Provision Language
Section B: General Terms and Conditions
13. Audit/Access to Records
a. Managing Entity, or a third party designated by Managing Entity, reserves the right to inspect, upon Managing Entity’s reasonable advance notice and during normal business hours, Portfolio Company’s physical facilities, all aspects of the Statement of Work undertaken under this Agreement, and all books, records, and documents of any kind pertaining to the Agreement. Portfolio Company agrees to provide copies of any records, receipts, accounts or other documentation to Managing Entity in a timely fashion as reasonably requested by Managing Entity.
b. The United States Comptroller General, at its discretion, shall have access to and the right to examine records of the Portfolio Company, for a period of three (3) years after final payment is made. This requirement only applies to any record that is created or maintained in the ordinary course of business or pursuant to a provision of law.
c. Portfolio Company must keep all usual and proper records and books of accounts in accordance with Generally Accepted Accounting Principles (GAAP) relating to performance of the Statement of Work for a minimum period of three (3) years after completion of closeout of the Agreement and after the final Report has been submitted to Managing Entity and approved, or until 06/30/2028, whichever is later. During this period, Managing Entity, or an authorized representative, or Funders shall have the right to audit, at its own expense, all financial books, accounts, and records of funds received, and costs and commitments incurred under this Agreement. If any audit reveals a material discrepancy or error in reporting, Portfolio Company will repay the unallowable cost(s), including any applicable indirect costs. Portfolio Company expressly acknowledges its understanding that its activities pursuant to this Agreement and all financial books, records, and accounts pertaining thereto may be subject to audit by Managing Entity, and Portfolio Company agrees to cooperate fully in the performance of any such audit.
d. Portfolio Company shall forward to Managing Entity (carbxinv@bu.edu) a copy of any company CARB-X program specific audit, and a copy of company’s annual financial audit, within 30 days of completion.
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.
Quarterly progress reports will be submitted to Managing Entity through Box as specified by the CARB-X Alliance Lead (see Attachment 3A), on a date that will be determined in advance with the CST. Reports should include programmatic components as detailed in Attachments 1 and 2. Quarterly progress reports are not required for the period when the final report is due.
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Invention Reports: See Section B, Article 19 for requirements related to invention reporting.
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.
Clinical Studies Status Updates: Portfolio Company 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. Portfolio Company shall provide such status updates on a monthly basis.
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Changes in the status of ongoing clinical study protocols:
a. Major Changes: Portfolio Company must notify CARB-X 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:
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- 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 o 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 R&D, Alliance Lead, and Research Compliance Lead (see attachment 3A), followed by a letter signed by Portfolio Company’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:
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- 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: Portfolio Company must submit a monthly report of all changes in the status of any ongoing clinical study protocols.
Required Time Sensitive Notifications on FDA safety reports of serious adverse events: Under an IND or IDE, Portfolio Company must provide FDA safety reports of serious adverse events. Portfolio Company must submit copies of such FDA safety reports to the CARB-X Chief of Research and Development, as detailed below.
a. Expedited safety report of unexpected or life-threatening experience or death: A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven (7) calendar days after the IND sponsor’s receipt of the information, must be submitted to CARB-X and BARDA within 24 hours of FDA notification.
b. Expedited safety reports of serious and unexpected adverse experience: A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to CARB-X and BARDA within 24 hours of FDA notification.
c. IDE reports of unanticipated adverse device effect: A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to CARB-X and BARDA within 24 hours of FDA notification.
d. Other adverse events documented during the course of the trial should be included in the annual IND or IDE report and reported to CARB-X and BARDA.
FDA or EMA Audits
In the event of an FDA or EMA inspection which occurs that relates to products under this Agreement, or for any other FDA or EMA inspection that has the reasonable potential to impact the performance of this Agreement, Portfolio Company shall provide CARB-X with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR) (or the corresponding forms from the EMA). Portfolio Company shall provide CARB-X with copies of the plan for addressing areas of non-conformance to FDA or EMA regulations for GLP, GMP, or GCP guidelines as identified in the audit report, status updates during the plan’s execution and a copy of all final responses to the FDA or EMA.
a. Portfolio Company shall notify CARB-X within 5 business days of a scheduled FDA or EMA audit or within 12 hours of an ad hoc site visit/audit if the FDA or EMA does not provide advanced notice.
b. Portfolio Company shall provide copies of any FDA or EMA audit report received from sub-recipients that occur as a result of this agreement or for products funded hereunder within three (3) business days of receiving correspondence from the FDA or EMA.
c. Within five (5) business days of audit report, Portfolio Company shall provide CARB-X with a plan for addressing areas of nonconformance, if any are identified.
d. For the purposes of this Attachment, “EMA” includes all constituent national drug regulatory authorities.
