CHIESI FARMACEUTICI SPA
and
CORNERSTONE THERAPEUTICS
INC.
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Page
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ARTICLE I PURCHASE AND SALE OF SHARES
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2
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Section 1.1. Purchase and Sale
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2
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Section 1.2. Consideration
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3
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3
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Section 1.4. Closing Deliveries by
Purchaser
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3
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Section 1.5. Closing Deliveries by the
Company
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3
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ARTICLE II REPRESENTATIONS AND WARRANTIES OF THE
COMPANY
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3
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Section 2.1. Organization;
Qualification
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3
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Section 2.2. Capitalization
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4
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Section 2.3. Subsidiaries
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6
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Section 2.4. Validity of New
Shares
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6
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6
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Section 2.6. Consents and Approvals; No
Violations
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7
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Section 2.7. SEC Reports; Financial
Statements; Accounting Matters
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8
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Section 2.8. Absence of Certain Changes or
Events
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9
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Section 2.9. Information
Supplied
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9
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Section 2.10. Benefit Plans; Employees and
Employment Practices
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9
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12
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Section 2.12. Compliance with Applicable
Laws
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12
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Section 2.13. Tax Matters
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14
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Section 2.14. Intellectual
Property
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15
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Section 2.15. Opinion of Financial
Advisor
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16
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Section 2.16. Brokers and Other
Advisors
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16
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Section 2.17. Real Property Holding
Corporation
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16
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Section 2.18. Environmental
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16
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Section 2.19. Real Property
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16
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Section 2.20. Tangible Personal
Property
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17
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Section 2.21. Related–Party
Transactions
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17
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Section 2.22. Company Material
Contracts
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17
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19
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Section 2.24. No Illegal
Payments
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19
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Section 2.25. No Additional
Representations
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19
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ARTICLE III REPRESENTATIONS AND WARRANTIES OF
PURCHASER
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19
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Section 3.1. Organization
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19
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(continued)
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Page
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19
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Section 3.3. Consents and Approvals; No
Violations
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20
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Section 3.4. Information
Supplied
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20
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20
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21
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Section 3.7. Brokers and Other
Advisors
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22
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Section 3.8. Investment Intent
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22
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Section 3.9. No Additional
Representations
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22
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22
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Section 4.1. Conduct of Business by the
Company
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22
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Section 4.2. No Solicitation
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25
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Section 4.3. Stockholder Approval;
Preparation of Proxy Statement
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26
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Section 4.4. Access to Information;
Confidentiality
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27
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Section 4.5. Reasonable Best Efforts to
Consummate
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28
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Section 4.6. Public
Announcements
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29
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Section 4.7. Contact with Customers and
Suppliers
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29
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Section 4.8. Transfer Taxes
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29
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Section 4.9. Charter Amendment Approval;
Filing of the Certificate of Incorporation
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29
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Section 4.10. Notification of Certain
Matters
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30
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Section 4.11. Share Issuance
Top-Up
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30
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31
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Section 5.1. Conditions to Each
Party’s Obligations
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31
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Section 5.2. Conditions to Obligations of
Purchaser
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31
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Section 5.3. Conditions to Obligations of
the Company
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32
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ARTICLE VI TERMINATION; AMENDMENT AND
EXPENSES
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32
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32
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Section 6.2. Effect of
Termination
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34
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Section 6.3. Fees and Expenses
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34
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ARTICLE VII MISCELLANEOUS
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35
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Section 7.1. Representations and Warranties
Do Not Survive
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35
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35
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Section 7.3. Entire Agreement
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36
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36
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ii
(continued)
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Page
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36
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Section 7.6. No Third-Party
Beneficiaries
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37
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Section 7.7. Assignment; Binding
Effect
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37
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Section 7.8. GOVERNING LAW
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37
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Section 7.9. CONSENT TO JURISDICTION AND
SERVICE OF PROCESS; WAIVER OF JURY TRIAL
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37
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38
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Section 7.11. Invalid Provisions
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38
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Section 7.12. Counterparts
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38
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Section 7.13. Interpretation
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38
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Exhibit A:
Employment Agreements
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Exhibit B:
Stockholders Agreement
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Exhibit C:
Governance Agreement
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Exhibit D:
Purchaser Registration Rights Agreement
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Exhibit E:
Stockholders Registration Rights Agreement
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Exhibit F:
Form of Charter Amendment
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Exhibit G:
Amended Bylaws
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Exhibit H:
Form of U.S. Curosurf Agreement
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Company
Disclosure Schedule
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Schedule A: List of Individuals Entering
into Employment Agreements
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Schedule B: List of Stockholders Entering
into Stockholders Voting Agreement
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Schedule C: Data Regarding U.S. Sales of
Curosurf
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iii
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Page
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8
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40
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39
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Charter Amendment Approval
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7
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1
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1
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9
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Company Disclosure Schedule
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3
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Company Intellectual Property
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16
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Company Material Contracts
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18
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5
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13
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5
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3
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Confidentiality Agreement
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29
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3
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8
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40
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Curosurf Intellectual Property
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22
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22
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7
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Page
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16
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9
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8
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Initial Stock Purchase Agreement
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1
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1
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16
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4
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1
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ordinary course of business
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39
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27
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1
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Purchaser Registration Rights
Agreement
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1
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Purchaser Voting Agreement
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2
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39
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7
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1
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27
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Stockholders Registration Rights
Agreement
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2
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Stockholders Voting Agreement
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2
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39
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26
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15
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15
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33
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35
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to the Company’s knowledge
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39
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2
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3
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3
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iv
This STOCK
PURCHASE AGREEMENT , dated as of May 6, 2009 (this “
Agreement” ), is by and between CHIESI FARMACEUTICI
SPA, a corporation organized under the laws of Italy (“
Purchaser ”), and CORNERSTONE THERAPEUTICS INC., a
Delaware corporation (the “ Company
”).
WHEREAS ,
the parties wish to engage in a series of transactions pursuant to
which, among other things (i) Purchaser will purchase an
aggregate of 1,600,000 shares of common stock, par value $0.001 per
share, of the Company (“ Common Stock ”) from
two of the Company’s stockholders for an aggregate
consideration of $8,800,000 (which represents $5.50 per share) (the
“ Initial Stock Sale ”); (ii) Purchaser
will contribute to the Company $15,465,075 in cash and the U.S.
