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), ▇▇▇▇▇▇▇ shall, if it exercises the ▇▇▇▇▇▇▇ Option, utilize PPD Development, LP or an Affiliate thereof to perform all Phase III Trials with respect to such indications.

  • 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.

  • Each of Toray and Acologix hereby covenant 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 in Europe or North America; or (ii) market, sell or promote any Competitive Product in Europe or North America; in each case without the prior written consent of the other Party.

  • 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.

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

  • 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 ************.

  • 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.

  • The JSC shall develop a transition plan for transferring responsibility for the foregoing activities from OncoMed to BSP no later than [***] prior to BSP’s Commencement of Phase II Trials for such Late BSP Development Compound.

  • 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 [***].

  • GSK shall have the final decision-making authority with respect to [***] design and content of any such Phase II Trials, including without limitation any later adjustments thereto, such final decision- [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.


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.