definiens: means, on a Licensed Compound - by - Licensed Compound basis, any product used to identify, diagnose, screen, or monitor patients with a predisposition to a humancondition, disease, or disorder, or to predict prognosis, safety, or efficacy of therapeutic treatment of ahuman condition, disease, or disorder in a patient, and in each case which product : ( a ) contains suchLicensed Compound, a functional fragment of such Licensed Compound, any variant of the foregoing(including splice variants ), any nucleic acid sequence encoding any of the foregoing, or a complementarynucleic acid sequence to such nucleic acid sequence ; or ( b ) primarily functions by determining theabsence or presence ( or quantity ) of any Biomarker for each that is present in a Patient Sample, in eachcase ( ( a ) and ( b ) ), developed for use in connection with the applicable Licensed Compound orpharmaceutical or biological product comprising such Licensed Compound