EXHIBIT 1.1
ISTA PHARMACEUTICALS,
INC.
2,500,000 SHARES
COMMON STOCK
($.001 PAR VALUE PER
SHARE)
PLACEMENT AGENCY
AGREEMENT
Dated August 5,
2004
TABLE OF CONTENTS
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Page
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1. Agreement to Act as
Placement Agents
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2
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2. Payment and
Delivery
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3
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3. Representations and
Warranties of the Company
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3
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3.1. Effective
Registration Statement
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3
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3.2. Contents of
Registration Statement
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4
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3.3. Incorporated
Documents
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4
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3.4. Due
Incorporation
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4
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3.5.
Subsidiary
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5
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3.6. Placement Agency
Agreement
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5
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3.7. Description of
Capital Stock
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5
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3.8. Authorized
Stock
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5
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3.9. Validly Issued
Shares
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5
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3.10. No Breach
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5
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3.11. No Conflict
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6
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3.12. Authorization
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6
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3.13. Legal Proceedings;
Exhibits
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6
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3.14. Compliance with Act
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6
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3.15. Warrants and
Options
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7
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3.16. No Registration or Other
Rights
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7
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3.17. Offering
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7
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3.18. Price Stabilization and
Manipulation
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7
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3.19. Broker/Dealer
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7
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3.20. Legal, Tax, Accounting
Advice
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7
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3.21. Agreements
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7
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3.22. No Relationship
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8
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3.23. Not an Investment
Company
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8
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3.24. Compliance with Environmental
Laws
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8
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3.25. Regulatory
Compliance
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8
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3.26. Absence of Material
Changes
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9
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3.27. Collaboration
Agreements
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9
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3.28. Good Title to
Properties
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9
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3.29. Intellectual Property
Rights.
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9
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3.30. No Labor Disputes
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12
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3.31. Insurance
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12
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3.32. Governmental
Permits
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12
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3.33. No Unlawful
Payments
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12
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3.34. Accounting Controls
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12
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3.35. Financial
Statements
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13
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3.36. Accountants
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13
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3.37. Taxes
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13
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3.38. Books and Records
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13
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3.39. Listing of Common
Stock
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14
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TABLE OF CONTENTS
(continued)
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Page
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3.40. Lock-Up
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14
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3.41. Share Certificates
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14
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3.42. Bona Fide Independent
Market
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14
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4. Covenants of the
Company
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14
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4.1. Furnish Copies of
Registration Statement and Prospectus
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14
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4.2. Notification of
Amendments or Supplements
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15
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4.3. Reports
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15
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4.4. Continued
Compliance with Securities Laws
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15
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4.5. Blue Sky
Laws
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16
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4.6. Earnings
Statement
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16
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4.7. Use of
Proceeds
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16
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4.8. Listing
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16
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4.9. Transfer
Agent
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16
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4.10. Exchange Act
Compliance
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16
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4.11. Market Standoff
Provision
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16
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5. Conditions to the
Placement Agents’ Obligations
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17
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5.1. Effective
Registration Statement
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17
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5.2. Prospectus Filed
with Commission
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17
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5.3. No Stop
Order
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17
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5.4. No NASD
Objection
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17
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5.5. No Material Adverse
Change
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17
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5.6. Officer’s
Certificate
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18
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5.7. Opinion of Company
Counsel
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18
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5.8. Opinion of
Placement Agents’ Counsel
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18
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5.9. Accountant’s
Comfort Letter
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18
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5.10. Lock-Up Agreements
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18
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5.11. Additional
Documents
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18
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6. Expenses
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18
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7. Indemnity and
Contribution.
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19
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7.1. Indemnification of
the Placement Agents by the Company
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19
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7.2. Indemnification by
the Placement Agents
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20
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7.3. Indemnification
Procedures
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20
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7.4. Contribution
Agreement
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21
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7.5. Contribution
Amounts
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22
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7.6. Survival of
Provisions
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22
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8.
Effectiveness
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22
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9.
Termination
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23
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TABLE OF CONTENTS
(continued)
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Page
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10. Counterparts
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23
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11. Headings; Table of
Contents
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23
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12. Notices
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24
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13. Successors
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25
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14. Partial
Unenforceability
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26
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15. Governing Law
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26
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16. Consent to
Jurisdiction
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26
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17. Waiver of Immunity
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26
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18. Entire Agreement
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26
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19. Amendments
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26
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20. Sophisticated
Parties
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27
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-iii-
August 5, 2004
PLACEMENT AGENCY
AGREEMENT
Banc of America Securities LLC
9 West 57 th Street, 40 th Floor
New York, New York 10019
Thomas Weisel Partners LLC
One Montgomery Street, Suite 3700
San Francisco, California 94104
Lazard Frères & Co. LLC
30 Rockefeller Plaza
New York, New York 10020
C.E. Unterberg, Towbin LLC
350 Madison Avenue
New York, New York 10017
Ladies and Gentlemen:
ISTA Pharmaceuticals, Inc., a
Delaware corporation (the “Company”), proposes to issue
and sell to certain investors (collectively, the
“Investors”) a minimum of 1,250,000 shares of its
Common Stock, $.001 par value per share (the “Common
Stock”) (the “Minimum Shares”), and a maximum of
2,500,000 shares of Common Stock (the “Maximum
Shares”). The shares of Common Stock to be issued are
hereinafter referred to as the “Shares”. The Company
desires to engage Banc of America Securities LLC
(“BofA”) and Thomas Weisel Partners LLC
(“TWP” and, together with BofA, the
“Representatives”), Lazard Frères & Co. LLC
and C.E. Unterberg, Towbin LLC (collectively, with BofA and TWP,
the “Placement Agents”) as its exclusive placement
agents in connection with such issuance and sale. The Shares are
described in the Prospectus that is referred to below.
