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 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, 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.

Examples of Phase II Clinical Study in a sentence

• 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).

• 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.

• Title: A Single Centre Open Label Phase II Clinical Study to Evaluate the Immunogenicity and Safety of Inactivated Japanese Encephalitis Vaccine in 60 Healthy Indian Participants in the Age Group of 1 To <3 Years – A Dose Response Study.

• Phase II Data” means the final study report for the Day 57 period for a Phase II Clinical Study [*].

• Almirall shall pay the entire commercial milestone payments under item 5 or 6, respectively, of the chart above if Athenex performs, at its entire cost, such a Phase II Clinical Study with respect to the applicable Additional Indication or second Additional Indication, respectively.

More Definitions of Phase II Clinical Study

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 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) 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 xxx.xxxxxxxxxxxxxx.xxx (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) in connection with obtaining Marketing Authorization Approval in the United States, a Clinical Study in human patients, the primary intention of which is to collect data on dosages and demonstrate clinical safety and efficacy of a Licensed Product in a target population for a specific disease or condition under study, as more fully defined in 21 C.F.R. § 312.21(b), as may be amended or (b) in connection with obtaining Marketing Authorization Approval in any other jurisdiction, the equivalent of any such Clinical Study in such other country or jurisdiction.