Letter Agreement Regarding Subcontracted Testing Services under Development and Production Agreement – Siegfried (USA), Inc., Siegfried Ltd., and Momenta Pharmaceuticals, Inc.

Summary

This letter agreement, dated January 26, 2005, is between Siegfried (USA), Inc., Siegfried Ltd., and Momenta Pharmaceuticals, Inc. It modifies their existing Development and Production Agreement to allow Siegfried to engage specific subcontractors for testing services related to the manufacture of a pharmaceutical product for Momenta. Momenta agrees to reimburse Siegfried for the actual testing costs plus an administrative fee. Siegfried remains responsible for the subcontractors’ work and must ensure subcontractors are bound by terms comparable to the main agreement. Copies of relevant agreements and invoices will be provided to Momenta.

EX-10.15 4 a2154299zex-10_15.txt EXHIBIT 10.15 Exhibit 10.15 Siegfried SIEGFRIED (USA), INC. 33 Industrial Park Road Pennsville, NJ 08070 USA ###-###-#### +1 616-835-0321mobile ###-###-#### fax ***@*** 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 www.siegfried-usa.com Page 1 of 3 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 obligating [**] to terms and conditions comparable to those set forth in Sections 7 and 8 of the Agreement and sufficient in order for SIEGFRIED to comply with its obligations to MOMENTA under Sections 7 and 8 of the Agreement and (b) any final payment to [**], a binding agreement obligating [**] to terms and conditions comparable to those set forth in Sections 7 and 8 of the Agreement and sufficient in order for SIEGFRIED to comply with its obligations to MOMENTA under Sections 7 and 8 of the Agreement. Copies of such agreements shall be furnished to MOMENTA in order for MOMENTA to ascertain such compliance. MOMENTA hereby consents to SIEGFRIED's engagement of the two subcontractors identified below in connection with [**] TESTING [**] TESTING") of those quantities of the PRODUCT to be used by MOMENTA in support of the ANDA covering the PRODUCT. The [**] TESTING shall be conducted under the terms and conditions of the Agreement, with the following modifications: 6. SIEGFRIED shall contract the services of [**] testing of the PRODUCT. Such testing shall be conducted (a) out of the facilities of [**] and (b) pursuant to a quotation and scope of work that will be furnished to and approved in advance by MOMENTA. SIEGFRIED has previously approved this facility of [**] as a contract laboratory per SIEGFRIED's internal procedures. 7. SIEGFRIED shall contract the services of [**] to perform the [**] testing of the PRODUCT as per the previously provided quotation and scope of work received from [**]. The expedited services quoted therein by [**] shall be used by SIEGFRIED only if authorized by MOMENTA. In addition, SIEGFRIED shall contract the services of [**] to perform the [**] testing of the PRODUCT. Such testing shall be conducted pursuant to a quotation and scope of work that will be furnished to and approved in advance by MOMENTA. SIEGFRIED has previously approved [**] as a contract laboratory per SIEGFRIED's internal procedures. 8. MOMENTA shall pay SIEGFRIED the actual costs of [**] TESTING as invoiced by [**] and [**] plus [**]percent ([**]%) for administrative costs. Invoicing and payment shall 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. 9. SIEGFRIED will provide a copy of the [**] and [**] invoices for [**] TESTING when invoicing MOMENTA. 10. 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 the commencement of any [**] TESTING by (a) [**] a binding agreement obligating [**] to terms and conditions comparable to those set forth in Sections 7 and 8 Page 2 of 3 Siegfried of the Agreement and sufficient in order for SIEGFRIED to comply with its obligations to MOMENTA under Sections 7 and 8 of the Agreement and (b) [**] a binding agreement obligating [**] to terms and conditions comparable to those set forth in Sections 7 and 8 of the Agreement and sufficient in order for SIEGFRIED to comply with its obligations to MOMENTA under Sections 7 and 8 of the Agreement. Copies of such agreements shall be furnished to MOMENTA in order for MOMENTA to ascertain such compliance. Further an advance copy of the quality agreement between [**] and SIEGFRIED shall be furnished to MOMENTA for comment by MOMENTA. If the foregoing is in conformity with your understanding, please execute both copies of this Letter Agreement and return one fully executed copy to me. Sincerely, /s/ Scott Powers Scott Powers Offered by: SIEGFRIED (USA), INC. By: /s/ Scott Powers Date: January 26, 2005 ----------------------- ------------------- SIEGFRIED LTD. By: /s/ Dennis P. Bauer Date: January 27, 2005 ----------------------- ------------------- Agreed and accepted: MOMENTA PHARMACEUTICALS, INC. By: /s/ John E. Bishop Date: 31 Jan 05 ----------------------- ----------------------- Page 3 of 3