NDA Acceptance Target Combo Product Milestone means the first granting by the FDA of Product Approval for a Target Combo Product for any indication in the U.S.
Development Milestone Event has the meaning set forth in Section 7.1.
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;
KPI Target means the acceptable performance level for a KPI as set out in each KPI;
Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.
Milestone Event has the meaning set forth in Section 8.4.
Project Milestones means the project milestones set forth in Schedule-G;
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 is defined in Section 5.3.
Milestone means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;
Milestone Date means the date set against the relevant Milestone in the Implementation Plan;
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).
Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.
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.
Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.
Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).
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 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).
Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.
Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.
Soft Target means a target that will suffer minimum damage and cause minimum damage to the subject vehicle in the event of a collision.
Initial Indication means the use of a Product for the treatment of opioid addiction.
Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.
Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.
Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.