Phase II Clinical definition

Phase II Clinical. Trial shall mean a human clinical trial that is required for Regulatory Approval where a product is tested in a limited number of patients for the purpose of establishing dose ranging and/or first indication of efficacy of product for a therapeutic or prophylactic use.
Phase II Clinical. Trial shall mean a potentially controlled human clinical trial involving a sufficient number of patients with the disease or condition of interest to obtain sufficient efficacy and safety data of a candidate drug in the targeted patient population to support a Phase III Clinical Trial of a candidate drug for its intended use, and to define the optimal dosing regimen, such as trials referred to in 21 C.F.R. §312.21(b) and foreign equivalents. Typical elements of a Phase II Clinical Trial are described in more detail in Section 3.1.3.2 of ICH Topic E8 (GENERAL CONSIDERATIONS FOR CLINICAL TRIALS). Collaboration and License Agreement Main Body
Phase II Clinical. Trial" an investigation or series of investigations to assess the efficacy and safety of a medical product in patients as approved by the appropriate Regulatory Authority, excluding specifically the first study or studies (whether approved by a Regulatory Authority or not) whose principal objective is to evaluate safety across a range or doses in a small number of subjects (Phase I);

Examples of Phase II Clinical in a sentence

  • Press Release Merck Signs Two Deals for Novel HIV Drug Candidates and Initiates Phase II Clinical Trial of MK-1439 for HIV Merck remains committed to advancing treatment for people with HIV WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the company has signed two licensing agreements for investigational HIV drug candidates.

  • Effective upon the written certification by Prana that Prana has within the eight (8) year period after the Effective Date begun a new Phase II Clinical Study (excluding any such studies performed before the Effective Date) for approval by a Regulatory Authority of CQ, PQ, or any Derivative, the Obligations described in Section l(c)(i) will terminate in accordance with the terms of Section 2.4(b) of the Patent Assignment Agreement and no longer constitute an Obligation hereunder.

  • In the event that Novartis exercises the Buyback Right with respect to a Compound after the First Patient First Visit in a Phase II Clinical Trial for such Compound, then Novartis or its Affiliates shall pay to Evotec (i) [***] (ii) [***] (if any) that would have been paid with respect to such Compound pursuant to Section 5.2 but for Evotec’s exercise of the Development Option for such Compound, each within sixty (60) calendar days after the receipt by Novartis of Evotec’s Invoice for the same.

  • Novartis shall use Commercially Reasonable Efforts to provide an adequate supply of properly forecast Clinical Supply Requirements (post Phase II Clinical Trials) and Commercial Requirements of the Trap-2 Product in the Trap-2 Territory during the applicable Term of this Agreement.

  • Such information shall include, but not be limited to, Phase II Clinical Data of the same type and having substantially the same level of detail of information that Alfa provided to Salix with respect to Crohn’s disease and the Crohn’s EIR Product prior to the Amendment Effective Date.


More Definitions of Phase II Clinical

Phase II Clinical. Trial” 10 1.55 “Phase III Clinical Trial” 10
Phase II Clinical. Study shall mean a research study of Aviptadil with human subjects inter alia aimed at determining the safe and effective dose range in the proposed indication and prospectively designed to generate sufficient data to enter and commence Phase III clinical trials. Regulatory Approval shall mean with respect to a country or jurisdiction, any and all approvals, licenses, registrations, or authorizations of any regulatory or other governmental authority necessary to market and sell a product in such country or jurisdiction.
Phase II Clinical. TRIALS" means those trials on sufficient numbers of patients that are designed to establish the safety and preliminary efficacy of a drug for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed and that satisfy the requirements of 21 CFR 312.21(b) (or its successor regulation), or its foreign equivalent.
Phase II Clinical. Study shall mean a preliminary efficacy and safety study of a candidate drug or medical device product in the target patient population.
Phase II Clinical. Trials” 5
Phase II Clinical. Study shall mean a human clinical study in any country in the world that would satisfy the requirements of 21 C.F.R. §312.21(b) as amended from time to time. * Confidential Treatment Requested. Omitted portions filed with the Commission.
Phase II Clinical. Trial” 6 1.61. “Phase III Clinical Trial” 6 1.62. “Program Molecule” 7 1.63. “Program Patent Rights” 7 1.64. “Regulatory Approval” 7 1.65. “Regulatory Authority” 7 1.66. “Research Plan” 7 1.67. “Research Program” 7 1.68. “Research Program Term” 7 1.69. “ROW” 7 1.70. “Small Molecule” 7 1.71. “Sublicensee” 7 1.72. “Territory” 7 1.73. “Third Party” 7 1.74. “Valid Claim” 7 1.75. Additional Definitions 8 ARTICLE II. GRANTS OF RIGHTS 9 2.1. High Point Grants of Rights 9 2.2. Calithera Grants of Rights 9 2.3. Rights Retained by the Parties 9 2.4. Section 365(n) of the Bankruptcy Code 9 2.5. Exclusivity 9 ARTICLE III. RESEARCH 10 3.1. General 10 3.2. High Point FTE Commitments 10 3.3. Research Program Coordinators 10 3.4. Calithera Contributions 10 3.5. High Point Assistance 10 ARTICLE IV. DEVELOPMENT 11 4.1. General 11 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.