Curosurf Rights (as defined below) in exchange for 11,902,741
newly-issued shares of Common Stock (the “ New Shares
”); and (iii) upon completion of the Initial Stock Sale
and the Company Stock Sale (as defined below), Purchaser will own
approximately 13,502,741 shares of Common Stock;
WHEREAS ,
concurrently with the execution and delivery of this Agreement,
Purchaser and two stockholders of the Company are entering into a
stock purchase agreement (the “ Initial Stock Purchase
Agreement ”), dated the same date as this Agreement,
which provides for the Initial Stock Sale to be consummated upon
the terms and subject to the conditions set forth therein and
substantially concurrently with the consummation of the
transactions contemplated by this Agreement;
WHEREAS ,
concurrently with the execution and delivery of this Agreement,
certain executives of the Company set forth on
Schedule A hereto are entering into employment
agreements with the Company (the “ Employment
Agreements ”), each dated the same date as this
Agreement, which shall become effective upon the Closing (as
defined below), copies of which are attached hereto as
Exhibit A ;
WHEREAS ,
concurrently with the execution and delivery of this Agreement,
Purchaser, certain stockholders of the Company and the Company are
entering into a Stockholders Agreement (the “ Stockholders
Agreement ”), dated the same date as this Agreement,
which shall become effective upon the Closing and which provides
for, among other things, restrictions on transfers of Common Stock
owned by the stockholders and certain call options and rights of
first offer over Common Stock owned by the executives, a copy of
which is attached hereto as Exhibit B ;
WHEREAS ,
concurrently with the execution and delivery of this Agreement, the
Company, Purchaser and, solely with respect to the sections
identified therein, certain stockholders of the Company named
therein are entering into a Governance Agreement (the “
Governance Agreement ”), dated the same date as this
Agreement, which shall become effective upon the Closing and which
sets forth certain rights and obligations of the Company and
Purchaser concerning, among other things, certain corporate
governance matters, the voting of Purchaser’s shares of
Common Stock and certain limitations on future acquisitions and
dispositions of shares of Common Stock by Purchaser, a copy of
which is attached hereto as Exhibit C ;
WHEREAS ,
concurrently with the execution and delivery of this Agreement, the
Company and Purchaser are entering into a Registration Rights
Agreement (the “ Purchaser Registration Rights
Agreement ”), dated the same date as this Agreement,
which shall become effective upon the Closing and which sets forth
Purchaser’s right to require the Company to file with the SEC
(as defined below) certain registration statements under the
Securities Act (as defined below) with respect to the resale of the
shares of Common Stock acquired pursuant to the Initial Stock Sale
and Company Stock Sale, a copy of which is attached hereto as
Exhibit D ;
WHEREAS ,
concurrently with the execution and delivery of this Agreement, the
Company and certain stockholders of the Company are entering into a
Registration Rights Agreement (the “ Stockholders
Registration Rights Agreement ”), dated the same date as
this Agreement, which shall become effective upon the Closing and
which sets forth such stockholders’ rights to require the
Company to file with the SEC (as defined below) certain
registration statements under the Securities Act (as defined below)
with respect to the resale of the shares of Common Stock owned by
such stockholders, a copy of which is attached hereto as
Exhibit E ;
WHEREAS ,
the Governance Agreement contemplates that an amendment to the
Company’s certificate of incorporation in the form attached
hereto as Exhibit F (the “ Charter
Amendment ”) will be adopted, filed, and become effective
following the Closing in accordance with applicable law, and the
amended and restated bylaws of the Company in the form attached
hereto as Exhibit G (the “ Amended Bylaws
”) will be adopted concurrently with the approval of the
transactions contemplated by this Agreement and will become
effective at or prior to the Closing;
WHEREAS ,
the board of directors of the Company has, by the unanimous vote of
the directors present (i) determined that the Company Stock
Sale is fair to and in the best interests of the Company and the
Company’s stockholders, (ii) approved this Agreement,
the Charter Amendment, the Amended Bylaws and the other Transaction
Documents (as defined below) and the transactions contemplated
hereby and thereby, (iii) declared advisable the Charter
Amendment, and (iv) resolved to submit each of the Company
Stock Sale and the Charter Amendment to a vote of the
Company’s stockholders and, subject to the terms hereof, to
recommend approval by the stockholders of the Company Stock Sale
and the Charter Amendment;
WHEREAS ,
concurrently with the execution and delivery of this Agreement,
Purchaser and certain of the existing stockholders of the Company
set forth on Schedule B hereto are entering into a
voting agreement (the “ Stockholders Voting Agreement
”), dated the same date as this Agreement, pursuant to which
such existing stockholders have agreed to vote all of the shares of
Common Stock that are beneficially owned by them on the applicable
record date in favor of the approval of the Company Stock Sale and
the approval and adoption of the Charter Amendment; and
WHEREAS ,
concurrently with the execution and delivery of this Agreement, the
Company and Purchaser are entering into a voting agreement (the
“ Purchaser Voting Agreement ”, and, together
with this Agreement, the Initial Stock Purchase Agreement, the
Employment Agreements, the Stockholders Agreement, the Governance
Agreement, the Purchaser Registration Rights Agreement, the
Stockholders Registration Rights Agreement, the Charter Amendment,
the Amended Bylaws, the Stockholders Voting Agreement and the
Purchaser Voting Agreement, the “ Transaction
Documents ”), dated the same date as this Agreement,
pursuant to which Purchaser has agreed to vote all of the shares of
Common Stock that will be beneficially owned by them after the
Closing and on the applicable record date in favor of the approval
of and adoption of the Charter Amendment.
NOW,
THEREFORE , the parties hereby agree as follows:
PURCHASE AND SALE OF
SHARES
Section 1.1.
Purchase and Sale . At the Closing, upon the terms and
subject to the conditions set forth in this Agreement and following
the closing of the Initial Stock Sale, the Company will issue and
sell the New Shares to Purchaser, and Purchaser will purchase and
accept the New Shares from the Company (the “ Company
Stock Sale ”).
2
Section 1.2.
Consideration . The consideration (the “
Consideration ”) to be paid by Purchaser to the
Company for the New Shares at the Closing shall be (a) U.S.$
15,465,075 (the “ Cash Consideration ”) and
(b) the license, grant, assignment and transfer of the
exclusive rights to distribute and market Curosurf in the United
States (the “ U.S. Curosurf Rights ”) pursuant
to and in accordance with the terms of a license and distribution
agreement between Purchaser and the Company in the form of
Exhibit H , to be dated prior to or as of the date of
the Closing (the “ U.S. Curosurf Agreement
”).
Section 1.3.
Closing . The closing of the Company Stock Sale (the “
Closing ”) shall be held at the offices of Clifford
Chance US LLP, 31 West 52 nd Street, New York, New York 10019, at
10:00 a.m. local time, on the second business day following
the satisfaction or waiver of all conditions set forth in
Article V (other than conditions that, by their nature,
are to be satisfied at the Closing, but subject to the satisfaction
or waiver of those conditions) or at such other time or place as
Purchaser and the Company mutually shall agree. The date of the
Closing is referred to herein as the “ Closing Date
”.
Section 1.4.
Closing Deliveries by Purchaser . At the Closing, Purchaser
shall deliver or cause to be delivered to the Company:
(a) the Cash
Consideration, by wire transfer of immediately available funds in
United States dollars to such account or accounts as the Company
may direct in advance by written notice to Purchaser;
and
(b) a duly
executed counterpart of the U.S. Curosurf Agreement.
Section 1.5.
Closing Deliveries by the Company . At the Closing, the
Company shall deliver to Purchaser:
(a) certificates
representing the New Shares; and
(b) a duly
executed counterpart of the U.S. Curosurf Agreement.
REPRESENTATIONS AND WARRANTIES OF
THE COMPANY
The Company
represents and warrants to Purchaser that (i) except as set
forth in the disclosure schedule delivered by the Company to
Purchaser prior to the execution and delivery of this Agreement
(the “ Company Disclosure Schedule ”), which
schedule shall identify any exceptions to the representations,
warranties and covenants contained in this Agreement (with specific
reference to the particular Section or subsection to
which such information relates; provided , that an item
disclosed in any Section or subsection shall be deemed to
have been disclosed for each other Section or
subsection of this Agreement to the extent the relevance is
readily apparent on the face of such disclosure) and
(ii) except as disclosed in the Company SEC Documents (as
defined below) filed and publicly available before the date of this
Agreement (except for the forward-looking statements therein and
the risk factors thereof):
Section 2.1.
Organization; Qualification .
(a) The
Company and each of its subsidiaries is a corporation duly
organized, validly existing and in good standing (to the extent
such concept exists in the relevant jurisdiction) under the laws of
the jurisdiction of its organization and has all requisite
corporate power and authority to own, license, use, lease and
operate its assets and properties and to carry on its business as
it is now being conducted. The Company has made available to
Purchaser before the date of this Agreement complete and
correct
3
copies of its
certificate of incorporation and bylaws and the certificate of
incorporation and bylaws (or corresponding organizational
documents) of each of its subsidiaries (collectively, the “
Charter Documents ”). Such Charter Documents are in
full force and effect and the Company is not in default of any
provision thereunder.
(b) The
Company and each of its subsidiaries is duly qualified or licensed
to do business and in good standing in each jurisdiction in which
the assets or property owned, licensed, used, leased or operated by
it or the nature of the business conducted by it makes such
qualification or licensing necessary, except in such jurisdictions
where the failure to be so duly qualified or licensed and in good
standing would not have a Material Adverse Effect. For purposes of
this Agreement, a “ Material Adverse Effect ”
means any event, circumstance, change or effect individually or in
the aggregate that has or would reasonably be expected to have a
material adverse effect on the business, assets, properties,
liabilities, results of operations or financial condition of the
Company and its subsidiaries taken as a whole or impairs, prevents
or delays the ability of the Company to perform its obligations
hereunder, other than any event, circumstance, change or effect due
to (A) general economic, market or political conditions,
except in the event those conditions have a materially
disproportionate effect on the Company and its subsidiaries, taken
as a whole, as compared to other persons operating in the same
industry, (B) matters generally affecting the industry in
which the Company operates, except in the event those conditions
have a materially disproportionate effect on the Company and its
subsidiaries, taken as a whole, as compared to other persons
operating in the same industry, (C) the announcement or
expectation of this Agreement, the other Transaction Documents or
the transactions contemplated hereby or thereby, including any
termination of, reduction in or other negative impact on
relationships, contractual or otherwise, with any funding sources,
customers, suppliers, distributors, licensors, licensees, partners
or employees of the Company or any of its subsidiaries to the
extent related to the announcement or performance of this Agreement
and the other Transaction Documents or the identity of Purchaser,
(D) any of the requirements or limitations imposed on any
party pursuant to this Agreement or the other Transaction
Documents, including compliance with any covenants in this
Agreement and such other Transaction Documents, (E) changes in
applicable laws or regulations or in accounting policies or
principles or in any interpretations of any of the foregoing,
(F) any outbreak or escalation of war or armed hostilities or
any act of terrorism, (G) earthquakes, hurricanes or other
natural disasters or acts of God, (H) any failure by the
Company to meet any published estimates or expectations as to
revenues, earnings or other measures of financial or operating
performance, (I) any failure by the Company to meet any
projections, forecasts or budgets prepared by or on behalf of the
Company, it being understood however that the factors giving rise
to any such failure are not otherwise excluded by this clause
(I) from the definition of “Material Adverse
Effect” or (J) a decline in the Company’s stock
price, in and of itself.
