Provision Language
<p><em><strong>Definitionsstrong>em>p>
<p>“<strong>Increased Outbreak Preparation Needstrong>” means 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 Product to address potential Outbreaks.p>
<p><span style=”text–decoration: underline;”><strong>14. Equitable Accessstrong>span>p>
<p><strong>14.1 Equitable Access.strong> CEPI is committed to achieving equitable access to the outputs of all CEPI–supported programmes, including access to all applicable <a href=”#kt“>Project Resultsa> in accordance with this Agreement, pursuant to CEPI’s “Equitable Access” Policy. Equitable Access to Chikungunya vaccines means the regular supply of the vaccines in all Non–Traveler’s Market Countries that have a demand for the vaccines at an affordable price (as outlined in Clause 14.2) and, in the context of an <a href=”#kt“>Outbreaka> or Increased Outbreak Preparation Need, means that appropriate vaccines are first available to populations in the Affected Territory when and where they are needed, including to end an Outbreak or curtail an epidemic, regardless of ability to pay. Consistent with CEPI’s Equitable Access Policy, CEPI is also committed to supporting Equitable Access so that the economics are sustainable to the manufacturer.p>
<p><strong>14.2strong> With respect to pricing, the Awardee will ensure that : to the extent that Awardee commercializes Product which utilizes or otherwise benefits from, whether directly or indirectly, any Project Result, (i) the distribution of the Product in Non–Traveler’s Market Countries that are LMICs will be [***], and (ii) the distribution of the Product in Non–Traveler’s Market Countries that are not <a href=”#kt“>LMICsa> will be at [***]. In any case, “sustainable price” shall never be below Awardee’s manufacturing costs.p>
<p><span style=”text–decoration: underline;”><strong>16. Preparation for Outbreaksstrong>span>p>
<p>[…]p>
<p><strong>16.7 Outbreak in Awardee’s Traveler’s Market.strong> Notwithstanding anything to the contrary herein, in the event any country in the Awardee’s Traveler’s Market is included in the Affected Territory, Clauses <span style=”text–decoration: underline;”><a href=”https://ghiaa.org/provision_document/cepi–valneva–chikungunya–vaccine–funding–agreement–3/” target=”_blank” rel=”noopener“>16a>span> and <span style=”text–decoration: underline;”><a href=”https://ghiaa.org/provision_document/cepi–valneva–chikungunya–vaccine–funding–agreement–10/” target=”_blank” rel=”noopener“>17a>span> shall not apply to such country in the Awardee’s Traveler’s Market on the condition that Awardee shall, at the request of public health agencies in such country in the Awardee’s Traveler’s Market, supply the Product to all such public health agencies that request the Product in a quantity and at a price as agreed with the relevant public health agencies. The price agreed with the relevant public health agency shall not exceed the [***]. For purposes of this Clause 16.7, “similar volume” shall mean a volume within the range of [***]. For clarity, if Awardee fails to comply with the foregoing supply obligation with respect to any country in the Awardee’sTraveler’s Market that is included in the Affected Territory, the terms of Clauses 16 and 17 shall apply to such country in the Awardee’s Traveler’sMarket that is included in the Affected Territory. However, if the reason why Awardee cannot comply with the supply obligation is that (i) the quantity of Product requested by the relevant public health agency is impossible to fulfill due to Awardee’s capacities or (ii) the price [***] would be unsustainable to Awardee, Clauses 16 and 17 shall not apply in such case. In any case, “sustainable price” shall never be below Awardee’s manufacturing costs.p>
