definiens: means a study of a Licensed Product inhuman patients with a defined dose or a set of defined doses of a Licensed Productdesigned to ( a ) ascertain efficacy and safety of such Licensed Product for its intendeduse ; ( b ) define warnings, precautions and adverse reactions that are associated with theLicensed Product in the dosage range to be prescribed ; and ( c ) support preparing andsubmitting applications for Regulatory Marketing Approval to the competent RegulatoryAuthorities in a country of the world, as and to the extent defined for the United States in21 C.F.R. § 312.21(c ), or its successor regulation, or the equivalent regulation in anyother country . shall also include any other human clinical trialserving as a pivotal study from which the data are actually submitted to the applicableRegulatory Authority in connection with a Regulatory Marketing Approval Application, whether or not such trial is called a study . Without limiting the generality of theforegoing, a clinical study shall be deemed to be a hereunder ifsuch study has been designated by the sponsor as a Phase 3 [ III ] clinical trial onwww.clinicaltrials.gov ( or any successor website maintained by the U.S. NationalInstitutes of Health ( or any successor agency of the U.S. Government ) )