Exhibit 10.4
[***] Certain portions of this exhibit have been omitted because they are not material and the registrant customarily and actually treats that information as private or confidential.
Joint Development and Commercialization AGREEMENT
BETWEEN
vertex pharmaceuticals incorporated
VERTEX PHARMACEUTICALS (EUROPE) LIMITED
AND
CriSpr THERAPEUTICS AG
CRISPR THERAPEUTICS LIMITED
CRISPR THERAPEUTICS, INC.
TRACR HEMATOLOGY LTD.
table of contents
|
| Page | |
ARTICLE 1 DEFINITIONS | 2 | ||
|
|
| |
ARTICLE 2 Antitrust FILINGS | 12 | ||
|
|
|
|
2.1. |
| Antitrust Filings | 12 |
2.2. |
| Resolution of Any Objections | 13 |
2.3. |
| Provisions Effective As of the Amendment Date | 13 |
|
|
| |
ARTICLE 3 GOVERNANCE | 14 | ||
|
|
|
|
3.1. |
| Joint Oversight Committee | 14 |
3.2. |
| Transition Committee | 14 |
3.3. |
| Alliance Managers | 15 |
3.4. |
| Disbandment of Committees | 16 |
|
|
| |
ARTICLE 4 Development | 16 | ||
|
|
|
|
4.1. |
| Development Plan and Follow-On Research | 16 |
4.2. |
| Regulatory Matters | 17 |
4.3. |
| Quality Agreement | 18 |
4.4. |
| Diligence | 18 |
4.5. |
| Clinical Trial Data | 18 |
|
|
| |
ARTICLE 5 Medical Affairs Activities | 19 | ||
|
|
| |
ARTICLE 6 Commercialization | 19 | ||
|
|
|
|
6.1. |
| Responsibilities | 19 |
6.2. |
| Commercialization Plans | 19 |
6.3. |
| Participation in Significant Commercial Meetings | 19 |
6.4. |
| Reporting | 20 |
6.5. |
| Diligence | 20 |
|
|
| |
ARTICLE 7 Manufacturing | 20 | ||
|
|
|
|
7.1. |
| Transfer of Assigned Contracts to Vertex | 20 |
7.2. |
| Manufacturing Technology Transfer | 20 |
7.3. |
| Vertex Manufacturing Responsibilities | 21 |
|
|
| |
ARTICLE 8 Transition ACTIVITIES | 21 | ||
|
|
|
|
8.1. |
| Transition Plan | 21 |
8.2. |
| Transition Activities | 21 |
|
|
| |
ARTICLE 9 CRISPR Activities | 22 | ||
|
|
|
|
9.1. |
| CRISPR Activities Plan | 22 |
9.2. |
| Diligence | 22 |
9.3. |
| Reporting | 22 |
i
|
|
| |
ARTICLE 10 FINANCIAL TERMS; Allocation of Net Profit and Net Loss | 22 | ||
|
|
|
|
10.1. |
| Payments Under Original Agreement | 22 |
10.2. |
| Amendment Upfront Payment | 23 |
10.3. |
| Milestone Payment | 23 |
10.4. |
| Allocation | 23 |
10.5. |
| Calculation | 23 |
10.6. |
| Payment of Expenses; Summary Statements | 23 |
10.7. |
| Reconciliation | 24 |
10.8. |
| Books and Records | 25 |
10.9. |
| Payment Method; Currency | 26 |
10.10. |
| Late Payment | 26 |
10.11. |
| Capital Equipment | 26 |
|
|
| |
ARTICLE 11 Adverse Events | 26 | ||
|
|
|
|
11.1. |
| Pharmacovigilance Agreement | 26 |
11.2. |
| Global Safety Database | 26 |
11.3. |
| Access to Safety Information | 26 |
11.4. |
| Notice of Certain Events | 27 |
|
|
| |
ARTICLE 12 Subcontracting | 27 | ||
|
|
| |
ARTICLE 13 LICENSE GRANTS | 27 | ||
|
|
|
|
13.1. |
| Acknowledgment of Option Exercise | 27 |
13.2. |
| License Grants to Vertex | 27 |
13.3. |
| License Grants to CRISPR | 28 |
13.4. |
| Licenses to Improvements | 29 |
13.5. |
| Sublicensing | 29 |
13.6. |
| No Implied Licenses | 29 |
13.7. |
| Third Party Agreements | 30 |
|
|
| |
ARTICLE 14 INTELLECTUAL PROPERTY | 31 | ||
|
|
| |
ARTICLE 15 REPRESENTATIONS AND WARRANTIES | 31 | ||
|
|
|
|
15.1. |
| Representations and Warranties of Vertex | 31 |
15.2. |
| Representations and Warranties of CRISPR | 32 |
15.3. |
| CRISPR Covenants | 33 |
15.4. |
| Vertex Covenants | 35 |
15.5. |
| Disclaimer | 35 |
|
|
| |
ARTICLE 16 INDEMNIFICATION; INSURANCE | 35 | ||
