Item 1.01 Entry Into a Material Definitive Agreement.
On March 26, 2020, Translate Bio MA, Inc. (the “Company”), a wholly owned subsidiary of Translate Bio, Inc. (“Translate Bio”), entered into a First Amendment to Collaboration and License Agreement (the “Amendment”) with Sanofi Pasteur, Inc. (“Sanofi”), which amended that certain Collaboration and License Agreement entered into between the parties as of June 8, 2018 (the “Agreement”). Pursuant to the Agreement, the parties agreed to develop a mRNA vaccine platform and mRNA vaccines for up to five infectious disease pathogens (the “Licensed Fields”). The Amendment amends the Agreement to include vaccines against SARS-CoV-2 as an additional Licensed Field, increasing the number of Licensed Fields to up to six. The aim of the Amendment is to help address the SARS-CoV-2 pandemic.
Pursuant to the Amendment, the parties agreed that no upfront fee is payable by Sanofi to the Company with respect to the addition of SARS-CoV-2 as a Licensed Field. The parties also agreed that certain provisions of the Agreement, including provisions related to milestone payments, royalties and royalty reductions, shall not apply to vaccine products for the prevention, treatment or cure of SARS-CoV-2 that are purchased by a governmental authority while SARS-CoV-2 is a declared pandemic. The parties agreed to negotiate in good faith the royalty terms applicable to such products, which terms shall reflect the economic conditions applicable to commercializing such products and shall not exceed the royalty terms for the existing Licensed Fields.
In the event that the parties are unable to mutually agree on terms relating to the conduct of clinical development and commercialization of a product related to SARS-CoV-2, or if Sanofi is in breach of its material obligations with respect to SARS-CoV-2, the Company has the right to terminate and revoke the license granted to Sanofi with respect to SARS-CoV-2 with sixty (60) days written notice, and SARS-CoV-2 shall cease to be a Licensed Field under the Agreement. Upon any such termination and revocation by the Company, the parties have agreed to negotiate in good faith a termination agreement with respect to the Company’s use of any technology arising from the collaboration that is owned by Sanofi or jointly-owned by the parties, that is necessary or useful to the further development or commercialization of a product directed to SARS-CoV-2.
Pursuant to the Amendment, the parties have agreed to a collaboration budget covering the costs of the initial collaboration activities, which will consist of discovery andpre-clinical research. The parties agreed to enter into an additional amendment related to activities directed to clinical development or commercialization of a product related to SARS-CoV-2, which could include the applicable royalty terms.
Pursuant to the Amendment, the Company granted to Sanofi exclusive, worldwide licenses to certain intellectual property rights of the Company, to develop, commercialize and manufacture mRNA vaccines against SARS-CoV-2. Sanofi granted to the Companynon-exclusive, sublicenseable licenses under certain patent rights claiming certain improvements or technology arising from the SARS-CoV-2 collaboration. The terms of such licenses are identical to those granted in other Licensed Fields in the Agreement, provided that the economic terms and responsibilities for clinical development and commercialization are subject to the parties’ mutual agreement and the Agreement’s further amendment.
The foregoing summary of the Amendment is qualified in its entirety by reference to the full text of the Amendment, a copy of which Translate Bio intends to file as an exhibit to its Quarterly Report on Form10-Q for the quarter ending March 31, 2020.
Item 8.01 Other Events.
On March 27, 2020, Translate Bio issued a press release announcing the Amendment.
