Document:

EX-10.11

 Exhibit 10.11 

200500453-11412 
  

							
	[ILLEGIBLE]	 		 		 	p.1
			
	 [ILLEGIBLE]
	 		 	 [ILLEGIBLE]

 LETTER AGREEMENT 

This is a letter agreement {‘Letter Agreement’} entered into and between: 
  

	 	(1)	LIPOXEN TECHNOLOGIES LIMITED, a company registered in England and Wales with company number 03401495 having its registered office is at Suite 303, Hamilton House, Mabledon Place, London [ILLEGIBLE] and a place of
business at 2 Royal College Street, London NW1 ONH, England (“Lipoxen”); 

  

	 	(2)	SERUM INSTITUTE OF INDIA LIMITED, a company incorporated under the Laws of India, having its principal place of business at S. No. 212/2, Off Soll Poonawalla Road, Hadapsar, Pune - 411 028, India (“SII”);

  

	 	(3)	BAXTER HEALTHCARE CORPORATION, a Delaware Corporation having its principal place of business at One Baxter Parkway, Deerfield, Illinois 60015 (“BHC”); and 

 

	 	(4)	BAXTER HEALTHCARE SA, a corporation organized and existing under the laws of Switzerland and having its principle place of business being Hartistrasse 2, Postfach 8304, [ILLEGIBLE], Switzerland
(“BHSA”). 

 WHEREAS, BHSA and BHC, both of which being referred to herein as ‘Baxter’, and Lipoxen have entered into an
‘Exclusive Research, Development and License Agreement dated August 15, 2005 (‘Baxter License’); 
 WHEREAS, Lipoxen and SII have
entered into various agreements concerning the [***] ‘Development and Manufacturing Agreement’ dated 2006 (‘Lipoxen/SII Agreements’); 

WHEREAS, SII will benefit directly by the [***] Baxter and other CUSTOMERS, as defined in the Lipoxen/SII Agreements: 

WHEREAS, Baxter is willing to exercise its option under the Baxter License to pursue the [***] POTENTIAL PRODUCTS and COMMERCIAL PRODUCT(S), as defined in the
Baxter 

  
 - 1 - 

							
	 [ILLEGIBLE]
	 		 		 	p.3
			
	 [ILLEGIBLE]
	 		 	 [ILLEGIBLE]

 

 
License provided that it receives various assurances and commitments from SII and Lipoxen as more fully defined herein: 
  

	 	1)	SII and Lipoxen acknowledge and agree that pursuant to and during the term of the Baxter License, Lipoxen [***] with Baxter in the [***] of POTENTIAL PRODUCTS and COMMERCIAL PRODUCT(S) within the FIELD, all such terms
as defined in the Baxter License, and that pursuant to the Lipoxen/SII Agreements [***] any third party [***] 

  

	 	2)	SII and Lipoxen acknowledge and agree that pursuant to the Baxter License, Baxter [***] POLYSIALIC ACID, as defined in the Baxter License, from SII; 

 

	 	3)	SII and Lipoxen acknowledge and agree that pursuant to the Baxter License that [***] within the FIELD as specifically defined in the Baxter License; 

 

	 	4)	SII and Lipoxen further acknowledge and agree that in light of these commitments and further to allow Baxter [***] under the Baxter License that each company [***] neither shall knowingly whether [***] or provide any
party or entity other than Baxter [***] for the [***] of any product within the FIELD, as set forth in the Baxter License; 

  

	 	5)	SII and Lipoxen further acknowledge and agree that in light of [ILLEGIBLE] commitments and further to allow Baxter to [***] under the Baxter License that each company provides [***] shall knowingly whether
directly or indirectly provide any information pertaining to the [***] any party or entity [***] Baxter [***] the FIELD and specifically shall not [***] Baxter for the [***] of any product within the FIELD, as set forth in the Baxter License,
however it is clarified that this clause [***] outside the FIELD. SII can file the documents containing this information [***] with the Regulatory Authorities in [***] 

  
 - 2 - 

							
	 [ILLEGIBLE]
	 		 		 	p.4
			
	[ILLEGIBLE]	 		 	 [ILLEGIBLE]

 

	 	6)	SII and Lipoxen acknowledge and agree that pursuant to Article 4 of the Baxter License Lipoxen [***] to Baxter for use in the FIELD only, and Baxter is [***] from Lipoxen, [***] defined in the Baxter License; Such
circumstance relates to Baxter’s right to [***] FIELD [***] of the first PHASE 2 CLINICAL TRIAL. 

