BIOTRONIK maintains complete and accurate lists and records that reflect all sales of products and related transactions, as required by law, and to comply with EU rules, the provisions of the Council Directive on Medical Devices or other legal requirements applicable to a country in the territory, in order to guarantee the traceability of each product 1.1. Subject to the conditions set forth therein, Given Japan appoints suzuken as the exclusive distributor of the product for customers in the region, subject to the exceptions and restrictions mentioned therein, and Suzuken accepts this date. To fulfill its obligations as an exclusive distributor, Given Japan suzuken grants Suzuken the non-negotiable right (except provided in Section 15) to market, market and sell the product directly to customers in the territory. Suzuken may not use the Product for any purpose other than those of this Agreement without the express, prior written permission of Given Japan, and Suzuken may not sell, market or market the Product or conduct marketing activities regarding the Product outside the Territory. Under this Agreement, Suzuken has no distribution rights for Given Imaging products other than the Product. Suzuken will not market the product as such in combination with other products or technologies or as a product in its own right and will not attempt to separate the components from the product or use any component separately and not as part of the product, without the prior written consent of Japan. CONOR has established and maintains a quality management system in accordance with ISO 13485 and other relevant quality management standards and regulations, such as Council Directive 93/42/EEC of 14 June 1993 on medical devices. CONOR ensures and guarantees that the actual production of the product will be done under the certified quality management system. . .
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