EX-10.14



 Exhibit 10.14 

DATED AUGUST, 10 2010 

LIPOXEN TECHNOLOGIES, LTD. 

- and - 
 BAXTER
HEALTHCARE CORPORATION AND BAXTER HEALTHCARE SA 
 AMENDMENT NUMBER FOUR TO THE EXCLUSIVE RESEARCH, 

DEVELOPMENT AND LICENSE AGREEMENT 

 

  
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 DATE OF AMENDMENT NUMBER FOUR 10 AUGUST 2010 

PARTIES 
  

	(1)	LIPOXEN TECHNOLOGIES, LTD. whose registered office is at whose registered office at London Bioscience Innovation Centre, 2 Royal College St., London NWI ONH, England (“LIPOXEN”).


  

	(2)	BAXTER HEALTHCARE CORPORATION having its principal place of business at One BAXTER Parkway, Deerfield, Illinois 60015 (“BHC”) 


 

	(3)	BAXTER HEALTHCARE SA, a corporation organized and exiting under the laws of Switzerland having its principal place of business at Hertistr.28304, Wallisellen, Switzerland (“BHSA”)(BHC and BHSA
collectively referred to as “BAXTER”). 

 INTRODUCTION 

 

	 	(A)	WHEREAS, LIPOXEN entered into an Exclusive Research, Development and License Agreement (hereinafter the “AGREEMENT”) with BAXTER on August 15, 2005; 


 

	 	(B)	WHEREAS, the PARTIES have amended the AGREEMENT pursuant to the previous amendment agreements set out in Schedule B of this AMENDMENT NUMBER FOUR (“AMENDMENT”); 


 

	 	(C)	WHEREAS, the PARTIES desire to further amend the AGREEMENT in accordance with and subject to the provisions of this AMENDMENT; 

  

	 	(D)	WHEREAS, the AGREEMENT [***] to LIPOXEN in relation to BAXTER SOLE INVENTIONS and the PARTIES have agreed that in relation to those certain rights that LIPOXEN [***] provided that BAXTER [***] to LIPOXEN such that
LIPOXEN [***] claimed any BAXTER SOLE INVENTIONS under the [***] 

  

	 	(E)	WHEREAS, the AGREEMENT [***] to BAXTER in relation to LIPOXEN SOLE INVENTIONS and the PARTIES have agreed that in relation to certain of those rights that BAXTER, consistent with the terms of the AGREEMENT, [***] BAXTER
under the AGREEMENT; 

  

	 	(F)	WHEREAS, the PARTIES desire to work more closely with each other and have better exposure to those patent applications filed by either PARTY on a SOLE INVENTION. 


  
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 NOW, THEREFORE, in consideration of the foregoing and the covenants and promises contained in this AMENDMENT and
in accordance with and subject to the terms and conditions specified below the PARTIES agree as follows: 
 AMENDMENT OF THE AGREEMENT 

The Parties hereby agree to amend the Agreement as provided below. Capitalized terms used in this Amendment that are not otherwise defined
herein shall have the meanings provided in the Agreement. 
  

	 	1.	“AMENDMENT COMMENCEMENT DATE” means      August, 2010. 

  

	 	2.	The Definitions are hereby amended with effect from the EFFECTIVE DATE to add the following Sections 1.75 and 1.76 as new definitions: 


1.75 [***] means all BAXTER SOLE INVENTIONS that utilize or incorporate DELIVERY AGENTS, including but not limited to:- (a) [***]
(i) to part (vi) of the LIPOXEN CORE TECHNOLOGY; and (b) [***] DELIVERY AGENTS with other [***]. 
 1.76 [***] means all
PATENTS and PATENT APPLICATIONS that (i) are owned by BAXTER, and (ii) include any claim that [***] INVENTIONS including, for the avoidance of doubt [***] PATENT RIGHTS. A PATENT or PATENT APPLICATION shall not be excluded from the
definition of [***] PATENT RIGHTS if, in addition to claims relating to the [***] INVENTIONS, it also has claims to [***] DELIVERY AGENTS. 

1.77 “EXISTING [***] PATENT RIGHTS” means the patent applications set out in Schedule A of this Agreement. 

 

	 	3.	Section 1.35 is hereby amended with effect from the EFFECTIVE DATE by deleting the words “For the purposes of clarification, the LIPOXEN CORE TECHNOLOGY [***].” 


