MAPGuideⓇ
Equitable Access Toolkit
Establishing Equitable Access Objectives in License Agreements
License agreements can approach equitable access in different ways, for example:
As the sole or primary purpose of the license, potentially pursuant to one or both parties’ mission, policies, or obligations under an R&D funding agreement;
As a secondary objective of the license alongside commercialization of the licensed product in major markets; or
Not as a direct objective or expectation of the agreement, but with humanitarian use or other IP rights management provisions that are designed to allow others to pursue activities intended to facilitate equitable access to the product.
When facilitating equitable access to an end product is one of the direct objectives of the agreement, it can be useful to discuss these principles early on in agreement negotiations. This can help to align expectations both for the commitments to be made in the agreement, and for the conduct of future activities related to the licensed rights.
The access principles discussed during agreement negotiations can be documented as a statement in the preamble and/or as a provision in the main body of an agreement affirming the parties’ commitment to, and understanding of, the equitable access objectives for a licensed product.
The inclusion of an “access principles” provision in a license agreement may also be useful if a licensee later fails to fulfil its access obligations, as it could be leveraged in dispute resolution proceedings to demonstrate that the licensee was always aware of the licensor’s equitable access objectives.
Examples from the MAPGuide
WHEREAS, [PDP] is a not‐for‐profit entity whose mission is to develop safe, effective, field adapted and affordable new treatments for people suffering from neglected diseases, and ensure equitable access to such treatments (the “Mission”);
WHEREAS, acting in the public interest, [PDP] bridges existing research and development (“R&D”) gaps for these diseases by initiating and coordinating drug R&D projects in collaboration with the international research community, the public sector, the pharmaceutical industry and other relevant partners;
[…]
WHEREAS, Partner and [PDP] desire to collaborate to undertake a development and distribution program with respect to such Molecule, which includes clinical development, manufacture and distribution of a Product on an Affordable Basis in the Territory.
Source: taken from DNDi’s template Development Collaboration and License Agreement. Partner types: PDP, industry/academic institutions; Product type: treatments for neglected diseases; Development stage at signature: template intended for use from Phase 1 clinical trials through to proof of concept in humans. Read in context.
WHEREAS, as part of its public mission to bring products to the marketplace, [Licensor] uses good faith efforts to enable underserved communities, which have limited access to adequate quantities of medical innovations arising from [Licensor’s] laboratories, to have affordable access to these innovative products.
Source: taken from a license agreement between UCLA (Licensor) and Radiopharm Theranostics (Licensee). Partner types: academic institution, industry; Product type: cancer treatment (“DUNP19” antibody); Development stage at signature: pre-clinical. Read in context.
The [Licensor] has developed a [technology] which may help reduce the oral dosage of certain [treatments] and therefore may help reduce the cost of such [treatment] regimens. The [Licensor] would like to maximise the impact of this technology and to reach as many people living with [disease] as possible, in the most affordable manner for low- and middle-income countries. The [Licensor] acknowledges that outside the Territory (namely high income countries) access to drugs in low income groups can also be a challenge and the [Licensor’s] licensing strategy for [disease] drugs and other essential medicines aims to be socially responsible.
Source: taken from a license agreement between the University of Liverpool (Licensor) and MPP (Licensee). Partner types: multilateral, academic institution; Product type: HIV therapeutic (nanomedicine); Development stage at signature: early clinical. Read in context.
The common objectives of the Parties are to enable Sublicensees (as defined below) to provide, with a sense of urgency, affordable and sustainable access to quality Licensed Product (as defined below) for patients in need in countries in the Territory (as defined below) while preserving the efficacy and appropriate use of the Licensed Product and encouraging good antimicrobial stewardship (the Access and Stewardship Objectives).
Source: taken from a license and technology transfer agreement between Shionogi (Licensor) and GARDP (Licensee). Partner types: PDP, industry; Product type: antibiotic (cefiderocol); Development stage at signature: licensed product on WHO EML. Read in context.
Both Parties acknowledge that the key objective of this Agreement is to ensure that Licensed Products are made widely available as quickly as possible and on a continuing basis, at an affordable and sustainable price, to the Public Sector of Low– and Middle–Income countries and in sufficient quantities to meet the needs of those countries (the “Access Objective”). [Licensor] acknowledges that in High Income Countries (“HICs”), access to drugs in low income groups can also be a challenge and [Licensor’s] licensing strategy for HICs aims to be socially responsible.
Source: taken from a patent and know-how license between the University of Washington (Licensor) and the Medicines Patent Pool (Licensee). Partner types: multilateral, academic institution; Product type: HIV therapeutic (long-acting injectable); Development stage at signature: pre-clinical. Read in context.
[Company] and [PDP] acknowledge and agree that it is their common intent that any Product will be made available in a manner (including price considerations) that facilitates its widespread use in [Disease]-Endemic Countries.
Source: an extract of language used in MMV (PDP) development agreements. Partner types: PDP, industry; Product type: malaria therapeutics; Development stage at signature: early- through late-stage development.
WHEREAS, [Licensor] entered into a grant agreement [number] with [Funder] […] with the key objective to Develop and Commercialise the Final Product as a complementary vector control method to reduce [disease] transmission.
WHEREAS, under the [Funder] Agreement, [Licensor] agreed to grant to [Licensee] a licence under the Licensed Technology solely to allow [Licensee] to enter into sub-licence agreements for the Development and Commercialisation of the Final Product in the Field for the benefit of the Public Sector in the Territory in order to achieve the Access Objective required by [Funder] under the [Funder] Agreement.
Source: taken from a license agreement between MedinCell (Licensor) and MPP (Licensee). Partner types: industry, multilateral; Product type: malaria vector control (long-acting ivermectin injectable); Development stage at signature: pre-clinical. Read in context.
WHEREAS, Licensee has represented to [Licensor], in order to induce [Licensor] to enter into this Agreement, that Licensee shall commit itself to commercially reasonable efforts to develop, obtain regulatory approval for and commercialize such products, and thereafter make them available in both Developed Countries and Developing Countries, each as defined below.
Source: taken from a license agreement between Harvard University (Licensor) and Tectonic Therapeutic (Licensee). Partner types: academic institution, industry; Product type: unknown; Development stage at signature: unknown. Read in context.
How do the access principles set out in a funding agreement align with the parties’ organizational access policies?
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.