ANNEX. Comparison of the Four Pillars of ISGlobal’s Preferred Supplier Model and CEPI’s Policies

ACCESS

necessary data. health impact, with collection of the whom the product represents a greater prioritising those most in need for Equitable access to the final product, of the new drugs. regulatory and market access situation will also take into consideration the are urgently needed. The model which new treatments and diagnostics priority diseases (to be defined) for in neglected, chronic and other high a tangible share of its R&D efforts preferred supplier will have to invest the public health needs of society, the biomedical research agenda prioritises Sharing needs: to ensure that the

manufacturing, supply, and availability. be sustainable for the awardee to maintain to optimal marginal cost as possible, must Prices, while set as low as possible and as close populations in need. to best facilitate timely and sustainable access for availability, volume of doses and regulatory steps licensed vaccine in countries, manufacturing and in terms of registration and launch of the be determined, and (ii) the awardee’s obligations boundaries for the price of a licensed vaccine will awardee will set out (i) the processes by which the The individual contract between CEPI and the ● Equitable access to the final product. »

conducting phase 3 clinical trials. stockpiles for emergency use and its use for access to and release of investigational vaccine Follow WHO recommendations with respect to awardee does not have capability/capacity. volumes with awardee or with a third party if Negotiation of manufacturing commitments and emergency of international concern. Equitable access during an epidemic or a public health

investigational stockpile and any additional doses. of doses of each of the project vaccines for both the such volume will be achieved. An estimate of the cost Vaccines that may be produced and dates by when Estimates of number of doses of each of the Project the scale-up where such scale-up is necessary. manufacturing and a good-faith estimate of the cost of A progress report on the scale-up of the platform for Affected Territories. sector agency agrees is affordable for use in the ensure that the vaccine price is at a level the public- Partners have also agreed to measures that will equitable access and is sustainable for the manufacturer. to protect global health at a price that does not limit deployment and administration of licensed vaccines community to ensure the procurement, allocation, Collaborating with other actors in the global health clinical trials. by CEPI, including by securing resources for pivotal community to enable licensure of vaccines funded Coordinating with other actors in the global health when an outbreak occurs. investigational stockpiles to be used free of charge Funding the development of vaccines and maintaining

MODEL PRINCIPLES PREFERRED SUPPLIER

CEPI-INITIAL

CEPI-REVISITED

Preferred Supplier Model and CEPI’s PoliciesComparison of the Four Pillars of ISGlobal’s

ANNEX

TRANSPARENCY

in the pricing negotiation. assets, which will be taken into account production cost of new products and be required to share information on the recipient of the public R&D funds will about production and R&D costs: the Other aspects, such as transparency R&D efforts. relevant information to inform future creation of a public database with data could be especially useful in the ultimately been abandoned. Those related to drug candidates that have results and all the information provide access to the clinical trial results, a preferred supplier will and better access to clinical trials transparency, sharing of information Sharing results: to promote greater

the vaccine, and other relevant information. other mechanisms for recovering cost of manufacturing manufacturing capacity, procurement agreements, and existing comparable products, cost of maintaining goods, expected volume/scale of production, price of philanthropic investments in the vaccine, cost of take into account information about public and transparent and agreed methodology that will related to pricing will be established through a CEPI and the awardee will agree that obligations results) via a public route. well as sharing of data and results (including negative accessible database before patient recruitment as This includes registering clinical trials in a publicly follow-on research that will increase innovation. with the broader scientific community to foster all data and information arising from CEPI funding publications are obligatory and awardees must share Public disclosure of results and open access of

final publication. or immediately after the publisher’s official date of made freely available upon acceptance for publication must be deposited in PubMed Central or otherwise manuscript of all research publications published to be published open access. A copy of the final CEPI requires all results arising from their funding discoverable public route. must be disclosed publicly through an easily Clinical data and results (including negative results) the Agreements. of confidentiality and ownership rights under subject to reasonable protection for partners’ rights diagnostics and epidemic preparedness mechanisms, assays, animal models, correlates of protection or to topics of interest, such as disease-specific Requiring partners to share project data relevant

