definiens: means any diagnostic test, reagent(s ) or kit that ( a ) is useful for carrying out [ an extracorporeal diagnostic assay ) to determine levels of BNP in biological materials, which assay [ has been approved for commercial sale by the United States Food and Drug Administration ( if sold in the United States ) ] or a [ corresponding governmental agency ) of the [ country of sale ] within the Territory, if [ such approval is required ] ; and ( b ) ( i ) if made, used, offered for sale, soldor imported, absent the license granted hereby, would infringe the valid claims of the Patent Rights ( if in an issued patent ), or ( ii ) contains, incorporates, uses or was developed using the Know how . As used herein, a is a claim which has not been dedicated to the public or held invalid or unenforceable by a non - appealed or non - appealable decision of a court of competent jurisdiction