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

  • If Coherus and Licensee are unable to resolve any Licensee comments within such thirty (30)-day period, any delay involved in the filing beyond the initial thirty (30)-day period shall be credited to Coherus, on a day-for-day basis, in determining the order of entrance to market for the EU Regulatory Approval Milestone.

  • 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].

  • 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.

  • Pfizer Payments to BIND 33 8.1. Initial License Fee 33 8.2. Option Fee 34 8.3. Development Milestone Payments 34 8.4. Supplemental NDA Milestone Payments 35 8.5. Regulatory Approval Milestone Payments 36 8.6. First Commercial Sale Milestone Payments 36 8.7. Sales Milestones 37 8.8. Royalties 38 8.9. Third Party Licenses 39 8.10.

  • The Regulatory Approval Milestone Payment is due upon achieving the milestone and is payable to PHS within [**] days thereof.

  • 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.

  • 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.

  • If the Company fails to timely deliver a Deemed Achievement Response Notice prior to the expiration of the Deemed Achievement Response Period, then the Regulatory Approval Milestone shall be deemed to have been achieved for all purposes of the Call Option.

  • Notwithstanding anything contained in this Agreement to the contrary, however, from the date of this Agreement until achievement of the Qualifying Regulatory Approval Milestone, Baxter and UroGen will use at least commercially reasonable efforts to mutually agree in good faith on the milestones/benchmarks, budget and timetable for the Development Work.

  • For clarity, such milestone payment shall not be due if the Regulatory Approval Milestone is achieved after January 1, 2027.


More Definitions of Regulatory Approval Milestone

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 means, and will be deemed to
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Regulatory Approval Milestone means the Company’s achievement of Regulatory Approval for the Initial Device.
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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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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
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Regulatory Approval Milestone has the meaning set forth in Section 8.2(b)(i).
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Related to Regulatory Approval Milestone

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • 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 as set out in Schedule C hereto;

  • 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.

  • 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.

  • 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 has the meaning set forth in Section 7.2.1.

  • Development Milestone is defined in Section 5.3.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • 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 8.2.1.

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

  • 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).

  • Development approval means a document from a governmental entity which authorizes the commencement of a development.

  • 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 governmental approval, agreement, determination or decision establishing prices for a Licensed 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;