Final FDA Approval Sample Clauses

Final FDA Approval. For purposes of this Agreement, "Final FDA Approval" shall be deemed to have been received by the Company, Parent or the Surviving Corporation, as the case may be, at such time as such party has received such approval from the U.S. Food and Drug Administration ("FDA") as is adequate to permit such party to begin the marketing, distribution in interstate commerce and selling of DAB(389)IL-2 in the United States for cutaneous T-Cell lymphoma ("CTCL") if such approval is supported to any material extent by clinical and development efforts conducted by the Company prior to the Closing Date. The approval contemplated by the aforesaid sentence shall include approval by the FDA of the content of the label (the "Label") under which DAB(389)IL-2 is to be marketed for CTCL; provided, however, that if, as of the later of the ninetieth day following the Closing Date and the ninetieth day following receipt by Parent or the Surviving Corporation, as the case may be, of a "Complete Review" letter from the FDA in respect of DAB(389)IL-2 for CTCL, Parent or the Surviving Corporation, as the case may be, has failed to reach agreement with the FDA regarding the contents of the Label, Parent shall, or shall cause the Surviving Corporation to:
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Final FDA Approval. Within 30 days after final FDA approval of the first of the Product ANDAs, Purepac shall pay to Organichem [/*[CONFIDENTIAL TREATMENT REQUESTED]*/].
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Related to Final FDA Approval

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Required Regulatory Approvals Certain transactions required, permitted or otherwise contemplated by this Agreement may under certain circumstances require prior filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner. Such transactions include: (a) issuance or purchase of any additional capital stock of the Company or other securities convertible into or exchangeable or exercisable for capital stock of the Company pursuant to Sections 1.2 or 3.4; (b) transfer of Shares to a wholly owned subsidiary of a Shareholder, to another Shareholder or to a wholly owned subsidiary of another Shareholder pursuant to Sections 3.1(a) or 3.4; (c) exercise of preemptive rights by a Shareholder pursuant to Section 3.2; and (d) exercise of call rights by the Company or a Shareholder pursuant to Section 3.3 (including pursuant to the two provisos in Section 3.1(b)). Notwithstanding anything to the contrary contained in this Agreement, any such transactions requiring filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner shall not, to the extent within the control of a party hereto, be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained, and to the extent not within the control of an applicable party hereto, such party shall use best efforts to cause such transactions not to be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained.

  • 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.

  • Project Approval The County may issue a Job Order Authorization for the Work, to include the firm-fixed-price of the Job Order and the project duration. Contractor agrees that all clauses of this Contract are applicable to any Job Order issued hereunder. The County reserves the right to reject a Contractor’s Quote based on unjustifiable quantities and/or methods, performance periods, inadequate documentation, or other inconsistencies or deficiencies on the Contractor’s part in the sole opinion of the County. The County reserves the right to issue a unilateral Job Order authorization for the Work if a Quote price cannot be mutually agreed upon. This is based upon unjustifiable quantities in the sole opinion of the County. The County also reserves the right to not issue a Job Order Authorization if the County’s requirement is no longer valid or the project is not funded. In these instances, the Contractor has no right of claim to recover Quote expenses. The County may pursue continuing valid requirements by other means where Contract was not reached with the Contractor.

  • No Regulatory Approval By CenterState or Charter, 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.

  • Final Approval Hearing “Final Approval Hearing” shall mean the hearing at which the Court will consider and finally decide whether to enter the Final Judgment.

  • New Project Approval Consultant and District recognize that Consultant’s Services may include working on various projects for District. Consultant shall obtain the approval of District prior to the commencement of a new project.

  • Preliminary Approval Within a reasonable time after execution of this Settlement Agreement by the Parties, Plaintiff shall apply to the Court for the entry of an Order:

  • 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.

  • Final Approval After Acceptance, Engineer shall perform any required modifications, changes, alterations, corrections, redesigns, and additional work necessary to receive Final Approval by the County. "Final Approval" in this sense shall mean formal recognition that the Engineering Services have been fully carried out.

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