Provision Language
2. Background
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. SIIPL will obtain Regulatory Approval of the single-dose SIIPL Product in the SIIPL Territory, including, but not limited to, India and other Key Countries, and WHO prequalification as further set forth in Section 6.5 below.
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6. Development Plan, Regulatory Activities, Diligence, and potential Clinical Trials
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6.2 Development Plan. Not later than [***] after the Effective Date, SIIPL shall provide VALNEVA with a detailed written plan for SIIPL’s Development of the SIIPL Product throughout the SIIPL Territory including but not limited to Development and regulatory strategies and timelines for Development activities, deliverables, CMC strategy and path towards Regulatory Approval (the “Development Plan”), subject to and as further described in this Section 6.2. SIIPL will obtain and maintain all Regulatory Approvals required to Develop and Commercialize the SIIPL Product throughout the SIIPL Territory at SIIPL’s own cost. SIIPL will perform all Development of the SIIPL Product in accordance with the Development Plan. The Development Plan and any updates thereto will include a high-level summary of key Development activities for the SIIPL Product and approximate timelines for such activities, provided that such timelines are subject to change due to applicable timelines and requirements of Regulatory Authorities, including for obtaining and maintaining permissions and other Regulatory Approvals. The Development Plan and updates thereto will include all Development activities necessary to obtain and maintain all Regulatory Approvals to Commercialize the SIIPL Product in each country in the SIIPL Territory and any other activities otherwise recommended or required by the applicable Regulatory Authority in any country in the SIIPL Territory to obtain or maintain such Regulatory Approvals. SIIPL will update the Development Plan as necessary during the Term and will provide each such update to VALNEVA for review and comment. SIIPL will incorporate all reasonable comments received from VALNEVA regarding Development activities for the SIIPL Product that are relevant to obtaining or maintaining Regulatory Approvals to Commercialize the SIIPL Product in any country in the SIIPL Territory.
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6.4 Regulatory Activities. Subject to and as further described in this Section 6.4, SIIPL will have sole control over and decision-making authority with respect to all regulatory activities for the SIIPL Product in the SIIPL Territory, including obtaining and maintaining, in its name or the name of its designee, all Regulatory Approvals, licenses, and permits required to Commercialize the SIIPL Product in the SIIPL Territory, and any correspondence or meetings with Regulatory Authorities regarding any of the foregoing, provided that SIIPL shall give VALNEVA [***] prior written notice that SIIPL will be providing any such submissions for VALNEVA’s 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 VALNEVA into such regulatory submissions (including with respect to the inclusion or exclusion of VALNEVA’s Confidential Information). SIIPL shall allow VALNEVA and CEPI to participate in meetings with the relevant Regulatory Authority as a silent observer, provided the Regulatory Authority so accepts. At VALNEVA’s and CEPI’s reasonable request, SIIPL shall request a meeting with Regulatory Authorities to address any significant unresolved issues. 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 SIIPL Product in the SIIPL Territory. Upon SIIPL’s request and without incremental charge to SIIPL, VALNEVA will provide reasonable support to SIIPL (which support shall be detailed in the Development Plan) to obtain or maintain Regulatory Approval to Commercialize the SIIPL Product in any country in the SIIPL Territory, and in the activities in support thereof, to the extent VALNEVA has the resources to do so. VALNEVA will provide letters of authorization as necessary for SIIPL to exercise its right of reference to drug master files and VALNEVA may, at either Party’srequest, participate in any meetings (in person or by teleconference) with any Regulatory Authority regarding any Regulatory Approval necessary to Commercialize the SIIPL Product in the SIIPLTerritory, in each case, without incremental charge to SIIPL.
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8. Manufacture and Commercialization
8.2 Right of Reference. Regulatory Cooperation. VALNEVA will provide SIIPL with applicable information, reports, documents, certificates, and any other materials regarding the Licensed Technology that are reasonably requested by SIIPL and necessary for SIIPL to Manufacture, have Manufactured the SIIPL Product, to Develop the SIIPL Product and to obtain and maintain Regulatory Approval for the SIIPL Product in the SIIPL Territory.
8.3 Regulatory Inquiries. VALNEVA will promptly notify SIIPL in writing of any governmental or regulatory inquiries, inspections, or audits directly related to the Licensed Technology and any findings related to the same. SIIPL will promptly notify VALNEVA in writing of any governmental or regulatory inquiries, inspections, or audits directly related to the SIIPL Product and any findings related to the same.
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8.28 Regulatory Inquiries. VALNEVA will promptly notify SIIPL in writing of any governmental or regulatory inquiries, inspections, or audits directly related to the Licensed Technology or any findings related to the same. SIIPL will promptly notify VALNEVA in writing of any governmental or regulatory inquiries, inspections or audits directly related to the SIIPL Product and any findings related to the same.
8.29 SIIPL Product Recalls and Withdrawals. Each Party will promptly notify the other in writing in detail if (a) any batch of SIIPL Product is alleged or proven to be the subject of a recall, market withdrawal, or correction in the SIIPL Territory; (b) such Party reasonably determines that a recall is necessary; or (c) such Party becomes aware of any quality or risk issues related to SIIPL Product. SIIPL will be responsible for instituting a recall, market withdrawal, or correction of the SIIPL Product at its own cost and expense unless a recall is required due solely to any Latent Defects in the VALNEVA Drug Substance. Each Party will cooperate as reasonably requested by the Party responsible for recall.
8.30 Pharmacovigilance (PV) Agreement. The Parties shall enter into a Pharmacovigilance Agreement as and when required and on mutually agreed terms between the Parties.