Common use of Product Control Clause in Contracts

Product Control. Supplier shall ensure that that each unit of Product shall, at the time of its shipment materially comply with the Specifications. In the event of any failure for such unit to materially comply with the Specifications, Supplier shall repair or replace such unit to conform to the Specifications, as set forth in Article 11 of the Distributor Agreement. Supplier shall provide Distributor the Specifications, which shall include (without limiting the definition in the Agreement) performance and reliability specifications. Before commercial launch at a time and on conditions to be mutually agreed by the Parties, Supplier shall provide evidence that the Products materially comply with the Specifications including but not limited to the performance and reliability specification, by Product demonstrations, sharing of test, verification and validation reports or similar means. Supplier shall consider any advice from Distributor in good faith. Distributor must authorize the initial shipment of new Products within three (3) business days after Supplier releases the Products and provides a certificate to Distributor with a signature of its Quality Manager that the Products comply with (a) their Specifications (b) all relevant quality and regulatory requirements of safety & effectiveness in the country of distribution (at minimum FDA 510(k) clearance, UL (or CSA) certification for US, and all applicable IEC standards). This certificate will contain all references to the obtained product safety testing approvals. In addition to article 5.3 (Change Process) of the Distribution Agreement, in case of changes which affect the way the Product interacts with Distributor Equipment both Parties will mutually investigate Product compatibility and mutually approve, before shipment of Products with the change. Supplier shall make reasonable efforts to support any Distributor request for compatibility tests and provide all relevant documentation. As long as this Product change is not approved by Distributor, Supplier will ensure the availability of the previous Product version. Notwithstanding the fact that Distributor may have worked with Supplier in the preparation of the Specifications for Products, Distributor is relying on the technical expertise of Supplier with respect to the adequacy of the Specifications and with respect to the proper manufacture of the Product. Therefore Supplier shall be responsible for the Products materially meeting the Specifications, but also to the Products achieving a quality level consistent with normal expectations of products in the medical industry.