Regulatory Approval Milestone definition

Regulatory Approval Milestone means, and will be deemed to occur upon, Parent’s or its Affiliates’ (or their respective successors or assigns) first receipt of approval by the FDA of a new drug application or other regulatory approval application which approval grants Parent or its Affiliates (or their respective successors or assigns) the right to market and sell the Regulatory Approval Product in the United States.
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Regulatory Approval Milestone is defined in Section 5.4.1.
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Regulatory Approval Milestone means the occurrence of both of the following (a) Vorasidenib being granted approval for a New Drug Application (NDA) from the FDA for the United States and with an approved label that specifically permits Vorasidenib’s use as a single agent for the adjuvant treatment of patients with Grade 2 glioma that have an IDH1 or IDH2 mutation; and (b) if, and only if, the approval for a New Drug Application (NDA) referred to in clause (a) requires the approval of a Vorasidenib Companion Diagnostic Test, then the Vorasidenib Companion Diagnostic Test being granted a Premarket Approval from the FDA for the United States; provided that any accelerated approval by the FDA of Vorasidenib or the Vorasidenib Companion Diagnostic Test shall not be deemed to satisfy clause (a) or (b), as applicable.
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Examples of Regulatory Approval Milestone in a sentence

  • The Rights Agent shall hold the Aggregate Regulatory Approval Milestone Payment in a non-interest bearing account until such payment is made in accordance with the foregoing sentence.

  • Notwithstanding the foregoing, in no event shall Parent be required to pay the Regulatory Approval Milestone Payment more than once and Parent shall not be required to pay the Regulatory Approval Milestone Payment if the Regulatory Approval Milestone occurs after the expiration of the Regulatory Approval Milestone Period.

  • The Parties agree to cooperate with one another and use reasonable efforts to reduce or eliminate Tax withholding or similar obligations in respect of any payments under this Agreement, including but not limited to the upfront payment or any Development Milestone Payments, Regulatory Approval Milestone Payments, Commercial Milestone Payments, Sales Milestone Payments or royalties paid by GSK to Scynexis under this Agreement.

  • The fourth tranche in an aggregate principal amount of $25,000 was available upon satisfaction of certain conditions, including the approval by the FDA of a biologics license application in respect of SER-109 (the "Regulatory Approval Milestone") by no later than December 15, 2023.

  • Iterum, in its sole discretion, may defer the Development Milestone Payments for Development Milestone (2) and Development Milestone (3) under Section 5.3 (each event a “Regulatory Approval Milestone” and each payment a “Regulatory Approval Payment”) for up to [ * ] from the occurrence of the Regulatory Approval Milestone.

  • 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.

  • Regulatory Approval Milestone Event Regulatory Milestone Payment 1.

  • The fourth tranche in an aggregate principal amount of $25,000 is available upon satisfaction of certain conditions, including the approval by theFDA of a biologics license application in respect of SER-109 (the "Regulatory Approval Milestone") by no later than December 15, 2023.


More Definitions of Regulatory Approval Milestone

Regulatory Approval Milestone means the Company’s achievement of Regulatory Approval for the Initial Device.
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Regulatory Approval Milestone means that (i) the FDA has approved a Biologics License Application for SER-109 for an indication relating to the treatment of recurrent Clostridioides difficile infection with a label or indication that is generally consistent with that sought in Borrower’s Biologics License Application submission and (ii) Borrower has received the $125,000,000 payment related to the “First Regulatory Approval by the FDA for the first Collaboration Product” as set forth in Section 7.2(a) of the Nestle License Agreement (2021).
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Regulatory Approval Milestone has the meaning set forth in Section 8.2(b)(i).
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Regulatory Approval Milestone means the receipt by the Company of FDA 510(k) Clearance of the Camber Sacroiliac (SI) Fixation System, where such FDA 510(k) Clearance includes an amended indications for use statement that does not include the requirement to use one or more SICONUS SI Joint Fixation System screws) during sacroiliac joint fusion as such requirement is currently set forth in FDA 510(k) Clearance #K203503.
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Related to Regulatory Approval Milestone

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

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

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities set out in Schedule C hereto;

  • 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.

  • 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.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

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

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

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

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

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

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • 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.

  • Development approval means any written authorization from a

  • 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).

  • Pricing Approval means such mandatory governmental approval, agreement, determination or decision establishing prices for the Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

  • 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.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • 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.

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

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.