CONFIDENTIAL
EXECUTION VERSION
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
AGREEMENT AND PLAN OF
MERGER
Onyx
Pharmaceuticals, Inc.,
a Delaware corporation;
Profiterole Acquisition
Corp.,
a Delaware corporation;
Proteolix,
Inc.,
a Delaware corporation;
Shareholder
Representative Services LLC,
a Colorado limited liability company,
as the Stockholders’ Agent.
Dated as of October 10,
2009
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
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Section
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Page
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1. Description of Transaction
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1
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1.1 Merger of Merger Sub into the
Company
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1
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1
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1.3 Closing; Effective Time
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1
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1.4 Certificate of Incorporation and Bylaws;
Directors and Officers
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2
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2
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1.6 Treatment of Stock Options
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6
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1.7 Contingent Consideration
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7
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1.8 Payment of Milestone Payments in Parent
Common Stock
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15
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17
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1.10 Exchange of Certificates
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17
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19
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2. Representations and Warranties of the
Company
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19
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2.1 Due Organization; Subsidiaries;
Etc.
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19
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2.2 Charter Documents; Records
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20
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20
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2.4 Financial Statements and Related
Information
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22
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23
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24
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25
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2.9 Equipment; Real Property
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26
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2.10 Intellectual Property
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26
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31
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2.12 Compliance with Legal
Requirements
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33
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33
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2.14 Governmental Authorizations; No
Subsidies
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35
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36
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2.16 Employee and Labor Matters; Benefit
Plans
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38
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2.17 Environmental Matters
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41
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42
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2.19 Related Party Transactions
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42
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2.20 Legal Proceedings; Orders
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42
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2.21 Authority; Binding Nature of Agreement;
Inapplicability of Anti-takeover Statutes
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43
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2.22 Non-Contravention; Consents
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43
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44
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44
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2.25 Information Statement
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i
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
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Section
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Page
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3. Representations and Warranties of Parent and
Merger Sub
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45
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45
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3.2 Non-Contravention; Consents
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45
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3.3 Authority; Binding Nature of
Agreement
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45
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45
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46
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4. Certain Covenants of the Company
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46
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4.1 Access and Investigation
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46
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4.2 Operation of the Business of the
Company
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46
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49
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49
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4.5 Termination of Certain Employee Benefit
Plans
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49
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4.6 Termination/Amendment of
Agreements
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50
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50
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50
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4.9 Net Cash Shortfall Amount
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50
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4.10 Third Quarter Financial
Statements
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50
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5. Certain Covenants of the Parties
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51
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51
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51
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52
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52
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53
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5.6 Communications with Employees
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53
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5.7 Resignation of Officers and
Directors
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53
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5.8 Amendment to Certificate of
Incorporation
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53
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5.9 Directors and Officers
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53
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5.10 Investor Representation Letters
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54
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6. Conditions Precedent to Obligations of Parent
and Merger Sub
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54
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6.1 Accuracy of Representations
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54
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6.2 Performance of Covenants
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55
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6.3 Governmental Consents
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55
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6.4 No Material Adverse Effect
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55
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55
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6.6 Certificate Amendment
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55
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6.7 Agreements and Documents
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55
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57
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57
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6.10 No Legal Proceedings
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57
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6.11 No Company Options/Warrants
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58
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6.12 Termination of Employee Plans
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58
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ii
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
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Section
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Page
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6.13 Section 280G Stockholder
Approval
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58
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6.14 Pay-Off Letters; Insider
Receivables
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58
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6.15 Securities Exemption
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58
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7. Conditions Precedent to Obligations of the
Company
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58
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7.1 Accuracy of Representations
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58
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7.2 Performance of Covenants
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59
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59
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59
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59
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59
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59
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8.2 Termination Procedures
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60
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8.3 Effect of Termination
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60
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61
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9.1 Survival of Representations, Etc.
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61
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62
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63
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64
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9.5 Defense of Third Party Claims
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64
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65
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9.7 Exercise of Remedies Other Than by
Parent
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65
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10. Miscellaneous Provisions
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66
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66
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68
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68
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69
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10.7 Counterparts and Exchanges by Electronic
Transmission or Facsimile
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69
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10.8 Governing Law; Dispute
Resolution
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69
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10.9 Assignment; Successors and
Assigns
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70
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10.10 Remedies Cumulative; Specific
Performance
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70
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70
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10.12 Waiver of Jury Trial
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71
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71
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71
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10.15 Parties in Interest
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71
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71
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10.17 Disclosure Schedule
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71
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71
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iii
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Exhibit A
Certain Definitions
Annex 1 to
Exhibit A Persons Whose Knowledge is Imputed to the
Company
Exhibit B
Form of Escrow Agreement
Exhibit C
Form of Release Agreement
Exhibit D
Dispute Resolution Procedures
Exhibit E
Form of Certificate Amendment
iv
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Agreement
and Plan of Merger
This Agreement and Plan of
Merger (the “ Agreement ”) is made
and entered into as of October 10, 2009, by and among:
Onyx Pharmaceuticals,
Inc., a Delaware corporation (“ Parent
”); Profiterole
Acquisition Corp., a Delaware corporation and a
wholly-owned subsidiary of Parent (“ Merger Sub
”); Proteolix,
Inc., a Delaware corporation (the “ Company
”); and, with respect to Sections 1.7, 1.8, 9, 10.1 and
10.15 only, Shareholder
Representative Services LLC , a Colorado limited
liability company, as the Stockholders’ Agent (as defined in
Section 10.1). Certain other capitalized terms used in this
Agreement are defined in Exhibit A .
A.
Parent, Merger Sub and the Company intend to effect a merger of
Merger Sub into the Company (the “ Merger ”) in
accordance with this Agreement and the Delaware General Corporation
Law (the “ DGCL ”). Upon consummation of the
Merger, Merger Sub will cease to exist, and the Company will become
a wholly-owned subsidiary of Parent.
B.
The respective boards of directors of Parent, Merger Sub and the
Company have approved this Agreement and the Merger.
C.
As an inducement for Parent and Merger Sub to enter into this
Agreement, concurrently with the execution and delivery hereof,
certain stockholders and/or optionees of the Company are entering
into Noncompetition and Non-Solicitation Agreements in favor of
Parent (collectively, the “ Noncompetition and
Non-Solicitation Agreements ”), which Noncompetition and
Non-Solicitation Agreements shall become effective contingent upon,
and subject to, the occurrence of the Effective Time (as defined in
Section 1.3).
D.
As an inducement for Parent and Merger Sub to enter into this
Agreement, concurrently with the execution and delivery hereof,
each of the Major Stockholders is entering into a Stockholder
Support Agreement in favor of Parent (a “ Support
Agreement ”).
The parties to
this Agreement agree as follows:
1.
Description of
Transaction
1.1 Merger of
Merger Sub into the Company. Upon the terms and subject to the
conditions set forth in this Agreement, at the Effective Time (as
defined in Section 1.3), Merger Sub shall be merged with and
into the Company, and the separate existence of Merger Sub shall
cease. The Company will continue as the surviving corporation in
the Merger (the “ Surviving Corporation
”).
1.2 Effect of
the Merger. The Merger shall have the effects set forth in this
Agreement and in the applicable provisions of the DGCL.
1.3 Closing;
Effective Time. The consummation of the transactions
contemplated by this Agreement (the “ Closing ”)
shall take place at the offices of Dewey & LeBoeuf LLP, 1950
University Avenue, East Palo Alto, California 94303 at
10:00 a.m. on a date to be designated by Parent, which
shall
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
be no later
than the second business day after the satisfaction or waiver of
the last to be satisfied or waived of the conditions set forth in
Sections 6 and 7 (other than those conditions set forth in
Sections 6.6, 6.7(e), 6.7(f), 6.7(g), 6.7(j) and 7.4(b), which
are to be satisfied at the Closing, but subject to the satisfaction
or waiver of such conditions) or at such other time and date as
Parent and the Company may designate. The date on which the Closing
actually takes place is referred to in this Agreement as the
“ Closing Date .” Contemporaneously with or as
promptly as practicable after the Closing, a properly executed
certificate of merger (the “ Certificate of Merger
”) conforming to the requirements of the DGCL shall be filed
with the Secretary of State of the State of Delaware. The Merger
shall become effective as of the time that the Certificate of
Merger is filed with and accepted by the Secretary of State of the
State of Delaware (the “ Effective Time
”).
1.4
Certificate of Incorporation and Bylaws; Directors and
Officers. Unless otherwise determined by Parent prior to the
Effective Time:
(a) except as set forth in Section 5.9 hereof, the
certificate of incorporation of the Surviving Corporation shall be
amended and restated as of the Effective Time in a form acceptable
to Parent;
(b) except as set forth in Section 5.9 hereof, the
bylaws of the Surviving Corporation shall be amended and restated
as of the Effective Time to conform to the bylaws of Merger Sub as
in effect immediately prior to the Effective Time; and
(c) the directors and officers of the Surviving Corporation
immediately after the Effective Time shall be those Persons
designated by Parent in its sole discretion.
1.5 Conversion
of Shares.
(a) Conversion . Subject to Sections 1.5(d),
1.8, 1.9 and 1.10, at the Effective Time, by virtue of the Merger
and without any further action on the part of Parent, Merger Sub,
the Company or any stockholder of the Company, each share of
Company Capital Stock outstanding immediately prior to the
Effective Time shall be converted into the right to receive from
Parent, following the surrender of the certificate representing
such share of Company Capital Stock in accordance with
Section 1.10, the following consideration:
(i) each share of Company Capital Stock held in the
Company’s treasury or owned by Parent, Merger Sub, the
Company or any direct or indirect wholly-owned subsidiary of
Parent, Merger Sub or the Company immediately prior to the
Effective Time, if any, shall be canceled without payment of any
consideration with respect thereto;
(ii) each share of Series A Preferred Stock outstanding
immediately prior to the Effective Time shall be converted into the
right to receive: (A) an amount in cash equal to: (1) the
Series A Preference Per Share Amount (as defined in
Section 1.5(b)); plus (2) the Residual Upfront Per
Share Amount (as defined in Section 1.5(b)); minus
(3) the Indemnification Escrow Contribution Amount (as defined
in Section 1.5(b)) per share of Series A Preferred Stock;
minus (4) the Expenses Escrow Contribution Amount (as
defined in Section 1.5(b)) per share of Series A
Preferred Stock; plus (B) any cash disbursements
required to be made from the Indemnification Escrow Fund with
respect to such share to the former holder thereof in accordance
with the terms of the Escrow Agreement, as and when such
disbursements are required to be made; plus
(C) any
2
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
cash
disbursements required to be made from the Expenses Escrow Fund
with respect to such share to the former holder thereof in
accordance with the terms of the Escrow Agreement, as and when such
disbursements are required to be made; plus (D) any
amounts required to be paid (or shares of Parent Common Stock to be
issued) by Parent with respect to such share to the former holder
thereof in accordance with the terms of Sections 1.7 and 1.8,
as and when such payments (or issuances) are required to be
made;
(iii) each share of Series A-1 Preferred Stock
outstanding immediately prior to the Effective Time shall be
converted into the right to receive: (A) an amount in cash
equal to: (1) the Series A-1 Preference Per Share Amount
(as defined in Section 1.5(b)); plus (2) the
Residual Upfront Per Share Amount; minus (3) the
Indemnification Escrow Contribution Amount per share of
Series A-1 Preferred Stock; minus (4) the Expenses
Escrow Contribution Amount per share of Series A-1 Preferred
Stock; plus (B) any cash disbursements required to be
made from the Indemnification Escrow Fund with respect to such
share to the former holder thereof in accordance with the terms of
the Escrow Agreement, as and when such disbursements are required
to be made; plus (C) any cash disbursements required to
be made from the Expenses Escrow Fund with respect to such share to
the former holder thereof in accordance with the terms of the
Escrow Agreement, as and when such disbursements are required to be
made; plus (D) any amounts required to be paid (or
shares of Parent Common Stock to be issued) by Parent with respect
to such share to the former holder thereof in accordance with the
terms of Sections 1.7 and 1.8, as and when such payments (or
issuances) are required to be made;
(iv) each share of Series B Preferred Stock outstanding
immediately prior to the Effective Time shall be converted into the
right to receive: (A) an amount in cash equal to: (1) the
Series B Preference Per Share Amount (as defined in
Section 1.5(b)); plus (2) the Residual Upfront Per
Share Amount; minus (3) the Indemnification Escrow
Contribution Amount per share of Series B Preferred Stock;
minus (4) the Expenses Escrow Contribution Amount per
share of Series B Preferred Stock; plus (B) any
cash disbursements required to be made from the Indemnification
Escrow Fund with respect to such share to the former holder thereof
in accordance with the terms of the Escrow Agreement, as and when
such disbursements are required to be made; plus
(C) any cash disbursements required to be made from the
Expenses Escrow Fund with respect to such share to the former
holder thereof in accordance with the terms of the Escrow
Agreement, as and when such disbursements are required to be made;
plus (D) any amounts required to be paid (or shares of
Parent Common Stock to be issued) by Parent with respect to such
share to the former holder thereof in accordance with the terms of
Sections 1.7 and 1.8, as and when such payments (or issuances)
are required to be made;
(v) each share of Series C Preferred Stock outstanding
immediately prior to the Effective Time shall be converted into the
right to receive: (A) an amount in cash equal to: (1) the
Series C Preference Per Share Amount (as defined in
Section 1.5(b)); plus (2) the Residual Upfront Per
Share Amount; minus (3) the Indemnification Escrow
Contribution Amount per share of Series C Preferred Stock;
minus (4) the Expenses Escrow Contribution Amount per
share of Series C Preferred Stock; plus (B) any
cash disbursements required to be made from the Indemnification
Escrow Fund with respect to such share to the former holder thereof
in accordance with the terms of the Escrow Agreement, as and when
such disbursements are required to be made; plus
(C) any cash disbursements required to be made from the
Expenses Escrow Fund with respect to such share to the former
holder thereof in accordance with the terms of the Escrow
Agreement, as and when such disbursements are required to be made;
plus (D) any
3
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
amounts
required to be paid (or shares of Parent Common Stock to be issued)
by Parent with respect to such share to the former holder thereof
in accordance with the terms of Sections 1.7 and 1.8, as and
when such payments (or issuances) are required to be
made;
(vi) each share of Company Common Stock outstanding
immediately prior to the Effective Time (other than those referred
to in Section 1.5(a)(i)) shall be converted into the right to
receive: (A) an amount in cash equal to : (1) the
Residual Upfront Per Share Amount; minus (2) the
Indemnification Escrow Contribution Amount per share of Company
Common Stock; minus (3) the Expenses Escrow
Contribution Amount per share of Company Common Stock; plus
(B) any cash disbursements required to be made from the
Indemnification Escrow Fund with respect to such share to the
former holder thereof in accordance with the terms of the Escrow
Agreement, as and when such disbursements are required to be made;
plus (C) any cash disbursements required to be made
from the Expenses Escrow Fund with respect to such share to the
former holder thereof in accordance with the terms of the Escrow
Agreement, as and when such disbursements are required to be made;
plus (D) any amounts required to be paid by Parent with
respect to such share to the former holder thereof in accordance
with the terms of Section 1.7, as and when such payments are
required to be made; and
(vii) each share of the common stock, par value $0.001 per
share, of Merger Sub outstanding immediately prior to the Effective
Time shall be converted into one share of common stock of the
Surviving Corporation.
The amount of
cash, if any, that each stockholder of the Company is entitled to
receive at any particular time for the shares of Company Capital
Stock held by such stockholder shall be rounded to the nearest cent
(with $0.005 being rounded upward) and computed after aggregating
the cash amounts payable at such time for all shares of each class
and series of Company Capital Stock held by such
stockholder.
(b) Definitions . For purposes of this
Agreement:
(i) The “ Aggregate Liquidation Preference
Amount ” shall be the sum of : (A) the
Series A Preference Per Share Amount multiplied by the
aggregate number of shares of Series A Preferred Stock outstanding
immediately prior to the Effective Time; plus (B) the
Series A-1 Preference Per Share Amount multiplied by the
aggregate number of shares of Series A-1 Preferred Stock
outstanding immediately prior to the Effective Time; plus
(C) the Series B Preference Per Share Amount
multiplied by the aggregate number of shares of
Series B Preferred Stock outstanding immediately prior to the
Effective Time; plus (D) the Series C Preference
Per Share Amount multiplied by the aggregate number of
shares of Series C Preferred Stock outstanding immediately
prior to the Effective Time.
(ii) The “ Aggregate Residual Upfront Consideration
Amount ” shall be: (A) the Aggregate Upfront
Transaction Value; minus (B) the Aggregate Liquidation
Preference Amount.