IP & PRICING

of the final price. taken into account in the negotiation of the new asset so that these can be the real R&D and production costs be required to share information on The recipient of public R&D funds will the donor a say in such decisions. also influence the final price, giving arising from the end product. It will participation in the commercial benefits will impact IP protection and/or The amount of public funding

equitable access obligations. advance development of the vaccine candidate or meet or multiple third-parties is deemed necessary to candidate if facilitating technology transfer to one knowledge and materials related to the vaccine know-how, trade secrets, and other undisclosed upfront in the contract for accessing the awardee’s CEPI will be entitled to activate arrangements agreed in the event of a defined trigger. vaccine candidate or meet equitable access obligations to enable third-parties to advance development of the worldwide license of foreground and background IP and the awardee will agree a process to activate a vaccine development and equitable access, CEPI When the awardee is unable or unwilling to further foreground IP related to priority pathogens. worldwide license on necessary background IP and IP, but rather to seek a non-exclusive, sub-licensable, CEPI’s preferred approach is not to take ownership of

or manufacturing to continue. licences and technology transfer to enable the research the original partner would provide the necessary IP agreed to by CEPI and the original partner to whom Trusted Partner. This would be an entity jointly Ensure project continuity by using a Preferred or forward with another partner. and to access the materials and data needed to move rights allow CEPI to use and/or sublicense IP rights partnering agreement. Once triggered, the step-in reasonable efforts to fulfil its obligations under the obligations or cannot, will not, or has not used Step-in rights if the partner is in breach of its

GOVERNANCE

multilateral organisations. groups as well as investment banks and associations, civil society and advocacy all stakeholders, including patient indicators should involve and consider The development of metrics and international level. applicable at national, regional and the public sector. This model could be criteria if they want to engage with Companies would have to fulfil these appropriate metrics and indicators. direct existing mechanisms by way of of a set of principles that will help to supplier model entails the development The implementation of a preferred

equitable access during a public health emergency. stakeholders; and expedite regulatory approval and data and results to facilitate collaboration between make use of global platforms for sharing clinical trial consistent with global norms and with the WHO; adopt and implement data-sharing best practices In support of ongoing global efforts, CEPI will revise, conducting and completing phase 3 clinical trials. on the use of investigational vaccine stockpiles for WHO, affected countries and other partners, decide stockpiles for emergency use; and, together with the access to and release of the investigational vaccine Follow the WHO’s recommendations with respect to which necessitates emergency use, CEPI will: In the case of an epidemic or a PHEIC declared by WHO,

BENEFITS SHARED RISKS/

a say in those decisions. as the final price and the donor will have associated with the final product as well participation in the commercial benefits on the IP protection and/or the funding received will have repercussions the R&D cycle. The amount of public investment received at any point in publicly acknowledge all forms of public development, a preferred supplier would of the R&D risks at every stage of the balanced and transparent distribution Sharing risks: to ensure a more

a non-profit organisation. pool for re-investment in other projects since CEPI is by CEPI will immediately be returned to the funding during contracting. Any commercial benefits recouped entered into with awardees on a case-by-case basis the principles by which specific arrangements will be commensurate with CEPI’s investment. These are and equivalent benefit-sharing arrangement such commercial benefits or choose an alternate accrue to the awardee, CEPI will recoup a share of In circumstances in which commercial benefits may

the Parties shall execute in a timely manner.” sharing shall be subject to a separate agreement that private or ancillary benefit that may arise. Any benefits the proposed Development and Exploitation, and any of the CEPI Funding, the public benefit derived from being exploited, the public and philanthropic nature Product Background IP and Product Foreground IP financial contribution of each of the Parties to the and proportionate manner, taking account of the (if any) arising are to be managed in a fair, equitable “The Parties shall agree in good faith how such benefits