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 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 ***Confidential Treatment Requested 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.
Examples of PoC Criteria in a sentence
The Parties agree that the PoC Criteria for any particular Collaboration Target may not be materially amended after establishment by [***], except upon agreement of the Parties.
Notwithstanding anything to the contrary, if GSK has not exercised a GSK Program Option for a Candidate Selection Compound in a Program, and [***] and such Candidate Selection Compound did not meet the PoC Criteria for such Program, GSK, in its sole discretion, during the applicable GSK Program Option Period as set forth in Section 4.1.2(b)(ii), may elect to exercise its GSK Program Option for such Candidate Selection Compound.
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.
Beginning after [***], the Parties shall begin to develop PoC Criteria to be used to evaluate Candidate Selection Compounds directed to such Collaboration Target in the PoC Trials.
Such PoC Criteria shall be documented with sufficient specificity and clarity to determine whether a particular Candidate Selection Compound meets such criteria.
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 proof-of-concept criteria for identification of a Lead Candidate that is Directed to an EH Collaboration Target.
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 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 [********].
PoC Criteria means the clinical and non-clinical criteria for determining if a Candidate Selection Compound under study in a PoC Trial demonstrates a [***]. The PoC Criteria may include one or more biomarkers. The initial PoC Criteria are to be agreed between the Parties within five (5) days of the Execution Date pursuant to a letter agreement between the Parties; provided, that more specific and/or detailed PoC Criteria may be finalized in writing by the JRC (with input from the JPC) during the Research Term with respect to Candidate Selection Compounds. It is understood and agreed by the Parties that if more specific and/or detailed PoC Criteria are not finalized in writing by the JRC that the PoC Criteria set forth in the letter agreement will apply.
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) [***].