definiens: shall mean the reasonable belief of X4 or any of its Affiliates ’ or Sublicensees ’ based upon additio nal information that becomes available or an analys is of the existing information at any time, that the medical risk / benefit profile of the Licensed Compound or a Licensed Product is so unfavorable that it would be incompat ible with the welfare of patients to Develop or Commercialize such Licensed Compound or Licensed Pr oduct or to continue to Develop or Commercialize it . In the event of a dispute as to whether a Material Saf ety Issue exists, the Parties shall resolve the dis pute in accordance with Section 13.5, unless the Data Safet y Monitoring Board or any institutional Review Boar d or any Regulatory Authority has recommended to X4 or Genzy me, or their Sublicensees or Affiliates, to termina te an ongoing Clinical Study of the Licensed Compound or Licensed Product or has halted or placed any such o ngoing Clinical Study on hold, or a Regulatory Authority h as withdrawn or requested that X4 withdraw any appl icable Regulatory Approval for a Licensed Product, all of which foregoing circumstances shall be deemed concl usive evidence of the existence of a Material Safety Issu e giving rise to X4 ’s right to terminate under this Section 12.4.2