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 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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Examples of NDA Equivalent in a sentence

  • If Elan is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Elan shall at Acorda’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Acorda shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its license rights under this Agreement.

  • Similarly, if Elan is entitled to market, distribute and sell the Product in a particular country, and Acorda is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Acorda shall at Elan’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Elan shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its rights under this Agreement.

  • The NDA and any NDA Equivalent or application for Regulatory Approval filed in Territory for the Product shall remain the property of Acorda, provided that Acorda shall allow Elan access thereto to enable Elan to fulfil its obligations and exercise its rights hereunder.

  • 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.

  • Elan shall be responsible, at Elan’s expense, for filing for and maintaining all license and permits pertinent to Elan’s Facility, as distinct from the Regulatory Approvals specific to the Product, without prejudice to Elan’s responsibilities under the Licence Agreement in respect of preparation and delivery to Acorda for incorporation into the NDA or any NDA Equivalent, of the CMC Section.

  • 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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Related to NDA Equivalent

  • Therapeutic equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • Dose equivalent (HT) means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

  • Lead equivalent means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

  • Aluminum equivalent means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question.

  • Generic Equivalent or "generically equivalent" means a drug that has an identical amount of the same active chemical ingredients in the same dosage form, that meets applicable standards of strength, quality and purity according to the United States pharmacopeia or other nationally recognized compendium and that, if administered in the same amounts, will provide comparable therapeutic effects. Generic equivalent or generically equivalent does not include a drug that is listed by the federal food and drug administration as having unresolved bioequivalence concerns according to the administration's most recent publication of approved drug products with therapeutic equivalence evaluations.

  • Committed dose equivalent (HT,50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

  • Effective dose equivalent (HE), means the sum of the products of the dose equivalent to each organ or tissue (HT), and the weighting factor (wT,) applicable to each of the body organs or tissues that are irradiated.

  • B/A Equivalent Loan shall have the meaning assigned to such term in Section 2.22(h).

  • BA Equivalent Loan any Loan in Canadian Dollars bearing interest at a rate determined by reference to the BA Rate in accordance with the provisions of Section 2.

  • 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.

  • Alternate Currency Equivalent means, at any time, with respect to any amount denominated in Dollars, the equivalent amount thereof in the applicable Alternate Currency as determined by the Administrative Agent or the applicable Issuing Bank, 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 Alternate Currency with Dollars.

  • U.S. Dollar Equivalent means, on any date of determination, (a) with respect to any amount in US Dollars, such amount, and (b) with respect to any amount in any Alternative Currency, the equivalent in US Dollars of such amount, determined by the Administrative Agent pursuant to Section 1.05 using the Exchange Rate with respect to such Alternative Currency at the time in effect under the provisions of such Section.

  • Canadian Dollar Equivalent of any amount which is expressed in United States Dollars means, on any date, the Canadian dollar equivalent of such amount determined by multiplying such amount by the U.S. - Canadian Exchange Rate in effect on such date;

  • USD Equivalent means (i) in respect of each FX Offsetting Transaction, each FX Direct Transaction and each Reverse Dealer Transaction that is a FX Transaction or Currency Option Transaction (assuming (1) the exercise of any Currency Option Transaction and (2) in respect of any Non-Deliverable FX Transaction, the actual exchange of the amounts of the relevant currencies), (y) if there is a USD amount payable either to or by JPMC under such FX Offsetting Transaction, FX Direct Transaction, or Reverse Dealer Transaction, as the case may be, such USD amount or (z) if there is no USD amount payable either to or by JPMC under such FX Offsetting Transaction, FX Direct Transaction, or Reverse Dealer Transaction, as the case may be, then the Dollar Value, determined by JPMC, of the amount of currency payable to JPMC under such FX Offsetting Transaction or Reverse Dealer Transaction, as the case may be, and (ii) in respect of each Bullion Offsetting Transaction, each Bullion Direct Transaction, or Reverse Dealer Transaction that is a Bullion Trade or Bullion Option, as the case may be, (assuming the exercise of any Bullion Option), the Dollar Value, determined by JPMC, of the relevant quantity of Bullion payable to JPMC under such Bullion Offsetting Transaction, Bullion Direct Transaction, or Reverse Dealer Transaction, as the case may be,.

  • Dose equivalent (HT means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

  • Sterling Equivalent means at the time of determination thereof (a) with respect to Sterling, the amount in Sterling and (b) with respect to any amount in Dollars, the equivalent of such amount in Sterling determined by Administrative Agent at such time on the basis of the Exchange Rate for the purchase of Sterling with Dollars on the most recent Computation Date provided for in Section 2.8(a).

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • 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.

  • Base Currency Equivalent means, with respect to an amount on a Valuation Date, in the case of an amount denominated in the Base Currency, such Base Currency and, in the case of an amount denominated in a currency other than the Base Currency (the “Other Currency”), the amount of Base Currency required to purchase such amount of the Other Currency at the spot exchange rate determined by the Valuation Agent for value on such Valuation Date.

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • Canadian Dollar means the lawful currency of Canada.

  • Euro Equivalent means, at any time, with respect to any amount denominated in Dollars, the equivalent amount thereof in Euros 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 Euros with Dollars.

  • Dollar-Denominated Production Payments means production payment obligations recorded as liabilities in accordance with GAAP, together with all undertakings and obligations in connection therewith.

  • Carbon dioxide equivalent or “CO2 equivalent” or “CO2e” means the number of metric tons of CO2 emissions with the same global warming potential as one metric ton of another greenhouse gas. Global warming potential values shall be determined consistent with the definition of Carbon Dioxide Equivalent in MRR section 95102(a).