definiens: means : ( a ) a good faith determination by the Boar d that, based at least in part on the occurrence or observation of a Safety I ssue, the Licensed Product presents a risk of death, a life - threatening condition or a serious safety or health concern to patients such that Licensee can not ethi cally and in good faith continue to administer, or permit the ad ministration of, the Licensed Product to patients ; ( b ) a data safety monitoring board has recommended the termina tion of any clinical trial of the Licensed Product after the occurrence or observation of a Safety Issue ; ( c ) th e FDA or other applicable regulatory authority has issued a clinical hold, or otherwise required or recommended termination or suspension of, any clinical trial o f the Licensed Product after the occurrence or observatio n of a Safety Issue ; or ( d ) a good faith determinat ion by the Board that based on the occurrence or observation o f a Safety Issue, and taking into account all other relevant factors, the continued development and possible com mercialization of the Licensed Product is not comme rcially reasonable for Licensee