definiens: means any untoward medical event or reaction that at any dose : results in death, is Iife­threatening ; requires inpatient hospitalization or prolongation of present hospitalization ; results in persistent or significant disability / incapacity ; is a congenital anomaly / birth defect ; is a medically important event or reactions for other reasons serious . ) [COMPANY] agrees to report adverse events and serious adverse events that occur during the development and marketing of Licensed Products to the relevant regulatory authorities promptly according to the applicable regulations . All appropriate records will be retained as per [COMPANY] 's internal retention process . If this Agreement is terminated under Sections 12.2 or 12.4, [COMPANY] will, upon [COMPANY] 's request, supply [COMPANY] with relevant safety information with respect to Licensed Products in either a MedWatch or CIOMS I format or other such form as is in general international use