Exhibit 10.1


SECOND AMENDMENT TO CO-DEVELOPMENT AGREEMENT


This
Second Amendment to Co-Development Agreement (this “Second Amendment”) is made
as of May 24, 2007, by and between Southern Research Institute (“SRI”) and
Bioenvision, Inc. (as successor-in-interest to Eurobiotech Group, Inc.) (“Bioenvision”).


RECITALS:


A.            SRI
and Eurobiotech Group, Inc. entered into that certain Co-Development  Agreement, dated as of August 31, 1998, and
that certain Amendment to the Co-Development Agreement (the “First Amendment”),
dated as of March 12, 2001 (collectively, the “Co-Development Agreement”).


B.            The parties desire to further amend
the Co-Development Agreement as provided herein to (i) provide that SRI will be
entitled to a 7% royalty on all product sales, whether such sales are made
directly by Bioenvision or by a sublicensee, sales partner or distributor, (ii)
to delete the profit-sharing agreement set forth in Section 6 of the current
Co-Development Agreement in exchange for an agreement by Bioenvision to pay to SRI
certain milestone payments provided for in this Second Amendment, and (iii) to
make certain other changes to the Co-Development Agreement in order to clarify
the respective rights and obligations of the parties.


C.            The parties specifically acknowledge
that certain co-development agreement, dated March 12, 2001, between
Bioenvision, Inc. and ILEX Oncology, Inc., predecessor-in-interest to Genzyme
Corporation (“Genzyme”, and such agreement, as amended, is the “ILEX
Co-Development Agreement”), and agree that this Second Amendment does not
purport to amend the Ilex Co-Development Agreement.


D.            The parties specifically acknowledge
that certain License Agreement, dated and effective September 12, 2006, between
Bioenvision and SRI (the “Japan License”), pursuant to which SRI granted to
Bioenvision an exclusive license to manufacture, sell, market and distribute
Product in Japan and “Southeast Asia” (as defined in the ILEX Co-Development
Agreement”), and agree that this Second Amendment does not purport to amend the
Japan License.


E.             Capitalized terms used but not
otherwise defined herein shall have the meaning(s) ascribed to such terms in
the Co-Development Agreement.













 


AGREEMENT


In
consideration of the foregoing and the mutual covenants and agreements set
forth in this Second Amendment and for other consideration, the receipt and
sufficiency of which is hereby acknowledged, the parties hereto agree as
follows:


1.                                       Article
1 “DEFINITIONS” is hereby amended by deleting the text in Sections 1.C., 1.F.,
1.G., 1.H. and 1.L. (definition of “Net Income” included in the First
Amendment) in their entirety and replacing each with the following text: “RESERVED.”  Article 1 is further amended by adding the
following text immediately following Section 1.P. thereof:


a.                                       Direct
Sales” shall mean all sales of the Product made by Bioenvision in the
Territory, but not including sales by Bioenvision to a Sales Partner.


b.                                      “Indirect
Sales” shall mean sales of the Product by any 
Sales Partner in the Territory.


c.                                       “Net
Sales Revenue” shall mean the gross revenue recognized by Bioenvision or its
Sales Partner, as applicable, from the sale of the Product through normal
distribution channels to a third party (other than an Affiliate of Bioenvision
or a Sales Partner) in the Territory, less Allowable Costs.


d.                                      “Sales
Partner” shall mean any third party to which Bioenvision grants a Sublicense of
some or all of the rights licensed to Bioenvision by SRI under Article 2 or
Article 3 hereof.


e.                                       “Sublicense”
shall mean an agreement pursuant to which Bioenvision grants a sublicense of or
otherwise transfers some or all of the rights licensed to Bioenvision by SRI
under Article 2 or Article 3 hereof.  If
Bioenvision enters into an agreement with such a third party pursuant to which
such third party shall have the right to control the marketing and sale of the
Product within a defined territory (for example, a marketing and/or
distribution arrangement under which a third party will have the right to
market, sell and/or resell the Product), then such an agreement shall be deemed
to be a “Sublicense.”  For avoidance of
doubt, in certain limited circumstances in which if Bioenvision enters into an
agreement with a third party under which such third party will exercise certain
of the rights licensed to Bioenvision under Article 2 hereof (other than the
marketing or sale of the Product) for the benefit of Bioenvision (for example,
if Bioenvision enters into a contract with a contract research organization or
a contract sales organization, and Bioenvision retains the right to oversee and




