definiens: shall mean any recall, field corrective action, safety alert, notification or other regulatory action with respect to a Product 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 determine the necessity of conducting any Remedial Action . Each party will maintain adequate records to permit Cambridge to trace the manufacture of the Products and the distribution and use of the Products . In the event Cambridge determines that any Remedial Action with respect to a Product sold to a S1 M Target Account should be commenced or Remedial Action is required by any governmental authority having jurisdiction over the matter, Cambridge will control and coordinate all efforts necessary to conduct such Remedial Action, provided, however, that Cambridge shall be solely responsible for the direct and indirect costs of any Remedial Action relating to any of the Products . 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 Cambridge . Cambridge shall monitor on - going manufacturing quality trends and promptly notify S1 M in writing of any known material safety - related defects that are known to directly and materially impact present S1 M inventory or previously distributed Products . Notification shall include description of issue, product / batch scope, and scope mitigation recommendation . Cambridge shall follow - up within three Business Days of notification with a Risk AnalysislHealth Hazard Evaluation associated with the issue outlining investigative elements associated with issues severity, occurrence, and detection