COMMENCED BY AVECIA UNDER
THIS AGREEMENT SHALL BE COMPLETED BY AVECIA AND DELIVERED TO PHARMATHENE
WHEREUPON PHARMATHENE SHALL PAY AVECIA IN FULL THEREOF IN ACCORDANCE WITH THE
TERMS;
Page 13 of 29
CONFIDENTIAL
(C)
ALL RECORDS RELATING TO THE PRODUCTION AND
ANALYSIS OF DRUG SUBSTANCE AND RETAINED SAMPLES OF MATERIALS, COMPONENTS AND
DRUG SUBSTANCE SHALL BE TRANSFERRED TO PHARMATHENE IF REQUESTED BY PHARMATHENE,
EXCEPT AS PROVIDED IN SECTION 3.5(D).
(D)
AVECIA SHALL, UPON PHARMATHENE'S PRIOR
WRITTEN REQUEST, RETURN OR DESTROY ANY PHARMATHENE CONFIDENTIAL INFORMATION IN
THE POSSESSION OR CONTROL OF AVECIA.
LIKEWISE, PHARMATHENE SHALL, UPON AVECIA'S
PRIOR WRITTEN REQUEST, RETURN OR DESTROY ANY AVECIA CONFIDENTIAL INFORMATION IN
THE POSSESSION OR CONTROL OF PHARMATHENE, EXCEPT AVECIA CONFIDENTIAL INFORMATION
AS TO WHICH PHARMATHENE RETAINS RIGHTS UNDER THIS AGREEMENT.
NOTWITHSTANDING
THE FOREGOING PROVISIONS:
(I) AVECIA MAY RETAIN AND PRESERVE, AT ITS SOLE COST
AND EXPENSE, SAMPLES AND STANDARDS OF EACH BATCH FOLLOWING TERMINATION OR
EXPIRATION OF THIS AGREEMENT SOLELY FOR USE IN DETERMINING AVECIA'S RIGHTS AND
OBLIGATIONS HEREUNDER, (II) EACH PARTY MAY RETAIN SUCH OF THE OTHER PARTY'S
CONFIDENTIAL INFORMATION AS MAY BE REQUIRED BY APPLICABLE LAWS, REGULATIONS, OR
GUIDELINES AND (III) PHARMATHENE MAY CONTINUE TO RETAIN, USE AND HAVE USED
AVECIA CONFIDENTIAL INFORMATION THAT IS REQUIRED TO MAINTAIN MARKETING APPROVAL
AND/OR IS USEFUL TO PRODUCE DRUG SUBSTANCE AND PRODUCT, AND (IV) AVECIA MAY
RETAIN CONFIDENTIAL INFORMATION OF PHARMATHENE TO THE EXTENT REQUIRED FOR AVECIA
TO SUPPLY DRUG SUBSTANCE TO PHARMATHENE OR ITS AFFILIATE PURSUANT TO A CONTRACT
WITH RESPECT TO SUCH SUPPLY.
4.
COMPLIANCE
4.1
MANUFACTURING COMPLIANCE:
AVECIA SHALL ADVISE
PHARMATHENE IMMEDIATELY IF AN AUTHORISED AGENT OF ANY REGULATORY BODY VISITS
AVECIA'S MANUFACTURING FACILITY AND MAKES AN INQUIRY REGARDING AVECIA'S
PRODUCTION OF DRUG SUBSTANCE FOR PHARMATHENE.
UPON SUCH NOTICE BEING GIVEN,
PHARMATHENE, OR ITS DESIGNEE, SHALL, UPON PROMPT NOTICE TO AVECIA, BE PERMITTED
TO BE PRESENT AT SUCH VISIT IF PHARMATHENE REASONABLY BELIEVES THAT SUCH VISIT
IS RELATED TO THE PRODUCTION OR STORAGE OF DRUG SUBSTANCE AND/OR PROGRAMMES
UNDER THIS AGREEMENT.
MANUFACTURING DEVIATIONS AND INVESTIGATIONS WHICH OCCUR
DURING PRODUCTION OF DRUG SUBSTANCE AND WHICH DO NOT CAUSE THE PRODUCTION TO BE
NON-COMPLIANT WITH THE DRUG SUBSTANCE REQUIREMENTS, SHALL NOT BE DEEMED TO CAUSE
SUCH DRUG SUBSTANCE TO BE NON-CONFORMING.
4.2
CLEANING VALIDATION:
AVECIA SHALL PROVIDE TO
PHARMATHENE DETAILS OF ALL OTHER PRODUCTS MANUFACTURED IN THE SAME STREAM OF
AVECIA'S FACILITY AS ANY DRUG SUBSTANCE PRODUCED UNDER THIS AGREEMENT, INCLUDING
DOSAGE INFORMATION, AND SHALL DEMONSTRATE SUCCESSFUL CLEANING VERIFICATION.
4.3
RESERVE SAMPLES:
AVECIA SHALL BE RESPONSIBLE
FOR OBTAINING AND MAINTAINING SUFFICIENT QUANTITIES OF DRUG SUBSTANCE RESERVE
SAMPLES PURSUANT TO CGMP AS SPECIFIED IN THE APPROPRIATE PROJECT PLAN.
Page 14 of 29
CONFIDENTIAL
4.4
AUDITS:
AUDITS OF THE PORTIONS OF AVECIA'S
FACILITY USED FOR PRODUCTION OF DRUG SUBSTANCE SHALL BE CONDUCTED IN ACCORDANCE
WITH THE QUALITY AGREEMENT OR THE APPLICABLE PROJECT PLAN.
IF PHARMATHENE
CHOOSES TO AUDIT AVECIA OTHER THAN IN ACCORDANCE WITH SECTION 2.12 OF THE
QUALITY AGREEMENT, PHARMATHENE AGREES TO REIMBURSE AVECIA FOR AVECIA'S
REASONABLE EXPENSES INCURRED IN HOSTING THE AUDIT.