“Quality Agreement” means an agreement containing customary and commercially reasonable terms that will provide, among other things, quality standards for the Vaccine Components or Product, as applicable, the requirements for product release, the respective roles and responsibilities of each Party in these processes, the standards and procedures for the handling of any deviations from the usual quality standards or product release requirements, and/or any complaints, the processes and allocation of responsibilities for reporting of these matters, and related topics.
2. Supply and Other Responsibilities
c. Pharmacovigilance Agreement. Prior to SIIPL’s commencement of Development and Commercialization of the Product in the SIIPL Territory, the Parties will negotiate and enter into a safety reporting agreement on customary, commercially reasonable and mutually agreeable terms.
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
4.1 Inspection; Acceptance and Rejection. SIIPL will inspect shipments upon receipt for any visible damage or missing quantities of the Vaccine Components or Licensed Know-How. SIIPL may also test shipments of Vaccine Components using the applicable methods of analysis specified in the Quality Agreements. If there are any issues with a shipment ofVaccine Components or Licensed Know-How or if SIIPL [***] believes that the VaccineComponents do not comply with the Vaccine Component Specification, cGMP, or other applicable requirements under the Quality Agreements then SIIPL must notify Novavax [***] after its receipt of a shipment. If SIIPL does not notify Novavax within such period, then SIIPL will be deemed to have accepted the Vaccine Components or Licensed Know-How as conforming to the order and meeting the applicable Vaccine Component Specifications and quality requirements under this Agreement.
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.
4.6 Quality Inspection. SIIPL will have the right to inspect Novavax’ facilities, offices, or other properties used or utilized for the manufacture, storage, handling, and shipping of Vaccine Components pursuant to the Quality Agreements [***] at [***] sole expense. All such audits will occur with [***] notice (but no less than [***) on Novavax’ premises during Novavax’ normal business hours. If Novavax uses any contract manufacturer(s) to satisfy its obligations under this Agreement, Novavax will provide its quality inspection reports for such contract manufacturer(s) upon request from SIIPL.
4.7 Regulatory Inquiries. Novavax will [***] notify SIIPL in writing of any governmental or regulatory inquiries, inspections, or audits directly related to the Vaccine Components and Licensed Know-How and any findings related to the same. SIIPL will permit such governmental or regulatory body to inspect and audit its facilities and documents, including facilities and documents of its contract manufacturer(s), related to Vaccine Components at [***] cost and expense, and notify and update Novavax of such inquiries, inspections and audits.
4.8 Recalls. Each Party will [***] notify the other in writing in detail if (a) any batch of Vaccine Components provided hereunder or Product is alleged or proven to be the subject of a recall, market withdrawal, or correction in such Party’s territory; (b) such Party [***] determines that a recall is necessary; or (c) such Party becomes aware of any quality or risk issues related to Vaccine Components or Product. SIIPL will be responsible for instituting a recall, market withdrawal, or correction of the Product at [***] cost and expense, unless a recall is required due solely to the failure of the Vaccine Components Manufactured by Novavax to meet the Vaccine Component Specification at the time of delivery, or failure of Novavax to Manufacture Vaccine Components in accordance with cGMP or other Applicable Laws, in which case SIIPL will also be responsible for instituting a recall, market withdrawal, or correction at [***] cost and expense. Each Party will cooperate as [***] requested by the Party responsible for recall.
4.9 Safety Reporting. Each Party will advise the other Party in writing of any adverse event related to the Vaccine Components or Product within [***] after becoming aware of such event, and provide any and all information, document, and materials that are related to such adverse event. Further details of the Parties’ obligations in regard to safety reporting will be set forth in the Pharmacovigilance Agreements.