Phase III Completion Milestone definition

Phase III Completion Milestone means the positive outcome of the first Phase III Clinical Trial for a Product based on the final study report for such trial and demonstrating a safety and efficacy profile sufficient to warrant preparation and filing of an NDA as determined by Novartis, such safety and efficacy profile to be provided to NexMed by Novartis prior to the initiation of the first Phase III Clinical Trial.
Sample 1
Phase III Completion Milestone means the positive outcome of the first Phase III Clinical Trial for a Product based on the final study report for such trial and demonstrating a safety and efficacy profile sufficient to warrant preparation and filing of an NDA as determined by Novartis, such safety and efficacy profile to be provided to NexMed by Novartis prior to the initiation of the Phase III Clinical Trial.
Sample 1

Related to Phase III Completion Milestone

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

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

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • 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 Event has the meaning set forth in Section 8.4.

  • project completion period means the period of sixty (60) months commencing from and expiring on for the construction and obtaining of Temporary Occupation Permit or Permits for the whole of the Development as provided in clause 3.3;

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

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

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

  • Project Completion Date means the date on which the Completion Certificate is issued;

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

  • Milestone means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;

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

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

  • Final Completion Date means the date on which Final Completion occurs.

  • Final Completion means the date determined and certified by A/E and Owner on which the Work is fully and satisfactorily complete in accordance with the Contract.

  • Target Completion Date has the meaning given such term in Section 3.3(b).

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

  • Project Completion means completion of the Redevelopment in accordance with this Agreement to the state where the whole of the Morley Shopping Centre, as so redeveloped, is capable of occupation for its intended purpose;

  • Project Completion Schedule means the progressive Project Milestones set forth in Schedule-J for completion of the Project Highway on or before the Scheduled Completion Date;

  • 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.

  • Completion Period means the period starting from the date of issue of "Order" and required to complete the work in all respect.

  • Substantial Completion Date means the date on which Substantial Completion occurs.

  • Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • Scheduled Project Completion Date shall have the meaning specified in Section 6.3 (c);

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