definiens: ), which shall define the pharmacovigilance responsibi lities of the Parties and include safety data excha nge procedures governing the coordination of collection, investigation, reporting and exchange of informat ion concerning any adverse experiences, and any product complaints associated with adverse experiences, re lated to any Licensed Drug Candidate and Licensed Product su fficient to enable each Party ( and their respective Related Parties, if any ) to comply with its legal and regul atory obligations . The SDEA shall be modified in wr iting before obtaining the Regulatory Approval for such L icensed Drug Candidates and Licensed Products in ei ther -32- Territory, to enable each Party ( and their respecti ve Related Parties, if any ) to comply with its lega l and regulatory obligations . The Parties shall use Comme rcially Reasonable Efforts to amend the SDEA to add as parties any Related Parties . The Parties shall in g ood faith discuss and negotiate to determine the ow nership and responsibility for the development and maintenance of the global safety database for Licensed Drug Can didates and Licensed Products at an appropriate timing befo re the first IND application for the Licensed Drug Candidates and Licensed Products is submitted by ei ther Party to any Regulatory Authority in any count ry of the world