Section 2.2.
Capitalization .
(a) The
authorized capital stock of the Company consists of 90,000,000
shares of Common Stock and 5,000,000 shares of preferred stock, par
value $0.001 per share (“ Company Preferred Stock
”). At the close of business on May 5, 2009,
(i) 12,499,370 shares of Common Stock were issued and
outstanding (including an aggregate of 475,355 restricted shares
granted under the Company Option Plans (as defined below)),
(ii) no shares of Company Preferred Stock were issued and
outstanding, (iii) 2,069,090 shares of Common Stock were
issuable upon the exercise of options and other similar rights (the
“ Company Stock Awards ”) granted under the
Company’s 2000 Equity Incentive Plan, 2003 Stock Incentive
Plan, 2004 Stock Incentive Plan, 2005 Stock Incentive Plan and 2005
Stock Option Plan (each as amended from time to time and
collectively, the “ Company Option Plans ”) and
(iv) 725,633 shares of Common Stock were reserved and
available for issuance pursuant to outstanding warrant agreements.
All outstanding shares of capital stock of the Company have been
duly authorized and validly issued and are fully paid and
nonassessable, were issued in compliance with all applicable
federal and state securities laws, and have not been issued in
violation of any preemptive or similar rights. The
4
Company has
duly reserved 153,083 shares of Common Stock for future issuances
pursuant to the Company Option Plans. Except as set forth above in
this Section 2.2(a) , and for changes since the date
referred to above resulting from the exercise of Company Stock
Awards outstanding on such date in accordance with their terms,
there are no outstanding shares of capital stock or other voting
securities of the Company, securities of the Company convertible
into or exchangeable for shares of capital stock or other
securities of the Company or subscriptions, options, warrants,
puts, calls, phantom stock rights, stock appreciation rights,
stock-based performance units, agreements, understandings, claims
or other commitments or rights of any type granted or entered into
by the Company or any of its subsidiaries relating to the issuance,
sale, repurchase or transfer of any securities of the Company or
that give any person or entity the right to receive any economic
benefit or right similar to or derived from the economic benefits
and rights of securities of the Company. There are no outstanding
obligations of the Company or any of the Company’s
subsidiaries to repurchase, redeem or otherwise acquire or make any
investment in (by means of a loan, capital contribution or
otherwise) any securities of the Company, any of the
Company’s subsidiaries or any other person or to vote or to
dispose of any securities of the Company or any of the
Company’s subsidiaries.
(b) The
Company is not a party to any contract obligating the Company,
directly or indirectly, to issue additional securities and there is
no circumstance or condition that may give rise to a claim by any
person that such person is entitled to acquire any securities of
the Company. Other than the Stockholders Voting Agreement and the
Purchaser Voting Agreement, the Company is not a party to any
stockholder agreements, voting agreements, voting trusts or any
such other similar arrangements with respect to the transfer,
voting or other rights associated with its securities and, to the
Company’s knowledge, there are no such agreements to which
the Company is not a party.
(c) The
Company has provided to Purchaser a report dated as of
December 31, 2008 and updated through May 5, 2009, that
sets forth with respect to all equity grants that are outstanding
as of such date: (i) the name of each holder of such equity
grants; (ii) the total number of shares subject to such equity
grants originally issued to such holder; (iii) the date on
which such equity grants were issued; (iv) the number of
shares subject to the equity grants which have vested and the
number of shares that remain subject to such equity grant;
(v) the vesting schedule for such equity grants; (vi) the
term of such equity grants; (vii) the purchase price per share
of such equity grants; and (viii) whether such equity grant
has been designated an “incentive stock option” as
defined in Section 422 of the Internal Revenue Code of 1986,
as amended (the “ Code ”). The Company has
delivered to Purchaser accurate and complete copies of (A) its
standard form of grant agreement for equity grants, (B) any
agreement that deviates in any material respect from the standard
form of agreement for equity grants and (C) the Company Option
Plans.
(d) All
outstanding Company Stock Awards have been duly authorized and
validly issued and were issued in compliance with all applicable
federal and state securities laws.
(e) All
shares of Common Stock subject to issuance upon exercise of the
Company Stock Awards, upon issuance in accordance with the terms
and conditions specified in the instruments pursuant to which they
are issuable, will be duly authorized, validly issued, fully paid
and nonassessable.
(f) The
Company does not have outstanding any bonds, debentures, notes or
other obligations or debt securities the holders of which have the
right to vote (or convertible into, or exercisable or exchangeable
for, securities having the right to vote) on any matter.
5
Section 2.3.
Subsidiaries .
(a)
Section 2.3(a) of the Company Disclosure Schedule lists
each subsidiary of the Company and sets forth with respect to each
such subsidiary the jurisdiction of incorporation or organization,
the authorized and outstanding capital stock of such subsidiary and
the owner(s) of record of such outstanding capital stock. All the
outstanding shares of capital stock (or other securities having by
their terms voting power to elect a majority of directors or others
performing similar functions) of each such subsidiary are owned by
the Company, by another wholly-owned subsidiary of the Company or
by the Company and another wholly-owned subsidiary of the Company,
free and clear of all liens, charges, security interests,
mortgages, pledges, options, preemptive rights, rights of first
refusal or first offer, proxies, levies, voting trusts or
agreements, or other adverse claims or restrictions on title or
transfer of any nature whatsoever (collectively, “
Encumbrances ”), and are duly authorized, validly
issued, fully paid and nonassessable. There are no securities
convertible into or exchangeable for shares of capital stock or
other securities of any subsidiary of the Company, or
subscriptions, options, warrants, puts, calls, phantom stock
rights, stock appreciation rights, stock-based performance units,
agreements, understandings, claims or other commitments or rights
of any type granted or entered into by the Company or any of its
subsidiaries relating to the issuance, sale, repurchase or transfer
of any securities of any subsidiary of the Company or that give any
person or entity the right to receive any economic benefit or right
similar to or derived from the economic benefits and rights of
securities of any subsidiary of the Company. Except for the capital
stock of its subsidiaries, the Company does not own, directly or
indirectly, any capital stock or other ownership interest in any
person. The Company is not subject to any obligation or requirement
to provide funds to or make any investment (in the form of a loan,
capital contribution or otherwise) in any person.
(b) Other
than the shares of capital stock set forth in
Section 2.3(a) of the Company Disclosure Schedule , no
subsidiary of the Company has outstanding securities of any kind.
No subsidiary of the Company is party to any contract obligating
such subsidiary, directly or indirectly, to issue any additional
securities and there is no circumstance or condition that may give
rise to a claim by any person that such person is entitled to
acquire the securities of any such subsidiary.
(c) No
subsidiary of the Company has outstanding any bonds, debentures,
notes or other obligations or debt securities the holders of which
have the right to vote (or convertible into, or exercisable or
exchangeable for, securities having the right to vote) on any
matter.
(d) Other
than the subsidiaries set forth in Section 2.3(a) of the
Company Disclosure Schedule , neither the Company nor any
subsidiary of the Company, directly or indirectly, owns any
securities or other interest in any corporation, partnership, joint
venture or other business association or entity.
(e) There are
no obligations, contingent or otherwise, of the Company or any
subsidiary of the Company to provide funds to or make an investment
(in the form of a loan, capital contribution or otherwise) in any
entity.
Section 2.4.
Validity of New Shares . When issued and paid for in
accordance with the provisions of this Agreement, the New Shares
will be duly authorized and validly issued, fully paid and
nonassessable and free of any Encumbrances other than Encumbrances
(i) imposed under applicable securities laws or
(ii) imposed under any of the Transaction
Documents.
(a) The
Company has all requisite corporate power and authority to execute
and deliver this Agreement and each other Transaction Document to
which it is a party and to perform and consummate the transactions
contemplated hereby and thereby. The execution, delivery and
performance of this
6
Agreement and
each other Transaction Document to which it is a party and the
consummation by the Company of the transactions contemplated by
this Agreement and the other Transaction Documents to which the
Company is a party have been duly authorized by all necessary
corporate action on the part of the Company and no other corporate
proceedings on the part of the Company are necessary to authorize
this Agreement or any other Transaction Document to which the
Company is a party or to consummate transactions contemplated
hereby and thereby, other than (i) the approval of the Company
Stock Sale by a majority of the votes cast by all stockholders
entitled to vote, as required under the rules of the NASDAQ Capital
Market (the “ Stock Sale Approval ”); and
(ii) the approval of the Charter Amendment by the affirmative
vote of the holders of not less than 75% of the issued and
outstanding shares of Common Stock (the “ Charter
Amendment Approval ”). This Agreement, the Amended Bylaws
and each other Transaction Document to which the Company is a party
has been duly executed and delivered by the Company and, assuming
the accuracy of the representations made in Section 3.2
, constitute valid and binding obligations of the Company,
enforceable against the Company in accordance with their respective
terms.
