definiens: means all b ooks, records, files, documents, data, information and correspondence of Arena or its Curr ent Affiliates to the extent ( A ) relating to the Co mpounds, Products, Product Assets and/or Assumed Liabilities, ( B ) are used or held for use in the Product Opera tions or ( C ) were generated in the conduct of the Product Op erations, including ( only to such extent ) ( i ) all r ecords with respect to supply sources ; ( ii ) all non - clinical, p re - clinical and clinical study data referenced in t he APD811 IND and all such data generated since the filing of the APD811 IND relating to the development or manufact uring of APD811 or any other Compounds or Products and any m aterials used in connection therewith, including al l raw data relating to any such studies, all case report forms relating thereto, all statistical programs de veloped ( or modified in a manner to the use or function thereof ) to analyze such data, and all investigator brochu res for such studies ; ( iii ) all market research data, market int elligence reports, statistical programs ( if any ) us ed for marketing and sales research with respect to the Products ; ( i v ) promotional, advertising and marketing 73 materials, sales forecasting models, medical educat ion materials, sales training materials, web site c ontent and advertising and display materials relating to the P roducts ; ( v ) all records, including vendor and supp lier lists, manufacturing records, sampling records, standard o perating procedures and batch records, related to t he manufacturing process for APD811 or any other Compo und or Product ; ( vi ) all data contained in laborato ry notebooks to the extent relating to APD811 or any o ther Compounds or Products or relating to the biolo gical, physiological, mechanical or formula properties of any of the foregoing ; ( vii ) all adverse experience reports and files related thereto ( including source documentati on ) and all periodic adverse experience reports and all data contained in electronic data bases relating to peri odic adverse experience reports with respect to APD 811 or the Product ; ( viii ) all analytical and quality control data relating to APD811 or the Product ; and ( ix ) al l correspondence, minutes or other communications wit h the FDA or any other Governmental or Regulatory Authority relating to APD811 owned or held by Arena or any of its Current Affiliates as of or prior to the Closing other than any Excluded Assets . For the avo idance of doubt, Regulatory Documentation shall not include any Excluded Assets