Regulatory Filings Approvals Sample Clauses

Regulatory Filings Approvals. 13.1 ABI will be responsible for and required to:
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Regulatory Filings Approvals. In the event of termination by GSK pursuant to Section 10.4, or by Unigene pursuant to Section 10.2 or 10.3, GSK shall ensure that all regulatory filings and approvals relating to the Licensed Product are assigned to Unigene (to the extent legally permissible in the relevant country) within a reasonable time after any termination of GSK’s rights under this Agreement. Any costs incurred by GSK for such assignment or transfer shall be at GSK’s expense. In the event that no such assignment and/or transfer pursuant to this Section may legally be made, then GSK shall surrender such regulatory approvals or applications for cancellation. To the extent that such are related to Licensed Product, all such data, files, materials, information, filings and approvals shall thereafter be deemed to be Unigene’s Confidential Information and subject to the confidentiality provisions of this Agreement, and shall be transferred to the possession of Unigene.
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Regulatory Filings Approvals. CytoDyn shall be responsible for preparing and filing all Regulatory Materials for the Licensed Product in the Territory and outside of the Territory and shall be the owner of all Regulatory Approvals issuing therefrom. CytoDyn shall be responsible for answering any queries from Regulatory Authorities, including those related to Manufacture of the Licensed Product. CytoDyn shall provide Vyera with a copy (which may be wholly or partly in electronic form) of all Regulatory Materials with respect to Licensed Product in the Field in the Territory. CytoDyn shall provide Vyera with reasonable advance notice of any scheduled meeting with the FDA relating to Development and/or the BLA for the Licensed Product in the Field in the Territory, and Vyera shall have the right to silently observe (if and to the extent permitted by the FDA) and, if the Parties mutually agree in writing in advance, participate in any such meeting. CytoDyn shall promptly furnish Vyera with copies of all material correspondence or minutes of material meetings with the FDA in each case relating to the Licensed Product in the Field in the Territory. For clarity, CytoDyn shall have no obligation to share information regarding its development activities, its regulatory meetings or other activities with respect to PRO 140 outside of the Field and/or outside of the Territory.
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Regulatory Filings Approvals. 13.1 Subject to Section 13.3, Taiho will be responsible for and required to:
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Regulatory Filings Approvals. Any regulatory filings made in pursuit of ---------------------------- approval or registration of Joint Products shall be filed by *. Notwithstanding the foregoing, in the case of Type II or Type III Drug Candidates, other than one developed as a Replacement Compound under the License Agreement, the JSC will endeavor to *. In the event of a lack of consensus in the JSC hereunder, the issue will be escalated in accordance with Section 4.6. In the event the issue is not resolved upon such escalation, the final decision shall *.
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Regulatory Filings Approvals. (a) Following the closing of the Merger, each of Cingular and the AWS Parties, on the one hand, and the Triton Parties, on the other hand, agree to take all necessary actions, including filing all necessary regulatory notifications and seeking all necessary regulatory approvals, in order to consummate the transactions contemplated by this Agreement and to diligently pursue the processing of any such applications and filings before the FCC and other applicable Governmental Authorities. Such actions shall include the following:
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Regulatory Filings Approvals 
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Related to Regulatory Filings Approvals

  • 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;

  • 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.

  • 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.

  • Regulatory Matters and Approvals Each of the Parties will give any notices to, make any filings with, and use its reasonable best efforts to obtain any necessary authorizations, consents, and approvals of governments and governmental agencies in connection with the transactions contemplated by this Agreement. Without limiting the generality of the foregoing:

  • Consents, Licenses, Approvals, etc Lender shall have received copies of all consents, licenses and approvals, if any, required in connection with the execution, delivery and performance by Borrower, and the validity and enforceability, of the Loan Documents, and such consents, licenses and approvals shall be in full force and effect.

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