The Company has prepared and filed,
in accordance with the provisions of the Securities Act of 1933, as
amended, and the rules and regulations thereunder (collectively,
the “Act”), with the Securities and Exchange Commission
(the “Commission”) a registration statement under the
Act on Form S-3 (File No. 333-114815) (the “registration
statement”). The registration statement has been declared by
the Commission to be effective under the Act. The Company will next
file with the Commission pursuant to Rule 424(b) under the Act a
final prospectus supplement describing the offering of the Shares,
in such form as has been provided to, discussed with, and approved,
by the Placement Agents.
The term “Registration
Statement” as used in this Agreement means the registration
statement at the time it became effective and as supplemented or
amended prior to the execution of this Agreement, including (i) all
financial schedules and exhibits thereto and (ii) all documents
incorporated by reference or deemed to be incorporated by reference
therein. The term “Basic
-1-
Prospectus” as used in this Agreement
means the prospectus dated as of May 18, 2004 that is part of
the registration statement. The term “Prospectus
Supplement” as used in this Agreement means the final
prospectus supplement specifically relating to the Shares, in the
form filed with, or transmitted for filing to, the Commission
pursuant to Rule 424 under the Act. The term
“Prospectus” as used in this Agreement means the Basic
Prospectus together with the Prospectus Supplement except that if
such Basic Prospectus is amended or supplemented on or prior to the
date on which the Prospectus Supplement was first filed pursuant to
Rule 424(b), the term “Prospectus” shall refer to the
Basic Prospectus as so amended or supplemented and as supplemented
by the Prospectus Supplement. Any reference herein to the
registration statement, the Registration Statement, the Basic
Prospectus, any Prospectus Supplement or the Prospectus shall be
deemed to refer to and include (i) the documents incorporated by
reference therein pursuant to Form S-3 (the “Incorporated
Documents”) and (ii) the copy of the Registration Statement,
the Basic Prospectus, the Prospectus Supplement, the Prospectus or
the Incorporated Documents filed with the Commission pursuant to
its Electronic Data Gathering, Analysis and Retrieval system
(“EDGAR”) and, in the case of the Basic Prospectus, the
Prospectus Supplement and the Prospectus, such document in the form
first delivered to the Placement Agents for use in connection with
the offering of the Shares. Any reference herein to the terms
“amend,” “amendment” or
“supplement” with respect to the Registration
Statement, the Basic Prospectus, the Prospectus Supplement or the
Prospectus shall be deemed to refer to and include the filing of
any document under the Securities Exchange Act of 1934, as amended,
and the rules and regulations thereunder (collectively, the
“Exchange Act”) after the effective date of the
Registration Statement (in the case of the Registration Statement
and the Basic Prospectus), or the date of the Prospectus Supplement
(in the case of the Prospectus Supplement and the Prospectus), as
the case may be, deemed to be incorporated therein by reference. As
used herein, “business day” shall mean a day on which
the New York Stock Exchange (the “NYSE”) is open for
trading.
The Company hereby confirms its
agreement with the Placement Agents as follows:
1.
Agreement to Act as Placement Agents . Upon the basis of the
representations and warranties of the Company and subject to the
terms and conditions set forth in this Agreement, the Company
engages the several Placement Agents to act as its exclusive
placement agents, on a best efforts basis, in connection with the
offer and sale by the Company of Shares to the Investors. Subject
to the terms and conditions set forth herein, offers for the
purchase of Shares may be solicited by the Placement Agents as
agent for the Company at such times and in such amounts as the
Placement Agents shall deem advisable. The Company shall have the
sole right to accept offers to purchase the Shares and may reject
any such offer, in whole or in part.
As compensation for services
rendered, at the time of purchase (as defined below) the Company
shall pay to the Placement Agents, by Federal Funds wire transfer
to an account or accounts designated by the Placement Agents, an
amount equal to 6% of the gross proceeds received by the Company in
respect of the sale of the Shares (the “Fee”), with 42%
of the Fee payable to Banc of America Securities LLC, 37% of the
Fee payable to Thomas Weisel Partners LLC, 16% of the Fee payable
to Lazard Frères & Co. LLC and 5% of the Fee payable to
C.E. Unterberg, Towbin LLC. The Shares are being sold at a price of
$8.50 per share. The Placement Agents may retain other brokers or
dealers to act as subagents on their behalf in connection with the
offering
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and sale of the Shares. Anything in this
Agreement to the contrary notwithstanding, the obligations of the
Placement Agents under this Agreement are several and not
joint.
This Agreement shall not give rise
to any commitment by the Placement Agents or any of their
affiliates to underwrite or purchase any of the Shares or otherwise
provide any financing, and the Placement Agents shall have no
authority to bind the Company in respect of the sale of any Shares.
