MAPGuideⓇ
Equitable Access Toolkit
How Do Data Sharing and Publication Provisions Support Equitable Access Goals?
Sharing data, materials and results generated under funded projects can help to inform related research and development in the field, as well as supporting broader transparency over the use of public and philanthropic funds to support the development of, and equitable access to, medical products. Agreement provisions related to data and materials sharing may include obligations for open access publication or dissemination of project results, as well as requirements to share confidential or commercially sensitive data or materials with the funder or other designated entities.
Publication of project results
Funding agreements commonly require the publication of project results, in accordance with “open access” principles and/or a funder’s open access policy. Publication provisions often require “prompt” publication of results, but may allow for delays to the extent required for the funded partner to protect its intellectual property. These provisions may also include specific requirements for certain types of information such as clinical trial data or negative results, and/or rights for the funder to publish project-related data (subject to the protection of the funded partners confidential information).
Examples from the MAPGuide
Publication of Project Results: [Funder] encourages [Developer]’s timely publication of Project Data and other Project Results in scientific literature. With regard to pre-clinical studies, the Parties agree that [Developer] shall be required to publish (i) correlate of protection data no later than [***] after the date of submission of such data to the relevant regulatory authorities; and (ii) the results of the NHP and mosquito studies no later than [***] after the date of the final report for such studies. No less than [***] prior to submission of any such proposed publication, [Developer] shall submit such publication to [Funder] for review. In the event that [Funder] has any comments on the proposed publication, [Developer] shall cooperate with [Funder] in good faith to incorporate [Funder]’s comments prior to publication. All such publications (other than publications that relate exclusively to the [Developer]-Funded Study) shall include a statement that the work was “funded in whole or in part by [Funder] and EU Horizon 2020.” With respect to publications relating to clinical trials other than the [Developer]-Funded Study, [Developer] shall credit where appropriate the country in which the clinical trials were performed and make the results of such clinical trials available to the relevant country’s Ministry of Health or equivalent. In the event [Funder] wishes to publish any Project Results, [Funder] shall submit such proposed publication to [Developer] for review no less than [***] prior to submission for publication and if, within [***] after receipt of such proposed publication, (i) [Developer] notifies [Funder] of specific content in such proposed publication that constitutes Trade Secret Information or Confidential Information within [Developer] Background IP, then [Funder] shall remove such specific content from the proposed publication, or (ii) [Developer] notifies [Funder] that there is patentable subject matter contained in such proposed publication, [Funder] shall delay submission of the proposed publication for a reasonable period of time requested by [Developer], not to exceed [***]. […]
Open access: [Funder] requires “Open Access” for Project Data. This means that a copy of the final manuscript of all research publications, journal articles, scholarly monologues and book chapters published under this Clause [x] must be deposited into PubMed Central (or Europe PubMed Central) or otherwise made freely available upon acceptance for publication or immediately after the publisher’s official date of final publication. Moreover, all peer-reviewed published research that is funded, in whole or in part, by [Funder] shall be published in accordance with the principles of “Plan S” – Accelerating the transition to full and immediate Open Access to scientific publications, a UK and European data sharing initiative for research funded by public grants.
Related definitions:
- “Project Data” refers to all data and information, including all pre-clinical and clinical study data, produced or arising as a result of the Project.
- “Project Materials” means the drug product and the clinical trial materials.
- “Project Results” the outcomes and results of the Project, may comprise biological samples, data, intellectual property, materials, any Product and Investigational Product, publications, reference standards, technology and other results and shall include all Project IP, Project Data and Project Materials.
Source: taken from a USD $23.4 million funding agreement between CEPI (Funder) and Valneva (Developer). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: phase 3 clinical trials. Read in context.
The [Developer] will (in addition to the publication requirements of any grant agreement with the [Funder]): (i) publish the results and information developed in connection with each Project within a reasonable period of time after such information or results are obtained, subject to reasonable delays or limitations on content of such publications that are necessary to protect intellectual property and trade secrets covering the development and Platform Technology itself. All publications must be made in accordance with “open access” terms and conditions consistent with the [Funder]’s Open Access Policy.
Source: taken from a strategic relationship letter agreement between the Gates Foundation (Funder) and BioNTech (Developer) signed in relation to a USD $55 million investment in BioNtech by the Foundation. Partner types: philanthropic funder, industry; Product type: products for the prevention or treatment of TB and HIV; Development stage at signature: preclinical. Read in context.
(a) [Funder] supports the unrestricted access to the published research resulting from the Project and the public dissemination of the results or datasets underpinning any clinical trial or other preclinical or animal-based research, including positive and negative results.
(b) Therefore, the [Developer] will endeavor to the greatest extent possible, consistent with timely filing of patent applications, to publish results from the Project (whether positive or negative and as described in (a) above), so that the results of this Project are placed in the peer-reviewed literature as soon as practical.
(c) The [Developer] will make available any publications of research funded by [Funder] through PubMed Central (PMC) and Europe PubMed Central as soon as possible and in any event no later than six months from the date of final publication (in accordance with the Wellcome Trust’s Open Access Policy, and the ASPR Public Access Plan.
