PROVISIONS OF SECTION 6(C) HEREOF, FHC AGREES TO AND SHALL
INDEMNIFY BIOSITE AGAINST, AND HOLD BIOSITE HARMLESS FROM, ALL CLAIMS, ACTIONS,
COSTS, EXPENSES AND DAMAGES (INCLUDING WITHOUT LIMITATION REASONABLE ATTORNEYS'
FEES AND EXPENSES) ARISING OUT OF: (I) REPRESENTATIONS OR CLAIMS BY FHC WITH
RESPECT TO THE PRODUCTS WHICH ARE NOT AUTHORIZED BY BIOSITE; (II) WILLFUL ACT OR
OMISSION BY OR ON BEHALF OF FHC IN CONNECTION WITH THE SALE, MARKETING,
PROMOTION OR DISTRIBUTION OF THE PRODUCTS; (III) FAILURE BY FHC TO COMPLY IN ANY
MATERIAL RESPECT WITH GOVERNMENTAL REGULATORY REQUIREMENTS RELATING TO THE
PRODUCTS WHICH ARE APPLICABLE TO DISTRIBUTORS OF PRODUCTS; OR (IV) MATERIAL
BREACH OF THIS AGREEMENT BY FHC.
SUCH INDEMNITY SHALL BE PROVIDED IN ACCORDANCE
WITH THE PROCEDURES SET FORTH IN SECTION 4(L) OF THIS AGREEMENT.
(G)
EACH SHIPMENT FROM BIOSITE SHALL CONTAIN
NUMBERS IDENTIFYING THE MANUFACTURING LOT OR LOTS FOR CONTROL PURPOSES.
FHC
SHALL KEEP ACCURATE RECORDS THAT WILL ENABLE FHC TO DETERMINE THE PRODUCT LOTS
RECEIVED BY SPECIFIC CUSTOMERS OF THE PRODUCT.
FHC SHALL MAKE SUCH INFORMATION
AVAILABLE TO BIOSITE IN THE EVENT OF A PRODUCT RECALL OR PRODUCT CORRECTIVE
ACTION REQUESTED BY BIOSITE OR REQUIRED BY ANY GOVERNMENTAL AGENCY WITHIN TEN
(10) DAYS AFTER SUCH REQUEST BY BIOSITE.
FHC SHALL PROVIDE BIOSITE WITH
INFORMATION REGARDING THE PRIOR MONTH'S SALES INCLUDING THE [***], AND SHALL
PROVIDE BIOSITE WITH SUCH INFORMATION IN NO EVENT LATER THAN THE LAST DAY OF THE
MONTH, DURING THE TERM OF THIS AGREEMENT AND DURING ANY TIME THEREAFTER
* Confidential Treatment Requested
8
THAT FHC SELLS ANY PRODUCT AS PERMITTED HEREUNDER.
ADDITIONALLY, ON THE
EFFECTIVE DATE, [***] THE COMMENCEMENT OF [***], [***] BEFORE THE COMMENCEMENT
OF THE [***], AND WITHIN [***] AFTER TERMINATION OF THIS AGREEMENT, FHC SHALL
PROVIDE TO BIOSITE [***].
(H)
FHC SHALL COMPLY WITH BIOSITE'S REASONABLE
INSTRUCTIONS REGARDING THE STORAGE AND HANDLING OF THE PRODUCTS, AND EXCEPT AS
OTHERWISE PROVIDED IN THIS AGREEMENT, FHC SHALL BE SOLELY RESPONSIBLE FOR THE
COST THEREOF.
(I)
AT BIOSITE'S REQUEST, FHC SHALL SUBMIT
TO BIOSITE SUCH OTHER REPORTS AS ARE CUSTOMARILY PROVIDED BY FHC TO SUPPLIERS
SIMILARLY SITUATED WITH BIOSITE.
(J)
BOTH PARTIES SHALL KEEP ACCURATE RECORDS
SUFFICIENT TO PERMIT VERIFICATION OF SALES DATA FOR THE PRODUCTS.
UPON WRITTEN
REQUEST AND UPON REASONABLE NOTICE DURING REGULAR BUSINESS HOURS, EACH PARTY
SHALL PERMIT AN INDEPENDENT CERTIFIED PUBLIC ACCOUNTANT REASONABLY ACCEPTABLE TO
THE PARTY BEING AUDITED OR OTHER ACCEPTABLE REPRESENTATIVE OF THE REQUESTING
PARTY REASONABLY ACCEPTABLE TO THE PARTY BEING AUDITED TO INSPECT SUCH RECORDS
IN ORDER TO VERIFY ANY SALES OR RECALL INFORMATION REASONABLY REQUIRED BY THE
PROVISIONS OF THIS AGREEMENT, PROVIDED THAT ONLY ONE SUCH INSPECTION ANNUALLY
SHALL BE PERMITTED AND THE PARTIES SHALL NOT BE REQUIRED TO KEEP SUCH RECORDS
FOR LONGER THAN FIVE (5) YEARS.
ALL INFORMATION RECEIVED AS A RESULT OF SUCH
INSPECTIONS SHALL BE SUBJECT TO SECTION 9 OF THIS AGREEMENT.
(K)
FHC SHALL PROMPTLY ADVISE BIOSITE OF ANY
CHANGES IN FHC'S ORGANIZATION OR PERSONNEL WHICH MAY MATERIALLY, ADVERSELY
AFFECT FHC'S ABILITY TO PERFORM UNDER THIS AGREEMENT,