definiens: means internal or external expenses incurred in accordance with the Development Plan andthe Development Budget, including the costs of all clinical trials and preclinical studies, including post - marketingtrials . The types of expenses included in this category are investigator grants, laboratory services, clinical PK assays, carcinogenicity studies, CMC studies, CRO services and pass - throughs, pharmacovigilence and risk managementactivities, costs for packaging, distribution and reconciliation ( including labels and translations, inventory control, IVRS, off - site storage and destruction ), data management ( including EDC ), clinical study reports, drug costs ( API & DP ), investigator meetings, monitoring, SAB costs, DSMB costs, key opinion leader costs, program specific travel, metabolomics assays, courier services and clinical trial liability insurance costs . Development Expenses includequality assurance costs for auditing clinical trial activities and preclinical studies support ( report reviews and CMC [ * * ] = Portions of this exhibit have been omitted pursuant to a confidential treatment request