Archiving. Both Parties shall maintain a record of each AE, overdose, misuse, abuse, medication error, lack of effect, AESI, lactation report or pregnancy report indefinitely, in accordance with current regulatory requirements and each Party’s respective procedures. Such maintenance will include: a) a copy of the report (standardized AE collection form, including relevant source documentation) b) the date of the initial receipt or creation of the report c) the date of provision of the report to the other Party.
Appears in 3 contracts
Sources: Commercialization and License Agreement (Aptalis Holdings Inc.), Commercialization and License Agreement (Aptalis Pharma Inc), Commercialization and License Agreement (Aptalis Pharma Inc)