Key Approval definition

Key Approval means any technical, medical, scientific or other license, registration, authorization or approval of any Agency (including any approval of a New Drug Application or Biologic License Application) necessary for the development, manufacture or commercialization of a pharmaceutical product in any regulatory jurisdiction.
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Examples of Key Approval in a sentence

  • Licensee acknowledges and agrees that it shall be permitted to use any such WHO Prequalification or SRA Approval solely to support any filings to an Agency for Key Approval to Commercialize Licensed Product in the Field in the Territory and shall in no event be permitted to use any such WHO Prequalification or SRA approval as the basis of, or for a reference to, support for any filings to an Agency for Key Approval to Commercialize Licensed Product outside the Field and/or outside the Territory.

  • Licensee will also report to MPP and Pfizer the date of first commercial sale of each Licensed Product, whether such sale is to a Public Purchaser, Governmental Authority or private entity or person and whether such sale is made under an emergency use authorization (“EUA”) or Key Approval within five (5) business days thereafter.

  • Licensee acknowledges and agrees that it shall be permitted to use any such WHO Prequalification or SRA approval solely to support any filings to an Agency for Key Approval to Commercialize Licensed Product in the Field in the Territory and shall in no event be permitted to use any such WHO Prequalification or SRA approval as the basis of, or for a reference to, support for any filings to an Agency for Key Approval to Commercialize Licensed Product outside the Field and/or outside the Territory.

  • Licensee will also report to MPP and Shionogi the date of first commercial sale of each Licensed Product, whether such sale is to a Public Purchaser, Governmental Authority or private entity or person and whether such sale is made under an emergency use authorization (EUA) or Key Approval within five business days thereafter.

  • Any Modification required in connection with a Franchisee Initiated Change to Key Approval will be deemed to be a Modification proposed by the relevant Franchisee under clause 14.2 and clause 14.2 shall apply to such deemed Modification.

  • Licensee will also report to MPP and Pfizer the date of first commercial sale of each Licensed Product, whether such sale is to a Public Purchaser, Governmental Authority or private entity or person and whether such sale is made under an emergency use authorization (“ EUA”) or Key Approval within five (5) business days thereafter.

  • Licensee will also report to MPP and Pfizer the date of first commercial sale of each Licensed Product, whether such sale is to a Public Purchaser, Governmental Authority or private entity or person and whether such sale is made under an emergency use authorization (“EUA”) or Key Approval within five (5) business daysthereafter.

Related to Key Approval

  • 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.

  • 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.

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

  • FCC Approval means the FCC’s grant of the FCC Applications, including any grants by operation of law; provided that the possibility that an appeal, request for stay, or petition for rehearing or review by a court or administrative agency may be filed with respect to such grant, or that the FCC may reconsider or review such grant on its own authority, shall not prevent such grant from constituting FCC Approval for purposes of the Plan.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.