definiens: means any human clinical trial that has as its principal purpose, and that isreasonably constituted to achieve, a preliminary evaluation of clinical efficacy and safety, and/or to obtain anindication of the dosage regimen in human subjects, as required under the United States Federal Food, Drugand Cosmetic Act and the regulations promulgated thereunder or the substantitive equivalent of such a humanclinical trial as required by a Regulatory 4845 - 2749 - 0310\1THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION ( THE ) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TOSELECTED PORTIONS . ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVEBEEN FILED SEPARATELY WITH THE COMMISSION . OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH