definiens: means : ( i ) a Licensed Compound or Licensed Product in combinat ion with one or more other active pharmaceutical ingredients in a single dosage form ( a ) ; ( ii ) the combination of a Licensed Compound or Licensed Product and any separately packaged drug or biological product, administered either seq uentially or concurrently, where such separately packaged drug or biological product is a pproved for marketing and sale under the Laws where such separately packaged drug or biologi cal product is sold together with a Licensed Compound or Licensed Product ( a ) ; ( iii ) the combination of a Licensed Compound or Licensed Product and any separately packaged drug or biological product, administered either seq uentially or concurrently, where such separately packaged drug or biological product is a pproved for marketing and sale under the Laws where such separately packaged drug or biologi cal product is sold separately from a Licensed Compound or Licensed Product ; or ( iv ) the combination of a Licensed Compound or Licensed Product and any Companion Diagnostic ( a )