Common use of Product Conformity Clause in Contracts

Product Conformity. The Company shall be the legal manufacturer of the Products and FDA and CE Registration of the Products shall be in the name of the Company. The Customer is solely the distributor of the Products purchased from the Company under the Customer’s name (“KEYSTONE”). Accordingly, the Company agrees to obtain FDA clearance and CE Registration of Products charging the costs detailed in Annex II. Company guarantees that it will maintain and/or obtain again, under the same conditions as when signing this Agreement, CE mark and/or FDA Clearance of Products bought by the Customer in accordance with this Agreement based on the current applicable regulations (e.g. EN ISO 13485, MDR...) during the term of the Agreement. The Company agrees to provide documentation of FDA clearance and CE Declaration of Conformity to the Customer so that the Customer can comply, or cause compliance with, reqistration requirements as an initial importer. As between CE registration and FDA clearance, the Company shall prioritize obtaining FDA clearance so that FDA clearance may be obtained as soon as reasonably possible. The Company and the Customer will collaborate as may be mutually agreed in other registrations of Products as requested by the Customer from time to time in the future under any registration registration requirements in compliance with Health Canada, and with other legally required registrations in Great Britain, Switzerland, Asia, Mexico, and Latin America. The Company shall otherwise cause the Products to comply with all legal requirements applicable to the Products in the United States initially and in each other jurisdiction in the Territory if and when the Territory is expanded as described in the immediately preceding paragraph (collectively, “Applicable Law”). The Customer has to register as initial importer of the Products in the United States and the Customer must ensure that the initial importer of products is registered as required in each other jurisdiction in the Territory if and when the Territory is expanded.