Development Milestone Event Notice definition

Development Milestone Event Notice has the meaning set forth in Section 5.4.1.
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Development Milestone Event Notice has the meaning set forth in Section 9.3.1.
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Development Milestone Event Notice of any Licensed Product that includes a particular Payload or any Replacement Product achieving a development milestone event set forth in Table 9.3 below (each, a “Development Milestone Event”). Such notice will be provided within [***] after such Development Milestone Event is achieved by Novartis or any of its Affiliates. In the case such Development Milestone Event is achieved by a Sublicensee, Novartis’s notice shall be provided within [***] after Novartis receives notice from the corresponding Sublicensee.
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Examples of Development Milestone Event Notice in a sentence

  • After receipt of a Development Milestone Event Notice, Voyager shall submit an invoice to Novartis substantially in the form of Exhibit A with respect to the corresponding Development Milestone Payment.

  • After receipt of a Development Milestone Event Notice, Voyager shall submit an Invoice to Novartis with respect to the corresponding Development Milestone Payment.

  • Sarepta acknowledges receipt from Myonexus of a Development Milestone Event Notice with respect to Development Milestone 2 and agrees that all conditions to payment of the Development Milestone Payment 2 set forth in the Warrant have been satisfied as of the date of this Letter Agreement.

Related to Development Milestone Event Notice

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

  • 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.

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

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

  • 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.

  • Sales Milestone Payment has the meaning set forth in Section 8.3.1.

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

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

  • Milestone Payment means a payment identified in the Implementation Plan to be made following the issue of a Satisfaction Certificate in respect of Achievement of the relevant Milestone;

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

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

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • 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).

  • 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 Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • 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.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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.