definiens: shall mean the costs and expenses associated with Development activities actually incurred by the Parties or their Affiliates for a particular Product during the measurement period and in the territories described in Section 3.2.4(d ) . The costs and expenses associated with Development activities shall include, but are not limited to, costs of studies on the toxicological, pharmacological, metabolical or clinical aspects of a Product, including clinical trials, conducted internally or by individual investigators or consultants and necessary for the purpose of obtaining, maintaining and/or expanding marketing approval of a Product, process development, process improvement and scale - up and recovery costs ( including plant costs ), validation costs, including qualification lots, the manufacture of clinical supplies of Product, including failed batches, costs for preparing, submitting, reviewing or developing data or information for the purpose of submission to a governmental authority to obtain, maintain and/or expand manufacturing and/or marketing approval of a Product and costs of marketing studies related to a Product . shall also include expenses for data management, statistical designs and studies, document preparation, and other administration expenses associated with the clinical testing program . In determining chargeable under this Agreement, each Party will use its respective project accounting systems, and will review and approve its project accounting systems and methodologies with the other Party . The Parties hereby agree that efforts of the employees of a Party or its Affiliates in performing its activities hereunder shall be charged as Development Costs at the FTE Rate