definiens: means, with respect to Zai Lab, clinical drug o r biologic product development activities with respect to a Licensed Product(s ) for use in Cl inical Trials in the Field in the Zai Lab Territory and associated test method development and stability te sting, toxicology, qualification and validation, Clinica l Trials ( including Clinical Trials commenced after Regulatory Approval ), statistical analysis and report writing, the preparation and submission of I NDs, BLAs and Regulatory Materials, regulatory affairs with respect to the foregoing, post - marketi ng appro val commitments and all other activities necessary or useful or Schedule 1 -- iv otherwise requested or required by a Regulatory Aut hority or as a condition or in support of obtaining or maintaining a Regulatory Approval . means, with r espect to INCY, all of the foregoing plus manufacturing scale- up and process development and manufacturing of pro ducts for use in Clinical Trials . means the performance of any of the foregoing act ivities