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Exhibit 10.34 COLLABORATIVE RESEARCH AND LICENSE
AGREEMENT between ARCHEMIX CORP. and
MERCK, KGaA January 17, 2007 Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
TABLE OF CONTENTS
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Page
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1. DEFINITIONS
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1
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2. ADMINISTRATION OF THE COLLABORATION
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19
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2.1 Joint Steering Committee
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19
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2.2 Joint Project Team
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21
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3. RESEARCH PROGRAM
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24
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3.1 Implementation of the Research Program
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24
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3.2 Annual Research Plans
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25
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3.3 Conduct of Research Program
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25
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3.4 Records
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26
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3.5 Selection of Program Targets
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27
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3.6 Identification of Lead Compounds and Optimized Lead
Compounds
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29
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3.7 Development Candidates
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29
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3.8 MERCK Decision Not to Go Forward
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29
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3.9 Supply of Proprietary Materials
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30
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3.10 Research Program Term
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30
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4. DEVELOPMENT PROGRAM; COMMERCIALIZATION OF PRODUCTS
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30
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4.1 Objectives of the Development Program
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30
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4.2 Responsibility for Development of Development Candidates and
Commercialization of Products
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30
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4.3 Annual Development Plans
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31
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4.4 Product Commercialization Plans
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31
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4.5 Development and Commercialization Diligence
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31
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4.6 Compliance
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32
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4.7 Cooperation
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32
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4.8 Exchange of Reports; Information; Updates
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32
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4.9 Development and Commercialization Rights and
Restrictions
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34
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4.10 Product Recalls
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35
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5. PAYMENTS
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35
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5.1 Technology Access and License Fee
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35
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5.2 License Maintenance Fee
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35
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5.3 R&D Funding
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35
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5.4 Milestone Payments
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36
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5.5 Payment of Royalties; Royalty Rates; Accounting and
Records
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38
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
i
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Page
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6. TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY;
NON-SOLICITATION
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42
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6.1 Confidentiality
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42
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6.2 Publicity
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44
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6.3 Publications and Presentations
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44
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6.4 Prohibition on Solicitation
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45
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7. LICENSE GRANTS; EXCLUSIVITY
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45
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7.1 Research and Development Licenses
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45
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7.2 Commercialization License
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50
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7.3 Right to Sublicense
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50
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7.4 Right to Subcontract
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50
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7.5 No Other Rights
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50
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7.6 Exclusivity
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51
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8. INTELLECTUAL PROPERTY RIGHTS
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51
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8.1 ARCHEMIX Intellectual Property Rights
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51
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8.2 MERCK Intellectual Property Rights
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51
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8.3 Joint Technology Rights
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51
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8.4 Patent Coordinators
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51
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8.5 Inventorship
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52
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8.6 Cooperation
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52
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9. FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS
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52
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9.1 Patent Filing, Prosecution and Maintenance
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52
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9.2 Legal Actions
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55
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9.3 Trademark and Copyright Ownership Prosecution, Defense and
Enforcement
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58
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10. TERM AND TERMINATION
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58
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10.1 Term
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58
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10.2 Termination
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59
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10.3 Consequences of Termination of Agreement
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59
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10.4 Rights and Duties of the Parties following Breach by MERCK
of Diligence Obligations
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62
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10.5 Surviving Provisions
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62
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11. REPRESENTATIONS AND WARRANTIES
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63
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11.1 Mutual Representations and Warranties
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63
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11.2 ARCHEMIX’ Representations and Warranties
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63
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11.3 Acknowledgment of MERCK
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64
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
ii
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Page
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12. INDEMNIFICATION
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64
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12.1 Indemnification of MERCK by ARCHEMIX
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64
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12.2 Indemnification of ARCHEMIX by MERCK
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65
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12.3 Indemnification of Gilead and UTC by MERCK
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65
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12.4 Conditions to Indemnification
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65
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12.5 Warranty Disclaimer
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66
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12.6 No Warranty of Success
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66
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12.7 Limited Liability
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66
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13. MISCELLANEOUS
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66
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13.1 Arbitration
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66
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13.2 Change of Control
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68
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13.3 Notices
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69
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13.4 Governing Law
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70
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13.5 Binding Effect
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70
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13.6 Headings
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70
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13.7 Counterparts
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70
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13.8 Amendment; Waiver
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70
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13.9 No Third Party Beneficiaries
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71
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13.10 Purposes and Scope
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71
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13.11 Assignment and Successors
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71
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13.12 Force Majeure
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71
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13.13 Interpretation
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71
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13.14 Integration; Severability
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71
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13.15 Further Assurances
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72
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
iii
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List of Schedules
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Schedule 1
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Optimized Lead Compound Selection Criteria
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Schedule 2A
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Program Targets
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Schedule 2B
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Target Replacement List
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Schedule 3
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Licensed Patent Rights
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Schedule 4
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Excluded Aptamers
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Schedule 5
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Excluded Targets
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Schedule 6
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Development Candidate Selection Criteria
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Schedule 7
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Form of Press Release
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Schedule 8
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Regional Offices or Countries in which Patent
Applications are to be Nationalized or Otherwise Prosecuted, Filed
and Maintained
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Schedule 9
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Material Terms to be Included in Form of
Co-Promotion Agreement
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Schedule 10
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Merck’s Standard Exchange Rate Methodology
Applied In Its External Reporting
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Schedule 11
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Program Chemistries
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
iv
COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
This COLLABORATIVE RESEARCH AND
LICENSE AGREEMENT (this "Agreement") is entered into as of
January 17, 2007, by and between Archemix Corp., a Delaware
corporation with offices at 300 Third Street, Cambridge, MA 02142
("ARCHEMIX"), and Merck KGaA, a company organized under the laws of
Germany with offices at Frankfurter Str. 250, 64293 Darmstadt,
Germany ("MERCK"). Each of MERCK and ARCHEMIX is sometimes referred
to individually herein as a "Party" and collectively as the
"Parties." WHEREAS, ARCHEMIX has
developed and controls certain technology, patent rights and
proprietary materials related to (a) the identification and
optimization of aptamers using its proprietary SELEX™ process
and SELEX™ technology, and (b) the use of such aptamers
for treating, preventing or delaying onset or progression of human
diseases or conditions; and WHEREAS,
MERCK is engaged in the research, development and commercialization
of human therapeutics; and WHEREAS,
the Parties desire to enter into a collaboration for the purposes
of identifying aptamers against certain identified targets, and
developing and commercializing products derived from such aptamers
for the prevention, treatment and delay of onset or progression of
cancer. NOW, THEREFORE, in
consideration of the mutual covenants contained herein, and for
other good and valuable consideration, the Parties hereto,
intending to be legally bound, hereby agree as follows: 1.
DEFINITIONS Whenever used
in this Agreement with an initial capital letter, the terms defined
in this Section 1 and in Schedule 9 attached
hereto shall have the meanings specified.
1.1 " Adverse Event "
means any untoward, undesired or unplanned medical occurrence in a
human clinical trial subject or a patient, which occurrence has a
temporal relationship to administration of a Development Candidate
or Product, whether or not considered related to the Development
Candidate or Product, including, without limitation, any
undesirable sign (including abnormal laboratory findings of
clinical concern), symptom or disease associated with the use of
such Development Candidate or Product.
1.2 " Affiliate "
means, with respect to any Person, any other Person that, directly
or indirectly through one or more affiliates, controls, or is
controlled by, or is under common control with, such Person. For
purposes of this definition, "control" means (a) ownership of
fifty percent (50%) or more of the shares of stock entitled to vote
for the election of directors in the case of a corporation, or
fifty percent (50%) or more of the equity interests in the case of
any other type of legal entity, (b) status as a general
partner in any partnership, or (c) any other arrangement
whereby a Person controls or has the right to control the board of
directors of a corporation or equivalent governing body of an
entity other than a corporation. 1.3
" Annual Development Plan " means, with respect to
each Optimized Lead Compound and Development Candidate and Contract
Year, the written plan for the Development Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
Program for such Optimized Lead Compound and Development
Candidate for such Contract Year, as such written plan may be
amended, modified or updated, as further described in
Section 4.3. 1.4 " Annual
Net Sales " means, with respect to any Calendar Year, the
aggregate amount of the Net Sales for such Calendar Year.
1.5 " Annual Research Plan
" means the written plan describing the research activities to
be carried out by each Party during each Contract Year of the
Research Program Term in conducting the Research Program pursuant
to this Agreement as well as a budget therefore, as such written
plan may be amended, modified or updated, as further described in
Section 3.2. 1.6 "
Applicable Laws " means Federal, state, local, national
and supra-national laws, statutes, rules and regulations, including
any rules, regulations, guidance, guidelines or requirements of
Regulatory Authorities, national securities exchanges or securities
listing organizations, that are in effect from time to time during
the Term and apply to a particular activity hereunder.
1.7 " Aptamer " means
(a) any naturally or non-naturally occurring oligonucleotide
identified by ARCHEMIX through the SELEX® Process that binds
with high specificity and affinity to a Target; and (b) any
oligonucleotide Derived from the oligonucleotide of (a) that
has such high specifity and affinity.
1.8 " ARCHEMIX Background
Technology " means any Technology that is used by ARCHEMIX,
or provided by ARCHEMIX for use, in the Research Program and/or the
Development Program that is (a) Controlled by ARCHEMIX as of the
Effective Date or (b) conceived or first reduced to practice
by employees of, or consultants to, ARCHEMIX after the Effective
Date other than in the conduct of ARCHEMIX Research Activities or
ARCHEMIX Development Activities and without the use in any material
respect of any MERCK Technology (other than Collaboration
Aptamers), MERCK Patent Rights or MERCK Materials. For purposes of
clarity, ARCHEMIX Background Technology (a) shall include the
SELEX® Process and SELEX® Technology and (b) shall not
include Collaboration Aptamers, ARCHEMIX Program Technology or
ARCHEMIX’s interest in Joint Technology.
1.9 " ARCHEMIX Decision
" means a decision with respect to the following issues: (a)
the conduct of the [***] against [***]; (b) whether ARCHEMIX
is to incur any [***]; (c) whether ARCHEMIX is to be obligated
to perform any [***]; (d) whether ARCHEMIX is to incur any
[***] in the performance of [***] or [***]; (e) the expansion,
at MERCK’s request, of the number of FTEs to be provided by
ARCHEMIX under the Research Program beyond [***] in any [***]; and
(f) the inclusion of any [***] MERCK as [***] Program Target.
1.10 " ARCHEMIX Development
Activities " means all Development activities specified to
be conducted by ARCHEMIX in any Annual Development Plan (or
amendment thereto) and approved by ARCHEMIX’s representatives
on the JPT and JSC (without resort to the dispute resolution
procedures set forth in Section 2.1.6). Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
2
1.11 " ARCHEMIX-Gilead
License Agreement " means the License Agreement between
Gilead Sciences, Inc. and ARCHEMIX dated October 21, 2001, as
amended. 1.12 " ARCHEMIX
Materials " means any Proprietary Materials that are
Controlled by ARCHEMIX and used by ARCHEMIX, or provided by
ARCHEMIX for use, in the Research Program and/or the Development
Program. For purposes of clarity, ARCHEMIX Materials shall include
all Aptamers provided by ARCHEMIX for use in the Research Program.
1.13 " ARCHEMIX Patent
Rights " means any Patent Rights Controlled by ARCHEMIX
that contain one or more claims that cover ARCHEMIX Technology.
1.14 " ARCHEMIX Program
Technology " means (a) any oligonucleotide of an
Enriched Pool that is not a Program Oligonucleotide; (b) any
Program Technology that is conceived or first reduced to practice
by employees of, or consultants to, ARCHEMIX, alone or jointly with
any Third Party, without the use in any material respect of any
MERCK Technology (other than Collaboration Aptamers), MERCK Patent
Rights, MERCK Materials or Joint Technology; and (c) any
Program Technology, regardless of whether conceived or first
reduced to practice by employees of, or consultants to, ARCHEMIX,
MERCK, or both Parties, alone or jointly with any Third Party, that
relates to, or constitutes, the SELEX® Process or SELEX®
Technology. For purposes of clarity, ARCHEMIX Program Technology
does not include Program Generic Technology, Program
Aptamer-Specific Technology and/or Development Program Technology.
1.15 " ARCHEMIX Research
Activities " means all activities specified to be conducted
by ARCHEMIX in any Annual Research Plan (or amendment thereto) that
are (a) approved by the JPT and the JSC and (b) to the
extent involving matters that are ARCHEMIX Decisions, approved by
ARCHEMIX in accordance with Section 2.1.6.
