definiens: shall mean either ( a ) a trial on sufficient numbers of patients that is designed to establish that a Product is safe and efficacious for its intended use, and to define warnings, precaution s and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, and to support Regulatory Approval of such Product or label expansion of such Product, or ( b ) a clinical trial that began as a trial on sufficient numbers of patients that is designed to establish the safety and biological activity of a Product for its intended use, and to define warnings, precautions and adverse reactions that are associated with the Product in the dosage range to be pres cribed, after such date as the U.S. Food and Drug Administration or its successor ( or equivalent regulatory authority ) has indicated that the applicable Party may reasonably continue such trials with the intention to establish that a Product is safe and ef ficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be < PAGE > 6 prescribed, and to support Regulatory Approval of such Product or label expansion of such Product