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 (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 a ‘proof of concept’ trial being time-bound access to a dedicated Cyferd operated tenancy for the purposes of evaluating the Cyferd Product’s features and functionality

Examples of PoC Trial in a sentence

• Such Backup Product, upon completion of its POC Trial, shall also become a Licensed GT Product, subject to the license grants set forth in Section 5.1, and the Parties shall determine if such Backup Product achieves Demonstration of Clinical POC pursuant to Section 2.11.4.

• Promptly after the generation by Xencor, or the receipt by Xencor from a contract services organization (as applicable), of the POC Trial Report, Xencor shall deliver the POC Trial Report to Amgen, and, during the […***…] period after such delivery, the DC shall convene one or more times as reasonably requested by Amgen in order to permit Amgen to discuss the results of the Phase 2 POC Trial with Xencor personnel.

• The Parties intend that during the Research Term and under the Research Plan, Dimension will discover and develop […***…] GT Produc[…***…] and complete a POC Trial for […***…] GT Product, which […***…] GT Product, upon completion (successful or not) of such POC Trial, shall be deemed a “Licensed GT Product” after which point, Bayer’s licenses set forth in Section 5.1 shall apply, and Bayer shall have sole responsibility for further development, manufacture and Commercialization of such Licensed GT Product.

• Notwithstanding the foregoing, in sufficient advance of any Phase II/III Trial by Bayer (including prior to completion of the POC Trial), Dimension and Bayer shall meet and discuss and, if Bayer considers it appropriate, engage ReGenX and any other necessary Third Parties for purposes of developing processes necessary to enable Bayer’s commercial manufacturing of the Licensed GT Product for use in the Field.

• In the event […***…] Licensed GT Product is the subject of a POC Trial, but fails to achieve Demonstration of Clinical POC (as determined pursuant to Section 2.11.4), at Bayer’s discretion and request, the Parties shall amend the Research Plan and Research Budget to add activities to identify and develop […***…] GT Product and conduct a POC Trial for such […***…] GT Product (the “Backup Product”) and as needed, extend the then-current Research Term to conduct such activities.

More Definitions of PoC Trial

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.

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

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 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