THIRD Amendment to Commercial Supply Agreement for Exenatide
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R §§ 200.80(b)(4)
And 240.24b-2
Exhibit 10.2
CONFIDENTIAL
THIRD Amendment to Commercial Supply Agreement for Exenatide
THIS THIRD AMENDMENT (Amendment) is effective as of September 20, 2010 and is by and between AMYLIN PHARMACEUTICALS, INC., a Delaware corporation (Amylin), having a place of business at 9360 Towne Centre Drive, San Diego, California 92121 USA and BACHEM AMERICAS, INC., a California corporation, having a place of business at 3132 Kashiwa Street, Torrance, CA 95050 USA and BACHEM INC, a California corporation, having a place of business at 3132 Kashiwa Street, Torrance, CA 90505 (collectively Bachem).
WHEREAS, Amylin and Bachem entered into an Agreement effective as of December 23, 2003, directed to the supply of commercial scale Exenatide, as amended (the Commercial Supply Agreement));
WHEREAS, Amylin and Bachem have agreed to modify the pricing and exclusivity provisions of the Commercial Supply Agreement;
WHEREAS, Amylin and Bachem have mutually agreed to modify the Specifications; and
NOW, THEREFORE, in consideration of the premises above and the terms and conditions set forth below, the parties agree as follows:
1. Paragraph 2.3 is hereby deleted and replaced with the following:
2.3 The price for the Product shall be based on minimum order volumes of [***] per order, or the [***], whichever is less, and shall be [***] ($[***]), which price shall include the costs of Materials and analytical release testing. If Materials costs or waste disposal costs change by more than [***] percent ([***]%) over the [***], the price for the Product may be adjusted, subject to the parties mutual written agreement, to reflect the change in such costs.
The price is based on current specifications. The parties agree that changes to the Product Specifications that are set forth in Exhibit 1.1 attached herein and incorporated by this reference dated June 16, 2010, will not result in any change to the price set forth above; provided, however that, if such changes to the Product Specifications reflect process capabilities that are outside the process capabilities demonstrated by Bachem in manufacturing validation batches, then the parties will discuss whether such price would require adjustment as a consequence.
If certain process improvements can be identified, Bachem and Amylin will jointly decide on a course of action, provided that no change to the manufacturing process for Product may be implemented without Amylins prior written approval. Bachem will quote for the work that implementation of changes involves. Amylin can then elect to pursue this option. Any cost savings that insue from the implementation of these changes would be [***] between the parties.
2. Paragraph 3.14 is hereby deleted in its entirety and not replaced.
***Confidential Treatment Requested
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3. Under Article 12, Notices of the Agreement, contact information is hereby deleted and replaced with the following:
If to Amylin: | Amylin Pharmaceuticals |
| 9360 Towne Centre Drive |
| San Diego, CA 92121 |
| Telefax No: 858 ###-###-#### |
| Attn: Paul Marshall, Senior Vice President, Operations |
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With a copy to: | Amylin Pharmaceuticals |
| 9360 Towne Centre Drive |
| San Diego, CA 92121 |
| Telefax No.: 858 ###-###-#### |
| Attn: Marcea Bland Lloyd, Senior Vice President and General Counsel |
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If to Bachem | Bachem Americas, Inc. |
| 3132 Kashiwa Street |
| Torrance, CA 90505 |
| Telefax No.  ###-###-#### |
| Attn: Philip Ottiger, President & Chief Executive Officer |
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With a copy to: | Bachem, Inc. |
| 3132 Kashiwa Street |
| Torrance, CA 90505 |
| Telefax No.  ###-###-#### |
| Attn: Alex Fässler, Chief Operating Officer |
4. Except as expressly stated above, the Agreement remains in full force and effect in accordance with its terms. Unless otherwise stated in this Amendment each defined term herein shall have the same meaning ascribed to such term in the Agreement.
