Phase II Studies definition

Phase II Studies means clinical studies in human patients, the primary intention of which is to collect data on dosages and demonstrate clinical safety and efficacy in a target population for a specific disease or condition under study (i.e., statistically significant differences between groups for clinical endpoints, which may include generally accepted surrogate pharmacodynamic endpoints), with respect to (i) the United States, as more fully defined in 21 C.F.R. § 312.21(b), as may be amended; or (ii) the equivalent of such a clinical study for submission to the EMEA; or (iii) equivalent submission in such other country or jurisdiction.

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Phase II Studies means that portion of the clinical U.S. ---------------- Development Plan, ROW Development Plan or Development relating to each Collaboration Product which provides for well controlled clinical trials of such Collaboration Product in patients, including clinical studies conducted in patients with the condition, and designed to evaluate clinical efficacy and safety for such Collaboration Product for one or more indications, as well as to obtain an indication of the dosage regimen required, as more fully defined in 21 C.F.R. (S) 312.21(b).

Phase II Studies means that portion of the Development Plan or Development relating to each Alliance Product which provides for well controlled clinical trials of such Alliance Product in patients, including clinical studies conducted in patients with the disease or condition, and designed to evaluate clinical efficacy and safety for such Alliance Product for one or more indications, and/or to obtain an indication of the dosage regimen required.

Examples of Phase II Studies in a sentence

• MacroGenics shall lead any discussions between the Parties related to Quality Assurance Measures for clinical supply of the Licensed Compound Bulk Drug Substance and Licensed Compound Drug Product for Phase I Studies and Phase II Studies.

• No royalties shall be payable on Phase I Studies, Phase II Studies or Phase III Studies to obtain the initial approval of a Collaboration Product or Collaboration Product used in studies to obtain approval of a Second Indication.

• Amerimmune shall maintain, and shall require its Third Party contractors to maintain in all material respects, complete, current, and accurate records of all Development activities conducted by it under this Agreement, and all Trial Results and other data and information resulting from the Research Program and any Clinical Trials, including all Phase I or Phase II Studies conducted pursuant thereto.

• For clarity, Celgene’s obligation to share Global Development Costs shall not include any Development Costs incurred prior to the Development Cost Initiation Date or any Development Costs related to any Clinical Trial for which the FPD occurred prior to the Development Cost Initiation Date even if completed following the Development Cost Initiation Date; instead, Celgene’s obligations will be limited to Development activities related to any company-sponsored Phase II Studies or later stages of Development.

• Within [***] after the POC Period, MINERALYS shall determine whether to commence Global Clinical Trials including additional Phase II Studies or Phase III Studies for a Product containing MT-4129 regarding at least one of such completed POC Period Studies.

More Definitions of Phase II Studies

Phase II Studies means Phase II(a) Studies and Phase II(b) Studies.

Phase II Studies means that portion of the clinical development program which provides for initial trials of a Product on limited numbers of patients for the purpose of determining dose and evaluating safety and efficacy in the proposed therapeutic indication more fully defined in 21 C.F.R. 312.21(b).

Phase II Studies means, subject to Section 6.2.2, that portion of the Development Plan or Development relating to each Collaboration Product which provides for well controlled clinical trials of such Collaboration Product in patients, including clinical studies conducted in patients with the condition, and designed to evaluate clinical efficacy and safety for such Collaboration Product for one or more indications, as well as to obtain an indication of the dosage regimen required, as more fully defined in 21 C.F.R. (S) 312.21(b). [*]=CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

Phase II Studies as used in this Section 5.7 means not only the Phase Studies as defined in Section 1.20, but also any additional clinical studies required by a health regulatory authority in a country in the Territory, or deemed necessary by Chugai, for Government Approval of the Finished Product in such country.

Phase II Studies means controlled clinical studies conducted

Phase II Studies shall have the meaning ascribed to such term in SECTION 7.1 herein.

Phase II Studies means that portion of the clinical development program which provides for small scale clinical trials primarily to determine safety of a product and other factors, such as dosing range.