Provision Language
Definitions
“VALNEVA Drug Substance” shall mean the active ingredient of the VALNEVA Product as further defined in the Drug Substance Supply Agreement.
8. Manufacture and Commercialization.
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8.7 VALNEVA Drug Substance. During the Term of this Agreement VALNEVA will supply VALNEVA Drug Substance to SIIPL for the Manufacture of the SIIPL Product. The terms and conditions of such VALNEVA Drug Substance supply are set forth in the Drug Substance Supply Agreement. For clarity, any Sub-licensee will have to enter into a separate supply agreement with VALNEVA for the supply of VALNEVA Drug Substance to such Sub-licensee.
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8.19 Manufacturing Capacity. SIIPL shall at all times during the Term of this Agreement maintain the capability to Manufacture the SIIPL Product in sufficient quantities 1) to satisfy market demands in the SIIPL Territory based on the Forecasted Quantities according to Section 8.20, and 2) the Safety Stock agreed under the CEPI Side Letter.
8.20 Market Demand Forecasts. No later than [***] prior to the anticipated First Commercial Sale of the SIIPL Product, and thereafter on a quarterly basis, SIIPL shall submit to VALNEVA a [***] rolling forecast of the estimated quantity of SIIPL Product to be Manufactured by SIIPL to satisfy market demands in the SIIPL Territory (“Forecasted Quantities”).
8.21 Manufacturing Shortfall. Manufacturing Shortfall and Failure to Supply. In the event that SIIPL anticipates, or in the event SIIPL’s actual Manufacturing capacity will, or does not meet Forecasted Quantities resulting in a shortfall (“Manufacturing Shortfall”), SIIPL shall immediately notify VALNEVA in writing of any such anticipated or actual Manufacturing Shortfall. If an anticipated or actual Manufacturing Shortfall is expected to last more than [***], the Parties shall promptly upon receipt of notice meet to discuss SIIPL’s efforts to remedy the Manufacturing Shortfall and ways to maintain its Manufacturing capacity. Furthermore, upon VALNEVA’s request, SIIPL shall provide VALNEVA with all materials, documents and other information relevant to confirm SIIPL’s efforts and their respective status.
8.22 During a period whereby SIIPL is in a Manufacturing Shortfall situation, and upon notice of such Manufacturing Shortfall situation, the Parties shall discuss in good faith the potential supply of VALNEVA’s or any designated Third Party’s, chikungunya product into the SIIPL Territory for as long as the Manufacturing Shortfall situation remains so as to preserve the availability of a chikungunya product within the SIIPL Territory.
8.23 In the event that (i) SIIPL is in Manufacturing Shortfall and does not cure such Manufacturing Shortfall within [***] from the date of VALNEVA’s receipt of notice thereof, such Manufacturing Shortfall shall be deemed a material breach for purposes of this Agreement.