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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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Siegfried
be in accordance with Section 10.1 of the Agreement. For purposes
of
Section 9.4 of the Agreement, the foregoing fee shall be attributed
to
RAW MATERIAL TESTING.
4. SIEGFRIED will provide a
copy of the [**] and [**] invoices for RAW
MATERIAL TESTING when invoicing MOMENTA.
5. SIEGFRIED shall remain
primarily responsible to Momenta for the work
of [**] and [**]. Further, SIEGFRIED represents and warrants
to
Momenta that it has or will have in place prior to (a) any
final
payment to [**], a binding agreement obligating [**] to terms
and
conditio