  

	 	7)	SII and Lipoxen also acknowledge and agree that pursuant to the Lipoxen/SII Agreements, and specifically the ‘Development and Manufacturing Agreement’ dated 2nd August 2006, Lipoxen [***] to Baxter as a
CUSTOMER, as defined in such Agreement; 

  

	 	8)	SII and Lipoxen acknowledge and agree that in light of these commitments and further to induce Baxter to [***] the Baxter License that each company [***] event Lipoxen is [***] under the Baxter License to [***] Baxter
with [***] for what ever reason, including but not limited to bankruptcy or insolvency, that in addition to the rights Baxter may have under the Baxter License [ILLEGIBLE] SII and Lipoxen agree that Baxter [***] Baxter and Lipoxen by [***]
with SII; and 

  

	 	9)	SII specifically acknowledges and agrees that in light of these commitments and further to induce Baxter [***] the Baxter License that SII [***] with Baxter [***] in the event Lipoxen is [***] under the Baxter License
to [***] Baxter [***] for what [ILLEGIBLE]. 

 Except as provided in this Letter Agreement all of the terms and conditions of the
Baxter License and the Lipoxen/SII Agreements shall remain in full force and effect, and shall not be modified or altered except as provided herein. 
 All
of the parties acknowledge that this Letter Agreement shall constitute a modification or alteration of some of the terms and conditions of the Baxter License and the Lipoxen/SII Agreements. 

  
 - 3 - 

							
	 [ILLEGIBLE]
	 		 		 	p.2
			
	[ILLEGIBLE]	 		 	 [ILLEGIBLE]

 

 All of [ILLEGIBLE] parties further acknowledge and agree that this Letter Agreement can be executed in
more than one counterpart, each of which constitutes an original and all of which together shall [ILLEGIBLE] one enforceable agreement. For purposes of this Letter Agreement and any other document that is required to be delivered pursuant to
this Letter Agreement, [ILLEGIBLE] of signatures shall be deemed to be original signatures. In addition, if any of the parties sign [ILLEGIBLE] copies of this Letter Agreement, such copies shall be deemed originals. 

IN WITNESS WHEREOF, the parties hereto have caused their authorized representatives to execute this Letter Agreement by signing below: 

 

									
	Signed:	  		  	Signed:	  		  	
	For and behalf of:	  	For and behalf of:	  	
	Lipoxen Technologies Limited	  	Baxter Healthcare SA	  	
					
	Signature:	  	 

  
	  	Signature:	  	 

  
	  	 

  

	Name:	  	 [ILLEGIBLE]
	  	Name:	  	 F.de Freine
	  	R.Binggeli
	Title:	  	CEO	  	Title:	  	 Finance Director
 Baxter Healthcare SA
	  	 Director of Tax, Europe
 Baxter
Healthcare SA

	Date:	  	December 11, 2006	  	Date:	  		  	Dec. 13, 2006
		  		  		  		  	
					
	Signed:	  		  	Signed:	  		  	
	For and behalf of:	  	For and behalf of:	  	
	[ILLEGIBLE] Institute of India Limited	  	Baxter Healthcare Corporation	  	
					
	Signature:	  	 

  
	  	Signature:	  	 

  
	  	
	Name:	  	 [ILLEGIBLE]
	  	Name:	  	[ILLEGIBLE] 	  	
	Title:	  	Company Secretary	  	Title:	  	Corporate Vice President-President BioScience	  	
	Date:	  	11th December [ILLEGIBLE]	  	Date:	  	December 13, 2006	  	

  
 - 4 -EX-10.12

 Exhibit 10.12 
  

					
	 FROM: [ILLEGIBLE]
	  	PHONE NO.   : 00442076811314	  	13 DEC.   2006 01: 58 PM P1

 AMENDMENT 
 This
is an amendment to the Research, Development and License Agreement (“R&L AGREEMENT”) entered into on August 15, 2005, by and between Lipoxen Technologies Limited, a company registered in England and [ILLEGIBLE] with company
number 03401495 and having its registered office at suit [ILLEGIBLE] WC1H [ILLEGIBLE] (“LIPOXEN”); [ILLEGIBLE] Healthcare SA (“BHSA”), a corporation organized and existing under the laws of Switzerland, and
Baxter Healthcare Corporation (“BHC”) having its principal place of business at One [ILLEGIBLE] Parkway, [ILLEGIBLE], [ILLEGIBLE] 

WHEREAS, LIPOXEN has [***] to the terms of Article 2.3 of the R&L AGREEMENT before the ACCEPTANCE DATE (as defined in the R&L AGREEMENT), and
specifically by December 13, 200 [ILLEGIBLE]; 
 WHEREAS, [***] provided that the R&L AGREEMENT [***] as provided below: 

ACCORDINGLY, BAXTER and LIPOXEN agree to the following amendments and modifications of the R&L AGREEMENT: 

 