Regulatory Submissions and Correspondence
a. Draft Clinical Study Report: submit to Managing Entity at least 20 business days prior to the anticipated FDA or other regulatory authority submission date, for submission to BARDA by Managing Entity. If corrective action is recommended, Portfolio Company will use reasonable efforts to address, in writing or by corrective action, all concerns raised by BARDA prior to FDA or other regulatory authority submission.
b. Draft Regulatory Meeting Briefing Packets: submit to Managing Entity at least 15 business days prior to anticipated submission to the regulatory authority, for submission to BARDA by Managing Entity. If corrective action is recommended, Portfolio Company will address in writing its considerations of all concerns raised by BARDA. Portfolio Company will consider revising documents to address BARDA’s concerns and/or recommendations prior to submission to regulatory authorities.
c. Final FDA or other regulatory submissions: submit to Managing Entity concurrently or no later than 2 business days after submission to FDA or other regulatory authority, for submission to BARDA by Managing Entity.
d. Managing Entity may request that Portfolio Company provide any regulatory correspondence (FDA, EMA, etc.) for products supported under this Agreement.
Non-Routine Reports and Notifications
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 R&D and Alliance Lead (see Attachment 3A). Additional report recipients are as indicated below.
Incident Report
Portfolio Company shall communicate and document all critical program concerns, risks, or potential risks with CARB-X.
a. 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.
b. Additional updates within 24 hours of additional developments.
c. Portfolio Company shall submit within 3 business days a Corrective Action Plan (if deemed necessary by either party) to address any potential issues.
d. If corrective action is deemed necessary, Portfolio Company must address in writing, its consideration of concerns raised by CARB-X within 3 business days of receiving such concerns in writing.
Final Reports for Clinical, Non-Clinical Studies, Manufacturing Campaigns
Managing Entity may request that Portfolio Company provide Clinical, Non-Clinical Studies, Manufacturing Campaigns, and other product development final reports to Managing Entity for review and comment.
Standard Operating Procedures
Managing Entity may request that Portfolio Company shall make internal and subcontractor Standard Operating Procedures (SOPs) available for review electronically.
QA Audits and Reports
Managing Entity reserves the right to participate in QA audits at the Portfolio Company. Upon completion of the audit/site visit the Portfolio Company shall provide a report capturing the findings, results and next steps in proceeding. If action is requested of the Portfolio Company, 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 Managing Entity. The Portfolio Company shall provide responses from the site to address these concerns and plans for corrective action execution.
Technical Documents
Managing Entity may request that Portfolio Company provide Managing Entity 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.
Submission of available Audits and Financial Statements:
Portfolio Company shall forward to Managing Entity (carbxinv@bu.edu) a copy of any company CARB-X program specific audit, and a copy of company’s annual financial audit, within 30 days of completion.
Animal Model or Other Technology Transfer Package
Managing Entity may request that Portfolio Company provide Animal Model or Other Technology Transfer Package relevant data.
Final Reporting Requirements (Closeout/Post-Award)
The section below includes Final (Closeout) reporting requirements. All Portfolio Companies will be instructed on when and how to submit final closeout documents prior to the award end date.
Final Progress Report will be submitted to the CARB-X Chief of Research and Development (see Attachment 3A) within 30 days after the end of the period of performance.
Final Invoice: A final statement of cumulative costs incurred, including cost sharing, marked “FINAL,” must be submitted through Salesforce NOT LATER THAN 45 days after the end of the period of performance. The final statement of costs shall constitute Portfolio Company’s final financial report.
Invention Report: The Portfolio Company will submit to cxinvent@bu.edu a final invention report, in the form prescribed by the Managing Entity, within 30 days of the end of the Period of Performance. A negative report is required.
Post-completion Reporting
Portfolio Company shall report to the Managing Entity during the 24-month period following the completion of the Agreement any significant funding, regulatory events, or major transactions involving the Project, including new equity funding, out licensing or collaboration agreements, regulatory approvals, and litigation involving the Project, as well as the Ad Hoc reporting specified above as reasonably requested by the Managing Entity. Portfolio Company shall also annually report to the Managing Entity the Portfolio Company’s Stewardship and Access Plan (as defined in Section C) after the termination of the Agreement. Reports to Managing Entity are to be submitted to the CARB-X Chief of R&D, Alliance Lead, and Managing Entity Administrative Contact (see Attachment 3A).
Section C CARB-X Special Terms and Conditions
Article III. Monitoring
3.01 The Portfolio Company’s progress in furtherance of Milestones and Deliverables will be monitored as follows:
(a) In quarterly programmatic and monthly financial reports provided by the Portfolio Company to Managing Entity as detailed in Attachment 4 (Reporting Requirements);
(b) In the course of regularly scheduled meetings (at least once per quarter) with the Company Support Team;
(c) By the Portfolio Company’s Scientific Advisory Board (the “SAB”);
(d) By the Portfolio Company’s ad hoc reports reasonably requested by Managing Entity or as detailed in Attachment 4; and
(e) By a written Portfolio Company report provided to Managing Entity when the Portfolio Company determines it has completed a Milestone, in consultation with the Company Support Team.
6. Intellectual Property
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6.03 Project IP Rights. In addition to the reporting requirements detailed in Attachment 4 and this Section C, the Portfolio Company shall provide written notice to the Managing Entity 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 Portfolio Company and third parties to sublicense, transfer, or otherwise exploit the Project IP Rights.