Exhibit 10.1
|
[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) customarily and actually treated by the registrant as private or confidential. |
COLLABORATION AND LICENSE AGREEMENT
by and between
REPARE THERAPEUTICS INC.
and
HOFFMANN-LA ROCHE INC. and F. HOFFMANN-LA ROCHE LT
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Article I |
| Definitions | 1 | |
Article II |
| Governance | 25 | |
| Section 2.1 |
| JSC | 25 |
| Section 2.2 |
| Decision Making. During the JSC Term: | 28 |
| Section 2.3 |
| Scope of Governance | 29 |
| Section 2.4 |
| Alliance Managers | 29 |
| Section 2.5 |
| Expiration of the JSC | 30 |
| Section 2.6 |
| Potential Change of Control | 30 |
Article III |
| P/L Sharing Opt-In and Termination | 30 | |
| Section 3.1 |
| P/L Sharing Opt-In | 30 |
| Section 3.2 |
| Termination of P/L Sharing Period; Expiration of P/L Sharing Period | 31 |
Article IV |
| Co-Promotion Opt-In and Termination | 34 | |
| Section 4.1 |
| Co-Promotion Opt-In | 34 |
| Section 4.2 |
| Launch of Licensed Product in Other Indication | 35 |
| Section 4.3 |
| Termination of Co-Promotion Period; Expiration of Co-Promotion Period | 35 |
Article V |
| Development | 37 | |
| Section 5.1 |
| Development of Licensed Products | 37 |
| Section 5.2 |
| Records; Technology Transfer | 42 |
Article VI |
| Manufacture and Supply | 43 | |
| Section 6.1 |
| Manufacturing Responsibility | 43 |
| Section 6.2 |
| Manufacturing Costs | 43 |
| Section 6.3 |
| Transfer of Manufacturing Technology | 44 |
Article VII |
| Regulatory Matters | 44 | |
| Section 7.1 |
| Responsibility | 44 |
| Section 7.2 |
| Transfer of Existing IND and Other Regulatory Documentation | 44 |
| Section 7.3 |
| Regulatory Interactions | 44 |
| Section 7.4 |
| Pharmacovigilance | 45 |
| Section 7.5 |
| Recalls, Market Withdrawals or Corrective Actions | 45 |
Article VIII |
| Commercialization | 45 | |
| Section 8.1 |
| Commercialization Responsibilities for Licensed Products | 46 |
| Section 8.2 |
| Shared Territory Commercialization Reports | 47 |
Article IX |
| Diligence | 47 | |
| Section 9.1 |
| Compliance with Laws | 47 |
| Section 9.2 |
| Diligence Obligations | 47 |
| Section 9.3 |
| No Representation | 48 |
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Article X |
| Grant of Rights; Exclusivity | 48 | |
| Section 10.1 |
| License Grants | 48 |
| Section 10.2 |
| Sublicense Rights | 49 |
| Section 10.3 |
| Sublicense Requirements | 49 |
| Section 10.4 |
| Third Party Contractors | 50 |
| Section 10.5 |
| Affiliates | 50 |
| Section 10.6 |
| Repare Cost Share Third Party Agreements | 51 |
| Section 10.7 |
| Exclusivity | 51 |
| Section 10.8 |
| No Implied Licenses or Rights | 53 |
| Section 10.9 |
| Section 365(n) of the Bankruptcy Code | 53 |
Article XI |
| Financial Provisions | 54 | |
| Section 11.1 |
| Partial Consideration | 54 |
| Section 11.2 |
| Milestone Payments | 54 |
| Section 11.3 |
| Royalties for Licensed Products | 59 |
| Section 11.4 |
| P/L Sharing Period Financial Provisions | 64 |
| Section 11.5 |
| Cost Share Third Party Agreements | 64 |
| Section 11.6 |
| Financial Records | 65 |
| Section 11.7 |
| Audits | 65 |
| Section 11.8 |
| Tax Matters | 66 |
| Section 11.9 |
| Foreign Derived Intangible Income Deduction | 68 |
