EXHIBIT 10.23
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
UNIVERSITY OF CALIFORNIA, LOS ANGELES
AGREEMENT NO. 081082716
This Agreement is entered into this April 4, 2001, by and between THE REGENTS OF
THE UNIVERSITY OF CALIFORNIA, a California corporation, on behalf of its Los
Angeles Campus, hereinafter called "University," and NORTHWEST BIOTHERAPEUTICS,
INC., hereinafter called "Sponsor."
1. Statement of Work
Work under this Agreement will commence on the date hereof and be
performed by the University on a best effort basis in accordance with
the statement of work attached as Exhibit A hereof ("Work").
2. Deliverables
A final technical report to Sponsor upon conclusion of work performed
hereunder will be the only deliverable under this Agreement unless
additional deliverables are set forth in Exhibit B hereof.
3. Performance Period
Work under this Agreement will be performed during the period of April
4, 2001 through April 3, 2002 ("Performance Period") unless earlier
terminated pursuant to Article 15. Sixty (60) days before the end of the
Performance Period, Sponsor may give notice that it will fund the Work
for an additional one (1) year period at the same level unless the
Parties mutually agree in writing to a different amount.
4. Cost to Sponsor
The cost to Sponsor for University's performance hereunder will be
$55,000 direct costs plus $34,150 indirect costs for a total of $84,150.
5. Payment
Payments will be made quarterly to University by Sponsor in accordance
with Exhibit C hereof. Checks will be made payable to The Regents of the
University of California, reference Agreement No. CE01082716, and will
be sent to:
UCLA Remittance Center
10920 Wilshire Blvd., Ste. 107
Los Angeles, CA 90024
6. Principal Investigator
University's performance hereunder will be under the direction of Dr.
Michael Roth, Principal Investigator. In the event that the Principal
Investigator becomes unable or unwilling to continue work under this
Agreement and an alternate Principal Investigator is (i) not agreeable
to Sponsor, or (ii) has not been designated within thirty (30) days
after Dr. Roth ceases his services hereunder, Sponsor will have the
option to terminate this Agreement in accordance with Article 15 hereof.
7. Rights in Data
University will have the right to copyright, publish (subject to Article
12), disclose, disseminate and use, in whole and in part, any data and
information developed or received by University under this Agreement
that is not subject to the Confidentiality obligations of Article 11
hereof. Sponsor will have the right to publish and use any technical
reports and information specified to be delivered hereunder. It is
agreed, however, that under no circumstances will Sponsor state or imply
in any publication or other published announcement that University has
tested or approved any product.
8. Supplies and Equipment
In the event that University purchases supplies or equipment hereunder,
title to such supplies and equipment will vest in University.
9. Patents and Inventions
Inventorship of developments or discoveries first conceived and actually
reduced to practice in the performance this Agreement ("Subject
Inventions") will be determined in accordance with U.S. Patent Law and
this Agreement. Except as stated below, all rights to Subject Inventions
made solely by employees of University will belong solely to University
and all rights to Subject Inventions made solely by employees of Sponsor
will belong solely to Sponsor. All rights to Subject Inventions made
jointly by employees of University and employees of Sponsor and any
developments or discoveries conceived and actually reduced to practice
as part of the Investigational New Drug work described in Exhibit A,
Paragraph 1. will belong jointly to University and Sponsor. To the
extent that Sponsor pays all direct and indirect costs set forth in
Article 4 above, and to the extent that the University is legally able,
Sponsor will be granted a time-limited first right to negotiate an
option or license under University's rights in any Subject Invention
that belongs either solely to University or jointly to University and
Sponsor. With respect to filing patents where University and Sponsor are
co-inventors, University is obligated to file such patent application
upon Sponsors request and will allow Sponsor the opportunity, if it so
elects, to review and have right to make reasonable changes to all
documents prior to filing.
University will promptly disclose to Sponsor any Subject Inventions.
Sponsor will hold such disclosure on a confidential basis and will not
disclose the information to any third
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party without consent of University. Sponsor will advise the University
in writing within sixty (60) days of such disclosure to Sponsor whether
or not it wishes to secure an option or commercial license ("Election
Period"). Sponsor will have ninety (90) days from the date of election
to conclude an option or license agreement with University ("Negotiation
Period"). Said license will contain reasonable terms, will require
diligent performance by Sponsor for the timely commercial development
and early marketing of Subject Inventions, and include Sponsor's
obligation to reimburse University's patent costs for all Subject
Inventions subject to the license. In the event it is necessary in the
opinion of University to file any patent applications to protect a
Subject Invention during the Election or Negotiation Periods, University
will promptly notify Sponsor in writing of such decision and Sponsor
will reimburse patent costs incurred by University during such 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 Sponsor 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
obligation to Sponsor with respect to such Subject Invention.
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.
10. Copyright
Copyright in works, including computer software, created or fixed in a
tangible medium of expression by University under this Agreement will
vest in University. At Sponsor's request and to the extent that
University has the legal right to do so, University will grant to
Sponsor a license to such works on reasonable terms and conditions,
including reasonable royalties, as the parties mutually agree in a
separate writing.