(iii) The “ Aggregate Upfront Transaction Value
” shall be: (A) $276,000,000; minus (B) if and
only if the Closing Date occurs on or prior to November 15,
2009, the Net Cash Shortfall Amount, if any, as set forth and
represented in the Merger Consideration Certificate (as defined in
Section 6.7(f)).
4
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(iv) The “ Expenses Escrow Amount ” shall
mean $250,000.
(v) The “ Expenses Escrow Contribution Amount
” means, with respect to each share of Company Capital Stock
held by a Non-Dissenting Stockholder and each share of Company
Common Stock subject to a Company Option, in each case outstanding
immediately prior to the Effective Time, an amount determined by
dividing : (A) the Expenses Escrow Amount; by
(B) the sum of (1) the total number of outstanding
shares of Company Capital Stock held by the Non-Dissenting
Stockholders immediately prior to the Effective Time; plus
(2) the total number of shares of Company Common Stock that
were subject to Company Options outstanding immediately prior to
the Effective Time.
(vi) The “ Fully Diluted Company Share Number
” shall be the sum of: (A) the aggregate number
of shares of Company Common Stock outstanding immediately prior to
the Effective Time (including: (1) any such shares that are
subject to a repurchase option or risk of forfeiture under any
restricted stock purchase agreement or other Contract; (2) any
such shares subject to issuance pursuant to Company Options and
Company Warrants that are exercised or deemed exercised as of
immediately prior to the Effective Time; and (3) any such
shares subject to issuance pursuant to any Company Preferred Stock
converted to Company Common Stock prior to the Effective Time);
plus (B) the aggregate number of shares of Company
Common Stock issuable upon the conversion of Company Preferred
Stock outstanding immediately prior to the Effective Time;
plus (C) the aggregate number of shares of Company
Capital Stock purchasable under or otherwise subject to Company
Options (whether vested or unvested) outstanding immediately prior
to the Effective Time; plus (D) the aggregate number of
shares of Company Capital Stock purchasable under or otherwise
subject to any rights (other than Company Options and Company
Warrants) to acquire shares of Company Capital Stock (whether or
not immediately exercisable) outstanding immediately prior to the
Effective Time; plus (E) the aggregate number of shares
of Company Common Stock issuable upon the conversion of any
convertible securities of the Company (other then shares of Company
Preferred Stock) outstanding immediately prior to the Effective
Time.
(vii) The “ Initial Indemnification Escrow
Amount ” shall mean $27,600,000.
(viii) The “ Indemnification Escrow Amount
” shall mean $31,600,000.
(ix) The “ Indemnification Escrow Contribution
Amount ” means, with respect to each share of Company
Capital Stock held by a Non-Dissenting Stockholder and each share
of Company Common Stock subject to a Company Option, in each case
outstanding immediately prior to the Effective Time, an amount
determined by dividing : (A) the Initial
Indemnification Escrow Amount; by (B) the sum of
(1) the total number of outstanding shares of Company Capital
Stock held by the Non-Dissenting Stockholders immediately prior to
the Effective Time; plus (2) the total number of shares
of Company Common Stock that were subject to Company Options
outstanding immediately prior to the Effective Time.
(x) “ Net Cash Shortfall Amount ” shall
mean the amount, if any, by which: (A) the sum (without
duplication) of (1) unpaid Company Transaction Expenses as of
immediately after the Closing and (2) $5,002,984; exceeds
(B) the amount by which the aggregate amount of all cash and
cash equivalents of the Company as of immediately after the
Closing, determined in accordance with GAAP, exceeds the
aggregate amount of all Indebtedness of the
5
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Company as of
immediately after the Closing (it being understood that all amounts
used in calculating “Net Cash Shortfall Amount” shall
be based on the amounts set forth and represented in the Merger
Consideration Certificate).
(xi) The “ Residual Upfront Per Share Amount
” shall be determined by dividing : (A) the
Aggregate Residual Upfront Consideration Amount; by
(B) the Fully Diluted Company Share Number.
(xii) The “ Series A Preference Per Share
Amount ” shall be equal to $1.00.
(xiii) The “ Series A-1 Preference Per Share
Amount ” shall be equal to $1.00.
(xiv) The “ Series B Preference Per Share
Amount ” shall be equal to $2.22.
(xv) The “ Series C Preference Per Share
Amount ” shall be equal to $2.66.
(c) Escrow Contribution . At the Effective Time,
Parent shall cause to be delivered to the Escrow Agent in
cash:
(i) as a contribution to the Indemnification Escrow Fund and
the Expenses Escrow Fund with respect to each share of Company
Capital Stock held by the Non-Dissenting Stockholders immediately
prior to the Effective Time, an amount equal to the Indemnification
Escrow Contribution Amount and the Expenses Escrow Contribution
Amount, respectively, applicable to such share of Company Capital
Stock; and
(ii) as a contribution to the Indemnification Escrow Fund
and the Expenses Escrow Fund with respect to each share of Company
Common Stock that is subject to a Company Option that is
outstanding immediately prior to the Effective Time, an amount
equal to the Indemnification Escrow Contribution Amount and the
Expenses Escrow Contribution Amount, respectively, applicable to
such share of Company Common Stock.
Each of the
Indemnification Escrow Fund and the Expenses Escrow Fund:
(A) shall be held by the Escrow Agent in accordance with the
terms of this Agreement and the terms of the Escrow Agreement;
(B) shall be held as a trust fund and shall not be subject to
any lien, attachment, trustee process or other judicial process of
any creditor of any Person; and (C) shall be held and
disbursed solely for the purposes and in accordance with the terms
of this Agreement and the Escrow Agreement.
(d) Adjustments . In the event that the Company, at
any time or from time to time between the date of this Agreement
and the Effective Time, declares or pays any dividend on Company
Capital Stock payable in Company Capital Stock or in any right to
acquire Company Capital Stock, or effects a subdivision of the
outstanding shares of Company Capital Stock into a greater number
of shares of Company Capital Stock, or in the event the outstanding
shares of Company Capital Stock shall be combined or consolidated,
by reclassification or otherwise, into a lesser number of shares of
Company Capital Stock, or a record date with respect to any of the
foregoing shall occur during such period, then the amounts payable
in respect of shares of Company Capital Stock pursuant to
Section 1.5(a) and the amounts payable in respect of shares of
Company Capital Stock subject to Company Options pursuant to
Section 1.6 shall be appropriately adjusted.
6
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
1.6 Treatment
of Stock Options . Subject to Section 1.10(h), at the
Effective Time, each Company Option that is outstanding and
unexercised immediately prior to the Effective Time, whether or not
vested, shall become fully vested immediately prior to the
Effective Time and shall be cancelled at the Effective Time and the
holder thereof shall be entitled to receive for each share of
Company Common Stock subject to such Company Option (a) an
amount in cash equal to: (i) the Residual Upfront Per Share
Amount; minus (ii) the exercise price per share of
Company Common Stock subject to such Company Option; minus
(iii) the Indemnification Escrow Contribution Amount per share
of the applicable Company Common Stock; minus (iv) the
Expenses Escrow Contribution Amount per share of the applicable
Company Common Stock; plus (b) any cash disbursements
required to be made from the Indemnification Escrow Fund with
respect to such share to the former holder of such Company Option
in accordance with the Escrow Agreement, as and when such
disbursements are required to be made; plus (c) any
cash disbursements required to be made from the Expenses Escrow
Fund with respect to such share to the former holder of such
Company Option in accordance with the Escrow Agreement, as and when
such disbursements are required to be made; plus
(d) any amounts required to be paid by Parent with respect to
such share to the former holder thereof in accordance with the
terms of Section 1.7, as and when such payments are required
to be made. Prior to the Effective Time, the Company shall take all
action that may be necessary (under the Company Option Plan or
otherwise) to effectuate the provisions of this Section 1.6.
and to ensure that, from and after the Effective Time, each holder
of an outstanding Company Option cancelled as provided in this
Section 1.6 shall cease to have any rights with respect
thereto, except the right to receive the consideration specified in
this Section 1.6 without interest.
1.7 Contingent
Consideration .
(a) Definitions . For purposes of this
Section 1.7:
(i) “ 003-A1 Study ” shall mean that
human clinical study of the Product referred to internally by the
Company as PX-171-003-A1, which is ongoing as of the date of this
Agreement, in relapsed and refractory multiple myeloma
patients.
(ii) “009 Study ” shall mean the planned
human clinical study of the Product referred to internally by the
Company as PX-171-009 in relapsed multiple myeloma
patients.
(iii) “011 Study ” shall mean the planned
human clinical study of the Product referred to internally by the
Company as PX-171-011 in relapsed and refractory multiple myeloma
patients.
(iv) “ Agreed Trial Design ” with respect
to the 003-A1 Study, 009 Study and 011 Study shall mean a human
clinical study of the Product that reflects, in all material
respects, the material elements for such study as described in the
protocol summary for such study agreed between Parent and the
Company as of the date of this Agreement.
(v) “ Applicable Efforts ” shall mean
those efforts and resources consistent with the usual practice of
Parent and its Subsidiaries in pursuing, in a reasonably timely
manner, the development and approval of its own pharmaceutical
products that are of similar market potential and strategic value
to the Product, taking into account relevant factors including
product labeling or anticipated labeling, market potential, past
performance of the Product, medical and clinical considerations,
safety and tolerability profile, present and future regulatory
environment and competitive conditions, all as measured by the
facts and circumstances at the time such
7
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
efforts are
due; provided, however, that in no event shall
Parent’s obligation to use Applicable Efforts ever require
Parent to conduct any registrational studies other than the 003-A1
Study, the 011 Study and the 009 Study.
(vi) “ Contingent Payment Shares ” of a
particular Participating Securityholder shall mean: (A) each
outstanding share of Company Capital Stock held by such
Participating Securityholder immediately prior to the Effective
Time; and (B) each share of Company Common Stock subject to
outstanding Company Options held by such Participating
Securityholder immediately prior to the Effective Time.
(vii) “ MAA ” shall mean a marketing
authorization application filed with the EMEA.
(viii) A “ Material Modification ”
to the Agreed Trial Design for the 003-A1 Study, 009 Study or 011
Study shall mean a material modification to such Agreed Trial
Design, other than any Permitted Modification to the Agreed Trial
Design for such study.
(ix) “ Milestone Event 2 Termination Date
” shall mean [ * ]; provided, however, that
(A) if Milestone Event 2 has not occurred by [ * ], and such
failure to occur by [ * ] is due to (1) a request by the FDA
for an updated safety database, or to allow the FDA to hold an
advisory committee meeting, or to complete either clinical or
manufacturing audits or to finalize the prescribing information
content, (2) a request by the FDA for Parent to further
analyze, format or submit Product data available from studies at
the time of such request or (3) an extension by the FDA of the
PDUFA action date with respect thereto, then the Milestone Event 2
Termination Date shall be extended until [ * ]; or (B) if
Parent implements a Material Modification to the Agreed Trial
Design for the 011 Study, the Milestone Event 2 Termination Date,
as may be extended in accordance with clause “(A)”,
will be extended further by the time period equal to the
difference, in days, between (1) the expected date of
completion (measured by the date of last visit of the last patient
enrolled) of the 011 Study, under the Agreed Trial Design for such
study (as modified by any Permitted Modifications) and (2) the
actual date of completion (measured by the date of last visit of
the last patient enrolled) of the 011 Study as implemented with
such Material Modification.
(x) “ Milestone Event ” shall mean each
event referred to in the chart in Section 1.7(b) under the
heading “Milestone Event”.
(xi) “ Milestone Payment ” shall mean any
payment that becomes due and payable upon the occurrence of a
Milestone Event pursuant to Section 1.7(b).
(xii) “ Milestone Termination Date ”
means, with respect to each Milestone Event other than Milestone 1,
the date for completion of such event in the chart set forth in
Section 1.7(b).
(xiii) “ NDA ” shall mean a new drug
application filed with the FDA.
(xiv) A “ Permitted Modification ” to the
Agreed Trial Design for the 003-A1 Study, 009 Study or 011 Study
shall mean a modification to the Agreed Trial Design for such
study: (A) that a Regulatory Authority clearly indicates in
writing or in such Regulatory
8
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Authority’s minutes of an oral meeting is
required for such Regulatory Authority to grant Regulatory Approval
based on the results of such study; (B) with respect to the
011 Study only, that is required to obtain the approval of a
sufficient number of institutional review boards (as described in
21 CFR 56), or any similar bodies in the European Union, that would
reasonably be expected to allow Parent to (1) conduct and
complete the 011 Study and (2) be in a position to submit the
MAA referred to in Section 1.7(h)(ii)(B) to CHMP by [ * ];
(C) with respect to the 011 Study only, that is required to
address a negative public reaction to the 011 Study in the medical
or general community in such a manner as would reasonably be
expected to allow Parent to (1) conduct and complete the 011
Study and (2) be in a position to submit the MAA referred to
in Section 1.7(h)(ii)(B) to CHMP by [ * ]; or (D) with
respect to the 011 Study only, that would not, individually or in
the aggregate with all other modifications that are not otherwise
excluded pursuant to clause “(A),” clause
“(B)” or clause “(C)” of this sentence,
reasonably be expected to have, and does not in fact have, an
adverse impact on the achievement by Parent of Milestone Event 2 or
Milestone Event 3.
(xv) “ Related Milestone Event ” shall
mean: (A) with respect to the 001-A3 Study, Milestone Event 2
and Milestone Event 3; (B) with respect to the 011 Study,
Milestone Event 3; and (C) with respect to the 009 Study,
Milestone Event 4 and Milestone Event 5.
(xvi) “ Technical Failure ” shall mean
Parent’s reasonable determination that the Product presents
unacceptable levels of safety risks such that Parent terminates
development of the Product.
(b) Milestone Events and Milestone Payments . Upon
the occurrence of any of the Milestone Events set forth in the
chart below under the heading “Milestone Event,” the
Milestone Payment set forth opposite such Milestone Event in the
chart below shall become due and payable in accordance with
Section 1.7(c):
9
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
|
|
|
|
|
|
|
Milestone Event
|
|
Milestone Payment
|
The occurrence
of the date that is 180 days after the date of the final
patient’s first visit (as determined pursuant to the protocol
for the 003-A1 Study as of the date of this Agreement) in the
003-A1 Study (the occurrence of the date that is 180 days
after the date of such patient’s first visit, “
Milestone Event 1 ”)
|
|
$
|
40,000,000
|
|
|
|
|
|
|
|
Regulatory
Approval by the FDA, on or before the Milestone Event 2 Termination
Date, of the Product as therapy in treating relapsed/refractory
multiple myeloma based on the results of the 003-A1 Study and/or
the 011 Study (“ Milestone Event 2 ”)
|
|
$
|
170,000,000
|
|
|
|
|
|
|
|
Regulatory
Approval by the EMEA, on or before [ * ], of the Product as therapy
in treating relapsed/refractory multiple myeloma based on the
results of the 011 Study and/or the 003-A1 Study (“
Milestone Event 3 ”)
|
|
$
|
65,000,000
|
|
|
|
|
|
|
|
Regulatory
Approval by the FDA, on or before [ * ], of the Product as therapy
in treating relapsed multiple myeloma based on the results of the
009 Study (“ Milestone Event 4 ”)
|
|
$
|
150,000,000
|
|
|
|
|
|
|
|
Regulatory
Approval by the EMEA, on or before [ * ], of the Product as therapy
in treating relapsed multiple myeloma based on the results of the
009 Study (“ Milestone Event 5 ”)
|
|
$
|
150,000,000
|
|
For purposes of
the foregoing Milestone Events, where such event is referred to as
being based on the results of the 003-A1 Study, the 011 Study or
the 009 Study, as the case may be, it is understood that such
reference includes any Permitted Modification or Material
Modification, or other modification to such study, as may be
implemented in accordance with this Section 1.7.
In the event
that: (1) Parent does not conduct and/or complete the 011
Study; (2) Parent elects to conduct another study in Europe;
and (3) the EMEA grants Regulatory Approval, on or before [ *
], of the Product as therapy in treating relapsed/refractory
multiple myeloma based on the results of such other study and/or
the 003-A1 Study, the Milestone Payment that would otherwise have
become due and payable upon the occurrence of Milestone Event 3
shall instead become due and payable upon the occurrence of such
Regulatory Approval.
Notwithstanding
anything to the contrary contained in this Agreement, each
Milestone Payment is payable one time only, regardless of the
number of Products that satisfy the condition or the number of
indications for which the condition is satisfied.
(c) Distribution of Milestone Payments .
