definiens: or means, with respect to a product, technology, process, method, or mode of administration that, in the absence of ownership of or a license granted under a particular Valid Claim, the manufacture, use, offer for sale, sale, or importation of such produ ct or the practice of such technology, process, method, or mode of administration would infringe such Valid Claim or, in the case of a claim that has not yet issued, would infringe such claim if it were to issue and become a Valid Claim, in each case, [ * * * ] 4 1.44 means, with respect to an individual or entity, that such individual or entity has been debarred or suspended under 21 U.S.C. § 335(a ) or ( b ), the subject of a conviction described in Section 306 of the FD&C Act, excluded from a feder al or governmental health care program, debarred from federal contracting, convicted of or pled nolo contendere to any felony, or to any federal or state legal violation ( including misdemeanors ) relating to prescription drug products or fraud, the subject to OFAC sanctions or on the OFAC list of specially designated nationals, or the subject of any similar sanction of any Governmental Authority in the Territory