PoC Trial definition

PoC Trial means, with respect to a Collaboration Program, the first phase 2a Clinical Study in human patients with a pharmacokinetic or target reduction endpoint or other therapeutic or physiological endpoint.

PoC Trial means, with respect to any Collaboration Compound, a [***] Clinical Trial or a [***] Clinical Trial of such Collaboration Compound that is reasonably designed to demonstrate successfully the PoC Compound Criteria. For clarity, the PoC Trial is intended only to demonstrate the safety, and to provide preliminary evidence of activity, of a particular Collaboration Compound, and is not intended to be a pivotal trial or to otherwise provide data sufficient to support Regulatory Approvals.

PoC Trial means the first human in-patient study designed to provide evidence of efficacy, safety and tolerability of SPC-3649 or an SPC-3649 Product.

Examples of PoC Trial in a sentence

• Opt-Out means an election by one Party to cease further participation in funding and conducting the NSCLC POC Trial or in funding Additional Development Costs.

• As mentioned, my project hopes to complicate what such a criterion actually means for political praxis.

• The NSCLC POC Trial will be fully funded by Biodesix up to a maximum of $15 million, referred to as the “Cap”.

• The Parties acknowledge that the initial Development Plan, including the initial NSCLC POC Trial Plan contained therein, does not set forth all material activities, timelines, obligations and specifications necessary for the execution 14 EXECUTION VERSION of the Development Plan, and further acknowledge that requests from Regulatory Authorities may necessitate modifications to the Development Plan.

• In no event shall the Special Independent Match Contributions made to the Compensation Deferral Account be eligible for withdrawal under this provision.

More Definitions of PoC Trial

PoC Trial means (a) with respect to the AR Mutant Program, the AR Mutant POC Trial and (b) with respect to the NIK Program, the NIK POC Trial.

PoC Trial means, with respect to a Program, the first human in-patient study designed to provide evidence of efficacy, safety and tolerability of a Collaboration Compound within such Program, which if conducted by Regulus, shall be consistent with the [...***...]agreed upon by the Parties and the PoC Financial Cap, subject to Section 3.5.5. For purposes of clarity, the PoC Trial is intended only to demonstrate the [...***...] of a particular Development Candidate, and is not intended to be a [...***...], or intended to otherwise provide data [...***...].

PoC Trial means the first proof of concept [***] that meets the POC Trial Criteria.

PoC Trial means a Phase II Study of the Compound tipifarnib in HRAS mutant patients in the Field, as more fully described in the Development Plan.

PoC Trial means with respect to any Research Program Development Candidate, NP201 Development Candidate or Tail Compound, as applicable, the first human clinical trial that either: (i) is reasonably designed to; and/or (ii) actually does, establish POC in humans. For clarity, the concept of a “Proof of Concept Trial” is intended only to identify the time point at which the POC of a particular Research Program Development Candidate, NP201 Development Candidate or Tail Compound has been demonstrated, and a “Proof of Concept Trial” is not [*]

PoC Trial means a Phase II Study of the Compound tipifarnib in HRAS mutant patients in the Field, as more fully described in the Development

PoC Trial means the first phase 2 clinical trial that is reasonably designed to provide initial evidence of efficacy of the relevant product and it is not intended to be a pivotal clinical trial or a dose ranging study.