MAPGuideⓇ
Equitable Access Toolkit
Supporting Equitable Access through Data and Materials Sharing Provisions in License Agreements
Mechanisms for sharing data, materials, and research results generated under license or collaboration agreements can help to inform related research and development in the field, and, in some cases, can support transparency over licensing or collaboration activities intended to achieve public benefit from products or technologies developed with the use of public or philanthropic funding.
Data and materials sharing requirements in license and collaboration agreements often relate to the publication and/or dissemination of data and results, for example:
Publication on an open access basis, potentially in compliance with open access obligations under related funding agreements;
Publication of negative as well as positive results; and
Rights for all agreement parties to review proposed publications and request the removal of confidential information and/or delays to seek patent protection prior to publication.
Additional considerations, particularly for agreements including R&D collaboration activities, may include any confidential sharing of data and/or materials between the agreement parties that is not otherwise covered under the scope of the licensed rights, or grantback provisions under the agreement.
Examples from the MAPGuide
The Parties will publish the scientific and technological results of the work performed under this Project in order to make the information available to the wider vector control community, so as to disseminate the information in accordance with the Charitable Objectives and the Global Access Strategy, while preserving the need for prior protection of inventions (e.g. patent) before any publication is made. The mode of publication must be appropriate to effective and timely communication with that community (subject to any prior change to the publication to protect inventions), and the support of the FNIH should be acknowledged in any such publication.
Source: taken from a research and product development agreement between the Bayer CropScience and SentiSearch, made pursuant to a grant award made by the Foundation for the National Institutes of Health under which Bayer is a sub-grantee. Partner types: industry; Product type: insect vector control; Development stage at signature: discovery. Read in context.
Notwithstanding Article [x] above and in accordance with [Collaboration Partner]’s Mission on providing free access to the public of its research as per its Scientific and Clinical External Communications Policy (as published in [Collaboration Partner]’’s website), as well as the requirements of several donors to [Collaboration Partner]’, [Collaboration Partner]’ and Partner will publish the scientific data and/or results of the Development and Distribution Program in scientific journals, abstracts, conferences, databases, as well as present such data at professional meetings. The Parties shall first seek to publish such data jointly. Should either Party opt not to participate in the publication, the other Party shall be free to publish the data in accordance with the terms of this Article [x].
Independent draft manuscripts of written publications or oral presentations that include any part of the results of the Development and Distribution Program or Confidential Information shall be sent to the other Party for review at least twenty eight (28) days prior to the contemplated publication and eight (8) days for abstracts and presentations. Within this period, the other Party shall be entitled to object to the proposed publication or presentation on the grounds that it contains or refers to a patentable subject matter. Should patenting be sought by a Party, the other Party shall refrain from making any publication or presentation for an additional period of ninety (90) days from the date of the patenting Party’s objection to allow the filing of Patent Rights.
[…]
The Parties shall ensure that any publication agreement or copyright transfer agreement allows peer–reviewed manuscripts and scientific data to be published in an open access journal (e.g. PLOS) or database.
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.
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.
The data generated under any Research Plan shall be promptly uploaded by the appropriate Party into the [Collaboration Partner]’ electronic repository ScienceCloud accessible by both Parties or shared by such other means as may be agreed between the Parties from time to time.
[…]
In order to avoid duplication of efforts, in the event that either Party performs, alone or in collaboration with a third party, any research and development activities in the Field on any Molecule, that Party shall provide the other Party, on a confidential basis, with any information arising from such research and development activities that is relevant to the Research Program or Development Program.
Source: taken from DNDi’s template Research 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 early stage discovery through to pre-clinical studies. Read in context.
What data and materials will the licensor share with the licensee (or collaboration parties share with each other) as part of the licensed IP under the agreement?
Is there a need for additional obligations for rapid data sharing in the context of health emergencies?
What are the requirements for sharing data related to any clinical trials under the agreement?
Under what circumstances will foreground IP be shared between the agreement parties for development collaboration purposes? Under what circumstances will background or foreground IP be shared with third parties through a sublicense and/or technology transfer agreement?
In addition to providing data and materials, what information should the agreement parties report to each other on a periodic basis?
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.
