OR OTHER BUSINESS
FORMS CONTAINING TERMS OR CONDITIONS IN ADDITION TO OR DIFFERENT FROM THE TERMS
AND CONDITIONS SET FORTH IN THIS AGREEMENT, AND THE TERMS OF THIS AGREEMENT
SHALL SUPERSEDE ANY PROVISION IN ANY PURCHASE ORDER, SPECIFICATION OR OTHER
DOCUMENT THAT IS IN ADDITION TO OR INCONSISTENT WITH THE TERMS OF THIS
AGREEMENT.
*
CONFIDENTIAL TREATMENT REQUESTED
11
(D)
ACKNOWLEDGEMENT.
IF ALKERMES HAS NOT NOTIFIED CEPHALON WITHIN
[**] BUSINESS DAYS OF RECEIVING A FIRM PO THAT THE TERMS OF SUCH FIRM PO ARE NOT
IN ACCORDANCE WITH THE PROVISIONS OF THIS AGREEMENT AND THAT ALKERMES THEREFORE
REJECTS SUCH FIRM PO, SUCH FIRM PO SHALL BE DEEMED ACCEPTED.
IN THE EVENT THAT
ALKERMES REJECTS A FIRM PO, THE PARTIES WILL PROMPTLY CONSULT WITH EACH OTHER TO
RESOLVE THE UNDERLYING ISSUES AS PROMPTLY AS FEASIBLE, AND SUCH FIRM PO WILL BE
MODIFIED ACCORDINGLY.
ONCE ACCEPTED, FIRM POS MAY NEITHER BE CANCELED NOR
MODIFIED BY EITHER PARTY, EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT.
3.9
DELIVERY DATES.
ALKERMES SHALL DELIVER THE PRODUCT AND PLACEBO IN
ACCORDANCE WITH FIRM POS, AS SUCH FIRM POS MAY HAVE BEEN MODIFIED WITH THE
AGREEMENT OF THE PARTIES, SOLELY IN ACCORDANCE WITH THE PROVISIONS OF THIS
AGREEMENT.
IF ALKERMES REASONABLY EXPECTS ANY DELAY IN SHIPMENT TO CEPHALON, IT
SHALL PROMPTLY INFORM CEPHALON OF SUCH EXPECTED DELAY, SHALL IMMEDIATELY UPDATE
THE DELIVERY SCHEDULE AND SHALL USE ITS COMMERCIALLY REASONABLE MANUFACTURING
EFFORTS TO MINIMIZE THE DELAY.
[**].
3.10
SHIPMENT.
(A)
TERMS.
ALKERMES SHALL SHIP THE PRODUCT TO THE DESTINATIONS
SPECIFIED BY CEPHALON IN THE TERRITORY.
PRODUCTS SHALL BE DELIVERED FCA
(INCOTERMS 2000) ALKERMES' (OR ITS CONTRACT MANUFACTURER'S, IF APPLICABLE)
MANUFACTURING FACILITY IN THE APPLICABLE MONTH OF DELIVERY SPECIFIED IN THE
FIRM PO.
ALKERMES SHALL ARRANGE FOR THE DELIVERY OF THE PRODUCT TO THE CARRIER
SPECIFIED IN THE APPLICABLE FIRM PO.
TITLE AND RISK OF LOSS SHALL PASS TO
CEPHALON UPON DELIVERY OF EACH ORDER OF PRODUCT TO SUCH CARRIER.
NOTWITHSTANDING ANYTHING TO THE CONTRARY, CEPHALON SHALL BE RESPONSIBLE, AND
PAY THIRD PARTIES DIRECTLY, FOR ALL OUTBOUND COSTS FROM ALKERMES' (OR ITS
CONTRACT MANUFACTURER'S, IF APPLICABLE) MANUFACTURING FACILITY TO ANY
DESTINATION OR DESTINATIONS SPECIFIED BY CEPHALON.
ALKERMES SHALL PACK AND
ADDRESS THE PRODUCT IN ACCORDANCE WITH THE FIRM POS.
(B)
SHIPPING DOCUMENTS.
ALKERMES WILL SEND WITH EACH SHIPMENT OF THE
PRODUCT A PACKING LIST CONTAINING THE PURCHASE ORDER NUMBER, BATCH OR LOT
NUMBER, MANUFACTURING DATE, EXPIRY DATE, DOSAGE UNIT AND TOTAL QUANTITY
DELIVERED.
(C)
SHELF LIFE OF PRODUCT AT TIME OF SHIPMENT.
UNLESS OTHERWISE
AGREED BY THE PARTIES, ONCE ALKERMES IS ABLE TO ESTABLISH A SHELF LIFE FOR THE
PRODUCT OF GREATER THAN [**] FROM THE DATE OF MANUFACTURE IN ACCORDANCE WITH
APPLICABLE LAWS, ALKERMES SHALL ENSURE THAT THE PRODUCT SHALL HAVE A MINIMUM OF
[**] OF SHELF LIFE REMAINING AT THE TIME THAT IT IS SHIPPED TO CEPHALON; [**].
3.11
COMPLIANCE.
ALKERMES SHALL BE RESPONSIBLE FOR THE MANUFACTURE OF
THE
*
CONFIDENTIAL TREATMENT REQUESTED
12
PRODUCT IN ACCORDANCE WITH THE PROCEDURES, CGMPS AND THE QUALITY