Provision Language
Definitions
“Conforming Product(s)” shall mean SIIPL Product(s) that have been Manufactured in conformance with, and are otherwise themselves in conformance with, Applicable Law (including but not limited to cGMP), Regulatory Approvals, and other terms and conditions of this Agreement and the Project Agreements.
8. Manufacture and Commercialization.
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8.5 Manufacture of Conforming Product. SIIPL shall at its sole cost and expense Manufacture Conforming Product in accordance with this Agreement, including the Quality Agreement, in sufficient quantities to meet market demand in the SIIPL Territory based on the Forecasted Quantities according to Section 8.20. SIIPL and/or its Sub-licensees shall be the exclusive manufacturer of the SIIPL Product intended for sale in the SIIPL Territory.
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8.9 Quality Agreement. As between the Parties, all matters pertaining to quality control and quality assurance, stability testing and waste under this Agreement shall be governed by a separate Quality Agreement to be entered into between the Parties. Such Quality Agreement is incorporated herein by reference hereto and shall be concluded as soon as possible following the Effective Date.
8.10 Fill & Finish. In accordance with Section 8.5 SIIPL shall at its sole cost and expense Manufacture (including the fill & finish) the SIIPL Product. Manufacture shall be done at a SIIPL Facility or a facility of the Sub-licensee that (i) complies with and is maintained in accordance with Applicable Law, applicable facility specifications and other terms and conditions of the Project Agreements.
8.11 Packaging and labelling. SIIPL shall at its sole cost and expense be responsible for the packaging and labelling of the SIIPL Product and procure all required materials therefore in accordance with the Quality Agreement.
8.12 Product Testing. All SIIPL Product Manufactured hereunder will be tested for conformance according to the Quality Agreement. SIIPL shall conduct all tests that are SIIPL’s responsibility according to the Quality Agreement, at SIIPL’s sole cost and expense.
8.13 Retention of Samples. In accordance with the Quality Agreement, SIIPL shall retain a sufficient quantity of samples of each batch of SIIPL Product Manufactured hereunder to allow at least full duplicate testing by or for VALNEVA and as otherwise required by Applicable Law, including stability samples for the period required by Applicable Law. Upon VALNEVA’s request, SIIPL shall make such samples available to VALNEVA for inspection and testing in accordance with the Quality Agreement. SIIPL shall properly store the retained samples in a suitable storage facility and otherwise in accordance with Applicable Law.
8.14 Retention of Records. In accordance with the Quality Agreement, SIIPL shall maintain and retain books and records, excluding financial records, pertaining to the Manufacture and testing of SIIPL Product and as otherwise required by Applicable Law for the period required by Applicable Law including without limitation sufficient books and records to ensure SIIPL’s and VALNEVA’s ability to perform a complete lot history via lot tracing of the SIIPL Product and to otherwise ensure compliance with Applicable Law. Without limiting the generality of the foregoing, such books and records shall contain testing and quality assurance records, batch production records, deviation reports, Raw Materials, data, analytical assays and data, standard operating procedures and other process documents and records directly related to the manufacture of SIIPL Product and any other information that may berequired to be retained under Applicable Law.