Provision Language
Definitions
“Affected Territory” means any country, or any geographic area within a country, in which there is an Outbreak or for which there is an Increased Preparation Need.
“Increased Outbreak Preparation Need” shall mean when, having considered all reasonably accessible and relevant information including epidemiological data, travel and migration patterns and the likely availability of other products or product candidates, CEPI determines, in its sole discretion in consultation with experts (for example a sub-group or subcommittee of CEPI’s Scientific Advisory Committee that CEPI determines has appropriate expertise), that there is a heightened need for the SIIPL Product to address potential Outbreaks.
“Outbreak” means a public health emergency on a national or regional scale declared by one or more public health agencies, in each case as a result of a material increase in the number of cases of people infected with chikungunya including any regional outbreak, an epidemic or a pandemic.
WHEREAS:
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(D) VALNEVA has entered into a funding agreement with CEPI (as defined below) aiming to accelerate Regulatory Approval of the VALNEVA Product, secure supply of the chikungunya vaccine in regions where there is an Outbreak or an Increased Outbreak Preparation Need and, support WHO prequalification to facilitate broader access in low- and middle-income countries. VALNEVA and SIIPL have agreed to enter into this Agreement to address the needs of a chikungunya vaccine in the SIIPL Territory (as defined below);
8. Manufacture and Commercialization.
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8.25 Equitable Access Plan. SIIPL acknowledges and agree that the objectives with this Agreement are to (i) speed up the development of a chikungunya vaccine in the SIIPL Territory, (ii) ensure that there is a regular supply of the SIIPL Product in countries that have a demand for the vaccine at an affordable price, and (iii) in the context of an Outbreak or an Increased Outbreak Preparation Need to ensure that the SIIPL Product is first available to populations in the Affected Territory when and where they are needed. Based on the aforementioned, the initial plan to support such objectives (the “Equitable Access Plan“) set out in the CEPI Side Letter outlining, among other things, how the SIIPL Product will be made available to all populations in the SIIPL Territory and Affected Territories without undue delay and at an affordable price.