definiens: ) that will define the responsibilities of the parties in respect of pharmacovigilance in relation to theProduct in the framework of this Agreement, including with regard to the process for the transfer andexchange of safety data and contacts with Regulatory Authorities, in accordance with Applicable Laws . Theparties shall enter into the PVA on terms no less stringent than those required by ICH or other applicableguidelines . From the Effective Date of this Agreement, parties shall exchange safety data relating to theProduct within appropriate timeframes and in an appropriate format to ensure compliance with the reportingrequirements of all applicable Regulatory Authorities on a worldwide basis . In no case shall exchange ofAdverse Events ( or ) occur later than five ( 5 ) calendar days for fatal / life threatening AEs, nine ( 9)calendar days for other related serious AEs, twenty - four ( 24 ) calendar days for non - serious AEs for postmarketing cases, and in addition to the timelines for fatal and related serious AEs, twelve ( 12 ) calendar daysfor other serious, unrelated AE cases, twenty - four ( 24 ) calendar days for pregnancy and overdose with no AE, and twenty - seven ( 27 ) calendar days for serious ICSR following the end of study unblinding for clinical trials