 2
 









 


control such third party’s performance), then such
arrangements shall not be “Sublicenses” and such third parties shall not be “Sales
Partners.”


f.                                         “Sublicense
Revenue” shall means all consideration received by Bioenvision from a third
party for the grant, or in connection with the exercise of rights under, a
Sublicense, but excluding royalty payments based on Indirect Sales.  Sublicense Revenue shall include all upfront
license fees, milestone payments and the fair market value of any rights
granted to Bioenvision to use, market, sell, distribute, develop, import or
export products or technologies of a third party, in either case, received by
Bioenvision from any Sales Partner pursuant to a Sublicense.  Bioenvision
shall not be entitled to deduct from Sublicense Revenues any start-up costs,
research and development costs, general administrative expenses or other costs.  For clarity, (i) revenues derived from
Indirect Sales shall be deemed not to be Sublicense Revenue, and (ii) Bioenvision
shall not be obligated to pay SRI with respect to any such monies paid to
Bioenvision by a Sales Partner: (A) in exchange for shares of Bioenvision stock
or other equity securities, up to the fair market value thereof; (B) to fund
salaries, materials and related capital in support of specific research
activities pursuant to the applicable Sublicense; or (C) for Product or other
property or assets up to an amount equal to the lesser of the fair market value
of such Product (meaning, the amount Bioenvision charges to third parties for
similar quantities of Product sold on similar delivery, payment and other
terms), property or assets, or Bioenvision’s actual cost to acquire or
manufacture such Product, property or assets.


g.                                      “Allowable
Costs” shall mean the following actual, documented costs incurred by the seller
(either Bioenvision or Sales Partner) that relate specifically to the sale of
the Product for which Net Sales Revenue is being calculated:  (i) value added, sales, or use taxes, duties
or other governmental tariffs; (ii) trade, quantity and cash discounts,
credits, rebates, or allowances; (iii) Product returns and bad debts; (iv)
freight, shipping, transportation, and insurance charges; (v) discounts
mandated by, or granted to meet the requirements of, applicable territorial
laws or regulations; (vi) market based commissions paid to unaffiliated
contract sales organizations under non-exclusive sales arrangements, not to
exceed 8.0% unless agreed to in advance in writing by SRI; and (vii) any other
customary and reasonable deductions that may be made from the sales price of
the Product in the Territories. 
Allowable Costs shall not include any (i) start-up costs, (ii) 



 3
 









 


research and development costs, or (iii) corporate
overhead and general administrative expenses.


All
references to “sublicenses” in the Agreement shall be deemed to be deleted and
replaced with the term “Sublicenses.”


All
references to “sublicensees,” “distributors” and “joint ventures” shall be
deemed to be deleted and replaced with the term “Sales Partner.”


2.                                       Article
5 of the Co-Development Agreement is hereby deleted in its entirety and
replaced with the following:


5.             ACQUISITION


A.            Genzyme Royalties. 
For purposes of the ILEX Co-Development Agreement and only for such
purpose, it is agreed that the royalties received by Bioenvision from ILEX, its
Affiliates or sublicensees for the sales of Clofarabine or any Product in the
Field and in the Territory (as such terms are defined in the ILEX
Co-Development Agreement) shall be divided between SRI and Bioenvision
according to the percentage set forth in the following table:




	
  Annual Net Sales

  Revenue ($Million)

  	
   

  	
  Total Royalty

  (% Net Sales Revenue)

  	
   

  	
  % Total Royalty to SRI

  
	
  0 – 30

  	
   

  	
  8.75

  	
   

  	
  71.429

  
	
  30 – 100

  	
   

  	
  11.25

  	
   

  	
  55.556

  
	
  100-200

  	
   

  	
  12.50

  	
   

  	
  56.000

  
	
  200 – 500

  	
   

  	
  15.00

  	
   

  	
  50.000

  
	
  500+

  	
   

  	
  18.75

  	
   

  	
  53.333

  






 


Bioenvision will pay SRI its percentage of the
royalties as per above within five (5) business days of receipt by Bioenvision
from ILEX of the royalty payments due Bioenvision in accordance with Article
8.2 of the ILEX Co-Development Agreement by electronic wire transfer of funds
in US dollars as per above to the following account (or such other account
designated by SRI in writing from time to time):


AmSouth Bank


Account No. 


