definiens: shall mean a recall ( a ) initiated at the direction of the Federal Food and Drug Administration or other regulatory authority, arising out of, based on, or caused by defects in materials or workmanship, improper manufacture of the Products, or failure of the Products to meet the Specifications ; or ( b ) initiated voluntarily by either Party where evidence indicates that defects in materials or workmanship, improper manufacture of the Products, or failure of the Products to meet the Specifications warrants such a recall . Each Party shall promptly notify the other Party of any situation which may lead to an Initiated Recall of the Products, however, [COMPANY] and ACLARA shall have joint authority as to whether to institute a voluntary recall . [COMPANY] shall notify ACLARA, in writing, if it is required to implement a total or partial Initiated Recall . Both Parties agree to work together to properly manage an Initiated Recall, foremost in terms of urgency and safety for the end customer, and secondly for the efficient utilization of resources to accomplish such Initiated Recall . The costs of any total or partial Initiated Recall shall be allocated as follows, regardless of whether it was recalled by ACLARA, [COMPANY], or a governmental or regulatory authority : ( a ) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably be deemed to be the direct result of negligent or willful acts or omissions on the part of ACLARA, ACLARA shall bear the out - of - pocket costs and expenses associated with the Initiated Recall ; ( b ) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably be deemed to be the direct result of negligent or willful acts or omissions on the part of [COMPANY], [COMPANY] shall bear the out - of­pocket costs and expenses associated with the Initiated Recall ; ( c ) if the defects or problems giving rise to the reason for the Initiated Recall can reasonably deemed to be the direct result of negligent or willful acts or omissions by both Parties, each Party will bear a portion of the out - of - pocket costs and expenses roughly commensurate with its proportional responsibility for the Initiated Recall, and ( d ) if it can not reasonably be determined which party was responsible for the defects or problems giving rise to the reason for the Initiated Recall, then the Parties shall equally share the out - of - pocket costs and expenses associated with the Initiated Recall