 

	 	4.	Section 1.39 is hereby deleted in its entirely and replaced, with effect from the Effective Date, by the following: 


1.39 “LIPOXEN PATENT RIGHTS” means all of the PATENTS and PATENT APPLICATIONS CONTROLLED by LIPOXEN, including those rights licensed
to LIPOXEN by BAXTER within the [***] PATENT RIGHTS, which (i) pertain to [***] and [***] 

  
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 POTENTIAL PRODUCTS or COMMERCIAL PRODUCTS, and (ii) [***] PRODUCTS or COMMERCIAL PRODUCT(S)
pursuant to the license set forth in Section 3.1; including those contained in Schedule V of this Agreement, which excludes, for the avoidance of doubt, the MANUFACTURING TECHNOLOGY. 

 

	 	5.	Section 13.4 is hereby amended with effect from the Effective Date to be Section 13.4.1 and by the insertion of the words “excluding the BAXTER SOLE INVENTIONS” after the words “SOLE
INVENTIONS”. 

  

	 	6.	A new Section 13.4.2 is hereby included in the Agreement with effect from the Effective Date as follows: 


13.4.2 [***] of BAXTER SOLE INVENTIONS and Licensure of [***] PATENT RIGHTS to LIPOXEN by BAXTER 

13.4.2.1 Ownership. All BAXTER SOLE INVENTIONS (including the [***] INVENTIONS), and all intellectual property rights in them (including,
without limitation, the [***] PATENT RIGHTS), [***] of BAXTER, even if any such BAXTER SOLE INVENTIONS/[***] [***] of the LIPOXEN CORE TECHNOLOGY. LIPOXEN shall cooperate in all respects to ensure that ownership of the BAXTER SOLE INVENTIONS [***]
INVENTIONS is [***] BAXTER. Subject to the terms of this Section 13.4.2, BAXTER shall have the right to protect the BAXTER SOLE INVENTIONS [***] INVENTIONS in any manner that BAXTER [***] PATENT APPLICATIONS to be included in the [***] PATENT
RIGHTS. BAXTER [***] INVENTIONS (or any PATENT or PATENT APPLICATION relating to the [***]) to a THIRD PARTY, an AFFILIATE or a SUBLICENSEE, without the consent of LIPOXEN other than in the circumstances set out in parts (i) to (iii) of
Section 16 of the AGREEMENT, [***] (on terms reasonably acceptable to LIPOXEN) of the terms of the AGREEMENT to the relevant assignee/transferee. 

