NDA Filing definition

NDA Filing means the acceptance by the FDA of the filing of an NDA for the applicable Licensed Product.

NDA Filing means a New Drug Application filed as a result of activities under this Agreement with the FDA, or the equivalent application to the equivalent agency in any other country of the Territory, the filing of which is necessary to market and sell a Product, including all amendments and supplements to any of the foregoing.

NDA Filing means the submission of an NDA to the FDA or equivalent Governmental Authority in a foreign country.

Examples of NDA Filing in a sentence

• Roche’s ability to make such deductions to Development Event payments pursuant to Section 12.7 shall be limited to […***…] of any individual Development Event payment after the first NDA Filing Development Event payment for such Licensed Product.

• The first meeting of the JCC shall be held within twenty (20) calendar days of the later of (a) the NDA Filing date for the first NDA for the Co-Promoted Product to which Ambit as previously exercised its Co-promotion Option or (b) the effective date agreed to by the Parties for the Co-Promotion Agreement.

• With respect to each Product in clinical development in the U.S., Astellas shall determine in good faith the projected date of the NDA Filing for the first NDA covering such Product in the U.S., and shall inform Ambit of such date and shall keep Ambit fully apprised at JSC meetings of any changes in such projected date, so that Ambit has reasonable advance notice of the estimated date that NDA Filing will occur with respect to the Product.

• The Phase II Initiation, Phase III Initiation and NDA Filing milestones in US, EU and Japan are only payable for first Product under this Agreement, regardless of how many times the milestone may be achieved with another Product.

• Pharmasset may exercise its co-promotion right with regard to a Product by giving written notice thereof to Roche at any time during the period commencing upon NDA Filing in the US for such Product and ending three (3) months following such date, provided that at the time of such exercise Pharmasset has an established sales force in the US directed to sales to HIV treatment providers.

More Definitions of NDA Filing

NDA Filing means the acceptance by the FDA of the filing of an NDA for the applicable Product.

NDA Filing means for a given Product, the date that an NDA is filed for the Product.

NDA Filing means the filing of a new drug application or other application ("NDA") with the FDA, to obtain NDA Approval.

NDA Filing means the acceptance of an NDA for initial review by the applicable Regulatory Authority: (a) in the U.S., (b) as a centralized filing with the EMEA, or (c) in Japan, as applicable; provided in each case that such acceptance shall be deemed to have occurred (if it has not occurred already) ninety (90) days following submission of such NDA with the applicable Regulatory Authority unless such Regulatory Authority provides any comments to such submission or otherwise indicates in writing that such filing has not been accepted, in which event, such acceptance shall not be deemed to have occurred until such comments or objections have been addressed to the satisfaction of the Regulatory Authority.

NDA Filing means, collectively, (i) the new drug application submitted to the FDA for and with respect to the Product, including any and all amendments, supplements, post-marketing data, and other information and documents included therein, attached thereto or incorporated by reference therein, as well as all correspondence to and/or from the FDA, related thereto and (ii) any and all individual investigational new drug applications filed with the FDA, together with all submissions, amendments and supplements to the FDA, all data generated thereunder and all correspondence to and/or from the FDA related thereto.

NDA Filing shall have the meaning given such term in the Services Agreement.

NDA Filing means, with respect to a particular Drug Product, the acceptance of an NDA by the FDA or acceptance of an equivalent filing by the equivalent agency in a Major Foreign Market country.