Routing No. 


For Intellectual Property



 4
 









 


B.            Sublicense Revenue.  Bioenvision shall pay to each of Genzyme
and/or SRI, as applicable, a percentage of any and all Sublicense Revenue
received by Bioenvision from a Sales Partner within five (5) days after receipt
thereof by Bioenvision:


(i)            when required under the ILEX
Co-Development Agreement, 33.3% to Bioenvision, 33.3% to Genzyme and 33.3% to
SRI or, if this provision does not apply, then;


(ii)           50% to Bioenvision and 50% to SRI.


3.                                       Article
6 of the Co-Development Agreement is hereby deleted in its entirety (including,
but not limited to, the provisions of Section 6.A. of the Co-Development
Agreement and all references to the phrase “profit sharing compensation”) and
is replaced with the following:


6.             COMMERCIALIZATION
STAGE


A.            Payment of Royalties on Net Sales Revenue.  In accordance with Article 2 and Article 3,
Bioenvision shall have exclusive rights to make, have made, use and sell the
Product in the Territory under the following terms: For the Patent and
Technical Information license granted herein, Bioenvision shall pay to SRI a
royalty of seven percent (7%) of Net Sales Revenue from Direct Sales and
Indirect Sales of all Product(s) in the Territory during the term of this
Agreement (which royalty shall not be subject to renegotiation or reduction
without SRI’s prior written consent, which can be withheld in SRI’s sole and
absolute discretion).  Such royalty shall
be payable, on a country-by-country basis, for the longer of: (a) ten (10) years
from the date of first commercial sale of such Product in such country and (b)
the expiration or termination of the last patent within the Patents licensed by
SRI to Bioenvision under Article 2 that claims the manufacture, use, sale or
importation of the Product at the time of sale in such country.


B.            Milestone Payments on Net Sales Revenue.  In addition to the foregoing royalties,
Bioenvision will pay each of the following milestone payments to SRI for any
and all Net Sales Revenue booked by Bioenvision or its Sales Partner as
revenues under U.S. Generally Accepted Accounting Principles, for Direct Sales
and Indirect Sales in the Territory as is set forth below.  For avoidance of doubt: (a) each of the
following milestone payments shall be payable up to a maximum of one (1) time,
and (b) such milestone payments shall be payable in lieu of the profit-sharing
arrangements set forth in the Agreement prior to the date of this Amendment:



 5
 









 


·                                          Bioenvision
shall pay SRI $1,000,000 within forty-five (45) days after the end of the first
calendar year during which either (a) annual Net Sales Revenue are equal to or
greater than $30,000,000 or (b) cumulative Net Sales Revenues from such
calendar year and prior years during the term are equal to or greater than $150,000,000;


·                                          Bioenvision
shall pay SRI $1,000,000 within forty-five (45) days after the end of the first
calendar year during which either (a) annual Net Sales Revenue are equal to or
greater than $40,000,000 or (b) cumulative Net Sales Revenues from such calendar
year and prior years during the term are equal to or greater than $200,000,000;


·                                          Bioenvision
shall pay SRI $3,000,000 within forty-five (45) days after the end of the first
calendar year during which either (a) annual Net Sales Revenue are equal to or
greater than $50,000,000 or (b) cumulative Net Sales Revenues from such
calendar year and prior years during the term are equal to or greater than
$250,000,000;


·                                          Bioenvision
shall pay SRI $20,000,000 within forty-five (45) days after the end of the first
calendar year during which either (a) annual Net Sales Revenue are equal to or
greater than $100,000,000 or (b) cumulative Net Sales Revenues from such
calendar year and prior years during the term are equal to or greater than
$500,000,000;