|
|
|
|
16.1. |
| Indemnification by Vertex | 35 |
16.2. |
| Indemnification by CRISPR | 36 |
16.3. |
| Procedure | 36 |
16.4. |
| Other Third Party Claims | 36 |
16.5. |
| Insurance | 36 |
ii
16.6. |
| Limitation of Consequential Damages | 37 |
|
|
| |
ARTICLE 17 TERM; TERMINATION | 38 | ||
|
|
|
|
17.1. |
| Co-Co Agreement Term; Expiration | 38 |
17.2. |
| Termination of the Agreement | 38 |
17.3. |
| Opt-Out | 42 |
17.4. |
| Consequences of Expiration or Certain Terminations of the Agreement | 44 |
17.5. |
| Alternative Remedies for Material Breach | 45 |
17.6. |
| Survival | 45 |
|
|
| |
ARTICLE 18 CONFIDENTIALITY | 45 | ||
|
|
|
|
18.1. |
| Confidentiality | 45 |
18.2. |
| Authorized Disclosure | 46 |
18.3. |
| SEC Filings and Other Disclosures | 46 |
18.4. |
| Public Announcement; Publications | 46 |
18.5. |
| Site Media Materials | 47 |
18.6. |
| Confidentiality Obligations of CRISPR Personnel | 48 |
|
|
| |
ARTICLE 19 MISCELLANEOUS | 48 | ||
|
|
|
|
19.1. |
| Assignment | 48 |
19.2. |
| Effects of Change of Control | 49 |
19.3. |
| Force Majeure | 49 |
19.4. |
| Representation by Legal Counsel | 49 |
19.5. |
| Notices | 49 |
19.6. |
| Amendment | 51 |
19.7. |
| Waiver | 51 |
19.8. |
| Severability | 51 |
19.9. |
| Descriptive Headings | 51 |
19.10. |
| Export Control | 51 |
19.11. |
| Data Privacy Matters | 51 |
19.12. |
| Governing Law | 52 |
19.13. |
| Entire Agreement | 52 |
19.14. |
| Independent Contractors | 52 |
19.15. |
| Interpretation | 52 |
19.16. |
| No Third Party Rights or Obligations | 53 |
19.17. |
| Further Actions | 53 |
19.18. |
| Counterparts | 53 |
19.19. |
| CRISPR Entities | 53 |
SCHEDULE A: CRISPR In-License Agreements
SCHEDULE B: Designated Shared Products
SCHEDULE C: Vertex In-License Agreements
SCHEDULE D: Assigned Contracts
SCHEDULE E: Other Manufacturing Contracts
SCHEDULE F: Preliminary Transition Plan
SCHEDULE G: Annual OPEX Cap
iii
SCHEDULE H: CRISPR Disclosure Schedule
SCHEDULE I: Form of Non-Disclosure Agreement
SCHEDULE J: Form of Joint Press Release
iv
AMENDED AND RESTATED
Joint Development and Commercialization AGREEMENT
This AMENDED AND RESTATED JOINT DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (this “Agreement”) is entered into as of April 16, 2021 (the “Amendment Date”) by and between, on the one hand, Vertex Pharmaceuticals Incorporated, a corporation organized and existing under the laws of The Commonwealth of Massachusetts (“Vertex Parent”), and Vertex Pharmaceuticals (Europe) Limited, a private limited liability company organized under the laws of England and Wales (“Vertex UK” and, together with Vertex Parent, “Vertex”) and, on the other hand, CRISPR Therapeutics AG, a corporation organized under the laws of Switzerland (“CRISPR AG”), CRISPR Therapeutics, Inc., a corporation organized under the laws of the state of Delaware (“CRISPR Inc.”), CRISPR Therapeutics Limited, a corporation organized under the laws of England and Wales (“CRISPR UK”), and TRACR Hematology Ltd, a UK limited company (“Tracr” and together with CRISPR AG, CRISPR Inc. and CRISPR UK, “CRISPR”), and amends and restates that certain Joint Development and Commercialization Agreement entered into as of December 12, 2017 (the “Effective Date”) by and between Vertex and CRISPR (the “Original Agreement”). Vertex and CRISPR each may be referred to herein individually as a “Party” or collectively as the “Parties.”
