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" 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);

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).

Examples of Phase II Clinical in a sentence

• BTC shall provide Auxilium with a copy of a Phase II Clinical Trial report and, any additional data or results in its control.

• Except as otherwise agreed by the JSC, Ipsen shall make and supply, or cause to be made and supplied, all necessary clinical supply of the injection formulation of the Licensed Compound and/or Licensed Product (described in Appendix D hereto) that is available to Ipsen on the Effective Date for use by Nuvios for the performance of Phase I and first Phase II Clinical Trials under the Development Plan.

• The period during which Auxilium may exercise an Additional Indication Option (the “Exercise Period”) shall commence on the date on which BTC submits a Phase II Clinical Trial report to Auxilium for the Product for such Additional Indication and ends one hundred and twenty (120) days thereafter.

• This Agreement shall expire upon completion of the Phase II Clinical Trials contemplated under this Agreement, unless extended by mutual agreement of the Parties.

• Until the earlier of (i) the completion of the Development Plan, or (ii) the grant of a Sublicense hereunder, BioLine shall not acquire or continue developing any projects in the fields of non-Hodgkins lymphomas and/or acute myeloid leukemia, except that BioLine may acquire and continue developing any such projects until the commencement of Phase II Clinical Trials for such projects (or any earlier stage).

More Definitions of Phase II Clinical

Phase II Clinical. Trials” 5

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. 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" 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 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” 10 1.55 “Phase III Clinical Trial” 10

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.