(b) The board
of directors of the Company, at a meeting duly called and held, by
the unanimous vote of all the directors present (i) adopted a
resolution approving this Agreement, the Charter Amendment and each
other Transaction Document to which the Company is a party,
(ii) approved the Company Stock Sale, the other transactions
contemplated hereby and the transactions contemplated by the
Transaction Documents; (iii) determined that the Company Stock
Sale is fair to, and in the best interests of, the Company and its
stockholders; (iv) declared the Charter Amendment advisable;
(v) took all actions necessary to render any anti-takeover statute
or regulation inapplicable to each of the transactions contemplated
by the Transaction Documents; and (vi) resolved to recommend
that the Company’s stockholders vote in favor of the Company
Stock Sale and the Charter Amendment.
(c) The board
of directors of the Company has taken all actions so that the
restrictions contained in Section 203 of the General
Corporation Law of the State of Delaware (the “ DGCL
”) applicable to a “business combination” (as
defined in such Section 203), and any other applicable law,
will not apply to Purchaser or its affiliates with respect to the
execution and delivery of this Agreement and the other Transaction
Documents and the consummation of the transactions contemplated by
this Agreement and the other Transaction Documents. No other
anti-takeover statute or regulation applies to this Agreement and
the other Transaction Documents and the consummation of the
transactions contemplated by this Agreement and the other
Transaction Documents. The Company does not have any stockholder
rights plan in effect.
Section 2.6.
Consents and Approvals; No Violations .
(a) The
execution, delivery and performance by the Company of this
Agreement and each other Transaction Document to which it is a
party and the consummation by the Company of the transactions
contemplated hereby and thereby do not and will not require any
filing or registration with, notification to, or authorization,
permit, consent or approval of, or other action by or in respect
of, any U.S. or non-U.S. government, regulatory or administrative
authority, agency, instrumentality or commission or any court,
tribunal, judicial or arbitral body or other similar authority (a
“ Governmental Authority ”) other than
(i) the filing of the Charter Amendment with the Secretary of
State of the State of Delaware (the “ DSOS ”),
(ii) compliance with any applicable requirements of the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended
(the “ HSR Act ”), (iii) compliance with
any applicable requirements of the Securities Exchange Act of 1934,
as amended (the “ Exchange Act ”),
(iv) compliance with any applicable requirements of the NASDAQ
Capital Market and (v) where the failure to obtain such
consents, approvals, authorizations or permits or to make such
filings or notifications would not reasonably be expected to have a
Material Adverse Effect.
7
(b) Subject
to the receipt of the Charter Amendment Approval and the filing of
the Charter Amendment with the DSOS, the execution, delivery and
performance by the Company of this Agreement and each other
Transaction Document to which the Company is a party and the
consummation by the Company of the transactions contemplated hereby
and thereby do not and will not (i) conflict with or result in
any breach of any provision of the Charter Documents or
(ii) result in a violation or breach of, or constitute (with
or without notice or lapse of time or both) a default under, or
give rise to any right of termination, amendment, cancellation,
acceleration or loss of rights or benefits or the creation or
acceleration of any right or obligation under or result in the
creation of any Encumbrance upon any of the properties or assets of
the Company or any of its subsidiaries under, any of the terms,
conditions or provisions of any note, bond, mortgage, indenture,
deed of trust, loan, credit agreement, lease, license, permit,
concession, franchise, purchase order, sales order, contract,
agreement or other instrument, understanding or obligation, whether
written or oral (a “ contract ”), to which the
Company or any of its subsidiaries is a party or by which any of
its properties or assets may be bound or (iii) violate any law
applicable to the Company, any of its subsidiaries or any of their
properties or assets, except in the case of clause (iii) for
violations, breaches or defaults that would not reasonably be
expected to have a Material Adverse Effect.
Section 2.7.
SEC Reports; Financial Statements; Accounting Matters
.
(a) The
Company has filed with the Securities and Exchange Commission (the
“ SEC ”) all reports on Form 10-K, 10-Q and 8-K,
and all proxy materials, required to be filed or furnished by it
since October 31, 2008 (collectively, the “ Company
SEC Documents ”). None of the Company SEC Documents, when
filed, contained any untrue statement of a material fact or omitted
to state a material fact required to be stated therein or necessary
in order to make the statements therein, in light of the
circumstances under which they were made, not misleading. No
subsidiary of the Company is required to make any filings with the
SEC or any similar Governmental Authority, the NASDAQ Capital
Market or any other stock exchange or quotation service.
(b) The
audited consolidated financial statements of the Company included
in the Company’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2008 (the “ 2008 Annual
Report ”), including any related notes thereto, were
prepared in accordance with United States generally accepted
accounting principles applied on a consistent basis during the
periods involved (except as may be set forth in the notes thereto
and fairly present in all material respects the consolidated
financial position of the Company and its consolidated subsidiaries
as at the dates thereof and the consolidated results of their
operations and cash flows for the periods indicated.
(c) The
Company is in compliance with (i) the applicable provisions of
the Sarbanes-Oxley Act of 2002 and (ii) the applicable listing
and corporate governance rules and regulations of the NASDAQ
Capital Market.
(d) The
Company maintains a system of internal controls over financial
reporting (as defined in Rules 13a-15(f) and 15d-15(f) under
the Exchange Act) sufficient to provide reasonable assurances
regarding the reliability of financial reporting and preparation of
financial statements for external purposes in accordance with
United States generally accepted accounting principles. There are
no significant deficiencies or material weaknesses in the design or
operation of the Company’s internal controls that would
adversely affect the Company’s ability to record, process,
summarize and report financial data. There is no fraud, whether or
not material, that involves management or other employees who have
a significant role in the Company’s internal controls. The
Company has (i) implemented disclosure controls and procedures
(as defined in Rule 13a-15(e) under the Exchange Act) to
ensure that material information relating to the Company, including
its consolidated subsidiaries, is recorded, processed, summarized
and reported within the time periods specified by the SEC’s
rules and forms and
8
is accumulated
and made known to the management of the Company as appropriate to
allow timely decisions regarding required disclosure, and that all
such information is accumulated and communicated to the
Company’s management as appropriate to allow timely decisions
regarding required disclosure and to make the certifications of the
Chief Executive Officer and the Chief Financial Officer of the
Company required under the Exchange Act with respect to such
reports and (ii) has disclosed, based on its most recent
evaluation prior to the date of this Agreement, to the
Company’s outside auditors and the audit committee of the
board of directors of the Company (x) any significant
deficiencies and material weaknesses in the design or operation of
internal controls over financial reporting that are reasonably
likely to adversely affect in any material respect the
Company’s ability to record, process, summarize and report
financial information and (y) any fraud, whether or not
material, that involves management or other employees who have a
significant role in the Company’s internal control over
financial reporting.
(e) There are
no liabilities, obligations or commitments of any nature
whatsoever, asserted or unasserted, known or unknown, absolute or
contingent, accrued or unaccrued, matured or unmatured or otherwise
of the Company or any of its subsidiaries that would be required to
be reflected or reserved against in a consolidated balance sheet of
the Company and its consolidated subsidiaries prepared in
accordance with United States generally accepted accounting
principles other than (i) liabilities reflected, accrued,
reserved against or otherwise disclosed in the Company’s
audited consolidated balance sheet as of December 31, 2008,
included in the 2008 Annual Report (the “ Company Balance
Sheet ”), (ii) liabilities incurred in the ordinary
course of business since the date of such balance sheet (the
“ Balance Sheet Date ”), (iii) liabilities
or obligations incurred pursuant to or in connection with the
transactions contemplated by this Agreement and
(iv) liabilities or obligations that would not reasonably be
expected to result in a Material Adverse Effect.
(f)
Section 2.7(f) of the Company Disclosure Schedule sets
forth a draft, dated May 6, 2009, of the form of Quarterly
Report on Form 10-Q for the quarter ended March 31, 2009 to be
filed by the Company with the SEC (the “ First Quarter
Form 10-Q ”). As of the date hereof, the First
Quarter Form 10-Q does 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
therein, in light of the circumstances under which they were made,
not misleading.
Section 2.8.
Absence of Certain Changes or Events . Since the Balance
Sheet Date and through and including the date of this Agreement,
(a) the business of the Company has been conducted in the
ordinary course of business in all material respects, except as
permitted under Section 4.1 and (b) there has not
been any development, occurrence or event that, individually or in
the aggregate with other developments, occurrences or events since
that date, has had a Material Adverse Effect.
Section 2.9.
