definiens: means a human clinical study of a biopharmaceutical product, the design of which is acknowledged bythe FDA to be sufficient for such clinical study to satisfy the requirements of 21 C.F.R. 312.21(c ) ( as amended or any replacement thereof ), ora similar human clinical study prescribed by the Regulatory Authority in a country other than the United States, the design of which isacknowledged by such Regulatory Authority to be sufficient for such clinical study to satisfy the requirements of a pivotal efficacy and safetyclinical study, provided that if a Phase II Clinical Study has not previously been completed with respect to such product, then a clinical studyshall not be deemed a until the design of such clinical study is acknowledged in writing by a Regulatory Authority(either prospectively or following completion of the clinical study ) to be sufficient for such clinical study to be included as a pivotal efficacy andsafety clinical study in an application for Regulatory Approval filed with the applicable Regulatory Authority in the applicable country orjurisdiction