definiens: means a Clinical Study in humans that is intended to obtain the data sufficient to support the filing of an NDA for a pr oduct with any applicable Regulatory Authority . Reg istration Studies include any Clinical Studies designed as a pivotal study to confirm with statistical significa nce the efficacy and safety of a product with respect to a given indication ( whether structured as a superiori ty, equivalence or non - inferiority study ), which study is performed for purposes of filing an NDA to obtai n Regulatory Approval for such product or such indica tion from the applicable Regulatory Authority ( rega rdless of whether such Clinical Study is identified as a Phas e 3 Clinical Study on ClinicalTrials.gov ), includin g a Clinical Study as described under 21 C.F.R. § 312.21(c ) with respect to the United States ( or, with respect to a jurisdiction other than the United States, a similar Clinical St udy )