Provision Language
Definitions
“Licensed Manufacturing Know-How” means all Know-How that (a) is Controlled by VALNEVA or any of its Affiliates as of the Effective Date, (b) is Developed by VALNEVA during the Term of this Agreement, and (c) directly relates to the fill & finish Manufacture of the VALNEVA Product but does not include the Know-How relating to VALNEVA Drug Substance and/or related processes. The detailed scope of the Licensed Manufacturing Know-How is defined in the Technology Transfer Agreement.
“Technology Transfer” shall mean the transfer of Licensed Manufacturing Know-How (as further defined in the Technology Transfer Agreement), relating to the formulation, fill, lyophilization and finish processes necessary for the proper Development and Manufacturing of the SIIPL Product in the SIIPL Territory.
“Technology Transfer Agreement” shall mean that certain Technology Transfer Agreement between the Parties, dated as of even date herewith, setting forth terms and conditions relating to the Technology Transfer of the Licensed Manufacturing Know-How from VALNEVA to SIIPL.
“VALNEVA Drug Substance” shall mean the active ingredient of the VALNEVA Product as further defined in the Drug Substance Supply Agreement.
2. Background.
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2.2 The Parties’ activities under this Agreement and the Project Agreements are as follow:
a. VALNEVA will transfer its Licensed Manufacturing Know-How to SIIPL under the terms and conditions of the Technology Transfer Agreement within a period agreed therein.
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c. VALNEVA will supply VALNEVA Drug Substance to SIIPL for purposes of the Technology Transfer and thereafter for the commercial Manufacturing of the SIIPL Product.
8. Manufacture and Commercialization.
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8.4 Commencement of Commercial License. The Parties agree that with the completion of the transfer of Documentation of the Licensed Manufacturing Know-How to SIIPL as set forth in the Technology Transfer Agreement SIIPL is able to use and benefit from the Commercial License under Section 3.1.