definiens: means activlUcs relanng to the prepar.tllOn for and conductwg of Phase I Trials . Phase 2 Trials . Phase 3 Tnals . mcluding Phase 3B Trials . and label cxpan, lon trials . obtaining Regul3l0ry Approval of a Collaboration Product . and all activitic, relating \0 developing the HbiliLy to manufacture the same . This includes . blll is not limited to : ( a ) preclinical testlllg . to.ticology . formulation, clinical studies . regulatory affairs and outside counsel regulatory lcgal services ; and ( b ) manufacturing process development for bulk and final fonns of Collaboration Compounds and Collabol1ltion Products . validation documcntalJon . all documentation geneMlted in connection with the manufacturing or proceosing activities and manufacturing and quality assurance technical support activitics before the first commercial salc of a Collaborution Produc\. Development excludes Phase 4 Trials