definiens: as defined by the then current ICH guidelines, involving the Compound and/or the Product ( all such reports, ) . adverse events shall be reported to the other Party within four working days ( if the event is fatal or life - threatening ) or ten working days ( if otherwise ) after a Party 's ( a ) becoming aware of such an event and shall either be reported by facsimile or telephone . The reporting Party shall report on a quarterly basis all other adverse events that are known to the reporting Party through either the receipt of clinical study documentation or post - market surveillance . In addition, the reporting Party shall report all known instances of use ofthe Product during pregnancy . In any event, each Party shall promptly notify the other of any complaint received by such Party in sufficient detail and in sufficient time to allow the responsible Party to comply with any and all regulatory requirements imposed upon it in any country . Each Party shall also advise the other of any regulatory developments ( e.g., proposed recalls, labeling and other registrational dossier changes, etc . ) affecting the Compound or the Product in any country