definiens: means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Product, including : marketing, promoting, distributing, medical affairs, obtaining pricing and reimbursement approval for a Product, and so called, and in each case to the extent sold above cost ; any marketing study, epidemiological study, modeling and pharmaco -economic study, investigator -initiated clinical trial or post -marketing surveillance stu dy of a Product, in each case that is not intended for use as a basis for obtaining Regulatory Approval ( including expanded labeling ) with respect to such Product ; Manufacturing Products for commercial sale, samples or any of the foregoing studies ; importi ng and exporting Products ; and the preparation and submission of Regulatory Documentation and interacting with Regulatory Authorities regarding any of the foregoing activities . When used as a verb, and means to engage in C ommercialization, and has a corresponding meaning . When used as an adjective, modifies the following noun to allow for the foregoing activities