(i) Subject to Section 1.10(h) and to the
Stockholders’ Agent’s rights pursuant to
Section 10.1(d), if the Milestone Payment that becomes due and
payable upon the occurrence of Milestone Event 1 (the “
First Milestone Payment ”) becomes due and
payable
10
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
pursuant to
Section 1.7(b), Parent shall: (A) pay to each
Participating Securityholder (or, at Parent’s election, cause
the Payment Agent (as defined in Section 1.10(a)) to deliver
to each Participating Securityholder), within seven business days
following the achievement of Milestone Event 1, in respect of each
Contingent Payment Share of such Participating Securityholder, an
amount determined by dividing $36,000,000 by the Fully Diluted
Share Number; and (B) cause to be delivered to the Escrow
Agent as a contribution to the Indemnification Escrow Fund with
respect to each Contingent Payment Share of such Participating
Securityholder, an amount equal to $4,000,000 divided by the
aggregate number of Contingent Payment Shares held by all
Participating Securityholders.
(ii) Subject to Parent’s rights pursuant to
Sections 1.8 and 9.6 and the Stockholders’ Agent’s
rights pursuant to Section 10.1(d), if any other Milestone
Payment becomes due and payable pursuant to Section 1.7(b),
Section 1.7(d) or Section 1.7(i), Parent shall pay to
each Participating Securityholder (or, at Parent’s election,
cause the Payment Agent to deliver to each Participating
Securityholder), within 25 Trading Days following the achievement
of the Milestone Event applicable to such Milestone Payment, in
respect of each Contingent Payment Share of such Participating
Securityholder, an amount determined by dividing such Milestone
Payment by the Fully Diluted Share Number.
(d) Acceleration of Milestone Payments .
Notwithstanding anything to the contrary in this Agreement,
immediately upon the occurrence of a Specified Bankruptcy Event, to
the extent not previously paid, 100% of the Milestone Payments as
to which a Milestone Termination Date has not yet occurred shall
become due and payable; provided, however , that in a case
under title 11 of the United States Code, if Parent or the
Surviving Corporation assumes this Agreement in accordance with
section 365 of title 11 of the United States Code and cures any and
all outstanding defaults, including any and all monetary and
non-monetary defaults, within five business days of entry of an
order authorizing such assumption, then any Milestone Payments as
to which a Milestone Termination Date has not yet occurred shall
not be deemed accelerated in accordance with this
Section 1.7(d), but shall remain due and payable in accordance
with the deadlines and subject to the conditions set forth in
Sections 1.7(b) and 1.7(i). Nothing in this Agreement shall be
construed, explicitly or implicitly, as consent or agreement by or
on behalf of the Stockholders’ Agent or the Participating
Securityholders to any proposed action by the Parent or the
Surviving Corporation in a bankruptcy proceeding, including any
proposed assumption, assumption and assignment or other disposition
of this Agreement.
(e) Milestone Payments Generally . The parties
acknowledge and agree that Parent’s or the Surviving
Corporation’s achievement of the Milestone Events are
material factors in determining the valuation of the Company by
Parent. Therefore, except as provided in Sections 1.7(d) or
1.7(i), the Participating Securityholders shall have no right to
receive any particular Milestone Payment (or any portion thereof)
unless and until the particular Milestone Event that must be
achieved in order for the Participating Securityholders to receive
such Milestone Payment is achieved by the applicable Milestone
Termination Date as determined pursuant to this
Section 1.7.
(f) Milestone Rights Not Transferable . The right of
any Participating Securityholder to receive any Milestone Payment:
(i) does not give the Participating Securityholder dividend
rights, voting rights, liquidation rights, preemptive rights or
other rights of holders of capital stock of the Surviving
Corporation; (ii) shall not be evidenced by a certificate or
other instrument; (iii) shall not be assignable or otherwise
transferable by such Participating Securityholder, except by will,
upon death or by operation of law; (iv) shall not accrue or
pay interest on any portion thereof; and (v) does not
represent
11
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
any right other
than the right to receive the consideration set forth in this
Section 1.7 and Section 1.8. Any attempted transfer of
the right to any Milestone Payment by any holder thereof (other
than as specifically permitted by the immediately preceding
sentence) shall be null and void.
(g)
Information Obligations . Subject to the Stockholders’
Agent first entering into a confidentiality agreement with Parent
in form and substance reasonably satisfactory to Parent containing
restrictions on the use and disclosure of confidential information
of Parent or its affiliates, for so long as one or more Milestone
Payments may reasonably become payable: (x) (i) during the period
commencing on the date that is three months following the Closing
Date and ending on the date of acceptance of the NDA described in
Section 1.7(h)(i) or, if applicable, Section 1.7(i)(ii)(1)
(the “ Acceptance Date ”), Parent shall provide,
on a quarterly basis, a written report to the Stockholders’
Agent in reasonable detail regarding the technical development of
the Products and the status of efforts to achieve the Milestone
Payments (each such report, an “ Update Report
”); and (ii) after the Acceptance Date, Parent shall
provide an Update Report to the Stockholders’ Agent on a
semi-annual basis; and (y) Parent shall notify the
Stockholders’ Agent of a proposed implementation of a
material modification to the Agreed Trial Design for the 003-A1
Study, 009 Study or 011 Study at least 30 days prior to any
such implementation (unless a patient safety issue requires any
such material modification to be implemented in less than 30 days,
in which case Parent shall provide such notice to the
Stockholders’ Agent as soon as is practicable) and shall
notify the Stockholders’ Agent that such material
modification has been implemented within 10 days after any
such implementation (each such report, a “ Material
Modification Report ”) and (z) Parent shall notify
the Stockholders’ Agent within five business days after the
date on which any Milestone Payment becomes payable. Within
30 days after delivery of an Update Report, or within
10 days after delivery of a Material Modification Report, if
the Stockholders’ Agent requests a meeting with
representatives of Parent to discuss such report, Parent shall use
its commercially reasonable efforts to make available for such a
meeting those of its senior medical and regulatory employees as are
responsible for the applicable activities set forth in the Update
Report or Material Modification Report. Provided that Parent has
made available to the Stockholders’ Agent at the requested
meeting those employees of Parent as the Stockholders’ Agent
may have reasonably requested, the Stockholders’ Agent may
not request more than one such meeting for any Update Report or
Material Modification Report. All information contained in any
Update Report or Material Modification Report, or conveyed to the
Stockholders’ Agent in any meeting regarding an Update Report
or Material Modification Report, shall be subject to the
confidentiality agreement between Parent and the
Stockholders’ Agent.
(h) Applicable Efforts . Subject to
Section 1.7(i), commencing upon the Closing, Parent and its
Subsidiaries shall use Applicable Efforts to implement and conduct
all research, development and clinical manufacturing activities
for, and regulatory activities with respect to, the Product (which
may include activities conducted through third parties) that are
components of or directly related to or required for the
achievement of the Milestone Events by the applicable Milestone
Termination Dates. Without limiting and notwithstanding the
foregoing, subject to Section 1.7(i), commencing upon the
Closing, Parent and its Subsidiaries shall:
(i) with respect to Milestone Event 2 only: (A) conduct
and complete the 003-A1 Study based on the Agreed Trial Design for
such study (as modified by any Permitted Modifications);
(B) submit the NDA for the Product for the Milestone Event 2
indication to the FDA by [ * ] and use Applicable Efforts to cause
such NDA to be accepted for filing by the FDA, provided in each
case that Parent determines in its reasonable discretion that
Milestone Event 2 would reasonably be expected to be achieved based
upon the outcome of the relevant studies; and (C) if Parent
was required to submit the NDA referred to in clause
“(B)” above to the FDA, use
12
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Applicable
Efforts to obtain Regulatory Approval for the Product for the
Milestone Event 2 indication such that Milestone Event 2 would
reasonably be expected to be achieved on or before the Milestone
Event 2 Termination Date;
(ii) with respect to Milestone Event 3 only: (A) use
Applicable Efforts to conduct and complete the 011 Study based on
the Agreed Trial Design for such study (as modified by any
Permitted Modifications); (B) submit the MAA for the Product
for the Milestone Event 3 indication to the EMEA’s Committee
for Medicinal Products for Human Use (“ CHMP ”)
by [ * ] and use Applicable Efforts to cause the designation of day
0 of the MAA review clock by EMEA with respect to such MAA,
provided in each case that there is a reasonable basis for
submission thereof based upon the outcome of the relevant studies;
and (C) if Parent was required to submit the MAA referred to
in clause “(B)” above to CHMP, use Applicable Efforts
to obtain Regulatory Approval for the Product for the Milestone
Event 3 indication such that Milestone Event 3 would reasonably be
expected to be achieved on or before [ * ];
(iii) with respect to Milestone Event 4 only:
(A) conduct and complete the 009 Study based on the Agreed
Trial Design for such study (as modified by any Permitted
Modifications); (B) complete the interim analysis for the 009
Study using the Independent Review Committee as contemplated by the
Agreed Trial Design for such study; (C) complete the final
analysis for the 009 Study using the Independent Review Committee
as contemplated by the Agreed Trial Design for such study;
(D) submit the NDA for the Product for the Milestone Event 4
indication to the FDA by [ * ] and use Applicable Efforts to cause
such NDA to be accepted for filing by the FDA, provided in each
case that there is a reasonable basis for submission thereof based
upon the outcome of the relevant studies; and (E) if Parent
was required to submit the NDA referred to in clause
“(D)” above to the FDA, use Applicable Efforts to
obtain Regulatory Approval for the Product for the Milestone Event
4 indication such that Milestone Event 4 would reasonably be
expected to be achieved on or before [ * ]; and
(iv) with respect to Milestone Event 5 only:
(A) conduct and complete the 009 Study based on the Agreed
Trial Design for such study (as modified by any Permitted
Modifications); (B) complete the interim analysis for the 009
Study using the Independent Review Committee as contemplated by the
Agreed Trial Design for such study; (C) complete the final
analysis for the 009 Study using the Independent Review Committee
as contemplated by the Agreed Trial Design for such study;
(D) submit the MAA for the Product for the Milestone Event 5
indication to CHMP by [ * ] and use Applicable Efforts to cause the
designation of day 0 of the MAA review clock by EMEA with respect
to such MAA, provided in each case that there is a reasonable basis
for submission thereof based upon the outcome of the relevant
studies; and (E) if Parent was required to submit the MAA
referred to in clause “(D)” above to CHMP, use
Applicable Efforts to obtain Regulatory Approval for the Product
for the Milestone Event 5 indication such that Milestone Event 5
would reasonably be expected to be achieved on or before [ *
].
The provisions
of this Section 1.7(h) with respect to any specified Milestone
Event shall terminate and be of no further force and effect upon
the earliest of: (i) the payment of the applicable Milestone
Payment pursuant to Section 1.7(c), Section 1.7(d) or
Section 1.7(i)(i); (ii) the occurrence of the applicable
Milestone Termination Date; and (iii) the occurrence of a
Technical Failure (it being understood that if a Technical Failure
occurs, then all provisions in Section 1.7(h) shall terminate with
respect to all Milestone Events). Notwithstanding anything to the
contrary in this Agreement, but subject to
Section 1.7(i),
13
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Parent, the
Company and the Stockholders’ Agent hereby acknowledge and
agree that no failure by Parent or its Subsidiaries to complete any
of the actions referenced in this Section 1.7(h) by the
specified date shall, in and of itself, be the basis of any claim
relating to any alleged breach of this Agreement by Parent, where
Parent has undertaken Applicable Efforts to achieve such actions
within such specified timeframe.
(i) Failure to Achieve Milestone Events .
(i) If: (A) a Milestone Event is not satisfied by the
applicable Milestone Termination Date; (B) prior to the
occurrence of the applicable Milestone Termination Date, other than
with respect to a Material Modification to the applicable Agreed
Trial Design (which shall be subject to Section 1.7(i)(ii)),
Parent breached its obligations under Section 1.7(h) with
respect to such Milestone Event, including by the failure by Parent
or its Subsidiaries to complete any of the actions referenced in
Section 1.7(h) by the date specified therefor; and
(C) the Stockholders’ Agent demonstrates that
Parent’s breach was a direct and primary cause of the failure
of such Milestone Event to be satisfied prior to the applicable
Milestone Termination Date, then the Milestone Payment that would
otherwise have become due and payable upon the satisfaction of such
Milestone Event (but no other Milestone Payment) shall immediately
become due and shall be payable in accordance with
Section 1.7(c).
(ii) If Parent implements a Material Modification to the
Agreed Trial Design for the 003-A1 Study, 009 Study or 011 Study,
then (x) the Milestone Termination Date(s) applicable to such
study’s Related Milestone Event(s) (but no other Milestone
Event) shall cease to be applicable, and the Milestone Payment(s)
that would become due and payable upon the satisfaction of such
Milestone Event(s) (but no other Milestone Payment) shall become
due and payable in accordance with Section 1.7(c) upon the
occurrence of the Milestone Event(s) (without regard to the
Milestone Termination Date contemplated thereby) at any time and
(y) the obligations of Parent set forth in Sections 1.7(h)(i)
through (iv) shall cease to be applicable with respect to such
study’s Related Milestone Event(s) (but no other Milestone
Event) and shall thereafter be replaced with the following
obligations, as applicable:
(1) with respect to Milestone Event 2 only: (A) conduct
and complete the 003-A1 Study based on the Agreed Trial Design for
such study, as modified, using Applicable Efforts; (B) submit
the NDA for the Product for the Milestone Event 2 indication to the
FDA and use Applicable Efforts to cause such NDA to be accepted for
filing by the FDA on or before the date that is 9 months after
the last patient’s last visit in the 003-A1 Study, provided
in each case that Parent determines in its reasonable discretion
that Milestone Event 2 (without regard to the Milestone Termination
Date contemplated thereby) would reasonably be expected to be
achieved based upon the outcome of the relevant studies; and
(C) if Parent was required to submit the NDA referred to in
clause “(B)” above to the FDA, use Applicable Efforts
to obtain Regulatory Approval for the Product for the Milestone
Event 2 indication such that Milestone Event 2 would reasonably be
expected to be achieved;
(2) with respect to Milestone Event 3 only: (A) conduct
and complete the 011 Study, based on the Agreed Trial Design for
such study, as modified, using Applicable Efforts and, if a
Material Modification is made to the 003-A1 Study, the 003-A1
Study, based on the Agreed Trial Design for such study, as
modified, using
14
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Applicable
Efforts; (B) submit the MAA for the Product for the Milestone
Event 3 indication to the CHMP and use Applicable Efforts to cause
the designation of day 0 of the MAA review clock by EMEA with
respect to such MAA on or before the date that is 9 months
after the last patient’s last visit in the 011 Study,
provided in each case that there is a reasonable basis for
submission thereof based upon the outcome of the relevant studies;
and (C) if Parent was required to submit the MAA referred to
in clause “(B)” above to CHMP, use Applicable Efforts
to obtain Regulatory Approval for the Product for the Milestone
Event 3 indication such that Milestone Event 3 would reasonably be
expected to be achieved;
(3) with respect to Milestone Event 4 only: (A) conduct
and complete the 009 Study based on the Agreed Trial Design for
such study, as modified, using Applicable Efforts;
(B) complete the interim analysis for the 009 Study using the
Independent Review Committee as contemplated by the Agreed Trial
Design for such study, as modified; (C) complete the final
analysis for the 009 Study using the Independent Review Committee
as contemplated by the Agreed Trial Design for such study, as
modified; (D) submit the NDA for the Product for the Milestone
Event 4 indication to the FDA and use Applicable Efforts to cause
such NDA to be accepted for filing by the FDA on or before the date
that is 9 months after the last patient’s last visit in
the 009 Study, provided in each case that there is a reasonable
basis for submission thereof based upon the outcome of the relevant
studies; and (E) if Parent was required to submit the NDA
referred to in clause “(D)” above to the FDA, use
Applicable Efforts to obtain Regulatory Approval for the Product
for the Milestone Event 4 indication such that Milestone Event 4
would reasonably be expected to be achieved; and
(4) with respect to Milestone Event 5 only: (A) conduct
and complete the 009 Study based on the Agreed Trial Design for
such study, as modified, using Applicable Efforts;
(B) complete the interim analysis for the 009 Study using the
Independent Review Committee as contemplated by the Agreed Trial
Design for such study, as modified; (C) complete the final
analysis for the 009 Study using the Independent Review Committee
as contemplated by the Agreed Trial Design for such study, as
modified; (D) submit the MAA for the Product for the Milestone
Event 5 indication to CHMP and use Applicable Efforts to cause the
designation of day 0 of the MAA review clock by EMEA with respect
to such MAA on or before the date that is 9 months after the
last patient’s last visit in the 009 Study, provided in each
case that there is a reasonable basis for submission thereof based
upon the outcome of the relevant studies; and (E) if Parent
was required to submit the MAA referred to in clause
“(D)” above to CHMP, use Applicable Efforts to obtain
Regulatory Approval for the Product for the Milestone Event 5
indication such that Milestone Event 5 would reasonably be expected
to be achieved.
