Facility Approval definition

Facility Approval means the FDA approval of the NDA Manufacturing Supplement for the Facility.
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Facility Approval has the meaning set forth in Section 9.2.
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Facility Approval means any approval, permit or certification of a Regulatory Authority required to manufacture Product in the Facility in accordance with the terms of this Agreement and Applicable Law.
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Examples of Facility Approval in a sentence

  • If Nevro does not issue the Facility Approval Notice within [***] ([***]) days after all regulatory approvals (including Nevro Approvals) necessary to manufacture the Product at the new location have been obtained and CCC has reasonably demonstrated that it can manufacture Products in accordance with this Agreement at such new location, then all prices for the Products will automatically [***] unless and until Nevro issues the Facility Approval Notice.

  • This Agreement shall take effect as of the Effective Date and shall remain in effect until the seventh anniversary of Facility Approval or until ACSD has received all payments due under Section 6.2 unless sooner terminated in accordance with Section 12.2 or extended in accordance with this Section 12.1. Thereafter, this Agreement shall automatically renew for additional two-year terms.

  • This Agreement shall take effect as of the Effective Date and shall remain in effect until the sixth anniversary of Facility Approval or until ACSD has received all payments due under Section 6.2 unless sooner terminated in accordance with Section 12.2 or extended in accordance with this Section 12.1. Thereafter, this Agreement shall automatically renew for additional two-year terms.

  • The target date for [*] for the ACSD facility (the Facility Approval Target Date) is [*].

  • The target date for FDA approval of the NDA Manufacturing Supplement for the ACSD facility (the Facility Approval Target Date) is [*].

  • Following Facility Approval, ACSD may continue operating [*] with the [*].

  • If Nevro does not issue the Facility Approval Notice within [***] ([***]) days after all regulatory approvals (including Nevro Approvals) necessary to manufacture the Product at the new location have been obtained and CCC has reasonably demonstrated that it can manufacture Products in accordance with this Agreement at such new location, then all prices for the Products will automatically [***] ([***]%) unless and until Nevro issues the Facility Approval Notice.

  • The Acquired Subsidiaries own, possess or lawfully use, in the operation of the Business, all material Authorizations which are necessary for them to conduct the Business or for the ownership and use of their respective Assets, including any required AUC Facility Approval (the Material Authorizations).

  • The City developed an initial work plan for soil investigation to delineate horizontal extent of PCB and began efforts to evaluate needs in order to file an EPA application consistent with the EPA PCB Facility Approval Streamlining Toolbox processes.

  • In the event that Facility Approval is received, but Cubist does not choose to purchase [*], Cubist may defer the purchase and the payment for Product until the following year, [ *].


More Definitions of Facility Approval

Facility Approval means the FDA approval of the NDA Manufacturing Supplement for the Facility. FACILITY APPROVAL TARGET DATE is defined in Section 2.1 herein.
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Facility Approval means the earlier of (i) FDA Approval, and (ii) receipt by BioVectra of a notice from Keryx approving the Manufacture of Product in the Facility.
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Related to Facility 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:

  • Preliminary Approval means the Court’s Order Granting Preliminary Approval of the Settlement.

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

  • Requisite Approval means the affirmative vote of the holders of (a) at least a majority of the outstanding shares of Company Capital Stock, voting together as a single class and (b) at least a majority of the outstanding shares of Series A-1 Preferred Stock, Series B Preferred Stock and Series C Preferred Stock, voting together as a single class on an as-converted basis.