definiens: means those Internal Expenses and External Expenses incurred by a Party that arereasonably or directly allocable to the performance of Development activities in accordance with the StrategicPlan and the Development Budget, other than Regulatory Expenses, including ( i ) the costs of non - clinical andpreclinical studies, Clinical Trials, expanded access programs, post - Approval clinical studies, investigator grants, laboratory services, clinical PK assays, carcinogenicity studies, CMC studies, CRO services and pass - throughs, pharmacovigilance and risk management activities, packaging, distribution and reconciliation ( including labelsand translations, inventory control, IVRS, off - site storage and destruction ), data management ( including EDC),clinical study reports, investigator meetings, monitoring, SAB costs, DSMB costs, key opinion leader costs, program specific travel, metabolomics assays, courier services and clinical trial liability insurance costs, qualityassurance costs for auditing clinical trial activities and preclinical studies support ( report reviews ), ( ii ) expensesof any comparator drug used in Clinical Trials or any post - Approval clinical studies, and ( iii ) expenses incurred byeither Party directly or reasonably allocable to the performance of ( or preparation for performance of ) MedicalAffairs activities . Development Expenses for a Product will not include any expenses included in the definition ofCost of Goods or Distribution Expenses for such Product