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Exhibit 10.15
Siegfried
SIEGFRIED (USA), INC.
33 Industrial Park Road
Pennsville,
NJ 08070
USA
+1 616-895-4553
+1 616-835-0321mobile
+1
419-710-5687 fax
scott.powers@siegfried-usa.com
Confidential Materials omitted and
filed separately with the
Securities and Exchange Commission.
Asterisks denote omissions.
January
26, 2005
Dr.
John E. Bishop
Vice
President, Pharmaceutical Sciences & Manufacturing
Momenta
Pharmaceuticals, Inc.
675
West Kendall Street
Cambridge,
MA 02142
Dear
John:
Reference
is made to the Development and Production Agreement for Active
Pharmaceutical
Ingredient between Siegfried (USA), Inc. and Siegfried Ltd.
("SIEGFRIED")
and Momenta Pharmaceuticals, Inc. ("MOMENTA") dated October 10,
2003,
as amended by Letter Agreements dated February 14, 2004, May 17, 2004 and
September
29, 2004 (the "Agreement"). Capitalized terms used herein and not
otherwise
defined shall have the meanings given such terms in the Agreement.
MOMENTA
hereby ratifies SIEGFRIED's engagement of the two subcontractors
identified
below in connection with the testing ("RAW MATERIAL TESTING") of
certain
raw materials used by SIEGFRIED in the manufacture of those
quantities
of the PRODUCT to be used by MOMENTA in support of the ANDA
covering
the PRODUCT. The RAW MATERIAL TESTING shall be deemed to have been
conducted
under the terms and conditions of the Agreement, with the following
modifications:
1.
SIEGFRIED has contracted the services of [**] to perform (a) the USP
testing of [**], as per the
previously provided quotation and scope of
work received from [**], and (b) the
[**] testing of [**].
SIEGFRIED had previously approved
[**] as a contract laboratory per
SIEGFRIED's internal procedures.
2.
SIEGFRIED has contracted the services of [**] to perform
microbiological testing of [**] out
of the facilities of [**].
SIEGFRIED had previously approved
this facility of [**] as a
contract laboratory per SIEGFRIED's
internal procedures.
3.
MOMENTA shall pay SIEGFRIED the actual costs of RAW MATERIAL TESTING
as invoiced by [**] and [**] plus
[**] percent ([**]%) for
administrative costs. Invoicing and
payment shall
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