| Section 11.10 |
| Currency Exchange | 68 |
| Section 11.11 |
| Late Payments | 68 |
| Section 11.12 |
| Blocked Payments | 68 |
| Section 11.13 |
| Prohibitions on Payments | 68 |
Article XII |
| Intellectual Property | 69 | |
| Section 12.1 |
| Ownership of Inventions | 69 |
| Section 12.2 |
| Prosecution of Patents | 70 |
| Section 12.3 |
| Third Party Infringement | 71 |
| Section 12.4 |
| Hatch-Waxman | 73 |
| Section 12.5 |
| Claimed Infringement; Claimed Invalidity | 73 |
| Section 12.6 |
| Patent Term Extensions | 75 |
| Section 12.7 |
| Patent Marking | 75 |
| Section 12.8 |
| Other Roche Intellectual Property | 75 |
| Section 12.9 |
| Application of 35 U.S.C. § 102(c) | 75 |
Article XIII |
| Confidentiality | 76 | |
| Section 13.1 |
| General | 76 |
| Section 13.2 |
| Permitted Disclosure | 76 |
| Section 13.3 |
| Publicity; Terms of this Agreement; Non-Use of Names | 77 |
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| Section 13.4 |
| Publications | 78 |
| Section 13.5 |
| Term | 79 |
| Section 13.6 |
| Return of Confidential Information | 79 |
| Section 13.7 |
| Vicarious Responsibility | 80 |
| Section 13.8 |
| Non-Use of Name | 80 |
| Section 13.9 |
| Information Security Incident | 80 |
Article XIV |
| Representations and Warranties | 81 | |
| Section 14.1 |
| Mutual Representations | 81 |
| Section 14.2 |
| Additional Repare Representations | 82 |
| Section 14.3 |
| Additional Roche Representations | 83 |
| Section 14.4 |
| Covenants | 83 |
| Section 14.5 |
| Disclaimer | 84 |
Article XV |
| Indemnification; Product Liabilities | 84 | |
| Section 15.1 |
| Indemnification by Roche | 84 |
| Section 15.2 |
| Indemnification by Repare | 84 |
| Section 15.3 |
| Indemnification Procedures | 85 |
| Section 15.4 |
| Shared Territory Damages | 85 |
| Section 15.5 |
| LIMITATION OF LIABILITY | 86 |
| Section 15.6 |
| Insurance | 86 |
Article XVI |
| Term and Termination | 86 | |
| Section 16.1 |
| Term | 86 |
| Section 16.2 |
| Termination | 87 |
| Section 16.3 |
| Effects Of Termination | 89 |
| Section 16.4 |
| Survival | 95 |
| Section 16.5 |
| Termination a Nonexclusive Remedy | 95 |
| Section 16.6 |
| Accrued Liabilities | 95 |
Article XVII |
| Government Approvals | 95 | |
| Section 17.1 |
| Government Approvals | 95 |
Article XVIII |
| Miscellaneous | 97 | |
| Section 18.1 |
| Dispute Resolution | 97 |
| Section 18.2 |
| Submission to Arbitration for Resolution; Waiver of Jury Trial | 97 |
| Section 18.3 |
| Governing Law | 97 |
| Section 18.4 |
| Assignment | 97 |
| Section 18.5 |
| Debarment | 98 |
| Section 18.6 |
| Effects of Change of Control | 98 |
| Section 18.7 |
| Disposition of Rights to Payment | 99 |
| Section 18.8 |
| Force Majeure | 99 |
| Section 18.9 |
| Notices | 99 |
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| Section 18.10 |
| Waiver | 100 |
| Section 18.11 |
| Severability | 100 |
| Section 18.12 |
| Entire Agreement | 101 |
| Section 18.13 |
| Modification | 101 |
| Section 18.14 |
| Independent Contractors; No Intended Third Party Beneficiaries | 101 |
| Section 18.15 |
| Interpretation; Construction | 101 |
| Section 18.16 |
| Performance by Affiliates | 101 |
| Section 18.17 |
| Counterparts; eSignature | 102 |
