CARB-X Research Subaward Agreement

Business model | Governance

Structural Questions

Do the parties govern the project through a joint steering committee (“JSC”)? If so, what are the parties expressly designated roles and responsibilities with respect to the JSC?
Are there other committees, important governance bodies, or designated individual positions? What are the parties’ roles and responsibilities with respect to them?
Are the parties required to meet in accordance with a defined schedule for decision-making and progress reporting activities?
What are the resolution mechanisms for disputes related to the agreement?
Are there any requirements for policies or procedures to manage potential conflicts of interest?

Summary of Approaches

Do the parties govern the project through a joint steering committee (“JSC”)? If so, what are the parties expressly designated roles and responsibilities with respect to the JSC?
- There will be a Company Support Team (CST) including representatives of CARB-X and its funders, which will monitor progress towards the achievement of Milestones and Deliverables.
Are there other committees, important governance bodies, or designated individual positions? What are the parties’ roles and responsibilities with respect to them?
- The Subrecipient must form a Scientific Advisory Board which will be responsible for monitoring progress along with the CST.
- There will be clinical teleconferences between the Subrecipient, CARB-X and BARDA.
Are the parties required to meet in accordance with a defined schedule for decision-making and progress reporting activities?
- The CST will meet at least quarterly.
- Clinical teleconferences will start one month prior to clinical study startup activities and be held every 2 weeks until last subject, last visit, or for a longer period at the discretion of CARB-X and BARDA.
What are the resolution mechanisms for disputes related to the agreement?
- The parties will attempt to resolve disputes through good faith negotiations and informal dispute resolution. Any unresolved issues shall be arbitrated in accordance with the International Arbitration Rules of the American Arbitration Association.
Are there any requirements for policies or procedures to manage potential conflicts of interest?
- Subrecipients must have a written and enforced conflict of interest policy and must report any financial conflicts of interest to CARB-X before the expenditure of funds under the agreement and within 45 days of any subsequently identified conflicts.

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>em>span>p>
PHS–Specific Requirements Promoting Objectivity in Research Applicable to Subrecipients (42 CFR strong>Part 50 Subpart F)strong>p>
a) 42 CFR Part 50. 604 requires that institutions conducting PHS–funded research “Maintain an up–to–date, written, enforced policy on financial conflicts of interest.” Further, “If the Institution carries out the PHS–funded research through a subrecipient (e.g., subcontractors or consortium members), the Institution (awardee Institution) must take reasonable steps to ensure that any subrecipient Investigator complies with this subpart by incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient’s Investigators.”p>
Subrecipient must designate herein whether the financial conflicts of interest policy of ☐ Pass–through Entity Institution, or ☐ Subrecipient Institution (check one) will apply. If applying its own financial conflicts of interest policy, by execution of this Subaward Agreement, Subrecipient Institution certifies that its policy complies with 42 CFR Part 50.p>
b) Subrecipient shall report any financial conflict of interest to Pass–through Entity’s Administrative Representative, as designated on Attachment 3A. Any financial conflicts of interest identified shall subsequently be reported to HHS. Such report shall be made before expenditure of funds authorized in this Subaward Agreement and within 45 days of any subsequently identified financial conflict of interest.p>
Special terms and conditionsstrong>span>p>
16. Disputesstrong> (this clause applicable to foreign subrecipients only)p>
The parties shall attempt to resolve disputes through good faith negotiations. Any dispute arising under or related to this Subaward Agreement shall be resolved to the maximum possible extent through informal dispute resolution. Unresolved issues shall be arbitrated in accordance with the International Arbitration Rules of the American Arbitration Association.p>
Attachment 4: Reporting Requirementsstrong>em>span>p>
<ul>
<li>[…]li>
<li>Company Support Team Meetings:strong> For all formal CST Meetings noted in Attachment 6, Article II, to be held at a frequency determined in advance by the CST, Subrecipient will submit: (1) an agenda for each meeting at least 5 business days in advance of meeting; and (2) meeting minutes within 5 business days after each such meeting. Final agendas and miutes will be saved in CDR by Subrecipient.li>
<li>[…]li>
<li>CARB–X Clinical Teleconferences:strong> Starting one month prior to clinical study startup activities and through last subject, last visit, Subrecipient, PTE and <a href=”#kt“>BARDAa> will have CARB–X Clinical Teleconferences every two weeks. If PTE and BARDA determine that longer follow–up is required, the meetings will be scheduled beyond last subject, last visit (see Att 2a, PTE Prime Award, Clinical Terms of Award).li>
<li>[…]li>
ul>
Attachment 6: Research Subaward Agreementstrong>em>span>p>
3. Monitoringstrong>span>p>
3.01 strong>The Subrecipient’s progress in furtherance of Milestones and Deliverables will be monitored as follows:p>
[…]p>
(b) In the course of regularly scheduled meetings (at least once per quarter) with the Company Support Team;p>
(c) By the Subrecipient’s Scientific Advisory Board (the “SABstrong>em>”);p>
[…]p>
Section 3.02 Subrecipient SAB and Company Support Teamstrong>p>
(a) span>The Subrecipient shall establish (or shall demonstrate that it has already established) an SAB within sixty (60) days of executing the Subaward Agreement and the SAB shall continue to meet regularly during the Term. The Subrecipient will inform the PTE of SAB membership, including changes to SAB membership, by reporting such SAB membership to the Company Support Team.p>
(b) span>The Company Support Team may include representatives from the PTE and its funders.p>

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