Exhibit 10.8(C)


 


First Amendment to

Toll Manufacturing And Packaging Agreement

By and Between

Abbott Laboratories and Cephalon, Inc.


 


THIS
AMENDMENT is entered into as of the 1 day of October 2004, by and between
Abbott Laboratories (“ABBOTT”) and Cephalon, Inc. (“CEPHALON”), and amends
that certain Toll Manufacturing And Packaging Agreement dated October 31,
2000 (the “Agreement”).


 


Whereas,
CEPHALON has requested a three year extension of the Agreement; and


 


Whereas,
ABBOTT has suitable facilities and equipment and sufficient qualified personnel
to continue to manufacture the Active Drug Substance and final product dosage
form and is willing to provide such services on the terms and conditions set
forth below.


 


Now, therefore, the
parties agree as follows:


 


1.               Effective
October 1, 2004, Section 2.5 shall be deleted in its entirety and
replaced with   the following language:


 


“Unless
terminated in accordance with the provisions of Article XIX, this
Agreement will become effective and remain in effect for a period of eight (8) years
and two (2) months from the Effective Date of October 31, 2000 and
shall not expire until December 31, 2008 (the “Initial Term”), and, unless
either party gives written notice of non-renewal at least one hundred eighty
(180) days prior to the end of the Initial Term (or any renewal term), this
Agreement shall be renewed for consecutive terms of two (2) years.”


 


2.               Effective
October 1, 2004, Section 5.1 shall be amended by adding the following
language as a separate paragraph at the end of such section:


 


“Notwithstanding
the foregoing, ABBOTT shall provide the Active Drug Substance only for so long
as ABBOTT continues to self-manufacture the Active Drug Substance. Should
ABBOTT elect to no longer self-manufacture the Active Drug Substance, ABBOTT
shall:


 


a)              provide Cephalon
with a minimum of [**] months notice of such discontinuance


 


b)             make
all reasonable efforts to produce enough additional Active Drug Substance to
cover a forecasted [**] months worth of finished product production, which
when added to the [**] months normal inventory will provide Cephalon with forecast
coverage for [**] months beyond the discontinuation date


 


c)              provide
reasonable support to CEPHALON to assist CEPHALON’s efforts to qualify an
alternate manufacturer of the Active Drug Substance. CEPHALON will reimburse
Abbott for all efforts expended at the then current costs plus [**]%.


 










** Portions of this
exhibit have been omitted and filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 





















 


Additionally,
CEPHALON will reimburse Abbott for all efforts expended to complete NON’s
(Notice of New Drug Substance filing in LU) registration related to
intermediate production.”


 


3.               Effective
October 1, 2004, Section 5.1 shall be amended by replacing the second
sentence the following sentence:


 


“Abbott
assumes full responsibility and liability for the storage and handling of all
Commodities and Components.”


 


4.               Effective
October 1, 2004, Section 5.3 shall be added as follows:


 


“If,
during the term of this Agreement it becomes necessary for Abbott, at Cephalon’s
sole discretion, to develop and manufacture a tiagabine degradation reference
standard, Cephalon shall be solely responsible for any and all costs associated
therewith.”


 


5.               Effective
October 1, 2004, Section 6.2 shall be amended by deleting the
inadvertent reference to “Schedule E” and replacing it with the correct
reference to “Schedule C,” and by adding the following paragraph at the
end of such section:


 


“The
parties agree that there will be no formal increase in the reserve capacity as
reflected on Schedule C; however, CEPHALON has provided ABBOTT with a
planning forecast as reflected below and ABBOTT’s current capacity planning
model indicates that ABBOTT should have sufficient Active Drug Substance and
finished Product capacity to meet Cephalon’s projected demand during the Term
of the Agreement. The parties hereby agree that as long as CEPHALON keeps
ABBOTT aware of its long range demand based on the monthly forecast update,
ABBOTT will alert CEPHALON of any potential shortfall as soon as it became
evident, and at that time the parties will agree on a course of action, be it
implementation of a take or pay reserve capacity agreement,. transfer of
production to the Abbott Park facility which is already approved in the NDA for
the 4 mg, 12, mg and 16 mg Product tablets, CEPHALON’s selection of an
alternate third party manufacturing facility, or another alternative
arrangement as mutually agreed to by the Parties.”


