THE RELEVANT POLICY TOGETHER WITH A
COPY OF EACH RECEIPT ISSUED, FROM TIME TO TIME, BY THE INSURER IN RESPECT OF THE
PAYMENT OF PREMIUM THEREON.
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5.
MANUFACTURING EQUIPMENT
5.1.
THE MANUFACTURER SHALL WORK WITH THE COMPANY
TO PREPARE A PROTOCOL SETTING FORTH THE PROCEDURES FOR TESTING AND VALIDATING
THE QUALITY OF THE MANUFACTURING EQUIPMENT (THE "EQUIPMENT VALIDATION
PROTOCOL"). THE MANUFACTURER SHALL THEN PERFORM THE TESTING OUTLINED IN THE
EQUIPMENT VALIDATION PROTOCOL AS WELL AS RECORD THE TEST DATA AND PROVIDE THE
COMPANY WITH A DETAILED REPORT.
5.2.
THE EQUIPMENT VALIDATION PROTOCOL SHALL BE
SUBJECT TO THE APPROVAL OF THE COMPANY. THE MANUFACTURER SHALL PROMPTLY
IMPLEMENT ALL CHANGES IN THE EQUIPMENT VALIDATION PROTOCOL REQUIRED BY THE
COMPANY IN ACCORDANCE WITH THE COMPANY'S INSTRUCTIONS.
5.3.
PRIOR TO USING THE MANUFACTURING EQUIPMENT FOR
THE MANUFACTURE PURSUANT TO THIS AGREEMENT, THE COMPANY SHALL BE ENTITLED TO
INSPECT SAME, IN ACCORDANCE WITH THE EQUIPMENT VALIDATION PROTOCOL, AND THE
MANUFACTURER SHALL NOT COMMENCE ANY MANUFACTURING ACTIVITIES, SAVE FOR TESTING
AND VALIDATION PURPOSES, WITHOUT THE PRIOR WRITTEN APPROVAL OF THE COMPANY.
6.
SUB-CONTRACTING
The Parties recognize that the Manufacturer may need to use sub-contractors for
the Manufacture of the Products, however, the Manufacturer shall not have the
right to subcontract the Manufacture or any portion thereof to any third party,
without the prior written consent of the Company and subject to the terms and
conditions to be mutually agreed upon with respect to any subcontract.
7.
QUALITY AND REGULATORY PROCEDURES
7.1.
THE COMPANY SHALL HAVE THE RIGHT TO OBSERVE
THE PRODUCTS IN THE PROCESS OF MANUFACTURE AND TO INSPECT FINISHED PRODUCTS AT
ANY TIME DURING NORMAL BUSINESS HOURS, EITHER AT THE MANUFACTURING FACILITIES OR
AT THE STORAGE FACILITIES OF THE MANUFACTURER, AND TO INSPECT THE MANUFACTURER'S
SUBCONTRACTORS. ANY SUCH INSPECTION OR THE LACK OF IT SHALL NOT DEROGATE FROM
ANY UNDERTAKING OR OBLIGATION OF THE MANUFACTURER CONTAINED HEREIN.
7.2.
THE MANUFACTURER AGREES THAT THE COMPANY, FOR
THE PURPOSE OF MAINTAINING THE COMPANY'S STATUS AS MEETING THE REQUIREMENTS
UNDER ISO 9001, EN46001 AND ISO 13485 OR ANY OTHER PURPOSE, OR A THIRD PARTY ON
ITS BEHALF, SHALL BE ENTITLED, DURING NORMAL BUSINESS HOURS AND UPON REASONABLE
ADVANCE NOTICE, TO PERFORM A QUALITY AUDIT OF THE MANUFACTURER'S MANUFACTURING
OPERATIONS (INCLUDING ITS SUBCONTRACTORS) AND THE MANUFACTURER SHALL RESPOND TO
ALL AUDIT FINDINGS IN A TIMELY MANNER.
7.3.
THE MANUFACTURER SHALL MANUFACTURE THE
PRODUCTS SOLELY WITH THE MATERIALS AND SHALL NOT USE ANY SUBSTITUTE MATERIALS
WITHOUT THE PRIOR
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WRITTEN APPROVAL OF THE COMPANY. THE MANUFACTURER SHALL PURCHASE THE MATERIALS
SOLELY FROM SUPPLIERS APPROVED BY THE COMPANY.
7.4.
EACH PRODUCT LOT SHALL BE IDENTIFIED DURING
ALL PHASES OF MANUFACTURE AND FINISHED PRODUCTS PERMANENTLY IDENTIFIED BY A
CONTROL NUMBER TO FACILITATE FULL TRACEABILITY OF ITS MANUFACTURE AND FIELD
PLACEMENT.
7.5.
THE MANUFACTURER SHALL CAREFULLY DOCUMENT THE
MANUFACTURE OF EACH PRODUCT LOT IN THE DEVICE HISTORY RECORD ("DHR").
THE DHR
SHALL DOCUMENT, INTER ALIA, THE LOT CONTROL NUMBER, THE DATE OF MANUFACTURE, THE
QUANTITY MANUFACTURED FOR THE LOT, IDENTIFICATION