definiens: means an Investigational New Drug application fil ed with the FDA for a Drug Product in order to obta in approval for the commencement of clinical trials means unpatented technical and other information, including information comprising or relating to concepts, discoveries, inventions, data, designs, formulae, ideas, methods, models, assays, researc h plans, procedures, designs for experiments and tests and r esults of experimentation and testing ( including re sults of research or development ) processes ( including manuf acturing processes, specifications and techniques ), laboratory records, chemical, pharmacological, toxi cological, clinical, [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THI S DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SEC URITIES ACT OF 1933, AS AMENDED