Completion of Current Phase II Study Contingent Payment means a payment in the amount of $[]*.
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).
Completion Payment means the payment for the 20% of the Charges for each Apprenticeship that under the ESFA Rules is only paid once an Apprentice takes their end point assessment, including as the case may be Apprenticeships funded by Transferred Levy Funds;
project completion period means the period of sixty (60) months commencing from and expiring on for the construction and obtaining of Temporary Occupation Permit or Permits for the whole of the Development as provided in clause 3.3;
Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.
Project Completion Date means the date on which the Completion Certificate is issued;
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.
Final Completion Date means the date on which Final Completion occurs.
Substantial Completion Date means the date on which Substantial Completion occurs.
Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).
Project Milestone means the project milestone set forth in Schedule-J;
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.
Target Completion Date has the meaning given such term in Section 3.3(b).
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
Milestone Event has the meaning set forth in Section 8.4.
Final Completion means the date determined and certified by A/E and Owner on which the Work is fully and satisfactorily complete in accordance with the Contract.
Development Milestone Event has the meaning set forth in Section 7.1.
Notice to Proceed (NTP) means the authorization issued by the CO to start performance on this Contract.
Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.
Milestone Date means the date set against the relevant Milestone in the Implementation Plan;
Completion Period means the period starting from the date of issue of "Order" and required to complete the work in all respect.
Milestone Payment Date has the meaning set forth in Section 2.4(a).
Guaranteed Substantial Completion Date or “Guaranteed Substantial Completion Dates” has the meaning set forth in Section 5.3B.
Sales Milestone Payment is defined in Section 5.3.
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;
Successful Completion means that in the reasonable opinion of the Customer, Deliverables completed by the Supplier are fit for purpose, completed on time and otherwise meet all the criteria defined under this Contract;
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.