MAPGuideⓇ
Equitable Access Toolkit
License Agreement Provisions to Support Public Health Emergency Response
License, collaboration and technology transfer agreements for health products or technologies with known or potential applications as medical countermeasures against disease outbreaks, epidemics, or pandemics may include provisions intended to support rapid and equitable access to the product during a health emergency. Examples of these provisions include:
Requirements for the licensee to reserve a specified volume or proportion of total manufacturing capacity for supply to public health agencies at an affordable price;
Enforcement and continuity mechanisms to enable manufacturing and supply by a third party in the event that the licensee is unable to meet demand for the licensed product in a timely manner during a health emergency;
Waived or reduced royalties or other license fees during a public health emergency to support affordable pricing;
Mechanisms to authorize sales outside of the licensed territory to meet emergency response needs; and/or
Commitments by the parties to share research results with the outbreak research community.
Examples from the MAPGuide
In the event that [Transfer Recipient] develops and commercialises a Product that is responsive to a Public Health Emergency of International Concern as declared by WHO, to as soon as practically possible make available no less than ten percent of its real-time production capacity of Product for WHO and/or Public Sector Agencies at a price to be negotiated in good faith, but in no event to exceed its Cost of Production plus a twenty percent mark-up.
Source: taken from a technology transfer agreement between MPP and Biovac under the WHO mRNA Technology Transfer Programme. Partner types: multilateral, industry; Product type: COVID-19 vaccine; Development stage at signature: early stage development. Read in context.
The [Licensee] grants to [Licensor] a non-exclusive and royalty-free license to make, use, manufacture and sell in the Field of Use the [disease] vaccine products Developed by the [Licensee] in the exercise of the Licensed Rights, in the event of a public health emergency.
Source: taken from a license agreement between the Public Health Agency of Canada (PHAC; Licensor) and Bioprotection Systems Corporation (Licensee). Partner types: public research agency, industry; Product type: Ebola vaccine; Development stage at signature: late stage clinical development. Read in context.
The license provided under Section [x] of this Agreement is royalty-free until the end of the month in which the World Health Organization (WHO) declares the end of the Public Health Emergency of International Concern regarding COVID-19.
Source: taken from a license agreement between Merck (licensor) and MPP (licensee). Partner types: multilateral, industry; Product type: COVID-19 therapeutic (molnupiravir); Development stage at signature: late clinical/pending EUA. Read in context.
For the avoidance of doubt, neither Licensees nor any Licensees’ Sublicensee may directly or indirectly Supply the Licensed Product in any jurisdiction outside of the Territory, except when expressly authorized by [Transferor], especially for humanitarian purposes to meet the demand of international organizations, such as WHO, OPAS, UNICEF, among others.
Source: taken from a technology transfer agreement between AstraZeneca (Transferor) and Fiocruz (Transfer Recipient/Licensee). Partner types: industry, state-owned manufacturer; Product type: COVID-19 vaccine; Development stage at signature: conditional/emergency use authorization. Read in context.
For the avoidance of doubt, the parties agree that due to the seriousness of the current global crisis, it is important for the global scientific community to have access to information that indicates whether a given compound may be effective against the Pathogens of Interest. Accordingly the parties commit (in the case of the Institution, to the extent that it is free to do so) to either (i) publishing the Results even if the Material is inactive or poorly active in the relevant tests or animal models used in the Work, or (ii) allowing the Results to be available in databases set up by any of Global Stakeholders.
Source: taken from a model fast track testing and evaluation agreement developed by Public Health England (PHE). Partner types: public research agency, industry/academic institution; Product type: pathogens of interest during a One Health crisis; Development stage at signature: early stage R&D. Read in context.
How will the licensee’s activities align with actions taken by other stakeholders to support emergency response?
Is the scope of the licensed rights, including territory, know-how and technology transfer, sufficient to enable rapid manufacturing, scale up, and supply by generics or biosimilar manufacturers?
What are the requirements to make the product available at an affordable price?
What are the requirements to ensure that products manufactured for emergency response meet appropriate quality standards?
Are there any special considerations for the conduct of clinical trials and sharing of trial results by the licensee during disease outbreaks
How should data and results arising from the license agreement be shared to further the field, both during and outside of health emergencies?
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.