THE REGENTS OF
THE UNIVERSITY OF CALIFORNIA , on behalf of its Los Angeles
Campus (hereinafter “University”), and Northwest
Biotherapeutics Inc., (hereinafter “Company”), agree
that University will perform for a clinical study (hereinafter
“the Study”) in accordance with the protocol entitled
“Phase 1 Clinical Trial Evaluating Booster Vaccinations of
DCVax ®
-Brain for Treatment of
Glioblastoma” (attached as Exhibit A) on the following
terms and conditions:
1.
INVESTIGATOR; INVESTIGATOR OBLIGATIONS :
A. Linda
Liau, M.D., Ph.D., is the named principal investigator
(“Investigator”) and will be responsible for conducting
the Study; Company is not a “Sponsor”, as that term is
defined by the Food and Drug Administration (“FDA”)
Federal Code of Regulations 21 CFR 312.3(b), of the Study.
Investigator will not represent in the informed consent or
elsewhere that Company is the Study Sponsor.
B. Company
acknowledges that Investigator is the author of the Study protocol
and research design. The Study protocol and design shall be the
property of the University, but Company shall have certain rights
of access to and use of Study data in accordance with this
Agreement. The Investigator will inform the Company of any changes
in the Protocol that significantly affect the Study objectives or
Study subject safety and any other material changes.
C. The
Study will be conducted in accordance with the Protocol, FDA
defined Good Clinical Practice Guidelines (GCPs) and all applicable
laws and regulations. Investigator, to the extent required to do so
by applicable law, will obtain and maintain: (a) an
Investigational New Drug application (“IND”) pursuant
to FDA regulations, (b) University’s institutional
review board (“IRB”) review and approval or exemption,
and/or (c) written patient informed consent (“Informed
Consent”) approved by the IRB and signed by the Study patient
or Study patient legal representative as required. The University
and Investigator are fully responsible for the adequacy of the
Informed Consent and Company has no liability related to nor
obligation to review or comment on that document.
D. University through Investigator shall
provide Company with a final report of the research efforts under
this Agreement as described in Exhibit B.
E. As
Study Sponsor, INSTITUTION and INVESTIGATOR are solely responsible
for reporting any adverse events or safety reports in connection
with the Study that may be required by applicable law to be made to
the FDA or other regulatory authority. INSTITUTION and INVESTIGATOR
shall provide Company with a copy of any such reports
simultaneously with submission to the FDA or other
agency.
F. The
Investigator shall limit the use and evaluation of Study Drug, as
defined herein, to activities directly related to the Protocol and
shall not transfer any Company Study Drug to any third party,
without the prior written consent of Company.
A. Company
will not provide DCVax-Brain (“Study Drug”) for use in
this Study. Such Study Drug will continue to be prepared by
Investigator.
B. Payment. The cost to Company for the
Study is $215,829.00 USD (inclusive of University’s
applicable overhead rate for investigator initiated studies), to be
paid in accordance with the schedule attached as Exhibit C.
The total amount will be adjusted if needed, according to actual
patient visits as outlined in Exhibit C. Additional testing,
treatment or other procedures not specifically authorized by
Company or set forth in this Agreement, will not be reimbursed by
the Company unless prior approval by the parties is made in
writing.