definiens: means ( a ) all preclinical and cl inical protocols, studies, data, results, study - rel ated forms, materials ( excluding solely the Compound ) an d reports ( e.g., investigator brochures, informed c onsent forms, data safety monitoring board related documen ts, patient recruitment related materials, biocompa tibility studies, animal studies, safety studies, and chemis try, manufacturing and control data ) resulting from any preclinical or clinical study or trial of the Produ ct or generated in the course of the Development Pr ogram, ( b ) any certificates of any audit of any such precl inical or clinical study or trial, any record or re port of any audit of such preclinical or clinical study or trial cont aining a finding that involves the absence or failu re of a critical process, system or related component, a key interna l control and/or an issue with considerable risk to a Party and which warrants immediate remediation to address, an d any other audit record or report of such preclini cal or clinical study to the extent necessary to respond t o a request, requirement, or order by a Government Authority, upon the request of the Party that is the subject o f the Government Authority ’s request, requirement, or order, and ( c ) all INDs, NDAs, any unfiled applications, c omponents or materials normally associated with an IND or NDA, regulatory filings or applications comparable to INDs or NDAs in any foreign jurisdictions, drug master files, and other regulatory applications and Regula tory Approvals regarding the Product ( excluding any of the foregoing relating to the Compound apart from the P roduct )