AND THE SUPPLIER'S BURDENED COST
(INCLUDING LABOR (IF EXPENDED), STORAGE, AND DOCUMENTED RESTOCKING CHARGES PAID
BY SUPPLIER TO ITS SUPPLIERS, BUT EXCLUDING A MARK-UP) FOR ALL OTHER ITEMS
SUPPLIER SHALL PROVIDE PURCHASER AN INVOICE THAT ITEMIZES AND DESCRIBES IN
REASONABLE DETAIL THE FOREGOING CHARGES WITH RESPECT TO EXCESS INVENTORY AND THE
REASONS SUPPLIER CANNOT AVOID SUCH CHARGES WITHIN THIRTY (30) DAYS AFTER THE
EVENT DESCRIBED IN SUBSECTIONS (A) THROUGH (E) ABOVE THAT GAVE RISE TO SUCH
CHARGES.
IN NO EVENT SHALL PURCHASER'S RESPONSIBILITY FOR CHARGES WITH RESPECT
TO EXCESS INVENTORY EXCEED AN AMOUNT EQUAL TO THE TOTAL PURCHASE PRICE FOR THE
QUANTITY OF PRODUCTS ON THE THEN CURRENT THREE (3) MONTH PURCHASE ORDER .
4.
CHANGES TO SPECIFICATIONS.
4.1
CHANGES BY PURCHASER.
IF THE PURCHASER DESIRES TO CHANGE THE
SPECIFICATIONS, IT WILL NOTIFY THE SUPPLIER OF SUCH PROPOSED CHANGE IN WRITING.
WITHIN THIRTY (30) DAYS FOLLOWING RECEIPT OF
7
CONFIDENTIAL
CERTAIN INFORMATION HAS BEEN REDACTED
CONFIDENTIAL TREATMENT REQUESTED
SUCH A NOTICE FROM THE PURCHASER, THE SUPPLIER SHALL NOTIFY THE PURCHASER OF THE
COST OF IMPLEMENTING SUCH CHANGE AND THE IMPACT SUCH A CHANGE WOULD HAVE ON THE
PURCHASE PRICE AND THE MANUFACTURING LEAD-TIME.
THE PURCHASER WILL THEN NOTIFY
THE SUPPLIER IN WRITING WHETHER IT WANTS TO IMPLEMENT SUCH CHANGE TAKING INTO
ACCOUNT THE IMPLEMENTATION COSTS AND THE MANUFACTURING LEAD TIME AND PURCHASE
PRICE IMPACT.
SPECIFICATIONS FOR ANY CHANGE TO THE PRODUCT SHALL BE FINALIZED
BY THE PURCHASER IN A MUTUALLY AGREED TO TIME-FRAME PRIOR TO THE PLACEMENT OF
THE FIRST ORDER FOR EACH PRODUCT TO BE MANUFACTURED WITH SUCH CHANGED
SPECIFICATIONS.
AFTER APPROVAL BY THE PURCHASER, SUCH CHANGE SHALL THEN BECOME
PART OF THE SPECIFICATIONS.
4.2
CHANGES BY SUPPLIER TO SPECIFICATIONS OR PROCESS.
NO CHANGES TO
THE SPECIFICATIONS SHALL BE MADE BY THE SUPPLIER WITHOUT THE PRIOR WRITTEN
APPROVAL OF THE PURCHASER.
SUPPLIER SHALL NOT MAKE ANY CHANGES TO THE
MANUFACTURING PROCESS WHICH MAY REQUIRE THE SUBMISSION OF ANY AMENDMENT, FILING
OR OTHER DOCUMENTATION WITH ANY REGULATORY AUTHORITY UNLESS SUCH CHANGE HAS BEEN
IDENTIFIED, REVIEWED AND APPROVED IN WRITING BY THE PURCHASER.
THE PURCHASER
SHALL PROVIDE A RESPONSE TO ANY SUCH PROPOSED CHANGES AS SOON AS IS PRACTICABLY
POSSIBLE AFTER RECEIPT.
5.
QUALITY AND REGULATORY MATTERS.
5.1
FACILITY REVIEWS.
THE PURCHASER OR ITS DESIGNEE SHALL HAVE THE
RIGHT, UPON REASONABLE ADVANCE WRITTEN NOTICE AND DURING REGULAR BUSINESS HOURS,
TO INSPECT THE FACILITIES BEING USED BY THE SUPPLIER FOR PRODUCTION OF THE
PRODUCTS SOLELY TO CONFIRM THAT SUCH FACILITIES ARE ADEQUATE TO MEET THE
REQUIREMENTS OF THIS AGREEMENT, THE REGULATORY AUTHORITY, ISO13485, AND ANY
APPLICABLE SUCCESSORS TO THOSE ISO REQUIREMENTS.
SUPPLIER SHALL REASONABLY
COOPERATE WITH PURCHASER AND ITS DESIGNEE WITH RESPECT TO SUCH INSPECTIONS.
IF
ANY SUCH INSPECTION REVEALS THAT THE MANUFACTURING FACILITIES DO NOT SATISFY
SUCH REQUIREMENTS, THEN THE PURCHASER SHALL PROVIDE WRITTEN NOTICE OF SUCH FACT,
WHICH NOTICE SHALL CONTAIN IN REASONABLE DETAIL THE DEFICIENCIES FOUND IN THE
MANUFACTURING FACILITIES AND, IF PRACTICABLE, THOSE STEPS THE SUPPLIER SHOULD
UNDERTAKE IN ORDER TO REMEDY SUCH DEFICIENCIES.
ANY INSPECTION MADE