13.4.2.2 Grant. BAXTER [***] to LIPOXEN [***] BAXTER), [***] PATENT RIGHTS to: (i) [***] (ii) [***]. 

13.4.2.3 Term of Grant. The term of the license rights granted to LIPOXEN under Section 13.4.2.2 [***]


  
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 PATENT RIGHTS. For the avoidance of doubt, [***] LIPOXEN under this Section 13.4.2 [***]
AGREEMENT [***] 
 13.4.2.4 Right to Sublicense. From the EFFECTIVE DATE, LIPOXEN [***] Section 13.4.2.2 [***] Baxter unless [***]
within the FIELD in which case LIPOXEN [***] AGREEMENT, be entitled to grant a sublicense of the rights within the FIELD to any person other than BAXTER. The PARTIES agree that for the term of the AGREEMENT, to the [***] FIELD pursuant to SECTION
3.1 of the AGREEMENT. 
 13.4.2.5 Control. The PARTIES acknowledge that for the purposes of the AGREEMENT, LIPOXEN shall CONTROL [***]
BAXTER as set out in SECTION 13.4.2.4 above. 
 13.4.2.6 Assignment. LIPOXEN [***] 13.4.2.2 to any person to whom it assigns the AGREEMENT
in accordance with Section 16 of the AGREEMENT. 
 13.4.2.7 Notification. BAXTER shall notify LIPOXEN in writing immediately if:-
(a) BAXTER does not intend to file a PATENT APPLICATION in relation to a [***] (“ABANDONED [***] INVENTIONS”), or (b) BAXTER intends to abandon any [***] PATENT RIGHT (“ABANDONED [***]”). LIPOXEN shall have the right in
its own name and at its sole expense to prosecute and maintain PATENT APPLICATIONS and PATENTS in relation to (he ABANDONED [***] INVENTIONS and to prosecute and maintain the ABANDONED [***] PATENT RIGHTS, in which case BAXTER hereby agrees to
transfer and assign and shall transfer and assign to LIPOXEN its entire right, title and interest in and to such ABANDONED [***] INVENTIONS and ABANDONED [***] PATENT RIGHTS and the ABANDONED [***] INVENTIONS shall be treated as the SOLE INVENTION
of LIPOXEN for the purposes of this AGREEMENT, including Sections 13.3, 13.4 and 13.6. Any notification under this Section 13.4.2.7 by BAXTER shall be given to LIPOXEN with sufficient time to enable LIPOXEN to exercise its rights under this
Section. 
 13.4.2.8 Additional Filings. If BAXTER proposes to file (or has filed) a PATENT APPLICATION in relation to a [***] INVENTION and
the application can or does include claims relating to DELIVERY AGENTS, LIPOXEN shall have the right but not the obligation in its own name and at its sole expense to file a PATENT APPLICATION as a new application, or as a divisional, continuation,
or continuation-in-part (or via any other equivalent mechanism in any jurisdiction) of the original PATENT APPLICATION, which covers the relevant [***] INVENTION in so far as it relates solely and specifically to DELIVERY AGENTS and proteins which
fall outside the FIELD (“DELIVERY AGENT CLAIMS”) and at LIPOXEN’S sole discretion, prosecute such PATENT 

  
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 APPLICATION. BAXTER shall be allowed to [***] DELIVERY AGENT CLAIMS. BAXTER agrees [***] such
DELIVERY AGENT CLAIMS to LIPOXEN and the INVENTIONS that are the subject of such DELIVERY AGENT CLAIMS [***] as SOLE INVENTIONS of LIPOXEN for the purposes of this Agreement, including Sections 13.3, 13.4 and 13.6. If LIPOXEN [***] a PATENT
APPLICATION with DELIVERY AGENT CLAIMS, BAXTER [***] to [***] of such DELIVERY AGENT CLAIMS following which the INVENTION which is the subject of such PATENT APPLICATIONS [***] the SOLE INVENTION [***] BAXTER for the purposes of this AGREEMENT,
including SECTIONS 13.3,13.5 and 13.6. 
 13.4.2.9 Broader Filings. In addition to LIPOXEN’s rights pursuant to Section 13.4.2.8,
if BAXTER [***] a PATENT APPLICATION [***] and LIPOXEN [***] PATENT APPLICATION [***] BAXTER, LIPOXEN shall notify BAXTER [***] BAXTER shall either:- 

(a) [***] PATENT APPLICATION in [***] of LIPOXEN, where, in such case, LIPOXEN [***] PATENT APPLICATION, and any PATENT that issues there from
per the terms of this Section, 13.4.2, and in particular, Sections 13.4.2.1 and 13.4.2.2; or 
 (b) [***] LIPOXEN [***] PATENT APPLICATION
as a new application, or as a divisional, continuation, or continuation-in-part (or via any other equivalent mechanism in any jurisdiction) of the original PATENT APPLICATION, [***] DELIVERY AGENTS (“BROAD DELIVERY AGENT CLAIMS”) and at
Lipoxen’s [***] PATENT APPLICATION. BAXTER [***] and [***] in and to such BROAD DELIVERY AGENT CLAIMS to LIPOXEN and the INVENTIONS that are the subject of such BROAD DELIVERY AGENT CLAIMS shall be treated as SOLE INVENTIONS of LIPOXEN for the
purposes of Sections 13.3, 13.4 and 13.6 of this AGREEMENT. 
 13.4.2.10 Baxter name on Broader Filings. If LIPOXEN [***] PATENT APPLICATION
pursuant to Section 13.4.2.9(b) of this AGREEMENT and the PATENT APPLICATION [***] to DELIVERY AGENTS, the relevant application shall be [***] of BAXTER and LIPOXEN and BAXTER shall [***] LIPOXEN [***] to the [***] PATENT APPLICATION and any
PATENTS resulting from it. The PATENT APPLICATION shall be deemed to be a JOINT PATENT APPLICATION provided that:- (a) LIPOXEN shall still 

