definiens: shall mean fomlulalion development and optimization . manufacturing of clinical Irill Olmerinls, < lnalylical methods development, process scale - up and validation, 3nd other s~(Viccs required by Wal1ler . if any . as more fully set roT1h in one or more SOWs issued · under [ his Agreement . E : lch SOW hereunder must be in writing ilnd m.ust be signed by both Warner aud EUrllnd . Each SOW shall be governed hy the I'erms and oondilions of this Agreement . Any matcri~1 ch ~ ng.1 : in an SOW shnll be agreed to in wl ~ ljng in advance by [COMPANY] and Wamer . and Wanler shall be rc ~ rClnsihle fortll ! ! agrecd - ul > OIl COSt Many additional d~~velopmcnt work (, ONFIDLNTt, . "ll