definiens: shall mean activities with respect to the research and development of Collaboration Products for applications within the Field, comprising preclinical, clinical, regulatory, business development and all other activities relating to the research and development of Collaboration Products, all in accordance with the Development Plan and Budget in effect at the time . For avoidance of doubt, the Development Program will include, but not be limited to, toxicological, pharmacological and any other studies, the results of which are intended for use in obtaining Marketing Approvals, as well as development and documentation of methods, processes and procedures for the manufacture and/or preparation of Collaboration Products and establishment and validation of CO facilities for the clinical and commercial manufacture and/or preparation of Collaboration Products . Subject to the provisions of Article 14 below, it is understood that activities of each party 's internal patent personnel related to Prosecution and futerference Activities for such party 's Patents ( i.e., the CO Patents or the JT Patents, as applicable ) shall be part of the Development Program in accordance with the Development Plan and Budget . For avoidance of doubt, the Develo ment Program with res ect to a articular Collaboration Product shall not include pre­launch marketing or promotion, or activities com ri in t e launc such Collaboration Product ; provided that actiVIties relating to ongoing research, clinical studies and other development pertaining to such Collaboration Product that are conducted after its launch ( including without limitation, Phase IV trials ) shall nonetheless be within the Development Program