RECITALS
WHEREAS, the Parties and certain of their Affiliates (as defined below) have entered into that certain Strategic Collaboration, Option and License Agreement dated as of October 26, 2015, as amended by that certain Amendment No. 1 by and between the Parties dated as of the Effective Date and that certain Amendment No. 2 (“Amendment No. 2”) by and between the Parties dated as of June 6, 2019 (the “Collaboration Agreement”);
WHEREAS, pursuant to the Collaboration Agreement, Vertex and CRISPR are conducting a strategic collaboration focused on exploring potential targets related to certain diseases and creating therapeutics using gene editing [***], including the CRISPR/Cas System, to treat such diseases, including the Shared Products (as defined below);
WHEREAS, pursuant to Section 4.1.1 of the Collaboration Agreement, Vertex has obtained an Option (as defined therein) with respect to [***], and the execution of the Original Agreement constituted the exercise by Vertex of the Option with respect to [***];
WHEREAS, the Parties have agreed that [***] under the Collaboration Agreement;
WHEREAS, the Parties entered into the Original Agreement in accordance with Section 6.1.2(c) of the Collaboration Agreement in order for the Parties to conduct additional research with respect to and develop and commercialize the Shared Products; and
WHEREAS, the Parties now desire to amend and restate the Original Agreement in its entirety as set forth herein.
1
NOW, THEREFORE, in consideration of the respective covenants, representations, warranties and agreements set forth herein, the Parties hereto agree as follows:
For purposes of this Agreement, the following capitalized terms will have the meanings set forth in this ARTICLE 1. Capitalized terms used but not defined herein will have their respective meanings set forth in the Collaboration Agreement.
| 1.1. | “Agreement” has the meaning set forth in the Preamble. |
| 1.2. | [***]. |
| 1.3. | “Alliance Manager” has the meaning set forth in Section 3.3.1. |
| 1.4. | “Amendment Date” has the meaning set forth in the Preamble. |
| 1.5. | “Amendment Date Provisions” has the meaning set forth in Section 2.3. |
| 1.6. | “Amendment Effective Date” means the later of (a) the Amendment Date or (b) the Antitrust Clearance Date, provided that the Effective Date shall not occur if either Party has exercised its termination right under Section 17.2.1 prior to the Antitrust Clearance Date. |
| 1.7. | “Amendment No. 2” has the meaning set forth in the Recitals. |
| 1.8. | “Annual OPEX Cap” has the meaning set forth in Section 10.7.2. |
| 1.10. | “Approvals” has the meaning set forth in Section 18.5.3. |
| 1.11. | “Approved Action” has the meaning set forth in Section 18.5.3. |
| 1.12. | “Assigned Contract” has the meaning set forth in Section 7.1. |
| 1.13. | [***]. |
| 1.14. | [***]. |
| 1.15. | “[***] Third Party Agreement” has the meaning set forth in Section 13.7.2. |
2
|
| 1.16. | [***]. |
| 1.17. | [***]. |
| 1.18. | “Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30 or December 31, during the Co-Co Agreement Term, or the applicable part thereof during the first or last calendar quarter of the Co-Co Agreement Term. |
| 1.19. | “Calendar Year” means any calendar year ending on December 31, or the applicable part thereof during the first or last year of the Co-Co Agreement Term. |
| 1.20. | “Challenging Party” has the meaning set forth in Section 17.2.4. |
| 1.22. | “Co-Co Agreement Term” means the period commencing on the Effective Date and ending on the expiration of this Agreement pursuant to Section 17.1, unless terminated earlier as provided herein. |
| 1.24. | “Combination Product” has the meaning set forth in Section 1.81. |
| 1.25.1. | [***]; |
| 1.25.2. | [***]; |
| 1.25.4. | [***]; |
| 1.25.5. | [***]; |
| 1.25.6. | [***]; |
| 1.25.8. | [***]; |
| 1.25.9. | [***]; and |
Commercialization Costs will exclude all of the payments set forth in Section 7.1 of the Collaboration Agreement, Research Costs, Development Costs, Transition Costs, Manufacturing Costs, Medical Affairs Costs, Patent Costs, Quality Costs,
3
Other Out-of-Pocket Costs and Expenses attributable to general corporate activities, executive management, investor relations, treasury services, business development, corporate government relations, external financial reporting and other overhead activities.
| 1.28. | [***]. |
| 1.29. | “[***] Agreement” has the meaning set forth in Section 13.7.3. |
| 1.30. | [***]. |
| 1.32. | “Cost of Goods Sold” means [***]. |
| 1.33. | “CRISPR” has the meaning set forth in the Preamble. |
| 1.34. | “CRISPR Activities Plan” has the meaning set forth in ARTICLE 9. |
4
|
| 1.35. | “CRISPR Background Know-How” means any Know-How, other than Joint Program Know-How and CRISPR Program Know-How, that (a) [***] and (b) [***]. |
| 1.36. | “CRISPR Background Patents” means any Patent, other than a Joint Program Patent, CRISPR Program Patent or CRISPR Platform Technology Patent that (a) [***] and (b) [***]. |
| 1.39. | [***]. |
| 1.40. | [***]. |
| 1.41. | “Designated Personnel” means [***]. |
| 1.42. | “Designated Shared Products” means those Shared Products initially listed on Schedule B [***]. |
| 1.43. | [***]. |
| 1.45. | “Development Costs” means, [***]: |
| 1.45.1. | [***]; |
| 1.45.3. | [***]; |
| 1.45.4. | [***]; |
5
|
| 1.45.5. | [***]; and |
| 1.45.6. | [***]. |
[***].
