Master Alliance Provisions Guide (MAPGuide)

CEPI – CureVac, Framework Partnering Agreement

  • Protecting & sharing information | Publication of results

7. Partner Obligations

7.11 Partner reporting and compliance. Subject to specific Work Packages, Partner shall provide the following reports, notifications and samples to CEPI: […]

7.11.4. 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.

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7.11.11. 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 CEPI evidence of such publication within [*****] of the same.

7.11.12. Publications. The Partner shall ensure that the Project Lead furnishes CEPI with a copy of any proposed publication or presentation which relates to Project Technology at least [*****] in advance of the submission of such proposed publication or presentation to a journal, editor or publication.

7.11.13. Open Access. A copy of the final manuscript of all research publications, journal articles, scholarly monologues and book chapters that relate to any Work Package of the Project 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. All peer–reviewed published research funded, in whole or in part, by CEPI shall be published in accordance with the following requirements of Gates: https://www.gatesfoundation.org/How–We–Work/General–Information/Open–Access–Policy.

7.11.14. Open Data. The Partner shall publicly share Data and results (including negative results) arising from the CEPI funding as close to real time as possible in accordance with CEPI’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 CEPI 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.