definiens: shall mean any national or local agency, authority, department, inspectorate, minister, ministry official, parliame nt or public or statutory person ( whether autonomous or not ) of any government of any country having jurisdiction over either any of the activities contemplated by this Agreement or th e Parties including the U.S. Food and Drug Administration, the European Commission, The Court of First Instance and the European Court of Justice ; 1.1.8 shall mean any and all technical or commercial info rmation which is now or at any time hereafter during the te rm of this Agreement in the possession of either Party or Its Affiliates and is derived from the other Party or its Affiliates which is of a confidential nature or is received in circumstances in which that Party knows or should know that the information is confidential including with out limitation, data, know- how, formulae, processes, designs, photographs, drawings, specific ations, software programs and samples and any other material bearing or incorporating any suc h information together with financial and commercial information relating to the business of either Party ; 1.1.9 shall mean the development, manufacture, sale and /or distribution of Licensed Products or other use based on the Lice nsed Patent Rights and Clinical Data directed to encapsulated cells producing viral part icles and encapsulated cells expressing biomolecules