| 1.47. | “DOJ” has the meaning set forth in Section 2.1. |
| 1.49. | “Effective Date” has the meaning set forth in the Preamble. |
| 1.50. | “Exclusive License” has the meaning set forth in Section 13.2.1. |
| 1.53. | “FTC” has the meaning set forth in Section 2.1. |
| 1.56. | “GDPR Letter Agreement” has the meaning set forth in Section 19.11. |
6
| Development activities for any other Shared Product for which Vertex intends to file an IND. |
| 1.59. | “Global Safety Database” has the meaning set forth in Section 11.2. |
| 1.60. | [***]. |
| 1.61. | [***]. |
| 1.62. | [***]. |
| 1.63. | “HSR” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder. |
| 1.64. | “Initial Shared Product” means [***]. |
| 1.65. | “JOC” has the meaning set forth in Section 3.1.1. |
| 1.67. | “Licensed CRISPR Know-How” means (a) CRISPR Background Know-How, (b) CRISPR Program Know-How and (c) CRISPR’s interest in the Joint Program Know-How. |
| 1.68. | “Licensed CRISPR Patents” means (a) CRISPR Background Patents, (b) CRISPR Platform Technology Patents, (c) CRISPR Program Patents and (d) CRISPR’s interest in the Joint Program Patents. |
| 1.69. | “Licensed CRISPR Technology” means, subject to Section 13.2.3 and Section 13.7.2, any and all Licensed CRISPR Patents and Licensed CRISPR Know-How. |
| 1.72. | “Licensed Vertex Technology” means, subject to Section 13.2.3 and Section 13.7.2, any and all Licensed Vertex Patents and Licensed Vertex Know-How. |
| 1.73. | “Major [***] Countries” means [***]. |
7
|
| (b) | [***]; |
| (c) | [***]; and |
[***].
| 1.78. | “MSL” means medical science liaisons. |
| (a) | [***]; |
| (b) | [***]; |
| (c) | [***]; |
8
|
| (d) | [***]; and |
| (e) | [***]. |
Generally, only items that are deducted from the Selling Party’s gross invoiced sales price of such Shared Product, 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 such Shared Product (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 such Shared Product.
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 will be reported with the next Summary Statement. Sales between or among Vertex and its Affiliates 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. A Shared Product will not be deemed to be sold if such Shared 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 Shared 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 a Selling Party sells a Shared Product in the form of a combination product containing a Shared 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 will be calculated by multiplying actual Net Sales of such Combination Product as determined in the first 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 Shared Product in the
9
Territory, with the prices weighted in the calculation to reflect the actual relative sales value of such Shared 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 Shared Product component is not sold separately), the Parties shall determine Net Sales for the Shared Product in such Combination Product in good faith by mutual agreement [***].
[***].