	1.	Replace Article 2.1 with the following: 

 “In General BAXTER [ILLEGIBLE] LIPOXEN
with[***] or other THERAPEUTIC AGENTS to [ILLEGIBLE] developing DELIVERY AGENTS and POTENTIAL PRODUCTS to be utilized by BAXTER in its research and development activities to [***] other THERAPEUTIC AGENT. BAXTER shall as soon as possible
after the EFFECTIVE DATE provide all of the BAXTER KNOW-HOW to LIPOXEN. At BAXTER’s sole discreation BAXTER may or may not provide to LIPOXEN data [ILLEGIBLE] by BAXTER in [***] other THERAPEUTIC AGENTS, including data relating
[ILLEGIBLE] the [***] (and protocols on the various techniques used), [***] [ILLEGIBLE] [***] stability data (including native proteins) and publications (patent and research papers).” 

					
	 FROM : [ILLEGIBLE]
	  	PHONE NO. : 00442076811314	  	13 DEC. 2006  01 : 59 PM P2

  

	2.	Add the following definition 1.75: 

 “THIRD PARTY PRODUCT” means a product brought to
the market by a third party which contains a THERAPEUTIC AGENT [***], (i) which product competes with a COMMERCIAL PRODUCT and (ii) which product does not infringe a VALID PATENT CLAIM. 

 

	3.	Amend Article 8.3 by adding the statement, “and the term for paying such royalty [***] after – [***] –, and add the following paragraph between the first and second paragraphs: 

“The ROYALTY RATE shall [***] respect of COMMERCIAL PRODUCTS sold or supplied in a country where there exists a THIRD PARTY PRODUCT. In
the event LIPOXEN and BAXTER [***] whether such THIRD PARTY PRODUCT infringes a VALID PATENT CLAIM, [***] LIPOXEN [***] and if LIPOXEN elects to bring an action against such THIRD PARTY PRODUCT [ILLEGIBLE] that such THIRD PARTY PRODUCT
infringes a VALID PATENT CLAIM. In the event LIPOXEN succeeds [ILLEGIBLE] such action [***] LIPOXEN, which sums LIPOXEN [***] BAXTER. 
  

	4.	Amend Article 8.4 by adding the following sentence: 

 “In the event a THIRD PARTY PRODUCT
is sold or supplied in a country in which a COMMERCIAL PRODUCT is sold or supplied then BAXTER’s [***] FIRST COMMERCIAL SALE. In the event LIPOXEN and BAXTER [***] as to whether such THIRD PARTY PRODUCT infringes a VALID PATENT CLAIM, then
[***] LIPOXEN [***] when and if LIPOXEN elects to bring an action against such THIRD 

					
	 FROM : [ILLEGIBLE]
	  	PHONE NO. : 00442076811314	  	13 DEC. 2006  01 : 59 PM P3

  

 PARTY PRODUCT asserting that such THIRD PARTY PATENT infringes a VALID PATENT CLAIM. In the
event LIPOXEN action then [***] All capitalized terms used herein which are not specifically defined in this Amendment shall have the meaning [ILLEGIBLE] forth in the R&L AGREEMENT. 

 

	5.	The remaining terms of the R&L AGREEMENT shall remain in full force and [ILLEGIBLE]. 

  

	6.	This Amendment may be executed in more than one counterpart, each of which constitutes an original and [ILLEGIBLE] of which together shall constitute one enforceable agreement. For purposes of this Amendment and
any other document required to be delivered pursuant to this Amendment, [ILLEGIBLE] of signatures shall be deemed to be original signatures. In addition, if any one of the PARTIES sign facsimile copies of this Amendment, such copies shall be
deemed originals 

 IN WITNESS WHEREOF, the PARTIES hereto have caused their authorized representatives to execute this Amendment by signing
below: 
  

							
	Signed:	  		  		  	
	For and on behalf of:	  		  	For and on behalf of:	  	
	Lipoxen	  		  	Baxter Healthcare Corporation	  	

  

											
	Signature	  	 /s/ M. Scott Maguire
	  		  	Signature	  	 /s/ Joy A. Amundson
	  	
	Name:	  	M. Scott Maguire	  		  	Name:	  	Joy A. Amundson	  	
	Title:	  	CEO	  		  	Title:	  	 Corporate Vice President,
 President
BioScience
	  	
	Signed:	  		  		  		  		  	

  

					
	For and on behalf of:	  		  	
	BAXTER HEALTHCARE SA	  		  	

											
						
	Signature	  	 /s/ F. de Freine
	  		  		  	 /s/ Rebecca Binggeli
	  	
	Name:	  	F. de Freine	  		  		  	Rebecca Binggeli	  	
	Title:	  	 Finance Director
 Baxter Healthcare SA
	  		  		  	 Director of Tax, Europe
 Baxter Healthcare
SA
	  	

 Dec. 13, 2006

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00229-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00229-of-00352.parquet"}]]