definiens: means it is [COMPANY] ’ or any of its Affiliates ’ or Sublicensees ’ reasonable belief, after due inquiry and in a manner consistent withBMS ’ then - current decision - making policies and procedures with respect to such a determination, that there is an unacceptablerisk for harm in humans based upon : ( i ) pre - clinical safety data, including data from animal toxicology studies ; or ( ii ) theobservation of serious adverse effects in humans after a Licensed Product has been administered to or taken by humans, suchas during a clinical trial or after the launch of a Product . [COMPANY] shall provide Zymo with all relevant data for such terminatedLicensed Product but shall not be obligated to assign to Zymo any Regulatory Filings relating to such terminated LicensedProduct ( but for clarity, shall assign the Ex - US Core Patents back to Zymo ) . If Zymo does not agree with [COMPANY] ’ opinion thatBMS ’ termination was due to Safety Reasons, such dispute shall be handled in accordance with Article Seventeen