Regulatory Rights. The Contractor agrees to the following:
a. Regulatory Data. Regeneron shall provide to the OTTR and OTAS copies of formal FDA submissions pertaining to the scope of the project, no later than 10 business days before submission to the FDA. For clarity, CMC Data included in such submissions shall be subject to Section 7.3.b.
Regulatory Rights. Upon request, Licensee shall grant Licensor a “right of reference” for the FDA or any equivalent foreign regulatory body to any submissions containing ****. Upon request, Licensor shall grant Licensee a “right of reference” for the FDA or any equivalent foreign regulatory body to any submissions containing ****.
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 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...
Regulatory Rights. The Parties will evaluate the regulatory framework for each Prototype Project, including the need for Awardee to secure a Transfer of Regulatory Obligations or other authorization from the regulatory Sponsor of a product regulated by the FDA; the possibility of Awardee serving as Sponsor of any necessary regulatory filings with the FDA; and the need for one or more of the Parties to enter into other agreements to secure access to intellectual property or regulatory information necessary to perform the research. These terms, along with other material terms of Awardee's engagement, shall be formalized either in the Statement of Work, or under a separate agreement. Prototype Projects may include research with investigational drugs, biologics or medical devices that are regulated by the U.S. Food and Drug Administration (FDA) and require FDA pre-market approval or clearance before commercial marketing may begin. The Parties anticipate that for most Prototype Projects contemplated under this Agreement, a third party 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 will control research under this agreement. However, in some cases, Awardee or the Government may serve as the regulatory Sponsor for research conducted under this Agreement; and in other cases, the research may not be subject to FDA oversight, and therefore there will be no regulatory SponsorThe Government may serve as the regulatory Sponsor for research conducted under this Agreement; and in other cases, the research may not be subject to FDA oversight, and therefore there will be no regulatory Sponsor. The Senior Director Medical Regulatory (SDMR) is the JPEO-CBRND 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. The Awardee shall invite the SDMR to all FDA meetings and regulatory discussions applicable to this Agreement. Regarding any Technology developed under this agreement for which Awardee serves as regulatory Sponsor, the Awardee agrees to the following:
Regulatory Rights. Section 18.5.2 notwithstanding, Sepracor shall forthwith take all actions necessary, in the form required by the laws and regulations applicable in the Territory, so as to ensure that Nycomed or its designee may exercise Nycomed's rights under the Regulatory Approvals for Product in the Territory in a full and unrestricted way as from the date as of which the expiry or Termination of this Agreement becomes effective. Section 5.2.1, Section 5.2.2 and Section 18.5.2 notwithstanding, to the extent that any Regulatory Rights as hereinafter defined should have vested in Sepracor or a designee of Sepracor, Sepracor shall, upon Nycomed's first request, forthwith take all actions necessary in order to effect the most expeditious transfer to Nycomed or its designee, in the form required by the laws and regulations applicable in the Territory, all regulatory rights relating to the Compound and the Product in the Field including, without limitation, all Regulatory Approvals, and scientific dossiers, governmental authorizations, social security approvals and other similar rights or benefits held by or for Nycomed which may be attached to the Product in the Territory (collectively, the "Regulatory Rights") such that title to and ownership of such Regulatory Rights vests in Nycomed or its appointee as from the date as of which the expiry or Termination of this Agreement becomes effective. In case of any delays, if necessary, Sepracor expressly permits Nycomed or its designee to Sepracor's Regulatory Rights for the registration and/or Commercialization of the Product in the Territory and in the Field. To the extent relevant and required by applicable legislation in the Territory, until such date as of which any such transfer may be completed, Sepracor agrees to confer to Nycomed Commercialization rights in the form as may be required under the Legal Requirements including, without limitation, the appointment of Nycomed or its designee, as the case may be, as Sepracor's sales agent, so as to permit and assist Nycomed in an uninterrupted Commercialization of the Products under the Trademark in the Territory. The costs and expenses incurred by Sepracor in carrying out its obligations under this Section 19.1.2 shall be (i) [**] if this Agreement has been terminated primarily due to the fault of Nycomed, (ii) borne by [**] if this Agreement has been terminated primarily due to the fault of Sepracor, and (iii) [**] if this Agreement has been terminated without either Party bei...
Regulatory Rights. Redhill is the sponsor of the Study Drug Regulatory Application. As such, Redhill has certain standing before the FDA that entitles it to exclusive communications related to the Study Drug Regulatory Application. This clause protects the return on research and development investment made by the U.S. Government in the event of certain regulatory product development failures related to Technology. Regarding any Technology developed under this Agreement for which Redhill serves as regulatory sponsor, Redhill agrees to the following:
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.
Regulatory Rights. Globalstar shall use all reasonable efforts to obtain, perfect and maintain (including complying with all necessary conditions) all Regulatory Rights for each country listed in Attachment 8 as soon as practicable in accordance with the priorities and target dates set forth in Attachment 8, and shall take no actions that are detrimental to the obtaining, perfection and maintenance of such Regulatory Rights. [*].
Regulatory Rights. The Contractor agrees to the following:
a. Regulatory Data. Regeneron shall provide to the OTTR and OTAS copies of formal FDA submissions pertaining to the scope of the project, no later than 10 business days before submission to the FDA. For clarity, CMC Data included in such submissions shall be subject to Section 7.3.b.
b. Rights of Reference. Upon mutual agreement, Regeneron will grant to the Government a right of reference to any Regulatory Application submitted in support of this Project Agreement, solely for the purpose of the Government conducting a clinical trial with the drug product supplied under this Project Agreement under a protocol approved by Regeneron for performance by the Government. In such a case, Xxxxxxxxx agrees to provide a letter of cross-reference to the Government and file such letter with the appropriate FDA office. Nothing in this paragraph reduces the Government’s data rights as articulated in other provisions of this award.
c. Clause 7.4.b. will survive the acquisition or merger of the Contractor by or with a third party. This clause will survive the expiration of this contract.
Regulatory Rights. This Agreement includes research with drugs that are regulated by the FDA and require FDA clearance before commercial marketing may begin. The Parties anticipate that Recipient or its designee will serve as the Sponsor of the Regulatory Application that will permit commercial marketing of VIR-2482 or any other molecule funded under this Agreement. The Sponsor of the Regulatory Application to FDA (as the terms "sponsor", "sponsor- investigator", 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 him to exclusive communications related to the Regulatory Application. Regarding any technology developed Under This Agreement for which Recipient or its designee serves as regulatory Sponsor, Recipient agrees to the following, which will flow down to subcontractors performing regulatory functions: A. Regulatory Submissions. [***].
