Master Alliance Provisions Guide (MAPGuide)

CEPI – Valneva, Chikungunya Vaccine Funding Agreement

  • Equitable Access | Affordable pricing
  • Equitable Access | Territory access commitments

14. Equitable Access

14.1 Equitable Access. CEPI is committed to achieving equitable access to the outputs of all CEPI-supported programmes, including access to all applicable Project Results 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 Outbreak 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.

14.2 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 LMICs will be at [***]. In any case, “sustainable price” shall never be below Awardee’s manufacturing costs.

[“Awardee’s Traveler`s Market” means those countries listed below [redacted] and any country that is defined by the Organization for Economic Co-operation and Development from time to time as a high income country; provided that if any such country becomes an LMIC, such country will no longer be included in the Awardee’s Traveler’s Market and will become a Non-Traveler’s Market Country.]

14.3 LMIC Manufacturer. To facilitate achievement of the conditions set out in Clauses 14.1 and 14.2, Awardee has agreed to transfer its technology to an LMIC manufacturer as outlined in the IPDP. Without limiting Awardee’s obligations under the IPDP, Awardee will, within [***] of the signature date of this Agreement, or within such other time period as may be set out in the IPDP if the IPDP is amended in accordance with Clause 2.4, sign a Sub-Awardee agreement with an LMIC manufacturer, which Sub-Awardee agreement shall meet the requirements of Clause 3.3 and shall obligate such LMIC manufacturer to manufacture the Product for regular supply in all Non-Traveler’s Market Countries that have a demand for Product and to supply the Product to Non-Traveler’s Market Countries under the conditions of Clause 14.2. Prior to signing such Sub-Awardee agreement with an LMIC manufacturer and prior to completion of technology transfer to enable such LMIC manufacturer to manufacture and supply the Product to Non-Traveler’s Market Countries, Awardee shall fulfill manufacturing and supply obligations for Non-Traveler’s Market Countries as set out in the IPDP.

14.4 Regulatory Approvals in LMICs. Awardee will, or will obligate its Sub-Awardee(s) to, use reasonable endeavours to obtain regulatory approvals and licensure for the Product in Non-Traveler’s Market Countries where there is a demand for the Product. The Parties, through the JMAG, may discuss and agree on a list of such Non-Traveler’s Market Countries in which to seek such approvals and licensure and on a schedule for seeking such approvals and licensure, and Awardee will, or will obligate its Sub-Awardee(s) to, use reasonable endeavours to meet such schedule in such countries.