Master Alliance Provisions Guide (MAPGuide)

CARB-X Research Subaward Agreement

  • Business model | Governance

Attachment 2: Prime Award Terms & Conditions

PHS-Specific Requirements Promoting Objectivity in Research Applicable to Subrecipients (42 CFR Part 50 Subpart F)

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.”

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.

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.

Special terms and conditions

16. Disputes (this clause applicable to foreign subrecipients only)

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.

Attachment 4: Reporting Requirements

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  • Company Support Team Meetings: 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.
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  • CARB-X Clinical Teleconferences: Starting one month prior to clinical study startup activities and through last subject, last visit, Subrecipient, PTE and BARDA 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).
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Attachment 6: Research Subaward Agreement

3. Monitoring

3.01 The Subrecipient’s progress in furtherance of Milestones and Deliverables will be monitored as follows:

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(b) In the course of regularly scheduled meetings (at least once per quarter) with the Company Support Team;

(c) By the Subrecipient’s Scientific Advisory Board (the “SAB”);

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Section 3.02 Subrecipient SAB and Company Support Team

(a) 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.

(b) The Company Support Team may include representatives from the PTE and its funders.