MAPGuideⓇ
Equitable Access Toolkit
License Agreement Provisions to Support Product Availability
Agreement provisions related to availability could address the actions needed to make an end product available as well as making project data, results and/or materials available to the scientific community, policy makers and other stakeholders. Relevant provisions include:
Is the goal of achieving widespread availability acknowledged as part of the overall access objectives for the agreement?
What is the licensed territory? Is the license exclusive or non-exclusive? Are there any limitations in exclusivity or reserved rights to allow third parties to make the product available in underserved markets?
What is the expected procurement pathway for the licensed product? What type of commitments should the licensee make in respect of meeting demand for the access territory?
What are the available regulatory pathways? What regulatory strategy will best facilitate timely availability?
How will the design of any clinical trials under the agreement align with product registration requirements for the access territory?
Will the licensee be required to enter into sublicense and technology transfer arrangements to support widespread and timely availability of the product?
When and how will project results be published? Are there any other mechanisms through which the parties will make project data and/or materials available to the scientific community?
Should the licensee make commitments to support the rapid availability of the funded product, data or materials for health emergency response?
Will the licensee undertake any activities intended to support uptake and adoption of the product in the access territory?
What availability commitments will be established and developed as part of an evolving access plan for the product?
This toolkit has been built based on the data in the MAPGuide and the GHIAA team’s experience of negotiating and implementing agreements. We intend that the toolkit will evolve and expand over time based on input from MAPGuide users and availability of new agreements showing examples of alternative approaches. We welcome ongoing constructive dialogue around these materials and encourage you to contact us or fill in our feedback survey to share your thoughts, questions and suggestions.
