definiens: means the protocol as of the Effective Date or as may be amended byBioCryst during the Term for the Phase III Clinical Trials for which BioCryst is the sponsor for the LicensedProduct in the Field registered at www.clinicaltrials.gov as ( a ) “ Efficacy and Safety Study of BCX7353 as anOral Treatment for the Prevention of Attacks in HAE ( APeX-2 ) ” and ( b ) “ Study to Evaluate the Efficacy andSafety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan ( APeX - J ) . ” 1.57 means any Person becoming 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, or having previously beenexcluded, from a federal or governmental health care program, debarred from federal contracting, convicted ofor 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 speciallydesignated nationals, or the subject of any similar sanction of any Governmental Authority in the Territory