  
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[***] PATENT APPLICATION; and (b) despite the joint names on the PATENT APPLICATION only LIPOXEN [***] to BAXTER, [***] otherwise [***] PATENT APPLICATION which relate to DELIVERY AGENTS. If
[***] LIPOXEN [***] such PATENT APPLICATION, by way of filing a divisional patent application or otherwise, such that the PATENT APPLICATION [***] DELIVERY AGENTS [***] polymers, LIPOXEN [***] the PATENT APPLICATION into LIPOXEN’S [***] PATENT
APPLICATION shall be deemed to be a BROAD DELIVERY AGENT CLAIM for the purposes of SECTION 13.4.2.9(b). The PARTIES acknowledge that the patent application filed by LIPOXEN in the joint names of LIPOXEN and BAXTER on 20 July 2010, entitled
“Glycopolysialylation of non-blood Coagulation Proteins” shall be [***] prior to the AMENDMENT COMMENCEMENT DATE. 
 13.4.2.11
Warranty. BAXTER warrants that as at the AMENDMENT COMMENCEMENT DATE:- (a) the EXISTING [***] PATENT RIGHTS are the only PATENTS and/or PATENT APPLICATIONS owned by BAXTER which [***] and (b) BAXTER is not [***] PATENT APPLICATION filed by
BAXTER at the time of the AMENDMENT COMMENCEMENT DATE. 
 13.4.2.12 Terms of Sublicenses. To the extent [***] Lipoxen from a sublicensee
specifically in respect of any of the [***] under Section 13.4.2.2, Lipoxen [***] to BAXTER [***] LIPOXEN specifically in respect of sublicensing the rights to the [***] PATENT RIGHT to a third party until such time as BAXTER has been [***].
For the purposes of this Section 13.4.2.10, the [***] for a specific [***] shall be deemed to be [***] BAXTER in the prosecution and/or maintenance of the relevant [***] PATENT RIGHT provided [***]. BAXTER shall keep up to date and detailed
records [***] it [***] in relation to the [***] PATENT RIGHTS and shall, if asked in writing to do so by LIPOXEN, provide an [***], in relation to any and all [***] PATENT RIGHTS which are the subject of a sub-licence granted by LIPOXEN. 

 

	 	7.	Section 13.5 is hereby amended with effect from the EFFECTIVE DATE by renumbering the Section as 13.5.1 and by inserting the words “[***] LIPOXEN SOLE INVENTIONS” after the words “SOLE
INVENTlONS”. 


  
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	 	8.	A new Section 13.5.2 is hereby included in the AGREEMENT with effect from the EFFECTIVE DATE as follows:- 


13.5.2 Ownership of LIPOXEN SOLE INVENTIONS and rights of BAXTER therein:- 

13.5.2.1 Ownership. All LIPOXEN SOLE INVENTIONS, and all intellectual property rights in them, [***] even if any such LIPOXEN SOLE INVENTIONS
[***] BAXTER CORE TECHNOLOGY. BAXTER shall cooperate in all respects to [***] in LIPOXEN. Subject to the terms of this Section 13.5.2, LIPOXEN shall have the right to protect the LIPOXEN SOLE INVENTIONS in any manner that LIPOXEN deems
appropriate including, without limitation, the filing of additional PATENT APPLICATIONS to be included in the LIPOXEN PATENT RIGHTS. LIPOXEN [***] (or any PATENT or PATENT APPLICATION relating to the LIPOXEN SOLE INVENTIONS) to a THIRD PARTY, an
AFFILIATE or a SUB-LICENSEE, without the consent of BAXTER other than in the circumstances set out in parts (i) to (iii) of Section 16 of the AGREEMENT, in which case [***] (on terms reasonably acceptable to BAXTER) of the terms of
the AGREEMENT [***]. 
  

	 	9.	Section 13.6 is hereby deleted in its entirety and replaced with effect from the Commencement Date by the following: 


13.6 Each PARTY shall have sole discretion and right to prepare, file, prosecute, maintain and defend PATENT APPLICATIONS or PATENTS for
INVENTIONS it solely owns under this AGREEMENT. However, pursuant to the following, the PARTIES [***]. [***] to SOLE INVENTIONS [***] with the right to prosecute each such PATENT APPLICATION [***] for a PATENT. 