| 1.82. | “Non-Challenging Party” has the meaning set forth in Section 17.2.4. |
| 1.83. | “OPEX Overage” has the meaning set forth in Section 10.7.2. |
| 1.84. | “Opt-Out” has the meaning set forth in Section 17.3.1. |
| 1.87. | “Original Agreement” has the meaning set forth in the Preamble. |
| 1.88. | “Other Manufacturing Contract” has the meaning set forth in Section 7.1. |
| 1.89. | “Other Out-of-Pocket Costs” means, [***]: |
| 1.89.1. | [***]; |
| 1.89.2. | [***]; |
| 1.89.4. | [***]; |
| 1.89.5. | [***]; and |
| 1.89.6. | [***]. |
| 1.90. | “Party” or “Parties” has the meaning set forth in the Preamble. |
| 1.91. | “Patent Challenge” has the meaning set forth in Section 17.2.4. |
| 1.94. | “Preliminary Transition Plan” has the meaning set forth in Section 8.1. |
10
|
| 1.96. | “Quality Agreement” has the meaning set forth in Section 4.3. |
| 1.97. | “Quality Costs” means, [***]. |
| 1.99. | “Research Costs” means, [***]. |
| 1.102. | “Shared Agent” means [***]. |
| 1.103. | “Shared Product” means (a) the Initial Shared Product and (b) any other pharmaceutical product, medical therapy, preparation, substance, or formulation comprising or employing, in whole or in part, a Shared Agent. |
| 1.104. | “Shared Target” means (a) [***], (b) [***], (c) the [***] and (d) [***]. |
| 1.105. | “Site Media Materials” has the meaning set forth in Section 18.5.1. |
| 1.106. | “Specified Shared Product Information” has the meaning set forth in Section 18.1. |
| 1.107. | “Subcontract” has the meaning set forth in ARTICLE 12. |
| 1.108. | “Subcontractor” has the meaning set forth in ARTICLE 12. |
| 1.109. | “Sublicense Revenue” means, [***]. |
| 1.111. | “Summary Statement” has the meaning set forth in Section 10.6. |
| 1.112. | “Terminated Shared Product” has the meaning set forth in Section 17.4. |
11
| 1.115. | “Transition Activities” has the meaning set forth in Section 8.1. |
| 1.116. | “Transition Committee” has the meaning set forth in Section 3.2.1. |
| 1.117. | “Transition Costs” means, [***]. |
| 1.119. | “Vertex” has the meaning set forth in the Preamble. |
| 1.121. | “Vertex Know-How” means (a) any Know-How, other than Joint Program Know-How and Vertex Program Know-How, that (i) [***] and (ii) [***]. |
| 1.122. | “Vertex Parent” has the meaning set forth in the Preamble. |
| 1.123. | “Vertex Patents” means (a) any Patent, other than a Joint Program Patent or Vertex Program Patent, that (i) [***] and (ii) [***]. |
| 1.124. | “Vertex Technology” means any and all Vertex Patents and Vertex Know-How. |
| 1.125. | “Vertex UK” has the meaning set forth in the Preamble. |
12
13
|
| (a) | discuss any near-term operational decisions to be made with respect to the Research, Development or Manufacture of the Shared Products prior to completion of the Transition Activities; |
| (b) | discuss strategy for the Shared Products; |
| (c) | discuss the Global Development Plan and each Global Commercialization Plan, including the cost estimates therein, and any updates thereto; |
| (d) | discuss the updates provided by the Parties regarding the activities under this Agreement; |
| (e) | discuss the updates provided by each Party with respect to [***]; |
| (f) | [***]; |
| (g) | discuss matters pertaining to the research activities described in Section 4.1.2; and |
| (h) | perform such other information-sharing functions as are specifically assigned to the JOC under this Agreement. |
14
| 3.2.2. | Responsibilities Prior to the Amendment Effective Date. Following the Amendment Date and prior to the Amendment Effective Date, the Transition Committee will: |
| (b) | serve as a forum for discussion of any other planning matters relating to the Transition Activities. |
| 3.2.3. | Responsibilities Following the Amendment Effective Date. Following the Amendment Effective Date, the Transition Committee will: |
| (a) | coordinate and oversee the Transition Activities of the Parties under ARTICLE 8, including any [***]; and |
| (b) | prepare and discuss any amendments or updates to the Transition Plan and submit such amendments or updates to the Parties for approval. |
| 3.2.4. | Discontinuation of the Transition Committee. The Transition Committee will disband with respect to this Agreement following the completion of substantive Transition Activities under ARTICLE 8. |
15
| 4.1.3. | Bioinformatics. Except as otherwise set forth in the Transition Plan, CRISPR will be responsible for maintaining [***] and will provide Vertex access as reasonably needed with respect to the Shared Products, including access to validation data and reports. CRISPR will consult with Vertex if any material changes or updates are to be made to [***] and take |
16
| reasonable steps to provide such changes or updates to Vertex. Additionally, CRISPR will provide reasonable support to Vertex if [***]. |
17
| with Vertex’s internal policies disclosed to CRISPR regarding attendance and participation in such meetings, conferences and discussions. |
18
|
ARTICLE 5
Medical Affairs Activities
Vertex will control and will have the sole right to conduct, in its sole discretion, all Medical Affairs Activities with respect to the Shared Products in the Territory, except as expressly set forth in the Transition Plan or a CRISPR Activities Plan. Such Medical Affairs Activities will be conducted using Commercially Reasonable Efforts.
