definiens: shall mean tangible and intangible technical information found in research notebooks, folders, e - files ( CDs, diskettes, tape, hard drives, external drives, third - party note taking applications, cloud and flash storage ) containing the researchers and/or inventors ’ work relatedto the Licensed Patents including but not limited to : 4 Preclinical Materials, methods, techniques and observations related to : a)Preclinical animal efficacy and toxicity datab)Viral transduction of immune effector cellsc)Generation of chemotherapy resistant immune effector cellsd)Transducing CARs into immune effector cells Regulatory Pre - IDE briefing documentsPre - IDE meeting submission and minutesIDE application / submissionIDE approvalPre - IND briefing documents ( if any)Pre - IND submissionPre - IND meeting notesPre - IND meeting minutesIND submissionIND meeting notes and minutesIND correspondence and approvalsAny regulatory correspondence, submissions, requests for meeting, minutes and approval of protocol changesAll IRB submissions, comments, revisions and resubmissions ( if any ) related to clinical trials CMC Manufacturing SOPs / Protocols related to CMC a)Manufacturing SOPs / Protocols for CMC for single and multi - site cross validationb)All analytical data and analysis performed in preparation for CMC submission, including data for validation and qualification of assaysc)All third party contracts and correspondence including, data, SOPs, and analysis generated in preparation for CMC submission ( e.g.,CROs that contributed mycobacterial analysis, mass spec, viral contamination analysis etc.)d)Most recent Pharm / Tox data updatese)Any data and analysis prepared for CMC filing, including third party contractorsf)Regulatory documents related to anticipated CMC filings 5 Clinical Draft Clinical trial protocol(s)Final Clinical trial protocol(s)Statistical design(s ) and protocols for clinical trialsAny minutes / submissions / correspondence from CRTC ( Cancer center Translational Research Committee ) meetingAny minutes / submissions / correspondence from NIH RACAny minutes / submissions / correspondence from Brain Tumor Working GroupCopies of all grants and grant applications that funded the research and clinical studiesAll existing manuscripts in preparation or submission covering the research or clinical studiesAny pharmacy reports related to study drug shipping, handling, and distribution to investigators, including pharmacy contacts at each clinical site Contact information for study participants, including but not limited to investigators, scientific advisors, statisticians, nurse coordinators, qualityand regulatory personnel