***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

















 


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

















 


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

















 


EXHIBIT 1.1


 


4
















 


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

















 


[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

















 


[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

















 


[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

















 


[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

















 


[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 


 


10