EX-10.44








    EXHIBIT 10.44



 




    AMENDMENT
    #1 TO THE

    CLINICAL TRIAL AGREEMENT BETWEEN

    VION PHARMACEUTICALS, INC. AND THE

    DIVISION OF CANCER TREATMENT AND DIAGNOSIS, NCI

    DATED MARCH 2, 2006



 



    The purpose of this amendment (“Amendment”), effective
    as of the last date signed below (“Effective Date”),
    is to change certain terms of the above referenced Clinical
    Trials Agreement (CTA) (“Agreement”). These changes
    are reflected below and except for these changes, all other
    provisions remain in full force and effect. Two
    (2) originals of this amendment are provided for execution;
    one is to remain with the National Cancer Institute, and the
    second is to remain with Vion Pharmaceuticals.



 


		
	
    1.  
	
    Expiration
    Date




 



    The CTA shall be amended to extend the term for conducting
    clinical studies with this Agent for a period of two
    (2) years. The date of expiration of this CTA is now
    January 9, 2008.



 


		
	
    2.  
	
    Article 1.
    Definitions




 



    “CTIS” means Capital Technology Information Service.



 


		
	
    3.  
	
    Article 6.
    Drug Information and Supply




 



    Article 6 is hereby amended as follows:



 



    The contact person for DCTD will be Mr. Charles Hall,
    Chief, Pharmaceutical Management Branch (Telephone Number
    301-496-5725).



 



    Add the following paragraph:



 



    Collaborator agrees to provide to the Pharmaceutical Management
    Branch (PMB) the Clinical Investigator’s Brochure (IB) for
    Agent and all subsequent revisions/editions. In addition to
    being filed to the CTEP IND, the IB will be on file in the PMB
    and will be distributed to all investigators participating on a
    clinical trial using the agent. For NCI trials using agent
    manufactured by NCI, PMB will attach a cover sheet to the IB
    clearly indicating the trial is sponsored by NCI and the agent
    is supplied by the NCI. All distribution will be accompanied by
    a statement about the confidentiality of the document and it is
    anticipated that distribution will be electronic. All electronic
    distribution will be done using Adobe Acrobat. Any IB received
    by the PMB that is not in this format will be converted before
    distribution. Hard copy IBs should be sent to IB Coordinator,
    Pharmaceutical Management Branch, CTEP, DCTD, NCI, 6130
    Executive Blvd, Room 7149, Rockville, MD 20852. Electronic
    versions should be emailed to the IB Coordinator at
    IBCoordinator@mail.nih.gov.



 


		
	
    4.  
	
    Article 7.
    Data Rights




 



    Article 7 is hereby amended to add the following paragraph
    to the end of the Article:



 



    DCTD will not execute a Funding Agreement for clinical trials
    for development of Agent unless the institution agrees to
    provide information to Collaborator in accord with applicable
    Federal regulations, including the Standards for Privacy of
    Individually Identifiable Health Information set forth in
    45 C.F.R. Part 164. DCTD shall advise all institutions
    conducting NCI-sponsored clinical trials that they must comply
    with all applicable federal regulations for the protection of
    human subjects, including the Privacy Rule.



 


		
	
    5.  
	
    Add the
    following Article 23:




 



    Article 23.  Monitoring




    

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    CTEP/DCTD utilizes the contract services of two companies (CTMS)
    for assistance in the monitoring of DCTD-sponsored clinical
    trials. Collaborator will be responsible for making arrangements
    directly with the appropriate DCTD contractors to receive
    reports from DCTD-sponsored trials. This will include quarterly
    reports, adverse event reports and summary reports. Each CTMS
    will be reimbursed by Collaborator for the cost of reformatting
    (if any) and reproduction of the data. CTIS, the contractor for
    most Phase 2 and 3 studies will provide these reports
    electronically in a format compatible with Collaborator’s
    database at a cost of $2000 per year, payable directly to CTIS.
    Theradex, the CTMS NCI Phase 1 contractor, will also provide
    reports directly to Collaborator in a format negotiated by
    Collaborator and Theradex. Contact information for each
    contractor will be provided as needed.



 



    Any additional requests which involve the collection of more
    than summarized data provided annually will be at the expense of
    Collaborator. Should DCTD conduct an audit to confirm the
    anti-tumor activity of a treatment regimen using Agent,
    Collaborator is encouraged to attend and participate in the data
    review. Since data will be collected under the NCI IND, should
    Collaborator choose to contact an investigator to collect or
    review data, Collaborator must first contact the Regulatory
    Affairs Branch, DCTD for prior approval, which approval shall
    not be unreasonably withheld. Upon approval of
    Collaborator’s request, the Regulatory Affairs Branch will
    notify the investigator(s) of Collaborator’s request and
    instruct the investigator(s) to provide full access to the
    requested data. Collaborator will reimburse the investigator(s)
    for any and all costs associated with fulfilling
    Collaborator’s request.



 




    AGREED TO
    AND ACCEPTED BY:



 


	 	 	 
	

    For the National Cancer Institute:


	
 
	
 

	
 
	
 
	
 

	

    /s/  James
    Doroshow



	
 
	
    February 13, 2006

	
    

	
 
	
    


	

    James Doroshow, M.D., FACP


	
 
	
    Date

	

    Director, Division of Cancer Treatment and Diagnosis


	
 
	
 

	
 
	
 
	
 

	

    For Vion Pharmaceuticals:


	
 
	
 

	
 
	
 
	
 

	

    /s/  Ann
    Cahill



	
 
	
    March 2, 2006

	
    

	
 
	
    


	

    Ann Cahill PA-C


	
 
	
    Date

	

    Vice President, Clinical Development


	
 
	
 










    

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