·                                          Bioenvision
shall pay SRI $40,000,000 within forty-five (45) days after the end of the
first calendar year during which either (a) annual Net Sales Revenue are equal
to or greater than $200,000,000 or (b) cumulative Net Sales Revenues from such
calendar year and prior years during the term are equal to or greater than
$1,000,000,000;


·                                          Bioenvision
shall pay SRI $40,000,000 within forty-five (45) after the end of the first
calendar year during which either (a) annual Net Sales Revenue are equal to or
greater than $500,000,000 or (b) cumulative Net Sales Revenues from such
calendar year and prior years during the term are equal to or greater than
$2,500,000,000.


C.            All such Net Sales Revenue as has accrued from the date
of receipt of approval by the EMEA to market and sell the Product in the
European Union shall be included in Net Sales Revenue for the purpose of 



 6
 









 


determining whether and when the Net Sales Revenue
thresholds identified above have been achieved.


D.            The foregoing royalties and milestone payments shall not
apply to:


(i)            Direct Sales or Indirect Sales made
in North America pursuant to the ILEX Co-Development Agreement (the ILEX
Co-Development Agreement shall apply to such sales); or


(ii)           Sales made in Japan and/or Southeast
Asia (as defined in the Japan License) pursuant to the Japan License (the Japan
License shall apply to such sales).


4.                                       Section
23 of the Co-Development Agreement is hereby deleted in its entirety and is
hereby replaced with the following:


23.           ASSIGNABILITY


A.            Except as expressly
provided hereunder, neither this Agreement nor any rights or obligations
hereunder may be assigned or otherwise transferred by either party without the
prior written consent of the other party (which consent shall not be
unreasonably withheld); provided, however, that either party may
assign this Agreement and its rights and obligations hereunder without the
other party’s consent to an Affiliate or in connection with a Change of
Control.  The rights and obligations of
the parties under this Agreement shall be binding upon and inure to the benefit
of the successors and permitted assigns of the parties.  Any assignment not in accordance with this
Agreement shall be null and void ab initio.


B.            For purposes of this Article 23, “Change
of Control” shall be deemed to have taken place if (a) a third party, including
a “group” as defined in section 13(d)(3) of the Securities Exchange Act of 1934
but excluding the current directors of Bioenvision, becomes the beneficial
owner of shares having fifty percent (50%) or more of the total number of  votes that may be cast for the election of
directors of Bioenvision; or (b) as the result of, or in connection with, any
cash tender or exchange offer, merger or other business combination, sale of assets
or contested election, or any combination of the foregoing transactions (a “Transaction”),
(X) the persons who were directors of Bioenvision before the Transaction shall
cease to constitute a majority of the Board of Directors of Bioenvision or any
successor to Bioenvision, or (Y) there is the sale, exchange of other
disposition of all or substantially all of Bioenvision’s assets to a third
party.  Bioenvision shall provide to SRI
written notice of any Change in 



 7
 









 


Control within two (2) business days
following a Change of Control of Bioenvision.


5.                                       Notwithstanding
any other provision of this Second Amendment or of the Co-Development
Agreement, Genzyme Corporation and its successors and assigns are hereby deemed
not to be a “Sales Partner,” and the ILEX Co-Development Agreement is hereby deemed
not to be a “Sublicense” for purposes of Article 6 of the Co-Development
Agreement (as revised by this Second Amendment).  Except as specifically
provided herein, none of the terms and provisions set forth in this Second
Amendment shall have any affect upon the rights and obligations of the parties
hereto under the Ilex Co-Development Agreement. 
The terms and provisions of the Ilex Co-Development Agreement shall
remain in full force and effect.


6.                                       None
of the terms and provisions set forth in this Second Amendment shall have any
effect upon the rights and obligations of the respective parties hereto
pursuant to the Japan License.  The terms
and provisions of the Japan License shall remain in full force and effect.


