Exhibit 10.3
Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Double asterisks denote omissions.
STRATEGIC COLLABORATION AND LICENSE AGREEMENT
BETWEEN
vertex pharmaceuticals incorporated
AND
VERVE THERAPEUTICS, INC.
STRATEGIC COLLABORATION AND LICENSE AGREEMENT
This Strategic Collaboration and License Agreement (this “Agreement”) is entered into as of July 18, 2022 (the “Effective Date”) by and between Vertex Pharmaceuticals Incorporated, a corporation organized under the laws of the Commonwealth of Massachusetts (“Vertex”) and Verve Therapeutics, Inc., a corporation organized under the laws of the State of Delaware (“Company”). Vertex and Company each may be referred to herein individually as a “Party” or collectively as the “Parties.”
RECITALS
WHEREAS, Company owns or controls certain Patents and Know-How relating to Delivery Systems and Gene Editing Systems;
WHEREAS, Vertex is a biopharmaceutical company that possesses expertise in developing and commercializing human therapeutics;
WHEREAS, Vertex and Company desire to enter into this Agreement, pursuant to which (a) the Parties would collaborate under a Research Plan to discover and Research Licensed Agents and Products in the Field and (b) Vertex would have the right to Research, Develop, Manufacture and Commercialize Licensed Agents and Products in the Field; and
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:
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Only items that are deducted from the Selling Party’s [**] sales 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 [**] sales for purposes of the calculation of Net Sales; provided that amounts written off by the Selling Party by reason of uncollectible debt pursuant to clause (a) or amounts of compulsory payments deducted pursuant to clause (f) above, respectively, may be deducted from Net Sales in accordance with clause (a) or clause (f) above, respectively, regardless of its classification in the Selling Party’s published financial statements.
A qualifying amount may be deducted only once regardless of the number of the preceding categories that describes 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 a subsequent quarterly report. Sales between or among Vertex, its Affiliates and, solely in the case of Royalty Products, 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, solely in the case of Royalty Products, 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. For clarity, Net Sales include sales such as so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales,” even if such sales occur prior to receipt of Marketing Approval.
If a sale, transfer or other disposition with respect to a Product involves consideration other than cash or is not at arm’s length, the Net Sales from such sale, transfer or other disposition will be calculated based on the average Net Sales price of the Product in arm’s length sales for cash in the relevant country during the same Calendar Quarter as such sale, transfer or other disposition or, in the absence of such sales, based on the fair market value of the Product as mutually determined by the Parties.
Solely for purposes of calculating Net Sales, [**] (“Other Product”) (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) (such combination product, a “Combination Product”), Net Sales of such Combination Product in any country for the purpose of determining the payments due to Company pursuant to this Agreement will be calculated by [**]. If the [**] selling price of the [**] in such country can be determined but the [**] selling price of the Other Product in such country cannot be determined, then Net Sales of the Combination Product in such country for purposes of determining the payments due to Company pursuant to this Agreement will be calculated by [**]. If such separate sales are not made in a country, then Net Sales of the Combination Product in such country for purposes of determining the payments due to Company pursuant to this Agreement will be calculated by [**]; provided that
17
if the Parties are unable to agree on such fraction, then either Party may, by written notice to the other Party, refer any such Dispute to the Executive Officers, who will confer in good faith on the resolution of the issue. Absent mutual agreement by the Executive Officers within [**] after such referral, either Party may invoke Baseball Arbitration to determine such fraction.
18
19
20
21
22
23
24
25
Research, DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION
26
27
28
29
30
31
32
33
GOVERNANCE
34
35
36
37
38
LICENSE GRANTS; Exclusivity
39
40
41
42
43
During the discussion period under clause (a), prior to the time of divestiture pursuant to clause (b) or prior to the termination of activities pursuant to clause (c), as applicable, Company and its Affiliates will use Commercially Reasonable Efforts to segregate all discovery, research, development, manufacturing or commercialization activities relating to the Distracting Product from Research, Development, Manufacture and Commercialization with respect to Licensed
44
Agents or Products under this Agreement, including using Commercially Reasonable Efforts to ensure that (i) no personnel involved in performing discovery, research, development, manufacturing or commercialization activities with respect to such Distracting Product have access to non-public plans or information relating to the Research, Development, Manufacture or Commercialization of Licensed Agents or Products under this Agreement (except that management personnel may review and evaluate plans and information regarding the Research, Development and Commercialization of Products under this Agreement in connection with portfolio decision-making) and (ii) no personnel involved in performing Research, Development, Manufacture or Commercialization activities with respect to Licensed Agents or Products under this Agreement have access to non-public plans or information relating to the discovery, research, development, manufacture or commercialization of such Distracting Product (except that management personnel may review and evaluate plans and information regarding the discovery, research, development, manufacture and commercialization of such Distracting Product in connection with portfolio decision-making).
