***NCI/ DCTD Standard Language to Be Incorporated into All Protocols
Involving Agent(s) Covered by a Clinical Trials Agreement (CTA) or a
Cooperative Research and Development Agreement (CRADA), hereinafter
referred to as Collaborative Agreement:***

The agent(s) supplied by CTEP, DCTD, NCI used in this protocol is/are
provided to the NCI under a Collaborative Agreement (CRADA, CTA) between
the Pharmaceutical Company(ies) (hereinafter referred to as
ACollaborator(s)@) and the NCI Division of Cancer Treatment and
Diagnosis. Therefore, the following obligations/guidelines, in addition
to the provisions in the AIntellectual Property Option to Collaborator@
(http:// ctep.cancer.gov/industry) contained within the terms of award,
apply to the use of the Agent(s) in this study:

1\. Agent(s) may not be used for any purpose outside the scope of this
protocol, nor can Agent(s) be transferred or licensed to any party not
participating in the clinical study. Collaborator(s) data for Agent(s)
are confidential and proprietary to Collaborator(s) and shall be
maintained as such by the investigators. The protocol documents for
studies utilizing investigational Agents contain confidential
information and should not be shared or distributed without the
permission of the NCI. If a copy of this protocol is requested by a
patient or patient's family member participating on the study, the
individual should sign a confidentiality agreement. A suitable model
agreement can be downloaded from: http://ctep.cancer.gov.

2\. For a clinical protocol where there is an investigational Agent used
in combination with (an)other investigational Agent(s), each the subject
of different collaborative agreements , the access to and use of data by
each Collaborator shall be as follows (data pertaining to such
combination use shall hereinafter be referred to as \"Multi-Party
Data.@):

> a\. NCI will provide all Collaborators with prior written notice
> regarding the existence and nature of any agreements governing their
> collaboration with NIH, the design of the proposed combination
> protocol, and the existence of any obligations that would tend to
> restrict NCI\'s participation in the proposed combination protocol.
>
> b\. Each Collaborator shall agree to permit use of the Multi-Party
> Data from the clinical trial by any other Collaborator solely to the
> extent necessary to allow said other Collaborator to develop, obtain
> regulatory approval or commercialize its own investigational Agent.
>
> c\. Any Collaborator having the right to use the Multi-Party Data from
> these trials must agree in writing prior to the commencement of the
> trials that it will use the Multi-Party Data solely for development,
> regulatory approval, and commercialization of its own investigational
> Agent.

3\. Clinical Trial Data and Results and Raw Data developed under a
Collaborative Agreement will be made available exclusively to
Collaborator(s), the NCI, and the FDA, as appropriate and unless
additional disclosure is required by law or court order. Additionally,
all Clinical Data and Results and Raw Data will be collected , used and
disclosed consistent with all applicable federal statutes and
regulations for the protection of human subjects, including, if
applicable, the *Standards for Privacy of Individually Identifiable
Health Information* set forth in 45 C.F.R. Part 164.

4\. When a Collaborator wishes to initiate a data request, the request
should first be sent to the NCI, who will then notify the appropriate
investigators (Group Chair for Cooperative Group studies, or PI for
other studies) of Collaborator\'s wish to contact them.

5\. Any data provided to Collaborator(s) for Phase 3 studies must be in
accordance with the guidelines and policies of the responsible Data
Monitoring Committee (DMC), if there is a DMC for this clinical trial.

6\. Any manuscripts reporting the results of this clinical trial must be
provided to CTEP for immediate delivery to Collaborator(s) for advisory
review and comment prior to submission for publication. Collaborator(s)
will have 30 days from the date of receipt for review. Collaborator
shall have the right to request that publication be delayed for up to an
additional 30 days in order to ensure that Collaborator's confidential
and proprietary data, in addition to Collaborator(s)'s intellectual
property rights, are protected. Copies of abstracts must be provided to
CTEP for forwarding to Collaborator(s) for courtesy review as soon as
possible and preferably at least three (3) days prior to submission, but
in any case, prior to presentation at the meeting or publication in the
proceedings. Press releases and other media presentations must also be
forwarded to CTEP prior to release. Copies of any manuscript, abstract
and/or press release/ media presentation should be sent to:

Regulatory Affairs Branch, CTEP, DCTD, NCI

Executive Plaza North, Suite 7111

Bethesda, Maryland 20892

FAX 301-402-1584

Email: anshers@ctep.nci.nih.gov

The Regulatory Affairs Branch will then distribute them to
Collaborator(s). No publication, manuscript or other form of public
disclosure shall contain any of Collaborator=s confidential/ proprietary
information.

.