The sale of the Shares shall be made pursuant to purchase
agreements in the form included as Exhibit A hereto (the
“Purchase Agreements”).
2.
Payment and Delivery . Subject to the terms and conditions
hereof, payment of the purchase price for, and delivery of
certificates for, the Shares shall be made at the office of
Stradling Yocca Carlson & Rauth a Professional Corporation (or
at such other place as shall be agreed upon by the Placement Agents
and the Company), at 10:00 A.M., New York City time, on August 11,
2004 (unless another time shall be agreed to by the Placement
Agents and the Company). Subject to the terms and conditions
hereof, payment of the purchase price for the Shares shall be made
to the Company by Federal Funds wire transfer, against delivery of
certificates for the Shares, through the facilities of The
Depository Trust Company (“DTC”), to such persons, and
shall be registered in such name or names and shall be in such
denominations, as the Placement Agents may request at least one
business day before the time of purchase (as defined below).
Payment of the purchase price for the Shares shall be made at the
time of purchase by the purchasers thereof directly to the Company.
Notwithstanding anything herein or in any Purchase Agreement to the
contrary, no Shares which the Company has agreed to sell pursuant
to this Agreement or any Purchase Agreement shall be deemed to have
been purchased and paid for, or sold by the Company, until such
Shares shall have been delivered to the purchaser thereof and
payment of the purchase price therefore has been received by the
Company. The time at which such payment and delivery are to be made
is hereinafter sometimes called “the time of purchase.”
Electronic transfer of the Shares shall be made at the time of
purchase in such names and in such denominations as the Placement
Agents shall specify.
Deliveries of the documents described in Section
6 hereof with respect to the purchase of the Shares shall be made
at the offices of Stradling Yocca Carlson & Rauth a
Professional Corporation, at 9:00 A.M., New York City time, on the
date of the closing of the purchase of the Shares.
3.
Representations and Warranties of the Company . The Company
represents and warrants to and agrees with each of the Placement
Agents, as of the date hereof, that:
3.1.
Effective Registration Statement. The Company meets the
requirements for the use of Form S-3 under the Act and the offering
of the Shares complies with Rule 415 under the Act. The
Registration Statement has become effective under the Act; no stop
order suspending the effectiveness of the Registration Statement or
providing or suspending the use of the Basic Prospectus, the
Prospectus Supplement or the Prospectus is in effect, and no
proceedings for such purpose are pending before or, to the
Company’s knowledge, threatened by the Commission. Any
required filing of the Prospectus and any supplement thereto
pursuant to Rule 424 (b) of the Act has been and will be made in
the manner and within the time period required by such Rule
424(b).
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3.2.
Contents of Registration Statement . (i) The Registration
Statement, when it became effective, did not contain and, as
amended or supplemented, if applicable, will not contain any untrue
statement of a material fact or omit to state a material fact
required to be stated therein or necessary to make the statements
therein not misleading, (ii) the Registration Statement complied
when it became effective, complies and, as amended or supplemented,
if applicable, will comply and the Prospectus complies and, as
amended or supplemented, if applicable, will comply in all material
respects with the Act and the applicable rules and regulations of
the Commission thereunder and (iii) the Prospectus does not contain
and, as amended or supplemented, if applicable, will not contain
any untrue statement of a material fact or omit to state a material
fact necessary to make the statements therein, in the light of the
circumstances under which they were made, not misleading, except
that the representations and warranties set forth in this paragraph
do not apply to statements or omissions in the Registration
Statement or the Prospectus based upon information relating to any
Placement Agent furnished to the Company in writing by such
Placement Agent through the Representatives expressly for use
therein. The Chief Executive Office and the Chief Financial Officer
of the Company have signed, and the Company has furnished to the
Commission, all certifications required by Section 906 of the
Sarbanes-Oxley Act of 2002; such certifications contain no
qualifications or exceptions to the matters certified therein and
have not been modified or withdrawn; and neither the Company nor
any of its officers has received notice from any governmental
entity questioning or challenging the accuracy, completeness, form
or manner of filing or submission of such certifications. The
Company’s Subsidiary is not required to file any forms,
reports or other documents with the Commission.
3.3.
Incorporated Documents . The documents incorporated or
deemed to be incorporated by reference in the Registration
Statement and the Prospectus, at the time they became effective or
were or hereafter are filed with the Commission, complied and will
comply in all material respects with the requirements of the Act
and the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), and at the time the Registration
Statement and any amendments thereto become effective, when read
together with the other information in the Prospectus, and at the
time of purchase, did not, do not and will not contain an untrue
statement of a material fact or omit to state a material fact
required to be stated therein or necessary to make the statements
therein, in the light of the circumstances under which they were
made, not misleading.
3.4. Due
Incorporation . The Company has been duly incorporated, is
validly existing as a corporation in good standing under the laws
of the State of Delaware, has the corporate power and authority to
own, lease and operate its property and to conduct its business as
described in the Prospectus and is duly qualified to transact
business and is in good standing in each jurisdiction in which the
conduct of its business as described in the Prospectus or its
ownership, operation or leasing of property requires such
qualification, except to the extent that the failure to be so
qualified or be in good standing would not cause a material adverse
change, in the business, properties, assets, results of operations,
condition (financial or otherwise) or operations of the Company,
whether or not arising in the ordinary course of business, other
than changes that affect the specialty pharmaceutical industry
generally (a ”Material Adverse Effect”).
