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).

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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.

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.

Examples of Phase II Clinical Study in a sentence

• For other Licensed Products, the Section 5.1 Notice cannot be made to JJCC prior to the end of the first Phase II Clinical Study for such Licensed Product.

• No later than thirty (30) days following the later of the Initiation by Licensor of the first Phase II Clinical Study for a Collaboration Compound in the Metabolic Indication and Licensee’s exercise of the Collaboration Candidate Option for the Collaboration Compound that is the subject of the Phase II Clinical Study, Licensee shall pay Licensor a milestone payment equal to Fifty Million Dollars ($50,000,000).

• In the event that ABARIS does not elect to delay the Phase II Clinical Study under Section 2.9.1, ABARIS may terminate the Program A Obligations by providing written notice of such termination to PARI.

• PARI acknowledges that: (a) the development, manufacture, verification and delivery of the Test Inhalers according to the Test Inhaler Delivery Schedule is critical to the Phase II Clinical Study for the Existing Formulation; and (b) in setting the Test Inhaler Delivery Schedule, ABARIS has taken into account certain risks, some of which cannot be fully foreseen as of the Effective Date.

• PARI acknowledges that it may be prudent for ABARIS to conduct the Phase II Clinical Study without using the Test Inhalers in order to avoid putting ABARIS’ clinical program at risk or causing financial risk or penalty to ABARIS.

More Definitions of Phase II Clinical Study

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.

Phase II Clinical Study means a study of a Product in human patients to determine initial efficacy and dose range finding before embarking on Phase III Clinical Studies.

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, as to a particular Licensed Product (a) for an oncology product, a clinical study in humans that is intended to obtain information on the Licensed Product’s activity for an Indication at a prescribed (or otherwise limited) dose and administration schedule, as well as additional information on the Licensed Product’s safety and toxicity, or (b) for a non-oncology product, a dose ranging clinical study in humans to evaluate further the efficacy and safety of the Licensed Product in the targeted patient population and to define the optimal dosing regimen. Without limiting the generality of the foregoing, a clinical study shall be deemed to be a “Phase II Clinical Study” hereunder if such study has been designated by the sponsor as a Phase II clinical trial on ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ (or any successor website maintained by the U.S. National Institutes of Health (or any successor agency of the U.S. Government)).

Phase II Clinical Study means a human clinical study for which a primary endpoint is a preliminary determination of efficacy in patients with the disease being studied, as described in 21 C.F.R. § 312.21(b), including any such clinical study in any country other than the United States.

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 study of a Licensed Product in human patients to determine initial efficacy and dose range finding before embarking on Phase III Clinical Studies.