Exhibit 10.5


 


***Text Omitted and Filed Separately


Confidential Treatment Requested


Under 17 C.F.R. Section 200.80(b)(4)


And 240.24b-2


 


THIRD AMENDMENT TO SUPPLY AGREEMENT


 


THIS THIRD AMENDMENT to the Supply Agreement originally made and
entered into as of October 1, 2003, by and between Amylin Pharmaceuticals, Inc.
(“AMYLIN”) and Mallinckrodt Inc. (“MALLINCKRODT”), as amended effective on and
as of January 1, 2006 and February 12, 2007, is made and entered into
between AMYLIN and MALLINCKRODT effective on and as of January 1, 2008.


 


WHEREAS, the parties desire to amend the aforementioned Supply
Agreement for the third time in certain respects,


 


NOW, THEREFORE, the parties hereto agree as follows:


 


1.                                       Section 1.19
of the Supply Agreement shall be deleted in its entirety, and replaced by the
text set forth immediately below:


 


“Exenatide Drug” means finished formulated dosage drug product
containing Product.”


 


2.                                       Section 1.28
of the Supply Agreement shall be amended by removing the period at the end of
the sentence, replacing it with a comma and adding the words “which shall be
identified by a specific lot number assigned by MALLINCKRODT.”


 


3.                                       Section 1.32
will be deleted in its entirety and, to avoid difficulties with references in
the Supply Agreement, the subsections of Section 1 that follow will not be
renumbered.  As a consequence of the
deletion of Section 1.32, the phrase “Normal Lot quantity,” as it appears
in Section 2.2 of the Supply Agreement shall be deleted.


 


4.                                       All
references to ‘Exenatide Injection Drug” will be replaced with references to “Exenatide
Drug”.


 


5.                                       Clause (iv) of
Section 2.3 of the Supply Agreement shall be deleted in its entirety, and
replaced by the text set forth immediately below to be inserted immediately
after clause (iii) of Section 2.3:


 


“(iv)  during each of the fourth and fifth Contract Years, either (A) at
least [***] percent ([***]%) of the total quantity of Product purchased by
AMYLIN during each of such Contract Years for the manufacture of Exenatide Drug
for commercial sale anywhere in the world where MALLINCKRODT has authorized
reference of its Drug Master File for Product or (B) [***] ([***])[***] of
Product, whichever is greater, and


 






*CONFIDENTIAL
TREATMENT REQUEST(ED)


 

















 


(v)  during the sixth Contract Year and every subsequent Contract
Year thereafter, at least [***] ([***])[***] of Product.”


 


6.                                       Clauses (v) and
(vi) of Section 2.4 shall be deleted in their entirety and the
following text shall be inserted in Section 2.4 of the Supply Agreement
after the end of clause (iv):


 


“(v) if in any given Contract Year the amount of Product ordered
for delivery is greater than [***] ([***])[***] but less than [***]
([***])[***], the price per gram will be $[***],


 


(vi)  if in any given Contract Year the amount of Product ordered
for delivery is greater than or equal to [***] ([***])[***] but less than [***]
([***])[***], the price per gram will be $[***],


 


(vii) if in any given Contract Year the amount of Product ordered
for delivery is greater than or equal to [***] ([***])[***] but less than [***]
([***])[***], the price per gram will be $[***], and


 


(viii) if in any given Contract Year the amount of Product ordered
for delivery is greater than or equal to [***] ([***])[***], the price per gram
will be $[***].”


 


7.                                       The
existing text of Section 2.8 of the Supply Agreement shall be deleted in
its entirety and replaced with a new text as set forth below:


 


“On the first day of each calendar [***] (i.e., [***]) during the term
hereof, AMYLIN shall submit to MALLINCKRODT, in writing, a rolling forecast for
Product covering production of Product hereunder for a [***] ([***])[***]
period beginning on the first day of the calendar [***] commencing after the
first day of the calendar [***] on which any such rolling forecast is to be
submitted (e.g., if a forecast is submitted on [***], the [***] ([***])[***]
forecast period will begin on the following [***]).  The first [***] of any rolling forecast
submitted by AMYLIN shall be binding and, therefore, in no event shall AMYLIN
purchase less than [***] percent ([***]%) of the quantity of Product forecasted
for the first quarter of such rolling forecast. 
The second [***] of any rolling forecast submitted by AMYLIN shall be
partially binding to the extent that in no event shall AMYLIN purchase less
than [***] percent ([***]%) of the quantity of Product forecasted for the
second [***] of such rolling forecast. 
The balance of any rolling forecast (i.e., the portion of the forecast
covering the last [***] ([***]) calendar [***]) shall not be binding and will
be utilized by MALLINCKRODT for production planning purposes only, but in all
circumstances AMYLIN shall act in 


