Proof of Concept Trial definition

Proof of Concept Trial or “PoC Trial” shall mean, with respect to any Development Candidate, the first Phase 2 Clinical Trial of such Development Candidate that is reasonably designed, subject to Section 2.3.4(b), to satisfy the PoC Criteria if successful. For clarity, the Proof of Concept Trial is intended only to provide evidence of the efficacy of a particular Development Candidate and is not intended to be a pivotal trial or dose-ranging study or otherwise to provide data sufficient to support any Regulatory Approval.

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Proof of Concept Trial or “POC Trial” means the Phase I human proof of concept trial in patients for a GT Product as set forth in, and conducted pursuant to, the Research Plan.

Proof of Concept Trial or “PoC Trial” shall mean (a) with respect to a CCR9 Development Candidate, the PROTECT-1 Trial, and (b) with respect to any other Development Candidate, the first Phase 2 Clinical Trial of such Development Candidate that is reasonably designed to satisfy the PoC Criteria and demonstrate efficacy, with statistical significance within a [***] that is no longer than [***] in a [***] Indication approved by the JSC pursuant to Section 2.3.5. For clarity, the Proof of Concept Trial is intended only to demonstrate the efficacy of a particular Development Candidate, and is not intended to be a pivotal trial or dose-ranging study, or intended to otherwise provide data sufficient to support Regulatory Approvals. In the event that any single PoC Trial would exceed either (i) a total of [***] and/or (ii) a total cost of [***] Dollars ($[***]), the provisions of Section 2.3.6 shall apply.

Examples of Proof of Concept Trial in a sentence

The Parties acknowledge that the Proof of Concept Trial protocol may change in light of regulatory and clinical developments affecting the Licensed Product.
The costs of such Proof of Concept Trial shall be deemed Development Costs, which the Parties shall share on a 50/50 basis.
Promptly following the Effective Date of this Agreement, Schering shall transfer to Licensee free of charge (except reasonable costs of transfer as set forth below), in a mutually agreed manner, quantities of Bulk Licensed Product and related documentation (eg, batch records, process and release testing results, protocols, stability data and location of stability specimens) that are reasonably sufficient for Licensee to complete the Proof of Concept Trial and as are further described in Schedule 6.2.
The Parties shall use commercially reasonable efforts to complete such Proof of Concept Trial by the first quarter of 2006, subject to any unexpected delays caused by matters outside of Acorda’s control (such as FDA-required additional studies or delays).
As part of such Commercially Reasonable Efforts, Kythera will initiate (i.e., treat its first patient for) a Proof of Concept Trial within [***] ([***]) months of the Effective Date.

More Definitions of Proof of Concept Trial

Proof of Concept Trial means any Phase IIA Clinical Trial or Phase IIB Clinical Trial that is designed to demonstrate that a Collaboration Product meets clinical criteria established by the JDC with respect to a given indication.

Proof of Concept Trial means a Clinical Trial that is designed to establish, for (a) a Licensed Product as part of a Co-Administration Therapy, or (b) a Licensed Product in a particular Indication, in each case ((a) and (b)), safety and initial evidence of efficacy that would be supportive of moving forward with additional Clinical Trials for such Licensed Product as part of such a Co-Administration Therapy, or for such Licensed Product in such Indication, as applicable.

Proof of Concept Trial has the meaning ascribed to it in Section 3.3(a) of this Agreement.

Proof of Concept Trial means the first clinical trial in humans that is conducted for the purpose of determining the safety and efficacy of AXOKINE for weight reduction and glucose control in Type II diabetics (or as otherwise modified by the OC) and that the OC specifically designates as such.

Proof of Concept Trial or “PoC Trial” shall mean an initial phase II clinical trial of a Development Candidate [ * ].

Proof of Concept Trial or "POC TRIAL" shall mean an initial phase II clinical trial of a Development Candidate [ * ].

Proof of Concept Trial means a Clinical Trial of Licensed Product in patients that demonstrates efficacy on an efficacy endpoint and therefore justifies proceeding with pivitol Phase III Clinical Trials or other pivitol registration Clinical Trials required for Final Regulatory Approval of Licensed Product.