Phase IIa definition

Phase IIa means a Phase II clinical trial whose primary objective is to explore safety and tolerability (assessed in a descriptive analysis), including pharmacokinetic and pharmacodynamic effects in human patients in a study of at least four (4) weeks duration or longer.

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Phase IIa means a Phase II that utilizes the pharmacokinetic and pharmacodynamic information obtained from one or more previously conducted Phase I or other Phase IIa in order to confirm the optimal manner of use of the applicable Product or New Collaboration Compound (dose and dose regimes) and to better determine safety and efficacy.

Phase IIa means that part of the Phase II Clinical Trial designed to assess dosing requirements and efficacy of the Licensed Product. For the purposes of this Agreement, “completion of Phase IIA” means that stage of the Phase II Clinical Trial when the efficacy of the Licensed Product as specified in the Development Plan has been observed and properly recorded.

Examples of Phase IIa in a sentence

• Upon receipt of such notice the Parties shall discuss, through the medium of the JSC, the New Indication and the necessary changes to the Lifecycle Management Plan and GW Pharma will conduct Clinical Trials of Product of the New Indication until completion of Phase IIa Clinical Trials at its own cost and expense.

• The initial Development Plan for a Designated Shared Compound shall set time lines and priorities for the various Pre-Clinical Development and Development activities through Phase I Clinical Trials or Phase IIa Clinical Trials and identify which party, or whether a third party, is to be responsible for each activity.

• Following completion of Phase IIa Clinical Trials for such New Indication by GW Pharma, GW Pharma will promptly compile a data package, in a form set by the JSC, setting out the results of such clinical trials including all Phase IIa clinical data and the Final Report therefor (“Phase IIa Data Package”) and present it to Almirall at the next to occur meeting of the JSC.

• Almirall shall then review the Phase IIa Data Package and undertake its own *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

• As shown in the Table below, DOE approval is provided for the following Phase IIa subcontracts at not-to-exceed costs shown below.

More Definitions of Phase IIa

Phase IIa means a human clinical trial of a Licensed Compound or Licensed Product, the principal purpose of which is a determination of safety and initial efficacy, including proof-of-concept, in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of further clinical trials, or a similar clinical study prescribed by the Regulatory Authorities, 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 IIa means one or more Phase II trials (at least one of which trials was conducted in a Major Market Country) collectively designed to demonstrate (a) in the case of a Neurological Indication, safety and tolerability in the target population, and (b) in the case of a Psychiatric Indication, clinical proof of concept. [*] CONFIDENTIAL TREATMENT IS REQUESTED

Phase IIa means one or more Phase IIa trials (at least one of which is conducted in a Major Market Country) collectively designed to demonstrate preliminary proof of clinical efficacy using medically recognized surrogate markers or end points.

Phase IIa means a [**] Phase II study of a Licensed Product in patients with a disease target being studied.

Phase IIa means a human clinical trial performed to estimate the biologic or clinical effect of a pharmaceutical product in a target population.

Phase IIa means the construction of one or more buildings on the Phase IIA Property consisting of at least 9,000 gross leasable square feet of commercial space accommodating retail, restaurant, or service tenants.

Phase IIa as used herein, shall have the same meaning as such term is used in the SB/HGS License Agreement.