Provision Language
Section B: General Terms and Conditions
34. Dispute Resolution
a. This clause applicable to domestic Portfolio Companies only: Any action, suit or other proceeding pursuant to, arising under, or concerning this Agreement or the transactions contemplated hereby will be brought exclusively in any court of competent jurisdiction in Suffolk County, Commonwealth of Massachusetts. The parties agree to take any and all necessary or appropriate action to submit to the exclusive jurisdiction of any such court.
b. This clause applicable to foreign Portfolio Companies only: Any action, suit or other proceeding pursuant to, arising under, or concerning this Agreement or the transactions contemplated hereby will be brought exclusively in a final and binding arbitration with JAMS Boston Mediation, Arbitration and ADR Services (“JAMS”) in a venue located in Boston, Massachusetts and in accordance with the most recent JAMS Comprehensive Rules & Procedures.
35. Financial Conflicts of Interest
This Agreement is subject to PHS-Specific Requirements Promoting Objectivity in Research (42CFR Part 50 Subpart F). 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.
Under this Agreement, the financial conflicts of interest policy of ☐ Managing Entity ☐ Portfolio Company will apply. If applying its own financial conflicts of interest policy, by
execution of this Agreement, Portfolio Company certifies that its policy complies with 42 CFR Part 50.
Portfolio Company shall report any financial conflict of interest to Managing Entity’s Administrative Contact, as shown on Attachment 3A. Any financial conflicts of interest identified may subsequently be reported to Funders, before expenditure of funds authorized in this Agreement and within 45 days of any subsequently identified financial conflict of interest.
Attachment 4: Reporting Requirements
All reports shall be in English. All information provided to CARB-X under this Agreement may be shared with Managing Entity Funders as well as members of the CARB-X Governance Board for non-proprietary purposes relating to oversight under this Agreement.
Routine Reporting Requirements
The section below includes routine (frequent) reporting requirements. All reports should be submitted as stated.
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Team Meetings: For all formal CST Meetings, to be held at a frequency determined in advance by the CST, Portfolio Company 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 minutes will be saved in Box by Portfolio Company.
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Clinical Reporting Requirements
The section below includes Clinical reporting requirements if applicable. All reports should be submitted to the CARB-X Chief of R&D, CARB-X Alliance Lead, and CARB-X Research Compliance Lead (see attachment 3A), unless indicated otherwise below.
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Clinical Advisory Board (CAB) Meeting: A Clinical Advisory Board including external technical advisors will be convened by CARB-X, to provide guidance to Portfolio Companies on the clinical trial strategy and design. The one-time meeting would be targeted to take place at the start of the preclinical stage, approximately 9-months to a year ahead of filing an IND or equivalent.
CARB-X Clinical Trial Steering Committee (CTSC): Starting one month prior to clinical study startup activities and through last subject, last visit, Portfolio Company, CARB-X and BARDA will hold regular, biweekly meetings (via teleconference). Follow-up meetings may be required by CARB-X beyond last subject, last visit.
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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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.