[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
eXHIBIT 10.2
STRATEGIC COLLABORATION AND LICENSE AGREEMENT
BETWEEN
VERTEX PHARMACEUTICALS INCORPORATED
AND
CRISPR THERAPEUTICS AG
June 6, 2019
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
STRATEGIC COLLABORATION AND LICENSE AGREEMENT
This STRATEGIC COLLABORATION AND LICENSE AGREEMENT (this “Agreement”) is entered into as of June 6, 2019 (the “Execution Date”) by and between Vertex Pharmaceuticals Incorporated (“Vertex”) and CRISPR Therapeutics AG (“CRISPR”). Vertex and CRISPR each may be referred to herein individually as a “Party” or collectively as the “Parties.”
RECITALS
WHEREAS, CRISPR possesses certain Patents, Know-How, technology and expertise with respect to the CRISPR/Cas System (as defined below);
WHEREAS, Vertex possesses expertise in developing and commercializing human therapeutics;
WHEREAS, Vertex and CRISPR desire to enter into a strategic collaboration and license agreement to enable Vertex to research, develop, manufacture and commercialize products for the treatment of DMD and DM1 (each as defined below) using gene editing [***], including the CRISPR/Cas System (as defined below);
WHEREAS, pursuant to this Agreement, CRISPR will perform certain DM1 guide research activities related to initial guide work for DM1 in cells; and
WHEREAS, CRISPR will have the option to enter into a Co-Commercialization Agreement (as defined below) with Vertex for all DM1 Products.
NOW, THEREFORE, in consideration of the respective covenants, representations, warranties and agreements set forth herein, the Parties hereto agree as follows:
DEFINITIONS
For purposes of this Agreement, the following capitalized terms will have the following meanings:
| 1.1. | “Acquisition Transaction” has the meaning set forth in Section 4.4.2. |
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| governing board, but is restricted from electing such majority by contract or otherwise, until such time as such restrictions are no longer in effect, or (b) possesses, directly or indirectly, the power to direct or cause the direction of the management or policies of an such Person (whether through ownership of securities or other ownership interests, by contract or otherwise). |
| 1.4. | “Agreement” has the meaning set forth in the Preamble. |
| 1.5. | “Agreement Term” means the period commencing on the Effective Date and ending on the expiration of this Agreement pursuant to Section 10.1, unless terminated earlier as provided herein. |
| 1.6. | “Alliance Manager” has the meaning set forth in Section 3.3.1. |
| 1.7. | “Alternative Product” means any Product, other than a CRISPR Product, that is Researched, Developed, Manufactured or Commercialized by Vertex or its Affiliates or Sublicensees. |
| 1.8. | “Applicable Law” means all applicable laws, statutes, rules, regulations and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, agency or other body, domestic or foreign, including any applicable rules, regulations, guidelines, or other requirements of the Regulatory Authorities that may be in effect from time to time. |
| 1.10. | “Audited Party” has the meaning set forth in Section 6.9. |
| 1.11. | “Auditing Party” has the meaning set forth in Section 6.9. |
| 1.12. | “Available” has the meaning set forth in Section 1.33. |
| 1.13. | “[***] Arbitration” means the arbitration process set forth in Schedule A. |
| 1.14. | “[***] Expert” has the meaning set forth in Schedule A. |
| 1.15. | “BLA” means a Biological License Application that is submitted to the FDA for marketing approval for a Product pursuant to 21 C.F.R. § 601.2. |
| 1.16. | “[***]” means, [***]. |
| 1.17. | “[***]” means [***]. |
| 1.18. | “Breaching Party” means the Party that is believed by the other Party to be in material breach of this Agreement. |
| 1.19. | “Business Day” means a Monday, Tuesday, Wednesday, Thursday or Friday that is not a day on which banking institutions in Boston, Massachusetts are authorized or obligated to close. |
3
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.21. | “Calendar Year” means any calendar year ending on December 31, or the applicable part thereof during the first or last year of the Agreement Term. |
| 1.24. | “Clinical Trial” means a study in humans that is conducted in accordance with GCP and is designed to generate data in support of an Approval Application. |
| 1.25. | “Co-Commercialization Agreement” has the meaning set forth in Section 5.1.6(a). |
| 1.27. | “Combination Product” has the meaning set forth in Section 1.122. |
4
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.30. | “Competitive Infringement” has the meaning set forth in Section 7.7.1. |
| 1.34. | “[***]” has the meaning set forth in Section 4.6.1(b). |
| 1.36. | “Cost Report” has the meaning set forth in Section 6.3.2. |
5
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.38. | “CREATE Act” means the Cooperative Research and Technology Enhancement Act of 2004, 35 U.S.C. § 103(c)(2)-(c)(3). |
