definiens: as defined by the then current Internation al Conference on Harmonization of Technical Requirements for R egistration of Pharmaceuticals for Human Use ( ) guidelines, involving the Compound and/or the Product ( all such reports, ) . adverse events, as defined by the then current ICH guidelines, shall be reported to the other Party within [ * ] ( if the event is fatal or life - threatening ) or [ * ] ( if otherwi se ) after a Party ’s ( a ) becoming aware of such an event and shall either be reported by email, or by facsimile or telephone if email is not available . 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 su rveillance . In addition, the reporting Party shall report all known instances of use of the Product during pr egnancy . 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 res ponsible Party to comply with any and all regulatory requirements imposed upon it in any country in the Territory . Each Party shall also advise the other of any regulatory dev elopments ( e.g., proposed recalls, labeling and other regist rational dossier changes, etc . ) affecting the Compound or the Product in any country in the Territory . [ * ] = Certain confidential information contained in this document, ma rked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, a s amended . Prepared by R.R. Donnelley Financial -- EX-10.10 https://www.sec.gov/Archives/edgar/data/1178253/000 1193125141047 ..