AMENDMENT NO. 3 TO CONTRACT MANUFACTURING AGREEMENT (Metreleptin SLD)
Pursuant to 17 CFR 229.601(b)(10)(iv), confidential information (indicated by [***]) has been omitted from this exhibit because it is both not material and
would likely cause competitive harm to the registrant if publicly disclosed.
Exhibit 10.11.4
AMENDMENT NO. 3 TO
CONTRACT MANUFACTURING AGREEMENT (Metreleptin SLD)
THIS AMENDMENT NO. 3 (the “Amendment”) is made as of 8th July 2013 (the “Amendment Effective Date”) by and between Amylin Pharmaceuticals, LLC (formerly known as and successor in interest to Amylin Pharmaceuticals, Inc.) with offices at 0000 Xxxxx Xxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000, XXX (“Amylin”) and Sandoz GmbH, with a principal place of business at Xxxxxxxxxxxx. 00, X0000 Xxxxx, Xxxxxxx (“Sandoz”).
WITNESSETH:
WHEREAS, Amylin and Sandoz are parties to a certain Contract Manufacturing Agreement in relation to Metreleptin SLD dated as of 30 September 2010, as amended (the “Agreement”); and
WHEREAS, Amylin and Sandoz desire to integrate the Agreement to reflect mutually agreed upon terms in accordance with the provisions of this Amendment.
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, Amylin and Sandoz agree as follows:
| 1. | Definitions. |
Capitalized terms used herein, but not otherwise defined, shall have the meanings ascribed to them in the Agreement.
| 2. | Amendments. |
2.1 Sandoz Release Specifications Table set forth in Schedule 2 of the Agreement, as amended and replaced by Clause 7 of the First Amendment to the Agreement, is hereby amended and entirely replaced by the document CP-No. / CP-Version 7206.3, which is incorporated herein by reference.
2.2 Amylin’s address and contact information has changed; therefore Section 30(1)1. is amended and replaced with the following:
| If to Amylin, address to: |
Amylin Pharmaceuticals, LLC 0000 Xxxxx Xxxxxx Xxxxx Xxx Xxxxx, XX 000000 Attention: [***] [***] |
|
| With a copy to: |
Vice President and Associate General Counsel, Transactions Contracts Center of Excellence Xxxxxxx-Xxxxx Squibb Company |
| Xxxxx 000 & Xxxxxxxx Xxxx Xxxx Xxxxxxxxx, Xxx Xxxxxx 00000-0000 |
| 3. | Reference to and Effect on the Agreement. |
3.1 On and after the Amendment Effective Date, each reference to “this Agreement,” “hereunder,” “hereof,” “herein,” or words of like import shall mean and be a reference to the Agreement as amended hereby. No reference to this Amendment need be made in any instrument or document at any time referring to the Agreement, a reference to the Agreement in any of such instrument or document to be deemed to be a reference to the Agreement as amended or integrated hereby.
3.2 Except as expressly amended or integrated by this Amendment including the Exhibit A attached hereto, the provisions of the Agreement shall remain in full force and effect.
| 4. | Counterparts. |
This Amendment may be executed in any number of counterparts, each such counterpart shall be deemed to be an original instrument, and all such counterparts together shall constitute but one agreement. Any such counterpart may contain one or more signature pages. This Amendment may be executed by facsimile signature pages.
IN WITNESS WHEREOF, the undersigned have caused this amendment to be executed and delivered on the date first written above.
| Sandoz GmbH | Amylin Pharmaceuticals, LLC |
| Date: | Aug 08, 2013 | Date: | 08 Aug 2013 | |
| By: | [***] | By: | [***] | |
| Name: | [***] | Name: | [***] | |
| Title: | [***] | Title: | [***] |
Sandoz GmbH
| Date: | August 1, 2013 | |
| By: | [***] | |
| Name: | [***] | |
| Title: | [***] |