definiens: means a production batch of the Product intended to have uniform character and ualit that is Processed b I3 in accordance with the terms and conditions of this A ree ~ ent I:,9r purp9sesofordrring, ea?p ~lini ~ lll:,~~t ~ h ;, * aJI, c?~si : ~~dfI2 ?, Ci of ; He . : OTMP ; proVIded, however, that the partl(;s llcknowle ~ g~ th, iit'13 's ablllty, to prodvcelOOC ; lmii;~ Batchesis 'd ~ pendant on ' its obtaining the ipgr6p~!Yie ' ~iie}idi9active, JtIat ~ iiIilS . Jiq!lse pf9)'ided (, further, tha~1 > riQ r to.the Primary Cbmpleti<)!i : ~ate, I3 wHLprOdi.\ce ( ZOC ! jmd, SOCi jli b!ltdies of clinical graile pF6duct, the number ' cost at which shallf'be a .eed u on b . ' the pilrtle~ ; fdrpurposes ; ' 6fswling ' up Hie Process 1.7 means all written information given to the FDA to support the approval of the Clinical Manufacturing Facility as being qualified and Validated to manufacture the Product for Clinical Trials