 

	 	13.6.1	BAXTER’S [***] LIPOXEN’s patent attorneys [***] PATENT APPLICATIONS relating to BAXTER SOLE INVENTIONS and [***] LIPOXEN’S [***] BAXTER SOLE INVENTION PATENT APPLICATIONS. Without prejudice to the
generality of the above, BAXTER shall:- 

  

	 	(a)	[***] in either the U.K. or the United States of America, prior to the contemplated filing of a PATENT APPLICATION relating to BAXTER SOLE INVENTIONS submit a substantially completed draft of the PATENT APPLICATION to
LIPOXEN; and 


  
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	 	(b)	[***] LIPOXEN’s [***] submissions [***] of PATENT APPLICATIONS relating to BAXTER SOLE INVENTIONS [***] which [***] the U.K. or the United States of America, prior to the due date of such official actions and
submissions. . 

  

	 	13.6.2	LIPOXEN’s [***] BAXTER’s patent attorneys during the prosecution of PATENT APPLICATIONS relating to LIPOXEN SOLE INVENTIONS [***] BAXTER’s [***] of such LIPOXEN SOLE INVENTION PATENT APPLICATIONS. Without
prejudice to the generality of the above, LIPOXEN shall:- 

  

	 	(a)	[***], which [***] in either the U.K. or the United States of America, prior to the [***] a PATENT APPLICATION relating to BAXTER SOLE INVENTIONS submit a substantially completed draft of the PATENT APPLICATION to
LIPOXEN; and 

  

	 	(b)	[***] BAXTER’s patent attorneys on any official actions and submissions that arise during the prosecution of PATENT APPLICATIONS relating to LIPOXEN SOLE INVENTIONS no later [***], [***] in either the U.K. or the
United States of America, [***] official actions and submissions. 

  

	 	10.	The following sentence in Section 13.7 is hereby amended with effect from the Commencement Date by the following: 


“[***] contemplated filing of such PATENT APPLICATION, the RESPONSIBLE PARTY [***] of the JOINT PATENT APPLICATION to the other PARTY for
[***].” 
 and replaced with, having effect from the Commencement Date by the following: 

“[***], [***] in either the U.K. or the United States of America, prior to the contemplated filing of such PATENT APPLICATION, the
RESPONSIBLE PARTY [***] JOINT PATENT APPLICATION to the other PARTY for [***]” 
  

	 	11.	A new Section 8.6 shall be inserted into the AGREEMENT with effect from the AMENDMENT COMMENCEMENT DATE as follows: 


“8.6 BAXTER [***] that have yet to be [***] LIPOXEN pursuant to Section 8.3 of this AGREEMENT [***]


  
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[***] a THIRD PARTY of [***] LIPOXEN and provided to BAXTER by LIPOXEN for the [***].” 
  

	 	12.	A new Section 15.7.4 shall be inserted into the AGREEMENT with effect from the AMENDMENT COMMENCEMENT DATE as follows: 


Section 15.7.4 of the Agreement shall be amended with effect from the Effective Date by the insertion of the following words at the start
of the Section:- “With the exception of the licence granted by Baxter to Lipoxen pursuant to Section 13.4.2 [***]”. 
  

	 	13.	Section 15.7.6 of the AGREEMENT shall be deleted in its entirety with effect from the EFFECTIVE DATE. 

  

	 	14.	LIPOXEN [***] by BAXTER [***] and [***] without prejudice to any of the PARTIES other rights under the AGREEMENT, the PARTIES agree that SCHEDULE IV of the AGREEMENT shall be amended with effect from the EFFECTIVE DATE
by inserting the amended dates as set out in the table below in place of the dates set out in the original AGREEMENT:- 

  

					
	Due Diligence Milestone Event	 	Original Date	 	Amended Date
	[***]	 	[***]	 	[***]
	[***]	 	[***]	 	[***]
	[***]	 	[***]	 	[***]

  

	 	15.	From the AMENDMENT COMMENCEMENT DATE BAXTER shall use its best endeavours [***] LIPOXEN [***] the PARTIES. 

  

	 	16.	Miscellaneous 

  

	 	a.	Full Force and Effect. Except as expressly amended by this Amendment, the Agreement shall remain unchanged and continue in full force and effect as provided therein. 


