“Data” shall mean recorded information, including but not limited to any reports of research activities, generated in the performance of activities under the Research Plan, including any such information related to gene sequences.
“Research Materials” means any tangible material, including any reagents, chemicals, biologicals and tissue samples provided by one Party for use by another Party in connection with the Research Plan or generated in the conduct of the Research Plan and shall include modifications and unmodified derivatives thereof (the “Original Materials”), and Research Materials shall additionally include any Progeny, Unmodified Derivatives and any of the forgoing materials incorporated in Modifications. “Progeny” means any unmodified descendent from any Original Material; “Unmodified Derivative” means any substance which constitutes an unmodified functional subunit or product expressed by any Original Material; and “Modification” means any substance that contains and/or incorporates a significant or substantial portion of any Original Material, or of Progeny or Unmodified Derivative.
2. Research, Governance, and Reports
2.10 Each Party shall provide each other Party with written progress reports and a final written report summarizing the results of its activities conducted under the Project as specified in the Research Plan and as reasonably requested by another Party to facilitate work under the Research Plan. Each Party shall use commercially reasonable efforts to submit the Project Results obtained by such Party in the conduct of activities under the Research Plan to each other Party’s Project Leader or designee referenced in the Research Plan on or before the due dates as described in the Research Plan. For the purpose of clarity, no party is obliged to provide any other Party Project Results or Data beyond the deliverables specified in the Research Plan.
7. Data Sharing
7.1 The Parties acknowledge that they are required to share Data promptly with other Parties and with the funder in the performance of activities ascribed to them under the Research Plan and in accordance with the terms of this section, subject to the provisions regarding the protection of Confidential Information and bilateral agreements with the funder. For the purpose of clarity, unless otherwise expressly provided for in this Agreement, no Party is obliged to provide any other Party Research Results or Data beyond the deliverables specified in the Research Plan.
7.2 Data must be collected, maintained and used in accordance with the necessary informed consent and regulatory approval (if applicable).
7.3 The Steering Committee may establish processes by which Data will be physically or electronically transferred among the Parties and with the funder, provided that costs associated with Data sharing activities, including costs to ensure that the Data is in a form compliant with applicable laws (anonymized, for example), and “Open Access” publications specified in this Agreement will be incorporated into the budget for the grant agreement or contract, as the case may be, with the funder.
7.4 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.
7.5 Project Leaders that wish to submit Data to repositories that aren’t listed in Appendix B should provide the SC [Steering Committee] with links and information regarding the unlisted repository. If there are no objections from any member of the SC within ninety (90) days, it will be added to Appendix B.
9.1 All publications on the Project that are published in peer-reviewed journals shall be on “open access” terms and conditions whereby users of such publications would be free to copy and redistribute them in any medium or format and transform and build upon the Data described in such publications for any purpose (including commercial) without further permission or fees being required. This can be accomplished by publishing under a Creative Commons Attribution 4.0 International (CC BY 4.0) license or equivalent. Such “open access” to the publication in peer-reviewed journals and any underlying Data does not imply a license to or waiver of patent rights or other intellectual property rights held by a Party.
9.2 Copies of documents (e.g. manuscripts, abstracts or verbal or poster presentations) that disclose any information in respect of the Project including Data, results and information resulting or arising from the Research Plan shall be submitted to each Party for review and approval at least thirty (30) days prior to the document’s submission for publication or presentation and at least fifteen (15) days prior for abstracts. Upon written request, the publishing Party shall remove or have removed any Confidential Information of another Party and/or delay submission and/or publication of the document up to sixty (60) days following the request to allow a Party to secure intellectual property rights. In conjunction with the foregoing, each Party agrees to allow use of sufficient non-confidential background information regarding Research Materials it provides to enable complete and accurate publication of the results of research utilizing those Research Materials.
9.3 In the event that the document to be published includes data, information or material generated by a Party’s scientists, and professional standards for authorship would provide that such scientists be included as co-authors of the document, the names of such scientists will be added as co-authors of the document. Such professional standards include the International Committee of Medical Journal Editors’ Recommendations (www.icmie.org).
9.4 When Data is published or otherwise publicly disseminated by a Party, the publishing or presenting Party is required to acknowledge the Party that generated the Data.
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/