EXHIBIT 10.1

 

AMENDMENT NO. 3 TO MANUFACTURING AGREEMENT

 

THIS AMENDMENT NO. 3 TO MANUFACTURING AGREEMENT (this “Third Amendment”) is made
and entered into as of March 25, 2009 (the “Effective Date”), by and between
Osiris Therapeutics, Inc., a Delaware corporation (“Osiris”), and
NuVasive, Inc., a Delaware corporation (“NuVasive”).

 

RECITALS

 

WHEREAS, on May 8, 2008, Osiris and NuVasive entered into an Asset Purchase
Agreement pursuant to which Osiris agreed to sell, and NuVasive agreed to
purchase, technology related to manufacturing the Osteocel product line (as more
specifically set forth therein), such sale and purchase taking place July 24,
2008, which Asset Purchase Agreement was subsequently amended September 30, 2008
(the “Purchase Agreement”).

 

WHEREAS, pursuant to the Purchase Agreement, on July 24, 2008, Osiris and
NuVasive entered into a Manufacturing Agreement whereby Osiris agreed to
manufacture and deliver to NuVasive, and NuVasive agreed to purchase, the
Product (as defined therein), which Manufacturing Agreement was subsequently
amended on September 30, 2008 and on October 22, 2008 (the “Manufacturing
Agreement”).

 

WHEREAS, Osiris and NuVasive wish to enter into this Third Amendment to provide
for the end of the Term of the Manufacturing Agreement and to provide for the
terms and conditions associated with such termination.

 

NOW, THEREFORE, in consideration for the mutual covenants of the parties
expressed herein, the sufficiency of which consideration is acknowledged, it is
agreed that the Manufacturing Agreement is amended as of the Effective Date as
follows:

 

AMENDMENT

 

1.                                 DEFINED TERMS.  EXCEPT AS OTHERWISE PROVIDED
IN THIS AMENDMENT, CAPITALIZED TERMS WILL HAVE THE MEANINGS ASSIGNED TO THEM IN
THE MANUFACTURING AGREEMENT.

 

2.                                 TERMINATION OF MANUFACTURING AGREEMENT. 
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THE MANUFACTURING AGREEMENT,
NUVASIVE AND OSIRIS AGREE THAT:

 

(A)                                  SECTION 7.1 OF THE MANUFACTURING AGREEMENT
SHALL BE DELETED IN ITS ENTIRETY AND INSERTING IN ITS PLACE THE FOLLOWING.

 

“THIS AGREEMENT SHALL COMMENCE ON THE EFFECTIVE DATE AND REMAIN IN EFFECT UNTIL
THE FIFTEENTH DAY FOLLOWING THE EXECUTION BY NUVASIVE AND OSIRIS OF THIS
AMENDMENT (THE “TERMINATION DATE”) AND IMMEDIATELY FOLLOWING THE TERMINATION
DATE, OSIRIS SHALL CEASE ALL MANUFACTURING OPERATIONS WITH RESPECT TO THE
PRODUCT EXCEPT AS SET FORTH IN THIS AGREEMENT AS AMENDED BY THE THIRD
AMENDMENT.”

 

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(B)                                 NUVASIVE AND OSIRIS SHALL USE COMMERCIALLY
REASONABLE EFFORTS TO OBTAIN THE CONSENT OF ALLOSOURCE TO TERMINATE THAT CERTAIN
AMENDED AND RESTATED TISSUE PROCUREMENT PROCESSING AND SUPPLY AGREEMENT BY AND
BETWEEN OSIRIS AND ALLOSOURCE, DATED FEBRUARY 1, 2008 (THE “ALLOSOURCE SUPPLY
AGREEMENT”).  IN THE EVENT THAT ALLOSOURCE DOES NOT AGREE TO TERMINATE THE
ALLOSOURCE SUPPLY AGREEMENT, NUVASIVE AGREES TO ASSUME THE ALLOSOURCE SUPPLY
AGREEMENT.

 

(C)                                  IN THE EVENT THAT ALLOSOURCE REQUESTS
PRODUCT TO BE SHIPPED IN FREEZERS DESIGNATED TO BE ASSETS OF NUVASIVE, NUVASIVE
HEREBY AUTHORIZES OSIRIS TO SHIP SUCH PRODUCT IN SUCH FREEZERS TO ALLOSOURCE.

 

3.                                 FULL FORCE AND EFFECT.  EXCEPT AS SET FORTH
IN THIS AMENDMENT, THE MANUFACTURING AGREEMENT SHALL CONTINUE UNMODIFIED AND IN
FULL FORCE AND EFFECT.

 

4.                                 COUNTERPARTS.  THIS AMENDMENT MAY BE EXECUTED
IN ANY NUMBER OF COUNTERPARTS, ALL OF WHICH SHALL BE DEEMED ONE ORIGINAL AND
COMPLETE INSTRUMENT.

 

5.                                 Insurance.  “Section 6.5 of the Manufacturing
agreement will be amended to replace the word “occurrence” to ‘claims made”.

 

 

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IN WITNESS WHEREOF, the parties have executed this Amendment No. 3 to
Manufacturing Agreement as of the date first set forth above.

 

 

OSIRIS THERAPEUTICS, INC.

 

NUVASIVE, INC.

 

 

 

 

 

 

By:

/s/ Richard W. Hunt

 

By:

/s/ Jason Hannon

Name:

Richard W. Hunt

 

Name:

Jason Hannon

Its:

Chief Financial Officer

 

Its:

Senior Vice President, General Counsel and Secretary

 

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