FINANCIAL PROVISIONS
45
Milestone Number | Milestone Event | Milestone Payment for a Type 1 Product | Milestone Payment for a Type 2 Product (subject to Section 5.4.3) |
1 | [**] | [**] | [**] |
2 | [**] | [**] | [**] |
3 | [**] | [**] | [**] |
4 | [**] | [**] | [**] |
46
Milestone Number | Milestone Event | Milestone Payment for a Type 1 Product | Milestone Payment for a Type 2 Product (subject to Section 5.4.3) |
5 | Annual Net Sales of a Royalty Product exceed $[**] | [**] | [**] |
6 | Annual Net Sales of a Royalty Product exceed $[**] | [**] | [**] |
7 | Annual Net Sales of a Royalty Product exceed $[**] | [**] | [**] |
47
Annual Net Sales (in Dollars) for such Royalty Product in the Territory | Royalty Rates as a Percentage (%) of Net Sales for a Type 1 Product | Royalty Rates as a Percentage (%) of Net Sales for a Type 2 Product |
Portion of Annual Net Sales up to and including $[**] | [**]% | [**]% |
Portion of Annual Net Sales that exceeds $[**] up to and including $[**] | [**]% | [**]% |
Portion of Annual Net Sales that exceeds $[**] | [**]% | [**]% |
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
INTELLECTUAL PROPERTY
63
64
65
66
67
68
69
70
71
72
REPRESENTATIONS AND WARRANTIES
73
74
75
76
77
78
79
INDEMNIFICATION; INSURANCE; LIMITATIONS
and except, in each case ((a)–(c)), to the extent such Third Party Claim results from or arises out of an event described in clause (a) through (c) of Section 8.1.2, as to which Third Party Claim each Party shall indemnify the other to the extent of their respective liability.
80
and except, in each case ((a)–(c)), to the extent such Third Party Claim results from or arises out of an event described in clause (a) through (c) of Section 8.1.1, as to which Third Party Claim each Party shall indemnify the other to the extent of their respective liability.
81
82
INSURANCE TYPE | MINIMUM LIMITS | MINIMUM COVERAGE | RESPECTIVELY MUST BE MAINTAINED BY |
Network Security and Privacy Liability | $[**] dollar) per claim/ $[**] dollar) annual aggregate | Coverage for all acts, errors, omissions, negligence, network security and privacy risks, including but not limited to unauthorized access, failure of security, breach of privacy perils, wrongful disclosure of data, disclosure of HIPAA / GDPR protected health information, collection, or other negligence in the handling of confidential information, privacy perils, and including coverage for related regulatory defense and penalties | Company |
Workers Compensation | Statutory | Statutory | Both Parties |
Commercial General Liability | $[**] dollar) per occurrence/ $$[**] dollar) annual aggregate | Coverage arising from premises, operations, products and completed operations, personal injury, advertising injury, bodily injury and property damage, including contractual liability | Both Parties |
Umbrella Liability | $[**] dollar) per occurrence and $[**] dollar) annual aggregate | Coverage provides excess, follow-form coverage above all liability limits required herein | Both Parties |
83
TERM; TERMINATION
84
85
86
CONFIDENTIALITY
87
88
In addition to the foregoing, Vertex may disclose Company’s Confidential Information to Third Parties in connection with the actual or potential Exploitation of Licensed Agents or Products; provided that such disclosure is covered by terms of confidentiality similar to those set forth herein.
If a Party deems it reasonably necessary to disclose Confidential Information belonging to the other Party pursuant to Sections 10.2(b) or 10.2(f), the disclosing Party will, to the extent possible, give reasonable advance notice of such disclosure to the other Party and take reasonable measures to ensure confidential treatment of such information.
89
90
MISCELLANEOUS
91
If to Vertex:
92
Vertex Pharmaceuticals Incorporated
Attn: Business Development
50 Northern Avenue
Boston, Massachusetts 02210
Email: [**]
with a copy to:
Vertex Pharmaceuticals Incorporated
Attn: Corporate Legal
50 Northern Avenue
Boston, Massachusetts 02210
Email: [**]
If to Company:
Verve Therapeutics, Inc.
Attn: Business Development
500 Technology Square
Cambridge, MA 02139
Email: [**]
with a copy to:
WilmerHale
Attn: Sarah Tegan Hogan
60 State Street
Boston, MA 02109
Email: sarah.hogan@wilmerhale.com
or to such other address as the Party to whom written 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 written notice will be deemed to have been given and received by the other Party: (a) when delivered if personally delivered; or (b) on receipt if sent by overnight courier or email.
93
94
95
96
97
98
[Signature Page Follows]
99
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their representatives thereunto duly authorized as of the Effective Date.
VERTEX PHARMACEUTICALS INCORPORATED |
By:__/s/ Reshma Kewalramani_________________ |
Name: Reshma Kewalramani Title: Chief Executive Officer and President |
|
|
VERVE THERAPEUTICS, INC. |
By:__/s/ Andrew Ashe__________________________ |
Name: Andrew Ashe Title: President, Chief Operating Officer, General Counsel And Secretary |
Signature Page to Strategic Collaboration and License Agreement
Annex I
Tax Appendix
[**]