definiens: shall mean use ( a ) in clinical research where the medical management of a human is involved, for ( aa ) the measurement, observation or determination of ( i ) the presence of a human disease, ( ii ) the stage, progression or severity of a human disease, ( iii ) the risk of contracting a disease, or ( iv ) the effect of a particular treatment on a human disease ; and/or ( bb ) the selection of patients for a particular treatment with respect to a human disease ; and/or ( b ) in clinical laboratory for tracking, testing or quality controlling of human body fluids or tissue samples, and/or CONFIDENTIAl TREATMENT REQUESTED Rosetta Co - exclusive Diagnostic License, GI2916 ZJE June 28, 2006, page 2 of 19 CONFIDENTIAL ( c ) designated and regulated by the FDA as a diagnostic test or ASR, to the extent used according to ( a ) and/or ( b ) above