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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intentionally blank]


 


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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