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3.5.
Subsidiary . The subsidiary of the Company, VisionEx
(VISIONEX PTE, LTD.) (the “Subsidiary”), has been duly
incorporated, is validly existing as a corporation in good standing
under the laws of the jurisdiction of its incorporation, has the
corporate power and authority to own, lease and operate its
properties and to conduct its business and is duly qualified to
transact business and is in good standing in each jurisdiction in
which the conduct of its business or its ownership, operation or
leasing of property requires such qualification, except to the
extent that the failure to be so qualified or be in good standing
would not have a Material Adverse Effect. All of the issued shares
of capital stock of the Subsidiary have been duly and validly
authorized and issued, are fully paid and non-assessable and are
owned directly by the Company, free and clear of any security
interest, mortgage, pledge, lien, encumbrance, claim or equity;
there is no outstanding option, right or agreement of any kind
relating to the issuance, sale or transfer of any capital stock or
other equity securities of the Subsidiary to any person except the
Company, none of the outstanding shares of capital stock of the
Subsidiary was issued in violation of preemptive or similar rights.
The Subsidiary does not constitute a “significant
Subsidiary” as defined in Rule 1-02(w) of Regulation S-X
promulgated under the Exchange Act.
3.6.
Placement Agency Agreement . The Company has full legal
right, power and authority to enter into and perform this Agreement
and to consummate the transactions contemplated herein. This
Agreement has been duly authorized, executed and delivered by the
Company, and is a valid and binding agreement of the Company,
enforceable in accordance with its terms, except as rights to
indemnification or contribution hereunder may be limited by
applicable law and except as the enforcement hereof may be limited
by bankruptcy, insolvency, reorganization, moratorium or other
similar laws relating to or affecting the rights and remedies of
creditors or by general equitable principles.
3.7.
Description of Capital Stock . The authorized capital stock
of the Company, including the Shares, conforms as to legal matters
to the description thereof contained in the Registration Statement
and the Prospectus.
3.8.
Authorized Stock . As of the date of this Agreement, the
Company has, and at the time of purchase will have, an authorized
capitalization not materially different from that which is set
forth in the Registration Statement and the Prospectus under the
heading “Capitalization.” All of the issued and
outstanding shares of capital stock of the Company have been duly
and validly authorized and issued and are fully paid and
non-assessable, have been issued in compliance with all applicable
laws (including, but not limited to, federal and state securities
laws) and were not issued in violation of any preemptive right,
resale right, right of first refusal or similar right.
3.9.
Validly Issued Shares . The Shares to be sold by the Company
have been duly authorized and, when issued and delivered against
payment therefor as provided herein and in the Purchase Agreements,
will be validly issued, fully paid and non-assessable, and the
issuance of such Shares will not be subject to any preemptive or
similar rights. No holder of the Shares will be subject to personal
liability by reason of being such a holder.
3.10. No
Breach . Except as described in the Prospectus, the Company is
not in breach of, or in default (nor has any event occurred which
with notice, lapse of time, or both would result in any breach of,
or constitute a default) (i) under its certificate of incorporation
or
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by-laws or (ii) in the performance or observance
of any obligation, agreement, covenant or condition contained in
any license, indenture, mortgage, deed of trust, bank loan or
credit agreement or other evidence of indebtedness, or any lease,
contract or other agreement or instrument to which the Company is a
party or by which it or any of its properties is bound which, with
respect to clause (ii) above, would reasonably be expected to
result in a Material Adverse Effect.
3.11. No
Conflict . The execution and delivery by the Company of, and
the performance by the Company of its obligations under, this
Agreement (including, without limitation, the issuance and sale of
the Shares and the consummation of the transactions contemplated
hereby) will not contravene or result in any breach of or
constitute a default or give rise to a right to accelerate the due
date of any payment due under any provision of applicable law or
the certificate of incorporation or by-laws of the Company or any
agreement or other instrument binding upon the Company incorporated
or deemed to be incorporated by reference in the Registration
Statement, or any judgment, order or decree of any governmental
body, agency or court having jurisdiction over the
Company.
3.12.
Authorization . No approval, authorization, consent or order
of or filing with any federal, state, local or foreign governmental
or regulatory commission, board, body, authority or agency or of or
with the NASDAQ, or approval of the shareholders of the Company, is
required in connection with (i) the execution, delivery and
performance by the Company of this Agreement and the consummation
of the transactions contemplated hereby or (ii) the sale and
delivery of the Shares being sold by the Company, other than (x)
such as have been obtained, or will have been obtained as of the
time of purchase, under the Act or the Exchange Act, (y) such
approvals as have been obtained in connection with the approval of
the listing of the Shares on the Nasdaq National Market System and
(z) any necessary qualification under the securities or blue sky
laws of the various jurisdictions in which the Shares are being
offered under the terms of this Agreement.
3.13.
