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.
In determining which Indication to pursue, the JSC shall take into consideration the estimated costs and possible trial design of the PoC Trial for such Indication for such Development Candidate, in addition to the relevant scientific, medical, safety and commercial considerations.
ChemoCentryx shall also have the option, at its discretion, to conduct an Asthma CCR9 PoC Trial; provided, however, that GSK shall have the right to review and comment on the design of the Asthma CCR9 PoC Trial before it is finalized, and GSK must approve the final study design and content of such Asthma CCR9 PoC Trial prior to initiation, such approval not to be unreasonably withheld.
The Parties understand and acknowledge that it is possible that the Asthma CCR9 PoC Trial may be completed prior to the PROTECT-1 Trial, and therefore GSK may first have the opportunity to exercise its Product Option with respect to CCX282 in accordance with Section 4.3.1(b) based upon data resulting from such Asthma PoC Trial, and not from the PROTECT-1 Trial.
Notwithstanding Sections 2.3.4(a) and (b), with respect to each Development Candidate nominated by the JSC, and in the course of such nomination process, the Parties shall mutually determine which potential Indication(s) to pursue for such Development Candidate and the related set of Progressed Collaboration Compounds, (other than CCX282 and its Back-up Compounds for which ChemoCentryx shall have the right to pursue in Crohns Disease and in the Asthma CCR9 PoC Trial as provided for in this Agreement).
The JSC may, at its discretion at any time during the Early Development Program (prior to conduct of the PoC Trial), substitute for the Development Candidate either of the two Back-up Compounds for further Development, provided such Back-up Compounds meet the Development Candidate Criteria.