| Item 1.01 | Entry into a Material Definitive Agreement. |
On June 1, 2022, Repare Therapeutics Inc. (the “Company”) entered into a collaboration and license agreement (the “Agreement”) with Hoffmann-La Roche Inc. and F. Hoffmann-La Roche Ltd (collectively, “Roche”) regarding the development and commercialization of the Company’s product candidate camonsertib (also known as RP-3500) and specified other ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) inhibitors (the “Licensed Products”). The transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions, and is expected to close in the third quarter of 2022.
Under the Agreement, the Company will grant Roche a worldwide, exclusive, sublicensable license to develop, manufacture, and commercialize Licensed Products. The Company will retain an option under the Agreement to enter into a U.S. co-development and profit share arrangement with Roche, exercisable prior to the commencement of the first pivotal clinical trial of camonsertib, and pursuant to which the Company would be responsible for specified shares of global and U.S.-specific development costs and would receive (or bear) fifty percent (50%) of U.S. profits (or losses) of Licensed Products containing camonsertib, which arrangement also includes a right for the Company to participate in U.S. co-promotion for Licensed Products containing camonsertib following a regulatory approval for a specified major indication in the United States.
The Company has agreed to complete specified ongoing clinical trials at the Company’s expense. The Company has also retained the right to conduct specified clinical trials of camonsertib in combination with the Company’s PKMYT1 compound (also known as RP-6306).
Roche is obligated to use commercially reasonable efforts to develop, seek regulatory approval for, and commercialize at least one Licensed Product in at least one indication in the United States and in specified European countries.
The parties have agreed to certain exclusivity terms on small molecule ATR inhibitor development for a specified period of time.
Under the terms of the Agreement, Roche has agreed to pay the Company an upfront payment of $125 million, and up to an aggregate of $1.172 billion upon the achievement of specified clinical regulatory, commercial and sales milestone events. The Company will also be entitled to receive tiered royalties (ranging from high-single-digits to high-teens) on sales of Licensed Products, subject to reductions in specified circumstances. Subject to earlier expiration of the royalty term in specified cases of generic competition, royalties will be paid, on a Licensed Product-by-Licensed Product and country-by-country basis, until, at the earliest, twelve (12) years after the first commercial sale of the applicable Licensed Product. If the Company exercises its co-development and profit share option, it will receive reduced milestone payment amounts, and it will not receive royalty payments in the United States.
Unless earlier terminated, the Agreement will expire upon the expiration of the last royalty term for the last Licensed Product (except that, if the Company exercises its co-development and profit share option, then the Agreement may expire at a later date in the United States). The Agreement may be terminated by Roche, on a Licensed Product-by-Licensed Product and country-by-country basis or in its entirety, upon 90 days’ prior written notice at any time prior to the first commercial sale of a Licensed Product, or upon 180 days’ prior notice at any time after the first commercial sale of a Licensed Product. Either party may, subject to specified cure periods, terminate the Agreement, on a Licensed Product-by-Licensed Product and country-by-country basis or in its entirety, in the event of the other party’s uncured material breach. Either party may also terminate the Agreement under specified circumstances relating to the other party’s insolvency. The Company may terminate the Agreement in the event Roche or its specified affiliates or sublicensees challenges the validity, scope, or enforceability of the licensed patent rights in specified circumstances.
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which, subject to any applicable confidential treatment, will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending June 30, 2022. The press release announcing the Agreement is attached hereto as Exhibit 99.1.