Information Supplied . The Proxy Statement (as defined
below) will not, at the time of the Stockholders Meeting (as
defined below), contain any untrue statement of a material fact or
omit to state any material fact required to be stated therein or
necessary in order to make the statements therein, in light of the
circumstances under which they are made, not misleading. The Proxy
Statement will, when filed by the Company with the SEC, comply as
to form in all material respects with the applicable provisions of
the Exchange Act and the rules and regulations thereunder.
Notwithstanding the foregoing, the Company makes no representation
or warranty with respect to any information which may be supplied
by or on behalf of Purchaser or any of its representatives or
advisers for inclusion in the Proxy Statement.
Section 2.10.
Benefit Plans; Employees and Employment Practices
.
(a)
Section 2.10(a) of the Company Disclosure Schedule
contains a complete and accurate list of each (x) “employee
pension benefit plan” (as defined in Section 3(2) of the
Employee Retirement
9
Income Security
Act of 1974, as amended (“ ERISA ”)) (referred
to herein as “ Pension Plans ”), “employee
welfare benefit plan” (as defined in Section 3(1) of
ERISA), and any other employee benefit plan (within the meaning of
Section 3(3) of ERISA) that is maintained or sponsored by the
Company or to which the Company contributes or for which the
Company has or may have any liability, contingent or otherwise,
either directly or as a result of an ERISA Affiliate, and (y) any
other benefit arrangement, obligation or practice to provide
benefits, other than salary, as compensation for services rendered,
to one or more present or former employees, directors, agents or
independent contractors, that is maintained or sponsored by the
Company or to which the Company contributes or for which the
Company has otherwise has or may have any liability, contingent or
otherwise, either directly or as a result of an ERISA Affiliate,
including, without limitation, bonus, nonqualified deferred
compensation, incentive compensation, stock ownership, stock
purchase, stock option, phantom stock, retirement, vacation,
severance, change of control, disability, workers’
compensation, death benefit, hospitalization, medical, fringe
benefit, excess benefit, executive compensation, stock
appreciation, restricted stock, indemnification, collective
bargaining agreement, vacation pay, sick leave, severance policies
or arrangements, or tuition reimbursement (collectively, “
Benefit Plans ”). With respect to each Benefit Plan,
the Company has made available to Purchaser a true, correct and
complete copy of: (i) any current plan documents and
amendments thereto; (ii) for the most recently ended plan
year, all IRS Form 5500 series forms (and any financial
statements and other schedules attached thereto) filed with respect
to any Benefit Plan; (iii) all current summary plan
descriptions and subsequent summaries of material modifications
with respect to each Benefit Plan for which such descriptions and
modifications are required under ERISA; (iv) the most recent
IRS determination letter for each Pension Plan that is intended to
be qualified under Section 401(a) of the Code; (v) all
notices that were issued within the preceding three years by the
IRS, Department of Labor, or any other Governmental Authority with
respect to any Benefit Plan; and (vi) any other material
document relating to a Benefit Plan. For purposes of this
Section 2.10 , the term “ Company ”
includes any ERISA Affiliate. For purposes of this
Section 2.10 , the term “ ERISA Affiliate
” shall mean any person that, together with the Company, is
or was at any time treated as a single employer under
Section 414 of the Code or Section 4001 of ERISA. Each
Pension Plan intended to be qualified under Section 401(a) of
the Code has been the subject of a determination letter from the
Internal Revenue Service to the effect that such Pension Plan is so
qualified under all currently applicable provisions of
Section 401(a) of the Code and, to the knowledge of the
Company, no circumstances exist that would adversely affect the
qualification of any such Pension Plan.
(b) Except as
would not, individually or in the aggregate, have a Material
Adverse Effect, each Benefit Plan has been operated and
administered in accordance with its terms and with applicable law,
including, but not limited to, ERISA, the Code and in each case the
regulations thereunder. Each Benefit Plan intended to be
“qualified” within the meaning of
Section 401(a) of the Code has received a favorable
determination letter from the IRS as to its tax exempt status, or
has pending an application for such determination from the IRS with
respect to those provisions for which the remedial amendment period
under Section 401(b) of the Code has not expired or is a
prototype plan covered by the prototype plan sponsor’s
favorable determination letter, and, to the knowledge of the
Company, there is not any reason why any such determination letter
should be revoked. The Company does not sponsor, maintain or
contribute to, or has any liability, contingent or otherwise, with
respect to, any employee benefit plan subject to Section 302
of ERISA, Section 412 of the Code or Title IV of ERISA. None
of the Benefit Plans is a multi-employer plan. The Company does not
contribute to, and has never contributed to or had any liability,
contingent or otherwise, with respect to, a multiemployer plan. The
Company does not contribute to, and has never contributed to or had
any liability, contingent or otherwise, with respect to, a plan
that has two or more contributing sponsors at least two of whom are
not under common control, within the meaning of Section 4063
of ERISA. No Benefit Plan provides benefits, including death or
medical benefits (whether or not insured), with respect to current
or former employees or beneficiary or covered dependent of an
employee or former employee or directors of the Company or any
subsidiary of the Company beyond their retirement or other
termination of service, other than (A) coverage
mandated
10
by applicable
Law or (B) death benefits or retirement benefits under any
“employee pension plan” (as such term is defined in
Section 3(2) of ERISA). Except as would not, individually or
in the aggregate, have a Material Adverse Effect, no liabilities as
a result of a failure to comply with the continuation coverage
requirements of Section 601 et seq. of ERISA and
Section 4980B of the Code has been incurred by the Company,
any subsidiary of the Company or any of their respective ERISA
Affiliates that has not been satisfied in full, and, to the
knowledge of the Company, no condition exists that shall result in
the Company, any subsidiary of the Company or any of their
respective ERISA Affiliates incurring any such liability. Except as
would not, individually or in the aggregate, have a Material
Adverse Effect, all amounts withheld from employee paychecks or
other amounts payable by the Company or a subsidiary of the Company
with respect to each Benefit Plan in respect of current or prior
plan years have been contributed to the applicable Benefit Plan or
paid or accrued in accordance with generally accepted accounting
principles. Except as would not, individually or in the aggregate,
have a Material Adverse Effect, neither the Company nor a
subsidiary of the Company has engaged in a transaction in
connection with which the Company or a subsidiary of the Company
reasonably could be subject to either a civil penalty assessed
pursuant to Section 409 or 502(1) of ERISA or a material tax
imposed pursuant to Section 4975 or 4976 of the Code. There
are no pending or, to the knowledge of the Company, threatened or
anticipated claims (other than routine claims for benefits) by, on
behalf of or against any of the Benefit Plans or any trusts related
thereto which would reasonably be expected to result in any
liability of the Company or any subsidiary of the Company. Neither
the Company nor its subsidiaries has agreed or otherwise committed
to, whether in writing or otherwise, increase or improve the
compensation, benefits or terms and conditions of employment or
service of any director, officer, employee or consultant other than
as required under an applicable Benefit Plan. Each Benefit Plan may
be amended and terminated in accordance with its terms. No Benefit
Plan is presently under audit or examination (nor has notice been
received of a potential audit or examination) by the IRS, the
Department of Labor or any other Governmental Authority, and no
matters are pending with respect to any Benefit Plan under any IRS
program.
(c) No
payments or benefits under any Benefit Plan or other agreement of
the Company, singularly or in the aggregate, will be considered
“excess parachute payments” under Section 280G of
the Code. Neither the Company nor any subsidiary has the obligation
to indemnify, hold harmless or gross-up any individual with respect
to any excise tax imposed under Section 4999 of the Code. No
payments or benefits under any Benefit Plan or other agreement of
the Company are, or expected to be, subject to the disallowance of
a deduction under Section 162(m) of the Code. Neither the Company
nor any subsidiary has the obligation to indemnify, hold harmless
or gross-up any individual with respect to any penalty tax or
interest under Section 409A of the Code. To the knowledge of
the Company, each Benefit Plan that is a “nonqualified
deferred compensation plan” (as defined in
Section 409A(d)(1) of the Code) is in documentary compliance
with Section 409A of the Code. The Company believes that each
nonqualified deferred compensation plan that is subject to
Section 409A of the Code has been operated since
January 1, 2005 in good faith compliance with
Section 409A of the Code.
(d)
Section 2.10(d) of the Company Disclosure Schedule
lists each Benefit Plan, employment, severance, consulting or other
contract or with or for the benefit of any officer, director or
employee of the Company or any of its subsidiaries that provides
for any payment, additional benefits, severance, termination,
vesting or acceleration of benefits or rights or otherwise, or
other payments or liabilities, upon a “change of
control” or the execution of this Agreement or the
consummation of any of the transactions contemplated
hereby.
(e) The
Company does not maintain, have any obligation to contribute to or
have any liability, contingent or otherwise, with respect to, any
benefit plan or arrangement outside the United State and has never
had any obligation or liability with respect to any such benefit
plan or arrangement. The Company does not employ any individual
outside the United States.
