definiens: shall mean criteria Cistablished by GSj9(at or about the time of first - time - in - humans ( ) testing ( i.e., at Phase I clinical trials ) to determine if a Candidate Selection Compound, [COMPANY] Development Compound or [COMPANY] Development Compound under study demonstrates a clinically meaningful benefit - to - risk rofile in treatin the applicable disorder . This shall include a ~ opulation tll - aris reasoDably representative of the proposeapatient population ; appropnate and validated endpoint ( s ) that may be used in further phases of development ; doses in a fmal, commercializable formulation that show efficacy with a reasonable safety and tolerability profile ; and efficacy res onses that consistent ' . d in the Tar et Product Profile as established by GS ereunder . Any Candidate Selection Compound, [COMPANY] Development Compound or PharmacopeIa Development Compound advanced by [COMPANY] into Phase III clinical trials will be deemed to have met all of the Proof - of - Concept Compound Criteria and to be a Proot : of - Concept Compound