Legal Proceedings; Exhibits . There are no legal or
governmental proceedings pending or, to the Company’s
knowledge, threatened to which the Company or the officers or
directors of the Company (in their capacity as officers or
directors, as the case may be), is a party, or to which any of the
properties of the Company is subject, that might result in a
Material Adverse Effect or materially and adversely affect the
consummation of the transactions contemplated in this Agreement or
the performance by the Company of its obligations hereunder, that
are required to be described in the Registration Statement or the
Prospectus and are not so described or any statutes, regulations,
contracts or other documents that are required to be described or
incorporated by reference in the Registration Statement or the
Prospectus or to be filed or incorporated by reference as exhibits
to the Registration Statement that are not described or filed or
incorporated as required. The Company is not subject to any
judgment order or decree that materially restricts its business
practices or its ability to acquire any property or conduct its
business as described in the Prospectus in any area.
3.14.
Compliance with Act . Each preliminary prospectus filed as
part of the registration statement as originally filed or as part
of any amendment thereto, or filed pursuant to Rule 424 under the
Act, complied when so filed in all material respects with the Act
and the applicable rules and regulations of the Commission
thereunder.
-6-
3.15.
Warrants and Options . Except as disclosed in the
Registration Statement and the Prospectus, there are no outstanding
(i) securities or obligations of the Company convertible into or
exchangeable for any capital stock of the Company; (ii) warrants,
rights or options to subscribe for or purchase from the Company any
such capital stock or any such convertible or exchangeable
securities or obligations; (iii) obligations of the Company to
issue any shares of capital stock, any such convertible or
exchangeable securities or obligation, or any such warrants, rights
or options; or (iv) contractual obligation of the Company to
repurchase, redeem or otherwise acquire any Shares of Common Stock
of the Company or to provide funds to make any investment in any
other person or entity.
3.16. No
Registration or Other Rights . There are no contracts,
agreements or understandings between the Company and any person or
entity granting such person or entity the right, contractual or
otherwise, to require the Company to issue to it or to file a
registration statement under the Act with respect to any securities
of the Company or to require the Company to include such securities
with the Shares registered pursuant to the Registration Statement
other than as described in the Registration Statement or as have
been waived in writing in connection with this offering. In
addition, no person or entity has preemptive rights, co-sale
rights, rights of first refusal or other rights to purchase any of
the Shares.
3.17.
Offering . In connection with this offering, the Company has
not offered and will not offer shares of its Common Stock or any
other securities convertible into or exchangeable or exercisable
for shares of Common Stock in a manner in violation of the Act; the
Company has not distributed and will not distribute any offering
material in connection with the offer and sale of the Shares, other
than the Prospectus, the Registration Statement and other materials
permitted by the Act.
3.18.
Price Stabilization and Manipulation . The Company and each
of its officers, directors and controlling persons has not taken,
and will not take, directly or indirectly, any action which is
designed to or which has constituted or which might reasonably be
expected to cause or result in stabilization or manipulation of the
price of any security of the Company to facilitate the sale or
resale of the Shares or which is otherwise proscribed by Regulation
M promulgated by the Commission.
3.19.
Broker/Dealer . The Company (i) is not required to register
as a “broker” or “dealer” in accordance
with the provisions of the Exchange Act or the regulations
promulgated thereunder, and (ii) directly, or indirectly through
one or more intermediaries, does not control any member firm of the
NASD.
3.20.
Legal, Tax, Accounting Advice . The Company has not relied
upon any of the Placement Agents or legal counsel to the Placement
Agents for any legal, tax or accounting advice in connection with
the offering and sale of the Shares.
3.21.
Agreements . All agreements between the Company and third
parties filed as exhibits to the Registration Statement,
incorporated or deemed to be incorporated by reference in the
Registration Statement or referenced in the Prospectus are legal,
valid and binding obligations of the Company, enforceable in
accordance with their respective terms, except to the
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extent enforceability may be limited by
bankruptcy, insolvency, reorganization, moratorium or similar laws
affecting creditors’ rights generally and by general
principles of equity.
3.22. No
Relationship . No relationship, direct or indirect, exists
between or among the Company, on the one hand, and the directors,
officers, stockholders, customers or suppliers of the Company, on
the other hand, which is required by the Act to be described in the
Registration Statement or the Prospectus that is not so
described.
3.23. Not
an Investment Company . The Company is not and, after giving
effect to the offering and sale of the Shares and the application
of the proceeds thereof as described in the Prospectus, will not be
an “investment company” or an entity
“controlled” by an “investment company” as
such term is defined in the Investment Company Act of 1940, as
amended.
3.24.
Compliance with Environmental Laws . The Company (i) is in
compliance in all material respects with any and all applicable
foreign, federal, state and local laws, orders, rules, regulations,
directives, decrees and judgments relating to the protection of
human health and safety, the environment or hazardous or toxic
substances or wastes, pollutants or contaminants
(“Environmental Laws”); (ii) has received all permits,
licenses or other approvals required of it under applicable
Environmental Laws, to conduct its business as described in the
Prospectus; and (iii) is in compliance with all terms and
conditions of any such permit, license or approval, except where
such noncompliance with Environmental Laws, failure to receive
required permits, licenses or other approvals or failure to comply
with the terms and conditions of such permits, licenses or
approvals would not, individually or in the aggregate, have a
Material Adverse Effect. There are no costs or liabilities
associated with Environmental Laws (including, without limitation,
any capital or operating expenditures required for clean-up and any
potential liabilities to third parties) which would, individually
or in the aggregate, have a Material Adverse Effect. To the
Company’s knowledge, there are no pending or threatened
administrative, regulatory or judicial actions, suits, demands,
demand letters, claims, liens, notices of noncompliance or
violation, investigation or proceedings relating to any
Environmental Law against the Company and there are no events or
circumstances that would reasonably be expected to form the basis
of an order for clean-up or remediation, or an action, suit or
proceeding by any private party or governmental body or agency,
against or affecting the Company or any of its predecessors in
interest relating to hazardous materials or any Environmental Laws.
