definiens: " cGMp · B8086 / HB / GKl5Nov04 2 means any Company, partnership or other entity which directly or indirectly Controls, is Controlled by or is under common Control with the relevant party to this Agreement . means the ownership of more than fifty per cent ( 50 % ) of the issued share capital or the legal power to direct or cause the direction of the general management and policies of the party in question ; means this agreement incorporating Schedules 1 ( Product Specification ), 2 ( Services ) . 3 ( Price and Terms of Payment ) and Schedule 4 ( [COMPANY] Patents ) as amended or varied from time to time by written agreement of the parties ; means the total Product obtained from one fermentation and associated purification using the Process and carried out in accordance with cGMP ; means the cell line, particulars of which are set out in Schedule 1 ; means Good Manufacturing Practices and General Biologics Products Standards as promulgated under cGMP run(s ) CONFIDENTIAL the US Federal Food Drug and Cosmetic Act at 21CFR ( Chapters 210,211,600 and 610 ) and the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356 / EEC . For the avoidance of doubt, LB 's operational quality standards are defined in internal GMP poliCy documents ; means Product which is required under Schedule 2 to be manufactured in accordance with cGMP ; means the 2000 ( two thousand ) liter fennentation run(s ) to be perfonned under this Agreement means [COMPANY] Inc and its successors in title and lawful assigns ; means all technical and other infonnation not known to LB or not in the public domain relating to the Cell Line, the Process ( including for the avoidance of doubt improvements or modifications thereto from time to time ) and the Product, from time to time supplied by the Customer to LB ; means the Materials supplied by Customer to LB ( if any ) and identified as such by Schedule 1 hereto ; means all patents and patent applications of any kind throughout the world owned by or licensed to Customer that are necessary or useful in performance of the Services excluding the LB Patent Rights ;, or has the meaning given to it in Clause 4.1 ; B8086 / HB / GKJ5Nov04 3 means the United States Food and Drug Administration ; means [COMPANY] Biologics piC and its Affiliates and successors in title and lawful assigns ; means all technical and other infonnation relating directly or indirectly to the Process known to LB from time to time other than Customer Intonmation and information in the public domain ; means all patents and patent applications of any kind throughout the world relating to the Process which from time to time LB is the owner of or is entitled to use ; means the price specified in Schedule 3 for the Services ; means the process for the production of the Product from the Cell Line, including any improvements or modifications thereto from time to time ; f, ;, CONFIDENTIAL means all or any part of the product manufactured using the Process ( including any sample thereof ), particulars of which are set out in Schedule 1 and includes all derivatives thereof made by LB ; means all or any part of the services which are the subject of the Agreement ( including, without limitation, cell culture evaluation, purification evaluation, assay evaluation and qualification, a 130 liter pilot run, master, working and extended cell bank creation, sample and bulk production, and characterization, cGMP manufacture ), particulars of which are set out in Schedule 2 ; means the specification for Product, particulars of which are set out in Schedule 1 ; means the tenns of payment specified in Schedule 3 ; means any third party instructed by LB to carry out tests on the Cell Line or the Product