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

  • 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.

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

Related to Development Milestone Event Notice

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

  • Development Milestone is defined in Section 5.3.

  • 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.

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

  • 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.

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

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

  • 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 has the meaning set forth in Section 4.2.

  • 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 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).

  • 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 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.

  • Notice-triggering PI means the PI identified in CCC § 1798.29(e) whose 25 unauthorized access may trigger notification requirements under CCC § 1709.29. For purposes of this 26 provision, identity shall include, but not be limited to, name, identifying number, symbol, or other 27 identifying particular assigned to the individual, such as a finger or voice print, a photograph or a 28 biometric identifier. Notice-triggering PI includes PI in electronic, paper or any other medium.