definiens: means all data resulting from any clinical in vitro or in vivo study, or clinical trial, or CMCdevelopment of any Program Compound or Product, including the applicable protocol for each such study or trial, aswell as all associated site related documentation, including all training materials, all correspondence with the sites, investigator brochures, investigational review board correspondence, data monitoring committee minutes ; operationaldocumentation and any CMC data including documentation and information related to production of drug substanceand drug product including information associated with labeling and packaging . For purposes of clarity, Clinical Datashall include all trial - related materials, including trial master files, project management reports, training manuals andcopies of communications to third party vendors, site related materials, site training manuals, recruitment materials ortools provided to clinical sites to aid in the execution of any study conducted with a Program Compound or Productand all completed and/or draft study reports, data analyses, and summaries and any published or publication drafts ofany studies related thereto