Amendment No. 2 to License Agreement between AstraZeneca AB and The Medicines Company

Contract Categories: Intellectual Property › License Agreements
Summary

AstraZeneca AB and The Medicines Company have agreed to amend their existing license agreement regarding clevidipine. This amendment updates the deadlines for The Medicines Company to file New Drug Applications (NDAs) in the United States, major markets, and Japan. The new deadlines are September 30, 2007 for the U.S., September 30, 2009 for other major markets, and December 31, 2010 for Japan. All other terms of the original agreement remain in effect.

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EX-10.38 5 y74894exv10w38.htm EX-10.38: AMENDMENT NO.2 TO LICENSE AGREEMENT EX-10.38
Exhibit 10.38
AMENDMENT NO. 2
TO
LICENSE AGREEMENT
          THIS AMENDMENT NO. 2 (“Amendment No. 2”) to the AGREEMENT (as defined below) is entered into as of 22 October, 2008 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 regarding clevidipine effective as of March 28, 2003 and as amended on April 25, 2006 (the “Agreement”); and
          WHEREAS, the parties desire to further 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 3.7.2 is amended and restated as follows:
          “3.7.2 Time Limit for Filing an NDA.
  (a)   TMC shall no later than 30 September 2007 have made a Filing of an NDA in the United States.
 
  (b)   TMC shall no later than 30 September 2009 have made a filing of an NDA in all the additional Major Markets, except as provided for in Article 3.7.2(c).
 
  (c)   TMC shall no later than 31 December 2010 have made a Filing of an NDA in Japan.”
3.   This Amendment No. 2 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. 2 shall be effective as of the date first written above.

 

 

Exhibit 10.38
          IN WITNESS WHEREOF, this Amendment No. 2 has entered into force as of the date first written above.
             
ASTRAZENECA AB (publ)   THE MEDICINES COMPANY
 
            
 
            
By:
  /s/ Gunnar Olsson   By:   /s/ John Kelley
 
           
 
  Name: Gunnar Olsson       Name: John Kelley
 
  Title: VP & Head of CVGI Therapy Area       Title: President and Chief Operating Officer