definiens: means ( a ) all adverse event reports and other data, information and materialsrelating to adverse experiences and other safety issues with respect to the Product ; ( b ) all material correspondencebetween Sun and any Governmental Authority relating to the Product, including any filings, submissions, safetyreports or updates, complaint files and product quality reviews and all clinical or pre - clinical data derived from clinicalstudies conducted or sponsored by Sun ; ( c ) the NDA ; and ( d ) all other records, data and material held by Sun withrespect to its compliance with the FDA Act, CDAPCA, CSA, PPACA and applicable regulations issued by aRegulatory Authority ( both with respect to the Product and to Sun ’s activities subject to the FDA Act, CDAPCA, CSA, PPACA or the applicable regulations issued by a Regulatory Authority ) as set out in Schedule 1(bbb )