| 1.40. | “CRISPR Agreement Breach” has the meaning set forth in Section 10.2.3(a). |
| 1.41. | “CRISPR Background Know-How” means any Know-How, other than Joint Program Know-How and CRISPR Program Know-How, that (a) [***] and (b) [***]. |
| 1.42. | “CRISPR Background Patents” means any Patent, other than a Joint Program Patent, CRISPR Program Patent or CRISPR Platform Technology Patent that (a) [***] and (b) [***]. |
| 1.43. | “CRISPR Breach Event” has the meaning set forth in Section 10.2.3(a). |
| 1.44. | “CRISPR Indemnified Party” has the meaning set forth in Section 9.1. |
| 1.48. | “[***] Patent” has the meaning set forth in Section 7.2. |
| 1.49. | “CRISPR Program Breach” has the meaning set forth in Section 10.2.3(a). |
| 1.50. | “CRISPR Program Know-How” has the meaning set forth in Section 7.1.2(a). |
6
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.51. | “CRISPR Program Patents” has the meaning set forth in Section 7.1.2(a). |
| 1.52. | “CRISPR Program Technology” has the meaning set forth in Section 7.1.2(a). |
| 1.53. | “CRISPR/Cas System” means a clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR-associated (Cas) protein system that comprises (a) [***] and (b) [***]. |
| 1.55. | “Disclosing Party” has the meaning set forth in Section 11.1. |
| 1.56. | “Distracting Product” has the meaning set forth in Section 4.4.1. |
| 1.61. | “DM1 Guide Research Plan” means the research plan setting forth the design, optimization and research activities for the DM1 Guide Research. |
| 1.62. | “DM1 Guide Research Plan Budget” has the meaning set forth in Section 2.1.1. |
| 1.63. | “DM1 Guide Research Term” means the period of time beginning on the Effective Date and ending upon the [***] anniversary thereof; provided that [***] may, in its sole discretion, elect to terminate such DM1 Guide Research Term after the [***] anniversary of the Effective Date on [***] days’ prior written notice to [***]; and provided further, that, if [***] does not elect to terminate the DM1 Guide Research Term before such [***] anniversary and any DM1 Guide Research activities under the DM1 Guide Research Plan are incomplete on such [***] anniversary, [***] will, at [***] election, complete such activities, and the DM1 Guide Research Term will be extended for up to [***] additional months to complete such activities or such longer period as may be agreed upon by both Parties. |
7
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.66. | “DM1 Program Data Package” means, with respect to the DM1 Program, a data package containing [***]. |
| 1.71. | “DOJ” has the meaning set forth in Section 4.7.1. |
| 1.73. | “EMA” means the European Medicines Agency and any successor entity thereto. |
| 1.74. | “European Commission” means the European Commission or any successor entity that is responsible for granting Marketing Approvals authorizing the sale of pharmaceuticals in the European Union. |
| 1.76. | “Exclusive License” has the meaning set forth in Section 4.1.1. |
| 1.77. | “Execution Date” has the meaning set forth in the preamble hereto. |
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[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.78. | “Executive Officer Resolution Period” has the meaning set forth in Section 3.1.3. |
| 1.79. | “Executive Officers” means the Chief Executive Officer of CRISPR, initially Samarth Kulkarni, and the Chief Executive Officer of Vertex, initially Jeffrey Leiden. |
| 1.80. | “Existing CRISPR Agreement” has the meaning set forth in Section 1.45. |
| 1.81. | “Exon” means, [***] |
| 1.82. | “FDA” means the United States Food and Drug Administration and any successor entity thereto. |
| 1.83. | “FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder. |
| 1.85. | “First Commercial Sale” means with respect to a Product, the first sale of such Product by Vertex, its Affiliate or its Sublicensee to a Third Party resulting in Net Sales in a particular country after any required Marketing Approval for the Product has been obtained in such country. |
| 1.87. | “FTC” has the meaning set forth in Section 4.7.1. |
| 1.89. | “GAAP” means United States generally accepted accounting principles, consistently applied. |
| 1.91. | “[***] Joint Program Know-How” has the meaning set forth in Section 7.1.2(d). |
| 1.92. | “[***] Joint Program Patents” has the meaning set forth in Section 7.1.2(d). |
| 1.93. | “[***] Joint Program Technology” has the meaning set forth in Section 7.1.2(d). |
| 1.94. | “[***]” means [***]. |
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[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.97. | “Governmental Authority” means any court, agency, department, authority or other instrumentality of any national, state, county, city or other political subdivision. |
| 1.98. | “HSR” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder. |
| 1.102. | “Indemnifying Party” has the meaning set forth in Section 9.3. |
