definiens: means internal and/or external expenses and costs of a Phase 2 PoC Trial, including, without limitation, investigator grants, laboratory services, clinical PK assays, carcinogenicity stud ies, CMC studies, CRO services and pass - throughs, pharmacovigilance a nd risk management activities, costs for packaging, distribution and reconciliation ( including labels a nd translations, inventory control, IVRS, off - site storage anddestruction ), data management ( including EDC ), clin ical study reports, drug costs ( API, Compound or dr ug productcontaining a Compound ) at Isis ’ Cost of Goods, inve stigator meetings, monitoring, DSMB costs, program- specifictravel, metabolomics assays, courier services, clin ical trial liability insurance costs ( allocated to such trial ) qualityassurance costs for auditing clinical trial activit ies and preclinical 93 studies support ( report reviews and CMC review ) . Is is ’ internal costs with respect to its employees pe rforming suchactivities will be calculated at the FTE Rate at su ch time