definiens: means any Law of any Governmental Body applicable to the Company that relates to : ( i ) research, investigation, development, quality, safety, efficacy and manufacturing of pharmaceutical products ; ( ii ) Good Laboratory Practices, GoodClinical Practices, and Good Manufacturing Practices ; ( iii ) investigational use ; ( iv ) manufacturing facilities compliance and approval ; ( v ) withrespect to pharmaceutical products, safety surveillance, mandated reporting of incidents, occurrences, diseases and events record keepingand filing of required reports with the applicable Governmental Body ; ( vi ) the import into, or export out of, the U.S. of drugs and materials andtechnology related to pharmaceutical products ; ( vii ) protection against biosafety risk ; ( viii ) the oversight of pharmaceutical or otherinterventional or non - interventional research studies, including medical and research record retention ; and ( x ) human and animal subjectsprotection in research