CE Xxxx. Amedica shall continue its application for a CE Xxxx for the femoral component and shall own such CE Xxxx in perpetuity once granted. OSI shall be entitled to use the CE Xxxx for as long as OSI markets, distributes, and sells the Products. OSI shall be responsible for the CE Xxxx approval for the complete hip system that will be utilized in concert with Amedica’s CE Marked femoral components.
CE Xxxx. To Purchaser's Knowledge, Purchaser should receive in ------- a timely manner the written notification from its Notified Body that the CE Certificate for the Finished Product will be issued in the Purchaser"s name, provided that Purchaser receives in a timely manner the documents Sellers are required to deliver under Section 4.1.
CE Xxxx. To the extent it has not done so prior to the Effective Date, Distributor shall obtain, as soon as reasonably practicable after the Effective Date, a CE Xxxx on the Product pursuant to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (the “Medical Device Directive”) and shall maintain such CE Xxxx on the Product during the Term of this Agreement. Distributor shall be appointed as the European authorized representative for purposes of the Medical Device Directive and OSUR shall provide Distributor with all reasonable assistance with respect to obtaining and maintaining the CE Xxxx, at no cost for OSUR. Distributor shall comply with all obligations placed on the European authorized representative by the Medical Device Directive. Distributor shall provide OSUR with copies of all documents and significant correspondence sent or received in connection with obtaining authority to affix a CE Xxxx, including any agreement with a notified body.