No property that is or has been owned, leased or occupied by the
Company or its Subsidiary has been designated as a Superfund Site
pursuant to the Comprehensive Environmental Response, Compensation
of Liability Act of 1980, as amended (42 U.S.C. Section 9601, et.
seq. “CERCLA”) or otherwise designated as a
contaminated site under applicable state or local law and the
Company has not been named as a “potentially responsible
party” under CERCLA.
3.25.
Regulatory Compliance . The Company is conducting its
business in compliance with the Fair Labor Standards Act, the rules
and regulations of the United States Food and Drug Administration
(“FDA”), and all applicable federal, state and local
laws, orders, rules, regulations, directives, decrees and judgments
of each of the jurisdictions in which it is conducting business,
including, without limitation, all applicable local, state and
federal laws and regulations governing health, sanitation, safety,
zoning and land use, except where the failure to be so in
compliance would not have a Material Adverse Effect. To the
Company’s knowledge,
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there are no pending or threatened
administrative, regulatory or judicial actions, suits, demands,
demand letters, claims, liens, notices of noncompliance or
violation, investigation or proceedings before the FDA or other
federal, state, local or foreign governmental bodies that involve
or affect the Company that, if the subject of an action unfavorable
to the Company, would be reasonably likely to result in a Material
Adverse Effect.
3.26.
Absence of Material Changes . Subsequent to the respective
dates as of which information is given in the Registration
Statement and the Prospectus, (i) the Company has not incurred any
material liability or obligation, direct or contingent, nor entered
into any material transaction not in the ordinary course of
business; (ii) the Company has not purchased any of its outstanding
capital stock, nor declared, paid or otherwise made any dividend or
distribution of any kind on its capital stock; (iii) there has not
been any material change in the capital stock, short-term debt or
long-term debt of the Company, except in each case as described in
the Prospectus, (iv) there has not been any development, whether or
not arising in the ordinary course of business, that would
reasonably be expected to result in a Material Adverse Effect, and
(v) there has not been any material loss or interference with the
business of the Company from fire, explosion, flood or other
calamity, whether or not covered by insurance, or from any labor
dispute or court or governmental action, order or decree. The
Company does not have any material contingent obligation which is
not disclosed in the Registration Statement.
3.27.
Collaboration Agreements . The Company has not received any
written notice of the termination or threatened termination of any
consulting, licensing, marketing, research and development,
cooperative or any similar agreement filed as an exhibit to the
Registration Statement, incorporated or deemed to be incorporated
by reference in the Registration Statement, including without
limitation, the collaborative agreements listed under the sections
of the Company’s Annual Report on Form 10-K for the year
ended December 31, 2003 entitled,
“Business—Collaborations”.
3.28.
Good Title to Properties . The Company does not own any real
property. The Company has good and marketable title to all personal
property owned by it which is material to the business of the
Company as described in the Registration Statement and the
Prospectus, in each case free and clear of all liens, encumbrances
and defects except such as are described in the Registration
Statement and the Prospectus or such as are not reasonably expected
to result in a Material Adverse Effect, and do not interfere with
the use made and proposed to be made of such property by the
Company; and any real property and buildings held under lease by
the Company is held by it under valid, subsisting and enforceable
leases with such exceptions as are not reasonably expected to
result in a Material Adverse Effect, do not interfere with the use
made and proposed to be made of such property and buildings by the
Company.
3.29.
Intellectual Property Rights .
3.29.1. Trademarks. To
the Company’s knowledge, all Company trademark registrations,
that are used or are likely to be used in the business of the
Company as described in the Registration Statement and the
Prospectus, are currently in compliance in all material respects
with all legal requirements (including the timely post-registration
filing of affidavits of use and incontestability and renewal
applications) other than any requirement that, if not satisfied,
would not result in a cancellation of any such registration or
otherwise materially
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affect the priority and enforceability of the
Company trademark in question. To the Company’s knowledge, no
registered Company trademark, that is used or is likely to be used
in the business of the Company as described in the Registration
Statement and the Prospectus, is now involved in any opposition or
cancellation proceeding in the United States Patent and Trademark
Office. To the Company’s knowledge, there has been no prior
use of any material Company trademark by any third party that
confers upon said third party superior priority to register such
Company trademark.
3.29.2. Patents. To the
Company’s knowledge, all issued Company patents, that are
used or are likely to be used in the business of the Company as
described in the Registration Statement and the Prospectus, are
currently in compliance with legal requirements (including payment
of filing, examination, and maintenance fee and proofs of working
or use) other than any requirement that, if not satisfied, would
not result in a revocation or otherwise materially affect the
enforceability of the Company patent in question. To the
Company’s knowledge, no Company patent, that is used or is
likely to be used in the business of the Company as described in
the Registration Statement and the Prospectus, is now involved in
any interference, reissue, reexamination or opposing proceeding in
the United States Patent and Trademark Office. To the
Company’s knowledge, no such action has been threatened. To
the Company’s knowledge, there is no issued patent or patent
application of any person that invalidates any claim of any issued
Company patent, that is used or is likely to be used in the
business of the Company as described in the Registration Statement
and the Prospectus.
