jolla common stock to be issued to Adamis stockholders
in connection with the merger will be less than the fair market
value of Adamis.
If the
conditions to the merger are not met, the merger may not
occur.
Even if the merger is approved by the stockholders of Adamis and
the issuance of shares pursuant to the merger agreement and the
reverse stock split are approved by the stockholders of La
Jolla, specified conditions must be satisfied or waived in order
to complete the merger, including, among others:
|
|
|
|
|
the representations and warranties of the other party set forth
in the merger agreement being true and correct as of the date of
the agreement and the date the merger occurs, except for
breaches or inaccuracies which would not have a material adverse
effect;
|
|
|
|
there shall not have been any material adverse change in the
business, assets or financial condition of the other party that
would have a material adverse effect;
|
14
|
|
|
|
|
stockholders of La Jolla must have approved the issuance of
shares pursuant to the merger agreement and the amendment to
La Jollas restated certificate of incorporation to
effect the reverse split of La Jolla common stock and
change the companys name, as described elsewhere
herein; and
|
|
|
|
stockholders of Adamis must have adopted the merger agreement
and approved the merger.
|
These and other conditions are described in detail in the merger
agreement, a copy of which is attached hereto as
Annex A. La Jolla and Adamis cannot assure you
that all of the conditions to the merger will be satisfied. If
the conditions to the merger are not satisfied or waived, the
merger may not occur or may be delayed, and La Jolla and
Adamis each may lose some or all of the intended benefits of the
merger.
La Jolla
and Adamis may not achieve the benefits they expect from the
merger, which may have a material adverse effect on the combined
companys business, financial condition and operating
results.
La Jolla and Adamis entered into the merger agreement with
the expectation that the merger will result in benefits to the
combined company. Post-merger challenges include the following:
|
|
|
|
|
creating a liquid trading market for La Jolla common stock on
the Over-the-Counter Bulletin Board to promote liquidity for
stockholders of the combined company and potentially greater
access to capital;
|
|
|
|
retaining the management and employees of Adamis;
|
|
|
|
obtaining additional financing required to fund
operations; and
|
|
|
|
developing new product candidates that utilize the assets and
resources of the combined company.
|
If the combined company is not successful in addressing these
and other challenges, then the benefits of the merger may not be
realized and, as a result, the combined companys operating
results and the market price of the combined companys
common stock may be adversely affected.
If the
merger does not qualify as a tax-free reorganization for U.S.
federal income tax purposes, Adamis stockholders will recognize
gain or loss on the exchange of their shares of Adamis common
stock.
La Jolla and Adamis intend for the merger to qualify as a
tax-free reorganization under Section 368(a) of the Code.
If the merger were to fail to qualify as a tax-free
reorganization, Adamis stockholders would generally recognize
gain or loss on each share of Adamis common stock surrendered in
the merger in the amount of the difference between their basis
in such share and the fair market value of the shares of
La Jolla common stock they receive in exchange for each
share of Adamis common stock. Adamis stockholders should consult
with their own tax advisor regarding the proper reporting of the
amount and timing of such gain or loss.
The
La Jolla Board did not obtain a fairness opinion in
determining whether or not to proceed with the transaction with
Adamis and, as a result, the fairness of the terms from a
financial point of view to La Jollas stockholders has
not been reviewed by an independent third party.
In analyzing the proposed transaction with Adamis, the Company
and the La Jolla Board conducted significant due diligence
on Adamis, including, among other things, reviewing Adamis
financial statements, material agreements and SEC filings and
comparing Adamis to comparable companies. In addition, the
La Jolla Board retained the services of a financial advisor
to evaluate the proposed merger. The La Jolla Board
believes it was qualified to conclude that the business
combination was fair to its stockholders from a financial
perspective because of the financial skills and background of
its directors and management and the advice received from its
financial advisor. Accordingly, the La Jolla Board did not
retain an investment banker in connection with its consideration
of the proposed merger and did not seek or obtain a fairness
opinion that the consideration to be paid to Adamis stockholders
in the merger, or the consideration to be held by La Jolla
stockholders immediately after the merger, is fair from a
financial point of view to La Jollas stockholders.
The La Jolla Board concluded that the costs of obtaining a
fairness opinion from a third party would likely be
disproportionately higher than any corresponding benefits that
would be realized by obtaining such an opinion, particularly in
light of La Jollas cash position and
La Jollas need to preserve as much cash as possible
to close the merger with Adamis. The cost of obtaining a
fairness opinion would also reduce the amount of cash that would
be available to the combined company. Accordingly, the
La Jolla Board did not have the benefit of an independent
assessment of the fairness of the transaction.
15
The
Adamis Board did not obtain a fairness opinion in determining
whether or not to proceed with the transaction with
La Jolla and, as a result, the fairness of the terms from a
financial point of view to Adamis stockholders has not
been reviewed by an independent third party.
Adamis did not not seek or obtain a fairness opinion from an
investment bank or other firm that the consideration to be
received by Adamis stockholders in the merger is fair from
a financial point of view to Adamis stockholders. In
analyzing the proposed transaction with La Jolla, Adamis
management and the Adamis Board conducted due diligence on
La Jolla, including, among other things, reviewing
La Jollas financial statements, material agreements,
SEC filings and range of estimated amounts of La Jolla cash
and cash equivalents at the anticipated closing date of the
merger. The Adamis Board believes it was qualified to conclude
that the terms of the business combination transaction,
including without limitation the formulas included in the merger
agreement for determining the La Jolla Reverse Split Ratio
and the range of percentages of the outstanding shares of the
combined company that the Adamis stockholders could be expected
to hold immediately after the merger, was fair to Adamis
stockholders from a financial perspective because of the
knowledge and background of its directors and management. The
Adamis Board also concluded that the costs of obtaining a
fairness opinion from a third party would likely be
disproportionately higher than any corresponding benefits that
would be realized by obtaining such an opinion, particularly in
light of Adamis and La Jollas cash position and
the history of negotiations with La Jolla regarding the
transaction, would not materially assist Adamis in discussions
with La Jolla, and would increase the amount of transaction
costs, reducing the amount of cash that would be available to
the combined company after the merger. Notwithstanding the
foregoing, the Adamis Board may be incorrect in its assessment
of the terms of the transaction, and the absence of a fairness
opinion may increase the risk that the terms of the proposed
merger may not be fair from a financial point of view to
Adamis stockholders.
Because
Adamis business will constitute the business of the
combined company after the closing of the merger, if any of the
events described in Risks Related to
Adamis occur, those events could cause the potential
benefits of the merger not to be realized and the market price
of the combined companys common stock to
decline.
Because of La Jollas limited operations, the combined
companys business immediately following the merger will be
the business conducted by Adamis immediately prior to the
merger. As a result, the risks described below under
Risks Related to Adamis are significant
risks to the combined company if the merger is completed. To the
extent any of the events in the risks described below under
Risks Related to Adamis occur, those
events could cause the potential benefits of the merger not to
be realized and the market price of the combined companys
common stock to decline.
Risks
Related to La Jolla
In addition to the other information contained in this joint
proxy statement/prospectus, you should carefully consider the
material risks described below. As discussed above,
La Jolla has entered into the merger agreement with Merger
Sub and Adamis, pursuant to which Merger Sub will merge with and
into Adamis, with Adamis as the surviving corporation becoming a
wholly-owned subsidiary of La Jolla. Following the
completion of the merger, the current management and board of
directors of La Jolla will have resigned and therefore have
no control over the ultimate decisions regarding the combined
companys operations and business. Prior to executing the
merger agreement with Adamis, the La Jolla Board approved a
plan of liquidation and dissolution and called a stockholder
meeting to vote on that plan, which meeting was cancelled upon
the execution of the merger agreement. If La Jolla is
unable to complete the merger or another strategic transaction,
it does not expect to be able to continue as a going concern and
will likely be required to liquidate in a voluntary dissolution
under Delaware law. All of the combined companys business
immediately following the merger will be the business conducted
by Adamis immediately prior to the merger, and most, if not all,
of the risk factors related to La Jollas business in
this joint proxy statement/prospectus will change from those
described herein based on La Jollas business to date
and otherwise may no longer be applicable to the combined
company. La Jolla encourages you to review the sections
entitled Risks Related to Adamis and Risks
Related to the Combined Company for a description of the
substantial portion of the expected risks of the combined
company if the merger is approved and completed.
16
La Jolla
may not be able to complete the merger with Adamis and failure
to do so could adversely affect its business.
La Jolla cannot assure you that it will close the pending
merger with Adamis in a timely manner or at all.
La Jollas consideration and completion of the merger
is subject to a variety of risks that could materially and
adversely affect La Jollas business and financial
results, including risks that it will forego strategic
opportunities while the closing of the merger is pending and
risks inherent in negotiating and completing any transaction. In
particular, the Adamis has the right to terminate the merger
agreement if La Jolla Net Cash at closing is less than
$2.3 million. While La Jolla has and will continue to
expend substantial effort to limit its expenses and preserve its
remaining cash, unforeseen liabilities or expenses, in some
cases over which La Jolla has no control, may arise that
could result in La Jolla Net Cash at closing being less
than $2.3 million. In such event, Adamis would be able to
terminate the merger agreement and the merger would not close.
If La Jolla does not close the merger with Adamis, the
La Jolla Board may elect to attempt to complete another
strategic transaction similar to the merger or otherwise (but
such opportunity might not be available), or may determine that
La Jolla should re-solicit its stockholders vote to
liquidate and dissolve.
If the
merger does not close, La Jolla may again seek to liquidate
in a voluntary dissolution under Delaware law, but may be unable
to do so.
If La Jolla is unable to consummate the merger with Adamis,
La Jolla would likely need to liquidate in a voluntary
dissolution under Delaware law. The La Jolla Board
previously approved a plan of liquidation and dissolution on
September 3, 2009. In connection with that plan of
liquidation, La Jolla convened a special meeting of its
stockholders to approve such plan, which meeting was adjourned
three times because of insufficient support from
La Jollas stockholders and which the La Jolla
Board cancelled in connection with La Jollas
execution of the merger agreement. In the event La Jolla is
unable to complete the merger with Adamis, it is likely that the
La Jolla Board will call another special meeting of
La Jollas stockholders to approve the plan of
liquidation and dissolution. If the La Jolla stockholders
approve the plan of liquidation and dissolution, La Jolla
would liquidate in a voluntary dissolution under Delaware law
and distribute remaining assets, if any, to its stockholders.
However, if La Jolla is still unable to receive the
necessary stockholder approval, La Jolla may be limited in
its ability to distribute remaining assets and stockholders may
not receive the value of these assets.
La Jolla
is currently not in compliance with NASDAQ rules regarding the
minimum bid price of its common stock and is at risk of being
delisted from the NASDAQ Capital Market.
On September 15, 2009, La Jolla received a NASDAQ
staff deficiency letter indicating that, for the prior 30
consecutive days, the bid price for La Jollas common
stock had closed below the minimum bid price of $1.00 per share
as required for continued inclusion on the NASDAQ Capital Market
under Listing Rule 5550(a)(2). If La Jolla does not
regain compliance with the minimum bid price rule, NASDAQ will
provide written notification that La Jollas common
stock will be delisted, after which La Jolla may appeal the
staff determination to the NASDAQ Listing Qualifications Panel
if it so chooses. Based on more recent communications with
NASDAQ, we expect that the combined entity would not satisfy
listing standards as of the closing of the merger. Accordingly,
NASDAQ may issue La Jolla a letter before the closing of the
merger indicating NASDAQs intent to immediately commence
delisting proceedings against La Jolla. La Jolla
anticipates that, if it receives a delisting letter from NASDAQ,
it would appeal such delisting determination. However, La Jolla
cannot ensure that it would be successful on appeal and
therefore La Jolla may lose its NASDAQ listing before the
closing of the merger.
If La Jolla is delisted from the NASDAQ Capital Market,
La Jolla common stock may be traded
over-the-counter
on the OTC Bulletin Board or in the pink
sheets. These alternative markets are generally considered
to be less efficient than, and not as broad as, the NASDAQ
Capital Market. Many OTC Bulletin Board stocks trade less
frequently and in smaller volumes than securities traded on the
NASDAQ markets, which could have a material adverse effect on
the liquidity of La Jolla common stock. If
La Jollas common stock is delisted from the NASDAQ
Capital Market, there may be a limited market for La Jolla
common stock, trading in La Jolla stock may become more
difficult and La Jollas share price could decrease
even further.
17
Specifically, you may not be able to resell your shares of
La Jolla common stock at or above the price you paid for
such shares, or at all. In addition, class action litigation has
often been instituted against companies whose securities have
experienced periods of volatility in market price. Any such
litigation brought against La Jolla could result in
substantial costs and a diversion of managements attention
and resources, which could hurt La Jollas business,
operating results and financial condition.
In addition, La Jolla common stock would be expected to
become subject to penny stock rules. The SEC generally defines
penny stock as an equity security that has a market
price of less than $5.00 per share, subject to certain
exceptions. La Jolla is not currently subject to the penny
stock rules because its common stock is listed on the NASDAQ
Stock Market. However, if La Jolla common stock is
delisted, La Jolla common stock would become subject to the
penny stock rules, which impose additional sales practice
requirements on broker-dealers who sell La Jolla common
stock. If La Jolla common stock were considered penny
stock, the ability of broker-dealers to sell La Jolla
common stock and the ability of La Jolla stockholders to
sell their shares in the secondary market would be limited and,
as a result, the market liquidity for La Jolla common stock
would be adversely affected. La Jolla cannot assure
stockholders that trading in La Jolla securities will not
be subject to these or other regulations in the future.
Risks
Related to Adamis
Adamis
limited operating history may make it difficult to evaluate its
business to date and the combined companys future
viability.
Adamis is in the early stage of operations and development, and
has only a limited operating history on which to base an
evaluation of its business and prospects, having just commenced
operations in 2006. Moreover, Adamis acquired Adamis Labs during
calendar year 2007. Adamis is subject to the risks inherent in
the ownership and operation of a company with a limited
operating history, such as regulatory setbacks and delays,
fluctuations in expenses, competition, the general strength of
regional and national economies, and governmental regulation.
Any failure to successfully address these risks and
uncertainties could seriously harm Adamis business and
prospects. Adamis may not succeed given the technological,
marketing, strategic and competitive challenges it will face.
The likelihood of Adamis success must be considered in
light of the expenses, difficulties, complications, problems and
delays frequently encountered in connection with the growth of a
new business, the continuing development of new drug development
technology, and the competitive and regulatory environment in
which Adamis operates or may choose to operate in the future.
Some
of Adamis potential products and technologies are in early
stages of development.
The development of new pharmaceutical products is a highly risky
undertaking, and there can be no assurance that any future
research and development efforts Adamis might undertake will be
successful. Adamis potential products in the influenza and
other viral fields will require extensive additional research
and development before any commercial introduction, and
development work on the generic nasal steroid product must still
be completed. There can be no assurance that any future
research, development or clinical trial efforts will result in
viable products or meet efficacy standards. Future clinical or
preclinical results may be negative or insufficient to allow
Adamis to successfully market its product candidates. Obtaining
needed data and results may take longer than planned or may not
be obtained at all. Any such delays or setbacks could have an
adverse effect on the ability of Adamis to achieve its financial
goals.
Adamis
is subject to substantial government regulation, which could
materially adversely affect Adamis business.
The production and marketing of Adamis products and
potential products and its ongoing research and development,
pre-clinical testing and clinical trial activities are currently
subject to extensive regulation and review by numerous
governmental authorities in the United States and will face
similar regulation and review for overseas approval and sales
from governmental authorities outside of the United States. Some
of the product candidates that Adamis is currently developing
must undergo rigorous pre-clinical and clinical testing and an
extensive regulatory approval process before they can be
marketed. This process makes it longer, more difficult and more
costly to bring Adamis potential products to market, and
Adamis cannot guarantee that any of its potential products will
be
18
approved. The pre-marketing approval process can be particularly
expensive, uncertain and lengthy, and a number of products for
which FDA approval has been sought by other companies have never
been approved for marketing. In addition to testing and approval
procedures, extensive regulations also govern marketing,
manufacturing, distribution, labeling, and record-keeping
procedures. If Adamis or its collaboration partners do not
comply with applicable regulatory requirements, such violations
could result in non-approval, suspensions of regulatory
approvals, civil penalties and criminal fines, product seizures
and recalls, operating restrictions, injunctions, and criminal
prosecution.
Withdrawal or rejection of FDA or other government entity
approval of Adamis potential products may also adversely
affect Adamis business. Such rejection may be encountered
due to, among other reasons, lack of efficacy during clinical
trials, unforeseen safety issues, inability to follow patients
after treatment in clinical trials, inconsistencies between
early clinical trial results and results obtained in later
clinical trials, varying interpretations of data generated by
clinical trials, or changes in regulatory policy during the
period of product development in the United States and abroad.
In the United States, there is stringent FDA oversight in
product clearance and enforcement activities, causing medical
product development to experience longer approval cycles,
greater risk and uncertainty, and higher expenses.
Internationally, there is a risk that Adamis may not be
successful in meeting the quality standards or other
certification requirements. Even if regulatory approval of a
product is granted, this approval may entail limitations on uses
for which the product may be labeled and promoted, or may
prevent Adamis from broadening the uses of Adamis current
or potential products for different applications. In addition,
Adamis may not receive FDA approval to export Adamis
potential products in the future, and countries to which
potential products are to be exported may not approve them for
import.
Manufacturing facilities for Adamis products will also be
subject to continual governmental review and inspection. The FDA
has stated publicly that compliance with manufacturing
regulations will continue to be strictly scrutinized. To the
extent Adamis decides to manufacture its own products, a
governmental authority may challenge Adamis compliance
with applicable federal, state and foreign regulations. In
addition, any discovery of previously unknown problems with one
of Adamis potential products or facilities may result in
restrictions on the potential product or the facility. If Adamis
decides to outsource the commercial production of its products,
any challenge by a regulatory authority of the compliance of the
manufacturer could hinder Adamis ability to bring its
products to market.
Some
of Adamis Labs products that have been drug listed with
the FDA are marketed without an approved new drug application or
abbreviated new drug application. The FDA could at some future
date seek to prevent marketing of these products, require that
such products be marketed only after submission and approval of
drug applications, or take other regulatory action against
Adamis with respect to these products, which could have an
adverse effect on Adamis.
Several of Adamis Labs products, including AeroHist
Caplets, AeroHist Plus Caplets, AeroKid Oral Liquid and AeroOtic
HC Ear Drops, and the Epi Syringe, were not the subject of a new
drug application or abbreviated new drug application, or ANDA,
and have not been specifically approved by the FDA for marketing
by Adamis. These products have been marketed for many years and,
Adamis believes, are similarly situated to products marketed by
many companies that are marketed without an approved new drug
application or abbreviated new drug application. The products
are drug listed with the FDA in the National Drug Code Directory
but such listing does not constitute FDA approval of the
products. In June 2006, the FDA issued a Compliance Policy Guide
for Marketed Unapproved Drugs, which addressed some of the
considerations utilized by the FDA in exercising its discretion
with respect to products marketed without FDA approval. The
guide does not establish legally enforceable responsibilities on
the FDA and generally only represents the agencys current
thinking on a topic. The guide emphasizes that any product that
is being marketed without required FDA approvals is subject to
FDA enforcement action at any time. If the FDA were to issue a
Federal Register Notice outlining revised conditions for
marketing, which could include calling for the submission of an
application for products such as Adamis cough/cold
products, then Adamis would take appropriate action so as to be
in compliance with any such policies. The FDA might also require
clinical trials in support of any such applications, and Adamis
would need to evaluate its alternatives in light of the costs
required to conduct such trials, which could be substantial,
compared to the economic benefit to Adamis from such products.
The FDA could also exercise its discretion to proceed against
Adamis
and/or other
companies that market similar
19
products without an FDA approval and require immediate
withdrawal of the products from the market, to prohibit Adamis
from marketing these products without first conducting required
trials and obtaining approvals, or to impose other penalties on
Adamis. Some of Adamis Labs unapproved products include
extended release formulations, which may subject Adamis to a
higher risk of FDA enforcement action. Such actions could have a
material adverse effect on Adamis business, financial
condition and results of operations.
Adamis
relies on third parties to conduct its clinical trials. If these
third parties do not successfully carry out their contractual
duties or meet expected deadlines, Adamis may be unable to
obtain, or may experience delays in obtaining, regulatory
approval, or may not be successful in commercializing
Adamis planned and future products.
Like many companies its size, Adamis does not have the ability
to conduct preclinical or clinical studies for its product
candidates without the assistance of third parties who conduct
the studies on its behalf. These third parties are usually
toxicology facilities and clinical research organizations, or
CROs, that have significant resources and experience in the
conduct of pre-clinical and clinical studies. The toxicology
facilities conduct the pre-clinical safety studies as well as
all associated tasks connected with these studies. The CROs
typically perform patient recruitment, project management, data
management, statistical analysis, and other reporting functions.
Adamis intends to rely on third parties to conduct clinical
trials of its product candidates and to use different toxicology
facilities and CROs for its pre-clinical and clinical studies.
Adamis reliance on these third parties for development
activities will reduce its control over these activities. If
these third parties do not successfully carry out their
contractual duties or obligations or meet expected deadlines, or
if the quality or accuracy of the clinical data they obtain is
compromised due to the failure to adhere to Adamis
clinical protocols or for other reasons, Adamis clinical
trials may be extended, delayed or terminated. If these third
parties do not successfully carry out their contractual duties
or meet expected deadlines, Adamis may be required to replace
them. Although Adamis believes there are a number of third-party
contractors it could engage to continue these activities,
replacing a third-party contractor may result in a delay of the
affected trial. Accordingly, Adamis may not be able to obtain
regulatory approval for or successfully commercialize its
product candidates.
Delays
in the commencement or completion of clinical testing of
Adamis product candidates could result in increased costs
to Adamis and delay its ability to generate significant
revenues.
Delays in the commencement or completion of clinical testing
could significantly impact Adamis product development
costs. Adamis does not know whether current or planned clinical
trials will begin on time or be completed on schedule, if at
all. The commencement of clinical trials can be delayed for a
variety of reasons, including delays in:
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obtaining regulatory approval to commence a clinical trial;
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reaching agreement on acceptable terms with prospective contract
research organizations and clinical trial sites;
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obtaining sufficient quantities of clinical trial materials for
any or all product candidates;
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obtaining institutional review board approval to conduct a
clinical trial at a prospective site; and
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recruiting participants for a clinical trial.
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In addition, once a clinical trial has begun, it may be
suspended or terminated by Adamis or the FDA or other regulatory
authorities due to a number of factors, including:
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failure to conduct the clinical trial in accordance with
regulatory requirements;
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inspection of the clinical trial operations or clinical trial
site by the FDA or other regulatory authorities resulting in the
imposition of a clinical hold;
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failure to achieve certain efficacy
and/or
safety standards; or
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lack of adequate funding to continue the clinical trial.
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20
Clinical trials require sufficient participant enrollment, which
is a function of many factors, including the size of the target
population, the nature of the trial protocol, the proximity of
participants to clinical trial sites, the availability of
effective treatments for the relevant disease, the eligibility
criteria for Adamis clinical trials and competing trials.
Delays in enrollment can result in increased costs and longer
development times. Adamis failure to enroll participants
in its clinical trials could delay the completion of the
clinical trials beyond current expectations. In addition, the
FDA could require Adamis to conduct clinical trials with a
larger number of participants than it may project for any of its
product candidates. As a result of these factors, Adamis may not
be able to enroll a sufficient number of participants in a
timely or cost-effective manner.
Furthermore, enrolled participants may drop out of clinical
trials, which could impair the validity or statistical
significance of the clinical trials. A number of factors can
influence the discontinuation rate, including, but not limited
to: the inclusion of a placebo in a trial; possible lack of
effect of the product candidate being tested at one or more of
the dose levels being tested; adverse side effects experienced,
whether or not related to the product candidate; and the
availability of numerous alternative treatment options that may
induce participants to discontinue from the trial.
Adamis, the FDA or other applicable regulatory authorities may
suspend clinical trials of a product candidate at any time if
Adamis or they believe the participants in such clinical trials,
or in independent third-party clinical trials for drugs based on
similar technologies, are being exposed to unacceptable health
risks or for other reasons.
Adamis
is subject to the risk of clinical trial and product liability
lawsuits.
The testing of human health care product candidates entails an
inherent risk of allegations of clinical trial liability, while
the marketing and sale of approved products entails an inherent
risk of allegations of product liability. Adamis currently
maintains liability insurance coverage of $5,000,000. However,
as Adamis conducts additional clinical trials and introduces
products into the United States market, the risk of adverse
events increases and Adamis requirements for liability
insurance coverage are likely to increase. Adamis is subject to
the risk that substantial liability claims from the testing or
marketing of pharmaceutical products could be asserted against
it in the future. There can be no assurance that Adamis will be
able to obtain or maintain insurance on acceptable terms,
particularly in overseas locations, for clinical and commercial
activities or that any insurance obtained will provide adequate
protection against potential liabilities. Moreover, Adamis
current and future coverages may not be adequate to protect
Adamis from all of the liabilities that it may incur. If losses
from liability claims exceed Adamis insurance coverage,
Adamis may incur substantial liabilities that exceed its
financial resources. In addition, a product or clinical trial
liability action against Adamis would be expensive and
time-consuming to defend, even if Adamis ultimately prevailed.
If Adamis is required to pay a claim, Adamis may not have
sufficient financial resources and its business and results of
operations may be harmed.
Adamis
does not have commercial-scale manufacturing capability, and it
lacks commercial manufacturing experience. Adamis will likely
rely on third parties to manufacture and supply its product
candidates.
Adamis does not own or operate manufacturing facilities for
clinical or commercial production of product candidates. Adamis
does not have any experience in drug formulation or
manufacturing, and it lacks the resources and the capability to
manufacture any of its product candidates on a clinical or
commercial scale. Accordingly, Adamis expects to depend on
third-party contract manufacturers for the foreseeable future.
Any performance failure on the part of Adamis contract
manufacturers could delay clinical development, regulatory
approval or commercialization of Adamis current or future
product candidates, depriving Adamis of potential product
revenue and resulting in additional losses.
The manufacture of pharmaceutical products requires significant
expertise and capital investment, including the development of
advanced manufacturing techniques and process controls.
Manufacturers of pharmaceutical products often encounter
difficulties in production, particularly in scaling up initial
production. These problems include difficulties with production
costs and yields, quality control (including stability of the
product candidate and quality assurance testing), shortages of
qualified personnel, as well as compliance with strictly
enforced federal, state and foreign regulations. If Adamis
third-party contract manufacturers were to encounter any of
these difficulties or otherwise fail to comply with their
obligations or under applicable regulations, Adamis
ability to
21
provide product candidates to patients in its clinical trials
would be jeopardized. Any delay or interruption in the supply of
clinical trial supplies could delay the completion of
Adamis clinical trials, increase the costs associated with
maintaining Adamis clinical trial programs and, depending
upon the period of delay, require Adamis to commence new trials
at significant additional expense or terminate the trials
completely.
Adamis products can only be manufactured in a facility
that has undergone a satisfactory inspection by the FDA and
other relevant regulatory authorities. For these reasons, Adamis
may not be able to replace manufacturing capacity for its
products quickly if it or its contract manufacturer(s) were
unable to use manufacturing facilities as a result of a fire,
natural disaster (including an earthquake), equipment failure,
or other difficulty, or if such facilities were deemed not in
compliance with the regulatory requirements and such
non-compliance could not be rapidly rectified. An inability or
reduced capacity to manufacture Adamis products would have a
material adverse effect on Adamis business, financial
condition, and results of operations.
If
Adamis fails to obtain acceptable prices or appropriate
reimbursement for its products, its ability to successfully
commercialize its products will be impaired.
Government and insurance reimbursements for healthcare
expenditures play an important role for all healthcare
providers, including physicians and pharmaceutical companies
such as Adamis that plan to offer various products in the United
States and other countries in the future. Adamis ability
to earn sufficient returns on its products and potential
products will depend in part on the extent to which
reimbursement for the costs of such products will be available
from government health administration authorities, private
health coverage insurers, managed care organizations, and other
organizations. In the United States, Adamis ability to
have its products eligible for Medicare, Medicaid or private
insurance reimbursement will be an important factor in
determining the ultimate success of its products. If, for any
reason, Medicare, Medicaid or the insurance companies decline to
provide reimbursement for Adamis products, its ability to
commercialize its products would be adversely affected. There
can be no assurance that Adamis potential drug products
will be eligible for reimbursement.
There has been a trend toward declining government and private
insurance expenditures for many healthcare items and this trend
may accelerate with proposed healthcare reform legislation.
Third-party payors are increasingly challenging the price of
medical and pharmaceutical products.
If purchasers or users of Adamis products and related
treatments are not able to obtain appropriate reimbursement for
the cost of using such products, they may forego or reduce such
use. Even if Adamis products are approved for
reimbursement by Medicare, Medicaid and private insurers, of
which there can be no assurance, the amount of reimbursement may
be reduced at times or even eliminated. This would have a
material adverse effect on Adamis business, financial
condition and results of operations.
Significant uncertainty exists as to the reimbursement status of
newly approved pharmaceutical products, and there can be no
assurance that adequate third-party coverage will be available.
Legislative or regulatory reform of the healthcare system
may affect Adamis ability to sell its products
profitably.
In both the United States and certain foreign jurisdictions,
there have been and are expected to be a number of legislative
and regulatory changes to the healthcare system in ways that
could impact Adamis ability to sell its products
profitably. In recent years, new legislation has been enacted in
the United States at the federal and state levels that effects
major changes in the healthcare system, either nationally or at
the state level. These new laws include a prescription drug
benefit plan for Medicare beneficiaries and certain changes in
Medicare reimbursement. Given the recent enactment of these
laws, it is still too early to determine their impact on the
biotechnology and pharmaceutical industries and Adamis
business. Further, the U.S. Congress is considering a
significant healthcare overhaul proposal that may affect
Adamis ability to market and sell products on favorable
terms, which would affect Adamis results of operations as
well as its ability to raise capital, obtain additional
collaborators or profitably market its products. Such proposals
may reduce Adamis revenues, increase its expenses or limit
the markets for its products. In particular, Adamis expects to
experience pricing pressures in connection with the sale of its
products due to the trend toward managed health care, the
increasing influence of health maintenance organizations and
additional legislative proposals.
22
Adamis
has limited sales, marketing and distribution
experience.
Adamis has limited experience in the sales, marketing, and
distribution of pharmaceutical products. There can be no
assurance that Adamis will be able to establish sales,
marketing, and distribution capabilities or make arrangements
with its current collaborators or others to perform such
activities or that such efforts will be successful. If Adamis
decides to market any of its new products directly, it must
either acquire or internally develop a marketing and sales force
with technical expertise and with supporting distribution
capabilities. The acquisition or development of a sales,
marketing and distribution infrastructure would require
substantial resources, which may not be available to Adamis or,
even if available, divert the attention of its management and
key personnel, and have a negative impact on further product
development efforts.
Adamis
may seek to enter into arrangements to develop and commercialize
its products. These collaborations, if secured, may not be
successful.
Adamis has entered into arrangements with third parties
regarding development and commercialization of some of its
products and may in the future seek to enter into collaborative
arrangements to develop and commercialize some of its potential
products both in North America and international markets. There
can be no assurance that Adamis will be able to negotiate
collaborative arrangements on favorable terms or at all or that
its current or future collaborative arrangements will be
successful.
Adamis strategy for the future research, development, and
commercialization of its products is expected to be based in
part on entering into various arrangements with corporate
collaborators, licensors, licensees, health care institutions
and principal investigators and others, and its commercial
success is dependent upon these outside parties performing their
respective contractual obligations responsibly and with
integrity. The amount and timing of resources such third parties
will devote to these activities may not be within Admins
control. There can be no assurance that such parties will
perform their obligations as expected. There can be no assurance
that Adamis collaborators will devote adequate resources
to its products.
If
Adamis is not successful in acquiring or licensing additional
product candidates on acceptable terms, if at all, Adamis
business may be adversely affected.
As part of its strategy, Adamis may acquire or license
additional product candidates that it believes have growth
potential. There are no assurances that Adamis will be able to
identify promising product candidates. Even if Adamis is
successful in identifying promising product candidates, Adamis
may not be able to reach an agreement for the acquisition or
license of the product candidates with their owners on
acceptable terms or at all.
Adamis may not be able to successfully identify any other
commercial products or product candidates to in-license, acquire
or internally develop. Moreover, negotiating and implementing an
economically viable in-licensing arrangement or acquisition is a
lengthy and complex process. Other companies, including those
with substantially greater resources, may compete with Adamis
for the in-licensing or acquisition of product candidates and
approved products. Adamis may not be able to acquire or
in-license the rights to additional product candidates and
approved products on terms that it finds acceptable, or at all.
If it is unable to in-license or acquire additional commercial
products or product candidates, Adamis ability to grow its
business or increase its profits could be severely limited.
If
Adamis competitors develop and market products that are
more effective than Adamis product candidates or obtain
regulatory and marketing approval for similar products before
Adamis does, Adamis commercial opportunity may be reduced
or eliminated.
The development and commercialization of new pharmaceutical
products that target influenza and other viral conditions, and
allergy and other respiratory conditions addressed by the
current and future products of Adamis Labs, is competitive, and
Adamis faces competition from numerous sources, including major
biotechnology and pharmaceutical companies worldwide. Many of
Adamis competitors have substantially greater financial
and technical resources, and development, production and
marketing capabilities than Adamis does. In addition, many of
these companies have more experience than Adamis in pre-clinical
testing, clinical trials and manufacturing of compounds, as well
as in obtaining FDA and foreign regulatory approvals. Adamis
also competes with academic institutions, governmental agencies
and private organizations that are conducting research in the
same fields.
23
Competition among these entities to recruit and retain highly
qualified scientific, technical and professional personnel and
consultants is also intense. As a result, there is a risk that
one of Adamis competitors will develop a more effective
product for the same indications for which Adamis is developing
a product or, alternatively, bring a similar product to market
before Adamis can do so. Failure of Adamis to successfully
compete will adversely impact the ability to raise additional
capital and ultimately achieve profitable operations.
If
Adamis suffers negative publicity concerning the safety of its
products in development, its sales may be harmed and Adamis may
be forced to withdraw such products.
If concerns should arise about the safety of any of Adamis
products that are marketed, regardless of whether or not such
concerns have a basis in generally accepted science or
peer-reviewed scientific research, such concerns could adversely
affect the market for these products. Similarly, negative
publicity could result in an increased number of product
liability claims, whether or not these claims are supported by
applicable law.
Adamis
failure to adequately protect or to enforce its intellectual
property rights or secure rights to third party patents could
materially harm its proprietary position in the marketplace or
prevent the commercialization of its products.
Adamis success depends in part on its ability to obtain
and maintain protection in the United States and other countries
for the intellectual property covering or incorporated into its
technologies and products. The patents and patent applications
in Adamis existing patent portfolio are either owned by
Adamis or licensed to Adamis. Adamis ability to protect
its product candidates from unauthorized use or infringement by
third parties depends substantially on its ability to obtain and
maintain valid and enforceable patents. Due to evolving legal
standards relating to the patentability, validity and
enforceability of patents covering pharmaceutical inventions and
the scope of claims made under these patents, Adamis
ability to obtain and enforce patents is uncertain and involves
complex legal and factual questions for which important legal
principles are unresolved.
There is a substantial backlog of patent applications at the
United States Patent and Trademark Office, or USPTO. Patents in
the United States are issued to the party that is first to
invent the claimed invention. There can be no assurance that any
patent applications relating to Adamis products or methods
will be issued as patents, or, if issued, that the patents will
not be challenged, invalidated or circumvented or that the
rights granted thereunder will provide a competitive advantage.
Adamis may not be able to obtain patent rights on products,
treatment methods or manufacturing processes that it may develop
or to which Adamis may obtain license or other rights. Even if
Adamis does obtain patents, rights under any issued patents may
not provide it with sufficient protection for its product
candidates or provide sufficient protection to afford Adamis a
commercial advantage against its competitors or their
competitive products or processes. It is possible that no
patents will be issued from any pending or future patent
applications owned by Adamis or licensed to Adamis. Others may
challenge, seek to invalidate, infringe or circumvent any
patents Adamis owns or licenses. Alternatively, Adamis may in
the future be required to initiate litigation against third
parties to enforce its intellectual property rights. The defense
and prosecution of patent and intellectual property claims are
both costly and time consuming, even if the outcome is favorable
to Adamis. Any adverse outcome could subject Adamis to
significant liabilities, require Adamis to license disputed
rights from others, or require Adamis to cease selling its
future products.
In addition, many other organizations are engaged in research
and product development efforts that may overlap with
Adamis products. For example, Adamis PFS Syringe
product competes against other self-administered epinephrine
products, including EpiPen, EpiPen Jr. and Twinject; Adamis
Labs line of allergy and respiratory products compete with
numerous prescription and non-prescription
over-the-counter
products targeting similar conditions; and with regard to the
Savvy product candidate, Ortho Pharmaceuticals and many other
companies offer contraceptive vaginal gel products. Such
organizations may currently have, or may obtain in the future,
legally blocking proprietary rights, including patent rights, in
one or more products or methods under development or
consideration by Adamis. These rights may prevent Adamis from
commercializing technology, or may require Adamis to obtain a
license from the organizations to use the technology. Adamis may
not be able to obtain any such licenses that may be required on
reasonable financial terms, if at all, and cannot be sure that
the patents underlying any such licenses will be valid or
enforceable. As with other companies in the pharmaceutical
industry, Adamis is subject to the risk that persons located in
other countries will engage in development, marketing
24
or sales activities of products that would infringe Adamis
patent rights if such activities were conducted in the United
States.
Adamis patents also may not afford protection against
competitors with similar technology. Adamis may not have
identified all patents, published applications or published
literature that affect its business either by blocking
Adamis ability to commercialize its product candidates, by
preventing the patentability of its products or by covering the
same or similar technologies that may affect Adamis
ability to market or license its product candidates. For
example, patent applications filed with the USPTO are maintained
in confidence for up to 18 months after their filing. In
some cases, however, patent applications filed with the USPTO
remain confidential for the entire time before issuance as a
U.S. patent. Patent applications filed in countries outside
the United States are not typically published until at least
18 months from their first filing date. Similarly,
publication of discoveries in the scientific or patent
literature often lags behind actual discoveries. Therefore,
Adamis or its licensors might not have been the first to invent,
or the first to file, patent applications on Adamis
product candidates or for their use. The laws of some foreign
jurisdictions do not protect intellectual property rights to the
same extent as in the United States, and many companies have
encountered significant difficulties in protecting and defending
these rights in foreign jurisdictions. If Adamis encounters such
difficulties or is otherwise precluded from effectively
protecting its intellectual property rights in either the United
States or foreign jurisdictions, Adamis business prospects
could be substantially harmed.
Adamis
corporate compliance programs cannot guarantee that Adamis is
now or will be in compliance with all potentially applicable
regulations.
The development, manufacturing, pricing, sales, and
reimbursement of pharmaceutical products, together with
Adamis general operations, are subject to extensive
regulation by federal, state and other authorities within the
United States and numerous entities outside of the United
States. Adamis is a small company and it relies on third parties
to conduct certain important functions. Adamis relies on a third
party clinical regulatory organization, Health Decisions, Inc.,
pursuant to an agreement between Adamis and the National
Institute of Child Health and Human Development, to conduct its
Phase III Savvy clinical trial, and will rely on third
parties to assist in evaluation of the results of that trial. In
addition, Adamis also has significantly fewer employees than
many other companies that have the same or fewer product
candidates in clinical development. If Adamis fails to comply
with any of these regulations, Adamis could be subject to a
range of regulatory actions, including suspension or termination
of clinical trials, restrictions on its products or
manufacturing processes, or other sanctions or litigation. In
addition, as a publicly-traded company, Adamis is subject to
significant regulations, including the Sarbanes-Oxley Act of
2002. While Adamis has developed and instituted a corporate
compliance program and continues to update the program in
response to newly implemented or changing regulatory
requirements, Adamis cannot assure you that it is now or will be
in compliance with all such applicable laws and regulations.
Failure to comply with potentially applicable laws and
regulations could also lead to the imposition of fines, cause
the value of Adamis common stock to decline and impede
Adamis ability to raise capital or lead to the failure of
Adamis common stock to continue to be traded on the OTC
Bulletin Board.
Risks
Related to the Combined Company
In determining whether you should approve the merger, the
issuance of shares of La Jolla common stock and other
matters related to the merger, as the case may be, you should
carefully read the following risk factors in addition to the
other risks described herein. You should especially focus on the
risks described under Risks Related to Adamis, as
the business of and risks related to Adamis will be the business
of and the risks related to the combined company.
The
combined company will require additional financing after the
consummation of the merger.
At September 30, 2009, Adamis and its subsidiaries together
had cash and cash equivalents of approximately $14,500 and
accounts receivable of approximately $160,000. As described in
greater detail below under the heading Adamis
Managements Discussion and Analysis of Financial Condition
and Results of Operations Liquidity and Capital
Resources Recent Convertible Note
Transactions, Adamis recently raised gross proceeds of
approximately $2,000,000 through the issuance of convertible
promissory notes and shares of Adamis common
25
stock. At the close of the merger, La Jolla estimates it will
have net cash of approximately $2.5 million to
$3.0 million. Even if the merger is concluded, the combined
company will require additional cash resources to continue
operations during 2010. The combined company will have capital
needs at various times during calendar year 2010, and such
capital needs will depend in part on the level of product
revenues, the amount of additional funds raised in equity or
debt transactions and the amounts spent on product development
efforts. The combined companys capital needs could include
$4 million or more for ongoing sales, general and
administrative activities and expenses and $9 million or
more on product development. However, lower revenues or other
factors could result in operations, sales and product
development activities, expenses and capital needs significantly
below these levels. Additional funding will be used to satisfy
existing obligations and liabilities and future working capital
needs, to build working capital reserves and to fund a number of
projects, which may include the following:
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market the Adamis Labs PFS Syringe product and the generic nasal
steroid product candidate;
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pursue the development of other product candidates;
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fund clinical trials and seek regulatory approvals;
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expand research and development activities;
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access manufacturing and commercialization capabilities;
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implement additional internal systems and infrastructure;
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maintain, defend and expand the scope of the combined
companys intellectual property portfolio; and
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hire additional management, sales, research, development and
clinical personnel.
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Statements in this joint proxy statement/prospectus, including
concerning Adamis anticipated or hoped-for target dates
for introduction of its nasal steroid and vaccine product
candidates, and for the commencement of clinical trials relating
to the steroid and vaccine product candidates, assume that
Adamis will have sufficient funding to support the timely
introduction of products and the conduct of clinical trials.
Failure to have sufficient funding could require Adamis to delay
product launches or clinical trials, which would have an adverse
effect on its business and results of operations and which could
increase the need for additional financing in the future.
Until the combined company can generate a sufficient amount of
revenue to finance its cash requirements, which the combined
company may never do, the combined company expects to finance
future cash needs primarily through public or private equity
offerings, debt financings, or licensing revenues from strategic
collaborations. Sales of additional equity securities will
dilute current stockholders ownership percentage in the
combined company. The combined company does not know whether
additional financing will be available on acceptable terms, or
at all. If the combined company is not able to secure additional
equity or debt financing when needed on acceptable terms, the
combined company may have to sell some of its assets or enter
into a strategic collaboration for one or more of the combined
companys product candidate programs at an earlier stage of
development than would otherwise be desired. This could lower
the economic value of these collaborations to the combined
company. In addition, the combined company may have to delay,
reduce the scope of, or eliminate one or more of its clinical
trials or research and development programs, or ultimately,
cease operations.
If adequate funding is not obtained, the board of directors of
the combined company will be required to explore alternatives
for the combined companys business and assets. These
alternatives might include seeking the dissolution and
liquidation of the combined company, seeking to merge or combine
with another company, selling or licensing some of the combined
companys intellectual property, or initiating bankruptcy
proceedings. There can be no assurance that any third party will
be interested in merging with the combined company or would
agree to a price and other terms that the combined company would
deem adequate. If the combined company filed for bankruptcy, it
would most likely not be able to raise any type of funding from
any source. In that event, the creditors of the combined company
would have first claim on the value of the assets of the
combined company which, other than remaining cash, would most
likely be liquidated in a bankruptcy sale. The combined company
can give no assurance as to the magnitude of the net proceeds of
such sale and whether such proceeds would be sufficient to
satisfy the combined companys obligations to its
creditors, let alone to permit any distribution to its equity
holders.
26
The
combined companys common stock price is expected to be
volatile, and the market price of its common stock may drop
following the merger.
The market price of the combined companys common stock
could be subject to significant fluctuations following the
merger. Market prices for securities of early-stage
pharmaceutical, biotechnology and other life sciences companies
have historically been particularly volatile. Some of the
factors that may cause the market price of the combined
companys common stock to fluctuate include:
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the results of the combined companys current and any
future clinical trials of its product candidates;
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the timing and results of ongoing preclinical studies and
planned clinical trials of the combined companys
preclinical product candidates;
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the entry into, or termination of, key agreements, including,
among others, key collaboration and license agreements;
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the results and timing of regulatory reviews relating to the
approval of the combined companys product candidates;
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the initiation of, material developments in, or conclusion of,
litigation to enforce or defend any of the combined
companys intellectual property rights;
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failure of any of the combined companys product
candidates, if approved, to achieve commercial success;
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general and industry-specific economic conditions that may
affect the combined companys research and development
expenditures;
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the results of clinical trials conducted by others on drugs that
would compete with the combined companys product
candidates;
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issues in manufacturing the combined companys product
candidates or any approved products;
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the loss of key employees;
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the introduction of technological innovations or new commercial
products by competitors of the combined company;
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changes in estimates or recommendations by securities analysts,
if any, who cover the combined companys common stock;
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future sales of the combined companys common stock;
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period-to-period
fluctuations in the combined companys financial results;
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publicity or announcements regarding regulatory developments
relating to the combined companys products;
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clinical trial results, particularly the outcome of more
advanced studies, or negative responses from both domestic and
foreign regulatory authorities with regard to the approvability
of the combined companys products;
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period-to-period
fluctuations in the combined companys financial results,
including the combined companys cash and cash equivalents
balance, operating expenses, cash burn rate or revenue levels;
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common stock sales in the public market by one or more of the
combined companys larger stockholders, officers or
directors;
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the combined companys filing for protection under federal
bankruptcy laws;
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a negative outcome in any litigation or potential legal
proceedings; or
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other potentially negative financial announcements including: a
review of any of the combined companys filings by the SEC,
changes in accounting treatment or restatement of previously
reported financial results or delays in the combined
companys filings with the SEC.
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27
Following the merger, stockholders of Adamis may sell a
significant number of shares of La Jolla common stock they
will receive in the merger. Significant sales could adversely
affect the market price for the combined companys common
stock for a period of time after completion of the merger.
Moreover, the stock markets in general have experienced
substantial volatility that has often been unrelated to the
operating performance of individual companies. These broad
market fluctuations may also adversely affect the trading price
of the combined companys common stock.
In the past, following periods of volatility in the market price
of a companys securities, stockholders have often
instituted class action securities litigation against those
companies. Such litigation, if instituted, could result in
substantial costs and diversion of management attention and
resources, which could significantly harm the combined
companys profitability and reputation.
The
combined companys common stock is expected to be traded on
the OTC Bulletin Board and be subject to additional trading
restrictions as a penny stock, which could adversely
affect the liquidity and price of such stock.
Following the merger, Adamis and La Jolla expect that the
combined companys common stock will be reported on the OTC
Bulletin Board. Because the combined companys common
stock will not initially be listed on any national securities
exchange, such shares will also be subject to the regulations
regarding trading in penny stocks, which are those
securities trading for less than $5.00 per share. The following
is a list of the general restrictions on the sale of penny
stocks:
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Before the sale of penny stock by a broker-dealer to a new
purchaser, the broker-dealer must determine whether the
purchaser is suitable to invest in penny stocks. To make that
determination, a broker-dealer must obtain, from a prospective
investor, information regarding the purchasers financial
condition and investment experience and objectives.
Subsequently, the broker-dealer must deliver to the purchaser a
written statement setting forth the basis of the suitability
finding and obtain the purchasers signature on such
statement.
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A broker-dealer must obtain from the purchaser an agreement to
purchase the securities. This agreement must be obtained for
every purchase until the purchaser becomes an established
customer. A broker-dealer may not effect a purchase of a
penny stock less than two business days after a broker-dealer
sends such agreement to the purchaser.
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The Securities Exchange Act of 1934, or the Exchange Act,
requires that before effecting any transaction in any penny
stock, a broker-dealer must provide the purchaser with a
risk disclosure document that contains, among other
things, a description of the penny stock market and how it
functions and the risks associated with such investment. These
disclosure rules are applicable to both purchases and sales by
investors.
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A dealer that sells penny stock must send to the purchaser,
within ten days after the end of each calendar month, a written
account statement including prescribed information relating to
the security.
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These requirements can severely limit the liquidity of
securities in the secondary market because few brokers or
dealers are likely to be willing to undertake these compliance
activities. As a result of the combined companys common
stock not being listed on a national securities exchange and the
rules and restrictions regarding penny stock transactions, an
investors ability to sell to a third party and the
combined companys ability to raise additional capital may
be limited. The combined company makes no guarantee that its
market-makers will continue to make a market in its common
stock, or that any market for its common stock will continue.
Adamis
principal stockholders will have significant influence over the
combined company, and your interests as a holder of
La Jolla common stock may conflict with the interests of
those persons.
Based on the number of outstanding shares of Adamis common stock
held by Adamis stockholders as of the date of this joint proxy
statement/prospectus, Adamis ten largest stockholders
beneficially own approximately 52.8% of the outstanding Adamis
common stock. As a result, those stockholders will be able to
exert a significant degree of influence or actual control over
the combined companys management and affairs after the
merger and
28
over matters requiring stockholder approval, including the
election of directors, any merger, consolidation or sale of all
or substantially all of the combined companys assets, and
any other significant corporate transaction. The interests of
these persons may not always coincide with the interests of the
combined company or its other stockholders. For example, such
persons could delay or prevent a change of control of the
combined company even if such a change of control would benefit
the combined companys other stockholders. The significant
concentration of stock ownership may adversely affect the
trading price of the combined companys common stock due to
investors perception that conflicts of interest may exist
or arise.
The
combined companys management will be required to devote
substantial time to comply with public company
regulations.
The Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, as
well as rules subsequently implemented by the SEC, impose
various requirements on public companies, including with respect
to corporate governance practices. The combined companys
management and other personnel will need to devote a substantial
amount of time to these requirements.
In addition, the Sarbanes-Oxley Act requires, among other
things, that the combined company maintain effective internal
controls for financial reporting and disclosure controls and
procedures. In particular, the combined company must perform
system and process evaluation and testing of its internal
controls over financial reporting to allow management to report
on the effectiveness of its internal controls over financial
reporting, as required by Section 404 of the Sarbanes-Oxley
Act. The combined companys compliance with
Section 404 will require that it incur substantial
accounting and related expense and expend significant management
efforts. The combined company may need to hire additional
accounting and financial staff to satisfy the ongoing
requirements of Section 404. Moreover, if the combined
company is not able to comply with the requirements of
Section 404, or if the combined company or its independent
registered public accounting firm identifies deficiencies in its
internal controls over financial reporting that are deemed to be
material weaknesses, the market price of the combined
companys stock could decline and the combined company
could be subject to sanctions or investigations by the SEC or
other regulatory authorities.
The
unaudited pro forma financial statements are presented for
illustrative purposes only and may not be an indication of the
combined companys financial condition or results of
operations following the merger.
The unaudited pro forma financial statements contained in this
joint proxy statement/prospectus are presented for illustrative
purposes only and may not be an indication of the combined
companys financial condition or results of operations
following the merger for several reasons. For example, the
unaudited pro forma financial statements have been derived from
the historical financial statements of La Jolla and Adamis
and certain adjustments and assumptions have been made regarding
the combined company after giving effect to the merger. The
information upon which these adjustments and assumptions have
been made is preliminary, and these kinds of adjustments and
assumptions are difficult to make with complete accuracy.
Moreover, the unaudited pro forma financial statements do not
reflect all costs that are expected to be incurred by the
combined company in connection with the merger. For example, the
impact of any incremental costs incurred in integrating the two
companies is not reflected in the pro forma financial
statements. As a result, the actual financial condition and
results of operations of the combined company following the
merger may not be consistent with, or evident from, these
unaudited pro forma financial statements.
Adamis
has incurred losses since its inception and anticipates that the
combined company will continue to incur losses. The combined
company may never achieve or sustain
profitability.
Even after the merger is concluded, it is expected that the
combined company will continue to incur losses. These losses may
increase as the combined company continues its research and
development activities, seeks regulatory approvals for its
product candidates and commercializes any approved products.
These losses may cause, among other things, the combined
companys stockholders equity and working capital to
decrease. The future earnings and cash flow from operations of
the combined companys business are dependent, in part, on
its ability to further develop its products and on revenues and
profitability from sales of products and product candidates of
its
29
Adamis Labs operations. There can be no assurance that the
combined company will grow and be profitable. There can be no
assurance that the combined company will be able to generate
sufficient product revenue to become profitable at all or on a
sustained basis. The combined company expects to have
quarter-to-quarter
fluctuations in revenues and expenses, some of which could be
significant, due to expanded manufacturing, marketing, research,
development, and clinical trial activities. If the combined
companys product candidates fail in clinical trials or do
not gain regulatory approval, or if the combined companys
products do not achieve market acceptance, the combined company
may never become profitable. The combined company will need to
increase product marketing and brand awareness and conduct
significant research, development, testing and regulatory
compliance activities that, together with projected general and
administrative expenses, are expected to result in substantial
operating losses for the foreseeable future. Even if the
combined company does achieve profitability, it may not be able
to sustain or increase profitability on a quarterly or annual
basis.
Adamis has received a going concern opinion from its
independent registered public accounting firm, which may
negatively impact the combined companys business.
Adamis audit opinions from its independent registered
public accounting firm regarding the consolidated financial
statements for the years ended March 31, 2009 and 2008
include an explanatory paragraph indicating that Adamis has
incurred recurring losses from operations and has limited
working capital to pursue its business alternatives, and that
these factors raise substantial doubt about its ability to
continue as a going concern. Without additional funds from debt
or equity financing, sales of assets, intellectual property or
technologies, or from a business combination or a similar
transaction, the combined company will exhaust its resources and
will be unable to continue operations. These factors raise
substantial doubt about the combined companys ability to
continue as a going concern.
The
combined company may be required to suspend, repeat or terminate
its clinical trials if the trials are not well designed, do not
meet regulatory requirements or the results are negative or
inconclusive, which may result in significant negative
repercussions on the combined companys business and
financial condition.
Before regulatory approval for any potential product can be
obtained, the combined company must undertake extensive clinical
testing on humans to demonstrate the tolerability and efficacy
of the product, both on its own terms, and as compared to the
other principal drugs on the market that have the same
therapeutic indication. The combined company cannot assure you
that it will obtain authorization to permit product candidates
that are already in the preclinical development phase to enter
the human clinical testing phase. In addition, the combined
company cannot assure you that any authorized preclinical or
clinical testing will be completed successfully within any
specified time period by the combined company, or without
significant additional resources or expertise to those
originally expected to be necessary. The combined company cannot
assure you that such testing will show potential products to be
safe and efficacious or that any such product will be approved
for a specific indication. Further, the results from preclinical
studies and early clinical trials may not be indicative of the
results that will be obtained in later-stage clinical trials. In
addition, the combined company or regulatory authorities may
suspend clinical trials at any time on the basis that the
participants are being exposed to unacceptable health risks.
Completion of clinical tests depends on, among other things, the
number of patients available for testing, which is a function of
many factors, including the number of patients with the relevant
conditions, the nature of the clinical testing, the proximity of
patients to clinical testing centers, the eligibility criteria
for tests as well as competition with other clinical testing
programs involving the same patient profile but different
treatments. The combined company will rely on third parties,
such as contract research organizations
and/or
co-operative groups, to assist it in overseeing and monitoring
clinical trials as well as to process the clinical results and
manage test requests, which may result in delays or failure to
complete trials, if the third parties fail to perform or to meet
the applicable standards. A failure by the combined company or
such third parties to keep to the terms of a product program
development for any particular product candidate or to complete
the clinical trials for a product candidate in the envisaged
time frame could have significant negative repercussions on the
combined companys business and financial condition.
30
Even
if the combined company receives regulatory approval to market
its product candidates, such products may not gain the market
acceptance among physicians, patients, healthcare payors and the
medical community.
Any products that the combined company may develop may not gain
market acceptance among physicians, patients, healthcare payors
and the medical community even if they ultimately receive
regulatory approval. If these products do not achieve an
adequate level of acceptance, the combined company, or future
collaborators, may not be able to generate material product
revenues and the combined company may not become profitable. The
degree of market acceptance of any of the combined
companys product candidates, if approved for commercial
sale, will depend on a number of factors, including:
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demonstration of efficacy and safety in clinical trials;
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the prevalence and severity of any unexpected side effects;
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the introduction and availability of generic substitutes for any
of the combined companys products, potentially at lower
prices (which, in turn, will depend on the strength of the
combined companys intellectual property protection for
such products);
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potential or perceived advantages over alternative treatments;
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the timing of market entry relative to competitive treatments;
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the ability to offer the combined companys product
candidates for sale at competitive prices;
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relative convenience and ease of administration;
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the strength of marketing and distribution support;
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sufficient third party coverage or reimbursement; and
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the product labeling or product insert (including any warnings)
required by the FDA or regulatory authorities in other countries.
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The
combined company may not complete its clinical trials in the
time expected, which could delay or prevent the
commercialization of its products, which may adversely affect
the combined companys future revenues and financial
condition.
Although for planning purposes the combined company will
forecast the commencement and completion of clinical trials, the
actual timing of these events can vary dramatically due to
factors such as delays, scheduling conflicts with participating
clinicians and clinical institutions and the rate of patient
enrollment. Clinical trials involving the combined
companys product candidates may not commence or be
completed as forecast. In certain circumstances, the combined
company will rely on academic institutions or clinical research
organizations to conduct, supervise or monitor some or all
aspects of clinical trials involving the combined companys
products. The combined company will have less control over the
timing and other aspects of these clinical trials than if it
conducted them entirely on its own. These trials may not
commence or be completed as the combined company expects and may
not be conducted successfully. Failure to commence or complete,
or delays in, any of the combined companys planned
clinical trials could delay or prevent the commercialization of
the combined companys products and harm its business and
may adversely affect the combined companys future revenues
and financial condition.
If the
combined company fails to keep pace with rapid technological
change in the biotechnology and pharmaceutical industries, its
products could become obsolete, which may adversely affect the
combined companys future revenues and financial
condition.
Biotechnology and related pharmaceutical technology have
undergone and are subject to rapid and significant change.
La Jolla and Adamis expect that the technologies associated
with biotechnology research and development will continue to
develop rapidly. The combined companys future will depend
in large part on its ability to maintain a competitive position
with respect to these technologies. Any compounds, products or
processes that the combined
31
company develops may become obsolete before the combined company
recovers any expenses incurred in connection with developing
these products, which may adversely affect the combined
companys future revenues and financial condition.
If the
combined company is unable to retain its management, research,
development, and clinical teams and scientific advisors or to
attract additional qualified personnel, the combined
companys product operations and development efforts may be
seriously jeopardized.
The combined companys success will be dependent upon the
efforts of a small management team and staff, including Dennis
J. Carlo, Ph.D. The employment of Dr. Carlo may be
terminated at any time by either the combined company or
Dr. Carlo. Adamis currently does not, and the combined
company will not, have key man life insurance policies covering
any of its executive officers or key employees. If key
individuals leave the combined company, the combined company
could be adversely affected if suitable replacement personnel
are not quickly recruited. There is competition for qualified
personnel in all functional areas, which makes it difficult to
attract and retain the qualified personnel necessary for the
operation of the combined companys business.
The loss of the services of any principal member of the combined
companys management and research, development and clinical
teams could significantly delay or prevent the achievement of
the combined companys scientific and business objectives.
Competition among biotechnology and pharmaceutical companies for
qualified employees is intense, and the ability to retain and
attract qualified individuals is critical to the combined
companys success. The combined company may be unable to
attract and retain key personnel on acceptable terms, if at all.
Adamis has relationships with consultants and scientific
advisors who will continue to assist the combined company in
formulating and executing its research, development, regulatory
and clinical strategies. These consultants and scientific
advisors are not Adamis employees and may have commitments to,
or consulting or advisory contracts with, other entities that
may limit their availability to the combined company. The
combined company will have only limited control over the
activities of these consultants and scientific advisors and can
generally expect these individuals to devote only limited time
to the combined companys activities. Adamis also relies on
these consultants to evaluate potential compounds and products,
which may be important in developing a long-term product
pipeline for the combined company. Consultants also assist
Adamis in preparing and submitting regulatory filings.
Adamis scientific advisors provide scientific and
technical guidance on the companys drug discovery and
development. Failure of any of these persons to devote
sufficient time and resources to the combined companys
programs could harm its business. In addition, these advisors
may have arrangements with other companies to assist those
companies in developing technologies that may compete with the
combined companys products.
La Jollas
stockholders will have limited ability to influence the combined
companys actions and decisions following the
merger.
Following the merger, original La Jolla stockholders will
own approximately 5% to 30% of the outstanding shares
(post-reverse stock split) of common stock of the combined
company. As a result, original La Jolla stockholders will
have only limited ability to influence the combined
companys business. Original La Jolla stockholders
will not have separate approval rights with respect to any
actions or decisions of the combined company or have separate
representation on the combined companys board of directors.
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This joint proxy statement/prospectus contains
forward-looking statements of La Jolla and
Adamis within the meaning of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements include:
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the potential value created by the proposed merger for
La Jollas and Adamis stockholders;
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the efficacy, safety and intended utilization of Adamis
products and product candidates;
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the conduct and results of Adamis research, discovery and
preclinical efforts and clinical trials;
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anticipated timelines for product development efforts;
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32
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the amount of time required to obtain regulatory approvals for
Adamis or the combined companys product candidates;
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Adamis plans regarding future research, discovery and
preclinical efforts and clinical activities, and Adamis
collaborative, intellectual property and regulatory activities;
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the amount of net cash that La Jolla anticipates it will
have on the closing of the merger and the number of Adamis
shares issued and outstanding as of the closing of the merger;
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information concerning possible future or assumed results of the
combined company;
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the period in which La Jolla and Adamis expect cash will be
available to fund their current operating plans, both before and
after giving effect to the merger;
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future required funding needs;
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the number of shares of common stock La Jolla expects to
issue in the merger and the ratio of the La Jolla reverse
stock split; and
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each of La Jollas and Adamis results of
operations, financial condition and businesses, and Adamis
products and drug candidates under development and the expected
impact of the proposed merger on the combined companys
financial and operating performance.
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Words such as anticipates, believes,
forecast, potential,
contemplates, expects,
intends, plans, seeks,
estimates, could, would,
will, may, can and similar
expressions identify forward-looking statements. These
forward-looking statements are not guarantees of future
performance and are subject to risks and uncertainties that
could cause actual results to differ materially from the results
contemplated by the forward-looking statements, including the
following:
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La Jolla and Adamis may not be able to complete the
proposed merger;
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La Jollas net cash at closing may be lower than
currently anticipated and the level of ownership in the combined
company may also be lower than anticipated for the La Jolla
stockholders;
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Adamis product candidates that appear promising in early
research and clinical trials may not demonstrate safety and
efficacy in subsequent clinical trials;
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commercial introduction of Adamis product candidates may
be delayed beyond La Jollas and Adamis current
expectations;
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revenues and income from Adamis Labs existing and
anticipated future products may not meet expectations;
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the combined company may not be able to obtain the equity or
debt financing necessary to support its anticipated level of
operations;
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risks associated with reliance on collaborative partners for
further clinical trials and other development
activities; and
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risks involved with development and commercialization of product
candidates.
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Many of the important factors that will determine these results
and values are beyond La Jollas and Adamis
ability to control or predict. You are cautioned not to put
undue reliance on any forward-looking statements. Except as
otherwise required by law, La Jolla and Adamis do not
assume any obligation to update any forward-looking statements.
In evaluating the merger, you should carefully consider the
discussion of risks and uncertainties in the section entitled
Risk Factors in this joint proxy
statement/prospectus.
33
THE
SPECIAL MEETING OF LA JOLLA STOCKHOLDERS
Date,
Time and Place
The special meeting of La Jolla stockholders (the
La Jolla Special Meeting) will be
held on
[ ],
2010, at
[ ],
San Diego, California, commencing at 10:00 a.m.,
Pacific Time. La Jolla is sending this joint proxy
statement/prospectus to its stockholders in connection with the
solicitation of proxies by the La Jolla board of directors
for use at the La Jolla special meeting and any
adjournments or postponements thereof. This joint proxy
statement/prospectus is first being furnished to stockholders of
La Jolla on or about
[ ],
20[ ].
Purposes
of the La Jolla Special Meeting
The La Jolla Special Meeting will be held for the following
purposes:
1. To consider and vote upon a proposal to approve the
issuance of La Jolla common stock to the stockholders of
Adamis Pharmaceuticals Corporation pursuant to the Agreement and
Plan of Reorganization dated as of December 4, 2009, by and
among La Jolla, Jewel Merger Sub, Inc., or Merger Sub, and
Adamis Pharmaceuticals Corporation, a copy of which is attached
as Annex A to the accompanying joint proxy
statement/prospectus, pursuant to which Merger Sub will merge
with and into Adamis, with Adamis surviving the merger as a
wholly-owned subsidiary of La Jolla, and pursuant to which
La Jolla would issue post-reverse split shares of common
stock to the stockholders of Adamis, resulting in a change of
control of La Jolla.
2. To consider and act upon a proposal to approve an
amendment to La Jollas restated certificate of
incorporation to effect a reverse split of the issued and
outstanding shares of La Jolla common stock, to occur
immediately before the closing of the proposed merger
transaction with Adamis, at a ratio based on the formula
described in the merger agreement, expected to be within a range
of 1:3 to 1:30, with the final ratio to be determined before the
merger as provided in the merger agreement, as described in the
accompanying joint proxy statement/prospectus.
3. To consider and act upon a proposal to approve an
amendment, which would become effective in connection with or
immediately following the closing of the proposed merger
transaction with Adamis, to our restated certificate of
incorporation to change our name from La Jolla
Pharmaceutical Company to Adamis Pharmaceuticals
Corporation, as described in the accompanying joint proxy
statement/prospectus.
4. To consider and act upon a proposal to approve, if
necessary, an adjournment of the La Jolla special meeting
to solicit additional proxies in favor of the proposals outlined
above.
5. To consider and act upon such other business and matters
or proposals as may properly come before the special meeting or
any adjournments or postponements thereof.
Recommendation
of La Jolla Board
THE LA JOLLA BOARD OF DIRECTORS HAS DETERMINED THAT THE
MERGER AND THE RELATED PROPOSALS TO BE PRESENTED AT THE
SPECIAL MEETING ARE ADVISABLE AND IN THE BEST INTERESTS OF LA
JOLLA AND ITS STOCKHOLDERS AND HAS APPROVED SUCH PROPOSALS. THE
LA JOLLA BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT LA JOLLA
STOCKHOLDERS VOTE FOR THE PROPOSALS SET FORTH
ABOVE.
Record
Date and Voting Power
Only holders of record of La Jolla common stock at the
close of business on
[ ],
2010 (the La Jolla Record Date),
are entitled to notice of, and to vote at, the
La Jolla special meeting or any adjournments or
postponements thereof. At the close of business on the
La Jolla Record Date,
[ ] shares
of La Jolla common stock were issued and outstanding and
entitled to vote. Each share of La Jolla common stock
entitles the holder thereof to one vote on each matter submitted
for stockholder approval. See the section entitled
Principal Stockholders of La Jolla in this
joint proxy statement/prospectus for information regarding
persons known to the management of La Jolla to be the
principal stockholders of La Jolla.
34
Voting
and Revocation of Proxies
The La Jolla proxy accompanying this joint proxy
statement/prospectus is solicited on behalf of the board of
directors of La Jolla for use at the La Jolla special
meeting.
If you are a stockholder of record of La Jolla as of the
La Jolla Record Date, you may vote in person at the
La Jolla special meeting or vote by proxy using the
enclosed proxy card or via the telephone or the Internet as
instructed in the materials you receive. Whether or not you plan
to attend the La Jolla special meeting, La Jolla urges
you to vote by proxy to ensure your vote is counted. You may
still attend the La Jolla special meeting and vote in
person if you have already voted by proxy.
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To vote in person, come to the La Jolla special meeting and
La Jolla will give you a ballot when you arrive.
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To vote using the proxy card, simply mark, sign and date your
proxy card and return it promptly in the postage-paid envelope
provided. To vote via the telephone or the Internet, please
refer to the instructions provided in the materials you receive.
If you vote before the La Jolla special meeting,
La Jolla will vote your shares as you direct.
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All properly executed La Jolla proxies that are not revoked
will be voted at the La Jolla special meeting and at any
adjournments or postponements of the La Jolla special
meeting in accordance with the instructions contained in the
proxy. If a holder of La Jolla common stock executes and
returns a proxy and does not specify otherwise, the shares
represented by that proxy will be voted FOR
proposals 1 through 4, as described in greater detail below.
A La Jolla stockholder of record as of the La Jolla
Record Date described above who has submitted a proxy may revoke
it at any time in one of three ways. First, a La Jolla
stockholder of record can send a written notice to the Corporate
Secretary of La Jolla stating that it would like to revoke
its proxy. Second, a La Jolla stockholder of record can
submit new proxy instructions either on a new proxy card, by
telephone or via the Internet. Third, a La Jolla
stockholder of record can attend the La Jolla special
meeting and vote in person. Attendance alone will not revoke a
proxy.
Required
Vote
The presence, in person or represented by proxy, at the
La Jolla special meeting of the holders of a majority of
the shares of La Jolla common stock outstanding and
entitled to vote at the La Jolla special meeting is
necessary to constitute a quorum at the meeting. Abstentions and
broker non-votes will be counted towards a quorum. Approval of
each of La Jolla Proposal Nos. 2 and 3 requires the
affirmative vote of holders of a majority of the outstanding
La Jolla common stock having voting power on the record
date for the La Jolla special meeting. Approval of each of
La Jolla Proposal Nos. 1 and 4 requires the
affirmative vote of the holders of a majority of the
La Jolla common stock having voting power present in person
or represented by proxy at the La Jolla special meeting.
Votes will be counted by the inspector of election appointed for
the meeting, who will separately count FOR and
AGAINST votes, and abstentions and broker non-votes.
Broker non-votes and abstentions will have the same effect as
AGAINST votes for La Jolla Proposal Nos. 2
and 3. For La Jolla Proposal Nos. 1 and 4, broker
non-votes will not be counted towards the vote total.
On the La Jolla Record Date, the directors and executive
officers of La Jolla held approximately
[ ] percent of the outstanding
shares of La Jolla common stock entitled to vote at the
La Jolla special meeting.
Solicitation
of Proxies
In addition to solicitation by mail, the directors, officers,
employees and agents of La Jolla may solicit proxies from
La Jollas stockholders by personal interview,
telephone, telegram or otherwise.
Other
Matters
As of the date of this joint proxy statement/prospectus, the
La Jolla board of directors does not know of any business
to be presented at the La Jolla special meeting other than
as set forth in the notice accompanying this joint proxy
statement/prospectus. If any other matters should properly come
before the La Jolla special meeting, it is intended that
the shares represented by proxies will be voted with respect to
such matters in accordance with the judgment of the persons
voting the proxies.
35
THE
SPECIAL MEETING OF ADAMIS STOCKHOLDERS
Date,
Time and Place
The special meeting of Adamis stockholders (the
Adamis special meeting) will be held
on
[ ],
2010, at the offices of
[ ],
San Diego, California, commencing at 10:00 a.m.,
Pacific Time. Adamis is sending this joint proxy
statement/prospectus to its stockholders in connection with the
solicitation of proxies by the Adamis board of directors for use
at the Adamis special meeting and any adjournments or
postponements of the special meeting. This joint proxy
statement/prospectus is first being furnished to stockholders of
Adamis on or about
[ ],
2010.
Purposes
of the Adamis Special Meeting
The purposes of the Adamis special meeting are:
1. To consider and vote upon a proposal to approve and
adopt the Agreement and Plan of Reorganization, dated
December 4, 2009, by and among La Jolla Pharmaceutical
Company, Jewel Merger Sub, Inc., or Merger Sub, and Adamis, a
copy of which is attached hereto as Annex A,
pursuant to which Merger Sub will merge with and into Adamis,
with Adamis surviving the merger as a wholly-owned subsidiary of
La Jolla.
2. To consider and act upon a proposal to approve, if
necessary, an adjournment of the Adamis special meeting to
solicit additional proxies in favor of the foregoing proposal.
3. To consider and act upon such other business and matters
or proposals as may properly come before the Adamis special
meeting or any adjournments or postponements thereof.
Recommendation
of Adamis Board of Directors
THE ADAMIS BOARD OF DIRECTORS HAS DETERMINED THAT THE MERGER
IS ADVISABLE AND IN THE BEST INTERESTS OF ADAMIS AND ITS
STOCKHOLDERS AND HAS APPROVED THE MERGER AND THE MERGER
AGREEMENT. THE ADAMIS BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS
THAT ADAMIS STOCKHOLDERS VOTE FOR ADAMIS
PROPOSAL NO. 1 TO APPROVE AND ADOPT THE MERGER
AGREEMENT.
THE ADAMIS BOARD OF DIRECTORS HAS DETERMINED THAT ADJOURNING
THE ADAMIS SPECIAL MEETING, IF NECESSARY, TO SOLICIT ADDITIONAL
PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF THE
FOREGOING PROPOSAL IS ADVISABLE AND IN THE BEST INTERESTS
OF ADAMIS AND ITS STOCKHOLDERS AND HAS APPROVED AND ADOPTED THE
PROPOSAL. THE ADAMIS BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS
THAT ADAMIS STOCKHOLDERS VOTE FOR ADAMIS
PROPOSAL NO. 2 TO ADJOURN THE ADAMIS SPECIAL MEETING,
IF NECESSARY, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT
SUFFICIENT VOTES IN FAVOR OF THE FOREGOING PROPOSAL.
Record
Date and Voting Power
Only holders of record of Adamis common stock at the close of
business on
[ ],
2010 (the Adamis Record Date), are
entitled to notice of, and to vote at, the Adamis special
meeting. There were approximately
[ ]
holders of record of Adamis common stock at the close of
business on the Adamis Record Date. At the close of business on
the Adamis Record Date,
[ ] shares
of Adamis common stock were issued and outstanding. Each share
of Adamis common stock entitles the holder thereof to one vote
on each matter submitted for stockholder approval. See the
section entitled Principal Stockholders of Adamis in
this joint proxy statement/prospectus for information regarding
persons known to the management of Adamis to be the principal
stockholders of Adamis.
Voting
and Revocation of Proxies
The Adamis proxy accompanying this joint proxy
statement/prospectus is solicited on behalf of the board of
directors of Adamis for use at the Adamis special meeting.
36
If you are a stockholder of record of Adamis as of the Adamis
Record Date, you may vote in person at the Adamis special
meeting or vote by proxy using the enclosed proxy card. Whether
or not you plan to attend the Adamis special meeting, Adamis
urges you to vote by proxy to ensure your vote is counted. You
may still attend the Adamis special meeting and vote in person
if you have already voted by proxy.
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To vote in person, come to the Adamis special meeting and Adamis
will give you a ballot when you arrive.
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To vote using the proxy card, simply mark, sign and date your
proxy card and return it promptly in the postage-paid envelope
provided. If you return your signed proxy card to Adamis before
the Adamis special meeting, Adamis will vote your shares as you
direct.
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All properly executed Adamis proxies that are not revoked will
be voted at the Adamis special meeting and at any adjournments
or postponements of the Adamis special meeting in accordance
with the instructions contained in the proxy. If a holder of
Adamis common stock executes and returns a proxy and does not
specify otherwise, the shares represented by that proxy will be
voted FOR Adamis Proposal No. 1 to approve
the merger agreement and the merger and FOR Adamis
Proposal No. 2 to adjourn the Adamis special meeting,
if necessary, to solicit additional proxies for
Proposal No. 1 in accordance with the recommendation
of the Adamis board of directors.
An Adamis stockholder of record as of the Adamis Record Date who
has submitted a proxy may revoke it at any time before it is
voted at the Adamis special meeting by executing and returning a
proxy bearing a later date, filing written notice of revocation
with the Secretary of Adamis stating that the proxy is revoked
or attending the Adamis special meeting and voting in person.
Required
Vote
The presence, in person or represented by proxy, at the Adamis
special meeting of the holders of a majority of the shares of
Adamis common stock outstanding and entitled to vote at the
Adamis special meeting is necessary to constitute a quorum at
the meeting. Abstentions and broker non-votes will be counted
towards a quorum. Approval of Adamis Proposal No. 1
requires the affirmative vote of holders of a majority of the
Adamis common stock having voting power outstanding on the
Adamis Record Date. Approval of Adamis Proposal No. 2
requires the affirmative vote of the holders of a majority of
the Adamis common stock and present in person or represented by
proxy at the Adamis special meeting.
Votes will be counted by the inspector of election appointed for
the meeting, who will separately count FOR and
AGAINST votes, abstentions and broker non-votes.
Abstentions will be counted towards the vote total for each
proposal and will have the same effect as AGAINST
votes. Broker non-votes will have the same effect as
AGAINST votes for Adamis Proposal No. 1.
For Adamis Proposal No. 2, broker non-votes will have
no effect and will not be counted towards the vote total.
On the Adamis Record Date, the directors and executive officers
of Adamis owned approximately 35% of the outstanding shares of
Adamis common stock entitled to vote at the Adamis special
meeting. The Principal Adamis Stockholders, who collectively
beneficially own approximately 16,271,693 shares, or
approximately 35% of the outstanding shares of Adamis common
stock, solely in their capacities as Adamis stockholders, are
subject to voting agreements and irrevocable proxies. Each such
stockholder has agreed in his voting agreement to vote all
shares of Adamis common stock that he beneficially owned as of
the date of the voting agreement, and that the stockholder
subsequently acquires, in favor of the merger, and against any
matter that would result in a breach of the merger agreement by
La Jolla and against any proposal made in opposition to, or
in competition with, the consummation of the merger and the
other transactions contemplated by the merger agreement. See the
section entitled The Merger Agreement Voting
Agreements in this joint proxy statement/prospectus.
Solicitation
of Proxies
In addition to solicitation by mail, the directors, officers,
employees and agents of Adamis may solicit proxies from
Adamis stockholders by personal interview, telephone,
telegram or otherwise.
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Other
Matters
As of the date of this joint proxy statement/prospectus, the
Adamis board of directors does not know of any business to be
presented at the Adamis special meeting other than as set forth
in the notice accompanying this joint proxy
statement/prospectus. If any other matters should properly come
before the Adamis special meeting, it is intended that the
shares represented by proxies will be voted with respect to such
matters in accordance with the judgment of the persons voting
the proxies.
THE
MERGER
This section and the section entitled The Merger
Agreement describe the material aspects of the merger and
the merger agreement. While La Jolla and Adamis believe
that this description covers the material terms of the merger
and the merger agreement, it may not contain all of the
information that is important to you. You should carefully read
this entire joint proxy statement/prospectus for a more complete
understanding of the merger and the merger agreement, including
the merger agreement attached hereto as Annex A.
Background
of the Merger
La Jolla
La Jolla had historically focused substantially all of its
research, development and clinical efforts and financial
resources toward the development of its Riquent (abetimus
sodium) product candidate. On February 11, 2009, the
La Jolla Board convened a meeting to discuss the futility
finding from the data monitoring board with respect to the
Riquent Phase 3 ASPEN study. Given the negative results, the
La Jolla Board determined that La Jolla should act
quickly with respect to minimizing costs and developing an
action plan regarding its options going forward. The
La Jolla Board accordingly established a Special Committee
to oversee and work with management on a cost-reduction plan, to
assess what value may be obtained from La Jollas
remaining assets, including Riquent and La Jollas
SSAO technology, to take next steps to maximize the value of
La Jollas remaining assets and to satisfy, to the
extent possible, all of La Jollas outstanding
obligations.
On February 12, 2009, La Jolla announced that Riquent
did not pass the interim futility analysis, the termination of
the ASPEN study and that La Jolla would be analyzing the
data from the interim analysis to assess whether Riquent could
be developed further. While analyzing the data from the interim
analysis, La Jolla was also in discussions with BioMarin
Pharmaceutical Inc., or BioMarin, with whom it had entered into
a development and commercialization agreement in January 2009,
regarding this analysis and whether BioMarin might wish to
purchase the rights to Riquent from La Jolla for further
development. However, in April 2009, BioMarin elected not to
purchase the rights to Riquent.
On February 23, 2009, La Jolla announced that, due to
the negative results of the interim efficacy analysis,
La Jolla would be reducing costs to preserve its remaining
cash and assets by substantially reducing its workforce and
operating expenses. In accordance with La Jollas plan
to substantially reduce its workforce, La Jollas full
time employees were reduced from approximately 95 as of
February 1, 2009 to 11 as of April 30, 2009.
In February and March 2009, La Jolla received written
proposals from four companies regarding potential strategic
transactions. Management reviewed these proposals with the
Special Committee in early March 2009 and was instructed by the
Special Committee to continue to evaluate such proposals and
remain ready to complete a strategic transaction if the proper
opportunity arose.
On March 27, 2009, management presented the four merger
proposals to the La Jolla Board and reviewed the terms of
each proposal in detail, including the consideration that would
be paid, the dilution to La Jollas stockholders, the
nature of the business that would be acquired, closing
conditions and the prospects for the completion of the
transaction. The La Jolla Board determined that, of the
four proposals discussed, one was worth pursuing. Accordingly,
the La Jolla Board instructed management to continue
discussions with such company, with definitive terms to be
presented for review and approval at a later time.
While La Jolla was in the process of negotiating a
strategic transaction with this potential merger candidate,
BioMarin brought suit against La Jolla claiming that
La Jolla and the La Jolla Board were in breach of
contract,
38
breach of covenant of good faith and fair dealing and breach of
their fiduciary duties. BioMarin brought suit to force
La Jolla to accelerate the timing for the registration of
approximately 10 million shares of restricted common stock
that BioMarin had purchased from La Jolla when entering
into the collaboration for Riquent in January 2009.
This lawsuit negatively impacted the merger discussions
La Jolla was having with the merger candidate discussed
above. The La Jolla Board accordingly concluded that, in
light of the ongoing lawsuit, it was impractical to continue
merger discussions. Therefore, on June 12, 2009, the
La Jolla Board determined it was in the best interests of
La Jolla to abandon attempts to enter into a merger or
other significant transaction and to begin to wind down the
business and discharge remaining obligations to creditors.
The lawsuit brought by BioMarin was resolved on July 17,
2009, upon the execution of a Settlement Agreement and Mutual
Release pursuant to which (i) BioMarin released all claims
previously asserted against La Jolla and the La Jolla
Board and (ii) La Jolla and the La Jolla Board
released all counterclaims that they may have otherwise asserted
against BioMarin. Since that time, La Jolla sought to
identify a suitable merger candidate or other strategic
transaction that would provide the potential for a better return
to La Jollas stockholders than dissolution. However,
no such opportunities were identified at that time that were
considered viable.
Due to the lack of viable strategic alternatives, the
La Jolla Board met on September 3, 2009 for the
purpose of considering the liquidation and dissolution of
La Jolla and other strategic alternatives available to
La Jolla. Management presented its analysis of
La Jollas financial situation, the status of
potential strategic transactions and the net assets that
management believed would be available for distribution to
stockholders upon the dissolution of La Jolla. After
discussion, the La Jolla Board determined that dissolution
was the most desirable option available to La Jolla and
directed management and the Special Committee to move ahead with
preparations for the dissolution and liquidation, including
preparations for the Special Meeting of Stockholders.
Nevertheless, the La Jolla Board also noted its fiduciary
duty to consider other viable alternatives that might be
presented to La Jolla prior to the filing of a certificate
of dissolution with the Secretary of State of the State of
Delaware and thus directed Dr. Gillespie to report to the
Special Committee any such viable alternatives presented to her.
Also at the September 3, 2009 meeting, Thomas H.
Adams, Ph.D., James N. Topper, M.D., Ph.D., and
Martin P. Sutter resigned from the La Jolla Board.
In accordance with the La Jolla Boards direction to
proceed with preparations for the liquidation and dissolution of
La Jolla, La Jolla continued to settle its remaining
obligations with creditors, minimize its ongoing expenses
(including abandoning the maintenance and further prosecution of
its Riquent patent estate and the sale of its SSAO patent
estate) and prepared a proxy statement soliciting the vote of
its stockholders to approve of the liquidation and dissolution
of La Jolla pursuant to a plan of complete liquidation and
dissolution. La Jolla filed its definitive proxy statement
with the SEC on October 1, 2009 and mailed the proxy
statement to the La Jolla stockholders on or about
October 7, 2009.
The proxy statement provided a detailed discussion of the
proposals to be considered at a special meeting of La Jolla
stockholders to be held on October 30, 2009. On
October 30, 2009, however, only 6% of the outstanding
shares of La Jolla had voted on such proposals. The meeting
was therefore adjourned to November 6, 2009 due to lack of
the required quorum to conduct business. The required quorum
still did not exist by the time of the November 6, 2009
meeting, resulting in the adjournment of the meeting to
November 13, 2009. On November 13, 2009, La Jolla
again lacked the requisite quorum to conduct business and
adjourned the meeting, for a third time, to November 24,
2009. La Jolla conferred with its proxy solicitor and the
proxy solicitor advised that it was unlikely that La Jolla
would achieve the necessary vote to move forward with the
proposed liquidation and dissolution. La Jolla therefore,
concurrent with preparing to dissolve, conducted a process to
evaluate other strategic opportunities. La Jolla announced
the cancellation of its special meeting of stockholders to
approve the plan of dissolution of La Jolla on
November 25, 2009.
In early October 2009, Dennis Carlo, the chief executive officer
of Adamis, contacted Dr. Gillespie inquiring whether
La Jolla had an interest in pursuing conversations
concerning a transaction between the two companies. On
October 8, 2009, the parties executed a mutual
nondisclosure agreement, and the parties began exchanging due
diligence materials. On October 13, 2009, Dr. Carlo
and David Marguglio, the vice president of business development
and investor relations of Adamis, met with Dr. Gillespie
and Gail Sloan, the Vice President of Finance of La Jolla.
Dr. Gillespie indicated that La Jolla was considering
alternatives to dissolving and winding up
39
the companys affairs and distributing any cash to its
stockholders remaining after paying and providing for all
obligations to its creditors. Dr. Carlo and
Mr. Marguglio discussed Adamis current and intended
business, and indicated that Adamis was interested in exploring
an acquisition or other transaction that would result in
additional cash funding for Adamis. The parties discussed
different possible ways that such a transaction might be
structured and issues relating to different possible structures.
On October 16, 2009, La Jolla distributed a draft term
sheet to Adamis describing a framework for discussions regarding
a possible merger transaction including a merger of Adamis into
La Jolla. On October 22, 2009, Adamis delivered a
revised term sheet to La Jolla, proposing a reverse merger
structure where a subsidiary of La Jolla would merge into
Adamis, Adamis would be the surviving corporation and a
wholly-owned subsidiary of La Jolla, and the stockholders
of Adamis would receive shares of common stock of La Jolla
on the basis of one share of La Jolla common stock for each
share of Adamis common stock. Before the closing of the merger,
La Jolla would effect a reverse stock split of its common
stock. The term sheet proposed that the ratio of the reverse
stock split would be determined based on the amount of net cash
of La Jolla as of the closing of the merger and a
discounted Adamis share price based on the Adamis stock price
and a percentage discount that varied at different ranges of
stock prices.
Between October 22, 2009 and November 2, 2009, the
parties continued to have discussions regarding a variety of
legal and business issues concerning issues relating to the
structure, valuation, timing and terms of a possible
transaction, and due diligence continued. On November 2,
2009, Adamis delivered a draft merger agreement to La Jolla.
As of November 2009, having reviewed a number of possible
strategic transaction opportunities, La Jolla was
considering three merger proposals and discussed those strategic
alternatives in detail with the La Jolla Board. The
La Jolla Board prioritized the merger candidates and
authorized La Jolla management to move forward in
discussions with two of the candidates and to complete the due
diligence and related work necessary to reach definitive terms
that could be presented to the Special Committee of the
La Jolla Board (the Special
Committee) for final approval.
On December 3, 2009, the Special Committee held a meeting,
with La Jollas legal counsel present. In connection
with that meeting, drafts of the merger agreement were
circulated to the directors. Dr. Gillespie summarized the
proposed terms of the transaction with Adamis, including the
range of expected percentage ownership of the combined company
that La Jolla stockholders would own, the proposed reverse
stock split of the La Jolla common stock before the merger
and the determination of the reverse stock split ratio including
the range of discounts from the weighted average Adamis stock
price to be used as a factor in calculating the ratio of the
La Jolla reverse stock split. The Special Committee
discussed the terms of the proposed transaction and limited
alternatives to the merger transaction. Following review, the
Special Committee approved the merger agreement and related
proposals and transactions.
Adamis
As part of managements ordinary process of considering
corporate and financing alternatives for Adamis, in early
October 2009, Dennis Carlo, the chief executive officer of
Adamis, contacted Dr. Gillespie inquiring whether
La Jolla had an interest in pursuing conversations
concerning a transaction between the two companies.
Dr. Carlo knew of Dr. Gillespie and of La Jolla
by virtue of his experience as an executive of pharmaceutical
companies in the San Diego area and his knowledge that
La Jolla had taken steps during 2009 to substantially
reduce its operations, preserve its cash and consider strategic
alternatives.
Discussions and negotiations between Adamis and La Jolla,
and their respective counsel, during the period from mid-October
2009 through the date the merger agreement was executed are
described above under the heading Background of the
Merger La Jolla. During the discussions
described above, Dr. Carlo and Mr. Marguglio were also
directors of Adamis, and Dr. Carlo apprised the other
Adamis director, Mr. Aloi, of the progress of discussions
with La Jolla and the terms being discussed, including the
general structure of the proposed reverse split of
La Jollas shares, the intent to structure a
transaction so as to be tax-free to the stockholders of both
companies, and the filing of a joint proxy/registration
statement with the SEC concerning the transaction. Issues
negotiated by the parties during this time included the
percentage discount and range of prices to which different
discounts would be applied that would be included in the formula
of determining the reverse stock split ratio, whether and in
what
40
circumstances La Jolla would have a right to terminate the
merger agreement if Adamis weighted average stock price
fell below certain price levels, whether Adamis would have a
right to terminate the merger agreement if La Jollas
net cash at closing fell below certain levels, which
restrictions would apply to the parties ability to issue
additional shares between the date of the merger agreement and
the closing of the merger, representations and warranties to be
made by the parties in the merger agreement and other matters.
These discussions culminated in a December 4, 2009 meeting
of the Adamis Board, with Adamis legal counsel present. In
connection with that meeting, drafts of the merger agreement and
principal ancillary agreements, including the voting agreements,
were circulated to the directors. Dr. Carlo summarized
Adamis current and expected cash position and expected
future cash requirements. Dr. Carlo and outside counsel
summarized the proposed terms of the transaction with
La Jolla, including the range of expected percentage
ownership of the combined company that La Jolla
stockholders would own, the proposed reverse stock split of the
La Jolla common stock before the merger and the
determination of the reverse stock split ratio including the
range of discounts from the weighted average Adamis stock price
to be used as a factor in calculating the ratio of the
La Jolla reverse stock split, the amount of cash,
liabilities and obligations that La Jolla expected to have
as of the anticipated closing date for the merger, the
representations, warranties, covenants, closing conditions and
indemnity provisions of the merger agreement and other material
terms. The Adamis board discussed the terms of the proposed
transaction, various strategic alternatives to the merger
transaction and Adamis current and expected cash needs.
Following review, the Adamis board approved the merger agreement
and related proposals and transactions. Following the board
meeting, the merger agreement and ancillary documents, including
the voting agreements with certain Adamis officers, were
finalized. The changes made to the merger agreement and other
agreements during this time were not substantive and did not
alter the consideration to be received by Adamis stockholders or
La Jolla stockholders or any other material term from the
version of the merger agreement and voting agreement circulated
to the Adamis board of directors in connection with the
December 4, 2009 meeting of the board of directors. The
merger agreement and ancillary documents were executed and
delivered by the parties on December 4, 2009.
Accordingly, on December 4, 2009, a definitive merger
agreement was signed between La Jolla, Adamis and Merger
Sub. In addition, certain directors and officers of Adamis
executed voting agreements with La Jolla. Prior to the
opening of trading markets on December 7, 2009,
La Jolla and Adamis each issued a press release announcing
the execution of the merger agreement.
La Jolla and Adamis determined the merger consideration
according to their respective views concerning the relative
valuations of the two companies at the time of the merger
negotiations. For example, the merger consideration was based in
part upon the range of net cash that La Jolla could
reasonably be expected to have at the closing, the range of
Adamis stock prices between the date of the merger agreement and
the closing of the merger, and La Jollas estimated
valuation of Adamis at the time, which estimate accounted for
Adamis future prospects. Because neither La Jolla nor
Adamis had performed a formal valuation during the negotiations,
such valuation could only be estimated, with an understanding by
both La Jolla and Adamis that their respective valuations,
whether estimated or otherwise, could be subject to change.
Following the negotiations described above, La Jolla and
Adamis ultimately agreed on the terms for the merger described
in this joint proxy statement/prospectus.
Reasons
for the Merger
The following discussion of the parties reasons for the
merger contains a number of forward-looking statements that
reflect the currents views of La Jolla
and/or
Adamis with respect to future events that may have an effect on
their future financial performance. Forward-looking statements
are subject to risks and uncertainties. Actual results and
outcomes may differ materially from the results and outcomes
discussed in the forward-looking statements. Cautionary
statements that identify important factors that could cause or
contribute to differences in results and outcomes include those
discussed in the sections entitled Risk Factors and
Forward-Looking Statements.
Mutual
Reasons for the Merger
In reaching the decision to adopt the merger agreement and
recommend the proposals discussed herein for approval by the
respective stockholders of La Jolla and Adamis, each board
of directors consulted with its respective management as well as
legal advisors. As discussed in greater detail below, these
consultations included discussions
41
regarding Adamis and La Jollas strategic
business plans, the costs and risks of executing those business
plans as independent companies, past and current business
operations and financial condition, future prospects, the
strategic rationale for the potential transaction, and the terms
and conditions of the merger agreement.
La Jolla and Adamis believe that the combined company will
have the following potential advantages:
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Existing Sales and Product Line. The combined
company will have an existing line of prescription products,
primarily the PFS Syringe product, that are promoted and sold to
physicians who specialize in allergy, respiratory disease and
pediatric medicine.
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Additional Product Candidates. The combined
company will have a number of additional product candidates in
the allergy and respiratory field, including the nasal steroid
product candidate.
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Intellectual Property Rights for Additional Product
Candidates. The combined company will have a
portfolio of intellectual property rights that may lead to
product candidates targeted at prevention and treatment of
certain viral diseases, which, if successfully developed, are
expected to address significant markets.
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Management Team. The combined company will be
led by the experienced senior management from Adamis.
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Stronger Balance Sheet. The anticipated net
cash from La Jolla will strengthen the balance sheet of
Adamis and support the commercialization and drug development
activities of Adamis.
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La Jollas
Reasons for the Merger
In addition to considering the factors outlined above, the
La Jolla Board considered the following factors in reaching
its conclusion to approve the merger and to recommend that the
La Jolla stockholders approve the issuance of shares of
La Jolla common stock in the merger and the resulting
change of control of La Jolla, and the related
transactions, all of which it viewed as supporting its decision
to approve the business combination with Adamis:
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the lack of a viable product candidate or cash resources to
develop a new product candidate following the failure of Riquent;
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the inability to obtain stockholder approval for the proposed
liquidation and dissolution of La Jolla;
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the consideration of La Jollas efforts to pursue
strategic alternatives to the merger, including engaging in a
merger transaction with another company or dissolving the
business;
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results of the due diligence review of Adamis business and
operations by La Jollas management, which confirmed,
among other things, that Adamis met the criteria set by the
La Jolla Board for a potential merger candidate;
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the fact that the transaction would be submitted to the
La Jolla stockholders for approval;
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the current and recent market prices for the La Jolla and
Adamis common stock;
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the results of efforts made by La Jolla management to
solicit indications of interest from third parties regarding a
potential business combination or other alternative transactions;
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the future prospects for La Jollas business, and the
costs of attempting to continue as an independent company;
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the terms and conditions of the merger agreement, including the
following related factors:
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the percentage of the combined company that the La Jolla
stockholders will receive in the transaction, which was expected
to be in the range of between approximately 5% and 30% of the
outstanding shares of the combined company;
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the limited number and nature of the conditions to Adamis
obligation to consummate the merger;
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42
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La Jollas rights under the merger agreement to
consider certain unsolicited acquisition proposals under certain
circumstances should La Jolla receive a superior proposal;
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the conclusion of the La Jolla Board that the potential
termination fee of $150,000, and the circumstances when such fee
may be payable, were reasonable;
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the no-solicitation provisions governing Adamis ability to
engage in negotiations with, provide any confidential
information or data to, and otherwise have discussions with, any
person relating to an alternative acquisition proposal; and
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the belief that the terms of the merger agreement, including the
parties representations, warranties and covenants, and the
conditions to their respective obligations, are reasonable under
the circumstances;
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La Jollas understanding of Adamis business,
including its product candidates, Adamis experienced
management team, and the prospects for value creation for
La Jolla stockholders in connection with the merger;
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the likelihood that the merger would be consummated, including
the likelihood that the merger will receive all necessary
approvals;
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the opportunity for La Jollas stockholders to
participate in the long-term value of Adamis product
candidate development programs as a result of the merger; and
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the La Jolla Boards consideration of strategic
alternatives to the merger, including engaging in a merger
transaction with another company or undertaking the liquidation
of La Jolla.
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In the course of its deliberations, the La Jolla Board also
considered a variety of risks and other countervailing factors
related to entering into the merger agreement, including:
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the risks related to the merger, Adamis and the combined company
as described in the Risk Factors section set forth
elsewhere in this joint proxy statement/prospectus, including
the risk that the combined company will not be successful in
developing additional commercial products, the risk that the
combined company will not be able to secure funding for such
development on commercially reasonable terms or at all, and the
risk that revenues from Adamis current and future products
will be less than expected;
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the $150,000 termination fee payable to Adamis upon the
occurrence of certain events and the potential effect of such
termination fee in deterring other potential acquirers from
proposing an alternative transaction that may be more
advantageous to La Jollas stockholders;
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the risks, challenges and costs inherent in combining the
operations of the two companies and the substantial expenses to
be incurred in connection with the merger, including the
possibility that delays or difficulties could adversely affect
the combined companys operating results and preclude the
achievement of some of the benefits anticipated from the merger;
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the possible volatility of the trading price of La Jolla
common stock resulting from the merger announcement;
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the risk that the merger might not be consummated in a timely
manner or at all;
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the fact that La Jollas stockholders would experience
material dilution by virtue of the reverse stock split and the
exchange ratio in the merger transaction and that the degree of
dilution could be increased by other stock issuances by Adamis
prior to the merger;
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the expected inability of the La Jolla common stock to
remain listed on Nasdaq if the merger were completed and the
potential reduction in the liquidity of the La Jolla common
stock if La Jolla were to cease being a Nasdaq-listed
company;
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the risk to La Jollas business, operations and
financial results in the event that the merger is not
consummated; and
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the fact that the prospects for the Adamis products and
product candidates involve uncertainty.
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43
The La Jolla Board also discussed potential alternatives to
the transaction, including pursuing a voluntary dissolution and
continuing to pursue an alternative business combination
transaction with a third party other than Adamis. The
La Jolla Board concluded that other potential transactions
with third parties might not be concluded and were not as
attractive as the proposed transaction with Adamis. The
La Jolla Board concluded that the proposed merger with
Adamis was a more attractive alternative for the La Jolla
stockholders than pursuing a dissolution proceeding, which would
require additional time and expense to complete and which would
result in less value to La Jollas stockholders. The
La Jolla Board reviewed the issues likely to be involved
with pursuing a voluntary dissolution and concluded that such an
alternative would not be in the best interests of the
La Jolla stockholders and was not likely to provide
superior value to the merger with Adamis. The La Jolla
Board concluded that it was unlikely to attract a superior
merger offer than the proposed transaction with Adamis, and that
attempting to continue looking for other transactions would
involve additional time and expense with no reasonable prospect
of a superior result for the La Jolla stockholders.
After evaluating the proposed transaction with Adamis and taking
into account all of the factors previously discussed and
considered by the La Jolla Board, the board unanimously
approved the merger transaction with Adamis and authorized
management to negotiate and enter into a definitive agreement on
terms consistent in material respects with the terms presented
to the La Jolla Board. In making its determination, the
La Jolla Board considered the percentage of the combined
company that would be held by La Jolla stockholders, the
existing business and future business prospects of Adamis, the
overall structure of the transaction, the terms of the merger
agreement and the factors and considerations described above.
The foregoing information and factors considered by the
La Jolla Board are not intended to be exhaustive but are
believed to include all of the material factors considered by
the La Jolla Board. The La Jolla Board viewed its
recommendation to approve the merger transaction as being based
upon its business judgment in light of La Jollas
financial position and the totality of the information presented
and considered, and the overall effect of the transaction on the
stockholders of La Jolla compared to other alternatives. In
view of the wide variety of factors considered in connection
with its evaluation of the merger and the complexity of these
matters, the La Jolla Board did not find it useful, and did
not attempt, to quantify, rank or otherwise assign relative
weights to these factors. In considering the factors described
above, individual members of the La Jolla Board may have
given different weight to different factors. The La Jolla
Board conducted an overall analysis of the factors described
above, including discussions with, and questioning of,
La Jollas management and La Jollas legal
advisors, and considered the factors overall to be favorable to,
and to support, its determination.
Interests of the La Jolla Board and Executive Officers
in the Proposed Transaction. The La Jolla
Board was aware that certain of La Jollas directors
and executive officers may have interests in the proposed
transaction that are different from, or in addition to, the
interests of La Jollas stockholders generally, and
that these interests may present them with actual or potential
conflicts of interest in the merger that may be different from,
or in addition to, interests they have as La Jolla
stockholders.
Adamis
Reasons for the Merger
The Adamis Board has determined that the terms of the proposed
merger are fair and in the best interests of Adamis and its
stockholders. Accordingly, the Adamis Board approved the merger
agreement and the merger contemplated thereby, and recommended
that Adamis stockholders vote FOR
approval of the merger agreement and the merger contemplated
thereby.
The Adamis Board considered a number of factors in reaching its
decision, without assigning any specific or relative weight to
such factors. The material factors considered included:
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information concerning the business, operations, net worth,
liabilities, cash assets and needs, and future business
prospects of Adamis and La Jolla, both individually and on
a combined basis;
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the belief that by combining operations, the combined company
would have better opportunities for future growth than Adamis
would have on its own;
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the current and prospective economic and competitive
environments facing Adamis as a stand-alone company;
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44
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the fact that the holders of Adamis common stock would own a
substantial majority of the outstanding common stock of the
combined company;
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the belief that the merger would provide Adamis with additional
financial resources, including immediate cash;
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the opportunity for Adamis stockholders to benefit from
potential appreciation in the value of the combined
companys common stock;
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the expectation that the merger would be accomplished on a
tax-free basis for United States federal income tax purposes for
United States taxpayers, except for taxes payable on cash
received by Adamis stockholders in lieu of fractional shares.
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In addition to considering the factors outlined above, the
Adamis Board considered the following factors in reaching its
conclusion to approve the merger and to recommend that the
Adamis stockholders approve the merger agreement, all of which
it viewed as supporting its decision to approve the business
combination with La Jolla:
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the results of the due diligence review of La Jollas
business and operations by Adamis management confirmed
that the assets and liabilities of La Jolla were
substantially as represented by La Jolla management;
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the terms and conditions of the merger agreement, including the
following related factors:
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the number of the shares of the combined company that the Adamis
stockholders will receive in the transaction;
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the nature of the conditions to La Jollas obligation
to consummate the merger and the Adamis Board belief concerning
the limited risk of non-satisfaction of such conditions;
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the limited number and nature of the conditions to Adamis
obligation to consummate the merger;
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the conclusion of the Adamis Board that the potential
termination fee of $150,000, and the circumstances in which such
fee may be payable, were reasonable;
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the no-solicitation provisions governing La Jollas
ability to engage in negotiations with, provide any confidential
information or data to, and otherwise have discussions with, any
person relating to an alternative acquisition proposal;
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the belief that the terms of the merger agreement, including the
parties representations, warranties and covenants, and the
conditions to their respective obligations, are reasonable under
the circumstances;
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the likelihood that the merger will be consummated, including
the likelihood that the merger will receive all necessary
approvals; and
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the Adamis Boards consideration of strategic alternatives
to the merger, including engaging in an alternate transaction
with another third party.
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The Adamis Board also considered a number of risks and
potentially negative factors in its deliberations concerning the
merger, including the risk factors described elsewhere in this
joint proxy statement/prospectus, and in particular:
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the fact that Adamis stockholders will not receive the
full benefit of any future growth in the value of their equity
that Adamis may have achieved as an independent company;
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the risks associated with the existing operations of
La Jolla;
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the limitations on Adamis, as set forth in the merger agreement,
from engaging in discussions and negotiations with any party
other than La Jolla concerning a business combination
involving Adamis;
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the possibility that Adamis will be required to pay the
termination fee provided for in the merger agreement;
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the possibility that La Jolla might have less than expected
net cash at the closing of the merger;
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45
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the risk that the potential benefits of the merger may not be
realized;
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the risks, challenges and costs inherent in combining the
operations of the two companies and the substantial expenses to
be incurred in connection with the merger, including the
possibility that delays or difficulties could adversely affect
the combined companys operating results and preclude the
achievement of some of the benefits anticipated from the merger;
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the possible volatility, at least in the short term, of the
trading price of Adamis common stock following the merger;
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the risk of diverting managements attention from other
strategic priorities to implement merger integration efforts;
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the risk that the merger might not be consummated in a timely
manner or at all and the potential adverse effect of the public
announcement of the merger on Adamis reputation;
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the risk to Adamis business, operations and financial
results in the event that the merger is not consummated; and
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various other risks associated with the combined company and the
merger, including those described in the section entitled
Risk Factors in this joint proxy
statement/prospectus.
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The Adamis Board determined that the merger is preferable to the
other alternatives that might be available to Adamis, such as
seeking additional equity or debt financings, or engaging in a
transaction with another party. The Adamis Board made that
determination because it believes that the merger will unite two
companies with complementary needs and assets, thereby creating
a combined company with greater capital strength and
profitability potential than Adamis possesses on a stand-alone
basis.
