definiens: or means a human clinical study conducted on human subjects, including any Phase 1Clinical Study, Phase 2 Clinical Study or Phase 3 Clinical Study that involves a test product, drug or device and that either is subject torequirements for prior submission to a Regulatory Authority or is not subject to requirements for prior submission to a Regulatory Authority but2 [ * * * ] 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 AMENDEDthe results of which are intended to be submitted later to, or held for inspection by, a Regulatory Authority as part of an application for a researchpermit or Regulatory Approval, and includes studies relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose rangingor efficacy of the product, drug or device