CARB-X Research Subaward Agreement

Protecting & sharing information | Publication of Results

Summary of Approaches

What information are the parties required or permitted to publish?
- The Subrecipient must endeavor to the greatest extent possible, to publish both positive and negative project results.
- The Subrecipient must coordinate with the CARB-X Principal Investigator at the beginning of the writing process if the publication is to include CARB-X data.
- CARB-X may use data created under the Subaward Agreement for the publication of anonymized academic research conducted by, or performed in collaboration with, the CARB-X’s Principal Investigator to the extent required for CARB-X to meet its obligations to the U.S. Government.
- The U.S. Government has the right to publish the data produced under a Federal award and allow others to publish such data for Federal purposes.
What is the required timeline for making data available? What are the acceptable publication channels?
- CARB-X funded research must be made available through PubMed Central (PMC) and Europe PubMed Central no later than 6 months after the date of publication.
Is compliance with a specific open access policy required?
- Publication should be in line with the Wellcome Trust’s Open Access Policy.

Annotations

This Cost-Reimbursement Research Subaward is intended for use between Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (“CARB-X”), a global non-profit partnership, and an organization receiving CARB-X funding (“Subrecipient”). There are two versions of the agreement, one for non-profit organizations, and one for for-profit companies. The agreements are substantially similar and the agreements are therefore analyzed jointly in the MAPGuide.

The agreement sets out the terms for CARB-X funding for early-stage products including access rights to project intellectual property for the Wellcome Trust (a CARB-X funding partner), which may be triggered in certain circumstances depending on the territory in which they will be used. The agreement also requires the development of a Stewardship and Access Plan for each product that enters pivotal clinical trials. The Plan will be published on CARB-X’s website.

CARB-X is also referred to as the “Pass Through Entity” (“PTE”). This term relates to the Prime Award agreement from CARB-X to the U.S. Department of Health and Human Services (“HHS”), one of CARB-X’s funders. Subrecipients are required to comply with certain terms from the Prime Award agreement, as well as several other CARB-X funders – the Bill & Melinda Gates Foundation (“Foundation”), the U.K. Secretary of State for Health and Social Care (“DHSC”) and the German Federal Ministry of Education and Research (“BMBF”).

Provision Language

Attachment 2: Prime Award Terms & Conditionsstrong>span>em>p>
Special Terms & Conditionsstrong>span>p>
5. Publications:strong> See Att 2a/Standard Terms and Conditions for required acknowledgment and disclaimer. See also Attachment 6, “Open Science.” Abstracts or manuscripts from any CARB–X partner involving CARB–X data must be coordinated with PTE PI at the beginning of the writing process. Subrecipient will provide the PTE with advance copies of all manuscripts related to the Project when they are submitted or re–submitted for publication. PI will have no role in the preparation, editing or approval of the manuscript.p>
9. Data Rights:strong> Subrecipient grants to PTE the right to use data created in the performance of this Subaward Agreement for the purpose of conducting and publishing anonymized academic research conducted by, or performed in collaboration with, the PTE Principal Investigator and to the extent required to meet PTE’s obligations to the Federal Government under its Prime Award. Per 45 CFR 75.322(d), the Federal Government has the right to: (1) obtain, reproduce, publish, or otherwise use the data produced under a Federal award; and (2) authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes.p>
Attachment 6: Research Subaward Agreementstrong>span>em>p>
5. Additional Subrecipient Obligationsstrong>span>p>
5.02 Open Sciencestrong>p>
(a) CARB–X 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 .p>
(b) Therefore, the Subrecipient 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.p>
(c) The Subrecipient will make available any publications of research funded by CARB–X 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 <a href=”https://wellcome.ac.uk/funding/managing–grant/open–access–policy,” target=”_blank” rel=”noopener“>Wellcome Trust’s Open Access Policya>span>, and the <a href=”https://www.phe.gov/Preparedness/planning/science/Documents/AccessPlan.pdf” target=”_blank” rel=”noopener“>ASPR Public Access Plana>span>.p>
(d) The Subrecipient will provide the PTE with advance copies of all manuscripts related to the Project when they are submitted or re–submitted for publication. The PTE will have no role in the preparation, editing or approval of the manuscript. An unpublished patent application will not be deemed to be a manuscript for the purposes of this subsection (d).p>
Attachment 8: Non Federal Sponsor Terms and Conditions – Gates Foundationstrong>em>span>p>
PUBLICATIONstrong>span>p>
In addition to the requirements detailed in Attachment 2/Special Terms and Conditions #5 and Attachment 6/5.02, if Subrecipient seeks publication in a peer–reviewed journal, such publication shall be under “open access” terms and conditions consistent with the Foundation’s Open Access Policy available at: <a href=”http://www.gatesfoundation.org/How–We–Work/General–Information/Open–Access–Policy” target=”_blank” rel=”noopener“>www.gatesfoundation.org/How–We–Work/General–Information/Open–Access–Policya>span>, 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. Subrecipient will mark any such publication subject to this clause with the appropriate notice or attribution, including author, date and copyright (e.g., © 20<> <Name>).p>

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