Master Alliance Provisions Guide (MAPGuide)

How Do Data Sharing and Publication Provisions Support
Equitable Access Goals?

Sharing information and data related to the activities under a funding agreement can help to inform related research and development in the field, therefore broadening the impact of a funder’s investment. Such information sharing can include:

1. Providing non-public information to a funder under confidentiality restrictions;

2. Sharing underlying scientific data (e.g. clinical trial data) with the research community; and

3. Formal publication of the results of a project.

Agreement provisions requiring the sharing and publication of data often include requirements to publish information in a timely manner (such as within a specified period after completion of a clinical trial), balanced against delays that may be needed to protect the intellectual property rights of the developer.

1. Sharing Non-Public Information

Some funding agreements require a developer to share data with the funder or organizations selected by the funder that either would not otherwise be made publicly available, or would only typically be made available at a later point in the project. These requirements can be made for several reasons including:

    • To enable comparison with other similar projects in the funder’s portfolio;
    • To support other projects in the funder’s portfolio;
    • To enable the harmonization of safety assessments across technology platforms and disease targets; and
    • To support the development of biological standards and assays for certain diseases.

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 Bill & Melinda Gates Foundation (“Gates Foundation”) (Funder) and Arsanis (Developer) in connection with an $8 million investment by Gates to support a Staphylococcus aureus antibody development program. 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 signal detection or meta-analyses of safety data (including across product candidates).

Source: Taken from a development funding agreement between CEPI (Funder) and Novavax (Developer) for a COVID-19 vaccine. 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:

a. 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

b. 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 development funding agreement between CEPI (Funder) and Valneva (Developer) for manufacturing and late-stage clinical development of a Chikungunya vaccine. Read in context.

2. Sharing data with the Research Community

Funding agreements can include requirements for developers to share certain datasets with the global health research community in a timely manner. These data sharing provisions may include:

Some funders also place particular emphasis on ensuring that the Ministry of Health for a country in which clinical trials are conducted is able to access the data generated from the work conducted in that country.

Examples from the MAPGuide

Subject to specific Work Packages, Partner shall provide the following reports, notifications and samples to [Funder]: […]

  • Epidemiology: Partner agrees to make data generated pursuant to clinical trials in the Field that are relevant to the epidemiology of any disease in the Field publicly available within [*****] of the generation of such data.
  • Publication of details of clinical trials under the Project. The Partner shall publish details of any clinical trial under the Project on a publicly accessible clinical trials register as required under law and, as applicable, prior to the commencement of patient recruitment for such clinical trial, and shall provide to [Funder] evidence of such publication within [*****] of the same. […]
  • Open Data: The Partner shall publicly share Data and results (including negative results) arising from the [Funder] funding as close to real time as possible in accordance with [Funder]’s Transparency Policy and customary research publication norms. The Partner shall share its Data through an easily discoverable public route (website or system) which includes a metadata description, where patient privacy is upheld, and the system follows a request-for-information approach (where requests are fulfilled subject to an independent review and approval step). If, according to a [Funder] policy, Partner Know-How is to be published such shall only occur, provided such Partner Know-How does not contain any Background Technology of the Partner, or Improvements to Background Technology of the Partner, and provided the JMAG has made a decision on this beforehand, taking the Partner’s reasonable concerns into account.

Related Definitions: “Data” means any and all scientific, technical or test data including Know-How, research data, clinical pharmacology data, immunogenicity data, CMC data (including analytical and quality control data and stability data), pre-clinical data, clinical data, information concerning clinical trials, pharmacoeconomic data and data in publications, Regulatory Filings, submissions to Regulatory Authorities, Platform Confirmations, marketing approvals and Master Files related thereto.

Source: taken from a development funding agreement between CEPI (Funder) and CureVac (Developer) for the development of CureVac’s mRNA platform for the rapid manufacturing of vaccines against infectious diseases. Read in context.

Dissemination of Project Results to the Broader Outbreak Community. As described in the [product development plan] and elsewhere in this Agreement, or as otherwise agreed by the [Joint Monitoring and Advisory Group], and subject to the payment by [Funder] of actual costs and reasonable protection for [Developer]’s rights under this Agreement, [Developer] shall disseminate Project Results (excluding any chemistry, manufacturing and controls (“CMC”) data, or any information that would violate relevant privacy laws, or any information that [Developer] can reasonably demonstrate to [Funder] is sensitive and should not be so disseminated) with the broader Outbreak research community, such as disease-specific assays and standards, animal models, correlates of protection or risk, or diagnostics and epidemic preparedness mechanisms.

Dissemination of Project Data to Countries Hosting Clinical Studies. Subject to reasonable protection for [Developer]’s rights under this Agreement, [Developer] shall, to the extent it has the legal right to do so, make all Project Data (excluding any chemistry, manufacturing and controls (CMC) data), such as results of disease-specific assays, animal models, correlates of protection or risk, or diagnostics and epidemic preparedness mechanisms arising from such clinical trial available to that country’s Ministry of Health or equivalent.

Publication of Project Data for the Outbreak Research Community. Project Data shall be shared rapidly with the broader community, consistent with [Developer]’s requirements as a public company, in accordance with (i) WHO’s 2016 Guidance for Managing Ethical Issues in Infectious Disease Outbreaks; (ii) WHO’s 2016 Guidance on Good Participatory Practices in Trials of Interventions Against Emerging Pathogens; (iii) and Wellcome Trust’s Statement on Sharing Research Data and Findings Relevant to the Coronavirus (COVID-19) Outbreak to which [Funder] is a signatory.

