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.
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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.
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Approval Milestone Event has the meaning set forth in Section 9.2.2.
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Examples of Approval Milestone Event in a sentence

  • 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).

  • 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).

  • 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.

  • Following the positive reception of educational materials by students and teachers in participating schools, and endorsement by the Ministry of Education, the subject “Renewable Energy Sources” has been introduced in the list of optional courses for 5th to 9th grade students by the ministerial order no.

  • 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 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.

  • For the avoidance of doubt, if a Product Reversion occurs with respect to an Option Product, then the Approval Milestone Payments will be due or payable with respect to the achievement of the corresponding Approval Milestone Events by such Licensed Product solely if any such Approval Milestone Event is achieved with respect to a Licensed Product following the date on which such Licensed Product ceases to be an 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. Section 1.58 of the Agreement “Phase 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”.
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Related to Approval Milestone Event

  • Milestone Event has the meaning set forth in Section 1.11(a).

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Milestone Date means the target date set out against the relevant Milestone in the Implementation Plan by which the Milestone must be Achieved;

  • Milestone Events has the meaning set forth in Section 7.2.

  • Development Milestone is defined in Section 5.3.

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • Milestone Payment means a payment identified in the Implementation Plan to be made following the issue of a Satisfaction Certificate in respect of Achievement of the relevant Milestone;

  • Project Milestones means the Project milestones set out in Schedule 3;

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Non-Approval Event means, in respect of the Benchmark:

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the applicable country or jurisdiction, but excluding any Pricing and Reimbursement Approval.

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.