19
| provided that CRISPR shall limit access to any of the materials, documents or information received under this Section 6.3 to the Designated Personnel. |
| 6.4. | Reporting. Vertex will provide the JOC with reasonably detailed summary updates regarding the progress of activities pursuant to each Global Commercialization Plan at each JOC meeting. |
20
ARTICLE 8
Transition ACTIVITIES
21
| 9.3. | Reporting. CRISPR will provide the JOC with reasonably detailed summary updates regarding the progress of activities pursuant to each CRISPR Activities Plan, if any, at each JOC meeting. |
ARTICLE 10
FINANCIAL TERMS; Allocation of Net Profit and Net Loss
22
23
24
| OPEX Cap for such Calendar Year, CRISPR shall be permitted to defer payment of an amount equal to such excess amount (the “OPEX Overage”) as set forth in Section 10.7.3. |
25
| 10.9.1. | All payments under this Agreement after the Amendment Effective Date will be paid in U.S. Dollars, by wire transfer (a) in the case of payments to [***], by [***] to an account of [***] designated by [***] (which account [***] may update from time to time in writing) and (b) in the case of payments to [***], by [***] to an account of [***] designated by [***] (which account [***] may update from time to time in writing). |
| 10.9.2. | 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 the [***] of the official rate of exchange of such domestic currency as quoted by [***], for the Calendar Quarter for which the payment is made. |
26
|
Vertex may subcontract the performance of any activities undertaken by Vertex under this Agreement with respect to the Shared Products to one or more Third Parties of Vertex’s choice (each such Third Party, a “Subcontractor”) pursuant to a written agreement in compliance with the terms of this Agreement and the Quality Agreement (a “Subcontract”). CRISPR may subcontract the performance of any activities undertaken by CRISPR under this Agreement (including under Section 4.1.2), in accordance with the Transition Plan or the applicable CRISPR Activities Plan, as applicable, to one or more Subcontractors of CRISPR’s choice pursuant to a Subcontract.
27
| respect to the Shared Targets and the license grant set forth in Section 10.2.1 of the Original Agreement, and shall be deemed to be the “Exclusive License” under the Collaboration Agreement with respect to the Shared Targets. |
28
| contracting Party, on or prior to the date on which such [***] becomes effective. |
29
|
30
| (ii) | [***]. If [***] (A) [***] or (B) (1) [***], (2) [***] and (3) [***], then, in each case ((A) and (B)), [***] will have the right, [***]. |
| (c) | Intellectual Property Rights. For purposes of Section 13.4 of this Agreement, (i) any [***], as applicable, and (ii) [***], as applicable. |
ARTICLE 14
INTELLECTUAL PROPERTY
The terms of the Collaboration Agreement will apply with respect to any and all Know-How and Patents discovered, developed, invented or created in connection with activities under this Agreement.
ARTICLE 15
REPRESENTATIONS AND WARRANTIES
| 15.1. | Representations and Warranties of Vertex. Vertex hereby represents and warrants to CRISPR, as of the Effective Date and as of the Amendment Date, that: |
31
|
| 15.1.1. | each of Vertex Parent and Vertex UK 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; |
| 15.1.2. | each of Vertex Parent and Vertex UK (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; |
| 15.1.3. | this Agreement has been duly executed and delivered on behalf of each of Vertex Parent and Vertex UK, and constitutes a legal, valid and binding obligation, enforceable against each of Vertex Parent and Vertex UK in accordance with the terms hereof; |
| 15.2.1. | each of CRISPR AG, CRISPR Inc., CRISPR UK and Tracr 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; |
| 15.2.2. | each of CRISPR AG, CRISPR Inc., CRISPR UK and Tracr (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; |
| 15.2.3. | 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; |
32
| 15.2.8. | [***], the Research, Development, Manufacture, use, sale, offer for sale, supply or importation by [***]; |
| 15.2.9. | there are no judgments or settlements against or owed by [***], pending or threatened claims or litigation, in either case relating to the Licensed CRISPR Technology; |
| 15.2.10. | the CRISPR Platform Technology Patents and CRISPR Background Patents are, or, upon issuance, will be, [***]; and |
| 15.2.11. | Schedule D lists all agreements between CRISPR and its [***] that, in each case, [***]. Schedule E lists all other agreements between CRISPR and [***] that, in each case, [***]. |
| 15.3. | CRISPR Covenants. Each of the CRISPR Entities, jointly and severally, hereby covenants to Vertex that, except as expressly permitted under this Agreement: |
33
| 15.3.6. | it will use Commercially Reasonable Efforts to obtain and maintain the requisite resources and expertise to perform its obligations hereunder; |
34
| is pending or, to CRISPR’s Knowledge, is threatened, relating to the debarment or conviction of CRISPR, any of its Affiliates or any such Person performing services hereunder or thereunder; and |
| 15.3.10. | within [***] days of the Amendment Date, CRISPR will provide or otherwise make available to Vertex [***]. |
| 15.4. | Vertex Covenants. Vertex hereby covenants to CRISPR that, except as expressly permitted under this Agreement: |
| 15.4.1. | it will use Commercially Reasonable Efforts to obtain and maintain the requisite resources and expertise to perform its obligations hereunder; |
ARTICLE 16
INDEMNIFICATION; INSURANCE
35
|
except, in each case ((a)-(b)), to the extent CRISPR is required to indemnify Vertex pursuant to Section 16.2.