 


Planning Forecast


 


	
   

  	
   

  	
   

  	
   

  	
  Lots

  	
   

  	
  Tablets

  	
   

  
	
  Strength

  	
   

  	
  Batch Size

  	
   

  	
  2006

  	
   

  	
  2007

  	
   

  	
  2008

  	
   

  	
  2006

  	
   

  	
  2007

  	
   

  	
  2008

  	
   

  
	
  2 mg

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  4 mg

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  12 mg

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  16 mg

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  



 










** Portions of this
exhibit have been omitted and filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 





















 


6.               Effective
October 1, 2004, Section 6.3 shall be added as follows:


 


“6.3
For purposes of clarification, effective January 1, 2005, CEPHALON will
provide to Abbott forecasts and orders for Active Drug Substance in a manner
consistent with the terms contained in this Article 6.”


 


7.               Effective
October 1, 2004, Section 7.3 shall be amended by deleting the section in
its entirety and replacing it with the following:


 


Price.


 


“7.3.1                  2004 Pricing


 


ABBOTT shall be entitled
to receive from CEPHALON, and CEPHALON shall pay to ABBOTT, a fee for all 100-count
units of Product delivered at a price equal to:


 


With
regard to the 2mg and 4mg: [**] percent ([**]%) of the average Net Sales from
the previous calendar quarter.


 


With
regard to the 12 mg and 16 mg: [**] percent ([**]%) of the average Net Sales
from the previous calendar quarter.


 


For any and all other
product and requested services, ABBOTT shall be entitled to receive from
CEPHALON and CEPHALON shall pay to ABBOTT a fee equal to ABBOTT’s cost plus [**]
percent ([**]%).


 


The price due to Abbott
hereunder, for the 4th Quarter 2004 shall be in accordance with and as set
forth in Schedule D for 2004.


 


7.3.2                        2005 Pricing


 


Effective January 1,2005,
the parties agree to further revise the above pricing procedure to establish an
annual fixed price which will allow CEPHALON to purchase Active Drug Substance
independent of the Product.


 


Any Active Drug Substance
manufactured by Abbott pursuant to this Agreement shall be shipped, on
consignment, FCA ABBOTT’s manufacturing plant to the location specified by
CEPHALON. Title and risk of loss shall pass to CEPHALON upon delivery of Active
Drug Substance to the carrier. Shipment shall be via a carrier designated by
CEPHALON. Title to, and risk of loss of, Active Drug Substance shall be
retained by CEPHALON for Active Drug Substance stored by ABBOTT; provided,
however, ABBOTT shall be responsible for replacing any Active Drug Substance
that is destroyed due to ABBOTT’s gross negligence or willful misconduct as
identified through exception documentation.


 


The price due to Abbott
hereunder, for 2005 shall be in accordance with and as set forth in Schedule D
for 2005.


 










** Portions of this
exhibit have been omitted and filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 





















 


For any and all other
product and requested services, ABBOTT shall be entitled to receive from
CEPHALON and CEPHALON shall pay to ABBOTT a fee equal to ABBOTT’s cost plus [**]
percent ([**]%).


 


7.3.3                        Price Adjustments


 


Effective on or about November 1,
2005 and on or about November 1 of each calendar year thereafter, Abbott
will provide Cephalon with an adjusted price for the next calendar year.


 


Price adjustments shall
be effective for deliveries beginning January 1 of each calendar year.


 


Such adjustment shall not
exceed the annual percentage increase of the most recent twelve (12) month
period for which firm figures are available in the Produce Price Index,
Pharmaceutical Preparations, Series Identification 325412325412, issued by
the Bureau of Labor Statistics, U.S. Department of Labor, or an equivalent and
mutually agreeable index should the above referenced index be discontinued.”


 


8.               On
January 1, 2005 ABBOTT will issue to CEPHALON an Active Drug Substance
inventory specifying the Abbott lot number and quantity for each lot that is in
transit, in raw material inventory and/or in work-in-process inventory as of January 1,
2005. Cephalon on will promptly issue a purchase order to ABBOTT for the such
inventory of Active Drug Substance existing in transit, in raw material
inventory or in work in process, and title to, and risk of loss of shall become
the responsibility of CEPHALON for this Active Drug Substance stored by ABBOTT;
provided, however, ABBOTT shall be responsible for replacing any Active Drug
Substance that is destroyed due to ABBOTT’s gross negligence or willful
misconduct


 


9.               Except
as specifically amended by this Amendment, all other terms and conditions of
this Agreement shall remain in full force and effect during the extended term
of the Agreement.  A copy of the
Agreement is attached for reference.


 


	
  Agreed:

  	
  Agreed:

  
	
   

  	
   

  
	
  Abbott
  Laboratories

  	
  Cephalon, Inc.

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Michael L.
  McGibbon

  	
   

  	
  By:

  	
  /s/ Robert J.
  Urban

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  General Manager,
  Pharma

  	
   

  	
  Title:

  	
  Vice President,
  Manufacturing & Engineering

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  December 15,
  2004

  	
   

  	
  Date:

  	
  December 2,
  2004

  	
   

  	
   

  
									



 


 










** Portions of this
exhibit have been omitted and filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 





















 


Schedule D

Cephalon, Inc.

