definiens: shall mean a multi - country Phase II Clinical Trial or Phase III Clinical Trial of a LicensedProduct that is conducted by Arcus, its Affiliates or a Third Party under authority from Arcus, is joined by TAIHO orany of its Affiliates or Sublicensees with respect to any part of the Clinical Trial conducted in Japan and is designed(a ) to satisfy the requirements of the Regulatory Authorities in Japan ( including sufficient numbers of Japanese ( orother mutually agreed Asian ) patients to satisfy such requirements ) and ( b ) ( i ) if such Clinical Trial is a Phase IIClinical Trial, to be sufficient without a further Clinical Trial, to form the basis for proceeding to a Phase III ClinicalTrial ( or filing a BLA or NDA in Japan and one or more Major Markets ) or ( ii ) if such Clinical Trial is a Phase III ClinicalTrial, to provide an adequate basis to obtain Marketing Approval in Japan and one or more Major Markets . For suchpurposes, to a Clinical Trial means that TAIHO or any of its Affiliates or Sublicensees ( or a combination ofthem ) ( A ) is the sponsor of such Clinical Trial in Japan, or is primarily responsible for carrying out or overseeing theconduct of such Clinical Trial in Japan, ( B ) is responsible for no more than its proportionate share of the costs of suchClinical Trial based on the number of patients in Japan ( or other mutually agreed Asians ) relative to all patients in theClinical Trial and ( C ) has mutually agreed with Arcus in a writing specifically referencing this Agreement that it isjoining such Clinical Trial . If TAIHO ( or its Affiliate or Sublicensee or any combination of them ) is a GlobalStudy, then the parties shall enter into an agreement specifying the parties ’ respective roles and responsibilities anddescribing how costs associated therewith shall be handled