NDA Equivalent definition

NDA Equivalent means the equivalent of an NDA, but in a legal jurisdiction other than the U.S.
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NDA Equivalent means any new registration application or submission including any supplements or amendments thereto, such as a foreign counterpart to the NDA, which Acorda may file for the Product with any regulatory authority in any regulatory jurisdiction in the Territory other than the United States that is required to obtain Regulatory Approval in such jurisdiction.
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NDA Equivalent means the equivalent of an NDA, but in a legal jurisdiction other than the US.
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Examples of NDA Equivalent in a sentence

  • To the extent required, Bayer shall either: (i) be responsible for the preparation and delivery to Licensee of the Summary CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in an NDA or NDA Equivalent in accordance with Applicable Laws and as the Parties may mutually agree; or (ii) provide Licensee with all data and information (including, without limitation, all Information) required to complete the Summary CMC Section in accordance with Applicable Laws.

  • Milestone Payment First Phase I Clinical Trial initiated $ 100,000 First Phase III Clinical Trial initiated $ 350,000 First NDA Approval in the U.S $ 500,000 First NDA Equivalent Approval outside of US $ 500,000 Upon first $25,000,000 of commercial sales of any Licensed Products $ 1,000,000 Each of the foregoing payments shall be made only once.


More Definitions of NDA Equivalent

NDA Equivalent means any new registration application or submission including any supplements or amendments thereto, such as a foreign counterpart to the NDA, which Acorda may file for the Product with any regulatory authority in any regulatory jurisdiction in the Territory other than the United States that is required to obtain Regulatory Approval in such jurisdiction. “NDA Timeline” shall mean the development and regulatory timeline attached hereto as Schedule 4. “Notional NSP” shall mean the estimated NSP of Product at the applicable time, which shall on a country-by-country basis be provided by Acorda to the Committee within ninety (90) days prior to commencement of each calendar year (or, for the Launch Year in any country, within ninety (90) days prior to the estimated date of First Commercial Sale in such country); provided, that:
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NDA Equivalent means an application equivalent to an NDA as defined in the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder, made to an FDA Equivalent of any country of the Territory, the filing of which is necessary to commence commercial sale of Oculex Product in such country.
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Related to NDA Equivalent

  • Morphine equivalent dose means a conversion of various opioids to a morphine equivalent dose by the use of accepted conversion tables.

  • Alternative Currency Equivalent means, at any time, with respect to any amount denominated in Dollars, the equivalent amount thereof in the applicable Alternative Currency as determined by the Administrative Agent or the L/C Issuer, as the case may be, at such time on the basis of the Spot Rate (determined in respect of the most recent Revaluation Date) for the purchase of such Alternative Currency with Dollars.

  • Therapeutically equivalent drug products means drug products that contain the same active

  • Therapeutically equivalent means a drug product with the same efficacy and toxicity when administered to an individual as the originally prescribed drug as provided for in Section 39‑24‑40.

  • Dollar Equivalent means, at any time, (a) with respect to any amount denominated in Dollars, such amount, and (b) with respect to any amount denominated in any Alternative Currency, the equivalent amount thereof in Dollars as determined by the Administrative Agent or the L/C Issuer, as the case may be, at such time on the basis of the Spot Rate (determined in respect of the most recent Revaluation Date) for the purchase of Dollars with such Alternative Currency.

  • Foreign Currency Equivalent means, with respect to any amount in Dollars, the amount of any Foreign Currency that could be purchased with such amount of Dollars using the reciprocal of the foreign exchange rate(s) specified in the definition of the term “Dollar Equivalent”, as determined by the Administrative Agent.

  • Canadian Dollar means the lawful money of Canada.