Phase 2 Clinical Trial definition

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.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedSchedule a Demo

Phase 2 Clinical Trial means a Clinical Trial that would satisfy the requirements of 21 U.S. CFR § 312.21(b) or any other applicable Laws.

Phase 2 Clinical Trial means a human clinical trial, the principal purposes of which are the evaluation of the efficacy of such product for a particular indication in the target patient population and a determination of the common side-effects and risks associated with the product in the dosage range to be prescribed and to obtain sufficient information about the efficacy for such pharmaceutical product in the disease or condition being studied to permit the design and dose of such product in a Registrational Clinical Trial. Phase 2 Clinical Trial shall exclude in all cases any combined Phase 1 Clinical Trial/Phase 2 Clinical Trial.

Examples of Phase 2 Clinical Trial in a sentence

• Upon receipt of such request, FibroGen shall make good faith and diligent efforts to present to the JSC for review all reasonably relevant data and other information (excluding chemical structures) Controlled by FibroGen that is related to those HIF Compounds that it reasonably believes offer substantial clinical benefit over then-current Collaboration Compounds from its library of HIF Compounds, including results from any Phase 2 Clinical Trial conducted in the Field.

• ARES TRADING shall be responsible for manufacturing and supplying Products for Development use after Phase 1 Clinical Trial in the Field in the Territory, provided that ARES TRADING may request Intrexon to conduct such manufacture and supply at least 18 months prior to the anticipated initiation of the first Phase 2 Clinical Trial for the first Indication with respect to a Product.

• If Allarity and/or its Affiliates or sublicensees have not achieved Successful Completion of the first Phase 2 Clinical Trial of the Product prior to December 31, 2022, then, in Allarity’s sole discretion, it may notify Eisai of its intention to continue Development activities of the Compound.

• Under the Research Program, the Parties will work collaboratively to (i) continue and complete IND-enabling pre- clinical studies for ARX618, (ii) conduct a Phase 1 Clinical Trial for ARX618 and (iii) prepare for the initiation of a Phase 2 Clinical Trial for ARX618 concurrently with the conduct of such Phase 1 Clinical Trial (the “Initial ARX618 Program”).

• If [***] has satisfied the Manufacturing Criteria with respect to the Compounds and Products within the Collaboration Program before [***] ([***]) months prior to the date on which ArriVent intends to file the first IND with respect to the Collaboration Program to any Regulatory Authority, ArriVent will purchase such Compounds or Products manufactured by [***] for use in any Phase 1 Clinical Trial or Phase 2 Clinical Trial (as long as such Phase 2 Clinical Trial is not a Registration Trial).

More Definitions of Phase 2 Clinical Trial

Phase 2 Clinical Trial means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(b), as amended, and is intended to explore a variety of doses, dose response, and duration of effect, and to generate evidence of clinical safety and effectiveness for a particular Indication or Indications 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 2 Clinical Trial means a study in humans for which a primary endpoint is a preliminary determination of efficacy in patients with the disease being studied, as more fully defined in 21 CFR §312.21(b) or comparable regulations in any country or jurisdiction outside the U.S., and any amended or successor regulations.

Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

Phase 2 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(b) or corresponding foreign regulations.

Phase 2 Clinical Trial means, as to a specific Licensed Product, a clinical study in humans designed with the principal purpose of determining initial efficacy and dosing of such Licensed Product in patients for the indication(s) being studied as described in 21 C.F.R. § 312.21(b); or a similar clinical study in a country other than the United States. Without limiting the foregoing, if (i) a protocol for a Phase 1 Clinical Trial includes the enrollment of a cohort of patients (“Phase 2 Cohort”) that would satisfy the foregoing definition of Phase 2 Clinical Trial, or (ii) a protocol for a Phase 1 Clinical Trial is amended to include the enrollment of a Phase 2 Cohort, then, in each case ((i)-(ii)), such Phase 1 Clinical Trial shall be deemed a Phase 2 Clinical Trial on and after the date of the first dosing of the first human subject in such Phase 2 Cohort.

Phase 2 Clinical Trial shall include without limitation any clinical trial that would satisfy requirements of 21 C.F.R. § 312.21(b).

Phase 2 Clinical Trial means any human clinical trial of a Royalty-Bearing Product conducted mainly to test the effectiveness of chemical or biologic agents or other types of interventions for purposes of identifying the appropriate dose for a Phase 3 Clinical Trial for a particular indication or indications that would satisfy the requirements of 21 CFR § 312.21(b) or its non-United States equivalents. A Phase 2/3 Clinical Trial shall be deemed to be a Phase 2 Clinical Trial with respect to the portion of that clinical trial that is regarded as its Phase 2 component, in accordance with the applicable protocol.