exv10w41



 





Exhibit 10.41



Portions of this exhibit were omitted and filed separately with the Secretary of the
Commission pursuant to an application for confidential treatment filed with the Commission pursuant
to Rule 24b-2 under the Securities Exchange Act of 1934. Such portions are marked by a series of
asterisks.




Amendment Number 1

to Research, Co-Development 

and Commercialization Agreement and Research License and Option

Agreement




     This Amendment Number 1 (the “Amendment”) to the Collaboration Agreement and the
License Agreement (both as defined below) is effective as of
October 20, 2006 (the “Effective
Date”), and is by and between BioGeneriX AG, a corporation organized under the laws of the Federal
Republic of Germany (“BioGeneriX”), and Neose Technologies, Inc., a corporation organized and
existing under the laws of the state of Delaware (“Neose”).



Background




     BioGeneriX and Neose entered into a Research, Co-Development and Commercialization Agreement
dated April 20, 2004 (the “Collaboration Agreement”), pursuant to which BioGeneriX and Neose are
collaborating to develop a next-generation G-CSF. BioGeneriX and Neose entered into a Research,
License and Option Agreement dated April 27, 2005 (the “License Agreement”), pursuant to which
BioGeneriX has the option to license certain technology for the development and commercialization
of an undisclosed protein. The Collaboration Agreement and the License Agreement are sometimes
referred to collectively as the “Agreements.”



     Neose and BioGeneriX desire to amend both Agreements as set forth herein. All capitalized
terms used in this Amendment and not otherwise defined shall have the meanings set forth in the
Collaboration Agreement, unless otherwise indicated.



Terms




     Now, therefore, intending to be legally bound, the parties hereto agree as follows:



1. Extension of BioGeneriX Decision Date.




     1.1. Section 1.4. Section 1.4 of the Collaboration Agreement is hereby amended and
restated in full to read as follows:


“BioGeneriX Decision Date” means December 31, 2006.




     1.2. Section 24.2. Section 24.2 of the Collaboration Agreement is hereby amended by
deleting the first sentence and replacing it with the following:





 




			
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          “This Agreement may be terminated by BioGeneriX by written notice to Neose on
the BioGeneriX Decision Date.”




     1.3. Section 24.4.2. Section 24.4.2 of the Collaboration Agreement is hereby deleted.


2. Extension of Option Expiration Date. Section 1.30 of the License Agreement is hereby
amended and restated in full to read as follows:




          “1.30. “Option Expiration Date” means December 31, 2006.”




3. Diligence Requirements.




     3.1. Termination by Neose. Neose shall have the right to terminate either or both of
the Collaboration Agreement and the License Agreement (provided that the License Agreement may be
so terminated only if the Option, as defined therein, has not been exercised in accordance with the
License Agreement), effective immediately upon notice to BioGeneriX, if any of the events listed in
Section 3.1.1 through Section 3.1.6 occurs. In the event Neose terminates the Collaboration
Agreement, Neose shall, at its election and upon written notice to BioGeneriX, be a “Continuing
Licensee” for purposes of Section 24 of the Collaboration Agreement, with the rights and
obligations set forth therein.



            3.1.1. The first patient in the first Phase I clinical trial is not dosed on or before the
earlier of (i) the 30th day following ****** approval and (ii) December 31, 2006.



            3.1.2. The first ******.



            3.1.3. The safety ******.



            3.1.4. The ******.



            3.1.5. A full and complete ******.



            3.1.6. The first ******.



     3.2. Effect of Termination. If the Agreement is terminated for any reason, including
without limitation a termination by Neose pursuant to Section 3.1 of this Amendment or by
BioGeneriX on the BioGeneriX Decision Date, the diligence requirements listed in Section 3.1 and
BioGeneriX’s obligation in Section 4 of this Amendment will terminate effective upon such
termination.



     3.3. Effect of Failure to Meet Diligence Requirements. The failure of BioGeneriX to
meet any diligence requirement will not constitute a breach of the Agreement.





