Regulatory Documentation and Technical Data Submissions Sample Clauses

Regulatory Documentation and Technical Data Submissions. As required by the OTA and requested by HJF, Redhill shall work in consultation with HJF and the Government Regulatory and Quality Affairs staff for the development of all regulatory submission packages to the FDA and include HJF and Government Regulatory and Quality Affairs staff in all formal discussions with the FDA. Redhill shall provide HJF and the U.S. Government copies of all technical data generated by Redhill prior to and during performance of the Study, necessary to pursue FDA approval and notify HJF and the Government of FDA decisions as these take place. If applicable, Redhill shall prepare an IND/BLA in the Electronic Common Technical Document (eCTD) format for submission to the FDA and the Government. Redhill shall submit all pre-IND, IND, pre-EUA, and/or BLA report submissions to HJF who will forward the submissions to the OTA Agreement Officer’s Representative. Redhill shall provide all written communications to and/or from the FDA to HJF and the Government as it takes place. Redhill shall courtesy copy HJF’s Principal Investigator and CRO on all email traffic to the FDA and will forward all emails received from the FDA to the Principal Investigator. Meeting minutes will be forwarded to the Principal Investigator within seven (7) calendar days of the meeting or teleconference.
Sample 1
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Related to Regulatory Documentation and Technical Data Submissions

  • Information and Technical Advice At the request of a Party, or upon its own initiative, the arbitration panel may obtain information from any source, including the Parties involved in the dispute, which it deems appropriate for the arbitration procedure. The arbitration panel also has the right to seek the opinion of experts as it deems appropriate. Any information obtained in this manner must be disclosed to each of the Parties and submitted for their comments. Interested parties are authorised to submit amicus curiae briefs to the arbitration panel in accordance with the rules of procedure.

  • Regulatory Filings NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.

  • Marketing Materials (a) During the term of this Agreement, the Sub-Adviser agrees to furnish the Manager at its principal office for prior review and approval by the Manager all written and/or printed materials, including but not limited to, PowerPointÒ or slide presentations, news releases, advertisements, brochures, fact sheets and other promotional, informational or marketing materials (the “Marketing Materials”) for internal use or public dissemination, that are produced or are for use or reference by the Sub-Adviser, its affiliates or other designees, broker-dealers or the public in connection with the Series, and Sub-Adviser shall not use any such materials if the Manager reasonably objects in writing within five business days (or such other period as may be mutually agreed) after receipt thereof. Marketing Materials may be furnished to the Manager by first class or overnight mail, facsimile transmission equipment, electronic delivery or hand delivery.

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