Milestone Event has the meaning set forth in Section 8.4.
Development Milestone Event has the meaning set forth in Section 7.1.
Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).
Milestone Date means the date set against the relevant Milestone in the Implementation Plan;
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
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 means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;
Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.
Sales Milestone Payment is defined in Section 5.3.
Project Milestone means the project milestone set forth in Schedule-J;
Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;
Milestone Payment Date has the meaning set forth in Section 2.4(a).
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 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.
Project Milestones means the project milestones set forth in Schedule-G;
Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]
Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.
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 II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.
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.
EBITDA Target means the Company's projected earnings before interest, taxes, one-time transition expenses, non-cash compensation expense charges, depreciation and amortization, as contained in the Company's budget for the Applicable Period and which is approved by the Board (without reference to any adjustments or revision, upwards or downwards, to such projected earnings which are subsequently approved by the Board as part of any subsequent revision to such budget), and (ii) the term "Financial Results" shall mean the Company's EBITDA calculated by reference to the Company's financial statements for the Applicable Period as filed with the Securities and Exchange Commission (the "SEC").
First Target Distribution means $0.4025 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 $0.4025 multiplied by a fraction of which the numerator is 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 clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.
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).
Class D Par Value Test means the test which will be satisfied as of any Measurement Date if, on such Measurement Date, the Class D Par Value Ratio is at least equal to the percentage specified in the definition of "Coverage Test".