definiens: means if Licensee, its Affi liates or any Sublicensee : ( a ) institutes, or cause s its counsel to institute, any interference, opposition, re - exam ination, review or similar proceeding with respect to any Licensed Patent with the U.S. Patent and Trademark Office or any foreign patent office ; ( b ) makes any filing or institutes any legal proceeding, or causes its coun sel to make any filing or institute any legal proce eding, with a court or other governmental body ( including, the U. S. Patent and Trademark Office or any foreign paten t office ) in which one or more claims or allegations challeng es the validity or enforceability of any Licensed P atent ; or ( c ) makes any filing with or certification to, or cause s its representative to make any filing with or cer tification to, the FDA pursuant to 21 U.S.C. § 355(b)(2)(A)(iv ) or 21 U.S.C. § 355(j)(2)(A)(vii)(IV ) with respect to any Licensed Patent