 

	 	b.	 Entire Agreement of the Parties. This Amendment and the Agreement constitute the complete final and exclusive understanding and agreement of the
BAXTER and LIPOXEN with respect to the subject matter of the 



  
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Agreement, and supersede any and all prior or contemporaneous negotiations, correspondence, understandings and agreements, whether oral or written, between BAXTER and LIPOXEN respecting the
subject matter of the Agreement. 

  

	 	c.	Counterparts. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. One or more counterparts of
this Amendment may be executed my facsimile or other electronic means. 


  
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 IN WITNESS WHEREOF, the parties hereto have executed this Amendment in duplicate originals by their authorized
officers as of the Effective Date of the Amendment. 
  

							
	SIGNED by	 	 /s/ M. Scott Maguire
	 	for	 	M. Scott Maguire
	 and on behalf of LIPOXEN

TECHNOLOGIES, LTD. in the presence of:
	 	CEO
				
	Witness	 		 		 	
				
	Signature:	 	



	 		 	
	Name:	 	[illegible]	 		 	
	Occupation:	 	[illegible]	 		 	
	Address:	 	[illegible]	 		 	
				
	SIGNED by	 	



	 	for	 	CVP/President Bioscience
		 	  
	 		 	
	 and on behalf of BAXTER

HEALTHCARE CORPORATION
 in the presence of
	 	
				
	Witness	 		 		 	
			
	Signature:	 	/s/ Alicia Webb	 	
	Name:	 	Alicia Webb	 		 	
	Occupation:	 		 		 	
	Address:	 		 		 	
				
	SIGNED by	 	  
	 	for	 	
	 and on behalf of BAXTER

HEALTHCARE SA
 in the presence of
	 	
				
	Witness	 		 		 	
				
	Signature:	 		 		 	
	Name:	 		 		 	
	Occupation:	 		 		 	
	Address:	 		 		 	


  
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 IN WITNESS WHEREOF, the parties hereto have executed this Amendment in duplicate originals by their authorized
officers as of the Effective Date of the Amendment. 
  

									
	SIGNED by	 	 /s/ M. Scott Maguire
	 	for	 	M. Scott Maguire	 	
	 and on behalf of LIPOXEN

TECHNOLOGIES, LTD. in the presence of:
	 	CEO	 	
					
	Witness	 		 		 		 	
					
	Signature:	 	



	 		 		 	
	Name:	 	[illegible]	 		 		 	
	Occupation:	 	[illegible]	 		 		 	
	Address:	 	[illegible]	 		 		 	
					
	SIGNED by	 	  
	 	for	 		 	
	 and on behalf of BAXTER

HEALTHCARE CORPORATION
 in the presence of
	 		 	
					
	Witness	 		 		 		 	
					
	Signature:	 		 		 		 	
	Name:	 		 		 		 	
	Occupation:	 		 		 		 	
	Address:	 		 		 		 	
					
	SIGNED by	 	 /s/ Ignacio Martinez de Lecea
	 	for	 		 	/s/ Sarah Byrne-Quinn
	 and on behalf of BAXTER

HEALTHCARE SA
 in the presence of
	 		 	 Ignacio Martinez de Lecea
 Sr. Counsel
ECEMEA
	 	 Sarah Byrne-Quinn

VP Business Development & Strategy

					
	Witness	 		 		 		 	
					
	Signature:	 	/s/ Mario Schultz	 		 		 	
	Name:	 	Mario Schultz	 		 		 	
	Occupation:	 	Legal Assistant	 		 		 	
	Address:	 	[illegible], 8304 Wallisellen	 		 		 	


  
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 SCHEDULE B 

PREVIOUS AMENDMENT AGREEMENTS 
  

	1.	Amendment dated August 15 2005 between LIPOXEN and BAXTER relating to THIRD PARTY PRODUCTS (“AMENDMENT ONE”) 

  

	2.	Amendment signed on December 11 and 13 between LIPOXEN, BAXTER and SERUM INSTITUTE OF INDIA LIMITED relating to POLYSIAL1C ACID (“AMENDMENT TWO”) 


 

	3.	Document headed “Second Amendment to Exclusive Research, Development and Licence Agreement” dated May 2009 relating to the First Milestone Event (“AMENDMENT THREE”) 


  
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