Document:

Letter Amendment

 Exhibit 10.3 
 November 24, 2010 
 Alphatec Spine Inc 

5818 El Camino Real 
 Carlsbad, CA 92008

 USA 
 Dear Sir, 

Letter of Amendment in respect of Supply Agreement between Invibio Inc. and Alphatec Spine, Inc. (formerly Alphatec Manufacturing, Inc.) dated
October 18, 2004, as amended (the “Agreement”). 
 Following our discussions we are writing to confirm that pursuant to
section 4.1 of the Agreement we have agreed to make the following amendments to the Agreement: 
 1. Clause 3.1 shall be amended so that the
Term of the Agreement shall be extended for an additional [***], therefore expiring on [***]. 
 2. Clause 2.3 shall be amended to incorporate
the revised pricing structure, [***], with effect from the date of this letter, as below: 
 [***] 

Prior to the start of a calendar year, Buyer shall provide Supplier with a non-binding forecast of its Material requirements for that calendar year and
on the basis of such forecast shall indicate the relevant pricing level (Base, Tier 1, Tier 2 or Tier 3) to be initially applied for Buyer’s Material orders during that calendar year. If by the end of a calendar year Buyer’s actual
Material orders are such that a different pricing level should have applied during that calendar year, then within twenty (20) days of the end of that calendar year Supplier shall either invoice or credit Buyer for the price difference. [***]

 [***] 
 Except as provided above
all other provisions of Clause 2.3 shall remain in full force and effect. 
 3. Buyer shall provide a full listing of its Buyer Product part
numbers for inclusion in Exhibit A as soon as such part numbers become available. 
 4. The first paragraph of Standard Condition 2 shall be
deleted and replaced as follows: 
 Except as permitted in this Agreement, Buyer or any Buyer subsidiaries shall not make commercially available
any implantable medical devices using any form of 

  
 Portions of
this Exhibit were omitted, as indicated by [***], and have been filed separately with the 
 Secretary of the Commission
pursuant to the Registrant’s application requesting confidential 
 treatment under Rule 24b-2 of the Securities
Exchange Act of 1934, as amended. 

 
polyaryletherketone, other than provided by Supplier during the Term (as extended) of this Agreement. Notwithstanding the foregoing, during the Term, a “Failure to Supply” shall occur,
on a size-by-size basis, if, [***] Supplier fails to supply [***] of the Materials set forth in such orders in accordance with the Specifications or Supply Manufacturing Definitions, as applicable by the delivery dates; provided that a Failure to
Supply shall not have been deemed to have occurred with respect to any orders that occur after the Buyer has ordered an amount of such size of Materials that is in excess of Buyer’s annual forecast of its requirements for such size of
Materials, as referred to in Section 2 above. Following a Failure to Supply, the Buyer shall be entitled to purchase any form of polyaryletherketone from third-party suppliers for use in implantable medical devices other than the Supplier with
respect to that particular size of Materials, until such time as Supplier notifies to Buyer in writing that it is able to provide Materials in accordance with Buyer’s requirements, and Buyer confirms such notification to its reasonable
satisfaction; always provided that in any particular lot of a Buyer Product, Buyer shall not co-mingle the Materials with any third-party supplier’s form(s) of polyaryletherketone and, Buyer shall maintain records for each particular Buyer
Product lot identifying the source of the polyaryletherketone used within that Buyer Product lot. 
 5. The definition of the term
“Affiliate” shall be deleted and replaced with the following: 
 “Affiliate of a party shall mean (a) its
Subsidiaries (as defined below), and Parent (as defined below) of a party and any other Subsidiaries of such Parent, or (b) any partnership, joint venture or other entity directly controlled by or under common control with such party, but in
each case only for so long as such ownership or control shall continue. Reference in this Agreement to “Buyer” shall encompass all Affiliates of Buyer, which are listed on Exhibit E attached hereto, as such list may be amended from
time to time by the Buyer. After being listed on Exhibit E attached hereto, an Affiliate of the Buyer shall be entitled to make separate orders for Materials to the Supplier, and such orders shall be included in any calculations made to
determine the correct discount percentage, always provided that such orders are included in Buyer’s annual forecast of its annual requirements for Materials as referred to at point 2 above. Notwithstanding the foregoing, the limitations set
forth in the first paragraph of Standard Condition 2 regarding the use of third-party suppliers for the supply of polyaryletherketone shall not apply to Affiliates of the Buyer that had a written agreement for the supply of polyaryletherketone with
a third-party supplier prior to becoming an Affiliate of the Buyer; provided that the Buyer shall not seek to circumvent the first paragraph of Standard Condition 2 by purchasing polyaryletherketone for use directly by Buyer through such
Affiliate(s). 
 Except as expressly provided in this letter of amendment, all other terms, conditions, and provisions of the Agreement shall
continue in full force and effect as provided therein. 
 This letter shall be governed by and construed in accordance with the laws of the
state of Colorado without regard to the conflict of law provisions thereof. 

  
 Portions of
this Exhibit were omitted, as indicated by [***], and have been filed separately with the 
 Secretary of the Commission
pursuant to the Registrant’s application requesting confidential 
 treatment under Rule 24b-2 of the Securities
Exchange Act of 1934, as amended. 

 [Signature Page Follows] 
 IN WITNESS WHEREOF, the parties have confirmed their acceptance of the contents of this letter. 
  

					
	 /s/ Gary Hume, Vice President
	 		  	 /s/ Dirk Kuyper, President and CEO

	For and on behalf of	 		  	For and on behalf of
	 Invibio Inc.
  
