definiens: shall mean all rights arising under issuedpatents and reissues, reexaminations, extensions and supplementary protectioncertificates thereof and all patent applications and any divisions, continuations, or continuations - in - part thereof or patents issuing thereon, 1.32, shall mean clinical trials inhealthy adults and/or in a small number of patients commencing upon the filingof a trial protocol with the appropriate regulatory body and designed todetermine the metabolism and pharmacologic actions of a product in humans, theside effects associated with increasing doses and to gather evidence oneffectiveness and meeting the requirements established by the FDA or by theequivalent Japanese agency for Phase I clinical trials, The completion of thePhase I Clinical Trials will be deemed to have occurred upon the first formalinternal issuance of trial results as measured by trial objectives, or in anyevent no later than the commencement of the Phase II Clinical Trials