| 1.103. | “Initiation” or “Initiate” means, with respect to any Clinical Trial, dosing of the first human subject in such Clinical Trial. |
| 1.104. | “Insolvency Event” has the meaning set forth in Section 10.2.5. |
| 1.105. | “Joint Advisory Committee” or “JAC” has the meaning set forth in Section 3.1.1. |
10
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.107. | “Joint Program Know-How” means [***] Joint Program Know-How, [***] Joint Program Know-How and Other Joint Program Know-How. |
| 1.108. | “Joint Program Patents” means [***] Joint Program Patents, [***] Joint Program Patents and Other Joint Program Patents. |
| 1.109. | “Joint Program Technology” means [***] Joint Program Technology, [***] Joint Program Technology and Other Joint Program Technology. |
| 1.112. | “Liability” has the meaning set forth in Section 9.1. |
| 1.113. | “Licensed Know-How” means [***]. |
| 1.114. | “Licensed Patents” means [***]. |
| 1.115. | “Licensed Technology” means, subject to Section 4.1.3 and Section 4.6.2, any and all Licensed Patents and Licensed Know-How. |
| 1.116. | “Major Market Country” means any one of the following countries: [***]. |
| 1.121. | “NDA” means a new drug application that is submitted to the FDA for marketing approval for a Product, pursuant to 21 C.F.R. § 314.3. |
11
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| (a) | [***]; |
| (b) | [***]; |
| (c) | [***]; |
| (d) | [***]; and |
| (e) | [***]. |
Generally, only items that are deducted from the Selling Party’s gross invoiced sales price of Product(s), as included in the Selling Party’s published financial statements and that are in accordance with GAAP, applied on a consistent basis, will be deducted from such gross invoiced sales price for purposes of the calculation of Net Sales. However, compulsory payments required by federal or state governments based upon sales volume or market share of Product(s) (but for clarity excluding taxes on the Selling Party’s net income), to the extent borne by the Selling Party, will be deducted from “Net Sales” regardless of its classification in the Selling Party’s published financial statements; provided that any such deduction will be limited to that share of such compulsory payment proportional to the share of the total sales volume or market share of the Selling Party used to compute the compulsory payment represented by applicable Net Sales of Product(s).
A qualifying amount may be deducted only once regardless of the number of the preceding categories that describe such amount. If a Selling Party makes any adjustment to such deductions after the associated Net Sales have been reported pursuant to this Agreement, the adjustments and payment of any royalties due will be reported with the next quarterly report. Sales between or among Vertex, its Affiliates and Sublicensees will be excluded from the computation of Net Sales if such sales are not intended for end use, but Net Sales will include the subsequent final sales to Third Parties by Vertex or any such Affiliates or Sublicensees. A Product will not be deemed to be sold if the Product is provided free of charge to a Third Party in reasonable quantities as a sample consistent with industry standard promotional and sample practices. [***].
If a sale, transfer or other disposition with respect to a Product involves consideration other than cash or is not at arm’s length, then the Net Sales from such sale, transfer or other disposition will be calculated on the [***].
Solely for purposes of calculating Net Sales, if Vertex or its Affiliates or any permitted Sublicensee sells a combination product containing both a Product and one or more other therapeutically or prophylactically active ingredients or delivery devices (whether combined in a single formulation or package, as applicable, or formulated separately but packaged under a single label approved by a Regulatory Authority and sold together for a single price) (a “Combination Product”), Net Sales of such Combination Product for the purpose of determining the payments due to CRISPR pursuant to this Agreement will be calculated by multiplying actual Net Sales of such Combination Product as determined in the first
12
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
paragraph of the definition of “Net Sales” by the fraction A/(A+B) where [***]. The weighted average invoice prices referenced above will be calculated with reference to the prevailing prices during the applicable Calendar Quarter in those top selling countries that equate to [***]% of Net Sales of the applicable Product in the Territory, with the prices weighted in the calculation to reflect the actual relative sales value of the Product in each of the countries to which the calculation relates. If it is not possible to determine the fraction A/(A+B) based on the criteria specified in the preceding sentence (e.g., if a Product component is not sold separately), the Parties shall determine Net Sales for the Product in such Combination Product in good faith by mutual agreement [***].
