Print Page  Close Window
STEREOTAXIS, INC. filed this Form S-1/A on 05/12/2004
Entire Document
 << Previous Page | Next Page >>

         provide similar Manufacturing Specifications to Biosense for the
         Components prior to Stereotaxis' first shipment of commercial
         quantities of the Components to Biosense ("Component Manufacturing
         Specifications"). From and after the delivery of such Manufacturing
         Specifications, the Daughter Products and Components will mean for all
         purposes of this Agreement those certain Daughter Products and
         Components reflected by and defined in the Manufacturing
         Specifications. Biosense, in the case of the DP Manufacturing
         Specifications, and Stereotaxis, in the case of the Component
         Manufacturing Specifications, will have the right to modify and will
         modify such Manufacturing Specifications from time to time to reflect
         modifications made by Biosense to the Daughter Products and by
         Stereotaxis to the Components, and in all cases, one party shall
         communicate such changes to the other party. Such modifications will in
         all cases be consistent with all applicable Daughter Product
         Specifications and Component Specifications. Any modifications not
         consistent with such specifications will require the unanimous approval
         of the Joint Steering Committee.

8.3      Packaging of Lots and Lot Sizes. The Daughter Products, in the case of
         Biosense, and Components, in the case of Stereotaxis, will be packaged
         and shipped in lots in accordance with the Daughter Product
         Specifications and the Component Specifications. Biosense will be
         solely responsible for all packaging of Daughter Products and
         Stereotaxis will be solely responsible for packaging of Components.

8.4      Quality Guidelines.

8.4.1    All Components supplied to Biosense by Stereotaxis will meet the
         requirements of the Component Specifications and the Component
         Manufacturing Specifications and the requirements of any applicable
         health regulatory agency.

8.4.2    All Daughter Products supplied by Biosense will be manufactured in
         accordance with the FDC Act, including, without limitation, the FDA QSR
         requirements at Biosense's plant located at Irwindale CA or other
         plants established by Biosense from time to time, including plants of
         Biosense's suppliers, if applicable (the "Facility"). It is understood
         that for all purposes of this Agreement "health regulatory agency" will
         include, without limitation, the European Commission.

8.5      Quality Control. Prior to each shipment of Daughter Products or
         Components, Stereotaxis or Biosense, as the case may be, will perform
         quality control procedures set forth in Section 8.4, to verify that
         such Daughter Products or Components, as the case may be, meet such
         Quality Guidelines and will provide the other Party with a certificate
         of compliance with each lot delivered to it.

8.6      Rejection. Biosense and Stereotaxis will have thirty (30) days
         following its receipt of a shipment of Daughter Products or Components,
         as the case may be, to reject Daughter Products or Components which
         fail to conform to the Quality Guidelines set forth in Section 8.4,
         which rejection will be accomplished in accordance with the provisions
         of Section 8.8 below. Each Party will have the right to reject shipment
         in lots based on prior agreed standards of statistically significant
         rejection rates of samples of such lot in accordance with the


 << Previous Page | Next Page >>