Maria Harris Counsel, Pharmaceuticals, Europe
Exhibit 10.60
|
Xxxxx Xxxxxx Counsel, Pharmaceuticals, Europe | |
April 20, 2010
Norwich Pharmaceuticals, Inc.
0000 Xxxxx Xxxxxxx 00
Xxxxxxx, XX 00000
Attention: Xxxxxxxxxxx X. Xxxxxxx, President
Dear Xx. Xxxxxxx:
Reference is made to the Contract Manufacturing Services Agreement between Procter & Xxxxxx Pharmaceuticals, Sarl (“PGP”) and Norwich Pharmaceuticals, Inc., dated January 30, 2006, as amended on July 11, 2006 (the “Agreement”). Capitalized terms used herein but not defined herein shall have the meaning assigned to such terms in the Agreement.
As you may be aware, in a transaction that closed on October 30, 2009 (the “Transaction”), The Procter & Xxxxxx Company sold its global prescription pharmaceuticals business, including PGP, to Xxxxxx Xxxxxxxx PLC (“Xxxxxx Xxxxxxxx”). As a result of the Transaction, PGP became a wholly-owned subsidiary of Xxxxxx Xxxxxxxx. In connection with such Transaction, we will assign the Agreement to Xxxxxx Xxxxxxxx Company, LLC, an Affiliate of PGP, effective May 1, 2010. As a result, on and after May 1, 2010, Xxxxxx Xxxxxxxx Company, LLC will be the counterparty to the Agreement and PGP will no longer be a party to the Agreement (the “Assignment”).
The parties hereto acknowledge and agree that Agreement shall be amended as follows:
| • | All references to “Procter & Xxxxxx Pharmaceuticals, Sarl” shall be replaced with references to “Xxxxxx Xxxxxxxx Company, LLC” and references to “P&G” shall be replaced with references to “Xxxxxx Xxxxxxxx”, |
| • | Section 3.12 of the Agreement is amended by deleting the text and replacing such text with the following: |
““Product(s)” means the products listed on Schedule A and any other products agreed to in writing by the parties from time to time.”,
| • | Section 9 of the Agreement is amended by deleting the text and replacing such text with the following: |
“9. FAILURE TO PERFORM: In the event Xxxxxx Xxxxxxxx requests performance of Contract Manufacturing Services hereunder and NPI is unable or unwilling to perform said Contract Manufacturing Services for reason(s) within NPI Control, or should NPI consistently and continually fail to meet Xxxxxx Xxxxxxxx’x quantity requirements, or NPI consistently fails to meet NPI’s Product Specifications, manufacturing standards, standards for quality assurance or release procedures, or should NPI fail to perform as described in Article 5.3 or
000 Xxxxxxxxxx Xxxxx x Xxxxxxxx, Xxx Xxxxxx 00000
Phone: (000) 000-0000 Fax: (000) 000-0000 000-000-0000
Article 6.8, or NPI experiences a significant quality systems failure including but not limited to receipt of an FDA warning letter or its Territory equivalent, Xxxxxx Xxxxxxxx has the unequivocal right, upon notice, to enter NPI’s Norwich Plant for the sole purpose of conducting an inspection and audit and NPI agrees to cooperate with Xxxxxx Xxxxxxxx in this event by making NPI personnel available to Xxxxxx Xxxxxxxx and its personnel. In addition, notwithstanding the provisions of Section 4.3, Xxxxxx Xxxxxxxx shall be free to purchase all or any portion of its Product requirements from any available source, or to move production into another of NPI’s facilities or to an alternate contract manufacturer should NPI fail to perform or should Xxxxxx Xxxxxxxx anticipate a failure to perform as evidenced by objective criteria and measures of performance for NPI required Contract Manufacturing Services hereunder. Xxxxxx Xxxxxxxx will provide NPI with a 10 business days notice of such an anticipated failure to perform and the opportunity to avoid or correct in a manner acceptable to Xxxxxx Xxxxxxxx such anticipated failure to perform.”
| • | Section 34 of the Agreement is amended by deleting the P&G Notice information and replacing such text with the following: |
“Xxxxxx Xxxxxxxx Company, LLC
000 Xxxxxxxxxx Xxxxx
Xxxxxxxx, XX 00000
Attention: General Counsel”
Except as specifically set forth herein, nothing contained herein is intended to, or shall be deemed to, alter, amend or modify any of the rights or obligations of the parties under the Agreement. This letter agreement shall be construed in accordance with and governed by the laws of the State of New York, without regard to the conflicts of laws rules thereof.
Please acknowledge the Assignment and your acceptance of, and agreement with, the terms of this letter agreement by executing this letter agreement in the spaces set forth below.
| Very truly yours, |
| /s/ Xxxxx Krasnikow Xxxxxx |
| Xxxxx Xxxxxxxxx Xxxxxx |
| Counsel, Pharmaceuticals, Europe |
000 Xxxxxxxxxx Xxxxx x Xxxxxxxx, Xxx Xxxxxx 00000
Phone: (000) 000-0000 Fax: (000) 000-0000 000-000-0000
Acknowledged and Agreed:
Norwich Pharmaceuticals, Inc.
| By: | /s/ Authorized Representative | |
| Name: | ||
| Title: |
000 Xxxxxxxxxx Xxxxx x Xxxxxxxx, XX 00000
Phone: 000-000-0000 Fax: 000-000-0000
Schedule A
|
95090001 58046417 95365063 98758655 98777035 |
Actonel 5 mg | |
| 95089953 58046411 95272350 |
Actonel 30 mg | |
| 95090003 95010514 95365211 |
Actonel 35 mg | |
| 95053234 98575582 |
Actonel 150 mg | |
| 95912056 | Actonel 75 mg | |
| 95945042 | Asacol UK 800mg printed | |
| 98578979 | Libertas 35 mg | |
| 80077003 | Actonel 30mg 30’s Canada Trade | |
| 15893454 | Didronel 200 mg Gran Export | |
| 15857838 | Didronel 400 mg Gran Export | |
| 15823051 | Didronel 400 mg Gran | |
| 15121219 | Full Service Bulk Calcium sold to Europe | |
000 Xxxxxxxxxx Xxxxx x Xxxxxxxx, XX 00000
Phone: 000-000-0000 Fax: 000-000-0000