11
(f) Neither
the Company nor any subsidiary of the Company is the subject of a
proceeding asserting it has committed an unfair labor practice,
nor, to the knowledge of the Company, is any such proceeding
threatened, nor is there any strike or other labor dispute by the
employees of the Company or any subsidiary of the Company pending
or threatened, nor does the Company have knowledge of any activity
involving any employee of the Company or any subsidiary of the
Company or labor organization seeking to certify a collective
bargaining unit or engaging in union organizational
activity.
Section 2.11.
Litigation . There are no suits, claims, actions,
proceedings or investigations pending or, to the knowledge of the
Company, threatened by or against the Company or any of its
subsidiaries before any Governmental Authority that, if adversely
determined, reasonably would be expected to result in a Material
Adverse Effect. Neither the Company nor any of its subsidiaries is
subject to any outstanding order, writ, judgment, decree,
injunction or settlement that reasonably that prohibits the Company
Stock Sale or any other transaction contemplated by the Transaction
Documents.
Section 2.12.
Compliance with Applicable Laws .
(a) The
Company and its subsidiaries are in compliance with all statutes,
laws, ordinances, rules, orders, regulations, guidelines or other
binding directives of any Governmental Authority (collectively,
“ laws ”) applicable to the Company or its
subsidiaries or by which any of their respective properties are
bound except where the failure to do so would not reasonably be
expected to have a Material Adverse Effect. Except as would not
result in a Material Adverse Effect, neither the Company nor its
subsidiaries has been notified in writing by any Governmental
Authority of any violation or investigation or to the
Company’s knowledge, orally of any violation or investigation
with respect to any such law, including, but not limited to, laws
enforced by United States Attorneys, the United States Food and
Drug Administration (the “ FDA ”), other federal
or state administrative agencies and attorneys general of U.S.
states and territories, the Centers for Medicare and Medicaid
Services, the European Medicines Agency (“ EMEA
”) and comparable Governmental Authorities in any
jurisdiction (collectively, “ Drug Law ”
)).
(b) The
Company and its subsidiaries have all applications, licenses,
requests for approvals, exemptions, permits, variances, orders,
approvals and other regulatory authorizations from Governmental
Authorities required to conduct their respective businesses as now
being conducted (the “ Company Permits ”),
except where the failure to hold such Company Permits or the
suspension or cancellation thereof would not reasonably be expected
to have a Material Adverse Effect , and no such suspension
or cancellation of any of the Company Permits is pending or, to the
knowledge of the Company, threatened, in each case. The Company and
its subsidiaries are in compliance with the terms and conditions of
the Company Permits, except where the failure so to comply would
not reasonably be expected to have a Material Adverse Effect. The
Company has made available to Purchaser all material Company
Permits from the FDA.
(c) The
Company has made available to Purchaser all (i) approved and
pending new drug applications (including Section 505(b)(2)
applications) and abbreviated new drug applications as of the date
hereof and (ii) all pre-clinical and clinical studies and
trials and bioequivalence studies referenced in the Company’s
investigational new drug applications, pending new drug
applications (including Section 505(b)(2) applications) and
abbreviated new drug applications previously or as of the date
hereof currently undertaken or sponsored by the Company or any
subsidiary of the Company. The Company has made available to
Purchaser true, complete and accurate copies of all material data
and reports with respect to such applications, studies and trials,
and all other material information regarding the quality, efficacy
and safety of the Products, as well as products subject to an
Investigational New Drug Application (“ Investigational
Products ”). The Company has made available to Purchaser
all material correspondence and contact information between the
Company, the FDA, EMEA and other Governmental
12
Authorities
regarding the products and Investigational Products in the
Company’s possession, as the case may be, and, to the extent
provided to the Company or any subsidiary of the Company, material
correspondence between the FDA, EMEA and other Governmental
Authorities relating thereto, including but not limited to
(1) reports of inspection observations from any Governmental
Authority related to manufacturing facilities where the products
are being manufactured, to the extent such report relates to a
product, (2) establishment inspection reports from any
Governmental Authority, to the extent such report relates to a
product, (3) any FDA Form 483s relating to the products
or any equivalent thereto from any Governmental Authority in any
applicable jurisdiction, (4) any minutes of meetings between
the Company and FDA, EMEA or other Governmental Authorities
regarding the products and (5) any notice, warning letter,
regulatory letter, Section 305 notice, or any other similar
communication to the Company or any of the subsidiaries stating
that their businesses were or are in material violation of any law,
clearance, Company Permit, consent, guidance or guideline, or were
or are the subject of any material pending or, to the knowledge of
the Company, threatened Governmental Authority investigation,
proceeding, review or inquiry.
(d) Except as
would not result in a Material Adverse Effect, none of the Company,
any of its subsidiaries or any officers or, to the Company’s
knowledge, employees of the Company or any of its subsidiaries is
currently, or has been convicted of any crime or been debarred
pursuant to 21 U.S.C. Section 335a(a) or 21 U.S.C.
Section 335a(b) or any similar law or to the Company’s
knowledge, engaged in any conduct for which debarment is mandated
by 21 U.S.C. Section 335a(a) or any similar law or authorized
by 21 U.S.C. Section 335a(b), or been charged with or
convicted under U.S. law for conduct relating to the development or
approval, or otherwise relating to the regulation of any product
that is a drug under the Generic Drug Enforcement Act of 1992, or
any other relevant or analogous law in any applicable
jurisdiction.
(e) None of
the Company, any of its subsidiaries or any officers or, to the
Company’s knowledge, employees of the Company or any of its
subsidiaries is currently excluded from participating in the
federal health care programs under Section 1128 of the Social
Security Act or any similar law, or otherwise made ineligible to
participate in U.S. federal or state health care programs, or any
other relevant or analogous law in any applicable jurisdictions or,
to the Company’s knowledge, engaged in any conduct for which
such person could be excluded from participating in the federal
health care programs under Section 1128 of the Social Security
Act or any similar law, or otherwise made ineligible to participate
in U.S. federal or state health care programs, or any other
relevant or analogous law in any applicable jurisdictions. Except
as would not result in a Material Adverse Effect, none of the
Company, any of its subsidiaries or any officers or, to the
Company’s knowledge, employees of the Company or any of its
subsidiaries is currently, or has violated or caused a violation of
any federal or state health care fraud and abuse or false claims
statute or regulation, including, without limitation, the
Medicare/Medicaid Anti-kickback provisions of the Social Security
Act, 42 U.S.C. § 1320a-7b(b), and the relevant regulations in
42 C.F.R. Part 1001, or any other relevant or analogous law in
any applicable jurisdictions. Except as would not result in a
Material Adverse Effect, neither the Company nor any subsidiary,
nor any officer, nor, to the Company’s knowledge, employee or
agent acting on behalf of the Company or any subsidiary, has,
unless corrected in a subsequent statement, act or disclosure made
prior to the date hereof, made an untrue statement of a material
fact or fraudulent statement to the FDA or any other Governmental
Authority, failed to disclose a material fact required to be
disclosed to the FDA or any other Governmental Authority, or
committed an act, made a statement, or failed to make a statement
that, at the time such disclosure was made, would reasonably be
expected to violate the FDA policy respecting “Fraud, Untrue
Statements of Material Fact, Bribery, and Illegal
Gratuities,” set forth in 56 Fed Reg. 46191
(September 10, 1991) or any similar policy or other relevant
or analogous law in any applicable jurisdiction. Except as would
not result in a Material Adverse Effect, none of the Company, any
of its subsidiaries or any officers or, to the Company’s
knowledge, employees of the Company or any of its subsidiaries has
provided any false or fraudulent information to the Centers for
Medicare & Medicaid
13
Services, any
of its contractors, or Part D prescription drug plans, for any
purpose, including, but not limited to, coverage of any of its
products or the setting of any reimbursement rates. Except as would
not result in a Material Adverse Effect, none of the Company, any
of its subsidiaries or any officers or, to the Company’s
knowledge, employees of the Company or any of its subsidiaries has
provided any false or fraudulent information to any compendia that
are used by any Federal healthcare program to establish coverage or
payment for any of the Company’s products. Except as would
not result in a Material Adverse Effect, none of the Company, any
of its subsidiaries or any officers or, to the Company’s
knowledge, employees of the Company or any of its subsidiaries has
furnished any false or fraudulent reimbursement advice to any
actual or potential customer, or has indicated how any actual or
potential customer could profit from seeking reimbursement for any
of the Company’s products. Except as would not result in a
Material Adverse Effect, each of the Company, its
subsidiaries’ officers and, to the Company’s knowledge,
employees of the Company or any of its subsidiaries, are all in
material compliance with the PhRMA Code on Interactions with
Healthcare Professionals.