For greater
clarity, a Permitted Modification to the Agreed Trial Design for
the 003-A1 Study, 009 Study or 011 Study shall not constitute a
Material Modification to such Agreed Trial Design. The provisions
of Section 1.7(i)(ii) with respect to any specified Milestone
Event shall terminate and be of no further force and effect upon
the earliest of: (i) the payment of the applicable Milestone
Payment pursuant to Section 1.7(c), Section 1.7(d) or
Section 1.7(i)(i); and (ii) the occurrence of a Technical
Failure (it being understood that if a Technical Failure occurs,
then all provisions in Section 1.7(i)(ii) shall terminate with
respect to all Milestone Events). Notwithstanding anything to the
contrary in this Agreement, Parent, the
15
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Company and the
Stockholders’ Agent hereby acknowledge and agree that no
failure by Parent or its Subsidiaries to complete any of the
actions referenced in Section 1.7(i)(ii)(1), Section
1.7(i)(ii)(2), Section 1.7(i)(ii)(3) or
Section 1.7(i)(ii)(4) by the specified date shall, in and of
itself, be the basis of any claim relating to any alleged breach of
this Agreement by Parent, where Parent has undertaken Applicable
Efforts to achieve such actions within such specified
timeframe.
1.8 Payment of
Milestone Payments in Parent Common Stock .
(a) Definitions . For purposes of this
Section 1.8:
(i) “ Participating Preferred Securityholders
” shall mean each of the Participating Securityholders that
held shares of Company Preferred Stock immediately prior to the
Effective Time.
(ii) “ Principal Market ” shall mean the
principal trading market or quotation system for shares of Parent
Common Stock at any applicable time.
(iii) “ SEC ” shall mean the Securities
and Exchange Commission.
(iv) “ Share Issuance Amount ” shall mean
the portion (expressed in dollars) of the applicable Milestone
Payment that Parent elects to satisfy by issuing shares of Parent
Common Stock to each of the Participating Preferred
Securityholders.
(v) “ Share Payment Closing Date ” shall
mean the date on which a Milestone Payment as to which Parent has
delivered a Share Payment Notice is distributed pursuant to
Section 1.7(c).
(vi) “ Share Payment Notice ” shall mean
a notice delivered by Parent to Participating Preferred
Securityholders of Parent’s election to issue shares of
Parent Common Stock pursuant to the provisions of this
Section 1.8 in satisfaction of all or a portion of the
applicable Milestone Payment.
(vii) “ Trading Day ” means any day on
which the Parent Common Stock is traded for at least two hours on
the Principal Market.
(viii) “ Volume Weighted Average Price ”
for the Parent Common Stock with respect to each Share Payment
Closing Date means the average of the daily volume-weighted average
prices for a share of Parent Common Stock on the Principal Market
during the period beginning at 9:30 a.m., New York City time, and
ending at 4:00 p.m., New York City time, as reported by Bloomberg,
over the 10-Trading Day period commencing on the sixth Trading Day
following the public announcement by Parent of achievement of the
applicable Milestone Event (adjusted as appropriate to reflect any
stock split, reverse stock split or similar transaction effected by
Parent between the commencement of such period and the Stock
Payment Closing Date).
(b) Right to Make Share Issuance . Subject to
Section 1.8(e) below, in lieu of making any Milestone Payment
(other than the First Milestone Payment) to the Participating
Preferred Securityholders in cash, except in connection with an
acceleration of any Milestone Payment pursuant to
16
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Section 1.7(d), Parent may elect to satisfy
all or any portion of such Milestone Payment that is owed to the
Participating Preferred Securityholders by the issuance to the
Participating Preferred Securityholders of shares of Parent Common
Stock (a “ Share Issuance ”) in accordance with
the provisions of this Section 1.8; provided, however,
that in no event shall Parent issue, or be obligated to issue,
shares of Parent Common Stock in payment of all or any portion of
any Milestone Payment if the issuance of such shares would require
or would have required the approval of Parent’s stockholders
under applicable rules of the Principal Market or other Legal
Requirements.
(c) Exercise of Right to Make Share Issuance . No
less than 15 Trading Days prior to the Share Payment Closing Date,
Parent may deliver to the Participating Preferred Securityholders
the Share Payment Notice. The Share Payment Notice shall be
irrevocable and shall specify the Share Issuance Amount. Parent
agrees that if Parent delivers a Share Payment Notice, Parent
shall, to the extent not previously publicly announced, publicly
announce the achievement of the Milestone Event with respect to the
applicable Milestone Payment by no later than 9:30 a.m., New York
City time, on the Trading Day that is 15 Trading Days prior to the
Share Payment Closing Date.
(d) Share Issuance Closing . On the Share Payment
Closing Date, subject to Section 1.8(f), Parent shall:
(i) issue to each Participating Preferred Securityholder, with
respect to each share of Company Preferred Stock held by such
Participating Preferred Securityholder immediately prior to the
Effective Time, a fraction of a share of Parent Common Stock having
a numerator equal to the Share Issuance Amount and having a
denominator determined by multiplying the aggregate number of
shares of Company Preferred Stock held by the Participating
Preferred Securityholders immediately prior to the Effective Time
by the Volume Weighted Average Price; and (ii) reduce the
amount of cash otherwise payable in respect of each share of
Company Preferred Stock in connection with the payment of such
Milestone Payment pursuant to Section 1.7(c) by subtracting
from such amount the amount determined by dividing (A) the
Share Issuance Amount by (B) the aggregate number of shares of
Company Preferred Stock held by the Participating Preferred
Securityholders immediately prior to the Effective Time. By no
later than 5:30 p.m., New York City time, on each Share Payment
Closing Date, Parent shall cause its transfer agent to
electronically transmit the applicable Milestone Shares, by
crediting the account of each Participating Preferred
Securityholder’s broker (as specified by such Participating
Preferred Securityholder no later than two Trading Days prior to
the Share Payment Closing Date) with DTC through its Deposit
Withdrawal Agent Commission (DWAC) system.
(e) Limitations on Share Issuances . It shall be a
condition precedent to any Share Issuance on any Share Payment
Closing Date that the shares of Parent Common Stock to be issued in
such Share Issuance shall as of such Share Payment Closing Date:
(i) be freely transferable without restriction under
applicable securities laws by the Participating Preferred
Securityholders, without any requirement for any further delivery
of any opinion of counsel or other instruction to Parent’s
transfer agent by Parent or otherwise, except to the extent that a
Participating Securityholder is an affiliate of Parent as of such
Share Payment Closing Date; (ii) have been duly authorized by
all necessary corporate action; (iii) be listed for trading on
a national securities exchange or quotation system in the United
States; and (iv) be validly issued, fully paid and
nonassessable. If Parent determines that registration of the shares
to be issued to the Participating Preferred Securityholders for
resale pursuant to a registration statement under the Securities
Act (as defined in Exhibit D ) is required for such
shares to meet the requirements set forth in
Section 1.8(e)(i), then the Stockholders’ Agent shall
use reasonable efforts to facilitate the negotiation, and the
execution and delivery by the Participating Preferred
Securityholders, of a customary registration rights agreement
relating thereto.
17
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(f) No Fractional Shares . No fractional shares of
Parent Common Stock shall be issued pursuant to this Agreement, and
no certificates or scrip for any such fractional shares shall be
issued. Any Participating Securityholder who would otherwise be
entitled to receive a fraction of a share of Parent Common Stock in
a Share Issuance (after aggregating all fractional shares of Parent
Common Stock issuable to such Participating Securityholder in such
Share Issuance) shall, in lieu of such fraction of a share, be paid
in cash the amount, rounded to the nearest whole cent (with $0.005
being rounded upward), without interest, determined by multiplying
such fraction by the closing price of a share of Parent Common
Stock on the Principal Market on the date of issuance of such share
of Parent Common Stock.
(g) Successors . In the event that a Person purchases
either (i) all of the issued and outstanding shares of capital
stock, or (ii) all or substantially all of the assets of
Parent or the Surviving Corporation in a transaction in which
Parent assigns its rights under Section 1.7 to such Person in
accordance with Section 10.9, in the case of clauses
“(i)” and “(ii)” all references to Parent
contained in this Section 1.8 shall be deemed to instead refer
to such Person, and all references to Parent Common Stock shall be
deemed to instead refer to shares of common stock shares (or any
equivalent class of shares) of such Person.
(a) Effect on Dissenting Shares . Notwithstanding any
provisions of this Agreement to the contrary, shares of Company
Capital Stock held by a holder who has demanded and perfected such
demand for appraisal of such holder’s shares of Company
Capital Stock in accordance with Section 262 of the DGCL (or,
if the Company is subject to Section 2115 of the California
General Corporation Law (the “ CGCL ”), in
accordance with Chapter 13 of the CGCL) and as of the Closing
has neither effectively withdrawn nor lost such holder’s
right to such appraisal (the “ Dissenting Shares
”) shall not be converted into the applicable Merger
Consideration, but shall be entitled to only such rights as are
granted by the DGCL (and, if the Company is subject to
Section 2115 of the CGCL, by the CGCL). Parent shall be
entitled to retain any Merger Consideration not paid on account of
such Dissenting Shares pending resolution of the claims of such
holders, and the Effective Time Holders shall not be entitled to
any portion of such retained Merger Consideration.
(b) Loss of Dissenting Share Status . Notwithstanding
the provisions of Section 1.9(a), if any holder of shares of
Company Capital Stock who demands appraisal of such holder’s
shares under the DGCL (or, if the Company is subject to
Section 2115 of the CGCL, the CGCL) shall effectively withdraw
or lose (through the failure to perfect or otherwise) such
holder’s right to appraisal, then as of the Closing or the
occurrence of such event, whichever later occurs, such
holder’s shares of Company Capital Stock shall automatically
be converted into the right to receive the applicable Merger
Consideration, without interest thereon, promptly following the
surrender of the certificate or certificates representing such
shares of Company Capital Stock.
(c) Notice of Dissenting Shares . The Company shall
give Parent: (i) prompt notice of any demands for appraisal of
shares of Company Capital Stock received by the Company,
withdrawals of any demands, and any other instruments or notices
served or otherwise delivered pursuant to the DGCL or the CGCL and
received by the Company; and (ii) the opportunity to direct
all negotiations and proceedings with respect to any such demands
for appraisal. The Company shall not, except with the prior written
consent of Parent, make any payment with respect to any demands for
appraisal of shares of
18
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Company Capital
Stock or offer to settle any such demands other than by operation
of law or pursuant to a final order of a court of competent
jurisdiction.
1.10 Exchange
of Certificates.
(a) Payment Agent . On or prior to the Closing Date,
Parent shall select a reputable bank or trust company reasonably
acceptable to the Company to act as payment agent in the Merger
(the “ Payment Agent ”). On or promptly
following the Closing Date, Parent shall deposit with the Payment
Agent cash sufficient to pay the cash consideration payable
pursuant to Sections 1.5(a)(ii)(A), 1.5(a)(iii)(A), 1.5(a)(v)(A)
and 1.5(a)(vi)(A). The cash amount so deposited with the Payment
Agent is referred to as the “ Payment Fund .”
The Payment Agent will invest the funds included in the Payment
Fund in the manner directed by Parent. Any interest or other income
resulting from the investment of such funds shall be the property
of, and will be paid to, Parent.
(b) Letter of Transmittal . Prior to the Effective
Time, the Company shall mail to each Person who is a record holder
of Company Capital Stock or Company Options immediately prior to
the Effective Time: (i) a letter of transmittal (or similar
document to be delivered to the holders of Company Options)
containing such provisions as Parent or the Payment Agent may
reasonably specify (including a provision confirming that delivery
of Company Stock Certificates (as defined in 1.10(d)) shall be
effected, and risk of loss and title to Company Stock Certificates
shall pass, only upon delivery of such Company Stock Certificates
to the Payment Agent, and a provision whereby such holder agrees to
be bound by the provisions of Sections 1.10, 9 and 10.1) (a
“ Letter of Transmittal ”); and
(ii) instructions for use in effecting the exchange of Company
Stock Certificates for the Merger Consideration, if any, payable
with respect to such Company Capital Stock. Upon the surrender to
the Payment Agent of a Company Stock Certificate (or an affidavit
of lost stock certificate as described in Section 1.10(e)),
together with a duly executed Letter of Transmittal and such other
customary documents as Parent or the Payment Agent may reasonably
request, the holder of such Company Stock Certificate shall be
entitled to receive in exchange therefor the Merger Consideration,
if any, which such holder has the right to receive pursuant to
Section 1.5(a) at the time of such surrender, and the Company
Stock Certificate so surrendered shall forthwith be canceled. From
and after the Effective Time, each Company Stock Certificate which
prior to the Effective Time represented shares of Company Capital
Stock shall be deemed to represent only the right to receive the
Merger Consideration payable with respect to such shares, and the
holder of each such Company Stock Certificate shall cease to have
any rights with respect to the shares of Company Capital Stock
formerly represented thereby. Upon the delivery to the Payment
Agent of a duly executed letter of transmittal and such other
customary documents as Parent or the Payment Agent may reasonably
request, a holder of Company Options that were outstanding
immediately prior to the Closing shall be entitled to receive in
exchange therefor the Merger Consideration payable in respect
thereof, which amount Parent shall cause to be paid through the
Surviving Corporation’s payroll agent. The Company shall
deliver a copy of the Letter of Transmittal to the
Stockholders’ Agent.
(c) Payments to Others . If payment of Merger
Consideration in respect of shares of Company Capital Stock
converted pursuant to Section 1.5 is to be made to a Person
other than the Person in whose name a surrendered Company Stock
Certificate is registered, it shall be a condition to such payment
that the Company Stock Certificate so surrendered shall be properly
endorsed or shall be otherwise in proper form for transfer and that
the Person requesting such payment shall have paid any transfer and
other Taxes required by reason of such payment in a name other than
that of the registered holder of the Company Stock Certificate
surrendered or shall have established to the satisfaction of Parent
that such Tax either has been paid or is not payable.
19
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(d) Stock Transfer Books . As of the Effective Time,
the stock transfer books of the Company shall be closed and there
shall not be any further registration of transfers of shares of
Company Capital Stock thereafter on the records of the Company. If,
after the Effective Time, certificates for shares of Company
Capital Stock (“ Company Stock Certificates ”)
are presented to the Surviving Corporation, they shall be canceled
and exchanged for the Merger Consideration, if any, payable with
respect to such shares as provided for in Section 1.5. No
interest shall accrue or be paid on any Merger Consideration
payable upon the surrender of a Company Stock Certificate which
immediately before the Effective Time represented outstanding
shares of Company Capital Stock.
(e) Lost Certificates . In the event any Company
Stock Certificate representing shares of Company Capital Stock
converted in connection with the Merger pursuant to
Section 1.5 shall have been lost, stolen or destroyed, Parent
may, in its discretion and as a condition precedent to the payment
of any Merger Consideration with respect to the shares of Company
Capital Stock previously represented by such Company Stock
Certificate, require the owner of such lost, stolen or destroyed
Company Stock Certificate to provide an appropriate affidavit and
an indemnity agreement in form and substance reasonably
satisfactory to Parent as indemnity against any claim that may be
made against the Payment Agent, Parent, the Surviving Corporation
or any affiliated party with respect to such Company Stock
Certificate.
(f) Undistributed Payment Funds . Any portion of the
Payment Fund that remains undistributed to Effective Time Holders
as of the date that is 180 days after the Closing Date shall
be delivered to Parent upon demand, and Effective Time Holders who
have not theretofore surrendered their Company Stock Certificates
or Company Warrants in accordance with this Section 1.10 shall
thereafter look only to Parent for satisfaction of their claims for
the Merger Consideration payable with respect to the shares of
Company Capital Stock previously represented by such Company Stock
Certificates or the shares of Company Capital Stock subject to such
Company Warrants, as applicable, without any interest
thereon.
(g) Escheat . Notwithstanding anything in this
Agreement to the contrary, neither Parent nor any other Person
shall be liable to any holder of shares of Company Capital Stock or
Company Warrants or to any other Person for any amount paid to a
public official pursuant to applicable abandoned property law,
escheat law or similar Legal Requirement. Any amounts remaining
unclaimed by holders of shares of Company Capital Stock or Company
Options immediately prior to such time as such amounts would
otherwise escheat to or become property of any Governmental Body
shall, to the extent permitted by applicable Legal Requirements,
become the property of Parent free and clear of any
Encumbrance.