| Section 18.18 |
| Certain US Federal Income Tax Treatment | 102 |
| Section 18.19 |
| Equitable Relief | 102 |
| Section 18.20 |
| Further Assurances | 102 |
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Exhibits
Exhibit A Development Plan
Exhibit B Financials for P/L Sharing Period
Exhibit C Tax Matters
Exhibit D Co-Promotion Principles
Schedules
Schedule 1.34 Development Technology Transfer Plan
Schedule 1.76 Manufacturing Technology Transfer Plan
Schedule 1.78 Structure
Schedule 1.84 Ongoing ISTs
Schedule 1.85 Ongoing Trials
Schedule 1.88 Other Indications
Schedule 5.1(a)(vi)(F) Safety Reporting Flow
Schedule 5.1(d)(ii) First Repare Trial
Schedule 13.3(a) Repare Press Release
[***]
Schedule 14.2 Disclosures
Schedule 14.2(h) Patents Controlled by Repare
v
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COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (this “Agreement”) is entered into as of June 1, 2022 (the “Execution Date”), by and between Repare Therapeutics Inc., a Canadian corporation (“Repare”) and Hoffmann-La Roche Inc., a New Jersey corporation (“Roche Inc.”), and F. Hoffmann-La Roche Ltd, a Swiss company (“Roche Ltd,” and, together with Roche Inc., “Roche”). Roche and Repare are each referred to herein by name or as a “Party”, or, collectively, as the “Parties”.
INTRODUCTION
WHEREAS, Repare is a biopharmaceutical company that owns or otherwise Controls the Molecules;
WHEREAS, Roche is a pharmaceutical company that has expertise and capabilities in the Development, Manufacturing, and Commercialization of human therapeutic products; and
WHEREAS, Repare and Roche desire to Develop and Commercialize the Molecules and Licensed Products worldwide in accordance with the terms and conditions set forth in this Agreement;
WHEREAS, Roche wishes to acquire worldwide, perpetual, exclusive rights to manufacture and sell the Molecules and Licensed Products, subject to and in accordance with the terms set forth in this Agreement;
WHEREAS, Repare is willing to convey to Roche worldwide, perpetual, exclusive rights to manufacture and sell the Molecules and Licensed Products, subject to and in accordance with the terms set forth in of this Agreement;
WHEREAS, Repare and Roche both recognize that the Development, Manufacturing, and Commercialization of the Molecules and Licensed Products worldwide in accordance with the terms and conditions set forth in this Agreement would be economically beneficial to each of them;
NOW, THEREFORE, in consideration of the respective representations, warranties, covenants, and agreements contained herein, and for other valuable consideration, the receipt and adequacy of which are hereby acknowledged, Repare and Roche hereby agree as follows:
Article I
Definitions
When used in this Agreement, each of the following terms shall have the meanings set forth in this Article I:
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Notwithstanding anything to the contrary in the foregoing, the terms of this Agreement shall be considered Confidential Information of the Parties, with each Party deemed both the Disclosing Party and the Receiving Party with respect thereto, and neither Party may rely on Section 1.22(a) or Section 1.22(d) with respect thereto.
