Interaction with the FDA Clause Samples

The 'Interaction with the FDA' clause defines the procedures and responsibilities for communicating with the U.S. Food and Drug Administration (FDA) regarding regulatory matters related to the agreement. It typically outlines which party is responsible for submitting documents, responding to FDA inquiries, and sharing regulatory updates or correspondence. This clause ensures that all interactions with the FDA are coordinated and transparent, minimizing regulatory risks and ensuring compliance with applicable laws.
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Interaction with the FDA. The Party responsible for a particular regulatory filing pursuant to Section 4.2(b) above (i.e., ZARS, with respect to the filing of an IND and Galderma, with respect to the filing of an MAA, if requested by ZARS) (the “Lead Regulatory Party”) shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, all applicable Regulatory Authorities in the Galderma Territory with respect to the regulatory submission for which such Party is the Lead Regulatory Party.
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Related to Interaction with the FDA

  • Cooperation with the Company The Executive agrees [a] to be reasonably available to answer questions for the Group’s (and any Group Member’s) officers regarding any matter, project, initiative or effort for which the Executive was responsible while employed by any Group Member and [b] to cooperate with the Group (and with each Group Member) during the course of all third-party proceedings arising out of the Group’s (and any Group Member’s) business about which the Executive has knowledge or information. For purposes of this Agreement, [c] “proceedings” includes internal investigations, administrative investigations or proceedings and lawsuits (including pre-trial discovery and trial testimony) and [d] “cooperation” includes [i] the Executive’s being reasonably available for interviews, meetings, depositions, hearings and/or trials without the need for subpoena or assurances by the Group (or any Group Member), [ii] providing any and all documents in the Executive’s possession that relate to the proceeding, and [iii] providing assistance in locating any and all relevant notes and/or documents.

  • COOPERATION WITH THIRD PARTIES The Contractor shall be responsible for fully cooperating with any third party, including but not limited to other Contractors or Subcontractors of the Authorized User, as necessary to ensure delivery or performance of Product.

  • Business with the Group The Agent and the Arranger may accept deposits from, lend money to and generally engage in any kind of banking or other business with any member of the Group.

  • Compliance with the FDIC Rule The Seller agrees to (i) perform the covenants set forth in Article XII of the Indenture applicable to it and (ii) facilitate compliance with Article XII of the Indenture by the Ally Parties.

  • Service with the Company During the Term of this Agreement, Executive agrees to perform such executive employment duties as the Board or the President shall reasonably assign to him from time to time.