CLINICAL STUDY AGREEMENTClinical Trial Agreement |
|
|
|
You are currently viewing: This Clinical Trial Agreement involves
NORTHWEST BIOTHERAPEUTICS INC. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here. |
|
|
|
Search Clinical Trial Agreement by:
EXHIBIT 10.35
CLINICAL STUDY AGREEMENT
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.
2. COMPANY OBLIGATIONS:
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.
4. PAYMENTS:
All payments will be made
payable to:
|
|
|
|
|
|
|
|
|
The Regents of the
University of California |
||
|
|
|
Tax I.D. Number: 95-6006143 |
|
|
|
|
|
|
|
|
|
|
|
All payments will be mailed
to: |
|
UCLA Remittance Center |
|
|
|
|
|
10920 Wilshire Boulevard |
|
|
|
|
|
Suite 107 |
|
|
|
|
|
Los Angeles, California
90024-1406 |
|
|
|
|
|
|
|
|
|
Payments shall reference: |
|
Investigator Name and Study
Title |
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.
8. INVENTIONS:
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 University and Company. To the
extent that Company pays all direct and indirect costs of University’s
performance hereunder, and to the extent that the University is legally able,
Company will be granted a 120-day first right to negotiate an option or license
to University’s rights in any Subject Invention that belongs either
solely to University or jointly to University and Company.
2
B. University will
promptly disclose to Company any Subject Inventions. Company will hold such
disclosure on a confidential basis and will not disclose the information to any
third party without consent of University. Company will advise the University
in writing within sixty (60) days of such disclosure to Company whether or
not it wishes to secure an option or commercial license (“Election
Period”). Company will have 120 days from the date of election to
conclude an option or license agreement with University (“Negotiation
Period”). If such option or license is not concluded within the
Negotiation Period, neither party will have any further obligations to the
other with respect to such Subject Invention. If Company does not elect to
secure such option or license; rights to such Subject Invention will be
disposed of in accordance with University’s policies, with no further
licensing obligation to Company with respect to such Subject Invention.
C. Nothing contained in
this Agreement shall be deemed to grant either directly or by implication,
estoppel, or otherwise, any rights under any patents, patent applications or
other proprietary interests, whether dominant or subordinate, or any other
invention, discovery or improvement of either party, other than the specific
rights covering Subject Inventions under this Agreement.
9. DATA: The
University shall own all Study data. The Company will have a right to access
and use the Study data, and other data obtained by the Investigator and/or
University relating to the patients treated under the Study (including, without
limitation, survival data), to the maximum extent permitted under University
policy and applicable laws. Nothing herein shall prevent University from using
or sharing information and data generated hereunder for ordinary research and
educational purposes of a university. Company may, upon prior notice and at
reasonable times, access Study data in whatever form available, however,
consistent with applicable law, individual subject identifiers shall not be
made available to Company. If Study data must be redacted for the purpose of
allowing Company access, then Company agrees to reimburse University for the
reasonable cost of generating such redacted reports.
10. INDEMNIFICATION:
A. University will
indemnify, defend and hold harmless Company, its trustees, officers, agents,
and employees from and against any and all liability, loss, expense (including
reasonable attorney’s fees), or claims for injury or damages arising out
of the performance of this Agreement, but only in proportion to and to the
extent such liability, loss, expense, attorney’s fees, or claims for injury
or damages are caused by or result from the negligent or intentional acts or
omissions of University, its trustees, officers, agents or employees.
B. Company will
indemnify, defend and hold harmless University, its trustees, officers, agents,
and employees from and against any and all liability, loss, expense (including
reasonable attorney’s fees), or claims for injury or damages arising out
of the performance of this Agreement, but only in proportion to and to the
extent such liability, loss, expense, attorney’s fees, or claims for
injury or damages are caused by or result from the negligent or intentional
acts or omissions of Company, its directors, officers, agents or employees.
C. An indemnified party
shall give prompt notice of any claim to the other party and the indemnified
party shall control the defense, settlement, or compromise of any such claim.
Notwithstanding the aforementioned, neither party shall have the right to admit
the guilt or fault of the other party in any such settlement.
11. INSURANCE:
Each party hereto represents that it maintains a policy or program of
insurance or self-insurance at levels sufficient to support its obligations
assumed herein. Upon request, Company will provide evidence of its insurance to
University. Company will provide to University written notice of cancellation
of its coverage at least thirty (30) days prior to such cancellation.
12. TERMINATION:
Either party may terminate this Agreement upon thirty (30) days
written notice. The parties will work together to safely withdraw Study
subjects from the Study over a mutually agreeable
3
period if thirty
(30) days notice is insufficient, based upon evaluation of risks to
subjects. If Company terminates the Study, before its completion, Company shall
reimburse University for all costs incurred in the conduct of the Study,
including non-cancelable commitments undertaken up to the point of termination.
The amount of this final payment will include the costs incurred for each
patient not completing the full course of the Study at the time it is
terminated. University will retain payment for non-cancelable obligations
incurred through the termination date. The provisions of Articles 5, 7, 8, 9,
10 of this Agreement will remain in effect after the termination or expiration of
this Agreement, for any occurrences arising out of the performance of the
Agreement prior to termination.
13. ORDER OF
PRECEDENCE: To the extent that any of the terms and conditions of this
Agreement are in conflict with the language of the Protocol attached, the terms
and conditions of this Agreement shall govern.
14. APPLICABLE LAW:
The laws of the State of California govern this Agreement.
15. NOTICE: Any
notice given pursuant to this Agreement will be written and sent to:
|
|
|
|
|
|
|
|
|
UNIVERSTIY: |
|
COMPANY: |
|
|
|
|
|
|
|
|
|
University of California |
|
Northwest Biotherapeutics,
Inc. |
|
|
|
Office Clinical Trials |
|
18701 120th Avenue
NE, Suite 101 |
|
|
|
10920 Wilshire Boulevard,
Suite 1200 |
|
Bothell, WA 98011 |
|
|
|
Los Angeles, California
90024 |
|
|
|