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DEFINITION | SECTION |
Acting Party | Section 11.8(a)(i) |
Acquired Party | Section 18.6(a) |
Acquired Program | Section 10.7(c)(iii) |
Acquirer Program | Section 10.7(c)(ii) |
Agreement | Preamble |
Alliance Manager | Section 2.4 |
Allocable Overhead | Exhibit B |
Allowable Commercialization Expenses | Exhibit B |
Antitrust Filings | Section 17.1(a) |
Antitrust Counsel Only Material | Section 17.1(c) |
Audit Team | Section 11.7(a) |
Auditee | Section 11.7(a) |
Auditor | Section 11.7(a) |
Certification Notice | Section 12.4 |
Co-Promotion Agreement | Section 4.1(b) |
Co-Promotion Cure Period | Section 4.3(c) |
Co-Promotion End Date | Section 4.3(e) |
Co-Promotion Expiration Notice | Section 4.3(d) |
Co-Promotion Opt-In Right | Section 4.1(a) |
Compulsory Sublicense | Section 1.20 |
Compulsory Sublicensee | Section 1.20 |
Cure Period | Section 16.2(b) |
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Defense Expenses | Section 12.5(c)(ii) |
Development Budget | Section 5.1(a)(i) |
Development Cost Share | Exhibit B |
Development Costs | Exhibit B |
Disclosing Party | Section 1.22 |
Dispute | Section 18.1 |
DOJ | Section 1.36 |
Electronic Delivery | Section 18.17 |
e-Signature | Section 18.17 |
Exclusivity Period | Section 10.7(a) |
Execution Date | Preamble |
Expert | Section 1.81 |
Expert Committee | Section 1.81 |
FTC | Section 1.36 |
FTC Letter | Section 1.36 |
H-W Suit Notice | Section 12.4 |
HSR Act | Section 1.4 |
IFRS | Section 1.1 |
Indemnified Party | Section 15.3 |
Indemnitor | Section 15.3 |
Initial Development Budget | Section 5.1(b) |
Invalidity Claim | Section 12.5(b) |
JSC | Section 2.1(a) |
JSC Term | Section 2.5 |
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Launch and Marketing Costs | Exhibit B |
Lead Molecule | Section 1.78 |
Manufacturing Costs | Exhibit B |
Medical Affairs Costs | Exhibit B |
Minimum Transfer Payment | Section 16.3(g)(iii) |
Negotiation Period | Section 18.7 |
Neutral Safety Committee | Section 5.1(d)(iii) |
New IST Sponsor | Section 1.82 |
Non-Acquired Party | Section 18.6(a) |
Non-Acting Party | Section 11.8(a)(i) |
Operating Profits or Losses | Exhibit B |
Opt-In Development Plan | Section 3.1(b) |
Other Shared Expense | Exhibit B |
Payment Rights | Section 18.7 |
P/L Sharing Cure Period | Section 3.2(c) |
P/L Sharing End Date | Section 3.2(e) |
P/L Sharing Expiration Notice | Section 3.2(d) |
P/L Sharing Opt-In Right | Section 3.1(a) |
P/L End Date | Section 3.2(e) |
Party or Parties | Preamble |
Patent Enforcement Expenses | Section 12.3(e)(ii)(A) |
Patent Prosecution Expenses | Section 12.2(d)(ii) |
Pharmacovigilance Agreement | Section 7.4 |
PII/Samples | Section 16.3(g)(ii) |
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Post-Approval Commitment Trial | Exhibit B |
Product Recall Expenses | Exhibit B |
Product Trademarks | Section 8.1(a)(ii) |
Profit & Loss Share | Exhibit B |
Publishing Notice | Section 13.4(a) |
Receiving Party | Section 1.22 |
Redacted Version | Section 13.3(a) |
Regulatory Expenses | Exhibit B |
Relative Commercial Value | Section 1.81 |
Remaining U.S. Recoveries | Section 12.3(f)(ii) |
Repare | Preamble |
Repare Co-Promotion Termination Notice | Section 4.3(a) |
Repare Indemnified Parties | Section 15.1 |
Repare-Originated Transfer Activities | Section 16.3(g)(iii) |
Repare P/L Sharing Termination Notice | Section 3.2(a) |
Repare Trial Collaboration Agreement | Section 5.1(d)(i) |
Repare Trial Data | Section 5.1(d)(i) |
Report | Exhibit B |
Roche | Preamble |
Roche Co-Promotion Termination Notice | Section 4.3(b) |
Roche Development Costs | Exhibit B |
Roche Formulation | Section 5.1(d)(iv) |
Roche Inc. | Preamble |
Roche Indemnified Parties | Section 15.2 |
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Roche Ltd | Preamble |
Roche P/L Sharing Termination Notice | Section 3.2(c) |
Roche Transfer Activities | Section 16.3(g)(iii) |
ROW Administration | Exhibit B |
Royalty Term | Section 11.3(b) |
Sales Costs | Exhibit B |
Shared Development Costs | Exhibit B |
Subcommittee | Section 2.1(d) |
Tax Action | Section 11.8(a)(i) |
Term | Section 16.1 |
Third Party Contractor | Section 10.4 |
Third Party Infringement | Section 12.3(a) |
Third Party Infringement Action | Section 12.5(a) |
Third Party Manufacturer | Exhibit B |
Trigger Trial | Section 1.96 |