1.16 " ARCHEMIX Technology
" means, collectively, ARCHEMIX Background Technology and
ARCHEMIX Program Technology. 1.17 "
Calendar Quarter " means each successive period of
three (3) consecutive calendar months commencing on
January 1, April 1, July 1 or October 1, as the case
may be, and ending on March 31, June 30,
September 30 or December 31, respectively; provided,
that, the initial Calendar Quarter shall commence on the Effective
Date and end on March 31, 2007.
1.18 " Calendar Year "
means each successive period of twelve (12) months commencing
on January 1 and ending on December 31.
1.19 " Change of
Control" means, with respect to a Party, (a) a merger,
consolidation, share exchange or other similar transaction
involving such Party and any Third Party which results in the
holders of the outstanding voting securities of such Party
immediately prior to such merger, consolidation, share exchange or
other similar transaction ceasing to hold more than fifty percent
(50%) of the combined voting power of the surviving, purchasing or
continuing entity immediately after such merger, consolidation,
share exchange or other similar transaction, (b) any
transaction or series of related transactions (other than an
investment transaction by an entity Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
3
not engaged in the pharmaceutical or biotechnology business, the
purpose of which is to raise capital for a Party) in which a Third
Party, together with its Affiliates, becomes the beneficial owner
of fifty percent (50%) or more of the combined voting power of the
outstanding securities of such Party, or (c) the sale or other
transfer to a Third Party of all or substantially all of such
Party’s assets which relate to this Agreement.
1.20 " Collaboration "
means the alliance of ARCHEMIX and MERCK established pursuant to
this Agreement for the purposes of identifying, researching and
Developing Development Candidates and Commercializing Products in
the Field in the Territory. 1.21 "
Collaboration Aptamer " means, collectively, Program
Oligonucleotides, Program Aptamers, Lead Compounds, Optimized Lead
Compounds, Development Candidates and/or Products.
1.22 " Combination Product
" means a combination or bundled product that is sold together
in a single package or as a unit at a single price by a Party, its
Affiliates or sublicensees (or Sublicensees, as the case may be)
and that includes: (a) a Product; and (b) a Supplemental
Product that is not within the Licensed Patent Rights, where both
the Product and the Supplemental Product are required to treat the
intended Indication and/or to achieve the intended use or effect.
1.23 " Commercialization
" or " Commercialize " means any and all
activities directed to the commercialization of a Product after
Commercialization Regulatory Approval has been obtained, including
marketing, manufacturing for commercial sale, promoting, detailing,
distributing, offering to sell and selling a Product, importing a
Product for sale, conducting post-marketing human clinical studies
and interacting with Regulatory Authorities regarding the
foregoing. When used as a verb, "to Commercialize" and
"Commercializing" means to engage in Commercialization and
"Commercialized" has a corresponding meaning.
1.24 " Commercially Reasonable
Efforts " means (a) with respect to activities of
ARCHEMIX in the Research Program, or, with respect to the conduct
of ARCHEMIX Development Activities, if any, or, with respect to
activities of ARCHEMIX in the Commercialization of a Waived
Compound which is the subject of a transition plan pursuant to
Section 7.1.2(c), the efforts and resources comparable to
those undertaken by ARCHEMIX in pursuing the research, discovery,
development, commercialization and intellectual property protection
of proprietary materials and the development of product candidates,
as applicable, that are not subject to the Collaboration and that
are at an equivalent stage of development or commercialization and
have similar market potential and are at a similar stage in their
lifecycle, and (b) with respect to activities of MERCK in the
Research Program, the Development of a particular Development
Candidate or the Commercialization of a particular Product, the
efforts and resources comparable to those undertaken by MERCK in
pursuing intellectual property protection and development of
product candidates and commercialization of products, as
applicable, that are not subject to the Collaboration and that are
at an equivalent stage of development or commercialization and have
similar market potential and are at a similar stage in their
lifecycle. For purposes of both (a) and (b) above, all
relevant factors as measured by the facts and circumstances at the
time such efforts are due shall be taken into account, including,
as Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
4
applicable and without limitation, mechanism of action; efficacy
and safety; product profile; actual or anticipated Regulatory
Authority approved labeling; and the nature and extent of market
exclusivity (including patent coverage, proprietary position and
regulatory exclusivity; cost, time required for and likelihood of
obtaining Commercialization Regulatory Approval; competitiveness of
alternative products and market conditions; actual or projected
profitability and availability of capacity to manufacture and
supply for commercial sale). 1.25
" Commercialization Regulatory Approval " means, with
respect to any Product, the Regulatory Approval required by
Applicable Laws to sell such Product for use in the Field in a
country or region in the Territory. "Commercialization Regulatory
Approval" shall include, without limitation, the approval of any
Drug Approval Application. For purposes of clarity,
"Commercialization Regulatory Approval" in the United States shall
mean final approval of an NDA for the first Indication or sNDA for
an additional Indication permitting marketing of the applicable
Product in interstate commerce in the United States,
"Commercialization Regulatory Approval" in the European Union shall
mean marketing authorization for the applicable Product pursuant to
Council Directive 2001/83/EC, as amended, or Council
Regulation 2309/93/EEC, as amended and "Commercialization
Regulatory Approval" in Japan shall mean final approval of an
application submitted to the Ministry of Health, Labor and Welfare
and the publication of a New Drug Approval Information Package
permitting marketing of the applicable Product in Japan, as any of
the foregoing may be amended from time to time.
1.26 " Competitive Entity
" means any Third Party in the top [***] companies ranked by
[***] in the most recently completed Calendar Year for which such
ranking is readily available from an unaffiliated Third Party.
1.27 " Competitive Program
" means any research, development or commercialization activity
that involves an Aptamer that targets a Program Target for use in
the Field. 1.28 " Confidential
Information " means (a) with respect to ARCHEMIX, all
tangible embodiments of ARCHEMIX Technology, (b) with respect
to MERCK, all tangible embodiments of MERCK Technology and
(c) with respect to each Party, (i) all tangible
embodiments of Joint Technology and (ii) all information,
Technology and Proprietary Materials disclosed or provided by or on
behalf of such Party (the "disclosing Party") to the other Party
(the "receiving Party") or to any of the receiving Party’s
employees, consultants, Affiliates or sublicensees (or
Sublicensees, as the case may be); provided, that, none of the
foregoing shall be Confidential Information if: (A) as of the
date of disclosure, it is known to the receiving Party or its
Affiliates as demonstrated by contemporaneous credible written
documentation, other than by virtue of a prior confidential
disclosure to such receiving Party; (B) as of the date of
disclosure it is in the public domain, or it subsequently enters
the public domain through no fault of the receiving Party;
(C) it is obtained by the receiving Party from a Third Party
having a lawful right to make such disclosure free from any
obligation of confidentiality to the disclosing Party; or
(D) it is independently developed by or for the receiving
Party without reference to or use of any Confidential Information
of the disclosing Party as demonstrated by contemporaneous credible
written documentation. For purposes of clarity, unless excluded
from Confidential Information pursuant to the proviso at the end of
the preceding sentence, any scientific, technical or financial
information of a Party that is disclosed at any meeting of the JSC,
JPT or JMC or disclosed Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
5
through an audit report shall constitute Confidential
Information of the disclosing Party. Notwithstanding anything
herein to the contrary, the terms of this Agreement shall
constitute Confidential Information of each Party.
1.29 " Contract Year "
means (a) the period beginning on the Effective Date and
ending on the first anniversary of the last day of the calendar
month in which the Effective Date falls and (b) each
succeeding twelve (12) month period thereafter.
1.30 " Control " or
" Controlled " means (a) with respect to
Technology or Patent Rights, the possession by a Party of the right
to grant a license or sublicense to such Technology or Patent
Rights as provided herein without the payment of additional
consideration to, and without violating the terms of any agreement
or arrangement with, any Third Party and without violating any
Applicable Laws and (b) with respect to Proprietary Materials,
the possession by a Party of the right to supply such Proprietary
Materials to the other Party as provided herein without the payment
of additional consideration to, and without violating the terms of,
any agreement or arrangement with any Third Party, and without
violating any Applicable Laws. 1.31
" CTN " means the notification submitted to the
Japanese Ministry of Health, Labor and Welfare prior to the
Initiation of a clinical trial in Japan.
1.32 " Derived " means
identified, obtained, developed, created, synthesized, generated,
designed or resulting from, based upon, containing or
incorporating; conjugated to or complexed with (whether directly or
indirectly, or in whole or in part).
1.33 " Detail " means,
with respect to a Co-Promoted Product, an interactive, live,
face-to-face contact of a Representative within the Co-Promotion
Territory with a medical professional with prescribing authority or
other individuals or entities that have a significant impact or
influence on prescribing decisions, in an effort to increase
physician prescribing preferences of such Co-Promoted Product for
its approved uses within the Co-Promotion Territory. When used as a
verb, "Detailing" means performing Details. When used as an
adjective, "Detailing" means of or related to performing Details.
1.34 " Development " or
" Develop " means, with respect to each Optimized
Lead Compound and Development Candidate, all non-clinical and
clinical activities performed in order to obtain Regulatory
Approval of a Product Derived from such Optimized Lead Compound or
Development Candidate in accordance with this Agreement up to and
including the obtaining of Commercialization Regulatory Approval of
such Product. For purposes of clarity, these activities include,
without limitation, in vivo animal efficacy testing, preclinical
safety testing, test method development and stability testing,
regulatory toxicology studies, formulation, process development,
manufacturing, manufacturing scale-up, development-stage
manufacturing, quality assurance/quality control development,
statistical analysis and report writing, clinical trial design and
operations, preparing and filing Drug Approval Applications, and
all regulatory affairs related to the foregoing. When used as a
verb, "Developing" means to engage in Development and "Developed"
has a corresponding meaning. Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
6
1.35 " Development
Candidate " means any Optimized Lead Compound that the JPT
nominates and the JSC accepts as a Development Candidate as set
forth in Section 3.7 and for which MERCK has paid the
Development Candidate Milestone Payment in the time allotted for
such payment in Section 5.4.1; provided, that, no Collaboration
Aptamer shall, after [***], be nominated or accepted as a
Development Candidate. 1.36 "
Development Candidate Milestone Payment " means the
payment to be made to ARCHEMIX upon occurrence of Milestone 2
pursuant to Section 5.4.1. 1.37
" Development Candidate Selection Criteria " or "
DCSC " means the guideline criteria for selecting
Optimized Lead Compounds that are sufficiently promising to warrant
further Development as Development Candidates as set forth in
Schedule 6 attached hereto, as such
Schedule 6 shall be amended from time to time by the
JSC, which amendment shall occur before any activities with respect
to such Development Candidate are initiated, in any material
respect, in the Development Program.
1.38 " Development Program
" means the Development activities to be conducted during the
Term with respect to each Optimized Lead Compound and Development
Candidate pursuant to the Annual Development Plan, with the
objective of developing such Optimized Lead Compound or Development
Candidate into a Product. 1.39 "
Development Program Technology " means any Technology
that is first conceived or reduced to practice within the
Development Program including but not limited to a process for
modifying, optimizing, using, formulating, delivering and/or
stabilizing a Collaboration Aptamer.
1.40 " Diagnosis "
means (a) the determination or monitoring of (i) the
presence or absence of a disease, (ii) the stage, progression
or severity of a disease or (iii) the effect on a disease of a
particular treatment; and/or (b) the selection of patients for
a particular treatment with respect to a disease.
1.41 " Diagnostic Product
" means In Vitro Diagnostics, In Vivo Diagnostic
Agents and any product used for Diagnosis. For purposes of clarity,
the term Diagnostic Product shall not include a product used for
the delay of the onset or progression of, or the treatment or
prevention of, an Indication. 1.42
" Drug Approval Application " means, with respect to
a Product in a particular country or region, an application for
Commercialization Regulatory Approval for such Product in such
country or region, including without limitation: (a) an NDA or
sNDA; (b) a counterpart of an NDA or sNDA in any country or
region in the Territory (including, without limitation, a CTN); and
(c) all supplements and amendments to any of the foregoing.
1.43 " Enriched Pool "
means a pool of oligonucleotides used to perform the SELEX®
Process against a Program Target in the performance of the Research
Program that (a) has undergone [***] or more [***] of [***]
and (b) wherein, using an [***] with [***] of [***] (i.e.,
[***]) and [***] of the applicable Program Target, at least [***]%
of the input pool of [***] is Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
7
[***] in the assay by the Program Target and the [***] fraction
of the [***] pool is at least [***] relative to the [***] fraction
for [***] (i.e., [***]) pool of [***].
1.44 " Effective Date "
means the date first set forth above.
