definiens: means that the Data Safety Monitoring Board for a Clinical Trial, or the Parti es by mutual written agreement, based upon addition al information that becomes available or an analysis o f then - existing information at any time, determines that Development or Commercialization, as applicable, of the Licensed Candidate and/or Licensed Products sh ould be discontinued because the medical risk / benefit of the Licensed Candidate or Licensed Products is suf ficiently unfavorable as to be incompatible with the welfare of patients to Develop or Commercialize or to conti nue to Develop or Commercialize 30 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH . A COMPLETE VERSION OF THIS EXHIBIT HAS BEE N FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSU ANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AM ENDED