Document:

EXHIBIT 10.1(e)

 

June 13, 2001

 

 

Amendment No.2

To Joint Research, Development and License Agreement dated May 28, 1999

 made between

 

Cephalon Inc.

145 Brandywine Parkway

West Chester Pennsylvania 19380-4245

 

and

 

H. Lundbeck A/S

9 Ottiliavej,

DK 2500 Valby

Denmark

 

 

1.             This is to confirm our
understanding concerning certain amendments and/or clarifications to be made
with respect to the Joint Research, Development and License Agreement between
Cephalon, Inc. (“Cephalon”) and H. Lundbeck A/S  (“Lundbeck”) dated
May 28, 1999 as amended by:

•        Clarification
Letter dated July 1, 1999 regarding the interpretation of Section 6.5,

•        Amendment
No.1 dated October 1999 regarding IT Year 2000 Conformity,

•        Clarification
Letter dated March 16, 2000 regarding Section 1.5, 1.27,5.7 and 17,

•        Marketing and Licensee Agreement made
between Cephalon, Kyowa Hakko and Lundbeck     dated
April 10, 2000

herein and
after together defined as the “Agreement”.

 

2.             All terms not otherwise defined or
amended herein are used as defined in the Agreement and shall remain in full
force and effect as set forth in the Agreement.

 

 

3.                  The purpose of this Amendment
No.2 is to amend the definition of Compounds, to

clarify which
compounds are considered to be Joint Compounds and to clarify each party’s
respective rights to New Compounds (defined below).

 

4.                   During the course of the
Research Program involving Lundbeck and Cephalon,

certain
compounds may demonstrate specified activity criteria, as determined by the
JMT, against certain targets in the stress activated protein kinase pathways,
as defined by the JMT. Such compounds that meet these activity criteria shall
be deemed “Compounds”.

 

5.                   The JMT may decide to have
new compounds synthesized based on those

Compounds
described in paragraph 4 above, or based on information obtained from outside
the collaboration, in both cases defined as “New Compounds.” Such New Compounds
may be synthesized by either Lundbeck or Cephalon (the “Synthesizing Party”),
as decided by the JMT. The Synthesizing Party shall be deemed to be the owner
of any New Compound it synthesizes.

 

6.                   Any New Compounds that do not
demonstrate the specified activity criteria, as

determined by
the JMT, automatically upon termination of the Research Program shall revert
back to, and become the exclusive property of the Synthesizing Party, and shall
not be considered part of the research and development collaboration, nor
subject to the Agreement or any modifications or amendments thereto. Further,
at the time of such reversion the other party automatically grants the
Synthesizing Party an irrevocable, royalty-free, exclusive license to its
Know-How and Patent Rights, with right to sublicense, to make, have made,
import, use and sell such compound (including any product made with it or employing
it) world-wide, which license survives termination of the Agreement.

 

7.                   Any New Compounds that
demonstrate the specified activity criteria, as determined

by the JMT,
shall be deemed to be Joint Compounds. The parties shall exchange New Compounds
that demonstrate such specified activity criteria and, until termination of the
Research Program, each party may request a reasonable number (up to three
percent of Compounds) and amount as specified by the JMT of such New Compounds
from the other party provided that they are in stock and available. Should one
party (the “First Party”) determine that the other party’s (the “Second Party”)
New Compound, could be commercialized outside of the Field, then the parties
may negotiate in good faith a payment, royalty or other fair market value
compensation for the Second Party.

 

 

8.                  In the course of the research
and collaboration between the Parties, if new Targets are

selected by
the JMT under the terms of the Agreement (“New Targets”), then at the sole
discretion of the JMT, New Compounds may be tested for activity against such
New Targets.

 

9.                    Any New Compounds that
demonstrate the specified activity criteria against a New

Target, as
defined by the JMT, shall be deemed to be Joint Compounds.

 

10.                  Any New Compounds that do not
demonstrate the specific activity criteria against a

New Target as
defined by the JMT, as well as any New Compounds that are deemed to be Joint
Compounds but are not designated as a Development Compound or a Backup Compound
shall be governed by paragraph 6 above for New Compounds that do not
demonstrate the specified activity criteria.

 

11.                  Any Patent Rights in a New
Compound shall be assigned to the Synthesizing Party

while
inventorship for any New Compound shall be determined by appropriate patent law
mutually agreeable to the Parties. The Party that synthesized the New Compounds
shall also be responsible for the preparation, filing, prosecution and
maintenance of such patents both inside and outside the Territory.

 

12.                  This Amendment No.2 shall form
an integral part of the Agreement and shall be

regarded as
incorporated into the Agreement in every respect as from the date both Parties
execute this Amendment No.2. In case of inconsistency between the terms and
conditions of the Agreement and this Amendment No.2 the latter shall prevail to
the extent of such inconsistency but no further.

