Post-Approval definition

Post-Approval means the written correspondence from the Authority indicating the Applicant is eligible to claim tax credits under A.R.S. § 41-1512.
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Post-Approval. Research shall mean ongoing research and development of a Collaboration Product, pursuant to this Agreement, after such Collaboration Product has received Regulatory Approval in a country of the Territory, including, without limitation, Phase IV Clinical Trials and clinical studies in support of additional indications within the Field or label changes for such Collaboration Product in such country during the term of this Agreement.
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Post-Approval. “Caution: For manufacturing, processing, or repacking.” • API identifier for BBS (Bulk Biological Substance). • Container no. • Batch or production run number. • Code generated at Sandoz. • Filling Volume (L). • Date of manufacture. • Date and Signature (of Operator).
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Examples of Post-Approval in a sentence

  • Celgene (itself or by or through any others, including any Affiliates or Sublicensees) will not materially deviate from the then current ROW Post-Approval Manufacturing Plan when Manufacturing Licensed Product for Commercialization for ROW Administration without first notifying the JGC in writing and providing an updated ROW Post-Approval Manufacturing Plan.

  • Prior to Regulatory Approval of Licensed Product in any country in the ROW, Celgene will provide to the JGC a Manufacturing plan for the ROW in form and substance at least as detailed as the applicable section of the U.S. Commercialization Plan (including covering the applicable three-year time period) (the “ROW Post-Approval Manufacturing Plan”).

  • Notwithstanding any other provision of this Agreement, Acceleron shall not be obligated to reimburse or share with Celgene any capital expenditures costs required for Celgene to Manufacture and supply Clinical Supplies for Phase 3 Clinical Trials or Post-Approval Clinical Trials.

  • The Parties shall discuss and agree in good faith any Post-Approval Commitment mandated by a Regulatory Authority upon the Regulatory Approval of the Licensed Product in the Territory, including the inclusion of such mandated Post-Approval Commitment in a Global Registrational Study.

  • The Parties will use Commercially Reasonable Efforts to complete the Post-Approval Initial Training as promptly as possible after regulatory approval has been obtained for the Product in the Territory and prior to the date of First Commercial Sale in the Territory.

  • Each Party will notify the other Party in reasonable detail of any complaint received by it or its Affiliates or Sublicensees with respect to Licensed Product within sufficient time to allow the other Party and its Affiliates or Sublicensees to comply with any and all regulatory and other requirements imposed upon them in any jurisdiction in which Licensed Product is tested in clinical studies, including Post-Approval Studies, or being marketed or sold.

  • Except as may be otherwise specified by the JDC, after the Option Exercise Date, Biogen Idec (or its Affiliates or Sublicensees) shall be responsible for, and shall be the holder of, all INDs (including IND submissions) with respect to Territory-Specific Clinical Trials or Post-Approval Clinical Studies conducted by or on behalf of Biogen Idec or any of its Affiliates or Sublicensees, and all Regulatory Approvals (including BLA submissions) for the Licensed Product in the Field in the Licensed Territory.

  • Celgene shall Manufacture and supply all Clinical Supplies for Phase 3 Clinical Trials and Post-Approval Clinical Trials; provided, however, that the Joint Development Committee may request, at least one (1) year prior to the anticipated launch of the first Phase 3 Clinical Trial or Post-Approval Clinical Trials, as applicable, that Acceleron Manufacture and supply such Clinical Supplies on terms to be agreed.

  • Except as provided in Section 2.7.4(a) with respect to Declined Activities, fifty percent (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which shall be included in the calculation of the Annual U.S. Profit/Loss) shall be borne by Astellas, and fifty percent (50%) of such costs shall be borne by Ambit.

  • UCB shall purchase Comparator Drug and Comparator Drug Placebo from Third Parties in accordance with its customary practices and shall supply such Materials for use in the Phase 3 Study and any Post-Approval Studies as set forth in the Development Plan.


More Definitions of Post-Approval

Post-Approval. “Caution: For manufacturing, processing, or repacking.” • NDA Number or IND Number. • The name, address and contact details (include contact name, telephone and fax number) of the API Sponsor Company (Unigene). • Labels showing that the shipment is done on dry ice. • ** • ** included in the carton. • If applicable: “For Investigational Use Only under BBIND #xxxxx”.
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Related to Post-Approval

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • Special Approval means approval by a majority of the members of the Conflicts Committee.

  • HSR Approval means expiration of all applicable waiting periods under the HSR Act (including any voluntary agreed extensions) or earlier termination thereof.