AMENDMENT NO. 3 TO DCA
Exhibit 10.4
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.
Execution Version
AMENDMENT NO. 3 TO DCA
This Amendment No. 3 (this “Third Amendment”) to that certain Definitive Collaboration Agreement dated as of June 9, 2020, as amended on May 27, 2022 and February 8, 2023 (the “DCA”), is made and entered into as of February 8, 2023 (“Third Amendment Effective Date”) by and among Glaxo Wellcome UK Limited, a private company limited by shares organized under the laws of England having an office at 000 Xxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx XX0 0XX, Xxxxxxx, registered under company number 00480080 (“GW”); and GlaxoSmithKline Biologicals S.A., a private company limited by shares organized under the laws of Belgium having its registered place of business at Xxx xx x’Xxxxxxxx 00 Xxxxxxxxx, 0000 Xxxxxxx, as assignee of the DCA from Xxxxxxx X.X. (“GSK Bio”, together with GW, “GSK”), and Vir Biotechnology, Inc., a Delaware corporation having an office at 000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxx Xxxxxxxxx, XX 00000 (“Vir”). Capitalized terms used but not otherwise defined in this Third Amendment shall have the meanings given to them in the DCA.
BACKGROUND
WHEREAS, GSK and Vir entered into the DCA, pursuant to which the Parties are collaborating on the development, manufacture, and commercialization of certain Collaboration Products for the prevention, treatment and prophylaxis of diseases caused by SARS-CoV-2 and potentially other Coronaviruses under three (3) Collaboration Programs: the Antibody Program, the Vaccine Program and the Functional Genomics Program;
WHEREAS, GSK and Vir now desire to enter into this Third Amendment to amend the DCA to amend the scope of the Antibody Program with respect to certain Terminated Antibody Products (as defined below) in accordance with Sections 14.2 and 20.11 of the DCA.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:
Section 1.16 “Antibody Product” means any product containing the 309 Antibody.
Section 1.17 “Antibody Program” means the Collaboration Program for Program Antibodies, as further described in Section 4.2.
Section 1.204 “Program Antibody” means (a) prior to the Third Amendment Effective Date: (i) any Antibody Controlled by Vir or its Affiliates as of the PCA
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Execution Date or thereafter until the end of the Initial Development Term that is directed against any Coronaviruses, including the 309 Antibody; (ii) any Antibody created, discovered, conceived or reduced to practice by either Party or both Parties jointly during the conduct of activities under the Antibody Development Plan during the Initial Development Term; and (iii) to the extent not included in the foregoing subclause (i) or (ii), any Antibody Controlled by either Party that the Parties agree during the Initial Development Term, through the JRDC, to include as the subject of Development activities under an Antibody Development Plan, and (b) following the Third Amendment Effective Date, the 309 Antibody.
“[***]” means the [***].
“Existing Terminated Antibody Products” means (a) any Antibody Controlled by Vir or its Affiliates as of the PCA Execution Date or thereafter until the Third Amendment Effective Date that is directed against any Coronaviruses, other than the Antibody Products (as amended by this Third Amendment), (b) all Antibodies created, discovered, conceived or reduced to practice by either Party or both Parties jointly under the Antibody Program as of the Third Amendment Effective Date, other than the Antibody Products (as amended by this Third Amendment), and (c) Variants of the Antibodies described in subclauses (a) and (b) incorporating [***].
“Terminated Antibody Products” means Existing Terminated Antibody Products and Vir Improved Terminated Antibody Products.
“[***]” means the [***].
“Vir Improved Terminated Antibody Products” means any Variants and Derivatives of any Existing Terminated Antibody Products created, discovered, conceived or reduced to practice after the Third Amendment Effective Date. For clarity, [***].
“(a) an Antibody Program for the Development, Manufacture and Commercialization of Antibody Products; provided that, for clarity, (i) if an Antibody arises from the Functional Genomics Program rather than the Antibody Program, such Antibody shall not be considered an Antibody Product and shall be considered as Functional Genomics Product, and (ii) [***];”
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“(d) Vir shall [***].”
“10.1.2 License Grant to Vir. On a Collaboration Program-by-Collaboration Program basis, GSK hereby grants to Vir as of the Effective Date the following:
(a) a non-exclusive, worldwide, sublicensable (subject to Section 10.4 and with GSK’s prior written consent in the case of any counterparty located in China (or that has a parent entity located in China) as the sublicensee, or in the case of activities to be conducted in China) license under the GSK Licensed Technology (i) to Develop and Manufacture Collaboration Products arising from such Collaboration Program subject to any obligations of GSK to Third Parties with respect to the applicable GSK Licensed Technology (which license shall apply to and remain in effect for each Antibody Product, Terminated Antibody Product and Functional Genomics Product that becomes a Sole Development Product of Vir); and (ii) with respect to any Antibody Product for which
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Vir has exercised the Co-Promotion Option, to Commercialize such Antibody Product to the extent necessary for Vir to perform activities for which it is responsible under the Co-Promotion Agreement to be entered into by the Parties;
(b) a co-exclusive (with GSK), worldwide, sublicensable (subject to Sections 5.4 and 7.4 and with GSK’s prior written consent in the case of any counterparty located in China (or which has a parent entity located in China) as the sublicensee, or in the case of activities to be conducted in China) license under GSK Program Technology (i) to Develop and Manufacture Collaboration Products arising from such Collaboration Program (which license shall apply to and shall remain in effect for any Antibody Product, Terminated Antibody Product and Functional Genomics Product that becomes a Sole Development Product of Vir and shall become exclusive with respect to such product), and (ii) with respect to any Antibody Product for which Vir has exercised the Co-Promotion Option, to Commercialize such Antibody Product to the extent necessary for Vir to perform activities for which it is responsible under the Co-Promotion Agreement to be entered into by the Parties; and”
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Terminated Antibody Product Royalty Table:
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[Signature page follows]
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IN WITNESS WHEREOF, the Parties have caused this Third Amendment to be executed as of the Third Amendment Effective Date by their respective duly authorized representatives as set forth below.
Glaxo Wellcome UK Limited
By: /s/ Xxxxxx Xxxxxxx
Name: Xxxxxx Xxxxxxx
Title: Authorized Signatory for Edinburgh Pharmaceutical Industries Limited, a corporate director
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[Signature Page to Amendment No. 3 to DCA]
IN WITNESS WHEREOF, the Parties have caused this Third Amendment to be executed as of the Third Amendment Effective Date by their respective duly authorized representatives as set forth below.
GlaxoSmithKline Biologicals S.A.
By: /s/ Xxxxxx Xxxxxxx
Name: Xxxxxx Xxxxxxx
Title: Director -and-
By: /s/ Xxxxxx Xxxxxxx
Name: Xxxxxx Xxxxxxx
Title: Director
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[Signature Page to Amendment No. 3 to DCA]
IN WITNESS WHEREOF, the Parties have caused this Third Amendment to be executed as of the Third Amendment Effective Date by their respective duly authorized representatives as set forth below.
By: /s/ Xxxxxx Xxxxxxx
Name: Xxxxxx Xxxxxxx, Ph.D.
Title: President and Chief Executive Officer
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[Signature Page to Amendment No. 3 to DCA]