ST BOTH A ROLLING MONTHLY FORECAST AND A [**]-YEAR FORECAST
OF EXPECTED PRODUCT REQUIREMENTS AND PLACEBO REQUIREMENTS.
(B)
FORECASTS DUE PERIODICALLY.
THEREAFTER DURING THE TERM, THE CT
SHALL PROVIDE TO THE ST:
(I)
A ROLLING MONTHLY FORECAST BY THE END OF EACH CALENDAR QUARTER;
AND
(II)
A [**]-YEAR FORECAST, ON OR BEFORE AUGUST 15TH OF EACH YEAR.
(C)
FORECAST BREAKDOWNS.
ALL OF THE FORECASTS PROVIDED UNDER THIS
AGREEMENT SHALL SPECIFY PLACEBO REQUIREMENTS BY THE NUMBER OF UNITS AND SHALL
BREAK DOWN PRODUCT REQUIREMENTS COVERED BY SUCH FORECAST BY CLINICAL
REQUIREMENTS AND
*
CONFIDENTIAL TREATMENT REQUESTED
10
COMMERCIAL REQUIREMENTS, AND BY THE NUMBER OF UNITS AND DOSAGE UNITS OF THE
PRODUCT.
(D)
FIRM ZONE; VOLUME LIMITATIONS.
[**].
NOTWITHSTANDING THE
FOREGOING, ALKERMES WILL NOT BE OBLIGATED TO MANUFACTURE VOLUMES OF PRODUCT OR
PLACEBO THAT ARE IN EXCESS OF ALKERMES' MANUFACTURING CAPACITY AS ESTABLISHED BY
THE STRATEGIC FORECAST FROM TIME TO TIME.
3.8
FIRM PURCHASE ORDERS FOR PRODUCT.
(A)
DELIVERY OF POS.
CEPHALON SHALL DELIVER FIRM PURCHASE ORDERS
(EACH, A "FIRM PO") FOR PRODUCT REQUIREMENTS AND PLACEBO REQUIREMENTS TO
ALKERMES AT LEAST [**] PRIOR TO THE REQUESTED DELIVERY DATE FOR PRODUCT AND
PLACEBO.
CEPHALON SHALL SUBMIT ON A MONTHLY BASIS SEPARATE FIRM POS FOR
COMMERCIAL REQUIREMENTS, CLINICAL REQUIREMENTS AND PLACEBO REQUIREMENTS.
THE
DETAILS OF A FIRM PO SHALL BE CONSISTENT WITH THE VOLUME REQUIREMENTS FOR
PRODUCT AND PLACEBO ESTABLISHED BY THE FIRM ZONE.
CEPHALON AGREES THAT IN THE
EVENT THAT A FIRM PO FOR PRODUCT OR PLACEBO DIFFERS SIGNIFICANTLY FROM THE
VOLUME REQUIREMENTS ESTABLISHED BY THE FIRM ZONE, EITHER BY SPECIFYING A LARGER
AMOUNT OF PRODUCT OR PLACEBO OR AN EARLIER DELIVERY DATE, ALKERMES MAY NOT BE
ABLE TO DELIVER SUCH PRODUCT OR PLACEBO IN ACCORDANCE WITH THE TERMS OF SUCH
FIRM PO, BUT SHALL USE ITS COMMERCIALLY REASONABLE MANUFACTURING EFFORTS TO
DELIVER SUCH PRODUCT OR PLACEBO AS SOON AS POSSIBLE AND SHALL CONFER WITH
CEPHALON REGARDING SUCH DELIVERY.
(B)
BATCH QUANTITIES.
THE PARTIES AGREE THAT NOTWITHSTANDING THE
QUANTITIES SPECIFIED IN THE FIRM POS FOR PRODUCT REQUIREMENTS AND PLACEBO
REQUIREMENTS, ALKERMES SHALL BE OBLIGATED TO MANUFACTURE AND SUPPLY PRODUCT ONLY
IN FULL BATCH QUANTITIES AND MAY MANUFACTURE AND SUPPLY PRODUCT IN AN AMOUNT
THAT IS GREATER OR LESS THAN THE AMOUNT SPECIFIED IN A FIRM PO AS A RESULT OF
THE MANUFACTURE AND SUPPLY OF SUCH FULL BATCH QUANTITIES.
(C)
TERMS.
EACH FIRM PO SHALL, SUBJECT TO THE LIMITATIONS SET FORTH
IN SECTION 3.8(A), SPECIFY THE (I) QUANTITY OF PRODUCT, IN NUMBER OF UNITS OF
EACH DOSAGE UNIT, AND THE NUMBER OF UNITS OF PLACEBO; (II)
MONTH OF DELIVERY;
(III) CARRIER; AND (IV) DESTINATION OR DESTINATIONS IN THE TERRITORY.
THE ONLY
TERMS OF A FIRM PO THAT SHALL BE BINDING ON THE PARTIES SHALL BE THOSE
IDENTIFIED IN THIS SECTION 3.8(C) THAT ARE SET FORTH ON THE FACE OF SUCH
FIRM PO.
NO MODIFICATION OR AMENDMENT TO THIS AGREEMENT SHALL BE EFFECTED BY OR
RESULT FROM THE RECEIPT, ACCEPTANCE, SIGNING OR ACKNOWLEDGMENT OF ANY PARTY'S
PURCHASE ORDERS, QUOTATIONS, INVOICES, SHIPPING DOCUMENTS