For the reasons set forth above, the Adamis Board recommended
that holders of Adamis common stock vote to approve the merger
agreement, the merger contemplated thereby, and the related
transactions.
Interests
of La Jollas Directors and Executive Officers in the
Merger
In considering the recommendation of the La Jolla Board
with respect to approving the issuance of shares of
La Jolla common stock to Adamis stockholders in connection
with the merger and the other matters to be acted upon by
La Jolla stockholders at the La Jolla special meeting,
La Jolla stockholders should be aware that Deirdre Y.
Gillespie, M.D. and Gail A. Sloan, the President and Chief
Executive Officer and the Vice President of Finance and
Secretary respectively, of La Jolla, have interests in the
merger that may be different from, or in addition to, interests
they have as La Jolla stockholders.
Pursuant to the Retention and Separation Agreement and General
Release of All Claims, dated as of December 4, 2009, by and
between La Jolla and Dr. Gillespie (the
Gillespie Retention Agreement), which
supersedes the severance provisions of Dr. Gillespies
existing employment agreement, as amended, Dr. Gillespie
received a retention bonus in the amount of $202,800 and is
entitled to receive a severance payment in the amount of
$405,600. Dr. Gillespie is entitled to both payments so
long as she does not resign her employment with La Jolla
prior to the earlier of (a) the closing of the merger with
Adamis and (b) March 31, 2010. If, however,
Dr. Gillespie voluntarily resigns her employment with
La Jolla prior to the earlier to occur of (a) the
closing of the merger and (b) March 31, 2010, she must
immediately repay her retention bonus to La Jolla and will
not receive a severance payment of $405,600 payable under the
Gillespie Retention Agreement.
Pursuant to the Retention and Separation Agreement and Release
of All Claims, dated as of December 4, 2009, by and between
La Jolla and Ms. Sloan (the Sloan
Retention Agreement), which supersedes the
severance provisions of Ms. Sloans existing
employment agreement, as amended, Ms. Sloan received a
retention bonus in the amount of $66,183.53 and is entitled to
receive a severance payment in the amount of $132,367.06.
Ms. Sloan is entitled to both payments so long as she does
not resign her employment with La Jolla prior to the
earlier of (a) the closing of the merger with Adamis and
(b) March 31, 2010. If, however, Ms. Sloan
voluntarily resigns her employment with La Jolla prior to
the earlier to occur of (a) the closing of the merger and
(b) March 31, 2010, she
46
must immediately repay her retention bonus to La Jolla and
will not receive a severance payment of $132,367.06 payable
under the Sloan Retention Agreement.
Moreover, on December 3, 2009, the La Jolla
Compensation Committee approved grants of restricted stock units
to each of Dr. Gillespie and Ms. Sloan with a
grant-date fair value of no more than $223,080 and $76,442 for
Dr. Gillespie and Ms. Sloan, respectively. The
restricted stock units of each of Dr. Gillespie and
Ms. Sloan will only vest upon the closing of the merger.
Ownership
Interests
La Jollas directors, executive officers and their
affiliates hold less than 1% of the shares of La Jolla
common stock that are outstanding on the date of this joint
proxy statement/prospectus.
Each of La Jollas executive officers and non-employee
directors also holds options to purchase shares of La Jolla
common stock. The options were previously granted under
La Jollas equity incentive plans pursuant to a stock
option agreement. Each option grant typically vests in a series
of annual installments over a number of years. However, the
option agreements provide that each option will vest and become
exercisable as to all shares covered by such option upon the
consummation of a merger involving La Jolla, subject to
certain exceptions that do not apply to the contemplated merger.
As a result, all of the outstanding options held by
La Jollas executive officers and non-employee
directors will immediately vest and become exercisable in full
upon consummation of the merger.
The following table shows the total number of options held as of
December 9, 2009 by each director and executive officer of
La Jolla. The options have exercise prices ranging between
$1.42 and $38.25 per share. Based on the difference between
$0.23 (the closing price of a share of La Jolla common
stock as quoted on The Nasdaq Capital Market on December 9,
2009) and the actual exercise price of each
individuals unvested options, none of the unvested options
held by La Jollas executive officers and non-employee
directors has any intrinsic value.
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Weighted
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Average
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Total Options
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Exercise Price
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Name
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Held
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Vested
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Unvested
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per Share
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Executive Officers:
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Deirdre Y. Gillespie
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1,250,000
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953,125
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296,875
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$
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4.20
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Gail A. Sloan
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345,513
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304,367
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41,146
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$
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6.55
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Directors:
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Robert A. Fildes, Ph.D.
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100,276
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100,276
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$
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6.30
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Stephen M. Martin
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105,400
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105,400
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$
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6.87
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Craig R. Smith, M.D.
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123,400
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123,400
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$
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4.85
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Frank E. Young, M.D., Ph.D.
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38,000
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38,000
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$
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3.83
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The La Jolla Board was aware of these potential conflicts
of interest and considered them in reaching its decision to
approve the transactions contemplated by the merger agreement
and to recommend that the La Jolla stockholders approve the
La Jolla proposals contemplated by this joint proxy
statement/prospectus.
Interests
of Adamis Directors and Executive Officers in the
Merger
In considering the recommendation of the Adamis Board with
respect to approving the merger, Adamis stockholders should be
aware that certain members of the board of directors and
executive officers of Adamis have interests in the merger that
may be different from, or in addition to, interests they have as
Adamis stockholders. Following the consummation of the merger,
the persons who currently constitute the Adamis board of
directors (Dr. Carlo and Messrs. Aloi and Marguglio)
will continue to serve on the board of directors of the combined
company and the existing executive officers of Adamis will
continue to serve in their respective positions with the
combined company. Adamis directors, executive officers and
their affiliates hold approximately 35% of the shares of Adamis
common stock that are outstanding on the date of this prospectus.
The Adamis Board was aware of these potential conflicts of
interest and considered them, among other matters, in reaching
its decision to approve the merger agreement and the merger and
to recommend that its stockholders approve the Adamis proposals
contemplated by this joint proxy statement/prospectus.
47
Ownership
Interests
As of December 4, 2009, certain of the major stockholders
of Adamis, sometimes referred to as the Principal Adamis
Stockholders, holding approximately 16,272,000 shares, or
approximately 35% of the outstanding shares of Adamis common
stock, solely in their capacity as Adamis stockholders, have
entered into voting agreements and irrevocable proxies with
La Jolla in connection with the merger. For a more detailed
discussion of the voting agreements see the section entitled
Agreements Related to the Merger Voting
Agreements.
Effective
Time of the Merger
The merger agreement requires the parties to consummate the
merger after all of the conditions to the consummation of the
merger contained in the merger agreement are satisfied or
waived, including obtaining the requisite approvals by the
stockholders of each of La Jolla and Adamis. The merger
will become effective after the reverse stock split and upon the
filing of a certificate of merger with the Secretary of State of
the State of Delaware or at such later time as is agreed by
La Jolla and Adamis and specified in the certificate of
merger. Neither La Jolla nor Adamis can predict the exact
timing of the consummation of the merger.
Regulatory
Approvals
La Jolla must comply with applicable federal and state
securities laws in connection with the issuance of shares of
La Jolla common stock in the merger and the filing of this
joint proxy statement/prospectus with the SEC.
Tax
Treatment of the Merger
La Jolla and Adamis intend the merger to qualify as a
reorganization within the meaning of Section 368(a) of the
Internal Revenue Code of 1986, as amended, or the Code. Each of
La Jolla and Adamis will use its commercially reasonable
best efforts to cause the merger to qualify as a reorganization
within the meaning of Section 368(a) of the Code, and not
to permit or cause any affiliate or any subsidiary of
La Jolla or Adamis to take any action or cause any action
to be taken that would cause the merger to fail to qualify as a
reorganization under Section 368(a) of the Code.
Certain
Material United States Federal Income Tax Considerations with
Respect to the Merger
General
The following general discussion summarizes certain material
United States federal income tax considerations relating to the
merger to La Jolla, Merger Sub, Adamis, and holders of
Adamis common stock who are United States
persons (as defined in Section 7701(a)(30) of the
Code) and who hold their Adamis common stock as a capital asset
within the meaning of Section 1221 of the Code. The term
non-United
States person means a person or holder other than a
United States person. If a partnership or other
flow-through entity is a beneficial owner of Adamis common
stock, the tax treatment of a partner in the partnership or an
owner of the entity will generally depend upon the status of the
partner or other owner and the activities of the partnership or
other entity.
This section does not discuss all of the United States federal
income tax consequences that may be relevant to a particular
stockholder in light of his or her individual circumstances or
to stockholders subject to special treatment under the federal
income tax laws, including, without limitation:
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brokers or dealers in securities or foreign currencies;
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stockholders who are subject to the alternative minimum tax
provisions of the Code;
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tax-exempt organizations;
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stockholders who are
non-United
States persons;
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expatriates;
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stockholders that have a functional currency other than the
United States dollar;
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banks, financial institutions or insurance companies;
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stockholders who acquired Adamis stock in connection with stock
option or stock purchase plans or in other compensatory
transactions; or
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stockholders who hold Adamis stock as part of an integrated
investment, including a straddle, hedge, or other risk reduction
strategy, or as part of a conversion transaction or constructive
sale.
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Assuming the merger is completed according to the terms of the
merger agreement and this joint proxy statement/prospectus, and
based upon customary assumptions and certain representations as
to factual matters by La Jolla and Adamis, it is the
opinion of Goodwin Procter LLP that the merger will be treated
for United States federal income tax purposes as a
reorganization within the meaning of Section 368(a) of the
Code. No ruling has been or will be sought from the Internal
Revenue Service, or the IRS, as to the United States federal
income tax consequences of the merger, and the following summary
is not binding on the IRS or the courts. This discussion is
based upon the Code, laws, regulations, rulings and decisions in
effect as of the date of this proxy statement/prospectus, all of
which are subject to change, possibly with retroactive effect
and to differing interpretations. This summary does not address
the tax consequences of the merger under state, local and
foreign laws or under United States federal tax law other than
income tax law. There can be no assurance that the IRS will not
challenge one or more of the tax considerations described herein.
Adamis stockholders are urged to consult their own tax
advisors as to the specific tax consequences to them of the
merger, including any applicable federal, state, local and
foreign tax consequences.
The following summary sets forth certain material
U.S. federal income tax considerations for the Adamis
stockholders and the corporate parties to the merger assuming
that the merger constitutes a reorganization within
the meaning of Section 368(a) of the Code.
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Adamis stockholders will not recognize any gain or loss upon the
receipt of La Jolla common stock in exchange for Adamis
stock in connection with the merger (except to the extent of
cash received in lieu of a fractional share of La Jolla
common stock, as discussed below).
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Cash payments received by an Adamis stockholder for a fractional
share of La Jolla common stock will be treated as if such
fractional share had been issued in connection with the merger
and then redeemed by La Jolla for cash. Adamis stockholders
will recognize capital gain or loss with respect to such cash
payment, measured by the difference, if any, between the amount
of cash received and the tax basis in such fractional share. The
gain or loss will generally be long-term capital gain or loss,
if, as of the effective date of the merger, the holding period
for the Adamis stock is longer than one year. The deductibility
of capital losses is subject to limitation.
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The aggregate tax basis of the La Jolla common stock
received by an Adamis stockholder in connection with the merger
will be the same as the aggregate tax basis of the Adamis stock
surrendered in exchange for La Jolla common stock, reduced
by any amount allocable to a fractional share of La Jolla
common stock for which cash is received.
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The holding period of the La Jolla common stock received by
an Adamis stockholder in connection with the merger will include
the holding period of the Adamis stock surrendered in connection
with the merger.
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A dissenting stockholder who perfects appraisal rights will
generally recognize gain or loss with respect to his or her
shares of the Adamis stock equal to the difference between the
amount of cash received and his or her basis in such shares.
Such gain or loss will generally be long term capital gain or
loss, provided the shares were held for more than one year
before the disposition of the shares. Interest, if any, awarded
in an appraisal proceeding by a court would be included in such
stockholders income as ordinary income.
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La Jolla, Merger Sub and Adamis will not recognize gain or
loss solely as a result of the merger.
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49
Backup
Withholding
If you are a non-corporate holder of Adamis stock you may be
subject to information reporting and backup withholding on any
cash payments received in lieu of a fractional share interest in
La Jolla common stock or cash payments for perfecting
appraisal rights. You will not be subject to backup withholding,
however, if you:
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furnish a correct taxpayer identification number and certify
that you are not subject to backup withholding on the substitute
Form W-9
or successor form included in the letter of transmittal to be
delivered to you following the completion of the merger; or
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are otherwise exempt from backup withholding.
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Any amounts withheld under the backup withholding rules will be
allowed as a refund or credit against your United States federal
income tax liability, provided you furnish the required
information to the IRS.
Tax
Return Reporting Requirements
If you receive La Jolla common stock as a result of the
merger, you will be required to retain records pertaining to the
merger, and you will be required to file with your United States
federal income tax return for the year in which the merger takes
place a statement setting forth certain facts relating to the
merger as provided in Treasury Regulations
Section 1.368-3(b).
Taxable
Acquisition
The failure of the merger to qualify as a reorganization within
the meaning of Section 368(a) of the Code would result in
an Adamis stockholder recognizing gain or loss with respect to
the shares of Adamis stock surrendered by such stockholder equal
to the difference between the stockholders basis in the
shares and the fair market value, as of the effective time of
the merger, of the La Jolla stock received in exchange for
the Adamis stock (and the cash received in lieu of a fractional
share of Adamis stock). In such event, a stockholders
aggregate basis in the La Jolla common stock so received
would equal its fair market value, and such stockholders
holding period would begin the day after the merger. The gain or
loss would generally be long-term capital gain or loss, if, as
of the effective date of the merger, the holding period for the
Adamis stock is longer than one year. The deductibility of
capital losses is subject to limitations. A dissenting
stockholder who receives cash will be required to recognize gain
or loss in the same manner as described above (see discussion of
dissenters in a reorganization above).
The foregoing discussion is not intended to be a complete
analysis or description of all potential United States federal
income tax consequences of the merger. In addition, the
discussion does not address tax consequences which may vary
with, or are contingent on, your individual circumstances.
Moreover, the discussion does not address any non-income tax or
any foreign, state or local tax consequences of the merger.
Accordingly, Adamis stockholders are urged to consult with their
own tax advisor to determine the particular United States
federal, state, local or foreign income or other tax
consequences to them of the merger.
Anticipated
Accounting Treatment
Adamis security holders are expected to own, after the merger,
between approximately 70% and 95% of the outstanding shares of
the combined company. Further, Adamis directors will initially
constitute the entirety of the combined companys board of
directors, and all members of the executive management of the
combined company will be from Adamis. Therefore, Adamis will be
deemed to be the acquiring company for accounting purposes and
the merger will be accounted for as a reverse merger and a
recapitalization.
The unaudited pro forma combined condensed consolidated
financial statements included in this joint prospectus/proxy
have been prepared to give effect to the proposed merger of
Adamis and La Jolla as a reverse acquisition of assets and
a recapitalization in accordance with accounting principles
generally accepted in the United States. For accounting
purposes, Adamis is considered to be acquiring La Jolla in
the merger and it is assumed that La Jolla does not meet
the definition of a business in accordance with The
Accounting Standards Codification Topic of Business Combinations
because of La Jollas current efforts to sell or
otherwise dispose of its operating assets and liabilities.
50
Appraisal
Rights
If the merger is completed, holders of Adamis common stock are
entitled to appraisal rights under Section 262 of the DGCL,
or Section 262, provided that they comply with the
conditions established by Section 262.
The discussion below is a summary regarding an Adamis
stockholders appraisal rights under Delaware law but is
not a complete statement of the law regarding dissenters
rights under Delaware law and is qualified in its entirety by
reference to the text of the relevant provisions of Delaware
law, which are attached hereto as Annex B.
Stockholders intending to exercise appraisal rights should
carefully review Annex B. Failure to precisely
follow any of the statutory procedures set forth in
Annex B may result in a termination or waiver of
these rights.
A stockholder of Adamis common stock who makes the demand
described below with respect to such shares, owns such shares at
the time of such demand, continuously is the record holder of
such shares through the effective time of the merger, who
otherwise complies with the statutory requirements of
Section 262 and who neither votes in favor of the merger
nor consents thereto in writing will be entitled to an appraisal
by the Delaware Court of Chancery, or the Delaware Court, of the
fair value of his, her or its shares of Adamis common stock in
lieu of the consideration that such stockholder would otherwise
be entitled to receive pursuant to the merger agreement. All
references in this summary of appraisal rights to a
stockholder or holders of shares of Adamis
common stock are to the record holder or holders of shares
of Adamis common stock. Except as described herein, stockholders
of Adamis will not be entitled to appraisal rights in connection
with the merger.
Under Section 262, where a merger is to be submitted for
approval at a meeting of stockholders, such as the Adamis
special meeting, not fewer than 20 days before the meeting,
a constituent corporation must notify each of the holders of its
stock for whom appraisal rights are available that such
appraisal rights are available and include in each such notice a
copy of Section 262. This joint proxy statement/prospectus
shall constitute such notice to the record holders of Adamis
common stock.
Stockholders who desire to exercise their appraisal rights must
satisfy all of the conditions of Section 262. Those
conditions include the following:
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Stockholders electing to exercise appraisal rights must not vote
for the adoption of the merger agreement. Voting
for the adoption of the merger agreement will result
in the waiver of appraisal rights. Also, because a submitted
proxy not marked against or abstain will
be voted for the proposal to adopt the merger
agreement, the submission of a proxy not marked
against or abstain will result in the
waiver of appraisal rights.
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A written demand for appraisal of shares must be filed with
Adamis before the taking of the vote on the merger agreement at
the Adamis special meeting. The written demand for appraisal
should specify the stockholders name and mailing address,
and that the stockholder is thereby demanding appraisal of his,
her or its Adamis common stock. The written demand for appraisal
of shares is in addition to and separate from a vote against the
merger agreement or an abstention from such vote. That is,
failure to return your proxy, voting against, or abstaining from
voting on, the merger will not satisfy your obligation to make a
written demand for appraisal.
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A demand for appraisal must be executed by or for the
stockholder of record, fully and correctly, as such
stockholders name appears on the stock certificate. If the
shares are owned of record in a fiduciary capacity, such as by a
trustee, guardian or custodian, this demand must be executed by
or for the fiduciary. If the shares are owned by or for more
than one person, as in a joint tenancy or tenancy in common,
such demand must be executed by or for all joint owners. An
authorized agent, including an agent for two or more joint
owners, may execute the demand for appraisal for a stockholder
of record. However, the agent must identify the record owner and
expressly disclose the fact that, in exercising the demand, he
is acting as agent for the record owner. A person having a
beneficial interest in Adamis common stock held of record in the
name of another person, such as shares of stock held in a voting
trust or by a nominee, must act promptly, in such persons
own name, to follow the steps summarized below in a timely
manner to perfect whatever appraisal rights the beneficial
owners may have.
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A stockholder who elects to exercise appraisal rights should
mail or deliver his, her or its written demand to Adamis at 2658
Del Mar Heights Road, #555 Del Mar, CA 92014, Attention:
Chief Financial Officer.
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51
Within 10 days after the effective time of the merger,
Adamis, as the surviving company, will provide notice of the
effective time of the merger to all Adamis stockholders who have
complied with Section 262 and have not voted in favor of
the adoption of the merger agreement.
Within 120 days after the effective time of the merger,
either Adamis or any stockholder who has complied with the
required conditions of Section 262 may commence an
appraisal by filing a petition in the Delaware Court, with a
copy served on Adamis in the case of a petition filed by a
stockholder, demanding a determination of the fair value of the
shares of all stockholders seeking to exercise appraisal rights.
There is no present intent on the part of Adamis to file an
appraisal petition, and stockholders seeking to exercise
appraisal rights should not assume that Adamis will file such a
petition or that Adamis will initiate any negotiations with
respect to the fair value of such shares. Accordingly, holders
of Adamis common stock who desire to have their shares appraised
should initiate any petitions necessary for the perfection of
their appraisal rights within the time periods and in the manner
prescribed in Section 262.
Within 120 days after the effective time of the merger, any
stockholder who has satisfied the requirements of
Section 262 will be entitled, upon written request, to
receive from Adamis a statement setting forth the aggregate
number of shares of Adamis common stock and Adamis preferred
stock not voting in favor of the adoption of the merger
agreement and with respect to which demands for appraisal were
received by Adamis and the aggregate number of holders of such
shares. Such statement must be mailed within 10 days after
the stockholders request has been received by Adamis or
within 10 days after the expiration of the period for the
delivery of demands as described above, whichever is later.
If a petition for an appraisal is timely filed and a copy
thereof is served upon Adamis, Adamis will then be obligated,
within 20 days after service, to file in the office of the
Register in Chancery a duly verified list containing the names
and addresses of all stockholders who have demanded an appraisal
of their shares and with whom agreements as to the value of
their shares have not been reached. Notice of a hearing on the
petition for an appraisal will be given by 1 or more
publications in a newspaper of general circulation published in
Wilmington, DE (or such other publication as the Court deems
advisable) at least 1 week before the day of the hearing
and, if ordered by the Delaware Court, the Register in Chancery
will give notice to the petitioning stockholders at the address
provided in the petition. At the hearing on such petition, the
Delaware Court will determine which stockholders are entitled to
appraisal rights. The Delaware Court may require the
stockholders who have demanded an appraisal for their shares and
who hold stock represented by certificates to submit their
certificates of stock to the Register in Chancery for notation
thereon of the pendency of the appraisal proceedings; and if any
stockholder fails to comply with such direction, the Delaware
Court may dismiss the proceedings as to such stockholder. If the
Delaware Court decides stockholders are entitled to appraisal
rights, the Delaware Court will appraise the shares of Adamis
common stock owned by such stockholders, determining the fair
value of such shares exclusive of any element of value arising
from the accomplishment or expectation of the merger, together
with a fair rate of interest, if any, to be paid upon the amount
determined to be the fair value.
Although the Adamis Board believes that the merger consideration
is fair, no representation is made as to the outcome of the
appraisal of fair value as determined by the Delaware Court, and
stockholders should recognize that such an appraisal could
result in a determination of a value higher or lower than, or
the same as, the consideration they would receive pursuant to
the merger agreement. Moreover, Adamis does not anticipate
offering more than the nature of the merger consideration to any
stockholder exercising appraisal rights and reserves the right
to assert, in any appraisal proceeding, that, for purposes of
Section 262, the fair value of a share of
Adamis common stock is less than the merger consideration. In
determining fair value, the Delaware Court is
required to take into account all relevant factors. The cost of
the appraisal proceeding may be determined by the Delaware Court
and taxed against the dissenting stockholder
and/or
Adamis as the Delaware Court deems equitable under the
circumstances. Each dissenting stockholder is responsible for
his or her attorneys and expert witness expenses,
although, upon application of a dissenting stockholder, the
Delaware Court may order that all or a portion of the expenses
incurred by any dissenting stockholder in connection with the
appraisal proceeding, including without limitation, reasonable
attorneys fees and the fees and expenses of experts, be
charged pro rata against the value of all shares of stock
entitled to appraisal.
Any stockholder who has duly demanded appraisal in compliance
with Section 262 will not, after the effective time of the
merger, be entitled to vote for any purpose any shares subject
to such demand or to receive payment of dividends or other
distributions on such shares, except for dividends or
distributions payable to stockholders of record at a date before
the effective time of the merger.
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At any time within 60 days after the effective time of the
merger, any stockholder will have the right to withdraw his, her
or its demand for appraisal and to accept the terms offered in
the merger agreement. After this period, a stockholder may
withdraw his, her or its demand for appraisal and receive
payment for his, her or its shares as provided in the merger
agreement only with the consent of Adamis. If no petition for
appraisal is filed with the court within 120 days after the
effective time of the merger, stockholders rights to
appraisal, if available, will cease. Inasmuch as Adamis has no
obligation to file such a petition, any stockholder who desires
a petition to be filed is advised to file it on a timely basis.
Any stockholder may withdraw such stockholders demand for
appraisal by delivering to Adamis a written withdrawal of his,
her or its demand for appraisal and acceptance of the merger
consideration, except (i) that any such attempt to withdraw
made more than 60 days after the effective time of the
merger will require written approval of Adamis and
(ii) that no appraisal proceeding in the Delaware Court
shall be dismissed as to any stockholder without the approval of
the Delaware Court, and such approval may be conditioned upon
such terms as the Delaware Court deems just; provided, however,
that any stockholder who has not commenced an appraisal
proceeding or joined that proceeding as a named party to
withdraw such stockholders demand for appraisal and to
accept the terms offered upon the merger or consolidation within
60 days after the effective date of the merger or
consolidation.
Failure by any Adamis stockholder to comply fully with the
procedures described above and set forth in Annex B
may result in termination of such stockholders
appraisal rights. In view of the complexity of exercising
appraisal rights under Delaware law, any Adamis stockholder
considering exercising these rights should consult with legal
counsel.
53
THE
MERGER AGREEMENT
The following is a summary of selected provisions of the
merger agreement. While La Jolla and Adamis believe that
this description covers the material terms of the merger
agreement, it may not contain all of the information that is
important to you. The merger agreement has been attached hereto
as Annex A to provide you with information regarding its
terms. It is not intended to provide any other factual
information about La Jolla, Adamis or Merger Sub. The
following description does not purport to be complete and is
qualified in its entirety by reference to the merger agreement.
You should refer to the full text of the merger agreement for
details of the merger and the terms and conditions of the merger
agreement.
The merger agreement contains representations and warranties
that La Jolla and Merger Sub, on the one hand, and Adamis,
on the other hand, have made to one another as of specific
dates. These representations and warranties have been made for
the benefit of the other parties to the merger agreement and may
be intended not as statements of fact but rather as a way of
allocating the risk to one of the parties if those statements
prove to be incorrect. In addition, the assertions embodied in
the representations and warranties are qualified by information
in confidential disclosure schedules exchanged by the parties in
connection with signing the merger agreement. While
La Jolla and Adamis do not believe that these disclosure
schedules contain information required to be publicly disclosed
under the applicable securities laws, other than information
that has already been so disclosed, the disclosure schedules do
contain information that modifies, qualifies and creates
exceptions to the representations and warranties set forth in
the attached merger agreement. Accordingly, you should not rely
on the representations and warranties as current
characterizations of factual information about La Jolla,
Merger Sub or Adamis, because they were made as of specific
dates, may be intended merely as a risk allocation mechanism
between La Jolla and Merger Sub and Adamis and are modified
by the disclosure schedules.
The
Merger and Effective Time of the Merger
The merger agreement provides that La Jollas
wholly-owned subsidiary, Merger Sub, will merge with and into
Adamis. Adamis will survive the merger as La Jollas
wholly-owned subsidiary. The closing of the merger will occur at
a time as La Jolla and Adamis agree, but no later than the
third business day after the satisfaction or waiver of the last
to be satisfied or waived of the closing conditions set forth in
the merger agreement, or at such other time, date and place as
La Jolla and Adamis mutually agree in writing. As soon as
practicable after the closing, La Jolla and Adamis will
file a certificate of merger with the Secretary of State of the
State of Delaware. The merger will become effective upon the
filing of such certificate or at such later time as may be
specified in such certificate and as agreed by La Jolla and
Adamis. La Jolla and Adamis currently expect that the
closing of the merger will take place by March 31, 2010, or
as soon thereafter as possible. However, because the merger is
subject to stockholder approvals and other conditions to
closing, neither La Jolla nor Adamis can predict exactly
when the closing will occur.
Merger
Consideration
Conversion
of Securities, Exchange Ratio
If the merger is completed, each share of Adamis common stock
outstanding immediately before the merger, other than Adamis
common stock held as treasury stock or held or owned by
La Jolla or any direct or indirect wholly-owned subsidiary
of Adamis or La Jolla, and any dissenting shares, will
automatically be converted into the right to receive one share
of La Jolla common stock. If any shares of Adamis common
stock outstanding immediately before the merger are unvested or
subject to any repurchase option or risk of forfeiture under an
agreement with Adamis, then the shares of La Jolla common
stock issued in exchange for such shares of restricted Adamis
common stock will to the same extent be unvested and subject to
the same repurchase option or risk of forfeiture. As further
described herein, La Jolla anticipates that immediately
following completion of the merger, the current holders of
Adamis common stock will own between approximately
70% 95% of the outstanding La Jolla common
stock.
54
Fractional
Shares
No fractional shares of La Jolla common stock will be
issued in exchange for shares of Adamis common stock at the
closing of the merger. In lieu of fractional shares,
La Jolla will pay cash to each Adamis stockholder for any
remaining fraction equal to the product of (i) such
fraction multiplied by (ii) the applicable price per share
which shall equal to the average closing price of La Jolla
common stock as reported on the Nasdaq Capital Market or the
OTCBB or, if the La Jolla common stock is not traded on the
OTCBB, then the pink sheets, on the five trading days
immediately before the effective time of the merger. Because the
exchange ratio in the merger is one share of La Jolla
common stock for one share of Adamis common stock, La Jolla
does not anticipate that there will be fractional shares
issuable to Adamis stockholders.
Reverse
Stock Split
The merger agreement provides that La Jollas
stockholders must approve an amendment to La Jollas
restated certificate of incorporation (the Charter
Amendment) to effect a reverse stock split of
La Jolla common stock as described herein. Upon the
effectiveness of the Charter Amendment effecting the reverse
stock split (the Split Effective
Time), the total number of outstanding shares of
La Jolla common stock immediately before the Split
Effective Time will be combined into a smaller number of shares.
Under the terms of the merger agreement, the shares of
La Jolla common stock issued and outstanding immediately
before the closing of the merger (which does not include
outstanding shares of Adamis common stock) will be combined in a
reverse stock split, with each share thereafter representing a
fractional share equal to the reverse stock split ratio. Under
the merger agreement, the Reverse Stock Split Ratio
is defined as a fraction, the numerator of which is one and the
denominator of which is the Pre-Effective La Jolla
Shares divided by the Post-Effective La Jolla
Stockholder Shares. The Reverse Split Ratio, which affects
only the existing La Jolla stockholders, is expected to
range between 1:3 and 1:30.
Pre-Effective La Jolla Shares is the sum of all
shares of La Jolla common stock before the effective date
of the merger that are: (a) issued and outstanding and
(b) issuable upon conversion of any preferred stock of
La Jolla. The Post-Effective La Jolla
Stockholder Shares is a number equal to (i) the
projected La Jolla Net Cash as of the closing date of the
merger plus $750,000, divided by (ii) the Adamis Discounted
Share Price. La Jolla Net Cash is the amount of
(A) La Jollas cash and cash equivalents and
current amounts receivable of La Jolla, as reflected in
La Jollas financial records, minus (B) all cash
liabilities and obligations of La Jolla as reflected in
La Jollas financial records, but excluding the
aggregate value of the fractional share payments and
out-of-pocket
expenses associated with the reverse stock split and the
post-closing exchange of certificates associated with the
reverse stock split.
The Adamis Discounted Share Price is defined in the
merger agreement as the volume weighted average closing price of
the Adamis common stock (as reported on the OTC
Bulletin Board or other market or quotation system on which
the Adamis common stock is quoted or traded) commencing on the
first business day after the date of the merger agreement, which
was December 7, 2009, and ending two trading days before
the closing date of the merger, discounted by an amount set
forth in the following table:
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Adamis Weighted Average Share Price
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% Discount
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Less than $0.25
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10% (not to go below $0.20 per share)
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$0.25 to $2.00
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25% (not to go below $0.20 per share)
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Greater than $2.00
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$1.50 (fixed price)
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The prices in the above table are subject to proportional
adjustments in the event of recapitalizations or similar events
affecting the Adamis common stock.
Please see the table on page 12 for an illustration of the
approximate percentage ownership of the outstanding shares of
common stock of the combined company that Adamis stockholders
and existing La Jolla stockholders would be expected to
hold immediately following the closing of the merger.
Accordingly, at the Split Effective Time, each outstanding
pre-reverse split La Jolla share will be reclassified into
a fraction of a share equal to the reverse split ratio. All
shares and fractions thereof held by a particular holder
55
will be aggregated into whole shares and La Jolla will
round down to the nearest whole share any fraction of a share
that any La Jolla stockholder would otherwise receive.
In lieu of fractional shares, La Jolla stockholders will
instead receive a check in the amount payable in lieu of
fractional shares. Notwithstanding the foregoing, La Jolla
may elect to round up each fractional share (after aggregating
all fractional shares issuable to such holder) to a whole share
at no additional cost to the stockholder. La Jolla
management does not expect the number of shares of La Jolla
common stock to be issued in connection with rounding up such
fractional interests to be significant.
Exchange
Procedures
Promptly after the effective time of the merger, American Stock
Transfer & Trust Company, LLC, or such other
exchange agent as La Jolla appoints, will provide
appropriate transmittal materials to holders of record of Adamis
common stock (other than with respect to any such shares held
directly or indirectly by La Jolla, Adamis or dissenting
stockholders of Adamis), advising such holders of the procedure
for surrendering their stock certificates to the exchange agent.
Upon the surrender of the holders shares of Adamis common
stock, along with a duly executed letter of transmittal and any
other required documents, the holder will be entitled to receive
in exchange therefor:
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a certificate representing the number of whole shares of
La Jolla common stock that such holder is entitled to
receive pursuant to the merger, as described in the section
entitled Conversion of Adamis Securities, Exchange
Ratio; and
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a check in the amount, after giving effect to any required tax
withholdings, of any cash payable in lieu of fractional shares
plus any unpaid non-stock dividends and any other dividends or
other distributions that such holder has the right to receive as
described in the next paragraph.
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Whenever a dividend or other distribution is declared by
La Jolla in respect of La Jolla common stock, the
record date for which is after the effective time of the merger,
that declaration will include dividends or other distributions
in respect of all shares issuable pursuant to the merger
agreement. No dividends or other distributions in respect of
La Jolla common stock shall be paid to any holder of any
unsurrendered shares of Adamis common stock until the
unsurrendered shares of Adamis common stock are surrendered for
exchange. No holder of unsurrendered shares of Adamis common
stock will be entitled to vote after the effective time of the
merger at any meeting of La Jolla stockholders until such
unsurrendered shares of Adamis common stock have been
surrendered for exchange.
Promptly after the effective time of the merger, American Stock
Transfer & Trust, LLC, or such other exchange agent as La
Jolla appoints, will provide written instructions to record
owners of La Jolla common stock for exchanging their
certificates representing pre-reverse stock split shares of La
Jolla common stock.
Treatment
of Adamis Options, Warrants and Convertible Securities
At the effective time of the merger, each outstanding stock
option to purchase Adamis common stock not exercised immediately
prior to the effective time of the merger, whether or not
vested, will be assumed by La Jolla and become exercisable, on a
one-to-one basis, for shares of La Jolla common stock. Any
restrictions on the exercise of any Adamis option assumed by La
Jolla will continue following the conversion and the term,
exercisability, vesting schedules and other provisions of
assumed Adamis options will remain unchanged.
At the effective time of the merger, each outstanding warrant to
purchase shares of Adamsi common stock not terminated or
exercised immediately prior to the effective time of the merger
will be assumed by La Jolla and will become exercisable, on a
one-to-one basis, for shares of La Jolla common stock.
Board of
Directors and Officers of the Combined Company
The merger agreement provides that, immediately after the
merger, the La Jolla Board will consist of a number of
directors determined by Adamis. On the date of the closing of
the merger, La Jolla must deliver resignations for
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all La Jolla directors. The initial directors of the
combined company will be the directors of Adamis immediately
before the merger is effected (i..e, Dr. Carlo and
Messrs. Aloi and Marguglio).
If the merger occurs, La Jolla and Adamis expect that
Dr. Carlo, the chief executive officer and president of
Adamis, will become the chief executive officer and president of
the combined company, and that the other current executive
officers of Adamis (Robert O. Hopkins as chief financial
officer, Richard L. Aloi as president of Adamis Labs and David
J. Marguglio as vice president of business development and
investor relations) will become executive officers of the
combined company and that the existing officers of La Jolla
will resign.
Representations
and Warranties
The merger agreement contains representations and warranties,
customary for transactions of this type, of La Jolla,
Merger Sub and Adamis as to, among other things:
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corporate organization and existence;
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corporate power and authority;
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capitalization and related matters;
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financial statements and documents filed with the SEC and the
accuracy of information contained in those documents;
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real property;
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no conflict, required filings and governmental approvals
required to complete the merger, except as contemplated by the
merger agreement;
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compliance with laws, contracts, certificate of incorporation
and bylaws;
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compliance with legal requirements of governmental entities;
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no pending legal proceedings;
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absence of certain changes;
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matters relating to each partys business (i.e., tax
matters, environmental matters, labor matters, intellectual
property, insurance coverage and employee and employee benefit
matters;
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validity of, and the absence of defaults under, certain
contracts;
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transactions with affiliates;
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no unlawful payment to governmental officers; and
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completeness of representations.
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In addition, the merger agreement contains further
representations and warranties of La Jolla as to, among
other things, the formation and operation of Merger Sub.
The representations and warranties have been made solely for the
benefit of the parties in connection with the merger agreement
and are not intended to be relied upon by any other person,
including the stockholders of La Jolla or Adamis. In
addition, the representations and warranties are qualified by
specific disclosures made to the other parties in connection
with the merger agreement, will not survive the closing, and may
not form the basis for any claims under the merger agreement
after the merger is completed, but their accuracy forms the
basis of one of the conditions to the obligations of
La Jolla and Adamis to complete the merger. Moreover, many
of the representations and warranties are subject to materiality
and knowledge qualifications contained in the merger agreement,
and are made only as of the date of the merger agreement or such
other date as is specified in the merger agreement.
Covenants;
Conduct of Business Pending the Merger
Adamis agreed that it will preserve its organization and conduct
its business in the usual and ordinary course, except as
otherwise permitted by the merger agreement, in compliance with
all applicable laws and regulations, and
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to take other
agreed-upon
actions. Adamis also agreed that during the period before the
effective time of the merger it will:
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use commercially reasonable efforts to conduct its business and
operations in compliance with all applicable legal requirements
and the requirements of all material Adamis contracts; and
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use its commercially reasonable efforts to preserve intact its
current business organization, use commercially reasonable
efforts to keep available the services of its current key
employees, officers and other employees and maintain its
relations and goodwill with all suppliers, customers, landlords,
creditors, licensors, licensees, employees and other persons
having business relationships with Adamis or its subsidiaries.
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Adamis also agreed to promptly notify La Jolla of
(A) any notice or other communication from any person
alleging that the consent of such person is or may be required
in connection with the merger or any of the other contemplated
transactions; and (B) any event that would reasonably be
expected to have a material adverse effect on Adamis.
Each of Adamis and La Jolla agreed that it will preserve
its organization and conduct its business in the usual and
ordinary course, except as otherwise permitted by the merger
agreement, in compliance with all applicable laws and
regulations, and to take other
agreed-upon
actions. La Jolla also agreed that during the period before
the effective time of the merger it would:
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use commercially reasonable efforts to conduct its business and
operations in compliance with all applicable legal requirements
and the requirements of all material La Jolla
contracts; and
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use its commercially reasonable efforts to preserve intact its
current business organization, use commercially reasonable
efforts to keep available the services of its current key
employees, officers and other employees and maintain its
relations and goodwill with all suppliers, customers, landlords,
creditors, licensors, licensees, employees and other persons
having business relationships with La Jolla or its
subsidiaries.
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Each of Adamis and La Jolla also agreed that, subject to
certain limited exceptions, without the consent of the other
party in writing, it would not, during the period before the
effective time of the merger:
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enter into any contract or commitment or engage in any
transaction not in the usual and ordinary course of business and
consistent with its normal business practices;
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do any act or omit to do any act, or permit any act or omission
to act, which will cause a material breach of any contract,
commitment or obligation of such party, which could have a
material adverse effect on the business, assets or financial
condition of such party, other than with respect to discontinued
operations;
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declare or pay any dividends on, or make any other distributions
in respect of any shares of its capital stock; or
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issue any options, warrants or other rights to acquire shares of
its capital stock or any other instruments convertible into
securities of such party (but excluding any shares of capital
stock issued upon the exercise of options or warrants, or the
conversion of convertible notes, outstanding on the date of the
merger agreement or referred to in La Jollas
disclosure schedules to the merger agreement);
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Additionally, Adamis and La Jolla have agreed under the
merger agreement that the La Jolla Net Cash may not be used
post-closing to pay any Adamis indebtedness for borrowed money
as of the closing of the merger or to pay any Adamis deferred
compensation or accrued bonuses in existence as of the closing
of the merger.
Notwithstanding the foregoing, Adamis may, during the period
before the effective time of the merger, carry out the following
types of transactions:
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any debt financing transaction for up to $2,000,000 of aggregate
principal;
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any equity financing transaction involving the issuance of up to
20% of Adamis common stock outstanding on the date of the
merger agreement; or
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the acquisition of one or more businesses, interests in
businesses, technologies, intellectual property or products or
issuing equity or debt instruments in connection in such a
financing, with an aggregate consideration paid or potentially
payable in connection with all such transactions that may not be
equal to
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more than $1,000,000 or result in the issuance or potential
issuance of more than 20% of the Adamis common stock outstanding
on the date of the merger agreement.
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See Risks Related to the Merger The Adamis
exchange ratio is fixed in the merger agreement, which means
that additional issuances by Adamis prior to closing will dilute
the La Jolla stockholders at closing for additional
information.
Each of Adamis and La Jolla also agreed to promptly notify
the other party of (A) any notice or other communication
from any person alleging that the consent of such person is or
may be required in connection with the merger or any of the
other contemplated transactions; and (B) any event that
would reasonably be expected to have a material adverse effect
on such party.
Additional
Agreements
Each of La Jolla and Adamis has agreed to use its
commercially reasonable efforts to:
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take all actions necessary to complete the merger;
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coordinate with the other party in preparing and exchanging
information for purposes of the registration statement filed
with the SEC, compliance with state and federal securities laws
and otherwise;
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obtain all consents, in form and substance reasonably
satisfactory to the other party, required for the consummation
of the transactions contemplated by the merger
agreement; and
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consult and agree with each other about any public statement
either will make concerning the merger, subject to certain
exceptions.
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La Jolla and Adamis further agreed that:
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each party will, subject to limited exceptions, promptly take
all steps necessary to duly call, give notice of, convene and
hold a meeting of its respective stockholders for the purposes
of approving the issuance of shares in the merger and the other
transactions contemplated by the merger agreement including, in
the case of La Jolla, the reverse split and amendments to
its restated certificate of incorporation, and will recommend
such approvals and use its best efforts to obtain such approvals;
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each party will promptly notify the other of any development or
change in circumstances that does or could reasonably be
expected to:
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call into question the validity of the merger agreement or any
action taken or to be taken pursuant to such agreement;
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adversely affect the ability of the parties to close the
transactions contemplated by the merger agreement;
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have any material adverse effect on such party; or
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make any of the representations and warranties in the merger
agreement untrue or incorrect; and
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use its commercially reasonable efforts to keep current its
filings with the SEC as required under Section 13 of the
Exchange Act.
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No
Solicitation
In the merger agreement, La Jolla and Adamis have agreed
that each party and their respective subsidiaries will not, nor
will either company authorize or permit any of its directors,
officers, investment bankers, attorneys, accountants or other
advisors or representatives to, directly or indirectly:
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knowingly solicit, initiate, encourage, induce or facilitate the
communication, making or announcement of any acquisition
proposal or acquisition inquiry or take any action that could
reasonably be expected to lead to an acquisition proposal or
acquisition inquiry;
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furnish any information regarding such party to any person in
connection with or in response to an acquisition proposal or
acquisition inquiry;
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engage in discussions or negotiations with any person with
respect to any acquisition proposal or acquisition inquiry;
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approve, endorse or recommend any acquisition proposal or effect
any material change in the recommendation of the partys
board of directors; or
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execute or enter into any letter of intent or similar document
or any contract relating to any acquisition transaction or enter
into any agreement in principle requiring such party to abandon,
terminate or fail to consummate the merger or breach its
obligations under the merger agreement.
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In the event that either party receives an offer, proposal or
request of the type discussed above, it has agreed to
immediately notify the other party and provide information as to
the identity of the offeror and the specific terms of such offer
or proposal, and such other information related thereto as the
other party may reasonably request.
Notwithstanding these restrictions, before obtaining stockholder
approval, either Adamis or La Jolla, sometimes referred to
as a Party, may furnish information and enter into discussions
or negotiations in response to an unsolicited, bona fide written
acquisition proposal when such Partys board of directors
determines in good faith that it constitutes, or is reasonably
likely to result in, a superior proposal (as defined in the
merger agreement) and the failure to take such action would
result in a breach of the fiduciary duties of the board of
directors. To the extent the Party determines that such offer
constitutes a superior proposal (as defined in the merger
agreement), the Party has agreed to give the other Party a
period of no less than three business days to negotiate
regarding modifications to the merger agreement.
However, the no-solicitation provisions do not restrict a Party
from taking any of the following activities:
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taking and disclosing to its stockholders a position with
respect to a tender or exchange offer by a third party;
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making any disclosure to its stockholders or furnishing
information to a third party who has made a bona fide
acquisition proposal if, in the good faith judgment of such
partys board of directors, after consultation with outside
counsel, failure to make such disclosures would be contrary to
its fiduciary obligations under applicable law; or
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furnishing information to a third party which has made a bona
fide acquisition proposal that is reasonably likely to be a
superior proposal, as defined below.
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For the purposes of the merger agreement, an acquisition
proposal means any offer or proposal (other than an offer
or proposal made or submitted by Adamis, on the one hand or
La Jolla, on the other hand to the other Party)
contemplating or otherwise relating to any acquisition
transaction with the other Party. An acquisition
transaction shall mean any transaction or series of
transactions (except for the Contemplated Transactions)
involving:
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any merger, consolidation, amalgamation, share exchange,
business combination, issuance of securities, acquisition of
securities, reorganization, recapitalization, tender offer,
exchange offer or other similar transaction in which (i) a
person or group (as defined in the Exchange Act and
the rules promulgated thereunder) of persons directly or
indirectly acquires beneficial or record ownership of securities
representing more than 50% of the outstanding securities of any
class of voting securities of a Party or any of its
Subsidiaries; or (ii) a Party or any of its Subsidiaries
issues securities representing more than 50% of the outstanding
securities of any class of voting securities of such Party or
any of its Subsidiaries (other than, solely with respect to
Adamis, through any capital raising transaction);
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any sale, lease, exchange, transfer, license, acquisition or
disposition of any business or businesses or assets that
constitute or account for: (i) 50% or more of the
consolidated book value of the assets of a Party and its
Subsidiaries, taken as a whole; or (ii) 50% or more of the
fair market value of the assets of a Party and its Subsidiaries,
taken as a whole; or
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any liquidation or dissolution of a Party.
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A superior proposal means an acquisition proposal
that the board of directors of a Party determines, in its
reasonable judgment, to be more favorable to such Partys
stockholders than the terms of the transactions contemplated by
the merger agreement.
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Meetings
of Stockholders and Proxy Statement
La Jolla is obligated under the merger agreement to take
all actions necessary under applicable law to hold and convene a
meeting of its stockholders for purposes of voting on
(i) the issuance of shares of La Jolla common stock in
connection with the merger and the resulting change of control
and (ii) the amendments to its certificate of incorporation
to effect a reverse stock split and to change its corporate name
at the closing of the merger. Further, La Jolla is required
to promptly distribute a registration statement and proxy
statement relating to such stockholder proposals.
In the merger agreement, La Jolla agreed to use its
reasonable best efforts to have the registration statement (of
which this joint proxy statement/prospectus is a part) declared
effective under the Securities Act as promptly as practicable
after filing, and commercially reasonable efforts to obtain all
regulatory approvals needed to ensure that the all the
La Jolla common stock issued in the merger will be
registered or qualified or exempt from registration or
qualification under the securities laws of every state mutually
agreed upon by Adamis and La Jolla.
Adamis is obligated under the merger agreement to hold and
convene a meeting of its stockholders for purposes of
considering the approval of the merger and the adoption of the
merger agreement, and to hold the meeting as promptly as
reasonably practicable after the effectiveness of the
registration statement (of which this joint proxy
statement/prospectus is a part).
Indemnification
and Insurance of Directors and Officers
The merger agreement provides that, for a period of three years
following the effective date of the merger, the combined company
will honor in all respects the obligations of La Jolla and
Adamis pursuant to any indemnification provisions under their
respective certificates of incorporation and bylaws as in effect
on the date of the merger agreement.
The merger agreement provides that, for a period of three years
from the date of the merger, the certificate of incorporation
and bylaws of La Jolla and the surviving corporation, as
the case may be, will contain provisions no less favorable with
respect to indemnification, advancement of expenses and
exculpation of present and former directors and officers of
La Jolla than are presently set forth in the certificate of
incorporation and bylaws of La Jolla, and while in place,
these provisions will not be amended, modified or repealed in a
manner that would adversely affect the rights of the directors
and officers of La Jolla. The merger agreement also
provides that La Jolla shall take no actions to terminate
or curtail the directors and officers tail liability
insurance coverage that is in place at the effective date of the
merger to insure those directors and officers of La Jolla
in place prior to the merger.
Conditions
to Completion of the Merger
Each partys obligation to complete the merger is subject
to the satisfaction or waiver by each of the parties, at or
before the merger, of various conditions, which include the
following:
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there must not have been issued any restraining order,
injunction or other order by any court of competent
jurisdiction, or other legal restraint or prohibition preventing
the consummation of the merger or other transactions
contemplated by the merger agreement, and there must not have
been any applicable legal requirement that has the effect of
making the consummation of the merger illegal;
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the requisite stockholder approvals shall have been obtained by
Adamis and La Jolla;
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any governmental authorization or consent required to be
obtained under any applicable antitrust or competitive law or
regulation (of which the parties believe there are none), or
under any other applicable legal requirement, shall have been
obtained and remain in full force and effect;
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there must not be any legal proceeding pending or threatened by
any governmental entity in which the entity indicates that it
intends to conduct any legal proceeding or take any other
action: (a) challenging or seeking to restrain the
consummation of the merger or any of the other contemplated
transactions; (b) relating to the merger and seeking to
obtain from La Jolla or Adamis any damages or other relief
that would have a material adverse effect on the combined
company; (c) seeking to prohibit or limit in any material
and adverse respect a partys ability to vote, transfer,
receive dividends with respect to or otherwise exercise
ownership rights
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with respect to the stock of La Jolla; (d) that could
have a material adverse effect on the ability of the combined
company to own the assets or operate the business of the
combined company; or (e) seeking to compel Adamis or
La Jolla (or any subsidiary of either) to dispose of or
hold separate any assets that are material to the combined
company as a result of or following the merger or any of the
contemplated transactions; and
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the registration statement on
Form S-4,
of which this joint proxy statement/prospectus is a part, must
have been declared effective by the SEC in accordance with the
Securities Act and must not be subject to any stop order or
proceeding, or any proceeding threatened by the SEC, seeking a
stop order.
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In addition, the obligation of La Jolla and Merger Sub to
complete the merger is further subject to the satisfaction or
waiver of the following conditions:
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the representations and warranties of Adamis contained in the
merger agreement shall have been true and correct as of the date
of the merger agreement and shall be true and correct on and as
of the closing date of the merger with the same force and effect
as if made on the closing date except (A) in each case, or
in the aggregate, where the failure to be true and correct would
not reasonably be expected to have a material adverse effect on
the combined company, or (B) for those representations and
warranties that address matters only as of a particular date
(which representations shall have been true and correct, subject
to the qualifications as set forth in the preceding clause (A),
as of such particular date);
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each of the covenants and obligations in the merger agreement
that Adamis is required to comply with or to perform at or
before the closing shall have been complied with and performed
by Adamis in all material respects, except where the failure to
perform such covenants or obligations would not have a material
adverse effect on the combined company;
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from the date of the merger agreement through the effective time
of the merger, there shall not have occurred any material
adverse effect on Adamis that shall be continuing as of the
effective time of the merger and that would have a material
adverse effect on the combined company;
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La Jolla shall have received the following agreements and
other documents, each of which shall be in full force and effect:
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a certificate of Adamis executed on its behalf by the chief
executive officer and chief financial officer of Adamis
confirming that the conditions set forth above have been duly
satisfied; and
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certificates of good standing (or equivalent documentation) of
Adamis in its jurisdiction of incorporation and the various
foreign jurisdictions in which it is qualified (except where the
failure to have obtained such certificates would not result in a
material adverse effect on the combined company), certified
charter documents, a certificate as to the incumbency of
officers and the adoption of resolutions of the board of
directors of Adamis authorizing the execution of the merger
agreement and the consummation of the contemplated transactions
to be performed by Adamis thereunder; and
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neither the principal executive officer nor the principal
financial officer of Adamis shall have failed to provide, with
respect to any Adamis SEC document filed (or required to be
filed) with the SEC on or after the date of the merger
agreement, any necessary certification in the form required
under
Rule 13a-14
under the Exchange Act and 18 U.S.C. § 1350,
which are certifications required under the Sarbanes Oxley
Act; and
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Receipt of an opinion of counsel from counsel to Adamis.
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In addition, the obligation of Adamis to complete the merger is
further subject to the satisfaction or waiver of the following
conditions:
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the representations and warranties of La Jolla and Merger
Sub contained in the merger agreement shall have been true and
correct as of the date of the merger agreement and shall be true
and correct on and as of the closing date with the same force
and effect as if made on the closing date except (A) in
each case, or in the aggregate, where the failure to be true and
correct would not reasonably be expected to have a material
adverse effect on the combined company, or (B) for those
representations and warranties that address matters
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only as of a particular date (which representations shall have
been true and correct, subject to the qualifications as set
forth in the preceding clause (A), as of such particular date);
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each of the covenants and obligations in the merger agreement
that La Jolla or Merger Sub is required to comply with or
to perform at or before the closing shall have been complied
with and performed in all material respects, except where the
failure to perform such covenants or obligations would not have
a material adverse effect on the combined company;
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from the date of the merger agreement through the effective time
of the merger, there shall not have occurred any material
adverse effect on La Jolla that continues as of the
effective time of the merger and that would have a material
adverse effect;
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Adamis shall have received the following documents:
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a certificate of La Jolla executed on its behalf by the
chief executive officer and vice president of finance of
La Jolla confirming that the conditions set forth above
have been duly satisfied;
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certificates of good standing (or equivalent documentation) of
each of La Jolla and Merger Sub in Delaware and the various
foreign jurisdictions in which it is qualified (except where the
failure to have obtained such certificates would not result in a
material adverse effect on the combined company), certified
charter documents, a certificate as to the incumbency of
officers and the adoption of resolutions of the boards of
directors of La Jolla and Merger Sub authorizing the
execution of the merger agreement and the consummation of the
contemplated transactions to be performed by La Jolla and
Merger Sub thereunder; and
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written resignations in forms reasonably satisfactory to Adamis,
dated as of the closing date and effective as of the closing,
executed by the directors and officers of La Jolla;
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neither the principal executive officer nor the principal
financial officer of La Jolla shall have failed to provide,
with respect to any La Jolla SEC document filed (or
required to be filed) with the SEC on or after the date of the
merger agreement, any necessary certification in the form
required under
Rule 13a-14
under the Exchange Act and 18 U.S.C. § 1350,
which are certifications required under the Sarbanes Oxley Act;
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La Jolla shall have caused the board of directors of
La Jolla to be constituted as set forth in the merger
agreement;
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each of the individuals identified by Adamis before the
effective time of the merger shall have been appointed officers
of La Jolla as of the effective time of the merger;
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the amendments to the La Jolla restated certificate of
incorporation, including the reverse stock split and the
corporate name change, as contemplated by the merger agreement,
shall have become effective under the DGCL; and
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receipt of an opinion of counsel from counsel to La Jolla.
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Other than the conditions regarding effectiveness of the
registration statement of which this joint proxy
statement/prospectus is part, the condition regarding having
obtained required stockholder approvals for the proposals
described in the joint proxy statement/prospectus, and the
conditions regarding having obtained any required governmental
authorization and no restraining order or injunction having been
issued or government proceeding pending preventing the
consummation of the merger, satisfaction of each of the
conditions to the merger is permitted by law to be waived in the
discretion of the board of directors of La Jolla or Adamis,
as applicable. Many of the other closing conditions, such as the
representations and warranties of the parties in the merger
agreement being true and correct as of the closing date and the
parties having performed all obligations under the merger
agreement that they are required to perform, are qualified by
the requirement that the failure of the condition must have a
material adverse effect on the combined company. The failure of
other closing conditions to be true, including the requirement
that La Jolla have taken required actions to cause the
board of directors and officers of the combined company to be as
described in the joint proxy statement/prospectus, the
requirement that there be no governmental proceeding pending
challenging or seeking to restrain the consummation of the
merger or related transactions, or the requirement that neither
La Jollas nor Adamis chief executive officer or
principal financial
63
officer have failed to provide any required certification under
the Sarbanes-Oxley Act, might or might not have a material
adverse effect on the combined company.
Termination
The merger agreement may be terminated at any time before the
completion of the merger, whether before or after the required
stockholder approvals to complete the merger have been obtained,
as set forth below:
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by mutual written consent duly authorized by the board of
directors of each of La Jolla and Adamis;
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by either La Jolla or Adamis if the merger has not been
consummated by March 31, 2010, but this right to terminate
the merger agreement will not be available to a party whose
failure to fulfill any material obligation of the merger
agreement or other material breach of the merger agreement has
been the cause of, or resulted in, the failure of the merger to
be completed by such date;
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by either La Jolla or Adamis if a court of competent
jurisdiction or any governmental entity having authority with
respect thereto has issued a final and nonappealable order,
decree or ruling or taken any other action that permanently
restricts, restrains, enjoins or otherwise prohibits the merger,
and the parties shall have used commercially reasonable efforts
to resist, resolve or lift, as applicable, such judgment,
injunction, order or decree;
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by either La Jolla or Adamis if (i) at the Adamis
stockholder meeting, Adamis stockholders shall have taken
a final vote on the merger and (ii) the merger shall not
have been approved or adopted by the Adamis stockholders;
provided, however, that the right to terminate the merger
agreement shall not be available to Adamis where the failure to
obtain a positive vote shall have been caused by the action or
failure to act of Adamis that amounts to a material breach of
the merger agreement by Adamis;
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by La Jolla if the Adamis discounted share price is less
than $0.20 per share and one of the following events exists:
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material manufacturing or supply problems with Adamis
Epinephrine PFS product (including API and syringe), or any
regulatory actions taken by the FDA, that result in or would be
expected to result in a commercial interruption in sales of such
product;
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any litigation is filed against Adamis, its directors or
officers asserting claims that could reasonably be expected to
result in the occurrence of a Material Adverse Effect as defined
in the merger agreement; or
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the loss of the services of Dennis J. Carlo as an officer,
director or full-time employee of Adamis for any reason;
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by Adamis, if, as of the date of the close of the merger
transaction, the net cash of La Jolla presented in the Net
Cash Certification required to be delivered by La Jolla is
less than $2.3 million;
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by Adamis if any of the following shall have occurred:
(i) a change in the La Jolla board recommendation
regarding the merger transaction; (ii) La Jolla shall
have failed to hold the La Jolla stockholder meeting within
60 days after the definitive proxy statement is declared
effective by the SEC, (iii) La Jolla or any of its
subsidiaries or representatives shall have failed to comply with
the no-solicitation covenants in the merger agreement in any
material respect, or (iv) La Jolla shall have
delivered a notice of superior proposal to Adamis;
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by La Jolla if any of the following shall have occurred:
(i) a change in the Adamis board recommendation regarding
the merger transaction; (ii) Adamis shall have failed to
hold the Adamis stockholder meeting within 60 days after
the definitive proxy statement is declared effective by the SEC;
(iii) Adamis or any of its subsidiaries or representatives
shall have failed to comply with the no-solicitation covenants
in the merger agreement in any material respect; or
(iv) Adamis shall have delivered a notice of superior
proposal to La Jolla; and
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by La Jolla if La Jolla intends to substantially
concurrently enter into an agreement with respect to a superior
proposal in compliance with its no solicitation covenants
described in the section above entitled The Merger
Agreement No Solicitation and has paid the
termination fee and expenses as described below.
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Fees and
Expenses
Each party is generally required to bear its own expenses
associated with the merger agreement and the consummation of the
merger, except as set forth below.
Adamis is entitled to a nonrefundable fee as liquidated damages
from La Jolla in the amount of: (i) $150,000 if the
merger agreement is terminated by Adamis because of (A) a
material change in the La Jolla Boards
recommendations concerning the merger,
(B) La Jollas failure to hold a stockholder
meeting to vote on the merger transaction within 60 days
after the registration statement is declared effective by the
SEC, (C) La Jollas notice to Adamis of a
superior proposal, or (D) La Jollas failure to
comply with its non-solicitation obligations,
(ii) terminated by La Jolla if the Adamis discounted
share price is less than $0.20 per share and one of the
following events exists: (a) material manufacturing or
supply problems with Adamis Epinephrine PFS product
(including API and syringe), or any regulatory actions taken by
the FDA, that result in or would be expected to result in a
commercial interruption in sales of such product; (b) any
litigation is filed against Adamis, its directors or officers
asserting claims that could reasonably be expected to result in
the occurrence of a material adverse effect; or (c) the
loss of the services of Dennis J. Carlo as an officer, director
or full-time employee of the Company for any reason or
(iii) if the merger agreement is terminated by
La Jolla or Adamis due to a failure to obtain the required
stockholder approvals, all reasonable accounting and legal fees
and costs incurred by the party in connection with the
transactions contemplated by the merger agreement (up to a
maximum of $100,000).
La Jolla is entitled to a nonrefundable fee as liquidated
damages from Adamis in the amount of: (i) $150,000 if the
merger agreement is terminated by La Jolla because of
(A) a material change in the Adamis Boards
recommendations concerning the merger, (B) Adamis
failure to hold a stockholder meeting to vote on the merger
transaction within 60 days after the registration statement
is declared effective by the SEC, (C) Adamis notice
to La Jolla of a superior proposal or (D) Adamis
failure to comply with its non-solicitation obligations, (ii)
(E) terminated by Adamis if, as of the closing date of the
merger, the La Jolla Net Cash as reflected on the Net Cash
Certification (as defined in the merger agreement) is less than
$2.3 million, or (iii) if the merger agreement is
terminated by La Jolla or Adamis due to a failure to obtain
the required stockholder approvals, all reasonable accounting
and legal fees and costs incurred by the party in connection
with the transactions contemplated by the merger agreement (up
to a maximum of $100,000).
Agreements
Related to the Merger Agreement
Voting
Agreements and Irrevocable Proxies
Dennis J. Carlo, Richard L. Aloi, David J. Marguglio and Robert
O. Hopkins, all of whom will be referred to collectively herein
as the Principal Adamis Stockholders, have entered into voting
agreements with La Jolla pursuant to which, among other
things, each such stockholder agreed, solely in his capacity as
an Adamis stockholder, to vote all of the stockholders
shares of Adamis common stock in favor of the issuance of
La Jolla common stock to Adamis stockholders in connection
with the merger and the other Adamis proposals described in this
joint proxy statement/prospectus, and against any matter that
would result in a breach of the merger agreement by
La Jolla and any proposal made in opposition to, or in
competition with, the consummation of the merger and the other
transactions contemplated by the merger agreement. As of
December 15, 2009, the Principal Adamis Stockholders
beneficially owned an aggregate of 16,271,693 shares of
Adamis common stock, representing approximately 35% of the
outstanding shares of Adamis common stock.
65
MATTERS
TO BE PRESENTED TO THE ADAMIS STOCKHOLDERS
ADAMIS
PROPOSAL NO. 1 APPROVAL OF THE
MERGER
At the Adamis special meeting, Adamis stockholders will be asked
to approve the merger agreement and the transactions
contemplated thereby, including the merger. Immediately
following the merger, Adamis stockholders are expected to own
between approximately 70% and 95% of the outstanding shares of
the combined company, and existing La Jolla stockholders
are expected to hold between approximately 5% and 30% of the
outstanding shares of the combined company. See Risks
Related to the Merger, and specifically those risk factors
discussing potential ownership percentages of each of the
La Jolla stockholders and the Adamis stockholders
post-merger, for additional information.
The terms of, reasons for and other aspects of the merger
agreement, the merger, the issuance of La Jolla common
stock to Adamis stockholders pursuant to the merger agreement,
and the resulting change in control of La Jolla, are
described in detail in other sections of this joint proxy
statement/prospectus.
Vote
Required; Recommendation of Board of Directors
The affirmative vote of the holders of a majority in voting
power of the shares of Adamis common stock outstanding on the
Adamis Record Date is required for approval of Adamis
Proposal No. 1.
THE ADAMIS BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT
ADAMIS STOCKHOLDERS VOTE FOR ADAMIS
PROPOSAL NO. 1 TO APPROVE THE MERGER AGREEMENT AND THE
TRANSACTIONS CONTEMPLATED THEREBY.
ADAMIS
PROPOSAL NO. 2 APPROVAL OF POSSIBLE
ADJOURNMENT OF THE ADAMIS SPECIAL MEETING
If Adamis fails to receive a sufficient number of votes to
approve the merger and the merger agreement, Adamis may propose
to adjourn the Adamis special meeting, for a period of not more
than 30 days, for the purpose of soliciting additional
proxies to approve such proposal. Adamis does not currently
intend to propose adjournment at the Adamis special meeting if
there are sufficient votes to approve the merger and the merger
agreement.
Vote
Required; Recommendation of Board of Directors
The affirmative vote of the holders of a majority in voting
power of the outstanding shares of Adamis common stock present
in person or represented by proxy at the Adamis special meeting
is required to approve the adjournment of the Adamis special
meeting for the purpose of soliciting additional proxies to
approve the merger and the merger agreement.
THE ADAMIS BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT
ADAMISS STOCKHOLDERS VOTE FOR ADAMIS
PROPOSAL NO. 2 TO ADJOURN THE SPECIAL MEETING, IF
NECESSARY, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT
SUFFICIENT VOTES IN FAVOR OF THE MERGER AND THE MERGER
AGREEMENT.
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ADAMIS
BUSINESS
In the discussion below, all statements concerning market
sizes, annual U.S. sales of products,
U.S. prescriptions and rates of prescriptions, the
incidence of diseases or conditions in the general population,
and similar statistical or market information are based on data
published by the following sources: IMS Health Sales
Perspectives, Retail and Non-Retail Combined Report, referred to
as the IMS Report; National Data Corporations Epinephrine
Prescription and Dollar data for 2007, referred to as the NDC
Report; Commercial and Pipeline Insight: Allergic Rhinitis,
published by DataMonitor October 2007, referred to as the
DataMonitor Report; and AAAAI American Academy of
Allergy, Asthma and Immunology Allergy Statistics for the
U.S. published in 2008, referred to as the AAAAI
Statistics.
Company
Overview
Adamis was founded in June 2006 as a Delaware corporation.
Adamis has three wholly-owned subsidiaries: Cellegy Holdings,
Inc.; Adamis Corporation; and Biosyn, Inc. Adamis Corporation
has two wholly-owned subsidiaries: Adamis Viral Therapies, Inc.
(biotechnology), or Adamis Viral; and Adamis Laboratories, Inc.
(specialty pharmaceuticals), or Adamis Labs. Cellegy Holdings
and Biosyn currently have no material operations.
Adamis Labs is a specialty pharmaceutical company that Adamis
acquired in April 2007. Adamis Labs has a line of prescription
products in the allergy and respiratory field that are sold
through its own sales force. These products generated net
revenues to Adamis of approximately $660,000 for Adamis
fiscal year ended March 31, 2009. Adamis Epinephrine
Injection USP 1:1000 (0.3mg Pre-Filled Single Dose Syringe)
product, or the PFS Syringe product, a pre-filled epinephrine
syringe product for use in the emergency treatment of extreme
acute allergic reactions, or anaphylactic shock, was launched in
July 2009. An additional product candidate in its product
pipeline is a generic inhaled nasal steroid for the treatment of
seasonal and perennial allergic rhinitis. Adamis goal is
to commence commercial sales of the nasal steroid product in the
first quarter of 2012, assuming adequate funding and no
unexpected delays. Based on Adamis knowledge of a
previously marketed pre-filled syringe indicated for
anaphylaxis, the anticipated lower price of the PFS Syringe
product relative to the leading syringe products currently
marketed and the ease of use of its product, Adamis believes
that the PFS Syringe product has the potential to compete
successfully shortly after full commercial introduction of the
product, although there can be no assurance that this will be
the case. To date, Adamis ability to fully execute its
plan for the commercial launch of the PFS Syringe product has
been hampered because of limited funding to support the launch.
Adamis Viral is focused on developing patented preventative and
therapeutic vaccines for a variety of viral diseases such as
influenza and hepatitis. The first target indication will be
avian influenza. Adamis believes that avian flu is a good
initial clinical application because there is a large potential
demand for a vaccine or other therapeutic product. However,
there are no assurances concerning whether such a product will
be developed or launched. After the merger, Adamis hopes to
initiate an initial clinical trial in the third quarter of 2010,
and, if the results are successful, to initiate clinical trials
in the United States in 2011, assuming adequate funding and no
unexpected delays. Future potential disease targets might
include therapeutic vaccines for Hepatitis C and Human
Papillomavirus.
Adamis general business strategy is to attempt to increase
sales of existing and proposed products and services from its
Adamis Labs operations to generate cash flow to help support the
vaccine product development efforts of Adamis Viral. Adamis
believes that the potential for increased revenues will be
driven by two new products.
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Commercial sales of the PFS Syringe product commenced in July
2009. The product competes in a well-established
U.S. market estimated to be over $150 million in
annual sales, based on industry data published in the NDC Report.
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Adamis Labs intends to introduce an aerosolized inhaled nasal
steroid that is designed to take a small share of the
U.S. market for nasal steroid products, estimated by Adamis
to be approximately $3 billion in annual sales, based on
the NDC Report. Adamis currently believes that this product
could be introduced as early as the first calendar quarter of
2012, although the actual date of introduction will depend on a
number of factors and the actual launch date could be later than
that date. Factors that could affect the actual launch date
include the outcome of discussions with the FDA concerning the
number and kind of clinical trials that the
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FDA will require before the FDA will consider regulatory
approval of the product, any unexpected difficulties in
licensing or sublicensing intellectual property rights for other
components of the product such as the inhaler, any unexpected
difficulties in the ability of suppliers to timely supply
quantities for commercial launch of the product, any unexpected
delays or difficulties in assembling and deploying an adequate
sales force to market the product, and adequate funding to
support sales and marketing efforts.
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To achieve these goals, as well as to support the overall
strategy, Adamis will need to raise a substantial amount of
funding and make substantial investments in equipment, new
product development and working capital. Adamis estimates that
approximately $1.5 million to $2 million will be
required to support the continued commercial launch of the PFS
Syringe product, and that approximately an additional
$3.5 million or more must be invested from the date of this
joint proxy statement/prospectus in the Adamis Labs operations
to support development and commercial introduction of the
aerosolized nasal steroid product candidate. The capital that is
expected to be provided from expected sales of these products
will be important to help fund expansion of those businesses and
the research and development of the anti-viral technology. If
adequate funding is obtained, clinical trials proceed
successfully, regulatory approvals are obtained and sales are
consistent with Adamis current expectations, following a
period of initial commercial introduction, Adamis believes that
revenues generated by Adamis Virals vaccine products could
exceed revenues from the Adamis Labs operations.
Effective April 1, 2009, Adamis completed a business
combination transaction with Cellegy Pharmaceuticals, Inc., or
Cellegy. The stockholders of Cellegy and the stockholders of
former Adamis Pharmaceuticals Corporation, or Old Adamis,
approved a merger transaction and related matters at an annual
meeting of Cellegys stockholders and at a special meeting
of Old Adamis stockholders, each held on March 23,
2009. On April 1, 2009, Cellegy completed the merger
transaction with Old Adamis. Before the merger, Cellegy was a
public company and Old Adamis was a private company.
In connection with the consummation of the merger and pursuant
to the terms of the definitive merger agreement relating to the
transaction, Cellegy changed its name from Cellegy
Pharmaceuticals, Inc. to Adamis Pharmaceuticals Corporation, and
Old Adamis changed its corporate name to Adamis Corporation.
Pursuant to the terms of the merger agreement, Cellegy effected
a reverse stock split of its common stock immediately before the
consummation of the merger Pursuant to this reverse stock split,
each approximately 10 shares of common stock of Cellegy
that were issued and outstanding immediately before the
effective time of the merger were converted into one share of
Cellegy common stock and any remaining fractional shares held by
a stockholder (after aggregating the fractional shares) were
rounded up to the nearest whole share.
As a result, the total number of shares of Cellegy that were
outstanding immediately before the effective time of the merger
were converted into approximately 3,000,000 shares of
post-reverse split shares of common stock of Cellegy. Pursuant
to the terms of the merger agreement, at the effective time of
the merger each share of Old Adamis common stock that was issued
and outstanding immediately before the effective time of the
merger ceased to be outstanding and was converted into the right
to receive one share of Adamis common stock. As a result,
approximately 44,038,989 shares of Adamis were issued
and/or are
issuable to the holders of the outstanding shares of common
stock of Old Adamis before the effective time of the merger. Old
Adamis, renamed Adamis Corporation, was the surviving entity as
a wholly-owned subsidiary of Adamis.
Adamis
Labs
On April 23, 2007, Adamis completed the acquisition of a
specialty pharmaceutical company named Healthcare Ventures
Group, Inc., or HVG. HVG had previously acquired a group of
allergy and respiratory products and certain related assets from
a third party company. The third party also transferred to HVG
members of its sales force and management team. Adamis created
the Adamis Laboratories subsidiary, which then acquired HVG in a
stock-for-stock
exchange. Adamis issued approximately 12.6 million new
shares of Adamis common stock to the shareholders of HVG. Under
the terms of the transaction agreements, approximately
6.7 million of these shares are subject to restrictions on
transfer as well as repurchase by Adamis if certain performance
targets based on revenue over a period of three years are not
achieved by Adamis Labs and if the holders do not remain
employed by Adamis during that period.
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Adamis Labs has a small base of established products, as well as
several product candidates that Adamis believes have the
potential to be successful products.
Current
Products
The current specialty pharmaceutical products are sold under a
prescription and promoted to physicians who specialize in
allergy, respiratory disease and pediatric medicine. The six
currently marketed products include:
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AeroHist®
Caplets (chlorpheniramine maleate 8mg, methscopolamine
nitrate 2.5 mg) extended release, scored caplets. Indicated
for the relief of symptoms of seasonal or perennial rhinitis.
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AeroHist®
Plus Caplets (chlorpheniramine maleate 8mg, phenylephrine
hydrochloride 20mg, methscopolamine nitrate 2.5 mg).
Indicated for the relief of symptoms of seasonal or perennial
rhinitis.
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AeroKid®
Oral Liquid (chlorpheniramine maleate 4mg/5ml, phenylephrine
hydrochloride 10mg/5ml, methscopolamine nitrate 1.25mg/5ml).
Indicated for the relief of symptoms of seasonal or perennial
rhinitis.
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AeroOtic®
HC Ear Drops (chloroxylenol 1mg, pramoxine hydrochloride
10mg, hydrocortisone 10mg). Indicated for the treatment of
superficial infections of the external auditory canal
complicated by inflammation caused by organisms susceptible to
the action of the antimicrobial and to control itching and
swimmers ear.
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Allergy Extracts allergy extracts, sterile
vials, and diluents used in preparation of allergy therapy. As
of July 2009, Adamis Labs ceased selling these products.
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Prelone®
(prednisolone syrup, USP, 15 mg per 5
ml). Indicated in various diseases and disorders
including allergic states and respiratory diseases.
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Net revenues to Adamis from sales of these products from
April 23, 2007, the date on which Adamis acquired Adamis
Labs, through Adamis fiscal year ended March 31,
2009, were approximately $1,281,000. During Adamis fiscal
year ended March 31, 2009, two customers, Cardinal Health
and McKesson, accounted for approximately 37% and 19% ,
respectively, of Adamis revenues. The products have not
been heavily promoted in the past due to funding limitations and
the competitive market for antihistamine/decongestant products.
Adamis believes there is limited growth potential for these
products, due in part to the widespread substitution of generic
products at the dispensing pharmacy level for the conditions
indicated for the Adamis Labs products.
The Prelone product is the subject of an ANDA approval from the
FDA. As Adamis believes is common with many drug products, the
Prelone product is manufactured by a third party manufacturer
who holds the ANDA approval relating to the product. Adamis owns
the trademark and intellectual property rights relating to the
product and distributes the product pursuant to those rights.
Product
Pipeline
Adamis Labs product pipeline includes the recently
launched epinephrine PFS Syringe product and an inhaled nasal
steroid product candidate. The first product, the PFS Syringe
product, was commercially launched in July 2009. The second
product, an aerosolized inhaled nasal steroid product for the
treatment of seasonal and perennial allergic rhinitis, is
targeted for commercial availability in the first quarter of
calendar year 2012, assuming adequate funding to support product
development and launch and no unanticipated delays in obtaining
regulatory approvals. Adamis Labs has an agreement with Catalent
Pharma Solutions, Inc. for sterile manufacturing product supply
for the PFS Syringe product and is in discussions with an
aerosol inhaler supplier for the aerosolized nasal steroid
product candidate.
Epinephrine
Pre-Filled Syringe
There is a well-defined, growing market in the United States for
patient-administered emergency epinephrine injectors used in the
treatment of anaphylaxis. Based on information in the NDC
Report, Adamis estimates that annual U.S. sales for
emergency epinephrine injectors were approximately
$150 million in 2006 and have historically grown at a rate
of approximately 15% per year. Currently, the emergency
epinephrine market is
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dominated by one brand,
EpiPen®,
which Adamis believes is relatively high priced. Adamis believes
there is an opportunity to bring to market a simpler, more
intuitive and user-friendly, lower-cost product that should be
competitive with existing products.
Anaphylaxis is usually triggered by an allergic reaction to
medication, food, insect stings, skin allergies or latex
allergies. This sudden, whole body allergic reaction results in
a potentially life threatening medical emergency. The recognized
treatment of choice for anaphylaxis is aqueous epinephrine
(adrenaline) delivered by injection.
There are two major causes of consumption of emergency
epinephrine injectors: use when a patient experiences an
anaphylactic attack, or expiration of the product. Of the two,
expiration is by far the largest cause of consumption. The
epinephrine contained in injectors has a limited shelf life, and
on average a new prescription must be obtained every 12 to
18 months. As a result, based on information in the AAAAI
Statistics, Adamis estimates that at least 70% of all
epinephrine injectors expire unused.
EpiPen, EpiPen Jr., and Twinject are the only
patient-administered epinephrine products available for sale as
emergency treatment of anaphylaxis in the United States. Based
on information in the IMS Report, the U.S. epinephrine
injector market was approximately $149 million in sales in
2005. EpiPen and EpiPen Jr. combined represented over
approximately 99% of all sales in the U.S. The physicians
that prescribe self-administered epinephrine are relatively
concentrated, with over 70% of prescriptions originating from
allergists and primary care physicians, according to the IMS
Report.
Based on information in the AAAAI Statistics, in the U.S., an
estimated 5% of the population suffers from insect sting
anaphylaxis, up to 6% are latex sensitive and up to 1.5% of
adults and 5% of children under three years of age experience
food related anaphylaxis. Adamis believes that anaphylaxis may
be under-diagnosed. In January 2001, a published study by AAAAI
revealed that up to 40 million Americans (15% of the total
population) may be at risk for anaphylaxis, a significantly
higher number than the historically estimated at-risk
population. According to information in the AAAAI Statistics,
approximately 3,000 people in the U.S. die each year
from anaphylaxis.
The number of prescriptions has grown annually as the risk of
anaphylaxis has become more widely understood. According to the
IMS Report, total prescriptions for EpiPen products more than
doubled in the five year period from 2001 to 2005. Adamis
estimates that the growth rate of annual prescriptions will
decline to a growth rate of approximately 4-5% per year by 2010.
Annual
Prescriptions for Emergency Epinephrine (000)
EpiPen was originally developed by Meridian Medical
Technologies, Inc. as an auto-injection system for use by
military personnel. It was designed for self-administration as
an antidote for chemical warfare agents and morphine. Meridian
Medical Systems, which is the manufacturer of the EpiPen and
EpiPen Jr., continues to focus on products for the military, and
its major customer is the United States Department of Defense.
The EpiPen products were introduced to the market in 1982, and
were the only epinephrine injectors for allergic emergencies
that were available until 2005. In August 2005, another company
introduced a competing product, Twinject Dual Pack 0.3mg
epinephrine auto injectors, which, Adamis believes due to
pricing and ease of use issues, has enjoyed only a small market
share in the United States. Twinject is currently owned by
Sciele Pharma, Inc.
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Adamis believes that there are barriers to market entry for new
competitors based on epinephrines susceptibility to
contamination, sensitivity to heat and light and a short
shelf-life, as well as the need for a competitor to possess the
expertise to overcome the packaging and delivery challenges of
introducing a competing product to the market. Adamis also
believes that the size of the market is too small to be a major
focus of the large pharmaceutical companies, although there can
be no guarantees that this will be the case.
Adamis believes that the primary opportunity lies in the
0.3 mg segment, which constitutes approximately 72% of the
total market (measured as a percent of U.S. sales), based
on EpiPen unit sales history and the NDC Report. When sales of
dual packs of EpiPen and TwinJect are converted to single units,
the total target market in the U.S. is about
2.5 million single units per year.
Adamis believes that there is an opportunity for a simpler,
low-cost, more intuitive and user-friendly pre-filled syringe to
compete in this largest segment of the market. Adamis believes
that its new product can compete effectively against EpiPen
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based on the following factors, among others:
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Market Knowledge. Mr. Richard Aloi,
president of Adamis Labs (formerly a Director at Center
Laboratories of Long Island, New York), had responsibility for
the U.S. introduction of
EpiPen®
and
EpiPen®
Jr. brands and helped to craft the marketing and sales strategy
that saw
EpiPen®
brands grow in units and dollars annually.
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Market Presence. Adamis Labs has provided
allergenic extracts for processing into desensitization or
immunotherapy injections to the same allergy physician group
that would prescribe the PFS Syringe product.
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Lower Price. Adamis believes that a
lower-priced option would be particularly attractive to
individuals potentially susceptible to anaphylaxis as well as
managed healthcare drug reimbursement plans providing patient
prescription reimbursement. Adamis introduced the PFS Syringe at
a price point reflecting a discount to the price of the market
leader,
EpiPen®,
in part to make the product more attractive to customers. At
this price, Adamis believes it can still obtain significant
gross margins.
|
|
|
|
Ease of Use. The
EpiPen®,
EpiPen®
Jr., and
Twinject®
are powerful spring-loaded devices. If not administered
properly, they can misfire or be misused. Adamis
0.3 mg PFS Syringe product will allow patients to
self-administer (self-inject) a pre-measured epinephrine dose
quickly with a device that does not have moving parts that the
user cannot control, which Adamis believes may increase product
safety.
|
There are three key supply components used in the manufacture of
PFS Syringe product: the pre-filled syringe containing the
epinephrine; the formulation solution; a specially designed
plunger rod that expels only the appropriate emergency amount of
0.3mg of epinephrine; and the plastic carrying case. Adamis owns
a proprietary epinephrine liquid formulation. Adamis has secured
component suppliers that will ship all components to the
manufacturer who completes the finished labeled product. Adamis
believes that the market for emergency epinephrine injectors
will grow, driven by increasing awareness, lower cost
alternatives, and promotion by new market entrants. Adamis
expects that the total market unit growth rate will continue to
grow as additional lower priced epinephrine products are
introduced, but total dollar market will plateau as a result as
the market matures with multiple lower priced products. Adamis
believes that the PFS Syringe product may acquire a share of the
market in a manner somewhat similar to the pattern established
by generic drugs, in that the price differential between the
expected price of the Adamis syringe product and the price at
which the market-leading product is currently sold will motivate
purchasers and reimbursing payors to choose the lower cost
alternative. Adamis also believes, however, that if its product
competes successfully, at least one of the current competitors
may introduce a competing, low-priced, pre-filled syringe while
maintaining the price points of its existing product lines.
Adamis believes that such a competing product might have a
comparable or lower price than the Adamis product. Adamis
believes that the PFS Syringe product has the potential to
compete successfully shortly after full commercial introduction
of the product, although there can be no assurance that this
will be the case. To date, Adamis ability to fully execute
its plan for the commercial launch of the PFS Syringe product
has been hampered because of limited funding to support the
launch.
71
Inhaled
Nasal Steroid
Adamis Labs is developing an aerosolized inhaled nasal steroid
for the treatment of seasonal and perennial allergic rhinitis.
The active ingredient is beclomethasone diproprionate, a
synthetic steroid that demonstrates potent glucocorticoid
activity. Glucocorticosteroids are hormones produced by the
adrenal cortex. Corticosteroids inhibit inflammation in allergic
reactions by interfering with the synthesis of prostaglandins
and leukotrienes, chemicals that are normally synthesized as
part of the inflammatory process. Adamis refers to the product
as Beclomethasone Aerosolized Nasal Steroid, or BANS.
The market for inhaled nasal steroids, or INS, as estimated by
Adamis based on the DataMonitor Report, is about $3 billion
annually in the U.S. and growing steadily. Although the
market is dominated by two multi-national pharmaceutical
companies, Adamis believes there is a niche that can be
exploited, and that an Adamis product candidate can achieve a
small percentage share of this large market.
INS products are sold under prescription for seasonal allergic
rhinitis. In addition to inhaled nasal steroids, many different
types of products treat the symptoms of allergic rhinitis: oral
antihistamines and decongestants are among the most popular for
self-medication/patient treatment. All physician specialties
report that the majority of their allergic rhinitis patients
receive intranasal steroids, either alone or in combination with
oral antihistamines. In general, physicians view intranasal
steroids as safe and effective.
There are four major physician specialties that treat patients
with allergic rhinitis: Allergists, Otolaryngologists, or ENTs;
Primary Care Physicians, or PCPs; and Pediatricians. Allergists,
along with ENTs, tend to be the most aggressive in terms of
pharmacological treatment of allergic rhinitis. On an individual
basis, the allergist is the largest prescriber of products
within the INS category. ENT physicians contribute half as many
prescriptions as allergists, but that is still about five times
the volume of the average primary care physician.
The INS market is highly seasonal with most of the sales
occurring in two periods: a spring season from April through May
or June; and a fall season occurring in September and October.
Based on information in the DataMonitor Report, Adamis estimates
that the INS market grew at an annual rate of over 5% from
31.7 million prescriptions in 2002 to an estimated
38.7 million prescriptions in 2006.
Total
U.S. Prescriptions for Inhaled Nasal Steroids
2002-2006e
(millions)
In the same period, total U.S. market sales grew from
$1.89 billion in 2002 to an estimated $3 billion for
2006. This average growth rate is about 10% per year, and
resulted primarily from steady price increases.
72
Total
U.S. Sales of Prescription Inhaled Nasal Steroids
2002-2006e
($ millions)
Adamis expects that the growth rate in average price increases
will decline and reach zero by 2011, due to increasing
competition from generic products.
Currently, the INS market is dominated by aqueous solution
formulations delivered by a pump. These aqueous pump spray
formulations have replaced CFC propellant INS products, which
once dominated the INS market. The propellant inhaled nasal
steroids that were previously available have been discontinued
due to CFC concerns for the environment. Based on information in
the IMS Report concerning 2005 sales, the two leading products
account for over 70% of total product sales in this market.
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
Market
|
|
Product
|
|
Sales
|
|
|
Share
|
|
|
|
(Millions)
|
|
|
|
|
|
Flonase®
|
|
$
|
1,208
|
|
|
|
46.4
|
%
|
Nasonex®
|
|
$
|
705
|
|
|
|
27.1
|
%
|
Nasacort®
AQ
|
|
$
|
348
|
|
|
|
13.4
|
%
|
Rhinocort®
|
|
$
|
325
|
|
|
|
12.5
|
%
|
Nasarel®
|
|
$
|
17
|
|
|
|
0.6
|
%
|
Total
|
|
$
|
2,603
|
|
|
|
100.0
|
%
|
Adamis believes that, in general, prescribing physicians view
all INS products as being generally similar in terms of efficacy
and safety. As a result, the INS market is sensitive to
promotion, and companies spend a great deal of effort and money
each year in the attempt to differentiate these products from
one another. Adamis believes that large amounts are spent on
direct-to-consumer
advertising for the two largest holders of market share,
Flonase®,
marketed by GlaxoSmithKline, and
Nasonex®,
marketed by Schering. In addition to
direct-to-consumer
advertisement, GSK and Schering also spend large amounts of
dollars in personal promotion detailing physicians and
distributing samples as well as journal advertisement.
Adamis does not anticipate competing directly against the two
leading companies in this market by attempting to out-spend or
out-promote them in the marketplace. Adamis believes that its
market opportunity lies in taking a small portion of the market
with a new aerosolized HFA version of a well-established product
at a substantial discount to the current prices of the leading
branded products.
Adamis expects BANS to be considered a new drug by
the FDA, and accordingly Adamis believes that it will be
required to submit data for an application for approval to
market BANS pursuant to Section 505(b)(2) of the Food Drug
and Cosmetics Act. Total time to develop the BANS product is
expected to be approximately 24 months from inception of
full product development efforts, assuming sufficient funding
and no unexpected delays. The table below shows the estimated
development timeline for the BANS product based on the number of
months from inception of full product development efforts.
73
Developmental
Timeline for BANS
(beclomethasone diproprionate)
Factors that could affect the actual launch date for the BANS
product candidate include the outcome of discussions with the
FDA concerning the number and kind of clinical trials that the
FDA will require before the FDA will consider regulatory
approval of the product, any unexpected difficulties in
licensing or sublicensing intellectual property rights for other
components of the product such as the inhaler, any unexpected
difficulties in the ability of suppliers to timely supply
quantities for commercial launch of the product, any unexpected
delays or difficulties in assembling and deploying an adequate
sales force to market the product, and adequate funding to
support sales and marketing efforts.
Adamis
Viral Therapies
Adamis Viral is focused on developing patented vaccine
technology that has the potential to provide protection against
a number of different viral infectious agents. This novel
vaccination strategy, which employs DNA plasmids, appears, based
on preclinical studies conducted to date, to have the ability to
train a persons immune system to recognize and
mount a defense against particular aspects of a virus
structure. If successful, Adamis believes this technology will
give physicians a new tool in generating immunity against a
number of viral infections that have been difficult to target in
the past.
The first target indication will be avian influenza. Avian flu
is a particularly good initial clinical application because
there is a large potential demand. Subsequent disease targets
might include therapeutic vaccines for Hepatitis C and Human
Papillomavirus.
The technology that provides the basis of Adamis Virals
research and development was developed by Dr. Maurizio
Zanetti, M.D., a professor at the Department of Medicine at
the University of California, San Diego. Dr. Zanetti
has developed and patented a method of DNA vaccination by
somatic transgene immunization, or STI. Adamis has entered into
a world-wide exclusive license with Dr. Zanetti, through a
company of which he is the sole owner, Nevagen, LLC, to utilize
the technology within the field of viral infectious agents.
Adamis believes that the technology has broad applications and
is targeting influenza for its initial proof of concept.
STI has already been tested in Phase I studies in man for other
vaccine applications. An immune response was elicited in the
study, and the results suggested that the procedure was safe.
Testing for influenza is currently at the preclinical stage. If
successful, STI may provide a vaccine for immunity to all forms
of influenza, including avian flu, although there are no
guarantees that any of the trials will be successful or that a
commercial product will be developed or marketed.
Current flu vaccines act by giving the immune system a preview
of certain proteins expected to be found on the coat of the flu
virus; however, the influenza virus changes its coat every
season. The changes make each years new version of the flu
unrecognizable to the immune system, and therefore immunity to
influenza must be reestablished with a new vaccine every fall.
The following summarizes the method proposed by Adamis to
develop long lasting and cross-reactive immunity using STI:
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|
|
|
|
Draw a small amount of blood from patient
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|
|
|
Separate the white blood cells
|
|
|
|
Add plasmid (DNA) to the white blood cells
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|
|
|
Incubate overnight to allow the plasmid to enter the white blood
cells (ex vivo transgenesis)
|
|
|
|
Inject white blood cells back to the individual to induce
immunity to the pathogen of choice, i.e., influenza, hepatitis,
etc.).
|
74
Adamis intends to initiate a clinical proof of
concept trial, currently anticipated to be conducted in
Thailand for the avian flu vaccine in the third quarter of 2010.
Preliminary discussions have been held with potential Thai
partners regarding the conduct of this trial. Adamis
current plan is to test a small number of human patients
(approximately 80) to demonstrate that Adamis
procedure induces both a cell-mediated and antibody response. An
antibody response, as measured by increased concentration of
antibodies, is generally accepted by the FDA as an indicator of
increased immunity to the disease. Adamis would further seek to
demonstrate a dose-response relationship for the treatment. If
the results of the initial trial are successful, Adamis intends
to file an Investigative New Drug application, or IND, with the
FDA and begin trials in the United States in 2011, assuming
adequate funding and no unexpected delays. If Adamis
assumptions regarding the development process and sufficient
funding are correct, Adamis believes the product could be
available for public use in the second half of 2013.
There are a number of factors, including those identified in the
Risk Factors section of this joint proxy statement/prospectus,
that could cause actual events to differ from Adamis
expectations concerning the timeline for product development and
the regulatory approval process. Adamis believes that it will be
able to obtain sufficient funding for its clinical trials and
product launches, but there can be no assurance that this will
be the case. Similarly, there are no assurances that the
clinical trials will be successful or that Adamis will be able
to submit an application for, or obtain approval from the FDA
for, an avian flu or vaccine product.
Overview
of History of the Flu
Avian influenza is a highly contagious virus that affects birds
and causes high mortality rates among chickens, ducks, geese,
etc. Humans that come into contact with contaminated birds can
become infected. However, the more widespread concern is the
possible mutation of the current form of avian flu. Some experts
predict that the virus will combine with existing human flu
viruses at some point and mutate to allow
human-to-human
transfer. The result could be a worldwide pandemic.
A pandemic occurs when a virus changes dramatically and spreads
easily across the world. A pandemic is not as common as an
epidemic. A flu epidemic happens nearly every year when a virus
spreads rapidly through a population. The history of major flu
outbreaks is summarized in the table below.
1918-1919:
Spanish flu pandemic
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|
|
|
|
The virus is thought to have spread through troop movements in
World War I.
|
|
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Estimated
20-40%
percent of the worlds population fell ill during the
outbreak.
|
|
|
|
Unlike other flu viruses, Spanish flu killed healthy adults -
approximately 500,000 in the U.S. and up to 50 million
worldwide.
|
1957: Asian flu pandemic
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|
|
|
|
Started in China and claimed an estimated 70,000 lives in the
U.S. mostly among the elderly population.
|
|
|
|
Experts identified the virus quickly and created a vaccine
available in limited quantities.
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1968: Hong Kong flu pandemic
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|
|
|
|
Flu pandemic killed about 34,000 in the U.S., mostly among the
elderly population.
|
|
|
|
This was the mildest pandemic of the 20th century, perhaps
because a similar flu virus created some cross immunity to the
new strain.
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1976: Swine flu scare
|
|
|
|
|
The killer virus was identified in Fort Dix,
New Jersey.
|
|
|
|
Over 40 million Americans were vaccinated and the virus did
not spread.
|
1977: Russian flu scare
|
|
|
|
|
A flu virus, similar to the avian flu that circulated in 1957,
spread around the world.
|
75
|
|
|
|
|
Mostly children and adults under age 23 were infected with
the new virus.
|
|
|
|
Some experts explain that young people, not exposed to the 1957
virus, were susceptible.
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1997: Avian flu scare
|
|
|
|
|
An avian flu outbreak hospitalized 18 people in Hong Kong
with an infection seen before only in birds.
|
|
|
|
Officials ordered all chickens slaughtered after six people died.
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2009: Swine flu
|
|
|
|
|
During 2009, the H1N1 influenza strain and the incidence of
illness and deaths in many countries throughout the world have
attracted the attention of the public, the FDA and numerous
companies seeking to develop vaccines or other therapies for
influenza.
|
Potential
Impact of Avian Flu Pandemic
In March 2007, the Lowry Institute published a report entitled
Global Macroeconomic Consequences of Pandemic Influenza.
The report considered the impact of four possible scenarios:
|
|
|
|
|
Mild, in which the pandemic is similar to the
1968-69 Hong
Kong flu;
|
|
|
|
Moderate, similar to the 1957 Asian flu;
|
|
|
|
Severe, similar to the
1918-19
Spanish flu;
|
|
|
|
An ultra scenario that is worse than the Spanish flu
outbreak;
|
The report estimated that a mild pandemic could kill
1.4 million people and cost $330 billion. In the
ultra scenario, they estimate that:
|
|
|
|
|
as many as 142 million people around the world could die;
|
|
|
|
global economic losses would be $4.4 trillion - the equivalent
of wiping out the Japanese economys annual output; and
|
|
|
|
there would be a large-scale collapse of Asian economic activity
causing global trade flows to dry up.
|
The Flu
Virus
Influenza viruses are classified as type A, B, or C based upon
their protein composition. Type A viruses are found in many
kinds of animals, including ducks, chickens, pigs, whales, and
also in humans. The type B virus widely circulates in humans.
Type C has been found in humans, pigs, and dogs and causes mild
respiratory infections, but does not spark epidemics. Type A
influenza is the most dangerous of the three. It is believed
responsible for the global flu outbreaks of 1918, 1957 and 1968.
Type A viruses are subdivided into subtypes based on the protein
layers projecting in spikes from the surface of the individual
virus. There are two different kinds of spikes on each virus:
one is the protein hemagglutinin, or HA, which allows the virus
to stick to a host cell and initiate infection; the
other is a protein called neuraminidase, or NA, which enables
newly formed viruses to exit the host cell. Scientists have
characterized approximately 16 HA varieties and 9 NA varieties.
Type A subtypes are classified by a naming system that includes
the place the strain was first found, a lab identification
number, the year of discovery, and, in parentheses, the variety
of HA and NA it possesses, for example, A/Hong Kong/156/97
(H5N1). If the virus infects non-humans, the host species is
included before the geographical site, as in A/Chicken/Hong
Kong/G9/97 (H9N2). There are no type B or C subtypes.
76
Influenza virus is one of the most mutable of viruses. These
genetic changes may be small and continuous or large and abrupt.
Small, continuous changes happen in type A and type B influenza
as the virus makes copies of itself. The process is called
antigenic drift. The drifting is frequent enough to make the new
strain of virus often unrecognizable to the human immune system.
Type A influenza also undergoes infrequent and sudden changes,
called antigenic shift. Antigenic shift occurs when two
different flu strains infect the same cell and exchange genetic
material. The novel assortment of HA or NA proteins in a shifted
virus creates a new influenza A subtype.
Because people have little or no immunity to such a new subtype,
its appearance tends to cause very severe flu epidemics or
pandemics. Due to either antigenic drift or shift, a new flu
vaccine must be produced each year to combat that years
prevalent strains.
In nature, the flu virus is found in wild aquatic birds such as
ducks and shore birds. It has persisted in these birds for
millions of years and does not typically harm them. But the
frequently mutating bird (avian) flu viruses can readily jump
the species barrier from wild birds to domesticated ducks and
then to chickens.
From there, the next stop in the infectious chain is often pigs.
Pigs can be infected by both bird influenza and the form of
influenza that infects humans. In a setting such as a farm,
where chickens, humans and pigs live in close proximity, pigs
act as an influenza virus mixing bowl. If a pig is infected with
avian and human flu simultaneously, the two types of virus may
exchange genes. Such a re-assorted flu virus can
sometimes spread from pigs to people depending on the precise
assortment of bird-type flu proteins that are transported into
the human population; the flu may be more or less severe.
In 1997, for the first time, scientists found that bird
influenza skipped the transitional step from bird to pig and
infected humans directly. Alarmed health officials feared a
worldwide epidemic or a pandemic. Fortunately, the virus could
not pass between people and thus did not spark an epidemic.
Scientists speculate that chickens may now also have the
receptor used by human-type viruses.
The recent spread of strains of avian influenza (H5N1) has
highlighted the threat posed by pandemic influenza. The H5N1
virus is one of 16 different known subtypes of avian influenza
(bird flu) viruses. All influenza viruses (human and avian) are
of significant concern to health officials because of their
ability to mutate rapidly and their propensity for acquiring
genes from viruses that infect other animal species.
H5N1 viruses have been found in birds around the world. As the
spread of H5N1 infection among birds increases, so too does the
opportunity for H5N1 to be transmitted directly from birds to
humans. Recently, human H5N1 infection has occurred throughout
Southeast Asia, most prominently in Indonesia, during large H5N1
outbreaks among poultry, causing great concern among health
officials.
If cases of human infections increase, people simultaneously
infected with human and avian influenza strains could become a
mixing vessel for the disease. The result could be
the emergence of a lethal H5N1 influenza virus
77
that is easily transmitted from person to person. Such an easily
transmissible virus could result in an epidemic with severe
public health consequences similar to the pandemic of 1918.
Currently, available anti-viral drugs and vaccines have limited
efficacy, and may become even less efficacious as the virus
continues to mutate. The challenge is to develop a vaccine that
induces an immune response that will protect against various
strains of the flu virus.
Preclinical
Animal Studies
Recently, experiments conducted by third parties for Adamis
utilizing the STI technology in mice have shown that T-cell
immunity can be induced in vivo by a single intravenous
inoculation of naïve B lymphocytes genetically programmed
by ex vivo transgenesis. Trangenesis is accomplished by
administering a plasmid DNA under control of a B cell specific
promoter. The process is entirely spontaneous and mimics the
process of viral infection, which is intracellular replication.
Results show the induction of systemic effector CD4 and CD8
T-cell responses within 14 days after administration of the
transgenic B cells. Durable immunologic memory is also induced.
It has been demonstrated that a single injection of 5 x
103
transgenic B lymphocyte induces complete protection from a
lethal virus challenge. The following outlines the protocol used
in the mouse trial:
|
|
|
|
|
a small amount of blood was drawn from mice
|
|
|
|
B cells were separated from the blood and transfected with DNA
from flu virus
|
|
|
|
transfected lymphocyctes, or priming B cells, were re-infused
into the mice
|
|
|
|
a lethal challenge of virus was administered via aerosol
14-21 days
after re-infusion
|
|
|
|
for controls, mice were injected with priming B cells
transfected with DNA not specific for the flu
|
A single injection of transgenic B lymphocytes in this trial was
sufficient to generate specific CD8 T-cell memory responses,
which protected mice from a lethal viral challenge. The immune
response that was induced was a reaction against the common
components of the influenza virus, and was cross-reactive,
meaning that it reacted against various types of flu virus
(avian or any other). Thus, this type of vaccine may be utilized
to protect individuals from various strains of influenza that
may occur.
License
Agreement
On July 28, 2006, Adamis entered into a worldwide exclusive
license agreement with Dr. Zanetti, through a company of
which he is the sole owner, Nevagen, to utilize the technology
within the field of viral infectious agents. The intellectual
property, or IP, licensed by Adamis includes the use of the
technology known as Transgenic Lymphocyte
Technology, or TLI, covered by patent applications titled
Somatic Transgene Immunization and related methods
including but not limited to ex vivo treatment of
an individuals lymphocytes with plasmid (non-
78
viral) DNA and administration of treated lymphocytes to the same
individual. The vaccine is constituted of the
individuals lymphocytes harboring plasmid DNA, for
example, DNA coding for selected epitopes of influenza virus.
The IP includes rights under two issued U.S. patents, three
U.S. patent applications and related patent applications
filed in European Union, Japan and Canada. The U.S. patent
was issued on October 9, 2007 and will expire on
April 27, 2019, 20 years from the filing date of the
earliest U.S. non-provisional application upon which the
patent claims priority.
The field for this exclusive license is the prevention and
treatment and detection of viral infectious diseases. The
geographic area covered by the exclusive license is worldwide.
The license will terminate with the expiration of the
U.S. patent for the IP.
As part of the initial license fee Adamis granted
Dr. Zanetti the right to purchase one million shares of
Adamis common stock at a price of $0.001 per share, and he
subsequently exercised that right. In addition, Adamis paid the
licensor an initial license fee of $55,000. For the first
product, Adamis will make payments upon reaching specified
milestones in clinical development and submission of an
application regulatory approval, potentially aggregating
$900,000 if all milestone payments are made. As of the date of
this joint proxy statement/prospectus, no milestones have been
achieved and no milestone payments have been made. The agreement
also provides that Adamis will pay the licensor royalties, in
the low single digits, payable on net sales received by Adamis
of products covered by the IP. If additional technologies are
required to be licensed to produce a functional product, the
royalty rate will be reduced by the amount of the royalty paid
to the other licensor, but not more than one-half the specified
royalty rate. Royalties and incremental payments with respect to
influenza will continue until reaching a cumulative total of
$10 million.
Adamis and the licensor have the right to sublicense with
written permission of the other party. In the event that the
licensor sublicenses or sells the improved technology to a third
party, then a portion of the total payments, to be decided by
mutual agreement, will be due to Adamis. If Adamis sublicenses
the IP for use in influenza to a third party, the licensor will
be paid a fixed percentage of all license fees, royalties, and
milestone payments, in addition to royalties due and payable
based on net sales.
If the IP is sublicensed by Adamis to another company for any
indication in the field covered by the license agreement other
than with respect to influenza, the licensor will be paid a
portion of all license fees, royalties and milestone payments,
with the percentage declining over time based on the year in
which the sublicense is granted. Certain incremental non-flu
sublicensing payments described in the license agreement are
specifically excluded from the royalty cap.
All improvements of the IP conceived of, or reduced to practice
by Adamis, or made jointly by Adamis and the licensor will be
owned by Adamis. Adamis granted Nevagen a royalty-free
nonexclusive license to use any improvements made on the
existing technology for research purposes only. Adamis has
agreed to grant to Nevagen a royalty-free license for any
improvement needed for the commercialization of the IP for
Nevagens use outside the field licensed to Adamis. If
Nevagen sublicenses or sells the improved technology to a third
party, then a portion of the total payments, to be decided by
mutual agreement, will be due to Adamis.
Adamis will have the right of first offer to license the
following additional technology from the licensor, if and when
it becomes available:
|
|
|
|
|
Technology for the application of related intellectual property
as a prophylactic or therapeutic cancer vaccine; and
|
|
|
|
Any additional technology developed by the licensor related to
the IP.
|
Adamis has the right to terminate the agreement if it is
determined that no viable product can come from the technology.
Upon such termination, Adamis would be required to transfer and
assign to the licensor all filings, rights and other information
in its control if termination occurs. Adamis would retain the
same royalty rights for license, or sublicense, agreements if
the technology is later developed into a product. Either party
may terminate the license agreement in the event of a material
breach of the agreement by the other party that has not been
cured or corrected within 90 days of notice of the breach.
79
Development
Process
The statements below, and elsewhere in this joint proxy
statement/prospectus regarding anticipated future events
concerning the development process of Adamis vaccine
product candidates, the clinical trial process, and the
regulatory approval process including the actions of the FDA,
are subject to several uncertainties and contingencies that
could cause actual results to differ in material respects from
the results and timelines anticipated in the discussion below.
