Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).
Development Milestone Event shall have the meaning set forth in Section 9.2(a).
Milestone Event has the meaning set forth in Section 8.4.
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
Project Milestone means the project milestone set forth in Schedule-J;
Project Milestones means the project milestones set forth in Schedule-G;
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 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.
Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.
Sales Milestone Payment shall have the meaning set forth in Section 8.4.
Milestone Date means the date set against the relevant Milestone in the Implementation Plan;
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;
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.
Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.
Milestone Payment Date has the meaning set forth in Section 2.4(a).
Milestone Payments has the meaning set forth in Section 4.2.
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.
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 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 I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.
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).
Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.
KPI Target means the acceptable performance level for a KPI as set out in each KPI;