definiens: has the meaning ascribed thereto in Section 5.8 . and have the correlative meaning ; means any individual, company, partnership or other entity which directly or indirectly, at present or in the future, controls, iscontrolled by or is under common control with a Party . For this purpose shall mean direct or indirect beneficial ownership of at leastfifty per cent ( 50 % ) of the voting share capital in such company or other business entity ; means this Biopharmaceutical Manufacturing Agreement ( including any amendment signed by the Parties hereto ), including allschedules and Exhibits attached hereto, and CCN ’s entered into hereunder ; shall mean a specific quantity of Product that is intended to be of uniform character and quality and is produced during the same cycleof manufacture ; means in relation to a Batch of Product, the production records showing how the Batch was manufactured ; means the agreed upon written list of testing, methods, limits and specifications applicable to in - process bulk harvest andProduct, applying to the manufacture and disposition of Product by [COMPANY], as defined in the Quality Agreement attached hereto as Exhibit 1,Annex 4, that may be amended by written agreement between the Parties ; means a contemplated change notification initiated by [COMPANY] in writing and provided to OPTHEA upon request of either Party, anddescribing any material deviation from the Services, and which must be approved by OPTHEA in writing before entering into force . Thestandard format of a CCN is attached hereto as Exhibit 4 ; or means the certificate containing the outcome of the disposition tests on the Product as performed by DSMor on behalf of [COMPANY] according to the Bill of Testing ; means current good manufacturing practices and general biological products standards as promulgated under the United StatesFederal Food Drug and Cosmetic Act at 21 CFR ( Chapters 210, 211, 600 and 610 ), the EEC Guide to Good Manufacturing Practices forMedicinal Products as promulgated under European Directive 2003/94 / EC ( replacing 91/356 / EEC ) and PIC / S Guide to Good ManufacturingPractice for Medicinal Products PE-009 - 08 Part 2, including any amendments to such regulations, to the extent these regulations relate toguidelines applicable for biopharmaceuticals and active pharmaceutical ingredients ; Page 6 of 63 Certain information contained in this document, identified by [ * * * ], has been redacted because it is both ( i ) not material and ( ii)would likely cause competitive harm to the Registrant if publicly disclosed