SHALL BE AMENDED, AS OF
THE AMENDMENT EFFECTIVE DATE, AS SET FORTH HEREIN.
UNLESS OTHERWISE DEFINED
HEREIN, ALL CAPITALIZED TERMS USED IN THIS AMENDMENT SHALL HAVE THE RESPECTIVE
MEANINGS ASCRIBED THERETO IN THE AGREEMENT.
2.
PPI, A CORPORATION EXISTING UNDER THE
LAWS OF THE STATE OF DELAWARE, U.S.A., IS HEREBY ADDED AS A PARTY TO THE
AGREEMENT.
THE REFERENCE TO "PATHEON" IN THE AGREEMENT SHALL INCLUDE PPI.
3.
THE DEFINITION OF "MANUFACTURING SITE"
IN SECTION 1.1 OF THE AGREEMENT IS AMENDED TO ADD TO THE END OF THE DEFINITION
THE CLAUSE, "OR AT 2110 EAST GALBRAITH ROAD, CINCINNATI, OHIO, USA."
4.
SCHEDULE E TO THE AGREEMENT IS HEREBY
DELETED AND REPLACED WITH SCHEDULE E ATTACHED HERETO.
5.
PPI IS HEREBY ADDED AS A PARTY TO THE
MARCH 1, 2004 QUALITY AGREEMENT BETWEEN PATHEON AND SEPRACOR THAT IS ATTACHED TO
THE AGREEMENT AS SCHEDULE G.
THE REFERENCE TO "PATHEON" IN THE QUALITY
AGREEMENT SHALL INCLUDE PPI.
Except as set forth herein, all other terms and conditions of the Agreement
shall remain in full force and effect for the term thereof.
In the event of any
conflict between this Amendment and the Agreement, the terms of this Amendment
shall control.
Upon execution, the Agreement and this Amendment shall be deemed
to constitute the entire Agreement.
IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by
duly authorized representatives on the dates set forth below.
PATHEON INC.
SEPRACOR, INC.
By:
/s/ Riccardo Trecroce
By:
/s/ Walt Piskorski
Name:
Riccardo Trecroce
Name:
Walt Piskorski
Title:
General Counsel &
Sr. Vice-President, Admin.
Title:
VP, MFG OPS
Date:
January 24, 2006
Date:
1-31-06
PATHEON PHARMACEUTICALS INC.
By:
/s/ Ricarrdo Trecroce
Name:
Riccardo Trecroce
Title:
Secretary
Date:
January 24, 2006
2
SCHEDULE E
BATCH NUMBERING AND EXPIRATION DATES
Each batch of the Product manufactured by Patheon will bear a unique lot number
using the Patheon batch numbering system.
This number will appear on all
documents relating to the particular batch of the Product.
Patheon will calculate the expiration date for the product for each batch by
adding the expiration period of the Product supplied by the Client to the date
of Manufacture of each batch.
3
AMENDMENT NO. 3 TO THE MANUFACTURING SERVICES AGREEMENT
THIS AMENDMENT (the "Amendment") to the Manufacturing Services Agreement is made
as of May 31, 2006 by and between Patheon Inc. ("Patheon"), having its principal
office at 7070 Mississauga Road, Mississauga, Ontario, Canada, L5N 7J8, Patheon
Pharmaceuticals Inc., having its principal office at 2110 East Galbraith Road,
Cincinnati, Ohio 45237-1625, U.S.A. and Sepracor Inc. ("Sepracor"), having its
principal office at 84 Waterford Drive, Marlborough, Massachusetts 01752, U.S.A.
WHEREAS Patheon and Sepracor entered into a Manufacturing Services Agreement
dated March 1, 2004, as amended by Amendment No. 1 to the Manufacturing Services
Agreement dated July 18, 2005 between Patheon and Sepracor, and as further
amended by Amendment No. 2 to the Manufacturing Services Agreement dated
November 1, 2005 among Patheon, Patheon Pharmaceuticals Inc. and Sepracor
(collectively, the "Agreement");