Exhibit 10.9


 


PUBLIC
HEALTH SERVICE


SECOND
AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT L-068-2002/0


 


AMENDMENT A-065-2003


 


This
Amendment A-065-2003 (“Second Amendment”) of the Exclusive Patent License
L-068-02/0 (“Agreement”), and of
the First Amendment L-068-02/1 (“First
Amendment”) of the Agreement, is
made between the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), or the Food and Drug Administration
(“FDA”), hereinafter singly or
collectively referred to as (“PHS”),
agencies of the United States Public Health Service within the Department of
Health and Human Services (“DHHS”)
through the Office of Technology Transfer, NIH,
having an address at 6011 Executive Boulevard, Suite 325, Rockville, Maryland
20852-3804, U.S.A. and Procept, Inc., having offices at the address
indicated on the Signature Page, hereinafter referred to as “Licensee”.


 


Whereas,
PHS desires the Agreement to be amended a second time in
order to resolve issues concerning the following: (a) Paragraph 6.04 and (b)
Appendix E of said Agreement, in order to establish the time frame of
sixty (60) days for the benchmark royalty payment; and


 


Whereas,
PHS desires the First Amendment to be amended a first time
in order to resolve issues concerning the following: (a) Paragraph 3 of the First Amendment L-068-02/1, in order to
properly reflect a change in the language of the agreement from “Amended
Appendix C will now read” to “Amendment to Appendix C shall now read,” and


 


Whereas,
PHS and Licensee are willing to amend the terms of the Agreement and of the First Amendment to accommodate these
issues.


 


Now
Therefore, PHS and Licensee, intending to be bound, hereby
agree that the following changes will be made to the Agreement and to the First
Amendment:


 


1.                                       Amended
Paragraph 6.04 of the Agreement
will now read as follows:


 


Licensee
agrees to pay PHS, within sixty
(60) days of achieving a benchmark, the benchmark royalties as set forth in
Appendix C.


 


2.                                       Amended
Appendix E of the Agreement will
now read:


 


APPENDIX
E—Benchmarks and Performance


 


The company has established the following
estimated timeline:


 


	
  Activity

  	
   

  	
  Timeframe

  
	
  First filing of a Licensee
  or sublicensee-sponsored Investigational New Drug Application with The United
  States Food and Drug Administration (FDA) or foreign equivalent in a Major
  Market Country

  	
   

  	
  2Q2002

  NB: Extension into 3Q2002 is allowable, if filing date is in
  compliance with the CRADA.

  
	
  Completion of enrollment of the first Licensee or sublicensee-sponsored Phase II or III clinical
  trial with the FDA or its foreign equivalent in a Major Market Country

  	
   

  	
  2Q2004

  
	
  First filing of a Product License Application or foreign equivalent
  in a Major Market Country

  	
   

  	
  3Q2007

  
	
  First receipt of Approval Letter by the FDA or foreign equivalent in
  a Major Market Country

  	
   

  	
  1Q2008

  



 


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The Licensee agrees to use their
commercially reasonable best efforts to attain the aforementioned milestones
for its performance under this agreement and, within sixty (60) days of achieving
a milestone, shall notify the PHS
that such milestone has been achieved.


 


3.                                       Amended
Paragraph 3 of the First Amendment
shall now read:


 


Amendment to
Appendix C shall now read:


 


Licensee agrees to
pay PHS sublicensing royalties as follows:


 


•                  The greater of
Twenty-Two and One-Half Percent (22.5%) of the royalties received by Licensee or any of its Affiliates from
Net Sales by any sublicensee,
including Sublicensee, of Licensed
Products or Licensed Processes or
One and Four Fifths Percent (1.8%) of Net Sales by any sublicensee(s), including any subtier
licensing.


 


SIGNATURES BEGIN ON NEXT PAGE


 


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SECOND AMENDMENT TO PHS LICENSE AGREEMENT L-068-02/0


 


PHS SECOND AMENDMENT TO PATENT LICENSE AGREEMENT—EXCLUSIVE


 


SIGNATURE PAGE


 


For PHS:


 


	
  /s/ Jack Spiegel

  	
   

  	
  December 31, 2002

  	
   

  
	
  Jack Spiegel, Ph.D.

  	
  Date

  
	
  Director, Division of Technology Development and Transfer

  	
   

  
	
  Office of Technology Transfer

  	
   

  
	
  National Institutes of Health

  	
   

  
	
   

  	
   

  
	
  Mailing Address for Notices:

  	
   

  
	
   

  	
   

  
	
  Office of Technology Transfer

  	
   

  
	
  National Institutes of Health

  	
   

  
	
  6011 Executive Boulevard, Suite 325

  	
   

  
	
  Rockville, Maryland 20852-3804 U.S.A.

  	
   

  



 


For Licensee (Upon, information and
belief, the undersigned expressly certify or affirm that the contents of any
statements of Licensee made or referred to in
this document are truthful and accurate.):


 


PROCEPT, INC.


 


369 Lexington Avenue

10th Floor

New York, NY 10017


 


	
  By: Salvatore A. Bucci

  
	
   

  
	
  Name:

  	
  /s/ Salvatore A. Bucci

  	
   

  
	
   

  
	
  Title: President and Chief Executive Officer

  
	
   

  
	
  Date:

  	
  January 13, 2003

  	
   

  
					



 


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ACKNOWLEDGEMENT
AND ACCEPTANCE


 


AOI Pharmaceuticals, Inc. (“AOIP”), by its signature below,
acknowledges and agrees to the following:


 


1.                                       AOIP shall be bound by the terms of Amendments L-068-02/2 and L-068-02/1 to the
Revised Licensing Agreement
(L-068-02/0).


 


2.                                       AOIP shall be bound by the terms of Article 4
of the Revised License Agreement as
amended by Amendment  L-068-02/1.


 


3.                                       Amendments L-068-02/2
and L-068-02/1 to the Revised License Agreement (L-068-02/0)
serve as Amendments to the Procept, Inc./AOIP Sublicensing Agreement.


 


For Sublicensee (Upon, information and belief, the undersigned
expressly certify or affirm that the contents of any statements of Sublicensee made or referred to in this
document are truthful and accurate.):


 


 


AOI PHARMACEUTICALS, INC.


 


An Access Oncology Company


750 Lexington Avenue


26th Floor


New York, NY 10022


 


 


	
  By: Craig Henderson, M.D.

  
	
   

  
	
   

  
	
  Name:

  	
  /s/ Craig Henderson

  	
   

  
	
   

  
	
  Title: Chief Executive Officer

  
	
   

  
	
  Date:

  	
  February 10, 2003

  	
   

  
					



 


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