(h) Withholding . Each of the Payment Agent, Parent
and the Surviving Corporation shall be entitled to deduct and
withhold from any consideration payable pursuant to this Agreement
to any security holder or former security holder of the Company
such amounts as Parent reasonably determines in good faith are
required to be deducted or withheld therefrom or in connection
therewith under the Code or any provision of state, local or
foreign Tax law or under any other applicable Legal Requirement. To
the extent such amounts are so deducted or withheld, such amounts
shall be treated for all purposes under this Agreement as having
been paid to the Person to whom such amounts would otherwise have
been paid.
1.11 Further
Action. If, at any time after the Effective Time, any further
action is reasonably determined by Parent to be necessary or
desirable to carry out the purposes of this Agreement or to vest
the Surviving Corporation or Parent with full right, title and
possession of and to all rights and property of
20
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Merger Sub and
the Company, the officers and directors of the Surviving
Corporation and Parent shall be fully authorized (in the name of
Merger Sub, in the name of the Company and otherwise) to take such
action.
2.
Representations and Warranties of the
Company
The Company
represents and warrants, to and for the benefit of the Indemnitees,
as follows:
2.1 Due
Organization; Subsidiaries; Etc.
(a) Organization . The Company has been duly
organized, and is validly existing and in good standing, under the
laws of the State of Delaware. The Company has full power and
authority: (i) to conduct its business in the manner in which
its business is currently being conducted; (ii) to own and use its
assets in the manner in which its assets are currently owned and
used; and (iii) to perform its obligations under all Contracts to
which it is a party or by which it is bound.
(b) Qualification . The Company is qualified,
licensed or admitted to do business as a foreign corporation, and
is in good standing (to the extent that the applicable jurisdiction
recognizes the concept of good standing), under the laws of all
jurisdictions where the property owned, leased or operated by it or
the nature of its business requires such qualification, license or
admission and where the failure to be so qualified, licensed or
admitted would have a Material Adverse Effect. Part 2.1(b) of
the Disclosure Schedule accurately sets forth each jurisdiction
where the Company is qualified, licensed or admitted to do
business.
(c) Directors and Officers . Part 2.1(c) of the
Disclosure Schedule accurately sets forth: (i) the names of
the members of the board of directors (or similar body) of the
Company; (ii) the names of the members of each committee of
the board of directors (or similar body) of the Company; and
(iii) the names and titles of the officers of the
Company.
(d) No Subsidiaries . The Company does not own any
shares or other securities of any other Entity. There are no
Entities that the Company is required or permitted to consolidate
for financial reporting purposes under GAAP. There are no Entities
that have been merged into or that otherwise are predecessors to
the Company. The Company has not agreed nor is obligated to make
any future investment in or capital contribution to any
Entity.
2.2 Charter
Documents; Records. The Company has made available to Parent
accurate and complete copies of: (a) the Charter Documents;
and (b) the minutes and other records of the meetings and
other proceedings (including any actions taken by written consent
or otherwise without a meeting) of the stockholders, the board of
directors and all committees of the board of directors of the
Company since January 1, 2004. All actions taken and all
transactions entered into by the Company have been duly approved by
all necessary action of the board of directors and stockholders of
the Company. There has been no violation of any of the provisions
of the Charter Documents, and the Company has not taken any action
that is inconsistent in any material respect with any resolution
adopted by the Company’s stockholders, board of directors or
any committee of the board of directors. The stock records and
minute books of the Company are accurate, up-to-date and complete
in all material respects, and have been maintained in accordance
with prudent business practices and all applicable Legal
Requirements.
21
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(a) Outstanding Securities . The authorized capital
stock of the Company consists of: (i) 170,945,000 shares of
Company Common Stock, of which 4,503,569 shares are issued and
outstanding as of the date of this Agreement; and
(ii) 149,890,000 shares of Company Preferred Stock, of which:
(A) 18,345,000 shares are designated as Series A
Preferred Stock, 17,800,000 shares of which are issued and
outstanding as of the date of this Agreement; (B) 18,345,000
shares are designated as Series A-1 Preferred Stock, 500,000
of which are issued and outstanding as of the date of this
Agreement (however, at no time is the Company authorized to issue
and have outstanding more than a total of 18,345,000 shares of
Series A Preferred Stock and Series A-1 Preferred Stock
together); (C) 26,600,000 shares are designated as
Series B Preferred Stock, 20,425,364 of which are issued and
outstanding as of the date of this Agreement; (D) 26,600,000
shares are designated as Series B-1 Preferred Stock, none of
which are issued and outstanding as of the date of this Agreement
(however, at no time is the Company authorized to issue and have
outstanding more than a total of 26,600,000 shares of Series B
Preferred Stock and Series B-1 Preferred Stock together);
(E) 30,000,000 shares are designated as Series C
Preferred Stock, 29,614,654 of which are issued and outstanding as
of the date of this Agreement; and (F) 30,000,000 shares are
designated as Series C-1 Preferred Stock, none of which are
issued and outstanding as of the date of this Agreement (however,
at no time is the Company authorized to issue and have outstanding
more than a total of 30,000,000 shares of Series C Preferred
Stock and Series C-1 Preferred Stock together). There are
94,905 shares of Common Stock and no shares of Preferred Stock held
in the Company’s treasury as of the date of this Agreement.
Part 2.3(a) of the Disclosure Schedule sets forth the names of
the Company’s stockholders and the class, series and number
of shares of Company Capital Stock owned of record by each of such
stockholders as of the date of this Agreement.
(b) Dividends, Authorization, Etc. The Company has
not declared or paid any dividends on any shares of Company Capital
Stock. All of the outstanding shares of Company Capital Stock have
been duly authorized and validly issued, and are fully paid and
nonassessable. Except as set forth in Part 2.3(b) of the
Disclosure Schedule, no shares of Company Capital Stock are subject
to forfeiture, restriction on transfer (other than restrictions on
transfer imposed by virtue of applicable federal and state
securities laws) or a right of repurchase by the Company (“
Restricted Company Shares ”). Each share of Company
Preferred Stock is convertible into shares of Company Common Stock
on a one-for-one basis.
(c) Stock Options . The Company has reserved
17,712,287 shares of Company Common Stock for issuance under the
Company Option Plan, of which options with respect to 13,896,080
shares are outstanding as of the date of this Agreement.
Part 2.3(c) of the Disclosure Schedule accurately sets forth,
with respect to each Company Option that is outstanding as of the
date of this Agreement: (i) the name of the holder of such
Company Option; (ii) the total number of shares of Company
Common Stock that are subject to such Company Option;
(iii) the exercise price per share of Company Common Stock
purchasable under such Company Option; and (iv) the expiration
date of such Company Option. Each grant of a Company Option was
duly authorized no later than the date on which the grant of such
Company Option was by its terms to be effective (the “
Grant Date ”) by all necessary corporate action,
including, as applicable, approval by the board of directors of the
Company (or a duly constituted and authorized committee thereof)
and any required stockholder approval by the necessary number of
votes or written consents, and the award agreement governing such
grant (if any) was duly executed and delivered by each party
thereto, each such grant was made in accordance with the terms of
the applicable compensation plan or arrangement of the Company and
all other applicable Legal Requirements, the per share exercise
price of each Company Option was equal to or greater than the
fair
22
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
market value of
a share of Company Common Stock on the applicable Grant Date and
each such grant was properly accounted for in accordance with GAAP
in the financial statements (including the related notes) of the
Company. The cancellation of Company Options at the Effective Time
and payment of cash in exchange therefor in accordance with
Section 1.6 will comply with the terms of the Company Option
Plan, all Contracts applicable to such Company Options and all
Legal Requirements and, as of the Closing, no former holder of a
Company Option will have any rights with respect to such Company
Option other than the right to receive cash in respect thereof as
contemplated by this Agreement.
(d) Warrants . Part 2.3(d) of the Disclosure
Schedule accurately sets forth, with respect to each Company
Warrant that is outstanding as of the date of this Agreement:
(i) the name of the holder of such Company Warrant;
(ii) the class, series and total number of shares of Company
Capital Stock that are subject to such Company Warrant and the
class, series and number of shares of Company Capital Stock with
respect to which such Company Warrant is immediately exercisable;
(iii) the date on which such Company Warrant was issued and
the term of such Company Warrant; and (iv) the exercise price
per share of Company Capital Stock purchasable under such Company
Warrant. The Company has made available to Parent accurate and
complete copies of each Contract pursuant to which any Company
Warrant is outstanding.
(e) No Other Securities . Except for the Company
Preferred Stock and except as set forth in Part 2.3(c) or
2.3(d) of the Disclosure Schedule, there is no:
(i) outstanding subscription, option, call, convertible note,
warrant or right (whether or not currently exercisable) granted or
issued by the Company to acquire any shares of Company Capital
Stock or other securities of the Company; (ii) outstanding
security, instrument or obligation granted or issued by the Company
that is or may become convertible into or exchangeable for any
shares of Company Capital Stock (or cash based on the value of such
shares) or other securities of the Company; (iii) Contract
under which the Company is or may become obligated to sell or
otherwise issue any shares of Company Capital Stock or any other
securities, including any promise or commitment to grant Company
Options or other securities of the Company to an employee of or
other service provider to the Company; or (iv) condition or
circumstance that may give rise to or provide a basis for the
assertion of a claim by any Person to the effect that such Person
is entitled to acquire or receive any shares of Company Capital
Stock or other securities of the Company from the Company. As of
immediately following the Effective Time, there will be no
outstanding options, warrants or other rights to purchase shares of
Company Capital Stock.
(f) Legal Issuance . All outstanding shares of
Company Capital Stock, all outstanding Company Options and Company
Warrants and all other securities that have ever been issued or
granted by the Company have been issued and granted in compliance
with: (i) all applicable securities laws and other applicable
Legal Requirements; and (ii) all requirements set forth in all
applicable Contracts. None of the outstanding shares of Company
Capital Stock were issued in violation of any preemptive rights or
other rights to subscribe for or purchase securities of the
Company. Part 2.3(f) of the Disclosure Schedule accurately
identifies each Company Contract relating to any securities of the
Company that contains any information rights, registration rights,
financial statement requirements or other terms that would survive
the Closing unless terminated or amended prior to the
Closing.
(g) Repurchased Shares . All shares of capital stock
of the Company ever repurchased or redeemed by the Company were
repurchased or redeemed in compliance with: (A) all applicable
securities laws and other applicable Legal Requirements; and
(B) all requirements set forth in all applicable
Contracts.
23
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
2.4 Financial
Statements and Related Information.
(a) Delivery of Financial Statements . The Company
has made available to Parent the following financial statements and
notes thereto (collectively, the “ Company Financial
Statements ”): (i) the audited balance sheets of the
Company as of December 31, 2006, December 31, 2007 and
December 31, 2008, and the related audited statements of
income, statements of stockholders’ equity and statements of
cash flows for the years ended December 31, 2006, December 31,
2007 and December 31, 2008, together with the notes thereto
and the unqualified report and opinion of Ernst & Young
relating thereto; (ii) the unaudited balance sheet of the
Company as of March 31, 2009, and the related unaudited
statement of income, statement of stockholders’ equity and
statement of cash flows for the three months ended March 31,
2009; and (iii) the unaudited balance sheet of the Company as
of June 30, 2009 (the “ Unaudited Interim Balance
Sheet ”), and the related unaudited statement of income,
statement of stockholders’ equity and statement of cash flows
for the six months ended June 30, 2009.
(b) Fair Presentation . The Company Financial
Statements present fairly the financial position of the Company as
of the respective dates thereof and the results of operations and
cash flows of the Company for the periods covered thereby. The
Company Financial Statements have been prepared in accordance with
GAAP applied on a consistent basis throughout the periods covered,
except that the financial statements referred to in
Sections 2.4(a)(ii) and 2.4(a)(iii) do not contain footnotes.
The financial statements delivered to Parent pursuant to
Section 4.10: (i) will present fairly the financial
position of the Company as of September 30, 2009 and the
balance sheet, results of operations and cash flows of the Company
for the nine months ended September 30, 2009; and
(ii) will be prepared in accordance with GAAP applied on a
basis consistent with the basis on which the Company Financial
Statements were prepared, except that the September 30
th Financial Statements (as defined in
Section 4.10) will not contain footnotes.
(c) Internal Controls . The books, records and
accounts of the Company accurately and fairly reflect, in
reasonable detail, the transactions in and dispositions of the
assets of the Company. The systems of internal accounting controls
maintained by the Company are sufficient to provide reasonable
assurance that: (i) transactions are executed in accordance
with management’s general or specific authorization;
(ii) transactions are recorded as necessary to permit
preparation of financial statements in conformity with GAAP and to
maintain accountability for assets; (iii) access to assets is
permitted only in accordance with management’s general or
specific authorization; and (iv) the recorded accountability
for assets is compared with the existing assets at reasonable
intervals and appropriate action is taken with respect to any
differences. Part 2.4(c) of the Disclosure Schedule lists, and
the Company has made available to Parent copies of, all written
descriptions of, and all policies, manuals and other documents
promulgating, such internal accounting controls.
(d) Insider Receivables . Part 2.4(d) of the
Disclosure Schedule provides an accurate and complete breakdown of
all amounts (including any Indebtedness) owed to the Company by any
Company Employee or stockholder of the Company (“ Insider
Receivables ”) as of the date of this Agreement. There
will be no outstanding Insider Receivables as of the Effective
Time.
(a) No Liabilities . The Company has no accrued,
contingent or other Liabilities of any nature, either matured or
unmatured (whether or not required to be reflected in financial
statements in accordance with GAAP, and whether due or to become
due), except for: (i) Liabilities identified as
such
24
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
in the
“liabilities” column of the Unaudited Interim Balance
Sheet; (ii) Liabilities that have been incurred by the Company
since the date of the Unaudited Interim Balance Sheet in the
ordinary course of business consistent with the Company’s
past practices; (iii) Liabilities incurred in connection with
this Agreement and the transactions contemplated by this Agreement;
and (iv) the Liabilities identified in Part 2.5(a) of the
Disclosure Schedule.
(b) Accounts Payable . Part 2.5(b) of the
Disclosure Schedule provides an accurate and complete breakdown and
aging of: (i) all accounts payable of the Company as of the
date of this Agreement; and (ii) all notes payable of the
Company and all other indebtedness of the Company for borrowed
money as of the date of this Agreement.
(c) No “Off-Balance Sheet” Arrangements .
The Company has not effected or otherwise been involved in any
“off-balance sheet arrangements” (as defined in
Item 303(a)(4)(ii) of Regulation S-K under the Securities
Exchange Act of 1934, as amended). Without limiting the generality
of the foregoing, the Company has not guaranteed any Indebtedness
or other obligation of any other Person.
(d) Director and Officer Indemnification . No event
has occurred, and no circumstance or condition exists, that has
resulted in, or that will or would reasonably be expected to result
in, any claim for indemnification, reimbursement, contribution or
the advancement of expenses by any Company Employee (other than a
claim for reimbursement by the Company, in the ordinary course of
business, of travel expenses or other out-of-pocket expenses of a
routine nature incurred by such Company Employee in the course of
performing such Company Employee’s duties for the Company)
pursuant to: (i) the terms of the Charter Documents;
(ii) any indemnification agreement or other Contract between
the Company and any such Company Employee; or (iii) any
applicable Legal Requirement.
(e) Claims by Securityholders . No event has
occurred, and no circumstance or condition exists, that has
resulted in, or that will or would reasonably be expected to result
in, any Liability of the Company to any current, former or alleged
holder of Company Capital Stock, Company Options or Company
Warrants in such holder’s capacity (or alleged capacity) as a
securityholder of the Company.
