Interaction with the FDA Sample Clauses

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.

  • Competition with the Company Until termination of his employment and for a period of one year commencing on the date of termination, the Executive (individually or in association with, or as a shareholder, director, officer, consultant, employee, partner, joint venturer, member, or otherwise, of or through any person, firm, corporation, partnership, association or other entity) shall not, directly or indirectly, compete with the Company (which for the purpose of this Agreement also includes any of its subsidiaries or affiliates) by acting as an officer (or comparable position) of, owning an interest in, or providing services to any entity within any metropolitan area in the United States or other country in which the Company was actually engaged in business as of the time of termination of employment or where the Company reasonably expected to engage in business within three months of the date of termination of employment. For purposes of this Agreement, the term “compete with the Company” shall refer to any business activity in which the Company was engaged as of the termination of the Executive’s employment or reasonably expected to engage in within three months of termination of employment; provided, however, the foregoing shall not prevent the Executive from (i) accepting employment with an enterprise engaged in two or more lines of business, one of which is the same or similar to the Company’s business (the “Prohibited Business”) if the Executive’s employment is totally unrelated to the Prohibited Business, (ii) competing in a country where as of the time of the alleged violation the Company has ceased engaging in business, or (iii) competing in a line of business which as of the time of the alleged violation the Company has either ceased engaging in or publicly announced or disclosed that it intends to cease engaging in; provided, further, the foregoing shall not prohibit the Executive from owning up to five percent of the securities of any publicly-traded enterprise provided as long as the Executive is not a director, officer, consultant, employee, partner, joint venturer, manager, or member of, or to such enterprise, or otherwise compensated for services rendered thereby.

  • 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.

  • Contact with Third Parties In the event that Supplier receives a request from a third party (including an individual) to access any Personal Information in Supplier’s possession, Supplier will promptly forward a copy of such request to DXC and will cooperate with DXC in responding to any such request. Upon DXC’s request, Supplier will make Personal Information in its possession available to DXC or any Third Party designated in writing by DXC and will update Personal Information in Supplier’s possession in accordance with DXC's written instructions. If any government or competent authority requests Supplier to disclose or allow access to Personal Information, Supplier shall, unless legally prohibited, immediately notify DXC of such request and shall not disclose or allow access to such Personal Information without first giving DXC an opportunity to consult with the requesting government or authority to seek to prevent such disclosure or access. Supplier will respond to any such government or enforcement authority request only after consultation with DXC and at DXC’s discretion, unless otherwise required by law. Supplier shall promptly notify DXC if any complaints are received from Third Parties about its Processing of Personal Information, and Supplier shall not make any admissions or take any action that may be prejudicial to the defense or settlement of any such complaint. Supplier shall provide DXC with such reasonable assistance as it may require in connection with resolving any such complaint.

  • Filings with the NYSE The Company will timely file with the NYSE all material documents and notices required by the NYSE of companies that have or will issue securities that are traded on the NYSE.

  • Failure to Comply with the 1934 Act So long as the Buyer beneficially owns the Note, the Company shall comply with the reporting requirements of the 1934 Act; and the Company shall continue to be subject to the reporting requirements of the 1934 Act.

  • COOPERATION WITH REGULATORY AUTHORITIES OR OTHER ACTIONS The parties to this Agreement each agree to cooperate in a reasonable manner with each other in the event that any of them should become involved in a legal, administrative, judicial or regulatory action, claim, or suit as a result of performing its obligations under this Agreement.

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