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;
Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).
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 Date means the date set against the relevant Milestone in the Implementation Plan;
Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;
Sales Milestone Payment shall have the meaning set forth in Section 8.4.
Project Milestones means the project milestones set forth in Schedule-G;
Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.
New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.
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;
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.
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).
KPI Target means the acceptable performance level for a KPI as set out in each KPI;
Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.
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.
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 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).
Additional Indication means any indication other than the Initial Indication.
Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).
Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.