definiens: shall mean any recall, field corrective action, safety alert, notification or other regulatory action with respect to one or more of the Hansen Products or the Fully Integrated EnSite System taken either by virtue of applicable federal, state, foreign or other law or regulation or good business judgment . The parties will assist each other in gathering and evaluating such information as is reasonably necessary to allow the party controlling the pertinent product to determine the necessity of conducting any Remedial Action . Each party will maintain adequate records to permit the other party to trace the manufacture of the Hansen Products and the Fully Integrated EnSite System and the distribution and use of the Hansen Products and the Fully Integrated EnSite System . In the event that the party in control of a product ( Le ., Hansen controls the Hansen Products and St. Jude controls the Fully Integrated EnSite System ) determines that any Remedial Action with respect to a product must be commenced or Remedial Action is required by any governmental authority having jurisdiction over the matter, the party in control of such product will control and coordinate all efforts necessary to conduct such Remedial Action . Without limiting the foregoing, such responsibility shall apply to any recall, whether required or recommended by any government or other authority or organization, or otherwise deemed appropriate by the party in control of such product