definiens: means written, telephonic or in - person communications from or with any Regulatory Authorityconcerning any of the following : key product quality attributes ( e.g., purity ) of Licensed Products, safety ﬁndings aﬀecting a Licensed Product(e.g ., Serious Adverse Events, emerging safety signals ), clinical or non - clinical findings affecting patient safety, lack of efficacy, receipt7 [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIALTREATMENT HAS BEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THESECURITIES EXCHANGE ACT OF 1934, AS AMENDEDor denial of Regulatory Approval, the design of Clinical Studies or the need for additional non - clinical studies ( e.g., additional toxicology orcarcinogenicity studies )