| 1.124. | “Non-Breaching Party” means the Party that believes the other Party is in material breach of this Agreement. |
| 1.125. | “[***]” has the meaning set forth in Section 4.6.1(d). |
| 1.126. | “Non-Disclosing Party” has the meaning set forth in Section 11.5.3. |
| 1.127. | “[***] Agreement” means that certain [***] Agreement entered into as of the Execution Date by and between the Parties. |
| 1.129. | “Other Joint Program Know-How” has the meaning set forth in Section 7.1.2(e). |
| 1.130. | “Other Joint Program Patents” has the meaning set forth in Section 7.1.2(e). |
| 1.131. | “Other Joint Program Technology” has the meaning set forth in Section 7.1.2(e). |
| 1.132. | “Out-of-Pocket Costs” means, with respect to a Party, costs and expenses paid by such Party to Third Parties (or payable to Third Parties and accrued in accordance with GAAP), other than Affiliates or employees of such Party. |
| 1.133. | “Outside Date” means (i) with respect to the DMD Program, the [***] anniversary of the Execution Date and (ii) with respect to the DM1 Program, the [***] anniversary of the Execution Date. |
| 1.134. | “Party” or “Parties” has the meaning set forth in the Preamble. |
| 1.135. | “Patent Coordinator” has the meaning set forth in Section 7.4. |
| 1.136. | “Patent Costs” means the reasonable fees and expenses paid to outside legal counsel, and filing, maintenance, disbursement and other reasonable Out-of-Pocket Costs paid to Third Parties, in connection with the Prosecution and Maintenance of Patents. |
13
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.139. | “Phase 1 Clinical Trial” means any Clinical Trial as described in 21 C.F.R. §312.21(a), or, with respect to a jurisdiction other than the United States, a similar Clinical Trial. |
| 1.144. | “[***] Joint Program Know-How” has the meaning set forth in Section 7.1.2(c). |
| 1.145. | “[***] Joint Program Patents” has the meaning set forth in Section 7.1.2(c). |
| 1.146. | “[***] Joint Program Technology” has the meaning set forth in Section 7.1.2(c). |
| 1.149. | “Receiving Party” has the meaning set forth in Section 11.1. |
14
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.154. | “Research Costs” means the costs and expenses that are actually incurred by or on behalf of a Party and specifically identifiable or specifically allocable to the Research activities conducted by such Party, including: (a) a Party’s and its Affiliates fully absorbed internal costs with respect to such activities; and (b) all Out-of-Pocket Costs incurred by a Party or its Affiliates, including payments made to Third Parties with respect to such Research activities (except to the extent that such costs have been included in internal costs). [***]. All other costs will be determined from the books and records of the applicable Party and its Affiliates maintained in accordance with GAAP. |
15
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.157. | “Schedule Revision Date” means the earlier of (a) the fifth day following the HSR Clearance Date and (b) the day on or after the HSR Clearance Date on which CRISPR provides to Vertex either (i) CRISPR’s supplemental or additional schedules (if any) pursuant to the proviso in the first sentence of Section 8.2, and a notice that no further supplemental, additional or updated schedules will be provided, or (ii) instead of providing any such supplemental, additional or updated schedules, a notice that no further supplemental, additional or updated schedules will be provided. |
| 1.158. | “Selling Party” has the meaning set forth in Section 1.122. |
| 1.159. | “Setoff Amount” has the meaning set forth in Section 10.3.2. |
| 1.160. | “[***]” has the meaning set forth in Section 10.3.3(a). |
| 1.161. | “Specified Agreement No. 1” means [***]. |
| 1.162. | “Specified Agreement No. 2” means [***]. |
| 1.163. | “Specified Endonuclease Agreement” means [***]. |
| 1.165. | “Specified Third Party Intellectual Property” means[***]. |
| 1.166. | “Subcontractor” means, with respect to a Party, a consultant, subcontractor or other vendor engaged by such Party or its Affiliates to perform activities under this Agreement. |
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[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 1.169. | “Target” means [***] of which is associated with a human disease and which is to be edited, [***] in order to treat, ameliorate or prevent such disease. |
| 1.170. | “Targeting” means [***] a Target or [***] thereof; provided, that with respect to [***], Targeting means [***]. |
| 1.174. | “United States” or “U.S.” means the fifty states of the United States of America and all of its territories and possessions and the District of Columbia. |
| 1.176. | “Vertex” has the meaning set forth in the Preamble. |
| 1.177. | “Vertex Background Know-How” means any Know-How, other than Joint Program Know-How and Vertex Program Know-How, that [***]. |
