Regulatory Obligations and Expenses. In connection with obtaining or maintaining Regulatory Approvals, interacting with Regulatory Authorities, filing or maintaining Regulatory Documentation, or maintaining regulatory records (in each case in relation to its System or the Combined System Implementations), unless required to comply with Applicable Laws, in no instance shall either Party take any action or omit to take any action that, directly or indirectly, would be reasonably likely to result in the other Party incurring (i) additional responsibilities to Regulatory Authorities or otherwise under Applicable Laws that are not listed or described in the Development Plan or Commercialization Plan, or (ii) additional internal or out-of-pocket expenses (including expenses related to additional reporting obligations) that are not listed or described in the Development Plan or Commercialization Plan, in each case without prior written consent of such other Party; provided, that the foregoing shall not limit either Party’s right to make any Minor Release or Major Release of its System or component thereof.
