ALL AUDITED DATA WILL BE
TREATED AS CONFIDENTIAL INFORMATION OF AVECIA AND PHARMATHENE SHALL NOT BE
PERMITTED TO REMOVE OR COPY DATA WITHOUT AVECIA'S PRIOR CONSENT, SUCH CONSENT
NOT TO BE UNREASONABLY DENIED.
4.5
UNLESS OTHERWISE AGREED BY PHARMATHENE, AVECIA
SHALL PRODUCE THE DRUG SUBSTANCE AND THE OTHER MATERIAL ONLY AT THE FACILITY.
4.6
AVECIA SHALL PRODUCE, PACKAGE, HANDLE, AND
PROVIDE QUALITY ASSURANCE FOR DRUG SUBSTANCE PRODUCED UNDER THIS AGREEMENT, AS
SET FORTH IN THE DRUG SUBSTANCE REQUIREMENTS AND IN ACCORDANCE WITH CGMP
RULES AND MARKETING AUTHORIZATION (IF APPLICABLE UNDER A PROJECT PLAN) AND IN
ALL MATERIAL RESPECTS IN ACCORDANCE WITH APPLICABLE LAWS, AND DELIVER TO
PHARMATHENE THE QUANTITIES OF DRUG SUBSTANCE SPECIFIED IN THE APPLICABLE PROJECT
PLAN.
4.7
AVECIA SHALL PACKAGE AND LABEL DRUG SUBSTANCE
FOR SHIPMENT IN ACCORDANCE WITH THE DRUG SUBSTANCE REQUIREMENTS AND DRUG
SUBSTANCE SPECIFICATION.
EACH DELIVERY SHALL BE ACCOMPANIED BY THE DISPOSITION
PACKAGE.
SHOULD AVECIA AT ANY TIME DURING THE TERM OF THIS AGREEMENT HAVE
REASON TO BELIEVE THAT IT SHALL BE UNABLE TO MEET A DELIVERY DATE (IF APPLICABLE
UNDER A PROJECT PLAN), AVECIA SHALL PROMPTLY NOTIFY PHARMATHENE.
4.8
AVECIA SHALL MAINTAIN ACCURATE RECORDS FOR THE
PRODUCTION OF DRUG SUBSTANCE AS REQUIRED BY APPLICABLE LAWS, INCLUDING CGMP.
PHARMATHENE SHALL HAVE THE RIGHT TO USE, READ, AUDIT, COPY AND REFERENCE ANY OF
THE FOREGOING IN CONNECTION WITH A FILING FOR OR MAINTAINING MARKETING
AUTHORIZATIONS OF DRUG SUBSTANCE; IN CONNECTION WITH THE REVIEW OF MANUFACTURING
ACTIVITIES RELATED TO PREVENTIVE MAINTENANCE, CALIBRATIONS, EQUIPMENT
VALIDATIONS, TESTING, HOUSEKEEPING, OR PERSONNEL TRAINING, OR AS OTHERWISE
AUTHORIZED BY THIS AGREEMENT.
PHARMATHENE SHALL OWN THE DRUG SUBSTANCE
REQUIREMENT AND ALL BATCH MANUFACTURING RECORDS.
4.9
AVECIA SHALL COMPLY WITH THE DRUG SUBSTANCE
REQUIREMENTS, CGMP AND APPLICABLE LAWS IN PRODUCING THE DRUG SUBSTANCE.
4.10
AVECIA SHALL EMPLOY SUFFICIENT AND APPROPRIATELY
QUALIFIED TECHNICAL AND OTHER STAFF TO PROPERLY FULFIL ITS OBLIGATIONS RELATING
TO THE PRODUCTION OF THE DRUG SUBSTANCE IN ACCORDANCE WITH THE PROVISIONS OF
THIS AGREEMENT.
4.11
AVECIA SHALL STORE SAMPLES OF EACH BATCH OF THE DRUG
SUBSTANCE IN ACCORDANCE WITH THE DRUG SUBSTANCE SPECIFICATION, AND DRUG
SUBSTANCE REQUIREMENTS, APPLICABLE LAWS, AND CGMP.
4.12
AVECIA SHALL PRODUCE OTHER MATERIAL IN ACCORDANCE
WITH THE MANUFACTURING PROCEDURES, SPECIFICATIONS, BATCH MANUFACTURING RECORDS,
MASTER BATCH RECORDS AND
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CONFIDENTIAL
any quality agreement, that are applicable to Other Material and in accordance
with Applicable Laws.
5.
DISPOSITION OF DRUG SUBSTANCE
5.1
DISPOSITION PROCEDURE:
(A)
DISPOSITION SHALL BE CARRIED OUT IN
ACCORDANCE WITH SECTIONS 2.5 AND 5.5 OF THE QUALITY AGREEMENT.
WITHIN FORTY-TWO
(42) CALENDAR DAYS AFTER BATCH PRODUCTION BY AVECIA, AVECIA WILL PROVIDE TO
PHARMATHENE THE DISPOSITION PACKAGE.
(B)
WITHIN TWENTY ONE (21) BUSINESS DAYS
FOLLOWING RECEIPT OF THE DISPOSITION PACKAGE, PHARMATHENE SHALL CONFIRM IN
WRITING WHETHER PHARMATHENE ACCEPTS AVECIA'S FINDINGS DETAILED IN THE
DISPOSITION PACKAGE, OR PROVIDE TO AVECIA A WRITTEN LIST OF QUESTIONS FOR DOSE
OUT PRIOR TO COMPLETION OF DISPOSITION.
(C)
DISPOSITION SHALL BE DEEMED TO BE COMPLETE
AND PHARMATHENE SHALL BE DEEMED TO HAVE WAIVED ITS RIGHT TO REJECT AVECIA'S
FINDINGS