THIS AGREEMENT.
IN THE EVENT BIOCON DOES FILE A DMF, BIOCON AGREES TO
PROMPTLY PROVIDE PAR AND/OR PAR'S DESIGNEE WITH A LETTER OF ACCESS TO SUCH
APPLICABLE DMFS FOR THE API.
BIOCON AGREES THAT IT SHALL NOT FILE A DMF RELATED
TO PRODUCTION OF API UNLESS SPECIFICALLY ASKED BY PAR, IN WRITING, TO FILE SUCH
A DMF.
IF A DMF IS FILED, CHANGES TO THE DMF MAY ONLY BE MADE IN ACCORDANCE
WITH THE PROCEDURE DELINEATED IN THE QUALITY AGREEMENT, THAT NOTWITHSTANDING, IN
NO CASE MAY A CHANGE TO THE DMF BE MADE UPON LESS THAN EIGHTEEN (18) MONTHS
PRIOR WRITTEN NOTICE TO PAR AND WITHOUT PAR'S WRITTEN CONSENT, WHICH SHALL NOT
BE UNREASONABLY WITHHELD, UNLESS SUCH CHANGE IS OF THE NATURE THAT DOES NOT
REQUIRE A FILING WITH ANY REGULATORY AUTHORITY.
BIOCON AGREES THAT IT WILL
PROMPTLY NOTIFY PAR OF ANY AND ALL CHANGES TO THE DMF.
ARTICLE 7
PRODUCT COMPLAINTS AND RECALLS
7.1
PRODUCT COMPLAINTS.
DURING THE TERM OF THIS AGREEMENT, BIOCON
SHALL ASSIST PAR WITH ANY NECESSARY INVESTIGATION ARISING FROM PRODUCT
COMPLAINTS OR ADVERSE DRUG EVENTS RELATING TO THE PRODUCT.
SUCH ASSISTANCE
SHALL INCLUDE BIOCON'S RE-TESTING THE API AT THE REASONABLE REQUEST OF PAR AND
FORWARDING THE RESULTS OF SUCH TESTING TO PAR AS SOON AS REASONABLY POSSIBLE.
BIOCON MAY CHARGE PAR FOR REASONABLE COSTS INCURRED RELATED TO THIS ASSISTANCE,
INCLUDING BUT NOT LIMITED TO TRAVEL EXPENSES AND RE-TESTING LAB TIME.
7.2
API SAFETY.
EACH PARTY SHALL NOTIFY THE OTHER PARTY OF ANY
REGULATORY ACTION TAKEN BY A REGULATORY AUTHORITY CONCERNING THE SAFETY OF THE
API WITHIN TWO (2) DAYS OF THE ACTION BEING TAKEN AND WILL PROVIDE THE OTHER
PARTY WITH COMPLETE INFORMATION CONCERNING THAT ACTION.
IN
10
ADDITION, EACH PARTY WILL NOTIFY THE OTHER OF ANY ACTION TAKEN ANYWHERE
CONCERNING THE SAFETY OF ANY PRODUCT PRODUCED WITH THE API, PROMPTLY UPON
BECOMING AWARE OF THE ACTION BEING TAKEN.
7.2.1
PRODUCT RECALLS.
IN THE EVENT OF A VOLUNTARY OR MANDATORY RECALL
OF A QUANTITY OF THE PRODUCT WHICH IS MATERIALLY ATTRIBUTABLE TO THE API
PURCHASED FROM BIOCON OR WHICH RESULTS FROM ANY NEGLIGENT ACT OR OMISSION OF
BIOCON, BIOCON AGREES THAT IT WILL ASSUME ALL RISK OF LOSS AND WILL INDEMNIFY
AND HOLD PAR AND ITS AFFILIATES HARMLESS FROM ANY AND ALL LOSS (EXCEPT
INCIDENTAL OR CONSEQUENTIAL LOSS, SUCH AS, FOR EXAMPLE, LOSS OF BUSINESS OR OF
PROFITS), LIABILITY, DAMAGE, CLAIM, COST AND EXPENSE (INCLUDING, WITHOUT
LIMITATION, REASONABLE ATTORNEY'S FEES AND LIABILITIES FOR PERSONAL INJURY
SUFFERED BY ANY PERSON) (COLLECTIVELY, "LOSS") DIRECTLY OR INDIRECTLY ARISING
FROM OR INCIDENTAL TO ANY SUCH RECALL OF PRODUCT UP TO [***] US DOLLARS
($[***]).
7.2.2
IN THE EVENT OF A VOLUNTARY OR MANDATORY RECALL OF A QUANTITY OF
THE PRODUCT WHICH IS NOT MATERIALLY ATTRIBUTABLE TO THE API OR WHICH HAS NOT
RESULTED FROM ANY NEGLIGENT ACT OR OMISSION OF BIOCON, PAR AGREES THAT IT WILL
ASSUME ALL RISK OF LOSS AND WILL INDEMNIFY AND HOLD BIOCON AND ITS AFFILIATES
HARMLESS FROM ANY AND ALL LOSS DIRECTLY OR INDIRECTLY