definiens: means all activities performed by or on behalf of either Party in the performance of any Development Plan for Collaboration Compounds, Collaboration Products and Diagnostic Products in the Fields . Development shall include, without limitation, Translational Research Activities and all activities related to research, preclinical testing, test method development and stability testing, toxicology, formulation, Clinical Trials, seeking Regulatory Approval and otherwise handling regulatory affairs, statistical analysis, report writing performed pursuant to the Development Plan with respect to Collaboration Products . Developmen, t shall not include Manufacturing or Commercialization . When used a ~ DevelopDevelopment Budget " ~eWls the written budget that sets forth, for the time period covered by the ' Qe : ie't ~ pment Plan, the total budget for the Parties to perform activities pursuifbt to the Development Plan . The initial Development Budget is attached hereto as Schedule 1.32 and may be amended from time to time by the Parties in accordance with Section 4.1.1