| 1.178. | “Vertex Background Patents” means any Patent, other than a Joint Program Patent or Vertex Program Patent that [***]. |
| 1.179. | “Vertex Indemnified Party” has the meaning set forth in Section 9.2. |
| 1.181. | “Vertex Program Patents” has the meaning set forth in Section 7.1.2(b). |
| 1.182. | “Vertex Program Technology” has the meaning set forth in Section 7.1.2(b). |
| 1.183. | “Vertex Technology” means (a) the Vertex Background Know-How, (b) the Vertex Background Patents, (c) the Vertex Program Technology and (d) Vertex’s interest in any Joint Program Technology. |
17
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
18
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 2.1.5. | Research Costs. Vertex will reimburse CRISPR for a portion of Research Costs for DM1 Guide Research incurred by CRISPR in accordance with Section 6.3. |
| 2.1.6. | End of DM1 Guide Research Term. Following the conclusion of the DM1 Guide Research Term, [***] will have no further obligation to perform any additional Research activities under this Agreement. |
GOVERNANCE
| (a) | review and discuss any amendments to the DM1 Guide Research Plan and the corresponding DM1 Guide Research Plan Budget; |
| (b) | provide comments and recommendations to each Party with respect to the conduct of activities under the DMD Program, the DM1 Program and the DM1 Guide Research; |
| (c) | provide a forum for the Parties to discuss the objectives and progress under the DMD Program, the DM1 Program and the DM1 Guide Research, and to exchange and review scientific information and data relating to the activities being conducted thereunder; |
| (d) | provide a forum for the Parties to discuss any material Licensed Know-How disclosed by CRISPR as described in Section 4.2.2; |
| (f) | perform such other duties as are specifically assigned to the JAC under this Agreement. |
19
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 3.3.2. | Specific Responsibilities. The Alliance Managers may be, but will not be required to be, members of the JAC. The Alliance Managers will serve as the primary contact point between the Parties for the purpose of providing each Party with information regarding the other Parties’ activities pursuant to this Agreement and will have the following responsibilities: |
| (a) | schedule meetings of the JAC and circulate draft written minutes from each meeting within [***] days after each such meeting; |
20
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| (b) | facilitate the flow of information and otherwise promote communication, coordination and collaboration between the Parties; |
| (c) | coordinate the various functional representatives of each Party, as appropriate, in developing and executing strategies and plans for Products; |
| (d) | provide a single point of communication for seeking consensus both internally within the respective Party’s organization and between the Parties regarding key strategy and planning issues; |
| (e) | coordinate and facilitate budget, finance and billing activities as overseen by the JAC; and |
ARTICLE 4.
LICENSE GRANTS; TECHNOLOGY TRANSFER
21
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
22
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 4.2.3. | [***]. |
| 4.2.4. | Rights of Reference. |
| (a) | [***]; |
| (b) | [***] |
23
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| (c) | [***]. |
[***].
| (c) | If [***] is contemplating [***], then (1) [***] may request that [***] use, in which case [***] shall use, Commercially Reasonable Efforts to [***], and such request must be made to [***] in writing within [***] Business Days after the disclosure described in Section 4.6.2(c)(i) is made to [***]; (2) [***] shall be responsible for payment of [***] percent ([***]%) of any obligation due in connection with [***]; and (3) all Know-How and Patents [***]. Notwithstanding the foregoing, if [***] is unsuccessful in [***], [***] shall provide [***] with prompt written notice thereof, and the provisions of Section 4.6.1(b) will apply, provided that, notwithstanding clause (ii) of Section 4.6.1(b), [***] will only have [***] Business Days after receipt of such written notice to elect to [***]. |
| 4.6.2. | [***]. Notwithstanding Section 4.6.1, Vertex [***] with respect to one or more [***] and, thereafter, [***]. |
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[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 4.7.3. | Other than the provisions of this Section 4.7, Section 8.1, Section 8.2, Sections 8.3.1 through 8.3.6, ARTICLE 11, Section 10.2.1, Section 12.5, and Section 12.11, and all definitions necessary to give effect to the foregoing provisions, each of which shall each become effective on the Execution Date, the rights and obligations of the Parties under this Agreement shall not become effective until the Effective Date. |
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[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
ARTICLE 5.