1.45 " Excepted Decision
" means any of the following decisions requiring the unanimous
approval of all members of the JSC: (a) any decision as to
whether a milestone has been achieved under this Agreement for
which a milestone payment is payable; and (b) any decision as
to whether a proposed Target is a [***].
1.46 " Excluded Aptamer
" means any Aptamer listed on Schedule 4 attached
hereto. 1.47 " Excluded
Target " means any Target listed on Schedule 5
attached hereto. 1.48 " Failed
Compound " means any Collaboration Aptamer directed against
a Failed Target. 1.49 " Failed
Target " means (a) any Program Target as to which the
JPT concludes and the JSC agrees, that ARCHEMIX is unable or
unlikely to identify [***] Program Target, (b) any Program
Target for which ARCHEMIX fails to identify [***]; (c) any
Program Target for which MERCK discontinues Development of [***],
provided, that, at such time no other [***] for such Program Target
are in Development, and (d) any Program Target for which [***]
meeting the applicable [***] exists and for which MERCK has not
[***] the [***] in the time allotted for such [***] in Section
5.4.1. For purposes of clarity, a Failed Target shall not be
considered a Program Target. 1.50
" FDA " means the United States Food and Drug
Administration or any successor agency or authority thereto.
1.51 " FDCA " means the
United States Federal Food, Drug, and Cosmetic Act, as amended.
1.52 " Field " means
[***]. For purposes of clarity, the Field shall not include the
research, development, manufacture, use or sale of Diagnostic
Products or Radio Therapeutics. 1.53
" First Commercial Sale " means, with respect to a
Product in a country in the Territory, the first sale, transfer or
disposition for value or for an end user of such Product in such
country. 1.54 " Force
Majeure " means any occurrence beyond the reasonable
control of a Party that (a) prevents or substantially
interferes with the performance by such Party of any of its
obligations hereunder and (b) occurs by reason of any act of
God, flood, fire, explosion, earthquake, strike, lockout, labor
dispute, casualty or accident, or war, revolution, civil commotion,
act of terrorism, blockage or embargo, or any injunction, law,
order, proclamation, regulation, ordinance, demand or requirement
of any government or of any subdivision, authority or
representative of any such government. Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
8
1.55 " FTE " shall
mean [***] hours of work devoted to or in support of the ARCHEMIX
Research Activities or the ARCHEMIX Development Activities that is
carried out by one or more appropriately trained employees of
ARCHEMIX, measured in accordance with ARCHEMIX’s time
allocation practices from time to time.
1.56 " FTE Cost "
means, for any period, the applicable FTE Rate multiplied by the
applicable number of FTEs in such period.
1.57 " FTE Rate " means
(a) for the [***] Contract Year, [***] Dollars (US $[***]);
(b) for the [***] Contract Year, [***] Dollars (US $[***]);
(c) for the [***] Contract Year, [***] Dollars (US $[***]);
(d) for each FTE or portion thereof greater than [***] in
[***] Contract Year during the Research Program Term, [***] Dollars
(US $[***]); and (e) for [***] Contract Year on and after the
expiration of the Research Program Term, an amount per Contract
Year to be determined by multiplying [***] Dollars (US $[***]) by
the [***] in the Consumer Price Index since the Effective Date
([***] for all items; [***]; available at [***] and adding or
subtracting the product of such multiplication to or from [***]
Dollars (US $[***]). The FTE rate includes all salary, employee
benefits, materials and all other expenses including support staff
and overhead for or associated with ARCHEMIX scientists performing
activities but does not include Third Party Costs as set forth in
Section 5.3.3. 1.58 "
GAAP " means United States generally accepted accounting
principles, consistently applied.
1.59 " Hatch-Waxman Act
" means the Drug Price Competition and Patent Term Restoration
Act of 1984, as amended. 1.60 "
ICC " means the International Chamber of Commerce in
Paris, France. 1.61 " IND
" means: (a) an Investigational New Drug Application as
defined in the FDCA and regulations promulgated thereunder or any
successor application or procedure required to initiate clinical
testing of a Development Candidate in humans in the United States;
(b) a counterpart of an Investigational New Drug Application
that is required in any other country or region in the Territory
before beginning clinical testing of a Development Candidate in
humans in such country or region; and (c) all supplements and
amendments to any of the foregoing.
1.62 " Indication "
means any human indication, disease or condition in the Field,
which can be treated, prevented, cured or the progression of which
can be delayed. For purposes of clarity, distinctions between human
indications, diseases or conditions with respect to a Product shall
be made by reference to the World Health Organization International
Classification of Diseases, version 10 (as revised and updated,
"ICD10"). 1.63 " Initiation
" means, with respect to a human clinical trial, the first date
that a subject or patient is dosed in such clinical trial.
1.64 " In Vitro
Diagnostics " means the use of the SELEX® Process or
Aptamers or PhotoAptamers identified through the use of the
SELEX® Process in the assay, testing or Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
9
determination, outside of a living organism, of a substance in a
test material. In Vitro Diagnostics shall include, among
other things, the use of the SELEX® Process or Aptamers or
PhotoAptamers identified through the use of the SELEX® Process
in the assay, testing or determination: (a) outside of a
living organism, (i) of a human substance in a test material,
often to identify or follow the progression of a disease or
disorder, or to select a patient for treatment; (ii) of a
plant substance, animal substance or other substance in a test
material, often to identify or follow the progression of a disease,
process, or disorder in a human or non-human organism; and
(iii) of environmental substances (as in water quality
testing); and (b) of a substance on a test material such as
cells (as in FACS analysis or other measurements of pathogens
within biological samples). 1.65 "
In Vivo Diagnostic Agent " means any product
containing one or more Aptamers that is used for any human in
vivo diagnostic purpose related to ( inter alia ) the
identification, quantification or monitoring of the propensity
toward, or actual existence of, any disease state.
1.66 " Joint Patent Rights
" means Patent Rights that contain one or more claims that
cover Joint Technology. 1.67 "
Joint Project Team " or " JPT " means the
committee composed of ARCHEMIX and MERCK representatives
established pursuant to Section 2.2.
1.68 " Joint Steering
Committee " or " JSC " means the committee
composed of ARCHEMIX and MERCK representatives established pursuant
to Section 2.1. 1.69 "
Joint Technology " means (a) all Program Generic
Technology and (b) any Program Technology other than Program
Aptamer-Specific Technology, that is (i) jointly conceived or
reduced to practice by employees of or consultants to MERCK and
employees of or consultants to ARCHEMIX or (ii) conceived or
reduced to practice solely by employees of or consultants to a
Party with the use in any material respect of any Technology,
Patent Rights or Proprietary Materials of the other Party. For the
avoidance of doubt, any Program Technology that relates to the
SELEX® Process or to the SELEX® Technology shall not be
considered Joint Technology irrespective of which Party conceived
or reduced to practice such improvement.
1.70 " Knowledge "
means, with respect to a Party, the actual knowledge of any
employee of such Party. 1.71 "
Lead Compound " means any Program Aptamer that [***]
Program Target that is first identified in the conduct of the
Research Program or Development Program, or any Aptamer [***] first
identified in the conduct of the Research Program or Development
Program that [***] Program Target; provided, that, no Collaboration
Aptamer shall, after [***], be nominated or designated as a Lead
Compound. 1.72 " Licensed
Patent Rights " means any ARCHEMIX Patent Rights and
ARCHEMIX’s interest in Joint Patent Rights that
(a) contain one or more claims that cover any Collaboration
Aptamer, including its manufacture or its formulation or a method
of its delivery Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
10
or of its use, or (b) are necessary for MERCK to exercise
the licenses granted to it pursuant to Sections 7.1 and 7.2.
For purposes of clarity, Licensed Patent Rights existing as of the
Effective Date include those listed on Schedule 3
attached hereto. 1.73 "
Licensed Technology " means any ARCHEMIX Technology and
ARCHEMIX’s interest in Joint Technology that (a) relates
to any Collaboration Aptamer, including its manufacture or its
formulation or a method of its delivery or of its use, and
(b) is necessary for MERCK to exercise the licenses granted to
it pursuant to Sections 7.1 and 7.2.
1.74 " Major Market Country
" means each of the [***] and [***].
1.75 " MERCK Background
Technology " means any Technology that is used by MERCK, or
provided by MERCK for use, in the Research Program and/or
Development Program that is (a) Controlled by MERCK as of the
Effective Date or (b) conceived or first reduced to practice
by employees of, or consultants to, MERCK after the Effective Date
other than in the conduct of MERCK Research Activities or MERCK
Development Activities and without the use in any material respect
of any Collaboration Aptamers, ARCHEMIX Technology, ARCHEMIX Patent
Rights, or ARCHEMIX Materials. For purposes of clarity, MERCK
Background Technology shall not include MERCK Program Technology or
MERCK’s interest in Joint Technology.
1.76 " MERCK Development
Activities " means all Development activities specified to
be conducted by MERCK in any Annual Development Plan (or amendment
thereto). 1.77 " MERCK
Materials " means any Proprietary Materials that are
Controlled by MERCK and used by MERCK, or provided by MERCK for
use, in the Research Program and/or the Development Program.
1.78 " MERCK Patent Rights
" means any Patent Rights Controlled by MERCK that contain one
or more claims that cover MERCK Technology.
1.79 " MERCK Program
Technology " means (a) any Program Technology that
(i) is not ARCHEMIX Program Technology or Joint Technology and
(ii) is conceived or first reduced to practice by employees
of, or consultants to, MERCK, alone or jointly with any Third
Party, without the use in any material respect of any ARCHEMIX
Technology, ARCHEMIX Patent Rights, ARCHEMIX Materials or Joint
Technology; (b) any Program Aptamer-Specific Technology; and
(c) any Development Program Technology.
1.80 " MERCK Research
Activities " means all activities specified to be conducted
by MERCK in any Annual Research Plan (or amendment thereto) that
are approved by the JPT and JSC. 1.81
" MERCK Technology " means, collectively, MERCK
Background Technology and MERCK Program Technology. Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
11
1.82 " Minimum FTE Funding
Commitment " means the funding of at least [***] ARCHEMIX
FTEs at the applicable FTE Rate for each Contract Year during the
Research Program Term. 1.83 "
NDA " means a New Drug Application, as defined in the
FDCA and regulations promulgated thereunder or any successor
application or procedure required to sell a Product in the United
States. 1.84 " Net Sales
" means the gross amount billed or invoiced by MERCK or any of
its Affiliates or Sublicensees to Third Parties throughout the
Territory for sales or other dispositions or transfers for value of
Products less (a) allowances for normal and customary trade,
quantity and cash discounts actually allowed and taken,
(b) transportation, insurance and postage charges, if prepaid
by MERCK or any Affiliate or Sublicensee of MERCK and included on
any such party’s bill or invoice as a separate item,
(c) credits, rebates, returns pursuant to agreements
(including, without limitation, managed care agreements) or
government regulations, to the extent actually allowed, and
(d) sales, use and other consumption taxes similarly incurred
to the extent included on the bill or invoice as a separate item.
In addition, Net Sales are subject to the following: If MERCK or
any of its Affiliates or Sublicensees effects a sale, disposition
or transfer of a Product to a customer in a particular country
other than on customary commercial terms or as part of a package of
products and services, the Net Sales of such Product to such
customer shall be deemed to be "the fair market value" of such
Product. For purposes of this subsection, "fair market value" shall
mean the value that would have been derived had such Product been
sold as a separate product to another customer in the country
concerned on customary commercial terms. In the case of pharmacy
incentive programs, hospital performance incentive program
chargebacks, disease management programs, similar programs or
discounts on "bundles" of products, all discounts and the like
shall be allocated among products on the basis on which such
discounts and the like were actually granted or, if such basis
cannot be determined, in proportion to the respective list prices
of such products or such other reasonable allocation method as the
Parties shall agree. For purposes of clarity, use of any Product in
clinical trials, pre-clinical studies or other research or
development activities, or disposal or transfer of Products for a
bona fide charitable purpose or a commercially reasonable sampling
program, shall not give rise to any Net Sales.
1.85 " Optimized Lead
Compound " means any [***] Compound that the JPT nominates
and the JSC accepts as meeting the OLSC for such Program Target;
provided, that, no [***] shall, after becoming a [***], be
nominated or designated as an Optimized Lead Compound.
1.86 " Optimized Lead Compound
Selection Criteria " or " OLSC " means the
guideline criteria for selecting Lead Compounds that are
sufficiently promising to warrant further research as an Optimized
Lead Compound as set forth in Schedule 1 attached
hereto, as such Schedule 1 may be amended from time to
time by the JSC, which amendment shall occur before Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
12
any research activities are initiated with respect to such
Optimized Lead Compound against the applicable Program Target.
