Document:

EX-10.11

 Exhibit 10.11 

Portions
of this exhibit, indicated by the mark “[***],” have been redacted pursuant to a confidential treatment request.

200500453-11412 
 [***] p1

 

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  [***]including a ‘Development and Manufacturing Agreement’ dated
                                                                                                                          2006 (‘Lipoxen/SII Agreements’); 

WHEREAS, SII will benefit directly
by [***] to 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 development and commercialization of various  POTENTIAL
PRODUCTS and COMMERCIAL PRODUCT(S), as defined in the Baxter 

  
 - 1 - 

[***]   
p.3

 

 
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 has agreed to work exclusively with Baxter in the development and commercialization  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 has agreed not to provid or supply any third party [***] for use with the FIELD;

  

	 	2)	SII and Lipoxen acknowledge and agree that pursuant to the Baxter License, Baxter will
either directly or indirectly optain a supply of [***] 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 to exercise its option  under the Baxter License that each company provides its assurances that  neither shall
knowingly whether directly or indirectly supply, manufacture for or   provide any party or entity other than Baxter [***] for
the making,  using, selling or developing 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 these commitments and further
to allow Baxter to exercise its option under the Baxter License that each company provides its assurances that neither shall
knowingly whether directly or indirectly provide any information pertaining to  [***] to any party or entity other
than Baxter for use within  the FIELD and specifically shall not knowingly provide any information in support of any
regulatory filing by any party or entity other than  Baxter for the making, selling, using or developing of  of any product
within the FIELD, as set forth in the Baxter License, however it is clarified that this clause shall not apply to supply
[***] outside the FIELD. SII can file the documents containing this information [***] with the Regulatory Authorities in
order to obtain the manufacturing license.

  
 - 2 - 

[***]     
p.4

 

	 	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 obligated to obtain the [***] from Lipoxen, excepting certain
circumstances  defined in the Baxter License; Such circumstance relates to Baxter’s right to to elect to [***] for use
within the FIELD only after completion  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 exercise its option under the Baxter License that each company provides it assurances that in the event Lipoxen is
unable, unwilling or incapable of fulfilling its obligations under the Baxter License to supply 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,  SII and Lipoxen agree that Baxter may obtain such supply from SII directly for terms similar to those agreed
to between  Baxter and Lipoxen byentering  into a direct supply agreement with SII; and

  

	 	9)	SII specifically acknowledges and agrees that in light of these commitments and further to
induce Baxter to exercise its option under the Baxter License that SII gives its assurances to enter into an agreement [***]
with Baxter for [***] in the event Lipoxen is unable, unwilling or incapable of fulfilling its obligations under the Baxter
License to supply Baxter [***] for what ever reason, including but not limited to bankruptcy or insolvency.

 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 - 

[***]         p.2

 

 All of the 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 constitute one enforceable agreement. For purposes of this Letter Agreement and any other document
 that is required to be delivered pursuant to this Letter Agreement,  facsimiles of signatures shall be deemed
 to be original signatures. In addition, if any of the parties sign facsimile 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 

 

Portions of this exhibit, indicated by the mark “[***],”
have been redacted pursuant to a confidential treatment request.

 

					
	 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 Wales with company number 03401495 and having its
                                                                                                                                  registered office at Suite 303, Hamilton House, Mabledon Place, London WC1H 9BB (“LIPOXEN”); Baxter 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 Baxter Parkway, Deerfield, Illinois 60015 (BNSA and BHC
                                                                                                                                  collectively referred to as “BAXTER”).

WHEREAS, LIPOXEN has requested
BAXTER to make its election to continue with  the collaboration pursuant 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,
2006; 
 WHEREAS, BAXTER  has agreed
                  to make such an alection provided that                   the                   R&L AGREEMENT is amended and modified 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 shall provide LIPOXEN [***] or other THERAPEUTIC AGENTS to use 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 compiled by BAXTER in [***] other THERAPEUTIC AGENTS, including data relating to the [***]
(and protocols on the various techniques used), [***] 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 [***], and,
                                                                                    (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 shall be
reduced to five (5) years  after – reduced by [***] –, and add the following paragraph between the first and
second paragraphs: 

“The ROYALTY
RATE shall be reduced by [***] in respect of COMMERCIAL PRODUCTS sold or supplied in a country where there exists a THIRD
PARTY PRODUCT. In the event LIPOXEN and BAXTER disagree as to whether such THIRD PARTY PRODUCT infringes a VALID PATENT
CLAIM, thenBaxter shall deposit any amount owed LIPOXEN exceeding the ROYALTY RATE reducte by [***] into an interest bearing
account when and if LIPOXEN elects to bring an action against such THIRD PARTY PRODUCT asserting that such THIRD PARTY
PRODUCT infringes a VALID PATENT CLAIM. In the event LIPOXEN succeeds in such action then BAXTER agrees to turn over the sums
in which royalty bearing account to  LIPOXEN, which sums LIPOXEN agrees shall constitute the full amount owed by
 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
                                                                                                     obligation to pay royalties shall expire [***] after the FIRST COMMERCIAL SALE. In the event LIPOXEN and BAXTER disagree
                                                                                                     as to
                                                                                                     whether                                                                                                       such THIRD
                                                                                                     PARTY                                                                                                      PRODUCT
                                                                                                     infringes a                                                                                                      VALID
                                                                                                     PATENT                                                                                                      CLAIM, then
                                                                                                     BAXTER shall deposit any amount which would be owed
                                                                                                     LIPOXEN beyond                                                                                                      such
                                                                                                     [***]                                                                                                      into an interest
                                                                                                     bearing account 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 succeeds in such action then BAXTER agrees to
turn over the sums in such royalty bearing account to LIPOXEN, which LIPOXEN agrees shall constitute the full amount owed by BAXTER.
All capitalized terms used herein which are not specifically defined in this Amendment shall have the meaning set forth in the
R&L AGREEMENT.

 

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

  

	6.	This Amendment may be executed in more than one counterpart, each of which constitutes an original
and all 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, facsimilies  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

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