Some of these uncertainties and contingencies are described
above under the heading Risks Factors Related to
Adamis. There is no guarantee that Adamis will be able to
complete clinical development and obtain approval from the FDA
for any vaccine product candidate.
Without direct discussions with the FDA, it is difficult to
precisely plan clinical development of a new therapeutic
treatment. However, the FDA has announced that it will seek ways
to accelerate the development and approval process for new
vaccines against avian influenza. Based on Adamis
interpretations of the FDAs position, Adamis has developed
a plan for clinical development that includes making a formal
application for marketing approval by late 2013, assuming
adequate funding and no unexpected delays.
Preclinical Development. Adamis anticipates
filing for an Investigational New Drug Application, or IND,
based on previously published data on this technology. Adamis
believes that having this data could shorten the process of
preclinical development and preparation of the IND, although
there can be no assurance that this will be the case. Adamis
believes that clinical trials could start within
60-90 days
after acceptance of the IND by the FDA. The total time to
complete an IND application is expected to be about one year
following receipt of sufficient funding.
Phase I/II Trial. The Phase I/II clinical
trial that would be specified in the IND would probably be
conducted in one center and require about
81/2 months
in total, as illustrated in the table below. Adamis estimates
the total cost of the clinical trial to be about $250,000. After
completion of the anticipated Phase I/II trial, Adamis expects
that it would meet with the FDA to review the trial results and
determine whether another Phase II trial will be required
or whether the next trial would be a Phase III trial,
assuming a successful Phase I/II trial.
Phase III Trial. The timing and cost of
the Phase III clinical trial will depend on the results of
the Phase I/II clinical trial, the amount of capital Adamis is
able to raise and requirements of the FDA. For planning
purposes, Adamis estimates that the Phase III trial will be
a multiple center study and require a total of approximately
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17 months, primarily due to the need to monitor and test
patients after the vaccination. Adamis estimates that the cost
of the trial will be approximately $10.7 million.
The FDA has recently announced guidelines for accelerated
approval of influenza vaccines, which provide for timeframes
that are significantly shorter than the average review process.
Accordingly, absent unexpected developments, Adamis believes it
may be able to submit its NDA for the influenza vaccine by late
2012 and, if approved, the product could be available for public
use by late 2013. However, there is no guarantee that Adamis
will be able to submit its NDA in such a timeframe or obtain
approval of its influenza vaccine product for marketing from the
FDA.
Cost
of Development
Adamis estimates that the total cost of clinical development for
the avian influenza vaccine is in the range of approximately
$20 million to $25 million. Of this amount,
approximately $5 million to $10 million will consist
of internal research and development expenses associated with
optimizing the effectiveness of the influenza DNA plasmid,
management of the clinical trials, and other activities
conducted by Adamis personnel; Adamis estimates that
approximately $15 million will be spent on activities
anticipated to be conducted by third parties, such as:
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production of the plasmid
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preclinical studies
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phase I/II clinical trials
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phase III clinical trials; and
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FDA Application fees.
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If clinical trials for the influenza vaccine are progressing
successfully, Adamis anticipates that it may seek to form a
strategic partnership with a large, international pharmaceutical
company capable of commercializing Adamis product in
markets outside of the United States, in the U.S. markets,
or worldwide. The formation of such a partnership depends on a
number of factors, including the status of Adamis other
business activities and products, the amount of funds that
Adamis has raised, and Adamis other capital needs and the
terms of any such partnership. In addition, Adamis has also
considered an alliance with one or more non-governmental
organizations, such as the Red Cross, as a viable method of
commercializing some of Adamis products domestically.
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Other
Product Candidates
Adamis Biosyn subsidiary has intellectual property
relating to a microbicide contraceptive product candidate named
Savvy®.
Savvy underwent Phase III clinical trials in Ghana and
Nigeria for reduction in the transmission of Human
Immunodeficiency Virus/Acquired Immunodeficiency Disease, or
HIV/AIDS, both of which were suspended in 2005 and 2006 and were
terminated before completion. Savvy is the subject of a
Phase III contraception trial in the United States. The
trial has been completed and the analysis of the results is
expected to be completed by the end of 2009. Biosyn is not
directly involved with the conduct and funding thereof, and
significant doubt exists concerning whether Savvy will be
commercialized or that Biosyn will ever realize revenues
therefrom.
Sources
and Availability of Raw Materials
Adamis purchases, in the ordinary course of business, necessary
raw materials, components and supplies essential to its
operations from several suppliers in the U.S. and overseas.
Adamis Labs has entered into a contract with a contract
manufacturing organization for the development and production of
its PFS Syringe product, and a contract with a different
contract manufacturing organization for the development and
production of its BANS product candidate. Adamis intends to
monitor these situations and to seek to provide a continued
supply of both raw materials and components.
Sales and
Marketing
Adamis Labs field force includes sales management,
customer service representatives, trade relations/reimbursement
specialists and executive management. Adamis expansion
plan, depending upon securing adequate funding, includes hiring
and training approximately
15-30
additional sales representatives to be strategically deployed in
the most valuable prescribing U.S. markets to support the
ongoing launch of the PFS Syringe product. For future field
force expansion and before the launch of Adamis
aerosolized inhaled nasal steroid, Adamis has identified the top
prescribing markets in the U.S. by utilizing physician data
aligned with zip code alignment data. Adamis expects to expand
to approximately 50 specialty field force sales representatives
before introducing the aerosolized nasal steroid product.
Physician calls by Adamis sales force are expected to be
to the highest prescribers of emergency epinephrine injectors in
each market and then modified, if required, when the aerosolized
nasal steroid product introduction occurs.
Governmental
Regulation
The production and marketing of Adamis products and
potential products and its ongoing research and development,
preclinical testing and clinical trial activities are currently
subject to extensive regulation and review by numerous
governmental authorities in the United States and will face
similar regulation and review for overseas approval and sales
from governmental authorities outside of the United States. Most
of the products Adamis is currently developing must undergo
rigorous preclinical and clinical testing and an extensive
regulatory approval process before they can be marketed. This
process makes it longer, more difficult and more costly to bring
Adamis potential products to market, and Adamis cannot
guarantee that any of its potential products will be approved.
The pre-marketing approval process can be particularly
expensive, uncertain and lengthy, and a number of products for
which FDA approval has been sought by other companies have never
been approved for marketing. In addition to testing and approval
procedures, extensive regulations also govern marketing,
manufacturing, distribution, labeling, and record-keeping
procedures. If Adamis or its collaboration partners do not
comply with applicable regulatory requirements, such violations
could result in non-approval, suspensions of regulatory
approvals, civil penalties and criminal fines, product seizures
and recalls, operating restrictions, injunctions, and criminal
prosecution.
Withdrawal or rejection of FDA or other government entity
approval of Adamis potential products may also adversely
affect Adamis business. Such rejection may be encountered
due to, among other reasons, lack of efficacy during clinical
trials, unforeseen safety issues, inability to follow patients
after treatment in clinical trials, inconsistencies between
early clinical trial results and results obtained in later
clinical trials, varying interpretations of data generated by
clinical trials, or changes in regulatory policy during the
period of product development in the United States and abroad.
In the United States, there is stringent FDA oversight in
product clearance and enforcement activities, causing medical
product development to experience longer approval cycles,
greater risk
82
and uncertainty, and higher expenses. Internationally, there is
a risk that Adamis may not be successful in meeting the quality
standards or other certification requirements. Even if
regulatory approval of a product is granted, this approval may
entail limitations on uses for which the product may be labeled
and promoted, or may prevent Adamis from broadening the uses of
Adamis current or potential products for different
applications. In addition, Adamis may not receive FDA approval
to export Adamis potential products in the future, and
countries to which potential products are to be exported may not
approve them for import.
Manufacturing facilities for Adamis products will also be
subject to continual governmental review and inspection. The FDA
has stated publicly that compliance with manufacturing
regulations will continue to be strictly scrutinized. To the
extent Adamis decides to manufacture its own products, a
governmental authority may challenge Adamis compliance
with applicable federal, state and foreign regulations. In
addition, any discovery of previously unknown problems with one
of Adamis potential products or facilities may result in
restrictions on the potential product or the facility. If Adamis
decides to outsource the commercial production of its products,
any challenge by a regulatory authority of the compliance of the
manufacturer could hinder Adamis ability to bring its
products to market.
To the extent that Adamis is able to successfully advance a
product candidate through clinical trials, it will be required
to obtain regulatory approval prior to marketing and selling
such product. Adamis is subject to extensive government
regulation that increases the cost and uncertainty associated
with its efforts to gain regulatory approval of its product
candidates. Preclinical development, clinical trials,
manufacturing, and commercialization of its product candidates
are all subject to extensive regulation by U.S. and foreign
governmental authorities. It takes many years and significant
expenditures to obtain the required regulatory approvals for
biological products. Satisfaction of regulatory requirements
depends upon the type, complexity and novelty of the product
candidate and requires substantial resources. Adamis cannot be
certain that any of its product candidates will be shown to be
safe and effective, or that it will ultimately receive approval
from the FDA or foreign regulatory authorities to market these
products. In addition, even if granted, product approvals and
designations such as fast-track may be withdrawn or
limited at a later time.
The process of obtaining FDA and other required regulatory
approvals is expensive. The time required for FDA and other
approvals is uncertain and typically takes a number of years,
depending on the complexity or novelty of the product. The
process of obtaining FDA and other required regulatory approvals
for many of Adamis products under development is further
complicated because some of these products use non-traditional
or novel materials in non-traditional or novel ways. For example:
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the FDA has not established guidelines concerning the scope of
clinical trials required for gene-based therapeutic and vaccine
products;
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the FDA has provided only limited guidance on how many subjects
it will require to be enrolled in clinical trials to establish
the safety and efficacy of gene-based products; and
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current regulations and guidance are subject to substantial
review by various governmental agencies.
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Therefore, U.S. or foreign regulations could prevent or
delay regulatory approval of Adamis products or limit its
ability to develop and commercialize products. These delays
could:
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impose costly procedures;
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diminish any competitive advantages; or
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negatively affect results of operations and cash flows.
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Adamis believes that the FDA and comparable foreign regulatory
bodies will separately regulate each product containing a
particular gene depending on its intended use. Presently, to
commercialize any product Adamis must sponsor and file a
regulatory application for each proposed use. Adamis must
conduct clinical studies to demonstrate the safety and efficacy
of the product necessary to obtain FDA approval. The results
obtained so far in clinical trials may not be replicated in
future trials. This may prevent any of the potential products
from receiving FDA approval.
83
Adamis will utilize recombinant DNA molecules in its product
candidates, and therefore must comply with guidelines instituted
by the NIH and its Office of Biotechnology Activities. The NIH
could restrict or delay the development of its product
candidates. In March 2004, the NIH Office of Biotechnology
Activities and the FDA Center for Biologics Evaluation and
Research launched the jointly developed Genetic Modification
Clinical Research Information System, or GeMCRIS, an
Internet-based database of human gene transfer trials. In its
current form, GeMCRIS enables individuals to easily view
information on particular characteristics of clinical gene
transfer trials, and includes special security features designed
to protect patient privacy and confidential commercial
information. These security features may be inadequate in design
or enforcement, potentially resulting in disclosure of
confidential commercial information.
The FDA and the NIH are considering rules and regulations that
would require public disclosure of additional commercial
development data that is presently confidential. In addition,
the NIH, in collaboration with the FDA, has developed an
Internet site, ClinicalTrials.gov, which provides public access
to information on clinical trials for a wide range of diseases
and conditions. Such disclosures of confidential commercial
information, whether by implementation of new rules or
regulations, by inadequacy of GeMCRIS security features, or by
intentional posting on the Internet, may result in loss of
advantage of competitive secrets.
A rule published in 2002 by the FDA, known commonly as the
Animal Rule, established requirements for
demonstrating effectiveness of drugs and biological products in
settings where human clinical trials for efficacy are not
feasible or ethical. The rule requires as conditions for market
approval the demonstration of safety and biological activity in
humans, and the demonstration of effectiveness under rigorous
test conditions in up to two appropriate species of animal.
Adamis believes, that with appropriate guidance from the FDA, it
may seek and win market approval under the Animal Rule for
certain DNA-based products for which human clinical efficacy
trials are not feasible or ethical. At the moment, however, it
cannot determine whether the Animal Rule would be applied to any
products of Adamis, or if applied, that its application would
result in expedited development time or regulatory review.
Any regulatory approval to market a product may be subject to
limitations on the indicated uses for which Adamis may market
the product. These limitations may restrict the size of the
market for the product and affect reimbursement by third-party
payers. In addition, regulatory agencies may not grant approvals
on a timely basis or may revoke or significantly modify
previously granted approvals.
Adamis, or its collaborative partners, are subject to numerous
foreign regulatory requirements governing the manufacturing and
marketing of Adamis potential future products outside of
the United States. The approval procedure varies among
countries, additional testing may be required in some
jurisdictions, and the time required to obtain foreign approvals
often differs from that required to obtain FDA approvals.
Moreover, approval by the FDA does not ensure approval by
regulatory authorities in other countries, and vice versa.
In addition to regulations imposed by the FDA, Adamis may also
be subject to regulation under the Occupational Safety and
Health Act, the Environmental Protection Act, the Toxic
Substances Control Act, the Research Conservation and Recovery
Act, as well as regulations administered by the Nuclear
Regulatory Commission, national restrictions on technology
transfer, import, export and customs regulations and certain
other local, state or federal regulations. From time to time,
other federal agencies and congressional committees have
indicated an interest in implementing further regulation of
biotechnology applications. Adamis cannot predict whether any
such regulations will be adopted or whether, if adopted, such
regulations will apply to its business, or whether Adamis would
be able to comply with any applicable regulations.
Even if Adamis products are approved by regulatory
authorities, if it fails to comply with ongoing regulatory
requirements, or if there are unanticipated problems with the
products, these products could be subject to restrictions or
withdrawal from the market. Even if regulatory approval of a
product is granted, the approval may be subject to limitations
on the indicated uses for which the product may be marketed or
contain requirements for costly post-marketing testing and
surveillance to monitor the safety or efficacy of the product.
Later discovery of previously unknown problems with the
products, including unanticipated adverse events or adverse
events of unanticipated severity or frequency, or failure to
comply with regulatory requirements, may result in restrictions
on such products or manufacturing processes, withdrawal of the
products from the market, voluntary or mandatory
84
recall, fines, suspension of regulatory approvals, product
seizures, injunctions or the imposition of civil or criminal
penalties.
As a result of these factors, Adamis may not successfully begin
or complete clinical trials in the time periods estimated, if at
all. Moreover, if Adamis incurs costs and delays in development
programs or fails to successfully develop and commercialize
products based upon its technologies, Adamis may not become
profitable, and its stock price could decline.
FDA
Approval Process
General
In the United States, the FDA regulates drug products under the
Federal Food, Drug, and Cosmetic Act, or FFDCA, and its
implementing regulations, and regulates biological drug products
under both the Public Health Service Act, or PHS Act, and its
implementing regulations, as well as the FFDCA. Adamis
product candidates include both biological drug products and
drug products. The process required by the FDA before
Adamis drug and biological drug product candidates may be
marketed in the United States generally involves the following:
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completion of extensive preclinical laboratory tests,
preclinical animal studies and formulation studies all performed
in accordance with the FDAs current Good Laboratory
Practice, or cGLP, regulations;
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submission to the FDA of an IND, which must become effective
before human clinical trials may begin;
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performance of adequate and well controlled human clinical
trials to establish the safety and efficacy of the product
candidate for each proposed indication;
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submission to the FDA of a new drug application, or NDA, for
drug products, or a Biologic License Application, or BLA, for
biological drug products;
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satisfactory completion of an FDA pre-approval inspection of the
manufacturing facilities at which the product is produced to
assess compliance with cGMP regulations; and
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FDA review and approval of the NDA or BLA prior to any
commercial marketing, sale or shipment of the drug or biological
drug.
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Preclinical tests include laboratory evaluation of product
chemistry, formulation and stability, as well as studies to
evaluate toxicity in animals. The results of preclinical tests,
together with manufacturing information and analytical data, are
submitted as part of an IND to the FDA. The IND becomes
effective 30 days after receipt by the FDA, unless the FDA,
within the
30-day time
period, raises concerns or questions about the conduct of the
clinical trial, including concerns that human research subjects
will be exposed to unreasonable health risks. In such a case,
the IND sponsor and the FDA must resolve any outstanding
concerns before the clinical trial can begin. A separate
submission to an existing IND must also be made for each
successive clinical trial conducted during product development,
and the FDA must grant permission before each clinical trial can
begin. Further, an independent institutional review board, or
IRB, for each medical center proposing to conduct the clinical
trial must review and approve the plan for any clinical trial
before it commences at that center and it must monitor the study
until completed. The FDA, the IRB or the sponsor may suspend a
clinical trial at any time on various grounds, including a
finding that the subjects or patients are being exposed to an
unacceptable health risk. Clinical testing also must satisfy
extensive good clinical practices, or GCPs, regulations and
regulations for informed consent.
Clinical
Trials
For purposes of an NDA or BLA submission and approval, human
clinical trials are typically conducted in the following three
sequential phases, which may overlap:
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Phase I Clinical Trials. Studies are initially
conducted in a limited population to test the product candidate
primarily for safety, dose tolerance, pharmacokinetics and, for
vaccine products, immunogenicity, is n healthy humans or in
patients. In some cases, a sponsor may decide to conduct what is
referred to as a Phase Ib evaluation, which is a
second, safety-focused Phase I clinical trial typically designed
to evaluate the impact of the drug candidate in combination with
currently approved drugs;
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Phase II Clinical Trials. Studies are
generally conducted in a limited patient population to identify
possible adverse effects and safety risks, to determine the
efficacy of the product for specific targeted indications and to
determine dose tolerance and optimal dosage. Multiple
Phase II clinical trials may be conducted by the sponsor to
obtain information prior to beginning larger and more extensive
Phase III clinical trials. In some cases, a sponsor may
decide to run what is referred to as a Phase IIb
evaluation, which is a second, confirmatory Phase II
clinical trial;
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Phase III Clinical Trials. These are
commonly referred to as pivotal studies. When Phase II
evaluations demonstrate that a dose range of the product is
effective and has an acceptable safety profile, Phase III
clinical trials are undertaken in large patient populations to
further evaluate dosage, to provide substantial evidence of
clinical efficacy and to further test for safety in an expanded
and diverse patient population at multiple,
geographically-dispersed clinical trial sites; and
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Phase IV Clinical Trials. In some cases,
the FDA may condition approval of an NDA or BLA for a product
candidate on the sponsors agreement to conduct additional
clinical trials to further assess the drugs safety and
effectiveness after NDA or BLA approval. Such post-approval
trials are typically referred to as Phase IV studies.
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There can be no assurance that Phase I, Phase II
trials or Phase III will be completed successfully within
any specific time period, if at all, with respect to any of
Adamis potential products subject to such testing.
After completion of the required clinical testing, an NDA or BLA
is prepared and submitted to the FDA. FDA approval of the NDA is
required before marketing of the product may begin in the United
States. The NDA and BLA must include the results of all
preclinical, clinical and other testing and a compilation of
data relating to the products pharmacology, chemistry,
manufacture and controls. The cost of preparing and submitting
an NDA or BLA is substantial, and there can be no assurance that
any approval will be granted on a timely basis, if at all. Under
federal law, the submission of most NDAs and BLAs are
additionally subject to a substantial application user fee, and
the manufacturer
and/or
sponsor under an approved new drug application is also subject
to annual product and establishment user fees. These fees are
typically increased annually.
The FDA has 60 days from its receipt of an NDA or BLA to
determine whether the application will be accepted for filing
based on the agencys threshold determination that it is
sufficiently complete to permit substantive review. Once the
submission is accepted for filing, the FDA begins an in-depth
review. The FDA has agreed to certain performance goals in the
review of new drug applications. Most such applications for
non-priority drug products are reviewed within ten months. The
review process may be extended by the FDA for three additional
months to consider certain information or clarification
regarding information already provided in the submission. The
FDA may also refer applications for novel drug products or drug
products which present difficult questions of safety or efficacy
to an advisory committee, typically a panel that includes
clinicians and other experts, for review, evaluation and a
recommendation as to whether the application should be approved.
The FDA is not bound by the recommendations of an advisory
committee, but it considers such recommendations carefully when
making decisions. The FDA may deny approval of an NDA or BLA if
the applicable regulatory criteria are not satisfied, or it may
require additional information including clinical or CMC data.
Even if such data are submitted, the FDA may ultimately decide
that the NDA or BLA does not satisfy the criteria for approval.
Data from clinical trials are not always conclusive and the FDA
may interpret data differently than Adamis or its collaborators
interpret data. Once issued, the FDA may withdraw product
approval if ongoing regulatory requirements are not met or if
safety problems occur after the product reaches the market.
Before approving an NDA or BLA, the FDA will typically inspect
one or more clinical sites to assure compliance with Good
Clinical Practices, or GCP. Additionally, the FDA will inspect
the facility or the facilities at which the drug is
manufactured. The FDA will not approve the product unless
compliance with current good manufacturing practices, or cGMP,
is satisfactory and the NDA or BLA contains data that provides
substantial evidence that the drug is safe and effective in the
indication studied. Failure to comply with GMP or other
applicable regulatory requirements may result in withdrawal of
marketing approval, criminal prosecution, civil penalties,
recall or seizure of products, warning letters, total or partial
suspension of production, suspension of clinical trials, FDA
refusal to review pending marketing approval applications or
supplements to approved applications, or injunctions, as well as
other legal or regulatory action against Adamis or its corporate
partners.
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After the FDA evaluates the NDA or BLA and the manufacturing
facilities, it issues an approval letter, an approvable letter
or a not-approvable letter. Both approvable and not-approvable
letters generally outline the deficiencies in the submission and
may require substantial additional testing or information in
order for the FDA to reconsider the application. If and when
those deficiencies have been addressed to the FDAs
satisfaction in a resubmission of the NDA or BLA, the FDA will
issue an approval letter.
An approval letter authorizes commercial marketing of the drug
with specific prescribing information for specific indications.
As a condition of NDA or BLA approval, the FDA may require
substantial post-approval testing and surveillance to monitor
the drugs safety or efficacy and may impose other
conditions, including labeling or distribution restrictions or
other risk-management mechanisms which can materially affect the
potential market and profitability of the drug. Once granted,
product approvals may be withdrawn if compliance with regulatory
standards is not maintained or problems are identified following
initial marketing.
Adamis
Labs Products
Several of Adamis Labs products, including AeroHist
Caplets, AeroHist Plus Caplets, AeroKid Oral Liquid and AeroOtic
HC Ear Drops, and the Epi Syringe, were not the subject of a new
drug application or abbreviated new drug application and have
not been specifically approved by the FDA for marketing by
Adamis. These products have been marketed for many years and,
Adamis believes, are similarly situated to products marketed by
many companies that are marketed without an approved new drug
application or abbreviated new drug application. The products
are drug listed with the FDA in the National Drug Code Directory
but such listing does not constitute FDA approval of the
products. In June 2006, the FDA issued a Compliance Policy Guide
for Marketed Unapproved Drugs, which addressed some of the
considerations utilized by the FDA in exercising its discretion
with respect to products marketed without FDA approval. The
guide does not establish legally enforceable responsibilities on
the FDA and generally only represents the agencys current
thinking on a topic. The guide emphasizes that any product that
is being marketed without required FDA approvals is subject to
FDA enforcement action at any time. If the FDA were to issue a
Federal Register Notice outlining revised conditions for
marketing, which could include calling for the submission of an
application for products such as Adamis cough/cold
products, then Adamis would take appropriate action so as to be
in compliance with any such policies. The FDA might also require
clinical trials in support of any such applications, and Adamis
would need to evaluate its alternatives in light of the costs
required to conduct such trials, which could be substantial,
compared to the economic benefit to Adamis from such products.
The FDA could also exercise its discretion to proceed against
Adamis
and/or other
companies that market similar products without an FDA approval
and require immediate withdrawal of the products from the
market, to prohibit Adamis from marketing these products without
first conducting required trials and obtaining approvals, or to
impose other penalties on Adamis. Some of Adamis Labs
unapproved products include extended release formulations, which
may subject Adamis to a higher risk of FDA enforcement action.
Such actions could have a material adverse effect on
Adamis business, financial condition and results of
operations.
The Prelone product is the subject of an ANDA approval from the
FDA. As Adamis believes is common with many drug products, the
Prelone product is manufactured by a third party manufacturer
which holds the ANDA approval relating to the product. Adamis
owns the trademark and intellectual property rights relating to
the product and distributes the product pursuant to those rights.
The
Hatch-Waxman Act
Abbreviated
New Drug Applications
In seeking approval for a drug through an NDA, applicants are
required to list with the FDA each patent with claims that cover
the applicants product. Upon approval of a drug, each of
the patents listed in the application for the drug is then
published in the FDAs Approved Drug Products with
Therapeutic Equivalence Evaluations, commonly known as the
Orange Book. Drugs listed in the Orange Book can, in turn, be
cited by potential competitors in support of approval of an
ANDA. An ANDA provides for marketing of a drug product that has
the same active ingredients in the same strengths and dosage
form as the listed drug and has been shown through
bioequivalence testing to be therapeutically equivalent to the
listed drug. ANDA applicants are not required to conduct or
submit results of pre-clinical or clinical tests to prove the
safety or effectiveness of their drug product,
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other than the requirement for bioequivalence testing. Drugs
approved in this way are commonly referred to as generic
equivalents to the listed drug, and can often be
substituted by pharmacists under prescriptions written for the
original listed drug.
The ANDA applicant is required to certify to the FDA concerning
any patents listed for the approved product in the FDAs
Orange Book. Specifically, the applicant must certify that:
(i) the required patent information has not been filed;
(ii) the listed patent has expired; (iii) the listed
patent has not expired, but will expire on a particular date and
approval is sought after patent expiration; or (iv) the
listed patent is invalid or will not be infringed by the new
product. A certification that the new product will not infringe
the already approved products listed patents or that such
patents are invalid is called a Paragraph IV certification.
If the applicant does not challenge the listed patents, the ANDA
application will not be approved until all the listed patents
claiming the referenced product have expired.
If the ANDA applicant has provided a Paragraph IV
certification to the FDA, the applicant must also send notice of
the Paragraph IV certification to the NDA and patent
holders once the ANDA has been accepted for filing by the FDA.
The NDA and patent holders may then initiate a patent
infringement lawsuit in response to the notice of the
Paragraph IV certification. The filing of a patent
infringement lawsuit within 45 days of the receipt of a
Paragraph IV certification automatically prevents the FDA
from approving the ANDA until the earlier of 30 months,
expiration of the patent, settlement of the lawsuit or a
decision in the infringement case that is favorable to the ANDA
applicant.
The ANDA application also will not be approved until any
non-patent exclusivity, such as exclusivity for obtaining
approval of a new chemical entity, listed in the Orange Book for
the referenced product has expired. Federal law provides a
period of five years following approval of a drug containing no
previously approved active ingredients, during which ANDAs for
generic versions of those drugs cannot be submitted unless the
submission contains a Paragraph IV challenge to a listed
patent, in which case the submission may be made four years
following the original product approval. Federal law provides
for a period of three years of exclusivity following approval of
a listed drug that contains previously approved active
ingredients but is approved in a new dosage form, route of
administration or combination, or for a new use, the approval of
which was required to be supported by new clinical trials
conducted by or for the sponsor, during which FDA cannot grant
effective approval of an ANDA based on that listed drug.
Section 505(b)(2)
New Drug Applications
Most drug products obtain FDA marketing approval pursuant to an
NDA or an ANDA. A third alternative is a special type of NDA,
commonly referred to as a Section 505(b)(2) NDA, which
enables the applicant to rely, in part, on the FDAs
findings of safety and efficacy of an existing product, or
published literature, in support of its application.
Section 505(b)(2) NDAs often provide an alternate path to
FDA approval for new or improved formulations or new uses of
previously approved products. Section 505(b)(2) permits the
filing of an NDA where at least some of the information required
for approval comes from studies not conducted by or for the
applicant and for which the applicant has not obtained a right
of reference. The applicant may rely upon the FDAs
findings with respect to certain pre-clinical or clinical
studies conducted for an approved product. The FDA may also
require companies to perform additional studies or measurements
to support the change from the approved product. The FDA may
then approve the new product candidate for all or some of the
label indications for which the referenced product has been
approved, as well as for any new indication sought by the
Section 505(b)(2) applicant.
To the extent that the Section 505(b)(2) applicant is
relying on studies conducted for an already approved product,
the applicant is subject to existing exclusivity for the
reference product and is required to certify to the FDA
concerning any patents listed for the approved product in the
Orange Book to the same extent that an ANDA applicant would.
Thus approval of a Section 505(b)(2) NDA can be stalled
until all the listed patents claiming the referenced product
have expired, until any non-patent exclusivity, such as
exclusivity for obtaining approval of a new chemical entity,
listed in the Orange Book for the referenced product has
expired, and, in the case of a Paragraph IV certification
and subsequent patent infringement suit, until the earlier of
30 months, settlement of the lawsuit or a decision in the
infringement case that is favorable to the
Section 505(b)(2) applicant.
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Fast
Track Designation
The FDAs fast track program is intended to facilitate the
development and to expedite the review of drugs and biological
drugs that are intended for the treatment of a serious or
life-threatening condition for which there is no effective
treatment and which demonstrate the potential to address unmet
medical needs for the condition. Under the fast track program,
the sponsor of a new drug or biological drug candidate may
request the FDA to designate the drug candidate for a specific
indication as a fast track drug concurrent with or any time
after the filing of the IND for the drug or biological drug
candidate. The FDA must determine if the candidate qualifies for
fast track designation within 60 days of receipt of the
sponsors request.
If fast track designation is obtained, the FDA may initiate
review of sections of an NDA or BLA before the application is
complete. This rolling review is available if the applicant
provides and the FDA approves a schedule for the submission of
the remaining information and the applicant pays applicable user
fees. However, the time period specified in PDUFA, which governs
the time period goals the FDA has committed to reviewing an
application, does not begin until the complete application is
submitted. Additionally, the fast track designation may be
withdrawn by the FDA if the FDA believes that the designation is
no longer supported by data emerging in the clinical trial
process.
In some cases, a fast track designated candidate may also
qualify for one or more of the following programs:
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Priority Review. Under FDA policies, a drug or
biological drug candidate is eligible for priority review, or
review within a six-month time frame from the time a complete
NDA or BLA is accepted for filing, if the candidate provides a
significant improvement compared to marketed drugs or biological
drugs in the treatment, diagnosis or prevention of a disease. A
fast track designated drug or biological drug candidate would
ordinarily meet the FDAs criteria for priority review,
however, fast track designation is not required to be eligible
for priority review.
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Accelerated Approval. Under the FDAs
accelerated approval regulations, the FDA is authorized to
approve drug and biological drug candidates that have been
studied for their safety and efficacy in treating serious or
life-threatening illnesses and that provide meaningful
therapeutic benefit to patients over existing treatments based
upon either an endpoint that is reasonably likely to predict
clinical benefit or on the basis of an effect on a clinical
endpoint other than patient survival. In clinical trials,
surrogate endpoints are alternative measurements of the symptoms
of a disease or condition that are substituted for measurements
of observable clinical symptoms. A candidate approved on the
basis of a surrogate endpoint is subject to rigorous
post-marketing compliance requirements, including the completion
of Phase IV or post-approval clinical trials to validate
the surrogate endpoint or confirm the effect of the drug
candidate on the clinical endpoint. Failure to conduct required
post-approval studies, or to validate a surrogate endpoint or
confirm a clinical benefit during post-marketing studies, will
result in the FDA withdrawing the drug or biological drug from
the market on an expedited basis. All promotional materials for
drug and biological drug candidates approved under accelerated
regulations are subject to prior review by the FDA.
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When appropriate, Adamis intends to seek fast track designation,
accelerated approval or priority review for its biological drug
candidates.
Satisfaction of FDA regulations and approval requirements or
similar requirements of foreign regulatory agencies typically
takes several years and the actual time required may vary
substantially based upon the type, complexity and novelty of the
product or disease. Typically, if a drug or biological drug
candidate is intended to treat a chronic disease, safety and
efficacy data must be gathered over an extended period of time.
Government regulation may delay or prevent marketing of drug or
biological drug candidates for a considerable period of time and
impose costly procedures upon our activities. The FDA or any
other regulatory agency may not grant approvals for new
indications for our drug and biological drug candidates on a
timely basis, or at all. Even if a drug or biological drug
candidate receives regulatory approval, the approval may be
significantly limited to specific disease states, patient
populations and dosages. Further, even after regulatory approval
is obtained, later discovery of previously unknown problems with
a drug or biological drug may result in restrictions on the
product or even complete withdrawal of the drug or biological
drug from the market. Delays in obtaining, or failures to
obtain, regulatory approvals for any of
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Adamis drug or biological drug candidates would harm
Adamis business. In addition, Adamis cannot predict what
adverse governmental regulations may arise from future
U.S. or foreign governmental action.
Citizen
Petitions
FDA regulations set forth procedures under which parties can
petition the FDA to take or refrain from taking certain actions.
NDA applicants occasionally submit such citizen petitions
requesting that the FDA deny or delay approval of an ANDA, or
impose specific additional requirements for approval on ANDAs
for a particular drug product. Many such petitions are
eventually denied by the FDA, but the submission of such
petitions, especially when submitted near the end of an ANDA
review, has often delayed the approval of an ANDA while the FDA
considers and responds to the issues presented. Congress
included provisions to address this practice in the recently
enacted FDA Amendments Act of 2007, or FDAAA. The FDAAA
prohibits the FDA from delaying approval of an ANDA due to the
submission of a citizen petition unless the delay is necessary
to protect the public health, and requires that the FDA take
final action on any such petition within 180 days of its
submission. In addition, the FDAAA requires that petitioners
certify, among other things, the date upon which the petitioner
first became aware of the information that forms the basis of
the request and the name of the person or entity funding the
petition.
Post-Approval
Requirements
Once an NDA is approved, a product will be subject to certain
post-approval requirements. For instance, the FDA closely
regulates the post-approval marketing and promotion of drugs,
including standards and regulations for
direct-to-consumer
advertising, off-label promotion, industry-sponsored scientific
and educational activities and promotional activities involving
the internet.
Drugs may be marketed only for the approved indications and in
accordance with the provisions of the approved labeling. Changes
to some of the conditions established in an approved
application, including changes in indications, labeling, or
manufacturing processes or facilities, require submission and
FDA approval of a new NDA or BLA or NDA or BLA supplement before
the change can be implemented. An NDA or BLA supplement for a
new indication typically requires clinical data similar to that
in the original application, and the FDA uses the same
procedures and actions in reviewing NDA or BLA supplements as it
does in reviewing NDAs or BLAs.
Adverse event reporting and submission of periodic reports is
required following FDA approval of an NDA or BLA. The FDA also
may require post-marketing testing, known as Phase IV
testing, risk minimization action plans and surveillance to
monitor the effects of an approved product or place conditions
on an approval that could restrict the distribution or use of
the product. In addition, quality control as well as drug
manufacture, packaging, and labeling procedures must continue to
conform to cGMP after approval. Drug manufacturers and certain
of their subcontractors are required to register their
establishments with the FDA and certain state agencies, and are
subject to periodic unannounced inspections by the FDA during
which the agency inspects manufacturing facilities to assess
compliance with cGMP. Accordingly, manufacturers must continue
to expend time, money and effort in the areas of production and
quality control to maintain compliance with cGMP. Regulatory
authorities may withdraw product approvals or request product
recalls if a company fails to comply with regulatory standards,
if it encounters problems following initial marketing, or if
previously unrecognized problems are subsequently discovered.
The distribution of prescription pharmaceutical products is also
subject to the Prescription Drug Marketing Act, or PDMA, which
regulates the distribution of drugs and drug samples at the
federal level, and sets minimum standards for the registration
and regulation of drug distributors by the states. Both the PDMA
and state laws limit the distribution of prescription
pharmaceutical product samples and impose requirements to ensure
accountability in distribution.
Anti-Kickback,
False Claims Laws & The Prescription Drug Marketing
Act
In addition to FDA restrictions on marketing of pharmaceutical
products, several other types of state and federal laws have
been applied to restrict certain marketing practices in the
pharmaceutical industry in recent years. These laws include
anti-kickback statutes and false claims statutes. The federal
healthcare program anti-kickback statute prohibits, among other
things, knowingly and willfully offering, paying, soliciting or
receiving remuneration to induce or in return for purchasing,
leasing, ordering or arranging for the purchase, lease or order
of any healthcare
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item or service reimbursable under Medicare, Medicaid or other
federally financed healthcare programs. This statute has been
interpreted to apply to arrangements between pharmaceutical
manufacturers on the one hand and prescribers, purchasers and
formulary managers on the other. Violations of the anti-kickback
statute are punishable by imprisonment, criminal fines, civil
monetary penalties and exclusion from participation in federal
healthcare programs. Although there are a number of statutory
exemptions and regulatory safe harbors protecting certain common
activities from prosecution or other regulatory sanctions, the
exemptions and safe harbors are drawn narrowly, and practices
that involve remuneration intended to induce prescribing,
purchases or recommendations may be subject to scrutiny if they
do not qualify for an exemption or safe harbor.
Federal false claims laws prohibit any person from knowingly
presenting, or causing to be presented, a false claim for
payment to the federal government, or knowingly making, or
causing to be made, a false statement to have a false claim
paid. In addition, certain marketing practices, including
off-label promotion, may also violate false claims laws. The
majority of states also have statutes or regulations similar to
the federal anti-kickback law and false claims laws, which apply
to items and services reimbursed under Medicaid and other state
programs, or, in several states, apply regardless of the payor.
New
Legislation
On September 27, 2007, the President of the United States
signed into law the Food and Drug Administration Amendments Act
of 2007, or FDAAA. The legislation grants significant new powers
to the FDA, many of which are aimed at improving drug safety and
assuring the safety of drug products after approval. In
particular, the new law authorizes the FDA to, among other
things, require post-approval studies and clinical trials,
mandate changes to drug labeling to reflect new safety
information, and require risk evaluation and mitigation
strategies for certain drugs, including certain currently
approved drugs. In addition, it significantly expands the
federal governments clinical trial registry and results
databank and creates new restrictions on the advertising and
promotion of drug products. Under the FDAAA, companies that
violate these and other provisions of the new law are subject to
substantial civil monetary penalties.
While the above provisions of the FDAAA, among others, will
undoubtedly have a significant effect on the pharmaceutical
industry, the extent of that effect is not yet known. As
regulations, guidance and interpretations are issued by the FDA
relating to the new legislation, its impact on the industry, as
well as our business, will become clearer. The changes and new
requirements it imposes on the drug review and approval process
and post-approval activities could make it more difficult, and
certainly more costly, to obtain approval for new pharmaceutical
products, or to produce, market, and distribute existing
products.
Approval
Outside the United States
In order to market any product outside of the United States,
Adamis must comply with numerous and varying regulatory
requirements of other countries regarding safety and efficacy
and governing, among other things, clinical trials and
commercial sales and distribution of our products. Approval
procedures vary among countries and can involve additional
product testing and additional administrative review periods.
The time required to obtain approval in other countries might
differ from and be longer than that required to obtain FDA
approval. Regulatory approval in one country does not ensure
regulatory approval in another, but a failure or delay in
obtaining regulatory approval in one country may negatively
impact the regulatory process in others.
To date, Adamis has not initiated any discussions with the
European Medicines Agency, or EMEA, or any other foreign
regulatory authorities with respect to seeking regulatory
approval for any indication in Europe or in any other country
outside the United States. As in the United States, the
regulatory approval process in Europe and in other countries is
a lengthy and challenging process. If Adamis fails to comply
with applicable foreign regulatory requirements, it may be
subject to fines, suspension or withdrawal of regulatory
approvals, product recalls, seizure of products, operating
restrictions and criminal prosecution.
Product
Liability Insurance
The manufacture and sale of human therapeutic products involve
an inherent risk of product liability claims and associated
adverse publicity. Adamis currently has only limited product
liability insurance, and there can be no
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assurance that Adamis will be able to maintain existing or
obtain additional product liability insurance on acceptable
terms or with adequate coverage against potential liabilities.
Such insurance is expensive, difficult to obtain and may not be
available in the future on acceptable terms, or at all. An
inability to obtain sufficient insurance coverage on reasonable
terms or to otherwise protect against potential product
liability claims could inhibit Adamis business. A product
liability claim brought against Adamis in excess of its
insurance coverage, if any, could have a material adverse effect
upon its business, financial condition and results of operations.
Competition
The biotechnology and pharmaceutical industries are
characterized by rapidly advancing technologies, intense
competition and a strong emphasis on proprietary products. Many
of Adamis competitors, including biotechnology and
pharmaceutical companies, academic institutions and other
research organizations, are actively engaged in the discovery,
research and development of products that could compete directly
or indirectly with Adamis products under development.
Adamis Labs Allergy Products. Adamis
Labs current line of allergy and respiratory products
compete with numerous prescription and non-prescription
over-the-counter
products targeting similar conditions, including, in the
seasonal or perennial rhinitis areas, cough and cold, as well as
prescription generic products. In addition, a number of
companies, including GSK, Merck, and AstraZeneca, produce
pharmaceutical products, such as antihistamines, corticosteroids
and anti-leukotriene agents, which manage allergy symptoms.
PFS Syringe Product. Adamis PFS Syringe
product competes against other self-administered epinephrine
products, including EpiPen, EpiPen Jr. and Twinject.
BANS. Adamis inhaled nasal steroid BANS
product, if developed, launched and marketed, is expected to
compete with several inhaled nasal steroid products that are
currently marketed, including Flonase, marketed by
GlaxoSmithKline, Nasonex, marketed by Schering, Nasacort AQ,
marketed by Aventis and Rhinocort, marketed by AstraZeneca.
Vaccine Technology. If Adamis successfully
develops a vaccine product for avian or other kinds of influenza
based on the STI technology, that product is expected to compete
with traditional and emerging influenza vaccines from companies
currently marketing these products, including GSK, Novartis,
Sanofi-Pasteur, Medimmune/AstraZeneca and CSL. In addition,
Adamis is aware of several companies developing potentially
competing universal vaccines for influenza, including Acambis,
VaxInnate, Merck, Vical and Dynavax Technologies Corporation,
and other companies of which Adamis is not aware are also likely
developing products intended to address influenza and other
indications targeted by Adamis. The prevalence during 2009 of
the H1N1 influenza virus and of illnesses and deaths throughout
the world resulting from the H1N1 virus may cause additional
companies to seek to develop vaccines or other therapies for
influenza.
Savvy. Biosyns Savvy contraceptive
product candidate, if developed, launched and marketed, would be
subject to competition from other microbicides that are
currently undergoing clinical trials and which may be sold by
prescription or
over-the-counter,
as well as non-microbicidal products such as condoms. There is
also a number of existing contraception products currently on
the market, which could greatly limit the marketability of the
Savvy contraception product candidate. As a result, there can be
no assurance that Biosyns Savvy product candidate, even if
developed, would be able to compete successfully with existing
products or other innovative products under development.
Many of the entities developing and marketing these competing
products have significantly greater financial resources and
expertise in research and development, manufacturing,
preclinical testing, conducting clinical trials, obtaining
regulatory approvals and marketing than Adamis. Smaller or
early-stage companies may also prove to be significant
competitors, particularly for collaborative agreements with
large, established companies and access to capital. These
entities may also compete with Adamis in recruiting and
retaining qualified scientific and management personnel, as well
as in acquiring technologies complementary to, or necessary for,
Adamis programs.
The pharmaceutical industry is characterized by extensive
research efforts and rapid and significant technological change
and intense competition. Adamis is much smaller in terms of size
and resources than many of its competitors in the United States
and abroad, which include, among others, major pharmaceutical,
chemical,
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consumer product, and biotechnology companies, specialized
firms, universities and other research institutions.
Adamis competitors may succeed in developing technologies
and products that are safer, more effective or less costly than
any developed by Adamis, thus rendering its technology and
potential products obsolete and noncompetitive. Many of these
competitors have substantially greater financial and technical
resources, clinical production and marketing capabilities and
regulatory experience than Adamis.
Patents
and Proprietary Technologies
Patents and other proprietary rights are important to
Adamis business. Adamis policy is to file patent
applications and protect inventions and improvements to
inventions that are commercially important to the development of
its business. Adamis also relies on trade secrets, know-how,
confidentiality agreements, continuing technology innovations
and licensing opportunities to protect its technology and
develop and maintain its competitive position.
It is Adamis policy to require its employees to execute an
invention assignment and confidentiality agreement upon
employment. Each agreement provides that all confidential
information developed or made known to the employee during the
course of employment will be kept confidential and not disclosed
to third parties except in specific circumstances. The invention
assignment generally provides that all inventions conceived by
the employee will be the exclusive property of Adamis. In
addition, it is Adamis policy to require collaborators and
potential collaborators to enter into confidentiality
agreements. There can be no assurance, however, that these
agreements will provide meaningful protection of Adamis
trade secrets.
Adamis is the exclusive licensee, under the license agreement
with Nevagen, of rights under two issued U.S. patents,
three U.S. patent applications and related patent
applications filed in the European Union, Japan and Canada,
relating to the STI technology, in the field of prevention and
treatment and detection of viral infectious diseases.
The licensed intellectual property, or IP, includes the use of
the technology known as Transgenic Lymphocyte
Technologym, or TLI, covered by patent applications
entitled Somatic Transgene Immunization and Related
Methods and related know how. TLI includes, but is not
limited to, creating a vaccine by exposing an individuals
lymphocytes to plasmid DNA encoding certain epitopes and
re-administering the treated lymphocytes to the individual. The
vaccines are made up of the individuals lymphocytes
harboring plasmid DNA encoding epitopes, e.g., selected epitopes
of influenza virus. Virtually all of Adamis current viral
product candidates, including the avian influenza candidate, are
based on technology covered by these patents and applications.
The IP includes rights under the following patents, including
all divisionals, continuations,
continuations-in-part,
reexaminations and reissues:
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US Patent #5,658,762 entitled DNA MOLECULES, EXPRESSION
VECTORS AND HOST CELLS EXPRESSING ANTIGENIZED ANTIBODIES, filed
June 6, 1995, granted August 19, 1997. The expiration
date for this patent is 2014.
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US Patent #7,279,462 entitled SOMATIC TRANSGENE
IMMUNIZATION AND RELATED METHODS, filed April 27, 1999,
granted October 9, 2007. The expiration date for this
patent is 2019.
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PCT Patent Application US00/11372/ WO 00/64488 entitled SOMATIC
TRANSGENE IMMUNIZATION AND RELATED METHODS, filed April 27,
2000.
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European Patent Application 009301284.7 entitled SOMATIC
TRANSGENE IMMUNIZATION AND RELATED METHODS, international filing
date April 27, 2000.
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Canadian Patent Application #2,369, 616 entitled SOMATIC
TRANSGENE IMMUNIZATION AND RELATED METHODS, international filing
date April 27, 2000.
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Japan Patent Application #2000-613478 entitled SOMATIC
TRANSGENE IMMUNIZATION AND RELATED METHODS, international filing
date April 27, 2000.
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US Patent Application No. 10,030,003 entitled SOMATIC
TRANSGENE IMMUNIZATION AND RELATED METHODS, international filing
date April 27, 2000.
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US Patent Application No. 11,640,778, entitled SOMATIC
TRANSGENE IMMUNIZATION AND RELATED METHODS, filed
December 16, 2006.
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BioSyn currently holds five patents worldwide relating to Savvy
gel for contraception and the reduction in transmission of HIV
infection. These patents expire at various dates between 2017
and 2021. Adamis is not aware of any organization that currently
has legally blocking proprietary rights relating to the Savvy
product candidate. However, it is impossible to anticipate the
breadth or degree of protection that any such patents will
afford, or whether we can meaningfully protect our rights to our
unpatented trade secrets. No assurance can be given that
competitors will not independently develop substantially
equivalent proprietary information and techniques, or otherwise
gain access to our trade secrets or disclose such technology.
Adamis failure to obtain patent protection or otherwise
protect its proprietary technology or proposed products may have
a material adverse effect on Adamis competitive position
and business prospects. The patent application process takes
several years and entails considerable expense. There is no
assurance that additional patents will issue from these
applications or, if patents do issue, that the claims allowed
will be sufficient to protect Adamis technology.
The patent positions of pharmaceutical and biotechnology firms
are often uncertain and involve complex legal and factual
questions. Furthermore, the breadth of claims allowed in
biotechnology patents is unpredictable. Adamis cannot be certain
that others have not filed patent applications for technology
covered by the pending STI applications or that the licensor of
the STI technology was the first to invent the technology that
is the subject of such patent applications. Competitors may have
filed applications for, or may have received patents and may
obtain additional patents and proprietary rights relating to
compounds, products or processes that block or compete with
those of Adamis. Adamis is aware of patent applications filed
and patents issued to third parties relating to HFA propellant
technology and aerosolized inhalers, and there can be no
assurance that any patent applications or patents will not have
a material adverse effect on potential products Adamis is
developing or may seek to develop in the future.
Patent litigation is widespread in the biotechnology industry.
Litigation may be necessary to defend against or assert claims
of infringement, to enforce patents issued to Adamis, to protect
trade secrets or know-how owned or licensed by Adamis, or to
determine the scope and validity of the proprietary rights of
third parties. Although no third party has asserted that Adamis
is infringing such third partys patent rights or other
intellectual property, there can be no assurance that litigation
asserting such claims will not be initiated, that Adamis would
prevail in any such litigation or that Adamis would be able to
obtain any necessary licenses on reasonable terms, if at all.
Any such claims against Adamis, with or without merit, as well
as claims initiated by Adamis against third parties, can be
time-consuming and expensive to defend or prosecute and to
resolve. If other companies prepare and file patent applications
in the United States that claim technology also claimed by
Adamis, it may have to participate in interference proceedings
to determine priority of invention which could result in
substantial cost to Adamis even if the outcome is favorable to
Adamis. There can be no assurance that third parties will not
independently develop equivalent proprietary information or
techniques, will not gain access to Adamis trade secrets
or disclose such technology to the public or that Adamis can
maintain and protect unpatented proprietary technology. Adamis
typically requires its employees, consultants, collaborators,
advisors and corporate partners to execute confidentiality
agreements upon commencement of employment or other
relationships with Adamis. There can be no assurance, however,
that these agreements will provide meaningful protection or
adequate remedies for Adamis technology in the event of
unauthorized use or disclosure of such information, that the
parties to such agreements will not breach such agreements or
that Adamis trade secrets will not otherwise become known
or be discovered independently by its competitors.
Employees
As of December 18, 2009, Adamis, including its
subsidiaries, had nine full-time employees. Most employees are
located in Florida and are engaged in activities relating to the
Adamis Labs operations. Adamis plans to continue to expand its
product development programs. To support this growth, Adamis
will need to expand managerial, operations, development,
regulatory, sales, commercialization, finance and other
functions. In addition, Adamis utilizes the services of
professional consultants, as well as regulatory and clinical
research organizations to
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supplement its internal staffs activities. None of
Adamis employees are represented by a labor union. Adamis
has experienced no work stoppages and believes that its employee
relations are good.
Properties
Following completion of the merger with La Jolla, Adamis
intends to lease space for its executive offices in or near Del
Mar, California. Adamis currently leases approximately
5,200 square feet of office and approximately
1,800 square feet of warehouse space in Boca Raton and
Coconut Creek, Florida, relating to its Adamis Labs operations.
The term of the office lease expired in December 2008. The
leases are continuing on a
month-to-month
basis, and Adamis expects either to enter into extensions of the
leases or enter into new lease arrangements. Adamis is currently
evaluating its space requirements and expects to either extend
its current leases or move into new facilities that will better
accommodate its needs.
Legal
Proceedings
Adamis is not currently a party to any material legal
proceedings.
Available
Information
Adamis annual reports on
Form 10-K,
quarterly reports on
Form 10-Q,
current reports on
Form 8-K,
and amendments to those reports filed with or furnished to the
Securities and Exchange Commission pursuant to
Section 13(a) or 15(d) of the Securities Exchange Act of
1934, as amended, are available free of charge through
Adamis website at www.adamispharmaceuticals.com as soon as
reasonably practicable after Adamis electronically files or
furnishes the reports with or to the Securities and Exchange
Commission.
Management
and Board of Directors
Please see the information for Dr. Carlo and
Messrs. Marguglio, Hopkins and Aloi, each of whom is a
director or officer of Adamis, under the heading
Management of the Combined Company below.
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ADAMIS
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
This discussion of Adamis financial condition and
results of operations contains certain statements that are not
strictly historical and are forward-looking
statements within the meaning of the Private Securities
Litigation Reform Act of 1995 and involve a high degree of risk
and uncertainty. Actual results may differ materially from those
projected in the forward-looking statements due to other risks
and uncertainties that exist in Adamis operations,
development efforts and business environment, the other risks
and uncertainties described in the section entitled Risk
Factors elsewhere in this joint proxy
statement/prospectus, and the other risks and uncertainties
described elsewhere in this joint proxy statement/prospectus.
All forward-looking statements included in this joint proxy
statement/prospectus are based on information available to
Adamis as of the date hereof, and except as may be required
under the Securities Exchange Act of 1934 and the rules and
regulations promulgated thereunder, Adamis assumes no obligation
to update any such forward-looking statements.
General
Adamis was founded in June 2006, as a Delaware corporation.
Adamis has three wholly-owned subsidiaries: Cellegy Holdings,
Inc., Adamis Corporation; and Biosyn, Inc. Adamis Corporation
has two wholly-owned subsidiaries: Adamis Viral Therapies, Inc.
(biotechnology), or Adamis Viral; and Adamis Laboratories, Inc.
(specialty pharmaceuticals), or Adamis Labs.
Adamis Labs is a specialty pharmaceutical company. Adamis Labs
currently has a line of prescription products that it markets
for a variety of allergy, respiratory disease and pediatric
conditions. Adamis acquired these products in April 2007 by
acquiring all of the outstanding shares of Healthcare Ventures
Group, a private company that had previously acquired the
products and related intellectual property, assets and personnel
from another corporation in February 2007, and subsequently
renaming Adamis as Adamis Labs. Adamis PFS Syringe
product, a pre-filled epinephrine syringe product for use in the
emergency treatment of extreme acute allergic reactions, or
anaphylactic shock, was launched in July 2009. An additional
product candidate in its product pipeline is a generic inhaled
nasal steroid for the treatment of seasonal and perennial
allergic rhinitis. Adamis goal is to commence commercial
sales of the nasal steroid product in the first quarter of 2012,
assuming adequate funding and no unexpected delays.
Adamis estimates that approximately $1.5 million to
$2 million will be required to support the continued
commercial launch of the PFS Syringe product, and that an
additional approximately $3.5 million or more must be
invested from the date of this joint proxy statement/prospectus
in the Adamis Labs operations to support development and
commercial introduction of the aerosolized nasal steroid product
candidate. The capital that is expected to be provided from
expected sales of these products will be important to help fund
expansion of those businesses and the research and development
of the anti-viral technology. If adequate funding is obtained,
clinical trials proceed successfully, regulatory approvals are
obtained and sales are consistent with Adamis current
expectations, following a period of initial commercial
introduction, believes that revenues generated by Adamis
Virals vaccine products could exceed revenues from the
Adamis Labs operations, although there are no assurances that
this will be the case. Adamis estimates that the total time to
develop the BANS product is expected to be approximately
24 months from inception of full product development
efforts, assuming sufficient funding and no unexpected delays.
Currently, neither manufacturing nor clinical trials have begun
for that product candidate. Adamis estimates that approximately
$6-$9 million will be invested to support the development
and commercial introduction of the inhaled nasal steroid product
candidate and its two other respiratory products. Factors that
could affect the actual launch date for the nasal steroid
product candidate include the outcome of discussions with the
FDA concerning the number and kind of clinical trials that the
FDA will require before the FDA will consider regulatory
approval of the product, any unexpected difficulties in
licensing or sublicensing intellectual property rights for other
components of the product such as the inhaler, any unexpected
difficulties in the ability of our suppliers to timely supply
quantities for commercial launch of the product, any unexpected
delays or difficulties in assembling and deploying an adequate
sales force to market the product, and adequate funding to
support sales and marketing efforts. Significant delays in
obtaining funding to support ongoing sales efforts for the
syringe product, or in the introduction of the steroid product,
could reduce revenues and income to Adamis, require additional
funding from other sources, and potentially have an adverse
effect on the ability to fund Adamis research and
development efforts for avian influenza and other vaccine
product candidates by Adamis Viral.
96
From inception, Adamis development efforts have been
focused on development of its vaccine technology, with the first
product candidate expected to be a vaccine for avian flu. Adamis
formed Adamis Viral to focus on developing that vaccine
technology. As the avian flu product candidate is at an earlier
stage of development, Adamis cannot estimate with any precision
the amount that will be required to support development,
clinical trials and commercial introduction of a product,
although the amounts are likely to be larger than the amounts
required to support the nasal steroid product candidate. Factors
that could affect the costs of developing such a candidate
include those described above for the steroid product candidate.
Adamis Virals product candidates are in the preclinical
stage, and it has not generated any revenues to date. From
June 6, 2006 (date of inception) through September 30,
2009, Adamis has spent a total of approximately $413,000 to
in-license and develop the Adamis Viral vaccine technology.
Research and development efforts will require the conduct of
both preclinical and clinical studies and significant additional
funding, and even if development and marketing efforts are
successful, substantial time may pass before significant
revenues will be realized; accordingly, even if Adamis Labs
generates revenues and net income, during this period Adamis
will require additional funds for its Adamis Viral operations,
the availability of which cannot be assured. Consequently,
Adamis is subject to many of the risks associated with early
stage companies, including the need for additional financings;
the uncertainty of research and development efforts resulting in
successful commercial products, as well as the marketing and
customer acceptance of such products; competition from larger
organizations; reliance on the proprietary technology of others;
dependence on key personnel; uncertain patent protection; and
dependence on corporate partners and collaborators.
To achieve successful operations of both its Adamis Viral and
Adamis Labs subsidiaries, Adamis will require additional capital
to continue research and development and marketing efforts and
to make capital investments in its operations. No assurance can
be given as to the timing or ultimate success of obtaining
future funding, and there are no assurances that Adamis will be
successful, with the limited experience and resources Adamis has
available at the present time, in developing and commercializing
the syringe product, an avian flu vaccine or any other vaccine
product or technology.
The process of developing new therapeutic products is inherently
complex, time-consuming, expensive and uncertain. Adamis must
make long-term investments and commit significant resources
before knowing whether its development programs will result in
products that will receive regulatory approval and achieve
market acceptance. Product candidates that may appear to be
promising at all stages of development may not reach the market
for a number of reasons. Product candidates may be found
ineffective or may cause harmful side effects during clinical
trials, may take longer to progress through clinical trials than
had been anticipated, may not be able to achieve the pre-defined
clinical endpoint due to statistical anomalies even though
clinical benefit may have been achieved, may fail to receive
necessary regulatory approvals, may prove impracticable to
manufacture in commercial quantities at reasonable cost and with
acceptable quality, or may fail to achieve market acceptance.
For these reasons, as well as other reasons identified under the
heading Risk Factors in our most recent annual
report on
Form 10-K,
Adamis is unable to predict the period in which material net
cash inflows from product candidates incorporating the vaccine
technology will commence.
Merger
of Cellegy and Adamis; Change of Corporate Name
Effective April 1, 2009, Adamis completed a business
combination transaction with Cellegy Pharmaceuticals, Inc., or
Cellegy. The stockholders of Cellegy and the former Adamis
Pharmaceuticals Corporation, or Old Adamis, approved a merger
transaction and related matters at an annual meeting of
Cellegys stockholders and at a special meeting of Old
Adamis stockholders each held on March 23, 2009. On
April 1, 2009, Cellegy completed the merger transaction
with Old Adamis. Before the merger, Cellegy was a public company
and Old Adamis was a private company.
In connection with the consummation of the merger and pursuant
to the terms of the definitive merger agreement relating to the
transaction, Cellegy changed its name from Cellegy
Pharmaceuticals, Inc. to Adamis Pharmaceuticals Corporation, and
Old Adamis changed its corporate name to Adamis Corporation.
Pursuant to the terms of the merger agreement, immediately
before the consummation of the merger Cellegy effected a reverse
stock split of its common stock. Pursuant to this reverse stock
split, each approximately 10 shares of common stock of
Cellegy that were issued and outstanding immediately before the
effective time of the merger
97
were converted into one share of common stock and any remaining
fractional shares held by a stockholder (after the aggregating
fractional shares) were rounded up to the nearest whole share.
As a result, the total number of shares of Cellegy that were
outstanding immediately before the effective time of the merger
were converted into approximately 3,000,000 shares of
post-reverse split shares of common stock of Adamis. Pursuant to
the terms of the merger agreement, at the effective time of the
merger each share of Old Adamis common stock that was issued and
outstanding immediately before the effective time of the merger
ceased to be outstanding and was converted into the right to
receive one share of common stock of Adamis. As a result,
approximately 44,038,989 shares of Adamis were issued
and/or are
issuable to the holders of the outstanding shares of common
stock of Old Adamis before the effective time of the merger. Old
Adamis, renamed Adamis Corporation, was the surviving entity as
a wholly-owned subsidiary of Adamis.
Critical
Accounting Policies and Estimates
Adamis has identified below some of its more significant
accounting policies. For further discussion of Adamis
accounting policies, see Note 1 in the Notes to the Adamis
Consolidated Financial Statements.
Accounting Standards Codification. In July
2009, the Financial Accounting Standards Board
(FASB) issued Statement of Financial Accounting
Standards Number 168, The FASB Accounting Standards
Codification and the Hierarchy of Generally Accepted Accounting
Principles, which identified the FASBs Accounting
Standards Codification (ASC) as the single source of
authoritative nongovernmental U.S. generally accepted
accounting principles (GAAP). The ASC reorganized
the thousands of U.S. GAAP pronouncements into roughly 90
accounting topics and displays all topics using a consistent
structure. It also includes relevant Securities and Exchange
Commission (SEC) guidance that follows the same
topical structure in separate sections in the ASC. All
previously existing accounting standards documents were
superseded by the ASC, which was effective for interim and
annual periods ending after September 15, 2009. All other
accounting literature not included in the ASC is
nonauthoritative. We believe that our adoption of this standard
on its effective date (July 1, 2009) did not have a
material effect on our consolidated financial statements.
Principles of Consolidation. The accompanying
consolidated financial statements include Adamis Pharmaceuticals
and its wholly owned subsidiaries, Adamis Labs and Adamis Viral.
All significant intercompany balances and transactions have been
eliminated in consolidation.
Use of Estimates. The preparation of
consolidated financial statements, in conformity with accounting
principles generally accepted in the United States, requires
management to make estimates, judgments and assumptions that
affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those
estimates.
Cash and Cash Equivalents. For purposes of the
consolidated statements of cash flows, Adamis considers all
highly liquid investments with original maturities at the date
of purchase of three months or less to be cash equivalents.
Accounts Receivable, Allowance for Doubtful Accounts and
Sales Returns. Trade accounts receivable are
stated net of an allowance for doubtful accounts and sales
returns. Adamis estimates an allowance based on its historical
experience of the relationship between actual bad debts and net
credit sales. At March 31, 2009 and 2008, no allowance for
doubtful accounts was recorded. Adamis has established an
allowance for sales returns based on managements best
estimate of probable loss inherent in the accounts receivable
balance. Management determines the allowance based on current
credit conditions, historical experience, and other currently
available information. The allowance for sales returns was
$19,501 and $21,022 at March 31, 2009 and 2008,
respectively.
Adamis has established an allowance for sales returns based on
managements best estimate of probable loss inherent in the
accounts receivable balance. Management determines the allowance
based on current credit conditions, historical experience, and
other currently available information.
Registration Payment Arrangements. Generally
Accepted Accounting Principles, or GAAP, for registration
payment arrangements specifies that the contingent obligation to
make future payments under a registration payment arrangement
should be separately recognized and measured.
98
Fair Value Measurements. The carrying amounts
of cash and cash equivalents, accounts receivable, accounts
payable, accrued liabilities and notes payable to stockholders
approximate fair value due to the short maturity of the
instruments.
Effective October 1, 2008, we adopted the provisions of the
Fair Values Measurements and Disclosures topic of the ASC, with
respect to our financial assets and liabilities. Under the ASC
accounting standards, fair value is defined as the exchange
price that would be received for an asset or paid to transfer a
liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction
between market participants on the measurement date. Valuation
techniques used to measure fair value should maximize the use of
observable inputs and minimize the use of unobservable inputs.
The accounting standards describe a fair value hierarchy based
on three levels of inputs, of which the first two are considered
observable and the last unobservable, that may be used to
measure fair value:
Level 1 Quoted prices in active markets
for identical assets or liabilities.
Level 2 Inputs other than Level 1
that are observable, either directly or indirectly, such as
quoted prices for similar assets or liabilities; quoted prices
in markets that are not active; or other inputs that are
observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level 3 Unobservable inputs that are
supported by little or no market activity and that are
significant to the fair value of the assets or liabilities.
Inventory. Inventory, consisting of allergy
and respiratory products, is recorded at the lower of cost or
market, using the weighted average method.
Property and Equipment. Property and equipment
are recorded at cost less accumulated depreciation. Depreciation
is computed using the straight-line method over the estimated
useful lives of the related assets. The cost of leasehold
improvements are amortized over the lesser of the lease term or
the life of the improvement, if shorter.
Useful lives used to depreciate property and equipment are as
follows:
|
|
|
|
|
|
|
Life in
|
|
|
Years
|
|
Office Furniture and Equipment
|
|
|
7
|
|
Computer Equipment and Software
|
|
|
3
|
|
Vehicles
|
|
|
3
|
|
Deferred Acquisition Costs. Adamis incurred
certain professional fees associated with specific potential
acquisition targets. These costs were capitalized as part of the
purchase price paid for the acquisition.
Revenue Recognition. Our primary customers are
pharmaceutical wholesalers. In accordance with our revenue
recognition policy, revenue is recognized when title and risk of
loss are transferred to the customer, the sale price to the
customer is fixed and determinable, and collectability of the
sale price is reasonably assured. Reported revenue is net of
estimated customer returns and other wholesaler fees. Our policy
regarding sales to customers is that we do not recognize revenue
from, or the cost of, such sales, where we believe the customer
has more than a demonstrably reasonable level of inventory. We
make this assessment based on historical demand, historical
customer ordering patterns for purchases, business
considerations for customer purchases and estimated inventory
levels. If our actual experience proves to be different than our
assumptions, we would then adjust such allowances accordingly.
We estimate allowances for revenue dilution items using a
combination of information received from third parties,
including market data, inventory reports from our major
U.S. wholesaler customers, when available, historical
information and analysis that we perform. The key assumptions
used to arrive at our best estimate of revenue dilution reserves
are estimated customer inventory levels and purchase forecasts
provided. Our estimates of inventory at wholesaler customers and
in the distribution channels are subject to the inherent
limitations of estimates that rely on third-party data, as
certain third-party information may itself rely on estimates,
and reflect
99
other limitations. We believe that such provisions are
reasonably ascertainable due to the limited number of
assumptions involved and the consistency of historical
experience.
Sales returns and discounts for the period ended March 31,
2008 were approximately $328,000. The table below reconciles the
Sales Returns Reserve Adjustment for the same period
ended March 31, 2008:
|
|
|
|
|
Beginning Balance Sales Returns & Discounts
|
|
$
|
0
|
|
Acquired Balance from HVG as of April 23, 2007
|
|
|
158,000
|
|
Less Actual Sales Returns & Discounts during Fiscal
2008
|
|
|
(328,000
|
)
|
Reserve needed to replenish correct reserve
|
|
|
191,000
|
|
|
|
|
|
|
Sub total
|
|
|
(137,000
|
)
|
|
|
|
|
|
Ending Sales Returns & Discounts as of March 31,
2008
|
|
$
|
21,000
|
|
|
|
|
|
|
The $137,000 adjustment to Sales Returns Reserve
Adjustment is the difference between the actual sales
returns & discounts $(328,000) and the amount needed
to replenish the reserve, $191,000.
Sales returns and discounts for the period ended March 31,
2009 were approximately $12,700. The table below reconciles the
Sales Returns Reserve Adjustment for the same period
ended March 31, 2009:
|
|
|
|
|
Beginning Balance Sales Returns & Discounts as of
March 31, 2008
|
|
$
|
21,022
|
|
Less Actual Sales Returns & Discounts during Fiscal
2009
|
|
|
(12,725
|
)
|
Reserve needed to replenish correct reserve
|
|
|
11,204
|
|
|
|
|
|
|
Sub total
|
|
|
(1,521
|
)
|
|
|
|
|
|
Ending Sales Returns & Discounts as of March 31,
2009
|
|
$
|
19,501
|
|
|
|
|
|
|
The $(1,521) adjustment to Sales Returns Reserve
Adjustment is the difference between the actual sales
returns & discounts $(12,725) and the amount needed to
replenish the reserve, $11,204.
Revenues under license and royalty agreements are recognized in
the period the earnings process is completed based on the terms
of the specific agreement. Advanced payments received under
these agreements are recorded as deferred revenue at the time
the payment is received and are subsequently recognized as
revenue on a straight-line basis over the longer of the life of
the agreement or the life of the underlying patent. Royalties
payable to Adamis under license agreements are recognized as
earned when the royalties are no longer refundable under the
terms defined in the agreement. To date no royalties have been
paid.
Goodwill and Intangible Assets. Intangible
assets include intellectual property and other patent rights
acquired. Consideration paid in connection with acquisitions is
required to be allocated to the acquired assets, including
identifiable intangible assets, and liabilities acquired.
Acquired assets and liabilities are recorded based on
Adamis estimate of fair value, which requires significant
judgment with respect to future cash flows and discount rates.
For intangible assets other than goodwill, Adamis is required to
estimate the useful life of the asset and recognize its cost as
an expense over the useful life. Adamis uses the straight-line
method to expense long-lived assets (including identifiable
intangibles). In accordance with GAAP, goodwill and other
intangible assets with indefinite lives are no longer
systematically amortized, but rather Adamis performs an annual
assessment for impairment by applying a fair-value based test.
This test is generally performed each year in the fourth fiscal
quarter. Additionally, goodwill and intangible assets are
reviewed for impairment whenever events or circumstances
indicate that the carrying amount of the asset may not be
recoverable. An impairment loss would be recognized based on the
difference between the carrying value of the asset and its
estimated fair value, which would be determined based on either
discounted future cash flows or other appropriate fair value
methods. The evaluation of goodwill and other intangibles for
impairment requires management to use significant judgments and
estimates including, but not limited to, projected future
revenue, operating results and cash flows. An impairment would
require Adamis to charge to earnings the write-down in value of
such assets.
Long Lived Assets. Adamis periodically
assesses whether there has been permanent impairment of its
long-lived assets held and used in accordance with GAAP, which
requires Adamis to review long-lived assets for
100
impairment whenever events or changes in circumstances indicate
that the carrying amount of an asset may not be recoverable.
Recoverability of assets to be held and used is measured by
comparison of the carrying amount of the asset to future net
undiscounted cash flows expected to be generated from the use
and eventual disposition of the asset.
Research and Development
Expenses. Adamis research and development
costs are expensed as incurred. Non-refundable advance payments
for goods and services to be used in future research and
development activities are recorded as an asset and are expensed
when the research and development activities are performed.
Research and development costs were approximately $740,000 and
$203,000 for the fiscal years ended March 31, 2009 and
2008, respectively, which were expensed. All of the costs in
fiscal 2008 related to Adamis viral and influenza product
development efforts. For fiscal 2009, approximately $728,000 of
the costs related to the PFS Syringe product, and approximately
$12,000 of the costs related to the viral and influenza product
development efforts.
Shipping and Handling Costs. Shipping and
handling costs are included in selling, general and
administrative expenses. Shipping and handling costs were
$13,651 and $23,046 for the years ended March 31, 2009 and
2008, respectively.
Advertising Costs. Advertising costs are
expensed as incurred. The Company incurred $2,848 and $0 of
advertising expense for the years ended March 31, 2009 and
2008, respectively.
Net Loss per Share. Adamis computes net loss
per share by dividing the income attributable to holders of
common stock for the period by the weighted average number of
shares of common stock outstanding during the period. Since the
effect of common stock equivalents was anti-dilutive, all such
equivalents were excluded from the calculation of weighted
average shares outstanding. There were 1,000,000 outstanding
warrants at March 31, 2009 and 2008.
Income Taxes. Adamis accounts for income taxes
using an asset and liability approach for financial accounting
and reporting for income taxes. Under the asset and liability
approach, deferred taxes are provided for the net tax effect of
temporary differences between the carrying amount of assets and
liabilities for financial reporting purposes and the amounts
used for income tax purposes. Valuation allowances are
established where management determines that it is more likely
than not that some portion or all of a deferred tax asset will
not be realized.
Discontinued Operations. The results of
operations for the years ended March 31, 2009 and 2008, and
the six month periods ended September 30, 2009 and 2008 and
the assets and liabilities at March 31, 2009 and 2008 and
September 30, 2009 and 2008 related to International
Laboratories, Inc. (INL), a formerly
wholly owned subsidiary of Adamis, have been accounted for as
discontinued operations in accordance with GAAP.
Results
of Operations
Adamis consolidated results of operations are presented
for the fiscal year ending March 31, 2009 and for the
fiscal year ending March 31, 2008. Adamis
consolidated interim results of operations are presented for the
three and six months ending September 30, 2009 and the
three and six months ending September 30, 2008. Adamis
acquired Adamis Labs on April 23, 2007 and INL on
December 31, 2007 and, accordingly, Adamis
consolidated results of operations for the fiscal year ended
March 31, 2008, do not include a full year of Adamis
Labs and INLs operations. Adamis completed its
disposition of INL on July 18, 2008.
Year
Ended March 31, 2009 and Year Ended March 31,
2008
Revenues and Cost of Sales. Adamis had
revenues of $659,538 and $621,725 for the year ending
March 31, 2009 and March 31, 2008 respectively. The
$37,813 increase in revenues compared to the year ended 2008 was
primarily the result of increased sales of Aerohist, Aerohist
plus and Extracts, offset in part by a reduction in sales of
Acapella.
Research and Development Expense. Adamis
incurred research and development expenses of $740,437 in fiscal
2009 and $203,489 in fiscal 2008. The increase was primarily due
to greater development costs of the prefilled Epi Syringe.
101
Selling, General and Administrative
Expenses. Selling, general and administrative
expenses for fiscal 2009 and 2008 were $4,852,966 and
$3,775,644, respectively. Selling, general and administrative
expenses consist primarily of legal fees, accounting and audit
fees, professional fees and employee salaries. The increase in
expenses for fiscal 2009 was primarily due to the merger with
Cellegy Pharmaceuticals. The increase in legal, accounting and
professional consulting expenses accounted for approximately
$806,000 of the variance.
Other Income (Expenses). Interest and other
income (expense) for fiscal 2009 and 2008 were $(451,038) and
$(321,983), respectively. Interest and other income (expense)
consists primarily of interest expense paid in connection with
various notes payable. The increase in interest expense for
fiscal 2009 compared to fiscal 2008 was primarily due to a full
year of interest expense charged from the note with Cellegy
Pharmaceuticals during fiscal 2009 and an increase in interest
income due to loans outstanding to International Labs during
fiscal 2008.
Six
Months Ended September 30, 2009 and 2008
Revenues and Cost of Sales. Adamis had
revenues of approximately $232,000 and $311,000 for the six
months ending September 30, 2009 and 2008, respectively.
The approximately $79,000 reduction in revenues for the first
six months of fiscal 2010 compared to the comparable period of
fiscal 2009 was primarily the result of reduced sales of
Aerohist, Prelone and Aero Otic, partially offset by sales of
the Pre-filled Epi Syringe product, which commenced in July
2009. Cost of sales for the six months ending September 30,
2009 and 2008 were approximately $68,000 and $181,000,
respectively. The decrease of approximately $113,000 was due to
an adjustment of inventory reserves with the introduction of the
Epi Syringe product.
Research and Development Expense. Adamis
incurred research and development expenses of approximately
$336,000 for the six months ended September 30, 2008 and
approximately $99,000 in the six month period ended
September 30, 2009. The reduction of research and
development for the two comparative periods was caused by the
completion of the prefilled EPI Syringe product and a reduction
in research and development activities in light of limited
available funds.
Selling, General and Administrative
Expenses. Selling, general and administrative
expenses for the six months ending September 30, 2009 and
2008 were approximately $1,283,000 and $2,336,000, respectively.
Selling, general and administrative expenses consist primarily
of legal fees, accounting and audit fees, professional fees and
employee salaries. The reduction in comparative six month period
expense levels is primarily a result of reduced salary levels,
which Adamis believes is temporary, offset somewhat by increased
professional fees and other related expenses.
Other Income (Expenses). Interest and other
income (expense) for the six month period ending
September 30, 2009 and 2008 was approximately $(12,000) and
$(390,000), respectively. Interest and other income (expense)
consists primarily of interest expense paid in connection with
various notes payable. The decrease in interest expense for the
six month period ended September 30, 2009 in comparison to
the same period for 2008 is due to interest from three debt
instruments that were retired in 2009.
Three
Months Ended September 30, 2009 and 2008
Revenues and Cost of Sales. Adamis had
revenues of approximately $126,000 and $202,000, for the three
months ending September 30, 2009 and 2008, respectively.
The decrease of $76,000 resulted from reduced sales of Aerohist,
Aero Kid and Prelone, partially offset by sales of the PFS
Syringe product. Cost of sales for the three months ending
September 30, 2009 and 2008 were approximately $19,000 and
$138,000, respectively. The decrease of $119,000 was due to an
adjustment of the inventory reserves with the introduction of
the PFS Syringe product.
Research and Development Expense. Adamis
incurred research and development expenses of approximately
$25,000 for the three months ended September 30, 2008 and
approximately $86,000 in the three month period ended
September 30, 2009. The increase in research and
development expenses in the second quarter of fiscal 2010
compared to the comparable period of fiscal 2009 was caused by
Adamis considering a joint venture in the development of the PFS
Syringe product during the second quarter of fiscal 2009. Once
Adamis determined not to pursue the joint venture, higher
development expenditures resulted in the second quarter of
fiscal 2010.
102
Selling, General and Administrative
Expenses. Selling, general and administrative
expenses for the three months ending September 30, 2009 and
2008 were approximately $553,000 and $1,334,000, respectively.
Selling, general and administrative expenses consist primarily
of legal fees, accounting and audit fees, professional fees and
employee salaries. The reduction in expense levels for the
second quarter of fiscal 2010 from the comparable period of
fiscal 2009 is primarily a result of reduced salary levels,
which Adamis believes is temporary, offset somewhat by increased
professional fees and other related expenses.
Other Income (Expenses). Interest and other
income (expense) for the three month period ending
September 30, 2009 and 2008 were approximately $(8,000) and
$(195,000), respectively. Interest and other income (expense)
consist primarily of interest expense paid in connection with
various notes payable. The decrease in interest expense for
quarter ended September 30, 2009 in comparison of same
period for 2008 is due to interest from three debt instruments
that were retired in 2009.
Liquidity
and Capital Resources
Fiscal
2009 and 2008
Since its inception, June 6, 2006, through March 31,
2009, Adamis has financed its operations principally through
debt financing and through private issuances of common stock.
Since inception, Adamis has raised a total of approximately
$10 million in debt and equity financing transactions,
consisting of approximately $4.3 million in debt financing
and approximately $5.7 million in equity financing
transactions. Adamis expects to finance future cash needs
primarily through proceeds from equity or debt financings,
loans,
and/or
collaborative agreements with corporate partners. Adamis has
used the net proceeds from debt and equity financings for
general corporate purposes, which have included funding for
research and development, selling, general and administrative
expenses, working capital, reducing indebtedness, pursuing and
completing acquisitions or investments in other businesses,
products or technologies, and for capital expenditures.
Adamis cash was $17,697 and $541 as of March 31, 2009
and March 31, 2008, respectively. The increase in cash was
primarily the result of selling, general and administrative
expenses, expansion of plant and merger costs, partially offset
by funds received from financing transactions.
Net cash used in operating activities from continuing operations
for fiscal 2009 and 2008 were approximately $4.2 million
and $2.9, respectively, due primarily to Adamis scale up
of sales operations and merger and acquisition costs. Adamis
expects net cash used in operating activities to increase going
forward as it completes product development, launches new
products, engages in additional product research and development
activities and pursues additional expansion of its sales base
and other business activities. Adamis incurred a one time
adjustment to record an intangible impairment of approximately
$3,151,000 due to its determination that the distribution
network acquired in the Adamis Labs acquisition did not meet the
expectations for the network that were part of the decision to
purchase Adamis Labs, would not sustain the introduction of the
PFS Syringe product and had no future value. The increase in
accounts payable/accrued expenses of approximately $446,000 from
fiscal 2008 relates primarily to the merger with Cellegy and the
increased level of spending that came with product development.
Net cash used in operating activities from discontinued
operations for fiscal 2008 of approximately $978,000 relate to
INLs contract packaging operations which were sold during
fiscal 2009.
Net cash provided by investing activities from continuing
operations was approximately $11,000 for fiscal 2008, compared
to net cash provided by investing activities from continuing
operations for fiscal 2009 of $6.6 million. The increase of
net cash from investing activities was provided by the sale of
INL. Net cash used in investing activities from discontinued
operations of approximately $3.9 million for fiscal 2008
relate to INLs contract packaging operations which were
sold in July 2008.
Net cash provided by (used in) financing activities from
continuing operations was approximately $7.8 million in
fiscal 2008 and approximately $(2.6 million) in fiscal
2009, primarily due to the receipt of proceeds from issuance of
common stock and debt financing in 2008 and the repayment of the
debt financing in 2009.
In fiscal year 2008, Adamis borrowed a total of $2,000,000 from
a third party institutional lender. The initial loan of
$1,000,000 was executed on December 21, 2007 and the second
loan of $1,000,000 was executed on January 9, 2008. The
loans matured in sixteen (16) months and had an interest
rate of 12% per year. The loans could
103
be prepaid with an additional payment of a premium of one
percent of the outstanding principal. As an inducement to make
the loan, Adamis issued to the third party 800,000 shares
of its common stock. Under the terms of the various loan
agreements, virtually all of the assets of Adamis and its
subsidiaries, including INL, were pledged as security. In
connection with the sale of INL in July 2008, the loan was fully
repaid and no outstanding balance or obligations remain under
the loan agreements.
On November 15, 2007, Adamis issued a promissory note to a
shareholder in the principal amount of $1,000,000. The note bore
interest at a rate of 10% per annum. In connection with the sale
of INL in July 2008, the loan was fully repaid.
As of March 31, 2009, Adamis had outstanding a total of
three promissory notes to Dennis J. Carlo, President and Chief
Executive Officer of Adamis, in the aggregate outstanding
principal amount of $99,765, reflecting loans made by
Dr. Carlo to Adamis. Each of these notes bears interest at
an annual rate of 10%.
In conjunction with signing the definitive agreement to merge
with Cellegy, Adamis borrowed $500,000 from Cellegy on
February 12, 2008. The loan had an interest rate of 10%.
Under the terms of the agreement, the loan was converted into
Adamis common stock at the time the merger was consummated and
the resulting shares issued were cancelled.
Six
Months Ended September 30, 2009
Adamis cash was approximately $15,000 and $706,000 as of
September 30, 2009 and September 30, 2008,
respectively. The decrease in cash was primarily the result of
selling, general and administrative expenses and merger costs.
Net cash used in operating activities from continuing operations
for the six months ended September 30, 2009 and 2008 were
approximately $221,000 and $3,207,000, respectively. Adamis
expects net cash used in operating activities to increase going
forward as it engages in additional product research and
development activities, pursues additional expansion of its
sales base and other business activities, assuming that it is
able to obtain sufficient funding. The increase in accrued
expenses of approximately $577,000 and the increase in accounts
payable of $429,000 was created by an increase in legal,
accounting, accrued compensation and consulting expenses due to
becoming a publicly traded company and reduction of cash
reserves.
Net cash provided by (used in) investing activities from
continuing operations was approximately $(17,000) and $6,481,000
for the six months ended September 30, 2009 and 2008.
Results for the quarter ended September 30, 2008, were
affected by proceeds received from the sale of INLs
contract packaging operations which were sold in July 2008.
Net cash provided by financing activities from continuing
operations was approximately $234,000 for the six months ended
September 30, 2009 and net cash used in financing
activities was approximately $2,874,000 for the six months ended
September 30, 2008. The differences between the two periods
were primarily due to the repayment of loans and related party
notes from the proceeds of the sale of INL.
At September 30, 2009, Adamis had no significant cash
balances and substantial liabilities and obligations. Even if
development and marketing efforts are successful, substantial
time may pass before significant revenues will be realized from
the PFS Syringe product or other products, and during this
period Adamis will require additional funds, the availability of
which cannot be assured. Consequently, Adamis is subject to the
risks associated with early stage companies, including the need
for additional financings; the uncertainty of research and
development efforts resulting in successful commercial products,
as well as the marketing and customer acceptance of such
products; unexpected issues with the FDA or other federal or
state regulatory authorities; competition from larger
organizations; reliance on the proprietary technology of others;
dependence on key personnel; uncertain patent protection; and
dependence on corporate partners and collaborators. To achieve
successful operations, Adamis will require additional capital to
continue research and development and marketing efforts. No
assurance can be given as to the timing or ultimate success of
obtaining future funding.
We prepared the condensed consolidated financial statements
assuming that we will continue as a going concern, which
contemplates the realization of assets and the satisfaction of
liabilities during the normal course of
104
business. In preparing these condensed consolidated financial
statements, consideration was given to the Companys future
business as described below, which may preclude Adamis from
realizing the value of certain assets. Adamis has limited cash
reserves, liabilities that exceed its assets and significant
cash flow deficiencies. Additionally, Adamis will need
significant funding for the future operations and the
expenditures that will be required to market existing products
and conduct the clinical and regulatory work to develop
Adamis product candidates. Managements plans include
seeking additional funding to satisfy existing obligations,
liabilities and future working capital needs, to build working
capital reserves and to fund its research and development
projects. There is no assurance that Adamis will be successful
obtaining the necessary funding to meet its business objectives.
Even giving effect to the convertible note transactions
described below, additional financing will be required to
support sales and marketing efforts relating to the syringe
product, product development and marketing efforts for the
Adamis Labs products, continued product research and development
on Adamis vaccine technology, and fund any product or
company acquisition opportunities, and cash flow from the Adamis
Labs operations are not expected to provide sufficient
cash to fund Adamis overall cash requirements for the
foreseeable future. Adamis future capital requirements
will depend upon numerous factors, including the following:
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the progress and costs of development programs;
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the commercial success of new products that are introduced;
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patient recruitment and enrollment in future clinical trials;
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the scope, timing and results of pre-clinical testing and
clinical trials;
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the costs involved in seeking regulatory approvals for product
candidates;
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the costs involved in filing and pursuing patent applications
and enforcing patent claims;
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the establishment of collaborations and strategic alliances;
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the cost of manufacturing and commercialization activities;
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the results of operations;
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the cost, timing and outcome of regulatory reviews;
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the rate of technological advances;
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ongoing determinations of the potential commercial success of
products under development;
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the level of resources devoted to sales and marketing
capabilities; and
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the activities of competitors.
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To obtain additional capital when needed, Adamis will evaluate
alternative financing sources, including, but not limited to,
the issuance of equity or debt securities, corporate alliances,
joint ventures and licensing agreements; however, there can be
no assurance that funding will be available on favorable terms,
if at all. There are no assurances that Adamis will be able to
successfully develop its products under development or that its
products, if successfully developed, will generate revenues
sufficient to enable it to earn a profit. If Adamis is unable to
obtain additional capital, management may be required to explore
alternatives to reduce cash used by operating activities,
including the termination of development efforts that may appear
to be promising to Adamis, the sale of certain assets and the
reduction in overall operating activities.
Recent
Convertible Note Transactions
Unsecured Convertible Note. On
December 29, 2009, Adamis issued to The G-Max Trust, or
G-Max, an unsecured convertible promissory note, referred to as
the G-Max Note, in the principal amount of $500,000 and also
issued 500,000 shares of common stock of Adamis, in a
private placement transaction for aggregate gross proceeds of
$500,000. Interest on the outstanding principal balance of the
G-Max Note accrues at a rate of 10% per annum
105
compounded monthly and is payable monthly commencing
February 1, 2010. All unpaid principal and interest on the
G-Max Note is due and payable on December 31, 2010,
sometimes referred to as the maturity date.
At any time on or before the maturity date, G-Max may convert
some or all of the unpaid principal and interest into shares of
Adamis common stock at a conversion price equal to $0.20 per
share (subject to adjustment for stock dividends, stock splits,
reverse stock splits, reclassifications or other similar events
affecting the number of outstanding shares of Adamis common
stock). Events of default under the G-Max Note include payment
defaults and uncured material breaches of the Note. Upon an
uncured event of default, G-Max may declare the entire unpaid
amount owed under the G-Max Note immediately due, subject to the
subordination provisions set forth in the
G-Max Note,
and may, at its option, charge default interest at a rate of 18%
per annum.
The G-Max Note includes piggyback registration rights providing
that at any time after one year after the date of the G-Max
Note, if the shares that Adamis issued to G-Max and the shares
of Adamis common stock that are issuable upon conversion of the
G-Max Note, together referred to as the Transaction Shares,
cannot be sold without restriction pursuant to SEC
Rule 144, then if Adamis files a registration statement
pursuant to the Securities Act of 1933, as amended, or the Act,
at any time on or before December 29, 2010, relating to an
offering for the account of others under the Act of any of its
equity securities, other than registration statements on
Form S-4
or
Form S-8,
Adamis will include in such registration any Transaction Shares
specified by G-Max. The G-Max Note also includes subordination
provisions providing that payment of principal, interest and any
other amounts that may become due pursuant to the G-Max Note and
any other obligation that Adamis may have to G-Max is
subordinated to the payment in full of all secured debt or other
senior indebtedness of Adamis.
Senior Secured Convertible Notes. In January
2010, Adamis completed a private placement financing transaction
with a small number of institutional investors led by Gemini
Master Fund, Ltd., pursuant to a Securities Purchase Agreement,
referred to as the SPA. Adamis issued 10% Senior Secured
Convertible Notes, referred to as the Secured Notes, in the
aggregate principal amount of $1.5 million and
1,500,000 shares of Adamis common stock, and received gross
proceeds of $1.5 million, excluding transaction costs and
expenses.
Interest on the Secured Notes is payable at a rate of 10% per
annum and is payable monthly on the first business day of each
month. Principal and any accrued and unpaid interest is due and
payable October 11, 2010. The Secured Notes are convertible
into shares of Adamis common stock at any time at the discretion
of the investor at an initial conversion price per share of
$0.20, subject to adjustment for stock splits, stock dividends
and other similar transactions and subject to the terms of the
Notes. The conversion price is also subject to price
anti-dilution adjustments providing that if Adamis issues equity
securities or securities convertible into equity securities at
an effective price per share below the conversion price (subject
to certain exceptions), the conversion price will be adjusted
downward to equal the price of the new securities.
Adamis obligations under the Secured Notes and the other
transaction agreements are guaranteed by Adamis principal
subsidiaries, including Adamis Corporation, Adamis Laboratories
and Adamis Viral, and are secured by a security interest in all
of the assets of Adamis and those subsidiaries, pursuant to a
security agreement. The transaction agreements include
restrictions on Adamis ability to engage in certain kinds
of transactions while the Secured Notes are outstanding without
the consent of two-thirds in interest of the holders of the
Secured Notes, including incurring or paying certain kinds of
indebtedness, entering into certain kinds of financing
transactions at prices below $0.20 per share, or encumbering
Adamis assets. In addition to the rights under the
security agreement to foreclose on the collateral in the event
of a default, the transaction documents include a variety of
liquidated damages, penalties and default provisions upon events
of default by Adamis, including without limitation an increase
in the principal amount and interest rate and a potential
decrease in the conversion price of the Secured Notes, and in
connection with certain other breaches of covenants of Adamis.
If the shares underlying the Secured Notes are not freely
tradeable under SEC Rule 144 after six months from the
closing of the Secured Note transaction, Adamis intends to file
a registration statement covering the resale of such shares. In
connection with the transaction, Adamis officers entered
into lockup agreements restricting sales of Adamis securities
owned by them for as long as any Notes are outstanding, subject
to certain limited exceptions.
Off
Balance Sheet Arrangements
At September 30, 2009 and March 31, 2009, Adamis did
not have any off balance sheet arrangements.
106
Recent
Accounting Pronouncements
The Fair Value Measurements and Disclosures topic of the ASC
includes certain concepts first set forth in September 2006,
which define the use of fair value measures in financial
statements, establish a framework for measuring fair value and
expand disclosure related to the use of fair value measures. In
February 2008, the FASB provides a one-year deferral of the
effective date of those concepts for non-financial assets and
non-financial liabilities, except those that are recognized or
disclosed in the financial statements at fair value at least
annually. The application of these concepts was effective for
our fiscal year beginning April 1, 2009, excluding the
effect of the one-year deferral noted above. See Fair
Value Measurements above. We are currently evaluating the
impact of adopting these concepts with respect to non-financial
assets and non-financial liabilities on our consolidated
financial statements, which will be effective beginning
April 1, 2010.
The Financial Instruments topic of the ASC includes certain
concepts first set forth in February 2007, under which we may
elect to report most financial instruments and certain other
items at fair value on an
instrument-by-instrument
basis with changes in fair value reported in earnings. After the
initial adoption, the election is made at the acquisition of an
eligible financial asset, financial liability, or firm
commitment or when certain specified reconsideration events
occur. The fair value election may not be revoked once an
election is made. The application of these concepts was
effective for our fiscal year beginning April 1,
2008 however, we have elected not to measure
eligible financial assets and liabilities at fair value.
Accordingly, the adoption of these concepts did not have a
significant impact on our consolidated financial statements.
The Business Combinations topic of the ASC establishes
principles and requirements for how an acquirer recognizes and
measures in its financial statements the identifiable assets
acquired, the liabilities assumed, and any noncontrolling
interest in an acquiree, including the recognition and
measurement of goodwill acquired in a business combination. The
provisions of this guidance became effective for our fiscal year
beginning April 1, 2009. Under these provisions, we would
have recorded the $147,747 of deferred acquisition costs
included in other non-current assets on our March 31, 2009
balance sheet as expense during the year then ended. This amount
was recorded as expense on April 1, 2009.
The Subsequent Events topic of the ASC establishes general
standards of accounting for and disclosure of events that occur
after the balance sheet date but before financial statements are
issued or are available to be issued. Certain of these
requirements, which were first effective for interim or annual
financial periods ending after June 15, 2009, relate to the
concept of financial statements being available to be
issued and require the disclosure of the date through
which an entity has evaluated subsequent events and the basis
for that date (i.e., whether that date represents the date the
financial statements were issued or were available to be
issued). Other than providing this disclosure, our adoption of
these requirements as of and for the period ended June 30,
2009 did not have a significant impact on our interim condensed
consolidated financial statements.
107
MANAGEMENT
OF THE COMBINED COMPANY
Executive
Officers and Directors of the Combined Company Following the
Merger
Following the merger, the combined companys board of
directors will consist of Dennis J. Carlo, Ph.D.,
David J. Marguglio and Richard L. Aloi, who are the current
directors of Adamis.
Pursuant to the merger agreement, all of La Jollas
current executive officers will resign immediately before the
completion of the merger. Following the merger, the management
team of the combined company is expected to be composed of the
management team of Adamis. The following table lists the names
and ages, as of December 9, 2009, and positions of the
individuals who are expected to serve as executive officers and
directors of the combined company upon completion of the merger.
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Name
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Age
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Position
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Dennis J. Carlo, Ph.D.
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65
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President, Chief Executive Officer, and Director
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Richard L. Aloi
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55
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President, Adamis Laboratories, and Director
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Robert O. Hopkins
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49
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Vice President, Finance and Chief Financial Officer
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David J. Marguglio
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38
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Vice President of Business Development and Investor Relations,
Director
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Directors
Dennis J. Carlo, Ph.D. Please see the
information below under the heading Executive
Officers.
Richard L. Aloi. Please see the information
below under the heading Executive Officers.
David J. Marguglio. Please see the information
below under the heading Executive Officers.
Executive
Officers
Dennis J. Carlo, Ph.D. Dr. Carlo has
been Adamis President and Chief Executive officer since
October 2006. From 1982 to 1987, he served as Vice President of
Research and Development and Therapeutic Manufacturing at
Hybritech Inc., which was acquired by Eli Lilly & Co
in 1985. After the sale to Lilly, Dr. Carlo, along with
Dr. Jonas Salk, James Glavin and Kevin Kimberland, founded
Immune Response Corporation, a public company, where he served
as its President and Chief Executive Officer from 1994 to 2002.
He served as president of Telos Pharmaceuticals, a private
biotechnology company, from 2003 to 2006. Dr. Carlo has
extensive experience in the development of vaccines and
biologics. Early in his career, as Director of developmental and
basic cellular immunology and Director of bacterial vaccines and
immunology at Merck & Co., he oversaw research and
product development for PNEUMOVAX (14-valent polysaccharide
vaccine), MENINGOVAX A, MENINGOVAX C, MENINGOVAX A-C, and H.
influenzae type b, and also directed a multi-disciplinary
task force whose goal was the development of novel adjuvants. At
Hybritech, he managed a successful program to carry out research
and development in the area of monoclonal antibody and cancer
therapy. At Immune Response Corporation, he established a
program for an AIDS therapeutic vaccine and led the product
development in clinical trials. Dr. Carlo received a B.S.
degree in microbiology from Ohio State University and has a
Ph.D. in Immunology and Medical Microbiology from Ohio State
University.
David J. Marguglio. Mr. Marguglio has
been Adamis Vice President of Business Development and
Investor Relations since its inception in June 2006. From 1996
to 2006, he held various positions with Citigroup Global
Markets, Smith Barney and Merrill Lynch. Before entering the
financial industry, from 1994 to 1996, he founded and ran two
different startup companies, the latter of which was eventually
acquired by a Fortune 100 company. From 1993 to 1994, he
served as financial counsel for the commercial litigation
division of a national law firm. Mr. Marguglio is a
licensed securities representative, securities agent, and
investment advisor. He received a degree in finance and business
management from the Hankamer School of Business at Baylor
University.
Robert O. Hopkins. Mr. Hopkins joined
Adamis in April 2007 and has been Vice President, Finance and
Chief Financial Officer since that time. From 2000 to 2004, he
was an Executive Vice President and the Chief Financial Officer
of Chatham Capital Corp. In that position he managed financial
operations for a corporation that
108
held several hospitals, an extensive life sciences operation and
a number of other business units within its portfolio.
Mr. Hopkins served as Chief Financial Officer of Veritel
Corp from 1999 and 2000, a biometric software company. He has
also served as Chief Operating Officer for Circle
Trust Company from 2004 to 2005, during which time he was
responsible for corporate reorganization after acquiring a
troubled trust company. From 2005 until Mr. Hopkins joined
Adamis in April 2007, he consulted for Acumen Enterprises
providing analysis and business plans for the various projects
with which the company was involved. From 1997 to 1999,
Mr. Hopkins was Senior Vice President for Finance for the
Mariner Post-Acute Network, Atlanta, Georgia. In this position
he was responsible for financial management of a division
consisting of 12 long-term, acute care hospitals. Among his
previous medical-related experience, he has served as Assistant
Administrator of Finance for Kindred Hospitals; President and
Chief Executive Officer of Doctors Hospital of Hyde Park; and
Vice President of Accounting for Cancer Treatment Centers of
America. Mr. Hopkins received a B.S. degree in Finance from
Indiana State University and an M.B.A. from Lake Forest Graduate
School of Management.
Richard L. Aloi. Mr. Aloi is President of
Adamis Laboratories and a director of Adamis. He joined Adamis
in connection with Adamis acquisition of Adamis Labs in
April 2007. He founded Aero Pharmaceuticals in 1997 and served
as its President from 1997 to 2007. He developed Aero into a
distributor of allergen extracts and related products, and
managed Aeros transition to a specialty pharmaceutical
provider. From 1979 to 1997, before founding Aero, Mr. Aloi
was Director of Sales and Marketing at Center Laboratories (a
division of E. Merck), a manufacturer of allergenic extracts and
prescription respiratory products, including the market leading
epinephrine auto-injector. At Center Laboratories, Mr. Aloi
oversaw a
50-person
marketing group which included over 35 field sales
representatives. His earlier positions within Center
Laboratories included Sales Representative, Regional Manager,
and National Sales Manager. Mr. Aloi has served in
leadership and advisory roles for industry groups, including the
Allergen Product Manufacturers Association, the American College
of Allergy Asthma & Immunology, and the American
Academy of Allergy Asthma & Immunology. Mr. Aloi
received a B.A. in Political Science from Boston College in 1976.
Adamis
Executive Compensation
The following table sets forth all compensation awarded, earned
or paid for services rendered in all capacities to Adamis during
the two fiscal years ended March 31, 2008 and 2009, to each
Adamis officer who is expected to serve as an executive officer
of the combined company after the merger. Old Adamis merged with
Cellegy Pharmaceuticals, Inc., effective April 1, 2009, and
Cellegy changed its name to Adamis in connection with the
closing of the Cellegy merger. The information below relates to
Old Adamis and to periods before the closing of the Cellegy
merger, when Old Adamis was a private company.
Summary
Compensation Table
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All Other
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Stock
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Compensation
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Name and Principal Position
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Year
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Salary ($)
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Bonus ($)
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Awards ($)
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($)
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Total ($)
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Dennis J. Carlo, Ph.D.
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2009
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$
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51,643
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$
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$
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|
|
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$
|
|
|
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$
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51,643
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President and Chief Executive Officer
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2008
|
|
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229,190
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|
|
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|
|
|
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|
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229,190
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Robert O. Hopkins
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2009
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$
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27,583
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$
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$
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$
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$
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27,583
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Vice President, Chief Financial Officer
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2008
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91,910
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91,910
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Richard L. Aloi
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2009
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$
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80,608
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$
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$
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|
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$
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|
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$
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80,608
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President, Adamis Laboratories, and Director
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2008
|
|
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|
181,367
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|
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|
|
|
|
|
|
|
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181,367
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|
David J. Marguglio
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2009
|
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$
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27,583
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|
$
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$
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$
|
|
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$
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27,583
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Vice President and Director
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2008
|
|
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134,410
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134,410
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For Adamis fiscal years 2008 and 2009, there were no stock
awards or option awards made to any of the above persons, and
none of the above persons hold any stock options. Information
regarding shares of stock held by the above persons that are
subject to vesting restrictions and rights of repurchase is
included elsewhere in this joint proxy statement/prospectus
under the heading Principal Stockholders of
Adamis Stock Repurchase Agreements. There are
no severance or change of control arrangements with any of the
above officers. Adamis has no written employment agreements or
similar arrangements for any of the above officers, and
compensation levels are
109
determined by the board of directors of Adamis from time to
time. If Dr. Carlo and Messrs. Aloi and Marguglio
become directors of the combined company upon the closing of the
merger transaction, by virtue of their status as officers of the
company they will not qualify as independent directors in
accordance with the listing requirements of the Nasdaq Stock
Market. During fiscal 2009, all of Adamis directors were
officers of Old Adamis and did not receive any compensation for
services as a director.
Executive officers are eligible to participate in all of
Adamis employee benefit plans, in each case on the same
basis as other employees. Adamis reimburses each executive
officer for all reasonable business other expenses incurred by
the officer in connection with the performance of the
officers duties.
Other
Under the Adamis 2009 Equity Incentive Plan, the administrator
of the plan may, in the written agreements relating to an award
made under the plan, provide that an award may be subject to
acceleration of vesting and exercisability upon or after a
Change in Control, as defined in the plan. Under the plan, a
Change in Control means the occurrence, in a single transaction
or in a series of related transactions, of any one or more of
the following events: (i) any person (with certain
exceptions) becomes the owner, directly or indirectly, of
securities of the company representing more than 50% of the
combined voting power of the companys then outstanding
securities other than by virtue of a merger, consolidation or
similar transaction, other than in connection with equity
financing transactions; (ii) there is consummated a merger,
consolidation or similar transaction involving (directly or
indirectly) the company and, immediately after the consummation
of such transaction, the stockholders of the company immediately
prior thereto do not own, directly or indirectly, either
(A) outstanding voting securities representing more than
50% of the combined outstanding voting power of the surviving
entity in such transaction or (B) more than 50% of the
combined outstanding voting power of the parent of the surviving
entity in such transaction, in each case in substantially the
same proportions relative to each other as their ownership of
the outstanding voting securities of the company immediately
before such transaction; (iii) the stockholders of the
company approve or the Board approves a plan of complete
dissolution or liquidation of the company, or a complete
dissolution or liquidation of the company shall otherwise occur,
except for a liquidation into a parent corporation;
(iv) there is consummated a sale, lease, exclusive license
or other disposition of all or substantially all of the
consolidated assets of the company and its subsidiaries, other
than a sale, lease, license or other disposition of all or
substantially all of the consolidated assets of the company and
its Subsidiaries to an entity, more than 50% of the combined
voting power of the voting securities of which are owned by
stockholders of the company in substantially the same
proportions relative to each other as their ownership of the
outstanding voting securities of the company immediately before
such sale, lease, license or other disposition; or (v) the
members of the Board immediately after the closing of the merger
transaction between La Jolla and Adamis, referred to as the
Incumbent Board, cease for any reason to constitute at least a
majority of the members of the Board, provided, however,
that if the appointment or election (or nomination for
election) of any new Board member was approved or recommended by
a majority vote of the members of the board then still in
office, such new member shall, for purposes of the plan, be
considered as a member of the Incumbent Board. Notwithstanding
the foregoing, the definition of Change in Control (or any
analogous term) in an individual written agreement between the
company and the plan participant will supersede the foregoing
definition with respect to awards subject to such agreement. The
Board may, in its sole discretion and without participant
consent, amend the definition of Change in Control
to conform to the definition of Change of Control
under Section 409A of the Internal Revenue Code of 1986, as
amended, and related Department of Treasury guidance. The
merger, as described herein, will not constitute a Change
in Control under the Adamis 2009 Equity Incentive Plan.
Compensation
Committee Interlocks and Insider Participation
During Old Adamis fiscal 2009 year, each of the
members of the board of directors was also an officer of Old
Adamis and participated in deliberations of Old Adamis
board of directors concerning executive officer compensation.
None of the members of Old Adamis board of directors
during fiscal 2009 served during fiscal 2009 on the compensation
committee (or equivalent), or the board of directors, of another
entity whose executive officer(s) served on Old Adamis
compensation committee or board of directors.