(f) The
Company and its subsidiaries have no knowledge of any material
failure (or any material investigation with respect thereto) by
them or any licensor, licensee, partner or distributor of the
Company or any of its subsidiaries to have at all times complied in
all material respects with their obligations to report accurate
pricing and other relevant information for the Company’s or
its subsidiaries’ products to a Governmental Authority and to
pricing services relied upon by a Governmental Authority or other
payors for such products.
(g) Except as
would not result in a Material Adverse Effect, no product
manufactured, tested, distributed, held and/or marketed by the
Company or any of its subsidiaries has been recalled, withdrawn,
suspended or discontinued (whether voluntarily or otherwise) since
the date such product was acquired by the Company or one of its
subsidiaries. Except as would not result in a Material Adverse
Effect, no proceedings (whether completed or pending) seeking the
recall, withdrawal, suspension or seizure of any such product or
pre-market approvals or marketing authorizations of any such
product are pending, or to the knowledge of the Company,
threatened, against the Company or any of its subsidiaries, nor
have any such proceedings been pending at any time since the date
such product was acquired by the Company or one of its
subsidiaries. The Company has provided or made available to
Purchaser all material current U.S. annual periodic reports and all
information about adverse drug experiences obtained or otherwise
received by the Company, in each case since December 31, 2005,
from any source, in the United States or outside the United States,
including information derived from clinical investigations prior to
any market authorization approvals, commercial marketing
experience, postmarketing clinical investigations, postmarketing
epidemiological/surveillance studies, reports in the scientific
literature, and unpublished scientific papers, relating to any
product or, to the Company’s knowledge, Investigational
Product manufactured, tested, distributed, held and/or marketed by
the Company, any of its subsidiaries in the possession of the
Company or any of its subsidiaries, except for any adverse drug
experiences or reports which would not result in a Material Adverse
Effect.
Section 2.13.
Tax Matters .
(a) Except as
would not reasonably be expected to have a Material Adverse Effect,
(i) all Tax Returns required to be filed with any taxing
authority by, or with respect to, the Company and its subsidiaries
have been filed, and such Company Tax Returns are correct and
complete in all material respects; (ii) the Company and its
subsidiaries have paid all Taxes shown as due and payable on such
Tax Returns; and (iii) the Company has made provision in its
financial statements for all Taxes payable by the Company and its
subsidiaries for which no Tax Return has yet been filed.
(b) There is
no action, suit, proceeding, audit or claim now pending against the
Company or any of its subsidiaries in respect of any
Tax.
14
(c) Except as
would not reasonably be expected to have a Material Adverse Effect,
the Company and its subsidiaries have withheld and paid all Taxes
required to have been withheld and paid in connection with amounts
paid or owing to any employee, independent contractor, creditor,
stockholder or other third party.
(d) For
purposes of this Agreement, (i) “ Tax ”
means any federal, state, local or foreign income, gross receipts,
property, sales, use, license, excise, franchise, employment,
payroll, withholding, alternative or add on minimum, ad valorem,
transfer or excise tax, or any other Tax, custom, duty,
governmental fee or other like assessment or charge of any kind
whatsoever, together with any interest, penalty, addition to Tax or
additional amount imposed by any governmental authority or any
obligation to pay Taxes imposed on any entity for which a party to
this Agreement is liable as a result of any indemnification
provision or other contractual obligation, and (ii) “
Tax Return ” means any return, report or similar
statement required to be filed with respect to any Tax (including
any attached schedules), including any information return, claim
for refund, amended return or declaration of estimated
Tax.
(e) Neither
the Company nor any of its subsidiaries has waived any statute of
limitations in respect of Taxes or agreed to any extension of time
with respect to a Tax assessment or deficiency.
(f) Neither
the Company nor any of its subsidiaries is party to any agreement,
contract arrangement or plan that has resulted or could result,
separately or in the aggregate, in the payment of any (i)
“excess parachute payment” within the meaning of
Section 280 of the Code (or any corresponding provision of
state, local or foreign Tax law) and (ii) amount that will not
be fully deductible as a result of Section 162(m) of the Code (or
any corresponding provision of state, local or foreign Tax
law).
(g) Notwithstanding
any other provision of this Article II , the provisions
of this Section 2.13 are the sole representations and
warranties of the Company relating to Tax, Tax Returns or any other
topic addressed in this Section 2.13 .
Section 2.14.
Intellectual Property .
(a) Except as
would not reasonably be expected to have a Material Adverse Effect,
(i) the Company and each of its subsidiaries own free and
clear of all Encumbrances (other than Permitted Encumbrances) or
have a valid and enforceable right to use all Intellectual Property
used in their businesses as currently conducted (the “
Company Intellectual Property ”); (ii) neither
the Company nor any of its subsidiaries has received any notice
since January 1, 2007 alleging that the conduct of the
business of the Company or its subsidiaries has infringed or
misappropriated the Intellectual Property of any other person or
challenging the validity or enforceability of any Company
Intellectual Property, and there is no suit, judicial, arbitral or
other similar proceeding or claim pending (or to the knowledge of
the Company, threatened) against the Company or any of its
subsidiaries or, to the knowledge of the Company, against any other
person, in which allegations to the same effect have been made;
(iii) to the knowledge of the Company, no other person is
infringing any Company Intellectual Property and (iv) to the
knowledge of the Company, the conduct of the respective businesses
of the Company and its subsidiaries does not infringe the
Intellectual Property of any other person. “ Permitted
Encumbrances ” means (i) Encumbrances for Taxes or
other governmental charges not yet due and payable or which are
being contested in good faith, (ii) mechanics’,
carriers’, warehousemen’s, workers’ and other
similar Encumbrances, (iii) Encumbrances on assets incurred to
finance the acquisition of such assets or the construction of
improvements thereon, (iv) easements, rights of way, building,
zoning and other similar encumbrances or title defects,
(v) Encumbrances on assets incurred in the ordinary course of
business and (vi) other Encumbrances that do not materially
impair the use of the underlying property in the ordinary
course.
15
(b) For
purposes of this Agreement, “ Intellectual Property
” means all patents, copyrights, trade secrets, trademarks,
trade names, service marks (including any applications for, and
registrations of any of the foregoing), ideas, concepts,
discoveries, know-how, technology, inventions, improvements,
modifications, techniques, processes, methods, operations,
products, services, models, prototypes, logos, styles, designs
(whether the design is ornamental or otherwise), computer programs
and related documentation, other works of authorship, mask works
and the like that are subject to patent, copyright, trade secret,
trademark or other intellectual property protection.
(c) Notwithstanding
any other provision of this Article II , the provisions
of this Section 2.14 are the sole representations and
warranties of the Company relating to Intellectual Property or any
other topic addressed in this Section 2.14 .
Section 2.15.
Opinion of Financial Advisor . The board of directors of the
Company has received the opinion of Houlihan Lokey Howard &
Zukin (the “ Financial Advisor ”), dated the
date of this Agreement, to the effect that, as of the date of this
Agreement, the Consideration to be received by the Company is fair
to the Company from a financial point of view.
Section 2.16.
Brokers and Other Advisors . No broker, investment banker,
financial advisor or other person, other than the Financial
Advisor, the fees and expenses of which will be paid by the
Company, is entitled to any broker’s, finder’s,
financial advisor’s or other similar fee or commission in
connection with the transactions contemplated by this Agreement
based upon arrangements made by or on behalf of the
Company.
Section 2.17.
Real Property Holding Corporation . The Company is not a
real property holding corporation within the meaning of
Section 897(c)(2) of the Code and any regulations promulgated
thereunder.
Section 2.18.
Environmental . The Company and its subsidiaries are and
have been in material compliance with all and to the
Company’s knowledge have no material liability under any
Environmental Laws (including all permits and licenses required
thereunder). “ Environmental Laws ” means all
federal, state, local, foreign, provincial laws (including common
law), statutes, regulations, and ordinances having the force or
effect of law, and all judicial and administrative orders and
determinations, concerning pollution or protection of the
environment and worker health and safety, including all those
relating to the presence, use, production, generation, handling,
transportation, treatment, storage, disposal, distribution,
labeling, testing, processing, discharge, release, threatened
release, exposure, control, or cleanup of any hazardous materials,
substances or wastes, chemical substances or mixtures, pesticides,
pollutants, contaminants, toxic chemicals, petroleum products or
byproducts, asbestos, or polychlorinated biphenyls, that were
enacted prior to the Closing Date and as they are in effect on the
Closing Date. Except as would not result in a Material Adverse
Effect, neither the Company nor any of its subsidiaries has
received any written notice of any violation of, or any material
liability under, any Environmental Law and no action, suit,
proceeding or orders are pending, or to the Company’s
knowledge, are threatened against the Company or any of its
subsidiaries pursuant to or alleging any violation or liability
under Environmental Laws.
