Phase II Studies definition

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 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.

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

Examples of Phase II Studies in a sentence

• 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.

• 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.

• To the extent not exercised prior to the Effective Date, the U.S. Borrower shall exercise all rights to conduct Phase II Studies at the Tulsa and McAlester Facilities (as such terms are used in the Acquisition Agreement), as set forth in Section 6.13(a) of the Acquisition Agreement, and shall use its best efforts to complete all such Phase II Studies within the time period set forth in Section 6.13(a)(v) of the Acquisition Agreement.

• IDM will provide SANOFI-SYNTHELABO with a summary report of the results of the Phase II Studies carried out on one or more IL-13 Products within six (6) months following completion of these Phase II Studies.

• Thereafter, Licensee shall, with the assistance of Licensor, arrange the Manufacture of additional clinical material to support Phase II Studies if the existing, transferred inventories are determined by Licensee to be inadequate to complete the Phase II Studies.

More Definitions of Phase II Studies

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.

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 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. EXECUTION COPY

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

Phase II Studies means controlled clinical studies conducted ---------------- to evaluate the effectiveness of the Product for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the Product, as prescribed by applicable FDA regulations (or equivalent regulations of the FDA-equivalent regulatory authority in the Territory).

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.