***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 Amylin’s 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

 

1

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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: 858-552-2212

 

Attn: Paul Marshall, Senior Vice President, Operations

 

 

With a copy to:

Amylin Pharmaceuticals

 

9360 Towne Centre Drive

 

San Diego, CA 92121

 

Telefax No.: 858-552-1936

 

Attn: Marcea Bland Lloyd, Senior Vice President and General Counsel

 

 

If to Bachem

Bachem Americas, Inc.

 

3132 Kashiwa Street

 

Torrance, CA 90505

 

Telefax No. 310-539-9428

 

Attn: Philip Ottiger, President & Chief Executive Officer

 

 

With a copy to:

Bachem, Inc.

 

3132 Kashiwa Street

 

Torrance, CA 90505

 

Telefax No. 310-530-2426

 

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.

 

2

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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.

 

 

 

 

 

 

By:

/s/ Philip Ottiger

 

By:

/s/ Paul Marshall

 

 

 

 

 

Name:

Philip Ottiger

 

Name:

Paul Marshall

 

 

 

 

 

Tltle:

President & CEO

 

Title:

Senior Vice President, Operations

 

 

Bachem, Inc.

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

/s/ Alex Fässler

 

 

 

 

 

 

 

 

Name:

Alex Fässler

 

 

 

 

 

 

 

 

Tltle:

Chief Operating Officer

 

 

 

 

3

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EXHIBIT 1.1

 

4

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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

 

 

 

 

 

 

 

Sharon Ho Burns

 

/s/ Sharon Ho Burns

 

Mfrg

 

16 June 2010

Approver (print name)

 

Signature

 

Dept.

 

Date

 

 

 

 

 

 

 

James Shanley

 

/s/ James Shanley

 

PQ

 

16 June 2010

Quality Mgmt (print name)

 

Signature

 

Dept.

 

Date

 

***Confidential Treatment Requested

 

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
LIMIT(1)

 

SPECIFICATION

 

METHOD

[***](5)

 

None

 

[***]

 

[***](2)

[***] by [***]

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

[***](2)

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***]

 

None

 

[***] mole ratio

 

 

[***] 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

 

***Confidential Treatment Requested

 

6

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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
LIMIT

 

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)

 

 

 

Page 2 of 5

 

***Confidential Treatment Requested

 

7

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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
LIMIT

 

SPECIFICATION

 

METHOD

[***]

 

None

 

NMT [***]% ([***])

 

 

[***]

 

None

 

NMT [***]% ([***])

 

[***](2)

[***]

 

None

 

NMT [***]% ([***])

 

[***](2)

[***]

 

None

 

NMT [***]% ([***])

 

 

[***](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:                       [***]

 

 

 

Page 3 of 5

 

***Confidential Treatment Requested

 

8

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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)

[***]

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

[***](1)

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***]

 

[***] mole ratio

 

 

[***] 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)

 

 

 

Page 4 of 5

 

Title:  Specification for AC2993 Drug Substance (Bachem)

 

***Confidential Treatment Requested

 

9

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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 [***]% ([***])

 

 

[***]

 

NMT [***]% ([***])

 

[***](1)

[***]

 

NMT [***]% ([***])

 

[***](1)

[***]

 

NMT [***]% ([***])

 

 

[***]

 

NMT [***]/g

 

[***](5)

 

--------------------------------------------------------------------------------

(1) [***]

(2) [***]

(3) [***]

(4) [***]

(5) [***]

 

NMT = Not more than

NLT = Not less than

 

END OF DOCUMENT

 

 

 

Page 5 of 5

 

***Confidential Treatment Requested

 

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