Exhibit 10.35 COLLABORATIVE RESEARCH AND LICENSE AGREEMENT between ARCHEMIX CORP. and MERCK KGaA June 6, 2007 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.
TABLE OF CONTENTS Page 1. DEFINITIONS 1 2. ADMINISTRATION OF THE COLLABORATION 27 2.1 Joint Steering Committee 27 2.2 Joint Project Team 31 2.3 Joint Development Committee 34 2.4 Alliance Management 36 3. RESEARCH PROGRAM 36 3.1 Implementation of the Research Program 36 3.2 Technology Transfer Activities 36 3.3 Research Projects 37 3.4 Annual Research Plans 37 3.5 Conduct of Research Program 38 3.6 Records 38 3.7 Designation of Program Targets 39 3.8 Replacement of Program Targets; Target Exclusivity List; ARCHEMIX Retained Rights 41 3.9 ARCHEMIX Internal Program Targets 42 3.10 Identification of Lead Compounds and Optimized Lead Compounds 46 3.11 Development Candidates 47 3.12 MERCK Decision Not to Go Forward 47 3.13 Supply of Proprietary Materials 47 3.14 Research Program Term 48 3.15 Conduct of Target Validation Activities 48 4. DEVELOPMENT PROGRAM; COMMERCIALIZATION OF PRODUCTS 48 4.1 Objectives of the Development Program 48 4.2 Responsibility for Development of Development Candidates and Commercialization of Products 48 4.3 Annual Development Plans 49 4.4 Product Commercialization Plans 50 4.5 Manufacture and Supply of Products for Development and Commercialization 50 4.6 Development and Commercialization Diligence 51 4.7 Compliance 51 4.8 Cooperation 52 4.9 Exchange of Reports; Information; Updates 52 4.10 Development and Commercialization Rights and Restrictions 53 5. EQUITY PURCHASE RIGHT 60 5.1 Purchase of Equity 60 5.2 Equity Purchase Right 61 6. PAYMENTS 63 6.1 SELEX License Maintenance Fee 63 6.2 Research License Maintenance Fee 63 6.3 Compound Option Exercise Fees 63 6.4 R&D Funding 64 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.
i
Page 6.5 Milestone Payments 65 6.6 Payment of Royalties; Royalty Rates; Accounting and Records 67 6.7 Net Income Payments 72 6.8 Payments 73 6.9 Taxes 73 6.10 US Partnership 73 6.11 Foreign Currency Exchange 74 7. TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY; NON-SOLICITATION 75 7.1 Confidentiality 75 7.2 Publicity 76 7.3 Publications and Presentations 77 7.4 Prohibition on Solicitation 77 8. LICENSE GRANTS; EXCLUSIVITY 78 8.1 SELEX License; Research and Development Licenses 78 8.2 Commercialization License 83 8.3 Limitation on License Grants 84 8.4 Right to Sublicense 84 8.5 Right to Subcontract 84 8.6 No Other Rights 85 8.7 Exclusivity 85 9. INTELLECTUAL PROPERTY RIGHTS 85 9.1 ARCHEMIX Intellectual Property Rights 85 9.2 MERCK Intellectual Property Rights 85 9.3 Joint Technology and Joint Co-Developed Program Technology Rights 85 9.4 Patent Coordinators 86 9.5 Inventorship 86 9.6 Cooperation 86 10. FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS 86 10.1 Patent Filing, Prosecution and Maintenance 86 10.2 Legal Actions 89 10.3 Trademark and Copyright Prosecution, Defense and Enforcement 93 10.4 Effect of Challenge 93 11. TERM AND TERMINATION 94 11.1 Term 94 11.2 Termination 94 11.3 Consequences of Termination of Agreement 95 11.4 Surviving Provisions 98 12. REPRESENTATIONS AND WARRANTIES AND COVENANTS 99 12.1 Mutual Representations and Warranties 99 12.2 ARCHEMIX' Representations and Warranties 99 12.3 Acknowledgment and Covenant of MERCK 100 13. INDEMNIFICATION 101 13.1 Indemnification of MERCK by ARCHEMIX 101 13.2 Indemnification of ARCHEMIX by MERCK 101 13.3 Indemnification of Gilead and UTC by MERCK 101 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.
ii
Page 13.4 Conditions to Indemnification 102 13.5 Warranty Disclaimer 102 13.6 No Warranty of Success 102 13.7 Limited Liability 102 14. MISCELLANEOUS 103 14.1 Arbitration 103 14.2 Change of Control 104 14.3 Notices 106 14.4 Governing Law 107 14.5 Binding Effect 107 14.6 Headings 107 14.7 Counterparts 107 14.8 Amendment; Waiver 108 14.9 No Third Party Beneficiaries 108 14.10 Purposes and Scope 108 14.11 Assignment and Successors 108 14.12 Force Majeure 108 14.13 Interpretation 108 14.14 Integration; Severability 109 14.15 Further Assurances 109 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.
