Approval Milestone Event definition

Approval Milestone Event means the first to occur for a particular Oragenics Product of (i) the First Commercial Sale of such Oragenics Product anywhere in the Territory, or (ii) the ninetieth (90th) day after the approval of an FDA New Product Application for such Oragenics Product by the FDA or equivalent regulatory action in a foreign jurisdiction.
Approval Milestone Event means the first to occur of (i) the first Commercial Sale of a Collaboration Product anywhere in the Territory, (ii) the approval of a New Drug Application and/or Biologics License Application for a Collaboration Product by the FDA in the United States or (iii) equivalent regulatory action in a foreign jurisdiction in addition to any required pricing approval in such foreign jurisdiction but in no event later than 3 months from such action in the foreign jurisdiction.
Approval Milestone Event. Section 1.58 of the AgreementPhase II Milestone Event”, Section 1.59 of the Agreement “Phase IIb/III Milestone Event”, and Section 1.60 of the Agreement “Prior Field” are hereby deleted in their entirety and each replaced with “Reserved”.

Examples of Approval Milestone Event in a sentence

  • For clarity, if the Regulatory Approval Milestone Event is achieved and any Previous Milestone Event(s) for Product has not yet been achieved for any reason, notwithstanding anything herein to the contrary, such Previous Milestone Event(s) shall be deemed to have been achieved and the corresponding milestone payment set forth above shall be payable simultaneous with the milestone payment for the achievement of the Regulatory Approval Milestone Event.

  • Within thirty (30) days of the achievement of an Approval Milestone Event (as defined in the Equity Agreement), Soligenix will pay to Intrexon, according to the timelines and procedures set forth in the Equity Agreement, one of the following: (i) [*****] in cash, or (ii) the Approval Milestone Shares (as defined in the Equity Agreement).

  • Within thirty (30) days of the achievement of the Approval Milestone Event (as defined in the Equity Agreement), Ampliphi will pay to Intrexon, according to the timelines and procedures set forth in the Equity Agreement, one of the following: (i) [*****] in cash, or (ii) the Approval Milestone Shares (as defined in the Equity Agreement).

  • In the event Oragenics desires to utilize an Oragenics Product that has reached an Approval Milestone Event for an indicated use that would not constitute the use of such Oragenics Product within the Field, Oragenics may request a modification of the Field of this Agreement to permit the inclusion of such indication.

  • Within [***] after Licensee becomes aware that a Development and Regulatory Approval Milestone Event or Sales Milestone Event was achieved, Licensee shall notify Licensor thereof in writing, including identifying the event and the date of its achievement.

  • Such Milestone Information shall be maintained for a period of five years following the end of the calendar year to which it pertains, and shall be furnished for inspection by the Stockholder Representative or any Representative of the Stockholder Representative reasonably acceptable to Parent for the sole purpose of determining the status of attainment of the Approval Milestone Event.

  • GSK shall pay to Amicus the amount set forth below for the achievement of the corresponding filing and approval milestones by GSK, its Affiliate or Sublicensee (or in the case of the Milestone 1 in the table below, by Amicus or its Affiliate): Filing and Approval Milestone Event Milestone Payment 1.

  • Within thirty (30) days of the achievement of the Approval Milestone Event (as defined in the Equity Agreement), Ampliphi will pay to Intrexon, according to the timelines and procedures set forth in the Equity Agreement, one of the following: (i) five million dollars ($5M) in cash, or (ii) the Approval Milestone Shares (as defined in the Equity Agreement).

  • No Approval Milestone Payment will be due or payable with respect to the achievement of the corresponding Approval Milestone Event by an Option Product anywhere in the Territory during the corresponding Development Option Period or Income Option Period even if a Product Reversion occurs with respect to such Option Product.

  • GSK shall notify Scynexis within [***] ([***]) following the first achievement of a given Regulatory Approval Milestone Event by GSK or any of its Affiliates or Sublicensees, and the corresponding Regulatory Approval Milestone Payment shall be due within [***] ([***]) after GSK’s receipt of a Valid Invoice in accordance with Section ‎6.7 for such Regulatory Approval Milestone Payment.


More Definitions of Approval Milestone Event

Approval Milestone Event has the meaning set forth in Section 9.2.2.