definiens: means the agreed upon cost per FTE by functional area, to be ad - justed wmuaUy ( beginning in January 2005 ) for inflation using the latest available U.S. ProducerPrice Index for Total Manufacturing Industries, unadjusted ( PCUOMFG # ) as a simple percent - age, Such adjustments shall be the responsibility of : ( i ) the Development Committee with re - spect to Development FTE Rates ; ( ii ) the Commercialization Committee with respect to Com - mercializallon FTE Rates ; and ( Hi ) the Development Committee or Commercialization Commit - tee, as applicable, with respect to Manufacturing FTE Rates . The initial FTE Rates ( on a per an - num basis ) are : IStales Investigational New Drug Application ( or any successor application ) and its foreignequivalents, and all subsequent submissions, supplements and amendments therC1O