Notice of Intent to Use definition

Notice of Intent to Use means notification to the FDA not later than ninety (90) days prior to the submission of a human drug application of the intent to use the Priority Review Voucher to obtain Priority Review of a human drug application, as described in 21 U.S.C. § 360ff(b)(4)(B)(i).
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Examples of Notice of Intent to Use in a sentence

  • Neither Seller nor any of its Affiliates has filed or submitted to the FDA a Notice of Intent to Use the Priority Review Voucher to obtain a Priority Review.

  • The CONTRACTOR shall be responsible for compliance with the FDEP Notice of Intent to Use the Generic Permit for Discharge of Groundwater from Dewatering Operations (FDEP Document 62-621.300(2)(b), which can be found at ▇▇▇▇▇://▇▇▇▇▇▇▇▇▇▇.▇▇▇/forms).

  • Buyer may, on or after the Effective Date and prior to Closing, submit a Notice of Intent to Use the Priority Review Voucher substantially in the form attached hereto as Exhibit F to the FDA of its intent to use the Priority Review Voucher to obtain Priority Review of a human drug application of Buyer’s choice in accordance with the applicable provisions of the FDC Act and the Priority Review Voucher (a “Pre-Closing PRV Notice”).

  • Neither Seller nor any of its Affiliates has filed or submitted to the FDA, or instructed or permitted any Third Party to file or submit to the FDA, a Notice of Intent to Use the Priority Review Voucher to obtain a Priority Review.

  • Without prejudice to Buyer’s discretion to withdraw a Notice of Intent to Use the Priority Review Voucher at any time by notice to the FDA, the Parties acknowledge and agree that Buyer may withdraw any Pre-Closing PRV Notice if Closing has not occurred by the date that is forty-five (45) days from the Effective Date.

  • Notice of Intent to Use Personal Leave Notice of intent to use Personal Leave shall be provided by the member to his/her immediate supervisor on the prescribed form at least five (5) days in advance of the anticipated absence.

  • In furtherance and not in limitation of the foregoing, Buyer shall timely pay all amounts due with respect to the Priority Review Fee in connection any submission of a Pre-Closing PRV Notice as contemplated by Section 4.1 or other Notice of Intent to Use the Priority Review Voucher by Buyer.

  • Neither Seller nor any of its Affiliates has filed or submitted, or Permitted any Third Party to file or submit, to the FDA a Notice of Intent to Use the Priority Review Voucher.

  • As of the Closing, Seller shall represent and warrant that: neither Seller nor any of its Affiliates has filed or submitted to the FDA, or instructed or permitted any Third Party to file or submit to the FDA, a Notice of Intent to Use the Priority Review Voucher to obtain a Priority Review.

  • Neither Seller nor any of its Affiliates has filed or submitted to the FDA, or instructed or permitted any Third Party to file or submit to the FDA, a Notice of Intent to Use the Priority Review Voucher to obtain a Priority Review or paid a Priority Review Fee in connection with the Priority Review Voucher.

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