Source: taken from the CARB-X template funding agreement. Partner types: non-profit funder, industry/academic institution/PDP; Product type: antibacterial products (antibiotics, preventatives, rapid diagnostics); Development stage at signature: discovery through to phase 1 clinical trial. Read in context.
The Intellectual Property Rights in, and ownership of, the Project Results will remain with the party having created or produced such results. Subject to the confidentiality provisions set out in Section [x] (Confidentiality) of this Agreement, the Recipient:
(i) hereby provides a non–exclusive, irrevocable, worldwide, royalty–free, sub-licensable license to WHO on behalf of [Funder] to use the Project Results for non–commercial public health, education and research purposes;
(ii) will provide [Funder] and/or WHO with the Project Results, or any part thereof, promptly following a request from Unitaid; and
(iii) will disseminate the Project Results promptly and broadly in the interests of public health, including, without limitation, in accordance with the Project Description.
In order to ensure that the Project Results may be shared and disseminated as broadly as possible in the interests of public health, the Recipient will:
(i) obtain all necessary consents and authorisations to sharing of the Project Results generated by such activities with [Funder] and/or WHO including, without limitation, from relevant national and regulatory authorities, ethical review boards, consultants and sub–contractors;
(ii) publish any scientific articles or chapters using or incorporating the Project Results in an appropriate open access mechanism in accordance with WHO’s policy on open access (available at: http://www.who.int/publishing/openaccess/en/); and
(iii) make the data generated by the Project publicly available on open access terms in an appropriate online data repository: (a) at the same time as publication, in relation to data supporting, or which may be necessary to validate, the main findings of any publication; and (b) no later than six (6) months after the last Milestone Payment, in relation to all other data which may have public health value.
Source: taken from the sample terms and conditions for Unitaid (Funder) funding for Recipients (Developer) under the UnitaidExplore program. Partner types: non-profit funder, industry; Product type: innovations with transformative potential for public health in LMICs; Development stage at signature: multiple. Read in context.
Sharing with funder or designated entities
Some funding agreements require a funded partner to share specified data and materials with the funder or organizations selected by the funder. Such obligations generally relate to information that would not be made publicly available, and are therefore often subject to confidentiality or non-disclosure requirements, as well as other restrictions to protect the funded partner’s commercially sensitive information, and/or material transfer agreements.
These types of data and materials sharing provision may be used for several reasons including:
(i) to support comparator or non-inferiority studies with other products in the same class;
(ii) to support other projects in the funder’s portfolio;
(iii) to enable the harmonization of safety assessments across technology platforms and disease targets;
(iv) to support the development of biological standards and assays for certain diseases; and/or
(v) for coordination purposes to facilitate the achievement of equitable access objectives for funded products or programs.
Examples from the MAPGuide
The [Developer] (in addition to the publication requirements of any applicable grants from the [Funder]): […]
(ii) will promptly provide to the [Funder] from time to time, upon the [Funder’s] reasonable request and subject to customary confidentiality restrictions, access to data and information regarding the [Developer’s] [product] development programs (including raw data and regarding antibodies being developed for use in developed countries and for any indication, subject to the [Funder] agreeing to appropriate confidentiality obligations) and each Program, and the reasonably contemplated use of the Platform Technology for such programs; and
(iii) will promptly provide to the [Funder] from time to time, upon the [Funder’s] request, rights to share such non-public data and information regarding each Program, and the reasonably contemplated use of the Platform Technology for such Programs, subject to the reasonable need to protect confidential information (including, in the event that the [Funder] proposes to share any such data or information with any Direct Competitor, such disclosure to a Direct Competitor shall be permitted only to the extent that the [Funder] or a [Funder]-supported Entity is collaborating with such competitor, and limited to the disclosure of data or information directly relating to the development, production or commercialization of a Product, as applicable to such collaboration) and to avoid untimely public disclosures that may bar access to patent protection or public disclosures that may undermine trade secret protection or may impact the market competitiveness of a [Developer] product.
Source: taken from a strategic relationship agreement between the Gates Foundation (Funder) and Arsanis (Developer) signed in connection with an USD $8 million investment by the Foundation. Partner types: philanthropic funder, industry; Product type: neonatal sepsis mAb (staphylococcus aureus); Development stage at signature: discovery. Read in context.
[…] [Funder] may engage one or more independent third-party laboratories or collaborators (“Assessors”), in confidence and at [Funder]’s expense, to evaluate Project Results, including the Project Vaccine, in order to provide [Funder] with directly comparable evaluations of similar materials produced under [Funder]’s portfolio of awarded projects. The results of the testing, analysis, meta-analysis or other assessments shall be subject to the confidentiality obligations under this Agreement. [Funder] shall provide to the [Developer] access to the results of such analysis or assessment relevant to [Developer]’s activities under the Project, including information regarding the methodology of the overall analysis or assessment and rationale for conclusions reached under such analysis or assessment sufficient to give context to such results, as well as reasonable access to discuss the same with any such Assessors. For clarity, one of [Funder]’s assessors is the Task Force for Global Health and its SPEAC team of vaccine safety experts.
