definiens: shall mean all methods, processes, techniques, compositions, technology, information, data, results of tests, studies, statistical and other analyses and expertise, which are not generally known including, but not limitedto, patent claims and related information not yet disclosed to the public, formulae, procedures, protocols, manufacturingtechnology relating to Product that is used by BPA or its Affiliates and is necessary for the formulation, manufacture, packaging, release testing, and stability and shelf life determination of Product in the Territory, including, but not limited to, specifications and test methods, manufacturing and packaging instructions, master formula, validation reports ( process, analytical methods and cleaning ), stability data and analytical methods, clinical and non - clinical safety and efficacy studies, marketing studies and absorption, excretion and metabolism studies, quality control and quality assurance processes, regulatory filings including, without limitation, NDAs, information relating to planned Phase IV trials or planned lineextensions, techniques, and results of experimentation and testing, which ( i ) relate to the Product, and ( ii ) are necessary oruseful to the development, marketing or manufacture of the Product in the Territory ( in the case of manufacture, worldwide),all to the extent as of the Closing Date of this Agreement owned or controlled ( including by means of any license orsublicense, provided that such rights can be licensed or sublicensed to a Third Party ) by BPA or its Affiliates