U.S. Administration | Exhibit B |
U.S. Development Costs | Exhibit B |
U.S. Phase IV Costs | Exhibit B |
US GAAP | Section 1.1 |
VAT | Section 11.8(a)(ii) |
Worldwide Development Costs | Exhibit B |
|
|
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Article II
Governance
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Article III
P/L Sharing Opt-In and Termination
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If Repare has timely exercised the P/L Sharing Opt-In Right, then:
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Article IV
Co-Promotion Opt-In and Termination
This Article IV shall only apply if Repare has (a) timely exercised its P/L Sharing Opt-In Right and (b) the P/L Sharing Period has not been terminated or expired.
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If Repare has timely exercised the Co-Promotion Opt-In Right, then:
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Article V
Development
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Article VI
Manufacture and Supply
Article VII
Regulatory Matters
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Article VIII
Commercialization
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Article IX
Diligence
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Article X
Grant of Rights; Exclusivity
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In addition, Roche shall, reasonably promptly, respond to Repare’s reasonable questions and requests for information regarding any sublicense that Roche has granted under this Agreement.
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Article XI
Financial Provisions
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Milestones | Amounts Owed Per Indication (in millions of US Dollars) | |||||
[***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
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Milestones | Amounts Owed Per Indication (in millions of US Dollars) | |||||
[***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
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Milestones | Payment (in US Dollars) |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
If more than one of the milestone events under this Section 11.2(b)(i) is achieved in the same Calendar Year outside of the P/L Sharing Period, then all corresponding milestone payments under this Section 11.2(b)(i) shall be paid in such Calendar Year.
Milestones | Payment (in US Dollars) |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
If more than one of the milestone events under this Section 11.2(b)(ii) is achieved in the same Calendar Year during the P/L Sharing Period, then all corresponding milestone payments under this Section 11.2(b)(ii) shall be paid in such Calendar Year.
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ROW Territory Annual Net Sales | Royalty Rate |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
U.S. Territory Annual Net Sales | Royalty Rate |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Each royalty rate set forth in the tables above will apply only to that portion of the U.S. Territory Annual Net Sales or ROW Territory Annual Net Sales (as applicable) of the applicable Licensed Product during a given Calendar Year that falls within the indicated portion. For example, if, in a given Calendar Year, the U.S. Territory Annual Net Sales of such Licensed Product by Roche and its Affiliates and Licensee Partners were [***] and the ROW Territory Annual Net Sales of such Licensed Product by Roche and its Affiliates and Licensee Partners were [***], then the royalties payable with respect to such U.S. Territory Annual Net Sales and ROW Territory Annual Net Sales would be:
[***]
For purposes of calculating aggregate Annual Net Sales under this Section 11.3(a), all Licensed Products that contain the same Molecule as an active ingredient shall be deemed to be the same Licensed Product.
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Article XII
Intellectual Property
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Article XIII
Confidentiality
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Notwithstanding the return or destruction of the Disclosing Party’s (and its Affiliates’) Confidential Information, the Receiving Party shall continue to be bound by its obligations of confidentiality and other obligations under this Article XIII.
