Document:

EXHIBIT 10.1(b)

 

Amendment No.1

 

to

Joint Research, Development and
License Agreement

 

Year 2000 Conformity

 

Ladies & Gentlemen:

 

This letter is to confirm
our understanding concerning an amendment to be made with respect to the Joint
Research, Development and License Agreement dated May 28, 1999 (the
“Agreement”), between Cephalon, Inc. (“Cephalon”) and H. Lundbeck A/S  (“Lundbeck”).  All terms not otherwise defined herein are
used as defined in the Agreement.  The
purpose of this amendment is to address Year 2000 compliance as it relates to
the computer systems and programs in use by Lundbeck and Cephalon which are
required to perform any and all services related to the Agreement.

 

Cephalon and Lundbeck
(hereinafter referred to as “Companies”) hereby make the following declaration
to each other:

 

 

WHEREAS:

 

A.                                   The “year 2000 problem” is understood to mean
a Software Program Code Line (stored information or equipment of any sort
treating data) that will denote a year with two digits rather than four ( e.g.
“97” instead of “1997”).  In connection
with the millennium this entails a risk that information relating to years may
be misunderstood or mistaken, e.g. the digits “01” are stated as year 1901 or
another year instead of the year 2001.

 

B.                                     The Companies hereby declare to be aware of
the year 2000 problem and that this problem can have unforseen and/or
unintended consequences for the ability of the Companies to fulfill their
obligations under the Agreement.

 

IT IS NOW HEREBY DECLARED:

 

1.                                       The Companies hereby declare that they do not
know or are aware of any circumstances or risks concerning the year 2000
problem which will directly or indirectly have the effect that the Companies
cannot fulfill their obligations or duties under the Agreement. Furthermore, the
Companies declare that they have made all reasonable efforts to correct
programs or other data treating equipment owned by the Companies so that
neither performance nor functionality is affected by dates prior to, during and
after the year 2000 so that the Companies are not hindered or prevented from
complying with their obligations under the Agreement.

 

2.                                       The Companies in carrying out their business
are to a wide extent dependent on receiving services from third parties and
subcontractors.  Whilst the Companies
have taken several initiatives to increase awareness of the year 2000 problem
among these third parties and subcontractors, the Companies provide no
guarantee or give any assurance to each other that the year 2000 problem will
not cause problems among its third parties/subcontractors which will have a
direct or indirect effect on the ability of the Companies to comply with their
obligations under the Agreement, in whole or in part.

 

3.                                       Notwithstanding the terms of any agreement
between the Companies and their sub-contractors, whether or not in writing, the
Companies are of the opinion that if the Companies are hindered or prevented
from complying with their obligations towards each other as a result of the
year 2000 problem experienced by the Companies and/or third party
contractors/subcontractors, this is to be considered a Force Majeure and the
Companies will not be liable for failure to perform any duty or obligations
under the Agreement. The Companies will, after they have been made aware of the
Force Majeure situation, without unnecessary 

 

 

delay inform each other of
the Force Majeure situation and will make all reasonable efforts to limit any
loss of each other and where relevant or possible seek alternative
subcontractors.  Each Company’s respective
obligations towards each other will be suspended in the period necessary to
rectify the problem.

 

4.                                       This declaration shall be effective for the
entire term of the Agreement.

 

5.                                       Except as amended hereby, the Agreement shall
remain in full force and effect.

 

If the foregoing accurately
reflects your understanding as to these matters, please indicate your agreement
in the space provided below, and return a signed copy to Lundbeck at your
earliest convenience.

 

 

	
   

  	
  Very truly yours,

  
	
   

  	
   

  
	
   

  	
  H. LUNDBECK A/S

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Claus Toflund

  	
   

  
	
   

  	
  Claus Toflund

  
	
   

  	
  Year 2000 Project Manager

  
	
   

  	
   

  	
   

  
	
  Acknowledged, agreed and
  accepted by:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  CEPHALON, INC.

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ John E. Osborn

  	
   

  	
   

  	
   

  
	
   

  	
  John E. Osborn

  	
   

  	
   

  
	
   

  	
  Senior Vice President and
  General CounselEXHIBIT 10.1(c)

 

March 16,
2000

 

 

H Lundbeck A/S

9 Ottiliavej

DK-2500 Valby,

Copenhagen, Denmark

 

ATTN             Dr Claus Braestrup

 

RE:                              Joint Research, Development and License
Agreement dated May 28, 1999

 

Dear Dr Braestrup:

 

This will serve to clarify
certain aspects of the Joint Research, Development and License Agreement
between Cephalon, Inc (“Cephalon”) and H Lundbeck A/S  (“Lundbeck”)
dated May 28, 1999 (the “Agreement”). 
All terms and conditions not otherwise defined or modified herein shall
remain in full force and effect as set forth In the Agreement.