iii
List of Exhibits Exhibit A SELEX Technology Transfer PlanExhibit B Form of Common Stock Purchase Agreement List of Schedules Schedule 1A Optimized Lead Compound Selection Criteria- MERCK Funded Research Projects; MERCK Internal Research Projects Schedule 1B Optimized Lead Compound Selection Criteria - ARCHEMIX Internal Research Projects Schedule 2A Target Exclusivity List Schedule 2B ARCHEMIX Internal Program Targets Schedule 3 Licensed Patent Rights Schedule 4 Excluded Aptamers Schedule 5A Development Candidate Selection Criteria - MERCK Funded Research Projects; MERCK Internal Research Projects Schedule 5B Development Candidate Selection Criteria - ARCHEMIX Internal Research Projects Schedule 6 Form of Press Release Schedule 7 Regional Offices or Countries in which Patent Applications are to be Nationalized or Otherwise Prosecuted, Filed and Maintained Schedule 8 Material Terms to be Included in Form of Co-Promotion Agreement Schedule 9 MERCK' s Standard Exchange Rate Methodology Applied in Its External Reporting Schedule 10 Program Chemistries Schedule 11 Calculation of Net Income Schedule 12 Form of Materials Transfer Agreement Schedule 13 Co-Development Costs and Guidelines for their Allocation and Co-Development Regulatory Costs Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to 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 June 6, 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 entered into the Collaborative Research and License Agreement dated as of January 17, 2007 (the " Initial Collaboration Agreement" ), pursuant to which the Parties agreed to collaborate for the purposes of identifying aptamers against two identified targets (the " Initial Targets" ) and developing and commercializing products derived from such aptamers for the prevention, treatment and delay of onset or progression of cancer; and WHEREAS, the Parties desire to enter into an additional agreement for the purpose of expanding the scope of the collaboration by identifying additional targets for use in identifying aptamers, and developing and commercializing products derived from such aptamers primarily for the prevention, treatment, cure and delay of onset or progression of cancer, inflammatory and/or autoimmune indications; and WHEREAS, the Parties agree that all Program Aptamer-Specific Technology (as hereinafter defined) resulting from the collaboration under the terms of this Agreement shall become the sole and exclusive property of MERCK; and WHEREAS, the Parties agree that all Technology (as hereinafter defined) relating to the SELEX Technology (as hereinafter defined) or SELEX Process (as hereinafter defined) resulting from the collaboration under the terms of this Agreement shall become the sole and exclusive property of ARCHEMIX. 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 8 , Schedule 11 and Schedule 13 attached hereto shall have the meanings specified.Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.
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 (including without limitation any Co-Developed Development Candidate) and Contract Year, the written plan for the Development Program for such Optimized Lead Compound and Development Candidate for such Contract Year (including a budget related thereto), 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 3.4. 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 or by MERCK through the SELEX Process in the practice of the SELEX License, 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 thePortions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.
2
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, other than MERCK SELEX Improvements, and (b) shall not include Collaboration Aptamers, ARCHEMIX Program Technology or ARCHEMIX' s interest in Joint Technology. 1.9 " ARCHEMIX Co-Developed Program Patent Rights" means any Patent Rights Controlled by ARCHEMIX that contain one or more claims that cover ARCHEMIX Co-Developed Program Technology. 1.10 " ARCHEMIX Co-Developed Program Technology" means any Co-Developed 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. For purposes of clarity, ARCHEMIX Co-Developed Program Technology does not include ARCHEMIX Program Technology or Program Aptamer-Specific Technology. 1.11 " ARCHEMIX Co-Development Participation Capacity" means, with respect to each Co-Developed Development Candidate, the number of FTEs that ARCHEMIX reasonably determines in good faith it has the capacity and capability to provide towards the Development of such Co-Developed Development Candidate in each Calendar Year. 1.12 " ARCHEMIX Co-Development Sharing Percentage" means, with respect to each Co-Developed Product, a percentage equal to either [***] percent ([***]%) (the " ARCHEMIX [***]% Co-Development Sharing Percentage" ) or [***] percent ([***]%) (the " ARCHEMIX [***]% Co-Development Sharing Percentage" ), as designated by ARCHEMIX pursuant to Section 4.10.2(a). 1.13 " ARCHEMIX Decision" means a decision with respect to the following issues: (a) the conduct by ARCHEMIX of the [***] against [***]; (b) whether ARCHEMIX is to incur any [***]; (c) whether ARCHEMIX is to be obligated to perform any [***] with respect to any [***] that is not a [***]; (d) whether ARCHEMIX is to incur any [***] in the performance of [***] or [***]; (e) the inclusion of any [***] MERCK on the [***]; (f) an increase in the number of FTEs used in any Research Project above [***] FTEs per [***]; (g) the conduct of all research and development activities with respect to an [***] prior to the receipt by ARCHEMIX of the applicable [***]; and (h) the [***] applicable to any ARCHEMIX [***]. 1.14 " ARCHEMIX De Novo Research Activities" means, with respect to any ARCHEMIX Internal Research Project and/or ARCHEMIX Internal Program Target, any research activities that (a) are not ARCHEMIX Research Activities and (b) involve the use byPortions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.
