definiens: shall mean the criteria to be established by the Joint Steering Committee, subject to the finalapproval of [COMPANY], for a given Development Candidate to meet following the PoC Trial in order to establish Proof of Conceptso as to be a possible Option Compound . The PoC Criteria shall set forth : ( a ) the end - points and relevant definitions andparameters for the PoC Trial in such a manner that following the PoC Trial, a determination can reasonably be made that suchendpoints 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 frombeing developed into a [ * * * ] and ( ii ) that show efficacy with a reasonable safety and tolerability profile in view of relevantclinical and regulatory considerations ; ( e ) a drug substance which is in a salt or other chemical form that is suitable formanufacture within a commercializable formulation ( i.e