5. Technology Transfer [amended]
5.1 Technology Transfer. Within [***], Novavax shall transfer to SIIPL (a) all Licensed Know–How Controlled by Novavax that is (a) necessary to Manufacture the Drug Substance, including transfer of [***], and (b) necessary to use the Vaccine Components, for the Manufacture of the Product, including assays, specifications, diagrams, technology, manufacturing process descriptions, protocols, and other written know–how by providing copies or samples of relevant documentation, materials, and other embodiments of any such Licensed Know–How (“Technology Transfer”).
5.2 Drug Substance Manufacture. In addition to the Clause 5.1 of the Agreement, as amended, stated hereinabove, the Parties further agree that for the purpose mentioned in the Amendment, the Technology Transfer and process Development and Manufacture of the Drug Substance shall be dealt in the manner provided hereunder:
5.2.1 Premises. The Parties hereby agree that SIIPL shall perform Technology Transfer, Process Development and any Manufacture and further Development of Drug Substance at SIIPL’s manufacturing facility, subject to the terms and conditions set forth in this Amendment.
5.2.2 Provision Raw Materials. The Parties agree that SIIPL shall be free to procure the raw materials necessary for SIIPL to Manufacture the Drug Substance. In the event SIIPL and Novavax agree that SIIPL may procure certain critical raw materials from certain of Novavax’ designated vendors, Novavax will instruct and authorize such designated vendors to directly transact with and supply SIIPL such critical raw materials as well as other consumables and information related thereto as may be necessary and required for SIIPL’s Manufacture of the Drug Substance at SIIPL’s manufacturing facility; provided Novavax shall have no liability and responsibility whatsoever regarding the quality of any such raw materials supplied to SIIPL by any such designated vendor. The list of critical raw materials and Novavax’ designated vendors is set forth in Appendix D and the template letter of authorization to be provided by Novavax to its designated vendors is set forth in Appendix E (provided that Novavax may provide such authorization in any form it deems sufficient). The Parties agree that if any raw materials are to be purchased from such Novavax’ authorized vendors, SIIPL shall seek prior written approval from Novavax of the quantities of such raw materials as may be required by SIIPL.
“Licensed Know-How” means all Know-How that is Controlled by Novavax or its Affiliates as of the Effective Date in relation to the Vaccine Components and which is necessary for the Development, Manufacture or Commercialization of Product.