2.6 Absence of
Changes. Except as set forth in Part 2.6 of the Disclosure
Schedule, between June 30, 2009 and the date of this
Agreement:
(a) there has not been any Material Adverse Effect, and no
event has occurred or circumstance has arisen that, in combination
with any other events or circumstances, will or would reasonably be
expected to have or result in a Material Adverse Effect;
(b) there has not been any material loss, damage or
destruction to, or any material interruption in the use of, any of
the Company’s material assets (whether or not covered by
insurance);
(c) the Company has not declared, accrued, set aside or paid
any dividend or made any other distribution in respect of any
shares of its capital stock or other securities, and the Company
has not repurchased, redeemed or otherwise reacquired any of its
shares of capital stock or other securities, other than from former
employees, directors and consultants pursuant to restricted stock
purchase agreements or stock option agreements providing for the
repurchase of such securities in connection with their termination
of service to the Company;
25
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(d) the Company has not sold, issued, granted or authorized
the sale, issuance or grant of: (i) any capital stock or other
security (except for Company Common Stock issued upon the exercise
of outstanding Company Options); (ii) any option, call,
warrant or right to acquire any capital stock or other security
(except for Company Options described in Part 2.3(c) of the
Disclosure Schedule); or (iii) any instrument convertible into
or exchangeable for any capital stock (or cash based on the value
of such capital stock) or other security;
(e) the Company has not amended or waived any of its rights
under, or permitted the acceleration of vesting under: (i) any
provision of the Company Option Plan; (ii) any provision of
any agreement evidencing any outstanding Company Option; or
(iii) any restricted stock agreement;
(f) there has been no amendment to any of the Charter
Documents (other than the Certificate Amendment), and the Company
has not effected or been a party to any Acquisition Transaction,
recapitalization, reclassification of shares, stock split, reverse
stock split or similar transaction;
(g) the Company has not made any individual capital
expenditure that exceeds $100,000;
(h) the Company has not amended or prematurely terminated,
or waived any material right or remedy under, any Contract that is
or would constitute a Material Contract (as defined in
Section 2.11(a));
(i) the Company has not: (i) acquired, leased or
licensed any material right or other material asset from any other
Person; (ii) sold or otherwise disposed of, or leased or
licensed, any material right or other material asset to any other
Person; or (iii) waived or relinquished any material
right;
(j) the Company has not written off as uncollectible, or
established any extraordinary reserve with respect to, any account
receivable or other indebtedness in excess of $10,000 with respect
to a single matter;
(k) the Company has not made any pledge of any of its assets
or otherwise permitted any of its assets to become subject to any
Encumbrance, except for pledges of immaterial assets made in the
ordinary course of business and consistent with past
practices;
(l) the Company has not: (i) lent money to any Person
(other than pursuant to routine and reasonable travel advances made
to current employees of the Company in the ordinary course of
business); or (ii) incurred or guaranteed any indebtedness for
borrowed money;
(m) the Company has not: (i) established, adopted or
amended any Company Employee Plan; (ii) made any bonus,
profit-sharing or similar payment to, or increased the amount of
wages, salary, commissions, fringe benefits or other compensation
(including equity-based compensation, whether payable in cash or
otherwise) or remuneration payable to, any of its directors,
officers or employees; (iii) funded any compensation
obligation (whether by grantor trust or otherwise); or
(iv) other than with respect to non-officer employees and in
the ordinary course of business and consistent with past practices,
hired any new employee;
26
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(n) the Company has not changed any of its methods of
accounting or accounting practices in any respect;
(o) the Company has not made or changed any Tax election,
adopted or changed a material accounting method in respect of
Taxes, entered into a Tax allocation agreement, Tax sharing
agreement, Tax indemnity agreement or closing agreement, settled or
comprised a claim, notice, audit report or assessment in respect of
Taxes, or consented to an extension or waiver of the statutory
limitation period applicable to a claim or assessment in respect of
Taxes;
(p) the Company has not commenced or settled any Legal
Proceeding;
(q) the Company has not entered into any material
transaction or taken any other material action outside the ordinary
course of business; and
(r) the Company has not agreed or legally committed to take
any of the actions referred to in clauses “(c)” through
“(q)” above.
(a) Good Title . The Company owns, and has good and
valid title to, all assets purported to be owned by it, including:
(i) all assets reflected on the Unaudited Interim Balance
Sheet; and (ii) all other assets reflected in the books and
records of the Company as being owned by the Company. All of said
assets are owned by the Company free and clear of any liens or
other Encumbrances, except for: (A) any lien for current Taxes
not yet due and payable; and (B) minor liens that have arisen
in the ordinary course of business and that do not (in any case or
in the aggregate) materially detract from the value of the assets
subject thereto or materially impair the operations of the Company.
Notwithstanding the foregoing, title with respect to Intellectual
Property is covered by Section 2.10.
(b) Leased Assets . Part 2.7(b) of the
Disclosure Schedule identifies all assets that are material to the
business of the Company and that are being leased to the Company
for which the annual rental payment for each such asset exceeds
$50,000.
2.8 Bank
Accounts. Part 2.8 of the Disclosure Schedule provides the
following information with respect to each account maintained by or
for the benefit of the Company at any bank or other financial
institution: (a) the name of the bank or other financial
institution at which such account is maintained; (b) the
account number; (c) the type of account; and (d) the
names of all Persons who are authorized to sign checks or other
documents with respect to such account.
2.9 Equipment;
Real Property.
(a) Equipment . All material items of equipment,
fixtures and other tangible assets owned by or leased to the
Company are reasonably adequate for the uses to which they are
being put, are in good condition and repair (ordinary wear and tear
excepted) and are adequate for the conduct of the Company’s
business in the manner in which such business is currently being
conducted.
27
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(b) Real Property . The Company does not own any real
property or any interest in real property, except for the leasehold
created under the real property leases or subleases identified in
Part 2.9(b) of the Disclosure Schedule.
2.10
Intellectual Property.
(a) Registered IP . Part 2.10(a) of the
Disclosure Schedule accurately identifies each item of Registered
IP in which the Company has or believes or has indicated to Parent
it has an ownership interest of any nature (whether exclusively,
jointly with another Person or otherwise) including:
(i) all Patents included in such Registered IP, and used in
the business or operations of the Company, including a listing of
the country of filing, owner, filing number, date of issue or
filing, expiration date and title of such Patent;
(ii) all registered trademarks and applications for
registration of trademarks included in such Registered IP and used
by the Company, including a listing of the country of filing,
description of goods or services, registration or application
number and date of issue; and
(iii) all registered copyrights and applications for
registration of copyrights included in such Registered IP used by
the Company, including a listing of the country of filing, owner,
filing number, date of issue and expiration date.
Part 2.10(a) of the Disclosure Schedule
also identifies any other Person that has an ownership interest in
any item of Registered IP listed on Part 2.10(a) of the
Disclosure Schedule and the nature of such ownership interest. The
Company has made available to Parent complete and accurate copies
of all applications, prosecution file histories that are not
publicly available and other material documents related to each
item of Registered IP within the scope of subclauses
(i) through (iii) above.
(b) Inbound Licenses . Part 2.10(b) of the
Disclosure Schedule accurately identifies: (i) each Contract
pursuant to which any Intellectual Property is or has been
licensed, sold, assigned or otherwise conveyed or provided to the
Company or pursuant to which the Company has otherwise received or
acquired any right in Intellectual Property being used in the
current business of the Company or related to Company
Pharmaceutical Products, whether or not currently exercisable and
including a right to receive a license (other than:
(A) agreements between the Company and its employees in the
Company’s standard form thereof; and (B) non-exclusive
“off the shelf” licenses to third party Computer
Software); and (ii) whether the licenses or rights granted to
the Company in each such Contract are exclusive or
non-exclusive.
(c) Outbound Licenses . Part 2.10(c) of the
Disclosure Schedule accurately identifies each Contract pursuant to
which any Person has been granted any license under, or otherwise
has received or acquired any right (whether or not currently
exercisable and including a right to receive a license) or interest
in, any Company IP. The Company is not bound by, and no Company IP
is subject to, any Contract containing any covenant or other
provision that in any way limits or restricts the ability of the
Company to use, exploit, assert or enforce any Company IP anywhere
in the world, other than as expressly provided in the provisions of
a Contract listed in Part 2.10(b) or Part 2.10(c) of the
Disclosure Schedule
28
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(d) Royalty Obligations . The Company is not
obligated to pay to any Person any royalties (including
Reach-Through Royalties (as defined below)), fees, commissions or
other amounts for the use by Company of any Company IP, other than
as provided in a Contract listed in Part 2.10(b) of the
Disclosure Schedule, and provided that no such Contract provides
for Reach-Through Royalties. “Reach-Through Royalties”
shall mean a royalty payable with respect to a Patent or other
Intellectual Property right, which is based on a percentage of
sales of products by or through the licensee of Company, where the
licensed item(s) of Intellectual Property, including research and
development tools and processes, is or are not incorporated into
and/or do not cover the product with respect to the sales of which
the royalty is payable.
(e) Standard Form Company IP Contracts . The
Company has made available to Parent a complete and accurate copy
of each standard form of Company IP Contract used by the Company,
including each standard form of: (i) development agreement;
(ii) employee agreement containing any assignment or license
of Intellectual Property or any confidentiality provision;
(iii) consulting or independent contractor agreement
containing any assignment or license of Intellectual Property or
any confidentiality provision; (iv) confidentiality or
nondisclosure agreement; (v) employee agreement or consulting
or independent contractor agreement; (vi) clinical trial
agreement; (vii) material transfer agreement; (viii) master
service agreement; or (ix) research agreement. Part 2.10(e) of
the Disclosure Schedule accurately identifies all Company IP
Contracts (including all development agreements, employee
agreements, consulting or independent contractor agreements,
clinical trial agreements, material transfer agreements, master
service agreements and research agreements), whether or not based
on the foregoing forms. The Company has made available to Parent
copies of all agreements listed in Part 2.10(e) of the
Disclosure Schedule.
(f) Ownership . The Company is the sole and exclusive
owner of all right, title and interest to and in the Company IP
(other than Intellectual Property exclusively licensed to the
Company, pursuant to Contracts identified in Part 2.10(b) of
the Disclosure Schedule and other than Registered IP listed in
Part 2.10(a) of the Disclosure Schedule which is co-owned by
any other Person, provided that such ownership has been described
in Part 2.10(a)) of the Disclosure Schedule, free and clear of
any Encumbrances (other than nonexclusive licenses granted pursuant
to the Contracts listed in Part 2.10(c) of the Disclosure
Schedule). Without limiting the generality of the
foregoing:
(i) all documents and instruments necessary to establish,
perfect and maintain the rights of the Company in any Registered IP
included in the Company IP have been validly executed, delivered,
filed and/or recorded in a timely manner with the appropriate
Governmental Body;
(ii) each Company Employee who is or was involved in the
creation or development of any Company IP has signed a valid and
enforceable agreement containing an irrevocable assignment of
Intellectual Property pertaining to such Company IP to the Company
and confidentiality provisions protecting the Company IP, and no
such Company Employee has any obligation to any university or other
Person with respect to such Company IP;
(iii) without limiting subsection 2.10(f)(v) below, the
Company has taken all reasonable steps to maintain the
confidentiality of and otherwise protect and enforce its rights in
all Trade Secrets pertaining to the Company, the Company IP or the
business of the Company;
29
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(iv) the Company owns or otherwise has, and after the
Closing the Surviving Corporation and its Subsidiaries will
continue to have, sufficient rights in all Intellectual Property
necessary to conduct the business of the Company as currently
conducted and currently planned by the Company to be
conducted;
(v) the Company has not divulged, furnished to or made
accessible any of its Trade Secrets that (A) relate to the
Compound or to other Company Pharmaceutical Products, and (B) are
used in or necessary for the conduct of its business as it is
currently conducted or is currently planned by the Company to be
conducted, to any Person who is not subject to a written agreement
to maintain the confidentiality of such Trade Secrets;
(vi) to the Knowledge of the Company, no officer or employee
of the Company is subject to any Contract with any other Person
which requires such officer or employee to assign any interest in
inventions or other Intellectual Property to such other Person or
keep confidential any Trade Secrets, proprietary data, customer
lists or other business or technical information; and
(vii) the Company has taken all actions which are necessary
in order to fully protect the Trade Secrets of the Company from
misappropriation in a manner consistent with prudent commercial
practice in the pharmaceutical and biotechnology
industries.
(g) Valid and Enforceable . All Company IP owned or
which the Company believes or has indicated to Parent is owned by
the Company is valid, subsisting and enforceable, and to the
Knowledge of the Company, all other Company IP is valid, subsisting
and enforceable. Without limiting the generality of the
foregoing:
(i) no trademark or trade name owned, used or applied for by
the Company conflicts or interferes with any trademark or trade
name owned, used or applied for by any other Person, and the
Company has taken reasonable steps to police the use of its
trademarks;
(ii) Part 2.10(g)(ii) of the Disclosure Schedule
accurately identifies and describes each action, filing, and
payment that must be taken or made on or before the date that is
120 days after the date of this Agreement in order to maintain
such item of Company IP in full force and effect (but excluding any
such action, filing or payment the requirement for which first
comes into being after the date of this Agreement and was unknown
prior to the date of this Agreement);
(iii) Part 2.10(g)(iii) of the Disclosure Schedule
accurately identifies and describes every interference, opposition,
reissue, reexamination or other Legal Proceeding that is or has
been pending or, to the Knowledge of the Company, overtly
threatened, in which the scope, validity or enforceability of any
Company IP is being, or has been, or would reasonably be expected
to be contested or challenged. To the Knowledge of the Company,
there is no legally supportable basis for a claim that any Company
IP is invalid or unenforceable, or, in the case of any claim(s) of
Patent applications included in the Company IP,
unpatentable;
(iv) all necessary registration, maintenance and renewal
fees in respect of the Company IP owned by the Company that is
Registered IP have been paid and all necessary
30
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
documents and
certificates have been filed with the relevant Governmental Body
for the purpose of maintaining the Company IP;
(v) no act has been done or omitted to be done by the
Company, which has had or would be reasonably expected to have the
effect of (A) rendering any Patent included in the Company IP
unenforceable; (B) impairing or dedicating to the public, or
entitling any Person to cancel, forfeit, modify or consider
abandoned, any Company IP; or (C) in the case of any claim(s)
of pending Patent applications included in the Company IP,
rendering such claim(s) unpatentable; and
(vi) the Company has diligently prepared and is diligently
preparing to file Patent applications for all inventions owned by
the Company and included within the Company IP that relates to a
Company Pharmaceutical Product and that the Company has deemed in
its reasonable business judgment to be best protected through
application for a Patent, in a manner and within a sufficient time
period to avoid statutory disqualification of any potential Patent
application. All prior art material to the patentability of the
claims in any issued Patent or Patent applications of the Company
of which the Company has Knowledge is cited in the respective
issued Patents, applications or associated file histories thereof,
and there is no other material prior art with respect to such
Patents of which the Company has Knowledge. The Company has
complied with all Legal Requirements regarding the duty of
disclosure, candor and good faith in connection with each Patent
and Patent application filed by the Company.
(h) No Third Party Infringement of Company IP . To
the Knowledge of the Company, no Person has infringed,
misappropriated or otherwise violated, and no Person is currently
infringing, misappropriating or otherwise violating, any Company
IP. Part 2.10(h) of the Disclosure Schedule accurately
identifies (and the Company has made available to Parent a complete
and accurate copy of) each letter or other written or electronic
communication or correspondence that has been sent by or to the
Company or any representative of the Company regarding any actual,
alleged or suspected infringement or misappropriation of any
Company IP, and provides a brief description of the current status
of the matter referred to in such letter, communication or
correspondence.
(i) Effects of This Transaction . Neither the
execution, delivery or performance of this Agreement or any other
agreements executed in connection with the transaction contemplated
by this Agreement nor the consummation of any of the transactions
contemplated by this Agreement or any such other agreement entered
into in connection herewith or therewith will, with or without
notice or lapse of time, result in, or give any other Person the
right or option to cause or declare: (i) a loss of, or
Encumbrance on, any Company IP; (ii) a breach of or default
under any Company IP Contract; (iii) the release, disclosure
or delivery of any Company IP by or to any escrow agent or other
Person; (iv) the grant, assignment or transfer to any other
Person of any license or other right or interest under, to or in
any of the Company IP; or (v) by the terms of any Company
Contract, a reduction of any royalties or other payments the
Company would otherwise be entitled to with respect to any Company
IP.
(j) No Infringement of Third Party IP . The Company
is not infringing, misappropriating or otherwise violating or
making unlawful use of any Intellectual Property of any other
Person, nor has it ever done so (including in conducting the
research and development activities of the Company). To the
Knowledge of the Company, the commercialization of the Company
Pharmaceutical Products intended as of the date of this Agreement
to be commercialized by the Company would not reasonably be
expected to infringe, misappropriate or otherwise violate or make
unlawful use of, any
31
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
Intellectual
Property of any other Person. For purposes of the foregoing,
“infringe” includes infringement directly,
contributorily, by inducement or otherwise. Without limiting the
generality of the foregoing:
(i) no infringement, misappropriation or similar
Intellectual Property claim or Legal Proceeding is pending or, to
the Knowledge of the Company, threatened against the Company or
against any other Person who is or may be entitled to be
indemnified, defended, held harmless or reimbursed by the Company
with respect to such claim or Legal Proceeding;
(ii) the Company has not received any written notice or
other formal communication (in writing or otherwise) from any
Person asserting any actual, alleged or suspected infringement,
misappropriation or violation by the Company, any Company Employee
or agents of the Company of any Intellectual Property of another
Person, including any letter or other communication suggesting or
offering that the Company obtain a license to any Intellectual
Property of another Person; and
(iii) other than as provided in indemnification provisions
of the Contracts identified in Part 2.10(b) and
Part 2.10(c) of the Disclosure Schedule, the Company is not
bound by any Contract to indemnify, defend, hold harmless or
reimburse any other Person with respect to, and the Company has not
otherwise assumed or agreed to discharge or otherwise take
responsibility for, any existing or potential intellectual property
infringement, misappropriation or similar claim (other than
indemnification provisions in the Company’s standard forms of
Company IP Contracts).