5. The terms and conditions of this Amendment are hereby incorporated into and made a part of the Supply Agreement.
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IN WITNESS WHEREOF, the parties have caused this Amendment to be executed as of the date written above.
Bachem Americas, Inc. |
| Amylin Pharmaceuticals, Inc. | ||
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By: | /s/ Philip Ottiger |
| By: | /s/ Paul Marshall |
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Name: | Philip Ottiger |
| Name: | Paul Marshall |
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Tltle: | President & CEO |
| Title: | Senior Vice President, Operations |
Bachem, Inc. |
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By: | /s/ Alex Fässler |
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Name: | Alex Fässler |
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Tltle: | Chief Operating Officer |
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EXHIBIT 1.1
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CONFIDENTIAL
[Amylin logo]
CONFIDENTIAL Do Not Reproduce
Document Approval Sheet
Document Type: | Specification |
Document Number: | SPEC-111 |
Title: | Specification for AC2993 Drug Substance (Bachem) |
Revision Number: | 10 |
Supersedes: | [***] |
Dept. Owner: | [***] |
Quality Program: | [***] |
Approvals
Rami Nagola |
| /s/ Rami Nagola |
| LQA |
| 16 June 2010 |
Initiator (print name) |
| Signature |
| Dept. |
| Date |
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Sharon Ho Burns |
| /s/ Sharon Ho Burns |
| Mfrg |
| 16 June 2010 |
Approver (print name) |
| Signature |
| Dept. |
| Date |
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James Shanley |
| /s/ James Shanley |
| PQ |
| 16 June 2010 |
Quality Mgmt (print name) |
| Signature |
| Dept. |
| Date |
***Confidential Treatment Requested
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[Amylin logo]
Title: Specification for AC2993 Drug Substance (Bachem)
Corporate Specification for AC2993 Drug Substance, Supplier: Bachem
Description: N/A
ATTRIBUTE |
| ALERT |
| SPECIFICATION |
| METHOD |
[***](5) |
| None |
| [***] |
| [***](2) |
[***] by [***] |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
| [***](2) |
[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] |
| None |
| [***] mole ratio |
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[***] by [***] |
| None |
| [***] ± [***] |
| [***](3) |
[***] by [***] |
| None |
| Consistent with reference standard |
| [***](2) |
[***](5) |
| NMT [***]% |
| NMT [***]% |
| [***](2) |
[***](5) |
| None |
| NMT [***]% |
| [***](4) |
[***] by [***] |
| NMT [***]% |
| Not required |
| [***](4) |
[***](5) |
| NLT [***]% |
| NLT [***]% |
| [***](2) |
[***] by [***](5) |
| NMT [***]% |
| NMT [***]% |
| [***](2) |
[***] by [***](5) |
| None |
| NMT [***]% |
| [***](2) |
[***] by [***](5) |
| None |
| NMT [***]% |
| [***](2) |
[***] by [***](5) |
| None |
| NMT [***]% |
| [***](2) |
[***](5) |
| NLT [***]% |
| NLT [***]% |
| [***](2) |
SPEC-111, Rev. 10 | Effective: 18 Jun 2010 | Page 1 of 5 |
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[Amylin logo]
Title: Specification for AC2993 Drug Substance (Bachem)
Corporate Specification for AC2993 Drug Substance, Supplier: Bachem
Description: N/A
ATTRIBUTE |
| ALERT |
| SPECIFICATION |
| METHOD |
[***] by [***](5) |
| NMT [***]% |
| NMT [***]% |
| [***](2) |
[***](5) |
| None |
| NMT [***]% |
| [***](2) |
[***](5) |
| None |
| NMT [***]% |
| [***](2) |
[***](5) |
| None |
| NMT [***]% |
| [***](2) |
