Master Alliance Provisions Guide (MAPGuideⓇ)
Territory Access Commitments
This issue in the MAPGuide refers to provisions that require product developers to apply for regulatory approval and make the approved product available in certain markets.
Questions to consider when developing a territory access commitments provision
- How should ‘territory’ be defined under the agreement? Should the definition make a distinction between different types of purchaser (e.g. public sector vs. private sector)?
- Should the developer be required to commit a proportion of the product manufactured to a certain country or group of countries?
- Should there be any commitments to identify and conduct technology transfers to additional manufacturers who could rapidly manufacture the funded product?
- What commitments should the developer make to develop a regulatory strategy for specific territories?
Example approaches found in the MAPGuide
- Development & License Agreements:
- The developer intends to ensure that products intended for use in a specified group of ‘access countries’ are used in those countries only. If the developer believes that parallel imports are occurring, then the parties will collaborate in good faith to take any action they agree is necessary.
- The sublicensee will use all reasonable efforts to provide an adequate supply of the licensed products to meet the therapeutic needs in the defined territory and will provide a strong supply network to support distribution of the products.
- The licensee agrees that they will make the product available to patient assistance programs.
- Developing countries classified as “upper middle income” countries by the Word Bank are subject to less stringent access restrictions, and the developer may obtain full or partial exclusivity in those territories to the extent consistent with the funder’s obligations and objectives in those countries.
- The developer will use commercially reasonable efforts to meet the supply requirements of public sector purchasers in the defined group of developing countries.
- Technology Transfer Agreements:
- The territory for exploitation is limited to the public market in order to meet the needs of the government health system in the contracting country