UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01 | Entry Into a Material Definitive Agreement. |
On January 15, 2020, Gritstone Oncology, Inc. (“Gritstone” or the “Company”) entered into a Non-Exclusive License and Development Agreement (the “License Agreement”) with Genevant Sciences GmbH (“Genevant”). Pursuant to the License Agreement, the Company obtained a nonexclusive license to Genevant’s lipid nanoparticle technology (“LNP Technology”) to develop and commercialize self-amplifying RNA (SAM) vaccines against SARS-CoV-2, the virus that causes COVID-19. Under the License Agreement, the Company agreed to pay Genevant an upfront payment of $1.5 million and up to an aggregate of $192.0 million per product, upon achievement of specified development and commercial milestones, as well as tiered royalties ranging from the mid-single digits to mid-teens on net sales of licensed products for a royalty term lasting until the later of expiration of the last covered patent under the license. In certain scenarios, in lieu of milestones and royalties, Genevant will be entitled to a percentage of any amounts that Gritstone receives from sublicenses to the COVID-19 program subject to certain conditions. The License Agreement expands the Company’s intellectual property rights to the LNP Technology originally obtained pursuant to its License Agreement with Arbutus Biopharma Corporation and Protiva Biotherapeutics, dated as of October 16, 2017, as amended.
The License Agreement continues in effect until the last to expire royalty term or early termination. The License Agreement is terminable by the Company for convenience with 90 days prior written notice or immediately if based on certain product safety or efficacy or regulatory criteria. Either party may terminate the agreement for material breach, subject to a cure period, and Genevant may terminate the agreement if the Company challenges a licensed patent.
The License Agreement contains, among other provisions, representation and warranties, indemnification obligations, confidentiality, audit and inspection, and intellectual property sharing provisions in favor of each party that are customary for an agreement of this nature.
The foregoing summary of the material terms of the License Agreement is qualified in its entirety by the terms of the License Agreement, which will be filed as an exhibit to the Company’s Annual Report of the year ended December 31, 2020.
| Item 8.01 | Other Events. |
On January 19, 2021, Gritstone announced that it is advancing development of a second generation vaccine against SARS-CoV-2, the virus that causes COVID-19, with potential for both prolonged protection and potency against Spike mutants. Gritstone and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, have entered into a clinical trial agreement to initiate clinical testing. A Phase 1 clinical trial, expected to be conducted through the NIAID-supported Infectious Diseases Clinical Research Consortium (IDCRC), is in development. The Bill & Melinda Gates Foundation (Gates Foundation) is supporting the preclinical evaluation of the vaccine.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| GRITSTONE ONCOLOGY, INC. | ||||||
| Date: January 22, 2021 | By: | /s/ Andrew Allen | ||||
| Andrew Allen | ||||||
| President and Chief Executive Officer | ||||||