definiens: or means all activities with respect to ARC 2172 or a LicensedProduct relating to : ( a ) the preparation for and conducting of Phase 1 Trials, Phase 2 Trials, and Phase 3Trials ; ( b ) the filing and obtaining of Regulatory Approval for a Licensed Product ; and ( c ) all activitiesrelating to developing the ability to manufacture ARC 2172 or Licensed Products . This includes, but is notlimited to : ( i ) preclinical testing, toxicology, formulation development, clinical studies, regulatory affairs andoutside counsel regulatory legal services ; and ( ii ) manufacturing process development and scale up for bulkand final forms of ARC 2172 and Licensed Products, validation documentation, all documentationgenerated in connection with the manufacturing or processing activities and manufacturing and qualityassurance technical support activities for ARC 2172 or Licensed Products prior to first commercial sale