Notwithstanding anything to the contrary set forth in Schedule
1 , for purposes of determining whether a Lead Compound has
been designated as an Optimized Lead Compound for Milestone 1 in
Section 5.4.1, [***] shall be required to be performed with
respect to such Lead Compound, whether or not included as part of
the OLSC. 1.87 " Patent
Rights " means the rights and interests in and to issued
patents and pending patent applications (which, for purposes of
this Agreement, include certificates of invention, applications for
certificates of invention and priority rights) in any country or
region, including all provisional applications, substitutions,
continuations, continuations-in-part, divisions, renewals, all
letters patent granted thereon, and all reissues, re-examinations
and extensions thereof, and all foreign counterparts of any of the
foregoing. 1.88 " Permitted
Screening Activities " means, [***] to any [***], any [***]
ARCHEMIX [***] to such [***] for [***] and/or for [***] for the
[***] of [***] Aptamers [***] bind to a [***] a [***].
1.89 " Person " means
an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust,
incorporated association, joint venture or similar entity or
organization, including a government or political subdivision,
department or agency of a government.
1.90 " Phase I Clinical
Trial " means a clinical trial conducted in healthy humans
or patients, which clinical trial is designed to establish the
safety, drug-drug interactions and/or pharmacokinetics of an
investigational drug given its intended use, and to support
continued testing of such drug in Phase II Clinical Trials.
1.91 " Phase II Clinical
Trial " means a clinical trial conducted in patients with a
particular disease or condition, which clinical trial is designed
to establish the safety, appropriate dosage and pharmacological
activity of an investigational drug given its intended use, and to
initially explore its efficacy for such disease or condition.
1.92 " Phase III Clinical
Trial " means a pivotal clinical trial conducted in
patients with a particular disease or condition, which clinical
trial is designed to ascertain efficacy and safety of an
investigational drug for its intended use and to define warnings,
precautions and Adverse Events that are associated with the
Development Candidate in the dosage range intended to be
prescribed, with the purpose of preparing and submitting
applications for Regulatory Approval or label expansion to the
pertinent Regulatory Authority in any country.
1.93 " Product " means
any pharmaceutical or medicinal item, substance or formulation that
contains, incorporates or comprises a Collaboration Aptamer or any
Aptamer Derived therefrom that binds a Program Target.
Notwithstanding the above, if a first pharmaceutical or medicinal
item, substance or formulation is deemed to be a Product for
purposes of this Agreement, any subsequent pharmaceutical or
medicinal item, substance or formulation will be considered to be
an additional Product for purposes of this Agreement only Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
13
to the extent that it is a new chemical entity (as defined by
the FDCA) with respect to the existing Product(s).
1.94 " Product
Commercialization Plan " means, with respect to each
Product, the written plan for the Commercialization of such Product
in the Territory (including, without limitation, expected
manufacturing scale-up, manufacture, formulation and filling
requirements for such Product and a detailed strategy, budget and
proposed timelines), as such plan may be amended or updated.
1.95 " Product Trademark
" means any trademark or trade name, whether or not registered,
or any trademark application or renewal, extension or modification
thereof, in the Territory, or any trade dress and packaging, in
each case (a) that are applied to or used with any Product by
MERCK and (b) together with all goodwill associated therewith
and promotional materials relating thereto.
1.96 " Program Aptamer
" means any [***] that is an [***] that [***] and that is first
identified in the performance of the Research Program or during
Development and/or any [***] that [***] that is [***] from such
[***] and that is first identified in the performance of the
Research Program or during Development.
1.97 " Program Aptamer-Specific
Patent Rights " means all Patent Rights that cover only
Program Aptamer-Specific Technology.
1.98 " Program Aptamer-Specific
Technology " means any Program Technology that relates
specifically to (a) any Collaboration Aptamer or (b) the
manufacture, formulation, delivery, production or use of a
Collaboration Aptamer. 1.99 "
Program Generic Patent Rights " means Patent Rights that
cover only Program Generic Technology.
1.100 " Program Generic
Technology " means any Program Technology that relates
generally to the manufacture, formulation, delivery, production or
use of Aptamers. 1.101 "
Program Oligonucleotide " means the [***] and [***]
obtained from an [***] and [***] and [***] in the performance of
the [***] against a [***] that is not a [***].
1.102 " Program Target
" means the Targets listed on Schedule 2A attached
hereto, as amended from time to time in accordance with
Section 3.5. 1.103 "
Program Technology " means any Technology (including,
without limitation, any new and useful process, method of
manufacture or composition of matter) or Proprietary Materials that
are conceived or first reduced to practice (actively or
constructively) by either Party in the conduct of the Research
Program. 1.104 " Proprietary
Materials " means tangible chemical, biological or physical
materials (a) that are furnished by or on behalf of one Party
to the other Party in connection with this Agreement, whether or
not specifically designated as proprietary by the Transferring
Party Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
14
or (b) that are otherwise conceived or reduced to practice
in the conduct of the Research Program or the Development Program.
1.105 " Quarterly FTE
Payment " means the minimum amount payable by MERCK to
ARCHEMIX for FTEs during each Calendar Quarter of the Research
Program Term pursuant to Section 5.3, which shall equal the
greater of: (a) $[***] per Calendar Quarter in the [***] Contract
Year, $[***] per Calendar Quarter in the [***] Contract Year, and
$[***] per Calendar Quarter in the [***] Contract Year; or
(b) the estimated FTE Cost as set forth in the Annual Research
Plan for such Calendar Quarter. 1.106
" Radio Therapeutic " means any product for human
therapeutic use that contains one or more Aptamers that targets
specifically any diseased tissue, cells or disease-specific
molecules or any tissue or cells which are affected by a disease or
located in the close neighborhood of a disease process and is
linked to or incorporates (a) radionucleotides or (b) any
structure or elements which develop therapeutic effects similar to
the effect of linking or incorporating radionucleotides after
submission of any kind of radiation.
1.107 " Regulatory Approval
" means, with respect to any country or region in the
Territory, any approval, product and establishment license,
registration or authorization of any Regulatory Authority required
for the manufacture, use, storage, importation, exportation,
distribution, transport or sale of a Product for use in the Field
in such country or region. 1.108 "
Regulatory Authority " means the FDA, or any counterpart
of the FDA outside the United States, or any other national,
supra-national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental
entity with authority over the distribution, importation,
exportation, manufacture, production, use, storage, transport,
clinical testing or sale of a Product.
1.109 " Regulatory Filings
" means, collectively: (a) all INDs, establishment license
applications, drug master files, applications for designation as an
"Orphan Product(s)" under the Orphan Drug Act, for "Fast Track"
status under Section 506 of the FDCA (21 U.S.C. § 356) or
for a Special Protocol Assessment under Section 505(b)(4)(B)
and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)), NDAs and
BLAs and all other similar filings (including, without limitation,
counterparts of any of the foregoing in any country or region in
the Territory); (b) all supplements and amendments to any of
the foregoing; and (c) all data and other information
contained in, and correspondence relating to, any of the foregoing.
1.110 " Representative
" means an individual (including a medical service liaison,
sales representative or other representative) employed and trained
by either Party or employed by a Third Party or self-employed and
trained by or on behalf of a Party, in any case, to Detail a
Co-Promoted Product. 1.111 "
Research Program " means the research program to be
conducted by the Parties during the Research Program Term pursuant
to the Annual Research Plan up to and including the selection of
Optimized Lead Compounds from Lead Compounds. For purposes of
clarity, the Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
15
Research Program does not include any Development activities
performed in the course of the Development Program.
1.112 " Research Program
Term " means the period beginning on the Effective Date and
ending on the last day of the third Contract Year; provided, that,
if this Agreement is terminated prior to the end of the Research
Program Term, the effective date of such early termination shall
become the last day of the Research Program Term.
1.113 " Royalty Term "
means, on a Product-by-Product and country-by-country basis, the
period beginning on the date of First Commercial Sale of a Product
in a country and ending on the later to occur of
(a) expiration of the last to expire Valid Claim of the
Licensed Patent Rights, Program Aptamer-Specific Patent Rights or
Joint Patent Rights in such country that covers such Product or its
identification, manufacture, use, import, offer for sale or sale or
(b) (i) with regard to the first Product for each Program
Target sold in such country, fifteen (15) years from the date
of the First Commercial Sale of such first Product in such country
or (ii) with regard to each additional Product for such
Program Target sold in such country, ten (10) years from the
date of the First Commercial Sale of each such additional Product
in such country. 1.114 "
SELEX® Portfolio " means those Patent Rights
licensed by Gilead to ARCHEMIX pursuant to the ARCHEMIX-Gilead
License Agreement. 1.115 "
SELEX® Process " means any process for the
identification or generation of a nucleic acid that binds to a
Target by means other than Watson-Crick base-pairing, including
without limitation any such process that (a) is covered by, or
is described in, the SELEX® Portfolio, including without
limitation U.S. Patent Nos. [***] or [***] (b) is covered by,
or is described in, any other Patent Rights Controlled by ARCHEMIX,
and (c) any continuations, divisionals and continuations-in
part substitutions, renewals, reissues, re-examinations and
extensions of and improvements to the inventions covered by, or
described in, the foregoing Patent Rights.
1.116 " SELEX®
Technology " means (a) generic aptamer compositions
and (b) any process for modifying, optimizing and/or stabilizing an
aptamer wherein such modification, optimization or stabilization
includes, without limitation minimization, truncation, conjugation,
pegylation, complexation, substitution, deletion and/or
incorporation of modified nucleotides.
1.117 " sNDA " means a
Supplemental New Drug Application, as defined in the FDCA and
applicable regulations promulgated thereunder.
1.118 " Sublicense
Agreement " means any agreement entered into by MERCK with
a Sublicensee. 1.119 "
Sublicensee " means any Third Party to which MERCK
grants a sublicense under the licenses granted to it under
Section 7.1 or 7.2. 1.120 "
Supplemental Product " means a product having
independent, supplementary or enabling therapeutic effect (e.g., as
a catalyst or adjuvant) or diagnostic utility. Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
16
1.121 " Target "
means a protein, cytokine, enzyme, receptor, transducer,
transcription factor, antigen or any other non-nucleic acid
molecule. 1.122 " Target
Replacement List " means the list of Targets on
Schedule 2B attached hereto, as amended pursuant to
Section 3.5.1. 1.123 "
Target Selection Field " means the treatment or
prevention in humans of cancer. 1.124
" Technology " means, collectively, inventions,
discoveries, improvements, trade secrets and proprietary methods,
whether or not patentable, including without limitation: (a)
methods of production or use of, and structural and functional
information pertaining to, chemical compounds; and
(b) compositions of matter, data, formulations, processes,
techniques, know-how and results (including, without limitation,
any negative results). 1.125 "
Terminated Compounds " means (a) all Collaboration
Aptamers upon any termination of this Agreement by ARCHEMIX
pursuant to Section 10.2.3 or Section 10.2.2 or by MERCK
pursuant to Section 10.2.1; and (b) the relevant
Collaboration Aptamers binding specifically to the Program Target
for which MERCK’s license is terminated by ARCHEMIX pursuant
to Section 10.2.2 due to failure of MERCK to meet its
diligence obligations, as provided in Section 10.4.
1.126 " Territory "
means all countries and territories of the world.
1.127 " Third Party "
means a Person other than MERCK and ARCHEMIX and their respective
Affiliates. 1.128 " URC License
Agreement " means the Restated Assignment and License
Agreement, dated July 17, 1991, by and between University
Research Corporation and Gilead as successor in interest to
NeXstar. 1.129 " UTC "
means University Technology Corporation, the successor to the
University Research Corporation.
1.130 " Valid Claim "
means any claim of a pending patent application or an issued
unexpired patent that (a) has not been finally cancelled,
withdrawn, abandoned or rejected by any administrative agency or
other body of competent jurisdiction, (b) has not been
permanently revoked, held invalid, or declared unpatentable or
unenforceable in a decision of a court or other body of competent
jurisdiction that is unappealable or unappealed within the time
allowed for appeal, (c) has not been rendered unenforceable
through disclaimer or otherwise, and (d) is not lost through
an interference proceeding. 1.131
" Waived Compound " means any Collaboration Aptamer
directed against a Waived Target.
1.132 " Waived Target "
means (a) any Program Target for which MERCK, in its sole
discretion, discontinues Development of a Development Candidate;
provided, that, no other Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
17
Development Candidates for such Program Target are in
Development at such time and (b) any Program Target which
MERCK designates as a Waived Target in writing to ARCHEMIX.
