definiens: means any required removal of Supply Product from inventory ofBioParadox, its Affiliates, designees and customers as required by FDA Quality SystemRegulations, 21 CFR 806 et seq ., and related Laws and Regulations, at the reasonablediscretion of [COMPANY] after determination that Supply Product contains a manufacturing, design or other defect rendering it unsuitable for medical or clinical use . If there is a Recall of anySupply Product anywhere in the Territory, each Party shall cooperate fully with the other ineffecting such Recall, including promptly returning any affected inventory in its possession andpromptly communicating to any customers information as to the Recall or instructions forcompliance with the Recall . [COMPANY] shall, at its sole option, cost, and expense(a ) promptly replace any Recalled Supply Product with new compliant Licensed Product ; or(b ) promptly issue a refund to [COMPANY] for any Recalled Supply Product . ThermoGenesisshall pay, or reimburse [COMPANY], for all reasonable out - of - pocket expenses incurrected ineffecting such Recall of Supply Product, including any shipping costs related to return and / orreplacement of recalled Supply Products