Provision Language
Definitions
“Working Cell Bank” (a) means the starting material for host cells in the cell culture process, which will enable Licensees or by third parties hired by Licensee to generate WCB needed for Drug Substance production, to be provided to Licensees in the quantities and conditions set forth in Schedule F (“COBRA WCB lote n. 2020#0077P); (b) means the starting material for host cells in the cell culture process, which will permit the production of IFA by the Licensee, to be supplied to the Licensee, to be provided to Licensees in the quantities and conditions set forth in Schedule F (“AstraZeneca WCB”). The terms Working Cell Bank (WCB) and Working Host Cell Bank (WHCB) are used interchangeably.
“Working Seed Lots” or “Working Virus Seed” (WVS) means the starting material to be used as the virus material in the cell culture infection process, to be provided to Licensees in the quantities and conditions set forth in Schedule F, which will enable Licensees to generate all subsequent WVS needed for Drug Substance production.
Preamble
Whereas, in the face of the unprecedented challenges of the SARS–CoV–2 pandemic, the Parties have the following objectives (collectively referred to herein as “the Objectives”):
[…]
Conduct the supply of technology and technological assistance, when applicable, to ensure the manufacture and supply of sufficient quantities of the Licensed Product to meet demand in the Territory.
[…]
2. Scope
2.03 Transfer of Technology
a) Under the Sublicence set forth in this Agreement and subject to any limitations set forth in the Head Licence, AstraZeneca shall supply the Licensed Know-How to Licensees to enable Licensees to Exploit the Licensed Products and scale up the IFA production. In order to facilitate the transfer, each Party will perform its obligations provided in the Technology Transfer Work Plan attached hereto as Schedule D.
b) AstraZeneca shall provide Licensees with Working Cell Banks and Working Seed Lots and other materials, in the quantities and conditions set forth in Schedule F, to support Licensee’s own Working Cell Banks and Working Seed Lots for the autonomous production IFA [API] by Licensees. AstraZeneca shall support the transfer of appropriate manufacturing processes and analytical testing for release once in one of Licensee’s facilities to enable large–scale IFA manufacturing for future commercial supply by Licenses, as provided for in the Supply of Technology Work Plan.
4. Manufacturing and Regulatory
4.07. Supply of Technology
Promptly after the Effective Date, AstraZeneca shall supply the Licensed Know-How required necessary for the Regulatory Activities of the Licensed Product and for the performance of the Purpose of this Agreement. Licensees shall obtain and make available such information, personnel, materials, services, facilities and other resources, and take such other actions, as are necessary or useful to enable AstraZeneca to supply such Know-How, as provided in Schedule D.