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.
3.
TERM: This Agreement shall become effective as of the
last date of signing by the last party to sign and shall continue
until completion of the Study or until termination pursuant to
Article 13.
All payments
will be made payable to:
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The Regents of
the University of California
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Tax I.D.
Number: 95-6006143
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All payments
will be mailed to:
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UCLA Remittance
Center
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10920 Wilshire
Boulevard
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Suite 107
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Los Angeles,
California 90024-1406
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Payments shall
reference:
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Investigator
Name and Study Title
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5.
CONFIDENTIALITY : Company will not disclose its
confidential information unless it is necessary to the Study. Any
information Company discloses to University and considers
confidential will be clearly marked in writing, as
“Confidential”, or if orally disclosed to University,
will be clearly identified as “Confidential”. Except as
required by law, University will not disclose such Company
confidential information for a period of five (5) years from
the expiration or termination of this Agreement. This obligation to
maintain confidentiality does not apply to information that:
(a) was known to University prior to its receipt from Company,
(b) the University independently develops, (c) is now
public knowledge or subsequently becomes such through no breach of
this Agreement, (d) is rightfully disclosed by third parties
to University, or (e) University is required by law to
disclose. University will use reasonable efforts to protect the
confidentiality of such information while in its
possession.
6.
PUBLICATION : University may publish Study results or
present Study results at meetings, seminars, or the like, but will
not disclose confidential information received from Company.
University agrees to submit a copy of all manuscripts, abstracts,
and /or presentation materials which report results of the Study,
to Company for review and comment forty-five (45) days prior
to its publication. Company will have said forty-five days to
review publication. Company will have no editorial rights over
manuscripts, but may comment on and request redaction of
confidential or proprietary information.
7.
UNIVERSITY AND COMPANY NAMES : California
Education Code section 92000 prohibits use of University’s
names to suggest that University endorses a product or service.
Company will not use University’s names, including
“UCLA,” without the express prior written approval,
except to identify University as the Study site when required to do
so by law. University will not use Company’s names without
the express prior written approval of Company, except when required
to do so by law.
A. Inventorship of developments or
discoveries first conceived and reduced to practice under this
Agreement (“Subject Inventions”) will be determined in
accordance with U.S. Patent Law. All rights to Subject Inventions
made solely by employees of University will belong solely to
University. All rights to Subject Inventions made solely by
employees of Company will belong solely to Company. All rights to
Subject Inventions made jointly by employees of University and
employees of Company will belong jointly to Univer
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