definiens: means the conduct of all activities that are reasonably required to obtain Marketing Approval of a Product, including, without limitation : ( i ) non - clinical studies ( including, without limitation, pharmacology, toxicology and pharmacokinetics ) ; ( ii ) regulatory affairs, project management, clinical operations, medical writing, bio - statistics, data management and drug safety, and clinical trials, in accordance with the cGLPs, cGCPs and cGMPs or other designated quality standards and Applicable Laws ; ( iii ) all activities relating to developing the ability to Manufacture such Product, including, without limitation, formulation, stability / analytical, packaging, delivery technologies and devices, bulk API and/or drug product production, Manufacturing fill / finish, Manufacturing process development, and quality assurance technical support, clinical supplies distribution and quality control testing and release, until such time as Manufacturing of such Product intended for commercial sale commences ; and ( iv ) any required post - Marketing Approval commitments