3
ARCHEMIX of the SELEX Process to identify Aptamers against ARCHEMIX Internal Program Targets. 1.15 " ARCHEMIX Development Activities" means all Development activities (including without limitation any Development activities with respect to Co-Developed Collaboration Aptamers) specified to be conducted by ARCHEMIX in any Annual Development Plan (or amendment thereto) and approved by ARCHEMIX' s representatives on the JPT, the JDC and the JSC (without resort to the dispute resolution procedures set forth in Section 2.1.6). 1.16 " ARCHEMIX Facility" means the facility of ARCHEMIX currently located at 300 Third Street, Cambridge, MA 02142. 1.17 " ARCHEMIX-Gilead License Agreement" means the License Agreement between Gilead Sciences, Inc. and ARCHEMIX dated October 21, 2001, as amended. 1.18 " ARCHEMIX Internal Program Targets" means the Program Targets identified on Schedule 2B attached hereto. 1.19 " ARCHEMIX Internal Research Projects" means the research projects being conducted by ARCHEMIX for the ARCHEMIX Internal Program Targets. 1.20 " 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. 1.21 " ARCHEMIX Minimum Co-Development Participation Level" means with respect to each Co-Developed Development Candidate, the lesser of (a) the ARCHEMIX Co-Development Participation Capacity with respect to such Co-Developed Development Candidate and ; (b) with respect to the ARCHEMIX [***]% Co-Development Sharing Percentage (i) for any Development activities conducted with respect to a Co-Developed Development Candidate at any time during the period commencing on the date of exercise by ARCHEMIX of the Co-Development and Co-Promotion Option with respect to such Co-Developed Development Candidate and continuing until the Initiation of Phase I Clinical Trials with respect to such Co-Developed Development Candidate, a number of ARCHEMIX FTEs equal to [***] percent ([***]%) of the Estimated Aggregate FTEs; (ii) for any Development activities conducted with respect to a Co-Developed Development Candidate at any time during the period commencing on the Initiation of Phase I Clinical Trials with respect to such Co-Developed Development Candidate and continuing until the Initiation of Phase II Clinical Trials with respect to such Co-Developed Development Candidate, a number of ARCHEMIX FTEs equal to [***] percent ([***]%) of the Estimated Aggregate FTEs; and (iii) for any Development activities conducted with respect to a Co-Developed Development Candidate during the period commencing on the Initiation of Phase II Clinical Trials with respect to such Co-Developed Development Candidate and continuing until the completion of Phase III Clinical Trials with respect to such Co-Developed Development Candidate (the " Late Stage Co-Development Activities" ), a number of ARCHEMIX FTEs equal to [***] percent ([***]%) of the Estimated Aggregate FTEs, or (c)Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.
4
with respect to the ARCHEMIX [***]% Co-Development Percentage (i) for any Development activities conducted with respect to a Co-Developed Development Candidate at any time during the period commencing on the date of exercise by ARCHEMIX of the Co-Development and Co-Promotion Option with respect to such Co-Developed Development Candidate and continuing until the Initiation of Phase I Clinical Trials with respect to such Co-Developed Development Candidate, a number of ARCHEMIX FTEs equal to [***] percent ([***]%) of the Estimated Aggregate FTEs; (ii) for any Development activities conducted with respect to a Co-Developed Development Candidate at any time during the period commencing on the Initiation of Phase I Clinical Trials with respect to such Co-Developed Development Candidate and continuing until the Initiation of Phase II Clinical Trials with respect to such Co-Developed Development Candidate, a number of ARCHEMIX FTEs equal to [***] percent ([***]%) of the Estimated Aggregate FTEs; and (iii) for any Late Stage Co-Development Activities, a number of ARCHEMIX FTEs equal to [***] percent ([***]%) of the Estimated Aggregate FTEs. For purposes of clarity, the determination and application of the ARCHEMIX Minimum Co-Development Participation Percentage shall not affect the determination or the application of the ARCHEMIX Co-Development Sharing Percentage. 1.22 " ARCHEMIX Patent Rights" means any Patent Rights Controlled by ARCHEMIX that contain one or more claims that cover ARCHEMIX Technology. 1.23 " 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. 1.24 " 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. 1.25 " ARCHEMIX Technology" means, collectively, ARCHEMIX Background Technology and ARCHEMIX Program Technology. 1.26 " 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.Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.
