EX-10.38: AMENDMENT NO.2 TO LICENSE AGREEMENT
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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 |