PRODUCTS
MEET SPECIFICATIONS.
SUPPLIER AGREES TO MANUFACTURE PRODUCTS IN A CONTROLLED
ENVIRONMENT ROOM (CER), WHICH SHALL BE MONITORED FOR PARTICULATE AND MICROBIAL
CONTROL ON A QUARTERLY BASIS.
THE INCOMING INSPECTION, NON-CONFORMANCE
PROCEDURE, QUALITY ASSURANCE PROCEDURES AND OTHER MANUFACTURING, TESTING, AND
INSPECTION PROCEDURES USED BY SUPPLIER IN CONNECTION WITH THE MANUFACTURE OF THE
PRODUCTS ARE COLLECTIVELY THE "PROCEDURES." ALL PROCEDURES, AND ANY CHANGES
THERETO, MUST BE APPROVED BY PURCHASER PRIOR TO THEIR USE BY SUPPLIER.
PURCHASER ACKNOWLEDGES THAT SUPPLIER IS IN THE BUSINESS OF PROVIDING CONTRACT
MANUFACTURING SERVICES TO THE MEDICAL DEVICE INDUSTRY AND, SUBJECT TO THE TERMS
OF THIS AGREEMENT, RESERVES THE RIGHT TO SUPPLY, DEVELOP, MANUFACTURE, SELL,
RESELL, OR CARRY-ON SIMILAR ACTIVITIES TO ANY THIRD PARTY, INCLUDING COMPETITORS
OF THE PURCHASER.
THE PRODUCTS WILL BE PRODUCED IN SUPPLIER'S JUAREZ MEXICO
FACILITY.
2.2
PURCHASE REQUIREMENTS.
SUBJECT TO THE TERMS AND CONDITIONS OF
THIS AGREEMENT, SUPPLIER MAY TERMINATE THIS AGREEMENT PURSUANT TO
SECTION 13.1(D) IF PURCHASER DOES NOT PURCHASE A MINIMUM QUANTITY OF [***]
PRODUCTS IN THE FIRST CONTRACT YEAR, [***] PRODUCTS IN THE SECOND CONTRACT YEAR,
AND [***] PRODUCTS IN THE THIRD CONTRACT YEAR.
NEW PRODUCTS SHALL BE ADDED TO
EXHIBIT A ONLY UPON MUTUAL AGREEMENT OF PRICING FOR SUCH NEW PRODUCT.
[***] CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
3
CONFIDENTIAL
CERTAIN INFORMATION HAS BEEN REDACTED
CONFIDENTIAL TREATMENT REQUESTED
2.2.1.
PURCHASE REQUIREMENTS FOR CERTAIN NEW PRODUCTS.
THE TERMS SET
FORTH IN THIS AGREEMENT WILL APPLY TO THE PRODUCTS LISTED ON EXHIBIT A AS OF THE
EFFECTIVE DATE AS WELL AS PURCHASER'S ESS405 AND THE ESS505 PRODUCTS ADDED IN
ACCORDANCE WITH SECTION 2.2 ("NEW PRODUCTS").
THE PARTIES SHALL USE REASONABLE
EFFORTS TO DETERMINE THE PRICE OF THE ESS405 AND ESS505 PRODUCTS WITHIN THIRTY
(30) DAYS AFTER SUPPLIER'S RECEIPT OF NEW PRODUCT SPECIFICATIONS FROM PURCHASER
("REVIEW PERIOD").
THE PARTIES EXPECT THAT THE PURCHASE PRICE FOR THE NEW
PRODUCTS WILL BE THE SAME AS OR SIMILAR TO THE PURCHASE PRICE FOR THE PRODUCTS
THAT ARE SET FORTH ON EXHIBIT A AS OF THE EFFECTIVE DATE ("EXISTING PRODUCTS"),
SUBJECT ONLY TO CHANGES IN THE SPECIFICATIONS, COMPONENT MANUFACTURING
PROCESSES, ASSEMBLY PROCESSES, PURCHASED MATERIALS, NEW PRODUCT VOLUMES OR
TESTING PROCEDURES OF THE NEW PRODUCTS FROM ANY EXISTING PRODUCTS.
3.
PURCHASE ORDERS, PRICES, TERMS, DELIVERY,
FORECASTS.
3.1
PURCHASE PRICE.
THE PURCHASE PRICE FOR EACH PRODUCT PURCHASED
FROM SUPPLIER SHALL BE AS SET OUT ON EXHIBIT B ("PURCHASE PRICE") AND SHALL BE
DUE AND PAYABLE NO LATER THAN THIRTY (30) DAYS FROM THE DATE OF THE INVOICE FOR
SUCH PRODUCT.
INVOICES SHALL BE DATED THE DATE THE APPLICABLE PRODUCTS ARE
SHIPPED.
THE PRICE FOR PRODUCTS DURING THE TERM AND ASSUMPTIONS UPON WHICH THEY
ARE PREDICATED SHALL BE AS DEFINED IN EXHIBIT B AND THE FOLLOWING: (I) AT ANY
TIME, IN THE EVENT OF INCREASES IN THE AMOUNT OF FIVE PERCENT (5%) OR MORE IN
THE MARKET PRICE OF RAW MATERIALS, COMPONENTS OR PACKAGING MATERIALS PURCHASED
BY SUPPLIER