 

1.                                       For purposes of clarification:

 

a)        the term “Cephalon Compounds” as defined In Section 1.5 of the
Agreement shall include, but shall not be limited to, any compound or chemical
entity that comprises, consists of, contains, incorporates or utilizes the
structure/pharmacophore of Structure I below.

 

[Graphic
Omitted]

 

Structure I

 

 

where A and B comprise,
consist of, or contain substituted or unsubstituted hydrogen-bond donor or
acceptor moleties and where Structure I can have any degree of unsaturation,
and

 

b)       the term “Lundbeck Compounds” as defined in Section 1 27 of the
Agreement shall include, but shall not be limited to, any compound or chemical
entity that has been or will be synthesized solely by Lundbeck or acquired from
a third party by Lundbeck

 

 

2.                                       The first sentence of Section 57 of the
Agreement is hereby amended and restated as follows: Cephalon hereby agrees
that it wil1 not grant to any third party (other than to an Affiliate) the
right to co-promote in Canada either the Kyowa Licensed Products, the Cephalon
Licensed Products, the Lundbeck Licensed Products or Joint Licensed Products
without first negotiating in good faith for a period not to exceed sixty (60)
days to reach agreement on mutually acceptable terms and conditions that would
grant such rights to Lundbeck

 

3.                                       For purposes of further clarification
regarding application of the terms of Article 17 of the Agreement

 

a)        If the Research Program is terminated
pursuant to Section 17 3 of the Agreement and a Cephalon Compound, a
Lundbeck Compound or a Joint Compound has not been designated a Development
Compound (or a Backup Compound) by the Joint Development Team on or prior to
such date of termination, then any and all rights to such Cephalon Compound
shall revert to Cephalon, any and all rights to such Lundbeck Compound shall
revert to Lundbeck and any and all rights to such Joint Compound shall revert
to Lundbeck in the Territory and to Cephalon outside of the Territory.  If a Cephalon Compound, a Lundbeck Compound
or a Joint  Compound has been so designated a Development
Compound (or a Backup Compound) by

 

 

such
date, then the rights and obligations of the Parties shall be as defined in
subsections 17 3(i) and (ii), and

 

b)       If a Cephalon Compound, a Lundbeck Compound or a Joint Compound has
been designated as a Development Compound but development of such Compound has
been discontinued pursuant to Section 174, then any and all rights to any
such Cephalon Compounds shall revert to Cephalon, any and all rights to such
Lundbeck Compounds shall revert to Lundbeck and any and all rights to any such
Joint Compounds shall revert to Lundbeck in the Territory and to Cephalon
outside the Territory, unless Lundbeck confirms in writing immediately upon any
such discontinuance that such Development Compound shall be replaced by a
Backup Compound shown to be active principally against the primary Target as
said discontinued Development Compound and that it will promptly commence
active development of said Backup Compound.

 

If the foregoing accurately
reflects your understanding as to these matters, please indicate your agreement
and acceptance in the space provided below and return a signed copy of this
letter to me

 

	
   

  	
  Very truly yours,

  
	
   

  	
  CEPHALON, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  /s/ Peter E. Grebow

  	
   

  
	
   

  	
  Peter E Grebow

  
	
   

  	
  Senior Vice President,

  
	
   

  	
  Business Development

  
	
  AGREED, ACKNOWLEDGED AND
  ACCEPTED

  	
   

  
	
   

  	
   

  
	
  H LUNDBECK A/S

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Claus Braestrup

  	
   

  	
   

  
	
  Name: Claus Braestrup

  	
   

  
	
  Title: Executive Vice
  President, R&DEXHIBIT 10.1(d)

 

Marketing and License Agreement

 

This Marketing
and License Agreement (this “Agreement”) is made and shall be effective as of
February 24, 2000 by and among Kyowa Hakim Kogyo Co., Ltd., a Japanese
corporation with its principal place of business located at 1-6-1 Ohtemachi,
Chiyoda-ku, Tokyo 100-8185, Japan (hereinafter referred to as “Kyowa”), H.
Lundbeck A/S, a Danish corporation with its principal place of
business located at 9 Ottiliavej, DK-2S00 Valby, Copenhagen, Denmark
(hereinafter referred to as “Lundbeck”), and Cephalon, Inc., a Delaware
corporation with its principal place of business located at 145 Brandywine
Parkway, West Chester, Pennsylvania 19380-4245, U.S.A. (hereinafter referred to
as “Cephalon”).