110
Certain
Transactions with Related Persons, Promoters and Certain Control
Persons
During fiscal 2009, there were no transactions or series of
similar transactions to which Adamis was a party in which the
amount involved exceeds the lower of (i) $120,000 or
(ii) one percent of the average of Adamis total
assets at the end of 2008 and 2009, and in which any current
director, executive officer or holder of more than 5% of our
common stock, or members of any such persons immediate
family, had or will have a direct or indirect material interest,
other than compensation described in Executive
Compensation, except as follows: Dennis Carlo, the chief
executive officer of Adamis, made a series of loans to Adamis
for working capital. As of December 21, 2009 the
outstanding principal amount under the loans total $319,565. The
terms of the loans include an interest rate of 10% with various
repayment dates. The loans are secured by the assets of Adamis
Labs.
Pursuant to the charter of Adamis audit committee,
Adamis audit committee has the responsibility to review
and approve the terms of all transactions between Adamis and any
related party, as that term is defined under applicable Nasdaq
listing standards; however, compensation arrangements with
related parties are reviewed by the Adamis compensation
committee or the entire Adamis board, and the board retains the
authority to review and approve other related party
transactions. In connection with consideration of related-party
transactions, the audit committee or the Adamis Board requires
full disclosure of material facts concerning the relationship
and financial interest of the relevant individuals involved in
the transaction, and then determines whether the transaction is
fair to Adamis. Approval is by means of a majority of the
directors who are not related parties with respect to the
transaction and are entitled to vote on the matter. The board
intends that any transaction with related parties will be on
terms no less favorable to Adamis than could be obtained from
unaffiliated third parties.
111
UNAUDITED
PRO FORMA COMBINED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Introduction
Adamis security holders are expected to own, after the merger,
between approximately 70%-95% of the combined company on a
fully-diluted basis. Further, Adamis directors will initially
constitute the entirety of the combined companys board of
directors and all members of the executive management of the
combined company will be from Adamis. Therefore, Adamis will be
deemed to be the acquiring company for accounting purposes and
the merger transaction will be accounted for as a reverse merger
and a recapitalization. The financial statements of the combined
entity after the merger will reflect the historical results of
Adamis before the merger and will not include the historical
financial results of La Jolla before the completion of the
merger. Stockholders equity and earnings per share of the
combined entity after the merger will be retroactively restated
to reflect the number of shares of common stock received by
Adamis security holders in the merger, after giving effect to
the difference between the par values of the capital stock of
Adamis and La Jolla, with the offset to additional paid-in
capital. As a result, the cost of the proposed merger is
measured at net assets acquired and no goodwill will be
recognized.
The following unaudited pro forma combined condensed
consolidated financial statements have been prepared to give
effect to the proposed merger of Adamis and La Jolla as a
reverse acquisition of assets and a recapitalization in
accordance with accounting principles generally accepted in the
United States. For accounting purposes, Adamis is considered to
be acquiring La Jolla in the merger. Consequently, all of
the assets and liabilities of La Jolla have been reflected
in the pro forma financial statements at their respective fair
values and no goodwill or other intangibles will be recorded as
part of acquisition accounting.
The unaudited pro forma condensed combined financial statements
do not include any adjustments for income taxes because the
combined company is anticipated to incur taxable losses for the
foreseeable future.
The actual amounts recorded for the merger transaction as of the
completion of the merger may differ materially from the
information presented in these unaudited pro forma combined
condensed consolidated financial statements as a result of:
|
|
|
|
|
the cash cost of La Jollas operations between the
signing of the merger agreement and the closing of the merger;
|
|
|
|
La Jollas net cash balance as calculated pursuant to
the merger agreement, which will partially determine the actual
number of shares of La Jolla common stock to be issued
pursuant to the merger;
|
|
|
|
the timing of completion of the merger; and
|
|
|
|
other changes in La Jollas assets that occur before
completion of the merger, which could cause material differences
in the information presented below.
|
The unaudited pro forma combined condensed consolidated
financial statements presented below are based on the historical
financial statements of Adamis and La Jolla, adjusted to
give effect to the acquisition of La Jolla by Adamis for
accounting purposes. The pro forma adjustments are described in
the accompanying notes presented on the following pages.
The unaudited pro forma combined condensed consolidated balance
sheet assumes that the proposed merger was completed as of
September 30, 2009. The historical balance sheet for Adamis
was derived from its unaudited condensed consolidated balance
sheets included in its
Form 10-Q
for the three and six months ended September 30, 2009,
included herein. The historical balance sheet for La Jolla
was derived from its unaudited condensed consolidated balance
sheets included in its
Form 10-Q
for the three and nine months ended September 30, 2009,
included herein.
The unaudited pro forma combined condensed consolidated
statements of operations assume that the merger took place as of
the beginning of the periods presented. The historical
statements of operations for Adamis was derived from its audited
consolidated statements of operations included in its Annual
Report on
Form 10-K
for the year ended March 31, 2009, and its unaudited
condensed consolidated statements of operations included in its
Form 10-Q
for the three and six months ended September 30, 2009,
included herein. The historical statements of
112
operations for La Jolla was derived from its audited
consolidated statements of operations included in its Annual
Report on
Form 10-K
for the year ended December 31, 2008, and its unaudited
condensed consolidated statements of operations included in its
Form 10-Q
for the three and six months ended June 30, 2009, included
herein.
The unaudited pro forma combined condensed consolidated
financial information is presented for illustrative purposes
only and is not necessarily indicative of the financial position
or results of operations that would have actually been reported
had the merger occurred at the dates stated above, nor is it
necessarily indicative of future financial position or results
of operations. The unaudited pro forma combined condensed
consolidated financial information has been derived from and
should be read in conjunction with the historical consolidated
financial statements and related notes of Adamis and
La Jolla which are included in this joint proxy
statement/prospectus.
113
Unaudited
Pro Forma Combined Condensed Consolidated Balance Sheet
As of September 30, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical
|
|
|
Pro Forma
|
|
|
Pro Forma
|
|
|
|
La Jolla
|
|
|
Adamis
|
|
|
Adjustments
|
|
|
As Adjusted
|
|
|
|
In thousands (000s)
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
5,830
|
|
|
$
|
15
|
|
|
$
|
|
|
|
$
|
5,845
|
|
Accounts receivable
|
|
|
|
|
|
|
159
|
|
|
|
|
|
|
|
159
|
|
Inventory, net
|
|
|
|
|
|
|
228
|
|
|
|
|
|
|
|
228
|
|
Prepaid expenses and other current assets
|
|
|
746
|
|
|
|
16
|
|
|
|
|
|
|
|
762
|
|
Related party receivables
|
|
|
|
|
|
|
77
|
|
|
|
|
|
|
|
77
|
|
Assets from discontinued operations
|
|
|
|
|
|
|
350
|
|
|
|
|
|
|
|
350
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
6,576
|
|
|
|
845
|
|
|
|
|
|
|
|
7,421
|
|
Property and equipment, net
|
|
|
|
|
|
|
28
|
|
|
|
|
|
|
|
28
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
6,576
|
|
|
$
|
873
|
|
|
$
|
|
|
|
$
|
7,449
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
692
|
|
|
$
|
1,628
|
|
|
$
|
|
|
|
$
|
2,320
|
|
Accrued expenses and other current payables
|
|
|
235
|
|
|
|
1,523
|
|
|
|
625
|
(B)
|
|
|
2,383
|
|
Accrued payroll and related expenses
|
|
|
98
|
|
|
|
|
|
|
|
|
|
|
|
98
|
|
Notes payable to related parties
|
|
|
|
|
|
|
335
|
|
|
|
|
|
|
|
335
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
1,025
|
|
|
|
3,486
|
|
|
|
625
|
|
|
|
5,136
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
1,025
|
|
|
|
3,486
|
|
|
|
625
|
|
|
|
5,136
|
|
Stockholders equity (deficit):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
657
|
|
|
|
5
|
|
|
|
(25
|
)(A)
|
|
|
632
|
|
|
|
|
|
|
|
|
|
|
|
|
(5
|
)(A)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional paid in capital
|
|
|
427,574
|
|
|
|
10,792
|
|
|
|
(427,574
|
)(A)
|
|
|
15,716
|
|
|
|
|
|
|
|
|
|
|
|
|
25
|
(A)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,899
|
(A)
|
|
|
|
|
Accumulated deficit
|
|
|
(422,680
|
)
|
|
|
(13,409
|
)
|
|
|
422,680
|
(A)
|
|
|
(14,034
|
)
|
|
|
|
|
|
|
|
|
|
|
|
(625
|
)(B)
|
|
|
|
|
Treasury stock
|
|
|
|
|
|
|
(1
|
)
|
|
|
|
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity (deficit)
|
|
|
5,551
|
|
|
|
(2,613
|
)
|
|
|
(625
|
)
|
|
|
2,313
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
6,576
|
|
|
$
|
873
|
|
|
$
|
|
|
|
$
|
7,449
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114
Unaudited
Pro Forma Combined Condensed Consolidated Statement of
Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical
|
|
|
|
|
|
|
|
|
|
La Jolla
|
|
|
Adamis
|
|
|
|
|
|
|
|
|
|
For the Year Ended
|
|
|
For the Year Ended
|
|
|
Pro Forma
|
|
|
Pro Forma
|
|
|
|
December 31, 2008
|
|
|
March 31, 2009
|
|
|
Adjustments
|
|
|
As Adjusted
|
|
|
|
In thousands (000s), except for per share data
|
|
|
Revenues
|
|
|
|
|
|
|
660
|
|
|
|
|
|
|
|
660
|
|
Cost of goods sold
|
|
|
|
|
|
|
262
|
|
|
|
|
|
|
|
262
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin
|
|
|
|
|
|
|
398
|
|
|
|
|
|
|
|
398
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
51,025
|
|
|
|
741
|
|
|
|
|
|
|
|
51,766
|
|
Selling, general and administrative
|
|
|
9,702
|
|
|
|
4,853
|
|
|
|
625
|
(B)
|
|
|
15,180
|
|
Asset impairment
|
|
|
2,810
|
|
|
|
|
|
|
|
|
|
|
|
2,810
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses
|
|
|
63,537
|
|
|
|
5,594
|
|
|
|
625
|
|
|
|
69,756
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(63,537
|
)
|
|
|
(5,196
|
)
|
|
|
(625
|
)
|
|
|
(69,358
|
)
|
Other income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
779
|
|
|
|
|
|
|
|
|
|
|
|
779
|
|
Interest expense
|
|
|
(96
|
)
|
|
|
(435
|
)
|
|
|
|
|
|
|
(531
|
)
|
Gain on fixed asset disposal
|
|
|
|
|
|
|
6
|
|
|
|
|
|
|
|
6
|
|
Loss on deposit
|
|
|
|
|
|
|
(22
|
)
|
|
|
|
|
|
|
(22
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
683
|
|
|
|
(451
|
)
|
|
|
|
|
|
|
232
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)
|
|
$
|
(62,854
|
)
|
|
$
|
(5,647
|
)
|
|
$
|
(625
|
)
|
|
$
|
(69,126
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(1.26
|
)
|
|
$
|
(0.07
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
|
49,689
|
|
|
|
24,887
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
115
Unaudited
Pro Forma Combined Condensed Consolidated Statement of
Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical
|
|
|
|
|
|
|
|
|
|
La Jolla
|
|
|
Adamis
|
|
|
|
|
|
|
|
|
|
For the Six Months
|
|
|
for the Six Months
|
|
|
|
|
|
|
|
|
|
Ended
|
|
|
Ended
|
|
|
Pro Forma
|
|
|
Pro Forma
|
|
|
|
June 30, 2009
|
|
|
September 30, 2009
|
|
|
Adjustments
|
|
|
As Adjusted
|
|
|
|
In thousands (000s), except for per share data
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues
|
|
$
|
|
|
|
$
|
232
|
|
|
|
|
|
|
$
|
232
|
|
Collaborative revenue
|
|
|
8,125
|
|
|
|
|
|
|
|
|
|
|
|
8,125
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
|
8,125
|
|
|
|
232
|
|
|
|
|
|
|
|
8,357
|
|
Cost of goods sold
|
|
|
|
|
|
|
67
|
|
|
|
|
|
|
|
67
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin
|
|
|
8,125
|
|
|
|
165
|
|
|
|
|
|
|
|
8,290
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
9,808
|
|
|
|
98
|
|
|
|
|
|
|
|
9,906
|
|
Selling, general and administrative
|
|
|
4,611
|
|
|
|
1,283
|
|
|
|
625
|
(B)
|
|
|
6,519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses
|
|
|
14,419
|
|
|
|
1,381
|
|
|
|
625
|
|
|
|
16,425
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(6,294
|
)
|
|
|
(1,216
|
)
|
|
|
(625
|
)
|
|
|
(8,135
|
)
|
Other income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
12
|
|
|
|
|
|
|
|
|
|
|
|
12
|
|
Interest expense
|
|
|
(13
|
)
|
|
|
(13
|
)
|
|
|
|
|
|
|
(26
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
(1
|
)
|
|
|
(13
|
)
|
|
|
|
|
|
|
(14
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)
|
|
$
|
(6,295
|
)
|
|
$
|
(1,229
|
)
|
|
$
|
(625
|
)
|
|
$
|
(8,149
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.10
|
)
|
|
$
|
(0.04
|
)
|
|
|
|
|
|
$
|
|
(C)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used on computing basic and diluted net loss per share
|
|
|
60,945
|
|
|
|
28,529
|
|
|
|
|
|
|
|
|
(C)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
116
Notes to
the Unaudited Pro Forma Combined Condensed Consolidated
Financial Statements
On December 4, 2009, La Jolla entered into an
Agreement and Plan of Reorganization with Adamis and Jewel
Merger Sub, Inc., a Delaware corporation and newly formed
wholly-owned subsidiary of La Jolla, or Merger Sub,
pursuant to which Merger Sub will be merged with and into
Adamis, with Adamis surviving after the merger as a wholly-owned
subsidiary of La Jolla.
If the merger is consummated, each Adamis stockholder will
receive, in exchange for each share of Adamis common stock held
or deemed to be held by such stockholder immediately before the
closing of the merger, a number of shares of La Jolla
common stock equal to one share (excluding in all cases Adamis
dissenting shares), after giving effect to a reverse stock split
affecting the La Jolla stockholders. As a result, La Jolla
anticipates that it will experience a change in control because
Adamis stockholders will own in excess of approximately 70% of
the outstanding common stock of La Jolla immediately after
the merger. Further, Adamis directors will initially constitute
the entirety of the combined companys board of directors
and all members of the executive management of the combined
company will be from Adamis. Therefore, Adamis will be deemed to
be the acquiring company for accounting purposes. Based on the
above and in accordance with accounting principles generally
accepted in the United States, the proposed merger is considered
to be a reverse acquisition and recapitalization. As a result,
the cost of the proposed merger is measured at net assets
acquired and no goodwill will be recognized.
(A) To adjust La Jollas historical common shares
to reflect the reverse stock split and issuance of post split
La Jolla shares to Adamis stockholders on a one for one
basis, as well as to eliminate La Jollas historical
additional paid-in capital and accumulated deficit. The pro
forma adjustment assumes that the reverse stock split of the
La Jolla shares contemplated by the merger agreement will
be 1:3.81 and that, pursuant to the terms of the merger
agreement, the La Jolla stockholders will hold
17,250,000 shares of the combined company immediately after
the merger.
(B) To expense and accrue estimated direct costs to be
incurred after September 30, 2009 by La Jolla and
Adamis to consummate the merger. Merger costs include fees
payable for legal, accounting, printing and other consulting
services.
(C) Based on a possible range of 1:3.5 to 1:30.3, the
expected impacts of the proposed reverse stock split of
La Jolla common stock on the pro forma adjusted basic and
diluted net loss per common share and the number of
weighted-average shares used in computing basic and diluted net
loss per common share for the six months ended
September 30, 2009, are as follows (in thousands, except
for per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Forma as Adjusted
|
|
|
|
|
|
|
Additional Share
|
|
|
For the Six Months
|
|
|
|
Pro Forma as
|
|
|
Adjustments for
|
|
|
Ended September 30, 2009 as
|
|
|
|
Adjusted for the
|
|
|
Reverse Stock
|
|
|
Adjusted for Reverse Stock
|
|
|
|
Six Months Ended
|
|
|
Split in the Range of
|
|
|
Split in the Range of
|
|
|
|
September 30, 2009
|
|
|
1:3.5
|
|
|
1:30.3
|
|
|
1:3.5
|
|
|
1:30.3
|
|
|
Net loss
|
|
$
|
(8,149
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(8,149
|
)
|
|
$
|
(8,149
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$
|
(0.29
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(0.17
|
)
|
|
$
|
(0.27
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing basic and diluted net
loss per common share
|
|
|
28,529
|
|
|
|
18,750
|
|
|
|
2,167
|
|
|
|
47,279
|
|
|
|
30,696
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
117
PRINCIPAL
STOCKHOLDERS OF ADAMIS
The following tables set forth information as of
December 9, 2009, concerning the beneficial ownership of
(i) any person known to Adamis to be the beneficial owner
of more than five percent of Adamis outstanding common
stock, (ii) each current director of Adamis,
(iii) each executive officer and (iv) all current
directors and officers as a group. Unless indicated otherwise
below, the address of each officer or director list below is
Adamis Pharmaceuticals Corporation, 2658 Del Mar Heights Road,
Suite #555, Del Mar, CA 92014.
The share numbers and percentages in the table below are based
on 45,972,303 shares of common stock of Adamis outstanding.
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
|
|
|
|
Beneficially
|
|
|
|
|
Name
|
|
Owned(1)
|
|
|
Percent
|
|
|
5% holders
|
|
|
|
|
|
|
|
|
Rand P. Mulford(2)
|
|
|
3,775,000
|
|
|
|
8.2
|
%
|
Thomas Parker(3)
|
|
|
2,357,058
|
|
|
|
5.1
|
|
Directors
|
|
|
|
|
|
|
|
|
Dennis J. Carlo(4)
|
|
|
8,368,000
|
|
|
|
18.2
|
|
Richard L. Aloi(6)
|
|
|
3,593,039
|
|
|
|
7.8
|
|
David J. Marguglio(7)
|
|
|
3,439,904
|
|
|
|
7.5
|
|
Other Officers
|
|
|
|
|
|
|
|
|
Robert O. Hopkins(5)
|
|
|
870,750
|
|
|
|
1.9
|
|
All Adamis directors and officers (4 persons)(8)
|
|
|
16,271,693
|
|
|
|
35.4
|
|
|
|
|
(1) |
|
Based upon information supplied by officers, directors and
principal stockholders. Beneficial ownership is determined in
accordance with rules of the SEC that deem shares to be
beneficially owned by any person who has or shares voting or
investment power with respect to such shares. Unless otherwise
indicated, the persons named in this table have sole voting and
sole investing power with respect to all shares shown as
beneficially owned, subject to community property laws where
applicable. Shares of common stock subject to an option that is
currently exercisable or exercisable within 60 days of the
date of the table are deemed to be outstanding and to be
beneficially owned by the person holding such option for the
purpose of computing the percentage ownership of such person but
are not treated as outstanding for the purpose of computing the
percentage ownership of any other person. Except as otherwise
indicated, the address of each of the persons in this table is
as follows:
c/o Adamis
Pharmaceuticals Corporation, 2658 Del Mar Heights Road, Suite
#555, Del Mar, CA 19512. |
|
(2) |
|
1,575,000 of these shares are subject to repurchase rights, as
described below. |
|
(3) |
|
1,571,372 of these shares are subject to repurchase rights, as
described below. |
|
(4) |
|
6,368,000 of these shares are subject to repurchase rights, as
described below. |
|
(5) |
|
290,250 of these shares are subject to repurchase rights, as
described below. |
|
(6) |
|
2,645,097 of these shares are subject to repurchase rights, as
described below. |
|
(7) |
|
2,537,019 of these shares are subject to repurchase rights, as
described below. |
|
(8) |
|
Includes 11,840,366 shares subject to repurchase rights, as
described below. |
Stock
Repurchase Agreements
Approximately 16,300,201 of the outstanding shares of common
stock of Adamis are subject to some form of restriction
agreements and may be repurchased or cancelled by Adamis. The
resale of all of the stock listed below is restricted, and
Adamis has the right of first refusal in the event of that the
holder thereof proposes to sell the stock.
118
|
|
|
|
|
|
|
Stockholder Group
|
|
Restricted Shares
|
|
Description
|
|
Current Officers and Directors
|
|
|
|
|
|
These shares were issued by Adamis before the merger with
Cellegy to certain executive officers of Adamis. These shares
are subject to repurchase by Adamis at $0.001 per share if
certain value or performance targets are not met, or if the
stockholder ceases to be employed at any time before dates
ranging from July 2009 to September 2010, depending on the date
of first employment of the officer with the time-based vesting
restrictions lapsing with respect to one-third of the shares
originally issued subject to these arrangements on each
anniversary of the date of first employment which range from
July 2006 to September 2007.
|
D. Carlo
|
|
|
6,368,000
|
|
R. Aloi
|
|
|
2,645,097
|
|
D. Marguglio
|
|
|
2,537,019
|
|
R. Hopkins
|
|
|
290,250
|
|
|
|
|
|
|
|
|
|
|
|
Total:
|
|
|
11,840,366
|
|
Current Employees and Consultants
|
|
|
333,333
|
|
Former Officers and Directors and
Former HVG Shareholder
|
|
|
|
|
R. Mulford
|
|
|
1,575,000
|
|
|
|
T. Parker
|
|
|
1,571,372
|
|
|
|
R. Frost
|
|
|
719,019
|
|
|
|
Aero Pharmaceuticals
|
|
|
261,111
|
|
|
|
|
|
|
|
|
|
|
Total:
|
|
|
4,126,502
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
16,300,201
|
|
|
|
|
|
|
|
|
|
|
PRINCIPAL
STOCKHOLDERS OF LA JOLLA
The following table sets forth information regarding beneficial
ownership of La Jolla common stock as of December 9,
2009 based on information available to La Jolla and filings
with the SEC by:
|
|
|
|
|
each of La Jollas directors;
|
|
|
|
each of La Jollas named executive
officers as defined by SEC rules;
|
|
|
|
all of La Jollas current directors and executive
officers as a group; and
|
|
|
|
each person or group of affiliated persons known by
La Jolla to be the beneficial owner of more than 5% of
La Jolla common stock.
|
Beneficial ownership and percentage ownership are determined in
accordance with the rules of the SEC and include voting or
investment power with respect to shares of stock. This
information does not necessarily indicate beneficial ownership
for any other purpose. Under these rules, shares of
La Jolla common stock issuable under stock options that are
exercisable within 60 days of December 9, 2009 are
deemed outstanding for the purpose of computing the percentage
ownership of the person holding the options, but are not deemed
outstanding for the purpose of computing the percentage
ownership of any other person.
119
Unless otherwise indicated and subject to applicable community
property laws, to La Jollas knowledge, each
stockholder named in the following table possesses sole voting
and investment power over their shares of La Jolla common
stock, except for those jointly owned with that persons
spouse. Percentage of beneficial ownership of La Jolla
common stock is based on 65,722,648 shares of common stock
outstanding as of December 9, 2009. Unless otherwise noted
below, the address of each person listed on the table is
c/o La Jolla
Pharmaceutical Company, 4365 Executive Drive, Suite 300,
San Diego, California 92121.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
|
|
|
|
|
|
|
Shares of
|
|
|
with Right to
|
|
|
|
|
|
|
|
|
|
Common
|
|
|
Acquire
|
|
|
Total
|
|
|
Percentage
|
|
|
|
Stock
|
|
|
within 60
|
|
|
Beneficial
|
|
|
of Common
|
|
Name and Address
|
|
Owned
|
|
|
Days
|
|
|
Ownership
|
|
|
Stock
|
|
|
Essex Woodlands Health Ventures Fund VI, L.P. and
|
|
|
|
|
|
|
4,139,014
|
|
|
|
4,139,014
|
|
|
|
5.9
|
%
|
Essex Woodlands Health Ventures Fund VII, L.P.
10001 Woodloch Forest Drive, Suite 175
The Woodlands, Texas 77380
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Craig R. Smith, M.D.(1)
|
|
|
|
|
|
|
123,400
|
|
|
|
123,400
|
|
|
|
*
|
%
|
Robert A. Fildes, Ph.D.(1)
|
|
|
|
|
|
|
100,276
|
|
|
|
100,276
|
|
|
|
*
|
%
|
Stephen M. Martin(1)
|
|
|
40
|
|
|
|
105,400
|
|
|
|
105,440
|
|
|
|
*
|
%
|
Frank E. Young, M.D., Ph.D.(1)
|
|
|
5,600
|
|
|
|
38,000
|
|
|
|
43,600
|
|
|
|
*
|
%
|
Deirdre Y. Gillespie, M.D.(1)(2)
|
|
|
|
|
|
|
1,005,208
|
|
|
|
1,005,208
|
|
|
|
1.5
|
%
|
Michael J.B. Tansey, M.D.(3)
|
|
|
|
|
|
|
535,000
|
|
|
|
535,000
|
|
|
|
*
|
%
|
All current executive officers and directors as a group
(6 persons)(4)
|
|
|
5,640
|
|
|
|
1,679,776
|
|
|
|
1,685,416
|
|
|
|
2.5
|
%
|
|
|
|
* |
|
Less than one percent. |
|
(1) |
|
Current director as of December 9, 2009. |
|
(2) |
|
Current executive officer as of December 9, 2009. |
|
(3) |
|
Former executive officer terminated April 20, 2009. |
|
(4) |
|
The six current executive officers and directors are comprised
of Dr. Smith, Dr. Fildes, Mr. Martin,
Dr. Young, and Dr. Gillespie (each of whom is included
within the table above), as well as Gail A. Sloan, the current
Vice President of Finance and Secretary as of December 9,
2009. As of December 9, 2009, Ms. Sloan owned no
La Jolla common stock and had the right to acquire
307,492 shares of La Jolla common stock within
60 days. |
BENEFICIAL
OWNERSHIP INFORMATION
The following table sets forth information concerning the
beneficial ownership of (i) any person known to
La Jolla to be the beneficial owner of more than five
percent of La Jollas outstanding common stock,
(ii) each current La Jolla director and each person
who is expected to become a director of the combined company
following the closing of the proposed merger, and (iii) all
current La Jolla directors and officers as a group, before
the proposed merger and immediately following the closing of the
proposed merger. The share numbers and percentages in the table
below for the period after the closing of the merger give effect
to an assumed 1:3.81 reverse split of the La Jolla common
stock before the closing of the merger. The table is based on
65,722,648 La Jolla shares outstanding before the merger
and 63,222,303 shares of common stock of the combined
company outstanding upon the consummation of the merger and
assumes La Jolla Net Cash equal to $2.7 million and an
Adamis Discounted Share Price of $0.25. Other than commitments
under the merger agreement described in this joint proxy
statement/prospectus, and commitments to issue shares upon the
exercise of stock options or restricted stock units,
La Jolla does not have any commitments to any such persons
with respect to the issuance of shares of its common stock.
Unless otherwise
120
indicated in the notes to the table, the address of the persons
listed on the table is
c/o La Jolla
Pharmaceutical Company, 4365 Executive Drive, Suite 300,
San Diego, California 92121.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
|
|
|
Shares
|
|
|
|
|
|
|
Beneficially
|
|
|
|
|
|
Beneficially
|
|
|
|
|
|
|
Owned
|
|
|
|
|
|
Owned
|
|
|
|
|
|
|
Before
|
|
|
|
|
|
After
|
|
|
|
|
Name
|
|
Merger(1)
|
|
|
Percent
|
|
|
Merger(1)
|
|
|
Percent(1)
|
|
|
Essex Woodlands Health Ventures Fund VI, L.P. and Essex
Woodlands Health Ventures Fund VII, L.P.(2)
|
|
|
4,139,014
|
|
|
|
5.9
|
%
|
|
|
1,086,355
|
|
|
|
1.7
|
%
|
10001 Woodloch Forest Drive, Suite 175
The Woodlands, Texas 77380
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
La Jolla Directors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Craig R. Smith, M.D.
|
|
|
123,400
|
(3)
|
|
|
*
|
%
|
|
|
32,388
|
|
|
|
*
|
%
|
Robert A. Fildes, Ph.D.
|
|
|
100,276
|
(4)
|
|
|
*
|
%
|
|
|
26,319
|
|
|
|
*
|
%
|
Stephen M. Martin
|
|
|
105,440
|
(5)
|
|
|
*
|
%
|
|
|
27,675
|
|
|
|
*
|
%
|
Frank E. Young, M.D., Ph.D.
|
|
|
43,600
|
(6)
|
|
|
*
|
%
|
|
|
11,444
|
|
|
|
*
|
%
|
Deirdre Y. Gillespie, M.D.
|
|
|
1,005,208
|
(7)
|
|
|
1.5
|
%
|
|
|
263,834
|
|
|
|
*
|
%
|
Adamis Directors (13)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dennis J. Carlo
|
|
|
|
|
|
|
|
|
|
|
8,368,000
|
(8)
|
|
|
13.2
|
%
|
Richard L. Aloi
|
|
|
|
|
|
|
|
|
|
|
3,593,039
|
(9)
|
|
|
5.7
|
%
|
David J. Marguglio
|
|
|
|
|
|
|
|
|
|
|
3,439,904
|
(10)
|
|
|
5.4
|
%
|
All La Jolla directors and officers as a group
|
|
|
1,685,416
|
(11)
|
|
|
2.5
|
%
|
|
|
16,714,059
|
(12)(14)
|
|
|
26.3
|
%
|
|
|
|
* |
|
Less than one percent. |
|
(1) |
|
Based upon information supplied by officers, directors and
principal stockholders. Beneficial ownership is determined in
accordance with rules of the SEC that deem shares to be
beneficially owned by any person who has or shares voting or
investment power with respect to such shares. Unless otherwise
indicated, the persons named in this table have sole voting and
sole investing power with respect to all shares shown as
beneficially owned, except for those jointly owned with that
persons spouse, subject to community property laws where
applicable. Shares of common stock subject to an option that is
currently exercisable or exercisable within 60 days of the
date of the table are deemed to be outstanding and to be
beneficially owned by the person holding such option for the
purpose of computing the percentage ownership of such person but
are not treated as outstanding for the purpose of computing the
percentage ownership of any other person. |
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(2) |
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Based on filings made by Essex Woodlands Health Ventures Funds,
including the Schedule 13D filed on December 23, 2005
and Forms 4 filed on April 12, 2007, May 14, 2008
and February 26, 2009, respectively. Includes warrants to
purchase 4,139,014 shares of La Jolla common stock
that are exercisable within 60 days. |
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(3) |
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Includes 123,400 shares subject to right to acquire within
60 days of the date of the table. |
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(4) |
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Includes 100,276 shares subject to right to acquire within
60 days of the date of the table. |
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(5) |
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Includes 105,400 shares subject to right to acquire within
60 days of the date of the table. |
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(6) |
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Includes 38,000 shares subject to right to acquire within
60 days of the date of the table. |
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(7) |
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Includes 1,005,208 shares subject to right to acquire within
60 days of the date of the table. |
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(8) |
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6,368,000 of these shares are subject to repurchase rights. |
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(9) |
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2,645,097 of these shares are subject to repurchase rights. |
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(10) |
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2,537,019 of these shares are subject to repurchase rights. |
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(11) |
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The six current executive officers and directors are comprised
of Dr. Smith, Dr. Fildes, Mr. Martin,
Dr. Young, and Dr. Gillespie (each of whom is included
within the table above), as well as Gail A. Sloan, the current
Vice President of Finance and Secretary. As of the date of this
table, Ms. Sloan owned no common stock and had the right to
acquire 307,492 shares of La Jolla common stock within
60 days. |
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(12) |
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Includes 11,840,366 shares subject to repurchase rights. |
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(13) |
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The address of each person is
c/o Adamis
Pharmaceuticals Corporation, 2658 Del Mar Heights Road,
Suite 555, Del Mar, CA 92014. |
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(14) |
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Includes all current La Jolla directors and officers as
group (6 persons) as well as each person expected to become
a director or officer of the combined company following the
merger (4 persons) including Robert O. Hopkins, the current
Vice President, Finance and Chief Financial Officer of Adamis.
As of the date of this table, Mr. Hopkins owned
870,750 shares of Adamis common stock, 290,250 of which
were subject to repurchase rights. |
DESCRIPTION
OF LA JOLLA CAPITAL STOCK
As of the date of this prospectus, the authorized capital stock
of La Jolla consisted of 225,000,000 shares of common
stock, par value $0.01 per share and 8,000,000 shares of
preferred stock, par value $0.01 per share. As of
December 18, 2009, there were 65,722,648 shares of
La Jolla common stock outstanding and no outstanding shares
of preferred stock.
The following is a summary of the rights of La Jolla common
stock and preferred stock. This summary is not complete. For
more detailed information, please see our restated certificate
of incorporation and bylaws, which are filed as exhibits to the
registration statement of which this prospectus is a part.
Common
Stock
The holders of La Jolla common stock are entitled to one
vote per share on all matters to be voted on by La Jolla
stockholders, including the election of directors.
La Jollas restated certificate of incorporation and
bylaws do not provide for cumulative voting rights. For a
discussion of the potential application of provisions of the
California Corporations Code, please see Applicability of
Provisions of California Corporate Law below.
Subject to preferences that may be applicable to any preferred
stock that may be authorized, the holders of La Jolla
common stock are entitled to receive ratably such dividends, if
any, as may be declared from time to time by the La Jolla
Board, in its discretion, out of legally available funds. Upon
La Jollas liquidation, dissolution or winding up,
subject to prior liquidation rights of preferred stock that may
be authorized, the holders of La Jolla common stock are
entitled to receive, on a pro rata basis, La Jollas
remaining assets available for distribution. The rights,
preferences and privileges of the holders of La Jolla
common stock are subject to, and may be adversely affected by,
the rights of the holders of shares of any series of preferred
stock that may be designated and issued in the future. Holders
of La Jolla common stock have no preemptive or other
subscription rights, and there are no conversion rights or
redemption or sinking fund provisions with respect to such
shares. All outstanding shares of La Jolla common stock
are, and all shares being offered by this joint proxy
statement/prospectus will be, fully paid and non-assessable.
Preferred
Stock
On the date of this joint proxy statement/prospectus, there were
no shares of La Jolla preferred stock outstanding. Under
La Jollas restated certificate of incorporation, the
La Jolla Board has the authority, without further action by
the stockholders, to issue up to 8,000,000 shares of
preferred stock in one or more series, to establish from time to
time the number of shares to be included in each such series, to
fix the rights, preferences and privileges of such shares (and
any qualifications, limitations or restrictions thereon), and to
increase or decrease the number of shares of any such series,
but not below the number of shares of such series then
outstanding.
The La Jolla Board may authorize the issuance of preferred
stock with voting or conversion rights that could adversely
affect the voting power or other rights of the holders of the
common stock. The issuance of preferred stock, while providing
flexibility in connection with possible acquisitions and other
corporate purposes, could, among other things, have the effect
of delaying, deferring or preventing a change in control of
La Jolla that may otherwise benefit holders of
La Jolla common stock and may adversely affect the market
price of the common stock and the voting and other rights of the
holders of common stock. La Jolla has no current plans to
issue any shares of preferred stock.
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Anti-Takeover
Provisions
Provisions of La Jollas restated certificate of
incorporation and amended bylaws, as they will be in effect
following the closing of the proposed merger, may delay or
discourage transactions involving an actual or potential change
in control of the combined company or change in the combined
companys management, including transactions in which
stockholders might otherwise receive a premium for their shares
or transactions that the combined companys stockholders
might otherwise deem to be in their best interests. Therefore,
these provisions may adversely affect the price of the combined
companys common stock. Among other things, the restated
certificate of incorporation and bylaws of the combined company
will:
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provide that the authorized number of directors may be changed
only by resolution of the board of directors;
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provide that all vacancies, including newly created
directorships, may, except as otherwise required by law, be
filled only by the board of directors;
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require that any action to be taken by our stockholders must be
effected at a duly called annual or special meeting of
stockholders and not be taken by written consent;
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provide that stockholders seeking to present proposals before a
meeting of stockholders or to nominate candidates for election
as directors at a meeting of stockholders must provide notice in
writing in a timely manner, and also specify requirements as to
the form and content of a stockholders notice;
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not provide for cumulative voting rights; and
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provide that special meetings of La Jolla stockholders may
be called only by the chairman of the board,
La Jollas president or by the board of
directors; and
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permit the board of directors to issue up to
8,000,000 shares of preferred stock, with any rights,
preferences and privileges as they may designate (including the
right to approve an acquisition or other change in the control
of La Jolla).
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The amendment of any of these provisions would require approval
by the holders of a majority of La Jollas then
outstanding common stock.
La Jolla is subject to Section 203 of the DGCL, which,
subject to certain exceptions, prohibits a Delaware corporation
from engaging in any business combination with an
interested stockholder for a period of three years
following the time that such stockholder became an interested
stockholder, unless:
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the board of directors of the corporation approves either the
business combination or the transaction that resulted in the
stockholder becoming an interested stockholder, before the time
the interested stockholder attained that status;
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upon the closing of the transaction that resulted in the
stockholder becoming an interested stockholder, the interested
stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction commenced,
excluding for purposes of determining the number of shares
outstanding those shares owned (a) by persons who are
directors and also officers and (b) by employee stock plans
in which employee participants do not have the right to
determine confidentially whether shares held subject to the plan
will be tendered in a tender or exchange offer; or
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at or subsequent to such time, the business combination is
approved by the board of directors and authorized at an annual
or special meeting of stockholders, and not by written consent,
by the affirmative vote of at least two-thirds of the
outstanding voting stock that is not owned by the interested
stockholder.
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With certain exceptions, an interested stockholder
is a person or group who or which owns 15% or more of the
corporations outstanding voting stock (including any
rights to acquire stock pursuant to an option, warrant,
agreement, arrangement or understanding, or upon the exercise of
conversion or exchange rights, and stock with respect to which
the person has voting rights only), or is an affiliate or
associate of the corporation and was the owner of 15% or more of
such voting stock at any time within the previous three years.
123
In general, Section 203 defines a business combination to
include:
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any merger or consolidation involving the corporation and the
interested stockholder;
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any sale, transfer, pledge or other disposition of 10% or more
of the assets of the corporation involving the interested
stockholder;
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subject to certain exceptions, any transaction that results in
the issuance or transfer by the corporation of any stock of the
corporation to the interested stockholder;
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any transaction involving the corporation that has the effect of
increasing the proportionate share of the stock or any class or
series of the corporation beneficially owned by the interested
stockholder; or
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the receipt by the interested stockholder of the benefit of any
loans, advances, guarantees, pledges or other financial benefits
provided by or through the corporation.
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A Delaware corporation may opt out of this provision
with an express provision in its original certificate of
incorporation or an express provision in its restated
certificate of incorporation or bylaws resulting from a
stockholders amendment approved by at least a majority of
the outstanding voting shares. However, La Jolla has not
opted out of this provision. Section 203 could prohibit or
delay mergers or other takeover or
change-in-control
attempts and, accordingly, may discourage attempts to acquire
La Jolla.
The authorized but unissued shares of La Jolla common stock
may be issued at any time and from time to time by the
La Jolla Board without stockholder approval. These
additional shares may be utilized for a variety of corporate
purposes, including future public offerings to raise additional
capital, corporate acquisitions and employee benefit plans. One
of the effects of the reverse stock split will be to effectively
increase the proportion of authorized shares of common stock
that are unissued relative to those that are issued. This could
result in the combined companys management being able to
issue more shares without further stockholder approval and could
render more difficult or discourage an attempt to obtain control
of the combined company by means of a proxy contest, tender
offer, merger or otherwise. La Jolla currently has no plans
to issue shares of its common stock, other than in connection
with the merger, the transactions contemplated thereby, in
connection with possible future fund-raising transactions after
the closing of the merger, and in the ordinary course of
business.
Transfer
Agent
The transfer agent for La Jolla common stock is American
Stock Transfer & Trust Company, LLC.
Listing
La Jollas common stock is currently listed on the
Nasdaq Capital Market under the symbol LJPC. The
common stock of the combined company is not expected to be
listed on the Nasdaq Capital Market and La Jolla common
stock will likely be delisted before the completion of the
merger (please see Risks Related to La Jolla
beginning on page 15 for additional information). La Jolla
and Adamis anticipate that the combined company will seek to
change its symbol in connection with the change of its corporate
name and be traded on the
over-the-counter
bulletin board.
COMPARISON
OF RIGHTS OF HOLDERS OF LA JOLLA STOCK AND ADAMIS
STOCK
Both La Jolla and Adamis are incorporated under the laws of
the State of Delaware and, accordingly, the rights of the
stockholders of each are currently, and will continue to be,
governed by the DGCL. If the merger is completed, Adamis
stockholders will be entitled to become stockholders of
La Jolla, and their rights will be governed by the DGCL,
the restated certificate of incorporation of La Jolla and
the bylaws of La Jolla, as amended.
The following is a summary of the material differences between
the rights of La Jolla stockholders and the rights of
Adamis stockholders under each companys respective charter
documents and bylaws. With respect to La Jolla, the
description of the charter documents reflect the certificate and
bylaws as they will be in effect immediately after the closing
of the merger, assuming that all of the Proposals described in
this joint proxy statement/prospectus are approved. While
La Jolla and Adamis believe that this summary covers the
material
124
differences between the two, this summary may not contain all of
the information that is important to you. This summary is not
intended to be a complete discussion of the respective rights of
La Jolla and Adamis stockholders and is qualified in its
entirety by reference to the DGCL and the various documents of
La Jolla and Adamis that are referred to in this summary.
You should carefully read this entire joint proxy
statement/prospectus and the other documents referred to herein
for a more complete understanding of the differences between
being a stockholder of La Jolla and being a stockholder of
Adamis. La Jolla has filed copies of its restated
certificate of incorporation and bylaws, as amended, with the
SEC, which are exhibits to the registration statement of which
this joint proxy statement/prospectus is a part, and will send
copies of these documents to you, free of charge, upon your
request. Adamis will also send copies of its documents referred
to herein to you upon your request. See the section entitled
Where You Can Find More Information.
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La Jolla
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Adamis
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Authorized
Capital
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The authorized capital stock of La Jolla consists of
225,000,000 shares of common stock, par value $0.01 per
share, and 8,000,000 shares of preferred stock, par value
$0.01 per share. The board has the authority to designate the
preferences, special rights, limitations or restrictions of the
shares of preferred stock without further stockholder approval.
As of December 18, 2009, approximately 65,722,648 shares of
common stock were issued and outstanding, and no shares of
preferred stock were issued and outstanding.
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The authorized capital stock of Adamis consists of
175,000,000 shares of common stock, par value $0.0001 per
share, and 10,000,000 shares of preferred stock, par value
$0.0001 per share. The board has the authority to designate the
preferences, special rights, limitations or restrictions of the
remaining shares of any class of stock or any series of any
class without further stockholder approval. As of
December 18, 2009, 45,972,303 shares of common stock
were issued and outstanding, and no shares of preferred stock
were issued and outstanding.
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Dividends
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Under Delaware law, subject to any restrictions in the
corporations certificate of incorporation, a Delaware
corporation may pay dividends out of surplus or, if there is no
surplus, out of net profits for the fiscal year in which
declared and for the preceding fiscal year. Delaware law also
provides that dividends may not be paid out of net profits if,
after the payment of the dividend, capital is less than the
capital represented by the outstanding stock of all classes
having a preference upon the distribution of assets.
La Jolla has never paid a dividend on its common stock.
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Same.
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Cumulative
Voting
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Under Delaware law, stockholders of a Delaware corporation do
not have the right to cumulate their votes in the election of
directors, unless such right is granted in the certificate of
incorporation of the corporation. La Jollas
certificate of incorporation does not provide for cumulative
voting by La Jolla stockholders.
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Adamis certificate of incorporation does not provide for
cumulative voting by Adamis stockholders.
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La Jolla
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Adamis
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Number of
Directors
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Delaware law provides that the board of directors of a Delaware
corporation shall consist of one or more directors as fixed by
the corporations certificate of incorporation or bylaws.
La Jollas bylaws provide that the number of directors
shall be fixed by the board from time to time. The board of
directors or the stockholders are authorized to set the number
of directors. The La Jolla Board currently consists of five
directors.
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Adamis board currently consists of three directors.
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Classified Board
of Directors
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Delaware law permits, but does not require, a Delaware
corporation to provide in its certificate of incorporation for a
classified board of directors, dividing the board into up to
three classes of directors with staggered terms of office, with
only one class of directors to be elected each year for a
maximum term of three years. La Jollas certificate of
incorporation provides for a classified board of directors
comprised of three classes of directors (Class 1, Class 2 and
Class 3). Only one class of directors is up for election each
year and, because there are three classes of directors, each
director in a class is up for re-election every three years.
Directors serve until their successors are elected or until
their earlier resignation or removal. The bylaws and certificate
of incorporation do not specify a specific term length for
service of a director.
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Delaware law permits, but does not require, a Delaware
corporation to provide in its certificate of incorporation for a
classified board of directors, dividing the board into up to
three classes of directors with staggered terms of office, with
only one class of directors to be elected each year for a
maximum term of three years. Adamis certificate of
incorporation does not provide for a classified board of
directors. Each director serves until his or her successor is
elected or until his or her earlier resignation or removal. The
bylaws and certificate of incorporation do not specify a
specific term length for service of a director.
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Removal of
Directors
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Delaware law provides that directors may be removed from office,
with or without cause, by the holders of a majority of the
voting power of all outstanding voting stock, unless the
corporation has a classified board and its certificate of
incorporation otherwise provides. La Jollas
certificate of incorporation does not provide for an alternative
method of removal of directors.
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Adamis bylaws provide that any director or the entire
board may be removed, with or without cause, by the holders of a
majority of the shares then entitled to vote at an election of
directors.
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La Jolla
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Adamis
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Vacancies
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Delaware law provides that, unless the corporations
certificate of incorporation or bylaws provide otherwise,
vacancies and newly created directorships resulting from an
increase in the authorized number of directors elected by the
stockholders having the right to vote as a single class may be
filled by a majority of the directors then in office.
La Jollas certificate of incorporation provides that
if the office of any director becomes vacant by reason of death,
resignation, disqualification, removal, failure to elect, or
otherwise, vacancies shall be filled solely by the board of
directors (unless there are no directors, in which case
vacancies will be filled by the stockholders).
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Same. Under the certificate of incorporation bylaws of Adamis,
if the office of any director becomes vacant by reason of death,
resignation, disqualification, removal, failure to elect, or
otherwise, the remaining directors, even if less than a quorum
and unless the board determines otherwise, by a majority vote of
such remaining directors, have the sole right to elect a
successor or successors who shall hold the office for the
unexpired term.
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Board Quorum
and Vote
Requirements
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At meetings of the board of directors, a majority of the
authorized directors shall constitute a quorum for the
transaction of business. The act of a majority of the directors
present at any meeting at which there is a quorum shall be the
act of the board. Only when a quorum is present may the board of
directors continue to do business at any such meeting.
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Same.
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Special Meetings
of Stockholders
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Delaware law permits special meetings of stockholders to be
called by the board of directors and any others persons
specified by the certificate of incorporation or bylaws.
Delaware law permits but does not require that stockholders be
given the right to call special meetings. La Jollas
bylaws provide that special meetings of stockholders may be
called by the board of directors, the chairman of the board or
the president.
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Delaware law permits special meetings of stockholders to be
called by the board of directors and any others persons
specified by the certificate of incorporation or bylaws.
Delaware law permits but does not require that stockholders be
given the right to call special meetings. Adamis bylaws
provide that special meetings of stockholders may be called by
the board of directors, the chairman of the board, the chief
executive officer, president or the holders of at least 25% of
all votes entitled to be cast on any issue proposed to be
considered at such special meeting. No business may be
transacted at a special meeting except that referred to in the
notice of meeting
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La Jolla
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Adamis
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Quorum for
Stockholder
Meetings
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Except as otherwise expressly provided by law or by
La Jollas certificate of incorporation or bylaws, at
all meetings of the stockholders, the holders of a majority of
the stock issued and outstanding and entitled to vote thereat,
present in person or represented by proxy, shall constitute a
quorum requisite for the transaction of business; provided,
however, that directors shall be elected by a plurality of the
votes of the shares present in person or represented by proxy at
the meeting and entitled to vote on the election of directors.
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Under Adamis bylaws, the presence at a meeting, in person
or by proxy, of holders of shares representing a majority of
votes entitled to vote on a matter constitutes a quorum for the
transaction of business; provided, however, that directors shall
be elected by a plurality of the votes of the shares present in
person or represented by proxy at the meeting and entitled to
vote on the election of directors.
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Advance Notice
Procedures for a
Stockholder
Proposal
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For nominations or other business to be properly brought before
a meeting by a stockholder, a stockholders notice must be
delivered to the corporation between 90 and 120 days before
the meeting; provided, however, that if less than
95 days notice or prior public disclosure of the date
of the scheduled meeting is given or made, notice by the
stockholder, to be timely, must be so delivered or received not
later than the close of business on the seventh day following
the earlier of (i) the date of the first public announcement of
the date of such meeting and (ii) the date on which such notice
of the scheduled meeting was mailed. The stockholders
notice must include certain information about the stockholder
and the proposal.
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Under Adamis bylaws for nominations or other business to
be properly brought before an annual meeting by a stockholder, a
stockholders notice must be delivered to Adamis between 90
and 120 days before to the first anniversary of the
preceding years annual meeting; provided, however, that if
the date of the annual meeting is advanced more than
30 days before or delayed by more than 30 days after
the anniversary of the preceding years annual meeting, the
notice must be delivered not earlier than the close of business
on the 120th day before such annual meeting and not later than
the later of the 90th day before such meeting or the 10th day
following the day on which public announcement of the date of
such meeting is first made. The stockholders notice must
include certain information about the stockholder and the
proposal.
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Action by Stockholders
Without a
Meeting
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Under Delaware law, unless a corporations certificate of
incorporation provides otherwise, any action which may be taken
at a meeting of the stockholders of a corporation may be taken
by written consent without a meeting. La Jollas
certificate of incorporation provides that any action permitted
to be taken at any annual or special meeting of stockholders
must be effected at a meeting and may not be effected by written
consent.
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Same. Adamis restated certificate of incorporation
provides that stockholders may not act by means of written
consent.
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La Jolla
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Adamis
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Amendment of Governing Documents
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Procedures for Amendment of Certificate of Incorporation: Under
Delaware law, the board of directors shall adopt a resolution
setting forth the proposed amendment and declaring its
advisability, and either call a special meeting of the
stockholders entitled to vote thereon or direct that the
proposed amendment shall be considered at the next annual
meeting of the stockholders. The amendment shall be approved by
a majority of the outstanding stock entitled to vote thereon. If
the proposed amendment would adversely affect the rights,
powers, par value, or preferences of the holders of either a
class of stock or a series of a class of stock, then the holders
of either the class of stock or series of stock, as appropriate,
shall be entitled to vote as a class.
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Procedures for Amendment of Certificate of Incorporation: Same.
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Procedures for Amendment of Bylaws: La Jollas bylaws
provide that the bylaws may be amended or repealed by the
stockholders or, except for Sections 2.07 and 3.01, by the
directors.
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Procedures for Amendment of Bylaws: Adamis bylaws provide
that the bylaws may be amended at any meeting of the board, upon
notice thereof in accordance with the bylaws, or at any meeting
of the stockholders by the vote of the holders of the majority
of the stock issued and outstanding and entitled to vote at such
a meeting.
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La Jolla
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Adamis
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Indemnification
of Directors,
Officers and Employees
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La Jollas bylaws provide that it will indemnify and
hold harmless against all expense, liability, and loss
(including attorneys fees, judgments, fines, ERISA excise
taxes or penalties and amounts paid in settlement), to the
fullest extent authorized by Delaware law, any director,
trustee, officer, employee of the corporation, or an agent of
another corporation, partnership, joint venture, trust, or other
enterprise (including service with respect to an employee
benefit plan), in connection with a proceeding to which he, she,
or it is made a party or threatened to be made a party or is
otherwise involved in any action, suit, or proceeding of a
civil, criminal, administrative, or investigative nature by
reason of being or having served in such a capacity. This
indemnification right continues after the individual ceases to
be a director, trustee, officer, employee, or agent and inures
to the benefit of the individuals heirs, executors, and
administrators. Notwithstanding the foregoing, an individual
that initiates a proceeding to enforce the right to
indemnification will only be indemnified if such a proceeding is
authorized by the board of directors.
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Adamis bylaws provide that it will indemnify and hold
harmless against all expense, liability, and loss (including
attorneys fees, judgments, fines, ERISA excise taxes or
penalties and amounts paid in settlement), to the fullest extent
authorized by Delaware law, any director, trustee, officer,
employee of the corporation, or an agent of another corporation,
partnership, joint venture, trust, or other enterprise
(including service with respect to an employee benefit plan), in
connection with a proceeding to which he, she, or it is made a
party or threatened to be made a party or is otherwise involved
in any action, suit, or proceeding of a civil, criminal,
administrative, or investigative nature by reason of being or
having served in such a capacity. This indemnification right
continues after the individual ceases to be a director, trustee,
officer, employee, or agent and inures to the benefit of the
individuals heirs, executors, and administrators.
Notwithstanding the foregoing, an individual that initiates a
proceeding to enforce the right to indemnification will only be
indemnified if such a proceeding is authorized by the board of
directors.
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La Jolla
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Adamis
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DGCL Section
203
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La Jolla is subject to the anti-takeover provisions of
Section 203 of the DGCL unless it falls within an applicable
exemption under Section 203 of the DGCL. In general, the statute
prohibits a publicly-held Delaware corporation from engaging in
a business combination with an interested
stockholder for a period of three years after the date of
the transaction in which the person became an interested
stockholder, unless the business combination is approved in a
prescribed manner. For purposes of Section 203, a business
combination includes a merger, asset sale, or other
transaction resulting in a financial benefit to the interested
stockholder, and an interested stockholder is a
person who, together with affiliates and associates, owns (or
within three years prior thereto, did own) 15% or more of the
corporations voting stock.
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Same. Adamis is also subject to the anti-takeover provisions of
Section 203 of the DGCL unless it falls within an
applicable exemption under Section 203 of the DGCL.
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Consideration of
Other
Constituencies
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La Jollas certificate of incorporation does not
contain any provision specifically authorizing or requiring
La Jolla Board to consider the interests of any
constituencies of La Jolla other than its stockholders in
considering whether to approve or oppose any corporate action.
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Adamis certificate of incorporation does not contain any
provision specifically authorizing or requiring the Adamis board
of directors to consider the interests of any constituencies of
Adamis other than its stockholders in considering whether to
approve or oppose any corporate action.
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However, Delaware law provides that, in the performance of their
duties to the corporation, directors are protected in relying on
good faith upon the records of the corporation and information,
opinions, reports, or statements presented to the corporation by
any of the corporations officers or employees, or
committees of the board of directors, or by any other person as
to matters the director reasonably believes are within such
other persons professional or expert competence and who
has been selected with reasonable care by or on behalf of the
corporation.
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However, Delaware law provides that, in the performance of their
duties to the corporation, directors are protected in relying on
good faith upon the records of the corporation and information,
opinions, reports, or statements presented to the corporation by
any of the corporations officers or employees, or
committees of the board of directors, or by any other person as
to matters the director reasonably believes are within such
other persons professional or expert competence and who
has been selected with reasonable care by or on behalf of the
corporation.
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131
MATTERS
TO BE PRESENTED TO THE LA JOLLA STOCKHOLDERS
LA JOLLA
PROPOSAL NO. 1 APPROVAL OF THE ISSUANCE
OF
COMMON STOCK TO ADAMIS STOCKHOLDERS IN THE MERGER
At the La Jolla special meeting, La Jolla stockholders
will be asked to approve the issuance of La Jolla common
stock to Adamis stockholders pursuant to the merger agreement
and the change in control of La Jolla resulting from the
issuance of La Jolla common stock in the merger.
Immediately following the merger, Adamis stockholders are
expected to own approximately 70% to 95% of the common stock
outstanding of the combined company, with existing La Jolla
stockholders holding approximately 5% to 30% of the common stock
outstanding of the combined company. See Risks Related to
the Merger, and specifically those risk factors discussing
potential ownership percentages of each of the La Jolla
stockholders and the Adamis stockholders post-merger, for
additional information.
The terms of, reasons for and other aspects of the merger
agreement, the merger, the issuance of La Jolla common
stock to Adamis stockholders pursuant to the merger agreement
and the resulting change in control of La Jolla, are
described in detail in other sections of this joint proxy
statement/prospectus.
Additionally, La Jolla expects to assume the Adamis 2009
Equity Incentive Plan, or the 2009 incentive plan. This plan,
which will terminate on February 6, 2019, provides for the
grant of incentive stock options, nonstatutory stock options,
restricted stock awards, restricted stock unit awards, stock
appreciation rights, performance stock awards, and other forms
of equity compensation, or collectively, stock awards. In
addition, the 2009 incentive plan provides for the grant of
performance cash awards. Incentive stock options may be granted
only to employees. All other awards may be granted to employees,
including officers, non-employee directors, and consultants. The
aggregate number of shares of common stock that may be issued
initially pursuant to stock awards under the 2009 incentive plan
is 7,000,000 shares, provided that the number of shares of
common stock reserved for issuance will automatically increase
on January 1 of each calendar year, from January 1, 2010
through and including January 1, 2019, by the lesser of
(a) 5.0% of the total number of shares of common stock
outstanding on December 31 of the preceding calendar year or
(b) a lesser number of shares of common stock determined by
the Adamis Board prior to the start of a calendar year for which
an increase applies. Following the assumption of the 2009
incentive plan, the combined company will be free to grant new
equity-based awards to eligible employees, officers, directors
and consultants.
No
Dissenters Rights
Under the DGCL, La Jolla stockholders are not entitled to
dissenters rights with respect to the merger or the
reverse stock split as described below in La Jolla
Proposal No. 2.
Vote
Required; Recommendation of Board of Directors
The affirmative vote of the holders of a majority of the shares
of La Jolla common stock having voting power present in
person or represented by proxy at the La Jolla special
meeting is required for approval of La Jolla
Proposal No. 1.
THE LA JOLLA BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT
LA JOLLAS STOCKHOLDERS VOTE FOR LA JOLLA
PROPOSAL NO. 1 TO APPROVE THE ISSUANCE OF LA JOLLA
COMMON STOCK TO ADAMIS STOCKHOLDERS PURSUANT TO THE MERGER
AGREEMENT AND THE RESULTING CHANGE IN CONTROL OF LA JOLLA.
LA JOLLA
PROPOSAL NO. 2 APPROVAL OF
PROPOSAL TO
AMEND LA JOLLAS RESTATED CERTIFICATE OF
INCORPORATION TO EFFECT A REVERSE STOCK SPLIT
The merger agreement provides that La Jollas
stockholders must approve an amendment to La Jollas
restated certificate of incorporation to effect the reverse
stock split of La Jolla common stock as described in this
joint proxy statement/prospectus. If approved, the reverse stock
split will be effective immediately before the effective time of
132
the merger. Upon the effectiveness of the amendment to
La Jollas restated certificate of incorporation
effecting the reverse stock split, referred to herein as the
split effective time, the total number of outstanding
La Jolla shares immediately before the split effective time
will be combined into a number of shares based on the formula
described below.
The number of shares that persons who are La Jolla
stockholders immediately before closing of the merger will hold
after the closing of the merger depends on the ratio of the
reverse stock split as determined pursuant to the merger
agreement. The Reverse Split Ratio is expected to range from 1:3
to 1:30 and applies only to existing holders of La Jolla
common stock. Under the terms of the merger agreement, the
shares of La Jolla common stock issued and outstanding
immediately before the closing of the merger will be combined in
a reverse stock split, with each share thereafter representing a
fractional share equal to the reverse stock split ratio. Under
the merger agreement, the Reverse Stock Split Ratio
is defined as a fraction, the numerator of which is one and the
denominator of which is the Pre-Effective La Jolla
Shares divided by the Post-Effective La Jolla
Stockholder Shares.
The Pre-Effective La Jolla Shares is defined in
the merger agreement as the sum of all shares of La Jolla
common stock before the effective date of the merger that are:
(a) issued and outstanding and (b) issuable upon
conversion of any preferred stock of La Jolla. The
Post-Effective La Jolla Stockholder Shares is
defined as a number equal to (i) the La Jolla Net Cash
as of the closing date of the merger plus $750,000, divided by
(ii) the Adamis Discounted Share Price. La Jolla
Net Cash is defined as the amount of
(A) La Jollas cash and cash equivalents and
current amounts receivable of La Jolla, as reflected in
La Jollas financial records as of the closing date of
the merger, minus (B) all cash liabilities and obligations
of La Jolla as reflected in La Jollas financial
records as of the closing date of the merger, but excluding the
aggregate value of the fractional share payments and
out-of-pocket
expenses associated with the reverse stock split and the
post-closing exchange of certificates associated with the
reverse stock split. In determining the La Jolla Net Cash prior
to the closing of the merger, La Jolla will prepare a
statement estimating the net cash and will deliver this estimate
to Adamis before closing. Adamis and La Jolla currently
expect that La Jollas adjusted net cash, taking into
account liabilities, will be between approximately
$2.5 million and $3.0 million as of the time that the
parties expect the merger to be completed. The actual amount of
adjusted net cash could be higher or lower than this range. The
amount of La Jollas net cash at the closing date of
the merger will depend primarily on when the La Jolla and
Adamis stockholder meetings are held and how long it takes to
satisfy the other closing conditions in the merger agreement,
the extent of La Jollas working capital needs until
the closing and the extent of unexpected expenses or cash needs
that may arise before the closing.
The Adamis Discounted Share Price is defined in the
merger agreement as the volume weighted average closing price of
the Adamis common stock (as reported on the OTC
Bulletin Board or other market or quotation system on which
the Adamis common stock is quoted or traded) commencing on the
first business day after the date of the merger agreement, which
was December 7, 2009, and ending two trading days before
the closing date of the merger, discounted by an amount set
forth in the following table:
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Adamis Weighted Average Share Price
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% Discount
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Less than $0.25
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10% (not to go below $0.20 per share)
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$0.25 to $2.00
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25% (not to go below $0.20 per share)
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Greater than $2.00
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$1.50 (fixed price)
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The prices in the above table are subject to proportional
adjustments in the event of recapitalizations or similar events
affecting the Adamis common stock.
By way of example only: (A) if the La Jolla Net Cash
as of the closing date of the merger is $2,000,000 and the
Adamis Average Share Price is $0.24, then the Adamis Discounted
Share Price would equal $0.216 and the Post-Effective
La Jolla Stockholder Shares would equal 12,731,481;
(B) if the La Jolla Net Cash as of the Closing Date is
$2,000,000 and the Adamis Average Share Price is $0.50, then the
Adamis Discounted Share Price would equal $0.375 and the
Post-Effective La Jolla Stockholder Shares would equal
7,333,333; and (C) if the La Jolla Net Cash as of the
Closing Date is $2,000,000 and the Adamis Average Share Price is
$2.01, then the Adamis Discounted Share Price would equal $1.50
and the Post-Effective La Jolla Stockholder Shares would
equal 1,833,333.
133
While the exact ratio of the reverse stock split will not be
calculable until near the closing of the merger, the following
table sets forth the approximate percentage ownership of the
outstanding shares of the combined company that Adamis
stockholders and current La Jolla stockholders would be
expected to hold immediately following the closing of the
merger, based on an assumed 45,972,303 outstanding Adamis shares
and 65,722,648 outstanding La Jolla shares at the closing
date of the merger, and reflecting the assumed high and low
amounts of La Jolla Net Cash ($3.0 million (high) and
$2.5 million (low), respectively) and different Adamis Weighted
Average Share Prices and related Adamis Discounted Share Prices.
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Total La Jolla
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Stockholders
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Approximate
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Ownership in
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Total Adamis Stockholders
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Adamis
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La Jolla
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the Combined
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Adamis
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Approximate Ownership in
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La Jolla Net
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Weighted
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Adamis
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Stockholders
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Company after Closing
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Stockholders
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the Combined Company after Closing
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Cash Plus
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Average
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Discounted
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Reverse Stock
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Share
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Exchange
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Share
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$750,000
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Share Price
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Share Price
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Split Ratio
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Amount
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%
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Ratio
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Amount
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%
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$3,750,000
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$
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2.00
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$
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1.50
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1 : 26.3
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2,500,000
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5
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1 : 1
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45,972,303
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95
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(high)
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$
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1.00
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$
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0.75
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1 : 13.1
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5,000,000
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10
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1 : 1
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45,972,303
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90
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$
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0.50
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$
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0.38
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1 : 6.6
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10,000,000
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18
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1 : 1
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45,972,303
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82
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$
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0.25
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$
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0.20
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1 : 3.5
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18,750,000
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29
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1 : 1
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45,972,303
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71
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$3,250,000
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$
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2.00
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$
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1.50
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1 : 30.3
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2,166,667
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5
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1 : 1
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45,972,303
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95
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(low)
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$
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1.00
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$
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0.75
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1 : 15.2
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4,333,333
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9
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1 : 1
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45,972,303
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91
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$
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0.50
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$
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0.38
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1 : 7.6
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8,666,667
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16
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1 : 1
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45,972,303
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84
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$
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0.25
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$
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0.20
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1 : 4
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16,250,000
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26
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1 : 1
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45,972,303
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74
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At the split effective time, each outstanding pre-reverse split
share of La Jolla common stock will be reclassified into a
fraction of a share equal to the reverse split ratio. All shares
and fractions thereof held by a particular record holder will be
aggregated into whole shares. The merger agreement provides that
no fractional shares will be issued in connection with the
reverse stock split. No fractional shares of La Jolla
common stock shall be issued in connection with the merger, and
no certificates or scrip representing such fractional shares
shall be issued. In lieu of fractional shares, holders of Adamis
common stock will instead receive from La Jolla an amount
of cash (rounded to the nearest whole cent), without interest,
equal to the product of (i) such fraction, multiplied by
(ii) the applicable price per share which shall be equal to
the average closing price of La Jolla common stock (as
reported on the Nasdaq Capital Market, or the OTC
Bulletin Board or, if the La Jolla common stock is not
traded on the Nasdaq Capital Market or the OTC
Bulletin Board, then the Pink Sheets, and, if not traded on
the Pink Sheets, then as determined in good faith by the
La Jolla Board) on the five trading days immediately prior
to the effective date of the merger (after giving effect to the
Reverse Stock Split). The reverse split would not reduce the
number of authorized shares of La Jolla common stock and
preferred stock set forth in La Jollas certificate of
incorporation, as proposed to be amended. Accordingly, La Jolla
will effectively gain additional authorized shares of common
stock as a result of the reverse stock split; neither Adamis nor
La Jolla presently has any plans for the issuance of these
additional shares.
If Adamis issues additional shares of its common stock before
the closing of the merger, then the La Jolla stockholders
will hold a lower percentage of the outstanding shares of the
combined company immediately after the merger. La Jolla
will publicly announce the final reverse stock split ratio.
134
The following table provides estimates of the number of shares
of La Jolla common stock authorized, issued and
outstanding, and reserved for issuance at the following times,
assuming that there are 65,722,648 La Jolla shares and
45,972,303 Adamis shares outstanding immediately before the
effective time of the merger: (i) before the reverse stock
split and closing of the merger, (ii) after the reverse
stock split but immediately before the effective time of the
merger, and (iii) after the reverse stock split and
immediately after the closing of the merger:
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Number of
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Shares of
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Number of Shares
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Number of
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Common Stock
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Issued and
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Shares Reserved
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Authorized
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Outstanding(1)
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For Issuance
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Before the Reverse Stock Split and Closing of the Merger:
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225,000,000
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65,722,648
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11,814,267
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(2)
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After Assumed 1: 1:30.3 Reverse Stock Split with
$2.5 million La Jolla Net Cash but Before Closing of the
Merger:
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225,000,000
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2,166,667
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389,479
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(3)
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After Assumed 1: 1:3.5 Reverse Stock Split with
$3.0 million La Jolla Net Cash but Before Closing of the
Merger:
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225,000,000
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18,750,000
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3,370,490
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(3)
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After Assumed 1: 1:30.3 Reverse Stock Split with
$2.5 million La Jolla Net Cash and Issuance of
Shares Following Closing of the Merger:
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225,000,000
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48,138,970
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2,805,057
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(4)
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After Assumed 1: 1:3.5 Reverse Stock Split with
$3.0 million La Jolla Net Cash and Issuance of
Shares Following Closing of the Merger:
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225,000,000
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64,722,303
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5,786,068
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(4)
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(1) |
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These estimates assume 65,722,648 shares of La Jolla
common stock issued and outstanding immediately before the
closing of the merger. |
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(2) |
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Includes shares issuable upon exercise of outstanding
La Jolla options and warrants, without giving effect to the
reverse stock split. Excludes the shares of common stock
reserved for issuance to Adamis stockholders in connection with
the merger. |
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(3) |
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Includes post-reverse split shares issuable upon exercise of
outstanding La Jolla options and warrants. Excludes an
additional estimated 45,972,303 shares of common stock
reserved for issuance to Adamis stockholders in connection with
the merger. |
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(4) |
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Includes post-reverse split shares issuable upon exercise of
outstanding La Jolla options and warrants. Includes
2,415,578 shares issuable upon the exercise of outstanding
Adamis options and warrants that will be assumed by
La Jolla in the merger. Excludes shares reserved for future
issuance under the Adamis 2009 Equity Incentive Plan that is
being assumed by La Jolla in connection with the merger. |
If La Jolla Proposal No. 2 is approved, and if
the reverse stock split is effected in connection with the
closing of the merger, the reverse stock split would become
effective upon the filing of a certificate of amendment to
La Jollas restated certificate of incorporation with
the Delaware Secretary of State.
The La Jolla board of directors will effect the reverse
stock split, if it is approved by the stockholders, only if the
proposal to approve the issuance of shares of La Jolla
common stock to Adamis stockholders pursuant to the merger
agreement, and the other proposals that the merger agreement
requires be approved, are approved, and only in connection with
the closing of the merger.
The amendment to La Jollas restated certificate of
incorporation to effect the reverse stock split will effect the
reverse stock split but will not change the number of authorized
shares of La Jolla common stock or the par value of
La Jolla common stock.
By approving the certificate of amendment to
La Jollas restated certificate of incorporation
effecting the reverse stock split, stockholders will be
approving the combination of any number of issued shares of
common stock shares into one share, pursuant to the formula set
forth in the merger agreement and described above.
135
Reasons
for the Reverse Stock Split
The primary purpose of the reverse stock split is to adjust the
number of outstanding La Jolla shares in relation to the
number of shares that will be issued to the Adamis stockholders
in the merger, and to have a smaller total number of outstanding
shares of La Jolla common stock immediately after the
merger.
Principal
Effects of the Reverse Stock Split
The amendment to La Jollas restated certificate of
incorporation effecting the reverse stock split is attached
hereto Annex C.
The reverse stock split, if effected, will occur simultaneously
for all outstanding shares of La Jolla common stock. The
reverse stock split will affect all of La Jollas
stockholders uniformly and will not affect any
stockholders percentage ownership interests in
La Jolla. The reverse stock split will not affect Adamis
stockholders that receive La Jolla stock in the merger, as
their shares will issued on a
one-for-one
basis after the reverse split occurs. Common stock issued
pursuant to the reverse stock split will remain fully paid and
non-assessable. The reverse stock split will not affect
La Jollas continuing to be subject to the periodic
reporting requirements of the Exchange Act.
If a reverse stock split is implemented, some stockholders may
consequently own less than one hundred shares of common stock. A
purchase or sale of less than one hundred shares, referred to as
an odd lot transaction, may result in incrementally
higher trading costs through certain brokers, particularly
full service brokers. Therefore, those stockholders
who own less than one hundred shares of common stock following
the reverse stock split may be required to pay higher
transaction costs if they sell their shares.
La Jolla has outstanding certain stock options and warrants
to purchase shares of common stock. Under the terms of the
outstanding stock options and warrants, a reverse stock split
will effect a reduction in the number of shares of common stock
issuable upon exercise of such stock options and warrants in
proportion to the exchange ratio of the reverse stock split and
will effect a proportionate increase in the exercise price of
such outstanding stock options and warrants, so that the
aggregate dollar amount payable for the purchase of the shares
subject to the options will remain unchanged. In connection with
a reverse stock split, the number of shares of common stock
issuable upon exercise or conversion of outstanding stock
options and warrants will be rounded to the nearest whole share,
and no cash payment will be made in respect of such rounding.
Procedure
for Effecting Reverse Stock Split and Exchange of Stock
Certificates
If La Jollas stockholders approve the amendment to
La Jollas restated certificate of incorporation
effecting the reverse stock split, the ratio of the reverse
stock split to be implemented will be determined as provided in
the merger agreement. La Jolla will file the certificate of
amendment with the Delaware Secretary of State in connection
with the closing of the merger transaction. Beginning at the
split effective time, each certificate representing pre-split
shares will be deemed for all corporate purposes to evidence
ownership of post-split shares.
As soon as practicable after the split effective time,
stockholders will be notified that the reverse stock split has
been effected. La Jolla expects that La Jollas
transfer agent will act as exchange agent for purposes of
implementing the exchange of stock certificates. Holders of
pre-split shares will be asked to surrender to the exchange
agent certificates representing pre-split shares in exchange for
certificates representing post-split shares in accordance with
the procedures to be set forth in a letter of transmittal to be
sent by La Jolla. No new certificates will be issued to a
stockholder until such stockholder has surrendered such
stockholders outstanding certificate(s) together with the
properly completed and executed letter of transmittal to the
exchange agent. Any pre-split shares submitted for transfer,
whether pursuant to a sale or other disposition, or otherwise,
will automatically be exchanged for post-split shares.
Stockholders should not destroy any stock certificate(s) and
should not submit any certificate(s) unless and until requested
to do so.
Fractional
Shares
No fractional shares will be issued in connection with the
reverse stock split. Stockholders of record who otherwise would
be entitled to receive fractional shares because they hold a
number of pre-split shares not evenly divisible by the number of
pre-split shares for which each post-split share is to be
reclassified (after aggregating
136
fractional shares), will be entitled, upon surrender to the
exchange agent of certificates representing such shares, to
receive a whole share of La Jolla common stock.
Accounting
Matters
The reverse stock split will not affect the stockholders
equity on La Jollas balance sheet. However, because
the par value of La Jolla common stock will remain
unchanged on the effective date of the split, the components
that make up the common stock capital account will change by
offsetting amounts. Depending on the size of the reverse stock
split the board of directors decides to implement, the stated
capital component will be reduced to approximately $172,500 from
its present amount, and the additional paid-in capital component
will be increased with the amount by which the stated capital is
reduced. The per share net income or loss and net book value of
La Jolla will be increased because there will be fewer
shares of La Jolla common stock outstanding. Prior
periods per share amounts will be restated to reflect the
reverse stock split.
No
Dissenters Rights
Under the DGCL, La Jolla stockholders are not entitled to
dissenters rights with respect to the reverse stock split
or the merger.
Certain
Federal Income Tax Considerations
The following discussion describes certain material United
States federal income tax considerations of the reverse stock
split. This discussion is based upon the Internal Revenue Code
of 1986, as amended, existing treasury regulations and current
administrative rulings and court decisions, all of which are
subject to change, possibly with retroactive effect, and to
differing interpretations. No ruling from the Internal Revenue
Service or opinion of tax counsel with respect to the matters
discussed herein has been requested, and there is no assurance
that the Internal Revenue Service would agree with the
conclusions set forth in this discussion. All stockholders
should consult with their own tax advisors.
This discussion may not address certain federal income tax
consequences that may be relevant to particular stockholders in
light of their personal circumstances or to certain types of
stockholders who may be subject to special treatment under the
federal income tax laws. This discussion assumes that
stockholders do not constructively own any shares of common
stock as a result of attribution from related persons or
entities. This discussion also does not address any tax
consequences under state, local, or foreign laws. It does not
address the consequences of the reverse stock split to holders
of options or warrants.
STOCKHOLDERS ARE URGED TO CONSULT THEIR TAX ADVISERS AS TO THE
PARTICULAR TAX CONSEQUENCES TO THEM OF THE REVERSE STOCK SPLIT,
INCLUDING THE APPLICABILITY OF ANY STATE, LOCAL, OR FOREIGN TAX
LAWS, OR ANY CHANGES IN APPLICABLE TAX LAWS.
Tax Consequences to
La Jolla. La Jolla will not recognize
any gain or loss solely as a result of the reverse stock split.
Tax Consequence to La Jolla Stockholders
Generally. No gain or loss should be recognized
by a stockholder who receives only shares of common stock as a
result of the reverse stock split.
Stockholders Tax Basis in Shares Received upon the
Reverse Stock Split. Except with respect to cash
received in lieu of fractional shares, the aggregate tax basis
of the shares of La Jolla common stock held by a
stockholder following the reverse stock split will equal the
stockholders aggregate basis in the shares of common stock
held immediately before the reverse stock split.
THE PRECEDING DISCUSSION IS INTENDED ONLY AS A SUMMARY OF
CERTAIN UNITED STATES FEDERAL INCOME TAX CONSEQUENCES OF THE
REVERSE STOCK SPLIT AND DOES NOT PURPORT TO BE A COMPLETE
ANALYSIS OR DISCUSSION OF ALL OF THE REVERSE STOCK SPLITS
POTENTIAL TAX EFFECTS. HOLDERS OF LA JOLLA COMMON STOCK ARE
URGED TO CONSULT THEIR OWN TAX ADVISORS AS TO THE SPECIFIC TAX
CONSEQUENCES
137
TO THEM OF THE REVERSE STOCK SPLIT AND THE APPLICABILITY AND
EFFECT OF FEDERAL, STATE, LOCAL AND OTHER APPLICABLE TAX
LAWS.
Vote
Required; Recommendation of Board of Directors
The affirmative vote of the holders of a majority of the shares
of La Jolla common stock having voting power outstanding on
the record date for the La Jolla special meeting is
required to approve the certificate of amendment to
La Jollas restated certificate of incorporation to
effect a reverse stock split of La Jolla common stock. If
the merger with Adamis is not completed for any reason, the
board of directors expects that this proposal will not be
implemented.
THE LA JOLLA BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT
LA JOLLAS STOCKHOLDERS VOTE FOR LA JOLLA
PROPOSAL NO. 2 TO AMEND LA JOLLAS RESTATED
CERTIFICATE OF INCORPORATION TO EFFECT A REVERSE STOCK SPLIT OF
LA JOLLA COMMON STOCK.
LA JOLLA
PROPOSAL NO. 3 APPROVAL OF
PROPOSAL TO
AMEND LA JOLLAS RESTATED CERTIFICATE OF
INCORPORATION TO EFFECT A NAME CHANGE
Name
Change
The La Jolla Board has unanimously adopted a resolution
approving, declaring advisable and recommending to the
La Jolla stockholders for their approval an amendment to
La Jollas restated certificate of incorporation to
change the name of La Jolla Pharmaceutical Company to
Adamis Pharmaceuticals Corporation in connection with the
closing of the merger transaction with Adamis. La Jolla
intends to file this amendment after the La Jolla
stockholders approve the name change, to take effect only upon
consummation of the merger. The proposed amendment effecting the
change in corporate name is attached hereto as
Annex D.
Purpose/Reasons
for the Amendment
Because of the relative contributions of business and assets to
the combined company by each of La Jolla and Adamis,
La Jolla believes that the name change will more accurately
reflect the combined companys business after the merger is
effective. In addition, under the merger agreement, approval of
the amendment described in this proposal is a condition that
La Jolla must satisfy to complete the merger with Adamis.
If the amendment is not approved, La Jolla may not be able
to complete the merger with Adamis and the other transactions
contemplated by the merger agreement unless Adamis agrees to
waive this condition to closing, which La Jolla believes is
not likely.
Vote
Required; Recommendation of Board of Directors
The affirmative vote of the holders of a majority of the shares
of La Jolla common stock having voting power outstanding on
the record date for the La Jolla special meeting is
required to approve the amendment to La Jollas
restated certificate of incorporation to change the corporate
name. If the merger with Adamis is not completed for any reason,
the La Jolla Board expects that this proposal will not be
implemented.
THE LA JOLLA BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT
LA JOLLAS STOCKHOLDERS VOTE FOR LA JOLLA
PROPOSAL NO. 3 TO AMEND LA JOLLAS RESTATED
CERTIFICATE OF INCORPORATION TO CHANGE THE CORPORATE NAME.
138
LA JOLLA
PROPOSAL NO. 4 APPROVAL OF POSSIBLE
ADJOURNMENT OF THE LA JOLLA SPECIAL MEETING
If La Jolla fails to receive a sufficient number of votes
to approve La Jolla Proposal Nos. 1, 2 and 3,
La Jolla may propose to adjourn the La Jolla special
meeting, for a period of not more than 30 days, for the
purpose of soliciting additional proxies to approve such
proposals. La Jolla currently does not intend to propose
adjournment at the La Jolla special meeting if there are
sufficient votes to approve such proposals.
Vote
Required; Recommendation of Board of Directors
The affirmative vote of the holders of a majority of the shares
of La Jolla common stock having voting power present in
person or represented by proxy at the La Jolla special
meeting is required to approve the adjournment of the
La Jolla special meeting for the purpose of soliciting
additional proxies to approve La Jolla Proposal Nos.
1, 2 and 3.
THE LA JOLLA BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT
LA JOLLAS STOCKHOLDERS VOTE FOR LA JOLLA
PROPOSAL NO. 4 TO ADJOURN THE SPECIAL MEETING, IF
NECESSARY, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT
SUFFICIENT VOTES IN FAVOR OF LA JOLLA PROPOSAL NOS. 1, 2
and 3.
139
LA
JOLLAS BUSINESS
Proposed
Merger with Adamis Pharmaceuticals Corporation
La Jolla had historically focused substantially all of its
research, development and clinical efforts and financial
resources toward the development of its
Riquent®
(abetimus sodium) product candidate, as a treatment for patients
with lupus. In February 2009, La Jolla announced that an
independent monitoring board for the
Riquent®
Phase 3 study had completed its review of the first interim
efficacy analysis and determined that continuing the study was
futile. La Jolla subsequently took steps to significantly
reduce its operating costs and ceased all Riquent development,
manufacturing and regulatory activities, and had commenced steps
to wind down its operations before entering into the merger
agreement.
Prior to executing the merger agreement with Adamis, the
La Jolla Board approved a Plan of Liquidation and
Dissolution and called stockholder meetings to vote on that
plan, however, the majority of La Jollas stockholders
failed to return their proxy cards or otherwise indicate their
votes with respect to this proposal prior to the start of these
stockholders meetings. If La Jolla is unable to
complete the merger or another strategic transaction, it does
not expect to be able to continue as a going concern and may
liquidate in a voluntary dissolution under Delaware law.
Following the completion of the merger, the current management
and board of directors of La Jolla will have resigned and
therefore have no control over the ultimate decisions regarding
the combined companys operations and business. All of the
combined companys business immediately following the
merger will be the business conducted by Adamis immediately
prior to the merger, and all of the descriptions of
La Jollas business in this joint proxy
statement/prospectus, as well as the trends and risks that apply
to La Jollas business, will change from those
described herein based on La Jollas business to date
and otherwise will no longer be applicable to the combined
company. In addition, because of the pending merger with Adamis,
La Jolla believes its historical operating results are not
indicative of future results. La Jolla encourages you to
review the section titled, Adamis Business in
this joint proxy statement/prospectus for a description of the
expected business and operations of the combined company if the
merger is approved and completed.
Overview
and Recent Developments
Since La Jollas inception in May 1989, La Jolla
had devoted substantially all of its resources to the research
and development of technology and potential drugs to treat
antibody-mediated diseases. La Jolla has never generated
any revenue from product sales and has relied on public and
private offerings of securities, revenue from collaborative
agreements, equipment financings and interest income on invested
cash balances for its working capital.
On January 4, 2009, La Jolla entered into a
development and commercialization agreement (the
Development Agreement) with BioMarin CF Limited
(BioMarin CF), a wholly-owned subsidiary of BioMarin
Pharmaceutical Inc. (BioMarin Pharma). Under the
terms of the Development Agreement, BioMarin CF was granted
co-exclusive rights to develop and commercialize Riquent in the
United States, Europe and all other territories of the world,
excluding the Asia Pacific region, and the non-exclusive right
to manufacture Riquent anywhere in the world. In connection with
the Development Agreement, La Jolla also entered into a
securities purchase agreement with BioMarin Pharma. In January
2009, BioMarin CF paid La Jolla a non-refundable
commencement payment of $7.5 million pursuant to the
Development Agreement and BioMarin Pharma paid La Jolla
$7.5 million in exchange for a newly designated series of
La Jollas preferred stock pursuant to the securities
purchase agreement. As described below, the Development
Agreement was terminated on March 27, 2009.
In February 2009, La Jolla was informed by an Independent
Monitoring Board for the Riquent Phase 3 ASPEN study that the
monitoring board completed its review of the first interim
efficacy analysis of Riquent and determined that continuing the
study was futile. La Jolla subsequently unblinded the data
and found that there was no statistical difference in the
primary endpoint, delaying time to renal flare, between the
Riquent-treated group and the placebo-treated group, although
there was a significant difference in the reduction of
antibodies to double-stranded DNA.
140
Based on these results, La Jolla immediately discontinued
the Riquent Phase 3 ASPEN study and the further development of
Riquent. La Jolla had previously devoted substantially all
of its research, development and clinical efforts and financial
resources toward the development of Riquent. In connection with
the termination of its clinical trials for Riquent,
La Jolla subsequently initiated steps to significantly
reduce its operating costs, including a reduction in force,
which was effected in April 2009. La Jolla also ceased the
manufacture of Riquent at its former facility in San Diego,
California, as well as all regulatory activities associated with
Riquent. La Jolla recorded a charge of approximately
$1.1 million in the quarter ended March 31, 2009, of
which $0.7 million was included in research and development
and $0.4 million was included in general and administrative
expense. This amount was paid in May 2009.
Following the futile results of the first interim efficacy
analysis of Riquent, BioMarin CF elected to not exercise its
full license rights to the Riquent program under the Development
Agreement. Thus, the Development Agreement between the parties
terminated on March 27, 2009 in accordance with its terms.
Pursuant to the Securities Purchase Agreement between
La Jolla and BioMarin Pharma, La Jollas
Series B-1
preferred shares purchased by BioMarin Pharma were automatically
converted into 10,173,120 shares of common stock upon the
termination of the Development Agreement. Additionally, all
rights to Riquent were returned to La Jolla.
In January 2009, La Jolla sold all of its auction rate
securities to its broker-dealer, UBS A.G. (UBS) at
par value of $10.0 million. As of December 31, 2008,
La Jolla had previously recognized a total impairment
charge of $2.3 million as a result of the illiquidity of
these securities, which was fully offset by a realized gain of
$2.3 million from UBSs repurchase agreement that
provided for a put option on these securities. Following the
sale of these investments, La Jolla no longer holds any
auction-rate securities.
In July 2009, La Jolla announced that, in light of the
current alternatives available to it, a wind down of its
business would be in the best interests of its stockholders.
Although the Board of Directors (the Board) approved
a Plan of Complete Liquidation and Dissolution (the Plan
of Dissolution) in September 2009, it was subject to
approval by holders of at least a majority in voting power of
La Jollas outstanding shares. La Jolla called a
special meeting of stockholders to vote on the Plan of
Dissolution however, the majority of its stockholders failed to
return their proxy cards or otherwise indicate their votes with
respect to this proposal.
Concurrent with the adoption by the La Jolla Board of the Plan
of Dissolution, Thomas H. Adams, Ph.D., James N.
Topper, M.D., Ph.D. and Martin P. Sutter each resigned
from the La Jolla Board and all committees and related
positions thereof. The resignations of Drs. Adams and
Topper and Mr. Sutter from the Board did not involve any
disagreement with La Jolla.
Also in connection with the adoption of the Plan of Dissolution,
the Board approved the termination of the Amended and Restated
Rights Agreement, dated December 2, 2008, by and between
La Jolla and American Stock Transfer &
Trust Co., LLC, as amended (the Rights
Agreement) effective as of September 23, 2009. The
Rights Agreement was terminated in connection with the
Boards approval of the liquidation and dissolution of
La Jolla.
In September 2009, La Jolla received a notice from the
Nasdaq Stock Market indicating that it is not in compliance with
Nasdaq Marketplace Rule 5550(a)(2) (the Minimum Bid
Price Rule) because, for 30 consecutive days, the bid
price of La Jolla common stock has closed below the minimum
level of $1.00 per share. Although this notification has no
effect on the current listing of La Jolla common stock, if
La Jolla does not regain compliance with the Minimum Bid
Price Rule Nasdaq will notify La Jolla that its common
stock will be delisted from the Nasdaq Stock Market. Based on
more recent communications with NASDAQ, we expect that the
combined entity would not satisfy listing standards as of the
closing of the merger. Accordingly, NASDAQ may issue La Jolla a
letter before the closing of the merger indicating NASDAQs
intent to immediately commence delisting proceedings against
La Jolla. La Jolla anticipates that, if it receives a
delisting letter from NASDAQ, it would appeal such delisting
determination. However, La Jolla cannot ensure that it would be
successful on appeal and therefore La Jolla may lose its NASDAQ
listing before the closing of the merger.
141
Employees
As of September 30, 2009, La Jolla had
3 full-time employees. None of La Jollas
employees are covered by collective bargaining agreements and
management considers relations with La Jollas
employees to be good.
Legal
Proceedings
La Jolla is not currently a party to any material legal
proceedings.
Available
Information
La Jollas annual reports on
Form 10-K,
quarterly reports on
Form 10-Q,
current reports on
Form 8-K,
and amendments to those reports filed with or furnished to the
Securities and Exchange Commission pursuant to
Section 13(a) or 15(d) of the Securities Exchange Act of
1934, as amended, are available free of charge through
La Jollas website at www.ljpc.com as soon as
reasonably practicable after La Jolla electronically files
or furnishes the reports with or to the Securities and Exchange
Commission.
142
LA
JOLLAS MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of financial condition
and results of operations should be read together with the
section titled, La Jollas Selected Historical
Condensed Financial Data in this joint proxy
statement/prospectus and La Jollas financial
statements and accompanying notes appearing elsewhere in this
joint proxy statement/prospectus. The forward-looking statements
in this report involve significant risks, assumptions and
uncertainties, and a number of factors, both foreseen and
unforeseen, could cause actual results to differ materially from
La Jollas current expectations. Forward-looking
statements include those that express a plan, belief,
expectation, estimation, anticipation, intent, contingency,
future development or similar expression. The analysis of the
data from La Jollas Phase 3 ASPEN trial of Riquent
showed that the trial did not reach statistical significance
with respect to its primary endpoint, delaying time to renal
flare or for either secondary endpoint, improvement in
proteinuria or time to major SLE flare and La Jolla decided
to stop the study as well as the further development of Riquent.
Accordingly, you should not rely upon forward-looking statements
as predictions of future events. Actual results may differ
materially from those projected in the forward-looking
statements due to other risks and uncertainties that exist in
La Jollas operations and business environment,
including those set forth in the section titled, Risk
Factors Risks Related to La Jolla in this
joint proxy statement/prospectus, the other risks and
uncertainties described in the section titled, Risk
Factors in this joint proxy statement/prospectus and the
other risks and uncertainties described elsewhere in this joint
proxy statement/prospectus. All forward-looking statements
included in this joint proxy statement/prospectus are based on
information available to La Jolla as of the date hereof,
and La Jolla assumes no obligation to update any such
forward-looking statement.
Overview
Since La Jollas inception in May 1989, La Jolla
has devoted substantially all of its resources to the research
and development of technology and potential drugs to treat
antibody-mediated diseases. La Jolla has never generated
any revenue from product sales and has relied on public and
private offerings of securities, revenue from collaborative
agreements, equipment financings and interest income on invested
cash balances for its working capital.
In February 2009, La Jolla was informed by an Independent
Monitoring Board for the Riquent Phase 3 ASPEN study that the
monitoring board completed its review of the first interim
efficacy analysis of Riquent and determined that continuing the
study was futile. La Jolla subsequently unblinded the data
and found that there was no statistical difference in the
primary endpoint, delaying time to renal flare, between the
Riquent-treated group and the placebo-treated group, although
there was a significant difference in the reduction of
antibodies to double-stranded DNA.
Based on these results, La Jolla immediately discontinued
the Riquent Phase 3 ASPEN study and the further development of
Riquent. La Jolla had previously devoted substantially all
of its research, development and clinical efforts and financial
resources toward the development of Riquent. In connection with
the termination of its clinical trials for Riquent,
La Jolla subsequently initiated steps to significantly
reduce its operating costs, including a reduction in force,
which was effected in April 2009. La Jolla also ceased the
manufacture of Riquent at its former facility in San Diego,
California, as well as all regulatory activities associated with
Riquent. La Jolla recorded a charge of approximately
$1.1 million in the quarter ended March 31, 2009, of
which $0.7 million was included in research and development
and $0.4 million was included in general and administrative
expense. This amount was paid in May 2009.
In July 2009, La Jolla announced that, in light of the
current alternatives available to it, a wind down of its
business would be in the best interests of its stockholders.
Although the La Jolla Board approved a Plan of Complete
Liquidation and Dissolution (the Plan of
Dissolution) in September 2009, it was subject to approval
by holders of at least a majority in voting power of
La Jollas outstanding shares. La Jolla called a
special meeting of stockholders to vote on the Plan of
Dissolution however, the majority of its stockholders failed to
return their proxy cards or otherwise indicate their votes with
respect to this proposal.
La Jolla did not change its basis of accounting as a result
of the La Jolla Boards adoption of the Plan of
Dissolution, given that the Plan of Dissolution cannot be
implemented without stockholder approval and the majority of
La Jollas stockholders failed to return their proxy
cards or otherwise indicate their votes with respect to
143
this proposal. If La Jolla is unable to complete the merger
with Adamis, the La Jolla Board will explore what, if any,
alternatives are available for the future of La Jolla.
Going
Concern and Managements Plan
La Jollas independent registered public accounting
firm has included an explanatory paragraph in their report on
La Jollas 2008 financial statements related to the
uncertainty and substantial doubt of La Jollas
ability to continue as a going concern.
While the basis of presentation remains that of a going concern,
La Jolla has a history of recurring losses from operations
and, as of September 30, 2009, La Jolla had an
accumulated deficit of $422.7 million, available cash and
cash equivalents of $5.8 million and working capital of
$5.6 million. These factors, as well as
La Jollas current inability to generate future cash
flows, raise substantial doubt about La Jollas
ability to continue as a going concern.
La Jolla management plans to address the expected shortfall
of working capital by completing the merger with Adamis. If
La Jolla cannot complete the merger with Adamis in a timely
manner, or otherwise obtain sufficient funding in the
short-term, it may cease operations or liquidate and dissolve.
The consolidated financial statements do not include any
adjustments relating to the recoverability and classification of
recorded asset amounts and classification of liabilities that
might be necessary should La Jolla be forced to take any
such actions.
Critical
Accounting Policies and Estimates
The discussion and analysis of financial condition and results
of operations are based on La Jollas condensed
consolidated financial statements, which have been prepared in
accordance with United States generally accepted accounting
principles. The preparation of these condensed consolidated
financial statements requires La Jolla to make estimates
and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosure of
contingent assets and liabilities. La Jolla evaluates its
estimates on an ongoing basis, including those related to
stock-based compensation. La Jolla bases its estimates on
historical experience and on other assumptions that
La Jolla believes to be reasonable under the circumstances,
the results of which form the basis for making judgments about
the carrying values of assets and liabilities that are not
readily apparent from other sources. Actual results may differ
materially from these estimates under different assumptions or
conditions.
La Jolla believes the following critical accounting
policies involve significant judgments and estimates used in the
preparation of its condensed consolidated financial statements.
Revenue
Recognition
La Jolla considers a variety of factors in determining the
appropriate method of revenue recognition under collaborative
arrangements, such as whether the elements are separable,
whether there are determinable fair values and whether there is
a unique earnings process associated with each element of a
contract.
Impairment
and useful lives of long-lived assets
La Jolla regularly reviews its long-lived assets for
impairment. La Jollas long-lived assets include costs
incurred to file its patent applications. La Jolla
evaluates the recoverability of long-lived assets by measuring
the carrying amount of the assets against the estimated
undiscounted future cash flows associated with them. At the time
such evaluations indicate that the future undiscounted cash
flows of certain long-lived assets are not sufficient to recover
the carrying value of such assets, the assets are adjusted to
their fair values. The estimation of the undiscounted future
cash flows associated with long-lived assets requires judgment
and assumptions that could differ materially from the actual
results.
For the year ended December 31, 2008, as a result of the
futility determination in the Phase 3 ASPEN trial, La Jolla
recorded a non-cash charge for the impairment of long-lived
assets of $2.8 million to write down the value of its
long-lived assets to their estimated fair values. La Jolla
disposed of or wrote off all of its remaining long-lived assets
during the nine months ended September 30, 2009 for a gain
of $0.3 million.
144
Share-based
compensation
Option-pricing models were developed for use in estimating the
value of traded options that have no vesting or hedging
restrictions and are fully transferable. Because the employee
and director stock options granted by La Jolla have
characteristics that are significantly different from traded
options, and because changes in the subjective assumptions can
materially affect the estimated value, in La Jollas
opinion the existing valuation models may not provide an
accurate measure of the fair value of the employee and director
stock options granted by La Jolla. Although the fair value
of the employee and director stock options granted by
La Jolla is determined using an option-pricing model that
value may not be indicative of the fair value observed in a
willing-buyer/willing-seller market transaction.
Share-based compensation expense was approximately
$2.3 million and $3.4 million for the nine months
ended September 30, 2009 and 2008, respectively. As of
September 30, 2009, there was approximately
$0.9 million of total unrecognized compensation cost
related to non-vested share-based payment awards granted under
all equity compensation plans.
Share-based compensation expense for the years ended
December 31, 2008 and December 31, 2007 was
approximately $4.4 million and $4.8 million,
respectively. As of December 31, 2008, there was
approximately $4.9 million of total unrecognized
compensation cost related to non-vested share-based payment
awards granted under all equity compensation plans.
Total unrecognized compensation cost will be adjusted for future
changes in estimated forfeitures. La Jolla currently
expects to recognize the remaining unrecognized compensation
cost over a weighted-average period of 1.1 years.
New
Accounting Pronouncements
See Note 1 in the accompanying notes to
La Jollas consolidated financial statements beginning
on
page F-1
in this joint proxy statement/prospectus.
Results
of Operations
The
Three and Nine Month Periods Ended September 30, 2009 and
2008
Revenue. For the nine months ended
September 30, 2009, revenue increased to $8.1 million
as a result of the Development Agreement entered into with
BioMarin CF in January 2009. The Development Agreement was
terminated in March 2009 following the negative results from
La Jollas Riquent Phase 3 ASPEN study. There were no
revenues for the three months ended September 30, 2009 and
2008 or the nine months ended September 30, 2008.
Vendor Settlements. During the nine months
ended September 30, 2009, La Jolla negotiated
settlements related to accounts payable obligations and accrued
liabilities with a majority of its vendors to preserve its
remaining cash and other assets. These negotiations resulted in
a reduction of approximately $2.6 million to accounts
payable obligations and accrued liabilities from amounts
originally invoiced and accrued, which were recorded upon the
execution of the settlement agreements. As a result of these
settlements, during the nine months ended September 30,
2009, there were decreases of $2.5 million and
$0.1 million to research and development and general and
administrative expenses, respectively.
Research and Development Expense. For the
three and nine months ended September 30, 2009, research
and development expenses decreased to ($0.2) million and
$9.6 million, respectively, from $14.1 million and
$38.2 million, respectively, for the same periods in 2008
as a result of the discontinuation of the Riquent Phase 3 ASPEN
study, salary and benefits decreases due to the termination of
all research personnel and the settlement of accounts payable
obligations and accrued liabilities noted above. For the nine
months ended September 30, 2009, this decrease was
partially offset by an increase in termination expense, mainly
relating to severance, of approximately $0.7 million
recorded as of March 31, 2009, as a result of the
termination of 64 research and development personnel in April
2009. La Jolla expects no or minimal research and
development expenditures going forward as La Jolla winds
down its operations.
145
General and Administrative Expense. For the
three and nine months ended September 30, 2009, general and
administrative expenses decreased to $1.0 million and
$5.6 million, respectively, from $2.8 million and
$6.8 million for the same periods in 2008. The decreases in
general and administrative expenses are primarily the result of
decreases in consulting and legal expense for the three and nine
months ended September 30, 2009 of $1.2 million and
$0.9 million, respectively. In addition, during April 2009,
10 general and administrative personnel were terminated,
resulting in salary and benefits decreases for the three and
nine months ended September 30, 2009 of $0.7 million
and $0.6 million, respectively. The decrease in general and
administrative expense for the nine months ended
September 30, 2009 was partially offset by an increase in
termination expense recorded as of March 31, 2009 relating
to severance of approximately $0.3 million as a result of
the termination of personnel in April 2009. La Jolla
expects decreased general and administrative expenditures going
forward as La Jolla winds down its operations.
Interest and Other Income, Net. Interest and
other income, net, decreased to less than $0.1 million for
the three and nine months ended September 30, 2009, from
$0.2 million and $0.6 million, respectively, for the
same periods in 2008. These decreases are primarily due to
moving all short-term investments to non-interest bearing cash
accounts during the quarter ended March 31, 2009.
Realized Loss on Investments, Net. Realized
loss on investments, net, of $0.4 million and
$1.4 million for the three and nine months ended
September 30, 2008 primarily consisted of the
other-than-temporary
impairment loss on La Jollas auction rate securities
recorded during the nine months ended September 30, 2008.
These securities were sold to UBS at par value in January 2009
with no realized loss on investments.
Results
of Operations
Years
Ended December 31, 2008 and 2007
Research and Development
Expense. La Jollas research and
development expense increased to $51.0 million for the year
ended December 31, 2008 from $46.6 million in 2007.
The increase in research and development expenses in 2008 from
2007 resulted primarily from an increase in clinical trial
expenses of approximately $7.8 million, offset by a
decrease in Riquent-related drug production of $4.1 million.
Research and development expense of $50.8 million for the
year ended December 31, 2008 related to lupus research and
development-related expense consisting primarily of
Riquent-related clinical trial expenses and clinical drug
supply, salaries and other costs related to manufacturing,
clinical and research personnel and fees for consulting and
professional outside services.
General and Administrative
Expense. La Jollas general and
administrative expense increased to $9.7 million for the
year ended December 31, 2008 from $9.1 million in
2007. The increase in general and administrative expense in 2008
from 2007 resulted primarily from an increase in general
corporate consulting, professional outside services and salaries
and wages of approximately $1.0 million, primarily as a
result of La Jollas previous partnering efforts for
Riquent. This increase was offset by a decrease in
La Jollas miscellaneous business expenses related to
lower patent abandonments during 2008 compared to 2007 (see 2008
patent impairment discussion below) and a decrease in
depreciation as a result of more assets being fully depreciated
in 2008.
Asset Impairments. La Jolla recorded a
$2.8 million impairment charge in 2008 (none in 2007 and
$0.1 million in 2006) because La Jolla no longer
believes that the estimated undiscounted future cash flows
expected to result from the disposition of certain of
La Jollas long-lived assets were sufficient to
recover the carrying value of these assets. This impairment
charge was due to the negative results from the Riquent Phase 3
ASPEN study announced in February 2009, which was an indicator
of impairment.
Interest Income and
Expense. La Jollas interest income
decreased to $0.8 million for the year ended
December 31, 2008 from $2.7 million for 2007 due to
lower average balances of cash and short-term investments and
lower average interest rates on La Jollas investments
as compared to 2007. Interest expense was comparable for the
years ended December 31, 2008 and 2007.
Net Operating Loss and Research Tax Credit
Carryforwards. At December 31, 2008,
La Jolla had federal and California income tax net
operating loss carryforwards that are subject to Section
382/383 limitations of net operating loss and research and
development credit carryforwards. In February 2009,
La Jolla experienced a change
146
in ownership at a time when La Jollas enterprise
value was minimal. As a result of this ownership change and the
low enterprise value, La Jollas federal and
California net operating loss carryforwards and federal research
and development credit carryforwards as of December 31,
2008 will be subject to limitation under IRC
Section 382/383 and more likely than not will expire unused.
Liquidity
and Capital Resources
From inception through September 30, 2009, La Jolla
has incurred a cumulative net loss of approximately
$422.7 million and has financed its operations through
public and private offerings of securities, revenues from
collaborative agreements, equipment financings and interest
income on invested cash balances. From inception through
September 30, 2009, La Jolla has raised approximately
$410.8 million in net proceeds from sales of equity
securities.
At September 30, 2009, La Jolla had $5.8 million
in cash and cash equivalents as compared to $19.4 million
of cash, cash equivalents and short-term investments at
December 31, 2008. La Jollas working capital at
September 30, 2009 was $5.6 million, as compared to
$3.0 million at December 31, 2008. The decrease in
cash, cash equivalents and short-term investments resulted from
the use of La Jollas financial resources to fund its
clinical trial and manufacturing activities until their
termination in 2009 and for other general corporate purposes.
This decrease was partially offset by the non-refundable
commencement payment of $7.5 million received from BioMarin
CF under the Development Agreement and the proceeds of
$7.5 million from the sale of 339,104 shares of
La Jollas preferred stock to BioMarin Pharma under
the Securities Purchase Agreement in January 2009.
At September 30, 2009, all of La Jollas
contractual obligations have been either paid in full or
settlement amounts have been accrued as of September 30,
2009. La Jolla expects to pay all remaining outstanding
obligations by December 31, 2009.
On July 31, 2009, La Jollas two building leases
expired. Pursuant to the lease for one of these buildings,
La Jolla was responsible for completing modifications to
the leased building prior to lease expiration. In July 2009,
approximately $315,000 was paid in accordance with the lease
provisions. La Jolla exited the buildings upon the
expiration of the leases in July 2009.
La Jolla is now pursuing the merger with Adamis. If the
merger with Adamis is not consummated and La Jolla is
unable to complete a different strategic transaction during
2009, La Jolla will likely be unable to continue as a going
concern and may be forced to cease operations or liquidate and
dissolve.
Off-Balance
Sheet Arrangements
La Jolla has no off-balance sheet arrangements that have or
are reasonably likely to have a current or future effect on its
consolidated financial condition, changes in its consolidated
financial condition, expenses, consolidated results of
operations, liquidity, capital expenditures or capital resources.
LEGAL
MATTERS
The validity of the shares of La Jolla common stock being
offered hereby will be passed on by Goodwin Procter LLP. Goodwin
Procter LLP will also deliver an opinion as to certain federal
income tax consequences of the merger. See the section entitled
Material U.S. Federal Income Tax Consequences
for more information.
EXPERTS
The consolidated financial statements of La Jolla
Pharmaceutical Company at December 31, 2008 and 2007, and
for each of the three years in the period ended
December 31, 2008, included in this joint proxy
statement/prospectus of La Jolla Pharmaceutical Company,
which is referred to and made a part of this prospectus and
registration statement, have been audited by Ernst &
Young LLP, independent registered public accounting firm, as set
forth in their report thereon (which contains an explanatory
paragraph describing conditions that raise substantial doubt
about La Jollas ability to continue as a going
concern as described in Note 1 to the consolidated
147
financial statements) appearing elsewhere herein, and are
included in reliance upon such report given on the authority of
such firm as experts in accounting and auditing.