 






*CONFIDENTIAL
TREATMENT REQUEST(ED)


 


2

















 


good faith and with reasonable care to submit rolling forecasts for
Product which are as accurate as possible under the circumstances.  If ordered by AMYLIN pursuant to this
Agreement, MALLINCKRODT agrees that it will be able to produce for AMYLIN (A) in
any [***] ([***]) calendar [***] at least [***] ([***])[***] of Product and (B) in
any single calendar [***] at least [***] ([***])[***] of Product.  MALLINCKRODT agrees to use commercially
reasonable efforts to produce additional quantities of Product if ordered by
AMYLIN pursuant to this Agreement; however, notwithstanding the foregoing
provisions of this Section 2.8 or the contents of any rolling forecast
submitted by AMYLIN to MALLINCKRODT, in no event shall MALLINCKRODT be required
to produce for AMYLIN in any relevant period more than the quantities of
Product set forth in the immediately preceding sentence unless specifically
agreed to by MALLINCKRODT by its written acceptance of an AMYLIN Purchase Order
containing such excess quantities.”


 


8.                                       In
Section 7.1 of the Supply Agreement replace “five (5) Contract Years”,
with “nine (9) Contract Years”, thereby extending the initial term of the Supply
Agreement by an additional four (4) years.


 


9.                                       In
section 7.2(v) of the Supply Agreement replace “fourth (4th)”
with “eighth (8th)”, with the effect that the termination right set
forth in Section 7.2(v) may not be exercised until after the elapse
of the eighth (8th) Contract Year.


 


10.                                 Exhibit B
of the Supply Agreement (as added by the parties pursuant to their second
amendment to the Supply Agreement effective February 12, 2007) shall be
deleted in its entirety, and replaced with the updated Exhibit B attached
hereto as Schedule A.


 


Except as expressly amended herein, all of the other terms of the
Supply Agreement shall remain unchanged and in full force and effect.


 


IN WITNESS WHEREOF, the parties hereto have executed this Third
Amendment to Supply Agreement effective as of the day above written.


 


	
   

  	
  Amylin Pharmaceuticals, Inc.

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Paul Marshall; 6/16/2008

  
	
   

  	
   

  	
  Paul Marshall

  
	
   

  	
   

  	
   Vice President, Operations

  
	
   

  	
   

  	
   

  
	
   

  	
  Mallinckrodt Inc.

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Richard C. Proehl; 5/12/08

  
	
   

  	
   

  	
  Richard C. Proehl

  



 






*CONFIDENTIAL
TREATMENT REQUEST(ED)


 


3

















 


EXHIBIT B


 


PRODUCT
SPECIFICATIONS


 


Purchase Specification AC2993 (Mallinckrodt)


 


	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Ala

  Arg

  Asx

  Glx

  Gly

  His

  Ile

  Leu

  Lys

  Met

  Phe

  Pro

  Ser

  Thr

  Trp

  Val

  	
   

  	
  [***] mole ratio

  [***] mole ratio

  [***] mole ratio

  [***] mole ratio

  [***] mole ratio

  [***] mole ratio

  [***] mole ratio

  [***] mole ratio

  [***] mole ratio

  [***] mole ratio

  [***] mole ratio|

  [***] mole ratio

  [***] mole ratio

  [***] mole ratio

  [***] mole ratio

  [***] mole ratio

  	
   

  	
  

  

  

  

  

  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] Daltons

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  Consistent with [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]%[***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***] acid [***] by [***]

  	
   

  	
  [***]%[***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  [***]

  	
   

  	
  [***]%[***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  [***]

  [***]

  [***]

  [***]

  [***]

  	
   

  	
  

  [***]%[***]

  [***]%[***]

  [***]%[***]

  [***]%[***].

  [***]%[***]

  	
   

  	
  [***]

  



 






*CONFIDENTIAL
TREATMENT REQUEST(ED)


 

















 


	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  [***]

  	
   

  	
  

  [***]% [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  [***]

  [***]

  [***]

  [***]

  [***]

  [***]

  [***]

  	
   

  	
  

  [***]% [***]

  [***]% [***]

  [***]% [***]

  [***]% [***]

  [***]% [***]

  [***]% [***]

  [***]% [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***] by [***]

  	
   

  	
  [***]% - [***]% of [***]

  ([***]%):

  [***]% - [***]% [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]% [***]

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]% [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]% [***]

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]% [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] ppm [***]

  Report individual values

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  Report Result

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] at [***] mg/mL in [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] – [***]%

  	
   

  	
  [***]

  



 






*CONFIDENTIAL
TREATMENT REQUEST(ED)