 

WITNESSETH:

 

WHEREAS, Kyowa,
under the terms and conditions of a license agreement dated as of May 15, 1992,
as amended (the “Kyowa License”), granted to Cephalon the right to develop, use
and sell pharmaceutical products containing the substance KT7515; said right,
including the right to sublicense, being exclusive in the United States of
America and semi-exclusive in the rest of the wor1d;

 

WHEREAS, under
the terms and conditions of that certain Joint Research, Development and
License Agreement dated as May 28, 1999 by and between Cephalon and Lundbeck
(the “Lundbeck Sublicense”), Cephalon granted to Lundbeck an exclusive
sublicense under the Kyowa License, product rights in certain territories
outside the United States of America to a product developed by Cephalon that is
based on KT7515 and which shall be known hereafter as CEP-1347;

 

WHEREAS,
Cephalon and Lundbeck, under the Lundbeck Sublicense, contemplated entering
into further discussions with Kyowa with the objective of obtaining from Kyowa
certain additional territorial marketing rights covering pharmaceutical
product(s) containing CEP-1347 (the “Product”);

 

WHEREAS, after
discussions with Cephalon on and Lundbeck, Kyowa wishes to grant and Lundbeck
wishes to accept a license from Kyowa to commercialize the Product in those countries
set forth on Exhibit A attached hereto (the “Lundbeck Exclusive Territory”);

 

WHEREAS, in
consideration of the grant of a license from Kyowa, Lundbeck wishes to grant to
Kyowa an option under which Kyowa may obtain certain co-promotion rights to the
Product in the United Kingdom, Germany and Italy; and

 

WHEREAS, as a
result of the agreements between Kyowa and Lundbeck hereunder, Cephalon wishes
to clarify and amend certain of its obligations both under the Kyowa License
and the Lundbeck Exclusive License.

 

 

NOW,
THEREFORE, for good and valuable consideration, the receipt and adequacy of
which is hereby affirmed, and intending to be bound legally, the parties hereby
agree as follows:

 

Article 1.
Grant of License. Kyowa hereby grants to Lundbeck all
of its semi-exclusive rights to commercialize the Product in the Lundbeck
Exclusive Territory. Kyowa and Lundbeck further agree to enter into a form of
license agreement, or to establish additional terms and conditions of
licensure, if any, as they may deem necessary to effectuate the intent of this
license grant, but in no event shall such further agreement or terms require
that Lundbeck pay Kyowa any remuneration, or to take any action for the benefit
of Kyowa that Lundbeck may deem detrimental to its own interests, beyond that
agreed upon herein. Under the Lundbeck Sublicense, Cephalon has granted to
Lundbeck all of its semi-exclusive rights to commercialize the Product in the
Lundbeck Exclusive Territory. On the basis of these two such semi-exclusive license
grants, Cephalon and Kyowa each hereby affirm to Lundbeck that (i) it has
granted to Lundbeck all of its respective rights to commercialize the Product
in the Lundbeck Exclusive Territory; and (ii) without any further remuneration
or action other than as provided herein, Lundbeck now holds an exclusive
license (exclusive even as to Cephalon and Kyowa) to commercialize the Product
in the Lundbeck Exclusive Territory.

 

Article 2.
Option to Obtain Certain Co-Promotion Rights. Subject
to the terms and conditions set forth herein, promptly following the submission
by Lundbeck of any marketing authorization application seeking approval of the
competent regulatory authority in any Country in the Lundbeck Exclusive
Territory (including, without limitation, the European Medicines Evaluation
Agency) to enable Lundbeck (or an affiliate or assignee of Lund beck) to market
the Product, Kyowa shall have the option (which may be exercised pursuant to
written notice provided Lundbeck) to co-promote the Product as the exclusive
authorized representative of Lundbeck in the United Kingdom, Germany and Italy.
In consideration of undertaking such co-promotion efforts, Lundbeck sha1l pay
Kyowa an amount equal to [**] percent ([**]%) of all earnings derived from the
sale of the Product in such countries or otherwise to compensate Kyowa in a
manner that provides Lundbeck and Kyowa with a respective share of earnings of
[**]. Kyowa and Lundbeck further
shall mutually agree on the nature and scope of said co-promotion rights, and
shall enter into a form of co-promotion agreement, or to establish additional
terms and conditions for such co-promotion, as they may deem necessary and
appropriate, but in no event shall such further agreement or terms require that
Lundbeck pay Kyowa any remuneration, or to take any action for the benefit of
Kyowa that Lundbeck may deem detrimental to its own interests beyond that
agreed upon herein. For purposes of clarification, the co-promotion rights of
Kyowa established hereunder shall survive for so long as Lundbeck shall be
selling the Product in the Lundbeck Exclusive Territory.

