definiens: means all books, files, papers, correspondence, databases, electronic files, documents and records in whatever medium, and wheth er original or copy, including the following ( in ea ch case to the extent the following exist ): all records wit h respect to supply sources ; all pre - clinical, clin ical, research and process development data ( including investigator br ochures, results and reports relating to products o r of any materials used in the research, development, manufa cture, marketing, sale or other commercialization o f products ( including all raw data, compilations and reports, all case report forms ) ) ; clinical safety a nd efficacy reports and corresponding safety databases ; all mar ket research data, market intelligence reports, sta tistical programs used for marketing, sales, research or dev elopment ; clinical trial budgets and forecasts ; cli nical trial expenditure reports for costs incurred to date over the trial life ; supplier listing for invoicing pur poses ; sales forecasting models, medical education materials, we b site content and advertising and display material s ; market / marketing studies, pricing / discount studies and plans, launch plans, promotional and marketing materials, sales force plans and training materials, customer lists ; manufacturing records, sampling records ( inc luding retained samples ), standard operating procedures an d batch records, related to manufacturing processes ( including analytical and quality control data and stability data, other chemistry, manufacturing, and control ( CMC ) data ) ; all laboratory notebooks relating to p roducts or relating to their biological, physiologi cal, mechanical or -3- other properties or compositions ; all adverse exper ience reports and files related thereto ( including source documentation ) and all periodic adverse experience reports and all data contained in electronic databa ses relating to periodic adverse experience reports ; all analyti cal and quality control data ; and all correspondenc e, minutes or other communications with any Governmental or Regul atory Authority ) ; all advertising materials, traini ng materials, product data, price lists, mailing lists, sales materials, marketing information, promotion and marketing materials, artwork for the production of packaging components, sales order files, distributo r files, product files, purchase order files, customer lists, supplier lists, business files . Books and Records shall exclude Regulatory Materials and Authorizations