Section 2.19.
Real Property .
(a) Neither
the Company nor any subsidiary owns any real property.
(b)
Section 2.19(b) of the Company Disclosure Schedule sets
forth the address of each parcel of leased real property and a true
and complete list of all leases for each such parcel of leased real
property. The Company has made available to Purchaser a true and
complete copy of each such lease
16
(including all
amendments, extensions, renewals and other agreements with respect
thereto). The Company has not received written notice of any
material default under any of such leases which has not been cured
or waived. The Company (or one of its subsidiaries) has a valid and
enforceable leasehold interest in each such parcel of leased real
property. Except as set forth in Section 2.19(b) of the Company
Disclosure Schedule , (i) the Company (or one of its
subsidiaries) has a valid and enforceable leasehold interest in
each such parcel of leased real property, (ii) to the
Company’s knowledge, neither the Company nor any of its
subsidiaries is in material default under such leases, and
(iii) to the Company’s knowledge, no event has occurred
that would (including upon the giving of notice or the passage of
time) constitute a material breach or material default thereunder
or allow the other party thereto to terminate or accelerate
performance under or otherwise modify any of such
leases.
(c) No
portion of such leased real property is currently being subleased,
licensed or underlet to any other party.
Section 2.20.
Tangible Personal Property . Except: (a) as set forth
on the Company Balance Sheet and (b) for Permitted
Encumbrances, the Company or one of its subsidiaries owns good and
marketable title to, free and clear of all Liens other than
Permitted Encumbrances, or has a valid and enforceable contract,
license or lease to use, all of the tangible personal property
shown on the Company Balance Sheet or acquired after the date of
the Company Balance Sheet, in each case, which is material to its
business or operations. Each such item of material personal
property is in operable condition and repair, subject to normal
wear and tear, except as would not result in a Material Adverse
Effect.
Section 2.21.
Related–Party Transactions . Except as disclosed in
the Company SEC Reports, no employee, officer, or director of the
Company or member of his or her immediate family or any affiliate
of the Company (other than a wholly-owned subsidiary of the
Company) is indebted to the Company, nor is the Company indebted
(or committed to make loans or extend or guarantee credit) to any
of them. To the Company’s knowledge, except as disclosed in
the Company SEC Reports, none of such persons has any direct or
indirect ownership interest in any firm or corporation with which
the Company is affiliated or with which the Company has a business
relationship, or any firm or corporation that competes with the
Company, except that employees, officers, or directors of the
Company and members of their immediate families may own stock in
publicly traded companies that may compete with the Company. Except
as disclosed in the Company SEC Reports, no member of the immediate
family of any officer or director of the Company is directly or
indirectly interested in any material contract with the
Company.
Section 2.22.
Company Material Contracts .
(a)
Section 2.22(a) of the Company Disclosure Schedule sets
forth a list as of the date of this Agreement of each of the
following types of written contracts to which any of the Company or
its subsidiaries is a party (collectively, the “ Company
Material Contracts ”), in each case, except to the extent
set forth in the exhibit index in a Company SEC Report:
(i) any
employment, management, severance, change in control or
indemnification arrangements or agreements with any current or
former employee of the Company or any of its subsidiaries or any
other person that has future required scheduled payments in excess
of $150,000 per annum, other than those terminable by the Company
or any of its subsidiaries on no more than 30 days notice
without material liability or obligation;
(ii) any
employee collective bargaining agreement;
17
(iii) any
agreement under which the Company or any of its subsidiaries has
advanced or loaned any amount to any of its directors, officers,
managers or employees outside of the ordinary course of
business;
(iv) any
agreement containing a covenant not to compete, exclusivity
provision, right of first or last refusal or negotiation or similar
right to any of the foregoing granted by the Company or any of its
subsidiaries in favor of a third party that materially impairs the
business of the Company and its subsidiaries as currently
conducted, taken as a whole;
(v) any
agreement relating to the licensing of any material Intellectual
Property by the Company or any of its subsidiaries to a third party
or by a third party to the Company or any of its subsidiaries or
otherwise affecting the Company’s ability to use or exploit
any material Company Intellectual Property or the Intellectual
Property rights of third parties material to the Company’s
business (in all cases, excluding agreements for commercially
available, off-the-shelf software);
(vi) any
material manufacturing or quality agreements relating to the sale
or distribution of any products of the Company;
(vii) any
material joint venture, partnership or similar
arrangement;
(viii) any
lease or similar agreement under which (a) the Company or one
of its subsidiaries is lessee of, or holds or uses, any machinery,
equipment, vehicle or other tangible personal property owned by a
third party or (b) the Company or one of its subsidiaries is a
lessor or sublessor of, or makes available for use by any third
party, any tangible personal property owned or leased by the
Company or one of its subsidiaries, in any case which has future
required scheduled payments in excess of $250,000 per
annum;
(ix) any
agreement or contract under which the Company or one of its
subsidiaries has borrowed any money or issued any note, indenture
or other evidence of Indebtedness (as defined in
Section 4.1(p) ) or guaranteed Indebtedness or
liabilities of others (other than intercompany Indebtedness among
the Company and its subsidiaries, guarantees of Indebtedness of the
Company or any of its subsidiaries, endorsements for the purpose of
collection, or purchases of equipment or materials made under
conditional sales contracts, in each case in the ordinary course of
business ) or any letter of credit issued on behalf of the Company
or any of its subsidiaries having an outstanding principal amount
in excess of $1,000,000;
(x) any
agreement for the sale or purchase of any material asset other than
in the ordinary course of business entered into since
January 1, 2008 with a purchase price in excess of
$1,000,000;
(xi) any
other agreement (including any consulting agreement), contract,
lease, license or instrument, in each case not included in clauses
(i) through (x) above or set forth on any of the other
sections of the Company Disclosure Schedule, to which the Company
or one of its subsidiaries is a party or by or to which any of
their assets are bound or subject that has a remaining term of more
than one year and is not terminable (without penalty) on notice of
12 months or less and that has future required scheduled
payments to or by the Company or one of its subsidiaries in excess
of $250,000 per annum (other than warranty obligations in the
ordinary course of business, purchase orders and
leases).
(b) The
Company has delivered to, or made available for inspection by,
Purchaser (including by filing with the SEC) a copy of each Company
Material Contract. Except as disclosed in the Company Disclosure
Schedule, each Company Material Contract is in full force and
effect, and is a valid binding
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and enforceable
obligation of the Company or its subsidiaries and, to the
Company’s knowledge, of the other parties thereto where such
failure to be so valid, binding and enforceable and in full force
and effect would not, individually or in the aggregate, constitute
a Material Adverse Effect. The Company or one of its subsidiaries,
as applicable, is not (with or without the lapse of time or the
giving of notice, or both) in material breach or default thereunder
except for those breaches or defaults that would not have a Company
Material Adverse Effect. The Company has not received any written
notice or, to the Company’s knowledge, threat of breach,
termination, cancellation or non-renewal that is currently in
effect with respect to any Company Material Contract.
Section 2.23.
Insurance . The Company maintains in full force and effect
such types and amounts of insurance issued by insurers of
recognized responsibility insuring the Company with respect to its
business and properties, in such amounts and against such losses
and risks which are usual and customary in the Company’s
business as to amount and scope.
Section 2.24.
No Illegal Payments . None of the Company, any of its
subsidiaries or, to the Company’s knowledge, any affiliate,
officer, agent or employee thereof, directly or indirectly, has,
since inception, on behalf of or with respect to the Company or any
of its subsidiaries, (a) made any unlawful domestic or foreign
political contributions, (b) made any payment or provided
services which were not legal to make or provide or which the
Company, any of its subsidiaries or any affiliate thereof or any
such officer, employee or other person should reasonably have known
were not legal for the payee or the recipient of such services to
receive, (c) received any payment or any services which were
not legal for the payer or the provider of such services to make or
provide, (d) had any material transactions or payments which
are not recorded in its accounting books and records or
(e) had any off-book bank or cash accounts or “slush
funds.”
Section 2.25.
No Additional Representations . Except as otherwise
expressly set forth in this Article II , none of the
Company, its subsidiaries or any other person acting on their
behalf makes any representation or warranty of any kind, express or
implied, in connection with the transactions contemplated by this
Agreement. Without limiting the generality of the foregoing, except
as expressly set forth in this Article II , no
representation or warranty is made by or on behalf of the Company
or its subsidiaries as to any information provided in any
management presentation, through any virtual or physical data room
or otherwise, including in respect of any financial projections,
estimates, forecasts or other data.
REPRESENTATIONS AND WARRANTIES OF
PURCHASER
Purchaser
represents and warrants to the Company as follows:
Section 3.1.
Organization . Purchaser is a corporation duly organized,
validly existing and in good standing (to the extent such concept
exists in the relevant jurisdiction) unde
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