definiens: shall mean all documents in Mirati ’s possession or otherwise owned by Mirati to the extent containing or reflecting Information, ot her than Collaboration Know - How, that pertain speci fically to Active Compound and/or Product and are generated or obtained by Mirati directly in the course of its performance of the Agreement, which include without limitation data pertaining to clinical samples ( ti ssue, blood, PK samples or extracts from biological sampl es ) obtained from trial participants and/or to any Mirati - developed diagnostic test that may be required to p ursue ongoing development or regulatory submissions, [ * * * ] = Certain Confidential Information Omitted [COMPANY] BioPharma and Mirati Therapeutics - Amendment # 4 to DDCOA ( G12C ) Page 1 of 7 Execution Version regulatory correspondence with health authorities, investigator financial disclosures, protocols and p rotocol amendments, clinical study reports including all ta bles, listings and figures, investigator brochures, trial master files, case report forms, clinical and safety data bases, analysis data sets, site monitoring and audi t reports, records of health authority inspections, clinical pharmacol ogy reports, data pertaining to tissue samples used for translational studies or to blood or plasma samples collected for translational, PK or diagnostic co - d evelopment, collected ECG, imaging studies and outputs from oth er specialized diagnostic tests in any available fo rmat and, to the extent permissible under applicable Third Party agreement(s ), access to any such Information gener ated and/or controlled by Third Party vendors or collaborators pertaining specifically to the clinical development of Active Compound and/or Product