FDA Meetings and Submissions Sample Clauses

FDA Meetings and Submissions. Medicas shall own all regulatory filings and Approvals for the Licensed Product in the Territory and Medicas shall be responsible for and shall control the regulatory strategy and interactions with regulatory authorities for the Licensed Product in the Territory and shall be the designated point of contact with such regulatory authorities. Medicas shall, upon request, provide Innova with copies of all data and registration submissions in connection with obtaining Approvals.
Sample 1
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FDA Meetings and Submissions. NexMed shall own all regulatory filings and Approvals for all Licensed Products in the Territory and NexMed shall be responsible for and shall control the regulatory strategy and interactions with regulatory authorities for all Licensed Products in the Territory and shall be the designated point of contact with such regulatory authorities, it being understood that NexMed shall consult with Warner with respect to such strategy and interactions and will consider in good faith any Warner recommendations relating thereto. Warner shall be entitled to participate in all meetings and discussions with the FDA relating to the Licensed Products. Prior to submitting any correspondence or other information relating to the Licensed Products to the FDA (an “FDA Submission”), NexMed shall (i) provide Warner with a copy of the FDA Submission and (ii) in the case of a material FDA Submission, provide Warner with a reasonable opportunity to review such FDA Submission and NexMed shall consider and discuss in good faith any comments or proposed changes to such submission by Warner. NexMed shall be responsible for pursuing, compiling and submitting all regulatory documents, and for interacting with the FDA. Nexmed shall be responsible for all product renewal fees payable to the FDA with respect to any Licensed Product under PDUFA.
Sample 1

Related to FDA Meetings and Submissions

  • Safety Meetings Accident investigation.

  • Meetings and Conferences ‌ From time to time the Government may require attendance at Government conferences and meetings at no additional cost to the Government.

  • Review Meetings During the review meetings the Project Managers shall discuss progress made by the Contractor in the performance of this Contract. Each party shall provide a status report, as desired by a Project Manager, listing any problem or concern encountered since the last meeting. Records of such reports and other communications issued in writing during the course of Contract performance shall be maintained by each party.

  • Reports/Meetings The Contractor shall develop reports and any other relevant documents necessary to complete the services and requirements as set forth in this Contract. The County’s Project Manager and the Contractor’s Project Manager will meet at a County designated location to discuss the Contractor’s performance and progress under this Contract, at the request of the County’s Project Manager. If requested by County, the Contractor’s Project Manager and other project personnel shall attend all meetings. The Contractor shall provide such information that is requested by the County for the purpose of monitoring progress under this Contract.

  • Progress Meetings The Engineer shall from time to time during the progress of the work confer with the State. The Engineer shall prepare and present such information as may be pertinent and necessary or as may be requested by the State in order to evaluate features of the work.

  • Reports and Meetings A. Sub-adviser shall furnish to the Board or Adviser, or both, as appropriate, such information, reports, evaluations, analyses and opinions as are required by law or that the Board or Adviser, as appropriate, may reasonably require, including, without limitation: compliance reporting and certification with respect to: 1. Affiliated Brokerage Transactions 2. Affiliated Underwritings 3. Cross Transactions 4. Prospectus Compliance 5. Code of Ethics 6. Soft Dollar Usage 7. Price Overrides/Fair Valuation Determinations B. Sub-adviser shall make available in person to the Board and to Adviser personnel of Sub-adviser as the Board or Adviser may reasonably request to review the investments and the investment program of the Fund and the services provided by Sub-adviser hereunder.

  • Joint Meetings 10.1(a) Should either party desire to discuss with the other any matter affecting generally the relationship of the parties, a meeting of Union and management representatives shall be arranged upon request of either party. Such meeting shall take place at a time mutually convenient to both parties. Any use of Company time for attendance at such meetings shall be arranged in advance by mutual agreement. 10.1(b) This Article is intended to provide a free avenue of communication between the Union and the Company, and suggestions, complaints, or other matters may be presented by either party, provided that neither party shall be required to discuss any item brought up by the other party nor be bound to act upon any item presented. However, both parties agree to discuss informal grievances and complaints.

  • Faculty Meetings Principals shall have the authority to schedule necessary faculty meetings; however, such meetings shall be as brief and well planned as possible. Such meetings shall be used for purposes that cannot be accomplished effectively through other means. Faculty meetings shall be scheduled in a manner that impacts teacher planning time to the least degree possible. If more than one faculty meeting is held in a month, the purpose of the meeting shall be announced to the faculty in advance.

  • Business Review Meetings In order to maintain the relationship between the Department and the Contractor, each quarter the Department may request a business review meeting. The business review meeting may include, but is not limited to, the following: • Successful completion of deliverables • Review of the Contractor’s performance • Review of minimum required reports • Addressing of any elevated Customer issues • Review of continuous improvement ideas that may help lower total costs and improve business efficiencies.

  • Open Meetings (a) All scheduled meetings of the Employer shall be open meetings, except in those cases where personnel, financial or other matters require that the meeting be considered confidential. (b) In those cases where a meeting is designated confidential, the Union shall be provided with a reason for such designation. (c) A designated member of the Union shall be provided a copy of the agenda and minutes of all open meetings. (d) Notwithstanding 18.04(b), any faculty member may request that an Union representative attend as an observer at meetings where the faculty member reasonably believes their working conditions under Article 12 will be affected. Management will be notified by the Union in advance of the meeting regarding their attendance at the meeting.

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