11. Regulatory Rights
The Parties agree that the terms in this Article 11 apply generally to this Agreement, and that the terms may be modified in any SOW issued under this Agreement by mutual agreement of the Parties. If a SOW does not address regulatory rights, the terms of this Article 11 will govern regulatory rights related to that SOW. To the extent there is any conflict between this Article 11 and the data rights provision contained in a SOW, the terms of the SOW shall control.
This Agreement may include research with one or more 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. Subject to further negotiation between the parties and set forth in the SOW, the Contractor may 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.
With respect to any products regulated by the FDA, the Contractor agrees to the following:
a) The Contractor 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 Contractor 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 Contractor 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 Contractor shall keep the Government reasonably apprised of planned FDA meetings and post-meeting outcomes relating to activities funded under this Agreement.
b) Communications. The Contractor 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 Contractor 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 Contractor has 48 hour advance notice of such Sponsor meeting from the FDA prior to the scheduled meeting time.
c) Non-compliance with section (b) may result in termination of the agreement.
d) Product Development Failure. Certain product development failures may trigger certain remedies in Section “e.” below for the Government advanced developer funding the development of the work contemplated in the applicable SOW. 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.
e) If any of the product development failures listed in section “d” occur, the Contractor, upon the request of the Government:
(i) shall transfer possession, ownership and sponsorship or holdership of any Regulatory Application (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 inform FDA of the transfer of sponsorship or holdership of the Regulatory Application transferred under section (e)(i) above; and
(iii) 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 Contractor, 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.
f) This clause will survive the acquisition or merger of the Contractor by or with a third party. This clause will also be included in any subcontracts/sub agreements relating to the development of the Technology. This clause will survive the expiration of this agreement.