RESEARCH, DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION OF PRODUCTS
| 5.1.1. | Responsibility. Except as otherwise provided in this Agreement, Vertex will be solely responsible for, and will have sole and exclusive control over, the Research and Development of Products. |
26
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
27
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| not be obligated to change any plans with respect to any Phase 1 Clinical Trial of a DM1 Product that are in effect at the time of CRISPR’s DM1 Program Option exercise, as a result of such DM1 Program Option exercise. Upon execution of the Co-Commercialization Agreement by the Parties, DM1 Products will no longer be Products under this Agreement. |
28
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 5.2.2. | Ownership. Ownership of all right, title and interest in and to any and all Regulatory Filings, Regulatory Approvals and Price Approvals directed to any Product in each country of the Territory will be held in the name of Vertex, its Affiliate, designee or Sublicensee. |
| 5.3. | Commercialization. |
| 5.3.3. | Branding. Vertex or its designated Affiliates or Sublicensees will select and own all trademarks used in connection with the Commercialization of any and all Products. CRISPR will not use nor seek to register, anywhere in the world, any trademark that is confusingly similar to any trademark used by or on behalf of Vertex, its Affiliates or Sublicensees in connection with any Product. |
| 5.5. | Applicable Laws. Each Party will, and will require its Affiliates, Sublicensees and Subcontractors to, comply with all Applicable Law in its and their Research, Development, Manufacture and Commercialization of Products, including where appropriate, cGMP, GCP and GLP (or similar standards). |
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[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
ARTICLE 6.
FINANCIAL PROVISIONS
Milestone Event | [***] | [***] | |||
[***] | [***] | [***] | |||
1 | [***] |
|
|
| [***] |
2 | [***] |
|
|
| [***] |
3 | [***] | [***] | [***] | [***] | [***] |
4 | [***] | [***] | [***] | [***] | [***] |
5 | [***] | [***] | [***] | [***] | [***] |
6 | [***] | [***] | [***] | [***] | [***] |
7 | [***] | [***] | [***] | [***] | [***] |
[***].
Milestone Event | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] |
30
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
31
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
32
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 6.7.2. | If any amounts that are relevant to the determination of amounts to be paid under this Agreement or any calculations to be performed under this Agreement are denoted in a currency other than U.S. Dollars, then such amounts will be converted to their U.S. Dollar equivalent using Vertex’s then-current standard procedures and methodology, including its then-current standard exchange rate methodology for the translation of foreign currency expenses into U.S. Dollars or, in the case of Sublicensees, such similar methodology, consistently applied. |
33
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
34
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
ARTICLE 7.
INTELLECTUAL PROPERTY
35
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
36
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 7.3. | Prosecution and Maintenance of Patents. The Parties hereby agree as follows with respect to the Prosecution and Maintenance of certain Patents, subject, in each case, to Third Party Obligations: |
| 7.3.4. | Other Joint Program Patents. The Parties will discuss and agree upon an allocation of responsibility for the Prosecution and Maintenance of the Other Joint Program Patents. |
37
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
For Vertex: [***]
For CRISPR: [***]
38
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
39
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| (a) | the amount of such recovery will first [***]; then |
| (b) | except to the extent otherwise set forth in a Co-Commercialization Agreement entered into pursuant to this Agreement, any remaining proceeds constituting direct or actual damages will be paid to, or retained by, [***]; and |
| (c) | except to the extent otherwise set forth in a Co-Commercialization Agreement entered into pursuant to this Agreement, any remaining proceeds constituting punitive or treble damages will be allocated between the Parties as follows: [***]. |
| 7.8.2. | Patents Solely Owned by CRISPR. CRISPR will retain all rights to pursue an infringement of any Patent solely owned by CRISPR that is not a Competitive Infringement and CRISPR will retain all recoveries with respect thereto. |
| 7.8.3. | Patents Solely Owned by Vertex. Vertex will retain all rights to pursue an infringement of any Patent solely owned by Vertex and Vertex will retain all recoveries with respect thereto. |
40
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction; provided that Vertex shall not be permitted to provide any such information with respect to CRISPR Platform Technology Patents without CRISPR’s prior written consent. |
ARTICLE 8.