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Article XIV
Representations and Warranties
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Article XV
Indemnification; Product Liabilities
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in each case, except to the extent that Repare has an indemnification obligation pursuant to Section 15.2 for such Damages.
in each case, except to the extent that Roche has an indemnification obligation pursuant to Section 15.1 for such Damages.
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Article XVI
Term and Termination
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For the avoidance of doubt, this Agreement shall not be effective until the Effective Date, and this Agreement may be subject to termination prior to the Effective Date as set forth in Section 17.1.
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In addition, the provisions of Section 12.2 through Section 12.9 shall terminate, Repare will have the first right (but not the obligation) to Prosecute each Joint Collaboration Patent, and Roche shall provide reasonable assistance to Repare, and shall cooperate with Repare, in connection with the transition of Prosecution responsibilities to Repare for each Joint Collaboration Patent, including execution of such documents as may be necessary to effect such transition.
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Article XVII
Government Approvals
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Article XVIII
Miscellaneous
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[***] | [***] |
[***] | [***] |
Any such notices shall be effective upon receipt by the Party to whom it is addressed.
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IN WITNESS WHEREOF, the Parties have executed this Collaboration and License Agreement as of the Execution Date.
REPARE THERAPEUTICS INC.
By: | /s/ Lloyd M. Segal | By: | /s/ Steve Forte |
Name: | Lloyd M. Segal | Name: | Steve Forte |
Title: | President and CEO | Title: | Executive Vice President and CFO |
HOFFMANN-LA ROCHE INC.
By: | /s/ John Parise |
|
|
Name: | John Parise |
|
|
Title: | Authorized Signatory |
|
|
F. HOFFMANN-LA ROCHE LTD
By: | /s/ James Sabry | By: | /s/ Hannah Boehm |
Name: | James Sabry | Name: | Hannah Boehm |
Title: | EVP, Head of Roche Pharma Partnering | Title: | Legal Counsel |
[Signature Page to Collaboration and License Agreement]
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Exhibit A
[***]
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Exhibit B
Financials for P/L Sharing Period
1. [***]
2. Development Costs Sharing
All Shared Development Costs by either Party after the start of the P/L Sharing Opt-In Period or by Roche in conducting the Trigger Trial shall be borne by the Parties in accordance with the Development Cost Share. As between the Parties, Roche shall solely bear all Roche Development Expenses. Shared Development Costs shall initially be borne by the Party incurring the applicable costs or expenses, subject to reimbursement in accordance with Section 3(e) Exhibit B.
3. Reporting and Payment for Development Costs Share
(a) On a quarterly basis within [***] following the end of each Calendar Quarter, Roche shall provide Repare Party a report of the actual amounts of Shared Development Costs incurred by such Party during such Calendar Quarter (and, solely with respect to the first such Calendar Quarter, the Shared Development Costs incurred by Roche in conducting the Trigger Trial).
(b) Each Party shall submit any supporting information or clarifications reasonably requested by the other Party related to such Shared Development Costs included in such Party’s report within [***] after such Party’s receipt of such request. The Parties, with the assistance of the JSC, shall conduct a reconciliation of Shared Development Costs for the subject Calendar Quarter within [***] after receipt of all such supporting information.
(c) In any event, no later than [***] after the end of the subject Calendar Quarter, and an invoice shall be issued to Repare (if any) for its full share of the Shared Development Costs for such Calendar Quarter so that each of the Parties bears its Development Cost Share after giving effect to such payment for such Calendar Quarter.
(d) Repare shall pay all amounts payable under any such invoice within [***] after its receipt of such invoice. Each Party (A) shall maintain records of Shared Development Costs incurred by such Party in accordance with Section 11.6 and (B) shall have the right to request an audit of such records of the other Party in accordance with the procedures set forth in Section 11.7.
