Review and Approval of Regulatory Submissions Sample Clauses

Review and Approval of Regulatory Submissions. At each JSC meeting, Licensee will present (a) key planned upcoming regulatory activities and (b) summaries of all meetings with Regulatory Authorities related to a Licensed Product in the territory of Japan. Upon Licensor’s request, Licensee will provide, within [***] Business Days of such request, copies of meeting minutes for any such meeting with Regulatory Authorities in the territory of Japan described in this Section 5.1.1(b) (Review and Approval of Regulatory Submissions). Licensee will provide to Licensor for review drafts of all Regulatory Submissions for which Licensee is responsible under this Agreement, including proposed responses to communications from Regulatory Authorities in the territory of Japan, reasonably in advance of any applicable submission deadline (and in no event less than [***] Business Days prior to such submission deadline). Licensor will reasonably consider any comments Licensee may have regarding such Regulatory Submissions. Licensee will ensure that its relevant Affiliates and Sublicensees, conduct
Sample 1
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Review and Approval of Regulatory Submissions. At each JSC meeting, Licensee will present (a) key planned upcoming Regulatory activities and (b) summaries of all meetings with Regulatory Authorities related to a Licensed Product in the Territory. Upon Licensor’s request, Licensee will provide, within [***] Business Days of such request, copies of meeting minutes for any such meeting with Regulatory Authorities in the Territory described in this Section 5.1.1(b) (Review and Approval of Regulatory Submissions). Licensee will provide to Licensor (through the JSC) for review drafts of all Regulatory Submissions for which Licensee is responsible under this Agreement, including proposed responses to communications from Regulatory Authorities in the Territory, reasonably in advance of any applicable submission deadline (and in no event less than [***] days prior to such submission deadline). Licensee will reasonably consider any comments Licensor may have regarding such Regulatory Submissions. Licensee will, and will ensure that its relevant Affiliates and Sublicensees, conduct all regulatory activities in compliance with this Section 5.1.1 (Review and Approval of Regulatory Submissions). 5.1.2
Sample 1

Related to Review and Approval of Regulatory Submissions

  • Review and Approval Documents specified above must be submitted for review and approval by CITY Purchasing and Contracts prior to the commencement of work by CONTRACTOR. Neither approval by CITY nor failure to disapprove the insurance furnished by CONTRACTOR shall relieve CONTRACTOR of CONTRACTOR’S full responsibility to provide the insurance required by this Contract. Compliance with the insurance requirements of this Contract shall not limit the liability of CONTRACTOR or its sub-contractors, employees or agents to CITY or others, and shall be in addition to and not in lieu of any other remedy available to CITY under this Contract or otherwise. CITY reserves the right to request and review a copy of any required insurance policy or endorsement to assure compliance with these requirements.

  • Regulatory Approvals All Requisite Regulatory Approvals shall have been obtained and shall remain in full force and effect and all statutory waiting periods in respect thereof shall have expired, and no such Requisite Regulatory Approval shall have resulted in the imposition of any Materially Burdensome Regulatory Condition.

  • Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.

  • No Regulatory Approval By Buyer or Company, if either of their respective boards of directors so determines by a vote of a majority of the members of its entire board, in the event any Regulatory Approval required for consummation of the transactions contemplated by this Agreement shall have been denied by final, non-appealable action by such Governmental Authority or an application therefor shall have been permanently withdrawn at the request of a Governmental Authority.

  • Regulatory Filings and Approvals Copies of all necessary governmental and third party approvals, registrations, and filings in respect of the transactions contemplated by this Agreement;

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

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