[Developer] shall provide reasonable assistance to [Funder] and any designated Assessor, including:
(a) ensuring that any samples to be transferred or exported by or on behalf of [Developer] from a clinical trial site or sample storage site are transferred and/or exported pursuant to the terms and conditions of a suitable to-be-agreed-upon material transfer agreement to be entered into between [Developer] and the Assessor in addition to any other applicable laws and regulations.
(b) cooperate in regard to data analysis, to the extent relevant under a given Work Package, by [Funder]’s Assessor by:
(i) providing data or other information generated under this Agreement to [Funder]’s designated Assessor as [Funder] shall request, including data regarding CMC, formulation or the results of any of its pre-clinical or clinical trials (duly anonymized and, upon [Funder]’s request, blinded) and other documents and information such as study protocols, case report forms needed to develop standardized approaches and tools for safety data management;
(ii) providing [Funder]’s designated Assessor with other data (duly anonymised and, upon [Funder]’s request, blinded) as [Funder] may reasonably request in order to conduct comparative assessments; and
(iii) providing [Funder]’s designated Assessor with clinical trial data (duly de- identified and, at [Funder]’s request, blinded) for the purposes of sign
Source: taken from a development funding agreement for up to USD $384 million between CEPI (Funder) and Novavax (Developer). Partner types: non-profit funder, industry; Product type: COVID-19 vaccine; Development stage at signature: phase 1 clinical trials. Read in context.
If any Work Package relates to the development of biological reference materials, [Developer] will provide relevant materials and data and shall grant rights to their use for International Standards development, to one of either the WHO or the Paul-Ehrlich- Institute (PEI) in Germany or, if agreed by the Parties, another independent standards development agency.
A Work Package may include the development of assays (including immunogenicity and potency/release assays), as will be described in the [product development plan].
The [Developer] will:
- as described in the [product development plan], participate in collaborative interlaboratory studies for evaluation of a candidate reference material. Such studies ultimately will be included in reports to the WHO Expert Committee on Biological Standardization; and
- provide written Standard Operating Procedures (“SOPs”) for any assays developed and qualified with [Funder] funding (in whole or in part) or with the use of samples or biological material facilitated by [Funder]. Transfer capacity and technology relating to such assays to a designated, independent third party laboratory if required by [Funder] for the assay to be validated for Phase 3 clinical trials. If and to the extent any SOPs incorporate Trade Secret Information or Confidential Information within [Developer] Background IP, [Funder] will maintain the confidentiality of such information in accordance with Clause [x] and [Developer] and the designated third party laboratory shall first enter into a customary confidentiality agreement with [Developer] governing the use and non-disclosure of such information, provided that [Developer] and such third party laboratory shall not delay the execution of such agreement.
Source: taken from a USD $23.4 million funding agreement between CEPI (Funder) and Valneva (Developer). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: phase 3 clinical trials. Read in context.
The [Funder] believes the requirement that the knowledge and information gained from the Project be promptly and broadly disseminated extends to data and datasets generated through the Project. During the term of this Agreement, You will make cleaned datasets available to the [Funder] upon request, at the time they are generated, and for internal [Funder] use only. Following the End Date, You will make all datasets available to the [Funder], upon request and for internal [Funder] use only. From the date that is six (6) months after the End Date, unless otherwise agreed with the [Funder], You will make all data generated under the Project available to the public in a manner and under conditions agreed to with the [Funder].
Source: taken from a global access and price commitments agreement between the Gates Foundation (Funder) and Icosavax (Developer), signed in connection with a USD $10 million grant agreement between the parties. Partner types: philanthropic funder, industry; Product type: COVID-19 vaccine; Development stage at signature: preclinical. Read in context.
The awardee will use commercially reasonable endeavours to make a limited amount of samples of marketed Product and/or Product in use under emergency use license available as comparator for other research in the Field, if reasonably justified by requestor under terms and conditions (including but not limited to the scope of research, protocol and reporting) agreed between the Parties, with the spirit to advance research in the Field.
Source: taken from a USD $41.3 million funding agreement between CEPI (Funder) and Valneva (Developer). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: licensed product. Read in context.
In the event that the [Developer] (alone or through a third party) is developing and commercializing the same antibodies in the Developed World as the [Funder] (alone or through a third party) is developing, the [Funder] and the [Devloper] agree to notify each other of such activities and, to the extent feasible, coordinate all activities with each other to ensure no negative impact on the research, development and commercialization of such antibodies being undertaken by the other party in the Developed World or Developing Countries, as the case may be.
Source: taken from a strategic relationship letter agreement between the Gates Foundation (Funder) and Visterra (Company/Developer) made in connection with a USD $6.8 million Series A preferred stock investment. Partner types: philanthropic funder, industry; Product type: platform technology, vaccines, therapeutics; Development stage at signature: early stage development. Read in context.
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 funded project?
Under what circumstances will the funded partner share project-related IP with third parties through a license and/or technology transfer agreement?
In addition to providing data and materials, what information should the funded partner report to the funder 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.