11. Confidentiality
During the Performance Period, Sponsor may provide University with
certain information or material, including oral disclosure of
information which will be reduced to writing within thirty (30) days,
which Sponsor has marked as "Confidential." Except as required by law,
University will receive and hold such information in confidence and
agrees to use reasonable effort to prevent its disclosure to third
parties. This obligation will continue in effect for three (3) years
after expiration or termination of the Agreement.
University will not consider information disclosed to it by Sponsor as
confidential which: (1) is now public knowledge or subsequently becomes
such through no breach of this Agreement; (2) is rightfully in
University's possession prior to Sponsor's disclosure as shown by
written records: (3) is rightfully disclosed to University by a third
party; or (4)
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is independently developed by or for University without reliance upon
confidential information received from Sponsor.
Sponsor acknowledges that University, as a public educational
institution, does not have financial resources to sustain liability for
disclosure of confidential information and cannot guarantee
confidentiality.
12. Publication
University will have the right, at its discretion, to release
information or to publish any material resulting from its performance
hereunder. University will furnish Sponsor with a copy of any proposed
written or oral publication (including manuscripts, abstracts, and oral
presentations) at least thirty (30) days prior to submission for
publication. Upon written notification by Sponsor, University agrees to
delete Sponsor's name and/or any of Sponsor's confidential information
and/or to delay publishing such proposed publication for a maximum of an
additional forty-five (45) days in order to protect the potential
patentability of any invention described therein.
13. Notice
Whenever any notice is to be given hereunder, it will be in writing and
sent to the following address:
University: The Regents of the University of California
Office of Contract and Grant Administration
10920 Wilshire Blvd., Suite 1200
Los Angeles, California 90024-1406
Attention: Laura Crowley
Industry Contract Officer
Sponsor: Northwest Biotherapeutics, Inc.
21720 23rd Dr. S.E., Suite 100
Bothell, Washington 98021
Attention: Alton L. Boynton, Ph.D.
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14. Termination
Either University or Sponsor may terminate this Agreement by giving
thirty (30) days written notice to the other. In the event of such
termination, University will cease further obligation of project funds
and will take all reasonable steps to cancel and otherwise minimize
termination costs. Sponsor will pay University actual direct and
indirect costs and noncancellable commitments incurred prior to the date
of termination and fair close-out related costs. If the total of such
costs is less than the total funds advanced, the balance will be
promptly returned to Sponsor.
15. Publicity
Neither party will use the name, trade name, trademark or other
designation of the other party in connection with any products,
promotion, advertising, press release, or publicity without the prior
written permission of the other party.
16. Indemnification
University will indemnify, defend and hold harmless Sponsor, its
directors, 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.
Sponsor 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 Sponsor, its directors, officers, agents or employees.
17. Excusable Delays
University will be excused from performance hereunder if a delay is
caused by inclement weather, fire, flood, strike, or other labor
dispute, acts of God, acts of governmental officials or agencies, or any
other cause beyond the control of University. The excusable delay is
allowed for the period of time affected by the delay. If a delay occurs,
the parties will revise the performance period or other provisions
hereunder as appropriate.
18. 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 Sponsor may assign this Agreement to a successor
in ownership of all or substantially all its business assets or to its
successor in interest upon a merger in which Sponsor is not the
surviving
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entity, in the field to which this Agreement relates. Such successor
will expressly assume in writing the obligation to perform in accordance
with the terms and conditions of this Agreement. Any other purported
assignment will be void.
19. Amendments
This document constitutes the entire agreement between parties, and may
be modified or amended only by written agreement signed by both parties.
THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA
By:___________________________________ By:_________________________________
(Signature) (Signature)
By: __________________________________ By: ________________________________
Title: _______________________________ Title: _____________________________
Date: ________________________________ Date: ______________________________
PRINCIPAL INVESTIGATOR
By:___________________________________
(Signature)
By: __________________________________
Date: ________________________________
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EXHIBIT A -- STATEMENT OF WORK
This exhibit defines the nature, scope and content of work to be performed under
the direction of Michael D. Roth, M.D., as Principal Investigator, working on
behalf of the UNIVERSITY and to be delivered to the SPONSOR in accordance with
the terms of this contract.
1. NATURE OF WORK: The University and Sponsor will jointly develop an
Investigational New Drug (IND) application entitled, "A PHASE I TRIAL
EVALUATING DENDRITIC CELLS PRIMED WITH IRRADIATED AUTOLOGOUS TUMOR CELLS FOR
THE ADJUVANT TREATMENT OF STAGE IB/II/IIIA NON-SMALL CELL LUNG CANCER
(NSCLC)," that will be submitted by the Sponsor to the Federal Drug
Administration (FDA). This IND application is specifically intended to
support a clinical trial performed by UCLA investigators in conjunction with
the Sponsor and may not be used by the Sponsor for any other purpose unless
specified and agreed to in writing by both parties.
