Phase III Milestone Date definition

Phase III Milestone Date means the date on which the Phase III Milestone has occurred.
Sample 1
Phase III Milestone Date means the date on which the Phase III Milestone has occurred. "Proportionate Part" means a fraction, the numerator of which is the number of Warrant Shares purchasable upon the exercise of this Warrant (as of the date on which the Company repurchases this Warrant pursuant to Section 1, or as of the date on which this Warrant is exercised, as applicable) by the Registered Holder (giving effect to any subdivision of this Warrant pursuant to Section 7), and the denominator of which is the aggregate number of Warrant Shares initially purchasable by all Registered Holders of this Warrant (as of the date on which the number of Warrant Shares is fixed, but subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization affecting the Common Stock occurring at any time after such date). "Termination Date" means the earliest to occur of (i) the fifth anniversary of the Approval Date, (ii) the tenth anniversary of the date hereof, (iii) if the License Agreement terminates prior to Approval Date, the date of such termination of the License Agreement and (iv) if the Warrant is repurchased by the Company for $12,500,000 pursuant to Section 1, the date of such repurchase.
Sample 1

Examples of Phase III Milestone Date in a sentence

  • Subject to Section 1(d), the Purchase Price shall be 150% of the 30-Day Average Common Stock Trading Price as of the Phase III Milestone Date (as defined below); provided, however, that the Purchase Price shall not, in any event, be less than $22.50 (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization affecting the Common Stock occurring at any time after the date hereof).

  • Conclusion‌ This paper set out to explore the relationship between the depth of banking crises and the political system.

Related to Phase III Milestone Date

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • Milestone Event has the meaning set forth in Section 8.4.

  • 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.

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Milestone means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;

  • Sales Milestone Payment is defined in Section 5.3.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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 Payment Date has the meaning set forth in Section 2.4(a).

  • 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 means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • 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).

  • 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;

  • 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.

  • 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.

  • 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 Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).