Attachment 1: Certifications and Assurance
Audit and Access to Records. Subrecipient certifies by signing this Subaward Agreement that it complies with the Uniform Administrative Requirements (2 CFR Part 200), will provide notice of the completion of required audits and any adverse findings which impact this subaward as required by parts 200.501– 200.521, and HHS implementation 45 CFR parts 75.501–75.521, and will provide access to records as required by parts 200.336, 200.337, and 200.201, and HHS implementation 45 CFR parts 75.364, 75.365, and 75.501, as applicable. In accordance with 45 CFR §75.501, subrecipients that are commercial organizations (including for–profit hospitals) have two options regarding audits:
(1) A financial related audit (as defined in the Government Auditing Standards, GPO Stock #020–000–00–265–4) of a particular award in accordance with Government Auditing Standards, in those cases where the recipient receives awards under only one HHS program; or, if awards are received under multiple HHS programs, a financial related audit of all HHS awards in accordance with Government Auditing Standards; or
(2) An audit that meets the requirements contained in this subpart. Commercial organizations that receive annual HHS awards totaling less than $750,000 are exempt from requirements for a non– Federal audit for that year, but records must be available for review by appropriate officials of Federal agencies. PTE (or a third party designated by PTE) reserves the right to inspect, upon PTE’s reasonable advance notice and during normal business hours, Subrecipient’s physical facilities, all aspects of the Statement of Work undertaken under this Subagreement, and all books, records, and documents of any kind pertaining to the Subagreement. Subrecipient agrees to provide copies of any records, receipts, accounts or other documentation to PTE in a timely fashion as reasonably requested by PTE.
Attachment 2: Prime Award Terms & Conditions
9. Data Rights: […] 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.
Attachment 4: Reporting Requirements
- A final progress report will be submitted to the CARB–X Chief of Research and Development within 30 days after the end of the period of performance.
- Quarterly progress reports will be submitted to CARB–X through the method specified by the CARB–X Alliance Lead, on a date that will be determined in advance with the CST. Reports should include programmatic components as detailed in Att 2a, PTE Prime Award Attachment B/Reporting Table, as applicable to Subrecipient. Quarterly progress reports are not required for the period when the final report is due.
- Monthly invoices and quarterly financial reports will be submitted in the manner described herein, subject to modification via written notice to the Subrecipient. Invoices will be submitted through STAR within 5 business days of the close of monthly books. Quarterly financial reports will be submitted to the CARB–X Finance & Grants Manager and should include sponsored and cost–share components for actual and projected expenditures and explanations of budget variances from the approved budget. Quarterly reports are not required for the period when the final report is due.
- Clinical Studies Status Updates: Subrecipient shall provide the CARB–X Chief of Research and Development with a status update of clinical studies that are actively enrolling patients to include by study site: cumulative enrollment; new enrollments; screen failures; patients dropped from study; AE and SAEs; activation or inactivation of study sites; investigator appointments or changes; and status of IRB/IEC review/approval/renewal. Status update shall also include a report of all changes in the status of any ongoing clinical study protocols (see Attachment 4a below). Subrecipient shall provide such status updates on a monthly basis.
- Invention Reports: In accordance with 37 CFR 401.14, Subrecipient agrees to notify the Federal Awarding Agency and PTE’s Administrative and copy the CARB–X R&D Chief Contact within 60 days after Subrecipient’s inventor discloses invention(s) in writing to Subrecipient’s personnel responsible for patent matters. The Subrecipient will submit a final invention report using Awarding Agency specific forms to the PTE PI within 30 days of the end of the total Subaward period of performance (including any approved Option periods) for submission to the Awarding Agency. A negative report is required.
- Property Inventory Reports: Annual Property Inventory Reports will be submitted to PTE’s Administrative contact within 30 days after the end of each 12–month period. Final Property Inventory Report is due 30 days after the total Subaward project end date (including any approved Option periods). The Subrecipient will submit property inventory reports using Tangible Property Report (SF 428). Other Special Reporting Requirements: Subrecipient invoices and monthly financial reports will be submitted through the CARB–X Digital Resources system using the Status Activity Report (STAR).
See also Att 4a (Adhoc Reporting Requirements).
All reports shall be in English. All information provided to PTE under this Subaward Agreement may be shared with members of the CARB–X Joint Oversight Committee, which includes representatives from the Wellcome Trust, BARDA, NIAID, UK/DHSC and with any other non–federal sponsors as applicable (such as the Bill and Melinda Gates Foundation), for non–proprietary purposes relating to oversight under this Subaward Agreement.
Attachment 4a: Ad Hoc Reporting Requirements
The section below includes non–routine (Ad hoc) reporting requirements. These reports are event driven and are due contingent upon Such events occurring. All reports should be submitted to the CARB–X Chief of Research and Development. Additional report recipients are as indicated below.
