Milestone Event has the meaning set forth in Section 8.2.1.
Development Milestone Event has the meaning set forth in Section 7.2.1.
Milestone Events has the meaning set forth in Section 7.2.
Development Milestone is defined in Section 5.3.
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
Milestone Date means the date set against the relevant Milestone in the Implementation 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.
Sales Milestone Payment shall have the meaning set forth in Section 8.4.
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 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.
Project Milestone means the project milestone set forth in Schedule-J;
Milestone Payment has the meaning set forth in Section 4.2.
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).
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 Milestones means the project milestones set forth in Schedule-G;
Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.
Milestone Notice has the meaning set forth in Section 2.4(a).
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").
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 Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial 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 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.
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.