(k) Information Technology . All Company IT Systems
have been properly maintained by technically competent personnel,
in accordance with standards set by the manufacturers or otherwise
in accordance with standards prudent in the industry, to ensure
proper operation, monitoring and use. The Company IT Systems are in
good working condition to effectively perform all information
technology operations necessary to conduct the business of the
Company as it is currently being conducted or is currently planned
by the Company to be conducted. The Company has not experienced
within the past three years any material disruption to, or material
interruption in, the conduct of business attributable to a defect,
bug, breakdown or other failure or deficiency of the Company IT
Systems. The Company has taken commercially reasonable measures to
provide for the back-up and recovery of the data and information
necessary to the conduct of the business of the Company (including
such data and information that is stored on magnetic or optical
media in the ordinary course) without material disruption to, or
material interruption in, the conduct of the business of the
Company. Part 2.10(k) of the Disclosure Schedule lists all
Contracts relating to such back-up and recovery, and identifies the
locations of relevant servers. The Company is not in breach of any
Contract related to any Company IT System, nor is the Company aware
of any event that, with the passage of time or the giving of
notice, or both, would constitute a breach of any Company Contract
related to any Company IT System. All Company IT Systems housing
data relevant for current or anticipated regulatory filings with
Regulatory Authorities have been and are in compliance with the
requirements outlined in 21 CFR Part 11, or similar Legal
Requirements set by Regulatory Authorities outside the United
States.
(l) Ownership of Data . All Company Data is owned by
the Company, free and clear of all Encumbrances, and is not subject
to any Company Contract (other than agreements with contract
research organizations entered into in connection with the
preclinical or clinical development of the Company Pharmaceutical
Products in the normal course and which have been made available to
Parent).
32
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
The Company has
all necessary and required rights to license, use, sublicense and
distribute the data contained in the Company Data, including in
connection with the operation of the Company IT Systems.
(m) Information Security . The Company has
established and is in compliance with a written information
security program that: (i) includes administrative, technical
and physical safeguards designed to safeguard the security,
confidentiality, and integrity of transactions and confidential or
proprietary of Company Data; and (ii) is designed to protect
against unauthorized access to the Company IT Systems or Company
Data and the systems of any third party service providers that have
access to Company Data or Company IT Systems. The Company has not
suffered a security breach with respect to the Company Data in the
last five years. The Company has not notified any Person of any
information security breach involving Personal Data. The Company is
in compliance with all privacy policies of the Company and all
applicable Legal Requirements related to information privacy and
security. The Company is not prohibited by any applicable Legal
Requirements, privacy policy of the Company or Company Contract
from providing Parent with the Personal Data, including the
clinical trials patients’ data, that has been, or will be,
provided to Parent, on or after the Closing Date, in connection
with the transactions contemplated by this Agreement.
(a) List of Contracts . Part 2.11(a) of the
Disclosure Schedule accurately identifies, in each case as of the
date of this Agreement:
(i) (A) each Company Contract relating to the
employment of, or the performance of services by, any Company
Employee (other than offer letters, proprietary information and
invention assignment agreements and stock option agreements entered
into in the ordinary course of business); (B) any Company
Contract pursuant to which the Company is or may become obligated
to make any severance, termination, retention, gross-up or similar
payment to any Company Employee; and (C) any Company Contract
pursuant to which the Company is or may become obligated to make
any bonus, incentive compensation or similar payment (other than
payment in respect of salary) to any Company Employee;
(ii) each Company Contract which provides for
indemnification of any officer, director, employee or
agent;
(iii) each Company Contract relating to the voting and any
other rights or obligations of a stockholder of the
Company;
(iv) each Company Contract relating to the merger,
consolidation, reorganization or any similar transaction with
respect to the Company;
(v) each Company Contract (including each Company IP
Contract) relating to the acquisition, transfer, development or
sharing of any technology or Intellectual Property (including any
joint development agreement, technical collaboration agreement or
similar agreement entered into by the Company);
(vi) any Company Contract with any clinical research
organization providing clinical trial services for any clinical
trial for any Company Pharmaceutical Product;
33
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(vii) any Company Contract with any contract manufacturing
organization providing manufacturing services for any Company
Pharmaceutical Product, including clinical supplies.
(viii) each Company Contract relating to the acquisition,
sale, spin-off or outsourcing of any Subsidiary or business unit or
operation of the Company;
(ix) each Company Contract creating or relating to any
partnership or joint venture or any sharing of revenues, profits,
losses, costs or liabilities;
(x) each Company Contract imposing any restriction on the
Company: (A) to compete with any other Person; (B) to
acquire any product or other asset or any services from any other
Person, to sell any product or other asset to or perform any
services for any other Person or to transact business or deal in
any other manner with any other Person; (C) to develop or
distribute any technology; (D) to use any Intellectual
Property; or (E) to manufacture any products;
(xi) each Company Contract: (A) granting exclusive
rights to license, market, sell or deliver any of the products or
services of the Company or of users of any marketplace, website or
service of the Company; or (B) otherwise contemplating an
exclusive relationship between the Company and any other
Person;
(xii) each Company Contract creating or involving any agency
relationship, distribution arrangement or franchise
relationship;
(xiii) each Company Contract regarding the acquisition,
issuance or transfer of any securities and each Company Contract
affecting or dealing with any securities of the Company, including
any restricted share agreements or escrow agreements but excluding
Company Option agreements;
(xiv) each Company Contract involving any loan, guaranty,
pledge, performance or completion bond or indemnity or surety
arrangement;
(xv) each Company Contract relating to the purchase or sale
of any asset by or to, or the performance of any services by or
for, any Related Party;
(xvi) each Company Contract relating to any liquidation or
dissolution of the Company;
(xvii) any Company Contract that contemplates or involves:
(A) the payment or delivery of cash or other consideration by
the Company in an amount or having a value in excess of $200,000 in
the aggregate; or (B) the performance of services having a
value in excess of $200,000 in the aggregate; and
(xviii) any other Company Contract that was entered into
outside the ordinary course of business of the Company.
34
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(Company
Contracts in the respective categories described in clauses
“(i) ” through “(xviii)” above, all Company
Contracts identified, or required to be identified, in
Part 2.11(a) of the Disclosure Schedule, and all Company
Contracts identified, or required to be identified, in Parts
2.10(b), 2.10(c) and 2.10(d) of the Disclosure Schedule and all
material Company Contracts identified or required to be identified
in Part 2.10(e) of the Disclosure Schedule are referred to in
this Agreement as “ Material Contracts
.”)
(b) Delivery of Contracts . The Company has made
available to Parent accurate and complete copies of all written
Material Contracts identified in Part 2.11(a) of the
Disclosure Schedule, including all amendments thereto.
Part 2.11(b) of the Disclosure Schedule provides an accurate
and complete description of the material terms of each Material
Contract that is not in written form. Each Contract identified in
Part 2.11(a) of the Disclosure Schedule is valid and in full
force and effect, and is enforceable by the Company in accordance
with its terms, subject to: (i) laws of general application
relating to bankruptcy, insolvency and the relief of debtors; and
(ii) rules of law governing specific performance, injunctive
relief and other equitable remedies.
(c) No Breach . Except as set forth in
Part 2.11(c) of the Disclosure Schedule: (i) the Company has
not violated or breached, or committed any default under, any
Company Contract that remains uncured, and, to the Knowledge of the
Company, no other Person has violated or breached, or committed any
default under, any Company Contract which remains uncured;
(ii) to the Knowledge of the Company, no event has occurred,
and no circumstance or condition exists, that (with or without
notice or lapse of time) will, or would reasonably be expected to:
(A) result in a violation or breach of any of the provisions
of any Company Contract; (B) give any Person the right to
declare a default or exercise any remedy under any Company
Contract; (C) give any Person the right to accelerate the
maturity or performance of any Company Contract; or (D) give
any Person the right to cancel, terminate or modify any Company
Contract; (iii) since January 1, 2006, the Company has
not received any notice or other communication regarding any actual
or possible violation or breach of, or default under, any Company
Contract; and (iv) the Company has not waived any of its
material rights under any Company Contract.
(d) No Renegotiation . No Person has a contractual
right pursuant to the terms of any Material Contract to renegotiate
any amount paid or payable to Company under any Material Contract
or any other material term or provision of any Material
Contract.
(e) Proposed Contracts . Part 2.11(e) of the
Disclosure Schedule identifies and provides a brief description of
each proposed Contract as to which any offer, award, written
proposal, term sheet or similar document, in each case that would
contain binding obligations of the Company if accepted by the
recipient, has been submitted by the Company.
2.12
Compliance with Legal Requirements.
(a) Compliance . The Company is, and has at all times
been, in compliance in all material respects with each Legal
Requirement that is applicable to it or to the conduct of its
business or the ownership of its assets. No event has occurred, and
no condition or circumstance exists, that will (with or without
notice or lapse of time) constitute or result in a material
violation by the Company of, or a material failure on the part of
the Company to comply with, any Legal Requirement that is
applicable to it, to the conduct of its business as currently
conducted or to a Company Pharmaceutical Product. Except as set
forth in Part 2.12 of the Disclosure Schedule, since
January 1, 2006, the Company has not received any written
notice or other written communication from any Person regarding any
actual or possible
35
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
violation of,
or failure to comply with, any Legal Requirement that is applicable
to it, to the conduct of its business as currently conducted or to
a Company Pharmaceutical Product.
(b) Certain Business Practices . Neither the Company,
nor (to the Knowledge of the Company) any Representative of the
Company with respect to any matter relating to the Company, has:
(i) used any funds for unlawful contributions, gifts,
entertainment or other unlawful expenses relating to political
activity; (ii) made any unlawful payment to foreign or
domestic government officials or employees or to foreign or
domestic political parties or campaigns or violated any provision
of the Foreign Corrupt Practices Act of 1977, as amended; or
(iii) made any other unlawful payment.
(a) All Necessary Approvals . The Company has
obtained all required exemptions, approvals, certifications,
registrations and authorizations from all applicable Regulatory
Authorities relating to its activities conducted with respect to
all Company Pharmaceutical Products as of the date of this
Agreement.
(b) Compliance . All submissions made to Regulatory
Authorities by the Company with respect to the Company
Pharmaceutical Products have complied in all material respects with
all applicable Legal Requirements. All preclinical studies and
clinical trials conducted by the Company have been, and are being,
conducted in compliance in all material respects with applicable
Legal Requirements, and the Company is reasonably monitoring
clinical sites for their compliance. The Company is not subject to
an FDA consent decree or any similar order of a Regulatory
Authority or Governmental Body. The Company has not received any
notice or any other form of communication from any Person regarding
any actual or possible violation of, or failure to comply with, any
Legal Requirement applicable to the manufacture, use, sale or
investigation of any Company Pharmaceutical Products, including any
FDA Form 483, Warning Letter or any other adverse action or
notice from the FDA or other applicable Regulatory
Authorities.
(c) Company Pharmaceutical Products . All Company
Pharmaceutical Products are being manufactured, developed, labeled,
stored, tested and shipped by the Company in compliance with all
applicable requirements under the United States Federal Food, Drug,
and Cosmetic Act, as amended, and the rules and regulations
promulgated thereunder (the “ FD&C Act ”),
the Public Health Service Act of 1944 and all applicable similar
state and non-U.S. Legal Requirements, including those relating to
investigational use and applications to market a new Pharmaceutical
Product.
(i) There has not been, and, to the Knowledge of the
Company, there are no facts, circumstances or conditions that could
result in, any material and adverse effect upon the use, integrity
or validity of any clinical trial conducted by the
Company.
(ii) Without limiting the generality of
Section 2.13(b), all preclinical studies and clinical trials
conducted by the Company have been, and are being, to the extent
applicable, conducted in compliance with all requirements of Good
Laboratory Practice (within the meaning of 21 CFR 58) and Good
Clinical Practice (within the meaning of 21 CFR 56) and all
requirements relating to protection of human subjects contained in
Title 21, Parts 50, 54, 56 and 58 of the United States Code of
Federal Regulations.
36
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(iii) No clinical trial of any Company Pharmaceutical
Product has been suspended, put on hold or terminated prior to
completion, and no Investigational New Drug Application (as defined
in the FD&C Act) that is required to be submitted with the FDA
before beginning clinical testing in human subjects, or an
equivalent non-U.S. filing or application (an “ IND
”) for any Company Pharmaceutical Product has been suspended,
withdrawn, rejected or refused, in each case, as a result of any
action by a Regulatory Authority or voluntarily by the Company. The
Company has not received any notice or other communication
indicating that a Regulatory Authority has commenced or threatened
to initiate any action to withdraw approval or terminate clinical
development of any Company Pharmaceutical Product, or to enjoin or
place any restriction on the testing of or any other activity with
respect to any Company Pharmaceutical Product.
(e) Access to Correspondence, Filings and Audits
.
(i) The Company has made available to Parent each
annual report filed by the Company with the FDA or any similar
state or non-U.S. Regulatory Authority with respect to the Product.
The Company has made available to Parent in an accurate and
complete manner all clinical data from completed clinical trials
(including all adverse events) known to the Company regarding the
Product. None of the individuals identified on Annex I to
Exhibit A has any actual knowledge of any clinical data
regarding the Product that is materially inconsistent with the
Specified Clinical Data. The Company has made available to Parent
all reports of monitoring visits of clinical studies, all internal,
third party and FDA audits of clinical studies and all internal,
third party and FDA audits related to compliance with applicable
FDA requirements. “ Specified Clinical Data ”
refers to clinical data (including adverse events) regarding the
Product that have been provided to Parent, or to which Parent has
been given access, during the due diligence process prior to the
date of this Agreement.
(ii) The Company has made available to Parent accurate
and complete copies of: (A) each IND and each similar state or
non-U.S. regulatory filing made on behalf of the Company, including
all related supplements, amendments and annual reports; and
(B) all correspondence and minutes of meetings or memoranda of
meetings or regulatory contacts with a Regulatory Authority that
concerns any Company Pharmaceutical Product.
(f) No False Statements . Neither the Company, nor
any officer, employee, or agent of the Company, has made any false
statement or failed to disclose a material fact in, the
applications, approvals, reports or other submissions to the FDA or
other Regulatory Authority or in or from any other records and
documentation prepared or maintained to comply with the
requirements of the FDA or other Regulatory Authorities relating to
any Company Pharmaceutical Product, or committed an act, made a
statement or failed to make a statement, that (in any such case)
establishes a basis for the FDA to invoke its policy respecting
“Fraud, Untrue Statements of Material Facts, Bribery, and
Illegal Gratuities,” set forth in 56 Fed. Reg. 46191
(September 10, 1991) or for the EMEA or any similar state or
non-U.S. Regulatory Authority to invoke any similar policy. The
Company has not, and no officer, employee or agent of the Company
or principal investigator or sub-investigator of any clinical
investigation sponsored by the Company has, on account of actions
taken for or on behalf of the Company, been convicted of any crime
under 21 U.S.C. Section 335a(a) or any similar state or
non-U.S. Legal Requirement or under 21 U.S.C. Section 335a(b)
or any similar state or non-U.S. Legal Requirement.
37
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(g) Debarment . The Company has not used in any
capacity associated with the manufacture or investigation of any
new drug the services of any Person who has been, or to the
Knowledge of the Company, is in the process of being, debarred
under the Generic Drug Enforcement Act of 1992, 21 U.S. C.
§§335a-335c.
(h) Clinical Research Organizations . The Company
uses commercially reasonable efforts to maintain its business
relationships with clinical research organizations with which there
are Company Contracts. To the Knowledge of the Company, there is no
basis for such clinical research organizations to terminate a
Company Contract or otherwise not to maintain a business
relationship with the Surviving Corporation after the Effective
Time.
2.14
Governmental Authorizations; No Subsidies.