 

Article 3. The
Kyowa License.

 

(a)          For so long as Lundbeck shall be required to
pay Kyowa those amounts established in Article 2 hereof, then in lieu of any
amounts otherwise due and payable to Kyowa under the Kyowa License Cephalon
shall pay directly to Kyowa a royalty in an amount equal to [**] percent
([**]%) of the Net Selling Price of CEP-1347 by Lundbeck in the Lundbeck
Exclusive Territory.

 

** 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.

 

 

(b)         Cephalon on and Kyowa acknowledge and agree
that nothing contained in this Agreement shall limit or otherwise affect
Cephalon’s semi-exclusive marketing rights to CEP-1347 in Japan and the rest of
Asia established under the Kyowa License.

 

Article 4. The
Lundbeck Sublicense.

 

(a)          Lundbeck and Cephalon acknowledge and agree
that upon the execution of this Agreement by the parties:

 

(i)                                     Cephalon
shall have satisfied its obligations under Section 5.5(b) of the Lundbeck
Sublicense;

 

(ii)                                  Section
5.5(c) and Section 17.2 of the Lundbeck Sublicense shall be void and of no
further force and effect;

 

(iii)                               The
additional license fee established under Section 7.3 of the Lundbeck Sublicense
shall be due and payable immediately upon the execution of   this Agreement; and

 

(iv)                              The
royalty rate(s) established under Section 7.2(a) of the Lundbeck Sublicense
shall be reduced by [**] percent ([**]%) for so long as Lundbeck shall be
required to pay Kyowa those amounts established in Article 2 hereof.

 

(b)         Lundbeck and Cephalon agree that the execution
and delivery of this Agreement satisfies the condition set forth in Section
7.4(a)(i)(A) of the Lundbeck Sublicense.

 

Article 5.
Genera1

 

(a)          Headings. The headings and captions used
herein are for the convenience of the parties only and they are not intended to
be construed to define, limit, or affect the construction or interpretation
hereof.

 

(b)         Entire Agreement. This Agreement, together
with the Lundbeck Sublicense, contains the entire agreement of the parties
regarding the subject matter hereof and supersedes all prior agreements,
understandings or conditions (whether oral or written) regarding the same.  This Agreement may not be changed, modified,
or amended except by a written instrument signed by all of the parties.

 

(c)          Further Assurances. Each party agrees to
execute, acknowledge and deliver such further instruments, and to take such
other actions, as may be necessary or appropriate to carry out the purposes and
intent of this Agreement.

 

(d)         Severability. If any Article or part thereof
contained in this Agreement is declared invalid by any court of competent
jurisdiction or government agency having jurisdiction, such declaration shall
not affect the remainder of the Article or the other Articles and each

 

** 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.

 

 

shall remain in full force and effect. To the extent possible, the
parties shall reform such invalidated Article or part thereof in a manner that
will render such provision valid without impairing the original intent of the
parties.

 

(e)          Counterparts. This Agreement may be executed
in counterparts, each of which shall be deemed to be an original and all of
which, when taken together. shall constitute the Agreement.

 

 

IN WITNESS
WHEREOF, the parties have executed this Agreement by their duly authorized
representatives as of the date first above written.

 

 

	
  H. LUNDBECK A/S

  	
  KYOWA HAKKO KOGYO CO., LTD.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Claus
  Braestrup

  	
   

  	
  By:

  	
  /s/ Yoh
  Tokoro

  	
   

  
	
  Claus
  Braestrup

  	
  Yoh Tokoro

  	
   

  
	
  Title:

  	
  Executive Vice President

  	
   

  	
  Title:

  	
  Senior Executive Officer

  	
   

  
	
  April 10, 2000

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  CEPHALON,
  INC.

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Peter E.
  Grebow

  	
   

  	
   

  	
   

  
	
  Title:
  Senior Vice President Worldwide Business Development

  	
   

  	
   

  
										

 

 

Exhibit
A - List
of Countries in the Lundbeck Exclusive Territory

 

Western Europe

Andorra

Austria

Belgium

Denmark

Finland

France

Germany

Greece

Iceland

Ireland

Italy

Liechtenstein

Luxembourg

Malta

Monaco

The
Netherlands

Norway

Portugal

Spain

Sweden

Switzerland

United Kingdom

 

Eastern Europe

 

Albania

Bulgaria

Czech Republic

Hungary

Poland

Romania

Serbia, Croatia, Macedonia, Bosnia-Herzegovina and any country that was
formerly part of Yugoslavia.

Slovakia

Any country
that was formerly part of the Soviet Union.

 

Other

 

Australia

New Zealand

South Africa

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