ARTICLE 8. Report and Data Requirements
M. Quality Agreement. The Awardee shall submit a quality agreement within 90 days of award for Government review. Upon acceptance the agreement is to be executed by both parties. This document must flow down to all subawards.
ARTICLE 13. Regulatory Rights
A. This Agreement includes research with an investigational drug, biologic or medical device that is regulated by the U.S. Food and Drug Administration (FDA) and requires FDA pre-market approval or clearance before commercial marketing may begin. It is expected this Agreement will result in the FDA clearance and commercialization of product(s) as set forth in this agreement (the “Technology”). The Awardee will serve as the Sponsor of the Regulatory Application (an Investigational New Drug Application (IND), Investigational Device Exemption (IDE), New Drug Application (NDA), Biologics License Application (BLA), Premarket Approval Application (PMA), or 510(k) Pre-Market Notification Filing (510(k)) or another regulatory filing submitted to FDA) that controls research under this agreement. The Sponsor of the Regulatory Application to FDA (as the terms “sponsor” and “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20) has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory Application.
B. The Senior Director Medical Regulatory (SDMR) is the JPEO-CBRND and DTRA-JSTO [Defense Threat Reduction Agency – Joint Science and Technology Office] representative for all regulatory and quality activities. The Awardee shall coordinate with the SDMR prior to communicating or meeting with the FDA, or other regulatory authorities, as appropriate.
C. The Awardee shall invite the SDMR to all FDA meetings and regulatory discussions applicable to this OTA Project.
1. With respect to any products under this Agreement regulated by the FDA for which the Awardee serves as Sponsor, the Awardee agrees to the following:
i. The Awardee shall provide to the Government all data, including top-line summaries and key conclusions from all studies, supporting the regulatory filing and commercial approval to the extent that such data, summaries, and conclusions are funded under this Agreement. In addition, the Awardee will offer the Government the opportunity to review and provide comments on a final draft of regulatory submissions which include data funded under this Agreement. The Government will review any such submissions promptly upon receipt. The Awardee shall reasonably consider any comments provided by the Government, and prior to submission shall provide notification to the Government of any additional edits or revisions. The Awardee shall keep the Government reasonably apprised of planned FDA meetings and post-meeting outcomes relating to activities funded under this Agreement.
ii. Communications. The Awardee shall provide the Government with all communications and summaries thereof, both formal and informal, to or from FDA regarding the regulatory submissions subject to this Agreement and ensure that the Government representatives are invited to participate in any formal Sponsor meetings with the FDA. The Awardee shall use its best efforts to ensure that the Government representatives are invited to participate in any informal Sponsor meetings with the FDA so long as the Awardee has 48 hour advance notice of such Sponsor meeting from the FDA prior to the scheduled meeting time.
iii. Non-compliance with section (C)(1)(i) or (C)(1)(ii) may result in termination of the agreement.
2. Product Development Failure. Certain product development failures may trigger certain remedies in Section (3) below for the Government advanced developer funding the development of the work in this Agreement. This remedy is not available to the Government for any cause outside of the following:
i. if this agreement is terminated for nonperformance; or
ii. the Contractor gives notice, required to be submitted to the Government no later than 30 business days, of any formal management decision to terminate this product development effort pre-market or to file for Federal bankruptcy protection.
3. If any of the product development failures listed in section (b) occur, the Awardee, upon the request of the Government:
i. shall transfer possession, ownership and sponsorship or holdership of any Regulatory Application submitted solely for approval of the Technology (including any associated expedited review designation, priority review voucher, or marketing exclusivity eligibility or award), regulatory correspondence, and supporting regulatory information related to the Technology to the Government or its designee;
ii. shall provide DoD or its designee with a letter (“Reference Letter”) providing permission to reference any Regulatory Application submitted to the FDA for a combination drug-device product that includes the Technology;
iii. shall inform FDA of the transfer of sponsorship or holdership of the Regulatory Application transferred under section (c)(i) above or the Reference Letter issued under section (c)(ii) above; and
iv. shall negotiate in good faith a non-exclusive license, at customary industry rates and under reasonable terms and conditions, to any patent, copyright or other intellectual property owned or controlled by the Awardee, developed prior to or outside the scope of this agreement, or any technical data that is necessary for the Government to pursue commercialization of this technology with a third party for sale to the Government or otherwise.
D. Awardee shall submit to the Government, within thirty (30) days of contract award, a fully executed sponsor authorization letter enabling FDA to disclose information to the JPEO-CBRND and its government support contractors related to the Technology under Public Law 115-92. A Template of the letter is available upon request. JPEO-CBRND shall submit the executed letter to the FDA only if the Technology becomes a DoD medical product priority under Public Law 115-92.