Additional Definitions
. In addition, each of the following definitions shall have the
respective meanings set forth in the section of this Agreement
indicated below:
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Definition
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Section
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Annual Reconciliation Statement
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5.3.1
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ARCHEMIX Change of Control Notice
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13.2.1(a)
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ARCHEMIX Indemnitees
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12.2
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Claims
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12.1
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Collaboration Manager
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2.2.6
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Co-Promote
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4.9.2(a)
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Co Promoted Product
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4.9.2(a)
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Co-Promotion
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4.9.2(a)
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Co-Promotion Agreement
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4.9.2(a)
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Designated Senior Officers
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2.1.6
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Dispute
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13.1.1
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Disputed Matter
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2.1.6
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Expert
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13.1.2(a)
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Filing Party
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9.1.4
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Gilead Indemnitee
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12.3
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Indemnified Party
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12.4
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Indemnifying Party
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12.4
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Infringement
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9.2.1(a)
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Infringement Notice
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9.2.1(a)
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JPT Term
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2.2.1
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JSC Term
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2.1.1
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Losses
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12.1
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MERCK Change of Control Notice
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13.2.2(a)
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MERCK Contribution
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5.3.1
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MERCK Indemnitees
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12.1
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Non-Filing Party
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9.1.4
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Patent Coordinator
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8.4
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Requested Chemistry
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5.5.1(b)
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Recipient Party
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3.8
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Term
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10.1
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Third Party Chemistry Payments
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5.5.1(b)
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Third Party Costs
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5.3.3
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Third Party Payments
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5.5.1(b)
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Transferring Party
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3.8
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
18
2. ADMINISTRATION OF THE COLLABORATION
2.1 Joint Steering
Committee .
2.1.1
Establishment . Within [***] days from the Effective
Date, ARCHEMIX and MERCK shall establish the Joint Steering
Committee. Unless otherwise agreed by the Parties, the term for the
JSC shall commence as of the Effective Date and continue until the
last day of the Research Program Term ("JSC Term"); provided, that,
the JSC Term shall be extended in the event that, and for so long
as, the JPT Term is extended or any Co-Promoted Products are being
Commercialized. The JSC shall have and perform the responsibilities
set forth in Section 2.1.4.
2.1.2
Membership. Upon establishment of the JSC, each Party
shall designate in writing, in its sole discretion, [***] members
to the JSC, which shall be members of its management. Unless
otherwise agreed by the Parties, one of MERCK’s designees
shall be designated by MERCK as the Chair. Each Party shall have
the right at any time to substitute individuals, on a permanent or
temporary basis, for any of its previously designated
representatives to the JSC, by giving written notice to the other
Party. Initial designees of the Parties to the JSC shall be
designated by each Party by written notice to the other Party as
soon as is reasonably practicable following the Effective Date.
2.1.3
Meetings .
(a)
Schedule of Meetings; Agenda . The JSC shall establish a
schedule of times for regular meetings, taking into account the
planning needs of the Collaboration and its responsibilities. In
urgent cases, special meetings of the JSC may be convened by any
member upon [***] days (or, if such meeting is proposed to be
conducted by teleconference, upon [***] days) written notice to the
other members; provided, that, (i) notice of any such special
meeting may be waived at any time, either before or after such
meeting, and such waiver shall be the equivalent to the giving of a
valid notice hereunder, and (ii) attendance of any member at a
special meeting shall constitute a valid waiver of notice from such
member. In no event shall the JSC meet less frequently than once in
each Calendar Year. Regular and special meetings of the JSC may be
held in person or by teleconference or videoconference; provided,
that, meetings held in person shall alternate between the
respective offices of the Parties. The Chair shall prepare and
circulate to each JSC member an agenda for each JSC meeting not
later than one (1) week prior to such meeting.
(b)
Quorum; Voting; Decisions . At each JSC meeting (i) the
presence in person of at least [***] [***] designated by each Party
shall constitute a quorum and (ii) all members designated by
each Party who are present shall have [***] on all matters before
the JSC at such meeting. All decisions of the JSC shall be made by
unanimous vote. Alternatively, the JSC may act by written consent
signed by at least [***] [***] designated by each Party subject to
Section 2.1.6. Whenever any action by the JSC is called for
hereunder during a time period in which the JSC is not scheduled to
meet, the Chair shall cause the JSC to take the action in the
requested time period by calling a special meeting or by
circulating a written consent. Representatives of each Party or of
its Affiliates who are not members of the JSC may attend Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
19
JSC meetings as non-voting observers with the consent of the
other Party, which shall not be unreasonably withheld, conditioned
or delayed.
(c)
Minutes . The JSC shall keep minutes of its meetings that
record all decisions and all actions recommended or taken in
reasonable detail. Drafts of the minutes shall be prepared and
circulated to the members of the JSC within a reasonable time after
the meeting, not to exceed [***] business days. The Chair shall
have responsibility for the preparation and circulation of draft
minutes. Each member of the JSC shall have the opportunity to
provide comments on the draft minutes. The minutes shall be
approved, disapproved and revised as necessary at the next JSC
meeting or within [***] days of the meeting whichever occurs first.
Upon approval, final minutes of each meeting shall be circulated to
the members of the JSC by the Chair.
2.1.4
Responsibilities . The JSC shall be responsible for
overseeing the conduct and progress of the Research Program and the
Development of Optimized Lead Compounds and Development Candidates
for which ARCHEMIX is performing Development activities. Without
limiting the generality of the foregoing, the JSC shall have the
following responsibilities:
(a) overseeing
the JPT’s performance of its responsibilities;
(b) reviewing
and approving each Annual Research Plan and each Annual Development
Plan under which ARCHEMIX is responsible for performing Development
activities;
(c) reviewing
and approving any amendment to an Annual Research Plan approved by
the JPT and submitted to it for its approval;
(d) reviewing
and approving any amendment to an Annual Development Plan under
which ARCHEMIX is responsible for performing Development activities
approved by the JPT and submitted to it for its approval;
(e) reviewing
data, reports or other information submitted to it by the JPT from
time to time;
(f) resolving
all JPT matters that are in dispute;
(g) reviewing
and either approving or rejecting any decision of the JPT to
nominate any Lead Compound as an Optimized Lead Compound or any
decision of the JPT to nominate any Optimized Lead Compound as a
Development Candidate;
(h) resolving
any dispute as to whether a milestone event under this Agreement
has occurred; and
(i) implementing
a mutually acceptable mechanism for reporting Adverse Events
between the Parties for each Development Candidate and Product; and
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
20
(j) making
such other decisions as may be delegated to the JSC pursuant to
this Agreement or by mutual written agreement of the Parties after
the Effective Date.
2.1.5
Interests of the Parties . Notwithstanding any other
provisions of this Agreement, all decisions made and all actions
taken by the JSC shall be made or taken in the best interest of the
Collaboration.
2.1.6
Dispute Resolution . The JSC members shall use
reasonable efforts to reach agreement on any and all matters. Such
reasonable efforts shall, if requested by any member of the JSC,
include the engagement of a mutually acceptable Person who is not
affiliated with either Party and has particular experience or
expertise with respect to a particular matter to advise the JSC,
the expense of any such Person to be borne equally by the Parties.
In the event that, despite such reasonable efforts, agreement on a
particular matter cannot be reached by the JSC within thirty
(30) days after the JSC first meets to consider such matter
(each such matter, a "Disputed Matter"), then, if the Disputed
Matter does not involve an Excepted Decision or an ARCHEMIX
Decision, and except as set forth in the last sentence of this
section, MERCK shall have the right to make the final decision on
such Disputed Matter, but shall only exercise such right in good
faith after full consideration of the positions of both Parties.
Notwithstanding the foregoing, (i) if the Disputed Matter
involves an ARCHEMIX Decision, then ARCHEMIX shall have the right
to make the final decision on such Disputed Matter but shall only
exercise such right in good faith after full consideration of the
positions of both Parties and (ii) if the Disputed Matter
involves an Excepted Decision, (A) the Chair of the JSC shall
refer such Disputed Matter to the President of ARCHEMIX and the
head of pre-clinical R&D of MERCK (the "Designated Senior
Officers"), who shall promptly initiate discussions in good faith
to resolve such Disputed Matter and (B) if such Disputed
Matter is not resolved by the Designated Senior Officers within ten
(10) days after the date the Designated Senior Officers first
met to consider such Disputed Matter or forty-five (45) days after
the date the JSC first met to consider such Disputed Matter, the
Disputed Matter shall be resolved in accordance with
Section 13.1. For purposes of clarity, under no circumstances
shall the determination of whether MERCK or ARCHEMIX has used or is
using Commercially Reasonable Efforts be submitted for resolution
under this Section 2.1.6. 2.2
Joint Project Team .
2.2.1
Establishment . Within [***] days from the Effective
Date, ARCHEMIX and MERCK shall establish the Joint Project Team.
Unless otherwise agreed by the Parties, the term for the JPT shall
commence as of the Effective Date and continue until the last day
of the Research Program Term ("JPT Term"); provided, that, the JPT
Term shall be extended in the event that, and for so long as,
ARCHEMIX has obligations to perform ARCHEMIX Development
Activities. The JPT shall have and perform the responsibilities set
forth in Section 2.2.4.
2.2.2
Membership . Upon establishment of the JPT, each
Party shall designate in writing, in its sole discretion, [***]
members to the JPT (which members shall be employees of such
Party). Unless otherwise agreed by the Parties, one of
ARCHEMIX’s designees shall be designated by ARCHEMIX as the
Chair of the JPT; provided, that, to the extent the JPT Term is
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
21
extended as provided in Section 2.2.1 beyond the Research
Program Term, MERCK shall have the right to designate one of
MERCK’s designees as the Chair of the JPT. Each Party shall
have the right at any time to substitute individuals, on a
permanent or temporary basis, for any of its previously designated
representatives to the JPT, by giving written notice to the other
Party. Initial designees of the Parties to the JPT shall be
designated by each Party by written notice to the other Party as
soon as is reasonably practicable following the Effective Date.
2.2.3
Meetings .
(a)
Schedule of Meetings; Agenda . The JPT shall establish a
schedule of times for regular meetings, in no event less frequently
than once per [***] during the JPT Term taking into account,
without limitation, the planning needs of the Research Program and
its responsibilities. In urgent cases special meetings may be
convened by any member upon [***] days (or, if such meeting is
proposed to be conducted by teleconference, upon [***] days)
written notice to the other members; provided, that,
(i) notice of any such special meeting may be waived at any
time, either before or after such meeting, and such waiver shall be
the equivalent to the giving of a valid notice hereunder, and
(ii) attendance of any member at a special meeting shall
constitute a valid waiver of notice from such member. Regular and
special meetings of the JPT may be held in person or by
teleconference or videoconference; provided, that, meetings held in
person shall alternate between the respective offices of the
Parties. The chair of the JPT shall prepare and circulate to each
JPT member an agenda for each JPT meeting no later than one
(1) week prior to such meeting.
(b)
Quorum; Voting; Decisions . At each JPT meeting,
(i) the presence in person of at least [***] members
designated by each Party shall constitute a quorum and
(ii) all members designated by each Party who are present
shall have [***] on all matters before the JPT at such meeting. All
decisions of the JPT shall be made by unanimous vote.
Alternatively, the JPT may act by written consent signed by at
least [***] members designated by each Party. Whenever any action
by the JPT is called for hereunder during a time period in which
the JPT is not scheduled to meet, the chair of the JPT shall cause
the JPT to take the action in the requested time period by calling
a special meeting or by circulating a written consent.
Representatives of each Party or of its Affiliates who are not
members of the JPT (including, without limitation, the Patent
Coordinators) may attend JPT meetings as non-voting observers
without the consent of the other Party. In the event that the JPT
is unable to resolve any matter before it, such matter shall be
referred to the JSC for decision, and, in case the JSC is unable to
resolve the matter, it shall be resolved in accordance with
Section 2.1.6.
(c)
Minutes . The JPT shall keep minutes of its meetings that
record all decisions and all actions recommended or taken in
reasonable detail. Drafts of the minutes shall be prepared and
circulated to the members of the JPT within a reasonable time after
the meeting, not to exceed [***] business days. The chair of the
JPT shall have responsibility for the preparation and circulation
of draft minutes. Each member of the JPT shall have the opportunity
to provide comments on the draft minutes. The minutes shall be
approved, disapproved and revised as necessary at the next JPT
meeting. Upon approval, final minutes of each meeting shall be
circulated to the members of the JPT by the chair of the JPT.
