definiens: means the Development activities conducted and Regulatory Filingsprepared and submitted pursuant to the Joint Development Plan, in each case for the purpose of obtaining RegulatoryApproval of the Co - Developed Product in the U.S., whether or not the data obtained from such Development activities and thecontent of such Regulatory Filings are used or incorporated in any submission of Regulatory Filings to RegulatoryAuthorities in any jurisdiction outside the U.S. for the purpose of obtaining Regulatory Approval of the Co - DevelopedProduct in such jurisdiction . For clarity, in the event the Joint Cancer Development Plan calls for a combined dossier forsubmission to the U.S. and EU regulatory authorities, the U.S. Co - Developed Product Development shall include theDevelopment activities conducted and Regulatory Filings prepared and submitted for such combined dossier . For furtherclarity, the U.S. Co - Developed Product Development shall not include any Sole - Funded Study