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 [**]%.

 

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** 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.

 

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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

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

 

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** 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.

 

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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.

 

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** 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.

 

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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

 

 

 

 

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** 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.

 

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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

 

 

 

 

 

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** 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.

 

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