except, in each case ((a)-(b)), to the extent Vertex is required to indemnify CRISPR pursuant to Section 16.1.
| 16.4. | Other Third Party Claims. If a Third Party brings a claim of any nature arising out of [***], other than [***], the [***]. [***] will [***]. The [***] will [***]. The [***]. If [***]. |
36
|
| (b) | [***] coverage in amounts not less than $[***]; |
| (c) | [***] in amounts not less than $[***] per incident and $[***] annual aggregate, which policy shall include [***], as applicable, and for [***]; and |
| (d) | [***] (also called [***]) in amounts not less than $[***] per claim and annual aggregate, covering [***]. |
Each such policy will be [***].
| 16.5.6. | Self-Insurance. Notwithstanding the foregoing, [***] may self-insure to the extent that it self-insures for its other activities. |
37
38
| to a particular Shared Product, with respect to the Shared Product affected by such breach or (B) if such breach relates to this Agreement as a whole, in its entirety, by providing written notice to CRISPR or (ii) elect to exercise the alternative remedy provisions set forth in Section 17.5 (in lieu of termination). |
39
40
41
Net Sales (in Dollars) for such Opt-Out Shared Product in the Territory | Opt-Out Royalty Rates as a Percentage (%) of Net Sales of such Opt-Out Shared Product |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
42
| of the Collaboration Agreement with respect to such Opt-Out Shared Product. |
| (a) | CRISPR (acting directly or through one or more Affiliates or sublicensees) will use Commercially Reasonable Efforts to [***] for the [***] in all [***]; |
| (b) | CRISPR (acting directly or through one or more Affiliates or sublicensees) will use Commercially Reasonable Efforts to [***], the [***] in each [***] where [***]; |
| (d) | following the first sale of the Opt-Out Shared Product giving rise to Net Sales (as defined in the Collaboration Agreement), within [***] days after the end of each Calendar Quarter, CRISPR will deliver a report to Vertex specifying on a country-by-country basis: [***]. All royalty payments due for each Calendar Quarter will be due and payable within [***] days after CRISPR’s delivery of the applicable report. |
43
| relating to such Opt-Out Shared Product. The Expenses of all activities under this Section 17.3.4 shall be shared equally by the Parties. |
| 17.3.6. | For the avoidance of doubt, the allocation of [***] and [***] pursuant to Section [***] with respect to an Opt-Out Shared Product shall terminate upon the effectiveness of the Opt-Out for such Opt-Out Shared Product. |
| 17.4.2. | Termination or expiration of this Agreement for any reason will be without prejudice to any rights or financial compensation that will have accrued to the benefit of a Party with respect to the Terminated Shared Product prior to such termination or expiration. Such termination or expiration will not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement. |
44
| Manufacture and Commercialization activities with respect to the Terminated Shared Product. |
| 17.4.5. | Except as set forth in Section 17.3, neither Party will have any further rights or obligations with respect to the Terminated Shared Product. |
45
| terms of this Agreement; and (c) not use, or permit to be used, the Specified Shared Product Information for any purpose other than as expressly authorized pursuant to the terms of this Agreement. Without limiting the generality of the foregoing, to the extent that Vertex or any of its Affiliates provides to CRISPR or any of its Affiliates any Specified Shared Product Information owned by any Third Party, CRISPR will, and will cause its Affiliates to, handle such Specified Shared Product Information in accordance with the terms and conditions of this ARTICLE 18. |
| 18.2.1. | file or prosecute patent applications as contemplated by this Agreement; |
| 18.2.2. | prosecute or defend litigation; |
| 18.2.3. | exercise its rights and perform its obligations hereunder; or |
| 18.2.4. | comply with Applicable Law, including the rules and regulations promulgated by the United States Securities and Exchange Commission or any equivalent governmental agency in any country in the Territory. |
If CRISPR deems it reasonably necessary to disclose the Specified Shared Product Information pursuant to this Section 18.2, CRISPR will, to the extent practicable, give reasonable advance written notice of such disclosure to Vertex and will take reasonable measures to ensure confidential treatment of such information.