 

13.                 This Amendment No.2 comes into
force when executed by both Parties and may be

executed in
counterpart and duplicate original.

 

[Remainder of
Page Intentionally Left Blank]

 

 

AGREED,
ACKNOWLEDGED AND ACCEPTED

 

 

IN WITNESS
THEREOF, the Parties have executed this Agreement by their duly authorized
representatives, as of the day and year first above written.

 

 

	
  H. LUNDBECK A/S

  	
   

  	
  CEPHALON,
  INC.

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Claus
  Braestup

  	
   

  	
  By:

  	
  /s/ Peter E.
  Grebow

  	
   

  
	
  Claus
  Braestrup

  	
  Peter E.
  Grebow

  	
   

  
	
  Executive
  Vice President, R& D

  	
   

  	
  Senior Vice
  President,

  	
   

  
	
   

  	
  Business
  DevelopmentEXHIBIT 10.1(f)

 

June 10, 2002

 

Amendment No.3

To Joint Research, Development and License Agreement dated May 28, 1999

made between

 

Cephalon Inc.

145 Brandywine Parkway

West Chester

Pennsylvania 19380-4245

 

and

 

H. Lundbeck A/S

9 Ottiliavej,

DK 2500 Valby

Denmark

 

 

1.                    This is to confirm our
understanding concerning certain amendments and/or

clarifications
to be made with respect to the Joint Research, Development and License
Agreement between Cephalon, Inc. (“Cephalon”) and H. Lundbeck A/S (“Lundbeck”)
dated May 28, 1999 as amended by:

•        Clarification
Letter dated July 1, 1999 regarding the interpretation of Section 6.5,

•        Amendment
No.1 dated October 1999 regarding IT Year 2000 Conformity,

•        Clarification
Letter dated March 16, 2000 regarding Section 1.5, 1.27, 5.7 and 17,

•        Marketing
and Licensee Agreement made between Cephalon, Kyowa Hakko and Lundbeck     dated April 10, 2000

•        Amendment
No.2 dated June 13, 2001

(hereinafter
together defined as the “Agreement”).

 

2.                   All terms not otherwise
defined or amended herein are used as defined in the Agreement and shall remain
in full force and effect as set forth in the Agreement.

 

 

3.                  The purpose of this Amendment
No.3 is to extend the Research Program and to

clarify the
definition of Cephalon Technology.

 

4.                   Cephalon and Lundbeck hereby
agree to extend the term of the Research Program

from May 28,
2002 until December 31, 2002 (the “Extended Research Term”). During the
Extended Research Term, Lundbeck agrees to provide financial support for the
employment by Cephalon of ten (10) FTEs, or a higher number of FTEs mutually
agreed in writing by both Parties, at the current FTE rate being charged by
Cephalon for 2002.

 

5.                  The term “Cephalon Technology”
is hereby amended to add the following sentence:

Cephalon
Technology includes the patent rights granted to Cephalon under the agreement
between Ya Fang Liu, Ph.D., M.D. and Cephalon, Inc. wherein Cephalon was
granted a worldwide, exclusive license to patent application, U.S. serial
number 09/156,367, entitled “Method for Identifying JNK and MLK Inhibitors for
Treatment of Neurological Conditions,” and all issued patents, continuing
patent applications, divisionals, continuations, continuations-in-part,
reissues, reexaminations and extensions derived therefrom, as well as any
foreign patent applications, granted foreign patents and foreign counterparts
and extensions thereof.

 

6.                    This Amendment No.3 shall
form an integral part of the Agreement and shall be

regarded as
incorporated into the Agreement in every respect as from the date both Parties
execute this Amendment No.3. In case of inconsistency between the terms and
conditions of the Agreement and this Amendment No.3 the latter shall prevail to
the extent of such inconsistency but no further.

 

7.                   This Amendment No.3 comes
into force when executed by both Parties and may be

executed in
counterpart and duplicate original.

 

[Remainder of
Page Intentionally Left Blank]

 

 

AGREED,
ACKNOWLEDGED AND ACCEPTED

 

 

IN WITNESS
THEREOF, the Parties have executed this Agreement by their duly

authorized
representatives, as of the day and year first above written.

 

 

	
  H. LUNDBECK
  A/S

  	
   

  	
  CEPHALON,
  INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Claus
  Braestrup

  	
   

  	
  By:

  	
  /s/ Peter E.
  Grebow

  	
   

  
	
  Claus
  Braestrup

  	
   

  	
  Peter E.
  Grebow

  
	
  Executive
  Vice President, R&D

  	
   

  	
  Senior Vice
  President, Business Development

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