Table 3.

Terms for key provisions in CEPI’s most recent call for proposals.

Key Provision	Brief Description of Terms for Negotiation
Equitable access and its relationship to price
Equitable access	Vaccines and other products developed with CEPI’s financial support must first be made available to populations when and where they are needed to end an outbreak or curtail an epidemic.
Cost and price	An investigational stockpile of vaccines having completed Phase II clinical trials will be established and available for distribution free of charge upon the occurrence of a disease outbreak or for use in clinical trials, as needed. Contractual obligations to expand or replenish stockpiles as needed and to ensure access to vaccines if they successfully complete the necessary field efficacy trials will also be a condition for CEPI support. Those access conditions include agreed upon methodologies to determine the cost of vaccines and their price. CEPI will work with other stakeholders to develop approaches to replenish the stockpile and maintain a manufacturing base, understanding the need for creative solutions for vaccines with very limited markets.
Ensuring vaccine development progresses as planned
The Public Health License	If CEPI determines that the awardee is unable or unavailable to develop the product as agreed, then CEPI will have the access to and the right to use materials, data, information and relevant background intellectual property to continue product development (through a “Public Health License” or “PHL”). A PHL consists of the package of materials (such as cell lines) and rights necessary to enable the research, development and manufacturing work on a given project to proceed. Such a license will enable CEPI to find another manufacturer (agreed-upon by both CEPI and awardee) to use the information and IP to continue the development of the product.
Management of intellectual property (IP)
Intellectual property	Awardees may choose to obtain intellectual property rights (such as patents or copyrights) for inventions, research materials, data bases and the like developed using funding from CEPI. If they seek such intellectual property protection, it will be at their own cost and they must promptly notify CEPI. Awardees commit themselves to manage the Project IP in a manner that complies with CEPI’s equitable access obligations. CEPI will monitor awardees adherence to that commitment. There is also the possibility that third parties may have IP rights that an awardee may need to use during the performance of a project funded by CEPI or to make and distribute vaccines arising from CEPI funding. If such third-party IP rights exist, the awardee will so notify CEPI and indicate how it will secure the necessary licenses or other permission to proceed.
Shared risk/benefit
Sharing of commercial benefits	In cases where CEPI-funded vaccines become commercially viable, CEPI will take an equitable and proportional share of any commercial revenues received by the awardee from the sale of the product in a non-outbreak situation. Either by sharing of funds or services to support CEPI’s work (e.g., funds used to support CEPI’s future awards, using a certain number of CEPI-funded vaccine doses for distribution as determined by CEPI, use of awardee services in support of CEPI’s mission), CEPI will secure the full value of its inputs and reinvest those in pursuing its mission.
Data sharing and transparency
Dissemination and publication of project data and project materials	CEPI requires the timely publication and other dissemination of project data, including clinical study data. CEPI may require awardee to share project data with other awardees developing products against the same diseases. CEPI has committed to “Open Access” for project data, requiring that any final manuscripts of the research results must be publicly available and published in accordance with globally accepted standards, in particular the principles of “Plan S” (https://www.scienceeurope.org/wp-content/uploads/2018/09/Plan_S.pdf), an initiative developed by Science Europe regarding open access publishing. CEPI has committed to “Open Data” for project data, requiring that clinical data and results (including negative results) must be made publicly available as soon as possible after results are known in accordance with CEPI’s Transparency Policy (e.g., such data must be shared through an easily discoverable public route (website or system) that includes a metadata description, where patient privacy is upheld, and the system allows others to request the information). In addition, awardees must make public (on a clinical study register) the details of any clinical study conducted before any patients are recruited for the study. Awardees also will share clinical study results as close to real time as possible. CEPI requires the timely sharing of biological samples, candidate vaccines and other tangible materials produced under the Project, including with the scientific community to advance research.
Other
Accountability for the commitment to equitable access	CEPI will include a review of compliance with equitable access in its stage-gate reviews, which are reviews conducted by CEPI at key points in the technical development of vaccines or platforms it funds. The CEPI Board will maintain oversight on implementation of the equitable access policy through reviews of provisions in the funding agreements it concludes.