Master Alliance Provisions Guide (MAPGuideⓇ)
Access Plans & Principles
This issue is used to identify provisions that acknowledge the equitable access objectives of a project and require product developers to act in accordance with a funder’s access policies. To support compliance with these policies, funders may also require the development of an access plan which details the actions to be taken to ensure that the funded product is made accessible to populations in need.
Questions to consider when developing an Access Principles provision
- How should equitable or global access be defined?
- Should the developer be required to comply with the funder’s equitable access policies?
- Should the developer be required to establish a marketing or access plan to ensure access to products?
Example approaches found in the MAPGuide
- The parties acknowledge that the funder is making an investment in the developer to further its charitable purposes, including ensuring global access rights to low-cost medical products developed using the developer’s technology. The developer may only use funds from the investment for construction of a new manufacturing facility which will be capable of manufacturing drugs and vaccines to support the funder’s charitable purpose.
- The agreement sets out a number of ‘global access commitments’ and the developer may not enter into any arrangements that would restrict the funder’s rights in relation to those commitments. The agreement provides pro-forma language to be included in CureVac’s future agreements with third parties to ensure that the Foundation’s rights are not limited. The commitments will also survive acquisition of, or change of control in, the developer.
- The funder and developer will establish project plans for specific projects. The project plans will include product development & marketing plans, plans for product registration in access countries, and pricing for access countries
- The development and exploitation of the products must be consistent with the ‘access, not excess’ policy of the funder.
- The developer is required to prepare a ‘stewardship and access plan’ for each product that enters pivotal clinical trials. These plans will be published on the funder’s website. These obligations will survive termination or expiration of the agreement, as well as a transfer of interests in project intellectual property rights to a third party.
- The agreement acknowledges the funder’s commitment to achieving equitable access and the developer agrees that, if it commercializes the product, then distribution and pricing in LMICs will be in accordance with the funder’s equitable access and cost policies.
- The licensor will require any sublicensees that commercialize the product to do so in a manner that facilitates widespread availability.
- The developer will conduct development in a manner that ensures ‘global access’ which includes prompt and broad dissemination of knowledge and making funded products available and accessible at an affordable price.
- The agreement sets out commitments related to product registration, allocation of the product, pricing and cost of goods, which together form an Equitable Access Plan.
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