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 Outbreak Preparation Need. For clarity, the Affected Territory includes any country in Awardee’s Traveler’s Market and any Non-Traveler’s Market Countries, in each case in which there is an Outbreak or for which there is an Increased Outbreak Preparation Need.
16. Equitable Access
16.1 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 Product(s) to public health systems in all Non-Traveler’s Market Countries that have a demand for the vaccines at an affordable price (as outlined in Clause 16.4) 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.
16.2 Equitable Access Plan. The initial plan to support such Equitable Access commitment (the “Equitable Access Plan“) is set out in Annex G and sets out among other things how the Product will be suitable for Non Traveler’s Market use and made available to all populations in Affected Territories without undue delay and at an affordable but sustainable price (subject always to Clause 16.4). This Equitable Access Plan shall be reviewed by JMAG no less than every [***] and shall take into account production [***] and shall be updated throughout the Term to reflect such reviews or as otherwise agreed between the Parties. The Parties agree that a more detailed Equitable Access Plan will be agreed promptly after the Equitable Access Group is established. The Awardee will keep the JMAG and, if established, the Equitable Access Group, fully and regularly informed of its adherence to the Equitable Access Plan and its progress, or lack thereof, in meeting its objectives.
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16.4 Pricing. The parties recognize that the price of the product to public health systems in all non-Traveler’s Market Countries is critical to achieving Equitable Access. To the extent that Awardee, a Trusted Collaborator, any Sub-Awardee or LMIC Manufacturer commercializes the Product in public health systems in the Non-Traveler’s Market Countries which utilizes or otherwise benefits from, whether directly or indirectly, any Project Result, [***].
16.5. Information about Production, Supply, Pricing and Sales
16.5.1 Upon written request by CEPI, Awardee will provide, and will procure that its Sub-Awardees, LMIC Manufacturers and Trusted Collaborator provides, reasonable information about its production, supply, pricing and sales of Product, including its audited financial statements sufficient to enable CEPI to evaluate whether such activities are consistent with Awardee’s obligations under this Agreement.
16.5.2 Awardee shall ensure that its Sub-Awardee Instituto Butantan provides CEPI with updates on Sub-Awardee’s pricing discussions with relevant pricing authorities within Brazil and the other Non-Traveler’s Market Countries awarded to Butantan, including public sector procurement agencies such as AVAT, GAVI, PAHO, and various Ministries of Health, as applicable. Further, Sub-Awardee shall share with CEPI any official pricing data submitted to CMED and CONITEC in Brazil and to other relevant pricing authorities outside of Brazil.
18. Preparation for Outbreaks
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18.8 Outbreak in Awardee’s Traveler’s Market. 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 18 and 19 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 lowest supply price of the Product for similar volumes of Product agreed by Awardee with any customer in the Affected Territory in the [***] preceding the receipt of the Outbreak Notice by Awardee. For purposes of this Clause 18.8, “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’s Traveler’s Market that is included in the Affected Territory, the terms of Clauses 18 and 19 shall apply to such country in the Awardee’s Traveler’s Market 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 fulfil due to Awardee’s capacities or (ii) the price proposed by the public health agency would be unsustainable to Awardee, Clauses 18 and 19 shall not apply in such case. In any case, “sustainable price” shall never be below Awardee’s manufacturing costs.
