definiens: means any Person contracted by TGC to providemanufacturing - related products or services which constitute or are material toany Agreement Product, or any component or ingredient therein, or which resultin any work product or other information that TGC or GI would include or mightreasonably be expected to include in any document or report, including, withoutlimitation, an Approval Application, submitted to a Government Authority or besubject to review by a Government Authority including, without limitation, theFDA . Without limiting the foregoing, the term shallinclude any Person, other than an Outside Contractor, contracted by TGC whoseacts or omissions in connection with its assumption of any obligation of TGCunder this Supply Agreement or the PDA would be imputed to, and would thereforebe considered, the acts or omissions of TGC pursuant to FFDCA or by a GovernmentAuthority, including, without limitation, the FDA