The consolidated financial statements of Adamis Pharmaceuticals
Corporation at March 31, 2009 and 2008, and for each of the
years in the two-year period ended March 31, 2009, included
in this joint proxy statement/prospectus, which are referred to
and made a part of this prospectus and registration statement,
have been so included in reliance on the report of Goldstein
Lewin & Co., an independent registered public
accounting firm (which contains an explanatory paragraph
describing conditions that raise substantial doubt about
Adamis ability to continue as a going concern as described
in Note 1 of the consolidated financial statements), given on
the authority of said firm as experts in auditing and accounting.
WHERE YOU
CAN FIND ADDITIONAL INFORMATION
La Jolla and Adamis file annual, quarterly, current and
special reports, proxy statements and other information with the
SEC. You may read and copy any reports, statements or other
information that La Jolla or Adamis files at the SECs
Public Reference Room at 100 F. Street, N.E.,
Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330
for further information on the Public Reference Room. In
addition, the SEC maintains an Internet site that contains
annual, quarterly, current and special reports, proxy statements
and other information regarding issuers that file electronically
with the SEC, including La Jolla and Adamis, at
http://www.sec.gov.
As of the date of this joint proxy statement/prospectus,
La Jolla has filed a registration statement on
Form S-4
to register with the SEC the La Jolla common stock that
Adamis stockholders will be entitled to receive in the merger.
This joint proxy statement/prospectus is a part of that
registration statement and constitutes a prospectus of
La Jolla, as well as a proxy statement of La Jolla and
Adamis for their respective special stockholder meetings.
La Jolla has supplied all information contained in this
joint proxy statement/prospectus relating to La Jolla, and
Adamis has supplied all information contained in this joint
proxy statement/ prospectus relating to Adamis.
If you would like to request documents from La Jolla or
Adamis, please send a request in writing or by telephone to
either La Jolla or Adamis at the following address:
|
|
|
La Jolla Pharmaceutical Company
4365 Executive Drive, Suite 300
San Diego, CA 92121
Telephone:
(858) 452-6600
Attn: Vice President of Finance
|
|
Adamis Pharmaceuticals Corporation
2658 Del Mar Heights Rd., #555
Del Mar, CA 92014
Telephone: (858) 401-3984
Attn: Chief Financial Officer
|
You should rely only on the information contained in this
joint proxy statement/prospectus to vote your shares at the
La Jolla special meeting or the Adamis special meeting.
Neither La Jolla nor Adamis has authorized anyone to
provide you with information that differs from that contained in
this joint proxy statement/prospectus. This joint proxy
statement/prospectus is dated
[ ].
You should not assume that the information contained in this
joint proxy statement/prospectus is accurate as of any date
other than that date, and neither the mailing of this joint
proxy statement/prospectus to stockholders nor the issuance of
shares of La Jolla common stock in the merger shall create
any implication to the contrary.
Information
on Websites
Information on any Adamis or La Jolla website is not part
of this joint proxy statement/prospectus and you should not rely
on that information in deciding whether to approve any of the
proposals described in this joint proxy statement/prospectus,
unless that information is also in this joint proxy
statement/prospectus.
148
INDEX TO
FINANCIAL STATEMENTS
LA JOLLA
CONSOLIDATED FINANICAL STATEMENTS
Consolidated
Financial Statements for the Years Ended December 31, 2008,
2007 and 2006
|
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|
|
|
|
|
Page
|
|
|
|
|
F-2
|
|
|
|
|
F-3
|
|
|
|
|
F-4
|
|
|
|
|
F-5
|
|
|
|
|
F-6
|
|
|
|
|
F-7
|
|
Consolidated
Financial Statements for the Three and Nine Months Ended
September 30, 2009 and 2008 (unaudited)
ADAMIS
CONSOLIDATED FINANCIAL STATEMENTS
Consolidated
Financial Statements for the Years Ended March 31, 2009 and
2008
|
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|
|
|
|
Page
|
|
|
|
|
F-36
|
|
|
|
|
F-37
|
|
|
|
|
F-38
|
|
|
|
|
F-39
|
|
|
|
|
F-40
|
|
|
|
|
F-42
|
|
Consolidated
Financial Statements for the Three and Six Months Ended
September 30, 2009
and 2008 (unaudited)
F-1
Report of
Independent Registered Public Accounting Firm
The Board of Directors and Stockholders of La Jolla
Pharmaceutical Company
We have audited the accompanying consolidated balance sheets of
La Jolla Pharmaceutical Company as of December 31,
2008 and 2007, and the related consolidated statements of
operations, stockholders equity, and cash flows for each
of the three years in the period ended December 31, 2008.
These financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion. In our opinion, the financial
statements referred to above present fairly, in all material
respects, the consolidated financial position of La Jolla
Pharmaceutical Company at December 31, 2008 and 2007, and
the consolidated results of its operations and its cash flows
for each of the three years in the period ended
December 31, 2008, in conformity with U.S. generally
accepted accounting principles.
The accompanying financial statements have been prepared
assuming that La Jolla Pharmaceutical Company will continue
as a going concern. As more fully described in Note 1,
La Jolla Pharmaceutical Company has incurred recurring
operating losses, an accumulated deficit of $415.7 million
and working capital of $3.0 million at December 31,
2008. These conditions, among others, as discussed in
Note 1 to the consolidated financial statements, raise
substantial doubt about La Jolla Pharmaceutical
Companys ability to continue as a going concern.
Managements plans in regard to these matters also are
described in Note 1. The 2008 consolidated financial
statements do not include any adjustments to reflect the
possible future effects on the recoverability and classification
of assets or the amounts and classifications of liabilities that
may result from the outcome of this uncertainty.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States),
La Jolla Pharmaceutical Companys internal control
over financial reporting as of December 31, 2008, based on
criteria established in Internal Control Integrated
Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission and our report dated March 27, 2009
expressed an unqualified opinion thereon.
San Diego, California
March 27, 2009
F-2
La Jolla
Pharmaceutical Company
Consolidated
Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
(In thousands, except share and par value amounts)
|
|
|
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
9,447
|
|
|
$
|
4,373
|
|
|
|
|
|
Short-term investments,
available-for-sale
|
|
|
10,000
|
|
|
|
34,986
|
|
|
|
|
|
Prepaids and other current assets
|
|
|
785
|
|
|
|
1,018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
20,232
|
|
|
|
40,377
|
|
|
|
|
|
Property and equipment, net
|
|
|
357
|
|
|
|
1,271
|
|
|
|
|
|
Patent costs and other assets, net
|
|
|
250
|
|
|
|
2,757
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
20,839
|
|
|
$
|
44,405
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
4,626
|
|
|
$
|
2,203
|
|
|
|
|
|
Accrued clinical/regulatory expenses
|
|
|
3,957
|
|
|
|
6,282
|
|
|
|
|
|
Accrued expenses
|
|
|
1,008
|
|
|
|
664
|
|
|
|
|
|
Accrued payroll and related expenses
|
|
|
1,549
|
|
|
|
1,199
|
|
|
|
|
|
Credit facility
|
|
|
5,933
|
|
|
|
|
|
|
|
|
|
Current portion of obligations under notes payable
|
|
|
152
|
|
|
|
138
|
|
|
|
|
|
Current portion of obligations under capital leases
|
|
|
11
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
17,236
|
|
|
|
10,496
|
|
|
|
|
|
Non-current portion of obligations under notes payable
|
|
|
179
|
|
|
|
344
|
|
|
|
|
|
Non-current portion of obligations under capital leases
|
|
|
34
|
|
|
|
44
|
|
|
|
|
|
Commitments
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.01 par value; 8,000,000 shares
authorized, no shares issued or outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, $0.01 par value; 225,000,000 shares
authorized, 55,549,528 and 39,629,660 shares issued and
outstanding at December 31, 2008 and 2007, respectively
|
|
|
555
|
|
|
|
396
|
|
|
|
|
|
Additional paid-in capital
|
|
|
418,522
|
|
|
|
385,944
|
|
|
|
|
|
Other comprehensive income
|
|
|
|
|
|
|
14
|
|
|
|
|
|
Accumulated deficit
|
|
|
(415,687
|
)
|
|
|
(352,833
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
3,390
|
|
|
|
33,521
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
20,839
|
|
|
$
|
44,405
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-3
La Jolla
Pharmaceutical Company
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
(In thousands, except per share amounts)
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
51,025
|
|
|
$
|
46,635
|
|
|
$
|
32,834
|
|
General and administrative
|
|
|
9,702
|
|
|
|
9,058
|
|
|
|
9,287
|
|
Asset impairments
|
|
|
2,810
|
|
|
|
|
|
|
|
104
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses
|
|
|
63,537
|
|
|
|
55,693
|
|
|
|
42,225
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(63,537
|
)
|
|
|
(55,693
|
)
|
|
|
(42,225
|
)
|
Interest expense
|
|
|
(96
|
)
|
|
|
(82
|
)
|
|
|
(46
|
)
|
Interest income
|
|
|
779
|
|
|
|
2,699
|
|
|
|
2,826
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(62,854
|
)
|
|
$
|
(53,076
|
)
|
|
$
|
(39,445
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(1.26
|
)
|
|
$
|
(1.40
|
)
|
|
$
|
(1.21
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
|
49,689
|
|
|
|
37,818
|
|
|
|
32,588
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-4
La Jolla
Pharmaceutical Company
Consolidated
Statements of Stockholders Equity
For the
Years Ended December 31, 2006, 2007 and 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Other
|
|
|
|
|
|
Total
|
|
|
|
Common Stock
|
|
|
Paid-in
|
|
|
Comprehensive
|
|
|
Accumulated
|
|
|
Stockholders
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Income (Loss)
|
|
|
Deficit
|
|
|
Equity
|
|
|
|
(In thousands)
|
|
|
Balance at December 31, 2005
|
|
|
32,533
|
|
|
$
|
325
|
|
|
$
|
337,117
|
|
|
$
|
|
|
|
$
|
(260,312
|
)
|
|
$
|
77,130
|
|
Issuance of common stock under Employee Stock Purchase Plan
|
|
|
80
|
|
|
|
1
|
|
|
|
226
|
|
|
|
|
|
|
|
|
|
|
|
227
|
|
Exercise of stock options
|
|
|
56
|
|
|
|
1
|
|
|
|
125
|
|
|
|
|
|
|
|
|
|
|
|
126
|
|
Share-based compensation expense
|
|
|
24
|
|
|
|
|
|
|
|
5,051
|
|
|
|
|
|
|
|
|
|
|
|
5,051
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(39,445
|
)
|
|
|
(39,445
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
32,693
|
|
|
|
327
|
|
|
|
342,519
|
|
|
|
|
|
|
|
(299,757
|
)
|
|
|
43,089
|
|
Issuance of common stock, net
|
|
|
6,670
|
|
|
|
67
|
|
|
|
37,845
|
|
|
|
|
|
|
|
|
|
|
|
37,912
|
|
Issuance of common stock under Employee Stock Purchase Plan
|
|
|
97
|
|
|
|
1
|
|
|
|
260
|
|
|
|
|
|
|
|
|
|
|
|
261
|
|
Exercise of stock options
|
|
|
166
|
|
|
|
1
|
|
|
|
499
|
|
|
|
|
|
|
|
|
|
|
|
500
|
|
Share-based compensation expense
|
|
|
4
|
|
|
|
|
|
|
|
4,821
|
|
|
|
|
|
|
|
|
|
|
|
4,821
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(53,076
|
)
|
|
|
(53,076
|
)
|
Net unrealized gains on
available-for-sale
securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
|
|
|
|
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(53,062
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
|
39,630
|
|
|
|
396
|
|
|
|
385,944
|
|
|
|
14
|
|
|
|
(352,833
|
)
|
|
|
33,521
|
|
Issuance of common stock, net
|
|
|
15,615
|
|
|
|
156
|
|
|
|
27,877
|
|
|
|
|
|
|
|
|
|
|
|
28,033
|
|
Issuance of common stock under Employee Stock Purchase Plan
|
|
|
304
|
|
|
|
3
|
|
|
|
287
|
|
|
|
|
|
|
|
|
|
|
|
290
|
|
Exercise of stock options
|
|
|
1
|
|
|
|
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
Share-based compensation expense
|
|
|
|
|
|
|
|
|
|
|
4,411
|
|
|
|
|
|
|
|
|
|
|
|
4,411
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(62,854
|
)
|
|
|
(62,854
|
)
|
Net unrealized losses on
available-for-sale
securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14
|
)
|
|
|
|
|
|
|
(14
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(62,868
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008
|
|
|
55,550
|
|
|
$
|
555
|
|
|
$
|
418,522
|
|
|
$
|
|
|
|
$
|
(415,687
|
)
|
|
$
|
3,390
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-5
La Jolla
Pharmaceutical Company
Consolidated
Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(62,854
|
)
|
|
$
|
(53,076
|
)
|
|
$
|
(39,445
|
)
|
Adjustments to reconcile net loss to net cash used for operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
990
|
|
|
|
1,687
|
|
|
|
1,987
|
|
Loss on write-off/disposal of patents, property and equipment
and licenses
|
|
|
243
|
|
|
|
934
|
|
|
|
316
|
|
Loss on impairment of patents, property and equipment and
licenses
|
|
|
2,810
|
|
|
|
|
|
|
|
104
|
|
Share-based compensation expense
|
|
|
4,411
|
|
|
|
4,821
|
|
|
|
5,051
|
|
Amortization (accretion) of investment premium/discount
|
|
|
240
|
|
|
|
(227
|
)
|
|
|
36
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaids and other current assets
|
|
|
233
|
|
|
|
(14
|
)
|
|
|
(101
|
)
|
Accounts payable
|
|
|
2,423
|
|
|
|
78
|
|
|
|
1,259
|
|
Accrued clinical/regulatory expenses
|
|
|
(2,325
|
)
|
|
|
4,752
|
|
|
|
1,303
|
|
Accrued expenses
|
|
|
344
|
|
|
|
(473
|
)
|
|
|
(147
|
)
|
Accrued payroll and related expenses
|
|
|
350
|
|
|
|
(66
|
)
|
|
|
487
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used for operating activities
|
|
|
(53,135
|
)
|
|
|
(41,584
|
)
|
|
|
(29,150
|
)
|
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of short-term investments
|
|
|
|
|
|
|
(51,415
|
)
|
|
|
(16,700
|
)
|
Sales of short-term investments
|
|
|
24,665
|
|
|
|
55,750
|
|
|
|
44,050
|
|
Additions to property and equipment
|
|
|
(506
|
)
|
|
|
(354
|
)
|
|
|
(335
|
)
|
Increase in patent costs and other assets
|
|
|
(116
|
)
|
|
|
(628
|
)
|
|
|
(536
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
|
24,043
|
|
|
|
3,353
|
|
|
|
26,479
|
|
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of common stock
|
|
|
28,326
|
|
|
|
38,673
|
|
|
|
353
|
|
Proceeds from credit facility
|
|
|
6,000
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of notes payable
|
|
|
|
|
|
|
312
|
|
|
|
263
|
|
Payments on obligations under notes payable
|
|
|
(151
|
)
|
|
|
(209
|
)
|
|
|
(527
|
)
|
Payments on obligations under capital leases
|
|
|
(9
|
)
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
34,166
|
|
|
|
38,775
|
|
|
|
89
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
|
|
5,074
|
|
|
|
544
|
|
|
|
(2,582
|
)
|
Cash and cash equivalents at beginning of period
|
|
|
4,373
|
|
|
|
3,829
|
|
|
|
6,411
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
9,447
|
|
|
$
|
4,373
|
|
|
$
|
3,829
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$
|
96
|
|
|
$
|
82
|
|
|
$
|
46
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of noncash investing and financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligations incurred for property and equipment
|
|
$
|
|
|
|
$
|
55
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-6
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial Statements
|
|
1.
|
Organization
and Summary of Significant Accounting Policies
|
Organization
and Business Activity
La Jolla Pharmaceutical Company (the Company)
is a biopharmaceutical company dedicated to improving and
preserving human life by developing innovative pharmaceutical
products.
Basis
of Presentation
In February 2009, the Company announced that an Independent
Monitoring Board for the Riquent Phase 3 ASPEN study had
completed the review of their first interim efficacy analysis
and determined that continuing the study was futile. Based on
these results, the Company immediately discontinued the Riquent
Phase 3 ASPEN study and the development of Riquent. The Company
had previously devoted substantially all of its research,
development and clinical efforts and financial resources toward
the development of Riquent. In connection with the termination
of the clinical trials for Riquent, the Company subsequently
initiated steps to significantly reduce its operating costs
including a planned substantial reduction in personnel, which is
expected to be effected early in the second quarter of 2009. The
Company has also ceased the manufacture of Riquent. In addition,
the Company has incurred a net loss of $62.9 million in
2008, has had cumulative net losses of $415.7 million from
inception to date and has limited financial resources at
December 31, 2008.
These events raise substantial doubt about the Companys
ability to continue as a going concern. The accompanying
consolidated financial statements have been prepared assuming
that the Company will continue as a going concern. This basis of
accounting contemplates the recovery of the Companys
assets and the satisfaction of liabilities in the normal course
of business and this does not include any adjustments to reflect
the possible future effects on the recoverability and
classification of assets or the amounts and classification of
liabilities that might be necessary should the Company be unable
to continue as a going concern.
In light of the Companys decision to discontinue
development of the Riquent clinical program, the Company is
seeking to maximize the value of its remaining assets. The
Company is currently evaluating its strategic alternatives,
which include the following:
|
|
|
|
|
Sell or out-license the Companys remaining assets,
including the Companys SSAO compounds;
|
|
|
|
Pursue potential other strategic transactions, which could
include mergers, license agreements or other collaborations,
with third parties; or
|
|
|
|
Implement an orderly wind down of the Company if other
alternatives are not deemed viable and in the best interests of
the Company.
|
Principles
of Consolidation
The accompanying consolidated financial statements include the
accounts of the Company and its wholly-owned subsidiary,
La Jolla Limited, which was incorporated in England in
October 2004. There have been no significant transactions
related to La Jolla Limited since its inception.
Use of
Estimates
The preparation of consolidated financial statements in
conformity with United States generally accepted accounting
principles (GAAP) requires management to make
estimates and assumptions that affect the amounts reported in
the consolidated financial statements and disclosures made in
the accompanying notes to the consolidated financial statements.
Actual results could differ materially from those estimates.
F-7
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
Cash,
Cash Equivalents and Short-Term Investments
Cash and cash equivalents consist of cash and short-term, highly
liquid investments which include money market funds and debt
securities with maturities from purchase date of three months or
less and are stated at estimated fair value. Short-term
investments mainly consist of debt securities with maturities
from purchase date of greater than three months. In accordance
with Statement of Financial Accounting Standard
(SFAS) No. 115, Accounting for
Certain Investments in Debt and Equity Securities,
management has classified the Companys cash
equivalents and short-term investments as
available-for-sale
securities in the accompanying consolidated financial
statements.
Available-for-sale
securities are recorded at estimated fair value, with unrealized
gains and losses reported in other comprehensive income (loss).
Realized gains and losses and declines in value judged to be
other-than-temporary
on
available-for-sale
securities are included in interest income. The cost of
securities sold is based on the specific identification method.
Interest and dividends on securities classified as
available-for-sale
are included in interest income.
Concentration
of Risk
Cash, cash equivalents and short-term investments are financial
instruments which potentially subject the Company to
concentrations of credit risk. The Company deposits its cash in
financial institutions. At times, such deposits may be in excess
of insured limits. The Company invests its excess cash primarily
in government-asset-backed securities, and money market funds
invested in U.S. Treasury bills. The Company has
established guidelines relative to the diversification of its
cash investments and their maturities in an effort to maintain
safety and liquidity. These guidelines are periodically reviewed
and modified to take advantage of trends in yields and interest
rates. As of December 31, 2008, there was insufficient
demand at auctions for the Companys student loan auction
rate securities, representing a par value of approximately
$10,000,000. During January 2009, the Company sold all of these
auction rate securities to its broker-dealer at par value of
$10,000,000 (see Notes 2 and 10).
Impairment
of Long-Lived Assets and Assets to Be Disposed Of
In accordance with SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, if indicators
of impairment exist, the Company assesses the recoverability of
the affected long-lived assets by determining whether the
carrying value of such assets can be recovered through the
undiscounted future operating cash flows. If impairment is
indicated, the Company measures the amount of such impairment by
comparing the carrying value of the asset to the fair value of
the asset and records the impairment as a reduction in the
carrying value of the related asset and a charge to operating
results. Estimating the undiscounted future cash flows
associated with long-lived assets requires judgment and
assumptions that could differ materially from the actual results.
As a result of the futility determination in the Phase 3 ASPEN
trial, the Company discontinued the Riquent Phase 3 ASPEN study
and the development of Riquent. Based on these events, the
future cash flows from the Companys Riquent-related
patents are no longer expected to exceed their carrying values
and the assets became impaired. This rendered substantially all
of the Companys laboratory equipment, as well as a large
portion of its furniture and fixtures and computer equipment and
software impaired.
The Company performed a recoverability test of its long-lived
assets in accordance with SFAS No. 144. The
recoverability test was based on the estimated undiscounted
future cash flows expected to result from the Companys
long-lived assets. Based on the recoverability analysis
performed, management does not believe that the estimated
undiscounted future cash flows expected to result from the
disposition of certain of the Companys long-lived assets
are sufficient to recover the carrying value of these assets.
Accordingly, the Company recorded a non-cash charge for the
impairment of long-lived assets of $2,810,000 for the year ended
December 31, 2008 to write down the value of the
Companys long-lived assets to their estimated fair values.
Impairment charges included $2,061,000 for patents, $724,000 for
property and equipment, and $25,000 for licenses. The Company
recognized $0 and $104,000 in impairment losses for the years
ended December 31, 2007 and 2006, respectively.
F-8
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
Property
and Equipment
Property and equipment is stated at cost and depreciated using
the straight-line method over the estimated useful lives of the
assets (primarily five years). Leasehold improvements and
equipment under capital leases are stated at cost and
depreciated on a straight-line basis over the shorter of the
estimated useful life or the lease term. Property and equipment
is comprised of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Laboratory equipment
|
|
$
|
6,171
|
|
|
$
|
6,498
|
|
Computer equipment and software
|
|
|
4,654
|
|
|
|
4,727
|
|
Furniture and fixtures
|
|
|
477
|
|
|
|
491
|
|
Leasehold improvements
|
|
|
3,275
|
|
|
|
3,273
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,577
|
|
|
|
14,989
|
|
Less: Accumulated depreciation
|
|
|
(14,220
|
)
|
|
|
(13,718
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
357
|
|
|
$
|
1,271
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense for the years ended December 31, 2008,
2007 and 2006 was $737,000, $1,471,000, and $1,840,000,
respectively. Impairment charges of $724,000 during 2008 were
reflected as a reduction to the above noted costs.
Patents
The Company has filed numerous patent applications with the
United States Patent and Trademark Office and in foreign
countries. Legal costs and expenses incurred in connection with
pending patent applications have been capitalized. Costs related
to issued patents are amortized using the straight-line method
over the lesser of the remaining useful life of the related
technology or the remaining patent life, commencing on the date
the patent is issued. Total issued patent application costs (net
of 2008 impairment charges) and accumulated amortization were
$1,159,000 and $1,116,000 at December 31, 2008 and
$2,492,000 and $911,000 at December 31, 2007, respectively.
Total pending patent application costs (less 2008 impairment
charges) were $207,000 and $1,004,000 at December 31, 2008
and 2007, respectively. Capitalized costs related to patent
applications are charged to operations at the time a
determination is made not to pursue such applications or they
become impaired. Amortization expense for the years ended
December 31, 2008, 2007 and 2006 was $245,000, $207,000,
and $139,000, respectively.
Accrued
Clinical/Regulatory Expenses
The Company reviews and accrues clinical trial and
regulatory-related expenses based on work performed, which
relies on estimates of total costs incurred based on patient
enrollment, completion of studies and other events. The Company
follows this method since reasonably dependable estimates of the
costs applicable to various stages of a clinical trial can be
made. Accrued clinical/regulatory costs are subject to revisions
as trials progress to completion. Revisions are charged to
expense in the period in which the facts that give rise to the
revision become known. Historically, revisions have not resulted
in material changes to research and development costs.
Share-Based
Compensation
On January 1, 2006, the Company adopted
SFAS No. 123R, Share-Based Payment
(SFAS 123R), which is a revision of
SFAS No. 123, Accounting and Disclosure of
Stock-Based Compensation (SFAS 123).
SFAS 123R requires the measurement and recognition of
compensation expense for all share-based payment awards made to
employees and directors, including stock options, restricted
stock and purchases under the La Jolla Pharmaceutical
Company 1995 Employee Stock Purchase Plan (the
ESPP), based on estimated fair values.
SFAS 123R
F-9
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
supersedes the Companys previous accounting under
Accounting Principles Board Opinion (APB)
No. 25, Accounting for Stock Issued to Employees
(APB 25), and SFAS 123, for periods
beginning in fiscal 2006. In March 2005, the Securities and
Exchange Commission (SEC) issued Staff
Accounting Bulletin (SAB) No. 107
(SAB 107), which discusses the
interaction between SFAS 123R and certain SEC rules and
regulations and provides the SECs staff views regarding
the valuation of share-based payment arrangements for public
companies.
The Company has applied the provisions of SAB 107, related
to the calculation of its expected term, in its adoption of
SFAS 123R and for the period permitted by SAB 107.
Share-based compensation expense recognized under SFAS 123R
for the years ended December 31, 2008, 2007 and 2006,
respectively was approximately $4,422,000, $4,810,000 and
$5,048,000. As of December 31, 2008, there was
approximately $4,940,000 of total unrecognized compensation cost
related to non-vested share-based payment awards granted under
all equity compensation plans. As share-based compensation
expense recognized in the Consolidated Statement of Operations
for the fiscal years 2008, 2007 and 2006 is based on awards
ultimately expected to vest, share-based compensation expense
has been reduced for estimated forfeitures. SFAS 123R
requires forfeitures to be estimated at the time of grant and
revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. Total unrecognized
compensation cost will be adjusted for future changes in
estimated forfeitures. The Company expects to recognize that
cost over a weighted-average period of 1.2 years.
Compensation expense for options or stock awards issued to
non-employees, other than non-employee directors, has been
determined in accordance with Emerging Issues Task Force
96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services. Deferred charges for options granted to
such non-employees are periodically remeasured as the options
vest. In December 2008, the Company granted non-qualified stock
options to purchase a total of 15,000 shares of common
stock to a consultant at an exercise price equal to the fair
market value of the stock at the date of the grant. The Company
recognized compensation expense for these stock option grants of
approximately $1,000 for the year ended December 31, 2008.
In September and October 2007, the Company granted non-qualified
stock options to purchase a total of 12,000 shares of
common stock to consultants at an exercise price equal to the
fair market value of the stock at the date of each grant. For
the years ended December 31, 2008 and 2007, the Company
recognized compensation (credit) expense for these stock option
grants of approximately ($11,000) and $11,000, respectively. In
January 2006, the Company granted a non-qualified stock option
to purchase 1,000 shares of common stock to a consultant at
an exercise price equal to the fair market value of the stock at
the date of the grant. The Company recognized compensation
expense for these stock option grants of approximately $3,000
for the year ended December 31, 2006.
As permitted by SFAS 123R, the Company utilizes the
Black-Scholes option-pricing model as its method of valuation
for stock options and purchases under the ESPP. The
Black-Scholes model was previously utilized for the
Companys pro forma information required under
SFAS 123. The Companys determination of the fair
value of share-based payment awards on the date of grant using
an option-pricing model is affected by the Companys stock
price as well as assumptions regarding a number of highly
complex and subjective variables. These variables include, but
are not limited to, the Companys expected stock price
volatility over the term of the awards and actual and projected
employee stock option exercise behaviors.
F-10
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
Valuation
and Expense Information Under SFAS 123R and APB
25
The following table summarizes share-based compensation expense
(in thousands) related to employee and director stock options,
restricted stock and ESPP purchases under SFAS 123R for the
years ended December 31, 2008, 2007 and 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
Research and development
|
|
$
|
1,961
|
|
|
$
|
1,907
|
|
|
$
|
1,833
|
|
General and administrative
|
|
|
2,461
|
|
|
|
2,903
|
|
|
|
3,215
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense included in operating expenses
|
|
$
|
4,422
|
|
|
$
|
4,810
|
|
|
$
|
5,048
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, 2008, 2007, and 2006, the
Company estimated the fair value of each option grant and ESPP
purchase right on the date of grant using the Black-Scholes
option-pricing model with the following weighted-average
assumptions:
Options:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
Risk-free interest rate
|
|
|
3.2
|
%
|
|
|
4.7
|
%
|
|
|
4.8
|
%
|
Dividend yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Volatility
|
|
|
115.1
|
%
|
|
|
118.0
|
%
|
|
|
113.7
|
%
|
Expected life (years)
|
|
|
5.6
|
|
|
|
6.0
|
|
|
|
5.9
|
|
ESPP:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
Risk-free interest rate
|
|
|
1.1
|
%
|
|
|
4.5
|
%
|
|
|
4.8
|
%
|
Dividend yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Volatility
|
|
|
99.6
|
%
|
|
|
67.8
|
%
|
|
|
46.4
|
%
|
Expected life (years)
|
|
|
3 months
|
|
|
|
3 months
|
|
|
|
3 months
|
|
The weighted-average fair values of options granted were $1.70,
$3.71 and $3.92 for the years ended December 31, 2008, 2007
and 2006, respectively. The weighted-average purchase prices of
shares purchased through the ESPP were $0.95, $2.69 and $2.98
for the years ended December 31, 2008, 2007 and 2006,
respectively.
The risk-free interest rate assumption is based on observed
interest rates appropriate for the term of the Companys
employee and director stock options and ESPP purchases. The
dividend yield assumption is based on the Companys history
and expectation of dividend payouts. The Company has never paid
dividends on its common stock and the Company does not
anticipate paying dividends in the foreseeable future.
The Company used historical stock price volatility as the
expected volatility assumption required in the Black-Scholes
option-pricing model consistent with SFAS 123R. The
selection of the historical volatility approach was based on the
availability of historical stock prices for the duration of the
awards expected term and the Companys assessment
that historical volatility is more representative of future
stock price trends than other available methods.
The expected life of employee and director stock options
represents the weighted-average period the stock options are
expected to remain outstanding. Under SAB 107, the
simplified method is an acceptable method of calculating the
expected life of options granted through December 31, 2007.
However, for options granted after December 31, 2007,
companies are expected to use more detailed information about
employee exercise behavior, if
F-11
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
available, to calculate the expected life of options under
SAB 107 rather than the simplified method. For option
grants made during 2008, the Company calculated the expected
life using historical option exercise data. Under this method of
calculating the expected life of option grants, the expected
life for option grants made during the year ended
December 31, 2008 was 5.6 years for the new and
existing employee grants and the director grants. Under the
SAB 107 simplified method, the expected life calculated by
the Company for option grants made during the year ended
December 31, 2007 was 6.0 6.1 years for
the new and existing employee grants and 5.5 years for the
director grants. The expected life calculated by the Company for
option grants made during the year ended December 31, 2006
was 5.8 years for the new and existing employee grants,
6.1 years for the new officer grants, and 5.3
6.0 years for the director grants. The expected life for
ESPP purchase rights represents the length of each purchase
period. Because employees purchase stock quarterly, the expected
term for ESPP purchase rights is three months for shares
purchased during the years ended December 31, 2008, 2007
and 2006.
Because share-based compensation expense recognized in the
Consolidated Statement of Operations for fiscal years 2008, 2007
and 2006 is based on awards ultimately expected to vest, it has
been reduced for estimated forfeitures. SFAS 123R requires
forfeitures to be estimated at the time of grant and revised, if
necessary, in subsequent periods if actual forfeitures differ
from those estimates. Forfeitures were estimated based on
historical experience.
Restricted
Stock
On December 14, 2005, the Company issued 83,518 shares
of restricted stock to certain members of management in exchange
for services provided over the vesting period, pursuant to
certain retention agreements dated October 6, 2005. The
shares of restricted stock fully vested (i.e., the restrictions
lapsed) one year from the date of grant and were subject to
repurchase by the Company until the one-year anniversary of the
date of issuance. Pursuant to a separation agreement dated
March 17, 2006, the Companys repurchase right with
respect to 29,120 shares of restricted stock granted to the
former Chairman and Chief Executive Officer immediately lapsed
upon his resignation on March 14, 2006. As such and in
accordance with his retention agreement, the Company accelerated
the vesting of these shares of restricted stock. In addition,
the remaining 54,398 shares of restricted stock fully
vested on December 14, 2006, the one-year anniversary of
the date of issuance, and therefore the Companys
repurchase right with respect to these shares of restricted
stock has lapsed.
On March 15, 2006, the Company issued 20,000 shares of
restricted stock to the new Chairman of the Board in exchange
for services provided over the vesting period. The shares of
restricted stock vested with respect to 10,000 shares six
months after the issuance date and with respect to the remaining
10,000 shares upon the first anniversary of the issuance
date. On September 15, 2006 and March 15, 2007, the
vesting provisions with respect to the 20,000 shares of
restricted stock were met and therefore the Companys
repurchase rights lapsed. In both December 2006 and March 2007,
the Company issued an additional 3,600 shares of restricted
stock to the Chairman of the Board in accordance with the
Chairman Compensation Policy approved by the Board of Directors
on March 14, 2006 regarding the tax liability associated
with the restricted stock issued on March 15, 2006 and
vested on September 15, 2006 and March 15, 2007. All
of these additional shares of restricted stock immediately
vested on the date of issuance.
There was no restricted stock issued in 2008.
In accordance with SFAS 123R, the Company recognized
approximately $36,000, and $381,000, respectively, in
compensation expense for the restricted stock grants noted above
for the years ended December 31, 2007, and 2006, which
includes compensation expense for the acceleration of vesting.
There was no compensation expense related to restricted stock
grants during the year ended December 31, 2008.
F-12
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
Net
Loss Per Share
Basic and diluted net loss per share is computed using the
weighted-average number of common shares outstanding during the
periods in accordance with SFAS No. 128, Earnings
per Share and SAB No. 98. Basic earnings per share
(EPS) is calculated by dividing the net
income or loss by the weighted-average number of common shares
outstanding for the period, without consideration for common
share equivalents. Diluted EPS is computed by dividing the net
income or loss by the weighted-average number of common share
equivalents outstanding for the period determined using the
treasury-stock method. For purposes of this calculation, stock
options, common stock subject to repurchase by the Company, and
warrants are considered to be common stock equivalents and are
only included in the calculation of diluted earnings per share
when their effect is dilutive.
Because the Company has incurred a net loss for all three years
presented in the Consolidated Statements of Operations, stock
options, common stock subject to repurchase and warrants are not
included in the computation of net loss per share because their
effect is anti-dilutive. The shares used to compute basic and
diluted net loss per share represent the weighted-average common
shares outstanding, reduced by the weighted-average unvested
common shares subject to repurchase. There were no unvested
common shares subject to repurchase for the years ended
December 31, 2008 and 2007. The number of weighted-average
unvested common shares subject to repurchase for the year ended
December 31, 2006 was 8,000.
Comprehensive
Loss
In accordance with SFAS No. 130, Reporting
Comprehensive Income (Loss), unrealized gains and losses on
available-for-sale
securities are included in other comprehensive income.
Recently
Issued Accounting Standards
On January 1, 2008, the Company adopted the provisions of
Financial Accounting Standards Board (FASB)
SFAS No. 157, Fair Value Measurements
(SFAS 157). SFAS 157
establishes a framework for measuring fair value and expands
disclosures about fair value measurements. The changes to
current practice resulting from the application of SFAS 157
relate to the definition of fair value, the methods used to
measure fair value, and the expanded disclosures about fair
value measurements. See Note 3 for further details on the
impact of the adoption of SFAS 157 on the Companys
consolidated results of operations and financial condition for
the year ended December 31, 2008.
On January 1, 2008, the Company adopted the provisions of
FASB SFAS No. 159, The Fair Value Option for
Financial Assets and Financial Liabilities Including
an amendment of FASB Statement No. 115
(SFAS 159). SFAS 159 permits
entities to choose to measure many financial assets and
financial liabilities at fair value. Unrealized gains and losses
on items for which the fair value option has been elected are
reported in earnings. At this time, the Company has not elected
to account for any of its financial assets or liabilities using
the provisions of SFAS 159. As such, the adoption of
SFAS 159 did not have an impact on the Companys
consolidated results of operations and financial condition for
the year ended December 31, 2008.
In June 2007, FASB ratified the consensus reached by the
Emerging Issues Task Force (EITF) on EITF
Issue
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development
Activities
(EITF 07-3).
EITF 07-3
addresses the diversity that exists with respect to the
accounting for the non-refundable portion of a payment made by a
research and development entity for future research and
development activities. Under
EITF 07-3,
an entity would defer and capitalize non-refundable advance
payments made for research and development activities until the
related goods are delivered or the related services are
performed.
EITF 07-3
is effective for fiscal years beginning after December 15,
2007. On January 1, 2008 the Company adopted the provisions
of
EITF 07-3,
which did not have an impact on the Companys consolidated
results of operations and financial condition for the year ended
December 31, 2008.
F-13
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
In May 2008, the FASB issued SFAS No. 162, The
Hierarchy of Generally Accepted Accounting Principles
(SFAS 162). SFAS 162 identifies
the sources of accounting principles and the framework for
selecting the principles used in the preparation of financial
statements that are presented in conformity with generally
accepted accounting principles. SFAS 162 becomes effective
60 days following the SECs approval of the Public
Company Accounting Oversight Board amendments to Statement on
Auditing Standards No. 69, The Meaning of Present Fairly
in Conformity With Generally Accepted Accounting Principles,
for periods completed after January 1, 2009. The Company
does not expect the adoption of SFAS 162 to have a material
effect on the Companys consolidated financial statements.
|
|
2.
|
Cash
Equivalents and Short-term Investments
|
The following is a summary of the Companys
available-for-sale
securities (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Realized
|
|
|
Realized
|
|
|
Estimated Fair
|
|
|
|
Cost
|
|
|
Gains
|
|
|
Losses
|
|
|
Gains
|
|
|
Losses
|
|
|
Value
|
|
|
December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market accounts
|
|
$
|
2,686
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
2,686
|
|
Asset-backed auction rate securities
|
|
|
10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,270
|
)
|
|
|
7,730
|
|
Auction security rights
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,270
|
|
|
|
|
|
|
|
2,270
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
12,686
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
2,270
|
|
|
$
|
(2,270
|
)
|
|
$
|
12,686
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Realized
|
|
|
Realized
|
|
|
Estimated Fair
|
|
|
|
Cost
|
|
|
Gains
|
|
|
Losses
|
|
|
Gains
|
|
|
Losses
|
|
|
Value
|
|
|
December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market accounts
|
|
$
|
2,051
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
2,051
|
|
Obligations of United States government agencies
|
|
|
6,916
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,930
|
|
Asset-backed auction rate securities
|
|
|
28,056
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28,056
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
37,023
|
|
|
$
|
14
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
37,037
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The amortized cost of debt securities is adjusted for
amortization of premiums and accretion of discounts to maturity.
Included in cash and cash equivalents at December 31, 2008
and 2007 were $2,686,000 and $2,051,000, respectively, of
securities classified as
available-for-sale
as the Company expects to sell them in order to support its
current operations regardless of their maturity date. As of
December 31, 2008,
available-for-sale
securities and cash equivalents of $2,686,000 mature in one year
or less and $10,000,000 are due after one year. Securities that
have a maturity date greater than one year have their interest
rate reset periodically within time periods not exceeding
92 days.
As of December 31, 2008, the Companys cash, cash
equivalents and short-term investments total $19,447,000. The
Companys investment securities consist of money market
funds invested in U.S. Treasury bills and student loan
auction rate securities. There has been insufficient demand at
auction for all four of the Companys auction rate
securities during 2008. As a result, these securities are
currently not liquid. In the event the Company needs to access
the funds that are in an illiquid state, it will not be able to
do so without a loss of principal until a future auction on
these auction rate securities is successful, the securities are
settled at par by the broker-dealer or they are redeemed by the
issuer. The Company may incur a loss of principal if the Company
is required to sell or borrow against these securities in a
privately negotiated transaction. As a result, the Company has
recorded a
F-14
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
realized impairment loss on these securities of $2,270,000 in
2008. This realized loss was determined in accordance with
SFAS 157, which was adopted by the Company on
January 1, 2008 (see Note 3). The Companys
auction rate securities are classified as short-term
investments, and the realized impairment loss is included in the
Companys statement of operations.
During the fourth quarter of 2008, the Companys
broker-dealer, UBS, extended an offer of Auction Rate Securities
Rights (ARS Rights) to holders of illiquid
auction rate securities that were maintained by UBS as of
February 13, 2008. The ARS Rights provide the holder with
the ability to sell the auction rate securities, along with the
ARS Rights, to UBS at the par value of the auction rate
securities, during an applicable exercise period. The ARS Rights
are not transferable, not tradeable, and will not be quoted or
listed on any securities exchange or other trading network.
During November 2008, the Company executed a written agreement
with UBS to participate in the ARS Rights program for all
$10,000,000 of its outstanding auction rate securities, all of
which were maintained by UBS. Under the terms of the ARS Rights
agreement, the applicable exercise period began on
January 2, 2009 and ends January 4, 2011. ARS Rights
represent an asset akin to a put option, whereby the Company has
the right to put the auction rate securities back to
the broker-dealer during the exercise period for a payment equal
to the par value of the auction rate securities. As of
December 31, 2008, the fair value of the ARS Rights were
recorded as a realized gain of $2,270,000 and a corresponding
short-term investment. The realized gain from recording the ARS
Rights fully offsets the realized impairment loss on auction
rate securities that was recorded during 2008. During January
2009, all of the Companys auction rate securities were
sold to UBS at par value of $10,000,000 pursuant to the ARS
Rights agreement (see Note 10).
|
|
3.
|
Fair
Value of Financial Instruments
|
As a basis for considering market participant assumptions in
fair value measurements, SFAS 157 establishes a fair value
hierarchy that prioritizes the inputs to valuation techniques
used to measure fair value into three broad levels. The fair
value hierarchy gives the highest priority to quoted prices in
active markets for identical assets or liabilities
(Level 1) and the lowest priority to unobservable
inputs (Level 3). Due to the lack of actively traded market
data for the Companys student loan auction rate
securities, the value of these securities and resulting realized
impairment loss was determined using Level 3 hierarchical
inputs. These inputs include managements assumptions of
pricing by market participants, including assumptions about
risk. In accordance with SFAS 157, the Company used the
concepts of fair value based on estimated discounted future cash
flows of interest income over a projected five-year period
reflective of the length of time the Company anticipates it will
take the securities to become liquid. Discount rates ranging
from approximately 5% to 10% were utilized when preparing this
model. The Company classified all of the student loan auction
rate securities as short-term
available-for-sale
securities as the Company will need additional cash in the near
term and may be required to liquidate these auction rate
securities in order to continue operations. Because of the
Companys inability to hold these securities until their
maturity (which ranges between
20-30 years),
the Company believes the impairment of these securities is
other-than-temporary.
See Notes 1 and 10 for further details.
F-15
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
The Company measures the following financial assets at fair
value on a recurring basis. The fair value of these financial
assets at December 31, 2008 (in thousands) are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
|
|
|
|
|
|
Quoted Prices in
|
|
|
|
|
|
|
|
|
|
|
|
|
Active Markets
|
|
|
|
|
|
Significant
|
|
|
|
Balance at
|
|
|
for Identical
|
|
|
Significant Other
|
|
|
Unobservable
|
|
|
|
December 31,
|
|
|
Assets
|
|
|
Observable Inputs
|
|
|
Inputs
|
|
Description
|
|
2008
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
Cash and cash equivalents
|
|
$
|
9,447
|
|
|
$
|
9,447
|
|
|
$
|
|
|
|
$
|
|
|
Short-term investments
|
|
|
7,730
|
|
|
|
|
|
|
|
|
|
|
|
7,730
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ARS Rights (Note 2)
|
|
|
2,270
|
|
|
|
|
|
|
|
|
|
|
|
2,270
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
19,447
|
|
|
$
|
9,447
|
|
|
$
|
|
|
|
$
|
10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table sets forth the change in estimated fair
value for the Companys auction rate securities (in
thousands).
|
|
|
|
|
|
|
Fair Value Measurement Using
|
|
|
|
Significant Unobservable Inputs
|
|
|
|
(Level 3)
|
|
|
Beginning balance
|
|
$
|
|
|
Transfers in to Level 3
|
|
|
|
|
Auction rate securities
|
|
|
10,000
|
|
ARS Rights
|
|
|
2,270
|
|
Total realized/unrealized losses
|
|
|
|
|
Included in net loss
|
|
|
(2,270
|
)
|
Included in comprehensive loss
|
|
|
|
|
Purchases, issuances and settlements
|
|
|
|
|
|
|
|
|
|
Ending balance
|
|
$
|
10,000
|
|
|
|
|
|
|
Leases
In July 1992, the Company entered into a non-cancelable
operating lease for the rental of its research and development
laboratories and clinical manufacturing facilities. In October
1996, the Company entered into an additional non-cancelable
operating lease for additional office space. In 2004, the
Company exercised its options to extend these leases until July
2009.
In October 2007, the Company entered into a capital lease
agreement for $55,000 to finance the purchase of certain
equipment. The agreement is secured by the equipment, bears
interest at 10.00% per annum, and is payable in monthly
installments of principal and interest of approximately $1,000
for 60 months.
F-16
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
Annual future minimum lease payments as of December 31,
2008 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Operating
|
|
|
Capital
|
|
Years Ended December 31,
|
|
Leases
|
|
|
Leases
|
|
|
2009
|
|
$
|
491
|
|
|
$
|
15
|
|
2010
|
|
|
66
|
|
|
|
14
|
|
2011
|
|
|
49
|
|
|
|
14
|
|
2012
|
|
|
32
|
|
|
|
12
|
|
2013 and there-after
|
|
|
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
657
|
|
|
|
55
|
|
|
|
|
|
|
|
|
|
|
Less amount representing interest
|
|
|
|
|
|
|
(10
|
)
|
|
|
|
|
|
|
|
|
|
Present value of net minimum lease payments
|
|
|
|
|
|
|
45
|
|
Less current portion
|
|
|
|
|
|
|
(11
|
)
|
|
|
|
|
|
|
|
|
|
Noncurrent portion of capital lease obligations
|
|
|
|
|
|
$
|
34
|
|
|
|
|
|
|
|
|
|
|
Rent expense under all operating leases totaled $900,000,
$869,000, and $1,065,000 for the years ended December 31,
2008, 2007 and 2006, respectively. Equipment acquired under
capital leases included in property and equipment totaled
$43,000 (net of accumulated amortization of $12,000) and $54,000
(net of accumulated amortization of $1,000) at December 31,
2008 and 2007, respectively. Amortization expense associated
with this equipment is included in depreciation and amortization
expense.
Purchase
Obligations
As of December 31, 2008, the Company had total purchase
obligations of approximately $1,290,000, which consisted of
non-cancelable purchase commitments with third-party
manufacturers of materials to be used in the production of
Riquent. For the year ended December 31, 2008,
approximately $459,000 of the total purchase obligations were
not included in the Companys consolidated financial
statements. The Company intends to use its current financial
resources to fund its obligations under these purchase
commitments.
In December 2008, the Company secured a credit facility (the
Credit Facility) with UBS in the amount of
$6,000,000, fully collateralized by the Companys auction
rate securities. There was no net interest cost to the Company
as the interest rate charged by UBS was contractually equal to
the coupon rates of the auction rate securities. There were no
costs related to the establishment of the Credit Facility.
During December 2008, the Company drew the full $6,000,000
available under the Credit Facility, of which $5,933,000 was
outstanding as of December 31, 2008. During January 2009,
all of the Companys auction rate securities were sold to
UBS at par value of $10,000,000 pursuant to the ARS Rights
agreement, at which time the amount outstanding on the Credit
Facility as of December 31, 2008 was settled in full and
the Credit Facility agreement was terminated (see Note 10).
F-17
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
The following is a summary of the notes payable obligations that
are secured by financed property and equipment of approximately
$3,788,000 ($172,000 net of depreciation and 2008
impairment charges) as of December 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
|
|
|
|
|
Original Note
|
|
Date of Note
|
|
Rate (%)
|
|
|
Monthly Payments
|
|
Amount
|
|
|
|
|
|
|
|
|
(In thousands)
|
|
|
December 28, 2006
|
|
|
10.56
|
|
|
First 36 months at $8,000; last 12 months at $3,000
|
|
|
263
|
|
June 28, 2007
|
|
|
10.82
|
|
|
First 36 months at $2,000; last 12 months at $500
|
|
|
75
|
|
December 31, 2007
|
|
|
10.55
|
|
|
$6,000 for 48 months
|
|
|
236
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
574
|
|
|
|
|
|
|
|
|
|
|
|
|
Annual future minimum notes payable payments as of
December 31, 2008 are as follows (in thousands):
|
|
|
|
|
|
|
Notes
|
|
Years Ended December 31,
|
|
Payable
|
|
|
2009
|
|
$
|
177
|
|
2010
|
|
|
127
|
|
2011
|
|
|
69
|
|
|
|
|
|
|
Total
|
|
|
373
|
|
Less amount representing interest
|
|
|
(42
|
)
|
|
|
|
|
|
Present value of net minimum notes payable payments
|
|
|
331
|
|
Less current portion
|
|
|
(152
|
)
|
|
|
|
|
|
Noncurrent portion of notes payable
|
|
$
|
179
|
|
|
|
|
|
|
Preferred
Stock
As of December 31, 2008, the Companys Board of
Directors is authorized to issue 8,000,000 shares of
preferred stock with a par value of $0.01 per share, in one or
more series.
The Companys Certificate of Designation filed with the
Secretary of State of the State of Delaware designates
500,000 shares of preferred stock as nonredeemable
Series A Junior Participating Preferred Stock
(Series A Preferred Stock). Pursuant to
the terms of the Companys Stockholder Rights Plan, in the
event of liquidation, each share of Series A Preferred
Stock is entitled to receive, subject to certain restrictions, a
preferential liquidation payment of $10,000 per share plus the
amount of accrued unpaid dividends. The Series A Preferred
Stock is subject to certain anti-dilution adjustments, and the
holder of each share is entitled to 10,000 votes, subject to
adjustments. Cumulative quarterly dividends of the greater of
$1.00 or, subject to certain adjustments, 10,000 times any
dividend declared on shares of common stock, are payable when,
as and if declared by the Board of Directors, from funds legally
available for this purpose.
See Note 10 for discussion of preferred stock issued after
December 31, 2008.
F-18
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
Warrants
In connection with the December 2005 private placement, the
Company issued warrants to purchase 4,399,992 shares of the
Companys common stock. The warrants were immediately
exercisable upon grant, have an exercise price of $5.00 per
share and remain exercisable for five years.
In connection with the May 2008 public offering, the Company
issued warrants to purchase 3,903,708 shares of the
Companys common stock. The warrants were immediately
exercisable upon grant, have an exercise price of $2.15 per
share and remain exercisable for five years.
As of December 31, 2008, all of the warrants were
outstanding and 8,303,700 shares of common stock are
reserved for issuance upon exercise of the warrants.
Restricted
Stock
On December 14, 2005, the Company issued 83,518 shares
of restricted stock to certain members of management in exchange
for services provided over the vesting period, pursuant to
certain retention agreements dated October 6, 2005. The
shares of restricted stock fully vested (i.e., the restrictions
lapsed) one year from the date of grant and were subject to
repurchase by the Company until the one-year anniversary of the
date of issuance. Pursuant to a separation agreement dated
March 17, 2006, the Companys repurchase right with
respect to 29,120 shares of restricted stock granted to the
former Chairman and Chief Executive Officer immediately lapsed
upon his resignation on March 14, 2006. As such and in
accordance with his retention agreement, the Company accelerated
the vesting of these shares of restricted stock. In addition,
the remaining 54,398 shares of restricted stock fully
vested on December 14, 2006, the one-year anniversary of
the date of issuance, and therefore the Companys
repurchase right with respect to these shares of restricted
stock has lapsed.
On March 15, 2006, the Company issued 20,000 shares of
restricted stock to the new Chairman of the Board in exchange
for services provided over the vesting period. The shares of
restricted stock vested with respect to 10,000 shares six
months after the issuance date and vested with respect to the
remaining 10,000 shares upon the first anniversary of the
issuance date. On September 15, 2006 and March 15,
2007, the vesting provisions with respect to the
20,000 shares of restricted stock were met and therefore
the Companys repurchase rights lapsed.
In both December 2006 and March 2007, the Company issued an
additional 3,600 shares of restricted stock to the Chairman
of the Board in accordance with the Chairman Compensation Policy
approved by the Board of Directors on March 14, 2006
regarding tax liability associated with the restricted stock
issued on March 15, 2006 and vested on September 15,
2006 and March 15, 2007. All of these additional shares of
restricted stock immediately vested on the date of issuance.
There was no restricted stock issued in 2008.
In accordance with SFAS 123R, the Company recognized
approximately $36,000, and $381,000, respectively, in
compensation expense for the restricted stock grants noted above
for the years ended December 31, 2007, and 2006, which
includes compensation expense for the acceleration of vesting.
There was no compensation expense related to restricted stock
grants during the year ended December 31, 2008. The total
fair value of the restricted stock grants vested in 2007 was
approximately $77,000 of which approximately $41,000 was
recognized in 2006 and approximately $36,000 was recognized in
2007. The total fair value of the restricted stock grants vested
in 2006 was approximately $352,000 of which approximately
$12,000 was recognized in 2005 and approximately $340,000 was
recognized in 2006.
Stock
Option Plans
In June 1994, the Company adopted the La Jolla
Pharmaceutical Company 1994 Stock Incentive Plan (the
1994 Plan) under which, as amended,
1,640,000 shares of common stock (post-reverse stock split)
were
F-19
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
authorized for issuance. The 1994 Plan expired in June 2004 and
there were 748,612 options outstanding under the 1994 Plan as of
December 31, 2008.
In May 2004, the Company adopted the La Jolla
Pharmaceutical Company 2004 Equity Incentive Plan (the
2004 Plan) under which, as amended,
6,400,000 shares of common stock (post-reverse stock split)
have been authorized for issuance. The 2004 Plan provides for
the grant of incentive and non-qualified stock options, as well
as other share-based payment awards, to employees, directors,
consultants and advisors of the Company with up to a
10-year
contractual life and various vesting periods as determined by
the Companys compensation committee or the board of
directors, as well as automatic fixed grants to non-employee
directors of the Company. As of December 31, 2008, there
were a total of 4,878,348 options outstanding and no unvested
shares of restricted stock granted under the 2004 Plan and
1,242,432 shares remained available for future grant.
A summary of the Companys stock option activity (including
shares of restricted stock) and related data follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options
|
|
|
|
Options
|
|
|
|
|
|
Weighted-
|
|
|
|
Available
|
|
|
Number of
|
|
|
Average
|
|
|
|
for Grant
|
|
|
Shares
|
|
|
Exercise Price
|
|
|
Balance at December 31, 2005
|
|
|
3,190,231
|
|
|
|
2,148,028
|
|
|
$
|
16.09
|
|
Granted
|
|
|
(2,450,745
|
)
|
|
|
2,450,745
|
|
|
$
|
4.58
|
|
Restricted stock granted
|
|
|
(23,600
|
)
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
(56,012
|
)
|
|
$
|
2.25
|
|
Cancelled
|
|
|
240,382
|
|
|
|
(240,382
|
)
|
|
$
|
14.04
|
|
Expired
|
|
|
(100,983
|
)
|
|
|
|
|
|
$
|
26.39
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
855,285
|
|
|
|
4,302,379
|
|
|
$
|
9.83
|
|
Additional shares authorized
|
|
|
840,000
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
(1,027,973
|
)
|
|
|
1,027,973
|
|
|
$
|
4.30
|
|
Restricted stock granted
|
|
|
(3,600
|
)
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
(166,280
|
)
|
|
$
|
3.01
|
|
Cancelled
|
|
|
354,496
|
|
|
|
(354,496
|
)
|
|
$
|
14.20
|
|
Expired
|
|
|
(153,808
|
)
|
|
|
|
|
|
$
|
25.80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
|
864,400
|
|
|
|
4,809,576
|
|
|
$
|
8.56
|
|
Additional shares authorized
|
|
|
1,400,000
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
(1,481,900
|
)
|
|
|
1,481,900
|
|
|
$
|
2.02
|
|
Exercised
|
|
|
|
|
|
|
(1,097
|
)
|
|
$
|
2.51
|
|
Cancelled
|
|
|
663,418
|
|
|
|
(663,418
|
)
|
|
$
|
8.91
|
|
Expired
|
|
|
(203,486
|
)
|
|
|
|
|
|
$
|
19.80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008
|
|
|
1,242,432
|
|
|
|
5,626,961
|
|
|
$
|
6.80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, 2008, options cancelled
(included in the above table) consisted of approximately 459,932
options forfeited with a weighted-average exercise price of
$4.09.
As of December 31, 2008, options exercisable have a
weighted-average remaining contractual term of 6.4 years.
The total intrinsic value of stock option exercises, which is
the difference between the exercise price and closing price of
the Companys common stock on the date of exercise, during
the years ended December 31, 2008, 2007, and 2006 was
$2,000, $500,000, and $74,000, respectively. As of
December 31, 2008 and 2007, the total
F-20
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
intrinsic value, which is the difference between the exercise
price and closing price of the Companys common stock of
options outstanding and exercisable, was $0 and $844,000,
respectively.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
2008
|
|
2007
|
|
2006
|
|
|
|
|
Weighted-
|
|
|
|
Weighted-
|
|
|
|
Weighted-
|
|
|
|
|
Average
|
|
|
|
Average
|
|
|
|
Average
|
|
|
|
|
Exercise
|
|
|
|
Exercise
|
|
|
|
Exercise
|
|
|
Options
|
|
Price
|
|
Options
|
|
Price
|
|
Options
|
|
Price
|
|
Exercisable at end of year
|
|
|
3,522,747
|
|
|
$
|
9.08
|
|
|
|
2,808,588
|
|
|
$
|
11.44
|
|
|
|
1,859,139
|
|
|
$
|
16.27
|
|
Weighted-average fair value of options granted during the year
|
|
$
|
1.70
|
|
|
|
|
|
|
$
|
3.71
|
|
|
|
|
|
|
$
|
3.92
|
|
|
|
|
|
Exercise prices and weighted-average remaining contractual lives
for the options outstanding (excluding shares of restricted
stock) as of December 31, 2008 were:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
Remaining
|
|
|
Weighted-
|
|
|
|
|
|
Exercise
|
|
|
|
|
|
|
Contractual
|
|
|
Average
|
|
|
|
|
|
Price of
|
|
Options
|
|
Range of
|
|
|
Life
|
|
|
Exercise
|
|
|
Options
|
|
|
Options
|
|
Outstanding
|
|
Exercise Prices
|
|
|
(In Years)
|
|
|
Price
|
|
|
Exercisable
|
|
|
Exercisable
|
|
|
747,759
|
|
$
|
0.64
|
|
|
|
|
|
|
$
|
1.82
|
|
|
|
9.45
|
|
|
$
|
1.66
|
|
|
|
9,821
|
|
|
$
|
1.09
|
|
786,614
|
|
$
|
1.87
|
|
|
|
|
|
|
$
|
2.42
|
|
|
|
8.38
|
|
|
$
|
2.36
|
|
|
|
286,884
|
|
|
$
|
2.34
|
|
541,869
|
|
$
|
3.06
|
|
|
|
|
|
|
$
|
3.60
|
|
|
|
8.01
|
|
|
$
|
3.13
|
|
|
|
288,869
|
|
|
$
|
3.16
|
|
667,678
|
|
$
|
3.61
|
|
|
|
|
|
|
$
|
4.44
|
|
|
|
7.37
|
|
|
$
|
4.01
|
|
|
|
554,234
|
|
|
$
|
4.03
|
|
791,568
|
|
|
|
|
|
$
|
4.46
|
|
|
|
|
|
|
|
7.29
|
|
|
$
|
4.46
|
|
|
|
728,778
|
|
|
$
|
4.46
|
|
853,500
|
|
$
|
4.60
|
|
|
|
|
|
|
$
|
5.26
|
|
|
|
7.27
|
|
|
$
|
5.24
|
|
|
|
592,750
|
|
|
$
|
5.25
|
|
664,395
|
|
$
|
5.36
|
|
|
|
|
|
|
$
|
14.85
|
|
|
|
6.68
|
|
|
$
|
9.17
|
|
|
|
487,833
|
|
|
$
|
10.46
|
|
573,578
|
|
$
|
15.70
|
|
|
|
|
|
|
$
|
60.31
|
|
|
|
3.00
|
|
|
$
|
29.09
|
|
|
|
573,578
|
|
|
$
|
29.09
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,626,961
|
|
$
|
0.64
|
|
|
|
|
|
|
$
|
60.31
|
|
|
|
7.29
|
|
|
$
|
6.80
|
|
|
|
3,522,747
|
|
|
$
|
9.08
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2008, the Company has reserved
6,869,393 shares of common stock for future issuance upon
exercise of options granted or to be granted under the 1994 and
2004 Plans.
Employee
Stock Purchase Plan
Effective August 1, 1995, the Company adopted the ESPP
under which, as amended, 850,000 shares of common stock are
reserved for sale to eligible employees, as defined in the ESPP.
Employees may purchase common stock under the ESPP every three
months (up to but not exceeding 10% of each employees base
salary, or hourly compensation, and any cash bonus paid, subject
to certain limitations) over the offering period at 85% of the
fair market value of the common stock at specified dates. The
offering period may not exceed 24 months. During the years
ended December 31, 2008 and 2007, 303,937 and
97,104 shares of common stock were issued under the ESPP,
respectively. As of December 31, 2008, 833,023 shares
of common stock have been issued under the ESPP and
16,977 shares of common stock are available for future
issuance.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
2008
|
|
2007
|
|
2006
|
|
Weighted-average fair value of Employee Stock Purchase Plan
purchases
|
|
$
|
0.71
|
|
|
$
|
1.47
|
|
|
$
|
1.48
|
|
F-21
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
Stockholder
Rights Plan
The Company has adopted a Stockholder Rights Plan (the
Rights Plan), which was amended and restated
in December 2008 and subsequently amended in January 2009. The
Rights Plan provides for a dividend of one right (a
Right) to purchase fractions of shares of the
Companys Series A Preferred Stock for each share of
the Companys common stock. Under certain conditions
involving an acquisition by any person or group of 15% or more
of the common stock (or in the case of Grandfathered Persons, as
defined in the Rights Plan, the acquisition of common stock in
excess of the applicable Grandfathered Percentage, as defined in
the Rights Plan; or, in the case of BioMarin, 15% or more of
shares not issued under the securities purchase agreement
between BioMarin and the Company), the Rights permit the holders
(other than the 15% holder, or, in the case of Grandfathered
Persons, as defined in the Rights Plan, the acquisition of
common stock in excess of the applicable Grandfathered
Percentage, as defined in the Rights Plan; or, in the case of
BioMarin, 15% or more of shares issued under the securities
purchase agreement between BioMarin and the Company) to purchase
the Companys common stock at a 50% discount upon payment
of an exercise price of $30 per Right. In addition, in the event
of certain business combinations, the Rights permit the purchase
of the common stock of an acquirer at a 50% discount. Under
certain conditions, the Rights may be redeemed by the Board of
Directors in whole, but not in part, at a price of $0.001 per
Right. The Rights have no voting privileges and are attached to
and automatically trade with the Companys common stock.
The Rights expire on December 2, 2018.
The Company has established a 401(k) defined contribution
retirement plan (the 401(k) Plan), which was
amended in May 1999 to cover all employees. The 401(k) Plan was
also amended in December 2003 to increase the voluntary employee
contributions from a maximum of 20% to 50% of annual
compensation (as defined). This increase was effective beginning
January 1, 2004. The Company does not match employee
contributions or otherwise contribute to the 401(k) Plan. In
March 2009, the Company terminated the 401(k) Plan.
The Company adopted the provisions of FASB Interpretation
No. 48, Accounting for Uncertainty in Income
Taxes an Interpretation of FASB Statement
No. 109 (FIN 48) on January 1,
2007. FIN 48 prescribes a recognition threshold and
measurement attribute criteria for the financial statement
recognition and measurement of tax positions taken or expected
to be taken in a tax return. For those benefits to be
recognized, a tax position must be more-likely-than-not to be
sustained upon examination by taxing authorities. Upon
implementation, the Company had no unrecognized tax benefits. As
of December 31, 2008 there are no unrecognized tax benefits
included in the balance sheet that would, if recognized, affect
the Companys effective tax rate.
The Company is subject to taxation in the United States and
various state jurisdictions. The Companys tax years for
1993 and forward are subject to examination by the United States
and California tax authorities due to the carry forward of
unutilized net operating losses and research and development
credits.
The Company has not completed its Section 382/383 analysis
regarding the limitation of net operating loss and research and
development credit carryforwards. The Company does not presently
plan to complete its Section 382/383 analysis and unless
and until this analysis has been completed, the Company has
removed the deferred tax assets for net operating losses and
research and development credits generated through 2008 from its
deferred tax asset schedule and has recorded a corresponding
decrease to its valuation allowance.
At December 31, 2008, the Company had federal and
California income tax net operating loss carryforwards of
approximately $362,037,000 and $202,859,000, respectively. The
difference between the federal and California tax loss
carryforwards is primarily attributable to the capitalization of
research and development expenses for California income tax
purposes. In addition, the Company has federal and California
research and development tax credit carryforwards of $16,483,000
and $9,729,000, respectively. The federal net operating loss and
research
F-22
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
tax credit carryforwards will begin to expire in 2009 unless
previously utilized. The California net operating loss
carryforwards will begin to expire in 2010 unless previously
utilized. The California research and development credit
carryforwards will carry forward indefinitely until utilized. In
February 2009, the Company experienced a change in ownership at
a time when its enterprise value was minimal. As a result of
this ownership change and the low enterprise value, the
Companys federal and California net operating loss
carryforwards and federal research and development credit
carryforwards as of December 31, 2008 will be subject to
limitation under IRC Section 382/383 and more likely than
not will expire unused.
Significant components of the Companys deferred tax assets
as of December 31, 2008 and 2007 are listed below. A
valuation allowance of $14,330,000 and $10,923,000 at
December 31, 2008 and 2007, respectively, has been
recognized to offset the net deferred tax assets as realization
of such assets is uncertain. Amounts are shown in thousands as
of December 31 of the respective years:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards
|
|
$
|
|
|
|
$
|
|
|
Research and development credits
|
|
|
|
|
|
|
|
|
Capitalized research and development and other
|
|
|
14,330
|
|
|
|
10,923
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
14,330
|
|
|
|
10,923
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
|
14,330
|
|
|
|
10,923
|
|
Valuation allowance for deferred tax assets
|
|
|
(14,330
|
)
|
|
|
(10,923
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred taxes
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Development
and Stock Purchase Agreement
On January 4, 2009 (the Effective Date),
the Company entered into a development and commercialization
agreement (the Development Agreement) with
BioMarin CF Limited (BioMarin CF), a
wholly-owned subsidiary of BioMarin Pharmaceutical Inc.
(BioMarin Pharma), granting BioMarin CF
co-exclusive rights to develop and commercialize Riquent (and
certain potential follow-on products) (collectively,
Riquent) in the Territory, and
the non-exclusive right to manufacture Riquent anywhere in the
world. The Territory includes all countries of the
world except the Asia-Pacific Territory (i.e., all
countries of East Asia, Southeast Asia, South Asia, Australia,
New Zealand, and other countries of Oceania).
Under the terms of the Development Agreement, BioMarin CF paid
the Company a non-refundable commencement payment of $7,500,000
and purchased, through BioMarin Pharma, $7,500,000 of a newly
designated series of preferred stock (the Series B
Preferred Stock), pursuant to a securities purchase
agreement described more fully below.
Following the futile results of the first interim efficacy
analysis of Riquent, BioMarin CF has elected to not exercise its
full license rights to the Riquent program under the Development
Agreement. Thus, the Development Agreement between the parties
terminated on March 27, 2009 in accordance with its terms.
All rights to Riquent have been returned to the Company.
In connection with the Development Agreement, the Company also
entered into a securities purchase agreement, dated as of
January 4, 2009 (the Purchase Agreement)
with BioMarin Pharma. In accordance with the terms of the
agreement, on January 20, 2009, the Company sold
339,104 shares of Series B Preferred Stock at a price
per share of $22.1171 for gross proceeds totaling $7,500,000. On
March 27, 2009, in connection with the
F-23
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
termination of the Development Agreement, the Series B
Preferred Stock converted into 10,173,120 shares of Common
Stock.
Auction
Rate Securities
During January 2009, all of the Companys auction rate
securities were sold to UBS at par value of $10,000,000 pursuant
to the ARS Rights agreement (see Note 2). Upon the sale of
these auction rate securities, the amount outstanding on the
Credit Facility agreement as of December 31, 2008 was
settled in full and the Credit Facility was terminated.
Interim
Efficacy Analysis Results and Restructuring
Activities
In February 2009, the Company announced that an Independent
Monitoring Board for the Riquent Phase 3 ASPEN study had
completed the review of their first interim efficacy analysis of
Riquent and determined that continuing the study was futile. The
Company subsequently unblinded the data and found that there was
no statistical difference in the primary endpoint, delaying time
to renal flare, between the Riquent-treated group and the
placebo-treated group, although there was a significant
difference in the reduction of antibodies to double-stranded
DNA. There were 56 renal flares in 587 patients treated
with either
300-mg or
900-mg of
Riquent, and 28 renal flares in 283 patients treated with
placebo.
Based on these results, the Company immediately discontinued the
Riquent Phase 3 ASPEN study and the further development of
Riquent. The Company had previously devoted substantially all of
its research, development and clinical efforts and financial
resources toward the development of Riquent. In connection with
the termination of the clinical trials for Riquent, the Company
subsequently initiated steps to significantly reduce its
operating costs, including a planned substantial reduction in
personnel, which is expected to be effected early in the second
quarter of 2009. The Company has also ceased the manufacture of
Riquent at its facility in San Diego, California.
F-24
La Jolla
Pharmaceutical Company
Notes to
Consolidated Financial
Statements (Continued)
The following is a summary of the unaudited quarterly results of
operations for the years ended December 31, 2008 and 2007
(in thousands except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarters Ended
|
|
|
|
Mar. 31,
|
|
|
Jun. 30,
|
|
|
Sept. 30,
|
|
|
Dec. 31,
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
11,338
|
|
|
$
|
12,732
|
|
|
$
|
14,099
|
|
|
$
|
12,856
|
|
General and administrative
|
|
|
1,906
|
|
|
|
2,069
|
|
|
|
2,791
|
|
|
|
2,936
|
|
Asset impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,810
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(13,244
|
)
|
|
|
(14,801
|
)
|
|
|
(16,890
|
)
|
|
|
(18,602
|
)
|
Interest income (expense), net
|
|
|
(393
|
)
|
|
|
(134
|
)
|
|
|
(244
|
)
|
|
|
1,454
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(13,637
|
)
|
|
$
|
(14,935
|
)
|
|
$
|
(17,134
|
)
|
|
$
|
(17,148
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.34
|
)
|
|
$
|
(0.31
|
)
|
|
$
|
(0.31
|
)
|
|
$
|
(0.31
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
|
39,631
|
|
|
|
48,252
|
|
|
|
55,327
|
|
|
|
55,423
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
10,375
|
|
|
$
|
12,186
|
|
|
$
|
11,448
|
|
|
$
|
12,626
|
|
General and administrative
|
|
|
1,980
|
|
|
|
2,112
|
|
|
|
2,585
|
|
|
|
2,381
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(12,355
|
)
|
|
|
(14,298
|
)
|
|
|
(14,033
|
)
|
|
|
(15,007
|
)
|
Interest income, net
|
|
|
485
|
|
|
|
781
|
|
|
|
744
|
|
|
|
607
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(11,870
|
)
|
|
$
|
(13,517
|
)
|
|
$
|
(13,289
|
)
|
|
$
|
(14,400
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.36
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.36
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
|
32,737
|
|
|
|
39,256
|
|
|
|
39,577
|
|
|
|
39,607
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-25
LA JOLLA
PHARMACEUTICAL COMPANY
Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited)
|
|
|
(See Note)
|
|
|
|
(In thousands)
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
5,830
|
|
|
$
|
9,447
|
|
Short-term investments
|
|
|
|
|
|
|
10,000
|
|
Prepaids and other current assets
|
|
|
746
|
|
|
|
785
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
6,576
|
|
|
|
20,232
|
|
Property and equipment, net
|
|
|
|
|
|
|
357
|
|
Patent costs and other assets, net
|
|
|
|
|
|
|
250
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
6,576
|
|
|
$
|
20,839
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
692
|
|
|
$
|
4,626
|
|
Accrued clinical/regulatory expenses
|
|
|
|
|
|
|
3,957
|
|
Accrued expenses
|
|
|
235
|
|
|
|
1,008
|
|
Accrued payroll and related expenses
|
|
|
98
|
|
|
|
1,549
|
|
Credit facility
|
|
|
|
|
|
|
5,933
|
|
Current portion of obligations under notes payable
|
|
|
|
|
|
|
152
|
|
Current portion of obligations under capital leases
|
|
|
|
|
|
|
11
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
1,025
|
|
|
|
17,236
|
|
Noncurrent portion of obligations under notes payable
|
|
|
|
|
|
|
179
|
|
Noncurrent portion of obligations under capital leases
|
|
|
|
|
|
|
34
|
|
Commitments
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
657
|
|
|
|
555
|
|
Additional paid-in capital
|
|
|
427,574
|
|
|
|
418,522
|
|
Accumulated deficit
|
|
|
(422,680
|
)
|
|
|
(415,687
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
5,551
|
|
|
|
3,390
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
6,576
|
|
|
$
|
20,839
|
|
|
|
|
|
|
|
|
|
|
Note: The condensed consolidated balance sheet at
December 31, 2008 has been derived from the audited
consolidated financial statements as of that date but does not
include all of the information and disclosures required by
U.S. generally accepted accounting principles.
See accompanying notes.
F-26
LA JOLLA
PHARMACEUTICAL COMPANY
Condensed
Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited)
|
|
|
|
(In thousands, except per share amounts)
|
|
|
Revenue from collaboration agreement
|
|
$
|
|
|
|
$
|
|
|
|
$
|
8,125
|
|
|
$
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
(240
|
)
|
|
|
14,099
|
|
|
|
9,567
|
|
|
|
38,170
|
|
General and administrative
|
|
|
992
|
|
|
|
2,791
|
|
|
|
5,602
|
|
|
|
6,766
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses
|
|
|
752
|
|
|
|
16,890
|
|
|
|
15,169
|
|
|
|
44,936
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(752
|
)
|
|
|
(16,890
|
)
|
|
|
(7,044
|
)
|
|
|
(44,936
|
)
|
Interest and other income
|
|
|
54
|
|
|
|
163
|
|
|
|
64
|
|
|
|
653
|
|
Interest expense
|
|
|
|
|
|
|
(12
|
)
|
|
|
(13
|
)
|
|
|
(71
|
)
|
Realized loss on investments, net
|
|
|
|
|
|
|
(395
|
)
|
|
|
|
|
|
|
(1,352
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(698
|
)
|
|
$
|
(17,134
|
)
|
|
$
|
(6,993
|
)
|
|
$
|
(45,706
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.01
|
)
|
|
$
|
(0.31
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.96
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
|
65,723
|
|
|
|
55,327
|
|
|
|
62,555
|
|
|
|
47,764
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-27
LA JOLLA
PHARMACEUTICAL COMPANY
Condensed
Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited)
|
|
|
|
(In thousands)
|
|
|
Operating activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(6,993
|
)
|
|
$
|
(45,706
|
)
|
Adjustments to reconcile net loss to net cash used for operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
116
|
|
|
|
758
|
|
(Gain) loss on write-off/disposal of patents and property and
equipment
|
|
|
(326
|
)
|
|
|
193
|
|
Share-based compensation expense
|
|
|
2,344
|
|
|
|
3,400
|
|
Expense reduction from settlement of vendor obligations
|
|
|
(2,645
|
)
|
|
|
|
|
Realized loss on investments, net
|
|
|
|
|
|
|
1,352
|
|
Amortization of premium on investments
|
|
|
|
|
|
|
341
|
|
Change in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaids and other current assets
|
|
|
39
|
|
|
|
33
|
|
Accounts payable and accrued liabilities
|
|
|
(6,019
|
)
|
|
|
491
|
|
Accrued payroll and related expenses
|
|
|
(1,451
|
)
|
|
|
29
|
|
|
|
|
|
|
|
|
|
|
Net cash used for operating activities
|
|
|
(14,935
|
)
|
|
|
(39,109
|
)
|
Investing activities:
|
|
|
|
|
|
|
|
|
Sales of short-term investments
|
|
|
10,000
|
|
|
|
24,665
|
|
Net proceeds from sale of patents and property and equipment
|
|
|
841
|
|
|
|
43
|
|
Additions to property and equipment
|
|
|
(18
|
)
|
|
|
(484
|
)
|
Increase in patent costs and other assets
|
|
|
(6
|
)
|
|
|
(179
|
)
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
|
10,817
|
|
|
|
24,045
|
|
Financing activities:
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of common stock
|
|
|
|
|
|
|
28,263
|
|
Net proceeds from issuance of preferred stock
|
|
|
6,810
|
|
|
|
|
|
Payments on credit facility
|
|
|
(5,933
|
)
|
|
|
|
|
Payments on obligations under notes payable
|
|
|
(331
|
)
|
|
|
(112
|
)
|
Payments on obligations under capital leases
|
|
|
(45
|
)
|
|
|
(6
|
)
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
501
|
|
|
|
28,145
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(3,617
|
)
|
|
|
13,081
|
|
Cash and cash equivalents at beginning of period
|
|
|
9,447
|
|
|
|
4,373
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
5,830
|
|
|
$
|
17,454
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-28
LA JOLLA
PHARMACEUTICAL COMPANY
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2009
The accompanying unaudited condensed consolidated financial
statements of La Jolla Pharmaceutical Company and its
wholly-owned subsidiary (the Company) have been
prepared in accordance with U.S. generally accepted
accounting principles (GAAP) for interim financial
information and with the instructions to
Form 10-Q
and Article 10 of
Regulation S-X.
Accordingly, they do not include all of the information and
disclosures required by GAAP for complete financial statements.
In the opinion of management, all adjustments (consisting of
normal recurring accruals, including restructuring costs and
settlement of liabilities) considered necessary for a fair
presentation have been included. Operating results for the three
and nine months ended September 30, 2009 are not
necessarily indicative of the results that may be expected for
other quarters or the year ending December 31, 2009. For
more complete financial information, these unaudited condensed
consolidated financial statements, and the notes thereto, should
be read in conjunction with the audited consolidated financial
statements for the year ended December 31, 2008 included in
the Companys
Form 10-K
filed with the Securities and Exchange Commission on
March 31, 2009.
In February 2009, the Company announced that an Independent
Monitoring Board for the
Riquent®
Phase 3 ASPEN study had completed its review of the first
interim efficacy analysis and determined that continuing the
study was futile. Based on these results, the Company
immediately discontinued the Riquent Phase 3 ASPEN study and the
development of Riquent. The Company had previously devoted
substantially all of its research, development and clinical
efforts and financial resources toward the development of
Riquent. In connection with the termination of the clinical
trials for Riquent, the Company subsequently initiated steps to
significantly reduce its operating costs, including a reduction
in force, which was effected in April 2009 (see Note 6),
and ceased all Riquent manufacturing and regulatory activities.
In July 2009, the Company announced that, in light of the
current alternatives available to the Company, a wind down of
the Companys business would be in the best interests of
the Company and its stockholders. Although the Board of
Directors (the Board) approved a Plan of Complete
Liquidation and Dissolution (the Plan of
Dissolution) in September 2009, it is subject to approval
by holders of at least a majority in voting power of the
Companys outstanding shares. The Company has called a
special meeting of stockholders to vote on the Plan of
Dissolution, however to date, the majority of the Companys
stockholders have failed to return their proxy cards or
otherwise indicate their votes with respect to this proposal.
The Company has not changed its basis of accounting as a result
of the Boards adoption of the Plan of Dissolution, given
that the Plan of Dissolution cannot be implemented without
stockholder approval. Should the dissolution of the Company
pursuant to the Plan of Dissolution be approved by the required
vote of its stockholders, the Company would then change its
basis of accounting from the going concern basis to the
liquidation basis. If the Companys stockholders do not
approve the dissolution of the Company pursuant to the Plan of
Dissolution, the Board will explore what, if any, alternatives
are available for the future of the Company.
The accompanying unaudited condensed consolidated financial
statements have been prepared assuming that the Company will
continue as a going concern. This basis of accounting
contemplates the recovery of the Companys assets and the
satisfaction of liabilities in the normal course of business and
this does not include any adjustments to reflect the possible
future effects on the recoverability and classification of
assets or the amounts and classification of liabilities that
might be necessary should the Company be unable to continue as a
going concern or should the dissolution of the Company pursuant
to the Plan of Dissolution be approved by the Companys
stockholders. Certain assets, such as prepaid insurance (which
represents a significant component of prepaids and other current
assets), could have significantly lower values, or no value,
under the liquidation basis of accounting. While the basis of
presentation remains that of a going concern, the Company has a
history of recurring losses from operations, and as of
September 30, 2009, the Company had an accumulated deficit
of $422,680,000, available cash and cash equivalents of
$5,830,000 and working capital of $5,551,000. These factors, as
well as the Companys
F-29
LA JOLLA
PHARMACEUTICAL COMPANY
Notes to
Condensed Consolidated Financial
Statements (Continued)
current inability to generate future cash flows and the
potential stockholder approval of the Plan of Dissolution, raise
substantial doubt about the Companys ability to continue
as a going concern.
Principles
of Consolidation
The accompanying unaudited condensed consolidated financial
statements include the accounts of La Jolla Pharmaceutical
Company and its wholly-owned subsidiary, La Jolla Limited,
which was incorporated in England in October 2004. There have
been no significant transactions related to La Jolla
Limited since its inception. La Jolla Limited was formally
dissolved during October 2009 with no resulting accounting
consequences.
Use of
Estimates
The preparation of consolidated financial statements in
conformity with GAAP requires management to make estimates and
assumptions that affect the amounts reported in the unaudited
condensed consolidated financial statements and disclosures made
in the accompanying notes to the unaudited condensed
consolidated financial statements. Actual results could differ
materially from those estimates.
Recent
Accounting Pronouncements
In June 2009, the Financial Accounting Standards Board
(FASB) approved the FASB Accounting Standards
Codification (the Codification) when it issued
Statement of Financial Accounting Standards No. 168, The
FASB Accounting Standards Codification and the Hierarchy of
Generally Accepted Accounting Principles, which is included
in The Accounting Standards Codification
(ASC) Topic of Generally Accepted Accounting
Principles (the Topic). All existing accounting
standard documents, such as FASB, American Institute of
Certified Public Accountants, Emerging Issues Task Force and
other related literature, excluding guidance from the Securities
and Exchange Commission (SEC), have been superseded
by the Codification. All other non-grandfathered, non-SEC
accounting literature not included in the Codification has
become non-authoritative. The Codification did not change GAAP,
but instead introduced a new structure that combines all
authoritative standards into a comprehensive,
topically-organized online database. The Topic is effective for
financial statements issued for interim and annual periods
ending after September 15, 2009. The Topic impacts the
Companys financial statement disclosures as all future
references to authoritative accounting literature will be
referenced in accordance with the Codification. As a result of
the implementation of the Codification during the quarter ended
September 30, 2009, previous references to accounting
standards and literature are no longer applicable.
Effective April 1, 2009, the Company implemented The ASC
Topic of Subsequent Events. This guidance establishes
general standards of accounting for and disclosure of events
that occur after the balance sheet date and requires companies
to disclose the date through which subsequent events have been
evaluated, as well as whether that date is the date the
financial statements were issued or the date the financial
statements were available to be issued. The ASC Topic of
Subsequent Events became effective for interim or annual
periods ending after June 15, 2009 and did not have a
material impact on the Companys unaudited condensed
consolidated financial statements for the three and nine months
ended September 30, 2009.
Revenue
Recognition
On January 4, 2009, the Company entered into a development
and commercialization agreement (the Development
Agreement) with BioMarin CF Limited (BioMarin
CF), a wholly-owned subsidiary of BioMarin Pharmaceutical
Inc. (BioMarin Pharma). The Development Agreement
was terminated on March 27, 2009 following the failure of
the Phase 3 ASPEN trial. See Note 4 for further details
related to the Development Agreement.
F-30
LA JOLLA
PHARMACEUTICAL COMPANY
Notes to
Condensed Consolidated Financial
Statements (Continued)
The Company considers a variety of factors in determining the
appropriate method of revenue recognition under collaborative
arrangements, such as whether the elements are separable,
whether there are determinable fair values and whether there is
a unique earnings process associated with each element of a
contract.
Net
Loss Per Share
Basic and diluted net loss per share is computed using the
weighted-average number of common shares outstanding during the
periods. Basic earnings per share (EPS) is
calculated by dividing the net income or loss by the
weighted-average number of common shares outstanding for the
period, without consideration for common share equivalents.
Diluted EPS is computed by dividing the net income or loss by
the weighted-average number of common share equivalents
outstanding for the period determined using the treasury-stock
method. For purposes of this calculation, stock options, and
warrants are considered to be common stock equivalents and are
only included in the calculation of diluted EPS when their
effect is dilutive.
Because the Company has incurred a net loss for all periods
presented in the unaudited condensed consolidated statements of
operations, stock options and warrants are not included in the
computation of net loss per share because their effect is
anti-dilutive. The shares used to compute basic and diluted net
loss per share represent the weighted-average common shares
outstanding.
Comprehensive
Loss
Unrealized gains and losses on
available-for-sale
securities are included in other comprehensive income (loss).
There were no unrealized gains or losses on
available-for-sale
securities for the three or nine months ended September 30,
2009, and therefore net loss is equal to comprehensive loss for
these periods. The Companys comprehensive net loss was
$17,133,000 and $45,719,000 for the three and nine months ended
September 30, 2008, respectively.
Impairment
of Long-Lived Assets and Assets to Be Disposed Of
If indicators of impairment exist, the Company assesses the
recoverability of the affected long-lived assets by determining
whether the carrying value of such assets can be recovered
through the undiscounted future operating cash flows.
As a result of the futility determination in the Phase 3 ASPEN
trial, the Company discontinued the Riquent Phase 3 ASPEN study
and the development of Riquent. Based on these events, the
future cash flows from the Companys Riquent-related
patents are no longer expected to exceed their carrying values
and the assets became impaired as of December 31, 2008.
This rendered substantially all of the Companys laboratory
equipment, as well as a large portion of its furniture and
fixtures and computer equipment and software, impaired as of
December 31, 2008.
The Company recorded a non-cash charge for the impairment of
long-lived assets of $2,810,000 for the year ended
December 31, 2008 to write down the value of the
Companys long-lived assets to their estimated fair values.
The Company sold, disposed of, or wrote off all of its remaining
long-lived assets during the nine months ended
September 30, 2009 for a gain of $326,000.
|
|
3.
|
Fair
Value of Financial Instruments
|
Fair value is defined under The ASC Topic of Fair Value
Measurements and Disclosures as the exchange price that
would be received for an asset or paid to transfer a liability
(an exit price) in the principal or most advantageous market for
the asset or liability in an orderly transaction between market
participants on the measurement date. Valuation techniques used
to measure fair value under The ASC Topic of Fair Value
Measurements and Disclosures must maximize the use of
observable inputs and minimize the use of unobservable inputs.
The standard describes a
F-31
LA JOLLA
PHARMACEUTICAL COMPANY
Notes to
Condensed Consolidated Financial
Statements (Continued)
fair value hierarchy based on three levels of inputs, of which
the first two are considered observable and the last
unobservable, that may be used to measure fair value which are
the following:
|
|
|
|
|
Level 1 Quoted prices in active markets
for identical assets or liabilities.
|
|
|
|
Level 2 Inputs other than Level 1
that are observable, either directly or indirectly, such as
quoted prices for similar assets or liabilities; quoted prices
in markets that are not active; or other inputs that are
observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
|
|
|
|
Level 3 Unobservable inputs that are
supported by little or no market activity and that are
significant to the fair value of the assets or liabilities.
|
As of September 30, 2009, cash and cash equivalents were
comprised of cash in checking accounts. The Company held no
investments as of September 30, 2009.
As of December 31, 2008, cash and cash equivalents were
comprised of short-term, highly liquid investments with
maturities of 90 days or less from the date of purchase.
Investments were comprised of
available-for-sale
securities recorded at estimated fair value determined using
level 3 inputs. Unrealized gains and losses associated with
the Companys investments, if any, were reported in
stockholders equity.
At December 31, 2008, short-term investments were comprised
of $10,000,000 invested in auction rate securities, which were
sold to UBS at par value in January 2009 pursuant to an Auction
Rate Securities Agreement executed in November 2008.
|
|
4.
|
Development
and Stock Purchase Agreements
|
On January 4, 2009, the Company entered into the
Development Agreement with BioMarin CF, a wholly-owned
subsidiary of BioMarin Pharma, granting BioMarin CF co-exclusive
rights to develop and commercialize Riquent (and certain
potential follow-on products) (collectively,
Riquent) in the Territory, and the
non-exclusive right to manufacture Riquent anywhere in the
world. The Territory includes all countries of the
world except the Asia-Pacific Territory (i.e., all
countries of East Asia, Southeast Asia, South Asia, Australia,
New Zealand, and other countries of Oceania).
Under the terms of the Development Agreement, BioMarin CF paid
the Company a non-refundable commencement payment of $7,500,000
and purchased, through BioMarin Pharma, $7,500,000 of a newly
designated series of preferred stock (the
Series B-1
Preferred Stock), pursuant to a related securities
purchase agreement described more fully below.
Following the futile results of the first interim efficacy
analysis of Riquent received in February 2009, BioMarin CF
elected not to exercise its full license rights to the Riquent
program under the Development Agreement. Thus, the Development
Agreement between the parties terminated on March 27, 2009
in accordance with its terms. All rights to Riquent were
returned to the Company. Accordingly, the $7,500,000
non-refundable commencement payment received in connection with
this Development Agreement was recorded as revenue in the
quarter ended March 2009.
In connection with the Development Agreement, the Company also
entered into a securities purchase agreement, dated as of
January 4, 2009 with BioMarin Pharma. In accordance with
the terms of the agreement, on January 20, 2009, the
Company sold 339,104 shares of
Series B-1
Preferred Stock at a price per share of $22.1171 and received
$7,500,000. On March 27, 2009, in connection with the
termination of the Development Agreement, the
Series B-1
Preferred Stock converted into 10,173,120 shares of Common
Stock pursuant to the terms of the securities purchase
agreement. The total sales price included a premium over the
fair value of the stock issued of $625,000, which was recorded
as revenue in the quarter ended March 31, 2009.
F-32
LA JOLLA
PHARMACEUTICAL COMPANY
Notes to
Condensed Consolidated Financial
Statements (Continued)
Share-Based
Compensation
In June 1994, the Company adopted the La Jolla
Pharmaceutical Company 1994 Stock Incentive Plan (the 1994
Plan), under which, as amended, 1,640,000 shares of
common stock were authorized for issuance. The 1994 Plan expired
in June 2004 and there were 499,935 options outstanding under
the 1994 Plan as of September 30, 2009.
In May 2004, the Company adopted the La Jolla
Pharmaceutical Company 2004 Equity Incentive Plan (the
2004 Plan), under which, as amended,
6,400,000 shares of common stock have been authorized for
issuance. The 2004 Plan provides for the grant of incentive and
non-qualified stock options, as well as other share-based
payment awards, to employees, directors, consultants and
advisors of the Company with up to a
10-year
contractual life and various vesting periods as determined by
the Companys Compensation Committee or the Board of
Directors, as well as automatic fixed grants to non-employee
directors of the Company. As of September 30, 2009, there
were a total of 3,315,958 options outstanding under the 2004
Plan and 2,804,822 shares remained available for future
grant. In August 1995, the Company adopted the La Jolla
Pharmaceutical Company 1995 Employee Stock Purchase Plan (the
ESPP), under which, as amended, 850,000 shares
of common stock are reserved for sale to eligible employees, as
defined in the ESPP. Employees may purchase common stock under
the ESPP every three months (up to but not exceeding 10% of each
employees base salary or hourly compensation, and any cash
bonus paid, subject to certain limitations) over the offering
period at 85% of the fair market value of the common stock at
specified dates. The offering period may not exceed
24 months. As of September 30, 2009,
833,023 shares of common stock have been issued under the
ESPP and 16,977 shares of common stock are available for
future issuance.
Options or stock awards issued to non-employees, other than
non-employee directors, are periodically remeasured as the
options vest.
Share-based compensation expense recognized for the three months
ended September 30, 2009 and 2008 was $311,000 and
$1,119,000, respectively, and $2,344,000 and $3,409,000 for the
nine months ended September 30, 2009 and 2008,
respectively. As of September 30, 2009, there was $941,000
of total unrecognized compensation cost related to non-vested
share-based payment awards granted under all equity compensation
plans. Total unrecognized compensation cost will be adjusted for
future changes in estimated forfeitures. The Company expects to
recognize this compensation cost over a weighted-average period
of 1.1 years.
The following table summarizes share-based compensation expense
related to employee and director stock options, restricted stock
and ESPP purchases by expense category:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
|
(In thousands)
|
|
|
Research and development
|
|
$
|
|
|
|
$
|
563
|
|
|
$
|
632
|
|
|
$
|
1,565
|
|
General and administrative
|
|
|
311
|
|
|
|
556
|
|
|
|
1,712
|
|
|
|
1,844
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense included in operating expenses
|
|
$
|
311
|
|
|
$
|
1,119
|
|
|
$
|
2,344
|
|
|
$
|
3,409
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company determines the fair value of share-based payment
awards on the date of grant using the Black-Scholes
option-pricing model, which is affected by the Companys
stock price as well as assumptions regarding a number of highly
complex and subjective variables. Option-pricing models were
developed for use in estimating the value of traded options that
have no vesting or hedging restrictions and are fully
transferable. Although the fair value of the employee and
director stock options granted by the Company is determined
using an option-pricing model, that value may not be indicative
of the fair value observed in a willing-buyer/willing-seller
market transaction.
F-33
LA JOLLA
PHARMACEUTICAL COMPANY
Notes to
Condensed Consolidated Financial
Statements (Continued)
The Company estimated the fair value of each option grant and
ESPP purchase right on the date of grant using the Black-Scholes
option-pricing model with the following weighted-average
assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
Options:
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
Risk-free interest rate
|
|
|
|
|
|
|
3.3
|
%
|
|
|
0.6
|
%
|
|
|
3.2
|
%
|
Dividend yield
|
|
|
|
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Volatility
|
|
|
|
|
|
|
106.4
|
%
|
|
|
295.0
|
%
|
|
|
115.2
|
%
|
Expected life (years)
|
|
|
|
|
|
|
5.6
|
|
|
|
1.0
|
|
|
|
5.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
ESPP:
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
Risk-free interest rate
|
|
|
|
|
|
|
1.6
|
%
|
|
|
|
|
|
|
1.7
|
%
|
Dividend yield
|
|
|
|
|
|
|
0.0
|
%
|
|
|
|
|
|
|
0.0
|
%
|
Volatility
|
|
|
|
|
|
|
54.5
|
%
|
|
|
|
|
|
|
65.8
|
%
|
Expected life (months)
|
|
|
|
|
|
|
3.0
|
|
|
|
|
|
|
|
3.0
|
|
There were no purchases under the ESPP for the three or nine
months ended September 30, 2009. There were no options
granted in the three months ended September 30, 2009. The
weighted-average fair values of options granted was $1.18 for
the three months ended September 30, 2008. The
weighted-average fair values of options granted were $1.72 and
$1.71 for the nine months ended September 30, 2009 and
2008, respectively. For the ESPP, the weighted-average purchase
prices were $0.95 and $1.29 for the three and nine months ended
September 30, 2008, respectively.
A summary of the Companys stock option activity and
related data for the nine months ended September 30, 2009
follows:
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options
|
|
|
|
|
|
|
Weighted-
|
|
|
|
Number of
|
|
|
Average
|
|
|
|
Shares
|
|
|
Exercise Price
|
|
|
Balance at December 31, 2008
|
|
|
5,626,960
|
|
|
$
|
6.80
|
|
Granted
|
|
|
691,875
|
|
|
$
|
1.73
|
|
Exercised
|
|
|
|
|
|
$
|
|
|
Forfeited or expired
|
|
|
(2,502,942
|
)
|
|
$
|
5.23
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009
|
|
|
3,815,893
|
|
|
$
|
6.91
|
|
|
|
|
|
|
|
|
|
|
In connection with the termination of the clinical trials for
Riquent, the Company ceased all manufacturing and regulatory
activities related to Riquent and initiated steps to
significantly reduce its operating costs, including a reduction
of force, resulting in the termination of 74 employees who
received notification in February 2009 and were terminated in
April 2009. The Company recorded a charge of approximately
$1,048,000 in the quarter ended March 31, 2009, of which
$668,000 was included in research and development and $380,000
was included in general and administrative expense. The
$1,048,000 was paid in May 2009.
F-34
LA JOLLA
PHARMACEUTICAL COMPANY
Notes to
Condensed Consolidated Financial
Statements (Continued)
|
|
7.
|
Commitments
and Contingencies
|
The Company leased two adjacent buildings in San Diego,
California covering a total of approximately 54,000 square
feet. Both building leases expired in July 2009. Pursuant to one
of the leases, the Company was responsible for completing
modifications to the leased building prior to lease expiration.
In July 2009, approximately $315,000 was paid in accordance with
the lease provisions upon lease expiration and exit of the
buildings.
The Company renewed certain of its liability insurance policies
in March 2009 covering future periods. In addition, the Company
early terminated its operating leases during the quarter ended
June 30, 2009, and as a result paid a termination fee of
$100,000 in September 2009. There were no operating leases
remaining as of September 30, 2009.
|
|
8.
|
Settlement
of Liabilities
|
During the nine months ended September 30, 2009, the
Company negotiated settlements related to accounts payable
obligations and accrued liabilities with a majority of its
vendors. These negotiations resulted in reductions to accounts
payable obligations and accrued liabilities from those amounts
originally invoiced and accrued of approximately $765,000 and
$2,645,000 for the three and nine months ended
September 30, 2009, respectively, which were recorded as
expense reductions upon the execution of the settlement
agreements. As a result of these settlements, during the quarter
ended September 30, 2009 there were decreases of $711,000
and $54,000 to research and development and general and
administrative expenses, respectively. During the nine months
ended September 30, 2009 there were decreases of $2,499,000
and $146,000 to research and development and general and
administrative expenses, respectively.
In April 2009, the Company settled its notes payable obligations
at face value.
No events subsequent to September 30, 2009 that require
disclosure have occurred. The Company evaluated subsequent
events for disclosure through the time of filing on
November 13, 2009, which represents the date the financial
statements were issued.
F-35
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
Adamis Pharmaceuticals Corporation and Subsidiaries
Del Mar, California
We have audited the accompanying consolidated balance sheets of
Adamis Pharmaceuticals Corporation and Subsidiaries as of
March 31, 2009 and 2008, and the related consolidated
statements of operations, changes in stockholders equity
(deficit) and cash flows for the years then ended. These
financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the consolidated financial statements. An audit also includes
assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits
provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred
to above present fairly, in all material respects, the financial
position of Adamis Pharmaceuticals Corporation and Subsidiaries
as of March 31, 2009 and 2008, and the results of their
operations and their cash flows for the years then ended in
conformity with accounting principles generally accepted in the
United States of America.
The accompanying consolidated financial statements have been
prepared assuming the Company will continue as a going concern.
As discussed in Note 15 to the consolidated financial
statements, the Company has incurred recurring losses from
operations and has limited working capital to pursue its
business alternatives. These factors raise substantial doubt
about the Companys ability to continue as a going concern.
Managements plans with regard to these matters are also
described in Note 15. The 2009 and 2008 consolidated
financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
/s/ Goldstein
Lewin & Co.
GOLDSTEIN LEWIN & CO.