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
22
2.2.4
Responsibilities . The JPT shall be responsible for
(a) overseeing the conduct and progress of the Research
Program, the recommendation of Optimized Lead Compounds and the
recommendation of Development Candidates for which ARCHEMIX is
responsible for performing Development activities; and
(b) overseeing the Development of Optimized Lead Compounds and
Development Candidates for which, and the conduct and progress of
each Development Program under which, ARCHEMIX is responsible for
performing Development activities. Without limiting the generality
of the foregoing, the JPT shall have the following
responsibilities:
(a) preparing
or directing the preparation of, approving, and recommending to the
JSC for its approval all Annual Research Plans;
(b) preparing
or directing the preparation of and approving amendments to
JSC-approved Annual Research Plans as it deems appropriate in
furtherance of the objectives of the Research Program as set forth
in the Research Plan and, if any member of the JPT asserts that any
such JPT-approved amendment would change the objectives of such
Annual Research Plan, submitting such amendment to the JSC for its
consideration;
(c) monitoring
the progress of each Annual Research Plan and of each Party’s
activities thereunder;
(d) providing
a forum for consensual decision making with respect to the Research
Program;
(e) reviewing
data, reports or other information submitted by either Party with
respect to work conducted in the Research Program;
(f) preparing
for the JSC on at least a semi-annual basis a progress report for
the Research Program in reasonable detail and providing to the JSC
such additional information as it may request;
(g) recommending
amendments to the OLSC and/or DCSC as it deems appropriate in
furtherance of the objectives of the Research Program or
Development Program, as applicable, as set forth in the Research
Plan or Development Plan, as applicable;
(h) nominating
Lead Compounds as Optimized Lead Compounds for acceptance by the
JSC;
(i) nominating
Optimized Lead Compounds for which ARCHEMIX is responsible for
performing Development activities as Development Candidates for
acceptance by the JSC;
(j) preparing
or directing the preparation of, approving, and recommending to the
JSC for its approval all Annual Development Plans under which
ARCHEMIX is responsible for performing Development activities;
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
23
(k) preparing
or directing the preparation of and approving amendments to
JSC-approved Annual Development Plans under which ARCHEMIX is
responsible for performing Development activities, as it deems
appropriate in furtherance of the Development of Development
Candidates and, if any member of the JPT asserts that any such
JPT-approved amendment would change the objectives of that Annual
Development Plan, submitting such amendment to the JSC for its
consideration;
(l) monitoring
the progress of the Development of each Development Candidate for
which ARCHEMIX is performing Development activities, in accordance
with, and of each Party’s activities under, the applicable
Annual Development Plan;
(m) providing
a forum for consensual decision making with respect to the
Development Program under which ARCHEMIX is responsible for
performing Development activities;
(n) reviewing
data, reports or other information submitted by either Party with
respect to work conducted in the Development Program under which
ARCHEMIX is responsible for performing Development activities;
(o) preparing
for the JSC on at least a semi-annual basis a progress report for
the Development Program under which ARCHEMIX is responsible for
performing Development activities, in reasonable detail and
providing to the JSC such additional information as it may request;
(p) making
any other decisions as may be delegated to the JPT pursuant to this
Agreement or by mutual written agreement of the Parties after the
Effective Date and performing such activities as may be delegated
to the JPT pursuant to this Agreement, or by mutual written
agreement of the Parties after the Effective Date.
2.2.5
Interests of the Parties . Notwithstanding any other
provisions of this Agreement, all decisions made and all actions
taken by the JPT shall be made or taken in the best interest of the
Collaboration.
2.2.6
Alliance Management . Within [***] days of the
Effective Date, each Party shall appoint a person who shall oversee
contact between the Parties for all matters related to the
Collaboration between meetings of the JSC and JPT and shall have
such other responsibilities as the Parties may mutually agree in
writing after the Effective Date (each, a "Collaboration Manager").
Each Party may replace its Collaboration Manager at any time by
notice in writing to the other Party. 3. RESEARCH
PROGRAM 3.1
Implementation of the Research Program . The
objectives of the Research Program shall be the identification of
Lead Compounds for nomination by the JPT to the JSC for approval as
Optimized Lead Compounds pursuant to this Agreement. Except for the
MERCK Research Activities, if any, which shall be conducted by
MERCK at its sole expense, ARCHEMIX shall have the primary right
and responsibility to conduct the Research Program. Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
24
3.2 Annual Research
Plans .
3.2.1
Research Plan . The initial Annual Research Plan and
budget, which describes the research activities to be carried out
by each Party during the first Contract Year of the Research
Program Term, shall be prepared by the JPT and submitted to, and
approved by, the JSC within [***] days of the Effective Date. For
each Contract Year during the Research Program Term commencing with
the second Contract Year, an Annual Research Plan and budget shall
be prepared by or at the direction of the JPT and submitted to the
JSC for its approval. The JPT shall manage the preparation of each
Annual Research Plan in a manner designed to obtain JSC approval no
later than [***] days prior to the end of the then-current Contract
Year. Each Annual Research Plan shall: (a) set forth
(i) the research objectives and activities to be performed for
the Contract Year covered by the Annual Research Plan with
reasonable specificity, (ii) the research plans and protocols
to be employed to complete each stage of the Research Program,
(iii) changes to the OLSC and any other criteria that the JPT
will utilize to evaluate the results of the Research Program to
nominate Optimized Lead Compounds, (iv) the Party that shall
be responsible for performing such activities, (v) a timeline
and budget for such activities (including Third Party expenses to
be incurred for outsourced studies managed by ARCHEMIX), and
(vi) with respect to ARCHEMIX Research Activities, the number
of FTEs estimated to be required to perform such activities; and
(b) shall be consistent with the other terms of this
Agreement. Without limiting the generality of the foregoing, the
objectives of each Annual Research Plan shall include, as
appropriate from time to time during the Research Program Term,
conducting the necessary research activities to identify Lead
Compounds or to determine whether Lead Compounds should be
nominated to the JSC as Optimized Lead Compounds. Any Annual
Research Plan may be amended from time to time by the JPT pursuant
to Section 2.2.4 or by the JSC pursuant to 2.1.4. Each
amendment, modification and update to the Annual Research Plan
shall include the resulting changes to the budget, including the
number of FTEs to be utilized by ARCHEMIX, shall be set forth in a
written document prepared by, or at the direction of, the JPT and
approved by the JSC, shall specifically state that it is an
amendment, modification or update to the Annual Research Plan and
shall be attached to the minutes of the meeting of the JSC at which
such amendment, modification or update was approved by the JSC.
Without limiting the nature or frequency of any other amendments,
modifications or updates to the Research Plan that may be approved
by the JSC, the Annual Research Plan shall be updated at least once
prior to the end of each Contract Year to describe the research
activities to be carried out by each Party during the applicable
Contract Year during the Research Program Term in conducting the
Research Program pursuant to this Agreement.
3.2.2
Minimum FTEs . MERCK shall request and fund a minimum
of [***] FTEs per Contract Year during the three (3) year
Research Program Term. MERCK shall have the right to increase the
number of FTEs to be provided by ARCHEMIX for any Contract Year;
provided, that, (a) any increase above [***] FTEs for any
Contract Year shall be subject to MERCK’s notice obligation
under Section 3.3.2(c) and (b) any increase, at
MERCK’s request, above [***] FTEs for any Contract Year shall
be an ARCHEMIX Decision. 3.3
Conduct of Research Program . Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
25
3.3.1
ARCHEMIX Responsibilities . During the Research
Program Term, ARCHEMIX shall use Commercially Reasonable Efforts to
conduct the ARCHEMIX Research Activities using the number of FTEs
set forth in the Annual Research Plan.
3.3.2
MERCK Responsibilities . During the Research Program
Term, MERCK shall: (a) pay ARCHEMIX the Minimum Quarterly FTE
Payment in accordance with Section 5.3; (b) pay ARCHEMIX
the applicable FTE Rate per FTE per Contract Year for FTEs greater
than [***] in accordance with Section 5.3.1; (c) give
ARCHEMIX not less than [***] days’ written notice in the
event that MERCK requires a number of FTEs above [***] FTEs in any
Contract Year; (d) commit such resources as are reasonably
necessary to conduct the MERCK Research Activities set forth in the
Annual Research Plan; and (e) use Commercially Reasonable
Efforts to conduct the MERCK Research Activities, if any, set forth
in the Annual Research Plan.
3.3.3
Compliance and Funding . Each Party shall perform its
obligations under each Annual Research Plan in compliance in all
material respects with all Applicable Laws. For purposes of
clarity, with respect to each activity performed under an Annual
Research Plan that will or would reasonably be expected to generate
data to be submitted to a Regulatory Authority in support of a
Regulatory Filing or Drug Approval Application, the Party
performing such activity shall comply in all material respects with
the regulations and guidance of the FDA that constitute Good
Laboratory Practice or Good Manufacturing Practice (or, if and as
appropriate under the circumstances, International Conference on
Harmonization (ICH) guidance or other comparable regulation
and guidance of any Regulatory Authority in any country or region
in the Territory). Each Party shall be solely responsible for
paying the salaries and benefits of its employees.
3.3.4
Cooperation . Scientists at ARCHEMIX and MERCK shall
cooperate in the performance of the Research Program and, subject
to the terms of this Agreement and any confidentiality obligations
to Third Parties, shall exchange such data, information and
materials as are reasonably necessary for the other Party to
perform its obligations under any Annual Research Plan.
3.4 Records .
3.4.1
Record Keeping .
(a)
Research Program Records . Each Party shall maintain
complete and accurate records of its activities in the Research
Program in sufficient detail, in good scientific manner and
otherwise in a manner that reflects all work done and results
achieved. Subject to Article 6, each Party shall provide the
other Party with access during normal business hours and upon
reasonable advance notice to review such records to the extent
reasonably required for such other Party’s performance of its
obligations under this Agreement; provided, that, the non-reviewing
Party may redact information not relevant to the Research Program
prior to such review. Notwithstanding the foregoing, MERCK shall
not have the right to review any records that relate to any Failed
Compounds, Waived Compounds or Terminated Compounds. Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
26
(b)
Record Keeping Policies . Without limiting the generality of
Section 3.4.1(a), each Party agrees to maintain a policy that
requires its employees and consultants to record and maintain all
data and information developed during the Research Program.
3.4.2
Reports . ARCHEMIX shall keep the JPT regularly
informed of the progress of the Research Program. Without limiting
the generality of the foregoing, ARCHEMIX shall, at least once each
[***] during the Research Program Term, (a) provide reports to
the JPT in reasonable detail regarding the status of its activities
under the Research Program, (b) advise the JPT of its
identification of Lead Compounds and provide the JPT with any
supporting data applicable to such Lead Compounds, (c) provide
the JPT with the results of activities conducted in the Research
Program with respect to each Lead Compound so as to enable the JPT
to determine whether such Lead Compound meets the OLSC and should
be proposed to the JSC as an Optimized Lead Compound, (d) provide
the JPT with the results of activities conducted in the Development
Program, if any, with respect to each Optimized Lead Compound so as
to enable the JPT to determine whether such Optimized Lead Compound
meets the DCSC and should be proposed to the JSC as a Development
Candidate, (e) provide the JPT with such additional information
that it has in its possession as may be reasonably requested from
time to time by the JPT, and (f) provide MERCK, on or before
[***] days from the termination or expiration of the Research
Program Term, with a final report regarding all ARCHEMIX Research
Activities conducted by ARCHEMIX during the Research Program Term
to the extent not previously included in the reports described
above. MERCK shall (i) provide the JPT, at least once per
[***], with reports in reasonable detail regarding the status of
all MERCK Research Activities and such additional information that
it has in its possession as may be reasonably requested from time
to time by the JPT, (ii) provide the JPT with the results of
activities conducted in the Development Program under which
ARCHEMIX is responsible for performing Development activities with
respect to each Optimized Lead Compound so as to enable the JPT to
determine whether such Optimized Lead Compound meets the DCSC and
should be proposed to the JSC as a Development Candidate, and
(iii) provide ARCHEMIX, on or before [***] days from the
termination or expiration of the Research Program Term, with a
final report regarding all MERCK Research Activities conducted by
MERCK during the Research Program Term to the extent not previously
included in the reports described above.
3.5 Selection of Program
Targets .
3.5.1
Selection of Program Targets .
(a)
Initial Program Targets . The Parties hereby acknowledge and
agree that one (1) Program Target, as set forth on
Schedule 2A , has been so designated by the Parties as
of the Effective Date. MERCK shall provide written notice of a
second Program Target to ARCHEMIX within [***] weeks of the
Effective Date. ARCHEMIX shall accept or reject the proposed Target
as specified under 3.5.1.d) for the inclusion of a Target into the
Research Program.