7.                                       Section
20.A. of the Co-Development Agreement is hereby deleted in its entirety and is
hereby replaced with the following:


A.            The Co-Development Agreement (as amended hereby) shall
continue in effect until the later of: 
(i) expiration of the last to expire of all Patent(s), Improvement(s),
and Patent(s) licensed under this Co-Development Agreement (as amended),
including any extensions hereof and any periods of exclusivity by regulatory
agencies or other governmental bodies; (ii) with respect to such country in
which the Product is being sold, ten (10) years from the date of first
commercial sale of the Product in such country; (iii) Bioenvision is no longer
due any payments from Sales Partners; or (iv) Bioenvision is no longer directly
marketing a Product.


8.                                       Section
20.B. of the Co-Development Agreement is hereby deleted in its entirety.


9.                                       Appendix
IV of the Co-Development Agreement is hereby deleted in its entirety.


10.                                 Bioenvision
and SRI hereby agree and acknowledge as follows: (i) that the Clofarabine
Marketing and Distribution Agreement entered into by and between Bioenvision
and Mayne Pharma Limited (“Mayne Pharma”) on or about March 24, 2006 (the “Mayne
Agreement”) is a Sublicense and that Mayne Pharma is a Sales Partner for all
purposes of this Agreement, (ii) that SRI is hereby deemed to have consented to
the execution and delivery of the Mayne Agreement by Bioenvision, (iii) that
SRI, on behalf 



 8
 









 


of itself, its affiliates, successors and assigns,
hereby irrevocably waives any and all claims that the execution or delivery by
Bioenvision of the Mayne Agreement constituted, or constitutes, a breach of the
Co-Development Agreement by Bioenvision, and (iv) that Bioenvision hereby
agrees to pay to SRI all amounts due to SRI be paid in respect of payments
heretofore made to Bioenvision by Mayne Pharma under the Mayne Agreement by no
later than five (5) business days following the date of the execution of this
Second Amendment.


11.                                 Release.  Bioenvision agrees that all payments made by
Bioenvision to SRI pursuant to the Co-Development Agreement prior to the date
hereof were validly made in accordance with the terms of the Co-Development
Agreement.  Except as set forth in
Section 10 above and for the rights of SRI as a result of an audit by SRI of
the records of Bioenvision pursuant to the terms of the Co-Development
Agreement, each party hereto hereby releases and forever discharges the other
party and its successors, assigns and Affiliates from and against any and all
claims that it has or may have with respect to any payments made by one party
hereto to the other party hereto pursuant to the Co-Development Agreement on or
prior to the date hereof and agrees that it will not assert any claim or take
any other action seeking repayment of all or any portion of any such payments.  SRI and Bioenvision, on behalf of themselves
and their respective affiliates, successors and assigns, hereby irrevocably
waive any and all claims that they have or may have against the other party
with respect to any actual or alleged breach of the Co-Development Agreement by
the other party on or prior to the date hereof, and both SRI and Bioenvision
agree that a material breach of this Agreement does not exist on the date
hereof.


12.                                 Miscellaneous.


a.                                       Except
as modified in this Second Amendment, the terms and provisions of the
Co-Development Agreement shall remain in full force and effect.  If any of the terms or provisions of this
Second Amendment shall conflict with any terms or provisions of the
Co-Development Agreement, the terms of this Second Amendment shall govern.


b.                                      This
Second Amendment may be executed in one or more counterparts, each of which
shall be deemed to be an original but all of which together shall constitute
one and the same instrument.


c.                                       This
Amendment is to be read and construed with the Co-Development Agreement, as
previously amended, as constituting one and the same agreement.


[Signature
page follows]



 9
 









 


IN
WITNESS WHEREOF, the parties hereto have caused this Second Amendment to be
executed by their duly authorized officer, as of the date first above-written.


	
  

  	
  BIOENVISION, INC.

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ David P. Luci

  
	
   

  	
   

  	
  David P. Luci

  	
   

  
	
   

  	
   

  	
  Executive Vice President

  	
   

  
	
   

  	
   

  	
  and General Counsel

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  SOUTHERN RESEARCH INSTITUTE

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ David A. Rutledge

  
	
   

  	
   

  	
  Name:

  	
  David A. Rutledge

  
	
   

  	
   

  	
  Title:

  	
  Chief Financial Officer

  
						



 



 10