Milestone Event has the meaning set forth in Section 1.11(a).
Development Milestone Event has the meaning set forth in Section 7.2.1.
Milestone Events has the meaning set forth in Section 7.2.
Milestone Date means the target date set out against the relevant Milestone in the Implementation Plan by which the Milestone must be Achieved;
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 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.
Development Milestone is defined in Section 5.3.
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
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 Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;
Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.
Project Milestone means the project milestone set forth in Schedule-J;
Sales Milestone Payment shall have the meaning set forth in Section 8.4.
Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.
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 Payment Date has the meaning set forth in Section 2.4(a).
Project Milestones means the Project milestones set out in Schedule 3;
Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.
Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.
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 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 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 II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.
Milestone Payments means, collectively, the Development Milestone Payments and Sales Milestone Payments.
Third Target Distribution means $0.5250 per Unit per Quarter (or, with respect to the period commencing on the Closing Date and ending on September 30, 2005, it means the product of $0.5250 multiplied by a fraction of which the numerator is equal to the number of days in such period and of which the denominator is 92), subject to adjustment in accordance with Section 6.6 and Section 6.9.
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.