Master Alliance Provisions Guide (MAPGuide)

Gates Foundation – Novavax, RSV Vaccine Global Access Commitments Agreement

  • Protecting & sharing information | Publication of results

3. Global Access Commitments

In furtherance of the Charitable Purpose, Company agrees to the following “Global Access Commitments”:

(a) Prompt and Broad Dissemination of Knowledge and Information. Consistent with the Publication provisions of the Grant Agreement, Company will use reasonable and diligent steps to:

(i) publish (in a customary and reasonable manner as Company sees fit) information related to the Phase 3 Clinical Trial under the Project, which shall include:

(A) prospective registration of clinical trials on a WHO compliant clinical trial registry (e.g.,www.who.int/ictrp), with final clinical trial results publicized within 12 months from the completion date of the trial in accordance with WHO reporting guidelines/recommendations;

(B) publication of status of each clinical trial conducted under the Project on clintrials.gov within the earlier of 12 months of completion of each such clinical trial or the date imposed or specified by applicable law; and

(C) publication of final results of each clinical trial under the Project in one or more applicable peer reviewed open access journals within 12months from the last subject last visit time point of any such clinical trial, consistent with the provisions in the Grant Agreement.In the event of an inability to obtain peer reviewed publication, Company agrees to publish in manner that the Foundation determines in its reasonable discretion 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) (the “Publication Requirement”).