THE COMPANY AND/OR INITIATED
BY THE MANUFACTURER AND APPROVED IN WRITING BY THE COMPANY.
1.10.
"NON-CONFORMING PRODUCTS - ANY PRODUCT WHICH DOES
NOT CONFORM TO OR WHICH DEVIATES FROM, IN ANY MANNER AFFECTING FORM, FIT OR
FUNCTION, THE CORRESPONDING SPECIFICATIONS CONTAINED IN THE SPECIFICATIONS,
EITHER DURING THE COMPANY'S PRE-DELIVERY INSPECTION OR AT ANY LATER TIME, UNLESS
SUCH DEVIATION OR NON-CONFORMITY HAS BEEN APPROVED IN WRITING BY THE COMPANY.
1.11.
"PRODUCTS" - THE PRODUCTS SET FORTH IN APPENDIX
"1.11" ATTACHED HERETO AS SAME MAY BE AMENDED FROM TIME TO TIME BY A WRITTEN
INSTRUMENT SIGNED BY THE PARTIES.
1.12.
"PROPRIETARY INFORMATION" - SHALL MEAN AND INCLUDE
ANY AND ALL KNOW-HOW, DATA AND INFORMATION RELATING TO THE PRODUCTS AND/OR THE
COMPANY, DISCLOSED, MADE AVAILABLE TO AND/OR PREPARED AND/OR GENERATED BY THE
MANUFACTURER OR ON ITS BEHALF, INCLUDING, WITHOUT LIMITATION: (I) TECHNICAL,
ENGINEERING AND MANUFACTURE INFORMATION, PACKAGING, DESIGNS, MANUFACTURE
PROCESSES AND DEVELOPMENT, QUALITY CONTROL TECHNIQUES AND OTHER KNOW-HOW
RELATING TO OR USED, FROM TIME TO TIME, IN THE MANUFACTURE OF THE PRODUCTS; (II)
SALES, MANUFACTURING AND MARKETING INFORMATION; AND (III) INFORMATION CONTAINED
IN DOCUMENTS MARKED "CONFIDENTIAL".
2
1.13.
"SPECIFICATIONS" - THE SPECIFICATIONS OF THE
PRODUCTS AND THE MATERIALS WHICH ARE SET FORTH IN APPENDIX 1.13" ATTACHED
HERETO, INCLUDING ALL RELEVANT DRAWINGS PERTAINING TO THE PRODUCTS AND THE
MATERIALS, AS MAY BE AMENDED FROM TIME TO TIME PURSUANT TO THE PROVISIONS OF
SECTION 3.3 OF THIS AGREEMENT.
2.
REPRESENTATIONS OF THE MANUFACTURER
The Manufacturer hereby warrants and represents that at all times during which
this Agreement is in effect:
2.1.
IT WILL CONTINUE TO HAVE ALL ADEQUATE WORKING
CAPITAL, FACILITIES AND HIGHLY-QUALIFIED PERSONNEL TO ACCOMPLISH ALL OF ITS
UNDERTAKINGS PURSUANT TO THIS AGREEMENT.
2.2.
IT AND THE STERILIZATION FACILITIES IT
UTILIZES WILL MAINTAIN THE CERTIFICATIONS SET FORTH IN APPENDIX "2.2" ATTACHED
HERETO AND FULLY MEET ALL THE REQUIREMENTS PERTAINING THERETO.
2.3.
IT WILL NOT BE INVOLVED, DURING THE TERM OF
THIS AGREEMENT AND FOR THREE YEARS THEREAFTER, IN ANY WAY, DIRECTLY OR
INDIRECTLY, IN THE MANUFACTURING OF SHEATHS FOR THE USE IN MEDICAL IMAGING
APPLICATIONS OR IN THE MANUFACTURING OF PRODUCTS RELATED TO THE PRODUCTS, FOR
ANY PERSON OR ENTITY OTHER THAN THE COMPANY, EXCEPT WITH THE PRIOR WRITTEN
CONSENT OF THE COMPANY, WHICH CONSENT SHALL NOT BE UNREASONABLY WITHHELD.
3.
GENERAL OBLIGATION OF THE MANUFACTURER
3.1.
THE MANUFACTURER UNDERTAKES TO MANUFACTURE ALL
PRODUCTS FOR THE COMPANY IN ACCORDANCE WITH THE TERMS AND CONDITIONS OF THIS
AGREEMENT.
3.2.
THE MANUFACTURER UNDERTAKES TO MANUFACTURE THE
PRODUCTS ON A REGULAR AND ON-GOING BASIS, ACCORDING TO THE HIGHEST QUALITY
STANDARDS, IN STRICT CONFORMITY WITH THE SPECIFICATIONS AND WITH THE TERMS AND
CONDITIONS OF THIS AGREEMENT AND THE MANUFACTURER SHALL NOT DEVIATE FROM NOR
CHANGE THE SPECIFICATIONS, THE MANUFACTURE PROCESS OR THE MATERIALS WITHOUT THE
PRIOR WRITTEN APPROVAL OF THE COMPANY. THE MANUFACTURER SHALL CONTROL ALL
ENVIRONMENTAL CONDITIONS TO ASSURE THAT THERE IS NO ADVERSE EFFECT TO THE
PRODUCTS.
3.3.
THE SPECIFICATIONS MAY BE MODIFIED BY THE
COMPANY UPON REASONABLE ADVANCE WRITTEN NOTICE TO THE MANUFACTURER. THE