definiens: means all standards, specifications, guidelines and regulations as to quality, safety and performance as are consistently applied by [COMPANY] from time to time with respect to themanufacture and quality control of the relevant [COMPANY] Product in accordance with [COMPANY] ’s establishedquality system, standard operating procedures, and quality control procedures, and includes ( i ) anystandard(s ) as may be specifically determined to be applicable to the manufacture and quality control of therelevant [COMPANY] Product ( if any ) ( for example, with regard to the manufacturing of cell processing reagentsor processing aids ) by agreement between [COMPANY] and any relevant Regulatory Authority / ies and as setforth in [COMPANY] ’s relevant Master Files and/or the Quality Agreement and ( ii ) any standard(s ) as may beexpressly agreed between the Parties with respect to a relevant [COMPANY] Product from time to time in writingin this Agreement or in an amendment to this Agreement