definiens: shall mean the fully burdened costs of conducting development activities ( including the supply by ARADIGM of clinical trial quantities of Devices and Packaged Products ) pursuant to the Development Progral1U1le, including the costs of labor ( including all allocable benefits ), materials, outside consultants and research and development and corporate and overhead amounts reasonably allocable to such development activitiesIDJUt specifica lly excluding executive officers of ARADIGM other than those, such as the Vice Presidents for Research & Development, Regulatory Affairs, Medical Affairs and Engineering, whose activities are directly involved in the Development Programme ) ] 1.6 shall mean the phannaceutical development of the Packaged Products ( including Fonnulated Compounds and the disposable unit dose 195821 v9 / PA 4 73h09 ! . DOC 081098 CONFiDENTiAL . TREATMENT REQUESTED 3 } packaging ) and the Device, including the pre - clinical and clinical development programmes required for registration and approval of the Device and the Packaged Products in the Territory as provided for in this Agreement . The Development Programme shall initially consist of a development plan addressing the development of the Device and a Packaged Product containing the Initial Compound, but may be enlarged to include the development of Packaged Products containing one or more Other Compounds in accordance with Article 2.1