PDUFA Fee definition

PDUFA Fee means the fee payable to the FDA pursuant 21 U.S.C. 379h for the review of the initial NDA filed with respect to the Product.
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PDUFA Fee means any fee in connection with a Drug Approval Application in respect of a Licensed Product in the United States pursuant to the Prescription Drug User Fee Act of 1992, as amended.
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Examples of PDUFA Fee in a sentence

  • If either IntelGenx or RedHill pay the PDUFA Fee as outlined in Section 4.3, the party paying the fees will file the application and act as the applicant during the regulatory review process.

  • With respect to the fee paid by Seller pursuant to the Prescription Drug User Fee Act (PDUFA) in respect of Abstral in the aggregate amount of $803,740 which was paid by Seller prior to the Closing (the “PDUFA Fee”), Purchaser shall reimburse Seller a pro-rata amount equal to fifty-percent (50%) of the PDUFA Fee at the Closing totaling $351,636.

  • In connection with the filing and review of such NDA, Pfenex shall apply for and use Diligent Efforts to obtain a waiver (or reduction) with respect to the PDUFA Fee, as provided in 21 U.S.C. 379h(d); provided, however, if despite such Diligent Efforts, the FDA notifies Pfenex that any PDUFA Fee is payable, then the Parties shall share the cost of such PDUFA Fee equally (i.e., on a 50:50 basis).

  • Each Bank hereby makes the same acknowledgments with respect to the Syndication Agent and each Co-Documentation Agent as it makes with respect to the Administrative Agent in Section 9.11.

  • In connection with the filing and review of such NDA, Alvogen shall apply for and use Diligent Efforts to obtain a waiver (or reduction) with respect to the PDUFA Fee, as provided in 21 U.S.C. 379h(d); provided, however, if despite such Diligent Efforts, the FDA notifies Alvogen that any PDUFA Fee is payable, then the Parties shall share the cost of such PDUFA Fee in accordance with their Pro-Rata Portion.