(a) Governmental Authorizations . Part 2.14(a)
of the Disclosure Schedule identifies each Governmental
Authorization held by the Company, and the Company has made
available to Parent accurate and complete copies of all
Governmental Authorizations identified in Part 2.14(a) of the
Disclosure Schedule. The Governmental Authorizations identified in
Part 2.14(a) of the Disclosure Schedule are valid and in full
force and effect, and collectively constitute all Governmental
Authorizations necessary to enable the Company to conduct its
business in the manner in which its business is currently being
conducted. The Company is, and has at all times been, in compliance
with the terms and requirements of the Governmental Authorizations
identified in Part 2.14(a) of the Disclosure Schedule. Since
January 1, 2006, the Company has not received any notice or
other communication from any Governmental Body regarding:
(i) any actual or possible violation of or failure to comply
with any term or requirement of any Governmental Authorization; or
(ii) any actual or possible revocation, withdrawal,
suspension, cancellation, termination or modification of any
Governmental Authorization.
(b) No Subsidies . The Company does not possesses and
has never possessed, and the Company has no rights or interests
with respect to and has never had any rights or interests with
respect to, any grants, incentives or subsidies from any
Governmental Body.
(a) Tax Returns and Payments . All Tax Returns
required to be filed by or on behalf of the Company have been
timely and properly filed and are true, accurate and complete in
all material respects. All Taxes of the Company that are due and
payable have been timely and properly paid, other than any Taxes
for which proper and adequate accruals or reserves in accordance
with GAAP are included in the Financial Statements as provided in
the last sentence of this Section 2.15. All Taxes required to
be withheld by the Company have been properly and timely withheld
and remitted. The Company has made available to Parent accurate and
complete copies of all Tax Returns filed by the Company, other than
immaterial Tax Returns (e.g., Forms W-2 and 1099) unless
specifically requested by Parent. There are no jurisdictions in
which the Company is required to file a Tax Return other than the
jurisdictions in which the Company has filed Tax Returns. No claim
has ever been made by an authority in a jurisdiction where the
Company does not file Tax Returns that it is or may be subject to
taxation by that jurisdiction. The Company Financial Statements
properly and adequately accrue or reserve for Tax liabilities in
accordance with GAAP.
(b) Audits; Claims . No Company Tax Return has ever
been examined or audited by any Governmental Body. The Company has
not received from any Governmental Body any:
(i) notice
38
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
indicating an
intent to open an audit or other review; (ii) request for
information related to Tax matters; or (iii) notice of
deficiency or proposed Tax adjustment. No extension or waiver of
the limitation period applicable to any Tax Returns has been
granted by or requested from the Company that is still in effect.
No claim or Legal Proceeding is pending or, to the Knowledge of the
Company, threatened against the Company in respect of any Tax.
There are no liens for Taxes upon any of the assets of the Company
except liens for current Taxes not yet due and payable (and for
which there are adequate accruals, in accordance with
GAAP).
(c) Tax Sharing Agreements; Etc . The Company will
not be required to include any item of income in, or exclude any
item of deduction from, taxable income for any taxable period (or
portion there) ending after the Closing Date that would give rise
to a Tax liability for such post-Closing Tax period as a result of
any change in method of accounting, closing agreement, intercompany
transaction, installment sale or prepaid amount received for a
taxable period ending on or prior to the Closing Date. The Company
is not a party to or bound by any Tax allocation or sharing
agreement. The Company has never been a member of an Affiliated
Group, other than an Affiliated Group of which the Company is the
common parent. The Company has no Liability for the Taxes of any
other Person.
(d) Closing Agreements; Etc . The Company will not be
required to include any item of income in, or exclude any item of
deduction from, taxable income for any taxable period (or portion
there) ending after the Closing Date as a result of any change in
method of accounting, closing agreement, intercompany transaction,
installment sale or prepaid amount received for a taxable period
ending on or prior to the Closing Date. The Company is not a party
to or bound by any Tax allocation or sharing agreement. The Company
has never been a member of an Affiliated Group. The Company has no
Liability for the Taxes of any other Person.
(e) Distributed Stock . The Company has not
distributed stock of another Person, nor has the Company had its
stock distributed by another Person, in a transaction that was
purported or intended to be governed in whole or in part by
Section 355 or Section 361 of the Code.
(f) Tax Holidays . Part 2.15(f) of the
Disclosure Schedule sets forth all Tax exemptions, Tax holidays or
other Tax reduction agreements or arrangements applicable to the
Company. The Company has provided to the Parent all documentation
relating to any applicable Tax holidays or incentives. The Company
is in compliance with the requirements for any applicable Tax
holidays or incentives and none of the Tax holidays or incentives
will be jeopardized by the transaction contemplated in this
Agreement.
(g) Section 481 or 263A . The Company is not
currently, nor for any period for which a Tax Return has not been
filed will the Company be, required to include any adjustment in
Taxable income for any Tax period (or portion thereof) pursuant to
Section 481 or 263A of the Code (or any comparable provision
under state, local or foreign Tax laws) as a result of
transactions, events or accounting methods employed prior to the
Merger.
(h) Section 6662 . The Company has disclosed on
its Tax Returns any Tax reporting position taken in any Tax Return
which could result in the imposition of penalties under
Section 6662 of the Code (or any comparable provisions of
state, local or foreign law).
(i) Tax Shelters . The Company has not consummated or
participated in, nor is the Company currently participating in, any
transaction which was or is a “Tax shelter” transaction
as defined
39
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
in
Sections 6662 or 6111 of the Code or the Treasury Regulations
promulgated thereunder. The Company has not participated in, and is
not currently participating in, a “Listed Transaction”
or a “Reportable Transaction” within the meaning of
Section 6707A(c) of the Code or Treasury Regulation
Section 1.6011-4(b), or any transaction requiring disclosure
under a corresponding or similar provision of state, local, or
foreign law.
(j) Section 1.1502-6 . The Company has no
Liability for the Taxes of any Person (other than the Company and
any members of an Affiliated Group of which the Company is the
common parent) under Section 1.1502-6 of the Treasury
Regulations (or any similar provision of state, local or foreign
law) as a transferee or successor, by Contract or
otherwise.
(k) Section 1503 . The Company has not incurred
a dual consolidated loss within the meaning of Section 1503 of
the Code.
(l) Foreign Taxes . The Company has in its possession
official foreign government receipts for any Taxes paid by it to
any foreign Tax Authorities.
(m) FIRPTA . The Company is not, nor has the Company
ever been, a “United States real property holding
corporation” within the meaning of Section 897 of the
Code, and the Company has filed with the Internal Revenue Service
all statements, if any, which are required under
Section 1.897-2(h) of the Treasury Regulations.
(n) Withholding Taxes . The Company has complied with
all applicable Legal Requirements relating to the payment,
reporting and withholding of Taxes (including withholding of Taxes
pursuant to Sections 1441, 1442, 1445 and 1446 of the Code or
similar provisions under any foreign law), has, within the time and
in the manner prescribed by law, withheld from employee wages or
consulting compensation and timely paid over to the proper
governmental authorities (or is properly holding for such timely
payment) all amounts required to be so withheld and paid over under
all applicable Legal Requirements, including federal and state
income Taxes, Federal Insurance Contribution Act, Medicare, Federal
Unemployment Tax Act, relevant state income and employment Tax
withholding laws, and has timely filed all withholding Tax Returns,
for all periods.
(o) 409A . No Company Employee Plan and no grants,
awards or benefits thereunder are subject to Section 409A(a)
or 409A(b) of the Code or, if subject to Section 409A(a) of
the Code, have failed, in form or operation, to meet the
requirements of Section 409A(a)(2), 409A(a)(3) or 409A(a)(4)
of the Code.
2.16 Employee
and Labor Matters; Benefit Plans.
(a) Employee List . Part 2.15(a) of the
Disclosure Schedule contains a list of all current Company
Employees as of the date of this Agreement, and correctly reflects:
(i) their dates of employment; (ii) their positions;
(iii) their salaries; (iv) any other compensation payable
to them (including housing allowances, compensation payable
pursuant to bonus, deferred compensation or commission arrangements
or other compensation); and (v) any promises made to them with
respect to changes or additions to their compensation or benefits.
The Company is not, nor has the Company ever been, bound by or a
party to, or has a duty to bargain for, any collective bargaining
agreement or other Contract with a labor organization representing
any Company Employees and there are no labor organizations
representing, purporting to represent or, to the Knowledge of the
Company, seeking to
40
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
represent any
current Company Employees. The Company is not engaged, and the
Company has never been engaged, in any unfair labor practice of any
nature. There are no unfair labor practice complaints pending or,
to the Knowledge of the Company, threatened against the Company
before the National Labor Relations Board. The Company has not had
any strike, slowdown, work stoppage, lockout, job action or threat
thereof, or question concerning representation, by or with respect
to any of the Company Employees. No event has occurred, and no
condition or circumstance exists, that might directly or indirectly
give rise to or provide a basis for the commencement of any such
strike, slowdown, work stoppage, lockout, job action, labor dispute
or union organizing activity or any similar activity or
dispute.
(b) Leave of Absence . There is no current Company
Employee who is not fully available to perform work because of
disability or other leave.
(c) At Will Employment . Except as set forth in
Part 2.16(c) of the Disclosure Schedule, the employment of
each of the current Company Employees is terminable by the Company
at will. The Company has made available to Parent accurate and
complete copies of all employee manuals and handbooks, disclosure
materials and policy statements.
(d) Employee Departures/Restrictions . To the
Knowledge of the Company, no employee of the Company at the level
of senior manager or above: (i) intends to terminate his
employment with the Company; (ii) has received an offer to
join a business that may be competitive with the Company’s
business; or (iii) is a party to or is bound by any
confidentiality agreement, noncompetition agreement or other
Contract (with any Person) that may have an adverse effect on:
(A) the performance by such employee of any of his duties or
responsibilities as an employee of the Company; or (B) any
Company’s business or operations.
(e) Employee Plans and Agreements . Part 2.16(e)
of the Disclosure Schedule contains an accurate and complete list
of each Company Employee Plan. The Company does not intend, nor has
the Company committed, to establish or enter into any new Company
Employee Plan, or to modify any Company Employee Plan (except to
conform any such Company Employee Plan to the requirements of any
applicable Legal Requirements, in each case as previously disclosed
to Parent in writing or as required by this Agreement).
(f) Delivery of Documents . As applicable with
respect to each Company Employee Plan, the Company has delivered or
made available to Parent: (i) correct and complete copies of
all documents setting forth the terms of each Company Employee
Plan, including all amendments thereto and all related trust
documents; (ii) the most recent summary plan description
together with the summaries of material modifications thereto, if
any, with respect to each Company Employee Plan; (iii) all
material written Contracts relating to each Company Employee Plan,
including administrative service agreements and group insurance
contracts; (iv) the annual reports (Form 5500 series) for
the last three complete plan years; (v) the most recent letter
of determination from the U.S. Internal Revenue Service relating to
the tax-qualified status of each Company Employee Plan intended to
be qualified under Section 401(a) of the Code; (vi) all
written materials provided to any Company Employee relating to any
Company Employee Plan and any proposed Company Employee Plans, in
each case, relating to any amendments, terminations,
establishments, increases or decreases in benefits, acceleration of
payments or vesting schedules or other events that would result in
any liability to the Company; (vii) all correspondence to or
from any Governmental Body relating to any Company Employee Plan;
and (viii) all insurance policies in the possession of the
Company pertaining to fiduciary liability insurance covering the
fiduciaries for each Company Employee Plan.
41
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
(g) No Foreign Plans . The Company has not
established or maintained: (i) any plan, program, policy,
practice, Contract or other arrangement mandated by a Governmental
Body other than the United States; (ii) any Company Employee
Plan that is subject to any of the Legal Requirements of any
jurisdiction outside of the United States; or (iii) any
Company Employee Plan that covers or has covered Company Employees
whose services are or have been performed primarily outside of the
United States.
(h) Absence of Certain Retiree Liabilities . No
Company Employee Plan provides (except at no cost to the Company),
or reflects or represents any liability of the Company to provide,
retiree life insurance, retiree health benefits or other retiree
employee welfare benefits to any Person for any reason, except as
may be required by applicable Legal Requirements. Other than
commitments made that involve no future costs to the Company, the
Company has never represented, promised or contracted (whether in
oral or written form) to any Company Employee (either individually
or to Company Employees as a group) or any other Person that such
Company Employee(s) or other person would be provided with retiree
life insurance, retiree health benefit or other retiree employee
welfare benefits, except to the extent required by applicable Legal
Requirements.
(i) No Defaults . The Company has performed all
obligations required to be performed by it under each Company
Employee Plan and is not in default or violation of, and, to the
Knowledge of the Company, there is no default or violation by any
other party to, the terms of any Company Employee Plan. Each of the
Company Employee Plans has been operated and administered in all
material respects in accordance with applicable Legal Requirements,
including the applicable tax qualification requirements under the
Code. All contributions to, and material payments from, any Company
Employee Plan which may have been required to be made in accordance
with the terms of such Company Employee Plan or applicable Legal
Requirements have been timely made, and all contributions for any
period ending on or before the Closing Date which are not yet due,
but will be paid on or prior to the Closing Date, are reflected as
an accrued liability on the Unaudited Interim Balance Sheet. Each
Company Employee Plan can be amended, terminated or otherwise
discontinued after the date of this Agreement, without liability to
the Company or Parent (other than ordinary administration
expenses). There are no audits, inquiries or Legal Proceedings
pending or, to the Knowledge of the Company, threatened, by any
Person with respect to any Company Employee Plan.
(j) No Conflict . Except as set forth in
Part 2.16(j) of the Disclosure Schedule, neither the
execution, delivery or performance of this Agreement, nor the
consummation of the Merger or any of the other transactions
contemplated by this Agreement, will or may (either alone or upon
the occurrence of any additional or subsequent events):
(i) constitute an event under any Company Employee Plan, trust
or loan that will or may result (either alone or in connection with
any other circumstance or event) in any payment (whether of
severance pay or otherwise), acceleration, forgiveness of
indebtedness, vesting, distribution, increase in benefits or
obligation to fund benefits (through a grantor trust or otherwise)
with respect to any Company Employee; or (ii) create or
otherwise result in any Liability with respect to any Company
Employee Plan. Without limiting the generality of the foregoing, no
amount paid or payable by the Company in connection with the
transactions contemplated hereby (either solely as a result thereof
or as a result of such transactions in conjunction with any other
event) could be an “excess parachute payment” within
the meaning of Section 280G of the Code (or any corresponding
provisions of state, local or foreign Legal
Requirements).
(k) Compliance . The Company: (i) is in
compliance in all material respects with all applicable Legal
Requirements, Contracts and orders, rulings, decrees, judgments or
arbitration awards of
42
Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
any arbitrator
or any court or other Governmental Body respecting employment,
employment practices, terms and conditions of employment, wages,
hours or other labor-related matters, including Legal Requirements,
orders, rulings, decrees, judgments and awards relating to
discrimination, wages and hours, labor relations, leave of absence
requirements, occupational health and safety, privacy, harassment,
retaliation, immigration, wrongful discharge or violation of the
personal rights of Company Employees (or prospective employees or
other service providers), including, but not limited to, the
Workers’ Adjustment and Retraining Notification Act (and any
similar foreign, provincial, state or local statute or regulation,
including the provisions of California Labor Code
Sections 1400-1408); (ii) has withheld and reported all
amounts required by any Legal Requirement or Contract to be
withheld and reported with respect to wages, salaries and other
payments to any Company Employee; (iii) has no Liability for
any arrears of wages or any Taxes or any penalty for failure to
comply with any of the foregoing; and (iv) has no Liability
for any payment to any trust or other fund governed by or
maintained by or on behalf of any Governmental Body with respect to
unemployment compensation benefits, social security or other
benefits or obligations for any Company Employee (other than
routine payments to be made in the normal course of business and
consistent with past practice). Each Company Employee Plan intended
to be “qualified” within the meaning of
Section 401(a) of the Code has received a favorable IRS
determination letter with respect to such qualification and the
Tax-exempt status of its related trust, and no circumstances exist
which could result in liability to the Company in respect of such
qualified status. No Company Employee Plan is intended to meet the
requirements of Section 501(c)(9) of the Code.
(l) Title IV of ERISA . Neither the Company, nor any
ERISA Affiliate of the Company, has ever maintained, been a
participating employer, contributed to, or has had any liability
with respect to (i) any multiemployer plan as defined in
Section-3(37) or Section 4001(a)(3) of ERISA or 414(f) of the
Code; (ii) any multiple employer plan within the meaning of
Section 4063 or 4064 of ERISA or Section 413(c) of the
Code; or (iii) any other employee benefit plan, fund, program,
contract or arrangement that is subject to Section 412 of the
Code, Section 302 of ERISA or Title IV of ERISA.
(m) Labor Relations . The Company has good labor
relations, and, except as set forth in Part 2.16(m) of the
Disclosure Schedule, the C
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