Phase 2 Clinical Trials definition

Phase 2 Clinical Trials means a human clinical trial of a Product or a New Collaboration Compound, the principal purpose of which is a determination of safety and efficacy in the target patient population or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.
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Phase 2 Clinical Trials means human clinical trials conducted in patients with a Product anywhere in the world in accordance with cGCP and intended to demonstrate efficacy and a level of safety in the particular indication tested, as well as to obtain a preliminary indication of the unit and/or daily dosage regimen required.
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Phase 2 Clinical Trials shall have the meaning described in the ICH Harmonised Tripartite Guideline entitled “General Considerations for Clinical Trials,” as amended.
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Examples of Phase 2 Clinical Trials in a sentence

  • Subject to Section 2.4.2, Acceleron shall Manufacture all Clinical Supplies for Phase 1 Clinical Trials and Phase 2 Clinical Trials.

  • Notwithstanding any other provision of this Agreement, Celgene shall not be obligated to reimburse or share with Acceleron any capital expenditures costs required for Acceleron to Manufacture and supply such Clinical Supplies for Phase 1 Clinical Trials or Phase 2 Clinical Trials.

  • For purposes of clarification, upon transition of Manufacturing and supply obligations to Celgene pursuant to this Section 2.4.2 for a particular Licensed Compound or related Licensed Product, if any Clinical Supplies are needed for additional Phase 1 Clinical Trials or Phase 2 Clinical Trials for the same Licensed Compound or Licensed Product, such Manufacturing and supply responsibilities will be undertaken by Celgene in the same manner as set forth in this Section 2.4.2.

  • Other than as provided for in the EDP, Sanofi will have all rights to conduct, at Sanofi’s Cost, all Development of Compounds and Products in the Field, including all Phase 2 Clinical Trials and Phase 3 Clinical Trials, and any Phase 4 Clinical Trials, in its sole discretion (but subject to its diligence obligations under Section 3.3(a)).

  • Zosano shall be responsible for development and scale up of the manufacturing process and for the manufacturing of clinical supply of the Licensed Product for Novo Nordisk until completion of the Technology Transfer (i.e., for the preclinical studies, Phase 1 Clinical Trial(s), Phase 2 Clinical Trial(s) and, at Novo Nordisk’s option, Phase 3 Clinical Trial(s), including any necessary validation studies).

  • Zosano shall comply with U.S. cGMP for clinical supplies and all other governmental laws and regulations applicable in the U.S. in manufacturing and supplying Licensed Product for Phase 1 Clinical Trial(s) and Phase 2 Clinical Trial(s), as may be further set forth in the Quality Agreement.

  • Regardless of the location of the Phase 2 Clinical Trials, the foregoing coverage levels shall be instituted and maintained by a Program Acquirer at the time it chooses to commence Phase 3 Clinical Trials in the U.S. Before commencing other development or distribution activities subsequent to Phase 3 Clinical Trials in the U.S, a Program Acquirer shall institute and maintain customary product liability insurance with regard to such activities.

  • If Zosano is requested by Novo Nordisk to manufacture clinical supplies of Licensed Product for Phase 2 Clinical Trial(s) in the EU, Xxxxxx shall use Commercially Reasonable Efforts to comply with cGMP applicable in the EU in manufacturing and supplying Licensed Product for Phase 2 Clinical Trial(s); provided, however, that all costs associated with any modifications to Zosano’s facilities or other capital expenditures to meet EU cGMPs shall be borne by Novo Nordisk.

  • In the event that the JSC determines to pursue clinical development in any Indication other than the First Indication or the Indications in the Third Category (such Indication, an “Additional Indication”), ACI shall have an option (the “Additional Indication Clinical Funding Option”) to contribute up to [*****] of Lilly Development Costs during Phase 2 Clinical Trials and Phase 3 Clinical Trials for such Additional Indication.

  • Synchroneuron shall be entitled to have a representative attend and participate in (i) each meeting during which Somaxon's strategy with respect to meetings with the FDA or other like foreign government body is discussed and (ii) each meeting with the FDA or other like foreign government body during the conduct of Phase 2 Clinical Trials and Phase 3 Clinical Trials.

Related to Phase 2 Clinical Trials

  • 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 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Clinical Trial means any human clinical trial of a Product.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing 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 III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.