Gabitril Commercial Pricing effective January 1, 2005 through December 31,
2005


 


Table 1


Table 1 tablet pricing is applicable if product is manufactured with
Abbott Active Drug Substance


 


	
  Strength

  	
   

  	
  Abbott List Number

  	
   

  	
  Price

  	
   

  	
  Per

  	
   

  
	
   

  	
   

  	
  List-Label-Inv-Sales-TUC

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2mg

  	
   

  	
  3963-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  
	
  2mg

  	
   

  	
  3963-04-60

  	
   

  	
  [**]

  	
   

  	
  1000 (drum of
  60,000)

  	
   

  
	
  4mg

  	
   

  	
  3904-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  
	
  4mg

  	
   

  	
  3904-04-60

  	
   

  	
  [**]

  	
   

  	
  1000 (drum of
  60,000)

  	
   

  
	
  12mg

  	
   

  	
  3910-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  
	
  16mg

  	
   

  	
  3960-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  
	
  Tiagabine

  	
   

  	
  49462

  	
   

  	
  [**]

  	
   

  	
  KG

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Table 2

  
	
  Table 2 tablet pricing is applicable if product is
  manufactured with non-Abbott Active Drug Substance

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Strength

  	
   

  	
  Abbott List Number

  	
   

  	
  Price

  	
   

  	
  Per

  	
   

  
	
   

  	
   

  	
  List-Label-Inv-Sales-TUC

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2mg

  	
   

  	
  3963-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  
	
  2mg

  	
   

  	
  3963-04-60

  	
   

  	
  [**]

  	
   

  	
  1000 (drum of 60,000)

  	
   

  
	
  4mg

  	
   

  	
  3904-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  
	
  4mg

  	
   

  	
  3904-04-60

  	
   

  	
  [**]

  	
   

  	
  1000 (drum of
  60,000)

  	
   

  
	
  12mg

  	
   

  	
  3910-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  
	
  16mg

  	
   

  	
  3960-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  



 


 


	
  /s/ Michael L.
  McGibbon

  	
   

  	
  12/15/04

  	
   

  	
  /s/ Robert J.
  Urban

  	
   

  	
  12/2/2004

  	
   

  
	
  Abbott
  Laboratories

  	
  Dated

  	
  Cephalon, Inc.

  	
  Dated

  
	
  Michael L.
  McGibbon

  	
   

  	
   

  	
   

  
	
  General Manager,
  Pharma

  	
   

  	
   

  	
   

  



 


 










** Portions of this
exhibit have been omitted and filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 





















 


Schedule D

Cephalon, Inc.

Gabitril Commercial Pricing for 4th Quarter, 2004

(Based on 4% of Net Sales for 1st Quarter, 2004 for 100 count. Other
at cost + 25%)


 


Effective for material
shipped October 1, 2004 through December 31, 2004


 


	
  Strength

  	
   

  	
  Abbott List Number

  	
   

  	
  Price

  	
   

  	
  Per

  	
   

  
	
   

  	
   

  	
  List-Label-Inv-Sales-TUC

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2mg

  	
   

  	
   

  	
   

  	
  3963-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  
	
  2mg

  	
   

  	
  Full Lot

  	
   

  	
  3963-04-60

  	
   

  	
  [**]

  	
   

  	
  1000 (drum of
  60,000)

  	
   

  
	
  4mg

  	
   

  	
   

  	
   

  	
  3904-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  
	
  4mg

  	
   

  	
  Full Lot

  	
   

  	
  3904-04-60

  	
   

  	
  [**]

  	
   

  	
  1000 (drum of
  60,000)

  	
   

  
	
  12mg

  	
   

  	
   

  	
   

  	
  3910-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  
	
  16mg

  	
   

  	
   

  	
   

  	
  3960-04-20-17-03

  	
   

  	
  [**]

  	
   

  	
  bottle of 100

  	
   

  



 


	
  Accepted by:

  	
   

  	
  Accepted by:

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  /s/ Michael L.
  McGibbon

  	
   

  	
  12/15/04

  	
   

  	
  /s/ Robert J.
  Urban

  	
   

  	
  12/2/2004

  	
   

  
	
  Abbott
  Laboratories

  	
  Dated

  	
  Cephalon, Inc.

  	
  Dated

  
	
  Michael L.
  McGibbon

  	
   

  	
   

  	
   

  
	
  General Manager,
  Pharma

  	
   

  	
   

  	
   

  
								



 


 










** Portions of this
exhibit have been omitted and filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.