definiens: means any and all ( a ) research activities ( including drug discovery, identification or synthesis ) with respect to aproduct ( which may include related Diagnostics, if applicable ), or ( b ) preclinical and clinical development activities, and other development activities, withrespect to a compound or product ( which may include related Diagnostics, if applicable ), including test method development and stability testing, toxicology, formulation, process development, qualification and validation, manufacture scale - up, development - stage manufacturing, qualityassurance / quality control, clinical trials, statistical analysis and report writing, the preparation and submission of INDs and MAAs, regulatory affairs withrespect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority or as acondition or in support of obtaining, maintaining and/or expanding a Regulatory Approval . For clarity, Development shall include any Phase 4 ClinicalTrials, for example, studies that are required or requested in writing by a Regulatory Authority as a condition of, or in connection with, obtaining ormaintaining Regulatory Approval ( whether the trial is commenced prior to or after receipt of such Regulatory Approval ) ., and shall have their correlative meanings