4. Profit and Losses Sharing
The Parties agree that Roche will bear and be entitled to fifty percent (50%), and Repare will bear and be entitled to fifty percent (50%), of Operating Profits or Losses with respect to the Commercialization of Licensed Products in the U.S. Territory (“Profit & Loss Share”). When Net Sales exceed Allowable Commercialization Expenses, then there is a “Net Profit”, and when Allowable Commercialization Expenses exceeds Net Sales, then there is a “Net Loss”.
5. Principles of Operating Profits or Losses Calculation
B-1
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(a) The presentation of results of operation of the Parties with respect to Licensed Products for U.S. Administration will be based on each Party’s respective financial information presented separately and on a consolidated basis in the reporting format depicted as follows:
Illustrative Example Quarterly Operating Profits or Losses Calculation
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(b) If necessary, a Party will make the appropriate adjustments to the financial information it supplies under this Exhibit B to conform to the above format of reporting results of operation.
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(c) All U.S. Territory Annual Net Sales of Licensed Products will be booked by Roche.
(d) There shall be no double counting of any expenses or income in determining the Operating Profits or Losses under this Exhibit B.
(e) All employee Commercialization expenses shall be calculated in accordance with the FTE Rate.
(i) if there is a Net Profit for a Licensed Product in such Calendar Quarter, then Roche will pay to Repare a reconciling payment amount equal to Repare’s portion of the Net Profit for such Calendar Quarter within [***] after providing the consolidated financial statement to Repare; or
(ii) if there is a Net Loss for a Licensed Product in such Calendar Quarter, then Roche will invoice Repare for the amounts due to Licensee as a result of reconciliation. Payment by Repare will be due [***] after receiving such an invoice from Roche, as described in Section 3d.
In the event any payment is made after the date specified in Paragraph 3(d) of this Exhibit B, the paying Party will pay the past-due amounts with interest from the date originally due as provided in Section 11.11 of this Agreement (subject to the proviso therein regarding disputed payments).
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In the event any overpayment of any amounts specified in in Paragraph 3(d) of this Exhibit B is made, the Party receiving such overpayment will refund such overpayment amounts to the paying Party.
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Exhibit C
TAX MATTERS
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C-1
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Exhibit D
CO-PROMOTION PRINCIPLES
Topic | Principle |
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Schedule 1.34
Development Technology Transfer Plan
No. | Category | Item | Timeline of transfer (Roche's expected) | Method of Transfer |
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Schedule 1.76
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Schedule 1.78
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Schedule 1.84
Ongoing ISTs
University | PI | Type of agreement | Repare R&D Lead | Purpose | Cost | Status |
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Schedule 1.85
Ongoing Trials
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Schedule 1.88
Other Indications
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Schedule 5.1(a)(vi)(F)
Safety Reporting Flow
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Schedule 5.1(d)(ii)
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Schedule 13.3(a)
Repare Press Release
Repare Therapeutics Announces a Worldwide License and Collaboration Agreement with Roche for Camonsertib (RP-3500)
Repare will receive a $125 million upfront payment and is eligible to receive up to an additional $1.2 billion in potential development, regulatory, commercial and sales milestones, plus royalties on global net product sales.
Repare to host conference call today at 5:00 p.m. EDT
Cambridge, MA & Montreal, QC, June 1, 2022 (BUSINESS WIRE) -- Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced it has entered into a worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib (also known as RP-3500), a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of tumors with specific synthetic-lethal genomic alterations including those in the ATM gene (Ataxia-Telangiectasia mutated kinase). Under the collaboration, Roche will assume development of camonsertib with the potential to expand development into additional tumors and multiple combination studies.
“Camonsertib has the potential to help cancer patients across numerous solid tumors as a monotherapy and possibly in combination with other agents," said Kim Seth, Ph.D., EVP and Head of Business & Corporate Development at Repare. “Given the encouraging data Repare has generated for camonsertib as a potentially best-in-class ATR inhibitor with a promising tolerability profile and patient selection insights in areas of high unmet medical need, and Roche’s leading global footprint and unique expertise in precision oncology, we are confident that Roche is the ideal partner for us to drive the broad global development and commercialization of camonsertib.”
