definiens: shall mean each one of the following : Subterritory A -The United States, Canada and Mexico Subterritory B -European Community ( as described in Exhibit D ) Subterritory C -Japan and the Far East ( as described in Exhibit D ) Subterritory D -All other countries of the Territory 1.31 shall mean a drug delivery system which includes and is contained within an implantable ( or externally worn ) osmotic pump intended to function by releasing the active agent or agents on a controlled basis . The term shall include all materials, technology and attributes contained within, or incorporated in the osmotic pump ( other than the Drug itself ) and shall include the formulation and stabilization of a therapeutic agent ( such as the Drug ) in the System . The System shall not include a Catheter as defined in Section 1.2, or ( except to the extent agreed upon in writing by the parties ) any docking mechanism or other components used to connect a Catheter to the osmotic pump, and shall not include by way of example, any delivery system that is ingested in the gastrointestinal tract or that delivers drug through substantially intact skin