Exclusive Distribution Agreement Medical Device

BIOTRONIK initiates the translation of all user and technical manuals as well as the advertising and marketing information provided by CONOR in the languages of its customers and provides CONOR with prior copies of all these documents for CONOR approval. All translations held by CONORs at the time of entry into force are free of charge biotronics. All other translations necessary for the distribution of products in the territory must be obtained at the expense of BIOTRONIKs. BIOTRONIK has all of these translations and related intellectual property rights, but CONOR does not have the exclusive right to use these translations for the duration of this Agreement. CONOR has established and maintains a quality management system in accordance with ISO 13485 and other relevant standards for quality management and legislation, such as the Council`s 93/42/EEC Directive of 14 June 1993 on medical devices. CONOR ensures and guarantees that the actual production of the product is carried out within the framework of the certified quality management system. 1.2 No dealers. Suzuken cannot designate resellers for the product without Given Japan`s express prior written authorization, with the exception of commercial agents designated by hospitals and other health care providers for the purchase of medical supplies on their behalf. 17.12 Interpretation.

(i) in this agreement, unless the context requires something else, the singular includes the plural and vice versa, and a reference to a sex encompasses all sexes; (ii) “section”: a reference to part of this agreement; (iii) The terms “including,” “including” and “including” are considered to be followed by the words “unrestricted” or “but not limited to” or terms of similar meaning; (iv) the terms `below`, `below`, and `below`, as well as other similar terms of service used in this agreement, relate to the whole of this agreement and not to a particular part of this agreement; (v) references to agreements (including but not limited to this agreement) and other contractual instruments include all annexes, calendars, exhibits, annexes and annexes, as well as any subsequent changes and other changes to those agreements; (vi) References to contracting parties include their respective rights holders and their approved beneficiaries; and vii) The reference to a statute of specific application is a reference to the law as amended or amended at the time of reference. When BIOTRONIK markets a product research sten in the territory developed by BIOTRONIK or a third party, BIOTRONIK`s designation as an exclusive distributor of Section 2.1 products will be converted into an exclusive co-distributor of products. This agreement will be concluded on May 25, 2004 (effective date) 17.9 Full contract. This agreement, including all supplements and timetables, constitutes the whole agreement between the parties with respect to the purpose of this agreement and replaces all previous agreements, agreements or assurances made verbally or in writing between the parties on this matter. All manufacturing and product characteristic requirements, including, but not exclusively, technical, physical, chemical, environmental, labelling, packaging and additive requirements, which are described only in the specifications of the product in Appendix A of this agreement. (u) cooperate appropriately with Given Japan on all matters of medical vigilance and report all product problems; BIOTRONIK will immediately inform conor in writing of patent or copyright infringements or the unauthorized use of CONOR trade secrets or trademarks in the area to which BIOTRONIK has attracted attention. Conor, at its sole discretion, has the exclusive right to initiate proceedings against this third party on its behalf and on its behalf.

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