Exhibit
10.1


 


Confidential
Materials omitted and filed separately with the

Securities and Exchange Commission. 
Asterisks denote omissions.


AMENDMENT NO. 1


TO


LICENSE AGREEMENT


THIS AMENDMENT NO.
1 (“Amendment No. 1”) TO THE AGREEMENT (as defined below) is entered into as of
April 25, 2006 by and between ASTRAZENECA AB, a company incorporated under the
laws of Sweden with its registered office at SE-151 85 Södertälje, Sweden (“ASTRAZENECA”)
and THE MEDICINES COMPANY, a company incorporated under the laws of Delaware
with its registered office at 8 Campus Drive, Parsippany, New Jersey 07054,
United States (“TMC”).


WITNESSETH:


WHEREAS, the
parties hereto are parties to that certain License Agreement on clevidipine
that entered into effect as of March 28, 2003 (the “Agreement”); and


WHEREAS, the
parties desire to amend the Agreement as set forth herein.


NOW, THEREFORE,
the parties agree as follows:


1.             Capitalized terms used herein but
not otherwise defined herein, shall have the meanings provided in the Agreement.


2.             Article 1.26 is amended and
restated as follows:


“1.26.                                                                  “Major
Market” shall mean each of [**].”


3.             Article 1.45 is amended and restated
as follows:









 



 


“1.45.                      “Territory” shall mean
every country in the world.”


4.             Article 2.6 is deleted in its entirety.


5.             Article 2.7 is deleted in its
entirety.


6.             Article 3.7.2 is amended and
restated as follows:


“3.7.2      Time Limit for Filing an NDA.


(a)                                                                                  TMC shall no later than [**]
have made a Filing of an NDA in the United States.


(b)                                                                                 TMC shall no later than [**] or
[**] after having made a Filing of an NDA in the United States, whichever is
the earlier, have made a filing of an NDA in at least three (3) additional
Major Markets, provided, however, that if such Filing of an NDA has been made
in the European Union then one (1) Major Market shall be sufficient.


(c)                                                                                  TMC shall, subject to what is
stated in the second paragraph hereof, no later than [**] or [**] after having
made the last Filing of an NDA under Article 3.7.2(b), whichever is the
earlier, have made a Filing of an NDA in all Major Markets.


Notwithstanding
what is now stated, TMC shall no later than [**] have made a Filing of an NDA
in Japan.”


7.             Article 4.3.1 is amended and
restated as follows:


“4.3.1.                                                            Subject
to Article 15.1(i), TMC undertakes to supply ASTRAZENECA, ASTRAZENECA’s entire
need of Product for









 



clinical
trials, sale, promotion and marketing in any country where the license granted
under Article 2 has been terminated pursuant to Article 3.8 as more fully set
forth in that certain Supply Agreement dated June 24, 2004 as amended from time
to time (the “Supply Agreement”).”


8.             Article
4.3.2 is deleted in its entirety


9.             Article 5.1.4 is amended and restated as follows:


“5.1.4.                                                            TMC
shall notify ASTRAZENECA forthwith regarding, and provide copies of, any
correspondence with the regulatory authorities in the Territory that could
reasonably be of any significance regarding the possibility, time frame or
scope of any Filing of an NDA or any NDA Approval or which may otherwise relate
to such Filing of an NDA or NDA Approval.”


10.                                 Article
6 is amended by removal of the words “a final milestone payment in” in Article
6.1.5 and the addition of the following Article 6.1.6.:


“6.1.6.                                                            Within
thirty (30) days of TMC’s receipt of NDA Approval in the fourth Major Market,
TMC shall pay to ASTRAZENECA the amount of USD [**] ($[**]).”


11.           Article 6.6.2 is deleted in its
entirety.


12.           Article 8.3.5 is amended and restated
as follows:


“8.3.5.                                                            ASTRAZENECA,
its Affiliates or sub-licensees shall have the sole right to commence an action
for infringement of the ASTRAZENECA IP in any country in which the license
granted to TMC hereunder has reverted to ASTRAZENECA pursuant to









 



Article 3.8
against the Third Party, in its own name, together with the right to enforce
and collect any judgement thereon. TMC may join such proceedings voluntarily,
subject always to ASTRAZENECA’s, its Affiliates’ or sub-licensees’ right to
decide the conduct of such litigation. Any such joining of the proceedings
shall be at TMC’s cost and expense. TMC shall for such purpose have the right
to independently retain legal counsel and consultants, at its sole cost and
expense. Any monetary recovery (whether by settlement or judgement) in
connection with an infringement action commenced by ASTRAZENECA under this
Article 8.3.5 shall be retained by ASTRAZENECA.”


13.                                 Where
an Article is deleted pursuant to this Amendment no other provision will take
the number of such former Article, and the number of the deleted Article will
remain in the Agreement with no wording attached to it.


14.                                 Upon execution of this Amendment No. 1, TMC shall pay to ASTRAZENECA
the amount of USD [**] ($[**]).”


15.                                 This Amendment No. 1 shall be deemed to be part of the Agreement and,
as modified in accordance herewith, the Agreement is hereby ratified and
declared in full force and effect. This Amendment No. 1 shall be effective as
of the date first written above.









 



 


IN WITNESS WHEREOF, this Amendment No. 1 has
entered into force as of the date first written above.


 


	
  ASTRAZENECA AB (publ)

  	
   

  	
  THE MEDICINES COMPANY

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Signature: /s/
  Gunnar Olsson

  	
   

  	
  Signature: /s/ John Kelley

  
	
  Name: Gunnar
  Olsson 

  	
   

  	
  Name: John Kelley 

  
	
  Title: Vice
  President, Head of CVGI TherapyArea

  	
   

  	
  Title: President, C.O.O.