definiens: means all filings and supporting documents submitted or to be submitted to a Regulatory Authority in the Territory relating to the Compound(s ) or Collaboration Product(s ), and all data contained therein, including, without limitation, any INDs, NDAs and their counterparts in other countries, investigator 's brochures, correspondence to and from such Regulatory Authorities, minutes from teleconferences with Regulatory Authorities, registrations and licenses, regulatory drug lists, advertising and promotion documents shared with Regulatory Authorities, adverse event files and complaint files . In addition, Preclinical and Clinical Data shall include all investigator reports ( both preliminary and final ), statistical analysis, expert opinions and reports, safety and other electronic databases and all other material documentation and information related to Preclinical Development or clinical development of a Compound or a Product . Without limiting the foregoing, Preclinical and Clinical Data shall include all items described in Schedule 1 - 0 that are generated from a Research and Development Program . Notwithstanding the foregoing, Preclinical and Clinical Data shall not include filings, supporting documents, data . reports, analysis, databases or other documentation or information generated by a Non - ND Partner or [COMPANY] a Non - ND Partner ( as defined above under Licensed [COMPANY] Technology ), by an Opt - Out Non - ND Partner or [COMPANY] an Opt - Out Non - ND Partner ( as defined above under Licensed [COMPANY] Technology ) or by [COMPANY] pursuant to a Bona Fide Internal Research and Development Program