Provision Language
6. Development Plan, Regulatory Activities, Diligence, and potential Clinical Trials
[…]
6.5 Diligence Obligations. SIIPL will perform all activities set forth in the Development Plan in accordance with Applicable Law and use its best efforts to perform all such activities in accordance with the applicable timeframes set forth in the Development Plan, including but not limited to the obligation to apply for and use Commercially Reasonable Efforts to 1) obtain Regulatory Approval and/or licensure of the SIIPL Product within the SIIPL Territory, 2) obtain WHO prequalification, and 3) Commercialize the SIIPL Product in the SIIPL Territory. The Parties have agreed that SIIPL shall prioritize and use Commercially Reasonable Efforts to obtain Regulatory Approval and licensure of the SIIPL Product in the Key Countries. SIIPL shall use best efforts to implement the Launch Readiness Plan for Key Countries in accordance with agreed timelines. In case SIIPL fails to provide and implement such Launch Readiness Plan within the agreed timelines, Section 4.5 shall apply. SIIPL shall use Commercially Reasonable Efforts to apply for WHO prequalification no later than[***] after Regulatory Approval in India. SIIPL shall further use Commercially Reasonable Efforts to pursue UNICEF procurement of the SIIPL Product within the SIIPL Territory within [***] of obtaining WHO prequalification. SIIPL shall use best efforts to ensure the SIIPL Product is added onto the National Immunization Program of India and other Key Countries within [***] of Regulatory Approval of the SIIPL Product in India and other Key Countries, as applicable.
8. Manufacture and Commercialization.
[…]
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.
[…]
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 theSIIPL 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”).
Annex 1. SIIPL Territory
Key Countries: [***]
Additional countries: [***]
Key Countries and additional countries listed above together referred to as the SIIPL Territory.
In addition, within the SIIPL Territory, SIIPL shall have the exclusive right to supply and sell the SIIPL Product to:
(i) UNICEF, and
(ii) any Public and governmental agency.
The Parties acknowledge and agree that they shall engage in discussions, together with VALNEVA’s other licensees, regarding the territorial scope of exclusive, or non-exclusive supplies to UNICEF and GAVI respectively before end of 2025.