Regulatory Rights. The Contractor agrees to the following:
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.
Regulatory Rights. The Parties will evaluate the regulatory framework for the 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. The Prototype Project 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 the Prototype Project contemplated under this Agreement, 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 will control research under this agreement. However, in some cases, 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 Sponsor. 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 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. In the event Awardee serves as regulatory Sponsor for the Prototype Project, the Awardee agrees to the following:
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. Partner’s obligations pursuant to Section 18.6.1, Section 18.6.2 and Schedule 18.6.2 notwithstanding, Partner shall forthwith take all commercially reasonable 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 termination of this Agreement becomes effective.
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. 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. [***].
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. 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 that this agreement will result in the FDA authorization, clearance and commercialization of NVX-CoV-2373 as a Vaccine for SARS-CoV-2 Coronavirus (the “Technology”). Novavax is the Sponsor of the Regulatory Application (an investigational new drug application (IND), investigational device exemption (IDE), emergency use authorization (EUA), 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 the FDA) that controls research under this contract. As the Sponsor of the Regulatory Application to the 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), Novavax has certain standing before the FDA that entitles it to exclusive communications related to the 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 the Technology. 1 As used herein, “Government Use” as used “Purpose Rights“ has the meaning set forth in this Section 4.0 means Government purpose rights as defined in the Base Agreement, Article XI, Section 11.01(9).) of the Base Agreement, as modified by Section 8.2(b) below. BASE AGREEMENT NO.: 2020-530 July 2018 Novavax agrees to the following:
