NDA Approval Milestone definition

NDA Approval Milestone means the first approval by the FDA of a New Drug Application for a Product for an epilepsy indication.
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NDA Approval Milestone means the date upon which the FDA ---------------------- approves and authorizes OraPharma or its Affiliates to market MP for any indication in the oral cavity pursuant to 21 C.F.R. 314.105.
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NDA Approval Milestone is defined in Section 2.1(b). EXPLANATORY NOTE: [**] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.
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Examples of NDA Approval Milestone in a sentence

  • The Obligors shall have achieved the Recorlev NDA Approval Milestone.

  • Following receipt of the NDA Approval Milestone, and as consideration for the NDA Approval Milestone TRIS shall transfer the CCP-08 Product NDA to AYTU and shall (i) send to the FDA (with a copy to AYTU) any required properly executed forms (i.e., FDA Forms 356h and 1571, if applicable) and a letter transferring the NDA for such Product to AYTU and (ii) transfer the TRIS Regulatory Documentation related to such Product, excluding any DMFs or the contents thereof to AYTU.

  • Upon FDA Approval, Marathon shall pay to Faes the NDA Approval Milestone Payment, due and payable within [**] Business Days thereafter by wire transfer of cash or other immediately available funds to the account designated in writing by Faes, if (a) [**], Faes shall [**] or (b) Marathon shall [**].


More Definitions of NDA Approval Milestone

NDA Approval Milestone means the receipt of NDA Approval for a Company Therapeutic Product.
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NDA Approval Milestone is defined in Section 2.1(b).
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Related to NDA Approval Milestone

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

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

  • Development Milestone is defined in Section 5.3.

  • 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.

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

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

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

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

  • 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 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 Events has the meaning set forth in Section 7.2.

  • 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;

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

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

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • 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).

  • 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.

  • 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).

  • 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.

  • 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 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 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.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Non-Approval Event means, in respect of the Benchmark:

  • 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.