MAPGuideⓇ: Provision Database Methodology
On this page you will find our methodology for selecting agreements included in the MAPGuide provision database, and an explanation of our agreement type classifications. You can read more about our categorization of provisions by issue here.
Criteria for inclusion: Any actual, template or model contract related to the research, development, manufacture, commercialization and/or supply of a medical product with the aim of addressing global public health needs.
Data sources: SEC filings, government freedom of information disclosures, global health funder and non-profit websites, redacted agreements contributed directly to GHIAA.
Completeness of data: The collection of agreements in the MAPGuide should not be viewed as a ‘complete’ or ‘final’ set of the available data. As a resource constrained, small non-profit organization, GHIAA has a backlog of agreements to be analyzed and published, and is continuously searching for new relevant agreements. The MAPGuide contains agreements that organizations either must publish under legal or regulatory requirements, or are contributed to GHIAA. A limitation to our content is the significant number of agreements that organizations are not required or willing to make publicly available.
How to contribute: We encourage all organizations, whether public, private, academic or non-profit, to support GHIAA’s mission by contributing global health agreements to the MAPGuide. GHIAA accepts redacted and anonymized agreements, as well as extracts of relevant provisions (e.g. equitable access obligations). If you would like to submit an agreement, please contact email@example.com or complete this form.
Guide to Agreement Types
The ‘agreement type’ classification in the MAPGuide is based on the primary purpose of the agreement, often as stated in the agreement title or recitals.
Research and development (R&D) funding agreements: The primary purpose of an R&D funding agreement (sometimes also referred to as a grant agreement) is for one party to provide funds to another party to support the development of a medical product, in exchange for compliance with certain conditions.
R&D collaboration agreements: The primary purpose of an R&D collaboration agreement is to enable two or more parties to work together on the development of a medical product. The parties to an R&D collaboration agreement usually share their intellectual property for the purpose of the joint research and/or product development, therefore the agreements often have elements in common with licensing and technology transfer agreements.
License agreements: The primary purpose of a license agreement is the grant of rights from an intellectual property (IP) owner (licensor) to a third party (licensee), to allow the licensee to use the licensor’s IP for certain purposes, usually in exchange for a financial consideration. The rights granted under a license agreement usually relate to IP protected by patents, but they sometimes also include a transfer of related knowledge and materials which are not protected by patents and may therefore have some elements in common with a technology transfer agreement.
Technology transfer agreements: The primary purpose of a technology transfer agreement is to transfer the data, materials, documentation and knowledge needed for the transfer recipient to successfully use the intellectual property of another party for the development and/or manufacture of a medical product. These agreements often include detailed technology transfer plans and success criteria setting out the steps to be taken to complete the transfer. Since technology transfer agreements relate to the use of one party’s IP, they often have elements in common with license agreements.
Contract manufacturing agreements: The primary purpose of a manufacturing agreement is for a product developer to contract a third party (often referred to as a contract manufacturing organization, or CMO) to manufacture a product on the developer’s behalf. The CMO might then supply the finished product back to the developer, or alternatively sell it to a third party purchaser. Contract manufacturing agreements often require a grant of rights for the CMO to use the developer’s IP, as well as the transfer of sufficient information to enable the CMO to replicate the developer’s production processes, therefore these agreements often have elements in common with both license and technology transfer agreements.
Purchase and supply agreements: The primary purpose of a purchase and supply agreement is for one party to receive a product from another party, usually in exchange for a financial consideration. These agreements may be used for the purchase of finished product, or for components needed to manufacture a finished product (for example, adjuvant for a vaccine).
As noted in the descriptions above, the full scope of an agreement may mean that it has elements in common with other agreement types or is a combination agreement. These elements can be explored more easily using issue searches in the MAPGuide rather than filtering your search on an agreement type. In particular:
- Many agreements include a license grant for certain purposes or in certain circumstances. Search on the ‘License Grants’ issue to see a full list of examples.
- Technology transfer obligations can be found in a number of agreements, even when technology transfer is not the main focus of the agreement. Search on the ‘Technology Transfer’ issue to see a full list of examples.
- Supply of a product from one organization to another may be provided for in agreements other than purchase & supply agreements. Search on the ‘Product Supply’ issue to see a full list of examples.