definiens: shall mean, with respect to a product, any and all processes and activities conducted to obtain or maintain Marketing Appro vals for such product, including preclinical testing, test method development and stability testing, toxicology, formulation, process development, quality assurance / control development, statistical analysis, clinical studies ( including trials for additiona l indications for a product for which a Marketing Approval has been obtained ), quality of life assessments, pharmacoeconomics, post -marketing studies, label expansion studies, regulatory affairs, and further activities relating to development or preparatio n of such product for Commercialization . For clarity, Development shall include the manufacture of any product in support of the foregoing processes and activities, including, to the extent applicable, any packaging, labeling and other finishing activities, quality control and assurance testing, formulation development and other activities performed in support of the CMC ( chemistry, manufacturing and controls, or equivalent ) section of any MAA, in each case with respect to such product . and shall have their correlative meanings