Item 1.01 Entry into a Material Definitive Agreement
On March 3, 2020, Vir Biotechnology, Inc. (the “Company”) and Alnylam Pharmaceuticals, Inc. (“Alnylam”) entered into an amendment (the “Amendment”) to the Collaboration and License Agreement by and between the parties dated October 16, 2017, as amended by Letter Agreement dated November 13, 2018 and by Amendment No. 1 to the Collaboration and License Agreement effective December 17, 2019 (as further amended by the Amendment, the “Amended Alnylam Agreement”), to expand the parties’ existing collaboration to include the development and commercialization of RNAi therapeutics targetingSARS-CoV-2, the virus that causes the diseaseCOVID-19, and potentially other related coronaviruses, utilizing Alnylam’s recent advances in lung delivery of novel conjugates of siRNA – the molecules that mediate RNAi (the “COV Products”).
Pursuant to the Amended Alnylam Agreement, the parties will each be responsible forpre-clinical development costs incurred by such party in performing its allocated responsibilities under an agreed-upon initialpre-clinical development plan for COV Products. The parties will equally share costs incurred in connection with the manufacture ofnon-GMP drug product required forpre-clinical development prior to filing of an investigational new drug application for the first COV Product in the coronavirus program. Following the completion of initialpre-clinical development activities, if the Company exercises its option to progress one or more candidates arising from the coronavirus program into further development, the Company will be responsible for conducting all development, manufacturing and commercialization activities for COV Products, at its sole expense, subject to Alnylam’s right toopt-in, during a specified period, to share equally with the Company the profits and losses in connection with development and commercialization of COV Products.
If the Company exercises its option for the coronavirus program, and successfully develops one or more COV Products arising from such program, then unless Alnylam exercises its profit-sharing option, the Company will be required to pay Alnylam up to $15.0 million in the aggregate for the achievement of specified development milestones for the COV Products. Following commercialization, the Company will also be required to pay Alnylam specified sales milestones on achievement of specified levels of annual net sales, and a tiered royalty at specified rates on annual net sales of the applicable COV Products. However, with respect to sales to governmental authorities or sales for the purposes of biodefense, management of public health or other public policy reasons, such royalty will be payable at a percentage in the low single-digits, plus a pass-through amount of any royalties Alnylam is required to pay to third parties under any third partyin-license agreements related to the COV Products.
Except as amended in connection with the addition of the coronavirus program to the collaboration, the Alnylam Agreement remains in force between the parties in accordance with its terms. The foregoing description of the material terms of the Amendment is qualified in its entirety by reference to the full text of the Amendment, a copy of which will be filed as an exhibit to a subsequent filing with the Securities and Exchange Commission.
