definiens: means ( a ) techniques, data and information relating directly or indirectly to a Product or the Active Drug Substance or formulation, use ( including, without limitation, its use for particular indications, methods of delivering it, and sustaining therapeutic plasma levels of it and its metabolites, as well as other methods ), research, development, manufacture, having manufactured, marketing, offer for sale, sale, distribution, importation for sale or other disposal thereof, including, but not limited to, inventions, discoveries, practices, methods, knowledge, know - how, skill, analytical methods, trade secrets, experience and test data ( including non - clinical and clinical test data ) ; other data, records and information derived from, contained in or relating to Development, analytical and quality control and manufacturing data or descriptions ; Regulatory Documentation and adverse reactions ; and Commercialization, marketing, pricing, distribution, cost, and sales data or descriptions ; in all of the foregoing cases whether in written, electronic or any other form, and whether or not confidential, proprietary, patented or patentable, and ( b ) compounds, compositions of matter, assays and biological materials relating to a Product or the Active Drug Substance