Phase 2 Clinical Study definition

Phase 2 Clinical Study means a clinical study of an investigational Product in human patients anywhere in the Territory conducted to evaluate the effectiveness of the Product for a particular indication or indications in patients with the disease or condition under study and to generate more detailed safety, tolerability, and pharmacokinetics information associated with the Product, as described in 21 C.F.R. § 312.21(b) (as amended or any replacement thereof), or a comparable clinical study required by the relevant Regulatory Authority in a country other than the United States.

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Phase 2 Clinical Study means controlled human clinical studies conducted to evaluate the effectiveness of a drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug in compliance with 21 C.F.R. §312(b) or foreign equivalent, and shall include any clinical study that leads to a conditional regulatory approval, that is followed by a confirmatory Phase 3 Clinical Trial.

Phase 2 Clinical Study means a clinical study of a product that is designed to establish the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence pivotal clinical trials, as further defined in 21 C.F.R. § 312.21(b) (or the non-United States equivalent thereof).

Examples of Phase 2 Clinical Study in a sentence

• The Parties will establish a committee, no later than completion of the first Phase 2 Clinical Study for the first Regional Licensed Product, to (a) oversee Commercialization of Regional Licensed Products in the Territory, and (b) facilitate the flow of information between the Parties with respect to, and provide a forum to discuss, the Commercialization of T1 Antibody Candidates, T1 Licensed Products, Global Antibody Candidates and Global Licensed Products (the “JCC”).

• Sponsor will be responsible, [***], for producing, in compliance with applicable law, all Study Product for use in any Phase 2 Clinical Study, appropriately formulated, labeled and in sufficient quantities to complete the Clinical Study.

• In the event that a combined Phase 2 Clinical Study and Phase 3 Clinical Study is conducted for a Licensed Product, then Development and Regulatory Milestone Event A shall be deemed to be achieved when the fifth patient is dosed in the Phase 2 portion of the Clinical Study and Development and Regulatory Milestone Event B shall be deemed to be achieved when the fifth patient is dosed in the Phase 3 portion of the Clinical Study.

• Within thirty (30) days of the dosing of the first human in a Phase 2 Clinical Study in the Territory of a Drug Product, Taisho shall provide to Arena a Phase 2 Clinical Study Milestone of [*************************** (*******)].

• The Parties will establish a committee, no later than completion of the first Phase 2 Clinical Study for the first Regional Licensed Product or Optioned Licensed Product, to (a) oversee Commercialization of Regional Licensed Products and Optioned Licensed Products in the Territory, and (b) facilitate the flow of information between the Parties with respect to, and provide a forum to discuss, the Commercialization of Regional Licensed Products and Optioned Licensed Products (the “JCC”).

More Definitions of Phase 2 Clinical Study

Phase 2 Clinical Study means a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21 (b).

Phase 2 Clinical Study means a study of a Licensed Product in human patients 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 as and to the extent defined for the United States in 21 C.F.R. § 312.21(b), or its successor regulation, or the equivalent regulation in any other country. Without limiting the generality of the foregoing, a clinical study shall be deemed to be a “Phase 2 Clinical Study” hereunder if such study has been designated by the sponsor as a Phase 2 [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 2 Clinical Study means a clinical study in humans of the safety, dose ranging and efficacy of a pharmaceutical product, as further defined by Indian Regulatory Authorities, Federal Regulation 21 C.F.R. § 312.21(b) or its foreign equivalents.

Phase 2 Clinical Study means 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 that would satisfy the requirements specifically defined by the rules and regulations of the FDA under 21 § C.F.R. 312.21(b), or similar rules and regulations in other countries or jurisdictions.

Phase 2 Clinical Study means a human clinical study of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and that is designed or 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 or Applicable Law in a country other than the United States.

Phase 2 Clinical Study has the same meaning as set forth in 21 C.F.R. Section 312.21(b), including any and all amendments, modifications or changes thereto as may be made thereto in the future, or the equivalent thereof, in any applicable country within the Territory.

Phase 2 Clinical Study. Phase 2 Clinical Study shall mean a study of a Compound in patients to determine additional safety information and initial efficacy and dose range finding.