Phase II Trials definition

Phase II Trials means human clinical trials, the principal purpose of which is to evaluation of both clinical efficacy and safety of an investigational product, and/or to obtain a preliminary evaluation of the dosage regimen of an investigational product, as more fully defined in 21 C.F.R. §312.21(b) or similar clinical study in a country other than the United States.
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Phase II Trials means that portion of the clinical studies for the FDA submission and approval process which provides for the initial trials of a Licensed Product for the purposes of determining the efficacious therapeutic dose range and evaluating safety in the proposed therapeutic indication as more fully defined in 21 C.F.R. ss. 312.21(b), or a similar clinical study in a country other than the United States; and "Phase III Trials" shall mean that portion of the clinical studies for the FDA submission and approval process which provides for trials of a Licensed Product on sufficient numbers of patients to establish the safety and efficacy of such Licensed Product to support regulatory approval in the proposed application as more fully defined in 21 C.F.R. ss. 3122.21(c), or similar clinical study in a country other than the United States.
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Phase II Trials means the human clinical trials conducted on patients and designed to indicate a statistically significant level of efficacy, safety or tolerability for the relevant Collaboration Product in the desired indication, as well as to obtain some indication of dosage regimen required, and in accordance with the relevant Development Program. Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
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Examples of Phase II Trials in a sentence

  • If PPD Development, LP agrees in writing, in either case, that such Phase II Trials for any indications other than the Primary Indication shall be performed at [*] cost (except with respect to the CTM required for the performance of such Phase II Trials, which shall be supplied by [*] at its cost), Xxxxxxx shall, if it exercises the Xxxxxxx Option, utilize PPD Development, LP or an Affiliate thereof to perform all Phase III Trials with respect to such indications.

  • If [***] the Anti-Notch 1 Program in accordance with Scenario #2 following the Completion of the Phase I Trial Parts 1 and 2 for such Program (in lieu of Commencing Phase II Trials in accordance with Scenario #1), [***] set forth in Paragraph 5.3.1 of this Amendment No. 1 of [***].

  • All parties must treat the transfer of Cash and the claims identified in the Case Management Order to be tried in the Phase I, Phase IA and Phase II Trials and any proceeds thereof (collectively, the “Litigation Trust Assets”) as a transfer of such assets directly to the Litigation Trust Beneficiaries, followed by the transfer of such assets by the beneficiaries to the Litigation Trust.

  • This DSM plan is consistent with the National Institutes of Health (NIH) Policy for Data and Safety Monitoring (June 10, 1998) and Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials (June 5, 2000) as well as the National Cancer Institute (NCI) Data Safety Monitoring Guidelines (Approved 9/30/2014) and Data and Safety Monitoring of NCIH-Funded Clinical Research Policy (Reviewed 9/30/2014).

  • LICENSEE shall conduct such clinical trials (including without limitation, Phase I Trials, Phase II Trials, and/or Phase III Trials) as LICENSEE deems are desirable or necessary for Commercialization of the Licensed Products.

  • Each Party hereby covenants that for a period of [***] after the Effective Date, it will not (by itself or through authorization of, or collaboration with, others) (i) conduct any Phase II Trials or Phase III Trials for purposes of seeking Regulatory Approval of a Competitive Product; or (ii) market, sell or promote any Competitive Product.

  • Comparison of Patient Outcomes According to Histology Among Pemetrexed-Treated Patients With Stage IIIB/IV Non–Small-Cell Lung Cancer in Two Phase II Trials.

  • Subject to the terms set forth in this Article 7, GTC shall supply to LFB Biotech its requirements for the Initial Product for the conduct of the LFB Biotech Development Activities and for Phase II Trials and Phase III Trials at a transfer price ************.

  • Under Scenario #1 Following Completion of the Phase I Trial Parts 1 and 2; Payment for Commencement of Phase II Trials Under Scenario #1.

  • If [***] Development of the Anti-Notch 1 Program under Scenario #1 through to the Completion of the Phase II Trials as set forth in Paragraph 5.4.1 of this Amendment No. 1, then [***] with respect to the Anti-Notch 1 Program as is set forth in the first table in Section 8.2.1 of the Agreement.


More Definitions of Phase II Trials

Phase II Trials and “Phase III Trials” mean, respectively, human clinical trials designated by the U.S. Food and Drug Administration (FDA) as Phase I, Phase II (or Phase I/II), or Phase III trials.
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Phase II Trials means those clinical trials on sufficient numbers of patients that, if the defined end-points are met, are designed (and agreed to by the FDA, or other Regulatory Authority in the applicable region of the Territory) based upon existing data in the same patient population as of the start of the trial to evaluate the safety and efficacy of a drug as described in 21 CFR 321.21(b), or its successor regulation, or an equivalent foreign clinical trial." 1.8 AMENDMENT TO SECTION 7.3. Section 7.3(a)(ii) of the Agreement shall be replaced in its entirety and read as follows:
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Related to Phase II Trials

  • Phase II Trial means a clinical trial of a Licensed Product, designated as a Phase II Trial and the principal purpose of which is to make a preliminary determination that such Licensed Product is safe and active in a patient population for its intended use and is designed to obtain sufficient information about such Licensed Product’s efficacy to permit the design of a Phase III Trial(s), and generally consistent with 21 CFR § 312.21(b). For purposes of this definition, Phase II trial shall specifically exclude expansion cohorts from Phase I Trial(s).

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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 Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • 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.

  • Phase I Clinical Trial means a human clinical trial in any country that is intended to collect data on safety of a Product for a particular indication or indications in patients with the disease or indication under study or that would otherwise satisfy the requirements of 21 Code of Federal Regulations (“CFR”) §312.21(a) (U.S.) or its non-U.S. equivalent.

  • Phase 3 Trial means a clinical trial that provides for a pivotal human clinical trial of a Product, which trial is designed to: (a) establish that a Product is safe and efficacious for its intended use, (b) define warnings, precautions and adverse reactions that are associated with the Product in the dosage range to be prescribed, (c) support Regulatory Approval of such Product, and (d) be generally consistent with 21 C.F.R. § 312.21(c).

  • 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).

  • Phase 2 Clinical Trial means a Clinical Trial of a Product that utilizes the pharmacokinetic and pharmacodynamic information obtained from one or more previously conducted Phase 1 Clinical Trial(s) 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. For purposes of this Agreement, ‘initiation’ of a Phase 2 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 2 Clinical Trial.

  • 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 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • 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.

  • 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 1 Trial means a human clinical trial of a Product, the principal purpose of which is a preliminary determination of safety in patients or healthy individuals, or the metabolism and pharmacokinetic properties and clinical pharmacology of such Product, and generally consistent with 21 C.F.R. § 312.21(a).

  • 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.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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 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.

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

  • 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.

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

  • 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.

  • Study means the investigation to be conducted in accordance with the Protocol.