Exhibit 10.21


 


Amendment Agreement


 


This Amendment Agreement is made this 9th day of
January 2003 (“Effective Date”) by and between:


 


(1)                                  AVANT IMMUNOTHERAPEUTICS INC,
having a place of business at 119 Fourth Avenue, Needham, MA 02494-2725, United
States of America (“AVANT”); and


 


(2)                                  SMITHKLINE BEECHAM PLC,
having its registered office at 980 Great West Road, Brentford, Middlesex TW8
9GS, United Kingdom (“GSK”).


 


Whereas:


 


(A)                              AVANT (as legal successor
of Virus Research Institute, Inc.) and GSK entered in to a License Agreement
dated 1 December 1997 (the “Agreement”) relating to the field of
Rotavirus.


 


(B)                                As a result of, amongst
other things, increased requirements of regulatory authorities for clinical
safety data, the initiation of a Phase III clinical study under an IND in the
US, and therefore payment of the second milestone fee, has been delayed.


 


(C)                                Whereas GSK is
proposing to undertake a Phase III clinical study in Latin America.


 


(D)                               The parties hereto
(“Parties”) wish to amend the Agreement on the terms set out in this Amendment
Agreement.


 


Therefore, the Parties have agreed for good and valuable consideration,
receipt of which is hereby acknowledged:


 


1.                                       Paragraph
5.01 shall be deleted and replaced by the following:


 


“5.01                     Subject to the provisions of
Paragraph 5.02 below and the further provisions of this Paragraph 5.01,
LICENSEE will, in accordance with LICENSEE’s reasonable business and scientific
judgement, exercise its reasonable efforts and diligence in developing VACCINE.


 


Only in the event that:


 


(a)                                  a competitor vaccine
product against rotavirus is registered in one or more MAJOR MARKETS (each a
“RELEVANT MAJOR MARKET”): and


 


(b)                                 LICENSEE has
significant Phase IV data (as defined below) from countries that are not MAJOR
MARKETS to support applications for


 

















 


governmental approvals to market VACCINE in the RELEVANT MAJOR
MARKET(S),


 


shall LICENSEE be obliged to use its reasonable efforts and diligence
to undertake investigations and actions required to obtain appropriate
governmental approvals to market VACCINE in the RELEVANT MAJOR MARKET(S) and to
commercialise VACCINE in those RELEVANT MAJOR MARKET(S) in which such
governmental approval is obtained. For the purpose of this Paragraph 5.01 (b),
“significant Phase IV data” shall mean post-marketing safety data on 2 million
vaccinees with respect to the VACCINE so as to allow a proper assessment of the
Intussusception risk associated with the VACCINE.


 


All such activity shall be undertaken at LICENSEE’s expense. At
LICENSEE’s request and expense, LICENSOR shall supply LICENSEE with reasonable
technical assistance in undertaking such investigations and actions.”


 


2.                                       GSK hereby
agrees to pay AVANT US$1 million within 30 days of the Effective Date of this
Agreement. Such payment shall be considered as in lieu of the “second milestone
fee” of US 1million provided for in Paragraph 5.02(c) and such fee shall be
considered made in full.  For the
avoidance of doubt the proposed Phase III clinical study to be undertaken by
GSK in Latin America shall not be considered to be the pivotal Phase III study
as referred to in Paragraphs 5.02 (c) and (d).


 


3.                                       Paragraph
19.01 shall be deleted and replaced with the following:


 


“19.01            Any notice required or
permitted under this Agreement shall be sent by certified mail, return receipt
requested, postage pre-paid to the following addresses of the parties:


 


if to LICENSOR:


 


AVANT Immunotherapeutics, Inc.,


119 Fourth Avenue


Needham, MA 02494-2725,


USA


Attention: President


 


with a copy to:


Leon R. Yankwich


Yankwich and Associates


201 Broadway


Cambridge, MA  02139


USA


 


2

















 


if to LICENSEE:


 


SmithKline Beecham PLC.


980 Great West Road


Brentford


Middlesex TW8 9GS


United Kingdom


Attention: General Counsel


 


with a copy to:


GlaxoSmithKline Biologicals Manufacturing
S.A.


rue de l’lnstitut 89


1330 Rixensart, Belgium


Attention: President


 


4.                                       All other
provisions of the Agreement shall remain unchanged and in full force and
effect.


 


IN WITNESS WHEREOF, the parties, through their authorised officers,
have executed this Amendment Agreement on the date above written.


 


 


AVANT IMMUNOTHERAPEUTICS INC


 


 


	
  BY:

  	
  /s/ Dr. Una S. Ryan, O.B.E.

  	
   

  
	
   

  	
  Dr. Una S. Ryan, O.B.E.

  
	
   

  	
  President and C.E.O.

  
	
   

  	
   

  
	
   

  	
   

  
	
  SMITHKLINE BEECHAM PLC,

  
	
   

  
	
   

  	
   

  
	
  BY:

  	
  /s/ Moncef Slaoui

  	
   

  
	
   

  	
  Moncef Slaoui

  
	
   

  	
  Attorney in fact

  
				



 


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