definiens: means person - in - plant ; means the method for manufacture, harvesting and purification of theProduct as defined in the Master Batch Records approved byCustomer ; means Customer ’s proprietary biologics known as andexanet alfamanufactured in Batch form as Bulk Drug Substance ; Commercial Supply Agreement9 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securitiesand Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended . CONFIDENTIAL has the meaning set out in Section 4.10 ; has the meaning set out in Section 4.11 ; means media, resins, catalysts, solvents, filters, membranes, disposable analytical test kits, disposable bags, and other itemsconsumed for the manufacture of Products in accordance with thisAgreement as well as any subcontracted analytical testing of theProducts performed by Testing Laboratories during the performanceof the Services, means any action to withdraw from supply or distribution or to recovertitle to or possession of quantities of Product sold or shipped to thirdparties ( including, without limitation, the voluntary withdrawal ofProduct from the market or correction ) or the detention or destructionof any Product by any regulatory authorities ; means those mandatory regulatory requirements applicable to themanufacture of cGMP Product for human use in Europe, the UnitedStates of America or Japan ; has the meaning in Section 7.10(a )