1. Changes in the status of ongoing clinical study protocols:
a) Major Changes: Subrecipient must notify PTE within three (3) calendar days and provide copies of documents related to all major changes in the status of any ongoing clinical study protocols, including the following:
- All amendments or changes to the protocol, identified by protocol version number, date, or both, and dates it is valid
- All changes in informed consent documents, identified by version number, dates, or both, and dates it is valid
- Termination or temporary suspension of patient accrual
- Termination or temporary suspension of the protocol
- Any change in IRB approval
- Any other problems or issues that could affect the participants in the studies.
Notification of major changes should be by email to the CARB–X Chief of Research and Development, followed by a letter signed by Subrecipient’s authorized business official, detailing notification of the change of status to the IRB and a copy of any responses from the IRB or IEC.
Major changes are those that:
- Alter the risk to benefit assessment
- Affect the safety of the subjects
- Add new medical, social, or psychological risks
- Significantly alter the design or scientific aims of the study
- Affect a subject’s willingness to continue participation in the study
b) All Changes: Subrecipient must submit a monthly report of all changes in the status of any ongoing clinical study protocols.
3. Incident Report
Subrecipient shall communicate and document all critical program concerns, risks, or potential risks with PTE.
- Due within 24 hours of activity or incident or within 12 hours for a security activity or incident.
- Email or telephone with written follow–up
- Additional updates within 24 hours of additional developments.
- Subrecipient shall submit within 3 business days a Corrective Action Plan (if deemed necessary by either party) to address any potential issues.
- If corrective action is deemed necessary, Subrecipient must address in writing, its consideration of concerns raised by PTE within 3 business days of receiving such concerns in writing.
The section below includes PTE Initiated non–routine [Ad hoc] reporting requirements. These reports are due three (3) business days after request. All reports should be submitted to the CARB–X Chief of Research and Development. Additional report recipients are as indicated below.
1. Final Reports for Clinical, Non–Clinical Studies, Manufacturing Campaigns. PTE may request that Subrecipient provide Clinical, Non–Clinical Studies, Manufacturing Campaigns, and other product development final reports to PTE for review and comment.
2. Standard Operating Procedures. PTE may request that Subrecipient shall make internal and subcontractor Standard Operating Procedures (SOPs) available for review electronically.
3. Regulatory Correspondence and Submissions. PTE may request that Subrecipient provide any regulatory correspondence (FDA, EMA, etc.) for products supported under this agreement.
4. QA Audits and Reports. PTE reserves the right to participate in QA audits at the Subrecipient. Upon completion of the audit/site visit the Subrecipient shall provide a report capturing the findings, results and next steps in proceeding. If action is requested of the Subrecipient, detailed concerns for addressing areas of non–conformance to FDA or EMA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to PTE. The Subrecipient shall provide responses from the site to address these concerns and plans for corrective action execution.
5. Technical Documents. PTE may request that Subrecipient provide PTE with reports from the following agreement funded activities: Process Development Reports, Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay Technology Transfer Report, Batch Records, SOPs, Master Production Records, Certificate of Analysis, Clinical Studies Data or Reports, Toxicology Reports or any other reasonably requested Technical Documents.
6. Animal Model or Other Technology Transfer Package. PTE may request that Subrecipient provide Animal Model or Other Technology Transfer Package relevant data.
7. Post–completion Reporting. Subrecipient shall report to the PTE during the 24–month period following the completion of the Subaward Agreement any significant funding, regulatory events, or major transactions involving the Project, including new equity funding, outlicensing or collaboration agreements, regulatory approvals, and litigation involving the Project, as well as the Ad Hoc reporting specified above as reasonably requested by the PTE. Subrecipient shall also annually report to the PTE the Subrecipient’s Stewardship and Access Plan (as defined in Attachment 6, Article V) after the termination of the Subaward Agreement. Reports to PTE are to be submitted to the CARB–X Chief of Research and Development and PTE Administrative Contact.
Attachment 6: Research Subaward Agreement
3.01 The Subrecipient’s progress in furtherance of Milestones and Deliverables will be monitored as follows:
(a) In quarterly programmatic and monthly financial reports provided by the Subrecipient to the PTE on the CARB–X Digital Resources as detailed in Attachment 4 (Research Subaward Agreement Reporting Requirements);
(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”);
(d) By the Subrecipient’s ad hoc reports reasonably requested by the PTE or as detailed in Attachment 4a; and
(e) By a written Subrecipient report provided to the PTE when the Subrecipient determines it has completed a Milestone, in consultation with the Company Support Team.
6. Intellectual Property
6.03 Project IP Rights. In addition to the reporting requirements detailed in Attachment 4 and this Attachment 6 of the Subaward, the Subrecipient shall provide written notice to the PTE of any material:
(i) prosecution, defense or enforcement activities including any litigation or threatened litigation that is likely to have a significant impact on any Project IP Rights; and
(ii) completed transactions between the Subrecipient and third parties to sublicense, transfer, or otherwise exploit the Project IP Rights.