**EXHIBIT10.1**

 

**AMENDMENTNO. 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 “***EffectiveDate***”), by and between Osiris Therapeutics, Inc., aDelaware corporation (“***Osiris***”),and NuVasive, Inc., a Delaware corporation (“***NuVasive***”).

 

RECITALS

 

WHEREAS, on May 8, 2008, Osiris and NuVasiveentered into an Asset Purchase Agreement pursuant to which Osiris agreed tosell, and NuVasive agreed to purchase, technology related to manufacturing theOsteocel product line (as more specifically set forth therein), such sale andpurchase taking place July 24, 2008, which Asset Purchase Agreement wassubsequently amended September 30, 2008 (the “***PurchaseAgreement***”).

 

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

 

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

 

NOW, THEREFORE, in consideration for the mutualcovenants of the parties expressed herein, the sufficiency of whichconsideration is acknowledged, it is agreed that the Manufacturing Agreement isamended as of the Effective Date as follows:

 

AMENDMENT

 

# **1.**                                 Defined Terms. Except as otherwise provided in this Amendment, capitalized terms willhave the meanings assigned to them in the Manufacturing Agreement.

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# **2.**                                 Termination of Manufacturing Agreement.  Notwithstanding anything to the contrary inthe Manufacturing Agreement, NuVasive and Osiris agree that:

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### **(a)**                                  Section 7.1 of the Manufacturing Agreement shall be deleted in itsentirety and inserting in its place the following.

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### **“This Agreement shall commence on the Effective Dateand remain in effect until the fifteenth day following the execution byNuVasive and Osiris of this Amendment (the “***Termination Date*”) and immediately following the Termination Date, Osiris shall cease allmanufacturing operations with respect to the Product except as set forth inthis Agreement as amended by the Third Amendment.”

 

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### **(b)**                                 NuVasive and Osiris shall use commercially reasonable efforts to obtainthe consent of AlloSource to terminate that certain Amended and Restated TissueProcurement Processing and Supply Agreement by and between Osiris andAlloSource, dated February 1, 2008 (the “*AlloSource Supply Agreement*”).  In the event that AlloSource doesnot agree to terminate the AlloSource Supply Agreement, NuVasive agrees toassume the AlloSource Supply Agreement.

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### **(c)**                                  In the event that AlloSource requests Product to be shipped in freezersdesignated to be assets of NuVasive, NuVasive hereby authorizes Osiris to shipsuch Product in such freezers to AlloSource.

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# **3.**                                 Full Force and Effect. Except as set forth in this Amendment, the Manufacturing Agreement shallcontinue unmodified and in full force and effect.

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# **4.**                                 Counterparts. This Amendment may be executed in any number of counterparts, all ofwhich shall be deemed one original and complete instrument.

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

 

 

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IN WITNESS WHEREOF, the parties have executed thisAmendment No. 3 to Manufacturing Agreement as of the date first set forthabove.

 

 
| **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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