Regulatory Approval Milestone Event definition

Regulatory Approval Milestone Event means for a given Oragenics Product, the approval of a FDA New Product Application for such Oragenics Product by the FDA or equivalent regulatory action in a foreign jurisdiction.
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Regulatory Approval Milestone Event has the meaning set forth in Section 4.2(d).
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Examples of Regulatory Approval Milestone Event in a sentence

  • 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 [***] 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.

  • 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.

  • 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.

Related to Regulatory Approval Milestone Event

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

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

  • 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.

  • Development Milestone is defined in Section 5.3.

  • 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.

  • 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 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.

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

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

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

  • 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;

  • 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.

  • 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).

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

  • 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).

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

  • 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.

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

  • 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 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 I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.