Certified Public Accountants
Boca Raton, Florida
June 30, 2009
F-36
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
ASSETS
|
CURRENT ASSETS
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
17,697
|
|
|
$
|
541
|
|
Accounts Receivable
|
|
|
136,283
|
|
|
|
76,270
|
|
Inventory, Net
|
|
|
195,167
|
|
|
|
24,263
|
|
Prepaid Expenses and Other Current Assets
|
|
|
4,087
|
|
|
|
144,221
|
|
Assets from Discontinued Operations
|
|
|
350,000
|
|
|
|
9,626,425
|
|
|
|
|
|
|
|
|
|
|
Total Current Assets
|
|
|
703,234
|
|
|
|
9,871,720
|
|
PROPERTY AND EQUIPMENT, Net
|
|
|
31,726
|
|
|
|
53,980
|
|
DEFERRED ACQUISITION COSTS
|
|
|
147,747
|
|
|
|
101,247
|
|
OTHER ASSETS
|
|
|
|
|
|
|
21,871
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$
|
882,707
|
|
|
$
|
10,048,818
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT)
|
CURRENT LIABILITIES
|
|
|
|
|
|
|
|
|
Accounts Payable
|
|
$
|
972,522
|
|
|
$
|
991,144
|
|
Accrued Expenses
|
|
|
723,896
|
|
|
|
379,982
|
|
Liabilities from Discontinued Operations
|
|
|
|
|
|
|
6,246,161
|
|
Notes Payable to Related Parties
|
|
|
599,765
|
|
|
|
1,744,000
|
|
|
|
|
|
|
|
|
|
|
Total Current Liabilities
|
|
|
2,296,183
|
|
|
|
9,361,287
|
|
NOTES PAYABLE TO RELATED PARTY
|
|
|
|
|
|
|
500,000
|
|
LONG-TERM DEBT, Net of Financing Cost
|
|
|
|
|
|
|
1,680,000
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities
|
|
|
2,296,183
|
|
|
|
11,541,287
|
|
COMMITMENTS AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
STOCKHOLDERS EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
Preferred Stock Par Value $.0001;
20,000,000 Shares Authorized; Issued and Outstanding-None
|
|
|
|
|
|
|
|
|
Common Stock Par Value $.0001;
100,000,000 Shares Authorized; 37,306,704 and
35,390,129 Issued, 36,990,704 and 35,390,129 Outstanding,
Respectively
|
|
|
3,731
|
|
|
|
3,539
|
|
Additional Paid-in Capital
|
|
|
10,762,963
|
|
|
|
8,788,417
|
|
Accumulated Deficit
|
|
|
(12,179,854
|
)
|
|
|
(10,284,425
|
)
|
Treasury Stock at Cost 316,000 and 0 Shares,
Respectively
|
|
|
(316
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Stockholders Equity (Deficit)
|
|
|
(1,413,476
|
)
|
|
|
(1,492,469
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
882,707
|
|
|
$
|
10,048,818
|
|
|
|
|
|
|
|
|
|
|
The accompanying Notes are an integral part of these
Consolidated Financial Statements
F-37
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
Year Ended March 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
REVENUE
|
|
$
|
659,538
|
|
|
$
|
621,725
|
|
COST OF GOODS SOLD
|
|
|
262,008
|
|
|
|
348,640
|
|
|
|
|
|
|
|
|
|
|
Gross Margin
|
|
|
397,530
|
|
|
|
273,085
|
|
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES
|
|
|
4,852,966
|
|
|
|
3,775,644
|
|
RESEARCH AND DEVELOPMENT
|
|
|
740,437
|
|
|
|
203,489
|
|
GOODWILL IMPAIRMENT
|
|
|
|
|
|
|
3,150,985
|
|
|
|
|
|
|
|
|
|
|
Loss from Operations
|
|
|
(5,195,873
|
)
|
|
|
(6,857,033
|
)
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE)
|
|
|
|
|
|
|
|
|
Interest Income
|
|
|
|
|
|
|
55,998
|
|
Interest Expense
|
|
|
(434,933
|
)
|
|
|
(399,031
|
)
|
Gain on Fixed Asset Disposal
|
|
|
5,766
|
|
|
|
|
|
Loss on Deposit
|
|
|
(21,871
|
)
|
|
|
|
|
Other Income
|
|
|
|
|
|
|
21,050
|
|
|
|
|
|
|
|
|
|
|
Total Other Income (Expense)
|
|
|
(451,038
|
)
|
|
|
(321,983
|
)
|
|
|
|
|
|
|
|
|
|
(Loss) from Continuing Operations
|
|
|
(5,646,911
|
)
|
|
|
(7,179,016
|
)
|
Income (Loss) from Discontinued Operations
|
|
|
3,751,482
|
|
|
|
(2,544,111
|
)
|
|
|
|
|
|
|
|
|
|
Net (Loss)
|
|
$
|
(1,895,429
|
)
|
|
$
|
(9,723,127
|
)
|
|
|
|
|
|
|
|
|
|
Basic and Diluted (Loss) Income Per Share:
|
|
|
|
|
|
|
|
|
Continuing Operations
|
|
$
|
(0.23
|
)
|
|
$
|
(0.40
|
)
|
Discontinued Operations
|
|
|
0.16
|
|
|
|
(0.08
|
)
|
|
|
|
|
|
|
|
|
|
Basic and Diluted (Loss) Per Share
|
|
$
|
(0.07
|
)
|
|
$
|
(0.48
|
)
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Weighted Average Shares Outstanding
|
|
|
24,886,573
|
|
|
|
17,764,606
|
|
|
|
|
|
|
|
|
|
|
The accompanying Notes are an integral part of these
Consolidated Financial Statements
F-38
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
Paid-In
|
|
|
Accumulated
|
|
|
Treasury
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Stock
|
|
|
Total
|
|
|
Balance March 31, 2007
|
|
|
19,677,637
|
|
|
$
|
1,968
|
|
|
$
|
1,035,085
|
|
|
$
|
(561,298
|
)
|
|
$
|
|
|
|
$
|
475,755
|
|
Investment in HealthCare Venture Group, Inc.
|
|
|
5,159,807
|
|
|
|
516
|
|
|
|
2,579,388
|
|
|
|
|
|
|
|
|
|
|
|
2,579,904
|
|
Shares Released from Escrow-Issued at Par
|
|
|
719,019
|
|
|
|
72
|
|
|
|
(72
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment in International Laboratories, Inc.
|
|
|
2,000,000
|
|
|
|
200
|
|
|
|
999,800
|
|
|
|
|
|
|
|
|
|
|
|
1,000,000
|
|
Issuance of Common Stock for Loan Financing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.50 per share
|
|
|
800,000
|
|
|
|
80
|
|
|
|
399,920
|
|
|
|
|
|
|
|
|
|
|
|
400,000
|
|
Issuance of Common Stock for Cash $0.50 per share
|
|
|
6,591,000
|
|
|
|
659
|
|
|
|
3,294,841
|
|
|
|
|
|
|
|
|
|
|
|
3,295,500
|
|
Shareholder Loan Beneficial Conversion Feature
|
|
|
|
|
|
|
|
|
|
|
80,000
|
|
|
|
|
|
|
|
|
|
|
|
80,000
|
|
Shareholder Warrant, Unexcercised
|
|
|
|
|
|
|
|
|
|
|
80,000
|
|
|
|
|
|
|
|
|
|
|
|
80,000
|
|
Issuance of Common Stock in Lieu of Interest
|
|
|
50,000
|
|
|
|
5
|
|
|
|
24,995
|
|
|
|
|
|
|
|
|
|
|
|
25,000
|
|
Issuance of Common Stock for Cash $0.75 per share
|
|
|
392,666
|
|
|
|
39
|
|
|
|
294,460
|
|
|
|
|
|
|
|
|
|
|
|
294,499
|
|
Net (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,723,127
|
)
|
|
|
|
|
|
|
(9,723,127
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance March 31, 2008
|
|
|
35,390,129
|
|
|
|
3,539
|
|
|
|
8,788,417
|
|
|
|
(10,284,425
|
)
|
|
|
|
|
|
|
(1,492,469
|
)
|
Issuance of Common Stock for Cash $0.75 per share
|
|
|
1,339,651
|
|
|
|
134
|
|
|
|
1,004,604
|
|
|
|
|
|
|
|
|
|
|
|
1,004,738
|
|
Unexcercised Beneficial Conversion Feature
|
|
|
|
|
|
|
|
|
|
|
(80,000
|
)
|
|
|
|
|
|
|
|
|
|
|
(80,000
|
)
|
Issuance of Common Stock for Cash $0.65 per share
|
|
|
76,924
|
|
|
|
8
|
|
|
|
49,992
|
|
|
|
|
|
|
|
|
|
|
|
50,000
|
|
Issuance of Common Stock in Lieu of Payments for Services
|
|
|
500,000
|
|
|
|
50
|
|
|
|
999,950
|
|
|
|
|
|
|
|
|
|
|
|
1,000,000
|
|
Purchase of Treasury Stock
|
|
|
(316,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(316
|
)
|
|
|
(316
|
)
|
Net (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,895,429
|
)
|
|
|
|
|
|
|
(1,895,429
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance March 31, 2009
|
|
|
36,990,704
|
|
|
$
|
3,731
|
|
|
$
|
10,762,963
|
|
|
$
|
(12,179,854
|
)
|
|
$
|
(316
|
)
|
|
$
|
(1,413,476
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying Notes are an integral part of these
Consolidated Financial Statements
F-39
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
Year Ended March 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
|
Net (Loss) from Continuing Operations
|
|
$
|
(5,646,911
|
)
|
|
$
|
(7,179,016
|
)
|
Adjustments to Reconcile Net (Loss) from Continuing Operations
to Net Cash (Used in) Operating Activities:
|
|
|
|
|
|
|
|
|
Deferred Acquisition Cost Amortization
|
|
|
320,000
|
|
|
|
80,000
|
|
Depreciation Expense
|
|
|
19,519
|
|
|
|
19,798
|
|
Gain on Fixed Asset Disposal
|
|
|
(5,766
|
)
|
|
|
|
|
Goodwill Impairment
|
|
|
|
|
|
|
3,150,985
|
|
Interest Expense Converted to Equity
|
|
|
(72,000
|
)
|
|
|
177,000
|
|
Inventory Reserve Adjustment
|
|
|
(42,714
|
)
|
|
|
(308,479
|
)
|
Issuance of Stock in Lieu of Services
|
|
|
1,000,000
|
|
|
|
|
|
Loss on Deposit
|
|
|
21,871
|
|
|
|
|
|
Sales Returns Reserve Adjustment
|
|
|
(120,712
|
)
|
|
|
(137,326
|
)
|
Change in Assets and Liabilities:
|
|
|
|
|
|
|
|
|
(Increase) Decrease in:
|
|
|
|
|
|
|
|
|
Accounts Receivable
|
|
|
(60,013
|
)
|
|
|
61,948
|
|
Interest Receivable
|
|
|
|
|
|
|
29,699
|
|
Inventory
|
|
|
(128,190
|
)
|
|
|
321,589
|
|
Prepaid Expenses and Other Current Assets
|
|
|
140,134
|
|
|
|
(22,306
|
)
|
Other Assets
|
|
|
|
|
|
|
571
|
|
Deferred Acquisition Costs
|
|
|
(46,500
|
)
|
|
|
(101,247
|
)
|
Increase (Decrease) in:
|
|
|
|
|
|
|
|
|
Accounts Payable
|
|
|
(18,623
|
)
|
|
|
723,345
|
|
Accrued Expenses
|
|
|
464,627
|
|
|
|
292,482
|
|
|
|
|
|
|
|
|
|
|
Net Cash (Used in) Operating Activities from Continuing
Operations
|
|
|
(4,175,278
|
)
|
|
|
(2,890,957
|
)
|
Net Cash (Used in) Operating Activities from Discontinued
Operations
|
|
|
(811,960
|
)
|
|
|
(978,017
|
)
|
|
|
|
|
|
|
|
|
|
Net Cash (Used in) Operating Activities
|
|
|
(4,987,238
|
)
|
|
|
(3,868,974
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
Cash Acquired in HealthCare Ventures Group, Inc. Acquisition
|
|
|
|
|
|
|
12,611
|
|
Cash Received from Sale of International Laboratories, Inc.
|
|
|
2,304,000
|
|
|
|
|
|
International Laboratories, Inc. Obligation Repayments
|
|
|
4,322,082
|
|
|
|
|
|
Sale of Property and Equipment
|
|
|
8,501
|
|
|
|
|
|
Purchases of Property and Equipment
|
|
|
|
|
|
|
(1,500
|
)
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by Investing Activities from Continuing
Operations
|
|
|
6,634,583
|
|
|
|
11,111
|
|
Net Cash (Used in) Investing Activities from Discontinued
Operations
|
|
|
(862,122
|
)
|
|
|
(3,946,358
|
)
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by (Used in) Investing Activities
|
|
|
5,772,461
|
|
|
|
(3,935,247
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
Decrease in Subscriptions Receivable
|
|
|
|
|
|
|
126,000
|
|
Payments of Notes Payable to Related Parties
|
|
|
(1,752,316
|
)
|
|
|
(100,000
|
)
|
Payments of Loans Payable
|
|
|
(2,000,000
|
)
|
|
|
|
|
Proceeds from Issuance of Common Stock
|
|
|
1,054,738
|
|
|
|
3,589,999
|
|
Proceeds from Issuance of Loans Payable
|
|
|
|
|
|
|
2,000,000
|
|
Proceeds from Issuance of Notes Payable to Related Parties
|
|
|
99,765
|
|
|
|
910,000
|
|
Proceeds from Issuance of Notes Payable to Shareholders
|
|
|
|
|
|
|
1,242,000
|
|
|
|
|
|
|
|
|
|
|
Net Cash (Used in) Provided by Financing Activities from
Continuing Operations
|
|
|
(2,597,813
|
)
|
|
|
7,767,999
|
|
Net Cash Provided by Financing Activities from Discontinued
Operations
|
|
|
1,829,746
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash (Used in) Provided by Financing Activities
|
|
|
(768,067
|
)
|
|
|
7,767,999
|
|
|
|
|
|
|
|
|
|
|
Increase (Decrease) in Cash
|
|
|
17,156
|
|
|
|
(36,222
|
)
|
Cash:
|
|
|
|
|
|
|
|
|
Beginning
|
|
|
541
|
|
|
|
36,763
|
|
|
|
|
|
|
|
|
|
|
Ending
|
|
$
|
17,697
|
|
|
$
|
541
|
|
|
|
|
|
|
|
|
|
|
The accompanying Notes are an integral part of these
Consolidated Financial Statements
F-40
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
Year
|
|
|
Year
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
March 31,
|
|
|
March 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
|
|
|
|
|
|
|
|
|
Cash Paid for Interest
|
|
$
|
355,465
|
|
|
$
|
86,193
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING AND INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
Stock Issued to Acquire HealthCare Ventures Group, Inc.
(Note 2)
|
|
$
|
|
|
|
$
|
2,579,904
|
|
|
|
|
|
|
|
|
|
|
Stock Issued to Acquire International Laboratories, Inc.
(Note 2)
|
|
$
|
|
|
|
$
|
1,000,000
|
|
|
|
|
|
|
|
|
|
|
Stock Issued as Loan Acquisition Cost (Note 9)
|
|
$
|
|
|
|
$
|
400,000
|
|
|
|
|
|
|
|
|
|
|
Stock Warrant Issued (Note 8)
|
|
$
|
|
|
|
$
|
80,000
|
|
|
|
|
|
|
|
|
|
|
Capital from Beneficial Conversion Feature (Note 8)
|
|
$
|
(80,000
|
)
|
|
$
|
80,000
|
|
|
|
|
|
|
|
|
|
|
Stock Issued for Interest (Note 12)
|
|
$
|
|
|
|
$
|
25,000
|
|
|
|
|
|
|
|
|
|
|
Stock Issued for Services (Note 12)
|
|
$
|
1,000,000
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying Notes are an integral part of these
Consolidated Financial Statements
F-41
|
|
NOTE 1:
|
NATURE
OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
|
Nature
of Business
Adamis Pharmaceuticals Corporation and Subsidiaries is comprised
of the following companies: Adamis Pharmaceuticals Corporation,
Adamis Viral Therapies, Inc., Adamis Laboratories, Inc., and
International Laboratories, Inc. (collectively Adamis
Pharmaceuticals, the Company, we,
our). The Companys strategic objective is to
build a publicly-held company that combines the financial
stability and sales force of a specialty pharmaceutical company
with the near-term development of biopharmaceutical products
(Note 16).
Adamis Pharmaceuticals Corporation was established under the
laws of the State of Delaware on June 6, 2006 and has
devoted substantially all its efforts to establishing a new
business. Adamis Viral Therapies, Inc. was established under the
laws of the State of Delaware on March 23, 2007, and was
merged into Adamis Pharmaceuticals Corporation, the surviving
entity, on March 30, 2007. The merged company changed its
name to Adamis Viral Therapies, Inc. (Viral) on
March 30, 2007. Viral had no activity during the periods
ended March 31, 2009 and 2008.
Adamis Holding Corporation was established under the laws of the
State of Delaware on March 23, 2007. Adamis Holding
Corporation changed its name to Adamis Pharmaceuticals
Corporation on March 30, 2007. Viral transferred all of its
authorized and outstanding shares of stock to Adamis
Pharmaceuticals Corporation on March 30, 2007.
Adamis Laboratories, Inc. (formally known as HealthCare Ventures
Group, Inc.) was established under the laws of the State of
Delaware on September 2, 2005, and was acquired by the
Company on April 23, 2007 (Note 2). On April 24,
2007, Healthcare Ventures Group, Inc. changed its name to Adamis
Laboratories, Inc. (Adamis Labs). Adamis Labs is a
distributor of respiratory products.
International Laboratories, Inc. (INL) was
incorporated in the State of Florida in March 1981. INLs
operations consist of the packaging of prescription and
non-prescription pharmaceutical and nutraceutical goods mainly
for a major retailer (Notes 2 and 3).
Effective April 1, 2009, upon the merger with Cellegy
Pharmaceuticals, Inc. (Note 16), the Company changed its
name to Adamis Corporation.
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Principles
of Consolidation
The accompanying consolidated financial statements include
Adamis Pharmaceuticals and its wholly- owned subsidiaries,
Adamis Labs and INL. All significant intercompany balances and
transactions have been eliminated in consolidation.
Accounting
Estimates
The preparation of consolidated financial statements in
conformity with accounting principles generally accepted in the
United States of America requires management to make certain
estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and
liabilities at the date of the consolidated financial statement.
Actual results could differ from those estimates, and the
differences could be material.
Long-Lived
Assets
The Company periodically assesses whether there has been
permanent impairment of its long-lived assets held and used in
accordance with Statement of Financial Standards
(SFAS) No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets
(SFAS No. 144). SFAS No. 144
requires the Company to review long-lived assets for impairment
whenever events or changes in circumstances indicate that the
carrying amount of an asset may not be recoverable.
Recoverability of assets to be held and used is measured by
comparison of the carrying
F-42
amount of the asset to future net undiscounted cash flows
expected to be generated from the use and eventual disposition
of the asset.
Discontinued
Operations
As discussed in Note 3, the results of operations for the
years ended March 31, 2009 and 2008, and the assets and
liabilities at March 31, 2009 and 2008, related to INL have
been accounted for as discontinued operations in accordance with
SFAS No. 144. There were no operations or related
assets and liabilities of INL in the accompanying consolidated
financial statements of prior periods.
Cash
and Cash Equivalents
For purposes of the consolidated statements of cash flows, the
Company considers all highly liquid investments with original
maturities at the date of purchase of three months or less to be
cash equivalents. The Company had no cash equivalents at
March 31, 2009 and 2008.
Income
Taxes
The Company accounts for income taxes in accordance with
SFAS No. 109, Accounting for Income
Taxes (SFAS No. 109).
SFAS No. 109 requires an asset and liability approach
for financial accounting and reporting for income taxes. Under
the asset and liability approach, deferred taxes are provided
for the net tax effect of temporary differences between the
carrying amount of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes.
Valuation allowances are established where management determines
that it is more likely than not that some portion or all of a
deferred tax asset will not be realized.
On April 1, 2007, the Company adopted the provisions of
Financial Accounting Standards Board (FASB)
Interpretation No. 48, Accounting for Uncertainty on
Income Taxes, and Interpretation of SFAS No. 109,
Accounting for Income Taxes, which clarifies the accounting
for income taxes by prescribing the minimum recognition
threshold a tax position is required to meet and the measurement
attribute for financial statement disclosure of tax positions
taken or expected to be taken on a tax return, and did not have
a material impact on the Companys liability for
unrecognized tax benefits.
Revenue
Recognition
Our primary customers are pharmaceutical wholesalers. In
accordance with our revenue recognition policy, revenue is
recognized when title and risk of loss are transferred to the
customer, the sale price to the customer is fixed and
determinable, and collectability of the sale price is reasonably
assured. Reported revenue is net of estimated customer returns
and other wholesaler fees. Our policy regarding sales to
customers is that we do not recognize revenue from, or the cost
of, such sales, where we believe the customer has more than a
demonstrably reasonable level of inventory. We make this
assessment based on historical demand, historical customer
ordering patterns for purchases, business considerations for
customer purchases and estimated inventory levels. If our actual
experience proves to be different than our assumptions, we would
then adjust such allowances accordingly.
We estimate allowances for revenue dilution items using a
combination of information received from third parties,
including market data, inventory reports from our major
U.S. wholesaler customers, when available, historical
information and analysis that we perform. The key assumptions
used to arrive at our best estimate of revenue dilution reserves
are estimated customer inventory levels and purchase forecasts
provided. Our estimates of inventory at wholesaler customers and
in the distribution channels are subject to the inherent
limitations of estimates that rely on third-party data, as
certain third-party information may itself rely on estimates,
and reflect other limitations. We believe that such provisions
are reasonably ascertainable due to the limited number of
assumptions involved and the consistency of historical
experience.
Fair
Value of Financial Instruments
Effective April 1, 2008, the Company adopted
SFAS No. 157, Fair Value Measurement. In
February 2008, the FASB issued FASB Staff Position
No. FAS 157-2,
Effective Date of FASB Statement No. 157, which
provides a one-
F-43
year deferral of the effective date of SFAS No. 157
for non-financial assets and non-financial liabilities, except
those that are recognized or disclosed in the financial
statements at fair value at least annually. Accordingly, the
Company adopted the provisions of SFAS No. 157 with
respect to only its financial assets and financial liabilities.
The adoption of SFAS No. 157 did not impact the
Companys results of operations, but rather, provided the
Company with a framework for measuring fair value and enhanced
the Companys disclosures about fair value measurements.
Under SFAS No. 157, fair value is defined as the
exchange price that would be received for an asset or paid to
transfer a liability (an exit price) in the principal or most
advantageous market for the asset or liability in an orderly
transaction between market participants on the measurement date.
The carrying amounts of cash, accounts receivable, accounts
payable and accrued liabilities and debt approximated fair value
due to the short maturity of the instruments. Therefore, the
adoption of SFAS No. 157 did not have a material
impact on its financial position, results of operations and cash
flows for the year ended March 31, 2009.
Inventory
Inventory, consisting of allergy and respiratory products, is
recorded at the lower of cost or market, using the weighted
average method.
Property
and Equipment
Property and equipment are recorded at cost less accumulated
depreciation. Depreciation is computed using the straight-line
method over the estimated useful lives of the related assets.
The costs of leasehold improvements, if any, are amortized over
the lesser of the lease term or the life of the improvement, if
shorter.
Estimated useful lives used to depreciate property and equipment
are as follows:
|
|
|
|
|
|
|
Estimated Useful
|
|
|
Lives in Years
|
|
Office Furniture and Equipment
|
|
|
7
|
|
Computer Equipment and Software
|
|
|
3
|
|
Vehicles
|
|
|
3
|
|
Deferred
Acquisition Costs
The Company incurred certain professional fees associated with
specific potential acquisition targets. These costs, should the
acquisition occur, will be capitalized as part of the purchase
price paid for the acquisition. Should the acquisition not
occur, the Company will expense these costs when that
determination occurs (Note 16).
Accounts
Receivable, Allowance for Doubtful Accounts and Sales
Returns
Trade accounts receivable are stated net of an allowance for
doubtful accounts. The Company estimates an allowance based on
its historical experience of the relationship between actual bad
debts and net credit sales. At March 31, 2009 and 2008, no
allowance for doubtful accounts was recorded.
The Company has established an allowance for sales returns based
on managements best estimate of probable loss inherent in
the accounts receivable balance. Management determines the
allowance based on current credit conditions, historical
experience, and other currently available information. The
allowance for sales returns was $19,501 and $21,022 at
March 31, 2009 and 2008, respectively, and is included in
accrued expenses on the consolidated balance sheets.
Registration
Payment Arrangements
The Company accounts for registration payment arrangements under
FASB Staff Position
EITF 00-19-2,
Accounting for Registration Payment
Arrangements (FSP
EITF 00-19-2).
FSP
EITF 00-19-2
specifies that the contingent obligation to make future payments
under a registration payment arrangement should be separately
recognized and measured in accordance with SFAS No. 5,
Accounting for Contingencies. FSP
EITF 00-19-2
was
F-44
issued in December 2006. Early adoption of FSP
EITF 00-19-2
is permitted and the Company adopted FSP
EITF 00-19-2
effective January 3, 2007. At March 31, 2009, the
Company has no accrued estimated penalty. (Notes 10 and 13)
Research
and Development
The Company accounts for research and development costs in
accordance with SFAS No. 2, Accounting for Research
and Development Costs (SFAS No. 2) and
Emerging Issues Task Force (EITF) Issue
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development
Activities (EITF Issue
No. 07-3).
Under SFAS No. 2, research and development costs are
expensed as incurred. EITF Issue
No. 07-3
requires non-refundable advance payments for goods and services
to be used in future research and development activities to be
recorded as an asset and expensing the payments when the
research and development activities are performed.
Research and development costs, which primarily consist of
salaries, contractor fees, facility and building costs,
utilities, administrative expenses and other corporate costs,
expensed in accordance with such pronouncements were $740,437
and $203,489 for the years ended March 31, 2009 and 2008,
respectively. Expenses related to outside contractors for
development of the Epinephrine Syringe (epi) were
$135,634 and $150,000 for the years ended March 31, 2009
and 2008, respectively. Non-refundable advanced payments used
and expensed during the years ended March 31, 2009 and 2008
were $225,459 and $0, respectively. Non-refundable advanced
payments for products to be used in the development of EPI were
$0 and $39,769 at March 31, 2009 and 2008, respectively.
Expenses related to outside contractors for the development of
influenza technology were $379,344 and $50,000 for the years
ended March 31, 2009 and 2008, respectively.
Shipping
and Handling
Shipping and handling costs are included in selling, general and
administrative expenses. Shipping and handling costs were
$13,651 and $23,046 for the years ended March 31, 2009 and
2008, respectively.
Advertising
Expenses
Advertising costs are expensed as incurred as set forth in
Statement of Position (SOP)
No. 93-7,
Reporting on Advertising Costs. The Company
incurred $2,848 and $0 of advertising expense for the years
ended March 31, 2009 and 2008, respectively.
Net
Loss Per Share
The Company computes net loss per share in accordance with
SFAS No. 128, Earnings per Share,
under the provisions of which basic loss per share is computed
by dividing the loss attributable to holders of common stock for
the period by the weighted average number of shares of common
stock outstanding during the period. Since the effect of common
stock equivalents was anti-dilutive, all such equivalents were
excluded from the calculation of weighted average shares
outstanding. There were 1,000,000 outstanding warrants at
March 31, 2009 and 2008.
Recent
Accounting Pronouncements
In December 2007, the FASB issued SFAS No. 141
(revised 2007), Business Combinations
(SFAS No. 141(R)), which establishes the
principles and requirements for how an acquirer:
(1) recognizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed, and any
noncontrolling interest in the acquiree; (2) recognizes and
measures the goodwill acquired in the business combination or a
gain from a bargain purchase; (3) determines what
information to disclose to enable users of the financial
statements to evaluate the nature and financial effects of the
business combination; and (4) requires acquisition costs
incurred prior to acquisition to be expensed rather than
deferred. SFAS No. 141(R) replaces
SFAS No. 141. SFAS No. 141(R) is effective
in fiscal years beginning after December 15, 2008. The
Company has noted that under the provisions of
SFAS No. 141(R), $147,747 and $101,247 capitalized as
deferred acquisition costs at March 31, 2009 and 2008,
respectively, would be expensed.
F-45
In February 2008, the FASB issued FSP
SFAS No. 157-1,
Application of FASB Statement No. 157 to FASB
Statement No. 13 and Its Related Interpretive Accounting
Pronouncements That Address Leasing Transactions
(FSP SFS
No. 157-1),
and FSP
SFAS No. 157-2,
Effective Date of FASB Statement No. 157
(FSP
SFAS No. 157-2).
FSP
SFAS No. 157-1
removes leasing from the scope of SFAS No. 157. FSP
SFAS No. 157-2
delays the effective date of SFAS No. 157 for the
Company from its fiscal 2009 to 2010 year for all
nonfinancial assets and nonfinancial liabilities, except those
that are recognized or disclosed at fair value in the financial
statements on a recurring basis (at least annually). The Company
does not expect that its adoption of the provisions of FSP
SFAS No. 157-1
and FSP
SFAS No. 157-2
will have a material effect on its financial condition, results
of operations or cash flows.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interests in Consolidated Financial
Statements, which establishes accounting and recording
standards for the noncontrolling interest (minority interest) in
a subsidiary and for the deconsolidation of a subsidiary to make
them consistent with the requirements of
SFAS No. 141(R). SFAS No. 160 is effective
in fiscal years beginning after December 15, 2008. The
Company does not expect that its adoption of the provisions of
SFAS No. 160 will have a material effect on its
financial condition, results of operations or cash flows.
In June 2007, the FASB ratified EITF Issue
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods
or Services to Be Used in Future Research and Development
Activities. EITF Issue
No. 07-3
requires non-refundable advance payments for goods and services
to be used in future research and development activities to be
recorded as an asset and expensing the payments when the
research and development activities are performed. EITF Issue
No. 07-3
applies prospectively for new contractual arrangements entered
into in fiscal years beginning after December 15, 2007. The
Company currently recognizes these non-refundable advanced
payments as an asset upon payment, and expenses costs as goods
are used and services are provided.
Acquisition
of HealthCare Ventures Group, Inc.
On April 23, 2007, the Company acquired all of the
outstanding shares of HealthCare Ventures Group, Inc. in
exchange for 5,159,807 shares of common stock valued at
$0.50 per share, or approximately $2.6 million (the
HVG Acquisition). The purchase agreement provides
for an additional 7,451,304 restricted shares held in escrow
with issuance conditional upon future earnings targets, 719,019
of which were subsequently released and reissued at par value.
The acquired companys name was changed to Adamis Labs.
The HVG Acquisition was accounted for as a business combination
using the purchase method of accounting under the provisions of
SFAS No. 141. Accordingly, the results of Adamis
Labs operations have been included in the consolidated
financial statements from the date of acquisition. The
allocation of consideration for acquisitions requires extensive
use of accounting estimates and managements judgment to
allocate the purchase price of tangible and identifiable
intangible assets acquired and liabilities assumed based on
their respective fair values. Management believes fair values
assigned to the assets acquired and liabilities assumed are
based on reasonable estimates and assumptions.
F-46
The purchase price for the HVG Acquisition was allocated to
tangible and identifiable intangible assets acquired and
liabilities assumed based on their estimated fair values at the
acquisition date, with the excess being allocated to intangible
assets, as follows:
|
|
|
|
|
Cash
|
|
$
|
12,611
|
|
Accounts Receivable
|
|
|
138,218
|
|
Inventory
|
|
|
37,373
|
|
Prepaid and Other Current Assets
|
|
|
71,915
|
|
Property
|
|
|
69,645
|
|
Other Assets
|
|
|
22,442
|
|
Intangibles
|
|
|
3,150,985
|
|
Accounts Payable
|
|
|
(148,657
|
)
|
Accrued Liabilities
|
|
|
(191,611
|
)
|
Interest Payable
|
|
|
(33,017
|
)
|
Loan Payable
|
|
|
(550,000
|
)
|
|
|
|
|
|
Net Assets Acquired
|
|
$
|
2,579,904
|
|
|
|
|
|
|
During the year ended March 31, 2008, the Company recorded
an impairment charge related to the intangible asset (consisting
primarily of a distribution network) associated with the
transaction that the Company determined had no remaining value.
The following table represents summarized financial information
of the results of operations included in the Consolidated
Statement of Operations for the years ended March 31, 2009
and 2008, respectively:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
Revenue, net
|
|
$
|
659,538
|
|
|
$
|
621,725
|
|
Operating Loss
|
|
$
|
(1,760,599
|
)
|
|
$
|
(5,060,544
|
)
|
Net Loss from Operations
|
|
$
|
(1,788,033
|
)
|
|
$
|
(5,039,494
|
)
|
Acquisition
of International Laboratories, Inc.
On December 31, 2007, the Company acquired all of the
outstanding shares of INL in an all stock transaction for
2,000,000 shares of common stock valued at $0.50 per share,
or $1.0 million (the INL Acquisition). The
purchase agreement provided for an additional 8,000,000
restricted shares to be held in escrow with issuance conditional
upon future earnings targets (Note 3).
The INL Acquisition was accounted for as a business combination
using the purchase method of accounting under the provisions of
SFAS No. 141. Accordingly, the results of
International Laboratories, Inc.s operations have been
included in the consolidated financial statements beginning
December 31, 2007. The allocation of consideration for
acquisitions requires extensive use of accounting estimates and
management judgment to allocate the purchase price of tangible
and identifiable intangible assets acquired and liabilities
assumed based on their respective fair values. Management
believes the fair values assigned to the assets acquired and
liabilities assumed are based on reasonable estimates and
assumptions.
The purchase price for the INL Acquisition was allocated to
tangible and identifiable intangible assets acquired and
liabilities assumed based on their estimated fair values at the
acquisition date, with the excess being allocated to intangible
assets, as Management deems a significant customer agreement
with a finite term as the value purchased. The customer
agreement was with a major retailer, and without such agreement
Adamis would not have acquired INL. The length of the agreement
at the time of INLs purchase was in excess of two and
one-half years.
F-47
The purchase price was allocated as follows:
|
|
|
|
|
Cash and Cash Equivalents
|
|
$
|
219,321
|
|
Accounts Receivable
|
|
|
707,101
|
|
Prepaid Expenses and Other Current Assets
|
|
|
29,155
|
|
Inventory
|
|
|
305,723
|
|
Property
|
|
|
434,935
|
|
Intangible Asset Acquired
|
|
|
6,328,704
|
|
Accounts Payable
|
|
|
(1,757,312
|
)
|
Accrued Liabilities
|
|
|
(282,307
|
)
|
Deferred Revenue
|
|
|
(114,437
|
)
|
Current Portion of Long-Term Debt
|
|
|
(151,930
|
)
|
Long-Term Debt
|
|
|
(4,718,953
|
)
|
|
|
|
|
|
Net Assets Acquired
|
|
$
|
1,000,000
|
|
|
|
|
|
|
The customer agreement valued as the acquired intangible asset
had a remaining term of 2.5 years at the acquisition date.
Amortization of the intangible asset recorded during the years
ended March 31, 2009 and 2008 was $759,444 and $632,870,
respectively.
Subsequent to year-end, INL was sold. Accordingly, the assets,
liabilities, and results from operations are classified as
discontinued operations in the consolidated financial statements
(Note 3).
|
|
NOTE 3:
|
DISCONTINUED
OPERATIONS
|
Effective July 18, 2008, the Companys packaging
division (INL) (Note 2) was sold for $2,654,000. On
the closing date, $2,154,000 was paid to a lender
(investor Note 10) to retire long-term
debt. Additionally, $500,000 of the purchase price was held in
escrow to secure any of the Companys indemnification
obligations (Note 12). In addition, INL repaid loans and
accrued interest of $4,630,813 to Adamis Pharmaceuticals;
however, the Company forgave $570,618 of outstanding loans to
INL. The 8,000,000 shares of common stock held in escrow in
connection with the Companys purchase of INL were released
and cancelled in conjunction with the sale agreement.
In May 2009, INL settled litigation with MBA Marketing, LLC, in
which INL was the defendant, awarding the plaintiff $150,000
(Note 12). The settlement was included as an indemnity
obligation in the purchase agreement, and reduces the purchase
price, cash held in escrow and related receivable.
The following table presents information regarding the
calculation of the gain from the sale of INL:
|
|
|
|
|
Sale Price Imperium note payment
|
|
$
|
2,154,000
|
|
Sale Price Cash held in Escrow
|
|
|
350,000
|
|
|
|
|
|
|
Total Sale Price
|
|
|
2,504,000
|
|
|
|
|
|
|
INL Assets
|
|
|
9,615,763
|
|
INL Liabilities
|
|
|
(13,470,365
|
)
|
|
|
|
|
|
Net Liabilities
|
|
|
(3,854,602
|
)
|
Amount of inter-company loan not paid by Buyer
|
|
|
570,618
|
|
|
|
|
|
|
Total Basis
|
|
|
(3,283,984
|
)
|
|
|
|
|
|
Gain on Sale
|
|
$
|
5,787,984
|
|
|
|
|
|
|
Operating loss from INL from the acquisition date through
disposal, excluding the gain on sale, was $4,580,613.
Total income from discontinued operations for year ended
March 31, 2009 was $3,751,482, and total loss from
discontinued operations for the year ended March 31, 2008
was $2,544,111.
F-48
The following table presents the major classes of assets and
liabilities that have been presented as assets and liabilities
of discontinued operations at:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2009
|
|
March 31, 2008
|
|
Cash and Cash Equivalents
|
|
$
|
|
|
|
$
|
144,490
|
|
Purchase Price Held in Escrow
|
|
|
350,000
|
|
|
|
|
|
Accounts Receivable
|
|
|
|
|
|
|
1,361,973
|
|
Prepaid Expenses and Other Current Assets
|
|
|
|
|
|
|
12,634
|
|
Inventory
|
|
|
|
|
|
|
464,887
|
|
Property
|
|
|
|
|
|
|
1,946,607
|
|
Long-Term Assets
|
|
|
|
|
|
|
5,695,834
|
|
|
|
|
|
|
|
|
|
|
Total Assets from Discontinued Operations
|
|
$
|
350,000
|
|
|
$
|
9,626,425
|
|
|
|
|
|
|
|
|
|
|
Accounts Payable
|
|
$
|
|
|
|
$
|
2,957,629
|
|
Accrued Liabilities
|
|
|
|
|
|
|
455,456
|
|
Accrued Interest
|
|
|
|
|
|
|
2,036
|
|
Deferred Revenue
|
|
|
|
|
|
|
381,193
|
|
Debt
|
|
|
|
|
|
|
2,449,847
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities from Discontinued Operations
|
|
$
|
|
|
|
$
|
6,246,161
|
|
|
|
|
|
|
|
|
|
|
On January 22, 2009, the Company entered into a one-year
factoring and security agreement with a third party. The
agreement provides for a maximum funding amount of $300,000. The
agreement stipulates an initial and periodic (5 days)
factoring fee of .375%. The Company may take advances of 80% of
the net factored accounts. The Company had a factor receivable
of $11,528 at March 31, 2009.
|
|
NOTE 5:
|
CONCENTRATIONS
OF CREDIT RISK
|
Financial instruments that potentially subject the Company to
credit risk consist principally of cash, accounts receivable,
purchases and accounts payable.
Cash
The Company at times may have cash in excess of the Federal
Deposit Insurance Corporation (FDIC) limit. The
Company maintains its cash with larger financial institutions.
The Company has not experienced losses on these accounts and
management believes that the Company is not exposed to
significant risks on such accounts.
Sales
and Accounts Receivable
The Company is dependant on a limited number of customers for a
significant portion of its revenue. During the year ended
March 31, 2009, the Companys two largest customers,
Customers A and B accounted for approximately 37% and 19%,
respectively, of the Companys net sales. During the year
ended March 31, 2008, these two customers accounted for
approximately 35% and 38% respectively, of the Companys
net sales. During the year ended March 31, 2008 the Company
had a third Customer C that accounted for approximately 11% of
Companys net sales.
The Company grants credit to customers, substantially all of
whom are pharmaceutical distribution and medical parties located
throughout the United States. The Company typically does not
require collateral from customers. The Company monitors exposure
to credit losses and maintains allowances for anticipated losses
considered necessary under the circumstances.
F-49
Accounts receivable from Customer A amounted to approximately
72% of Companys accounts receivable at March 31,
2009. The Company had no accounts receivable from Customer B at
March 31, 2009. Accounts receivable from Customers A
amounted to approximately 30% of total accounts receivable at
March 31, 2008.
Trade accounts receivable were $124,755 and $76,270 at
March 31, 2009 and 2008 respectively.
Trade accounts receivable do not include factor receivable of
$11,528 and $0 at March 31, 2009 and 2008 respectively.
Purchases
and Accounts Payable
The Company had no outstanding balance greater than 10% of total
accounts payable at March 31, 2009 and 2008.
The Company is dependant on a limited number of vendors for a
significant portion of its trade purchases. The Company had one
vendor that comprised 98% and 13% of the total trade purchases
during the years ended March 31, 2009 and 2008,
respectively.
Inventory consists of the following at March 31, 2009 and
2008, respectively:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
Respiratory and Allergy Products
|
|
$
|
52,843
|
|
|
$
|
104,151
|
|
Less: Obsolescence Reserve
|
|
|
(37,175
|
)
|
|
|
(79,888
|
)
|
|
|
|
|
|
|
|
|
|
Respiratory and Allergy Products, Net
|
|
|
15,668
|
|
|
|
24,263
|
|
Pre-Launch epi Inventory
|
|
|
179,499
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory, Net
|
|
$
|
195,167
|
|
|
$
|
24,263
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 7:
|
PREPAID
EXPENSES AND OTHER CURRENT ASSETS
|
Prepaid expenses and other current assets at March 31, 2009
and 2008 consists of the following:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
Prepaid Insurance
|
|
$
|
3,452
|
|
|
$
|
64,755
|
|
Prepaid Rent
|
|
|
635
|
|
|
|
39,697
|
|
Prepaid Inventory
|
|
|
|
|
|
|
39,769
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
4,087
|
|
|
$
|
144,221
|
|
|
|
|
|
|
|
|
|
|
Prepaid inventory at March 31, 2008 consists of supplies
valued at a cost of $39,769, which was used for epi research,
development and testing. The remaining amount is expected to be
sold upon the launch of the epi product, and is now recorded as
pre-launch inventory (Note 6).
F-50
|
|
NOTE 8:
|
PROPERTY
AND EQUIPMENT
|
Property and Equipment consists of the following at
March 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
Office Furniture and Equipment
|
|
$
|
128,738
|
|
|
$
|
133,038
|
|
Computer Equipment
|
|
|
22,707
|
|
|
|
22,707
|
|
Computer Software
|
|
|
59,639
|
|
|
|
59,639
|
|
Vehicles
|
|
|
|
|
|
|
13,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
211,084
|
|
|
|
228,884
|
|
Less: Accumulated Depreciation
|
|
|
(179,358
|
)
|
|
|
(174,904
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
31,726
|
|
|
$
|
53,980
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 9:
|
NOTES PAYABLE
TO RELATED PARTIES
|
The Company had notes payable to related parties amounting to
$599,765 and $2,244,000 at March 31, 2009 and 2008,
respectively, which bear interest at various rates between 10%
and 12%. All of the notes payable were from related parties and
$480,000 at March 31, 2008 were not collateralized. The
remaining notes were collateralized by the Companys assets
or optional conversion features. The Company retired $1,744,000
of the notes payable in July 2008.
On November 15, 2007, the Company issued a convertible
promissory note to a shareholder for $1,000,000 (included in the
amounts above) that bore interest at 10% per annum, matured on
April 15, 2008, and granted a warrant, that expires on
November 15, 2012, to issue 1,000,000 shares of the
Companys common stock with an exercise price of $0.50 per
share.
The warrant also includes piggyback registration rights in the
event the Company files a registration statement with the
Securities and Exchange Commission (SEC) subsequent
to exercise of the warrant. The Company determined the present
value of the warrant at the grant date to be $0.42 per share
using the Black-Scholes method, assuming 0.10% volatility, 0.00%
dividend rate, and a discount rate of 3.67%.
The difference between the present value and the exercise price
for the warrants, or $80,000, was recorded as additional paid-in
capital and a discount to the note payable, and was accreted on
a straight-line basis as interest expense over the term of the
note. The balance of the discount was $8,000 at March 31,
2008.
The note also contained a conversion feature that extends the
shareholder the right to convert the note into $1,000,000 of the
Companys common stock at a rate of $0.50 per share, or
2,000,000 shares. The conversion of the $1,000,000 note,
net of the $80,000 discount, or $920,000, into
2,000,000 shares at a net value of $0.46 per share results
in a beneficial conversion. Accordingly, the benefit per share
was recorded as additional paid-in capital and a one-time
interest charge of $80,000.
The effective interest rate of the note considering the attached
warrant and beneficial conversion feature is 39.6%.
The note and accrued interest were retired on July 21,
2008, subsequent to the stated April 15, 2008 maturity
date. The Company continued to pay interest through the
retirement of the note, and there were no other penalties
required by the lender resulting from the default. The
additional paid-in capital recorded as a result of the
beneficial conversion feature was reversed as the feature was
not exercised.
On February 12, 2008, the Company issued a convertible
promissory note to Cellegy Pharmaceuticals, Inc.
(Cellegy) for $500,000 (included in the above
amount) that bears interest at 10% per annum, with an original
maturity date of June 12, 2009. The conversion feature
extends to Cellegy the right to convert the principal amount of
the note and accrued interest into shares of the Companys
common stock at the fair market value at the time of the note,
or $0.50 per share, in the event that the effective date of the
merger between Cellegy and the Company precedes the stated
maturity date or an event of default. The merger became
effective April 1, 2009 (Note 16).
F-51
On December 23, 2008, January 8, 2009, and
March 10, 2009, the Company issued promissory notes to a
shareholder for a total of $99,765 that bear interest of 10%
with all principal and interest due on the maturity dates of
December 31, 2009, January 8, 2010, and March 10,
2010, respectively.
Long-term debt at March 31, 2008 consisted of two
$1,000,000 notes payable to an investor. The Notes bore interest
at 12% and are due on April 1, 2009 and April 10,
2009, respectively. The investor was also issued
800,000 shares of the Companys stock as a condition
to issue the debt, valued at $0.50 per share, or $400,000,
recorded as deferred financing costs, which was amortized using
the straight-line method over the term of the note. Unamortized
financing costs at March 31, 2009 and 2008 amounted to
$320,000 and $0, respectively (Note 12).
On July 18, 2008, the Company retired all of its long-term
debt plus accrued interest and early payment penalties of
$154,000 in connection with the sale of INL. The remaining
balance of the unamortized financing costs was charged to
interest as a result of the retirement.
|
|
NOTE 11:
|
LICENSE
AGREEMENTS
|
On July 28, 2006, the Company entered into a nonexclusive,
royalty free license agreement with an entity for the technology
used to research and develop new viral therapies, and an
exclusive royalty-bearing license requiring a small percentage
of revenue received by the Company on future products developed
and sold with a payment cap of $10,000,000. The Company paid the
entity an initial license fee and granted one of the
entitys officers the right to purchase 1,000,000
Founders shares in the Company at price of $0.001 pursuant
to a separate stock purchase agreement. The Company also granted
the entity a royalty-free non-exclusive license to use any
improvements made on the existing technology for research
purposes only. The Company and the entity have the right to
sublicense with written permission of each party. In the event
that the entity sublicenses or sells the improved technology to
a third party, then a portion of the total payments, to be
decided by mutual agreement, will be due to the Company.
The Company is obligated to make the following milestone
payments to the entity based on commencement of various clinical
trials and submissions of an application to the FDA for
regulatory approval:
|
|
|
|
|
Amount
|
|
Date due
|
|
|
$50,000
|
|
|
Within 30 days of commencement of Phase I/II clinical trial.
|
|
50,000
|
|
|
Within 30 days of commencement of a separate Phase II
trial as required by the FDA.
|
|
300,000
|
|
|
Within 30 days of commencement of a Phase III trial.
|
|
500,000
|
|
|
Within 30 days of submission of a biological license
application or a new drug application with the FDA.
|
The total milestone payments are not to exceed $900,000 and can
only be paid one time and will not repeat for subsequent
products. At March 31, 2009, no milestones have been
achieved.
The agreement will remain in effect as long as the patent rights
remain in effect. Adamis has the right to terminate the
agreement if it is determined that no viable product can come
from the technology. Adamis would be required to transfer and
assign all filings, rights and other information in its control
if termination occurs. Adamis would retain the same royalty
rights for license, or sublicense, agreements if the technology
is later developed into a product. Either party may terminate
the license agreement in the event of a material breach of the
agreement by the other party that has not been cured or
corrected within 90 days of notice of the breach.
On September 22, 2006, the Company entered into an
agreement with an entity to manufacture an influenza vaccine for
the Company. The agreement requires the Company to pay $70,000
upon commencement of the project, followed by monthly payments
based upon services performed until the project is complete. No
product has been manufactured and no payments have been made at
March 31, 2009. Once the project begins, the total payments
will aggregate $283,420. The project has an open ended start
time. Adamis may terminate the agreement upon notice to the
other party, reimbursing the other party for non cancellable
materials and supplies ordered, and work in progress, through
the date of the termination.
F-52
|
|
NOTE 12:
|
COMMITMENTS
AND CONTINGENCIES
|
Contingencies
In conjunction with the issuance of the long-term debt and
private placement of 800,000 shares of Common Stock to one
investor (Notes 9 and 10), the Company entered into a
registration rights agreement on December 21, 2007, which
required the Company to file a registration statement for the
resale of the common shares. The Company must file a
registration statement within one year of the first closing date
(December 21, 2007). The Company must also use its best
efforts to have the registration statement declared effective
within 90 days of the filing with the Securities and
Exchange Commission (SEC). In addition, the Company
must use its best efforts to maintain the effectiveness of the
registration statement until all common shares have been sold or
may be sold without volume restrictions pursuant to
Rule 144(k) of the Securities Act.
If the registration statement is not filed or declared effective
within the allowable time frame or the Company cannot maintain
its effectiveness, the Company must pay partial liquidated
damages in cash to the investor amounting to $30,000 for each
30 day period that the Registration default remains uncured
up to a cumulative amount of $200,000. This obligation of the
Company is to cease if certain terms related to these shares in
conjunction with the merger are satisfied. The merger
transaction was completed April 1, 2009 (Note 16).
Litigation
INL was a party in a State of Florida 6th Judicial Circuit
action styled MBA MARKETING, LLC d/b/a EXPRESS PERSONNEL
SERVICES, a Florida limited liability company v.
INTERNATIONAL LABORATORIES, INC., a Florida for profit
corporation CASE NO.:
08-4941 CI
19. The claim was settled in May 2009, granting the plaintiff
$150,000, which the Company must deliver in two payments of
$75,000 within 75 days and 90 days, respectively, of
the settlement agreement. This amount is to be repaid from
assets of discontinued operations held in escrow (Note 3).
|
|
NOTE 13:
|
CAPITAL
STRUCTURE
|
The Company is authorized to issue 100,000,000 shares of
common stock and 20,000,000 shares of preferred stock with
a par value of $0.0001 per share.
In April 2007, the Company issued 5,159,807 shares of its
common stock in exchange for all of the outstanding shares of
HVG at $0.50 per share (Note 2). The Company had repurchase
options related to 1,000,000 of the shares, of which 684,000
have lapsed. The remaining 316,000 were exercised by the Company
and repurchased at $.001 per share per the repurchase agreement.
In November 2007, 669,019 shares of the Companys
common stock were reissued to executives of the Company with
various repurchase rights, which are not included in the
calculation of weighted average shares outstanding.
In November 2007, the Company issued 50,000 shares of its
common stock at $0.50 per share in lieu of interest associated
with an outstanding loan.
In December 2007, the Company issued 800,000 of its common stock
at $0.50 per share as costs to obtain long-term debt
(Note 10).
In December 2007, the Company issued 2,000,000 shares of
its common stock in exchange for all of the outstanding shares
of INL at $0.50 per share.
On various dates during 2007, the Company sold
6,591,000 shares of its common stock valued at $0.50 per
share, or $3,295,500, in a private placement.
On various dates during the period ended March 31, 2008,
the Company sold 392,666 shares of its common stock valued
at $0.75, or $294,499, in a private placement.
On various dates during the period ended March 31, 2009,
the Company sold 1,339,651 shares of its common stock
valued at $0.75, or $1,004,738, in a private placement.
F-53
On various dates during the period ended March 31, 2009,
the Company sold 76,924 shares of its common stock valued
at $0.65, or $50,000, in a private placement.
In December 2008, The Company issued 500,000 shares of its
common stock as payment for past consulting services. According
to the consulting agreement, the stock is guaranteed to have a
value of $1,000,000 within ten business days of the
agreements anniversary on March 20, 2010, and is
non-refundable. Therefore, the Company may be required to issue
additional shares of common stock to the consultant if the value
of the 500,000 shares issued is less than $1,000,000 on
such date.
The Company did not elect to file consolidated tax returns.
Accordingly, the deferred tax assets for each of the
consolidated companies can only be used to offset future tax
expense of the respective company.
The benefit for income taxes from continuing operations consists
of the following for the years ended March 31, 2009 and
2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
|
Adamis
|
|
2009
|
|
Adamis
|
|
2008
|
|
|
Pharmaceuticals
|
|
Adamis Labs
|
|
Pharmaceuticals
|
|
Adamis Labs
|
|
Current
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Deferred
|
|
|
(188,000
|
)
|
|
|
(793,000
|
)
|
|
|
(606,000
|
)
|
|
|
(741,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
(188,000
|
)
|
|
|
(793,000
|
)
|
|
|
(606,000
|
)
|
|
|
(741,000
|
)
|
Change in Valuation Allowance
|
|
|
188,000
|
|
|
|
793,000
|
|
|
|
606,000
|
|
|
|
741,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax Benefit, net
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At March 31, 2009 and 2008, the significant components of
the deferred tax assets from continuing operations are
summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
|
Adamis
|
|
2009
|
|
Adamis
|
|
2008
|
|
|
Pharmaceuticals
|
|
Adamis Labs
|
|
Pharmaceuticals
|
|
Adamis Labs
|
|
Net Operating Loss Carryforwards
|
|
$
|
1,051,000
|
|
|
$
|
1,559,000
|
|
|
$
|
812,000
|
|
|
$
|
843,000
|
|
Deferred Tax Assets
|
|
|
135,000
|
|
|
|
210,000
|
|
|
|
128,000
|
|
|
|
133,000
|
|
Deferred Tax (Liabilities)
|
|
|
(181,000
|
)
|
|
|
|
|
|
|
(123,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Deferred Tax Assets
|
|
|
1,005,000
|
|
|
|
1,769,000
|
|
|
|
817,000
|
|
|
|
976,000
|
|
Less Valuation Allowance
|
|
|
(1,005,000
|
)
|
|
|
(1,769,000
|
)
|
|
|
(817,000
|
)
|
|
|
(976,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Deferred Tax Assets
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We have determined at March 31, 2009 and 2008 that a full
valuation allowance would be required against all of our
operating loss carryforwards and deferred tax assets that we do
not expect to be utilized by deferred tax liabilities.
F-54
The following table reconciles our losses from continuing
operations before income taxes for the years ended
March 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
|
Adamis
|
|
2009
|
|
Adamis
|
|
2008
|
|
|
Pharmaceuticals
|
|
Adamis Labs
|
|
Pharmaceuticals
|
|
Adamis Labs
|
|
Income (Loss) from Continuing Operations
|
|
$
|
1,919,000
|
|
|
$
|
(1,778,000
|
)
|
|
$
|
(2,165,000
|
)
|
|
$
|
(5,014,000
|
)
|
Permanent Differences:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill Impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,151,000
|
|
Non-Cash Interest
|
|
|
248,000
|
|
|
|
|
|
|
|
257,000
|
|
|
|
|
|
Non-Cash Services
|
|
|
1,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INL Gain
|
|
|
(4,064,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Meals and Entertainment
|
|
|
|
|
|
|
3,000
|
|
|
|
64,000
|
|
|
|
14,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(897,000
|
)
|
|
$
|
(1,775,000
|
)
|
|
$
|
(1,844,000
|
)
|
|
$
|
(1,849,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal Statutory Rate 34.00%
|
|
$
|
652,000
|
|
|
$
|
(605,000
|
)
|
|
$
|
(736,000
|
)
|
|
$
|
(1,705,000
|
)
|
State Income Tax, net of Federal Tax 3.63%
|
|
|
70,000
|
|
|
|
(65,000
|
)
|
|
|
(79,000
|
)
|
|
|
(182,000
|
)
|
Intercompany Eliminations 37.63%
|
|
|
353,000
|
|
|
|
(124,000
|
)
|
|
|
88,000
|
|
|
|
(45,000
|
)
|
Permanent Differences 37.63%
|
|
|
(1,263,000
|
)
|
|
|
1,000
|
|
|
|
121,000
|
|
|
|
1,191,000
|
|
Change in Valuation Allowance
|
|
|
188,000
|
|
|
|
793,000
|
|
|
|
606,000
|
|
|
|
741,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected Tax Benefit
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We paid no income tax during the years ended March 31, 2009
and 2008. We do not expect to pay income tax in the fiscal year
ending March 31, 2009. Utilization of certain of the loss
carryforward under Internal Revenue Code
Section No. 382 may be limited.
The Companys consolidated financial statements are
prepared using the generally accepted accounting principles
applicable to a going concern, which contemplates the
realization of assets and liquidation of liabilities in the
normal course of business. However, as shown in the accompanying
consolidated financial statements, the Company has sustained
substantial losses from continuing operations since inception
and has not introduced new revenue producing products since
inception. In addition, the Company has used, rather than
provided, cash in its continuing operations. Without realization
of additional capital, it would be unlikely for the Company to
continue as a going concern. It is managements plan in
this regard to obtain additional working capital through debt
and equity financings. The consolidated financial statements do
not include any adjustments relating to the recoverability and
classification of recorded asset amounts and classification of
liabilities that might be necessary should the Company be unable
to continue in existence.
|
|
NOTE 16:
|
SUBSEQUENT
EVENT
|
Merger
with Cellegy
The Company entered into a merger agreement on February 12,
2008 with Cellegy. The stockholders of Cellegy and the Company
approved the merger transaction and related matters at an annual
meeting of Cellegys stockholders and at a special meeting
of Adamis stockholders each held on March 23, 2009. On
April 1, 2009, Cellegy completed the merger transaction
with the Company. In connection with the closing of the merger
transaction, the Companys $500,000 promissory note
converted into shares of the Companys stock, and these
shares were immediately cancelled in accordance with the
underlying note payable (Note 9).
F-55
In connection with the consummation of the merger and pursuant
to the terms of the merger agreement, Cellegy changed its name
from Cellegy Pharmaceuticals, Inc. to Adamis Pharmaceuticals
Corporation, and the Company changed its corporate name to
Adamis Corporation.
Pursuant to the terms of the merger agreement, immediately
before the consummation of the merger Cellegy affected a reverse
stock split of its common stock. Pursuant to this reverse stock
split, each 9.929060333 shares of common stock of Cellegy
that were issued and outstanding immediately before the
effective time of the merger was converted into one share of
common stock and any remaining fractional shares held by a
stockholder (after the aggregating fractional shares) were
rounded up to the nearest whole share (the Reverse
Split).
As a result, the total number of shares of Cellegy that were
outstanding immediately before the effective time of the merger
were converted into approximately 3,000,000 shares of
post-Reverse Split shares of common stock of the Company.
Pursuant to the terms of the merger agreement, at the effective
time of the merger, each share of the Companys common
stock that was issued and outstanding immediately before the
effective time of the merger ceased to be outstanding and was
converted into the right to receive one share of common stock of
Cellegy.
During 2008, the Cellegys common stock traded on the OTCBB
under the symbol CLGY.OB. In April, 2009, and
following the merger with Cellegy and the change of
Cellegys corporate name, the trading symbol for the common
stock changed to ADMP.
Also in connection with the closing of the merger, Cellegy
amended its certificate of incorporation to increase the
authorized number of shares of common stock from 50,000,000 to
175,000,000 and the authorized number of shares of preferred
stock from 5,000,000 to 10,000,000.
The assets acquired and liabilities assumed of Cellegy at
April 1, 2009 are summarized as follows:
|
|
|
|
|
Current Assets
|
|
$
|
91,000
|
|
Other Assets
|
|
|
557,000
|
|
Current Liabilities
|
|
|
504,000
|
|
Notes Payable Long-Term
|
|
|
778,000
|
|
Other assets includes $500,000, plus accrued interest, due from
the Company.
The cost of the acquisition* to Adamis is equal to
Cellegys stockholders deficit, which was
approximately $1,191,000 at March 31, 2009.
Cellegys stockholders also approved a new 2009 Equity
Incentive Plan (the 2009 Plan), which became
effective upon the closing of the merger. The 2009 Plan provides
for the grant of incentive stock options, non-statutory stock
options, restricted stock awards, restricted stock unit awards,
stock appreciation rights, performance stock awards, and other
forms of equity compensation (collectively stock
awards). In addition, the 2009 Plan provides for the grant
of performance cash awards. The aggregate number of shares of
common stock that may be issued initially pursuant to stock
awards under the 2009 Plan is 7,000,000 shares. The number
of shares of common stock reserved for issuance will
automatically increase on January 1 of each calendar year, from
January 1, 2010 through and including January 1, 2019,
by the lesser of (a) 5.0% of the total number of shares of
common stock outstanding on December 31 of the preceding
calendar year or (b) a lesser number of shares of common
stock determined by the Companys board of directors before
the start of a calendar year for which an increase applies.
* Cost of acquisition
does not include deferred acquisition costs at March 31,
2009, as the merger will be accounted for under
SFAS No. 141(R) due to the effective date of
April 1, 2009.
F-56
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
March 31,
|
|
|
|
2009
|
|
|
2009
|
|
|
|
(Unaudited)
|
|
|
|
|
|
ASSETS
|
CURRENT ASSETS
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
14,655
|
|
|
$
|
17,697
|
|
Accounts Receivable, Net
|
|
|
159,011
|
|
|
|
136,283
|
|
Inventory, Net
|
|
|
228,281
|
|
|
|
195,167
|
|
Prepaid Expenses and Other Current Assets
|
|
|
16,612
|
|
|
|
4,087
|
|
Related Party Receivables
|
|
|
76,732
|
|
|
|
|
|
Assets from Discontinued Operations
|
|
|
350,000
|
|
|
|
350,000
|
|
|
|
|
|
|
|
|
|
|
Total Current Assets
|
|
|
845,291
|
|
|
|
703,234
|
|
PROPERTY AND EQUIPMENT, Net
|
|
|
27,419
|
|
|
|
31,726
|
|
DEFERRED ACQUISITION COSTS
|
|
|
|
|
|
|
147,747
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$
|
872,710
|
|
|
$
|
882,707
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT
|
CURRENT LIABILITIES
|
|
|
|
|
|
|
|
|
Accounts Payable
|
|
$
|
1,628,302
|
|
|
$
|
972,522
|
|
Accrued Expenses
|
|
|
1,522,859
|
|
|
|
723,896
|
|
Notes Payable to Related Parties
|
|
|
334,565
|
|
|
|
599,765
|
|
|
|
|
|
|
|
|
|
|
Total Current Liabilities
|
|
|
3,485,726
|
|
|
|
2,296,183
|
|
COMMITMENTS AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
STOCKHOLDERS DEFICIT
|
|
|
|
|
|
|
|
|
Preferred Stock Par Value $.0001;
10,000,000 Shares Authorized; Issued and
Outstanding-None
|
|
|
|
|
|
|
|
|
Common Stock Par Value $.0001;
175,000,000 Shares Authorized; 47,073,989 and
37,306,704 Issued, 45,972,303 and 36,990,704 Outstanding,
Respectively
|
|
|
4,708
|
|
|
|
3,731
|
|
Additional Paid-in Capital
|
|
|
10,792,097
|
|
|
|
10,762,963
|
|
Accumulated Deficit
|
|
|
(13,408,719
|
)
|
|
|
(12,179,854
|
)
|
Treasury Stock at Cost 1,101,686 and
316,000 Shares, Respectively
|
|
|
(1,102
|
)
|
|
|
(316
|
)
|
|
|
|
|
|
|
|
|
|
Total Stockholders Deficit
|
|
|
(2,613,016
|
)
|
|
|
(1,413,476
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
872,710
|
|
|
$
|
882,707
|
|
|
|
|
|
|
|
|
|
|
The Accompanying Notes are an Integral Part of These Unaudited
Condensed Consolidated Financial Statements
F-57
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
September 30, 2009
|
|
|
September 30, 2008
|
|
|
September 30, 2009
|
|
|
September 30, 2008
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
REVENUE
|
|
$
|
125,870
|
|
|
$
|
202,339
|
|
|
$
|
232,340
|
|
|
$
|
311,481
|
|
COST OF GOODS SOLD
|
|
|
19,496
|
|
|
|
137,759
|
|
|
|
67,574
|
|
|
|
181,448
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Margin
|
|
|
106,374
|
|
|
|
64,580
|
|
|
|
164,766
|
|
|
|
130,033
|
|
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES
|
|
|
552,658
|
|
|
|
1,333,786
|
|
|
|
1,282,585
|
|
|
|
2,335,760
|
|
RESEARCH AND DEVELOPMENT
|
|
|
85,548
|
|
|
|
25,195
|
|
|
|
98,563
|
|
|
|
336,138
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from Operations
|
|
|
(531,832
|
)
|
|
|
(1,294,401
|
)
|
|
|
(1,216,382
|
)
|
|
|
(2,541,865
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest Expense
|
|
|
(8,250
|
)
|
|
|
(194,631
|
)
|
|
|
(12,483
|
)
|
|
|
(391,706
|
)
|
Gain on Sale of Asset
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,329
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other Income (Expense)
|
|
|
(8,250
|
)
|
|
|
(194,631
|
)
|
|
|
(12,483
|
)
|
|
|
(390,377
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from Continuing Operations
|
|
|
(540,082
|
)
|
|
|
(1,489,032
|
)
|
|
|
(1,228,865
|
)
|
|
|
(2,932,242
|
)
|
Income from Discontinued Operations
|
|
|
|
|
|
|
6,031,550
|
|
|
|
|
|
|
|
3,900,839
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income (Loss)
|
|
$
|
(540,082
|
)
|
|
$
|
4,542,518
|
|
|
$
|
(1,228,865
|
)
|
|
$
|
968,597
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Income (Loss) Per Share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing Operations
|
|
$
|
(0.02
|
)
|
|
$
|
(0.06
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.12
|
)
|
Discontinued Operations
|
|
|
|
|
|
|
0.24
|
|
|
|
|
|
|
|
0.16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Income (Loss) Per Share
|
|
$
|
(0.02
|
)
|
|
$
|
0.18
|
|
|
$
|
(0.04
|
)
|
|
$
|
0.04
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Weighted Average Shares Outstanding
|
|
|
29,249,925
|
|
|
|
24,697,594
|
|
|
|
28,529,015
|
|
|
|
24,438,410
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Accompanying Notes are an Integral Part of These Unaudited
Condensed Consolidated Financial Statements
F-58
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
September 30, 2009
|
|
|
September 30, 2008
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
|
Net (Loss) from Continuing Operations
|
|
$
|
(1,228,865
|
)
|
|
$
|
(2,932,242
|
)
|
Adjustments to Reconcile Net (Loss) from Continuing Operations
to Net
|
|
|
|
|
|
|
|
|
Cash (Used in) Operating Activities:
|
|
|
|
|
|
|
|
|
Depreciation Expense
|
|
|
9,195
|
|
|
|
9,349
|
|
Consulting Expense Paid in Common Stock
|
|
|
9,000
|
|
|
|
|
|
Gain on Sale of Asset
|
|
|
|
|
|
|
(1,329
|
)
|
Inventory Reserve Adjustment
|
|
|
1,733
|
|
|
|
(22,366
|
)
|
Loan Discount Accretion
|
|
|
|
|
|
|
328,000
|
|
Beneficial Conversion Feature Interest
|
|
|
|
|
|
|
(80,000
|
)
|
Sales Returns Reserve Adjustment
|
|
|
1,480
|
|
|
|
(10,681
|
)
|
Stock Based Compensation Expense
|
|
|
24,702
|
|
|
|
|
|
Change in Assets and Liabilities:
|
|
|
|
|
|
|
|
|
(Increase) Decrease in:
|
|
|
|
|
|
|
|
|
Accounts Receivable
|
|
|
(22,728
|
)
|
|
|
(84,496
|
)
|
Inventory
|
|
|
(34,847
|
)
|
|
|
(90,432
|
)
|
Prepaid Expenses and Other Current Assets
|
|
|
13,838
|
|
|
|
(199,970
|
)
|
Increase (Decrease) in:
|
|
|
|
|
|
|
|
|
Accounts Payable
|
|
|
428,656
|
|
|
|
(281,252
|
)
|
Accrued Expenses
|
|
|
577,286
|
|
|
|
157,927
|
|
|
|
|
|
|
|
|
|
|
Net Cash (Used in) Operating Activities from Continuing
Operations
|
|
|
(220,550
|
)
|
|
|
(3,207,492
|
)
|
Net Cash (Used in) Operating Activities from Discontinued
Operations
|
|
|
|
|
|
|
(662,603
|
)
|
|
|
|
|
|
|
|
|
|
Net Cash (Used in) Operating Activities
|
|
|
(220,550
|
)
|
|
|
(3,870,095
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
Cash Acquired in Cellegy Pharmaceuticals, Inc. Acquisition
|
|
|
65,114
|
|
|
|
|
|
Loans to Related Parties
|
|
|
(76,732
|
)
|
|
|
|
|
Purchase of Property and Equipment
|
|
|
(4,888
|
)
|
|
|
|
|
Cash Received from Sale of International Laboratories, Inc.
|
|
|
|
|
|
|
2,154,000
|
|
International Laboratories, Inc. Obligation Repayments
|
|
|
|
|
|
|
4,322,082
|
|
Sale of Property and Equipment
|
|
|
|
|
|
|
5,001
|
|
|
|
|
|
|
|
|
|
|
Net Cash (Used in) Provided by Investing Activities from
Continuing Operations
|
|
|
(16,506
|
)
|
|
|
6,481,083
|
|
Net Cash (Used in) Investing Activities from Discontinued
Operations
|
|
|
|
|
|
|
(862,122
|
)
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by (Used in) Investing Activities
|
|
|
(16,506
|
)
|
|
|
5,618,961
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
Payments of Notes Payable to Related Parties
|
|
|
|
|
|
|
(1,752,000
|
)
|
Proceeds from Issuance of Notes Payable to Related Parties
|
|
|
234,800
|
|
|
|
|
|
Proceeds from Issuance of Common Stock
|
|
|
|
|
|
|
878,740
|
|
Purchase of Treasury Stock
|
|
|
(786
|
)
|
|
|
(316
|
)
|
Payments of Loans
|
|
|
|
|
|
|
(2,000,000
|
)
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by (Used in) Financing Activities from
Continuing Operations
|
|
|
234,014
|
|
|
|
(2,873,576
|
)
|
Net Cash Provided by Financing Activities from Discontinued
Operations
|
|
|
|
|
|
|
1,829,746
|
|
|
|
|
|
|
|
|
|
|
Net Cash (Used in) Provided by Financing Activities
|
|
|
234,014
|
|
|
|
(1,043,830
|
)
|
|
|
|
|
|
|
|
|
|
(Decrease) Increase in Cash
|
|
|
(3,042
|
)
|
|
|
705,036
|
|
Cash:
|
|
|
|
|
|
|
|
|
Beginning
|
|
|
17,697
|
|
|
|
541
|
|
|
|
|
|
|
|
|
|
|
Ending
|
|
$
|
14,655
|
|
|
$
|
705,577
|
|
|
|
|
|
|
|
|
|
|
The Accompanying Notes are an Integral Part of These Unaudited
Condensed Consolidated Financial Statements
F-59
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
September 30, 2009
|
|
|
September 30, 2008
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
|
|
|
|
|
|
|
|
|
Cash Paid for Interest
|
|
$
|
|
|
|
$
|
208,470
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING AND INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
Forgiveness of Debt to International Laboratories, Inc.
|
|
$
|
|
|
|
$
|
570,618
|
|
|
|
|
|
|
|
|
|
|
Forgiveness of Debt and Accrued Interest to Cellegy
Pharmaceuticals, Inc.
|
|
$
|
556,610
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Reduction of Capital from Unexcercised Beneficial Conversion
Feature
|
|
$
|
|
|
|
$
|
80,000
|
|
|
|
|
|
|
|
|
|
|
Release of Shares of Common Stock From Escrow
|
|
$
|
673
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
The Accompanying Notes are an Integral Part of These Unaudited
Condensed Consolidated Financial Statements
F-60
|
|
Note 1:
|
Basis
of Presentation
|
The accompanying unaudited interim condensed consolidated
financial statements have been prepared in accordance with
generally accepted accounting principles for interim financial
information and with the instructions to
Form 10-Q
and Articles 8 and 10 of
Regulation S-X
promulgated by the Securities and Exchange Commission
(SEC). Accordingly, certain information and footnote
disclosures normally included in annual financial statements
have been condensed or omitted. In the opinion of management,
the accompanying unaudited interim condensed consolidated
financial statements reflect all adjustments (consists of normal
recurring adjustments) considered necessary for a fair statement
of all periods presented. The results of Adamis Pharmaceuticals
Corporation operations for any interim periods are not
necessarily indicative of the results of operations for any
other interim period or for a full fiscal year. These unaudited
interim condensed consolidated financial statements should be
read in conjunction with the consolidated financial statements
and footnotes thereto included in the Companys Annual
Report on
Form 10-K
for the year ended December 31, 2008 and
Form 8-K/A
as of and for the year ended March 31, 2009 filed on
July 1, 2009.
Liquidity
and Capital Resources
Our cash and cash equivalents were $14,655 and $17,697 at
September 30, 2009 and March 31, 2009, respectively.
We prepared the condensed consolidated financial statements
assuming that we will continue as a going concern, which
contemplates the realization of assets and the satisfaction of
liabilities during the normal course of business. In preparing
these condensed consolidated financial statements, consideration
was given to the Companys future business as described
below, which may preclude the Company from realizing the value
of certain assets.
The Company has negative working capital, liabilities that
exceed its assets and significant cash flow deficiencies.
Additionally, the Company will need significant funding for
future operations and the expenditures that will be required to
market existing products and conduct the clinical and regulatory
work to develop the Companys product candidates.
Managements plans include seeking additional funding to
satisfy existing obligations, liabilities and future working
capital needs, to build working capital reserves and to fund its
research and development projects. There is no assurance that
the Company will be successful in obtaining the necessary
funding to meet its business objectives.
|
|
Note 2:
|
Asset
Acquisition and Recapitalization
|
The stockholders of Cellegy Pharmaceuticals, Inc.
(Cellegy) and the former Adamis Pharmaceuticals
Corporation (Old Adamis) approved a merger
transaction and related matters at an annual meeting of
Cellegys stockholders and at a special meeting of Old
Adamis stockholders each held on March 23, 2009. On
April 1, 2009, Cellegy completed the merger transaction
with Old Adamis. In connection with the closing of the merger
transaction, the promissory note issued by Old Adamis converted
into shares of Old Adamis stock, and these shares were
immediately cancelled.
In connection with the consummation of the merger and pursuant
to the terms of the definitive merger agreement relating to the
transaction (the merger agreement), Cellegy changed
its name from Cellegy Pharmaceuticals, Inc. to Adamis
Pharmaceuticals Corporation (Adamis or the
Company), and Old Adamis changed its corporate name
to Adamis Corporation.
Pursuant to the terms of the merger agreement, immediately
before the consummation of the merger Cellegy effected a reverse
stock split of its common stock. Pursuant to this reverse stock
split, each 9.929060333 shares of common stock of Cellegy
that were issued and outstanding immediately before the
effective time of the merger were converted into one share of
common stock and any remaining fractional shares held by a
stockholder (after the aggregating fractional shares) were
rounded up to the nearest whole share (the Reverse
Split).
As a result, the total number of shares of Cellegy that were
outstanding immediately before the effective time of the merger
were converted into approximately 3,000,000 shares of
post-Reverse Split shares of common stock of the Company.
Pursuant to the terms of the merger agreement, at the effective
time of the merger, each share of
F-61
Adamis common stock that was issued and outstanding immediately
before the effective time of the merger ceased to be outstanding
and was converted into the right to receive one share of common
stock of the Company. As a result, the Company issued
approximately 44,038,989 post-Reverse Split shares of common
stock, inclusive of 6,732,285 contingent shares held in escrow,
were issuable to the holders of the outstanding shares of common
stock of Old Adamis before the effective time of the merger. Old
Adamis is the surviving entity as a wholly-owned subsidiary of
Cellegy.
Old Adamis security holders owned, immediately after the closing
of the merger, approximately 93.5% of the combined company on a
fully-diluted basis. Further, Old Adamis directors constitute a
majority of the combined companys board of directors and
all members of executive management of the combined company are
from old Adamis. Therefore, Old Adamis was deemed to be the
acquiring company for accounting purposes and the merger
transaction is accounted for as an asset acquisition
recapitalization in accordance with accounting principles
generally accepted in the United States. As a result, all of the
assets and liabilities of Cellegy have been reflected in the
financial statements at their respective fair market values and
no goodwill or other intangibles were recorded as part of
acquisition accounting and the cost of the merger is measured at
the net liabilities acquired. Transaction costs amounting to
$147,747 were considered as part of the assets acquired and
included as a reduction of additional paid-in capital. The
financial statements of the combined entity after the merger
reflect the historical results of Old Adamis prior to the merger
and do not include the historical financial results of Cellegy
prior to the completion of the merger. Stockholders equity
and earnings per share of the combined entity after the merger
have been retroactively restated to include the number of shares
received by Old Adamis security holders in the merger with the
offset to additional paid-in capital.
In connection with the closing of the merger, the Company
amended its certificate of incorporation to increase the
authorized number of shares of common stock from 50,000,000 to
175,000,000 and the authorized number of shares of preferred
stock from 5,000,000 to 10,000,000.
The Company released the remaining 6,732,285 re-purchasable
holdback shares related to the HVG Acquisition from escrow
during the quarter ended September 30, 2009. The
Companys rights of repurchase related to such shares have
not expired, are subject to certain restrictions and are still
treated as contingent consideration related to the HVG
Acquisition. As a result, no purchase price adjustment was
recorded during the current period, and the shares were recorded
at par value. The shares are considered anti-dilutive during the
period due to the outstanding repurchase options. On
August 14, 2009, the Company exercised its repurchase
option and repurchased 785,686 shares of common stock for
treasury at a total cost of $786 in connection with the
resignation of the former Vice President of Operations.
On September 21, 2009, the Company issued
35,000 shares of its common stock in lieu of payment for
consulting services with a value of $9,000.
|
|
Note 4:
|
Stock
Option Plans, Shares Reserved and Warrants
|
Cellegys stockholders approved a new 2009 Equity Incentive
Plan (the 2009 Plan), which became effective upon
the closing of the merger. The 2009 Plan provides for the grant
of incentive stock options, non-statutory stock options,
restricted stock awards, restricted stock unit awards, stock
appreciation rights, performance stock awards, and other forms
of equity compensation (collectively stock awards).
In addition, the 2009 Plan provides for the grant of performance
cash awards. The aggregate number of shares of common stock that
may be issued initially pursuant to stock awards under the 2009
Plan is 7,000,000 shares. The number of shares of common
stock reserved for issuance will automatically increase on
January 1 of each calendar year, from January 1, 2010
through and including January 1, 2019, by the lesser of
(a) 5.0% of the total number of shares of common stock
outstanding on December 31 of the preceding calendar year or
(b) a lesser number of shares of common stock determined by
the Companys board of directors before the start of a
calendar year for which an increase applies.
The Company granted options to purchase a total of
150,000 shares of common stock to directors upon the
closing of the merger. The stock options have an exercise price
of $0.60 per share, which is equal to the fair market value of
the Companys common stock on the date of the grant. The
stock options vest over a period of three years
F-62
from the date of the grant, and expire on the
10th anniversary of the grant date of the options. The
Company estimated that the stock options have a fair market
value of $0.30 per stock option using the Black-Scholes
valuation model. Managements assumptions included in the
model assumed volatility of 35.4%, a risk-free interest rate of
2.7% based on the
10-year
Treasury Rate at the date of the grant and no dividends. The
Company estimated a forfeiture rate of 5.5%.
During the period, the directors resigned from their duties.
Each director had 26,388 vested stock options for a total of
79,164. The remaining 73,806 stock options granted were
cancelled during the period. The total fair market value of only
the vested stock options was recorded during the period.
In August 2009, the Company hired an officer, who was granted a
stock option by the Company to purchase up to
250,000 shares of common stock. The stock options have an
exercise price of $0.22 per share, which is equal to the fair
market value of the Companys common stock on the date of
the grant. The stock options vest over a period of three years
from the date of the grant, and expire on the
10th anniversary of the grant date of the option. The
Company estimated that the stock option has a fair market value
of $0.11 per share using the Black-Scholes valuation model.
Managements assumptions included in the model were
volatility of 35.4%, a risk-free interest rate of 3.4% based on
the 10-year
Treasury Rate at the date of the grant and no dividends. The
Company estimated a forfeiture rate of 5.5%.
The Company recorded stock based compensation expense of $1,668
and $24,702 related to such stock options for the three and six
months ended September 30, 2009, respectively.
In August 2009, the Company issued warrants to purchase up to
600,000 shares of common stock to consultants retained to
assist the Company in fund-raising efforts. The warrants have an
exercise price of $0.25 per share, which is equal to the fair
market value of the Companys common stock at the date of
grant. The options have a five year term and expire on
August 26, 2014.
The following summarizes outstanding stock options at
September 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Average
|
|
|
Number of
|
|
|
|
Number of
|
|
|
Remaining
|
|
|
Exercise
|
|
|
Stock Options
|
|
|
|
Stock Options
|
|
|
Contractual Life
|
|
|
Price
|
|
|
Vested
|
|
|
1995 Equity Incentive Plan
|
|
|
20,641
|
|
|
|
4.68 Years
|
|
|
$
|
31.83
|
|
|
|
20,641
|
|
2005 Equity Incentive Plan
|
|
|
4,834
|
|
|
|
6.00 Years
|
|
|
$
|
13.30
|
|
|
|
4,834
|
|
Directors Stock Option Plan
|
|
|
7,654
|
|
|
|
3.91 Years
|
|
|
$
|
43.49
|
|
|
|
7,654
|
|
Non-Plan Stock Options
|
|
|
100,714
|
|
|
|
4.10 Years
|
|
|
$
|
43.82
|
|
|
|
100,714
|
|
Biosyn Stock Options
|
|
|
431
|
|
|
|
4.31 Years
|
|
|
$
|
2.90
|
|
|
|
431
|
|
2009 Equity Incentive Plan
|
|
|
329,164
|
|
|
|
7.51 Years
|
|
|
$
|
0.38
|
|
|
|
79,164
|
|
The Company has reserved shares of common stock for issuance
upon exercise at September 30, 2009 as follows:
|
|
|
|
|
Biosyn Stock Options
|
|
|
431
|
|
Directors Plan
|
|
|
7,654
|
|
Warrants
|
|
|
1,752,139
|
|
Non-Plan Stock Options
|
|
|
100,714
|
|
1995 Equity Incentive Plan
|
|
|
20,641
|
|
2005 Equity Incentive Plan
|
|
|
4,838
|
|
2009 Equity Incentive Plan
|
|
|
7,000,000
|
|
|
|
|
|
|
Total Shares Reserved
|
|
|
8,886,414
|
|
|
|
|
|
|
F-63
The following summarizes warrants outstanding at
September 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise Price
|
|
|
|
|
|
Expiration
|
|
|
|
Warrant Shares
|
|
|
per Share
|
|
|
Date Issued
|
|
|
Date
|
|
|
Biosyn Warrants
|
|
|
|
|
|
|
8,254
|
|
|
$
|
57.97 - $173.92
|
|
|
|
October 22, 2004
|
|
|
|
2013 - 2014
|
|
May 2005 PIPE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A
|
|
|
|
|
|
|
71,947
|
|
|
$
|
1.99
|
|
|
|
May 13, 2005
|
|
|
|
May 13, 2010
|
|
Series B
|
|
|
|
|
|
|
71,947
|
|
|
$
|
2.15
|
|
|
|
May 13, 2005
|
|
|
|
May 13, 2010
|
|
Old Adamis Warrants
|
|
|
|
|
|
|
1,000,000
|
|
|
$
|
0.50
|
|
|
|
November 15, 2007
|
|
|
|
November 15, 2012
|
|
Consultant Warants
|
|
|
|
|
|
|
600,000
|
|
|
$
|
0.25
|
|
|
|
August 26, 2009
|
|
|
|
August 26, 2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Warrants
|
|
|
|
|
|
|
1,752,139
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory consists of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
March 31,
|
|
|
|
2009
|
|
|
2009
|
|
|
Respiratory and Allergy Products
|
|
$
|
291,450
|
|
|
$
|
52,843
|
|
Less: Obsolescence Reserve
|
|
|
(63,169
|
)
|
|
|
(37,175
|
)
|
|
|
|
|
|
|
|
|
|
Respiratory and Allergy Products, Net
|
|
|
228,281
|
|
|
|
15,668
|
|
Pre-Launch epi Inventory
|
|
|
|
|
|
|
179,499
|
|
|
|
|
|
|
|
|
|
|
Inventory, Net
|
|
$
|
228,281
|
|
|
$
|
195,167
|
|
|
|
|
|
|
|
|
|
|
The Company launched the epinephrine syringe product in the
second fiscal quarter of 2010.
Ben
Franklin Note
Biosyn (a wholly owned subsidiary of Old Cellegy) issued a note
payable to Ben Franklin Technology Center of Southeastern
Pennsylvania (Ben Franklin Note) in October 1992, in
connection with funding the development of Savvy, a compound to
prevent the transmission of AIDS.
The Ben Franklin Note was recorded at its estimated fair value
of $205,000 and was assumed by Old Cellegy as an obligation in
connection with its acquisition of Biosyn in 2004. The repayment
terms of the non-interest bearing obligation include the
remittance of an annual fixed percentage of 3.0% applied to
future revenues of Biosyn, if any, until the principal balance
of $777,902 (face amount) is satisfied. Under the terms of the
obligation, revenues are defined to exclude the value of
unrestricted research and development funding received by Biosyn
from nonprofit sources. Absent a material breach of contract or
other event of default, there is no obligation to repay the
amounts in the absence of future Biosyn revenues. Cellegy
accreted the discount of $572,902 against earnings using the
interest rate method (approximately 46%) over the discount
period of five years, which was estimated in connection with the
Ben Franklin Notes valuation at the time of the
acquisition. At September 30, 2009, the outstanding balance
of the note was $777,902.
Accounting principles generally accepted in the United States
emphasize market-based measurement through the use of valuation
techniques that maximize the use of observable or market-based
inputs. The Ben Franklin Notes peculiar repayment terms
outlined above affects its comparability with main stream market
issues and also affects its transferability. The value of the
Ben Franklin Note would also be impacted by the ability to
estimate Biosyns expected future revenues which in turn
hinge largely upon the outcome of its ongoing Savvy
contraception trial, the results of which are currently under
review and which are not known by the Company. Given the above
factors and therefore the lack of market comparability, the Ben
Franklin Note would be valued based on Level 3 inputs. As
such, management has determined that the Ben Franklin Note will
have no future cash flows, as we do not
F-64
believe the product will create a revenue stream in the future.
As a result, the Note had no fair market value at the time of
the acquisition.
Notes
Payable to Related Parties
The Company had notes payable to related parties amounting to
$334,565 at September 30, 2009, which bear interest at 10%.
Accrued interest related to the notes was $14,877 at
September 30, 2009.
On various dates during the three and six months ended
September 30, 2009 and included in the amount above, the
Company issued promissory notes to shareholders for a total of
$47,500 and $234,800, respectively, that bear interest at 10%
with all principal and interest due on various maturity dates
during May June 2010.
|
|
Note 7:
|
Subsequent
Events
|
We evaluated all events or transactions that occurred after
September 30, 2009 up through November 23, 2009, the
date we filed this quarterly report.
F-65
Annex A
AGREEMENT
AND PLAN OF REORGANIZATION
among
LA JOLLA
PHARMACEUTICAL COMPANY
a Delaware corporation,
JEWEL
MERGER SUB, INC.,
a Delaware corporation
and
ADAMIS
PHARMACEUTICALS CORPORATION,
a Delaware corporation
Dated as
of December 4, 2009
TABLE
OF CONTENTS
|
|
|
|
|
|
|
|
|
Page
|
|
ARTICLE I THE MERGER
|
|
A-1
|
1.1
|
|
Merger of Merger Sub into Adamis
|
|
A-1
|
1.2
|
|
Effect of the Merger
|
|
A-2
|
1.3
|
|
Closing; Effective Time
|
|
A-2
|
1.4
|
|
Certificate of Incorporation and Bylaws; Directors and Officers
|
|
A-2
|
1.5
|
|
Reverse Split of La Jolla Common Stock
|
|
A-2
|
1.6
|
|
Shares to be Issued; Effect on Capital Stock
|
|
A-3
|
1.7
|
|
Calculation of the Exchange Ratio
|
|
A-4
|
1.8
|
|
Dissenting Shares
|
|
A-4
|
1.9
|
|
No Further Transfer of Adamis Capital Stock
|
|
A-5
|
1.10
|
|
Exchange of Certificates; Exchange Agent
|
|
A-5
|
1.11
|
|
Further Action
|
|
A-6
|
ARTICLE II REPRESENTATIONS AND WARRANTIES OF ADAMIS
|
|
A-6
|
2.1
|
|
Organization and Good Standing
|
|
A-6
|
2.2
|
|
Subsidiaries
|
|
A-7
|
2.3
|
|
Authority
|
|
A-7
|
2.4
|
|
No Conflict
|
|
A-7
|
2.5
|
|
Consents
|
|
A-7
|
2.6
|
|
Governmental Authorizations
|
|
A-8
|
2.7
|
|
Capitalization
|
|
A-8
|
2.8
|
|
SEC Reports; Financial Statements
|
|
A-8
|
2.9
|
|
Absence of Certain Changes
|
|
A-9
|
2.10
|
|
Interested Party Transactions
|
|
A-9
|
2.11
|
|
Intellectual Property
|
|
A-9
|
2.12
|
|
Taxes
|
|
A-10
|
2.13
|
|
Employee Benefit Plans
|
|
A-11
|
2.14
|
|
Employee Matters
|
|
A-12
|
2.15
|
|
Insurance
|
|
A-12
|
2.16
|
|
Compliance with Legal Requirements
|
|
A-12
|
2.17
|
|
Environmental Matters
|
|
A-13
|
2.18
|
|
Legal Proceedings
|
|
A-13
|
2.19
|
|
Contracts; No Defaults
|
|
A-13
|
2.20
|
|
Labor Matters
|
|
A-13
|
2.21
|
|
Unlawful Payments
|
|
A-14
|
2.22
|
|
Financial Advisor
|
|
A-14
|
2.23
|
|
Title to Assets; No Real Property
|
|
A-14
|
2.24
|
|
Representations Complete
|
|
A-14
|
ARTICLE III REPRESENTATIONS AND WARRANTIES OF LA JOLLA AND
MERGER SUB
|
|
A-14
|
3.1
|
|
Organization and Good Standing
|
|
A-14
|
3.2
|
|
Subsidiaries
|
|
A-14
|
3.3
|
|
Authority
|
|
A-15
|
3.4
|
|
No Conflict
|
|
A-15
|
3.5
|
|
Consents
|
|
A-15
|
A-i
|
|
|
|
|
|
|
|
|
Page
|
|
3.6
|
|
Governmental Authorizations
|
|
A-16
|
3.7
|
|
Capitalization
|
|
A-16
|
3.8
|
|
SEC Reports; Financial Statements
|
|
A-16
|
3.9
|
|
Absence of Certain Changes
|
|
A-17
|
3.10
|
|
Interested Party Transactions
|
|
A-17
|
3.11
|
|
Intellectual Property
|
|
A-17
|
3.12
|
|
Taxes
|
|
A-18
|
3.13
|
|
Employee Benefit Plans
|
|
A-19
|
3.14
|
|
Employee Matters
|
|
A-20
|
3.15
|
|
Insurance
|
|
A-20
|
3.16
|
|
Compliance with Legal Requirements
|
|
A-20
|
3.17
|
|
Environmental Matters
|
|
A-20
|
3.18
|
|
Legal Proceedings
|
|
A-21
|
3.19
|
|
Contracts; No Defaults
|
|
A-21
|
3.20
|
|
Labor Matters
|
|
A-21
|
3.21
|
|
Unlawful Payments
|
|
A-21
|
3.22
|
|
Financial Advisor
|
|
A-21
|
3.23
|
|
Title to Assets; No Real Property
|
|
A-22
|
3.24
|
|
Representations Complete
|
|
A-22
|
ARTICLE IV CONDUCT BEFORE THE EFFECTIVE TIME
|
|
A-22
|
4.1
|
|
Access and Investigation
|
|
A-22
|
4.2
|
|
Operation of La Jollas Business
|
|
A-22
|
4.3
|
|
Operation of Adamiss Business
|
|
A-23
|
4.4
|
|
Disclosure Schedule Updates
|
|
A-24
|
4.5
|
|
No Solicitation
|
|
A-24
|
ARTICLE V ADDITIONAL AGREEMENTS
|
|
A-26
|
5.1
|
|
Proxy Statement; Registration Statement
|
|
A-26
|
5.2
|
|
Adamis Stockholder Meeting; Change in the Adamis Board
Recommendation
|
|
A-27
|
5.3
|
|
La Jolla Stockholder Meeting; Change in the La Jolla
Board Recommendation; Adoption of Agreement by La Jolla as
Sole Stockholder of Merger Sub
|
|
A-28
|
5.4
|
|
Regulatory Approvals
|
|
A-30
|
5.5
|
|
Indemnification of Officers and Directors
|
|
A-30
|
5.6
|
|
Additional Agreements
|
|
A-30
|
5.7
|
|
Disclosure
|
|
A-31
|
5.8
|
|
Directors; Officers
|
|
A-31
|
5.9
|
|
Tax Matters
|
|
A-31
|
5.10
|
|
La Jolla Amendment
|
|
A-31
|
5.11
|
|
Adamiss Auditors
|
|
A-32
|
5.12
|
|
La Jollas Auditors
|
|
A-32
|
5.13
|
|
Legends
|
|
A-32
|
5.14
|
|
Confidentiality
|
|
A-32
|
5.15
|
|
FIRPTA Compliance
|
|
A-32
|
5.16
|
|
Rule 16b-3
|
|
A-32
|
5.17
|
|
Use of La Jolla Net Cash
|
|
A-32
|
A-ii
|
|
|
|
|
|
|
|
|
Page
|
|
ARTICLE VI CONDITIONS PRECEDENT TO OBLIGATIONS OF EACH PARTY
|
|
A-32
|
6.1
|
|
Stockholder Approval
|
|
A-32
|
6.2
|
|
No Restraints
|
|
A-32
|
6.3
|
|
Governmental Authorization
|
|
A-33
|
6.4
|
|
No Governmental Proceedings Relating to Contemplated
Transactions or Right to Operate Business
|
|
A-33
|
6.5
|
|
Registration Statement
|
|
A-33
|
ARTICLE VII ADDITIONAL CONDITIONS PRECEDENT TO OBLIGATIONS
OF LA JOLLA AND MERGER SUB
|
|
A-33
|
7.1
|
|
Accuracy of Representations
|
|
A-33
|
7.2
|
|
Performance of Covenants
|
|
A-33
|
7.3
|
|
No Material Adverse Effect
|
|
A-33
|
7.4
|
|
Consents
|
|
A-33
|
7.5
|
|
Agreements and Other Documents
|
|
A-34
|
7.6
|
|
Sarbanes-Oxley Certifications
|
|
A-34
|
7.7
|
|
SEC Reports
|
|
A-34
|
7.8
|
|
Legal Opinion
|
|
A-34
|
ARTICLE VIII ADDITIONAL CONDITIONS PRECEDENT TO OBLIGATION
OF ADAMIS
|
|
A-34
|
8.1
|
|
Accuracy of Representations
|
|
A-34
|
8.2
|
|
Performance of Covenants
|
|
A-34
|
8.3
|
|
No Material Adverse Effect
|
|
A-34
|
8.4
|
|
Consents
|
|
A-34
|
8.5
|
|
Documents
|
|
A-34
|
8.6
|
|
Sarbanes-Oxley Certifications
|
|
A-35
|
8.7
|
|
Board of Directors
|
|
A-35
|
8.8
|
|
Officers
|
|
A-35
|
8.9
|
|
Certificate of Amendment
|
|
A-35
|
8.10
|
|
SEC Reports
|
|
A-35
|
8.11
|
|
Legal Opinion
|
|
A-35
|
ARTICLE IX TERMINATION
|
|
A-35
|
9.1
|
|
Termination
|
|
A-35
|
9.2
|
|
Effect of Termination
|
|
A-37
|
9.3
|
|
Expenses; Termination Fees
|
|
A-37
|
ARTICLE X MISCELLANEOUS PROVISIONS
|
|
A-37
|
10.1
|
|
Non-Survival of Representations and Warranties
|
|
A-37
|
10.2
|
|
Amendment
|
|
A-37
|
10.3
|
|
Waiver
|
|
A-38
|
10.4
|
|
Entire Agreement; Counterparts; Exchanges by Facsimile
|
|
A-38
|
10.5
|
|
Applicable Law; Jurisdiction
|
|
A-38
|
10.6
|
|
Waiver of Jury Trial
|
|
A-38
|
10.7
|
|
Notices
|
|
A-38
|
10.8
|
|
Cooperation
|
|
A-39
|
10.9
|
|
Severability
|
|
A-39
|
10.10
|
|
Other Remedies; Specific Performance
|
|
A-39
|
10.11
|
|
Construction
|
|
A-39
|
A-iii
AGREEMENT
AND PLAN OF REORGANIZATION
THIS AGREEMENT AND PLAN OF REORGANIZATION (the
Agreement) is made and entered into as
of December 4, 2009, by and among La Jolla
Pharmaceutical Company, a Delaware corporation
(La Jolla), Jewel Merger Sub,
Inc., a Delaware corporation and wholly-owned subsidiary of
La Jolla (Merger Sub), and Adamis
Pharmaceuticals Corporation, a Delaware corporation
(Adamis). Certain capitalized terms
used in this Agreement are defined in Exhibit A attached
hereto.
RECITALS
A. The Board of Directors of La Jolla and Adamis have
each determined that it is in the best interests of their
respective stockholders for Adamis and La Jolla to enter
into a business combination transaction pursuant to which Merger
Sub will merge with and into Adamis (the
Merger), with Adamis continuing after
the Merger as the surviving corporation and wholly owned
subsidiary of La Jolla.
B. Pursuant to the Merger, each outstanding share of common
stock, $0.0001 par value per share, of Adamis
(Adamis Common Stock) will, in
accordance with the provisions of this Agreement, be converted
into the number of shares of La Jollas common stock,
$0.01 par value per share (La Jolla Common
Stock) equal to the Exchange Ratio.
C. In connection with, and immediately before the
consummation of, the Merger, a reverse stock split of
La Jolla Common Stock shall be consummated, pursuant to
which each outstanding share of La Jolla Common Stock shall
be converted into the number of shares of La Jolla Common
Stock determined as provided in Section 1.5 below.
D. The Board of Directors of La Jolla (i) has
approved and declared advisable this Agreement, the Merger and
the other transactions contemplated by this Agreement,
(ii) has determined that the Merger is in the best
interests of La Jolla and its stockholders and has
determined to recommend the approval of this Agreement and the
Merger to the stockholders of La Jolla, and (iii) has
determined to recommend that La Jolla, in its capacity as
the sole stockholder of Merger Sub, vote to adopt this Agreement
and approve the Merger and such other actions as are
contemplated by this Agreement.
E. The Board of Directors of Adamis (i) has approved
and declared advisable this Agreement, the Merger and the other
transactions contemplated by this Agreement and (ii) has
determined that the Merger is in the best interests of Adamis
and its stockholders and has determined to recommend the
approval of this Agreement and the Merger to the stockholders of
Adamis.
F. The parties hereto intend, by executing this Agreement,
to adopt a plan of reorganization within the meaning of
Section 368 of the Internal Revenue Code of 1986, as
amended.
G. As an inducement to La Jolla to enter into this
Agreement, concurrently herewith certain stockholders of Adamis
have entered into an agreement with La Jolla, in the form
attached hereto (a Voting Agreement),
pursuant to which each such person has agreed, among other
things, to vote the shares of capital stock of Adamis owned by
such person to approve this Agreement and the transactions
contemplated hereby.
AGREEMENT
The parties to this Agreement, intending to be legally bound,
agree as follows:
ARTICLE I
THE
MERGER
1.1 Merger of Merger Sub into
Adamis. Upon the terms and subject to the
conditions set forth in this Agreement and in accordance with
the Delaware General Corporation Law
(DGCL), at the Effective Time Merger
Sub shall be merged with and into Adamis, and the separate
existence of Merger Sub shall cease. Adamis will continue as the
surviving corporation following the Merger (the
Surviving Corporation).
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1.2 Effect of the Merger. The Merger
shall have the effects set forth in this Agreement and the
applicable provisions of the DGCL. As a result of the Merger,
Adamis will become a wholly-owned subsidiary of La Jolla.
Without limiting the generality of the foregoing, and subject
thereto, at the Effective Time, all the property, rights,
privileges, powers and franchises of Adamis and Merger Sub shall
vest in the Surviving Corporation, and all debts, liabilities
and duties of Adamis and Merger Sub shall become the debts,
liabilities and duties of the Surviving Corporation.
1.3 Closing; Effective Time. The
consummation of the transactions contemplated by this Agreement
(the Closing) shall take place in
San Diego, California, at 10:00 a.m., on a date and at
a location to be agreed by La Jolla and Adamis (the
Closing Date), which shall be no later
than the third Business Day after the satisfaction or waiver of
the last to be satisfied or waived of the conditions set forth
in Articles VI, VII and VIII (other than those conditions that
by their nature are to be satisfied at the Closing, but subject
to the satisfaction or waiver of such conditions), or at such
other time, date and place as La Jolla and Adamis may
mutually agree in writing. At the Closing, subject to the terms
and conditions of this Agreement, the parties hereto shall cause
the Merger to be consummated by executing and filing with the
Secretary of State of the State of Delaware a Certificate of
Merger with respect to the Merger, satisfying the applicable
requirements of the DGCL and in a form reasonably acceptable to
La Jolla and Adamis. The Merger shall become effective at
the time of the filing of such Certificate of Merger with the
Secretary of State of the State of Delaware or at such later
time as may be specified in such Certificate of Merger (the time
as of which the Merger becomes effective being referred to as
the Effective Time).
1.4 Certificate of Incorporation and Bylaws; Directors and
Officers. At the Effective Time:
(a) Adamis Certificate of
Incorporation. The Adamis Charter, as in
effect immediately before the Effective Time, shall be amended
in the Merger to read in its entirety as set forth on Exhibit
B-1 hereto and, as so amended, shall be the certificate of
incorporation of the Surviving Corporation until thereafter
amended as provided by the DGCL and such certificate of
incorporation;
(b) Adamis Bylaws. The Adamis
Bylaws, as in effect immediately before the Effective Time,
shall be amended to read in its entirety as set forth on
Exhibit B-2
hereto and, as so amended, shall be the bylaws of the Surviving
Corporation, until thereafter amended as provided by the DGCL
and such Bylaws;
(c) Adamis Directors. The
directors of Adamis immediately before the Effective Time shall
be the initial directors of the Surviving Corporation, each to
hold office in accordance with the certificate of incorporation
and bylaws of the Surviving Corporation; and
(d) Adamis Officers. The officers
of Adamis immediately before the Effective Time shall be the
initial officers of the Surviving Corporation, in each case
until their respective successors are duly elected or appointed
and qualified, or until their earlier death, resignation or
removal.
1.5 Reverse Split of La Jolla Common Stock.
(a) La Jolla Restated
Certificate. Immediately before the Effective
Time, and subject to receipt of the requisite stockholder
approval at the La Jolla Stockholder Meeting, La Jolla
shall cause to be filed an amendment to its certificate of
incorporation
and/or an
Amended and Restated Certificate of Incorporation (the
La Jolla Restated Certificate),
whereby without any further action on the part of La Jolla,
Adamis or any stockholder of La Jolla:
(i) The shares of La Jolla Common Stock issued and
outstanding immediately before the filing of the La Jolla
Restated Certificate shall be combined in a reverse stock split,
with each share thereafter representing a fractional share equal
to the Reverse Stock Split Ratio (the Reverse Stock
Split);
(ii) the total number of authorized shares of
La Jolla Common Stock and La Jolla Preferred Stock
shall be 225,000,000 and 8,000,000 shares, respectively.
(iii) With respect to the determination the La of
Jolla Net Cash as of the Closing Date and the number of
Post-Effective La Jolla Stockholder Shares, within five
(5) days before the Closing Date, La Jolla shall
deliver to Adamis (the date of such delivery, the
Net Cash Delivery Date) an unaudited
certification (the Net Cash
Certification) of the calculation of the projected
La Jolla Net Cash as of the Closing Date, with a detailed
schedule showing each item taken into account in determining the
amount of La Jolla Net Cash (including
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without limitation each Liability and each amount, if any,
reserved or taken into account with respect to Liabilities after
the Closing Date). Within two (2) days after the Net Cash
Delivery Date, Adamis will notify La Jolla whether Adamis
accepts the Net Cash Certification or whether Adamis disputes
the Net Cash Certification, setting forth in reasonable detail
the basis for such dispute. If Adamis accepts the original Net
Cash Certification, then the original Net Cash Certification
shall be the basis for determining La Jolla Net Cash at the
Closing Date. If Adamis disputes the initial Net Cash
Certification, the parties shall attempt to resolve the dispute
promptly. If a final resolution of the dispute is reached within
a ten-day
period following Adamiss objection, then the initial Net
Cash Certification, such changes as have been agreed upon, shall
be the final Net Cash Certification for all purposes under this
Agreement. If no final resolution of the dispute is reached
within such
ten-day
period, then the dispute shall be submitted to an independent
auditing firm mutually selected by Adamis and La Jolla, who
shall make a final determination with respect to such dispute
within ten (10) Business Days after submission of the
dispute or as soon as practicable thereafter. The expenses of
the auditing firm shall be allocated between the parties ratably
on the inverse basis of the percentage of disputed amount that
is awarded to Adamis (e.g., if 75% of the disputed amount is
awarded to Adamis, then 75% of the expense shall be allocated to
La Jolla). The La Jolla portion of such expenses will
be treated as a Liability that reduces the amount of
La Jolla Net Cash. The independent accounting firm shall
consider only the items in dispute. The final determination by
such auditing firm shall be binding upon the parties and the
initial Net Cash Certification, with such changes as have been
finally determined by such auditing firm, shall be the final Net
Cash Certification for all purposes under this Agreement.
(b) No Fractional Shares. No
fractional shares of La Jolla Common Stock shall be issued
in connection with the Reverse Stock Split, and no certificates
or scrip representing such fractional shares shall be issued.
La Jolla will round down to the nearest whole share any
fraction of a share that any La Jolla stockholder would
otherwise receive (after aggregating all fractional shares
issuable to such holder), and any holder of La Jolla Common
Stock who would otherwise be entitled to receive a fraction of a
share of La Jolla Common Stock (after aggregating all
fractional shares of La Jolla Common Stock issuable to such
holder) shall, in lieu of such fraction of a share and upon
surrender of such holders certificate representing such
fractional shares of La Jolla Common Stock, instead receive
from La Jolla an amount of cash (rounded to the nearest
whole cent), without interest, equal to the product of
(i) such fraction, multiplied by (ii) the applicable
price per share which shall be equal to the average closing
price of La Jolla Common Stock (as reported on the Nasdaq
Capital Market, or the OTC Bulletin Board or, if the
La Jolla Common Stock is not traded on the Nasdaq Capital
Market or OTC Bulletin Board, then the Pink Sheets, and, if
not traded on the Pink Sheets, then as determined in good faith
by La Jollas Board of Directors) on the five trading
days immediately prior to the effective date of the Reverse
Stock Split (giving effect to the Reverse Stock Split). In lieu
of the foregoing, La Jolla may, in its discretion, elect to
round up each fractional share (after aggregating all fractional
shares issuable to such holder) to a whole share. The aggregate
value of the fractional share payments and out-of-pocket
expenses associated with the Reverse Stock Split and the
post-Closing exchange of certificates (the Reverse
Split Expenses) shall be disregarded in
calculating the La Jolla Net Cash.
(c) Reverse Stock Split and the Exchange
Ratio. The Exchange Ratio set forth herein
assumes the effectiveness of the Reverse Stock Split set forth
above.
1.6 Shares to be Issued; Effect on Capital
Stock. Subject to the terms and conditions of
this Agreement, at the Effective Time, by virtue of the Merger
and without any action on the part of La Jolla, Merger Sub,
Adamis or any stockholder of Adamis, the following shall occur:
(a) Conversion of Adamis Common
Stock. Subject to the terms of Section
1.10(h), each share of Adamis Common Stock issued and
outstanding immediately before the Effective Time (other than
any shares of Adamis Common Stock to be canceled pursuant to
Section 1.6(b), if any, and excluding any Dissenting Shares
(to the extent provided in Section 1.8)) will be converted
automatically into the right to receive: (i) that number of
shares of La Jolla Common Stock equal to the Exchange
Ratio, and (ii) any cash, without interest, to be paid in
lieu of any fractional share of Adamis Common Stock in
accordance with Section 1.6(f).
(b) Cancellation of Treasury and La Jolla-Owned
Shares. Any shares of Adamis Capital Stock
held as treasury stock or held or owned by Adamis or
La Jolla immediately before the Effective Time shall be
canceled and shall cease to exist, and no consideration shall be
delivered in exchange therefore.
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(c) Adamis Restricted Stock. If
any shares of Adamis Common Stock issued and outstanding
immediately before the Effective Time are unvested or are
subject to a repurchase option or the risk of forfeiture or
under any applicable restricted stock purchase agreement, stock
restriction agreement, cancellation agreement or other agreement
with Adamis (such shares, the Adamis Restricted
Stock), then the shares of La Jolla Common
Stock issued in exchange for such shares of Adamis Restricted
Stock pursuant to Section 1.6(a) will to the same extent be
unvested and subject to the same repurchase option or risk of
forfeiture, and the certificates representing such shares of
La Jolla Common Stock shall accordingly be marked with
appropriate legends to reflect such repurchase option or risk of
forfeiture. Adamis and La Jolla shall take all action that
may be necessary to ensure that, from and after the Effective
Time, La Jolla is entitled to exercise any such repurchase
option or right of cancellation or other right set forth in any
such restricted stock purchase agreement or other agreement.
(d) Capital Stock of Merger
Sub. Each share of common stock of Merger Sub
issued and outstanding immediately before the Effective Time
shall automatically be converted into and exchanged for one
validly issued, fully paid and nonassessable share of common
stock of the Surviving Corporation. Each stock certificate of
Merger Sub evidencing ownership of any such shares shall, as of
the Effective Time, evidence ownership of such shares of common
stock of the Surviving Corporation.
(e) Adjustments to Exchange
Ratio. If, between the date of this Agreement
and the Effective Time, any outstanding shares of Adamis Common
Stock or La Jolla Common Stock shall have been changed
into, or exchanged for, a different number of shares or a
different class, by reason of any stock dividend, subdivision,
reclassification, recapitalization, split, reverse split,
combination or exchange of shares (other than the Reverse Stock
Split) (such transaction or event being referred to as a
Recapitalization), then the Exchange
Ratio, the Reverse Stock Split Ratio and, if applicable, the
per-share prices set forth in the definition of the
Post-Effective La Jolla Stockholder Shares shall, as
applicable, be correspondingly adjusted to provide the holders
of Adamis Capital Stock and Adamis Options and La Jolla
Stock and La Jolla Options the same economic effect as
contemplated by this Agreement before such event and any such
adjustment to the Exchange Ratio shall be approved by Adamis and
La Jolla. No Recapitalization may be effected by one party
with the prior written consent of the other party, which consent
will not be unreasonably withheld or delayed.
(f) No Fractional Shares. No
fractional shares of La Jolla Common Stock shall be issued
in connection with the Merger, and no certificates or scrip
representing such fractional shares shall be issued. The holder
of shares of Adamis Common Stock who would otherwise be entitled
to receive a fraction of a share of La Jolla Common Stock
(after aggregating all fractional shares of La Jolla Common
Stock to be received by such holder) shall, in lieu of such
fraction of a share and upon surrender of such holders
certificate representing shares of Adamis Capital Stock (the
Adamis Stock Certificate), instead
receive from La Jolla an amount of cash (rounded to the
nearest whole cent), without interest, equal to the product of
(i) such fraction, multiplied by (ii) the applicable
price per share which shall be equal to the average closing
price of La Jolla Common Stock (as reported on the Nasdaq
Capital Market, or the OTC Bulletin Board or, if the
La Jolla Common Stock is not traded on the Nasdaq Capital
Market or the OTC Bulletin Board, then the Pink Sheets,
and, if not traded on the Pink Sheets, then as determined in
good faith by La Jollas Board of Directors) on the
five trading days immediately prior to the Effective Date (after
giving effect to the Reverse Stock Split).
