CLINICAL STUDY AGREEMENT
EXHIBIT 10.35
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. Xxxxx Xxxx, 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: 00-0000000 | ||||
| All payments will be mailed to: | UCLA Remittance Center | |||
| 00000 Xxxxxxxx Xxxxxxxxx | ||||
| Xxxxx 000 | ||||
| Xxx Xxxxxxx, Xxxxxxxxxx 00000-0000 | ||||
| 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.
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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
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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 | 00000 000xx Xxxxxx XX, Xxxxx 000 | |||
| 00000 Xxxxxxxx Xxxxxxxxx, Xxxxx 0000 | Xxxxxxx, XX 00000 | |||
| Xxx Xxxxxxx, Xxxxxxxxxx 00000 | ||||
| ATTENTION: Industry Contract Officer | ATTENTION: Xxxxx X. Xxxxxxx | |||
| If by Fax: (000) 000-0000 |
Or such other address or number as shall be furnished in writing by any such party, and such
notice or communication shall, if properly addressed be deemed to have been given as of the date
delivered in person or sent by facsimile, one day after deposition with an overnight courier or 4
business days after deposition into the US mail.
16. COMPLIANCE WITH LAWS: The parties hereto acknowledge that they will comply with
laws, rules and regulations applicable to the performance of the Study. Applicable laws shall
include but not be limited to: Food and Drug Administration, Heath Insurance Portability and
Accountability Act, California Medical Information Act and other applicable laws.
17. FORCE MAJEURE: If a party fails to perform its obligations because of acts of
God, governmental restrictions, governmental regulations, governmental controls, judicial orders,
enemy or hostile government action, civil commotion, telecommunications failure (including, without
limitation, Internet failures), fires or other casualty or causes beyond the reasonable control of
the party obligated to perform, then that party’s performance shall be excused provided that such
party notifies the other party as soon as practicable of the existence of such condition and uses
reasonable efforts to resume performance in an expeditious manner.
18. RELATIONSHIP OF PARTIES: The parties hereto are independent contractors. Neither party
shall act nor represent itself, directly or by implication, as an agent of the other. Each party
shall be responsible for the direction and control of its employees, subcontractors, and/or
consultants and nothing under this Agreement shall create any relationship between the employees,
subcontractors and/or consultants of University and Company respectively.
19. ASSIGNMENT: Neither party will assign its rights or duties under this Agreement to
another without the prior express written consent of the other party; provided, however, that
Company may assign this Agreement to a successor in ownership of all or substantially all its
business assets in the field to which this Agreement relates. Such successor will expressly assume
in writing the obligation to perform in
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accordance with the terms and conditions of this Agreement. Any other purported assignment will be
void.
20. ENTIRE AGREEMENT; AMENDMENT: This Agreement represents the entire understanding of the
parties with respect to the subject matter. There are no representations, warranties,
understandings or agreements among the parties with respect to the subject matter contained herein
and therein, which are not fully expressed in this Agreement. This Agreement and the exhibits
attached hereto supersede all prior agreements and understandings between the parties with respect
to such subject matter. Any modification of this Agreement must be in writing and signed by the
parties.
REMAINDER OF PAGE INTENTIONALLY LEFT BLANK
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed in duplicate as of
the date last signed below.
| COMPANY: NORTHWEST BIOTHERAPEUTICS | THE REGENTS OF THE UNIVERSITY OF CALIFORNIA | |||||||||||
By:
|
By: | |||||||||||
| (Signature) | (Signature) | |||||||||||
| By: | Xxxxx X. Xxxxxxx | By: | Xxx Xxxxxxxx | |||||||||
| (Typed Name) | (Typed Name) | |||||||||||
| President | Industry Contract Offier | |||||||||||
| (Title) | (Title) | |||||||||||
Date:
|
2/14/2006 | Date: | 1/24/2006 | |||||||||
| READ AND ACKNOWLEGDED BY INVESTIGATOR: | ||||||
By: |
||||||
| (Signature) | ||||||
| By: | Xxxxx X. Xxxx | |||||
| (Typed Name) | ||||||
| Date: | 1/20/2006 | |||||
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EXHIBIT A – PROTOCOL
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EXHIBIT B – FINAL REPORT
Final report of the study will include:
| • | data related time of progression of disease | ||
| • | overall survival of patients | ||
| • | immunological data related to the study drug and stimulation of an immune response | ||
| • | completed case report forms including data related to adverse events, serious adverse events, etc. |
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EXHIBIT C – PAYMENT SCHEDULE
20% up front within 30 days of signing of agreement
12% per each booster cycle for 10 patients
20% upon final completion of CRF’s and study report
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