46
| 18.4.5. | Communications Coordination. Each Party’s communications or investor relations personnel or Alliance Managers will meet [***] (or more frequently as mutually agreed by the Parties) to review anticipated communications milestones and a calendar of potential communications events relating to activities under this Agreement. |
| 18.5.2. | Following the Amendment Effective Date, Vertex will have the sole right to produce new Site Media Materials, in its sole discretion. |
47
| 18.5.4. | All costs incurred in connection with any production of any Site Media Materials in accordance with this Agreement will be included in [***] shared by the Parties pursuant to this Agreement. |
48
| 19.2. | Effects of Change of Control. If, during the Co-Co Agreement Term, any [***] undergoes a Change of Control, then, [***]. |
If to Vertex:
Vertex Pharmaceuticals Incorporated
Attn: Business Development
50 Northern Avenue
Boston, Massachusetts 02210
E-mail: [***]
with a copy to:
Vertex Pharmaceuticals Incorporated
Attn: Corporate Legal
50 Northern Avenue
Boston, Massachusetts 02210
E-mail: [***]
and:
Ropes & Gray LLP
Attn: Marc A. Rubenstein
49
Prudential Tower
800 Boylston Street
Boston, Massachusetts 02199-3600
E-mail: [***]
If to CRISPR:
CRISPR Therapeutics AG
Attn: Chief Executive Officer
Baarerstrasse 14
6300 Zug
Switzerland
Email: [***]
with a copy to:
CRISPR Therapeutics AG
Attn: General Counsel
Baarerstrasse 14
6300 Zug
Switzerland
Email: [***]
and
Goodwin Procter LLP
Attn: Christopher Denn
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. 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. Any notices required or permitted under this Agreement that are delivered by Vertex to CRISPR AG pursuant to this Section 19.5 shall be deemed properly delivered hereunder to each of CRISPR UK, CRISPR AG, CRISPR Inc. and Tracr. Notwithstanding the foregoing, for the purposes of Sections 4.1.4, 4.2.2 and 6.3, any notice of a scheduled meeting thereunder may be in the form of an electronic calendar invitation sent to the e-mail address of the relevant designated CRISPR Senior-Level Employee and any such notice will be deemed to have been given when sent.
50
| 19.9. | 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. |
51
52
| 19.19.1. | CRISPR UK, CRISPR AG, CRISPR Inc. and Tracr shall be jointly and severally liable to Vertex for all obligations of CRISPR under this Agreement; |
| 19.19.4. | Any consent or approval of CRISPR permitted or required under this Agreement by any one of CRISPR UK, CRISPR AG, CRISPR Inc. or Tracr shall be binding upon all of the CRISPR Entities. |
[SIGNATURE PAGE FOLLOWS]
53
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their representatives thereunto duly authorized as of the Amendment Date.
VERTEX PHARMACEUTICALS INCORPORATED |
| CriSpr Therapeutics AG | ||||
|
|
|
|
|
|
|
By: |
| /s/ Reshma Kewalramani |
| By: |
| /s/ Rodger Novak |
|
|
|
|
|
|
|
Name: |
| Reshma Kewalramani |
| Name: |
| Rodger Novak |
|
|
|
|
|
|
|
Title: |
| Chief Executive Officer and President |
| Title: |
| President |
|
|
|
|
|
|
|
VERTEX PHARMACEUTICALS (EUROPE) LIMITED
|
| CRISPR THERAPEUTICS LIMITED | ||||
|
|
|
|
|
|
|
By: |
| /s/ Klas Holmlund |
| By: |
| /s/ Rodger Novak |
|
|
|
|
|
|
|
Name: |
| Klas Holmlund |
| Name: |
| Rodger Novak |
|
|
|
|
|
|
|
Title: |
| Director |
| Title: |
| Director |
|
|
|
|
|
|
|
|
|
|
| CRISPR THERAPEUTICS, INC. | ||
|
|
|
|
|
|
|
|
|
|
| By: |
| /s/ Samarth Kulkarni |
|
|
|
|
|
|
|
|
|
|
| Name: |
| Samarth Kulkarni |
|
|
|
|
|
|
|
|
|
|
| Title: |
| CEO and President |
|
|
|
|
|
|
|
|
|
|
| TRACR HEMATOLOGY LTD. | ||
|
|
|
|
|
|
|
|
|
|
| By: |
| /s/ Rodger Novak |
|
|
|
|
|
|
|
|
|
|
| Name: |
| Rodger Novak |
|
|
|
|
|
|
|
|
|
|
| Title: |
| Director |
[Signature Page to Amended and Restated Joint Development and Commercialization Agreement]
SCHEDULE A
CRISPR IN-LICENSE AGREEMENTS
[***]
55
DESIGNATED SHARED PRODUCTS
[***]
56
SCHEDULE C
VERTEX IN-LICENSE AGREEMENTS
[***]
57
SCHEDULE D
ASSIGNED CONTRACTS
[***]
58
SCHEDULE E
OTHER MANUFACTURING CONTRACTS
[***]
SCHEDULE F
PRELIMINARY TRANSITION PLAN
[***]
SCHEDULE G
ANNUAL OPEX CAP
[***]
SCHEDULE H
CRISPR DISCLOSURE SCHEDULE
[***]
SCHEDULE I
FORM OF NON-DISCLOSURE AGREEMENT
[***]
SCHEDULE J
FORM OF Press Release