definiens: means a study of a Licensed Product in human patients with a defined dose ora set of defined doses of a Licensed Product designed to ( a ) ascertain efficacy and safety of such LicensedProduct for its intended use ; ( b ) define warnings, precautions and adverse reactions that are associated with theLicensed Product in the dosage range to be prescribed ; and ( c ) support preparing and submitting applications forRegulatory Marketing Approval to the competent Regulatory Authorities in a country of the world, as and to theextent defined for the United States in 21 C.F.R.§ 312.21(c ), or its successor regulation, or the equivalentregulation in any other country . Phase III Clinical Study shall also include any other human clinical trial servingas a pivotal study from which the data are actually submitted to the applicable Regulatory Authority in connectionwith a Regulatory Marketing Approval Application, whether or not such trial is called a study