Clinical Trial Data. [Funder]’s Clinical Trials Policy requires that clinical data and results (including negative results) must be disclosed publicly in as close to real time as possible. Accordingly, such data must be shared through an easily discoverable existing public route (website or system) that includes a metadata description, where patient privacy is upheld, and the system follows a request-for-information approach (where requests are fulfilled subject to an independent review and approval step). Clinical trial data shall be submitted for publication within twelve (12) months after each final study report or report submitted to [Funder]. During the same time period, [Developer] shall make the results available to the relevant country’s Ministry of Health or equivalent. The clinical trial ID or registry identifier code/number shall be included in all publications of clinical trials.

Related Definitions:

    • “Project Data” refers to pre-clinical and clinical trial data (including any negative results, animal model deaths and any toxicology study issues) produced under the Project.
    • “Project Materials” refers to biological samples, Project Vaccines, and other tangible materials produced under the Project.
    • “Project Results” means all of the tangible results that are made or developed by Awardee under the Project, including the Project Vaccine, and directly related to such Product Vaccine, assays necessary for Project Vaccine production, whether in whole or in components, protocols used in Project Vaccine clinical or non-clinical evaluation, Project Data, and Project Materials.

Source: taken from a development funding agreement between CEPI (Funder) and Novavax (Developer) for a COVID-19 vaccine. Read in context.

For Data where standardized data formats, metadata standards and repositories exist, such as for certain genomic and transcriptomic data, the Party generating the Data will provide the funder and other Parties an appropriate link and identifier (e.g. accession number) to the Data. A list of publicly available repositories is listed in Appendix B. 

Appendix B: List of publicly available data repositories

  • Publicly available repositories that are in compliance with the data sharing requirements set forth in the Agreement.
  • GenBank – http://www.ncbi.nlm.nih.gov/genbank/
  • International Nucleotide Sequence Database Collaboration – http://www.insdc.org/
  • HIV Sequence Database – http://www.hiv.lanl.gov/content/sequence/HIV/mainpage.html
  • HIV Molecular Immunology Database – http://www.hiv.lanl.gov/content/immunology/index. The HIV Molecular Immunology Database is an annotated, searchable collection of HIV-1 cytotoxic and helper T-cell epitopes and antibody binding sites.
  • Nonhuman Primate HIV/SIV Vaccine Trials Database – http://www.hiv.lanl.gov/content/vaccine/home.html. This database, funded by the National Institutes of Health, contains information about vaccine studies using SIV and HIV in nonhuman primates.
  • Hepatitis C Virus (HCV) Database Project – http://hcv.lanl.gov/content/index
  • Hemorrhagic Fever Viruses (HFV) Database Project – http://hfv.lanl.gov/content/index
  • ImmPort – https://immport.niaid.nih.gov/immportWeb/

Source: taken from an anonymised agreement for a collaboration between an academic institution and a company, supported by a funder. Read in context.

3. Formal Publication

Partnering agreements commonly require the publication of project results in peer-reviewed journals or other scientific literature. Publication provisions often include “open access” requirements for publications in peer-reviewed journals, meaning that the information is made available online, at no cost, and with limited restrictions on reuse. You can also read more about publication of results provisions here.

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” refers to 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 development funding agreement between CEPI (Funder) and Valneva (Developer) for manufacturing and late-stage clinical development of a Chikungunya vaccine. Read in context.

Consistent with [Developer]’s Global Access commitments, if the Project description specifies Publication or Publication is otherwise requested by the [Funder], [Developer] will seek prompt Publication of any Funded Developments consisting of data and results. “Publication” means publication in a peer-reviewed journal or other method of public dissemination specified in the Project description or otherwise approved by the [Funder] in writing. Publication may be delayed for a reasonable period for the sole purpose of seeking patent protection, provided the patent application is drafted, filed, and managed in a manner that best furthers Global Access. If [Developer] seek Publication in a peer-reviewed journal, such Publication shall be under “open access” terms and conditions consistent with the [Funder]’s Open Access Policy available at: www.the gatesfoundation.org/How-We-Work/General-Information/Open-Access-Policy, which may be modified from time to time. Nothing in this section shall be construed as requiring Publication in contravention of any applicable ethical, legal, or regulatory requirements. [Developer] will mark any Publication of any Funded Development subject to this clause with the appropriate notice or attribution, including author, date and copyright (e.g., © 20<> <Name>).

Source: taken from a grant agreement between the Bill & Melinda Gates Foundation (Funder) and Arsanis (Developer) for the preclinical development of a monoclonal antibody treatment for respiratory syncytial virus infections. Read in context.

Subject to Existing Agreements, the [Developer] will [*****] to:

(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 in a manner that satisfies the requirement that such research be published in a form that is “available to the interested public” as described in Treasury Regulation 1.501(c)(3)-1(d)(5)(iii)(c)(2), which could include publication in a treatise, thesis, trade publication or a scientific journal, the presentation of a paper at a research conference or symposium and electronic publication, with due regard to delays or limitations on content of such publications that are necessary or useful (i) to protect the [Developer]’s intellectual property, trade secrets and confidential information covering, inter alia, the Platform Technology itself and/or (ii) to allow the [Developer] to obtain any intellectual property rights based on the results and information developed in connection with each Project.

Source: taken from a development funding agreement between the Bill & Melinda Gates Foundation (Funder) and CureVac (dDeveloper) for a COVID-19 vaccine. 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 template CARB-X (Funder) cost-reimbursement agreement with subrecipients (Developer) for the early stage development of antibiotics, vaccines, and rapid diagnostics against bacterial threats. Read in context.

Related Commentaries

Data sharing obligations should survive termination of the agreement to ensure that all data generated in connection with a funded project is made available to the scientific community.

Author: Bridie Telford

First publication date: November 21, 2022