3.29.3. Trade
Secrets. The Company has taken reasonable steps in accordance with
normal industry practice to protect its rights in the
Company’s confidential information and trade secrets, the
secrecy of which is material to the business of the Company as
described in the Registration Statement and the Prospectus. Without
limiting the generality of the foregoing, the Company generally
enforces a policy of requiring each relevant employee, consultant
and contractor to execute agreements that contain provisions
designed to prevent unauthorized disclosure of the Company’s
confidential information and Company trade secrets. With respect to
employees, such agreements assign to the Company all rights to any
Intellectual Property (as defined below) relating to the
Company’s business as described in the Registration Statement
and the Prospectus that is developed by the employee in the course
of his or her activities as an employee of the Company. With
respect to contractors and consultants, the agreements either
assign all rights in Intellectual Property developed pursuant to
the agreement, which the Company determined at the time was
material to its business or license such rights on agreed-upon
terms. Except under confidentiality obligations, to the
Company’s knowledge, there has been no disclosure by the
Company of material confidential information or material trade
secrets of Company.
3.29.4. License
Agreements. Except as disclosed in the Registration Statement and
the Prospectus, to the Company’s knowledge, the Company is
not in breach or default (nor has any event occurred which with
notice, lapse of time, or both would result in any breach of, or
constitute a default) under any license agreements granting to the
Company any right to incorporate any Intellectual Property into any
commercial product of the Company (collectively, the “Inbound
License Agreements”) filed as an exhibit to the Registration
Statement or any document incorporated or deemed to be incorporated
by reference in the Registration Statement or the Prospectus or any
license agreements under which the Company
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licenses or grants a third party rights to
incorporate any rights under any Company Intellectual Property into
any commercial product of such third party (collectively, the
“Outbound License Agreements”) filed as an exhibit to
the Registration Statement or any document incorporated or deemed
to be incorporated by reference in the Registration Statement or
the Prospectus.
3.29.5. Ownership;
Sufficiency of Intellectual Property Assets. The Company owns or
possesses adequate licenses or other rights to use, free and clear
of liens, orders and arbitration awards, all of the material
patents, patent rights, licenses, inventions, copyrights
(registered and unregistered), know-how (including trade secrets
and other unpatented and/or unpatentable proprietary or
confidential information, systems or procedures), trademarks,
service marks and trade names (collectively, the
“Intellectual Property”) used in its business. The
Company’s Intellectual Property constitutes all the material
Intellectual Property rights used in the operation of the
Company’s business as described in the Registration Statement
and the Prospectus.
3.29.6. Protection of
Intellectual Property. The Company has taken reasonable steps to
protect the material Intellectual Property of the
Company.
3.29.7. No
Infringement or Prospective Infringement by the Company. To the
Company’s knowledge, none of the products manufactured,
marketed, used, sold or licensed by the Company and/or as
anticipated to be manufactured, marketed, used, sold or licensed by
the Company, and none of the Intellectual Property used by the
Company in the conduct of the Company’s business as described
in the Registration Statement and the Prospectus, infringes upon,
violates or constitutes the unauthorized use of any valid and
enforceable rights owned or controlled by any third
party.
3.29.8. No
Pending or Threatened Infringement Claims. No litigation to which
the Company is a party is now pending and, to the Company’s
knowledge, no notice or other claim in writing has been received by
the Company (i) alleging that the Company has engaged in any
activity or conduct that infringes upon, violates or constitutes
the unauthorized use of the Intellectual Property rights of any
third party or (ii) challenging the ownership, use, validity or
enforceability of any Intellectual Property owned by or exclusively
licensed to or by the Company. To the Company’s knowledge, no
Intellectual Property, that is used or is likely to be used in the
business of the Company as described in the Registration Statement
and the Prospectus (y) that is owned by the Company is subject to
any outstanding order, judgment, decree, stipulation or agreement
materially restricting the use, sale, transfer, assignment or
licensing thereof by the Company, except as may be specifically
provided in any such Outbound License Agreement or other licenses,
or (z) that is the subject of an Inbound License Agreement is, to
the Company’s knowledge, subject to any outstanding judgment,
decree, stipulation or agreement materially restricting the use,
sale, transfer, assignment or licensing thereof by the Company,
except as provided in the Inbound License Agreements or other
licenses or agreements.
3.29.9. No
Infringement by Third Parties. To the Company’s knowledge, no
third party is misappropriating, infringing, diluting or violating
any Intellectual Property owned by the Company, that is used or is
likely to be used in the business of the Company as
-11-
described in the Registration Statement and the
Prospectus, and no such claims have been brought against any third
party by the Company.
3.30. No
Labor Disputes . No material labor dispute with the employees
of the Company exists, or, to the Company’s knowledge, is
imminent; and the Company does not have knowledge of any existing,
threatened or imminent labor disturbance by the employees of any of
its principal suppliers, manufacturers or contractors that could
have a Material Adverse Effect.
3.31.
