Phase II Program definition

Phase II Program means Phase II of the COVID-19 Customer Relief Program as described therein.
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Phase II Program means the summer program of continued resource definition and infill drilling on the McIlvenna Bay deposit that totaled 12,098m of drilling in 36 holes and was completed in 2018.
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Phase II Program means more.diamond drilling, if warranted, as a result of the completion of the Phase I program.
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Examples of Phase II Program in a sentence

  • See Component-specific instructions for more information on Direct to Phase II Program preparation and submission instructions.

  • This BAA is for Phase I proposals only unless the Component is participating in the Direct to Phase II Program.

  • If the Component is participating in the Direct to Phase II Program, refer to the Component-specific Direct to Phase II instructions for more information on proposal preparation.

  • If the Component is participating in the Direct to Phase II Program, refer to the Component-specific Direct to Phase II instructions for award information.

  • As prescribed in 1819.7302(b), insert the following clause: Limitation on Subcontracting - SBIR Phase II Program (OCT 2006) The Contractor shall perform a minimum of one-half of the research and/or analytical effort (total contract price less profit) conducted under this contract.

  • For the first program year of Phase II (Program Year 5), Phase II-Q Savings and CPP2ITD Savings will be the same as no savings will be verified for Phase II until November, after the end of Program Year 5.

  • The proposing small business concern has the capability to implement the technical approach, i.e., has or can obtain people and equipment suitable to the task.Please note, this BAA is for Phase I proposals only unless the Component is participating in theDirect to Phase II Program.

  • In the State of Indiana, the Indiana Department of Environmental Management (IDEM) is responsible for the development and oversight of the NPDES Phase II Program.

  • The Phase II Program Review will examine various aspects of the proposal, including program components, sponsor qualifications and site control.

  • Contracting officers shall insert the clause at 1852.219-81, Limitation on Subcontracting - SBIR Phase II Program, in all Phase II contracts awarded under the Small Business Innovation Research (SBIR) Program established pursuant to Public Law 97-219 (the Small Business Innovation Development Act of 1982).


More Definitions of Phase II Program

Phase II Program means, for a given Product, the earlier of the first Phase II Clinical Study, or the first Phase Ib/II Clinical Study, unless such first Phase Ib/II Clinical Study is also the first clinical study administering such Product to humans.
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Phase II Program means an Exploration Program conducted on the Properties costing at least $300,000 of Expenditures t identify an Ore body that can justify the Phase III Program.
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Related to Phase II Program

  • 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).

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Development Program means the implementation of the development plan.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Development Phase means the period before a vehicle type is type approved.

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Development Plans has the meaning set forth in Section 3.2.

  • 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.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Phase III means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Phase 2 means the second implementation phase of this section, beginning June 1, 2022 and continuing thereafter.

  • 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 means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.

  • (3) PROGRAM.—The term program’ means

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • 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.