Final FDA Approval definition

Final FDA Approval means approval of a Product by the FDA pursuant the Federal Food, Drug, and Cosmetic Act § 505(b), 21 U.S.C. 355(b).
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Final FDA Approval shall have the meaning assigned to such term in Section 6.1.
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Final FDA Approval means approval from the FDA that would allow a party to market and sell a Generic Equivalent.
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Examples of Final FDA Approval in a sentence

  • Parent shall perform all Development Activities in good scientific manner, and in compliance in all material respects with all requirements of applicable laws, rules and regulations, and shall proceed diligently to obtain Final FDA Approval by allocating sufficient time, effort, equipment, and skilled personnel to complete such activities successfully and promptly.

  • Grant of Final FDA Approval to Manufacture, Use **** Market and Sell Licensed Products in the United States Milestone payment(s) shall be due within thirty (30) days of receiving an approval or grant from FDA.

  • At least [* * *] in each calendar year, until Final FDA Approval, Endo shall update such Sales Projection, with one update to be delivered no later than [* * *] after NDA filing and a final update to be delivered within [* * *] after Final FDA Approval.

  • Commencing [**] months prior to the Anticipated Final FDA Approval of OVF, as provided by Cephalon, ▇▇▇▇ shall provide Cephalon with rolling [**] month forecast of its requirements of Cephalon Supplied Products.

  • In the event that the FDA Final Approval of OVF occurs prior to the Anticipated Final FDA Approval of OVF previously indicated to ▇▇▇▇ by Cephalon, Cephalon shall supply ▇▇▇▇ with Cephalon Supplied Products no later than thirty (30) days following FDA Final Approval of OVF.

  • Cephalon shall immediately notify ▇▇▇▇, the Commission, and any Interim Monitor, in writing, upon the occurrence of each of the following events: (i) submission of the NDA for OVF, (ii) receipt of a FDA Approvable Letter for OVF, (iii) Final FDA Approval of OVF, (iv) any determination by the FDA that ACTIQ may no longer be sold in the United States; and (v) any determination by the FDA that ACTIQ is not A/B Rated to ACTIQ SF.

  • Prior to the Second --------------------------------------- Closing the Company shall have received the Primsol Solution Final FDA Approval.

  • Cephalon shall inform ▇▇▇▇, the Commission, and any Interim Monitor, in writing every sixty (60) days from the Effective Date until FDA approval of: (1) ▇▇▇▇ Generic Product and (2) ▇▇▇▇ Generic SF Product, concerning the date of Anticipated Final FDA Approval of OVF.

  • At least *** in each calendar year, until Final FDA Approval, Endo shall update such Sales Projection, with one update to be delivered no later than *** after NDA filing and a final update to be delivered within *** after Final FDA Approval.

  • Prior to the Second Closing the Company shall have received the Primsol Solution Final FDA Approval.


More Definitions of Final FDA Approval

Final FDA Approval means receipt from the United States Food and Drug Administration ("FDA") of such approval as is commercially permissible and legally advisable to permit a third party to begin the marketing, distribution in interstate commerce and selling of DepoCyt in the United States.
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Final FDA Approval means approval by the FDA under Section 505(b) of the U.S. Federal Food, Drug and Cosmetic Act.
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