REPRESENTATIONS AND WARRANTIES
| 8.1. | Representations and Warranties of Vertex. Vertex hereby represents and warrants to CRISPR, as of the Effective Date and the Execution Date, that: |
| 8.1.1. | Vertex is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; |
41
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 8.2.1. | CRISPR is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; |
| 8.2.2. | CRISPR (a) has the requisite power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder and (b) has taken all requisite action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; |
| 8.2.3. | to CRISPR’s Knowledge, CRISPR has the requisite resources and expertise to perform its obligations hereunder; |
| 8.2.4. | this Agreement has been duly executed and delivered on behalf of CRISPR, and constitutes a legal, valid and binding obligation, enforceable against it in accordance with the terms hereof; |
| 8.2.6. | except with respect to any required HSR approvals, CRISPR has obtained all necessary consents, approvals and authorizations of all Governmental Authorities and other Persons or entities required to be obtained by CRISPR in connection with the execution and delivery of this Agreement; |
42
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 8.2.7. | the Licensed Technology constitutes all of the Patents and Know-How Controlled by CRISPR that are necessary to Research, Develop, Manufacture or Commercialize Products in the Field; |
| 8.2.10. | CRISPR has independently developed all Licensed Technology or otherwise has a valid right to use, and to permit Vertex, Vertex’s Affiliates and Vertex’s Sublicensees to use, the Licensed Technology for all permitted purposes under this Agreement; |
| 8.2.11. | the CRISPR Background Know-How is free and clear of liens, charges or encumbrances other than licenses granted to Third Parties that are not inconsistent with the rights and licenses granted to Vertex hereunder; |
43
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 8.2.18. | no Licensed Technology is subject to any funding agreement with any government or governmental agency; |
| 8.2.20. | there are no judgments or settlements against or owed by [***], pending or threatened claims or litigation, in either case relating to the Licensed Technology; |
| 8.3. | CRISPR Covenants. CRISPR hereby covenants to Vertex that, except as expressly permitted under this Agreement: |
44
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 8.3.7. | it will use Commercially Reasonable Efforts to obtain and maintain the requisite resources and expertise to perform its obligations hereunder; |
| 8.3.9. | it will not engage, in any capacity in connection with this Agreement any Person who either has been debarred by the FDA, is the subject of a conviction described in Section 306 of the FD&C Act or is subject to any such similar sanction; and |
| 8.4. | Vertex Covenants. Vertex hereby covenants to CRISPR that, except as expressly permitted under this Agreement: |
| 8.4.1. | it will use Commercially Reasonable Efforts to obtain and maintain the requisite resources and expertise to perform its obligations hereunder; |
| 8.4.2. | Vertex will not engage, in any capacity in connection with this Agreement, any Person who either has been debarred by the FDA, is the subject of a conviction described in Section 306 of the FD&C Act or is subject to any such similar sanction; and |
45
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 8.5. | Disclaimer. Except as otherwise expressly set forth in this Agreement, neither Party nor its Affiliates makes any representation or extends any warranty of any kind, either express or implied, including any warranty of merchantability or fitness for a particular purpose. Vertex and CRISPR understand that each Product is the subject of ongoing Research and Development and that neither Party can assure the safety, usefulness or commercial or technical viability of any Product. |
ARTICLE 9.
INDEMNIFICATION; INSURANCE
46
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
47
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 10.2. | Termination of the Agreement. |
48
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| relates solely to the DMD Program or the DM1 Program, with respect to the Program affected by such breach, or (ii) if such breach relates to both the DMD Program and the DM1 Program or this Agreement as a whole, in its entirety, by providing written notice to Vertex. |
49
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
50
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| (i) | the right of access to any intellectual property rights (including all embodiments thereof) of CRISPR, or any Third Party with whom CRISPR contracts to perform an obligation of CRISPR under this Agreement, and, in the case of any such Third Party, which is necessary for the Manufacture, use, sale, import or export of Products; and |
| (ii) | the right to contract directly with any Third Party to complete the contracted work. |
51
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| (i) | Whether the [***] by Vertex pursuant to Section 10.3.2 exceeds the mediator’s objective good faith estimate of [***]; and |
| (c) | Mediator Resolution. |
| (i) | If the mediator determines that [***] by Vertex pursuant to Section 10.3.2 [***], the Parties will promptly cause [***] as provided for in Section 6.10. [***]. |
| (ii) | If the mediator determines [***], Vertex may [***]. |
52
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
53
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 10.4.5. | Effective upon (a) a termination of this Agreement with respect to a Program, Vertex will, and hereby does, assign to CRISPR, or one or more of its designated Affiliates, Vertex’s ownership interest in any (i) [***] Patents and (ii) Know-How assigned to Vertex under Section 7.2, in each case ((i) and (ii)), pertaining solely to Products under the terminated Program, and (b) a termination of this Agreement in its entirety, Vertex will, and hereby does, assign to CRISPR, or one or more of its designated Affiliates, Vertex’s ownership interest in all [***] Patents and all Know-How assigned to Vertex under Section 7.2. |
54
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
If a Party deems it reasonably necessary to disclose Confidential Information belonging to the other Party pursuant to this Section 11.2, the Disclosing Party will to the extent possible give reasonable advance written notice of such disclosure to the other Party and take reasonable measures to ensure confidential treatment of such information. In addition to the foregoing and except as otherwise prohibited or limited by clause (b) of the following sentence, [***] may disclose [***] Confidential Information to Third Parties as reasonably required to facilitate the actual or potential Research, Development, Manufacture or Commercialization of Products; provided that such disclosure is covered by terms of confidentiality and non-use similar to those set forth herein.
