RESPECT TO PROPER CONDITIONS FOR THE
TRANSPORT AND STORAGE OF API.
UPON RECEIPT OF ANY BATCH OF API BY PAR FROM
BIOCON, PAR SHALL PROVIDE AND MAINTAIN SUITABLE STORAGE CONDITIONS THEREFORE AND
SHALL COMPLY WITH ANY WRITTEN INSTRUCTIONS PROVIDED BY SUPPLER THAT ARE REQUIRED
BY THE DMF IN RESPECT OF THE TRANSPORT AND STORAGE OF API.
6.2
QUALITY CONTROL AGREEMENT.
WITHIN SIXTY (60) DAYS FOLLOWING THE
EFFECTIVE DATE, THE PARTIES SHALL MUTUALLY AGREE UPON AN INTERCOMPANY QUALITY
AGREEMENT WHICH WILL APPROPRIATELY ADDRESS REGULATORY, OPERATIONAL AND QUALITY
OBLIGATIONS AND RESPONSIBILITIES (THE "QUALITY AGREEMENT").
EXCEPT AS PROVIDED
FOR IN SECTION 6.1.1, IN THE EVENT OF ANY TERMS OF THE QUALITY AGREEMENT
CONFLICT WITH OR ARE INCONSISTENT WITH THE TERMS OF THIS AGREEMENT, THE TERMS OF
THIS AGREEMENT SHALL GOVERN AND CONTROL.
8
6.3
INSPECTIONS.
UPON REASONABLE PRIOR NOTICE, PAR RESERVES THE RIGHT
TO AUDIT BIOCON'S MANUFACTURING, DISTRIBUTING AND STORAGE FACILITIES TO ASSURE
BIOCON'S COMPLIANCE WITH THE QUALITY AGREEMENT, CGMP AND ALL APPLICABLE LAWS.
THE AUDIT WILL CONSIST OF AN INTERNAL INSPECTION OF BIOCON'S PRODUCTION AND
LABORATORY FACILITIES AND DOCUMENTS RELATED TO THE API.
BIOCON AGREES TO
PROVIDE ACCESS TO ITS FACILITIES DURING AND OTHERWISE FACILITATE THIS AUDIT
PROCESS.
PAR SHALL ALSO HAVE THE RIGHT, UPON REASONABLE PRIOR NOTICE, TO HAVE A
PAR EMPLOYEE OR QUALIFIED EXTERNAL CONSULTANT PRESENT AT BIOCON'S MANUFACTURING
FACILITY AS AN OBSERVER DURING THE PRODUCTION OF THE API.
BIOCON ALSO AGREES TO
ALLOW ANY RELEVANT REGULATORY AUTHORITY TO INSPECT ANY OF ITS FACILITIES USED IN
FULFILLING ITS OBLIGATIONS UNDER THIS AGREEMENT WITH RESPECT TO THE PRODUCT.
6.4
NONCONFORMING API.
PAR MAY REJECT ANY SHIPMENT OF API AS
DEFECTIVE IF THE API DOES NOT CONFORM TO BIOCON'S OBLIGATIONS UNDER SECTION 6.1
AND/OR THE BIOCON'S PRODUCT WARRANTIES SET FORTH SECTION 9.2 OR WHICH IS
ADULTERATED OR MISBRANDED WITHIN THE MEANING OF THE ACT.
IN ORDER TO REJECT A
SHIPMENT, PAR MUST: (I) GIVE NOTICE TO BIOCON OF PAR'S INTENT TO REJECT SUCH
SHIPMENT TOGETHER WITH A WRITTEN INDICATION OF THE REASONS FOR SUCH POSSIBLE
REJECTION WITHIN FORTY FIVE (45) DAYS AFTER DELIVERY OF THE API TO PAR, OR IN
THE CASE OF LATENT DEFECTS, WITHIN FORTY-FIVE (45) DAYS AFTER THE DATE THAT PAR
DISCOVERS THE DEFECT AND (II) AS PROMPTLY AS REASONABLY POSSIBLE THEREAFTER,
PROVIDE BIOCON WITH NOTICE OF FINAL REJECTION (A "REJECTION NOTICE") AND THE
FULL BASIS THEREFORE.
IF NO SUCH NOTICE OF INTENT TO REJECT IS TIMELY RECEIVED
BY THE BIOCON, PAR SHALL BE DEEMED TO HAVE ACCEPTED SUCH DELIVERY OF API.
6.4.1
PAR'S TESTS RESULTS OR BASIS FOR THE REJECTION NOTICE SHALL BE
CONCLUSIVE UNLESS BIOCON NOTIFIES PAR IN WRITING WITHIN THIRTY (30) DAYS OF
RECEIPT OF PAR'S REJECTION NOTICE THAT BIOCON DISAGREES WITH SUCH TEST RESULTS
OR BASIS FOR REJECTION ("OBJECTION NOTICE").
IF PAR AND BIOCON FAIL WITHIN TEN
(10) DAYS AFTER DELIVERY OF AN OBJECTION NOTICE TO AGREE AS TO WHETHER THE API
IDENTIFIED IN THE REJECTION NOTICE IS DEFECTIVE, REPRESENTATIVE SAMPLES OF THE
BATCH OF API IN QUESTION SHALL BE SUBMITTED TO A MUTUALLY