1.7 Calculation of the Exchange
Ratio. For purposes of this Agreement, the
Exchange Ratio shall be one
(1) share of La Jolla Common Stock (assuming the
effectiveness of the Reverse Stock Split) in exchange for one
(1) share of Adamis Common Stock outstanding immediately
before the Effective Time.
1.8 Dissenting
Shares. Notwithstanding any other provision
of this Agreement to the contrary, if Section 262 of the
DGCL (or Chapter 13 of the California Corporations Code, to
the extent applicable to Adamis by virtue of Section 2115
thereof) provides for appraisal rights with respect to the
Merger, then any shares of Adamis Capital Stock that have not
been voted in favor of adoption of this Agreement, and with
respect to which a demand for payment and appraisal have been
properly made in accordance with (a) Section 262 of
the DGCL or (b) Chapter 13 of the California
Corporations Code (to the extent applicable to Adamis by virtue
of Section 2115 thereof) (such shares referred to as
Dissenting Shares), shall not be
converted into or represent a right to receive La Jolla
Common Stock pursuant to Section 1.6(a), but shall be
converted into the right to receive such consideration as may
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be determined to be due with respect to such Dissenting Shares
pursuant to the DGCL or the California Corporations Code, as
applicable; provided, however, that if a holder of
Dissenting Shares (a Dissenting
Stockholder) withdraws such holders demand
for such payment and appraisal or becomes ineligible for such
payment and appraisal then, as of the later of the Effective
Time or the date of which such Dissenting Stockholder withdraws
such demand or otherwise becomes ineligible for such payment and
appraisal, such holders Dissenting Shares will cease to be
Dissenting Shares and will be converted into the right to
receive La Jolla Common Stock as determined in accordance
with Section 1.6(a).
1.9 No Further Transfer of Adamis Capital
Stock. At the Effective Time all shares of
Adamis Capital Stock outstanding immediately before the
Effective Time shall automatically be exchanged, and all holders
of Adamis Capital Stock that were outstanding immediately before
the Effective Time shall cease to have any rights as
stockholders of Adamis, except the right to receive the
consideration described in Section 1.6(a) or
Section 1.8, as applicable. No further transfer of any such
shares of Adamis Capital Stock shall be made on such stock
transfer books after the Effective Time. Subject to
Section 1.10(f) if, after the Effective Time, any shares of
Adamis Capital Stock are presented to the Exchange Agent or to
Adamis or La Jolla, such Adamis shares shall be canceled
and shall be exchanged as provided in Section 1.10.
1.10 Exchange of Certificates; Exchange
Agent. Prior to the Effective Time,
La Jolla and Adamis will jointly select and designate a
national bank, trust company or transfer agent to act as agent
of La Jolla for purposes of, among other things, mailing
and receiving transmittal letters and distributing the
La Jolla Common Stock to the holders of Adamis Common Stock
(the Exchange Agent).
(b) La Jolla to Provide Common
Stock. Promptly after the Effective Time,
La Jolla shall supply or cause to be supplied or made
available to the Exchange Agent for exchange in accordance with
this Section 1.10, through such reasonable procedures as
La Jolla may adopt, instructions regarding issuance of
certificates evidencing the shares of La Jolla Common Stock
issuable pursuant to Section 1.6(a) in exchange for shares
of Adamis Capital Stock outstanding immediately before the
Effective Time (the Exchange Shares).
(c) Exchange Procedures. As
promptly as practicable after the Effective Time, the Exchange
Agent will mail to each holder of record of Adamis Capital Stock
whose shares would be converted into the right to receive shares
of La Jolla Common Stock pursuant to Section 1.6(a),
(i) a letter of transmittal in customary form;
(ii) such other customary documents as may be required
pursuant to such instructions; and (iii) instructions for
use in effecting the surrender of Adamis Capital Stock in
exchange for certificates (or, if La Jolla elects to have
shares be represented in uncertificated form, then notifications
of share ownership) representing shares of La Jolla Common
Stock. Upon surrender of Adamis Capital Stock for cancellation
to the Exchange Agent, together with such letter of transmittal
and other documents, duly completed and validly executed in
accordance with the instructions thereto, the holder of such
Adamis Capital Stock shall be entitled to receive in exchange
therefor (x) a certificate (or, for uncertificated shares,
a notification of share ownership) representing the number of
whole Exchange Shares into which the Adamis Common Stock
represented thereby shall have been converted into the right to
receive as of the Effective Time, (y) any dividends or
other distributions to which such holder is entitled pursuant to
Section 1.10(d), and (z) cash in respect of any
fractional shares as provided in Section 1.6(f), and the Adamis
Capital Stock so surrendered shall forthwith be canceled. Until
so surrendered, each such outstanding share of Adamis Capital
Stock will be deemed from and after the Effective Time, for all
corporate purposes other than the payment of dividends, to
evidence the ownership of the number of full shares of
La Jolla Common Stock into which such shares of Adamis
Capital Stock shall have been so converted and the right to
receive cash in lieu of the issuance of any fractional shares.
If any Adamis Stock Certificate shall have been lost, stolen or
destroyed, La Jolla may, in its discretion and as a
condition precedent to the issuance of any certificate (or
notification of share ownership) representing La Jolla
Common Stock, require the owner of such lost, stolen or
destroyed Adamis Stock Certificate to provide a reasonable
affidavit
and/or bond
as indemnity against any claim that may be made against the
Exchange Agent, La Jolla or the Surviving Corporation with
respect to such Adamis Stock Certificate.
(d) Distributions With Respect to Unexchanged
Shares. No dividends or other distributions
with respect to La Jolla Common Stock with a record date
after the Effective Time will be paid to the holder of any
unsurrendered Adamis Capital Stock with respect to the shares of
La Jolla Common Stock represented thereby until the holder
of record of such Adamis Capital Stock shall surrender such
shares of Adamis Capital Stock. Subject to applicable law,
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following surrender of any such Adamis Capital Stock, there
shall be delivered to the record holder of Adamis Capital Stock
a certificate representing whole shares of La Jolla Common
Stock issued in exchange therefor (including any cash in respect
of any fractional shares), without interest at the time of such
surrender, and the amount of any such dividends or other
distributions with a record date after the Effective Time
theretofore payable (but for the provisions of this Section)
with respect to such shares of La Jolla Common Stock.
(e) Transfers of Ownership. If any
certificate (or notification of share ownership) for shares of
La Jolla Common Stock is to be issued in a name other than
that in which Adamis Stock Certificate surrendered in exchange
therefor is registered, it will be a condition of the issuance
thereof that the Adamis Capital Stock so surrendered will be
properly endorsed and otherwise in proper form for transfer and
that the person requesting such exchange will have paid to
La Jolla or any agent designated by it any transfer or
other taxes required by reason of the issuance of a certificate
(or notification of share ownership) for shares of La Jolla
Common Stock in any name other than that of the registered
holder of the Adamis Capital Stock surrendered, or established
to the satisfaction of La Jolla or any agent designated by
it that such tax has been paid or is not payable, and shall
provide such written assurances regarding federal and state
securities law compliance as La Jolla may reasonably
request.
(f) Termination of Exchange
Shares. Any Exchange Shares which remain
undistributed to the stockholders of Adamis twelve
(12) months after the Effective Time shall be delivered to
La Jolla, upon demand, and any stockholders of Adamis who
have not previously complied with this Section shall thereafter
look only to La Jolla for payment of their claim for their
portion of the Exchange Shares and any dividends or
distributions with respect to the Exchange Shares.
(g) No Liability. Notwithstanding
anything to the contrary in this Section, none of the Exchange
Agent, La Jolla, Adamis or any party hereto shall be liable
to any person for any amount properly paid to a public official
pursuant to any applicable abandoned property, escheat or
similar law.
(h) Dissenting Shares. The
provisions of this Section shall also apply to Dissenting Shares
that lose their status as such, except that the obligations of
La Jolla under this Section shall commence on the date of
loss of such status and the holder of such shares shall be
entitled to receive in exchange such shares to which such holder
is entitled pursuant to Section 1.6.
1.11 Further Action. If, at any time
after the Effective Time, any further action that is
commercially reasonable and lawful is determined by
La Jolla to be necessary or appropriate to carry out the
purposes of this Agreement or to vest La Jolla with full
right, title and possession of all shares of Adamis Capital
Stock, the officers and directors of Adamis and La Jolla
shall be fully authorized (in the name of Adamis
and/or
La Jolla or otherwise) to take such action.
ARTICLE II
REPRESENTATIONS
AND WARRANTIES OF ADAMIS
Adamis represents and warrants to La Jolla that the
statements contained in this Article II are true and
correct as set forth herein and as qualified by the disclosure
letter separately delivered to La Jolla concurrently
herewith (the Adamis Disclosure
Letter). The disclosures set forth in the Adamis
Disclosure Letter shall be arranged in paragraphs corresponding
to the numbered and lettered paragraphs contained in this
Article II. The disclosures in any section or subsection of
the Adamis Disclosure Letter shall qualify other sections and
subsections in this Article II to the extent it is
reasonably clear from a reading of the disclosure that such
disclosure is applicable to such other sections and subsections.
2.1 Organization and Good
Standing. Adamis is a corporation duly
organized, validly existing, and in good standing under the laws
of its jurisdiction of incorporation, with requisite corporate
power and authority to conduct its business as now being
conducted and to own or use its properties and assets. Adamis is
duly qualified to do business as a foreign corporation and is in
good standing under the laws of each state or other jurisdiction
in which either the ownership or use of the properties owned or
used by it, or the nature of the activities conducted by it,
requires such qualification, except where the failure to be so
qualified or in good standing would not have a Material Adverse
Effect on Adamis.
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2.2 Subsidiaries.
(a) The Adamis Disclosure Letter sets forth all direct and
indirect Subsidiaries of Adamis. Adamis owns all of the equity
of each Subsidiary. Except as set forth on the Adamis Disclosure
Letter, Adamis does not have any Subsidiaries or affiliated
companies and does not otherwise own any shares in the capital
of or any interest in, or control, directly or indirectly, any
corporation, partnership, limited liability company,
association, joint venture or other business entity (each an
Entity). Except as set forth in
Section 2.2(a) of the Disclosure Letter, Adamis has not
agreed and is not obligated to make any future investment in or
capital contribution to any Entity, and Adamis has not
guaranteed and is not responsible or liable for any obligation
of any of the Entities in which it owns or has owned any equity
interest.
(b) Each Subsidiary of Adamis: (i) is a corporation
duly organized and validly existing under the laws of its
jurisdiction of incorporation, (ii) has all requisite
corporate power and authority to own, operate or lease the
properties and assets owned, operated or leased by such
Subsidiary and to carry on its business as it has been and is
currently conducted by such Subsidiary and (iii) is duly
qualified to do business and is in good standing in each
jurisdiction in which the properties owned or leased by it or
the operation of its business makes such license and
qualification necessary, except, in each of clauses (i),
(ii) and (iii), such failures which, when taken together
with all other such failures, would not have a Material Adverse
Effect on Adamis and its Subsidiaries, when considered together.
2.3 Authority. Adamis has all requisite
corporate power and authority to enter into this Agreement and
the other agreements to which it is a party expressly required
to be executed and delivered in connection with the transactions
contemplated hereby (collectively, the Ancillary
Agreements), to perform its obligations hereunder
and thereunder and to consummate the transactions contemplated
hereby and thereby. The execution and delivery of this Agreement
and the Ancillary Agreements and the consummation of the
transactions contemplated hereby and thereby have been duly
authorized by all necessary corporate action on the part of
Adamis, subject only to the approval of this Agreement by the
stockholders of Adamis. The Board of Directors of Adamis has
unanimously approved this Agreement and the Merger. This
Agreement has been (and the Ancillary Agreements will be at the
Closing) duly executed and delivered by Adamis, and this
Agreement constitutes (and the Ancillary Agreements will
constitute at the Closing) the valid and binding obligation of
Adamis enforceable against Adamis in accordance with their
terms, except as may be limited by bankruptcy, insolvency,
reorganization, moratorium or other similar laws affecting or
relating to creditors rights generally, and subject to
general principles of equity.
2.4 No Conflict. The execution and
delivery by Adamis of this Agreement and the Ancillary
Agreements to which Adamis is a party, does not, and the
consummation of the transactions contemplated hereby and thereby
will not (i) conflict with, or result in any violation of,
any provision of the Adamis Charter (in its current form and as
it may be amended immediately before the Effective Time) or the
Adamis Bylaws, (ii) except as would not reasonably be
expected to have a Material Adverse Effect on Adamis, result in
any violation of or default under (with or without notice or
lapse of time, or both), or give rise to a right of termination,
cancellation or acceleration of any obligation or loss of any
benefit under any mortgage, indenture, lease, contract, grant,
funding arrangement, or other agreement or instrument, permit,
concession, franchise or license of Adamis, (iii) subject
to obtaining the approval of Adamiss stockholders and
except as would not reasonably be expected to have a Material
Adverse Effect on Adamis, conflict with, or result in any
violation of any judgment, order, decree, statute, law,
ordinance, rule or regulation applicable to Adamis or any of its
properties or assets, or (iv) conflict with, or result in a
violation of any resolution adopted by Adamiss
stockholders, Adamiss board of directors or any committee
of Adamiss board of directors.
2.5 Consents. No consent, waiver,
approval, order or authorization of, or registration,
declaration or filing with or notice to, any Governmental Entity
or any party to any Material Contract of Adamis is required by
or with respect to Adamis or any of its Subsidiaries in
connection with the execution and delivery of this Agreement by
Adamis and any Ancillary Agreement to which Adamis is a party or
the consummation of the transactions contemplated hereby and
thereby, except for (i) such consents, waivers, approvals,
orders, authorizations, registrations, declarations and filings
as may be required under applicable securities laws,
(ii) the filing of the Certificate of Merger with the
Delaware Secretary of State, and (iii) such consents,
waivers, approvals, orders, authorizations,
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registrations, declarations or filings which, if not obtained or
made, would not have a Material Adverse Effect on Adamis.
2.6 Governmental Authorizations. Adamis
has obtained each material federal, state, county, local or
foreign governmental consent, license, permit, grant, or other
authorization of a Governmental Entity (a) pursuant to
which Adamis currently operates or holds any interest in any of
its properties, or (b) that is required for the operation
of Adamiss business or the holding of any such interest,
and all of such authorizations are in full force and effect,
except for such consents, licenses, permits, grants or other
authorizations, which if not obtained would not have a Material
Adverse Effect on Adamis.
2.7 Capitalization.
(a) The authorized capital stock of Adamis consists of
175,000,000 shares of Adamis Common Stock, $0.0001 par
value, and 10,000,000 shares of Adamis Preferred Stock,
$0.0001 par value, of which there were issued and
outstanding, as of the date of this Agreement,
45,972,303 shares of Adamis Common Stock and no shares of
Adamis Preferred Stock. All of the outstanding shares of Adamis
Capital Stock (i) have been duly authorized and validly
issued, and are fully paid and non-assessable, (ii) except
for rights of first refusal, exchange, repurchase, forfeiture
and/or
cancellation rights in favor of Adamis, are not subject to
preemptive rights or rights of first refusal created by statue,
the Adamis Charter, the Adamis Bylaws or any agreement to which
Adamis is a party or by which it is bound and (iii) have
been issued in compliance in all material respects with federal
and state securities laws. There are no declared or unpaid
dividends with respect to any shares of Adamis Capital Stock.
None of Adamiss debt could be classified as equity for tax
purposes.
(b) Section 2.7 of the Adamis Disclosure Letter sets
forth: (i) the number of outstanding options and warrants
to purchase shares of Adamis Common Stock; (ii) the number
of shares reserved for further issuance under the Adamis 2009
Equity Incentive Plan; (iii) with respect to each option
and warrant outstanding as of the date of this Agreement,
(A) the name of the holder of such option or warrant,
(B) the total number of shares of Adamis Common Stock that
are subject to such option or warrant and the number of shares
of Adamis Common Stock with respect to which such option or
warrant is immediately exercisable, (C) the date of which
such option or warrant was granted and the term of such option
or warrant, (D) the vesting schedule, if any, of such
option or warrant, (E) the exercise price per share of
Adamis Common Stock purchasable under such option or warrant and
(F) whether such option or warrant has been designated an
incentive stock option as defined in Section 422 of
the Code; and (iv) an accurate and complete description of
the terms of each repurchase option which is held by Adamis and
to which any of such shares is subject.
(c) Except as set forth in Section 2.7 of the Adamis
Disclosure Letter, there is no: (i) outstanding
subscription, option, call, warrant or right (whether or not
currently exercisable) to acquire any shares of the capital
stock or other securities of Adamis; (ii) outstanding
security, instrument or obligation that is or may become
convertible into or exchangeable for any shares of the capital
stock or other securities of Adamis; (iii) contract under
which Adamis is or may become obligated to sell or otherwise
issue any shares of its capital stock or any other securities;
or (iv) to Adamiss Knowledge, condition or
circumstance that may give rise to or provide a basis for the
assertion of a claim by any Person to the effect that such
Person is entitled to acquire or receive any shares of capital
stock or other securities of Adamis.
2.8 SEC Reports; Financial Statements.
(a) As of their respective filing dates, all annual,
quarterly or current reports, filed by Adamis with the SEC since
January 1, 2009 (including those that Adamis may file
subsequent to the date hereof) (such reports, as amended
Adamis SEC Reports) (i) were
prepared in accordance in all material respects with the
requirements of the Securities Act and the Exchange Act, as the
case may be, and the rules and regulations thereunder, except as
may be reflected in any amendments to such reports that Adamis
has filed with the SEC, (ii) as the same may have been
amended, did not contain any untrue statement of a material fact
or omit to state a material fact required to be stated therein
or necessary in order to make the statements made therein, in
the light of the circumstances under which they were made, not
misleading and (iii) were all the forms, reports and other
documents required to be filed under the Exchange Act. Since
January 1, 2009, Adamis has filed with the SEC all reports
that are required to have been filed.
(b) No Subsidiary of Adamis is or has been required to file
any form, report, registration statement or other document with
the SEC. The consolidated financial statements (including any
related notes thereto) contained in the Adamis SEC Reports (in
the form, as applicable, in any amendments to such Adamis SEC
Reports) (the Adamis
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Financial Statements): (i) complied as
to form in all material respects with the published rules and
regulations of the SEC applicable thereto; (ii) were
prepared in accordance with GAAP applied on a consistent basis
throughout the periods covered, except as may be indicated in
the notes to such financial statements and (in the case of
unaudited statements) as permitted by
Form 10-Q
of the SEC, and except that unaudited financial statements may
not contain footnotes and are subject to year-end audit
adjustments; and (iii) fairly present in all material
respects the consolidated financial position of Adamis and its
Subsidiaries as of the respective dates thereof and the
consolidated results of operations and cash flows of Adamis and
its Subsidiaries for the periods covered thereby. The unaudited
balance sheet of Adamis as of September 30, 2009, that is
included in the Adamis Financial Statements is referred to
herein as the Adamis Current Balance
Sheet.
(c) Adamis maintains a system of internal accounting
controls and disclosure controls and procedures sufficient, in
the judgment of Adamiss board of directors, to provide
reasonable assurance that (i) transactions are executed in
accordance with managements general or specific
authorizations, (ii) transactions are recorded as necessary
to permit preparation of financial statements in conformity with
GAAP and to maintain asset accountability, (iii) access to
assets is permitted only in accordance with managements
general or specific authorization, and (iv) the recorded
accountability for assets is compared with the existing assets
at reasonable intervals and appropriate action is taken with
respect to any differences.
(d) Adamis has not, in the twelve (12) months
preceding the date hereof, received notice from the trading
market or stock quotation system on which the Adamis Common
Stock is listed or quoted or any other trading market or stock
quotation system on which the Adamis Common Stock was previously
listed or quoted to the effect that Adamis is not in compliance
with the listing or maintenance requirements of such trading
market or stock quotation system. Adamis is, and has no reason
to believe that it will not in the foreseeable future continue
to be, in compliance with all such listing and maintenance
requirements.
2.9 Absence of Certain Changes. Since
the date of the Adamis Current Balance Sheet, except as set
forth in the Adamis Disclosure Letter or as disclosed in the
Adamis SEC Reports, there has not occurred (a) any change,
event or condition (whether or not covered by insurance) that
has resulted in, or would reasonably be expected to result in, a
Material Adverse Effect on Adamis; (b) any acquisition,
sale or transfer of any material assets or material properties
of Adamis or any creation of any security interest in such
assets or properties; (c) any change in accounting methods
or practices (including any change in depreciation or
amortization policies or rates) by Adamis or any revaluation by
Adamis of any of its assets; (d) any declaration, setting
aside, or payment of a dividend or other distribution with
respect to the shares of Adamis or any direct or indirect
redemption, purchase or other acquisition by La Jolla of
any of its shares of capital stock; (e) any Material
Contract entered into by Adamis, or any material amendment or
termination of, or default under, any Material Contract to which
Adamis is a party or by which it is bound, in each case that
would reasonably be expected to result in a Material Adverse
Effect on Adamis; (f) any amendment or change to Adamis
Charter or Adamis Bylaws; (g) any increase in or
modification of the compensation or benefits payable or to
become payable by Adamis to any of its directors or employees;
(h) any sale, issuance or authorization by Adamis of
(1) any capital stock or other security, (2) any
option or right to acquire any capital stock or any other
security, or (3) any Convertible Securities; any formation
by Adamis of any Subsidiary or any acquisition of any equity
interest or other interest in any other Equity (other than
Merger Sub); (i) any other material event that is not in
the Ordinary Course of Business; or (j) any agreement by
Adamis to do any of the things described in the preceding
clauses (a) through (i).
2.10 Interested Party
Transactions. Except as set forth in the
Adamis SEC Reports or as set forth in Section 2.10 of the
Adamis Disclosure Letter, Adamis is not indebted to any
director, officer or employee of Adamis (except for amounts due
as normal salaries and bonuses and in reimbursement of ordinary
expenses), and no such person is indebted to Adamis. Except as
set forth in the Adamis SEC Reports or as set forth in
Section 2.10 of the Adamis Disclosure Letter, Adamis is not
a party to any transaction of the type that would be required to
be disclosed pursuant to Item 404 of
Regulation S-K
promulgated by the SEC.
2.11 Intellectual Property.
(a) Adamis and each of its Subsidiaries owns or possesses
the right to use the Intellectual Property that is owned by or
licensed to Adamis and each of its Subsidiaries (the
Adamis Patent and Proprietary Rights),
except where the failure to own or possess such rights would not
have a Material Adverse Effect on Adamis or any of its
Subsidiaries, considered together.
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(b) Neither Adamis nor any of its Subsidiaries has received
any notice of any asserted rights with respect to any of the
Adamis Patent and Proprietary Rights which, if determined
unfavorably with respect to the interests of Adamis or any of
its Subsidiaries would have a Material Adverse Effect on Adamis
or any of its Subsidiaries, considered together.
(c) To Adamiss Knowledge, neither Adamis nor any of
its Subsidiaries has ever infringed (directly, contributorily,
by inducement, or otherwise), misappropriated, or otherwise
violated or made unlawful use of any right to Intellectual
Property of any other Person or engaged in unfair competition.
No infringement, misappropriation, or similar claim or Legal
Proceeding is pending or, to Adamiss Knowledge, threatened
against Adamis, any of its Subsidiaries or any other Person who
is or may be entitled to be indemnified, defended, held
harmless, or reimbursed by Adamis or any of its Subsidiaries
with respect to such claim or Legal Proceeding. Neither Adamis
nor any of its Subsidiaries has received notice or is otherwise
aware of any infringement of or conflict with asserted rights of
others with respect to any of Adamis Patent and Proprietary
Rights, which infringement or conflict (if the subject of any
unfavorable decision, ruling or finding), individually or in the
aggregate, would result in a Material Adverse Effect on Adamis
or any of its Subsidiaries, considered together.
(d) To Adamiss Knowledge, neither Adamis nor any of
its Subsidiaries has engaged in patent or copyright misuse or
any fraud or inequitable conduct in connection with any Adamis
Patent and Proprietary Rights, and no trademark or trade name
owned, used, or applied for by Adamis or any of its Subsidiaries
conflicts or interferes with any trademark or trade name owned,
used, or applied for by any other Person.
2.12 Taxes.
(a) As used in this Agreement, the terms
Tax and, collectively,
Taxes mean any and all
U.S. federal, state, local or foreign taxes, assessments
and other similar governmental charges, duties, impositions and
liabilities, including taxes based upon or measured by gross
receipts, income, profits, sales, use and occupation, and value
added, ad valorem, stamp transfer, franchise, withholding,
payroll, recapture, employment, excise and property taxes,
together with all interest, penalties and additions imposed with
respect to such amounts and any obligations under any agreements
or arrangements with any other person with respect to such
amounts and including any liability for taxes of a predecessor
Entity.
(b) Adamis and each of its Subsidiaries has prepared and
timely filed all Tax Returns relating to any and all Taxes
concerning or attributable to Adamis and such Tax Returns are
true and correct in all material respects and have been
completed in accordance with applicable law. Adamis has
delivered or made available to La Jolla correct and
complete copies of all federal income Tax Returns, examination
reports, and statements of deficiencies assessed against or
agreed to by Adamis or any of its Subsidiaries filed or received
since January 1, 2008 or, if later, since inception. None
of Adamis or any of its Subsidiaries is delinquent in the
payment of any Taxes due and owing by Adamis and each of its
Subsidiaries
(c) Adamis and each of its Subsidiaries has withheld and
timely paid all Taxes required to have been withheld and paid
with respect to any amounts paid or owing to any employee,
independent contractor, creditor, stockholder, or other third
party.
(d) There is no Tax deficiency outstanding or assessed or,
to Adamiss Knowledge, proposed against Adamis that is not
reflected as a liability on the Adamis Current Balance Sheet,
nor has Adamis executed any agreements or waivers extending any
statute of limitations on or extending the period for the
assessment or collection of any Tax (other than extensions which
have expired). No claim has ever been made by an authority in a
jurisdiction where Adamis does not file Tax Returns that it is
or may be subject to taxation by that jurisdiction. There are no
liens for Taxes (other than Taxes not yet due and payable) upon
any of the assets of Adamis. Neither Adamis nor any of its
Subsidiaries has been a party to any listed
transaction as defined in Section 6707(C)(2) of the
Code and
Section 1.6011-4(b)(2)
of the Treasury Regulations.
(e) To Adamiss Knowledge, Adamis has no liabilities
for unpaid Taxes that have not been accrued for or reserved on
the Adamis Financial Statements, whether asserted or unasserted,
contingent or otherwise. Neither Adamis nor any of its
Subsidiaries will incur any liability for Taxes through the
Effective Date other than in the ordinary course of business or
pursuant to this Agreement.
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(f) Neither Adamis nor any of its Subsidiaries has received
from any Governmental Entity any (i) written notice
indicating an intent to open an audit or other review,
(ii) written request for information related to Tax
matters, or (iii) written notice of deficiency or proposed
adjustment of or any amount of Tax proposed, asserted, or
assessed by any Governmental Entity against Adamis.
(g) Adamis is not a party to any tax-sharing agreement or
similar arrangement with any other party, and Adamis has not
assumed any obligation to pay any Tax obligations of, or with
respect to any transaction relating to, any other person or
agreed to indemnify any other person with respect to any Tax.
(h) Adamis has not been a member of an affiliated group of
corporations filing a consolidated federal income tax return
other than a group of which Adamis was the parent.
(i) Adamis has not been at any time a United States Real
Property Holding Corporation within the meaning of Section
897(c)(2) of the Code.
(j) Neither Adamis nor any of its Subsidiaries has filed a
consent under section 341(f) of the Code concerning
collapsible corporations. Neither Adamis nor any of its
Subsidiaries is a party to any contract, agreement, plan or
arrangement, including but not limited to the provisions of this
Agreement, covering any employee or former employee of Adamis or
any of its Subsidiaries that, individually or collectively,
could give rise to the payment of (i) any excess
parachute payment within the meaning of Section 280G of
the Code (or any corresponding provisions of state, local or
foreign Tax law) and (ii) any amount that will not be fully
deductible as a result of Section 162(m) of the Code (or
any corresponding provisions of state, local or foreign Tax
law). None of the Adamis common stock is subject to a
substantial risk of forfeiture within the meaning of
Section 83 of the Code.
(k) Adamis will not be required to include any item of
income in, or exclude any item of deduction from, taxable income
for any taxable period (or portion there) ending after the
Closing Date as a result of any: (A) change in method of
accounting for taxable period ending on or prior to the Closing
Date; (B) closing agreement as described in
Section 7121 of the Code (or any corresponding or similar
provision of state, local or foreign income Tax law) executed on
or prior to the Closing Date; (C) intercompany transactions
or any excess loss account described in Treasury Regulations
under section 1502 of the Code (or any corresponding or
similar provisions of state, local or foreign income Tax law);
(D) installment sale or open transaction disposition made
on or prior to the Closing Date; (E) prepaid amount
received on or prior to the Closing Date, or (F) election
with respect to the discharge of indebtedness under
Section 108(i) of the Code.
(l) Adamis has not distributed stock of another Person, or
has had its stock distributed by another Person, in a
transaction that was purported or intended to be governed in
whole or in part by section 355 or section 361 of the
Code.
2.13 Employee Benefit Plans.
(a) The Adamis Disclosure Letter contains a complete and
accurate list (to the extent not already filed as an exhibit
with the Adamis SEC Reports) of each Adamis Employee Agreement
and each plan, program, policy, practice, contract, agreement or
other arrangement providing for performance awards, bonus,
incentive, stock option, stock purchase, stock bonus, phantom
stock, stock appreciation right, supplemental retirement, fringe
benefits, cafeteria benefits or other benefits, whether written
or unwritten, including without limitation each employee
benefit plan within the meaning of Section 3(3) of
the Employee Retirement Income Security Act of 1974, as amended
(ERISA), which is sponsored,
maintained, contributed to, or required to be contributed to by
Adamis (or any subsidiary) and, with respect to any such plans
which are subject to Code Section 401(a), any trade or
business (whether or not incorporated) that is or at any
relevant time was treated as a single employer with Adamis
within the meaning of Section 414(b), (c), (m) or
(o) of the Code, (an ERISA
Affiliate) for the benefit of any person who
performs services for Adamis (or any subsidiary) or with respect
to which Adamis or any ERISA Affiliate has or may have any
liability (including without limitation contingent liability) or
obligation (collectively, the Adamis Employee
Plans). Adamis has furnished or made available to
La Jolla true and complete copies of documents embodying
each of the Adamis Employee Plans and, with respect to each
Adamis Employee Plan that is subject to ERISA reporting
requirements, Adamis has provided or made available copies of
the Form 5500 reports filed for the last two plan years.
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(b) Compliance. Each Adamis
Employee Plan has been administered in material compliance with
its terms and with the requirements of applicable law; and
Adamis and each ERISA Affiliate have performed all material
obligations required to be performed by them under, and are not
in any material respect in default under or violation of, any of
Adamis Employee Plans. No Adamis Employee Plan is intended to be
qualified under Section 401(a) of the Code. No
prohibited transaction, within the meaning of
Section 4975 of the Code or Sections 406 and 407 of
ERISA, and not otherwise exempt under Section 408 of ERISA,
has occurred with respect to any Adamis Employee Plan. There are
no claims or Legal Proceedings pending, or, to Adamiss
Knowledge, threatened or reasonably anticipated (other than
routine claims for benefits), against any Adamis Employee Plan
or against the assets of any Adamis Employee Plan. There are no
audits, inquiries or Legal Proceedings pending or, to
Adamiss Knowledge, threatened by any Governmental
Authority with respect to any Adamis Employee Plan. For at least
the three years preceding the date of this Agreement, neither
Adamis nor any of its Subsidiaries has incurred any penalty or
tax with respect to any Adamis Employee Plan under
Section 502(i) of ERISA or Sections 4975 through 4980
of the Code. Adamis and each of its Subsidiaries have made all
contributions and other payments required by and due under the
terms of each Adamis Employee Plan.
(c) No Title IV or Multiemployer
Plan. No Adamis Employee Plan is a
multiemployer plan (as defined in Section 3(37)
of ERISA) or a pension plan (as defined in
Section 3(2) of ERISA) subject to Title IV of ERISA.
(d) Future Commitments. No Adamis
Employee Plan provides (except at no cost to Adamis or any of
its Subsidiaries), or reflects or represents any liability of
Adamis or any of its Subsidiaries to provide, retiree life
insurance, retiree health benefits or other retiree employee
welfare benefits to any Person for any reason, except as may be
required by COBRA or other applicable Legal Requirements. Other
than commitments made that involve no future costs to Adamis or
any of its Subsidiaries, neither Adamis nor any of its
Subsidiaries has represented, promised or contracted (whether in
oral or written form) to any employee of Adamis or any other
Person that such employee or other Person would be provided with
retiree life insurance, retiree health benefit or other retiree
employee welfare benefits, except to the extent required by
applicable Legal Requirements.
(e) Effect of Transaction. The
consummation of the transactions contemplated by this Agreement
will not (i) entitle any current or former employee or
other service provider of Adamis or any ERISA Affiliate to
severance benefits or any other payment (including without
limitation unemployment compensation, golden parachute, bonus or
benefits under any Adamis Employee Plan), except as expressly
provided in this Agreement; or (ii) accelerate the time of
payment or vesting of any such benefits or increase the amount
of compensation due any such employee or service provider.
2.14 Employee Matters. Adamis is in
material compliance with all currently applicable laws and
regulations respecting terms and conditions of employment. There
are no proceedings pending or, to Adamiss Knowledge,
threatened, between Adamis, on the one hand, and any or all of
its current or former employees, on the other hand, which would
reasonably be expected to have a Material Adverse Effect on
Adamis. Except as may be reflected in the Adamis SEC Reports,
Adamis has provided all employees with all wages, benefits,
relocation benefits, stock options, bonuses and incentives, and
all other compensation that became due and payable through the
date of this Agreement.
2.15 Insurance. The Adamis Disclosure
Letter sets forth all policies of insurance maintained by, at
the expense of or for the benefit of Adamis. There is no
material claim pending under any of such policies as to which
coverage has been questioned, denied or disputed by the
underwriters of such policies. All premiums due and payable
under all such policies have been paid and, to Adamiss
Knowledge, Adamis is otherwise in compliance with the terms of
such policies. To Adamiss Knowledge, there is no
threatened termination of, or material premium increase with
respect to, any of such policies.
2.16 Compliance with Legal
Requirements. For all periods of time during
which the respective applicable statute of limitations periods
have not expired, except as disclosed in the Adamis SEC Reports
or in Section 2.16 of the Adamis Disclosure Letter,
(i) Adamis and each of its Subsidiaries has complied in all
material respects with, is not in material violation of, and has
not received any written or, to Adamiss Knowledge, other
notices of violation with respect to, any applicable Legal
Requirement or regulation with respect to the conduct of its
business, or the ownership or operation of its business; and
(ii) neither Adamis nor any of its Subsidiaries has
received any written or, to Adamiss Knowledge, other
notices or other communication from any Governmental Entity
regarding (A) any
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actual, alleged, possible, or potential violation of, or failure
to comply with, any applicable Legal Requirement, or
(B) any actual, alleged, possible, or potential obligation
on the part of Adamis or any of its Subsidiaries to undertake,
or to bear all or any portion of the cost of, any remedial
action related to compliance or non-compliance with any
applicable Legal Requirement, in each of the above cases which
if determined adversely to Adamis or any of its Subsidiaries
would reasonably be expected to have a Material Adverse Effect
on Adamis or its Subsidiaries, considered together.
2.17 Environmental Matters. To
Adamiss Knowledge, Adamis is, and at all times has been,
in compliance in all material respects with all Environmental
Laws and is not subject to any material liability under any
Environmental Law. Adamis has not received, nor to Adamiss
Knowledge has any other Person for whose conduct it is or may be
held responsible, received, any order, written notice, or other
written communication from (i) any Governmental Entity or
private citizen acting in the public interest, or (ii) the
current or prior owner or operator of any Facilities, asserting
or alleging any actual or potential violation of or failure to
comply with any Environmental Law, or any obligation to
undertake or bear the cost of any Environmental, Health, and
Safety Liabilities.
2.18 Legal Proceedings. Except as may
be disclosed in the Adamis SEC Reports, there is no pending
Legal Proceeding that has been commenced by or against Adamis.
To Adamiss Knowledge, no Person has threatened to commence
any Legal Proceeding against Adamis. Except as may be disclosed
in the Adamis SEC Reports, there is no judgment, decree or order
against Adamis, or, to Adamiss Knowledge, any of its
directors or officers (in their capacities as such), that could
prevent, enjoin, or materially alter or delay any of the
transactions contemplated by this Agreement, or any Ancillary
Agreement, or that would reasonably be expected to have a
Material Adverse Effect on Adamis. To Adamiss Knowledge,
no event has occurred, and no claim, dispute or other condition
or circumstance exists, that will, or that would reasonably be
expected to, give rise to or serve as a basis for the
commencement of any such Legal Proceeding.
2.19 Contracts; No Defaults.
(a) Each Material Contract of Adamis is set forth in
Section 2.19(a) of the Adamis Disclosure Letter or filed as an
exhibit to the Adamis SEC Reports, and is enforceable in
accordance with its terms, subject to (i) laws of general
application relating to bankruptcy, insolvency and the relief of
debtors, and (ii) rules of law governing specific
performance, injunctive relief and other equitable
remedies; and
(b) Adamis has not violated or breached, or committed any
default under, any Material Contract, in each of the above cases
where such violation, breach or default would have a Material
Adverse Effect on Adamis. Except as set forth in the Adamis
Disclosure Letter or the Adamis SEC Reports, no event has
occurred, and no circumstance or condition exists, that (with or
without notice or lapse of time) would reasonably be expected
to, (i) result in a violation or breach of any of the
provisions of any Material Contract of Adamis, (ii) give
any Person the right to declare a default or exercise any remedy
under any Material Contract of Adamis, (iii) give any
Person the right to accelerate the maturity or performance of
any Material Contract of Adamis, or (iv) give any Person
the right to cancel, terminate or modify any Material Contract,
in each of the above cases where such violation, breach or
default would have a Material Adverse Effect on Adamis. Neither
Adamis nor any of its Subsidiaries has received any notice or
other written or, to Adamiss Knowledge, oral communication
regarding any actual or possible violation or breach of, or
default under, any Material Contract of Adamis.
(c) The Adamis Disclosure Letter sets forth a list of all
material consents or waivers of, or notifications to, any
Governmental Entity or any third party that are required or
provided for under any Material Contract of Adamis or any of its
Subsidiaries in connection with the execution and delivery of
this Agreement and the Ancillary Agreements by Adamis and the
consummation of the transactions contemplated hereby and thereby.
2.20 Labor Matters. Adamis is not a
party to, or bound by, any collective bargaining agreement,
contract or other agreement or understanding with a labor union
or labor organization. Adamis is not the subject of any Legal
Proceeding asserting that Adamis has committed an unfair labor
practice or seeking to compel it to bargain with any labor
organization as to wages or conditions of employment. There is
no strike, work stoppage or other labor dispute involving Adamis
pending or, to Adamiss Knowledge, threatened against
Adamis.
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2.21 Unlawful Payments. To
Adamiss Knowledge, none of Adamis, or any officer,
director, employee, agent or representative of Adamis has made,
directly or indirectly, any bribe or kickback, illegal political
contribution, payment from corporate funds which was incorrectly
recorded on the books and records of Adamis, unlawful payment
from corporate funds to governmental or municipal officials in
their individual capacities for the purpose of affecting their
action or the actions of the jurisdiction which they represent
to obtain favorable treatment in securing business or licenses
or to obtain special concessions of any kind whatsoever, or
illegal payment from corporate funds to obtain or retain any
business.
2.22 Financial Advisor. Except as
disclosed in writing to La Jolla before the date of this
Agreement, no broker, finder or investment banker is entitled to
any commission or brokerage or finders fee in connection
with the Merger or any of the other transactions contemplated by
this Agreement based upon arrangements made by or on behalf of
Adamis.
2.23 Title to Assets; No Real Property.
(a) Adamis owns, and has good, valid and marketable title
to, all assets purported to be owned by it, including:
(i) all assets reflected on its balance sheet as of the
date of the Adamis Current Balance Sheet; (ii) all equity
interests of its Subsidiaries, all Adamis Patent and Proprietary
Rights and all of Adamiss rights under the Material
Contracts required to be identified in Section 2.19 of the
Adamis Disclosure Letter; and (iii) all other assets
reflected in Adamiss books and records as being owned by
Adamis. All of said assets are owned by Adamis free and clear of
any liens or other Encumbrances, except for (x) any lien
for current taxes not yet due and payable, and (y) minor
liens that have arisen in the ordinary course of business and
that do not (in any case or in the aggregate) materially detract
from the value of the assets subject thereto or materially
impair the operations of Adamis or any of its Subsidiaries.
(b) Except as set forth in Section 2.23 of the Adamis
Disclosure Letter, Adamis does not own any real property and
Adamis is not party to any lease for real property either as a
lessee or lessor.
2.24 Representations Complete. This
Agreement (as limited and qualified by the Adamis Disclosure
Letter) does not contain any representation, warranty or
information that (i) contains an untrue statement of a
material fact, or (ii) omits to state any material fact
necessary in order to make the statements herein (in the light
of the circumstances under which such statements have been made)
not misleading.
ARTICLE III
REPRESENTATIONS
AND WARRANTIES OF LA JOLLA AND MERGER SUB
La Jolla, and Merger Sub (with respect to the
representations, warranties and covenants of Merger Sub),
represent and warrant to Adamis that the statements contained in
this Article III are true and correct as set forth herein
and as qualified by the disclosure letter separately delivered
to Adamis concurrently herewith (the La Jolla
Disclosure Letter). The disclosures set forth in
the La Jolla Disclosure Letter shall be arranged in
paragraphs corresponding to the numbered and lettered paragraphs
contained in this Article III. The disclosures in any
section or subsection of the La Jolla Disclosure Letter
shall qualify other sections and subsections in this
Article III to the extent it is reasonably clear from a
reading of the disclosure that such disclosure is applicable to
such other sections and subsections.
3.1 Organization and Good
Standing. La Jolla is a corporation duly
organized, validly existing and in good standing under the laws
of the jurisdiction of its incorporation, with requisite
corporate power and authority to conduct its business as now
being conducted and to own or use its properties and assets.
La Jolla is duly qualified to do business as a foreign
corporation and is in good standing under the laws of each state
or other jurisdiction in which either the ownership or use of
the properties owned or used by it, or the nature of the
activities conducted by it, requires such qualification except
where the failure to be so qualified or in good standing would
not have a Material Adverse Effect on La Jolla.
3.2 Subsidiaries.
(a) The La Jolla Disclosure Letter sets forth all
direct and indirect Subsidiaries of La Jolla. La Jolla
owns all of the equity of each Subsidiary. Except as set forth
on the La Jolla Disclosure Letter, La Jolla does not
have any Subsidiaries or affiliated companies and does not
otherwise own any shares in the capital of or any interest in,
or control, directly or indirectly, any Entity. Except as set
forth in Section 3.2(a) of the Disclosure Letter,
La Jolla has
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not agreed and is not obligated to make any future investment in
or capital contribution to any Entity, and La Jolla has not
guaranteed and is not responsible or liable for any obligation
of any of the Entities in which it owns or has owned any equity
interest.
(b) Each Subsidiary of La Jolla: (i) is a
corporation duly organized and validly existing under the laws
of its jurisdiction of incorporation, (ii) has all
requisite corporate power and authority to own, operate or lease
the properties and assets owned, operated or leased by such
Subsidiary and to carry on its business as it has been and is
currently conducted by such Subsidiary and (iii) is duly
qualified to do business and is in good standing in each
jurisdiction in which the properties owned or leased by it or
the operation of its business makes such license and
qualification necessary, except, in each of clauses (i),
(ii) and (iii), such failures which, when taken together
with all other such failures, would not have a Material Adverse
Effect on La Jolla and its Subsidiaries, when considered
together.
3.3 Authority. Each of La Jolla
and Merger Sub has all requisite corporate power and authority
to enter into this Agreement and the Ancillary Agreements to
which it is a party, to perform its obligations hereunder and
thereunder and to consummate the transactions contemplated
hereby and thereby. The execution and delivery of this Agreement
and the Ancillary Agreements and the consummation of the
transactions contemplated hereby and thereby have been duly
authorized by all necessary corporate action on the part of
La Jolla and Merger Sub, subject only to the approval of
this Agreement by the stockholders of La Jolla and Merger
Sub. The Board of Directors of La Jolla and Merger Sub have
unanimously approved this Agreement and the Merger. This
Agreement has been (and the Ancillary Agreements will be at the
Closing) duly executed and delivered by La Jolla and Merger
Sub, and this Agreement constitutes and the Ancillary Agreements
will constitute at the Closing) the valid and binding
obligations of La Jolla and Merger Sub enforceable against
each of La Jolla and Merger Sub in accordance with their
terms, except as may be limited by bankruptcy, insolvency,
reorganization, moratorium or other similar laws affecting or
relating to creditors rights generally, and subject to
general principles of equity. Merger Sub has been formed solely
for the purpose of executing and delivering this Agreement and
consummating the transactions contemplated hereby. Since the
date of its incorporation, Merger Sub has neither engaged in nor
transacted any business or activity of any nature whatsoever
other than activities related to its corporate organization and
the execution and delivery of this Agreement and the related
documents and instruments. Merger Sub has no assets or
properties or debts, liabilities or obligations of any kind
whatsoever, and with the exception of this Agreement and the
related documents and instruments, is not a party to any
contract, agreement or undertaking of any nature.
3.4 No Conflict. The execution and
delivery by La Jolla of this Agreement and the Ancillary
Agreements to which La Jolla is a party, does not, and the
consummation of the transactions contemplated hereby and thereby
will not (i) conflict with, or result in any violation of,
any provision of the La Jolla Charter (in its current form
and as it may be amended immediately before the Effective Time)
or the La Jolla Bylaws, (ii) except as would not
reasonably be expected to have a Material Adverse Effect on
La Jolla, result in any violation of or default under (with
or without notice or lapse of time, or both), or give rise to a
right of termination, cancellation or acceleration of any
obligation or loss of any benefit under any mortgage, indenture,
lease, contract, grant, funding arrangement, or other agreement
or instrument, permit, concession, franchise or license of
La Jolla, (iii) subject to obtaining the approval of
La Jollas stockholders and except as would not
reasonably be expected to have a Material Adverse Effect on
La Jolla, conflict with, or result in any violation of any
judgment, order, decree, statute, law, ordinance, rule or
regulation applicable to La Jolla or any of its properties
or assets or (iv) conflict with, or result in a violation
of any resolution adopted by La Jollas stockholders,
La Jollas board of directors or any committee of
La Jollas board of directors.
3.5 Consents. No consent, waiver,
approval, order or authorization of or registration, declaration
or filing with or notice to, any Governmental Entity or any
party to any Material Contract is required by or with respect to
La Jolla or any of its Subsidiaries in connection with the
execution and delivery of this Agreement by La Jolla and
any Ancillary Agreement to which La Jolla is a party or the
consummation by La Jolla of the transactions contemplated
hereby and thereby, except for (i) such consents, waivers,
approvals, orders, authorizations, registrations, declarations
and filings as may be required under applicable securities laws,
(ii) the filing of the Certificate of Merger with the
Delaware Secretary of State and (iii) such consents,
waivers, approvals, orders, authorizations, registrations,
declarations or filings which, if not obtained or made, would
not have a Material Adverse Effect on La Jolla.
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3.6 Governmental
Authorizations. La Jolla has obtained
each material federal, state, county, local or foreign
governmental consent, license, permit, grant, or other
authorization of a Governmental Entity (a) pursuant to
which La Jolla currently operates or holds any interest in
any of its properties, or (b) that is required for the
operation of La Jollas business or the holding of any
such interest, and all of such authorizations are in full force
and effect, except for such consents, licenses, permits, grants
or other authorizations, which if not obtained would not have a
Material Adverse Effect on La Jolla.
3.7 Capitalization.
(a) The authorized capital stock of La Jolla consists
of 225,000,000 shares of Common Stock, $.01 par value,
and 8,000,000 shares of Preferred Stock, $.01 par
value, of which there were issued and outstanding as of the date
of this Agreement, 65,722,648 shares of Common Stock and no
shares of Preferred Stock. The shares of La Jolla Common
Stock to be issued pursuant to the Merger will be duly
authorized, validly issued, fully paid, and non-assessable, free
of any liens or encumbrances other than any liens or
encumbrances created by or imposed by the holders thereof, and
shall be issued in material compliance with all applicable
federal and state securities laws. All of the outstanding shares
of La Jolla Common Stock (i) have been duly authorized
and validly issued, and are fully paid and non-assessable,
(ii) except for rights of first refusal, exchange,
repurchase, forfeiture
and/or
cancellation rights in favor of La Jolla, are not subject
to preemptive rights or rights of first refusal created by
statue, La Jolla Charter, La Jolla Bylaws or any
agreement to which La Jolla is a party or by which it is
bound and (iii) have been issued in compliance in all
material respects with federal and state securities laws. There
are no declared or unpaid dividends with respect to any shares
of La Jolla Common Stock. None of La Jollas debt
could be classified as equity for tax purposes.
(b) Section 3.7 of the La Jolla Disclosure Letter
sets forth: (i) the number of outstanding options and
warrants to purchase shares of La Jolla Common Stock;
(ii) the number of shares reserved for further issuance
under the La Jolla Equity Incentive Plans and the
La Jolla Employee Stock Purchase Plan; (iii) with
respect to each option and warrant outstanding as of the date of
this Agreement, (A) the name of the holder of such option
or warrant, (B) the total number of shares of La Jolla
Common Stock that are subject to such option or warrant and the
number of shares of La Jolla Common Stock with respect to
which such option or warrant is immediately exercisable,
(C) the date of which such option or warrant was granted
and the term of such option or warrant (D) the vesting
schedule, if any, of such option or warrant, (E) the
exercise price per share of La Jolla Common Stock
purchasable under such option or warrant and (F) whether
such option or warrant has been designated an incentive
stock option as defined in Section 422 of the Code; and
(iv) an accurate and complete description of the terms of
each repurchase option which is held by La Jolla and to
which any of such shares is subject.
(c) Except as set forth in Section 3.7 of the
La Jolla Disclosure Letter, there is no:
(i) outstanding subscription, option, call, warrant or
right (whether or not currently exercisable) to acquire any
shares of the capital stock or other securities of
La Jolla; (ii) outstanding security, instrument or
obligation that is or may become convertible into or
exchangeable for any shares of the capital stock or other
securities of La Jolla; (iii) contract under which
La Jolla is or may become obligated to sell or otherwise
issue any shares of its capital stock or any other securities;
or (iv) to La Jollas Knowledge, condition or
circumstance that may give rise to or provide a basis for the
assertion of a claim by any Person to the effect that such
Person is entitled to acquire or receive any shares of capital
stock or other securities of La Jolla.
3.8 SEC Reports; Financial Statements.
(a) As of their respective filing dates, all annual,
quarterly or current reports, filed by La Jolla with the
SEC since January 1, 2009 (including those that
La Jolla may file subsequent to the date hereof) (such
reports, as amended the La Jolla SEC
Reports) (i) were prepared in accordance in
all material respects with the requirements of the Securities
Act and the Exchange Act, as the case may be, and the rules and
regulations thereunder, except as may be reflected in any
amendments to such reports that La Jolla has filed with the
SEC, (ii) as the same may have been amended, did not
contain any untrue statement of a material fact or omit to state
a material fact required to be stated therein or necessary in
order to make the statements made therein, in the light of the
circumstances under which they were made, not misleading and
(iii) were all the forms, reports and other documents
required to be filed under the Exchange Act. Since
January 1, 2009, La Jolla has filed with the SEC all
reports that are required to have been filed.
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(b) No Subsidiary of La Jolla is or has been required
to file any form, report, registration statement or other
document with the SEC. The consolidated financial statements
(including any related notes thereto) contained in the
La Jolla SEC Reports (in the form, as applicable, in any
amendments to such La Jolla SEC Reports) (the
La Jolla Financial Statements):
(i) complied as to form in all material respects with the
published rules and regulations of the SEC applicable thereto;
(ii) were prepared in accordance with GAAP applied on a
consistent basis throughout the periods covered, except as may
be indicated in the notes to such financial statements and (in
the case of unaudited statements) as permitted by
Form 10-Q
of the SEC, and except that unaudited financial statements may
not contain footnotes and are subject to year-end audit
adjustments; and (iii) fairly present in all material
respects the consolidated financial position of La Jolla
and its Subsidiaries as of the respective dates thereof and the
consolidated results of operations and cash flows of
La Jolla and its Subsidiaries for the periods covered
thereby. The unaudited balance sheet of La Jolla as of
September 30, 2009, that is included in the La Jolla
Financial Statements is referred to herein as the
La Jolla Current Balance Sheet.
(c) La Jolla maintains a system of internal accounting
controls and disclosure controls and procedures sufficient, in
the judgment of La Jollas board of directors, to
provide reasonable assurance that (i) transactions are
executed in accordance with managements general or
specific authorizations, (ii) transactions are recorded as
necessary to permit preparation of financial statements in
conformity with GAAP and to maintain asset accountability,
(iii) access to assets is permitted only in accordance with
managements general or specific authorization, and
(iv) the recorded accountability for assets is compared
with the existing assets at reasonable intervals and appropriate
action is taken with respect to any differences.
3.9 Absence of Certain Changes. Since
the date of the La Jolla Current Balance Sheet, except as
set forth in the La Jolla SEC Reports or as set forth in
Section 3.9 of the La Jolla Disclosure Letter, there
has not occurred (a) any change, event or condition
(whether or not covered by insurance) that has resulted in, or
would reasonably be expected to result in, a Material Adverse
Effect on La Jolla; (b) any acquisition, sale or
transfer of any material assets or material properties of
La Jolla or any creation of any security interest in such
assets or properties; (c) any change in accounting methods
or practices (including any change in depreciation or
amortization policies or rates) by La Jolla or any
revaluation by La Jolla of any of its assets; (d) any
declaration, setting aside, or payment of a dividend or other
distribution with respect to the shares of La Jolla or any
direct or indirect redemption, purchase or other acquisition by
La Jolla of any of its shares of capital stock;
(e) any Material Contract entered into by La Jolla, or
any material amendment or termination of, or default under, any
Material Contract to which La Jolla is a party or by which
it is bound, in each case that would reasonably be expected to
result in a Material Adverse Effect on La Jolla;
(f) any amendment or change to La Jolla Charter or
La Jolla Bylaws; (g) any increase in or modification
of the compensation or benefits payable or to become payable by
La Jolla to any of its directors or employees; (h) any
sale, issuance or authorization by La Jolla of (1) any
capital stock or other security, (2) any option or right to
acquire any capital stock or any other security, or (3) any
Convertible Securities; any formation by La Jolla of any
Subsidiary or any acquisition of any equity interest or other
interest in any other Equity (other than Merger Sub);
(i) any other material event not in the Ordinary Course of
Business; or (j) any agreement by La Jolla to do any
of the things described in the preceding clauses (a)
through (i).
3.10 Interested Party
Transactions. Except as set forth in the
La Jolla SEC Reports or as set forth in Section 3.10
of the La Jolla Disclosure Schedule, La Jolla is not
indebted to any director, officer or employee of La Jolla
(except for amounts due as normal salaries and bonuses and in
reimbursement of ordinary expenses), and no such person is
indebted to La Jolla. Except as set forth in the
La Jolla SEC Reports or in Section 3.22 of the
La Jolla Disclosure Letter, La Jolla is not a party to
any transaction of a type that would be required to be disclosed
pursuant to Item 404 of
Regulation S-K
promulgated by the SEC.
3.11 Intellectual Property.
(a) La Jolla and each of its Subsidiaries owns or
possesses the right to use the Intellectual Property that is
owned by or licensed to La Jolla (the
La Jolla Patent and Proprietary
Rights), except where the failure to own or
possess such rights would not have a Material Adverse Effect on
La Jolla or any of its Subsidiaries, considered together.
(b) Neither La Jolla nor any of its Subsidiaries has
received any notice of any asserted rights with respect to any
of the La Jolla Patent and Proprietary Rights which, if
determined unfavorably with respect to the interests of
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La Jolla or any of its Subsidiaries would have a Material
Adverse Effect on La Jolla or any of its Subsidiaries,
considered together.
(c) To La Jollas Knowledge, neither
La Jolla nor any of its Subsidiaries has ever infringed
(directly, contributorily, by inducement, or otherwise),
misappropriated, or otherwise violated or made unlawful use of
any right to Intellectual Property of any other Person or
engaged in unfair competition. No infringement,
misappropriation, or similar claim or Legal Proceeding is
pending or, to La Jollas Knowledge, threatened
against La Jolla, any of its Subsidiaries or any other
Person who is or may be entitled to be indemnified, defended,
held harmless, or reimbursed by the Company or any of its
Subsidiaries with respect to such claim or Legal Proceeding.
Neither La Jolla nor any of its Subsidiaries has received
notice or is otherwise aware of any infringement of or conflict
with asserted rights of others with respect to any of the
La Jolla Patent and Proprietary Rights, which infringement
or conflict (if the subject of any unfavorable decision, ruling
or finding), individually or in the aggregate, would result in a
Material Adverse Effect on La Jolla or any of its
Subsidiaries, considered together.
(d) To La Jollas Knowledge, neither
La Jolla nor any of its Subsidiaries has engaged in patent
or copyright misuse or any fraud or inequitable conduct in
connection with any La Jolla Patent and Proprietary Rights,
and no trademark or trade name owned, used, or applied for by
La Jolla or any of its Subsidiaries conflicts or interferes
with any trademark or trade name owned, used, or applied for by
any other Person.
3.12 Taxes.
(a) La Jolla has prepared and timely filed all Tax
Returns relating to any and all Taxes concerning or attributable
to La Jolla and such Tax Returns are true and correct in
all material respects and have been completed in accordance with
applicable law. La Jolla has delivered or made available to
Adamis correct and complete copies of all federal income Tax
Returns, examination reports, and statements of deficiencies
assessed against or agreed to by La Jolla or any of its
Subsidiaries filed or received since January 1, 2008. None
of La Jolla or any of its Subsidiaries is delinquent in the
payment of any Taxes due and owing by La Jolla and its
Subsidiaries.
(b) La Jolla and each of its Subsidiaries has withheld
and timely paid all Taxes required to have been withheld and
paid with respect to any amounts paid or owing to any employee,
independent contractor, creditor, stockholder, or other third
party.
(c) There is no Tax deficiency outstanding or assessed or,
to La Jollas Knowledge, proposed against
La Jolla that is not reflected as a liability on the
La Jolla Current Balance Sheet nor has La Jolla
executed any agreements or waivers extending any statute of
limitations on or extending the period for the assessment or
collection of any Tax (other than extensions which have
expired). No claim has ever been made by an authority in a
jurisdiction where La Jolla does not file Tax Returns that
it is or may be subject to taxation by that jurisdiction. There
are no liens for Taxes (other than Taxes not yet due and
payable) upon any of the assets of La Jolla. Neither
La Jolla nor any of its Subsidiaries has been a party to
any listed transaction as defined in
Section 6707(C)(2) of the Code and
Section 1.6011-4(b)(2) of the Treasury Regulations.
(d) To La Jollas Knowledge, La Jolla has no
liabilities for unpaid Taxes that have not been accrued for or
reserved on the La Jolla Financial Statements, whether
asserted or unasserted, contingent or otherwise. Neither
La Jolla nor any of its Subsidiaries will incur any
liability for Taxes through the Effective Time, other than in
the ordinary course of business or pursuant to this Agreement.
(e) Neither La Jolla nor any of its Subsidiaries has
received from any Governmental Entity any (i) written
notice indicating an intent to open an audit or other review,
(ii) written request for information related to Tax
matters, or (iii) written notice of deficiency or proposed
adjustment of or any amount of Tax proposed, asserted, or
assessed by any Governmental Entity against La Jolla.
(f) La Jolla is not a party to any tax-sharing
agreement or similar arrangement with any other party, and
La Jolla has not assumed any obligation to pay any Tax
obligations of, or with respect to any transaction relating to,
any other person or agreed to indemnify any other person with
respect to any Tax.
(g) La Jolla has not been a member of an affiliated
group of corporations filing a consolidated federal income tax
return other than a group of which La Jolla was the parent.
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(h) La Jolla has not been at any time a United States
Real Property Holding Corporation within the meaning of
Section 897(c)(2) of the Code.
(i) Neither La Jolla nor any of its Subsidiaries has
filed a consent under Section 341(f) of the Code concerning
collapsible corporations. Neither La Jolla nor any of its
Subsidiaries is a party to any contract, agreement, plan or
arrangement, including but not limited to the provisions of this
Agreement, covering any employee or former employee of
La Jolla or any of its Subsidiaries that, individually or
collectively, could give rise to the payment of (i) any
excess parachute payment within the meaning of
Section 280G of the Code (or any corresponding provisions of
state, local or foreign Tax law) and (ii) any amount that
will not be fully deductible as a result of Section 162(m)
of the Code (or any corresponding provisions of state, local or
foreign Tax law). None of the La Jolla common stock is
subject to a substantial risk of forfeiture within
the meaning of Section 83 of the Code.
(j) La Jolla will not be required to include any item
of income in, or exclude any item of deduction from, taxable
income for any taxable period (or portion there) ending after
the Closing Date as a result of any: (A) change in method
of accounting for taxable period ending on or prior to the
Closing Date; (B) closing agreement as
described in Section 7121 of the Code (or any corresponding
or similar provision of state, local or foreign income Tax law)
executed on or prior to the Closing Date; (C) intercompany
transactions or any excess loss account described in Treasury
Regulations under Section 1502 of the Code (or any
corresponding or similar provisions of state, local or foreign
income Tax law); (D) installment sale or open transaction
disposition made on or prior to the Closing Date;
(E) prepaid amount received on or prior to the Closing
Date; or (F) election with respect to the discharge of
indebtedness under Section 108(i) of the Code.
(k) La Jolla has not distributed stock of another
Person, or has had its stock distributed by another Person, in a
transaction that was purported or intended to be governed in
whole or in part by Section 355 or Section 361 of the
Code.
3.13 Employee Benefit Plans.
(a) The La Jolla Disclosure Letter contains a complete
and accurate list (to the extent not already filed as an exhibit
with the La Jolla SEC Reports) of each La Jolla
Employee Agreement and each plan, program, policy, practice,
contract, agreement or other arrangement providing for
performance awards, bonus, incentive, stock option, stock
purchase, stock bonus, phantom stock, stock appreciation right,
supplemental retirement, fringe benefits, cafeteria benefits or
other benefits, whether written or unwritten, including without
limitation each employee benefit plan within the
meaning of Section 3(3) of ERISA, which is sponsored,
maintained, contributed to, or required to be contributed to by
La Jolla (or any subsidiary) and, with respect to any such
plans which are subject to Code Section 401(a), any trade
or business (whether or not incorporated) that is or at any
relevant time was treated as a single employer with
La Jolla within the meaning of Section 414(b), (c),
(m) or (o) of the Code (an ERISA
Affiliate) for the benefit of any person who
performs services for La Jolla (or any subsidiary) or with
respect to which La Jolla or any ERISA Affiliate has or may
have any liability (including without limitation contingent
liability) or obligation (collectively, the
La Jolla Employee Plans).
La Jolla has furnished or made available to Adamis true and
complete copies of documents embodying each of the La Jolla
Employee Plans and, with respect to each La Jolla Employee
Plan that is subject to ERISA reporting requirements,
La Jolla has provided or made available copies of the
Form 5500 reports filed for the last two plan years.
(b) Compliance. Each La Jolla
Employee Plan has been administered in material compliance with
its terms and with the requirements of applicable law; and
La Jolla and each ERISA Affiliate have performed all
material obligations required to be performed by them under, and
are not in any material respect in default under or violation
of, any of the La Jolla Employee Plans. Any La Jolla
Employee Plan that is intended to be qualified under
Section 401(a) of the Code has obtained from the Internal
Revenue Service a favorable determination letter as to its
qualified status under the Code, including all currently
effective amendments to the Code. No prohibited
transaction, within the meaning of Section 4975 of the
Code or Sections 406 and 407 of ERISA, and not otherwise
exempt under Section 408 of ERISA, has occurred with
respect to any La Jolla Employee Plan. There are no claims
or Legal Proceedings pending, or, to La Jollas
Knowledge, threatened or reasonably anticipated (other than
routine claims for benefits), against any La Jolla Employee
Plan or against the assets of any La Jolla Employee Plan.
There are no audits, inquiries or Legal Proceedings pending or,
to La Jollas Knowledge, threatened by any
Governmental Authority with respect to any La Jolla
Employee Plan. For at least the three years preceding the date
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of this Agreement, neither La Jolla nor any of its
Subsidiaries has incurred any penalty or tax with respect to any
La Jolla Employee Plan under Section 502(i) of ERISA
or Sections 4975 through 4980 of the Code. La Jolla
and each of its Subsidiaries have made all contributions and
other payments required by and due under the terms of each
La Jolla Employee Plan.
(c) No Title IV or Multiemployer
Plan. No La Jolla Employee Plan is a
multiemployer plan (as defined in Section 3(37)
of ERISA) or a pension plan (as defined in
Section 3(2) of ERISA) subject to Title IV of ERISA.
(d) Future Commitments. No
La Jolla Employee Plan provides (except at no cost to
La Jolla or any of its Subsidiaries), or reflects or
represents any liability of La Jolla or any of its
Subsidiaries to provide, retiree life insurance, retiree health
benefits or other retiree employee welfare benefits to any
Person for any reason, except as may be required by COBRA or
other applicable Legal Requirements. Other than commitments made
that involve no future costs to La Jolla, La Jolla has
not represented, promised or contracted (whether in oral or
written form) to any employee of La Jolla or any other
Person that such employee or other Person would be provided with
retiree life insurance, retiree health benefit or other retiree
employee welfare benefits, except to the extent required by
applicable Legal Requirements.
(e) Effect of Transaction. The
consummation of the transactions contemplated by this Agreement
will not (i) entitle any current or former employee or
other service provider of La Jolla or any ERISA Affiliate
to severance benefits or any other payment (including without
limitation unemployment compensation, golden parachute, bonus or
benefits under any La Jolla Employee Plan), except as
expressly provided in this Agreement; or (ii) accelerate
the time of payment or vesting of any such benefits or increase
the amount of compensation due any such employee or service
provider.
3.14 Employee Matters. La Jolla is
in material compliance with all currently applicable laws and
regulations respecting terms and conditions of employment. There
are no proceedings pending or, to La Jollas
Knowledge, threatened, between La Jolla, on the one hand,
and any or all of its current or former employees, on the other
hand, which would reasonably be expected to have a Material
Adverse Effect on La Jolla. Except as may be reflected in
the La Jolla SEC Reports, La Jolla has provided all
employees with all wages, benefits, relocation benefits, stock
options, bonuses and incentives, and all other compensation that
became due and payable through the date of this Agreement.
3.15 Insurance. The La Jolla
Disclosure Letter sets forth all policies of insurance
maintained by, at the expense of or for the benefit of
La Jolla. There is no material claim pending under any of
such policies as to which coverage has been questioned, denied
or disputed by the underwriters of such policies. All premiums
due and payable under all such policies have been paid and, to
La Jollas Knowledge, La Jolla is otherwise in
compliance with the terms of such policies. To
La Jollas Knowledge, there is no threatened
termination of, or material premium increase with respect to,
any of such policies.
3.16 Compliance with Legal
Requirements. For all periods of time during
which the respective applicable statute of limitations periods
have not expired, and except as disclosed in the La Jolla
SEC Reports or in Section 3.16 of the La Jolla
Disclosure Letter, (i) La Jolla and each of its
Subsidiaries has complied in all material respects with, is not
in material violation of, and has not received any written or,
to La Jollas Knowledge, other notices of violation
with respect to, any applicable Legal Requirement or regulation
with respect to the conduct of its business, or the ownership or
operation of its business; and (ii) neither La Jolla
nor any of its Subsidiaries has received any written or, to
La Jollas Knowledge, other notices or other
communication from any Governmental Entity regarding
(A) any actual, alleged, possible, or potential violation
of, or failure to comply with, any applicable Legal Requirement,
or (B) any actual, alleged, possible, or potential
obligation on the part of La Jolla or any of its
Subsidiaries to undertake, or to bear all or any portion of the
cost of, any remedial action related to compliance or
non-compliance with any applicable Legal Requirement, in each of
the above cases which if determined adversely to La Jolla
or any of its Subsidiaries would reasonably be expected to have
a Material Adverse Effect on La Jolla or its Subsidiaries,
considered together.
3.17 Environmental Matters. To
La Jollas Knowledge, La Jolla is, and at all
times has been, in compliance in all material respects with all
Environmental Laws and is not subject to any material liability
under any Environmental Law. La Jolla has not received, nor
to La Jollas Knowledge has any other Person for whose
conduct
A-20
it is or may be held responsible, received, any order, written
notice, or other written communication from (i) any
Governmental Entity or private citizen acting in the public
interest, or (ii) the current or prior owner or operator of
any Facilities, asserting or alleging any actual or potential
violation of or failure to comply with any Environmental Law, or
any obligation to undertake or bear the cost of any
Environmental, Health, and Safety Liabilities.
3.18 Legal Proceedings. Except as may
be disclosed in the La Jolla SEC Reports, there is no
pending Legal Proceeding that has been commenced by or against
La Jolla. To La Jollas Knowledge, no Person has
threatened to commence any Legal Proceeding against
La Jolla. Except as may be disclosed in the La Jolla
SEC Reports, there is no judgment, decree or order against
La Jolla or, to La Jollas Knowledge, any of its
directors or officers (in their capacities as such), that could
prevent, enjoin, or materially alter or delay any of the
transactions contemplated by this Agreement, or any Ancillary
Agreement, or that would reasonably be expected to have a
Material Adverse Effect on La Jolla. To
La Jollas Knowledge, no event has occurred, and no
claim, dispute or other condition or circumstance exists, that
will, or that would reasonably be expected to, give rise to or
serve as a basis for the commencement of any such Legal
Proceeding.
3.19 Contracts; No Defaults.
(a) Each Material Contract of La Jolla is set forth in
Section 3.19(a) of the Disclosure Letter or filed as an exhibit
to the La Jolla SEC Reports and is enforceable in
accordance with its terms, subject to (i) laws of general
application relating to bankruptcy, insolvency and the relief of
debtors, and (ii) rules of law governing specific
performance, injunctive relief and other equitable remedies; and
(b) La Jolla has not violated or breached, or
committed any default under, any Material Contract, in each of
the above cases where such violation, breach or default would
have a Material Adverse Effect on La Jolla. Except as set
forth in the La Jolla Disclosure Letter or the
La Jolla SEC Reports, no event has occurred, and no
circumstance or condition exists, that (with or without notice
or lapse of time) would reasonably be expected to,
(i) result in a violation or breach of any of the
provisions of any Material Contract of La Jolla,
(ii) give any Person the right to declare a default or
exercise any remedy under any Material Contract of
La Jolla, (iii) give any Person the right to
accelerate the maturity or performance of any Material Contract
of La Jolla, or (iv) give any Person the right to
cancel, terminate or modify any Material Contract, in each of
the above cases where such violation, breach or default would
have a Material Adverse Effect on La Jolla. Neither
La Jolla nor any of its Subsidiaries has received any
notice or other written or, to La Jollas Knowledge,
oral communication regarding any actual or possible violation or
breach of, or default under, any Material Contract of
La Jolla.
(c) The La Jolla Disclosure Letter sets forth a list
of all material consents or waivers of, or notifications to, any
Governmental Entity or any third party that are required or
provided for under any Material Contract of La Jolla or any
of its Subsidiaries in connection with the execution and
delivery of this Agreement and the Ancillary Agreements by
La Jolla and the consummation of the transactions
contemplated hereby and thereby.
3.20 Labor Matters. La Jolla is
not a party to, or bound by, any collective bargaining
agreement, contract or other agreement or understanding with a
labor union or labor organization. La Jolla is not the
subject of any Legal Proceeding asserting that La Jolla has
committed an unfair labor practice or seeking to compel it to
bargain with any labor organization as to wages or conditions of
employment. There is no strike, work stoppage or other labor
dispute involving La Jolla pending or, to
La Jollas Knowledge, threatened against La Jolla.
3.21 Unlawful Payments. To
La Jollas Knowledge, none of La Jolla, or any
officer, director, employee, agent or representative of
La Jolla has made, directly or indirectly, any bribe or
kickback, illegal political contribution, payment from corporate
funds which was incorrectly recorded on the books and records of
La Jolla, unlawful payment from corporate funds to
governmental or municipal officials in their individual
capacities for the purpose of affecting their action or the
actions of the jurisdiction which they represent to obtain
favorable treatment in securing business or licenses or to
obtain special concessions of any kind whatsoever, or illegal
payment from corporate funds to obtain or retain any business.
3.22 Financial Advisor. Except as
disclosed in writing to Adamis before the date of this
Agreement, no broker, finder or investment banker is entitled to
any commission or brokerage or finders fee in connection
with the Merger or any of the other transactions contemplated by
this Agreement based upon arrangements made by or on behalf of
La Jolla.
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3.23 Title to Assets; No Real Property.
(a) La Jolla owns, and has good, valid and marketable
title to, all assets purported to be owned by it, including:
(i) all assets reflected on its balance sheet as of the
date of the La Jolla Current Balance Sheet; (ii) all
equity interests of its Subsidiaries, all La Jolla Patent
and Proprietary Rights and all of La Jollas rights
under the Material Contracts required to be identified in
Section 3.19 of the La Jolla Disclosure Letter; and
(iii) all other assets reflected in La Jollas
books and records as being owned by La Jolla. All of said
assets are owned by La Jolla free and clear of any liens or
other Encumbrances, except for (x) any lien for current
taxes not yet due and payable, and (y) minor liens that
have arisen in the ordinary course of business and that do not
(in any case or in the aggregate) materially detract from the
value of the assets subject thereto or materially impair the
operations of La Jolla or any of its Subsidiaries.
(b) La Jolla does not own any real property and
La Jolla is not party to any lease for real property either
as a lessee or lessor.
3.24 Representations Complete. This
Agreement (as limited and qualified by the La Jolla
Disclosure Letter) does not contain any representation, warranty
or information that (i) contains an untrue statement of a
material fact, or (ii) omits to state any material fact
necessary in order to make the statements herein (in the light
of the circumstances under which such statements have been made)
not misleading.
ARTICLE IV
CONDUCT
BEFORE THE EFFECTIVE TIME
4.1 Access and Investigation. Subject
to the terms of the Confidentiality Agreement which the Parties
agree will continue in full force following the date of this
Agreement, during the period commencing on the date of this
Agreement and ending at the Effective Time, unless this
Agreement is earlier terminated pursuant to the terms hereof
(the Pre-Closing Period), upon
reasonable notice each Party shall, and shall use commercially
reasonable efforts to cause such Partys Representatives
to: (a) provide the other Party and such other Partys
Representatives with reasonable access during normal business
hours to such Partys Representatives, personnel and assets
and to all existing books, records, Tax Returns, work papers and
other documents and information relating to such Party and its
Subsidiaries; (b) provide the other Party and such other
Partys Representatives with such copies of the existing
books, records, Tax Returns, work papers, product data, and
other documents and information relating to such Party and its
Subsidiaries, and with such additional financial, operating and
other data and information regarding such Party and its
Subsidiaries as the other Party may reasonably request; and
(c) permit the other Partys officers and other
employees to meet, upon reasonable notice and during normal
business hours, with the chief financial officer and other
officers and managers of such Party responsible for such
Partys financial statements and the internal controls of
such Party to discuss such matters as the other Party may deem
necessary or appropriate. Notwithstanding the foregoing, any
Party may restrict the foregoing access to the extent that any
Legal Requirement applicable to such party requires such Party
or its Subsidiaries to restrict or prohibit access to any such
properties or information or if such restriction is needed to
protect attorney-client privilege. No information or knowledge
obtained in any investigation pursuant to Section 4.1 shall
affect or be deemed to modify any representation or warranty
contained herein or the conditions to the obligations of the
parties to consummate the Merger.
4.2 Operation of La Jollas Business.
(a) Except as contemplated by this Agreement or with the
prior written consent of Adamis, during the Pre-Closing Period,
each of La Jolla and its Subsidiaries shall: (i) use
commercially reasonable efforts to conduct its business and
operations in the Ordinary Course of Business and in compliance
with all applicable Legal Requirements and the requirements of
all Contracts that constitute Material Contracts of
La Jolla; (ii) use its commercially reasonable efforts
to preserve intact its current business organization, use
commercially reasonable efforts to keep available the services
of its current key employees, officers and other employees and
maintain its relations and goodwill with all suppliers,
customers, landlords, creditors, licensors, licensees, employees
and other Persons having business relationships with
La Jolla or its Subsidiaries; (iii) not amend or
permit the adoption of any amendment to its certificate of
incorporation or bylaws, or effect or permit itself to become a
party to any Acquisition Transaction, recapitalization,
reclassification of shares, stock split, reverse stock split or
similar
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transaction; (iv) use its commercially reasonable efforts
to keep in full force all insurance policies identified in the
La Jolla Disclosure Letter; (v) not form any
Subsidiary or acquire any equity interest or other interest in
any other Entity; (vi) not (A) lend money to any
Person, or (B) incur or guarantee any indebtedness for
borrowed money; (vii) not (A) make or change any
election, change an annual accounting period, adopt or change
any accounting method, file any amended Tax Return,
(B) enter into any closing agreement, settle any Tax claim
or assessment relating to La Jolla or any of its
Subsidiaries, (C) surrender any right to claim a refund of
Taxes, (D) consent to any extension or waiver of the
limitation period applicable to any Tax claim or assessment
relating to La Jolla or any of its Subsidiaries, or
(E) take any other similar action relating to the filing of
any Tax Return or the payment of any Tax, if such election,
adoption, change, amendment, agreement, settlement, surrender,
consent or other action would have the effect of materially
increasing the Tax liability of La Jolla or any of its
Subsidiaries or materially decreasing any Tax attribute of
La Jolla or any of its Subsidiaries as of the Effective
Date; or (viii) not agree or commit to take any of the
actions described in clauses (iii) through (vii) above.
(b) La Jolla shall promptly notify Adamis of:
(A) any notice or other communication from any Person
alleging that the Consent of such Person is or may be required
in connection with any of the Contemplated Transactions; and
(B) any event that would reasonably be expected to have a
Material Adverse Effect on La Jolla.
4.3 Operation of Adamiss Business.
(a) Except as contemplated by this Agreement or with the
prior written consent of La Jolla, during the Pre-Closing
Period, each of Adamis and its Subsidiaries shall: (i) use
commercially reasonable efforts to conduct its business and
operations in the Ordinary Course of Business and in compliance
with all applicable Legal Requirements and the requirements of
all Contracts that constitute Material Contracts of Adamis;
(ii) use its commercially reasonable efforts to preserve
intact its current business organization, use commercially
reasonable efforts to keep available the services of its current
key employees, officers and other employees and maintain its
relations and goodwill with all suppliers, customers, landlords,
creditors, licensors, licensees, employees and other Persons
having business relationships with Adamis or its Subsidiaries;
(iii) not amend or permit the adoption of any amendment to
its certificate of incorporation or bylaws, or effect or permit
itself to become a party to any Acquisition Transaction,
recapitalization, reclassification of shares, stock split,
reverse stock split or similar transaction; (iv) use its
commercially reasonable efforts to keep in full force all
insurance policies identified in the Adamis Disclosure Letter;
(v) not form any Subsidiary or acquire any equity interest
or other interest in any other Entity; (vi) not
(A) lend money to any Person, or (B) incur or
guarantee any indebtedness for borrowed money; (vii) not
(A) make or change any election, change an annual
accounting period, adopt or change any accounting method,
(B) file any amended Tax Return, enter into any closing
agreement, settle any Tax claim or assessment relating to Adamis
or any of its Subsidiaries, (C) surrender any right to
claim a refund of Taxes, (D) consent to any extension or
waiver of the limitation period applicable to any Tax claim or
assessment relating to Adamis or any of its Subsidiaries, or
(E) take any other similar action relating to the filing of
any Tax Return or the payment of any Tax, if such election,
adoption, change, amendment, agreement, settlement, surrender,
consent or other action would have the effect of materially
increasing the Tax liability of Adamis or any of its
Subsidiaries or materially decreasing any Tax attribute of
Adamis or any of its Subsidiaries as of the Effective Date; or
(viii) not agree or commit to take any of the actions
described in clauses (iii) through (vii) above.
Notwithstanding the foregoing, Adamis shall be permitted during
the Pre-Closing Period to negotiate, enter into and consummate
the following types of transactions: (X) any debt financing
transaction for up to $2,000,000 of aggregate principal,
(Y) any equity financing transaction involving the issuance
of up to 20% of the Adamis Common Stock outstanding as of the
date of this Agreement, and (Z) the acquisition of one or
more businesses, interests in businesses, technologies,
intellectual property or products or issuing equity or debt
instruments in connection therewith, provided that the aggregate
consideration paid or potentially payable in connection with all
such transactions shall not either exceed $1,000,000 or result
in the issuance or potential issuance of more than 20% of the
Adamis Common Stock outstanding as of the date of this Agreement.
(b) Adamis shall promptly notify La Jolla of:
(A) any notice or other communication from any Person
alleging that the Consent of such Person is or may be required
in connection with any of the Contemplated Transactions; and
(B) any event that would reasonably be expected to have a
Material Adverse Effect on La Jolla.
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4.4 Disclosure
Schedule Updates. During the Pre-Closing
Period, Adamis on the one hand, and La Jolla on the other,
shall promptly notify the other Party in writing, by delivery of
an updated Adamis Disclosure Letter or La Jolla Disclosure
Letter, as the case may be, of: (i) the discovery by such
Party of any event, condition, fact or circumstance that
occurred or existed on or before the date of this Agreement and
that caused or constitutes a material inaccuracy in any
representation or warranty made by such Party in this Agreement;
(ii) any event, condition, fact or circumstance that
occurs, arises or exists after the date of this Agreement and
that would cause or constitute a material inaccuracy in any
representation or warranty made by such Party in this Agreement
if: (A) such representation or warranty had been made as of
the time of the occurrence, existence or discovery of such
event, condition, fact or circumstance; or (B) such event,
condition, fact or circumstance had occurred, arisen or existed
on or before the date of this Agreement; (iii) any material
breach of any covenant or obligation of such Party; and
(iv) any event, condition, fact or circumstance that could
reasonably be expected to make the timely satisfaction of any of
the conditions set forth in Articles VI, VII or VIII. No
notification given pursuant to this Section shall change, limit
or otherwise affect any of the representations, warranties,
covenants or obligations of the notifying Party contained in
this Agreement or its Disclosure Schedule for purposes of
Section 7.1 or 7.2, in the case of Adamis, or
Section 8.1 or 8.2 in the case of La Jolla.
4.5 No Solicitation.
(a) Except as set forth below, each Party agrees that
neither it nor any of its Subsidiaries shall, nor shall it nor
any of its Subsidiaries authorize or permit any of their
Representatives to directly or indirectly:
(i) solicit, initiate, knowingly encourage, induce or
facilitate the communication, making, submission or announcement
of any Acquisition Proposal or Acquisition Inquiry or take any
action that could reasonably be expected to lead to an
Acquisition Proposal or Acquisition Inquiry;
(ii) furnish any information regarding such Party to any
Person in connection with or in response to an Acquisition
Proposal or Acquisition Inquiry;
(iii) engage in discussions or negotiations with any Person
with respect to any Acquisition Proposal or Acquisition Inquiry;
(iv) approve, endorse or recommend any Acquisition Proposal
or, with respect to La Jolla, effect any Change in the
La Jolla Board Recommendation or, with respect to Adamis,
effect any Change in the Adamis Board Recommendation; or
(v) execute or enter into any letter of intent or similar
document or any Contract contemplating or otherwise relating to
any Acquisition Proposal or enter into any agreement in
principle requiring such Party to abandon, terminate or fail to
consummate the Merger or breach its obligations hereunder or
propose or agree to do any of the foregoing.
(b) Exceptions to Adamis No Solicitation.
(i) Notwithstanding anything contained in this Section,
before obtaining the Required Adamis Stockholder Vote, Adamis
may furnish nonpublic information regarding Adamis to, and enter
into discussions or negotiations with, any Person in response to
an unsolicited, bona fide written Acquisition Proposal made or
received after the date of this Agreement, which Adamiss
Board of Directors determines in good faith constitutes, or is
reasonably likely to result in, a Superior Proposal (and is not
withdrawn) if: (A) neither Adamis nor any Representative of
Adamis shall have failed to comply with this Section;
(B) the Board of Directors of Adamis concludes in good
faith, after consultation with outside counsel, that the failure
to take such action would result in a breach of the fiduciary
duties of the Board of Directors of Adamis under applicable law;
(C) within 24 hours following the furnishing of any
such nonpublic information to, or entering into discussions
with, such Person, Adamis gives La Jolla written notice of
the identity of such Person and of Adamiss intention to
furnish nonpublic information to, or enter into discussions
with, such Person or has furnished, or entered into discussions
with, such Person; (D) Adamis receives from such Person an
executed confidentiality agreement containing provisions
(including nondisclosure provisions, use restrictions,
non-solicitation provisions, no hire provisions and
standstill provisions) at least as favorable to
Adamis as those contained in the Confidentiality Agreement; and
(E) within 24 hours following the furnishing of any
such
A-24
nonpublic information to such Person, Adamis furnishes such
nonpublic information to La Jolla (to the extent such
nonpublic information has not been previously furnished by
Adamis to La Jolla). Without limiting the generality of the
foregoing, Adamis acknowledges and agrees that in the event any
Representative of Adamis takes any action that, if taken by
Adamis, would constitute a failure to comply with this Section
by Adamis, the taking of such action by such Representative
shall be deemed to constitute a failure to comply with this
Section by Adamis for purposes of this Agreement.
(ii) Notwithstanding anything to the contrary set forth in
this Agreement, if at any time before obtaining the Required
Adamis Stockholder Vote, Adamis receives an unsolicited bona
fide written Acquisition Proposal that did not relate to a
breach of this Section and which the Board of Directors of
Adamis determines in good faith constitutes a Superior Proposal,
and each of Adamis, its Subsidiaries and their Representatives
have otherwise complied with its obligations under this
Section 4.5, the Board of Directors of Adamis may, on three
(3) Business Days prior written notice (a
Notice of Superior Proposal) to
La Jolla (which notice shall include the forms of
agreements pursuant to which the Superior Proposal would be
implemented or, if no such agreements have been proposed, a
written summary of the material terms and conditions of such
Superior Proposal) (it being understood that Adamis must deliver
a new Notice of Superior Proposal and thereafter negotiate as
provided herein in the event of any modification to an
Acquisition Proposal if such modification results in the
determination that such Acquisition Proposal is a Superior
Proposal), take any action otherwise prohibited by
Section 4.5(a)(i), (a)(ii), (a)(iii), (a)(iv) or (a)(v) and
cause Adamis to terminate this Agreement pursuant to
Section 9.1(g) if (i) the Board of Directors of
Adamis, after consultation with outside counsel, shall have
first determined in good faith that there is a reasonable risk
that the failure to take such action would result in a breach of
its fiduciary duties under the DGCL, and (ii) Adamis shall
have notified La Jolla of such determination and offered to
discuss in good faith with La Jolla (and, if La Jolla
accepts, thereafter negotiates in good faith), for a period of
no less than three (3) Business Days, any adjustments in
the terms and conditions of this Agreement proposed by
La Jolla, and the Board of Directors of Adamis shall have
resolved, after taking into account the results of such
discussions and proposals by La Jolla, if any, that the
Acquisition Proposal remains a Superior Proposal.
(c) Exceptions to La Jolla No
Solicitation.
(i) Notwithstanding anything contained in this Section,
before obtaining the Required La Jolla Stockholder Vote,
La Jolla may furnish nonpublic information regarding
La Jolla to, and enter into discussions or negotiations
with, any Person in response to an unsolicited, bona fide
written Acquisition Proposal made or received after the date of
this Agreement, which La Jollas Board of Directors
determines in good faith constitutes, or is reasonably likely to
result in, a Superior Proposal (and is not withdrawn) if:
(A) neither La Jolla nor any Representative of
La Jolla shall have failed to comply with this Section;
(B) the Board of Directors of La Jolla concludes in
good faith, after consultation with outside counsel, that the
failure to take such action would result in a breach of the
fiduciary duties of the Board of Directors of La Jolla
under applicable law; (C) within 24 hours following
the furnishing of any such nonpublic information to, or entering
into discussions with, such Person, La Jolla gives Adamis
written notice of the identity of such Person and of
La Jollas intention to furnish nonpublic information
to, or enter into discussions with, such Person or has
furnished, or entered into discussions with, such Person;
(D) La Jolla receives from such Person an executed
confidentiality agreement containing provisions (including
nondisclosure provisions, use restrictions, non-solicitation
provisions, no hire provisions and standstill
provisions) at least as favorable to La Jolla as those
contained in the Confidentiality Agreement; and (E) within
24 hours following the furnishing of any such nonpublic
information to such Person, La Jolla furnishes such
nonpublic information to Adamis (to the extent such nonpublic
information has not been previously furnished by La Jolla
to Adamis). Without limiting the generality of the foregoing,
La Jolla acknowledges and agrees that in the event any
Representative of La Jolla takes any action that, if taken
by La Jolla, would constitute a failure to comply with this
Section by La Jolla, the taking of such action by such
Representative shall be deemed to constitute a failure to comply
with this Section by La Jolla for purposes of this
Agreement.
(ii) Notwithstanding anything to the contrary set forth in
this Agreement, if at any time before obtaining the Required
La Jolla Stockholder Vote, La Jolla receives an
unsolicited bona fide written Acquisition Proposal that did not
relate to a breach of this Section and which the Board of
Directors of La Jolla determines in good
A-25
faith constitutes a Superior Proposal, and each of
La Jolla, its Subsidiaries and their respective
Representatives have otherwise complied with its obligations
under this Section 4.5, the Board of Directors of
La Jolla may on three (3) Business Days prior
written Notice of Superior Proposal to Adamis (which notice
shall include the forms of agreements pursuant to which the
Superior Proposal would be implemented or, if no such agreements
have been proposed, a written summary of the material terms and
conditions of such Superior Proposal) (it being understood that
La Jolla must deliver a new Notice of Superior Proposal and
thereafter negotiate as provided herein in the event of any
modification to an Acquisition Proposal if such modification
results in the determination that such Acquisition Proposal is a
Superior Proposal), take any action otherwise prohibited by
Section 4.5(a)(i), (a)(ii), (a)(iii), (a)(iv) or (a)(v) and
cause La Jolla to terminate this Agreement pursuant to
Section 9.1(h) if (i) the Board of Directors of
La Jolla shall have first determined in good faith, after
consultation with outside counsel, that there is a reasonable
risk that the failure to take such action would result in a
breach of its fiduciary duties under the DGCL, and
(ii) La Jolla shall have notified Adamis of such
determination and offered to discuss in good faith with Adamis
(and, if Adamis accepts, thereafter negotiates in good faith),
for a period of no less than three (3) Business Days, any
adjustments in the terms and conditions of this Agreement
proposed by Adamis, and the Board of Directors of La Jolla
shall have resolved, after taking into account the results of
such discussions and proposals by Adamis, if any, that the
Acquisition Proposal remains a Superior Proposal.
(d) If any Party or any Representative of such Party
receives an Acquisition Proposal or Acquisition Inquiry at any
time during the Pre-Closing Period, then such Party shall
promptly (and in no event later than 24 hours after such
Party becomes aware of such Acquisition Proposal or Acquisition
Inquiry) advise the other Party orally and in writing of such
Acquisition Proposal or Acquisition Inquiry (including the
identity of the Person making or submitting such Acquisition
Proposal or Acquisition Inquiry, and the terms thereof). Such
Party shall keep the other Party fully informed with respect to
the status and terms of any such Acquisition Proposal or
Acquisition Inquiry and any modification or proposed
modification thereto and related agreements, draft agreements
and modifications thereof.
(e) Each Party shall immediately cease and cause to be
terminated any existing discussions with any Person that relate
to any Acquisition Proposal or Acquisition Inquiry as of the
date of this Agreement, and shall instruct its Representatives
accordingly. Each Party shall not terminate, release or permit
the release of any Person from, or waive or permit the waiver of
any provision of or right under, any confidentiality,
non-solicitation, no hire, standstill or similar
agreement (whether entered into before or after the date of this
Agreement) to which such Party is a party or under which such
Party has any rights, and shall enforce or cause to be enforced
each such agreement to the fullest extent possible.
(f) Nothing contained in this Section, Section 5.2
(with respect to Adamis) or Section 5.3 (with respect to
La Jolla) shall prohibit either of Adamis or La Jolla
from taking and disclosing to its stockholders a position with
respect to a tender offer contemplated by
Rule 14d-9
or
Rule 14e-2
promulgated under the Exchange Act or from making any disclosure
to its respective stockholders if, in the good faith judgment of
the Board of Directors of Adamis or La Jolla (as the case
may be), after consultation with outside counsel, that the
failure to so disclose would result in a breach of its fiduciary
duties under the DGCL; provided that disclosure to stockholders
pursuant to
Rule 14e-2
relating to an Acquisition Proposal or Acquisition Inquiry shall
be deemed to be a Change in Adamis Board Recommendation or
Change in the La Jolla Board Recommendation (as the case
may be) unless the Board of Directors of Adamis or La Jolla
(as the case may be) expressly, and without qualification,
concurrently with such disclosure reaffirms the Adamis Board
Recommendation or La Jolla Board Recommendation (as the
case may be).
ARTICLE V
ADDITIONAL
AGREEMENTS
5.1 Proxy Statement; Registration Statement.
(a) As promptly as practicable after the execution of this
Agreement, La Jolla and Adamis shall jointly prepare, and
La Jolla shall file, a joint registration statement and
proxy statement on
Form S-4
consisting of a proxy statement of Adamis in connection with the
Merger, a proxy statement of La Jolla in connection with
the Proposals
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(the Proxy Statement) and the
Registration Statement to register under the Securities Act the
issuance of shares of La Jolla Common Stock in connection
with the Merger. The Proxy Statement shall, among other things,
include the La Jolla Board Recommendation and
(i) solicit the approval of and include the recommendation
of the Board of Directors of La Jolla to
La Jollas stockholders that they vote in favor of the
Merger, (ii) solicit the approval of and include the
recommendation of the Board of Directors of La Jolla to
La Jollas stockholders that they vote in favor of the
La Jolla Charter Amendment; and (iii) solicit the
approval of and include the recommendation of the Board of
Directors of La Jolla to La Jollas stockholders
that they vote in favor of the La Jolla Name Change
Amendment; and (iv) solicit the approval of and include the
recommendation of the Board of Directors of La Jolla to
La Jollas stockholders that they vote in favor of the
Plan Amendment. Adamis shall promptly furnish to La Jolla
all information concerning Adamis and its Subsidiaries, and
shall use its commercially reasonable efforts to cause to be
finished all information with respect to its stockholders, that
is required to be disclosed in the Registration Statement and
the Proxy Statement. All information in the Registration
Statement and Proxy Statement concerning Adamis shall be subject
to the prior review and approval of Adamis.
(b) La Jolla and Adamis shall use reasonable efforts
to cause the Proxy Statement and La Jolla shall use
reasonable efforts to cause the Registration Statement to comply
with the applicable rules and regulations promulgated by the
SEC, and shall respond promptly to any comments of the SEC or
its staff and shall use reasonable best efforts to resolve any
comments of SEC on the Proxy Statement or the Registration
Statement as promptly as reasonably practicable. La Jolla
and Adamis shall each use commercially reasonable efforts to
cause the definitive Proxy Statement and Registration Statement
to be mailed to their stockholders as promptly as practicable
after review by the SEC has been completed. La Jolla shall
notify Adamis promptly upon the receipt of any comments from the
SEC or its staff or any other government officials and of any
request by the SEC or its staff or any other government
officials for amendments or supplements to the Proxy Statement
or Registration Statement and shall supply Adamis with copies of
all correspondence between La Jolla or any of its
representatives, on the one hand, and the SEC, or its staff or
any other government officials, on the other hand, with respect
to the Proxy Statement and the Registration Statement. Both
Parties and their respective counsel shall be given a reasonable
opportunity to review and comment upon the Proxy Statement and
Registration Statement and related materials, any proposed
amendment or supplement to the Proxy Statement or Registration
Statement and any response to any comments from the SEC or other
correspondence before its filing with the SEC or dissemination
to La Jollas stockholders or Adamiss
stockholders, and such materials shall be mutually satisfactory
before filing or dissemination. Whenever any event occurs which
is required to be set forth in an amendment or supplement to the
Proxy Statement or Registration Statement, Adamis or
La Jolla, as the case may be, shall promptly inform the
other of such occurrence and cooperate in filing with the SEC or
its staff or any other government officials,
and/or
mailing to stockholders of La Jolla or Adamis, such
amendment or supplement as promptly as possible. Without
limiting the foregoing, each of the parties shall promptly
provide the other party with corrections to any information
provided by it for use in the Proxy Statement and Registration
Statement, if and to the extent any such information shall be or
have become false or misleading in any material respect, and
La Jolla shall take all reasonable steps necessary to
correct the same and to cause the Proxy Statement and
Registration Statement as so corrected to be disseminated to
La Jollas stockholders and Adamiss
stockholders, in each case to the extent required by applicable
law or otherwise deemed appropriate by the parties.
(c) Before the Effective Time, La Jolla shall use
reasonable best efforts to have the Registration Statement
declared effective under the Securities Act as promptly as
practicable after filing, and commercially reasonable efforts to
obtain all regulatory approvals needed to ensure that the
La Jolla Common Stock to be issued in the Merger will (to
the extent required) be registered or qualified or exempt from
registration or qualification under the securities law of every
state of the United States (or such fewer states as the Parties
may mutually agree).
5.2 Adamis Stockholder Meeting; Change in the Adamis Board
Recommendation.
(a) Adamis shall take all action necessary under all
applicable Legal Requirements to call, give notice of and hold a
meeting of the holders of Adamis Capital Stock to vote on the
approval of the Merger, adoption of this Agreement, and related
matters (the Adamis Stockholder
Meeting). The Adamis Stockholder Meeting shall be
held as promptly as reasonably practicable after the
effectiveness of the Registration Statement. Adamis shall ensure
that all proxies and consents solicited in connection with the
Adamis Stockholder Meeting are solicited in compliance with all
applicable Legal Requirements.
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(b) Adamis agrees that, subject to Sections 4.5 and
5.2(d): (i) the Board of Directors of Adamis shall
recommend that the holders of Adamis Capital Stock vote to
approve the Merger and adopt this Agreement and the other
matters contemplated by this Agreement, and shall use
commercially reasonable efforts to solicit such approval (the
recommendation of the board of directors of Adamis that the
stockholders of Adamis vote to adopt this Agreement and such
other matters contemplated by this Agreement being referred to
as the Adamis Board Recommendation);
(ii) the Proxy Statement shall include a statement to the
effect that the Board of Directors of Adamis recommends that the
stockholders of Adamis vote to approve such proposals; and
(iii) the Board of Directors of Adamis shall not make or
effect any change, withdrawal, qualification or modification of
the Adamis Board Recommendation.
(c) Subject to Section 4.5, Adamis shall take all
action that is both reasonable and lawful to solicit the
approval of its stockholders of the proposals submitted to the
Adamis stockholders for approval and shall take all other action
reasonably necessary or advisable to secure the vote or consent
of the stockholders of Adamis required by the DGCL to obtain
such approvals. If, on the date of the Adamis Stockholder
Meeting or any subsequent adjournment thereof pursuant to this
Section, Adamis has not received proxies representing a
sufficient number of shares of Adamis Common Stock to approve
the proposals submitted to the Adamis stockholders for approval,
Adamis shall, if requested by La Jolla, adjourn the Adamis
Stockholder Meeting until such date or dates as Adamis
determines in good faith (subject to La Jollas prior
approval not to be unreasonably withheld, delayed or
conditioned) the Required Adamis Stockholder Vote is reasonably
likely to be obtained, and shall continue to use its
commercially reasonable efforts, together with its proxy
solicitor, to assist in the solicitation of proxies from
stockholders relating to Adamis stockholder approval.
(d) Notwithstanding anything to the contrary contained in
Section 5.2(b), at any time before the adoption of this
Agreement by the Required Adamis Stockholder Vote, the Board of
Directors of Adamis may effect a Change in the Adamis Board
Recommendation in accordance with the provisions of
Section 4.5(b), provided that La Jolla must receive
not less than three (3) Business Days prior written notice
from Adamis confirming that Adamiss Board of Directors has
determined to make a Change in the Adamis Board Recommendation.
For purposes of this Agreement, Change in Adamis
Board Recommendation means any:
(i) withholding, withdrawal, qualification or modification
of (or any proposal or resolution to withhold, withdraw, qualify
or modify) the Adamis Board Recommendation in any manner adverse
to La Jolla; (ii) action or statement by Adamis, any
of its Subsidiaries or any of their respective Representatives
in connection with the Adamis Stockholder Meeting contrary to
the Adamis Board Recommendation; (iii) taking any position
other than opposition (including making no recommendation), by
Adamiss Board of Directors with respect to an Acquisition
Proposal that has been publicly disclosed or otherwise become
known to any Person other than Adamis, La Jolla and their
respective Representatives after a reasonable amount of time has
elapsed for Adamiss Board of Directors to review and make
a recommendation with respect thereto (and in no event more than
ten Business Days after being publicly disclosed or otherwise
become known to any Person other than Adamis, La Jolla and
their respective Representatives); (iv) failure of
Adamiss Board of Directors to (A) if a tender offer,
take-over bid or exchange offer that constitutes or would
constitute an Acquisition Proposal (other than by La Jolla)
is commenced, recommend that the Adamis stockholders not accept
such tender offer, take-over bid or exchange offer after a
reasonable amount of time has elapsed for Adamiss Board of
Directors to review and make a recommendation with respect
thereto (and in no event more than ten Business Days following
commencement of such tender offer, take-over bid or exchange
offer), or (B) reaffirm in writing the Adamis Board
Recommendation in connection with a disclosure pursuant to
Section 4.5(f) or otherwise within two Business Days of a
request by La Jolla to do so; or (v) approval,
adoption or recommendation, or publicly disclosed proposal to
approve, adopt or recommend, an Acquisition Proposal.
(e) Adamiss obligation to call, give notice of and
hold Adamis Stockholder Meeting in accordance with
Section 5.2(a) shall not be limited or otherwise affected
by any Change in the Adamis Board Recommendation or the
commencement, disclosure, announcement or submission of a
Superior Proposal or Acquisition Proposal.
5.3 La Jolla Stockholder Meeting; Change in the
La Jolla Board Recommendation; Adoption of Agreement by
La Jolla as Sole Stockholder of Merger Sub.
(a) La Jolla shall take all action necessary under
applicable Legal Requirements to call, give notice of and hold a
meeting of the holders of La Jolla Common Stock to vote on
the Merger and the Reverse Split, the La Jolla Charter
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Amendment and the La Jolla Name Change Amendment and the
Plan Amendment (such meeting, the La Jolla
Stockholder Meeting). La Jolla shall use its
commercially reasonable efforts to ensure that all proxies
solicited in connection with the La Jolla Stockholder
Meeting are solicited in compliance with all applicable Legal
Requirements.
(b) La Jolla agrees that, subject to Sections 4.5
and 5.3(d): (i) the Board of Directors of La Jolla
shall recommend that the holders of La Jolla Common Stock
vote to approve the Merger, and (A) the issuance of shares
of La Jolla Common Stock in the Merger and the Reverse
Split, (B) adopt the La Jolla Charter Amendment,
(C) adopt the La Jolla Name Change Amendment,
(D) adopt the Plan Amendment, and (E) such other
matters as may be reasonably necessary to effect the Merger and
the other Contemplated Transactions, and shall use commercially
reasonable efforts to solicit such approval or adoption, as the
case may be (proposals (A) through (E)
being the Proposals), (ii) the
Proxy Statement shall include a statement to the effect that the
Board of Directors of La Jolla recommends that the
stockholders of La Jolla vote to approve the Proposals
(such recommendation being referred to herein as the
La Jolla Board Recommendation);
and (iii) the Board of Directors of La Jolla shall not
make or effect any Change in the La Jolla Board
Recommendation.
(c) Subject to Section 4.5, La Jolla shall take
all action that is both reasonable and lawful to solicit the
approval of its stockholders of the Proposals and shall take all
other action reasonably necessary or advisable to secure the
vote or consent of the stockholders of La Jolla required by
the DGCL to obtain such approvals. If, on the date of
La Jolla Stockholder Meeting or any subsequent adjournment
thereof pursuant to this Section, La Jolla has not received
proxies representing a sufficient number of shares of
La Jolla Common Stock to approve the Proposals,
La Jolla shall, if requested by Adamis, adjourn the
La Jolla Stockholder Meeting until such date or dates as
La Jolla determines in good faith (subject to Adamiss
prior approval not to be unreasonably withheld, delayed or
conditioned) the Required La Jolla Stockholder Vote is
reasonably likely to be obtained, and shall continue to use its
commercially reasonable efforts, together with its proxy
solicitor, to assist in the solicitation of proxies from
stockholders relating to La Jolla stockholder approval.
(d) Notwithstanding anything to the contrary contained in
Section 5.3(b), at any time before the adoption of this
Agreement by the Required La Jolla Stockholder Vote, the
Board of Directors of La Jolla may effect a Change in the
La Jolla Board Recommendation in accordance with the
provisions of Section 4.5(c), provided that Adamis must
receive not less than three (3) Business Days prior
written notice from La Jolla confirming that
La Jollas Board of Directors has determined to make a
Change in the La Jolla Board Recommendation. For purposes
of this Agreement, Change in the La Jolla Board
Recommendation means any: (i) withholding,
withdrawal, qualification or modification of (or any proposal or
resolution to withhold, withdraw, qualify or modify) the
La Jolla Board Recommendation in any manner adverse to
Adamis; (ii) action or statement by La Jolla, any of
its Subsidiaries or any of their respective Representatives in
connection with the La Jolla Stockholder Meeting contrary
to the La Jolla Board Recommendation; (iii) taking any
position other than opposition (including making no
recommendation), by La Jollas Board of Directors with
respect to an Acquisition Proposal that has been publicly
disclosed or otherwise become known to any Person other than
La Jolla, Adamis and their respective Representatives after
a reasonable amount of time has elapsed for La Jollas
Board of Directors to review and make a recommendation with
respect thereto (and in no event more than ten Business Days
after being publicly disclosed or otherwise become known to any
Person other than La Jolla, Adamis and their respective
Representatives); (iv) failure of La Jollas
Board of Directors to (A) if a tender offer, take-over bid
or exchange offer that constitutes or would constitute an
Acquisition Proposal (other than by Adamis) is commenced,
recommend that the La Jolla stockholders not accept such
tender offer, take-over bid or exchange offer after a reasonable
amount of time has elapsed for La Jollas Board of
Directors to review and make a recommendation with respect
thereto (and in no event more than ten Business Days following
commencement of such tender offer, take-over bid or exchange
offer), or (B) reaffirm in writing the La Jolla Board
Recommendation in connection with a disclosure pursuant to
Section 4.5(f) or otherwise within two Business Days of a
request by Adamis to do so; or (v) approval, adoption or
recommendation, or publicly disclosed proposal to approve, adopt
or recommend, an Acquisition Proposal.
