Item 1.01 Entry into a Material Definitive Agreement
GSK Collaboration Agreement
On June 9, 2020, Vir Biotechnology, Inc. (the “Company”), Glaxo Wellcome UK Limited and Beecham S.A. (together, “GSK”) entered into a definitive collaboration agreement in accordance with the terms set forth in the preliminary collaboration agreement entered into by the Company and certain GSK entities in April 2020 (the “Preliminary Agreement”) (such definitive collaboration agreement, the “Agreement”). The Agreement became effective as of April 29, 2020, which was the closing date for the associated stock purchase agreement between the parties (“Effective Date”). Under the terms of the Agreement, the Company and GSK agreed to collaborate to research, develop and commercialize products for the prevention, treatment and prophylaxis of diseases caused bySARS-CoV-2, the virus that causesCOVID-19, and potentially other coronaviruses. The collaboration is focused on the development and commercialization of three types of collaboration products under three programs: (1) antibodies targetingSARS-CoV-2, and potentially other coronaviruses (the “Antibody Program”); (2) vaccines targetingSARS-CoV-2, and potentially other coronaviruses (the “Vaccine Program”), and (3) products based on genome-wide CRISPR screening of host targets expressed in connection with exposure toSARS-CoV-2, and potentially other coronaviruses (the “Functional Genomics Program”). The initial antibodies under the Antibody Program will beVIR-7831 andVIR-7832, which have demonstrated high affinity for theSARS-CoV-2 spike protein and are highly potent in neutralizingSARS-CoV-2 in live virus-cellular assays.
For a period of four years following the Effective Date, the parties will conduct certain research and development activities under mutually agreed development plans and associated budgets for each of the three programs, and under the oversight of a joint steering committee. During such period, generally, subject to certain rights granted to WuXi Biologics (Hong Kong) Limited (“WuXi”) under existing agreements between WuXi and the Company, the parties will have an exclusive research collaboration with respect to antibody products directed toSARS-CoV-2 or to any other coronavirus, and in connection with functional genomics CRISPR screens for drug discovery and development in connection withSARS-CoV-2 or other coronaviruses. The Company will be primarily responsible for the development and clinical manufacturing activities for the Antibody Program, and for conducting the initial development activities directed to a vaccine in the Vaccine Program. GSK will be primarily responsible for the commercialization activities for the Antibody Program (except in connection with sales of antibody products licensed to WuXi in greater China), the later-stage development, manufacturing and commercialization activities for the Vaccine Program and the development, manufacturing and commercialization activities for the Functional Genomics Program. Each party is required to use commercially reasonable efforts to conduct the activities assigned to it under each development plan and to seek and obtain regulatory approval for collaboration products that arise from such activities in the United States and specified major markets. Subject to anopt-out mechanism, the parties will share all development costs, manufacturing costs and costs and expenses for the commercialization of the collaboration products, with the Company bearing 72.5% of such costs for the antibody products, 27.5% of such costs for the vaccine products, and the parties sharing equally all such costs for the functional genomics products. Pursuant to the Agreement, if the parties elect to conduct a technology transfer of manufacturing technology under the Company’s agreements with WuXi and Biogen Inc. (“Biogen”), the Company will bear 72.5% of the costs related to such manufacturing technology transfer and for commercial manufacturing of the antibody products under such agreements with WuXi and Biogen, and GSK will bear 27.5% of such costs. The parties will also share the committed costs for the reservation of manufacturing capacity for the drug substance for antibody products in the foregoing ratio under the Company’s agreement with Samsung BioLogics Co., Ltd, as well as such costs relating to committed manufacturing capacity for antibody products as are approved by the joint steering committee from time to time.
On a collaborationproduct-by-collaboration product basis, either party will have the right, at specified points in development, to opt out of itsco-funding obligations, and the other party may, at its election, either pursue such program unilaterally, or also cease the conduct and funding of such collaboration product. Unless a party has opted out prior to such time, the parties would share all profits and losses arising from any collaboration product in the same ratios in which the parties bore development costs for such collaboration program. For each collaboration product as to which a party exercises itsopt-out right, the commercializing party will pay to theopt-out party royalties on net sales of the applicable collaboration product at rates based on factors such as the stage of development of such collaboration product at the time theopt-out party exercises such right, and whether theopt-out party is the lead party, or a portion of the sublicense revenue if the commercializing party chooses to sublicense or
