Policies to Impact: October 2023
Global Healthcare Innovation Alliance Accelerator (GHIAA)
Our vision: A world in which medical innovations are promptly available to all populations in need.
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On October 16, 2023, the World Health Organization released a Negotiating Text for the WHO convention, agreement or other international instrument on pandemic prevention, preparedness, and response (now referred to as the “Pandemic Agreement”) to WHO member states.?
GHIAA has released comments and recommendations that seek to contribute to the ongoing dialogue on the provisions of the Pandemic Agreement, with a focus on the sections most relevant to the formation of partnerships and agreements related to publicly funded R&D, licensing and technology transfer, material transfer, and the procurement of pandemic-related products. We are particularly concerned that the Negotiating Text does not include any provisions related to equitable access conditions for publicly funded R&D, and emphasize the need to establish clear principles in this regard, to be adhered to as part of a consistent, global, and transparent approach.
Julie connected with old and new colleagues at the LES 2023 Annual Meeting, October 15-18 in Chicago and facilitated a workshop called “Licensing and Funding Healthcare Innovations for Global Impact” with panelists Chan Park of the Medicines Patent Pool , Lauren Sullivan of the Gates Foundation , and Emma Wheatley of CEPI (Coalition for Epidemic Preparedness Innovations) .??
The discussion centered around the critical role of both funding and licensing partnerships in facilitating global access to medical products, and the importance of planning early for the partnerships needed throughout the product development process to ensure timely availability of the products for all those who need them.
We frequently update the MAPGuide? with new agreements and provisions. We welcome you to contribute your own agreements here. We accept anonymized and redacted content, as well as template and model agreements. Some of our latest additions include:
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Medigen - MPP (C-TAP), COVID-19 Vaccine, Patent and Know How License Agreement: this Agreement is between Medigen Biotechnology Corp. a private corporation located in Taipei, and the Medicines Patent Pool (“MPP”). It concerns a list of materials including a cell line or working cell bank, a stable clone including clinical data, technical dossiers, and SOPs, and reasonable quantities of reference product (“Material”), as well as proprietary know-how and other technical knowledge (“Licensed Know-How”), all related to Medigen’s MVC-COV1901 COVID-19 vaccine. The Agreement is effective as of July 2023.
The Agreement provides a worldwide, non-exclusive license that permits the MPP to sublicense Medigen Materials and Licensed Know-how (together the “Licensed Technology”) to generic manufacturers who will develop and commercialize COVID-19 vaccines using the Licensed Technology (“Products”) for any use related to COVID-19 (“Field”), with the goal of making them accessible worldwide. MPP and Medigen must agree on the selection of sublicensees, and Sublicensees are required to use commercially reasonable efforts to make Products available worldwide at an affordable price. Sublicenses will pay technology fees and patent royalties to Medigen which are tiered depending on the income level classification of the country in which the Sublicensee is located (for technology fees), or the country of product sale (for patent royalties).
PHS - Aridis, Rotavirus Vaccine Exclusive and Non-Exclusive License Agreement: this agreement is between the agencies of the United States Public Health Service (“PHS”) and Aridis Pharmaceuticals . Under the agreement, Aridis receives a license to use PHS patents and biological materials for the development and commercialization of Licensed Products and Licensed Processes related to a human rotavirus vaccine. The license is exclusive in Europe, Canada, and the U.S., and non-exclusive worldwide.
The agreement contains “Developing World Access” requirements, including provision of a report on the potential Public Sector requirements for a Licensed Product to meet needs in Developing Countries, and a plan for fulfilling those requirements, either using Aridis’ own resources or a joint venture with a third party.?
If Aridis plans to meet the Public Sector needs using its own resources, then it must use commercially reasonable efforts to make a first delivery of a product to the Public Sector for distribution in Developing Countries within two years of First Commercial Sale. If Aridis plans to work with third parties, it must use commercially reasonable efforts to meet a timeline for negotiating and entering into agreements, and making a first delivery for distribution in Developing Countries.
NIH - UniQure, AAV5 Gene Therapies Exclusive and Non-Exclusive License Agreement: This agreement is between the The National Institutes of Health (“NIH”) and uniQure B.V.. Under the agreement, uniQure receives a license to make, use and sell Licensed Products and Licensed Processes using PHS’ AAV5 patents. The license is for: (a) therapeutic products to be delivered to the brain or liver for the treatment of diseases originating in the brain or liver, excluding arthritis (“Exclusive Licensed Field of Use”); (b) treatment of any human disease in any manner (“Non-Exclusive Licensed Field of Use”). The license grants apply worldwide.
UniQure must make payments to PHS including an initial license issue fee, minimum annual royalties, earned royalties, benchmark royalties and patent prosecution expenses. However, benchmark and earned royalties do not have to be paid in relation to pre-clinical or clinical development collaborations for Ultra-Orphan indications with a non-profit organization or academic institution (“Exempt Collaborator”). Under Amendment 1, uniQure and NIH agreed to a reduction in the payments required for sublicensing in order to expedite the development of therapeutics for rare diseases.
What we’re reading:?
Questions? We’d love to hear from you at [email protected].