 




			
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     3.4. Effect of Delay in Process Reagents. If a diligence requirement is missed
because of the failure of Neose to supply reasonable quantities of process reagents of appropriate
quality as described below:



	 	 	 	 	 
	Reagent	 	Supplier	 	Quality
	******

	 	******
	 	******
	******

	 	******
	 	******
	******

	 	******
	 	******
	******

	 	******
	 	******





the date for completion of the diligence requirement will be extended by the amount of the delay
caused by the delay in delivery.



4. Cost of Process Reagents. From and after January 1, 2007, BioGeneriX will pay for the
cost of the process reagents to be supplied by Neose pursuant to Section 6.2.4 of the Collaboration
Agreement. For the purpose of this Section 4, “cost” shall mean ******



5. Sharing of Information. With respect to Next-Generation G-CSF, BioGeneriX will provide
to Neose copies of (i) all preclinical data and reports not already provided to Neose within 10
days after receipt; (ii) all clinical data, including all raw data and data tables, and reports
within 10 days after receipt at BioGeneriX, ******, whichever occurs first; (iii) all written
correspondence and minutes of oral communications with regulatory authorities; (iv) serious adverse
event reports either within 2 working days after receipt at BioGeneriX, or simultaneous with notice
to BioGeneriX by ******, whichever occurs first; and (v) copies of all regulatory authority
correspondence from BioGeneriX, ****** within 5 working days after submission.



6. Confirmation of Preclinical Development Completion Date. With respect to
Next-Generation G-CSF Neose and BioGeneriX agree that Preclinical Development shall have been
completed as of ******.



7. Notices. Any notice, consent or report (each, a “Notice”) required or permitted to be
given by either Party under this Agreement shall be in writing and shall be either personally
delivered or sent by facsimile (confirmed by internationally-recognized express courier), or by
internationally-recognized express courier (such as Federal Express or DHL), to the other Party at
its address set forth below, or such new address as may from time to time be supplied under this
Agreement by a Party. Except as otherwise set forth in this Agreement, any Notice shall be
effective upon receipt by the addressee. Provided that all postage or delivery charges are prepaid
in full by the sender and the Notice has been addressed as set forth in this Agreement:




     7.1. if such Notice is sent by facsimile (confirmed by internationally recognized express
courier, which confirmation includes a copy of the report showing the





 




			
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date and time of transmission), then the Notice shall be deemed to be received upon
transmission (if transmitted on a business day) or the next business day following transmission;
and




     7.2. if such Notice is personally delivered or sent by internationally-recognized express
courier, then the Notice shall be deemed to be received three business days after deposit with the
courier service.





 




			
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	If to BioGeneriX:

	 	BioGeneriX AG
	 

	 	High-Tech-Park Neckarau
	 

	 	Janderstrasse 3
	 

	 	D-68199 Mannheim
	 

	 	Germany
	 

	 	Attention: Chief Financial Officer
	 
	 	 
	If to Neose:

	 	Neose Technologies, Inc.
	 

	 	102 Witmer Road
	 

	 	Horsham, PA 19044
	 

	 	USA
	 

	 	Attention: General Counsel





8. No Other Changes. Except as expressly modified in this Amendment or as is inconsistent
with the terms of this Amendment, the Collaboration Agreement and License Agreement shall remain
unchanged and in full force and effect.



9. Counterparts. This Amendment may be executed in one or more counterparts, each of which shall
be an original and all of which, together, shall constitute the same document.




[signature page follows]






 




			
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          In witness whereof, the parties have executed this Amendment as of the Effective
Date.



	 	 	 	 	 	 	 
	 	 	Neose Technologies, Inc.
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ George J. Vergis	 	 
	 

	 	 	 	George J. Vergis, Ph.D.	 	 
	 

	 	 	 	President and Chief Executive Officer	 	 
	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	BioGeneriX AG
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ Elmar Schäfer	 	 
	 

	 	 	 	Name: Elmar Schäfer	 	 
	 

	 	 	 	Title: CEO	 	 
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ Klaus Maleck	 	 
	 

	 	 	 	Name: Dr. Klaus Maleck, MBA	 	 
	 

	 	 	 	Title: CFO and Vice President Bus. Dev.