Phase II Clinical Trials definition

Phase II Clinical Trials means a Clinical Trial for the Product on a number of patients, no fewer than the number required to allow for the detection of statistical differences between the control and treated patients, for the purposes of determining dose and evaluating safety and efficacy in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

Phase II Clinical Trials means human clinical trials conducted to achieve a level of efficacy and safety of Product as well as a preliminary dosage in the particular indication tested.

Phase II Clinical Trials means investigational use of a Licensed Product for examining the suspected indication(s) and to determine potential short-term side effects in humans, under 21 C.F.R. Part 312 or comparable laws, rules, or regulations of another Regulatory Authority.

Examples of Phase II Clinical Trials in a sentence

• 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.

• 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).

• On or before a date to be established by the JSC but in no event later than [***] prior to initiation of manufacture of any Licensed Product Candidate that will be used by Baxalta in Clinical Trials, the Parties shall enter into a Supply Agreement pursuant to which Precision or its CMO, approved by the JSC as set forth below, will manufacture and supply clinical trial materials for Phase II Clinical Trials, including Phase II Ready Batches, to Baxalta.

• Upon Genentech’s written request, and in any event within thirty (30) days following completion of Phase II Clinical Trials of a Curis Product, Curis shall provide Genentech with written documentation of the Curis Expenses incurred by Curis with respect to such Curis Product.

More Definitions of Phase II Clinical Trials

Phase II Clinical Trials means those trials on sufficient numbers of patients that are designed to establish safety and assess the biological activity of a drug for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the to be prescribed dosage range.

Phase II Clinical Trials means the initial clinical testing of a Compound in humans who are patients with a disease for which the Compound is being tested with the intention of gaining a preliminary assessment of the safety, efficacy and dosing regimen of a Compound in treating such disease.

Phase II Clinical Trials means, as to a particular Licensed Product, those trials on sufficient numbers of patients that are designed to establish the preliminary safety, dosage and biological activity of such Licensed Product for its intended use, and to define warnings, precautions and adverse reactions that are associated with such Licensed Product in the dosage range to be prescribed, in any case to generate sufficient data to commence a Phase III Clinical Trial of such Licensed Product.

Phase II Clinical Trials means any human clinical trials for which a Primary Endpoint is a preliminary determination of safety, biological activity, efficacy or dose ranges of a Shared Product or Independent Product, as the case may be, in patients with the disease target being studied as required by the relevant Regulatory Authorities.

Phase II Clinical Trials means human clinical trials conducted in patients anywhere in the world in accordance with good clinical practice to demonstrate efficacy with the Product in the particular indication tested, as well as to obtain a preliminary indication of the limit and/or daily dosage regimen required.

Phase II Clinical Trials means those well-controlled clinical trials sponsored by Triangle, the primary objective of which (as reasonably determined by Triangle) is to ascertain additional data regarding the safety and tolerance of a Licensed Product and preliminary data regarding such Licensed Product’s antiviral effects against HBV.

Phase II Clinical Trials means those clinical trials as defined in 21 C.F.R. 312.21(b), as amended from time to time, or the corresponding regulation in jurisdictions other than the U.S.