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.
--------------------------------------------------------------------------------
© Edgar Online, source Glimpses