5
1.27 " Calendar Year" means each successive period of twelve (12) months commencing on January 1 and ending on December 31. 1.28 " Challenge" means any challenge to the validity or enforceability of any of the Licensed Patent Rights in the absence of a material breach of this Agreement, including without limitation by (a) filing a declaratory judgment action in which any of the Licensed Patent Rights is alleged to be invalid or unenforceable; (b) citing prior art pursuant to 35 U.S.C. a7301, filing a request for re-examination of any of the Licensed Patent Rights pursuant to 35 U.S.C. a7302 and/or a7311, or provoking or becoming party to an interference with an application for any of the Licensed Patent Rights pursuant to 35 U.S.C. a7135; or (c) filing or commencing any re-examination, opposition, cancellation, nullity or similar proceedings against any of the Licensed Patent Rights in any country. 1.29 " 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 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. 1.30 " Clinical Trial" means, collectively, a Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial, Phase IV Clinical Trial, or Marketing Support Clinical Trial, as applicable. 1.31 " Co-Developed Collaboration Aptamer" means, collectively, Co-Developed Development Candidates and Co-Developed Products. 1.32 " Co-Developed Development Candidate" means any Development Candidate as to which ARCHEMIX has exercised a Co-Development and Co-Promotion Option as described in Section 4.10.2(a) and has not exercised an Opt-Out Right with respect thereto. 1.33 " Co-Developed Product" means any Product with respect to which ARCHEMIX has exercised a Co-Development and Co-Promotion Option as described in Section 4.10.2(a) and has not exercised an Opt-Out Right with respect thereto. For purposes of clarity, a Co-Promoted Product is a Co-Developed Product. 1.34 " Co-Developed Program Patent Rights" means, collectively, ARCHEMIX Co-Developed Program Patent Rights, MERCK Co-Developed Program Patent Rights, and Joint Co-Developed Program Patent Rights.Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.
6
1.35 " Co-Developed 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) in the conduct of the Development Program by employees of, or consultants to, MERCK and/or employees of, or consultants to, ARCHEMIX in connection with the Development and/or Commercialization of a Co-Developed Collaboration Aptamer. For purposes of clarity, any Co-Developed Program Technology that relates to the SELEX Process or to the SELEX Technology shall be considered ARCHEMIX Co-Developed Program Technology irrespective of which Party conceived or reduced to practice such Technology. 1.36 " Co-Development Costs" means the costs set forth in Schedule 13 hereto. 1.37 " Co-Development and Co-Promotion Option Exercise Period" means, with respect to each Development Candidate, the later of (a) [***] days after the acceptance by the JSC of such Development Candidate in accordance with Section 3.11 and (b) [***] days after the submission by MERCK to ARCHEMIX of an initial outline of the Development activities contemplated by MERCK for such Development Candidate affecting the Co-Development Territory over a [***] year period (including an estimated budget and the Estimated Aggregate FTEs for such activities). 1.38 " Co-Development Regulatory Costs" means the cost components set forth in Schedule 13 hereto. 1.39 " Co-Development Territory" means the United States of America and its territories and possessions. 1.40 " Co-Promoted Product" means a Co-Developed Product with respect to which ARCHEMIX has not exercised, and has no longer the right to exercise, an Opt-Out Right. 1.41 " 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. 1.42 " Collaboration Aptamer" means, collectively, Program Oligonucleotides, Program Aptamers, Lead Compounds, Optimized Lead Compounds, Development Candidates (including without limitation Co-Developed Development Candidates) and/or Products (including without limitation Co-Developed Products). 1.43 " 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 Royalty-Bearing Product; and (b) a Supplemental Product that is not within the Licensed Patent Rights, where both the Royalty-Bearing Product and the Supplemental Product are required to treat the intended Indication and/or to achieve the intended use or effect. 1.44 " Commercialization" or " Commercialize" means any and all activities directed to the commercialization of a Product after Commercialization Regulatory Approval has beenPortions of this Exhibit were omitted ...
*End of Preview*
Click the 'Add to Cart' button to download the complete and formatted agreement.