[***](5) |
| None |
| NMT [***]% |
| [***](2) |
[***](5) |
| None |
| NMT [***]% |
| [***](2) |
[***](5) |
| None |
| NMT [***]% |
| [***](2) |
[***](5) |
| None |
| [***]% - [***]% of [***] |
| [***](8) |
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| Page 2 of 5 |
***Confidential Treatment Requested
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[Amylin logo]
Title: Specification for AC2993 Drug Substance (Bachem)
Corporate Specification for AC2993 Drug Substance, Supplier: Bachem
Description: N/A
ATTRIBUTE |
| ALERT |
| SPECIFICATION |
| METHOD |
[***] |
| None |
| NMT [***]% ([***]) |
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[***] |
| None |
| NMT [***]% ([***]) |
| [***](2) |
[***] |
| None |
| NMT [***]% ([***]) |
| [***](2) |
[***] |
| None |
| NMT [***]% ([***]) |
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[***](6) |
| [***] ppm |
| Not required |
| [***] |
[***](6) |
| [***]/mg |
| Not required |
| [***] |
[***] |
| None |
| [***]/g |
| [***](9) |
[***](6) |
| Report Results |
| Not required |
| [***](2) |
[***](6) |
| Report Results |
| Not required |
| [***](7) |
(1) [***]
(2) [***]
(3) [***]
(4) [***]
(5) [***]
(6) [***]
(7) [***]
(8) [***]
(9) [***]
NMT = Not more than
NLT = Not less than
Storage Temperature: Store at NMT [***]
Shipping Temperature: Ship at NMT [***]
Retest period: [***]
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| Page 3 of 5 |
***Confidential Treatment Requested
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[Amylin logo]
Title: Specification for AC2993 Drug Substance (Bachem)
Corporate Specification for AC2993 Drug Substance, Supplier: Bachem
Description: N/A
ATTRIBUTE |
| SPECIFICATION |
| METHOD |
[***] |
| [***] |
| [***](1) |
[***] |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
| [***](1) |
[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] |
| [***] mole ratio |
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[***] by [***] |
| [***] ± [***] |
| [***](2) |
[***] by [***] |
| Consistent with reference standard |
| [***](1) |
[***] |
| NMT [***]% |
| [***](1) |
[***] |
| NMT [***]% |
| [***](3) |
[***] by [***] |
| NLT [***]% |
| [***](1) |
[***] by [***] |
| NMT [***]% |
| [***](1) |
[***] by [***] |
| NMT [***]% |
| [***](1) |
[***] by [***] |
| NMT [***]% |
| [***](1) |
[***] by [***] |
| NMT [***]% |
| [***](1) |
[***] by [***] |
| NMT [***]% |
| [***](1) |
[***] by [***] |
| NMT [***]% |
| [***](1) |
[***] by [***] |
| NMT [***]% |
| [***](1) |
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| Page 4 of 5 |
Title: Specification for AC2993 Drug Substance (Bachem)
***Confidential Treatment Requested
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[Amylin logo]
Corporate Specification for AC2993 Drug Substance, Supplier: Bachem
Description: N/A
ATTRIBUTE |
| SPECIFICATION |
| METHOD |
[***] by [***] |
| NMT [***]% |
| [***](1) |
[***] by [***] |
| NMT [***]% |
| [***](1) |
[***] by [***] |
| NMT [***]% |
| [***](1) |
[***] by [***] |
| NMT [***]% |
| [***](1) |
[***] by [***] |
| NMT [***]% |
| [***](1) |
[***] |
| [***] |
| [***](4) |
[***] |
| NMT [***]% ([***]) |
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[***] |
| NMT [***]% ([***]) |
| [***](1) |
[***] |
| NMT [***]% ([***]) |
| [***](1) |
[***] |
| NMT [***]% ([***]) |
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[***] |
| NMT [***]/g |
| [***](5) |
(1) [***]
(2) [***]
(3) [***]
(4) [***]
(5) [***]
NMT = Not more than
NLT = Not less than
END OF DOCUMENT
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