definiens: shall me an * _ _ _ _ _ _ _ _ _ _ _ _ * . The shall mean * _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ * . Promptly after its agreemen t with the FDA, IDEC shall submit to P&U SPA a copy of * _ _ _ _ _ _ _ _ _ _ _ _ * . If a * _ _ _ _ _ _ _ _ _ _ _ * with the FDA, the parties shall agree upon reasonable alternativ e criteria to demonstrate clinical efficacy in any tu mor type . IDEC shall promptly notify [COMPANY] upon the occurrence of Clinical Efficacy . If [COMPANY] has r easonable reason to believe that Clinical * Indicates that material has been omitted and confi dential treatment has been requested therefor . All such omitted material has been filed separately with the Secretary of the Commission in the Company 's Appli cation Requesting Confidential Treatment pursuant to Rule 246 - 2 under the Securities Exchange Act of 1934, as amended