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.
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.
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2.
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Article 1.
Definitions
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“CTIS” means
Capital Technology Information Service.
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3.
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Article 6. Drug Information and
Supply
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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
wil