Insurance . The Company is insured by insurers of recognized
financial responsibility against such losses and risks and in such
amounts as are prudent and customary in the business in which it is
engaged; all policies insuring the Company are in full force and
effect and the Company is in compliance with the terms of such
policies in all material respects, and the Company has no reason to
believe that it will not be able to renew its existing insurance
coverage as and when such coverage expires or to obtain similar
coverage from similar insurers as may be necessary to continue its
business as described in the Registration Statement and the
Prospectus at a cost that would not have a Material Adverse
Effect.
3.32.
Governmental Permits . The Company possesses all
certificates, authorizations and permits issued by the appropriate
federal, state, local or foreign regulatory authorities (
“ Governmental Permits”) necessary to conduct
its business, including the ownership, operation or leasing of
property, and the Company is not in violation of, is not in default
under or has not received any notice of proceedings relating to the
possible revocation or modification of any such certificate,
authorization or permit which, individually or in the aggregate, if
the subject of an unfavorable decision, ruling or finding, would
have a Material Adverse Effect. All of the Governmental Permits are
valid and in full force and effect, except when the invalidity of
such Governmental Permits or the failure of such Governmental
Permits to be in full force and effect would not, singly or in the
aggregate, result in a Material Adverse Effect.
3.33. No
Unlawful Payments . Neither the Company, nor any other person
associated with or acting on behalf of the Company, including,
without limitation, any director, officer, agent or employee of the
Company, has, directly or indirectly, while acting on behalf of the
Company (i) used any corporate funds for unlawful contributions,
gifts, entertainment or other unlawful expenses relating to
political activity; (ii) made any unlawful payment to foreign or
domestic government officials or employees or to foreign or
domestic political parties or campaigns from corporate funds; (iii)
violated any provision of the Foreign Corrupt Practices Act of
1977, as amended; or (iv) made any other unlawful payment or
established or maintained any unlawful or unrecorded funds in
violation of Section 30A of the Exchange Act. The Company is in
compliance with the provisions of Section 13(b) of the Exchange
Act.
3.34.
Accounting Controls . The Company maintains a system of
internal accounting controls sufficient to provide reasonable
assurance that (i) transactions are executed in accordance with
management’s general or specific authorizations; (ii)
transactions are recorded as necessary to permit preparation of
financial statements in conformity with generally accepted
accounting principles and to maintain asset accountability; (iii)
access to assets is permitted only in accordance with
management’s 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. The Board of Directors of
the
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Company maintains an audit committee that meets
the listing standards imposed by the Nasdaq National Market for
companies whose stock is approved for quotation in that market and
the members of which are independent of the Company as required by
such listing standards. The audit committee meets regularly and has
reviewed with management and Ernst & Young, as appropriate, all
financial statements filed with the Commission from January 1, 2004
to the present.
3.35.
Financial Statements . The consolidated financial statements
of the Company included in the Registration Statement and the
Prospectus, together with related schedules and notes, present
fairly in all material respects the financial position of the
Company and its subsidiary as of the dates indicated and the
results of operations, stockholders’ equity, and cash flows
of the Company for the periods specified; such financial statements
have been prepared in conformity with generally accepted accounting
principles as applied in the United States and on a consistent
basis during the periods involved and in accordance with Regulation
S-X promulgated by the Commission; the financial statement
schedules included in the Registration Statement and the Prospectus
fairly present in all material respects the information required to
be shown therein; all requirements of Form S-3 and the Act and the
applicable rules and regulations of the Commission thereunder with
respect to financial statements and schedules to be included in the
Registration Statement and the Prospectus are satisfied in all
material respects; the selected financial data and the summary
financial information, if any, included in the Prospectus present
fairly the information shown therein and have been compiled on a
basis consistent with that of the audited financial statements
included in the Registration Statement; the pro forma financial
statements and other pro forma financial information, if any,
included in the Registration Statement and the Prospectus present
fairly the information shown therein, have been prepared in
accordance with the Commission’s rules and guidelines for pro
forma financial statements, have been properly compiled on the pro
forma bases set forth therein and, in the opinion of the Company,
the assumptions used in the preparation thereof are reasonable and
the adjustments used therein are appropriate to reflect the
transaction or circumstances referred to therein.
3.36.
Accountants . Ernst & Young, whose reports on the
financial statements of the Company are filed with the Commission
and are included in the Registration Statement and the Prospectus,
are and were, during the periods covered by such reports,
independent public accountants as required by the Act and the
applicable rules and regulations of the Commission
thereunder.
3.37.
Taxes . Except as described in the Registration Statement
and the Prospectus, the Company has filed on a timely basis all
material federal, state, local and foreign income and franchise tax
returns required to be filed through the date hereof and has paid
all taxes shown as due thereon; no tax deficiency has been asserted
against the Company, nor does the Company know of any tax
deficiency which is likely to be asserted; there are no tax audits
or investigations pending or threatened that, if adversely
determined, could have a Material Adverse Effect; nor are there any
material proposed additional tax assessments against the Company;
all tax liabilities are adequately provided for on the books of the
Company.
3.38.
Books and Records . The books of account, minute books,
stock record books and other records of the Company are complete
and correct in all material respects and
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have been maintained in accordance with sound
business practices and the requirements of Section 13(b)(2) of the
Exchange Act, including an adequate system of internal controls.
The minute books of the Company contain accurate and complete
records of all meetings held