Notwithstanding anything to the contrary contained herein, (a) in no event may [***] disclose [***] Confidential Information to any Third Party (including any of [***] investors, collaborators or licensees) engaged in [***], and (b) in no event may [***] disclose [***] Confidential Information, other than the terms and conditions of this Agreement, to any Third Party (including any of [***] investors, collaborators or licensees) that [***] as its primary business.
55
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
56
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
57
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 12.2.2. | Effects of Change of Control of CRISPR. If, during the Agreement Term, CRISPR undergoes a Change of Control to a Competitor, then upon the effective date of such Change of Control [***]. |
If to Vertex:
Vertex Pharmaceuticals Incorporated
Attn: Business Development
50 Northern Avenue
Boston, Massachusetts 02110
E-mail: [***]
with a copy to:
Vertex Pharmaceuticals Incorporated
Attn: Corporate Legal
50 Northern Avenue
Boston, Massachusetts 02110
E-mail: [***]
and:
Ropes & Gray LLP
Attn: [***]
Prudential Tower
800 Boylston Street
Boston, Massachusetts 02199-3600
E-mail: [***]
58
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
If to CRISPR:
CRISPR Therapeutics AG
Attn: Chief Executive Officer
Baarerstrasse 14
6300 Zug
Switzerland
E-mail: [***]
with a copy to:
CRISPR Therapeutics AG
Attn: General Counsel
Baarerstrasse 14
6300 Zug
Switzerland
E-mail: [***]
and:
Goodwin Procter LLP
Attn: [***]
100 Northern Avenue
Boston, Massachusetts 02210
E-mail: [***]
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. In addition, each Party will deliver a courtesy copy to the other Party’s Alliance Manager concurrently with such notice. Any such notice will be deemed to have been given: (a) when delivered if personally delivered on a Business Day (or, if delivered or sent on a non-Business Day, then on the next Business Day); (b) on receipt if sent by overnight courier; or (c) when confirmation of receipt is sent, if sent by electronic mail.
59
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 12.9. | Descriptive Headings. The descriptive headings of this Agreement are for convenience only and will be of no force or effect in construing or interpreting any of the provisions of this Agreement. |
60
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
[SIGNATURE PAGE FOLLOWS]
* - * - * - *
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[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their representatives thereunto duly authorized as of the Execution Date.
VERTEX PHARMACEUTICALS INCORPORATED | CRISPR THERAPEUTICS AG |
By: /s/ Jeffrey Leiden _____________________ |
By: /s/ Rodger Novak___________________ |
Name: Jeffrey Leiden Title: Chairman, President and Chief Executive Officer | Name: Rodger Novak Title: President |
[Signature Page to Strategic Collaboration and License Agreement]
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Schedule A
[***] Arbitration Procedures
[***]
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Schedule B
CRISPR In-License Agreements
[***]
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Schedule C
DM1 Guide Milestone Criteria
[***]
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Schedule D-1
Initial DM1 Guide Research Plan
[***]
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Schedule D-2
DM1 Guide Research Plan Budget
[***]
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Schedule E
Subcontractors
[***]
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Schedule F
CRISPR Background Know-How
(as of the Execution Date)
[***]
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Schedule G
[***] Patents
[***]
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Schedule H
CRISPR Disclosures
[***]