definiens: means, with respect to a [COMPANY] RNAi Program, the regulatoryapplications, submissions, presentations, meeting minutes, notifications, communications, correspondence, responses, registrations, and/or other filings made to, received from orotherwise conducted with a Governmental Authority ; copies of all registration dossiers andpackages, labels and regulatory certificates ; correspondence with the FDA, the United StatesDrug Enforcement Administration, any European Union Notified Body, the Ministry of Health, Labor and Welfare of Japan, or any other similar Governmental Authority in any country orjurisdiction, to the extent relating to the [COMPANY] RNAi Program ; vigilance reports ( including, butnot limited to, annual reports, expedited safety reports, and periodic safety update reports ), to theextent relating to the [COMPANY] RNAi Program ; relevant pricing information ; medical inquiries;written responses thereto and standard communication letters to healthcare providers, suppliers, customers or patients, including : ( a ) complete copies of regulatory files, including clinical data, and rights of reference ; ( b ) a copy of the safety surveillance database ; ( c ) copies of the variationsand all correspondence related thereto ; ( d ) copies of all labeling for all stock keeping units for allconfigurations of the related product ; ( e ) copies of all expert reports, pre - clinical and clinicalreports ; ( f ) copies of all FDA establishment inspection reports, inspectional observations on FDAForm 483s, responses thereto, and any other similar reports, observations, or responses from anyother Regulatory Authority, including Health Canada or the European Union Notified Bodies ( orany of its competent authorities ) ; ( g ) enforcement letters issued by any Regulatory Authorityrelating to the Product ; and ( h ) copies of all European Union Notified Body audit reports, certificates issued by a European Union Notified Body ( including ISO 13485:2003 / EN ISO13485:2012 ), certificates of compliance with the Medical Device Directive 93/42 / CE, and itsamendments, issued by a European Union Notified Body, in each case, to the extent relating tothe [COMPANY] RNAi Program, and all correspondence related to any of the foregoing