definiens: or means activities relating to obtain ing Regulatory Approval of Collaboration Products, and activities relating to developing and scaling up the ability to manufacture and to continue to manufacture Collaboration Compounds and Collaboration Products, including activities of Third Party manufa cturers to develop such manufacturing capabilities for Collaboration Products . Development includes but is not limited to Pre - Clinical Studies, pharmacology studies, toxicology studies, formulation, manufacturing process development and scale -up ( including bulk compound production ), quality assurance and quality control, technical support, pharmacokinetic studies, Clinical Studies, regulatory affairs activities and outside counsel regulatory legal services . For clarity, Development shall not include medicinal chemistry efforts directed at the production of new chemical variants of any [COMPANY] SARM Compound that are not themselves [COMPANY] SARM Compounds, but may include ( to the extent provided in the Development Plan ) the production of modified [COMPANY] SARM Compou nds that contain radioactive isotopes ( whether or not such modified compounds are included in [COMPANY] SARM Compounds ) or other labeling or tracing residues that are used in analyzing the activity, pharmacokinetics or pharmacodynamics of Collaboration Compounds as provided in the Development Plan, and activities directed toward developing a process for manufacturing Collaboration Compounds