Master Alliance Provisions Guide (MAPGuide)

Novavax – Serum Institute of India, COVID-19 Vaccine Supply and License Agreement

  • Other | Regulatory strategy

2. Supply and Other Responsibilities

2.5 Responsibilities of SIIPL
c. Regulatory Activities. Subject to and as further described in this Section 2.5.(c), SIIPL will have [***] with respect to all regulatory activities for the Product in the SIIPL Territory, including obtaining and maintaining, in its name or the name of its designee/Affiliates, all Regulatory Approvals, licenses, and permits required to Commercialize the Product in the SIIPL Territory, and any correspondence or meetings with regulatory authorities regarding any of the foregoing, provided that SIIPL shall give Novavax [***] notice that SIIPL will be providing any such submissions for Novavax’ review, which review shall not unreasonably delay such filings, or as may be decided by the Parties mutually, in advance of SIIPL ’s filing or submission thereof, and SIIPL will incorporate any reasonable comments received from Novavax into such regulatory submissions (including with respect to the inclusion or exclusion of Novavax’ Confidential Information). SIIPL will conduct such regulatory activities in accordance with the then current Development Plan. SIIPL will be solely responsible for all costs and expenses incurred by it to obtain and maintain such Regulatory Approvals required to Commercialize the Product in the SIIPL Territory. [***] Novavax will [***] and Novavax may, at either Party’s request, participate in any meetings (in person or by teleconference) with any regulatory authority regarding any Regulatory Approval necessary to Commercialize the Product in the SIIPL Territory, [***].

d. Diligence Obligations. SIIPL will perform all activities set forth in the Development Plan and use its [***] to perform all such activities in accordance with the applicable timeframes set forth in the Development Plan. In addition, SIIPL will use [***] to Develop and obtain Regulatory Approval for the Product in all countries in the SIIPL Territory.

4. Inspection, Quality and Audit

4.4 Records. Each Party will provide [***] to support the other Party’s efforts to obtain or maintain Regulatory Approvals related to the Vaccine Components or Product.

4.5 Right of Reference; Regulatory Cooperation

a. Documentation. Novavax will provide SIIPL with applicable information, reports, documents, certificates, and any other materials regarding Vaccine Components and Licensed Know-How that are [***] for SIIPL to Manufacture the Product, to Develop the Product and to obtain and maintain Regulatory Approval for the Product in the SIIPL Territory. Novavax will submit, maintain, and keep updated drug master files for the Vaccine Components and each facility in which Novavax Manufactures the Vaccine Components, SIIPL will submit, maintain, and keep updated drug master files for the Product and each facility in which SIIPL Manufactures the Product, and, following the Technology Transfer, for the Vaccine Components and each facility in which SIIPL Manufactures the Vaccine Components.

b. Right of Reference. Each Party hereby grants to the other Party a right of reference to the drug master files described in the forgoing Section 4.5(a) (Documentation) for use in obtaining Regulatory Approvals for the Vaccine Components or the Product as permitted under this Agreement or any other agreement between the Parties. Each Party will, at the other Party’s written request, provide accurate and complete copies of the applicable clinical study reports, authorize the appropriate regulatory authorities to reference such drug master files in support of BLAs and other regulatory submissions for the Vaccine Components or the Product (as applicable), and/or provide copies of all such authorization letters and take other [***] actions with regulatory authorities with respect to the Vaccine Components or the Product as requested by such regulatory authorities or the other Party in connection with obtaining and maintaining Regulatory Approvals for the Vaccine Components and the Product as set forth in this Agreement.