Phase II Clinical Study definition

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 Study means, as to a specific Licensed Product, (a) a preliminary efficacy and safety human clinical study in any country conducted to evaluate such product for a particular indication or indications in patients with the disease or condition under study, where at least one of the primary endpoints of such study is an efficacy endpoint, or (b) any human clinical study that satisfies the requirements of 21 C.F.R. § 312.21(b), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.

Phase II Clinical Study means, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety, dose ranging and efficacy of such Licensed Product for such indication, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial of such Licensed Product for such indication.

Examples of Phase II Clinical Study in a sentence

• Effective upon the written certification by Prana that Prana has within the eight (8) year period after the Effective Date begun a new Phase II Clinical Study (excluding any such studies performed before the Effective Date) for approval by a Regulatory Authority of CQ, PQ, or any Derivative, the Obligations described in Section l(c)(i) will terminate in accordance with the terms of Section 2.4(b) of the Patent Assignment Agreement and no longer constitute an Obligation hereunder.

• For purposes of this Agreement, "Obligation(s)" means the obligations of Prana (i) within eight (8) years of the Effective Date to begin a new Phase II Clinical Study (excluding any such studies begun before the Effective Date) for approval by a Regulatory Authority of CQ, PQ, or any Derivative and (ii) to make royalty or milestone payments as provided in the Patent Assignment Agreement that are not disputed in good faith.

• For purposes of this Agreement, "Obligation(s)" means the obligations of Prana (i) within eight (8) years of the Effective Date to begin a new Phase II Clinical Study (excluding any such studies begun before the Effective Date) for approval by a Regulatory Authority of CQ, PQ, or any <PAGE> Execution Version Derivative (as defined in the Derivative Agreement) and (ii) to make royalty or milestone payments as provided in Article 3 of the Patent Assignment Agreement that are not disputed in good faith.

More Definitions of Phase II Clinical Study

Phase II Clinical Study means a clinical investigation of a Licensed Product in human patients to determine initial efficacy for a particular indication, short-term side effects and/or dose range finding.

Phase II Clinical Study means a clinical study, other than a Phase III Clinical Study, designed to evaluate the efficacy of a drug. A Phase II Clinical Study is deemed to commence upon enrollment of the first human subject.

Phase II Clinical Study means: (a) that portion of the drug development and review process which provides for early controlled clinical studies conducted to obtain preliminary data on the effectiveness of an investigational new drug for a particular indication, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21 or any future revisions or substitutes therefor; or (b) a similar clinical study in any national jurisdiction other than the United States.

Phase II Clinical Study means a clinical trial of the Compound on patients, including possibly pharmacokinetics and dose ranging studies, the principal purposes of which are to make a preliminary determination that the Compound is safe for its intended use and to obtain sufficient information about the Compound’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its foreign equivalent in non-U.S. countries of the Territory. A Phase II Clinical Study can comprise a Phase IIa clinical study and a Phase IIb clinical study.

Phase II Clinical Study means a preliminary efficacy and dose ranging human clinical study of a License Product in the target patient population, as described under 21 C.F.R. §312.21(b) with respect to the United States, or, with respect to a jurisdiction other than the United States, a similar clinical study, in each case which shall be deemed commenced when the third patient in such study has received his or her initial dose of such Licensed Product or Buck Licensed Product;

Phase II Clinical Study means a clinical study as defined in 21 C.F.R. § 312.21(b), or, with respect to any other country or jurisdiction, the equivalent of such a clinical study in such other country or jurisdiction.

Phase II Clinical Study means, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety, dose ranging and efficacy of such Licensed Product for such indication, which is prospectively designed to generate sufficient data (if successful) to commence a Pivotal Clinical Study of such Licensed Product for such indication.