THE QUALITY
AGREEMENT DOCUMENT.
EACH EXECUTED BATCH MANUFACTURING RECORD FOR SUCH BATCH
SHALL BE ASSIGNED A UNIQUE BATCH NUMBER.
ANY DEVIATION FROM THE MASTER BATCH
RECORD, THE DRUG SUBSTANCE SPECIFICATION OR THE PROCESS SPECIFICATION SHALL BE
DEALT WITH IN ACCORDANCE WITH SECTIONS 2.10 AND 5.10 OF THE QUALITY AGREEMENT.
AVECIA SHALL PROVIDE PHARMATHENE WITH SUPPORTING PRODUCTION AND DISPOSITION
DOCUMENTATION REQUESTED BY PHARMATHENE IN A FORM SUITABLE FOR PHARMATHENE'S
SUBMISSION TO ANY REGULATORY AUTHORITY.
2.3
VENDOR AND SUPPLIER AUDIT AND CERTIFICATION:
AVECIA SHALL CERTIFY AND AUDIT ALL SUPPLIERS AND VENDORS OF RAW MATERIALS AND
CONSUMABLE ITEMS INTENDED FOR USE IN PRODUCTION OF DRUG SUBSTANCE IN ACCORDANCE
WITH AVECIA'S VENDOR ASSURANCE PROCEDURES.
AUDITS IN RESPECT OF ANY CRITICAL
RAW MATERIALS WHICH ARE MANDATED BY PHARMATHENE SHALL BE CONDUCTED SUBJECT TO
AGREEMENT OF A PROJECT PLAN COVERING SUCH AUDIT.
2.4
DELIVERY TERMS:
AVECIA SHALL DELIVER ALL DRUG
SUBSTANCE TO PHARMATHENE OR TO PHARMATHENE'S DESIGNATED CONSIGNEE.
ALL
DELIVERIES SHALL BE MADE EX WORKS THE FACILITY (INCOTERMS 2000), TO A CARRIER
DESIGNATED BY PHARMATHENE, AT PHARMATHENE'S EXPENSE.
PHARMATHENE SHALL PROCURE,
AT ITS COST, INSURANCE COVERING DAMAGE OR IOSS OF DRUG SUBSTANCE DURING
SHIPPING.
2.5
CONDUCT OF PROGRAMMES.
AVECIA SHALL CARRY OUT
EACH PROGRAMME :
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CONFIDENTIAL
(A)
IN ACCORDANCE WITH THE TERMS OF THIS
AGREEMENT; AND
(B)
WITH REASONABLE SKILL, CARE AND DILIGENCE
AND NO LESS THAN THE LEVEL OF SKILL, CARE AND DILIGENCE TO BE REASONABLY
EXPECTED OF A PROVIDER OF SIMILAR SERVICES.
For the avoidance of doubt, it shall not be considered a breach of this
Agreement or the applicable Project Plan by Avecia if a development objective of
a development Programme is not achieved so long as Avecia has complied with its
obligations set out in Section 2.5(b).
Time shall not be of the essence in the
performance of any development Programme or part thereof unless specifically
stated otherwise in the applicable Project Plan.
The parties acknowledge that,
having regard to the fact that some of the work to be performed hereunder may by
its nature be developmental, Avecia cannot and consequently does not guarantee
to PharmAthene the achievement of a successful outcome for a development
Programme.
2.6
CONSIDERATION:
PHARMATHENE SHALL PAY TO
AVECIA THE AMOUNTS AND AT THE TIMES SET OUT IN THE APPLICABLE PROJECT PLAN.
2.7
ISSUE OF INVOICES:
UNLESS OTHERWISE SPECIFIED
IN A PROJECT PLAN, AVECIA SHALL ISSUE INVOICES FOR THE SUMS SET OUT IN THE
APPLICABLE PROJECT PLAN AS SUCH SUMS FALL DUE AND PHARMATHENE SHALL PAY SUCH
SUMS WITHIN 30 CALENDAR DAYS OF THE DATE OF RECEIPT OF THE RELEVANT INVOICE,
UNLESS STATED OTHERWISE IN THE APPLICABLE PROJECT PLAN.
INTEREST SHALL BECOME
DUE ON LATE PAYMENTS AT AN ANNUAL RATE OF 2% ABOVE THE BASE LENDING RATE OF THE
BANK REFERRED TO IN SECTION 2.8 BELOW, FROM THE DATE ON WHICH PAYMENT FALLS DUE
UNTIL THE DATE OF PAYMENT.
2.8
BANK ACCOUNT DETAILS:
UNLESS OTHERWISE
AGREED, ALL AMOUNTS PAYABLE TO AVECIA UNDER THIS AGREEMENT SHALL BE PAID IN U.S.
DOLLARS, WITHOUT DEDUCTION, BY