(b)
Target Replacement List . The Parties hereby acknowledge and
agree that two (2) Targets, as set forth on the Target Replacement
List on Schedule 2B , have Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
27
been designated by the Parties as replacement Targets as of the
Effective Date. MERCK shall have the right to request that a Target
on the Target Replacement List be replaced (a) [***] and (b) [***].
During the first [***] Contract Years of the Research Program Term,
ARCHEMIX will inform MERCK in writing, if it intends to commence
negotiations with a Third Party with respect to a license,
collaboration or similar agreement relating to Aptamers against a
Target on the Target Replacement List.
(c)
Replacement of Program Targets . If at any time during the
first [***] Contract Years of the Research Program Term, the JSC
agrees that a Program Target is unlikely to produce an [***] or
[***], then (i) all activities under the Research Program with
respect to such Program Target shall cease; (ii) such Program
Target shall thereafter be deemed to be a Failed Target; and
(iii) MERCK shall have the right to replace such Failed Target
with a Target from the Target Replacement List in accordance with
Section 3.5.1(d). In addition, MERCK shall have the right at
any time during the first [***] Contract Years of the Research
Program Term to replace a Program Target with a Target from the
Target Replacement List in accordance with Section 3.5.1(d)
if: (i) MERCK reasonably believes based on published literature or
proprietary data first available after the designation of a Target
as a Program Target that such Program Target is [***] for use in
the Target Selection Field; or (ii) MERCK reasonably
determines that it is legally necessary to obtain a license or
other right, title or interest in and to an issued patent that had
not issued and/or had not been published as a pending application
at the time a Target was designated as a Program Target in order to
successfully research, Develop and Commercialize a Product that
binds such Program Target. Notwithstanding anything to the contrary
herein, any Program Target replaced in accordance with the
preceding sentence of this Section 3.5.1(c) shall be deemed a
Failed Target. A Target proposed by MERCK for inclusion in the
Research Program which is not on the Target Replacement List may be
rejected by ARCHEMIX for any reason, in its sole discretion.
(d)
Replacement of Targets . To the extent MERCK has the right
to propose that a Target be added to the Target Replacement List as
described in Section 3.5.1(b) or that a Failed Target be
replaced by a Target from the Target Replacement List as described
in Section 3.5.1(c), MERCK shall provide written notice to
ARCHEMIX. ARCHEMIX shall accept or reject the proposed Target
within [***] days after receipt of such notice from MERCK. A Target
proposed by MERCK for inclusion on the Target Replacement List or
in the Research Program shall only be rejected by ARCHEMIX if prior
to MERCK’s notice: (A) it is an [***], (B) ARCHEMIX
is prohibited by an executed contract from licensing Aptamers
against such proposed Target or its natural ligand(s), to MERCK,
(C) ARCHEMIX is in active negotiations, as [***] by [***] with
a Third Party with respect to a license, collaboration or similar
agreement relating to Aptamers against such Target or its natural
ligand(s), or (D) ARCHEMIX is developing, for its own benefit,
Aptamers against such Target or its natural ligand(s) under a bona
fide internal development program against such Target, has adopted
a research plan for such Target or its natural ligand, or has
formally designated such Target or its natural ligand(s) for
research. In addition to the reasons specified in the foregoing
clauses (A)-(D), ARCHEMIX also may reject a Target proposed by
MERCK for inclusion on the Target Replacement List if such Target
does not fall within the Target Selection Field. ARCHEMIX shall
give MERCK prompt written notice during the Research Program Term
if any of the restrictions on any Target that is rejected by
ARCHEMIX pursuant to the foregoing clause (A), (B), (C) or
(D) lapse, or are Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
28
otherwise terminated, such that the previously rejected Target
becomes eligible for inclusion as a Program Target or for inclusion
on the Target Replacement List.
(e)
Obligations of JPT . As promptly as practicable after
designation of a new Program Target in accordance with
Section 3.5.1(d), the JPT shall (i) develop and submit to
the JSC for its approval the OLSC and DCSC for such new Program
Target and (ii) prepare an update to the Annual Research Plan
to include the ARCHEMIX Research Activities to be conducted to
identify Lead Compounds against such new Program Target for
potential nomination as an Optimized Lead Compound.
3.5.2
Termination of Replacement Right . Notwithstanding
anything to the contrary in this Agreement, MERCK’s right to
add Targets to the Target Replacement List pursuant to Section
3.5.1(b) and/or replace Program Targets pursuant to
Section 3.5.1(c) shall terminate on the [***] of the [***]
Contract Year. 3.6 Identification of Lead Compounds and
Optimized Lead Compounds .
3.6.1
Lead Compounds . ARCHEMIX shall use Commercially
Reasonable Efforts in good faith to perform the SELEX® Process
to identify Lead Compounds in accordance with each Annual Research
Plan, as amended.
3.6.2
Optimized Lead Compounds . Within [***] days after
its receipt of each report from ARCHEMIX pursuant to
Section 3.4.2 identifying a Lead Compound as meeting the
applicable OLSC (or which either Party reasonably believes should
be an Optimized Lead Compound), the JPT shall review the data and
information and determine whether to nominate the Lead Compound to
the JSC for designation as an Optimized Lead Compound. If the JPT
elects to nominate any such Lead Compound as an Optimized Lead
Compound, the JPT shall promptly furnish all available information
to the JSC. The JSC shall consider such nomination within [***]
days, and if the JSC approves the nomination of the Lead Compound,
such Lead Compound shall be deemed to be an Optimized Lead Compound
for purposes of this Agreement. 3.7
Development Candidates . Within [***] days after
either Party reasonably concludes based upon available project
reports that an Optimized Lead Compound meets the applicable DCSC,
the JPT shall review the data and information and determine whether
to nominate the Optimized Lead Compound for designation as a
Development Candidate. If the JPT elects to nominate any such
Optimized Lead Compound as a Development Candidate, the JPT shall
promptly furnish all available information to the JSC. The JSC
shall consider such nomination within [***] days so as to enable
MERCK to determine whether or not continue Development of such
compound, and if the Optimized Lead Compound meets the DCSC and
MERCK accepts such Optimized Lead Compound for further Development,
such Optimized Lead Compound shall be deemed to be a Development
Candidate for purposes of this Agreement.
3.8 MERCK Decision Not to Go
Forward . MERCK has the right to determine in [***] not to
continue the Development and Commercialization of a Development
Candidate against a specific Program Target. Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
29
3.9 Supply of Proprietary
Materials . From time to time during the Research Program
Term, either Party (the "Transferring Party") may supply the other
Party (the "Recipient Party") with Proprietary Materials of the
Transferring Party for use in the Research Program. In connection
therewith, each Recipient Party hereby agrees that (a) it
shall not use such Proprietary Materials for any purpose other than
exercising its rights or performing its obligations under this
Agreement; (b) it shall use such Proprietary Materials only in
compliance with all Applicable Laws; (c) it shall not transfer
any such Proprietary Materials to any Third Party without the prior
written consent of the Transferring Party, except as expressly
permitted by this Agreement; (d) the Recipient Party shall not
acquire any right, title or interest in or to such Proprietary
Materials as a result of such supply by the Transferring Party; and
(e) upon the expiration or termination of the Research Program
Term, the Recipient Party shall, if and as instructed by the
Transferring Party, either destroy or return any such Proprietary
Materials that are not the subject of the grant of a continuing
license hereunder. 3.10
Research Program Term . The Research Program shall
commence on the Effective Date and shall continue until the last
day of the Research Program Term. 4. DEVELOPMENT PROGRAM;
COMMERCIALIZATION OF PRODUCTS
4.1 Objectives of the
Development Program . The objectives of the Development
Program shall be the selection and Development of Development
Candidates to enable the Commercialization of Products in the Field
in the Territory. 4.2
Responsibility for Development of Development Candidates and
Commercialization of Products . Except for the ARCHEMIX
Development Activities, if any, MERCK shall have [***], for all
aspects of the Development of Optimized Lead Compounds and
Development Candidates in accordance with the applicable Annual
Development Plan, and all aspects of the Commercialization of
Products in accordance with the applicable Product
Commercialization Plan, in the Field in the Territory, including,
without limitation, the conduct of: (a) all IND-enabling
non-clinical studies that are outside of the Research Program;
(b) all activities related to human clinical trials
(including, without limitation, Phase I Clinical Trials, Phase II
Clinical Trials and Phase III Clinical Trials); (c) all
activities relating to the manufacture and supply of Development
Candidates and Products (including all required process development
and scale up work with respect thereto); and (d) all
pre-marketing, marketing, promotion, sales, distribution, import
and export activities (including securing reimbursement, conducting
sales and marketing activities and any post-marketing trials or
post-marketing safety surveillance and maintaining databases),
subject in each case to Section 4.9.2. Without limiting the
generality of the foregoing, MERCK shall have [***], (i) to
make all Regulatory Filings for Development Candidates and Products
and file all Drug Approval Applications and otherwise seek all
Regulatory Approvals for Products, as well as to conduct all
correspondence and communications with Regulatory Authorities
regarding such matters, subject in each case to Section 4.9.2,
and (ii) to report all Adverse Events to Regulatory Authorities if
and to the extent required by Applicable Laws. All Regulatory
Approvals for Products shall be owned by MERCK, subject to
Section 10.3. Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
30
4.3 Annual Development
Plans . The initial Annual Development Plan shall be
prepared by MERCK and submitted to the JSC for its review within
[***] days of the date on which the JSC approves the selection of
an Optimized Lead Compound and in any event, on or prior to the
initiation of Development activities with respect thereto, which
shall describe the Development activities to be conducted for the
balance of the Contract Year. Thereafter, for each Contract Year
during the Term, an Annual Development Plan for each Optimized Lead
Compound and Development Candidate shall be prepared by MERCK and
provided to the JSC for its review and MERCK shall consult with the
JSC with respect to all significant Development decisions to be
made with respect to such Annual Development Plan. Each Annual
Development Plan shall: (a) set forth (i) the Development
objectives, activities, and timelines for the Contract Year covered
by the Annual Development Plan with reasonable specificity,
(ii) which activities, if any, are ARCHEMIX Development
Activities; provided, that, ARCHEMIX has agreed to perform such
activities, (iii) with respect to such ARCHEMIX Development
Activities, the number of FTEs estimated to be required to perform
such activities and the corresponding FTE Cost and (iv) the
expected Regulatory Filings and Drug Approval Applications to be
prepared and filed and the expected timetable of completing such
Development activities; and (b) be consistent with the other
terms of this Agreement. Any Annual Development Plan may be amended
from time to time by MERCK. Without limiting the nature or
frequency of any other amendments, modifications or updates to the
Annual Development Plan, the Annual Development Plan shall be
updated at least once prior to the end of each Contract Year to
describe the Development activities to be carried out by each Party
during the applicable Contract Year in conducting the Development
Program pursuant to this Agreement. Notwithstanding the above, the
preparation and management of the Annual Development Plan by the
JPT and JSC approval is only required for any Annual Development
Plan or amendment thereto under which ARCHEMIX is responsible for
performing any Development activities.
4.4 Product Commercialization
Plans . Within [***] days after the Initiation of a Phase
III Clinical Trial with respect to each Development Candidate,
MERCK shall prepare and provide to the JSC for its review a Product
Commercialization Plan for each Product Derived from such
Development Candidate, and shall inform the JSC with respect to all
significant Commercialization decisions to be made with respect to
such Product. 4.5 Development
and Commercialization Diligence .
(a)
Diligence Obligations . MERCK shall exercise Commercially
Reasonable Efforts during the Term to conduct the MERCK Development
Activities, to Develop [***] Development Candidate targeted at
[***] Program Target and to Commercialize [***] Product targeted at
[***] Program Target in the Field in the Territory.
(b)
Effect of Breach of Diligence Obligations . If ARCHEMIX at
any time believes that MERCK, on a country-by-country and
Product-by-Product basis, is not meeting its diligence obligations
pursuant to subsection (a) above, ARCHEMIX may give written
notice to MERCK requesting written justification, in the form of
detailed reasons that would support the proposition that MERCK is
meeting such diligence obligation. In such event, MERCK shall
provide such written justification to ARCHEMIX within [***] days
after such Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
31
notice is given. In the event that ARCHEMIX does not receive
such justification within such [***] day period or does not agree
with such justification, then ARCHEMIX shall have the right, in its
sole discretion, on a country-by-country and Product-by-Product
basis, to terminate MERCK’s rights with respect to such
Target, Development Candidate or Product, and the Collaboration
Aptamers against such Target pursuant to Section 10.4 (but
leaving unaffected MERCK’s rights under this Agreement to any
other Target and Collaboration Aptamer directed against such
Target). 4.6 Compliance
. Each Party shall perform its obligations under each Annual
Development Plan in good scientific manner and in compliance in all
material respects with all Applicable Laws. For purposes of
clarity, with respect to each activity performed under an Annual
Development Plan that will or would reasonably be expected to
generate data to be submitted to a Regulatory Authority in support
of a Regulatory Filing or Drug Approval Application, the Party
performing such activity shall comply in all material respects
with, if and as applicable, the regulations and guidance of the FDA
that constitute Good Laboratory Practice, Good Manufacturing
Practice or Good Clinical Practices (or, if and as appropriate
under the circumstances, International Conference on Harmonization
(ICH) guidance or other comparable regulation and guidance of
any Regulatory Authority in any country or region in the
Territory). Each Party shall be solely responsible for paying the
salaries and benefits of its employees conducting its activities
under Annual Development Plans. 4.7
Cooperation . Scientists at ARCHEMIX and MERCK shall
cooperate in the performance of each Development Program and,
subject to the terms of this Agreement and any confidentiality
obligations to Third Parties, shall exchange such data, information
and materials as are reasonably necessary for the other Party to
perform its obligations under any Annual Development Plan.
