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. 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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Examples of Approval Milestone Event in a sentence

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

  • It follows from (a) that:(b′) If c := c1c2 is a chord with c1 < c2 (in the clockwise order restricted to C[x, y] or C[y, x]), then a has a neighbor in C(c1, c2).For otherwise, G has a 2-separation over {c1, c2} contradicting the hypothesis of Case 2.2. Also,(b′′) Within a single segment C[x, y] or C[y, x], there are no non-overlapping chords (or equivalently, all the chords are nested).Suppose that the chords c := c1c2 and d := d1d2 are non-overlapping with c1 < c2 ™ d1 < d2 within, say C[x, y].

  • 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.

  • 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.

  • 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.

  • 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).

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

  • Milestone Event has the meaning set forth in Section 8.2.1.

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

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

  • 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 has the meaning set forth in Section 4.2.

  • 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).

  • 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 Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Milestone Notice has the meaning set forth in Section 2.4(a).

  • 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 the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use 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.