2. SCOPE OF WORK: The work to be performed by the University falls into three
categories:
A. Identification of reagents and resources for the IND protocol.
B. Develop and validate a protocol for preparing GMP-quality suspensions of
viable lung cancer cells from patients with stage IB/II/IIA NSCLC.
C. Collaborate in the design and writing of sections for the IND application.
3. CONTENT OF WORK:
A. Identification of reagents and resources for the IND protocol. University
investigators will identify and make known to the Sponsor a list of products
and manufacturers conforming to FDA-approved good manufacturing practices
(GMP) as required to carry out the protocol. This will include, as currently
available in the marketplace, resources for enzymes required for the
production of lung cancer cell suspensions (e.g. collagenase, DNAse,
hyaluronidase) and for reagents required for tumor purification (e.g.
antibodies and immunomagnetic beads) and characterization (e.g. tumor
identification reagents).
B. Develop and validate a protocol for preparing GMP-quality suspensions of
viable lung cancer cells from patients with stage IB/II/IIIA NSCLC.
University investigators will collect cancer specimens from the operating
room and evaluate techniques for preparing purified tumor cell suspensions
from these clinical samples. The goal will be to develop a GMP-quality
process by which tumors recovered at the time of surgery can be placed into
a transportation media and delivered to the Sponsor's cell processing
facility in the form of a viable cell suspension. In addition, techniques
for purifying and characterizing the tumor cell suspension after its arrival
at the Sponsor's facility will be investigated. Results from these
investigations will be formed into a detailed written protocol that will be
delivered to the Sponsor. This protocol will employ GMP-quality reagents, as
feasible given their current availability. The average viability, cell yield
and purity of the cancer cell suspension will be reported to the Sponsor.
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C. Design and write sections of the IND protocol. University investigators will,
in discussion and collaboration with the Sponsor, develop a Clinical Trial
Protocol and sections of a corresponding IND application for a study
entitled, "A PHASE I TRIAL EVALUATING DENDRITIC CELLS PRIMED WITH IRRADIATED
AUTOLOGOUS TUMOR CELLS FOR THE ADJUVANT TREATMENT OF STAGE IB/II/IIIA
NON-SMALL CELL LUNG CANCER (NSCLC)". The following sections will be prepared:
I. General Investigational Plan
II. Investigators Brochure
III. Detailed Protocol to include an Introduction, Objectives, Study Hypothesis
and Endpoints, Treatment Plan, Pretreatment Evaluation, On Study Evaluation,
Concomitant Medications, Adverse Events, and Criteria for Disease Evaluation.
IV. UCLA IRB application conforming to study guidelines
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EXHIBIT B -- DELIVERABLES
This exhibit defines the deliverables to be provided by Michael D. Roth, M.D.,
as Principal Investigator, working on behalf of the UNIVERSITY, to the SPONSOR
in accordance with the terms of this contract.
A. Identification of reagents and resources for the IND protocol. University
investigators will identify and make known to the Sponsor a list of products
and manufacturers conforming to FDA-approved good manufacturing practices
(GMP) as required to carry out the protocol.
B. Develop and validate a protocol for preparing GMP-quality suspensions of
viable lung cancer cells from patients with stage IB/II/IIIA NSCLC.
University investigators will prepare a detailed written protocol that will
be delivered to the Sponsor. This protocol will employ GMP-quality reagents,
as feasible given their current availability. The average viability, cell
yield and purity of the cancer cell suspension will be reported to the
Sponsor.
C. Design and write sections of the IND protocol. University investigators
will, in discussion and collaboration with the Sponsor, deliver the
following written sections of a Clinical Trial Protocol and corresponding
IND application for a study entitled, "A PHASE I TRIAL EVALUATING DENDRITIC
CELLS PRIMED WITH IRRADIATED AUTOLOGOUS TUMOR CELLS FOR THE ADJUVANT
TREATMENT OF STAGE IB/II/IIIA NON-SMALL CELL LUNG CANCER (NSCLC)".
i. General Investigational Plan
ii. Investigators Brochure
iii. Detailed Protocol to include an Introduction, Objectives,
Study Hypothesis and Endpoints, Treatment Plan, Pretreatment
Evaluation, On Study Evaluation, Concomitant Medications,
Adverse Events, and Criteria for Disease Evaluation.
iv. UCLA IRB application conforming to study guidelines
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EXHIBIT C - Payment Schedule
One third (33.33% or $28,050) of total direct and indirect costs ($84,150) will
be paid to the University within ten (10) days of the signing date of this
agreement. One-half of the remaining balance ($28,050) will be paid to the
University when the validated protocol for preparing GMP-quality suspensions of
viable lung cancer cells, as described in Exhibit B, item B, is delivered to the
Sponsor and on-half of the remaining balance ($28,050) will be paid to the
University when the necessary sections of the IND protocol and documentation of
UCLA IRB submission, as described in Exhibit B, item C, are delivered to the
Sponsor.
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