Phase II Study definition

Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

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Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

Phase II Study means a human clinical trial intended to explore a variety of doses, dose response, and duration of effect, and to generate evidence of clinical safety and effectiveness for a particular Indication or Indications in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities, from time to time, pursuant to applicable Law or otherwise, including for example the trials referred to in 21 C.F.R. §312.21(b), as amended (or the non-United States equivalent thereof).

Examples of Phase II Study in a sentence

• Following completion of each successful Phase II Study for such Product in such Future Indication, Alexion shall provide XOMA with written notice of such completion and enclose a copy of a summary analysis performed in accordance with the pre-specified statistical analysis plan filed with the FDA.

• Following completion of each successful Phase II Study for such Product in such Future Indication, XOMA shall provide Alexion with written notice of such completion and enclose a copy of a summary analysis performed in accordance with the pre-specified statistical analysis plan filed with the FDA.

• Upon expiration of this Agreement pursuant to Section 13.1, provided that Alexion has at the time of expiration completed a Phase II Study for a Product in any Future Indication which XOMA has not Opted Back In to prior to such expiration, Alexion shall have an exclusive (even as to XOMA), sublicensable license under the XOMA Technology to use, develop, make, have made, sell, have sold, offer for sale, import and export Products only for such Future Indication(s) in the Territory.

• Following completion of each such Phase II Study, XOMA shall provide Alexion with written notice of such completion and enclose a copy of a summary analysis performed in accordance with the pre-specified statistical analysis plan filed with the FDA.

• Within twenty (20) days after the execution of this Agreement, Seller shall commission a qualified engineering firm to conduct a Phase II Study for the Parcel of Owned Property designated as Item 2 on Schedule 3.15 and an asbestos study for each Parcel of Owned Property.

More Definitions of Phase II Study

Phase II Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) (as amended) (whether or not such trial is for the FDA), but which is not a Phase III Study or Phase IV Study.

Phase II Study means (a) a dose exploration, dose response, duration of effect, kinetics, dynamic relationship or preliminary efficacy and safety study of a Product in the target patient population or (b) a controlled dose-ranging clinical trial to evaluate further the efficacy and safety of a Product in the target patient population and to define the optimal dosing regimen.

Phase II Study means a clinical trial that is 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 equivalent in any other jurisdiction.

Phase II Study means a study of a Licensed Product in humans, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of a Pivotal Trial, or a similar Clinical Study prescribed by the relevant Regulatory Authority, from time to time, pursuant to applicable law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.

Phase II Study means a Phase II clinical trial as prescribed by applicable FDA regulations, or corresponding regulations of any comparable entity.

Phase II Study means, collectively, a Phase IIa Study and a Phase IIb Study.

Phase II Study means, in respect of a Sublicensed Product, (a) that portion of the FDA submission and approval process which provides for early controlled clinical studies conducted to obtain preliminary data on the effectiveness of a product for a particular indication, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(b) or any future revisions or substitutes thereof; or (b) similar clinical study in any national jurisdiction other than the United States.