“Roche is excited about the emerging DNA damage response field, which represents a promising new approach to precision oncology," said James Sabry, M.D., Ph.D., Global Head of Pharma Partnering, Roche. “We are looking forward to partnering with Repare Therapeutics to further
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develop camonsertib as a new potential treatment option for patients with significant unmet medical needs across a range of tumor types. The collaboration with Repare builds on Roche’s strategy of personalized healthcare and further strengthens our leadership in oncology.”
Under the terms of the agreement, Repare will receive a $125 million upfront payment, and is eligible to receive up to $1.2 billion in potential clinical, regulatory, commercial and sales milestones, including up to $55 million in potential near-term payments, and royalties on global net sales ranging from high-single-digits to high-teens. The collaboration also provides Repare with the ability to opt-in to a 50/50 U.S. co-development and profit share arrangement, including participation in U.S. co-promotion if U.S. regulatory approval is received. If Repare chooses to exercise its co-development and profit share option, it will continue to be eligible to receive certain clinical, regulatory, commercial and sales milestone payments, in addition to full ex-U.S. royalties.
The transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions.
Company Conference Call:
The Company will host a conference call with accompanying slides for analysts and investors today at 5:00 p.m. Eastern Time to further discuss the collaboration. To access the call, please dial (877) 870-4263 (U.S.) or (855) 669-9657 (Canada) or (412) 317-0790 (international) at least 10 minutes prior to the start time and ask to be joined to the Repare Therapeutics call. A live video webcast will be available in the Investor section of the Company’s website at https://ir.reparerx.com/news-and-events/events. A webcast replay will also be archived for at least 30 days.
About Repare Therapeutics’ SNIPRx® Platform
Repare’s SNIPRx® platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx® screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.
About Repare Therapeutics, Inc.
Repare Therapeutics is a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics.
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The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate camonsertib (also known as RP-3500), a potential leading ATR inhibitor currently in Phase 1/2 clinical development, its second clinical candidate, RP-6306, a PKMYT1 inhibitor currently in Phase 1 clinical development, a Polθ inhibitor program, as well as several early-stage, pre-clinical programs. For more information, please visit reparerx.com.
SNIPRx® is a registered trademark of Repare Therapeutics Inc.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in Canada. All statements in this press release other than statements of historical facts are “forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: Repare’s collaboration with Roche; the ability of the parties to complete the transaction in a timely manner or at all; the possibility that various closing conditions for the transaction may not be satisfied or waived, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the risk that Repare may not realize the potential benefits of this collaboration with Roche; the discovery, development and potential commercialization of potential product candidates using Repare’s SNIPRx® platform technology and under the strategic collaboration agreement, including the development of camonsertib; the ability of the parties to file applications for regulatory approval or receive regulatory approvals in a timely manner or at all; the therapeutic potential for camonsertib in oncology applications; and the potential of Repare to receive milestone payments and royalties under the strategic collaboration agreement. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including the impacts of the COVID-19 pandemic on the Company’s business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this
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press release are identified in the section titled "Risk Factors" in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (“SEC”) and the Québec Autorité des Marchés Financiers ("AMF") on March 1, 2022, and its other documents subsequently filed with or furnished to the SEC and AMF, including the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 filed with the SEC on May 5, 2022. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Repare Contact:
Steve Forte
Chief Financial Officer
Repare Therapeutics Inc.
info@reparerx.com
Investors:
Kimberly Minarovich
Argot Partners
repare@argotpartners.com
Media:
David Rosen
Argot Partners
david.rosen@argotpartners.com
212-600-1902
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Schedule 14.2
Disclosures
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Schedule 14.2(h)
Patents Controlled by Repare
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