Item 1.01 Entry into a Definitive Material Agreement.
On December 11, 2020, Relay Therapeutics, Inc. (the “Company”) entered into a Collaboration and License Agreement (the “Agreement”) with Genentech, Inc. (“Genentech”) and F. Hoffmann-La Roche Ltd (together with Genentech, “Licensee”). Pursuant to the Agreement, the Company and Licensee will collaborate on the development and commercialization of RLY-1971, the Company’s oral, small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (“SHP2”). RLY-1971 is currently being developed in a Phase 1a clinical trial for patients with advanced solid tumors (the “Phase 1a Trial”).
Development and Commercialization. Unless Licensee elects to exercise its option to conduct the remainder of the ongoing Phase 1a Trial, the Company will complete the Phase 1a Trial. Licensee will be responsible for conducting all subsequent clinical development of RLY-1971, including in any combination trials with Licensee’s compound, GDC-6036, that directly binds to and inhibits KRAS G12C, or other compounds.
The Company will retain the right to develop RLY-1971 or any other small molecule inhibitor of SHP2 developed by Licensee under the Agreement (each, a “Licensed Candidate”) or pharmaceutical product containing a Licensed Candidate (each, a “Licensed Product”) in combination with the Company’s compounds targeting fibroblast growth factor receptor 2, including RLY-4008, or compounds targeting phosphoinositide 3-kinase alpha, including candidates in the Company’s RLY-PI3K1047 program (a “Relay Combination Product”). If the Company opts in to the Profit-Cost Share described below, Licensee may share the development costs of any clinical trial for a Relay Combination Product.
Licensee will have the sole right and responsibility to commercialize Licensed Products, in any and all combinations, except that the Company will have the right to co-promote a Licensed Product solely as part of its commercialization of Relay Combination Products. Licensee will be solely responsible for all regulatory matters for all Licensed Candidates and Licensed Products after the assignment by the Company to Licensee of all related regulatory materials, including the investigational new drug application for the Phase 1a Trial, other than with respect to Relay Combination Products.
Financial Terms. Under the terms of the Agreement, the Company will receive $75 million in an upfront payment and is eligible to receive $25 million in additional near-term payments.
Profit-Cost Share. The Company has the option, exercisable one time in the Company’s sole discretion, to fund half of the development costs of RLY-1971 in the U.S. and share half of the net profits or net loss of commercializing RLY-1971 in the U.S. (the “Profit-Cost Share”). If the Company opts into the Profit-Cost Share, the Company will also be eligible to receive up to an aggregate of an additional $410 million upon the achievement of specified commercialization and sales-based milestones for RLY-1971 outside of the U.S and tiered royalties ranging from low-to-mid teens on annual net sales of RLY-1971 outside of the U.S., on a country-by-country basis, subject to reduction in certain circumstances. At any time prior to the third anniversary of the first commercial sale of RLY-1971 in the U.S., the Company may elect to opt-out of further participation in the Profit-Cost Share. If the Company elects to opt-out, then Licensee’s milestone and royalty payment obligations will revert to the financial terms that would be applicable if the Company had not opted into the Profit-Cost Share as described below, with certain adjustments.
Additional Financial Terms. If the Company does not opt into the Profit-Cost Share, Licensee will be responsible for all development costs of RLY-1971 other than the costs incurred by the Company for the Phase 1a Trial, and the Company will be eligible to receive up to an aggregate of an additional $695 million upon the achievement of specified development, commercialization and sales-based milestones for RLY-1971 worldwide. The Company will also be eligible to receive tiered royalties ranging from low-to-mid teens on annual worldwide net sales of RLY-1971, on a country-by-country basis, subject to reduction in certain circumstances. In the event of regulatory approval of both RLY-1971 and GDC-6036 in combination, the Company is eligible to receive additional royalties.
Intellectual Property. Under the Agreement, the Company grants an exclusive, worldwide, royalty-bearing license to Licensee, with the right to sublicense, to develop and commercialize RLY-1971. Between the parties, Licensee has the first right, but not the obligation, to file, prosecute and maintain any patents licensed to it pursuant to the Agreement, as well as to enforce infringement of or defend claims against such patents that relate to Licensed Candidates and Licensed Products. The parties will share any liabilities or damages arising from the enforcement of such patents or any third-party patent claims.
Exclusivity. Other than with respect to Relay Combination Products and other activities in accordance with the Agreement, the Company may not, directly or indirectly, conduct any activities related to the research, development, manufacture or commercialization of any SHP2 inhibitor. During the first three years of the term of the Agreement, Licensee will not, and will cause certain of its affiliates not to, sponsor or conduct a registrational trial for a SHP2 inhibitor other than a Licensed Product.
Termination. Unless earlier terminated, the Agreement will remain in effect until the later of the date on which Licensee is no longer developing or commercializing RLY-1971 in the U.S. if the Company has opted into the Profit-Cost Share and has not subsequently opted-out, or the expiration of all Licensee’s royalty payment obligations to the Company. The parties may terminate the Agreement for the other party’s material breach or insolvency or the failure to obtain merger control under applicable antitrust laws. Additionally, Licensee may terminate the Agreement for convenience, and the Company may terminate the Agreement for certain patent challenges by Licensee or if Licensee has not conducted any research, development, manufacturing or commercialization activities with respect to any Licensed Candidate or Licensed Product for a specified period.
