definiens: means a Party ’s reasonable belief that there is an unacceptable risk for harm in humans based upon ( a ) preclinical safety data, including data from animal toxicology studies, or ( b ) the observat ion of serious adverse effects in humans -14- [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24 b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED after the Licensed Product has been administered to humans, such as during a Clinical Study or after the First Commercial Sale, in each of clauses ( a ) and ( b ), which would materially imp act the safety or efficacy and the commercial feasibility of Licensed Product