IN THE DISPOSITION PACKAGE AND SHALL BE DEEMED TO HAVE ACCEPTED THE
DRUG SUBSTANCE, IF:
(I)
PHARMATHENE NOTIFIES AVECIA THAT PHARMATHENE ACCEPTS AVECIA'S
ASSESSMENT THAT A BATCH CONFORMS TO THE DRUG SUBSTANCE REQUIREMENTS; OR
(II)
PHARMATHENE FAILS TO NOTIFY AVECIA WITHIN TWENTY-ONE (21)
BUSINESS DAYS FOLLOWING RECEIPT OF THE DISPOSITION PACKAGE, WHICHEVER IS LONGER
WHETHER PHARMATHENE ACCEPTS AVECIA'S FINDINGS IN THE DISPOSITION PACKAGE; OR
(III)
THE LIST OF QUESTIONS PROVIDED BY PHARMATHENE UNDER
SECTION 5.1(B) IS CLOSED OUT TO THE PARTIES' MUTUAL SATISFACTION AS EVIDENCED IN
WRITING, SIGNED BY BOTH PARTIES.
5.2
NON- CONFORMING DRUG SUBSTANCE:
(A)
IF (I) AVECIA'S FINDINGS DETAILED IN THE
DISPOSITION PACKAGE INDICATE THAT A BATCH OF DRUG SUBSTANCE IS A NON-CONFORMING
BATCH OR (II) PHARMATHENE NOTIFIES AVECIA THAT PHARMATHENE DOES NOT ACCEPT
AVECIA'S FINDING THAT A BATCH IS IN CONFORMITY WITH THE DRUG SUBSTANCE
REQUIREMENTS DETAILED IN THE DISPOSITION PACKAGE AND INSTEAD PHARMATHENE
BELIEVES THAT THE DISPOSITION PACKAGE INDICATES THAT THE BATCH IS A
NON-CONFORMING BATCH, IT SHALL NOTIFY AVECIA BY TELEPHONE INCLUDING A DETAILED
EXPLANATION OF THE NON-CONFORMITY AND SHALL CONFIRM SUCH NOTICE IN WRITING TO
AVECIA BY FACSIMILE OR EMAIL.
UPON RECEIPT OF SUCH FACSIMILE OR EMAIL NOTICE,
AVECIA WILL INVESTIGATE SUCH ALLEGED NON-CONFORMITY, AND (I) IF AVECIA AGREES
THAT
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CONFIDENTIAL
SUCH DRUG SUBSTANCE IS A NON-CONFORMING BATCH, DELIVER TO PHARMATHENE A
CORRECTIVE ACTION PLAN WITHIN THIRTY (30) CALENDAR DAYS AFTER RECEIPT OF
PHARMATHENE'S WRITTEN NOTICE OF NON-CONFORMITY, OR SUCH ADDITIONAL TIME AS IS
REASONABLY REQUIRED IF SUCH INVESTIGATION OR PLAN REQUIRES DATA FROM SOURCES
OTHER THAN PHARMATHENE OR AVECIA, OR (II) IF AVECIA DISAGREES WITH PHARMATHENE'S
BELIEF THAT THE BATCH IS A NON-CONFORMING BATCH, AVECIA SHALL SO NOTIFY
PHARMATHENE BY TELEPHONE WITHIN THE THIRTY (30) CALENDAR DAY PERIOD AND CONFIRM
SUCH NOTICE IN WRITING BY FACSIMILE OR EMAIL.
(B)
IF THE PARTIES DISPUTE WHETHER THE
DISPOSITION PACKAGE INDICATES THAT A BATCH IS CONFORMING OR NON-CONFORMING AND
ARE UNABLE TO RESOLVE THE MATTER IN ACCORDANCE WITH SECTION 2.5.13 OF THE
QUALITY AGREEMENT, THE DISPOSITION PACKAGE WILL BE SUBMITTED TO A MUTUALLY
ACCEPTABLE LABORATORY OR CONSULTANT FOR RESOLUTION, WHOSE DETERMINATION OF
CONFORMITY OR NON-CONFORMITY, AND THE CAUSE THEREOF IF NON-CONFORMING, SHALL BE
BINDING UPON THE PARTIES.
PHARMATHENE SHALL BEAR THE COSTS OF SUCH LABORATORY
OR CONSULTANT, EXCEPT AS SET OUT IN SECTION 5.3.
5.3
REMEDIES FOR NON-CONFORMING BATCH:
(A)
IN THE EVENT A NON-CONFORMING BATCH RESULTS
FROM WILFUL OR INTENTIONAL MISCONDUCT AND/OR NEGLIGENCE AND/OR FAILURE TO COMPLY
WITH APPLICABLE LAWS OR THE QUALITY AGREEMENT, AS AGREED TO BY AVECIA OR AS
DETERMINED BY THE LABORATORY PURSUANT TO SECTION 2.5(B), THEN AVECIA, IN
CONSULTATION WITH PHARMATHENE, SHALL, AT AVECIA'S EXPENSE, REWORK OR REPROCESS
SUCH NON-CONFORMING BATCH OR PRODUCE A REPLACEMENT BATCH AND DISPOSITION SUCH
BATCH AS SOON AS REASONABLY PRACTICABLE.
IN SUCH EVENT, AVECIA SHALL BEAR THE
COSTS OF THE LABORATORY OR CONSULTANT ENGAGED UNDER SECTION 5.2(C).
(B)
IF A NON-CONFORMING BATCH RESULTS OTHER THAN
FROM THE CIRCUMSTANCES OF SECTION 5.3(A), THEN AVECIA AND PHARMATHENE SHALL MEET
TO AGREE A