definiens: ) shall mean any adverse medical occurrence in a patient to whom the Product has been administered and which does not necessarily have to have a causal relationship with the treatment ( as defined by 21 C.F.R. 312.32, 314.80 and any other applicable definitions in regulations promulgated by the FDA or ICH ) which require reporting by [COMPANY] to the FDA or other international regulatory agencies . Forest shall report all suspected ADE 's to [COMPANY] 's Drug Safety and Surveillance Department or its designee, via telephone at 1 - 877 - 4SANKYO ( 1 - 877 - 472 - 6596 ), as soon as possible within two calendar days of receipt of such information by any employee or subcontractor of Forest . If requested, Forest will make reasonable efforts to assist [COMPANY], or its designee, in obtaining ADE follow--16 - 199902 up infonnation from reporters initially identified by Forest . As owner of the NDA, [COMPANY] shall retain responsibility for all FDA reporting requirements, and Forest shall have no responsibility to report any ADE to the FDA . [COMPANY] will copy Forest on U.S. Periodic Reports, expedited reports and Periodic Safety Update Reports, within 3 business days of their submission to the appropriate agency