4.8 Exchange of Reports;
Information; Updates .
4.8.1
Development Program Reports . MERCK shall keep the
JSC regularly informed of the progress of its efforts to Develop
Development Candidates in the Field in the Territory. Without
limiting the generality of the foregoing, MERCK shall, at least
once each [***], provide the JSC with reports in reasonable detail
regarding the status of all preclinical IND-enabling studies and
activities (including toxicology and pharmacokinetic studies),
clinical trials and other activities conducted under the
Development Program; provided, that, for so long as ARCHEMIX is
obligated to perform ARCHEMIX Development Activities,
(a) MERCK shall provide the JSC with the reports described
above at least once each [***] and (b) ARCHEMIX and MERCK
shall, not less than once each [***], provide the JSC with reports
in reasonable detail regarding the status of all Development
Activities and such additional information that they have in their
possession as may be reasonably requested from time to time by the
JSC.
4.8.2
Commercialization Reports . MERCK shall keep the JSC
and ARCHEMIX regularly informed of the progress of MERCK’s
efforts to Commercialize Products in the Field in the Territory
through periodic updates. Without limiting the generality of the
foregoing, MERCK shall provide the JSC and ARCHEMIX with [***]
written updates to each Product Commercialization Plan, which shall
(a) summarize MERCK’s efforts to Commercialize Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
32
Products, (b) identify the Regulatory Filings and Drug
Approval Applications with respect to such Product that MERCK or
any of its Affiliates or Sublicensees have filed, sought or
obtained in the prior [***] month period or reasonably expect to
make, seek or attempt to obtain in the following [***] month period
and (c) summarize all clinical and other data generated by
MERCK with respect to Products. In addition, MERCK shall provide
such additional information that it has in its possession as may be
reasonably requested by ARCHEMIX regarding the Commercialization of
any Product, which request shall not be made more than once each
Calendar Year.
4.8.3
Adverse Event Reports; Review of Regulatory Filings and
Correspondence .
(a)
Adverse Events . In addition to the updates described in
Section 4.8.1 and 4.8.2, MERCK shall provide ARCHEMIX with all
Adverse Event information and product complaint information
relating to Development Candidates or Products as such information
is compiled or prepared by MERCK in the normal course of business
in connection with the Development of any Development Candidates or
Commercialization of any Product and, in any event, within time
frames consistent with reporting obligations under Applicable Laws.
MERCK shall provide such Adverse Event and product complaint
information hereunder to ARCHEMIX in accordance with
Section 13.3. ARCHEMIX may provide all such Adverse Event
information to other licensees of ARCHEMIX who have the right to
sell Aptamers for therapeutic purposes under a license from
ARCHEMIX; provided, that, such other licensees agree to maintain
the confidentiality thereof. ARCHEMIX will provide to MERCK Adverse
Event information obtained from other licensees of ARCHEMIX who
have the right to develop and sell Aptamers for therapeutic
purposes under a license from ARCHEMIX; provided, that, such other
licensees agree to share such information and MERCK agrees to
maintain the confidentiality thereof.
(b)
Preparation of Drug Approval Applications . MERCK shall
(i) consult with ARCHEMIX in good faith in the preparation of
all Drug Approval Applications for Products in the United States,
Japan and in the European Union and (ii) consider all comments
of ARCHEMIX in good faith, taking into account the best interests
of the Collaboration and of the Development of the applicable
Development Candidate and Commercialization of the applicable
Product on a global basis.
(c)
Meeting Attendance and Information . MERCK shall use
reasonable efforts to provide ARCHEMIX with at least [***] days
advance notice of any meeting with the FDA or other Regulatory
Authority regarding a Drug Approval Application relating to, or
Regulatory Approval for, any Development Candidate or Product,
(i) prior to the acceptance of an IND with respect to each
Development Candidate or Product and (ii) after acceptance of
an IND with respect to each Development Candidate or Product if the
subject matter of the meeting shall include any milestone event
applicable to such Development Candidate or Product. Upon written
request ARCHEMIX may send one person [***] to participate as an
observer in such meeting [***]; provided, that, (A) MERCK
approves such ARCHEMIX request for any such meetings occurring
after acceptance of the IND and (B) to the extent
MERCK’s approval is required, MERCK shall [***] any such
request of ARCHEMIX. Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
33
With regard to any meeting with the FDA or other Regulatory
Authority regarding a Drug Approval Application relating to, or
Regulatory Approval for, any Development Candidate or Product, to
which ARCHEMIX did not send a representative as provided in this
Section 4.8.3(c), MERCK will provide ARCHEMIX with a written
summary of information communicated and received thereat.
(d)
Right to Review . Notwithstanding anything to the contrary
in this Section 4.8.3, ARCHEMIX shall have the right, upon
written notice, to review all such Regulatory Filings and
correspondence at MERCK’s office at ARCHEMIX’s sole
expense. 4.9 Development and
Commercialization Rights and Restrictions .
4.9.1
Development and Commercialization Rights in the Field
. Except as provided in this Section 4.9, MERCK shall have
the [***] during the Term to Develop Development Candidates and
Commercialize Products in the Territory for use in the Field.
4.9.2
Co-Promotion .
(a)
Negotiation of a Potential Co-Promotion Agreement . Within
thirty (30) days from filing the NDA for a Product, ARCHEMIX
shall provide MERCK with (i) a written notice indicating
ARCHEMIX’ interest in the promotion and Detailing of such
Product in the United States of America and its territories and
possessions jointly with MERCK using a coordinated sales force
consisting of Representatives of both Parties ("Co-Promote" or
"Co-Promotion") and (ii) a business plan so as to document how
such proposed Co-Promotion for such Product is in the best interest
of both Parties. Upon receipt of such written notice, MERCK shall
enter into good faith negotiations with ARCHEMIX with the aim of
determining whether or not to enter into a separate Co-Promotion
agreement ("Co-Promotion Agreement") between the Parties. In the
event MERCK, in its sole discretion, agrees to enter into such
Co-Promotion Agreement with ARCHEMIX, then the terms applicable to
such Co-Promotion of the Product identified therein (each, a
"Co-Promoted Product") shall conform in all material respects with
the terms, conditions and provisions set forth in
Schedule 9 attached hereto and such additional
provisions as are usual and customary for inclusion in a
co-promotion agreement between companies in the pharmaceutical
industry of comparable sizes to the respective Parties. For
purposes of clarity, such additional terms shall supplement and
shall not materially expand, limit or change the terms set forth on
Schedule 9 . The Parties shall negotiate the
Co-Promotion Agreement in good faith and with sufficient diligence
as is required to execute and deliver the Co-Promotion Agreement
within [***] days after ARCHEMIX provides its written indication of
interest pursuant to the first sentence of this paragraph.
(b)
Failure to Agree . To the extent that MERCK enters into and
conducts negotiations with respect to the Co-Promotion Agreement
for a Product in good faith and the Parties fail to execute and
deliver the Co-Promotion Agreement within [***] day period
described in Section 4.9.2(a) above, then (i) MERCK shall
continue to have the exclusive right and responsibility during the
Term to Commercialize such Product in the Territory (including the
United States of America and its territories and possessions) for
use in the Field and (ii) the fact Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
34
that the Parties were unable to agree on a Co-Promotion
Agreement shall not entitle ARCHEMIX to claim damages or any other
sort of compensation whatsoever. 4.10
Product Recalls . In the event that any Regulatory
Authority issues or requests a recall or takes similar action in
connection with a Product, or in the event a Party reasonably
believes that an event, incident or circumstance has occurred that
may result in the need for a recall, market withdrawal or other
corrective action regarding a Product, such Party shall promptly
advise the other Party thereof by telephone or facsimile. Following
such notification, MERCK shall decide and have control of whether
to conduct a recall or market withdrawal (except in the event of a
recall or market withdrawal mandated by a Regulatory Authority, in
which case it shall be required) or to take other corrective action
in any country and the manner in which any such recall, market
withdrawal or corrective action shall be conducted; provided, that,
MERCK shall keep ARCHEMIX regularly informed regarding any such
recall, market withdrawal or corrective action. MERCK shall bear
all expenses of any such recall, market withdrawal or corrective
action (including, without limitation, expenses for notification,
destruction and return of the affected Product and any refund to
customers of amounts paid for such Product). 5.
PAYMENTS 5.1
Technology Access and License Fee . MERCK shall pay
ARCHEMIX a non-refundable technology access and license fee in the
amount of Three Million Dollars (US $3,000,000) by wire transfer
within thirty (30) days of the Effective Date, according to
instructions that ARCHEMIX shall provide.
5.2 License Maintenance Fee
. MERCK shall pay ARCHEMIX a non-refundable license maintenance
fee in the amount of [***] Dollars (US $[***]) by wire transfer
within [***] days of (i) the Effective Date and (ii) on
each of the [***] of the Effective Date during the Research Program
Term, according to instructions that ARCHEMIX shall provide.
5.3 R&D Funding .
5.3.1
Payment of R&D Funding . In consideration of the
performance by ARCHEMIX of its activities under the Annual Research
Plan(s) as described in Section 3.2, during the Research
Program Term MERCK will pay ARCHEMIX the applicable Quarterly FTE
Payment on or prior to the first day of each Calendar Quarter;
provided, that, an invoice corresponding with such Calendar Quarter
has been received by MERCK. Notwithstanding the above, in view of
the activities to be performed by ARCHEMIX during the initial
Calendar Quarter, MERCK will pay ARCHEMIX [***] Dollars (US $[***])
on the Effective Date; provided, that, an invoice corresponding
with the initial Calendar Quarter has been received by MERCK.
ARCHEMIX shall provide a report to the JPT within [***] days of the
end of each Calendar Quarter during the Research Program Term that
specifies the actual number of FTEs expended during the period
covered therein. Within [***] days of the end of each Calendar Year
during the Research Program Term, ARCHEMIX shall provide MERCK with
an annual reconciliation statement ("Annual Reconciliation
Statement") that specifies the actual number of FTEs expended
during the previous [***] Calendar Quarters in the aggregate. MERCK
shall Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
35
reimburse ARCHEMIX in full for any FTEs expended by ARCHEMIX in
excess of the cumulative FTE Costs owed by MERCK for such Calendar
Year (the "MERCK Contribution") as indicated by any Annual
Reconciliation Statement if such excess was approved by the JSC. To
the extent that any Annual Reconciliation Statement indicates that
ARCHEMIX expended FTEs in excess of the MERCK Contribution and such
excess was not approved by the JSC then, (a) MERCK shall reimburse
ARCHEMIX for all amounts in excess of the MERCK Contribution, not
to exceed [***] percent ([***]%) of the MERCK Contribution and
(b) all FTE Costs in excess of [***] percent ([***]%) of the
MERCK Contribution shall be borne by ARCHEMIX.
5.3.2
R&D Funding Audit Rights . ARCHEMIX shall keep
complete and accurate books and financial records pertaining to the
number of FTEs utilized in conducting the Research Program and the
ARCHEMIX Development Activities, if any, which books and financial
records shall be kept in accordance with GAAP and shall be retained
by ARCHEMIX until [***] years after the end of the Contract Year to
which they pertain. Upon [***] days written notice, MERCK shall
have the right to appoint at its expense an independent certified
public accountant reasonably acceptable to ARCHEMIX to audit the
books and financial records of ARCHEMIX relating to the number of
FTEs utilized in conducting the Research Program and the ARCHEMIX
Development Activities during any Contract Year; provided, that,
MERCK shall not have the right to audit any Contract Year more than
once or more than [***] years after the end of such Contract Year
or to conduct more than one such audit in any [***] period. All
books and financial records made available for audit shall be
deemed to
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