PoC Criteria means clinical and non-clinical criteria established pursuant to Section 3.6.1 to determine whether a Candidate Selection Compound under study demonstrates a [***].
PoC Criteria means the criteria to be established by the Joint Steering Committee, subject to the final approval of GSK, for a given Development Candidate to meet following the PoC Trial in order to establish Proof of Concept so as to be a possible Option Compound. The PoC Criteria shall set forth: (a) the end-points and relevant definitions and parameters for the PoC Trial in such a manner that following the PoC Trial, a determination can reasonably be made that such endpoints have been met; (b) where reasonable and appropriate, a [***] that is reasonably representative of the [***]; (c) appropriate and validated clinical and/or regulatory endpoint(s); (d) dose(s) administered in a [***] dosage which is/are (i) appropriate for a Phase 2 Clinical Trial as to which there is no known liability which would prevent the compound from being developed into a [***] and (ii) that show efficacy with a reasonable safety and tolerability profile in view of relevant clinical and regulatory considerations; (e) a drug substance which is in a salt or other chemical form that is suitable for manufacture within a commercializable formulation (i.e. there is no known impediment which would render as impractical the commercialization of such drug substance in the proposed salt or other chemical form); and (f) a degree of [***] efficacy that is consistent with the applicable [***].
PoC Criteria means the proof-of-concept criteria for identification of a Lead Candidate that is Directed to an EH Collaboration Target.
Examples of PoC Criteria in a sentence
The JSC will, a special ad hoc meeting to be scheduled, confirm that CCX282 meets such PoC Criteria.
The JSC shall establish the PoC Criteria for a Candidate Selection Compound directed to a particular Collaboration Target not later than the earlier of either (a) [***] prior to the expected [***] or (b) [***] have been made available to the JSC for review.
Such PoC Criteria shall be documented with sufficient specificity and clarity to determine whether a particular Candidate Selection Compound meets such criteria.
As such, we consider the impact a company’s operations, products, and services have on all stakeholders when deciding whether to invest in a company.
The JSC will, at a special ad hoc meeting to be scheduled, confirm that CCX282 meets such PoC Criteria and that the PoC Trial has successfully met the relevant endpoints.
More Definitions of PoC Criteria
PoC Criteria is hereby amended to change the term “Proof of Concept” in the first sentence to “proof of concept”.
PoC Criteria means the criteria mutually agreed between the Parties in writing the fulfillment of which will constitute successful Completion of the POC Phase;
PoC Criteria means the clinical and non-clinical criteria to be established by the Joint Program Subcommittee, subject to the agreement of the JSC and the final approval of GSK, to establish proof of concept for a given Development Candidate through the PoC Trial in a Program. The PoC Criteria shall set forth: (a) the [...***...] and relevant [...***...] for the PoC Trial in such a manner that, following the PoC Trial, a determination can reasonably be made that such [...***...]; (b) where reasonable and appropriate, a [...***...]; (c) appropriate and validated [...***...] (d) [...***...] (i) which is appropriate [...***...] as to which there is no[...***...]which would prevent the compound from being developed into a [...***...] (i.e., there is no known impediment which would render [...***...] the [...***...]) and (ii) that show [...***...]safety and tolerability profile in view of relevant clinical and regulatory considerations; (e) a [...***...] which is in a [...***...] that is suitable for [...***...] (i.e., there is no known impediment which would render [...***...]); (f) a [...***...] taking into account suitable [...***...] who could run such [...***...], any such contractors to be agreed by the JSC are understood and controlled [...***...] is reasonable for such indication; and (g) a [...***...] that is consistent with the applicable Target Product Profile.
PoC Criteria means the criteria to be established by the Joint Steering Committee, subject to the final approval of GSK, for a given Development Candidate to meet following the PoC Trial in order to establish Proof of Concept so as to be a possible Option Compound. The PoC Criteria shall set forth: (a) [***]; (b) [***]; (c) [***]; (d) [***]; (e) [***]; and (f) [***].
PoC Criteria means the criteria established by Acucela to be used to determine achievement by a Product of clinical proof of concept for the indication in the Field in which the POC Trial is conducted.
PoC Criteria means criteria established by the Joint Steering Committee, subject to Section 2.3.4(b), designed to establish proof of concept for a particular Indication, which shall consist of: (a) clinical or regulatory endpoints and parameters for the PoC Trial (or, with respect to a Follow- On Compound, the equivalent) designed (i) to indicate a degree or profile of efficacy
PoC Criteria means criteria established by the Joint Steering Committee, subject to Section 2.3.4(b), designed to establish proof of concept for a particular Indication, which shall consist of: (a) clinical or regulatory endpoints and parameters for the PoC Trial (or, with respect to a Follow-On Compound, the equivalent) designed (i) to indicate a degree or profile of efficacy EXECUTION VERSION -20- consistent with the [********] with a reasonable safety and tolerability profile in view of relevant clinical and regulatory considerations and (ii) in such a manner that, following the PoC Trial (or, with respect to a Follow-On Compound, the equivalent), a determination can reasonably be made whether such endpoints have been met; and (b) where reasonable and appropriate, a target population that is reasonably [********].