NDA Acceptance definition

NDA Acceptance means the written notification by the FDA that the NDA has met all the criteria for filing acceptance pursuant to 21 C.F.R.(S)314.101.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedBook a Demo

NDA Acceptance means the receipt of notice from the relevant Regulatory Authority that an NDA for the Covered Product has met all the criteria for filing acceptance.

NDA Acceptance means the written notification by the FDA or equivalent Governmental Authority in a foreign country that the NDA has met all the criteria for filing acceptance.

Examples of NDA Acceptance in a sentence

• In addition, in the event that BTC provides written notice of its intent within ninety (90) days after an NDA Acceptance for Frozen Shoulder, BTC will be allowed to provide up to ten percent (10%) of the Product Details for Dupuytren’s Disease in the Auxilium Territory.

• In the event that BTC provides written notice of its intent within ninety (90) days after an NDA Acceptance for a Product in the Field in the Territory indicated for use for any Exercised Indication, BTC will be allowed to provide up to ten percent (10%) of the Product Details for such Indication in the Auxilium Territory.

• In the event that BTC provides written notice of its intent within ninety (90) days after an NDA Acceptance for a Product in the Field in the Territory indicated for use for any Exercised Indication, BTC will be allowed to provide up to ten percent (10%) of the Product Details for such Indication.

• Without limiting the foregoing, Buyer shall use Commercially Reasonable Efforts to achieve each of the Milestones set forth in Section 2.8(a) and (b) as soon as practicable, it being acknowledged that prior to the Second Closing Date, conduct of the PREGNANT Study and Development efforts with respect to the achievement of the PTB NDA Acceptance Milestone shall be Seller’s responsibility.

• Buyer shall pay to Seller the PTB NDA Acceptance Milestone Payment within two (2) Business Days following expiration of the Review Period or resolution of any dispute in accordance with this Section 2.8(b)(ii)(A), as applicable.

More Definitions of NDA Acceptance

NDA Acceptance means acceptance for filing of an NDA by the applicable Competent Authority in the applicable jurisdiction.

NDA Acceptance means the written notification by the FDA that the NDA has met all the criteria for filing acceptance.

NDA Acceptance means the written notice of acceptance of a NDA sent by the FDA.

NDA Acceptance means, with respect to an NDA for a Product in the Field that has been submitted to the FDA by Shionogi or its Affiliate or Sublicensee, the date on which the applicant receives a notification from the FDA indicating that such NDA has been filed pursuant to 21 C.F.R. §314.101(a) or any equivalent or successor regulation.

NDA Acceptance means the earlier of (i) the date Cadence receives written notice from the FDA of acceptance by the FDA of an NDA filed by or on behalf of Cadence or its licensees with respect to any Product in the United States, or (ii) sixty (60) days following filing of such NDA with the FDA, provided that Cadence has not received a “Notice of Refusal to File” from the FDA with respect to such NDA.

NDA Acceptance means the earlier of: (i) receipt by GSK of written notice of acceptance from the FDA of an NDA filed by or on behalf of GSK under this Agreement necessary for Commercialization of Product in the United States, or (ii) sixty (60) days following filing of such an NDA with the FDA so long as GSK has not received a "Notice of Refusal to File" from the FDA with respect to such NDA.

NDA Acceptance means, with respect to each INDICATION, the earlier of (i) written notice of acceptance from the FDA of the NDA filed by or on behalf of SB under this AGREEMENT necessary for commercialization of PRODUCT for the relevant, whichever is appropriate, or (ii) sixty (60) days **=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. following filing of such NDA with the FDA, assuming that SB has not received a "Notice of Refusal to File" from the FDA with respect to such NDA.