Provision Language
6. Development Plan, Regulatory Activities, Diligence, and potential Clinical Trials
6.1 The Parties agree to form a Development Committee to oversee the Development Plan and the Development activities performed by SIIPL under this Agreement and the Project Agreements. The Parties acknowledge that development oversight is necessary solely for proper reporting by both VALNEVA and SIIPL to CEPI on the progress of the SIIPL Product to be accessible to the public health market in the SIIPL Territory, at an affordable price.
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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6.8 Development and Regulatory Records. SIIPL will maintain and retain for a period of [***], complete, current and accurate records of all Development and regulatory activities conducted by it hereunder, and all data and other information resulting from such activities. Such records will fully and properly reflect all work done and Results achieved in the performance of the Development and regulatory activities in good scientific manner appropriate for regulatory and patent purposes. These records will be made available to VALNEVA upon request.
8. Manufacture and Commercialization
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8.15 Inspections and Audits. In accordance with the Quality Agreement, VALNEVA shall have the right to conduct inspections, audits and investigations of the SIIPL Facility, equipment, record keeping procedures and records related to the Manufacture of the SIIPL Product up to [***] per calendar year with at least [***] prior written notice. VALNEVA shall also have the right at its discretion to have a representative reasonably acceptable to SIIPL present in the SIIPL Facility to observe and monitor the Manufacture of the SIIPL Product. SIIPL shall provide prompt written notice to VALNEVA of any inspections or investigations by the applicable Regulatory Authority directed towards the SIIPL Product or the SIIPL Facility used in the Manufacture of SIIPL Product and shall also provide VALNEVA with an English translation of the communication received form the Regulatory Authority, such translation to be prepared by a qualified translator. Prior to submitting any written communication to the Regulatory Authorities, SIIPL shall submit to VALNEVA for review and approval, the draft communication and an English translation thereof prepared by a qualified translator. Notwithstanding anything to the contrary, should SIIPL receive a citation as a result of a regulatory inspection or should SIIPL be found by VALNEVA to be in violation of any ApplicableLaw or any terms or conditions of this Agreement, VALNEVA shall be entitled to perform for cause inspections, audits and investigations of SIIPL’s applicable facilities, equipment, record keeping procedures and records related to the Manufacture of SIIPL Product as necessary to verify that SIIPLis thereafter in full compliance with Applicable Law and all terms or conditions of this Agreement.
10. Financial Terms
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10.5 Manufacturing Reports. Upon the finalization of a Manufacturing campaign, SIIPL shall furnish to VALNEVA the following documentation: 1) the Batch Record for the batch of VALNEVA Drug Substance used for Manufacturing, and 2) a Manufacturing report indicating amount of doses of SIIPL Product Manufactured, Drug Substance Aliquots used for the Manufacture, failed batches and losses together with the amount of the then current stock of VALNEVA Drug Substance Aliquots and the amount of SIIPL Product Manufactured (“Manufacturing Report”). The Parties shall discuss and mutually agree on the format to be used for the Manufacturing Report within [***] after the Effective Date.
10.6 Sales Reports. As agreed in this Agreement, SIIPL shall furnish to VALNEVA on a country-by-country basis: 1) a sales report including Net Sales, Net Profit, amount of doses of SIIPL Product sold, the Ex Manufacturing Price of SIIPL Product sold (in both local currency and in Euros (as per Section 11.1) and specifying Batch Record and percentage of SIIPL Product sold) pertaining to the corresponding SIIPL Product sold during the preceding calendar quarter, and 2) a certificate from its Certified Auditors for the calculation of its Payment obligations for every calendar quarter (the“Quarterly Certificates”) within [***] of the end of each such quarter.
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10.9 Consistent with this Agreement and the CEPI Side Letter, SIIPL shall:
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e.) Financial audits. SIIPL shall furnish a certificate from its Certified Auditors for the calculation of SIIPL’s Payment. As used herein, “Certified Auditors” means an auditor firm duly licensed to practice as an auditor and whose lead individual responsible for audits has sufficient experience for auditing biotechnology, biopharma or pharmaceutical companies and who is responsible and liable under Applicable Law. Notwithstanding the foregoing, VALNEVA shall have the right to, on an annual basis, request SIIPL to engage, at its own cost, the European accounting firm KNAV (contact details to be provided separately) to provide an additional certificate confirming the certificate from the Certified Auditor. For clarity, the financial terms agreed under this Section 10 do not apply to any potential combination vaccine development. If the Parties enter into a separate agreement on such combination vaccine development pursuant to Section 2.3 of this Agreement, the financials related to such development shall be agreed in such separate agreement. […]
11. Payment Terms
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11.3 Certifications. As agreed in this Agreement, SIIPL shall furnish to VALNEVA Quarterly Certificates from their Certified Auditors for the calculation of its Payment obligations under this Agreement.SIIPL shall pay to VALNEVA any underpayment reflected in such Quarterly Certificate within [***] of the end of the applicable calendar quarter and may credit any overpayment based on the results disclosed by such Quarterly Certificates against future Payment obligations of SIIPL due to VALNEVA.
11.4 Reconciliation. The Parties agree to conduct an annual reconciliation of the Payments made in accordance with Section 10 and Annex 5. Within [***] after the end of each calendar year, SIIPL shall furnish to VALNEVA a certificate issued by its Certified Auditors certifying the total amount of its respective Payment obligations accrued in such preceding Calendar Year (the “Annual Recalculation Certificate”). Along with the delivery of an Annual Recalculation Certificate, SIIPL shall pay to VALNEVA any underpayment reflected in such Annual Recalculation Certificate and may credit.