Provision Language
Definitions
“Commercial Benefits” means any economically quantifiable benefits that arise from the commercial exploitation of the Project Results other than in preparation for or in response to an Outbreak or Increased Outbreak Preparation Need. Examples of Commercial Benefits include the commercial licensing of Project IP, receipt of government-granted incentives such as Priority Review Vouchers and revenue from the commercialization of combination, derivative or follow-on products (including antibody products, assays and vaccines) or application of production technology.
17. Sharing of Commercial Benefits
17.1 Sharing of Commercial Benefits. CEPI has committed to its own funders to obtain a share of Awardee’s Commercial Benefits as a contribution to support CEPI’s programme activities.
17.2 The Awardee will: ensure any LMIC manufacturer – other than Instituto Butantan who shall remain bound by the safety stock requirements agreed under the prior funding agreement between the Parties, effective as of 1 April 2019, as amended – shall make the following contributions to CEPI:
i. Until the rolling safety stock has been established by each LMIC Manufacturer in accordance with Clause 17.2(ii), Awardee will ensure that the LMIC Manufacturer, at its own cost, maintain and make available to CEPI an Investigational Product reserve stockpile of [***] doses of drug product
ii. Awardee will ensure the LMIC Manufacturer produces, at its own cost, a one-year rolling safety stock comprised of not less than [***] doses of Finished Drug Product within [***] of receipt of marketing approval for the Product from a competent regulatory authority having jurisdiction over the relevant LMIC Manufacturer. The stock in paragraph 17.2(i) and this paragraph 17.2(ii) is referred to as (“Safety Stock“).
iii. Awardee will provide details of the Safety Stock to the global Technical Advisory Group to monitor Global Virtual Pooled Inventory (“TAG-GVPI“) once the TAG-GVPI is established.
iv. In case of an Outbreak or Increased Outbreak Preparation Need, CEPI may utilize such Safety Stock in the Affected Territory by giving notice in writing to Awardee and Awardee will ensure the LMIC Manufacturer dispatches all or some only of the Safety Stock, as instructed by CEPI and CEPI shall pay any reasonable costs incurred in connection with the utilization of the Safety Stock, including but not limited to transportation, distribution and storage in the Affected Territory. For clarity, Awardee shall ensure the LMIC Manufacturer makes no charge for the supply of the Safety Stock allocated to and used by CEPI in accordance with this paragraph 17.2(iv) and the storage costs of such Safety Stock, incurred prior to dispatch to the Affected Territory, shall be borne by the LMIC Manufacturer.
v. If the Safety Stock is used by CEPI in the case of an Outbreak or Increased Outbreak Preparation Need, CEPI or such third parties as CEPI may nominate shall be responsible for the costs of transportation of such Safety Stock from the LMIC Manufacturer’s facility. If, following the use of the Safety Stock as directed by CEPI, CEPI wishes to replenish the Safety Stock, Awardee shall, or shall obligate its LMIC Manufacturers to, produce such quantities of Product as are required to replenish the Safety Stock and CEPI shall pay Awardee for the costs of the production of such Product.