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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 ("[**] TESTING") of [**] 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 [**] 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 [**]
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 [**] testing
[**] 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 [**] 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
[**] TESTING.
4. SIEGFRIED will provide a
copy of the [**] and [**] invoices for [**]
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 obliga
