Master Alliance Provisions Guide (MAPGuideⓇ)
This issue refers to provisions that enable funders to assume the development and/or commercialization of funded products in the event of actual or anticipated failure by a developer to fulfil its obligations under an agreement. These provisions can be an important tool for a funder to ensure that a funded product is developed in a manner consistent with their access objectives. As shown in the MAPGuide, funders have used varying approaches and terminology for provisions related to ensuring continuity, for example Humanitarian License, Public Health License, Step-in Rights and Bayh-Dole ‘march-in’ rights.
Questions to consider when developing provisions for ensuring continuity
- What should be the conditions precedent to a funder’s exercise of continuity rights?
- Should rights for ensuring continuity vest upon execution of the agreement, or at a later stage in development?
- Should there be an escrow requirement?
- What is an appropriate scope for the continuity rights? What actions may the funder take and what are the obligations on the developer (e.g. technology transfer, material transfer, contract assignment)?
- Should there be any restrictions on the developer’s ability to transfer related IP to a third party?
Example approaches found in the MAPGuide
- The funder has a ‘Step-in’ right to develop, market or otherwise exploit the funded product, either by itself or through third parties, if the developer is not able to manufacture or deploy the product within appropriate timescale, quantity and/or cost parameters in response to an outbreak.
- Upon agreement signature the developer grants the funder a non-exclusive, fully paid-up, sublicensable and worldwide license, which is triggered when the developer fails to, or the funder reasonably expects that the developer will be unable to, take actions requested in the event of an outbreak.
- Funded entities are required to grant a non-exclusive, worldwide and royalty-free license to make, use or sell the funded development and background technology for the purpose of achieving global access, in order to further the funder’s charitable objectives.
- The developer will grant the funder a ‘Global Access License’ in connection with each project undertaken between the entities. The license will be worldwide, non-exclusive, irrevocable, fully-paid up and royalty-free and will include reasonably required background intellectual property. The license will only come into force in the event of in limited circumstances, and may only be used in a manner consistent with the funder’s charitable purpose. The developer will provide reasonable assistance as is necessary for the funder to effectively take advantage of the Global Access License.
- If the developer (i) gives notice it is discontinuing sale/manufacture of the product or is filing for bankruptcy protection; and (ii) has applied for an Emergency Use Authorization, then it is required to provide materials to enable the funder to continue manufacturing of the product with a third party. Any product manufactured under these circumstances will be for exclusive sale to the funder (US government).