definiens: shall mean as follows : shall mean that portion of the clinical development program which generally provides for the first introduction into humans of a product with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of the product, as more closely defined by the rules and regulations of the Food and Drug Administration ( FDA ) and corresponding rules and regulations in other countries ; shall mean that portion of the clinical development program which provides for the initial trials of a product on a limited number of patients for the primary purpose of evaluating safety, dose ranging and efficacy in the proposed therapeutic indication, as more closely defmed by the rules and regulations of the FDA and corresponding rules and regulations in other countries ; shall mean that portion of the clinical development program which provides for the continued trials of a product, in coordination with regulatory authorities, on a statistically significant number of patients for proof of the safety and efficacy of a product for the desired claims and indications and is conducted for the purposes of obtaining an -5 - 12293634 approvable PLA, as more closely defined by the rules and regulations of the FDA and corresponding rules and regulations in other countries