	 		  	 Alphatec Spine, Inc.
  

	 Date 3/3/11
	 		  	 Date 3/17/11

  
 Portions of
this Exhibit were omitted, as indicated by [***], and have been filed separately with the 
 Secretary of the Commission
pursuant to the Registrant’s application requesting confidential 
 treatment under Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.Amendment No. 2 to Development and License Agreement

 Exhibit 10.64 
 Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A
complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 
 AMENDMENT NO. 2 TO
DEVELOPMENT AND LICENSE AGREEMENT 
 This Amendment No. 2 to Development and License Agreement (“Amendment No. 2”) is
entered into effective February 8, 2011 (the “Amendment No. 2 Date”) by and between DURECT CORPORATION (“DURECT”) and NYCOMED DANMARK APS (“NYCOMED”). 

PRELIMINARY STATEMENTS 
 A. DURECT and NYCOMED have previously entered into that certain Development and License Agreement dated November 29, 2006, as amended by Amendment No. 1 effective February 18, 2010 (the
“Agreement”). 
 B. The Parties now desire to amend the Parties’ respective funding and other obligations
for the Joint Program during the Interim Period (defined below). 
 THEREFORE, in consideration of the premises and mutual
promises and covenants herein contained and for good and valuable consideration, the sufficiency of which is hereby acknowledged, DURECT and NYCOMED hereby agree as follows: 
 1. Unless otherwise defined herein, all capitalized terms used herein shall have the same meaning ascribed to such terms in the Agreement. References to section numbers herein shall refer to section
numbers in the Agreement. 
 2. During the period commencing from January 1, 2011 and until the earlier of i) [***] days
after DURECT provides NYCOMED with the results from the Phase III Clinical Study referred to as BESST (Bupivacaine Effectiveness and Safety in SABER Trial) (“BESST”) or ii) the effective termination date of the Agreement (such period the
“Interim Period”), the following shall be applicable: 
 (a) notwithstanding Section 4.5(a), DURECT shall
bear one hundred percent (100%) of the Development Costs under the JDP for the Product incurred during the Interim Period; and 
 (b) as between the Parties, DURECT shall be solely responsible for performing all activities under the JDP during the Interim Period; and 

(c) during the Interim Period, except for the activities set forth in Section 13.8 or in order to bring the [***] (shoulder)
On-Going Cohort 1 Trial to a full completion, Nycomed shall have no obligation to perform any activities under the JDP during the Interim Period, nor undertake any development, regulatory or commercialization activities assigned to it under the
Agreement, including but not limited to any work or activities under the JDP, the EU-CDP or development work for the Non-EU Jurisdictions unless required for patient safety reasons under Applicable Laws. 

  
 1 

CONFIDENTIAL 

 Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits
the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 (d) The following text shall be added at the end of Section 2.1(d)(i): 

“Notwithstanding the foregoing, during the Interim Period, if however the dispute is the subject of a deadlock
exclusively concerning activities to be performed under the JDP (including the amendment, performance or implementation thereof, but for avoidance of doubt, excluding any and all activities related to the On-Going Cohort 1 Trials (the hysterectomy
and shoulder trials) including but not limited to press releases, communications, study reports,) then, after the Parties having duly complied with the decision making process and escalation outlined in this Section 2.1, the matter is still the
subject of a deadlock, DURECT may, at its sole discretion and election, make the final decision.” 
 (e)
DURECT shall indemnify, defend and hold Nycomed and any Nycomed Related Party harmless from and against any Damages arising out of Third Party claims related to any activities performed by DURECT during the Interim Period. 

(f) This paragraph 2 of this Amendment No. 2 shall terminate and be of no force and effect after the expiration of
the Interim Period. 
 3. The following clause shall be inserted following “US-CDP” at the end of
Section 13.7(b): 
 “: provided, however, if DURECT has not delivered to NYCOMED the results from BESST by
December 31, 2011, then notwithstanding the foregoing, NYCOMED may terminate the Agreement at its sole election upon thirty (30) days prior written notice to DURECT,” 

4. Except as specifically provided in this Amendment No. 2, all other terms and conditions of the Agreement shall remain the same.

 5. This Amendment No. 2 shall be governed and interpreted in accordance with the law of the State of New York excluding
any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Amendment No. 2 to the substantive law of another jurisdiction. 

6. This Amendment No. 2 may be executed in any number of counterparts, each of which shall be deemed to be an original, and all of
which, taken together, shall constitute one and the same instrument. This Amendment No. 2 may be executed by any party hereto by means of a facsimile transmission of an originally executed counterpart, the delivery of which facsimile
transmission shall have the same force and effect as the delivery of the originally executed counterpart. 

  
 2 

CONFIDENTIAL 

 Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits
the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 [Signature Page Follows] 

 
  

  
 3 

CONFIDENTIAL 

 Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits
the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 IN WITNESS WHEREOF, each Party has caused this Amendment No. 2 to be executed by its duly
authorized representative as of the date noted above in the preamble. 
  

									
	DURECT CORPORATION	 		 	NYCOMED DANMARK APS
					
	By:	 	 /s/
	 		 	By:	 	 /s/

					
	Name:	 	 James E. Brown
	 		 	Name:	 	 Hakan Bjorklund

					
	Title:	 	 CEO
	 		 	Title:	 	 CEO

					
		 		 		 	By:	 	 /s/

					
		 		 		 	Name:	 	 Ghita Astrup

					
		 		 		 	Title:	 	 Managing Director

  
  

CONFIDENTIAL

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