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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2Sample 3
Approval Milestone Event means the first to occur of (i) the First Commercial Sale of an Oragenics Product anywhere in the Territory, or (ii) the approval of a New Drug Application for an Oragenics Product by the FDA or equivalent regulatory action in a foreign jurisdiction.
Sample 1Sample 2

Examples of Approval Milestone Event in a sentence

  • Histogenics shall pay Intrexon a milestone payment of one million United States dollars ($1,000,000) within thirty (30) days of each instance of the achievement of the Amended Approval Milestone Event, said payment being made, at Histogenics’ option subject to Section 5.3(b) and 5.3(c), either in cash or in shares of Histogenics’ common stock.

  • DCC has assumed that an external provider will carry out this assurance.

  • 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.

  • Histogenics shall pay Intrexon a milestone payment of five million United States dollars ($5,000,000) within thirty (30) days of the first instance of the achievement of the Approval Milestone Event, said payment being made, at Histogenics’ option subject to Section 5.3(b) and 5.3(c), either in cash or in shares of Histogenics’ common stock.

  • 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.

  • All of this in ½ hour! Come one, come all! Moderator • Charles A.

  • 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 [***] 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.

  • The trial judge had to consider whether the witness was an expert in the field and make a ruling in that regard.


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”.
Sample 1
Approval Milestone Event has the meaning set forth in Section 9.2.2.
Sample 1

Related to Approval Milestone Event

  • Milestone Event has the meaning set forth in Section 8.4.

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

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

  • 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 forth in Schedule-G;

  • 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).

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

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

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • 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 controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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.

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.