definiens: means any and all, reagents, chemicals, compounds, physical samples, models, specimens and any other similar physical substances that are used in the manufacture of the Product, including p rocesses and activities leading up to and peripheral to the manu facture of the Product ; shall have the meaning ascribed thereto in Clause 8.1 ; means the API compound described in Exhibit A sat isfying the Product Specifications ; means the specifications set out in Exhibit B for the Product, as may be revised from time to time by mutual written agreement of Cu stomer and Supplier ; has the meaning ascribed thereto in Clause 6.1 ; shall mean the written agreement regarding pharma ceutical quality reached between Customer and Supplier respecting quality co ntrol and quality assurance activities to be undert aken by Supplier in the performance of its duties hereunder and upon completion to be attached hereto as Exhib it E