(e) La Jollas obligation to call, give notice of
and hold the La Jolla Stockholder Meeting in accordance
with Section 5.3(a) shall not be limited or otherwise
affected by any Change in the La Jolla Board Recommendation
or the commencement, disclosure, announcement or submission of a
Superior Proposal or Acquisition Proposal.
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(f) La Jolla, as sole stockholder of Merger Sub, shall
adopt this Agreement as soon as practicable following the
Execution Date by action by written consent, as permitted by the
DGCL 228 in lieu of an actual meeting of the stockholders of
Merger Sub.
5.4 Regulatory Approvals. Each Party
shall use commercially reasonable efforts to file or otherwise
submit, as soon as practicable after the date of this Agreement,
all applications, notices, reports and other documents
reasonably required to be filed by such Party with or otherwise
submitted by such Party to any Governmental Entity with respect
to the Merger and the other Contemplated Transactions, and to
submit promptly any additional information requested by any such
Governmental Entity.
5.5 Indemnification of Officers and Directors.
(a) From and after the Effective Time through the third
anniversary of the date the Effective Time occurs, La Jolla
shall and shall cause the Surviving Corporation to, fulfill and
honor in all respects the obligations of La Jolla and
Adamis pursuant to any indemnification provisions under their
respective certificates of incorporation and bylaws as in effect
on the date of this Agreement (the persons entitled to be
indemnified pursuant to such provisions being referred to
collectively as the D&O Indemnified
Parties).
(b) The certificate of incorporation and bylaws of
La Jolla and the Surviving Corporation, as the case may be,
shall contain provisions no less favorable with respect to
indemnification, advancement of expenses and exculpation of
present and former directors and officers of La Jolla than
are presently set forth in the certificate of incorporation and
bylaws of La Jolla, which provisions shall not be amended,
modified or repealed for a period of three (3) years time
from the Effective Time in a manner that would adversely affect
the rights thereunder of the D&O Indemnified Parties.
(c) La Jolla shall take no actions to terminate or
curtail the directors and officers tail liability
insurance coverage that is in place at the Effective Time
insuring those directors and officers of La Jolla serving
prior to the Effective Time.
(d) La Jolla shall pay all expenses, including
reasonable attorneys fees, that may be incurred by the
D&O Indemnified Parties in connection with their
enforcement of their rights provided in this Section 5.5
pursuant to any indemnification provisions under their
respective certificates of incorporation and bylaws as in effect
on the date of this Agreement.
(e) The provisions of this Section are intended to be in
addition to the rights otherwise available to the D&O
Indemnified Parties by law, charter, statute, by-law or
agreement, and shall operate for the benefit of, and shall be
enforceable by, each of the D&O Indemnified Parties, their
heirs and their representatives.
(f) La Jolla shall cause the Surviving Corporation to
perform all of the obligations of the Surviving Corporation
under this Section.
5.6 Additional Agreements.
(a) Subject to Sections 4.5, 5.2(d), 5.3(d) and
5.6(b), the Parties shall use commercially reasonable efforts to
cause to be taken all actions necessary to consummate the Merger
and make effective the other Contemplated Transactions. Without
limiting the generality of the foregoing, but subject to
Section 5.6(b), each Party to this Agreement:
(i) shall make all filings and other submissions (if any)
and give all notices (if any) reasonably required to be made and
given by such Party in connection with the Merger and the other
Contemplated Transactions; (ii) shall use commercially
reasonable efforts to obtain each Consent (if any) reasonably
required to be obtained (pursuant to any applicable Legal
Requirement or Material Contract) by such Party in connection
with the Merger or any of the other Contemplated Transactions or
for such Contract to remain in full force and effect;
(iii) shall use commercially reasonable efforts to lift any
injunction prohibiting, or any other legal bar to, the Merger or
any of the other Contemplated Transactions; and (iv) shall
use commercially reasonable efforts to satisfy the conditions
precedent to the consummation of this Agreement. Each Party
shall provide to the other Party a copy of each proposed filing
with or other submission to any Governmental Entity relating to
any of the Contemplated Transactions, and shall give the other
Party a reasonable time before making such filing or other
submission in which to review and comment on such proposed
filing or other submission. Each Party shall promptly deliver to
the
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other Party a copy of each such filing or other submission made,
each notice given and each Consent obtained by such Party during
the Pre-Closing Period.
(b) Notwithstanding anything to the contrary contained in
this Agreement, no Party shall have any obligation under this
Agreement: (i) to dispose of or transfer or cause any of
its Subsidiaries to dispose of or transfer any assets;
(ii) to discontinue or cause any of its Subsidiaries to
discontinue offering any product or service; (iii) to
license or otherwise make available, or cause any of its
Subsidiaries to license or otherwise make available to any
Person any Intellectual Property; (iv) to hold separate or
cause any of its Subsidiaries to hold separate any assets or
operations (either before or after the Closing Date);
(v) to make or cause any of its Subsidiaries to make any
commitment (to any Governmental Entity or otherwise) regarding
its future operations; or (vi) to contest any Legal
Proceeding or any order, writ, injunction or decree relating to
the Merger or any of the other Contemplated Transactions if such
Party determines in good faith that contesting such Legal
Proceeding or order, writ, injunction or decree might not be
advisable.
5.7 Disclosure. Without limiting any of
either Partys obligations under the Confidentiality
Agreement, each Party shall not, and shall not permit any of its
Subsidiaries or any Representative of such Party to, issue any
press release or make any public disclosure regarding the Merger
or any of the other Contemplated Transactions unless:
(a) the other Party shall have approved such press release
or disclosure (which approval shall not be unreasonably
withheld); or (b) such Party shall have determined in good
faith, upon the advice of outside legal counsel, that such
disclosure is required by applicable Legal Requirements and, to
the extent practicable, before such press release or disclosure
is issued or made, such Party advises the other Party of, and
consults with the other Party regarding, the text of such press
release or disclosure; provided, however, that each of Adamis
and La Jolla may make any public statement in response to
specific questions by the press, analysts, investors or those
attending industry conferences or financial analyst conference
calls, so long as any such statements are consistent with
previous press releases, public disclosures or public statements
made by Adamis or La Jolla in compliance with this
Section 5.7.
5.8 Directors; Officers. Prior to
the Effective Time, and subject to the receipt of any required
stockholder vote, La Jolla shall take all action necessary
(i) to cause the number of members of the Board of
Directors of La Jolla to be fixed at a number to be
determined by Adamis, effective at the Effective Time;
(ii) to obtain the resignations, effective at the Effective
Time, of the directors of La Jolla determined by Adamis,
(iii) cause each of the individuals nominated by Adamis,
which individuals may be persons who are at the time directors
of Adamis and such additional persons as are reasonably
acceptable to La Jolla, to be appointed as a director of
La Jolla, effective at the Effective Time, (iv) to
have the Board of Directors of La Jolla appoint as officers
of La Jolla, effective at the Effective Time, such persons
as nominated by Adamis, which individuals may be persons who are
at the time officers of Adamis and such additional persons who
are reasonably acceptable to La Jolla; and (v) all
officers of La Jolla shall be terminated immediately prior
to Closing (such termination being deemed to be without cause)
and any severance payments due in connection with such
termination shall be paid at Closing.
5.9 Tax Matters.
(a) La Jolla, Merger Sub and Adamis shall use their
respective commercially reasonable efforts to cause the Merger
to qualify, and except as specifically contemplated by this
Agreement, shall use their respective commercially reasonable
efforts not to, and not to permit or cause any affiliate or any
subsidiary to, knowingly take any actions or cause any action to
be taken which would prevent the Merger from qualifying, as a
reorganization under Section 368(a) of the Code.
(b) This Agreement is intended to constitute, and the
parties hereto hereby adopt this Agreement as, a plan of
reorganization within the meaning Treasury
Regulation Sections 1.368-2(g)
and 1.368-3(a). La Jolla, Merger Sub and Adamis shall
report the Merger as reorganization within the meaning of
Section 368(a) of the Code, unless otherwise required
pursuant to a determination within the meaning of
Section 1313(a) of the Code.
5.10 La Jolla Amendment. Subject
to Section 5.3(d), La Jolla agrees to recommend to its
stockholders that the Certificate of Incorporation of
La Jolla be amended, by means of one of more amendments to
be mutually agreed upon by La Jolla and Adamis: (i) to
change the corporate name of La Jolla to a name designated
by Adamis before the definitive La Jolla Proxy Statement is
mailed to its stockholders (the La Jolla Name
Change Amendment); (ii) to amend the
La Jolla Pharmaceutical Company 2004 Equity Incentive Plan
(the La Jolla Stock Plan) to
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increase the number of shares reserved for issuance under the
La Jolla Stock Plan (the Plan
Amendment); and (iii) to approve the Reverse
Stock Split, and to make such other changes thereto as may be
determined by Adamis.
5.11 Adamiss Auditors. Adamis
will use its commercially reasonable efforts to cause its
management and its independent auditors to facilitate on a
timely basis (i) the preparation of financial statements
(including pro forma financial statements if required) for
inclusion in the Registration Statement and Proxy Statement to
comply with Legal Requirements, and (ii) the review of
Adamiss audit work papers for up to the past three years
or such lesser period of which Adamis has been in existence,
including the examination of selected interim financial
statements and data.
5.12 La Jollas
Auditors. La Jolla will use its
commercially reasonable efforts to cause its management and its
independent auditors to facilitate on a timely basis
(i) the preparation of financial statements (including pro
forma financial statements if required) for inclusion in the
Registration Statement and Proxy Statement to comply with Legal
Requirements, and (ii) the review by Adamis and its
Representatives of La Jollas audit work papers for up
to the past three years, including the examination of selected
interim financial statements and data.
5.13 Legends. La Jolla shall be
entitled to place such appropriate legends on the certificates
evidencing any shares of La Jolla Common Stock to be
received in the Merger by equity holders of Adamis as
La Jolla reasonably determines is required or appropriate
under applicable laws.
5.14 Confidentiality. Each of
La Jolla and Adamis hereby agrees that the information
obtained in any investigation pursuant to this Agreement, or
pursuant to the negotiation and execution of this Agreement or
the effectuation of the transaction contemplated hereby shall be
governed by the terms of the Confidential Disclosure Agreement
dated as of October 8, 2009, previously executed by and
between Adamis and La Jolla (the
Confidentiality Agreement).
5.15 FIRPTA Compliance. On the Closing
Date, Adamis shall deliver to La Jolla a properly executed
statement in a form reasonably acceptable to La Jolla for
purposes of satisfying La Jollas obligations under
Treasury
Regulation Section 1.1445-2(c)(3).
5.16
Rule 16b-3. The
Board of Directors of La Jolla, or a committee of
non-employee directors thereof (as such term is defined for
purposes of
Rule 16b-3(d)
under the Exchange Act) shall, reasonably promptly after the
date hereof, and in any event before the Effective Time, adopt a
resolution providing that the receipt, by those officers and
directors of Adamis who may be subject to the reporting
requirements of Section 16(a) of the Exchange Act with
respect to La Jolla Common Stock following the Effective
Time, of La Jolla Common Stock in the Merger is intended to
be an exempt transaction under such
Rule 16b-3.
5.17 Use of La Jolla Net
Cash. Adamis shall not, and La Jolla
commencing at the Effective Time shall not, use any of the
La Jolla Net Cash, as reflected on the Net Cash
Certification, to pay either (a) any Adamis indebtedness
for borrowed money in existence at the Effective Time, or
(b) any Adamis deferred compensation
and/or
accrued bonuses in existence at the Effective Time.
ARTICLE VI
CONDITIONS
PRECEDENT TO OBLIGATIONS OF EACH PARTY
The obligations of each Party to effect the Merger and otherwise
consummate the transactions to be consummated at the Closing are
subject to the satisfaction or, to the extent permitted by
applicable law, the written waiver by each of the Parties, at or
before the Closing, of each of the following conditions:
6.1 Stockholder Approval. This
Agreement and the Merger shall have been duly adopted by the
Required Adamis Stockholder Vote, and the Proposals and such
other matters as may be reasonably necessary to effect the
Merger and the other Contemplated Transactions shall have been
duly approved or adopted, as the case may be, by the Required
La Jolla Stockholder Vote.
6.2 No Restraints. No temporary
restraining order, preliminary or permanent injunction or other
order preventing the consummation of the Merger shall have been
issued by any court of competent jurisdiction or other
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Governmental Entity and remain in effect, and there shall not be
any Legal Requirement which has the effect of making the
consummation of the Merger illegal.
6.3 Governmental Authorization. Any
Governmental Authorization or other Consent required to be
obtained by any of the Parties under any applicable antitrust or
competition law or regulation or other Legal Requirement shall
have been obtained and shall remain in full force and effect.
6.4 No Governmental Proceedings Relating to Contemplated
Transactions or Right to Operate
Business. There shall not be any Legal
Proceeding pending, or overtly threatened in writing by an
official of a Governmental Entity in which such Governmental
Entity indicates that it intends to conduct any Legal Proceeding
or taking any other action: (a) challenging or seeking to
restrain or prohibit the consummation of the Merger or any of
the other Contemplated Transactions; (b) relating to the
Merger and seeking to obtain from La Jolla, Merger Sub or
Adamis any damages or other relief that would have a Material
Adverse Effect on the Combined Company; (c) seeking to
prohibit or limit in any material and adverse respect a
Partys ability to vote, transfer, receive dividends with
respect to or otherwise exercise ownership rights with respect
to the stock of La Jolla; (d) that could have a
Material Adverse Effect on the right or ability of the Combined
Company to own the assets or operate the business of the
Combined Company; or (e) seeking to compel Adamis,
La Jolla or any Subsidiary of La Jolla to dispose of
or hold separate any assets that are material to the Combined
Company as a result of or following the Merger or any of the
Contemplated Transactions.
6.5 Registration Statement. The
Registration Statement shall have become effective in accordance
with the provisions of the Securities Act, no stop order
suspending the effectiveness of the Registration Statement shall
have been issued by the SEC and no proceedings for that purpose
shall have been initiated by the SEC and not concluded or
withdrawn and all state securities or blue sky
authorizations necessary to carry out the transactions
contemplated hereby shall have been obtained and be in effect.
ARTICLE VII
ADDITIONAL
CONDITIONS PRECEDENT TO OBLIGATIONS OF LA JOLLA AND MERGER
SUB
The obligations of La Jolla and Merger Sub to effect the
Merger and otherwise consummate the transactions to be
consummated at the Closing are subject to the satisfaction or
the written waiver by La Jolla, at or before the Closing,
of each of the following conditions:
7.1 Accuracy of Representations. The
representations and warranties of Adamis contained in this
Agreement shall have been true and correct as of the date of
this Agreement and shall be true and correct on and as of the
Closing Date with the same force and effect as if made on the
Closing Date except (A) in each case, or in the aggregate,
where the failure to be true and correct would not reasonably be
expected to have a Material Adverse Effect on the Combined
Company, or (B) for those representations and warranties
which address matters only as of a particular date (which
representations shall have been true and correct, subject to the
qualifications as set forth in the preceding clause (A), as of
such particular date).
7.2 Performance of Covenants. Each of
the covenants and obligations in this Agreement that Adamis is
required to comply with or to perform at or before the Closing
shall have been complied with and performed by Adamis in all
material respects, except where the failure to perform such
covenants or obligations would not have a Material Adverse
Effect on the Combined Company.
7.3 No Material Adverse Effect. From
the Execution Date through the Effective Time, there shall not
have occurred any Material Adverse Effect on Adamis that shall
be continuing as of the Effective Time and that would have a
Material Adverse Effect on the Combined Company.
7.4 Consents. All of the Consents set
forth on Schedule 7.4 shall have been obtained and shall be
in full force and effect.
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7.5 Agreements and Other
Documents. La Jolla shall have received
the following agreements and other documents, each of which
shall be in full force and effect:
(a) a certificate of Adamis executed on its behalf by the
Chief Executive Officer and Chief Financial Officer of Adamis
confirming that the conditions set forth in Sections 7.1,
7.2, 7.3 and 7.4 have been duly satisfied; and
(b) certificates of good standing (or equivalent
documentation) of Adamis in its jurisdiction of incorporation
and the various foreign jurisdictions in which it is qualified
(except where the failure to have obtained such certificates
would not result in a Material Adverse Effect on the Combined
Company), certified charter documents, a certificate as to the
incumbency of officers and the adoption of resolutions of the
Board of Directors of Adamis authorizing the execution of this
Agreement and the consummation of the Contemplated Transactions
to be performed by Adamis hereunder.
7.6 Sarbanes-Oxley
Certifications. Neither the principal
executive officer nor the principal financial officer of Adamis
shall have failed to provide, with respect to any Adamis SEC
Document filed (or required to be filed) with the SEC on or
after the date of this Agreement, any necessary certification in
the form required under
Rule 13a-14
under the Exchange Act and 18 U.S.C. §1350.
7.7 SEC Reports. Adamis shall have
timely filed with the SEC all reports and other documents
required to be filed under the Securities Act or Exchange Act.
7.8 Legal Opinion. La Jolla shall
have received a legal opinion of Weintraub Genshlea Chediak LLP,
counsel to Adamis, in substantially the form set forth as
Exhibit 7.8.
ARTICLE VIII
ADDITIONAL
CONDITIONS PRECEDENT TO OBLIGATION OF ADAMIS
The obligations of Adamis to effect the Merger and otherwise
consummate the transactions to be consummated at the Closing are
subject to the satisfaction or the written waiver by Adamis, at
or before the Closing, of each of the following conditions:
8.1 Accuracy of Representations. The
representations and warranties of La Jolla and Merger Sub
contained in this Agreement shall have been true and correct as
of the date of this Agreement and shall be true and correct on
and as of the Closing Date with the same force and effect as if
made on the Closing Date except (A) in each case, or in the
aggregate, where the failure to be true and correct would not
reasonably be expected to have a Material Adverse Effect on the
Combined Company, or (B) for those representations and
warranties which address matters only as of a particular date
(which representations shall have been true and correct, subject
to the qualifications as set forth in the preceding clause (A),
as of such particular date).
8.2 Performance of Covenants. All of
the covenants and obligations in this Agreement that
La Jolla or Merger Sub is required to comply with or to
perform at or before the Closing shall have been complied with
and performed in all material respects, except where the failure
to perform such covenants or obligations would not have a
Material Adverse Effect on the Combined Company.
8.3 No Material Adverse Effect. From
the Execution Date through the Effective Time, there shall not
have occurred any Material Adverse Effect on La Jolla that
continues as of the Effective Time and that would have a
Material Adverse Effect on the Combined Company.
8.4 Consents. All the Consents set
forth on Schedule 8.4 shall have been obtained and shall be in
full force and effect.
8.5 Documents. Adamis shall have
received the following documents:
(a) a certificate of La Jolla executed on its behalf
by the Chief Executive Officer and Vice President of Finance of
La Jolla confirming that the conditions set forth in
Sections 8.1, 8.2 and 8.4 have been duly satisfied;
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(b) certificates of good standing (or equivalent
documentation) of each of La Jolla and Merger Sub in its
jurisdiction of incorporation and the various foreign
jurisdictions in which it is qualified (except where the failure
to have obtained such certificates would not result in a
Material Adverse Effect on the Combined Company), certified
charter documents, a certificate as to the incumbency of
officers and the adoption of resolutions of the Boards of
Directors of La Jolla and Merger Sub authorizing the
execution of this Agreement and the consummation of the
Contemplated Transactions to be performed by La Jolla and
Merger Sub hereunder; and
(c) Written resignations in forms reasonably satisfactory
to Adamis, dated as of the Closing Date and effective as of the
Closing, executed by the directors and officers of La Jolla
.
8.6 Sarbanes-Oxley
Certifications. Neither the principal
executive officer nor the principal financial officer of
La Jolla shall have failed to provide, with respect to any
La Jolla SEC Document filed (or required to be filed) with
the SEC on or after the date of this Agreement, any necessary
certification in the form required under
Rule 13a-14
under the Exchange Act and 18 U.S.C. §1350.
8.7 Board of Directors. La Jolla
shall have caused the Board of Directors of La Jolla to be
constituted as set forth in Section 5.8 of this Agreement.
8.8 Officers. Each of the individuals
identified by Adamis prior to the Effective Time shall have been
appointed officers of La Jolla as of the Effective Time.
8.9 Certificate of
Amendment. Amendments to the La Jolla
Restated Certificate of Incorporation, consisting of the
increase in the number of authorized shares and the Reverse
Stock Split (the La Jolla Charter
Amendment), as contemplated by this Agreement,
shall have become effective under the DGCL.
8.10 SEC Reports. La Jolla shall
have timely filed with the SEC all reports and other documents
required to be filed under the Securities Act or Exchange Act.
8.11 Legal Opinion. Adamis shall have
received a legal opinion of Goodwin Procter LLP, counsel to
La Jolla, in substantially the form set forth as
Exhibit 8.11.
ARTICLE IX
TERMINATION
9.1 Termination. This Agreement may be
terminated before the Effective Time (whether before or after
receipt of the Required Adamis Stockholder Vote or Required
La Jolla Stockholder Vote, unless otherwise specified
below):
(a) by mutual written consent duly authorized by the Boards
of Directors of La Jolla and Adamis;
(b) by either La Jolla or Adamis if the Merger shall
not have been consummated by March 31, 2010 (the
Outside Date); provided, however, that
the right to terminate this Agreement under this
Section 9.1(b) shall not be available to any Party whose
failure to fulfill or diligently pursue fulfillment of any
material obligation under this Agreement has been a principal
cause of or resulted in the failure of the Merger to occur on or
before the Outside Date;
(c) by either La Jolla or Adamis if a court of
competent jurisdiction or other Governmental Entity shall have
issued a nonappealable final order, decree or ruling or taken
any other nonappealable final action, in each case having the
effect of permanently restraining, enjoining or otherwise
prohibiting the Merger; provided, however, that neither Party
may terminate this Agreement pursuant to this
Section 9.1(c) unless that party first shall have used its
reasonable best efforts to procure the removal, reversal,
dissolution, setting aside or invalidation of any such order,
decree, ruling or action;
(d) by either La Jolla or Adamis if (i) the
La Jolla Stockholder Meeting (including any adjournments
and postponements thereof) shall have been held and completed
and La Jollas stockholders shall have taken a final
vote on the Merger, the La Jolla Charter Amendment and
(ii) any of the Merger or the La Jolla Charter
Amendment shall not have been approved or adopted at the
La Jolla Stockholder Meeting (and shall not have
A-35
been approved or adopted at any adjournment or postponement
thereof) by the Required La Jolla Stockholder Vote;
provided, however, that the right to terminate this Agreement
under this Section 9.1(d) shall not be available to
La Jolla where the failure to obtain the Required
La Jolla Stockholder Vote shall have been caused by the
action or failure to act of La Jolla and such action or
failure to act constitutes a breach by La Jolla of this
Agreement;
(e) by Adamis (at any time before the receipt of the
Required La Jolla Stockholder Vote) if a La Jolla
Triggering Event shall have occurred;
(f) by La Jolla (at any time before the receipt of the
Required La Jolla Stockholder Vote) if an Adamis Triggering
Event shall have occurred;
(g) by Adamis in accordance with the terms and subject to
the conditions of Section 4.5(b)(ii);
(h) by La Jolla in accordance with the terms and
subject to the conditions of Section 4.5(c)(ii);
(i) by Adamis, upon a material breach of any
representation, warranty, covenant or agreement on the part of
La Jolla or Merger Sub set forth in this Agreement, or if
any representation or warranty of La Jolla or Merger Sub
shall have become inaccurate, in either case such that the
conditions set forth in Section 8.1 or Section 8.2
would not be satisfied as of the time of such breach or as of
the time such representation or warranty shall have become
inaccurate, provided that if such inaccuracy in
La Jollas or Merger Subs representations and
warranties or breach by La Jolla or Merger Sub is curable
by La Jolla or Merger Sub, then this Agreement shall not
terminate pursuant to this Section 9.1(g) as a result of
such particular breach or inaccuracy until the earliest of
(i) the Outside Date; (ii) the expiration of a thirty
(30) day period commencing upon delivery of written notice
from Adamis to La Jolla or Merger Sub of such breach or
inaccuracy; and (iii) La Jolla or Merger Sub (as
applicable) ceasing to exercise commercially reasonable efforts
to cure such breach (it being understood that this Agreement
shall not terminate pursuant to this Section 9.1(g) as a
result of such particular breach or inaccuracy if such breach by
La Jolla or Merger Sub is cured before such termination
becoming effective);
(j) by La Jolla, upon a material breach of any
representation, warranty, covenant or agreement on the part of
Adamis set forth in this Agreement, or if any representation or
warranty of Adamis shall have become inaccurate, in either case
such that the conditions set forth in Section 7.1 or
Section 7.2 would not be satisfied as of the time of such
breach or as of the time such representation or warranty shall
have become inaccurate, provided that if such inaccuracy in
Adamiss representations and warranties or breach by Adamis
is curable by Adamis then this Agreement shall not terminate
pursuant to this Section 9.1(h) as a result of such
particular breach or inaccuracy until the earlier of
(i) the Outside Date; (ii) the expiration of a thirty
(30) day period commencing upon delivery of written notice
from La Jolla to Adamis of such breach or inaccuracy; and
(iii) Adamis ceasing to exercise commercially reasonable
efforts to cure such breach (it being understood that this
Agreement shall not terminate pursuant to this
Section 9.1(h) as a result of such particular breach or
inaccuracy if such breach by Adamis is cured before such
termination becoming effective);
(k) by either La Jolla or Adamis if (i) the
Adamis Stockholder Meeting (including any adjournments and
postponements thereof) shall have been held and completed and
Adamiss stockholders shall have taken a final vote on the
Merger and (ii) the Merger shall not have been approved or
adopted at the Adamis Stockholder Meeting (and shall not have
been approved or adopted at any adjournment or postponement
thereof) by the Required Adamis Stockholder Vote; provided,
however, that the right to terminate this Agreement under this
Section 9.1(k) shall not be available to Adamis where the
failure to obtain the Required Adamis Stockholder Vote shall
have been caused by the action or failure to act of Adamis and
such action or failure to act constitutes a breach by Adamis of
this Agreement;
(l) by La Jolla if the Adamis Discounted Share Price
(as defined in the definition of Post-Effective
La Jolla Stockholder Shares) is less than
$0.20 per share and an event of the type set forth on Schedule
9.1(l) has occurred; or
(m) by Adamis, if, as of the Closing Date, the
La Jolla Net Cash, as reflected on the Net Cash
Certification, is less than $2.3 million.
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9.2 Effect of Termination. In the event
of the termination of this Agreement as provided in
Section 9.1, this Agreement shall be of no further force or
effect; provided, however, that (i) Section 5.9, this
Section 9.2, Section 9.3, and Section 10 and the
Confidentiality Agreement shall survive the termination of this
Agreement and shall remain in full force and effect, and
(ii) the termination of this Agreement shall not relieve
any Party from any liability for any breach of any
representation, warranty, covenant, obligation or other
provision contained in this Agreement.
9.3 Expenses; Termination Fees.
(a) Except as set forth in this Section 9.3, all fees
and expenses incurred in connection with this Agreement and the
Contemplated Transactions shall be paid by the Party incurring
such expenses, whether or not the Merger is consummated.
(b) La Jolla shall pay Adamis a nonrefundable fee as
liquidated damages in the following amounts and circumstances:
(i) $150,000 if this Agreement is terminated by Adamis
pursuant to Section 9.1(e) or by La Jolla pursuant to
Sections 9.1(h) or 9.1(l); or (ii) if this Agreement
is terminated by La Jolla or Adamis pursuant to
Section 9.1(d), all reasonable accounting and legal fees
and costs incurred by Adamis in connection with the transactions
contemplated by this agreement (up to a maximum of $100,000)
(the fee payable in either of the above instances referred to as
the La Jolla Termination Fee).
Any La Jolla Termination Fee due under this Section shall
be paid to Adamis by wire transfer of
same-day
funds within five Business Days of termination.
(c) Adamis shall pay La Jolla a nonrefundable fee as
liquidated damages in the following amounts and circumstances:
(i) $150,000 if this Agreement is terminated by
La Jolla pursuant to Section 9.1(f) or by Adamis
pursuant to Sections 9.1(g) or 9.1(m); or (ii) if this
Agreement is terminated by La Jolla or Adamis pursuant to
Section 9.1(k), all reasonable accounting and legal fees
and costs incurred by La Jolla in connection with the
transactions contemplated by this agreement (up to a maximum of
$100,000) (the fee payable in either of the above instances
referred to as the Adamis Termination
Fee). Any Adamis Termination Fee due under this
Section shall be paid to La Jolla by wire transfer of
same-day
funds within five Business Days of termination.
(d) If either Party fails to pay when due any amount
payable by such Party under Section 9.3(b) or 9.3(c), as
applicable then (i) such Party shall reimburse the other
Party for reasonable costs and expenses (including reasonable
fees and disbursements of counsel) incurred in connection with
the collection of such overdue amount and the enforcement by the
other Party of its rights under this Section, and (ii) such
Party shall pay to the other Party interest on such overdue
amount (for the period commencing as of the date such overdue
amount was originally required to be paid and ending on the date
such overdue amount is actually paid to the other Party in full)
at a rate per annum equal to the prime rate (as
announced by Bank of America or any successor thereto) in effect
on the date such overdue amount was originally required to be
paid.
(e) The fees payable pursuant to this Section 9.3
shall be paid as liquidated damages and shall be the sole remedy
hereunder following a termination of the type set forth in this
Section 9.3. The parties acknowledge that the actual
damages incurred in connection with a termination as
contemplated under this Section 9.3 would be impossible to
ascertain and that the fees set forth in this Section 9.3
are an estimate of such damages and not a penalty for
termination.
ARTICLE X
MISCELLANEOUS
PROVISIONS
10.1 Non-Survival of Representations and
Warranties. The representations and
warranties of Adamis, Merger Sub and La Jolla contained in
this Agreement or any certificate or instrument delivered
pursuant to this Agreement shall terminate at the Effective
Time, and only the covenants that by their terms survive the
Effective Time and this Article 10 shall survive the
Effective Time.
10.2 Amendment. This Agreement may be
amended with the approval of the respective Boards of Directors
of Adamis and La Jolla at any time (whether before or after
the receipt of the Required Adamis Stockholder Vote or Required
La Jolla Stockholder Vote); provided, however, that after
any such adoption and approval of this Agreement by a
Partys stockholders, no amendment shall be made which by
law requires further approval of the stockholders of such Party
without the further approval of such stockholders. This
Agreement may not be amended except by an instrument in writing
signed on behalf of each of Adamis and La Jolla.
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10.3 Waiver.
(a) No failure on the part of any Party to exercise any
power, right, privilege or remedy under this Agreement, and no
delay on the part of any Party in exercising any power, right,
privilege or remedy under this Agreement, shall operate as a
waiver of such power, right, privilege or remedy; and no single
or partial exercise of any such power, right, privilege or
remedy shall preclude any other or further exercise thereof or
of any other power, right, privilege or remedy.
(b) No Party shall be deemed to have waived any claim
arising out of this Agreement, or any power, right, privilege or
remedy under this Agreement, unless the waiver of such claim,
power, right, privilege or remedy is expressly set forth in a
written instrument duly executed and delivered on behalf of such
Party; and any such waiver shall not be applicable or have any
effect except in the specific instance in which it is given.
10.4 Entire Agreement; Counterparts; Exchanges by
Facsimile. This Agreement and the other
agreements referred to in this Agreement constitute the entire
agreement and supersede all prior agreements and understandings,
both written and oral, among or between any of the Parties with
respect to the subject matter hereof and thereof; provided,
however, that the Confidentiality Agreement shall not be
superseded and shall remain in full force and effect in
accordance with its terms. This Agreement may be executed in
several counterparts, each of which shall be deemed an original
and all of which shall constitute one and the same instrument.
The exchange of a fully executed Agreement (in counterparts or
otherwise) by all Parties by facsimile shall be sufficient to
bind the Parties to the terms and conditions of this Agreement.
10.5 Applicable Law; Jurisdiction. This
Agreement shall be governed by, and construed in accordance
with, the laws of the State of California (except to the extent
that the DGCL governs the procedures relating to the Merger),
regardless of the laws that might otherwise govern under
applicable principles of conflicts of laws. In any action or
suit between any of the parties arising out of or relating to
this Agreement or any of the Contemplated Transactions:
(a) each of the parties irrevocably and unconditionally
consents and submits to the exclusive jurisdiction and venue of
the state and federal courts located in the State of California;
(b) if any such action or suit is commenced in a state
court, then, subject to applicable Legal Requirements, no Party
shall object to the removal of such action or suit to any
federal court located in the county of San Diego, and
(c) the parties agree that service of progress may be made
in the manner provided for in this Agreement for delivery of
notices.
10.6 Waiver of Jury Trial. EACH PARTY
TO THIS AGREEMENT HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES
ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY
LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO
THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY.
EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT (A) NO
REPRESENTATIVE OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR
OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF
LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER, (B) IT
UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF THIS WAIVER,
(C) IT MAKES THIS WAIVER VOLUNTARILY AND (D) IT HAS
BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER
THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS
SECTION 10.6.
10.7 Notices. Any notice or other
communication required or permitted to be delivered to any party
under this Agreement shall be in writing and shall be given by
means of hand delivery, registered mail, courier or express
delivery service, or facsimile. Notices shall be deemed
delivered and received (i) upon delivery by hand,
(ii) three (3) Business Days after deposit in the
U.S. mails, certified or registered mail, (iii) one
(1) Business Day after delivery to a reputable overnight
courier service for next
business-day
delivery (with confirmation of delivery), or (iv) one
(1) Business Day after transmission by facsimile to the
number set forth beneath the name of such party below (or to
such other address or facsimile telephone number as such party
shall have specified in written notice given to the other
parties here), with confirmation of successful transmission:
if to La Jolla:
4365 Executive Drive, Suite 300
San Diego, California 92121
Attention: Chief Executive Officer
Telephone No.:
(858) 452-6600
Facsimile No.:
(858) 626-2851
A-38
with a copy to:
Goodwin Procter LLP
4365 Executive Drive, Suite 300
San Diego, California 92121
Attention: Ryan Murr and Mitch Bloom
Telephone No.:
(858) 202-2700
Facsimile No.:
(858) 457-1255
if to Adamis:
Adamis Pharmaceuticals Corporation
2658 Del Mar Heights Road, #555
Del Mar, California 92014
Attention: President
Telephone No.:
(858) 401-3984
with a copy to:
C. Kevin Kelso, Esq.
Weintraub Genshlea Chediak
400 Capitol Mall, 11th Floor
Sacramento, California 95814
Telephone:
(916) 558-6000
Fax:
(916) 446-1611
Email: kkelso@weintraub.com
10.8 Cooperation. Each Party agrees to
cooperate fully with the other Party and to execute and deliver
such further documents, certificates, agreements and instruments
and to take such other actions as may be reasonably requested by
the other Party to evidence or reflect the Contemplated
Transactions and to carry out the intent and purposes of this
Agreement.
10.9 Severability. Any term or
provision of this Agreement that is invalid or unenforceable in
any situation in any jurisdiction shall not affect the validity
or enforceability of the remaining terms and provisions of this
Agreement or the validity or enforceability of the offending
term or provision in any other situation or in any other
jurisdiction. If a final judgment of a court of competent
jurisdiction declares that any term or provision of this
Agreement is invalid or unenforceable, the Parties hereto agree
that the court making such determination
10.10 Other Remedies; Specific
Performance. Except as otherwise provided
herein, any and all remedies herein expressly conferred upon a
Party will be deemed cumulative with and not exclusive of any
other remedy conferred hereby, or by law or equity upon such
Party, and the exercise by a Party of any one remedy will not
preclude the exercise of any other remedy. It is accordingly
agreed that the Parties shall be entitled to seek an injunction
or injunctions to prevent breaches of this Agreement and to
enforce specifically the terms and provisions hereof in any
court of the United States or any state having jurisdiction,
this being the addition to any other remedy to which they are
entitled at law or in equity. Notwithstanding the foregoing, in
the event that this Agreement is terminated by Adamis pursuant
to Section 9.1(d), 9.1(e), 9.1(g) or 9.1(i) or by
La Jolla pursuant to Section 9.1(d) or 9.1(f) or
9.1(k) above, Adamiss or La Jollas sole and
exclusive remedy hereunder shall be that provided in
Section 9.3(b) or (c), respectively.
10.11 Construction.
(a) For purposes of this Agreement, whenever the context
requires: the singular number shall include the plural, and vice
versa; the masculine gender shall include the feminine and
neuter genders; the feminine gender shall include the masculine
and neuter genders; and the neuter gender shall include
masculine and feminine genders.
(b) The Parties hereto agree that any rule of construction
to the effect that ambiguities are to be resolved against the
drafting Party shall not be applied in the construction or
interpretation of this Agreement.
A-39
(c) As used in this Agreement, the words
include and including, and variations
thereof, shall not be deemed to be terms of limitation, but
rather shall be deemed to be followed by the words without
limitation.
(d) Except as otherwise indicated, all references in this
Agreement to Sections, Exhibits and
Schedules are intended to refer to Sections of this
Agreement and Exhibits and Schedules to this Agreement.
(e) The bold-faced headings contained in this Agreement are
for convenience of reference only, shall not be deemed to be a
part of this Agreement and shall not be referred to in
connection with the construction or interpretation of this
Agreement.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
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IN WITNESS WHEREOF, the parties have caused this Agreement and
Plan of Reorganization to be executed as of the date first above
written.
LA JOLLA PHARMACEUTICAL COMPANY
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By:
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/s/ Deirdre
Y. Gillespie
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Name: Deirdre Y. Gillespie
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Title:
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President and Chief Executive Officer
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MERGER SUB
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By:
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/s/ Deirdre
Y. Gillespie
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Name: Deirdre Y. Gillespie
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Title:
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President and Chief Executive Officer
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ADAMIS PHARMACEUTICALS CORPORATION
Name: Dennis J. Carlo
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Title:
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President and Chief Executive Officer
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A-41
EXHIBIT A
CERTAIN
DEFINITIONS
For purposes of this Agreement:
Acquisition Inquiry shall mean, with
respect to a Party, an inquiry, indication of interest or
request for information (other than an inquiry, indication of
interest or request for information made or submitted by Adamis,
on the one hand or La Jolla, on the other hand, to the
other Party) that would reasonably be expected to lead to an
Acquisition Proposal from such Party.
Acquisition Proposal shall mean any
offer or proposal (other than an offer or proposal made or
submitted by Adamis, on the one hand or La Jolla, on the
other hand to the other Party) contemplating or otherwise
relating to any Acquisition Transaction with such Party.
Acquisition Transaction shall mean any
transaction or series of transactions (except for the
Contemplated Transactions) involving:
(a) any merger, consolidation, amalgamation, share
exchange, business combination, issuance of securities,
acquisition of securities, reorganization, recapitalization,
tender offer, exchange offer or other similar transaction in
which (i) a Person or group (as defined in the
Exchange Act and the rules promulgated thereunder) of Persons
directly or indirectly acquires beneficial or record ownership
of securities representing more than 50% of the outstanding
securities of any class of voting securities of a Party or any
of its Subsidiaries; or (ii) a Party or any of its
Subsidiaries issues securities representing more than 50% of the
outstanding securities of any class of voting securities of such
Party or any of its Subsidiaries (other than, solely with
respect to Adamis, through any capital raising transaction);
(b) any sale, lease, exchange, transfer, license,
acquisition or disposition of any business or businesses or
assets that constitute or account for: (i) 50% or more of
the consolidated book value of the assets of a Party and its
Subsidiaries, taken as a whole; or (ii) 50% or more of the
fair market value of the assets of a Party and its Subsidiaries,
taken as a whole; or
(c) any liquidation or dissolution of a Party.
Adamis shall have the meaning set
forth in the Preamble.
Adamis Bylaws shall mean the bylaws of
Adamis as currently in effect.
Adamis Capital Stock shall mean shares
of Adamis Common Stock and, if any, Adamis Preferred Stock.
Adamis Charter shall mean the
certificate of incorporation of Adamis, as in effect on the date
of this Agreement.
Adamis Common Stock shall have the
meaning set forth in the Recitals.
Adamis Current Balance Sheet shall
have the meaning set forth in Section 2.8(b).
Adamis Disclosure Letter shall have the
meaning set forth in the first paragraph of Article II.
Adamis Employee Agreement shall mean
each management, employment, severance, consulting, relocation,
repatriation or expatriation agreement or other contract between
Adamis or any of its Subsidiaries and any current employee
thereof, other than any such management, employment, severance,
consulting, relocation, repatriation or expatriation agreement
or other contract with such employee which is terminable
at will without any obligation on the part of Adamis
or any of its Subsidiaries to make any payments or provide any
benefits in connection with such termination.
Adamis Employee Plan shall have the
meaning set forth in Section 2.13(a).
Adamis Financial Statements shall have
the meaning set forth in Section 2.8(b).
Adamiss Knowledge shall mean
(a) the actual knowledge, after reasonable diligence, of
the officers and directors of Adamis and (b) such facts and
circumstances each of the officers and directors of Adamis
should have known given their involvement in Adamis and the
information available to them.
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Adamis Options shall mean all options,
warrants or other rights, if any, that may be outstanding to
purchase, acquire or otherwise receive shares of Adamis Capital
Stock (whether or not vested) held by current or former
employees or directors of or consultants to Adamis.
Adamis Patent and Proprietary Rights
shall have the meaning set forth in Section 2.11.
Adamis Preferred Stock shall mean
shares of preferred stock of Adamis.
Adamis Restricted Stock shall have the
meaning set forth in Section 1.6(c).
Adamis SEC Reports shall have the
meaning set forth in Section 2.8(a).
Adamis Stock Certificate shall have
the meaning set forth in Section 1.6(f).
Adamis Stockholder shall mean each
holder of any Adamis Capital Stock immediately before the
Effective Time.
Adamis Termination Fee shall have the
meaning set forth in Section 9.3(c).
Adamis Triggering Event shall be
deemed to have occurred if: (i) there shall have occurred a
Change in the Adamis Board Recommendation; (ii) Adamis
shall have failed to convene or hold the Adamis Stockholder
Meeting within sixty (60) days after the definitive Proxy
Statement is filed with the SEC (other than to the extent that
Adamis determines, in good faith, that the Required Adamis
Stockholder Vote will not be obtained at a meeting held within
such time, in such case the sixty (60) day period shall be
tolled until such time as Adamis determines, in good faith, that
the Required Adamis Stockholder Vote can be obtained at a
meeting, in each case in accordance with Section 5.2(d)),
(iii) Adamis or any of its Subsidiaries or Representatives
shall have failed to comply with the provisions set forth in
Section 4.5 of the Agreement in any material respect,
(iv) Adamis or any of its Representatives shall change the
Adamis Board Recommendation, or (v) Adamis shall have
delivered a Notice of Superior Proposal under
Section 4.5(b).
Agreement shall mean the Agreement and
Plan of Reorganization to which this Exhibit A is
attached, as it may be amended from time to time.
Ancillary Agreements shall have the
meaning as set forth in Section 2.3.
Business shall mean the business and
operations of a party.
Business Day shall mean any day other
than a day on which banks in the State of California are
authorized or obligated to be closed.
Certificate of Merger shall have the
meaning as set forth in Section 1.3.
Change in the Adamis Board
Recommendation shall have the meaning set forth in
Section 5.2.
Change in the La Jolla Board
Recommendation shall have the meaning set forth in
Section 5.3.
Closing shall have the meaning set
forth in Section 1.3.
Closing Date shall have the meaning
set forth in Section 1.3.
Code shall mean the Internal Revenue
Code of 1986, as amended.
Combined Company shall mean
La Jolla and Adamis and their respective Subsidiaries (and,
after the Closing, the Surviving Corporation), taken together as
a whole.
Confidentiality Agreement shall have
the meaning as set forth in Section 5.14 of this Agreement.
Consent shall mean any approval,
consent, ratification, permission, waiver or authorization
(including any necessary Governmental Authorization).
Contemplated Transactions shall mean
the Merger and the other transactions and actions expressly
contemplated by the Agreement.
Contract shall, with respect to any
Person, mean any written, oral or other agreement, contract,
subcontract, lease (whether real or personal property),
mortgage, understanding, arrangement, instrument,
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note, option, warranty, purchase order, license, sublicense,
insurance policy, benefit plan or legally binding commitment or
undertaking of any nature to which such Person is a party or by
which such Person or any of its assets are bound or affected
under applicable law.
Convertible Securities shall mean and
include options, warrants and other rights for the purchase of
common stock or any stock or security convertible into or
exchangeable for common stock.
Current Balance Sheet shall have the
meaning as set forth in Section 2.8.
D&O Indemnified Parties shall
have the meaning set forth in Section 5.2.
Dissenting Shares shall have the
meaning as set forth in Section 1.8.
Dissenting Stockholder shall have the
meaning set forth in Section 1.8.
Effective Time shall have the meaning
as set forth in Section 1.3.
Encumbrances shall mean any lien,
pledge, hypothecation, charge, mortgage, security interest,
encumbrance, claim, infringement, interference, option, right of
first refusal, preemptive right, community property interest or
restriction of any nature (including any restriction on the
voting of any security, any restriction on the transfer of any
security or other asset, any restriction on the receipt of any
income derived from any asset, any restriction on the use of any
asset and any restriction on the possession, exercise or
transfer of any other attribute of ownership of any asset).
Entity shall have the meaning set
forth in Section 2.2.
Environment shall mean soil, land
surface or subsurface strata, surface waters (including
navigable waters, ocean waters, streams, ponds, drainage basins,
and wetlands), ground waters, drinking water supply, stream
sediments, ambient air (including indoor air), plant and animal
life, and any other environmental medium or natural resource.
Environmental, Health, and Safety
Liabilities shall mean any cost, damages, expense,
liability, obligation, or other responsibility arising out of
any Environmental Law or Occupational Safety and Health Law and
consisting of or relating to:
(i) any fines, penalties, judgments, awards, settlements,
legal or administrative Legal Proceedings, damages, losses,
claims, demands and response, investigative, remedial,
compliance, corrective or inspection costs and expenses arising
under Environmental Law or Occupational Safety and Health Law
(including
on-site or
off-site contamination, occupational safety and health, and
regulation of chemical substances or products); or
(iii) financial responsibility under Environmental Law or
Occupational Safety and Health Law for cleanup costs or
corrective action, including any investigation, cleanup,
removal, containment, or other remediation or response actions
(Cleanup) required by applicable
Environmental Law or Occupational Safety and Health Law (whether
or not such Cleanup has been required or requested by any
Governmental Entity or any other Person) and for any natural
resource damages.
The terms removal, remedial, and
response action, include the types of activities
covered by the United States Comprehensive Environmental
Response, Compensation, and Liability Act, 42 U.S.C.
Section 9601 et seq., as amended
(CERCLA).
Environmental Law shall mean all
federal, state and local laws, statutes, regulations,
ordinances, codes, rules and other governmental restrictions and
requirements relating to the discharge of air pollutants, water
pollutants or processed waste water or otherwise relating in any
manner to the environment, pollutants or hazardous substances or
materials, including but not limited to the Federal Solid Waste
Disposal Act; the Federal Clean Air Act including, without
limitation, the Clean Air Act Amendments of 1990; the Federal
Water Pollution Control Act; the Hazardous Materials
Transportation Act; the Federal Toxic Substances Control Act;
the Federal Resource Conservation and Recovery Act of 1976;
CERCLA, all amendments to any of the foregoing statutes, and all
regulations promulgated by any federal or state agencies,
including the Environmental Protection Agency, regulations of
the Nuclear Regulatory Agency, and regulations of any state
A-44
department of natural resources or state environmental
protection agency previously, now or at any time hereafter in
effect.
ERISA shall have the meaning as set
forth in Section 2.13(a).
ERISA Affiliate shall have the meaning
as set forth in Section 2.13(a).
Exchange Act shall mean the Securities
Exchange Act of 1934, as amended.
Exchange Agent shall have the meaning
set forth in Section 1.10.
Exchange Ratio shall have the meaning
set forth in Section 1.7.
Exchange Shares shall have the meaning
set forth in Section 1.10(b).
Facilities shall mean any real
property, leaseholds, or other interests currently or formerly
owned or operated by a Party and any buildings, plants,
structures, or equipment (including motor vehicles, tank cars,
and rolling stock) currently or formerly owned or operated by
any Party.
GAAP shall mean United States
generally accepted accounting principles.
Governmental Authorization shall mean
any: (a) permit, license, certificate, franchise, grant,
funding arrangement, permission, variance, clearance,
registration, qualification, approval or authorization issued,
granted, given or otherwise made available by or under the
authority of any Governmental Entity or pursuant to any
applicable Legal Requirement; or (b) right under any
Contract with any Governmental Entity.
Governmental Entity shall mean any:
(a) nation, state, commonwealth, province, territory,
county, municipality, district or other jurisdiction of any
nature; (b) federal, state, local, municipal, foreign or
other government; or (c) governmental or quasi-governmental
authority of any nature (including any governmental division,
department, agency, commission, instrumentality, official,
ministry, fund, foundation, center, organization, unit, body or
Entity and any court or other tribunal, and for the avoidance of
doubt, any Taxing authority).
Hazardous Materials shall mean any
pollutant, chemical, substance and any toxic, infectious,
carcinogenic, reactive, corrosive, ignitable or flammable
chemical, or chemical compound, or hazardous substance, material
or waste, whether solid, liquid or gas, that is subject to
regulation, control or remediation under any Environmental Law
Requirement, including without limitation, crude oil or any
fraction thereof, and petroleum products or by-products.
Intellectual Property shall mean all
domestic and foreign intellectual property and proprietary
rights, including but not limited to all (i) inventions
(whether or not patentable and whether or not reduced to
practice), all improvements thereto, and all patents and patent
applications, (ii) trademarks, service marks, trade names,
domain names, trade dress, logos, corporate names and brand
names, together will all goodwill associated therewith, and all
applications and registrations in connection therewith,
(iii) all works of authorship (whether or not published),
copyrights and designs, and all applications and registrations
in connection therewith, (iv) source code and object code
versions of computer software (including data and related
documentation) and website content, and (v) trade secrets
and confidential business information (including ideas,
know-how, formulas, compositions, processes and techniques,
research and development information, technical data, designs,
drawings, specifications, research records, records of
inventions, test information, financial, marketing and business
data, pricing and cost information, business and marketing plans
and proposals and customer and supplier lists and information,
including all membership lists and databases and related
information and profiles).
IRS shall mean the United States
Internal Revenue Service.
La Jolla shall have the meaning
set forth in the Preamble.
La Jolla Board Recommendation
shall have the meaning set forth in Section 5.3.
La Jolla Bylaws shall mean the
bylaws of La Jolla as currently in effect.
A-45
La Jolla Charter shall mean the
certificate of incorporation of La Jolla, as in effect on
the date of this Agreement.
La Jolla Charter Amendment shall
have the meaning set forth in Section 8.9.
La Jolla Common Stock shall have
the meaning set forth in the Recitals.
La Jolla Disclosure Letter shall
have the meaning set forth in the first paragraph of
Article III.
La Jolla Employee Agreement shall
mean each management, employment, severance, consulting,
relocation, repatriation or expatriation agreement or other
contract between La Jolla or any of its Subsidiaries and
any current employee thereof, other than any such management,
employment, severance, consulting, relocation, repatriation or
expatriation agreement or other contract with such employee
which is terminable at will without any obligation
on the part of La Jolla or any of its Subsidiaries to make
any payments or provide any benefits in connection with such
termination.
La Jolla Employee Plan shall have
the meaning set forth in Section 3.13.
La Jolla Employee Stock Purchase
Plan means the La Jolla Pharmaceutical
Company 1995 Employee Stock Purchase Plan.
La Jolla Equity Incentive Plans
means (a) the La Jolla Pharmaceutical Company 1994
Stock Incentive Plan and (b) the La Jolla
Pharmaceutical Company 2004 Equity Incentive Plan.
La Jolla Financial Statements
shall have the meaning set forth in Section 3.8(b).
La Jollas Knowledge shall
mean (a) the actual knowledge, after reasonable diligence,
of La Jollas officers and directors and (b) such
facts and circumstances each of the officers and directors of
La Jolla should have known given their involvement in
La Jolla and the information available to them.
La Jolla Name Change Amendment
shall have the meaning set forth in Section 5.10.
La Jolla Net Cash shall mean the
amount of (A) La Jollas cash and cash
equivalents and current amounts receivable of La Jolla, as
reflected in La Jollas financial records as of the
Closing Date, minus (B) all cash Liabilities of
La Jolla as reflected in La Jollas financial
records as of the Closing Date, but excluding the Reverse Split
Expenses.
La Jolla Options shall mean
options or other rights to purchase or acquire shares of
La Jolla Common Stock issued by La Jolla.
La Jolla Patent and Proprietary
Rights shall have the meaning as set forth in
Section 3.11 of this Agreement.
La Jolla Preferred Stock shall
mean shares of preferred stock, par value $0.01 per share, of
La Jolla.
La Jolla Restated Certificate
shall have the meaning set forth in Section 1.5(a).
La Jolla SEC Reports shall have
the meaning set forth in Section 3.8.
La Jolla Stock Plan shall have
the meaning set forth in Section 5.10.
La Jolla Stockholder Meeting
shall have the meaning set forth in Section 5.3.
La Jolla Termination Fee shall
have the meaning set forth in Section 9.3.
La Jolla Triggering Event shall
be deemed to have occurred if: (i) there shall have
occurred a Change in the La Jolla Board Recommendation;
(ii) La Jolla shall have failed to convene or hold the
La Jolla Stockholder Meeting within sixty (60) days
after the definitive Proxy Statement is filed with the SEC
(other than to the extent that La Jolla determines, in good
faith, that the Required La Jolla Stockholder Vote will not
be obtained at a meeting held within such time, in such case the
sixty (60) day period shall be tolled until such time as
La Jolla determines, in good faith, that the Required
La Jolla Stockholder Vote can be obtained at a meeting, in
each case in accordance with Section 5.3(d)),
(iii) La Jolla or any of its Subsidiaries or
Representatives shall have failed to comply with the provisions
set forth in Section 4.5 of the Agreement
A-46
in any material respect, (iv) La Jolla or any of its
Representatives shall change the La Jolla Board
Recommendation, or (v) La Jolla shall have delivered a
Notice of Superior Proposal under Section 4.5(c).
Legal Proceeding shall mean any
action, suit, litigation, arbitration, proceeding (including any
civil, criminal, administrative, investigative or appellate
proceeding), hearing, inquiry, audit, examination or
investigation commenced, brought, conducted or heard by or
before, or otherwise involving, any court or other Governmental
Entity or any arbitrator or arbitration panel.
Legal Requirement shall mean any
federal, state, foreign, material local or municipal or other
law, statute, constitution, ordinance, code, rule, or regulation
issued, enacted, adopted, promulgated, implemented or otherwise
put into effect by or under the authority of any Governmental
Entity.
Liabilities (or when used with
reference to a single item described below,
Liability) means debts, liabilities
and obligations (whether pecuniary or not, including without
limitation obligations to perform or forbear from performing
acts or services), fines, or penalties, whether accrued or
fixed, absolute or contingent, matured or unmatured, determined
or undeterminable, known or unknown, and whether or not required
to be included in financial statements under GAAP, including
without limitation those arising under any law, action or
governmental order, liabilities for Taxes and those arising
under any contract, agreement, arrangement, commitment, employee
benefit plan (including without limitation the cost of any
severance, salary continuation or similar payment and the costs
of any obligation to maintain health insurance or other
benefits) or undertaking of any kind whatsoever (whether
written, express or implied).
Material Adverse Effect shall mean any
fact, change, event, factor, condition, circumstance,
development or effect that, individually or in the aggregate,
has, or would reasonably be expected to have, a material adverse
effect on the business, assets, liabilities, condition
(financial or otherwise), prospects or results of operations of
a Party and its Subsidiaries (including, following the Merger,
the Surviving Corporation and its Subsidiaries), taken as a
whole, other than to the extent such effects are due to:
(a) the announcement of the transactions contemplated by
this Agreement; (b) economic factors affecting the
national, regional or world economy; (c) any act or threat
of terrorism or war anywhere in the world, any armed hostilities
or terrorist activities anywhere in the world, any threat or
escalation or armed hostilities or terrorist activities anywhere
in the world or any governmental or other response or reaction
to any of the foregoing; (d) changes in GAAP or the
interpretation thereof, in each case to the extent required by
GAAP; (e) the Reverse Stock Split; or (f) any change
in the stock price or trading volume of La Jolla Common
Stock or Adamis Common Stock (it being understood that the facts
and circumstances giving rise to such change may be deemed to
constitute, and may be taken into account in determining whether
there has been, a Material Adverse Effect if such facts and
circumstances are not otherwise excluded by clauses (a) -
(e) of this definition).
For the avoidance of doubt, Material Adverse Effect
shall include, without limitation, any regulatory actions taken
by the FDA that would be expected to cause an interruption in
the ability of Adamis to commercialize the Epinephrine PFS
product.
Merger shall have the meaning set
forth in the Recitals.
Merger Sub shall have the meaning set
forth in the Preamble.
Material Contract shall mean any
agreement, instrument or document now in effect (including any
amendment to any of the foregoing):
(i) with any director, officer or affiliate of Adamis or
La Jolla, as the case may be;
(ii) evidencing, governing or relating to indebtedness for
borrowed money or which provides for the imposition of any lien
on any of its assets;
(iii) that involves expenditures or receipts in excess of
$50,000;
(iv) that in any material way purports to restrict the
business activity of a party or any of its affiliates or to
limit the freedom of a party or any of its affiliates to engage
in any line of business or to compete with any Person or in any
geographic area or to hire or retain any Person;
A-47
(v) relating to the employment of, or the performance of
services by, any employee or consultant; or pursuant to which a
party is or may become obligated to make any severance,
termination or similar payment to any employee or director; or
pursuant to which a party is or may become obligated to make any
bonus or similar payment (other than payments constituting base
salary) to any employee or director;
(vii) (A) relating to the acquisition, issuance, voting,
registration, sale or transfer of any securities of a party,
(B) providing any Person with any preemptive right, right
of participation, right of maintenance or any similar right with
respect to any securities of a Party, or (C) providing a
Person with any right of first refusal with respect to, or right
to repurchase or redeem, any securities, except for Contracts
pursuant to La Jolla Stock Option Plan, the Adamis Stock
Option Plan and Contracts between Adamis and any Person that
provide a right of first refusal, right of repurchase or
cancellation or similar right in favor of Adamis;
(viii) incorporating or relating to any guaranty or any
indemnity or similar obligation;
(ix) relating to any currency hedging;
(x) (A) imposing any confidentiality obligation on a
party (other than under agreements entered into in the Ordinary
Course of Business that are not material to the Party), or
(B) containing standstill provisions;
(xi) (A) to which any Governmental Entity is a party
or under which any Governmental Entity has any rights or
obligations, or (B) directly or indirectly benefiting any
Governmental Entity (including any subcontract or other Contract
between Adamis and any contractor or subcontractor to any
Governmental Entity), or (C) relating to any funding, grant
or similar agreement, proposal or commitment relating to product
of the party; and
(xii) that if terminated or breached would reasonably be
expected to have a Material Adverse Effect on the Party or on
any of the transactions contemplated by this Agreement or any of
the Ancillary Agreements.
Notice of Superior Proposal shall have
the meaning set forth in Section 4.5.
Ordinary Course of Business shall
mean, in the case of each of Adamis and La Jolla, such
actions taken in the ordinary course of its normal operations
and consistent with its past practices.
Outside Date shall have the meaning
set forth in Section 9.1(b).
Party or
Parties shall mean Adamis, Merger Sub
and La Jolla.
Person shall mean any individual,
Entity or Governmental Entity.
Post-Effective La Jolla Stockholder
Shares shall be a number equal to (i) the
La Jolla Net Cash as of the Closing Date plus $750,000,
divided by (ii) the Adamis Discounted Share Price. The
Adamis Discounted Share Price shall
mean the volume weighted average closing price of the Adamis
Common Stock (as reported on the OTC Bulletin Board or
other market or quotation system on which the Adamis Common
Stock is quoted or traded) commencing on the first Business Day
after the date of this Agreement and ending two trading days
before the Closing Date, discounted by an amount set forth in
the following table:
|
|
|
Adamis Average Share Price*
|
|
% Discount
|
|
Less than $0.25
|
|
10% (not to go below $0.20 per share)
|
$0.25 to $2.00
|
|
25% (not to go below $0.20 per share)
|
Greater than $2.00
|
|
$1.50 (fixed price)
|
|
|
|
* |
|
Subject to adjustment, as appropriate, in the event of
Recapitalization of Adamis. |
By way of example only: (A) if the La Jolla Net Cash
as of the Closing Date is $2,000,000 and the Adamis Average
Share Price is $0.24, then the Adamis Discounted Share Price
would equal $0.216 and the Post-Effective La Jolla
Stockholder Shares would equal 12,731,481; (B) if the
La Jolla Net Cash as of the Closing Date is $2,000,000 and
the Adamis Average Share Price is $0.50, then the Adamis
Discounted Share Price would equal $0.375 and the Post-Effective
La Jolla Stockholder Shares would equal 7,333,333; and
(C) if the
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La Jolla Net Cash as of the Closing Date is $2,000,000 and
the Adamis Average Share Price is $2.01, then the Adamis
Discounted Share Price would equal $1.50 and the Post-Effective
La Jolla Stockholder Shares would equal 1,833,333.
Pre-Closing Period shall have the
meaning as set forth in Section 4.1.
Pre-Effective La Jolla Shares
shall be the sum of all shares of La Jolla Common Stock
prior to the Effective Date that are: (a) issued and
outstanding and (b) issuable upon conversion of any
preferred stock of La Jolla.
Proposals shall have the meaning set
forth in Section 5.3(b).
Proxy Statement shall mean the joint
Proxy Statement to be filed with the SEC by La Jolla and
Adamis in connection with the Merger, as said statements may be
amended, and mailed to the La Jolla stockholders in
connection with the La Jolla Stockholder Meeting and to the
Adamis stockholders in connection with the Adamis Stockholder
Meeting.
Registration Statement shall mean the
registration statement on
Form S-4
(the
S-4)
to be filed with the SEC by La Jolla, together with all
amendment and supplements thereto and including the exhibits
thereto.
Representatives shall mean officers,
directors, employees, agents, attorneys, accountants, investment
bankers, advisors and representatives.
Required La Jolla Stockholder
Vote shall mean the vote of the La Jolla
stockholders that is required under the DGCL or other applicable
law to approve the Proposals.
Required Adamis Stockholder Vote shall
mean the vote of the Adamis Stockholders that is required under
applicable law to approve the Merger and the transactions
contemplated by this Agreement.
Reverse Stock Split shall have the
meaning set forth in Section 1.5(a)(i).
Reverse Stock Split Ratio shall be
expressed as a fraction, the numerator of which shall equal one
(1) and the denominator of which shall equal the
Pre-Effective La Jolla Shares divided by the Post-Effective
La Jolla Stockholder Shares.
Sarbanes-Oxley shall mean the
Sarbanes-Oxley Act of 2002, as it may be amended from time to
time.
SEC shall mean the United States
Securities and Exchange Commission.
Securities Act shall mean the
Securities Act of 1933, as amended.
Subsidiary An Entity shall be deemed
to be a Subsidiary of another Person if such Person
directly or indirectly owns, beneficially or of record,
(a) an amount of voting securities of other interests in
such Entity that is sufficient to enable such Person to elect at
least a majority of the members of such Entitys board of
directors or other governing body, or (b) at least 50% of
the outstanding equity, voting, beneficial or financial
interests in such Entity.
Superior Proposal means an Acquisition
Proposal that the board of directors of a Party determines, in
its reasonable judgment, to be more favorable to such
Partys stockholders than the terms of the transactions
contemplated by this Agreement.
Surviving Corporation shall have the
meaning set forth in Section 1.1.
Tax shall have the meaning set forth
in Section 2.12.
Tax Return shall mean any return
(including any information return), report, statement,
declaration, estimate, schedule, notice, notification, form,
election, certificate or other document or information filed
with or submitted to, or required to be filed with or submitted
to, any Governmental Entity in connection with the
determination, assessment, collection or payment of any Tax or
in connection with the administration, implementation or
enforcement of or compliance with any Legal Requirement relating
to any Tax.
Treasury Regulations shall mean the official
interpretations of the Code promulgated by the United States
Department of the Treasury.
Voting Agreement shall have the
meaning set forth in the Recitals.
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Schedule 9.1(l)
List of events:
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Material manufacturing or supply problems with Epinephrine
PFS product (including API and syringe), or any regulatory
actions taken by the FDA, that result in or would be expected to
result in a commercial interruption in sales of such product.
|
|
|
|
Any litigation filed against Adamis, its directors or officers
asserting claims that could reasonably be expected to result in
the occurrence of a Material Adverse Effect.
|
|
|
|
The loss of the services of Dennis J. Carlo as an officer,
director or full-time employee of the Company for any reason
whatsoever.
|
A-50
Execution
Copy
AMENDMENT
NO. 1 TO AGREEMENT AND PLAN OF REORGANIZATION
THIS AMENDMENT NO. 1 TO AGREEMENT AND PLAN OF REORGANIZATION
(this Amendment) is made as of
December 21, 2009, by and among La Jolla
Pharmaceutical Company, a Delaware corporation (the
Company), Jewel Merger Sub, Inc., a
Delaware corporation (Merger Sub) and
Adamis Pharmaceuticals Corporation, a Delaware corporation
(Adamis).
RECITALS
A. The Company, Merger Sub and Adamis entered into that
certain Agreement and Plan of Reorganization, dated as of
December 4, 2009 (the Merger
Agreement).
B. The Company, Merger Sub and Adamis desire to waive the
requirement that the Company amend its 2004 Equity Incentive
Plan to increase the number of shares reserved for issuance
thereunder.
C. The Company, Merger Sub and Adamis desire to amend
Section 10.10 of the Merger Agreement to correct
typographical errors to accurately reflect the agreement among
the parties with respect to the matters discussed therein.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing Recitals, and
for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties hereby
agree as follows:
1. Waiver. The Company, Merger Sub and
Adamis hereby waive the applicability of
Sections 5.1(a)(iv), 5.3(a) (but only to such extent as
Section 5.3(a) relates to the Plan Amendment, as defined in
the Merger Agreement), 5.3(b)(i)(D) and 5.10(ii) of the Merger
Agreement to effect the result that the Company shall not be
required to amend its 2004 Equity Incentive Plan to increase the
number of shares reserved for issuance thereunder.
2. Amendment of Section 10.10.
Section 10.10 of the Merger Agreement is hereby amended and
restated in its entirety to read as follows:
10.10. Other Remedies; Specific
Performance. Except as otherwise provided
herein, any and all remedies herein expressly conferred upon a
Party will be deemed cumulative with and not exclusive of any
other remedy conferred hereby, or by law or equity upon such
Party, and the exercise by a Party of any one remedy will not
preclude the exercise of any other remedy. It is accordingly
agreed that the Parties shall be entitled to seek an injunction
or injunctions to prevent breaches of this Agreement and to
enforce specifically the terms and provisions hereof in any
court of the United States or any state having jurisdiction,
this being the addition to any other remedy to which they are
entitled at law or in equity. Notwithstanding the foregoing, in
the event that this Agreement is terminated by Adamis pursuant
to Section 9.1(d), 9.1(e), 9.1(g), 9.1(k) or 9.1(m) or by
La Jolla pursuant to Section 9.1(d), 9.1(f), 9.1(h),
9.1(k) or 9.1(l) above, Adamiss or La Jollas
sole and exclusive remedy hereunder shall be that provided in
Section 9.3(b) or (c), respectively.
3. Continuity of Terms. Except as
expressly amended hereby, all the other terms and provisions of
the Merger Agreement shall remain in full force and effect.
4. Counterparts. This Amendment may be
executed in any number of counterparts, including facsimile
transmission and electronic (PDF) transmission copies, each of
which will constitute an original, and all of which together
will be considered one and the same agreement.
[Remainder
of this page intentionally left blank.]
A-51
IN WITNESS WHEREOF, the parties hereto have executed this
Amendment No. 1 to Merger Agreement as of the date first
above written.
LA JOLLA PHARMACEUTICAL COMPANY
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By:
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/s/ Deirdre
Y. Gillespie
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Name: Deirdre Y. Gillespie
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Title:
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President and Chief Executive Officer
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JEWEL MERGER SUB, INC.
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By:
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/s/ Deirdre
Y. Gillespie
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Name: Deirdre Y. Gillespie
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Title:
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President and Chief Executive Officer
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ADAMIS PHARMACEUTICALS CORPORATION
Name: Dennis J. Carlo
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Title:
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President and Chief Executive Officer
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Signature
Page to Amendment No. 1 to Agreement and Plan of
Reorganization
A-52
Annex B
§
262 APPRAISAL RIGHTS.
(a) Any stockholder of a corporation of this State who
holds shares of stock on the date of the making of a demand
pursuant to subsection (d) of this section with respect to
such shares, who continuously holds such shares through the
effective date of the merger or consolidation, who has otherwise
complied with subsection (d) of this section and who has
neither voted in favor of the merger or consolidation nor
consented thereto in writing pursuant to § 228 of this
title shall be entitled to an appraisal by the Court of Chancery
of the fair value of the stockholders shares of stock
under the circumstances described in subsections (b) and
(c) of this section. As used in this section, the word
stockholder means a holder of record of stock in a
stock corporation and also a member of record of a nonstock
corporation; the words stock and share
mean and include what is ordinarily meant by those words and
also membership or membership interest of a member of a nonstock
corporation; and the words depository receipt mean a
receipt or other instrument issued by a depository representing
an interest in one or more shares, or fractions thereof, solely
of stock of a corporation, which stock is deposited with the
depository.
(b) Appraisal rights shall be available for the shares of
any class or series of stock of a constituent corporation in a
merger or consolidation to be effected pursuant to
§ 251 (other than a merger effected pursuant to
§ 251(g) of this title), § 252,
§ 254, § 257, § 258,
§ 263 or § 264 of this title:
(1) Provided, however, that no appraisal rights under this
section shall be available for the shares of any class or series
of stock, which stock, or depository receipts in respect
thereof, at the record date fixed to determine the stockholders
entitled to receive notice of the meeting of stockholders to act
upon the agreement of merger or consolidation, were either
(i) listed on a national securities exchange or
(ii) held of record by more than 2,000 holders; and further
provided that no appraisal rights shall be available for any
shares of stock of the constituent corporation surviving a
merger if the merger did not require for its approval the vote
of the stockholders of the surviving corporation as provided in
§ 251(f) of this title.
(2) Notwithstanding paragraph (1) of this subsection,
appraisal rights under this section shall be available for the
shares of any class or series of stock of a constituent
corporation if the holders thereof are required by the terms of
an agreement of merger or consolidation pursuant to
§§ 251, 252, 254, 257, 258, 263 and 264 of this
title to accept for such stock anything except:
a. Shares of stock of the corporation surviving or
resulting from such merger or consolidation, or depository
receipts in respect thereof;
b. Shares of stock of any other corporation, or depository
receipts in respect thereof, which shares of stock (or
depository receipts in respect thereof) or depository receipts
at the effective date of the merger or consolidation will be
either listed on a national securities exchange or held of
record by more than 2,000 holders;
c. Cash in lieu of fractional shares or fractional
depository receipts described in the foregoing subparagraphs a.
and b. of this paragraph; or
d. Any combination of the shares of stock, depository
receipts and cash in lieu of fractional shares or fractional
depository receipts described in the foregoing subparagraphs a.,
b. and c. of this paragraph.
(3) In the event all of the stock of a subsidiary Delaware
corporation party to a merger effected under § 253 of
this title is not owned by the parent corporation immediately
prior to the merger, appraisal rights shall be available for the
shares of the subsidiary Delaware corporation.
(c) Any corporation may provide in its certificate of
incorporation that appraisal rights under this section shall be
available for the shares of any class or series of its stock as
a result of an amendment to its certificate of ncorporation, any
merger or consolidation in which the corporation is a
constituent corporation or the sale of all or substantially all
of the assets of the corporation. If the certificate of
incorporation contains such a provision, the procedures of this
section, including those set forth in subsections (d) and
(e) of this section, shall apply as nearly as is
practicable.
B-1
(d) Appraisal rights shall be perfected as follows:
(1) If a proposed merger or consolidation for which
appraisal rights are provided under this section is to be
submitted for approval at a meeting of stockholders, the
corporation, not less than 20 days prior to the meeting,
shall notify each of its stockholders who was such on the record
date for notice of such meeting with respect to shares for which
appraisal rights are available pursuant to subsection (b)
or (c) hereof of this section that appraisal rights are
available for any or all of the shares of the constituent
corporations, and shall include in such notice a copy of this
section. Each stockholder electing to demand the appraisal of
such stockholders shares shall deliver to the corporation,
before the taking of the vote on the merger or consolidation, a
written demand for appraisal of such stockholders shares.
Such demand will be sufficient if it reasonably informs the
corporation of the identity of the stockholder and that the
stockholder intends thereby to demand the appraisal of such
stockholders shares. A proxy or vote against the merger or
consolidation shall not constitute such a demand. A stockholder
electing to take such action must do so by a separate written
demand as herein provided. Within 10 days after the
effective date of such merger or consolidation, the surviving or
resulting corporation shall notify each stockholder of each
constituent corporation who has complied with this subsection
and has not voted in favor of or consented to the merger or
consolidation of the date that the merger or consolidation has
become effective; or
(2) If the merger or consolidation was approved pursuant to
§ 228 or § 253 of this title, then either a
constituent corporation before the effective date of the merger
or consolidation or the surviving or resulting corporation
within 10 days thereafter shall notify each of the holders
of any class or series of stock of such constituent corporation
who are entitled to appraisal rights of the approval of the
merger or consolidation and that appraisal rights are available
for any or all shares of such class or series of stock of such
constituent corporation, and shall include in such notice a copy
of this section. Such notice may, and, if given on or after the
effective date of the merger or consolidation, shall, also
notify such stockholders of the effective date of the merger or
consolidation. Any stockholder entitled to appraisal rights may,
within 20 days after the date of mailing of such notice,
demand in writing from the surviving or resulting corporation
the appraisal of such holders shares. Such demand will be
sufficient if it reasonably informs the corporation of the
identity of the stockholder and that the stockholder intends
thereby to demand the appraisal of such holders shares. If
such notice did not notify stockholders of the effective date of
the merger or consolidation, either (i) each such
constituent corporation shall send a second notice before the
effective date of the merger or consolidation notifying each of
the holders of any class or series of stock of such constituent
corporation that are entitled to appraisal rights of the
effective date of the merger or consolidation or (ii) the
surviving or resulting corporation shall send such a second
notice to all such holders on or within 10 days after such
effective date; provided, however, that if such second notice is
sent more than 20 days following the sending of the first
notice, such second notice need only be sent to each stockholder
who is entitled to appraisal rights and who has demanded
appraisal of such holders shares in accordance with this
subsection. An affidavit of the secretary or assistant secretary
or of the transfer agent of the corporation that is required to
give either notice that such notice has been given shall, in the
absence of fraud, be prima facie evidence of the facts stated
therein. For purposes of determining the stockholders entitled
to receive either notice, each constituent corporation may fix,
in advance, a record date that shall be not more than
10 days prior to the date the notice is given, provided,
that if the notice is given on or after the effective date of
the merger or consolidation, the record date shall be such
effective date. If no record date is fixed and the notice is
given prior to the effective date, the record date shall be the
close of business on the day next preceding the day on which the
notice is given.
(e) Within 120 days after the effective date of the
merger or consolidation, the surviving or resulting corporation
or any stockholder who has complied with subsections (a)
and (d) of this section hereof and who is otherwise
entitled to appraisal rights, may commence an appraisal
proceeding by filing a petition in the Court of Chancery
demanding a determination of the value of the stock of all such
stockholders. Notwithstanding the foregoing, at any time within
60 days after the effective date of the merger or
consolidation, any stockholder who has not commenced an
appraisal proceeding or joined that proceeding as a named party
shall have the right to withdraw such stockholders demand
for appraisal and to accept the terms offered upon the merger or
consolidation. Within 120 days after the effective date of
the merger or consolidation, any stockholder who has complied
with the requirements of subsections (a) and (d) of
this section hereof, upon written request, shall be entitled to
receive from
B-2
the corporation surviving the merger or resulting from the
consolidation a statement setting forth the aggregate number of
shares not voted in favor of the merger or consolidation and
with respect to which demands for appraisal have been received
and the aggregate number of holders of such shares. Such written
statement shall be mailed to the stockholder within 10 days
after such stockholders written request for such a
statement is received by the surviving or resulting corporation
or within 10 days after expiration of the period for
delivery of demands for appraisal under subsection (d) of
this section hereof, whichever is later. Notwithstanding
subsection (a) of this section, a person who is the
beneficial owner of shares of such stock held either in a voting
trust or by a nominee on behalf of such person may, in such
persons own name, file a petition or request from the
corporation the statement described in this subsection.
(f) Upon the filing of any such petition by a stockholder,
service of a copy thereof shall be made upon the surviving or
resulting corporation, which shall within 20 days after
such service file in the office of the Register in Chancery in
which the petition was filed a duly verified list containing the
names and addresses of all stockholders who have demanded
payment for their shares and with whom agreements as to the
value of their shares have not been reached by the surviving or
resulting corporation. If the petition shall be filed by the
surviving or resulting corporation, the petition shall be
accompanied by such a duly verified list. The Register in
Chancery, if so ordered by the Court, shall give notice of the
time and place fixed for the hearing of such petition by
registered or certified mail to the surviving or resulting
corporation and to the stockholders shown on the list at the
addresses therein stated. Such notice shall also be given by 1
or more publications at least 1 week before the day of the
hearing, in a newspaper of general circulation published in the
City of Wilmington, Delaware or such publication as the Court
deems advisable. The forms of the notices by mail and by
publication shall be approved by the Court, and the costs
thereof shall be borne by the surviving or resulting corporation.
(g) At the hearing on such petition, the Court shall
determine the stockholders who have complied with this section
and who have become entitled to appraisal rights. The Court may
require the stockholders who have demanded an appraisal for
their shares and who hold stock represented by certificates to
submit their certificates of stock to the Register in Chancery
for notation thereon of the pendency of the appraisal
proceedings; and if any stockholder fails to comply with such
direction, the Court may dismiss the proceedings as to such
stockholder.
(h) After the Court determines the stockholders entitled to
an appraisal, the appraisal proceeding shall be conducted in
accordance with the rules of the Court of Chancery, including
any rules specifically governing appraisal proceedings. Through
such proceeding the Court shall determine the fair value of the
shares exclusive of any element of value arising from the
accomplishment or expectation of the merger or consolidation,
together with interest, if any, to be paid upon the amount
determined to be the fair value. In determining such fair value,
the Court shall take into account all relevant factors. Unless
the Court in its discretion determines otherwise for good cause
shown, interest from the effective date of the merger through
the date of payment of the judgment shall be compounded
quarterly and shall accrue at 5% over the Federal Reserve
discount rate (including any surcharge) as established from time
to time during the period between the effective date of the
merger and the date of payment of the judgment. Upon application
by the surviving or resulting corporation or by any stockholder
entitled to participate in the appraisal proceeding, the Court
may, in its discretion, proceed to trial upon the appraisal
prior to the final determination of the stockholders entitled to
an appraisal. Any stockholder whose name appears on the list
filed by the surviving or resulting corporation pursuant to
subsection (f) of this section and who has submitted such
stockholders certificates of stock to the Register in
Chancery, if such is required, may participate fully in all
proceedings until it is finally determined that such stockholder
is not entitled to appraisal rights under this section.
(i) The Court shall direct the payment of the fair value of
the shares, together with interest, if any, by the surviving or
resulting corporation to the stockholders entitled thereto.
Payment shall be so made to each such stockholder, in the case
of holders of uncertificated stock forthwith, and the case of
holders of shares represented by certificates upon the surrender
to the corporation of the certificates representing such stock.
The Courts decree may be enforced as other decrees in the
Court of Chancery may be enforced, whether such surviving or
resulting corporation be a corporation of this State or of any
state.
(j) The costs of the proceeding may be determined by the
Court and taxed upon the parties as the Court deems equitable in
the circumstances. Upon application of a stockholder, the Court
may order all or a portion of the expenses incurred by any
stockholder in connection with the appraisal proceeding,
including, without limitation,
B-3
reasonable attorneys fees and the fees and expenses of
experts, to be charged pro rata against the value of all the
shares entitled to an appraisal.
(k) From and after the effective date of the merger or
consolidation, no stockholder who has demanded appraisal rights
as provided in subsection (d) of this section shall be
entitled to vote such stock for any purpose or to receive
payment of dividends or other distributions on the stock (except
dividends or other distributions payable to stockholders of
record at a date which is prior to the effective date of the
merger or consolidation); provided, however, that if no petition
for an appraisal shall be filed within the time provided in
subsection (e) of this section, or if such stockholder
shall deliver to the surviving or resulting corporation a
written withdrawal of such stockholders demand for an
appraisal and an acceptance of the merger or consolidation,
either within 60 days after the effective date of the
merger or consolidation as provided in subsection (e) of
this section or thereafter with the written approval of the
corporation, then the right of such stockholder to an appraisal
shall cease. Notwithstanding the foregoing, no appraisal
proceeding in the Court of Chancery shall be dismissed as to any
stockholder without the approval of the Court, and such approval
may be conditioned upon such terms as the Court deems just;
provided, however that this provision shall not affect the right
of any stockholder who has not commenced an appraisal proceeding
or joined that proceeding as a named party to withdraw such
stockholders demand for appraisal and to accept the terms
offered upon the merger or consolidation within 60 days
after the effective date of the merger or consolidation, as set
forth in subsection (e) of this section.
(l) The shares of the surviving or resulting corporation to
which the shares of such objecting stockholders would have been
converted had they assented to the merger or consolidation shall
have the status of authorized and unissued shares of the
surviving or resulting corporation.
B-4
Annex C
CERTIFICATE
OF AMENDMENT
TO THE RESTATED
CERTIFICATE OF INCORPORATION
OF
LA JOLLA PHARMACEUTICAL COMPANY
La Jolla Pharmaceutical Company, a corporation organized
under and existing under the laws of the State of Delaware (the
Corporation), certifies that:
FIRST: The name of the Corporation is
La Jolla Pharmaceutical Company.
SECOND: The Board of Directors of the
Corporation, acting in accordance with the provisions of
Sections 141 and 242 of the Delaware General Corporation
Law, adopted resolutions to amend Article FOURTH of the
Restated Certificate of Incorporation of the Corporation by
inserting the following paragraph at the end of such Article:
Effective upon the filing of this Certificate of Amendment
to the Restated Certificate of Incorporation with the Secretary
of State of the State of Delaware, each [***] shares of the
Corporations Common Stock outstanding immediately before
the filing of this Certificate of Amendment (Old Common
Stock) shall be combined and reclassified automatically
into one (1) share of Common Stock. The Corporation shall not
issue fractional shares on account of the Reverse Stock Split.
In lieu of fractional shares, the Corporation may issue a check
in the appropriate amount payable to such stockholder or may
elect to round up each fractional share (after aggregating all
fractional shares issuable to such stockholder) at no additional
cost to the stockholder.
THIRD: This Certificate of Amendment to the
Restated Certificate of Incorporation was submitted to the
stockholders of the Corporation and was duly approved by the
required vote of stockholders of the Corporation in accordance
with Sections 222 and 242 of the Delaware General
Corporation Law.
IN WITNESS WHEREOF, said Certificate of Amendment to the
Restated Certificate of Incorporation has been duly executed by
its authorized officer this day
of , .
LA JOLLA PHARMACEUTICAL COMPANY
Deirdre Y. Gillespie, M.D.
President and Chief Executive Officer
*** The ratio for the reverse stock split will be
determined pursuant to the terms of that certain Agreement and
Plan of Reorganization, dated as of December 4, 2009, by and
among the Corporation, Jewel Merger Sub, Inc. and Adamis
Pharmaceuticals Corporation as described in the accompanying
joint proxy statement/prospectus.
C-1
Annex D
CERTIFICATE
OF AMENDMENT
TO THE RESTATED
CERTIFICATE OF INCORPORATION
OF
LA JOLLA PHARMACEUTICAL COMPANY
La Jolla Pharmaceutical Company, a corporation organized
under and existing under the laws of the State of Delaware (the
Corporation), certifies that:
FIRST: The name of the Corporation is
La Jolla Pharmaceutical Company.
SECOND: The Board of Directors of the
Corporation, acting in accordance with the provisions of
Sections 141 and 242 of the Delaware General Corporation
Law, adopted resolutions to amend and restate Article FIRST
of the Restated Certificate of Incorporation of the Corporation
to read in its entirety as follows:
The name of this corporation is Adamis Pharmaceuticals
Corporation (hereinafter the Corporation).
THIRD: This Certificate of Amendment to the
Restated Certificate of Incorporation was submitted to the
stockholders of the Corporation and was duly approved by the
required vote of stockholders of the Corporation in accordance
with Sections 222 and 242 of the Delaware General
Corporation Law.
IN WITNESS WHEREOF, said Certificate of Amendment has been duly
executed by its authorized officer on this day
of , .
LA JOLLA PHARMACEUTICAL COMPANY
Deirdre Y. Gillespie
President and Chief Executive Officer
D-1
PART II
INFORMATION
NOT REQUIRED IN PROSPECTUS
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Item 20.
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Indemnification
of Directors and Officers
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La Jolla a Delaware corporation. Section 145(a) of the
General Corporation Law of the State of Delaware (the
DGCL) provides that a Delaware
corporation may indemnify any person who was or is a party or is
threatened to be made a party to any threatened, pending or
completed action, suit or proceeding, whether civil, criminal,
administrative or investigative, other than an action by or in
the right of the corporation, by reason of the fact that such
person is or was a director, officer, employee or agent of the
corporation, or is or was serving at the request of the
corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other
enterprise, against expenses, judgments, fines and amounts paid
in settlement actually and reasonably incurred by such person in
connection with such action, suit or proceeding if the person
acted in good faith and in a manner he or she reasonably
believed to be in or not opposed to the best interests of the
corporation, and, with respect to any criminal action or
proceeding, had no cause to believe his or her conduct was
unlawful.
Section 145(b) of the DGCL provides that a Delaware
corporation may indemnify any person who was or is a party or is
threatened to be made a party to any threatened, pending or
completed action or suit by or in the right of corporation to
procure a judgment in its favor by reason of the fact that such
person acted in any of the capacities set forth above, against
expenses actually and reasonably incurred by such person in
connection with the defense or settlement of such action or suit
if the person acted in good faith and in a manner he or she
reasonably believed to be in or not opposed to the best
interests of the corporation, except that no indemnification may
be made in respect to any claim, issue or matter as to which
such person shall have been adjudged to be liable to the
corporation, unless and only to the extent that the court in
which such action or suit was brought shall determine that,
despite the adjudication of liability but in view of all the
circumstances of the case, such person is fairly and reasonably
entitled to be indemnified for such expenses which the court
shall deem proper.
Section 145 of the DGCL further provides that to the extent
a present or former director or officer of a corporation has
been successful in the defense of any action, suit or proceeding
referred to in subsection (a) and (b) of
Section 145 or in the defense of any claim, issue or matter
therein, he or she shall be indemnified against expenses
actually and reasonably incurred by him or her in connection
therewith; that indemnification and advancement of expenses
provided for by Section 145 shall not be deemed exclusive
of any other rights to which those seeking indemnification or
advancement of expenses may be entitled under any bylaw,
agreement, vote of stockholders or disinterested directors or
otherwise; and that the corporation shall have the power to
purchase and maintain insurance on behalf of any person who is
or was a director, officer, employee or agent of the
corporation, or is or was serving at the request of the
corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other
enterprise, against any liability asserted against such person
and incurred by such person in any such capacity, or arising out
of his or her status as such, whether or not the corporation
would have the power to indemnify him or her against such
liabilities under Section 145.
As used in this Item 20, the term proceeding
means any threatened, pending, or completed action, suit, or
proceeding, whether or not by or in the right of La Jolla,
and whether civil, criminal, administrative, investigative or
otherwise.
As permitted by Section 102(b)(7) of the DGCL,
La Jollas certificate of incorporation provides that
a director shall not be liable to La Jolla or its
stockholders for monetary damages for breach of fiduciary duty
as a director. However, such provision does not eliminate or
limit the liability of a director for acts or omissions not in
good faith or for breaching his or her duty of loyalty, engaging
in intentional misconduct, knowingly violating the law, paying
an illegal dividend, approving an illegal stock repurchase, or
obtaining an improper personal benefit. A provision of this type
has no effect on the availability of equitable remedies, such as
injunction or rescission, for breach of fiduciary duty.
La Jollas bylaws require that directors and officers
be indemnified to the maximum extent permitted by Delaware law.
La Jolla has entered into indemnity agreements with each of
its directors and executive officers. These indemnity agreements
generally require that La Jolla pay on behalf of each
director and officer party thereto all
II-1
amounts that he or she is or becomes legally obligated to pay
because of any claim or claims made against him or her because
of any act or omission which he or she commits or suffers while
acting in his or her capacity as a director
and/or
officer of La Jolla and because of his or her being a
director
and/or
officer. Under the DGCL, absent an indemnity agreement or a
provision in a corporations bylaws or certificate of
incorporation, indemnification of a director or officer is
discretionary rather than mandatory (except in the case of a
proceeding in which a director or officer is successful on the
merits). In addition, if indemnification is unavailable and may
not be paid to an officer or director, La Jolla has agreed,
subject to a limited number of exceptions, to contribute to the
amount of expenses incurred or payable by the officer or
director, to the extent allowed by applicable law, in such
proportion as is appropriate to reflect the relative benefits
received by La Jolla, on the one hand, and by the officer
or director, on the other, from the transaction from which the
proceeding arose and the relative faults of the parties, as well
as any other applicable equitable considerations.
Consistent with La Jollas bylaw provision on the
subject, the indemnity agreements require La Jolla to make
prompt payment of defense and investigation costs and expenses
at the request of the director or officer in advance of
indemnification, provided that the recipient undertakes to repay
the amounts if it is ultimately determined that he or she is not
entitled to indemnification for such expenses and provided
further that such advance shall not be made if it is determined
that the director or officer would not be permitted to be
indemnified under applicable law. The indemnity agreements make
the advance of litigation expenses mandatory absent a special
determination to the contrary. Under the DGCL, absent an
indemnity agreement or a provision in a corporations
bylaws or certificate of incorporation, the advancement of
expenses is discretionary. Under the indemnity agreement, the
director or officer is permitted to petition the court to seek
recovery of amounts due under the indemnity agreement and to
recover the expenses of seeking such recovery if he or she is
successful. The benefits of the indemnity agreement will not be
available to the extent that an officer or director has other
indemnification or insurance coverage for the subject claim. In
addition, no indemnity will be paid by La Jolla: with
respect to remuneration paid to an officer or director if it is
determined by a final judgment that such remuneration was in
violation of law; on account of any suit or judgment rendered
against an officer or director for violating Section 16(b)
of the Securities Exchange Act of 1934, or analogous provisions
of law; if an officers or directors conduct is
adjudged to be fraudulent or deliberately dishonest, or
constitutes willful misconduct; or if it is adjudged that
indemnification is not lawful. Absent the indemnity agreement,
indemnification that might be made available to directors and
officers could be changed by amendments to our certificate of
incorporation or bylaws.
La Jolla currently maintains an insurance policy which,
within the limits and subject to the terms and conditions
thereof, covers certain expenses and liabilities that may be
incurred by directors and officers in connection with actions,
suits or proceedings that may be brought against them as a
result of an act or omission committed or suffered while acting
as a director or officer.
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Item 21.
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Exhibits
and Financial Statement Schedules
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EXHIBIT INDEX
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Exhibit Number
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Description
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2
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.1
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Agreement and Plan of Reorganization, by and among La Jolla
Pharmaceutical Company, Adamis Pharmaceuticals Corporation and
Jewel Merger Sub, Inc., dated as of December 4, 2009(17)
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2
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.2
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Amendment No. 1 to Agreement and Plan of Reorganization, by
and among La Jolla Pharmaceutical Company, Adamis
Pharmaceuticals Corporation and Jewel Merger Sub, Inc., dated as
of December 21, 2009 (filed herewith as part of
Annex A)
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3
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.1
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Restated Certificate of Incorporation(1)
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3
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.2
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Amended and Restated Bylaws(2)
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4
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.1
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Form of Common Stock Certificate(3)
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5
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.1
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Opinion of Goodwin Procter LLP regarding the legality of the
securities**
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8
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.1
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Opinion of Goodwin Procter LLP regarding tax matters**
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II-2
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Exhibit Number
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Description
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10
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.1
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Form of Indemnification Agreement(4)*
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10
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.2
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La Jolla Pharmaceutical Company 1994 Stock Incentive Plan
(Amended and Restated as of May 16, 2003)(6)*
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10
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.3
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La Jolla Pharmaceutical Company 1995 Employee Stock
Purchase Plan (Amended and Restated as of June 20,
2008)(12)*
|
|
10
|
.4
|
|
La Jolla Pharmaceutical Company 2004 Equity Incentive Plan
(Amended and Restated as of June 20, 2008)(12)*
|
|
10
|
.5
|
|
Form of Option Grant under the La Jolla Pharmaceutical
Company 2004 Equity Incentive Plan(7)*
|
|
10
|
.6
|
|
Amended and Restated Employment Agreement, dated
February 23, 2006, by and between the Company and Josefina
Elchico(1)*
|
|
10
|
.7
|
|
Amended and Restated Employment Agreement, dated
February 23, 2006, by and between the Company and Gail
Sloan(1)*
|
|
10
|
.8
|
|
Employment Agreement, dated March 15, 2006, by and between
the Company and Deirdre Y. Gillespie, M.D.(8)*
|
|
10
|
.9
|
|
Separation Agreement, dated March 17, 2006, by and between
the Company and Steven B. Engle(8)*
|
|
10
|
.10
|
|
Employment Offer Letter, dated July 10, 2006 and executed
July 14, 2006, by and between the Company and Michael
Tansey, M.D.(10)*
|
|
10
|
.11
|
|
Employment Agreement, dated December 4, 2006, by and
between the Company and Michael Tansey, M.D.(9)*
|
|
10
|
.12
|
|
Amendment to Chief Executive Officer Employment Agreement(5)*
|
|
10
|
.13
|
|
Promissory Note, dated as of December 31, 2007, between the
Company and General Electric Capital Corporation(13)
|
|
10
|
.14
|
|
Employment Agreement, dated March 4, 2008, by and between
the Company and Luke Seikkula(11)*
|
|
10
|
.15
|
|
Form of Warrant Agreement(14)
|
|
10
|
.16
|
|
Employment Agreement, dated March 4, 2008, by and between
the Company and Lisa
Koch-Hulle(15)*
|
|
10
|
.17
|
|
Underwriting Agreement, dated as of May 6, 2008, between
the Company and UBS Securities, LLC and Canaccord Adams, Inc.(14)
|
|
10
|
.18
|
|
First Amendment to Employment Agreement, dated December 24,
2008, by and between the Company and Gail Sloan.(15)*
|
|
10
|
.19
|
|
First Amendment to Employment Agreement, dated December 24,
2008, by and between the Company and Niv Caviar.(15)*
|
|
10
|
.20
|
|
First Amendment to Employment Agreement, dated December 26,
2008, by and between the Company and Vicki Motte.(15)*
|
|
10
|
.21
|
|
First Amendment to Employment Agreement, dated December 26,
2008, by and between the Company and Luke Seikkula.(15)*
|
|
10
|
.22
|
|
First Amendment to Employment Agreement, dated December 29,
2008, by and between the Company and Josefina Elchico.(15)*
|
|
10
|
.23
|
|
First Amendment to Employment Agreement, dated December 29,
2008, by and between the Company and Lisa Koch-Hulle.(15)*
|
|
10
|
.24
|
|
First Amendment to Employment Agreement, dated December 30,
2008, by and between the Company and Michael Tansey.(15)*
|
|
10
|
.25
|
|
First Amendment to Employment Agreement, dated December 31,
2008, by and between the Company and Deirdre Gillespie.(15)*
|
|
10
|
.26
|
|
Development and Commercialization Agreement, dated as of
January 4, 2009, by and between the Company and BioMarin CF
Limited(18)
|
II-3
|
|
|
|
|
Exhibit Number
|
|
Description
|
|
|
10
|
.27
|
|
Securities Purchase Agreement, dated as of January 4, 2009,
by and between the Company and BioMarin Pharmaceutical Inc.(18)
|
|
10
|
.28
|
|
Amendment No. 1 to Development and Commercialization
Agreement, dated as of January 4, 2009, by and between the
Company and BioMarin CF Limited(18)
|
|
10
|
.29
|
|
Amendment No. 1 to Securities Purchase Agreement, dated as
of January 4, 2009, by and between the Company and BioMarin
Pharmaceutical Inc.(18)
|
|
10
|
.30
|
|
Retention and Separation Agreement and General Release of All
Claims, dated December 4, 2009, by and between the Company
and Deirdre Y. Gillespie, M.D.(16)*
|
|
10
|
.31
|
|
Retention and Separation Agreement and General Release of All
Claims, dated December 4, 2009, by and between the Company
and Gail A. Sloan(16)*
|
|
10
|
.32
|
|
Form of Voting Agreement(16)
|
|
21
|
.1
|
|
Subsidiaries of La Jolla Pharmaceutical Company(19)
|
|
23
|
.1
|
|
Consent of Ernst & Young LLP, Independent Registered Public
Accounting Firm**
|
|
23
|
.2
|
|
Consent of Goldstein Lewin & Co., Independent Registered
Public Accounting Firm**
|
|
23
|
.3
|
|
Consent of Goodwin Procter LLP (included in Exhibits 5.1
and 8.1 hereto)**
|
|
24
|
.1
|
|
Power of Attorney(19)
|
|
99
|
.1
|
|
Form of Proxy Card for the La Jolla Pharmaceutical Company
Special Meeting(19)
|
|
99
|
.2
|
|
Form of Proxy Card for the Adamis Pharmaceuticals Corporation
Special Meeting(19)
|
|
99
|
.3
|
|
Consent of Dennis J. Carlo(19)
|
|
99
|
.4
|
|
Consent of David J. Marguglio(19)
|
|
99
|
.5
|
|
Consent of Richard L. Aloi(19)
|
|
|
|
* |
|
This exhibit is a management contract or compensatory plan or
arrangement. |
|
|
** |
|
Filed herewith. |
|
|
|
(1) |
|
Previously filed with the Companys Current Report on
Form 8-K
filed March 1, 2006 and incorporated by reference herein. |
|
|
|
(2) |
|
Previously filed with the Companys Quarterly Report on
Form 10-Q
for the quarter ended September 30, 2000 and incorporated
by reference herein. |
|
|
(3) |
|
Previously filed with the Companys Registration Statement
on
Form S-3
(Registration
No. 333-131246)
filed January 24, 2006 and incorporated by reference herein. |
|
|
(4) |
|
Previously filed with the Companys Quarterly Report on
Form 10-Q
for the quarter ended September 30, 2005 and incorporated
by reference herein. |
|
|
(5) |
|
Previously filed with the Companys Quarterly Report on
Form 10-Q for the quarter ended June 30, 2007 and
incorporated by reference herein. |
|
|
(6) |
|
Previously filed with the Companys Quarterly Report on
Form 10-Q
for the quarter ended June 30, 2003 and incorporated by
reference herein. |
|
|
(7) |
|
Previously filed with the Companys Annual Report on
Form 10-K
for the year ended December 31, 2004 and incorporated by
reference herein. |
|
|
(8) |
|
Previously filed with the Companys Current Report on
Form 8-K
filed March 20, 2006 and incorporated by reference herein. |
|
|
(9) |
|
Previously filed with the Companys Annual Report on
Form 10-K
for the fiscal year ended December 31, 2006 and
incorporated by reference herein. |
|
|
(10) |
|
Previously filed with the Companys Current Report on
Form 8-K
filed July 18, 2006 and incorporated by reference herein. |
|
|
(11) |
|
Previously filed with the Companys Current Report on
Form 8-K
filed March 4, 2008 and incorporated by reference herein. |
II-4
|
|
|
(12) |
|
Previously filed with the Companys Registration Statement
on
Form S-8
(Registration
No. 333-151825)
filed June 20, 2008 and incorporated by reference herein. |
|
(13) |
|
Previously filed with the Companys Annual Report on
Form 10-K
for the fiscal year ended December 31, 2007 and
incorporated by reference herein. |
|
(14) |
|
Previously filed with the Companys Current Report on
Form 8-K
filed May 7, 2008 and incorporated by reference herein. |
|
(15) |
|
Previously filed with the Companys Annual Report on
Form 10-K
for the fiscal year ended December 31, 2008 and
incorporated by reference herein. |
|
(16) |
|
Previously filed with the Companys Current Report on
Form 8-K
filed December 7, 2009 and incorporated by reference herein. |
|
(17) |
|
Previously filed with the Companys Current Report on
Form 8-K
filed December 7, 2009 and filed herewith as Annex A. |
|
(18) |
|
Previously filed with the Companys Quarterly Report on
Form 10-Q
filed May 18, 2009 and incorporated by reference herein. |
|
|
|
(19) |
|
Previously filed with the Companys Registration Statement
on Form S-4 filed December 22, 2009 and incorporated by
reference herein. |
(A) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are
being made, a post-effective amendment to this registration
statement:
(i) To include any prospectus required by
Section 10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events
arising after the effective date of the registration statement
(or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement.
Notwithstanding the foregoing, any increase or decrease in
volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered)
and any deviation from the low or high end of the estimated
maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to
Rule 424(b) if, in the aggregate, the changes in volume and
price represent no more than 20 percent change in the
maximum aggregate offering price set forth in the
Calculation Registration Fee table in the effective
registration statement;
(iii) To include any material information with respect to
the plan of distribution not previously disclosed in the
registration statement or any material change to such
information in the registration statement;
(2) That, for the purpose of determining any liability
under the Securities Act of 1933, each such post-effective
amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of
such securities at that time shall be deemed to be the initial,
bona fide offering thereof.
(3) To remove from registration by means of a
post-effective amendment any of the securities being registered
which remain unsold at the termination of the offering.
(B) The undersigned registrant hereby undertakes that, for
purposes of determining any liability under the Securities Act,
each filing of the registrants annual report pursuant to
Sections 13(a) or 15(d) of the Exchange Act (and, where
applicable, each filing of an employee benefit plans
annual report pursuant to Section 15(d) of the Exchange
Act) that is incorporated by reference in the registration
statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of
such securities at that time shall be deemed to be the initial
bona fide offering thereof.
II-5
(C)(1) The undersigned registrant hereby undertakes as follows:
that prior to any public reoffering of the securities registered
hereunder through use of a prospectus which is part of this
registration statement, by any person or party who is deemed to
be an underwriter within the meaning of Rule 145(c), the
issuer undertakes that such reoffering prospectus will contain
the information called for by the applicable registration form
with respect to reofferings by persons who may be deemed
underwriters, in addition to the information called for by the
other items of the applicable form.
(2) The registrant undertakes that every prospectus:
(i) that is filed pursuant to paragraph
(1) immediately preceding, or (ii) that purports to
meet the requirements of Section 10(a)(3) of the Securities
Act and is used in connection with an offering of securities
subject to Rule 415, will be filed as part of an amendment to
the registration statement and will not be used until such
amendment is effective, and that, for purposes of determining
any liability under the Securities Act, each such post-effective
amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of
such securities at that time shall be deemed to be the initial
bona fide offering thereof.
(D) Insofar as indemnification for liabilities arising
under the Securities Act may be permitted to directors, officers
and controlling persons of the registrant pursuant to the
foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the SEC such indemnification is
against public policy as expressed in the Securities Act and is,
therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment
by the registrant of expenses incurred or paid by a director,
officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in
connection with the securities being registered, the registrant
will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the Securities Act and will be governed by the final
adjudication of such issue.
(E) The undersigned registrant hereby undertakes to respond
to requests for information that is incorporated by reference in
the prospectus pursuant to Items 4, 10(b), 11, or 13 of
this form, within one business day of receipt of such request,
and to send the incorporated documents by first class mail or
other equally prompt means. This includes information contained
in documents filed subsequent to the effective date of the
registration statement through the date of responding to the
request.
(F) The undersigned registrant hereby undertakes to supply
by means of a post-effective amendment all information
concerning a transaction, and the company being acquired
involved therein, that was not the subject of and included in
the registration statement when it became effective.
II-6
SIGNATURES
Pursuant to the requirements of the Securities Act, the
registrant has duly caused this Registration Statement to be
signed on its behalf by the undersigned, thereunto duly
authorized, in the City of San Diego, California, on
January 15, 2010.
LA JOLLA PHARMACEUTICAL COMPANY
|
|
|
|
By:
|
/s/ DEIRDRE
Y. GILLESPIE, M.D.
|
Name: Deirdre Y.
Gillespie, M.D.
|
|
|
|
Title:
|
President and Chief Executive Officer
|
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons
in the capacities and on the dates indicated.
|
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
|
/s/ Deirdre
Y. Gillespie, M.D.
Deirdre
Y. Gillespie, M.D.
|
|
Principal Executive Officer
|
|
January 15, 2010
|
|
|
|
|
|
/s/ Gail
A. Sloan
Gail
A. Sloan
|
|
Principal Financial officer and
Principal Accounting Officer
|
|
January 15, 2010
|
|
|
|
|
|
*
Robert
A. Fildes, Ph.D.
|
|
Director
|
|
January 15, 2010
|
|
|
|
|
|
*
Steven
M. Martin
|
|
Director
|
|
January 15, 2010
|
|
|
|
|
|
*
Craig
R. Smith, M.D.
|
|
Director
|
|
January 15, 2010
|
|
|
|
|
|
*
Frank
E. Young, M.D., Ph.D.
|
|
Director
|
|
January 15, 2010
|
|
|
* : |
/s/ Deirdre Y. Gillespie, M.D.
|
Attorney-in-fact
II-7