SERVICES AGREEMENT between LIXTE BIOTECHNOLOGY, INC. and Freestate of Bavaria Represented by UNIVERSITY OF REGENSBURG for its Institute of Pathology, Franz- Josef-Strauss-Alle 11, D-93053 Regensburg
EXHIBIT
10.2
between
LIXTE
BIOTECHNOLOGY, INC.
and
Freestate
of Bavaria
Represented
by
UNIVERSITY
OF REGENSBURG
for
its
Institute
of Pathology,
Xxxxx-Xxxxx-Xxxxxxx-Xxxx
00, D-93053 Regensburg
Exhibit
10.2
This
Agreement is made as of the 5th
day of
January, 2007 (the “Effective
Date”),
between Lixte Biotechnology, Inc., a Delaware corporation having its principal
place of business at 000 Xxxxx 00X #0, Xxxx Xxxxxxxx, Xxx Xxxx 00000, Xxxxxx
Xxxxxx of America (“Lixte”),
and
The Free State of Bavaria, represented by the University of Regensburg, a German
entity having its principal place of business at 00000 Xxxxxxxxxx, Xxxxxxx,
in
turn represented by the Head of Administration (“University”).
WITNESSETH
WHEREAS,
University has expertise in the field of surgical oncology;
WHEREAS,
Lixte is a company engaged in finding improved methods for characterizing,
detecting, estimating prognosis for, treating and evaluating treatment response
for life-threatening diseases, particularly cancer;
WHEREAS,
University provides cancer samples and related biological fluid samples to
companies;
WHEREAS,
Lixte wishes to retain University to provide to it certain samples of primary
human cancer tissue and related biological fluids as set forth in this
Agreement; and
WHEREAS,
University wishes to provide such samples to Lixte on the terms and conditions
set forth below;
NOW,
THEREFORE, in consideration of the premises and mutual covenants set forth
hereinafter, University and Lixte agree as follows:
ARTICLE
I
DEFINITIONS
In
this
Agreement, each of the following words and phrases shall have the meaning set
forth below:
| 1.1 |
“Affiliate”
of a specified entity shall mean an entity that directly or indirectly
controls, is controlled by, or is under common control with, the
entity
specified. For this purpose, “control” shall mean the possession, directly
or indirectly, of the power to direct or cause the direction of the
management and policies of the entity whether through voting shares,
securities or otherwise.
|
| 1.2 |
“Cancer
Sample”
shall mean a sample of a human cancer prepared according to the procedures
set forth in Appendix A. The term Cancer Sample preceded by a cancer
type,
e.g., renal Cancer Sample, shall mean that the Cancer Sample is derived
from a cancer of that type. The human cancer which constitutes a
Cancer
Sample can include, without limitation, a tumor and a
carcinoma.
|
| 1.3 |
“Corresponding
Cancer Sample”,
with respect to a Section, shall mean the Cancer Sample from which
the
Section is obtained.
|
| 1.4 |
“Material”
shall mean Cancer Sample, Section, Serum Sample and/or Urine
Sample.
|
| 1.5 |
“Section”,
with respect to a Cancer Sample, shall mean (i) a slice of the Cancer
Sample prepared according to the procedures set forth in Appendix
A, or
(ii) a photomicrograph of such
slice.
|
| 1.6 |
“Serum
Sample”
shall mean a sample of human serum prepared according to the procedures
set forth in Appendix A.
|
| 1.7 |
“Supervisor”
shall mean the individual specified in Paragraph 2.9 having primary
responsibility for directing the services provided by the University
under
this Agreement. Supervisor shall have primary responsibility for
directing, without limitation, the following:
|
| 1.7.1 |
Providing
Materials to Lixte;
|
| 1.7.2 |
Ensuring
University’s adherence to the time limitations set forth in Paragraphs 2.2
and 2.4 of this Agreement;
|
| 1.7.3 |
Obtaining
all necessary authorizations, licenses, consents and approvals from
University’s ethics board (or equivalent);
|
| 1.7.4 |
Ensuring
that all Materials sent to Lixte are anonymous, i.e. that all patient
identifiers are removed therefrom;
|
| 1.7.5 |
Maintaining
a patient key to permit University to provide certain additional
information to Lixte with respect to each patient from whom Material
is
obtained;
|
| 1.7.6 |
Ensuring
that University’s performance of its obligations under this Agreement are
performed in accordance with good clinical practice;
and
|
| 1.7.7 |
Supervising
and documenting all individuals performing tasks in connection with
University’s obligations under this Agreement.
|
| 1.8 |
“Surgery”,
with respect to a Cancer Sample, shall mean the attempted curative
surgery
during which the solid tissue for the Cancer Sample is obtained.
|
| 1.9 |
“Urine
Sample”
shall mean a sample of human first morning urine prepared according
to the
procedures set forth in Appendix A.
|
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2 -
ARTICLE
II
SERVICES
| 2.1 |
For
each of the cancer-afflicted patients identified in Subparagraphs
2.1.1-2.1.8 below, University shall provide to Lixte for its inspection
one Section of a Cancer Sample obtained from such
patient:
|
| 2.1.1 |
at
least 10 patients afflicted with pancreatic cancer;
|
| 2.1.2 |
at
least 20 patients afflicted with stomach carcinomas, including at
least 10
patients afflicted with diffuse-type stomach tumors and at least
10
patients afflicted with intestinal-type stomach tumors;
|
| 2.1.3 |
at
least 10 patients afflicted with breast adenocarcinomas;
|
| 2.1.4 |
at
least 10 patients afflicted with bladder carcinomas;
|
| 2.1.5 |
at
least 10 patients afflicted with renal cell cancers;
|
| 2.1.6 |
at
least 10 patients afflicted with prostate adenocarcinomas;
|
| 2.1.7 |
at
least 10 patients afflicted with colon adenocarcinomas;
and
|
| 2.1.8 |
at
least 30 patients afflicted with ovarian carcinomas, including at
least 10
patients afflicted with serous carcinomas, and including, if the
numbers
of patients permit, (i) at least 10 patients afflicted with mucinous
carcinomas, and (ii) at least 10 patients afflicted with endometroid
carcinomas.
|
| 2.2 |
Within
six (6) months of the Effective Date, University shall provide to
Lixte at
least one-half of the Sections it is obligated to provide pursuant
to
Paragraph 2.1, namely at least 55 Sections, with the proviso that
these 55
Sections are comprised of 10 Sections from the 20-patient group of
Subparagraph 2.1.2, 15 Sections from the 30-patient group of Subparagraph
2.1.8, and 5 Sections from each of the 10-patient groups of Subparagraphs
2.1.1 and 2.1.3-2.1.7.
|
| 2.3 |
After
receiving each Section from University pursuant to Paragraph 2.1,
Lixte
may inspect the Section and (i) if based on that inspection the
Corresponding Cancer Sample meets the specifications set forth in
Appendix
A, Lixte may request that University provide to it the Corresponding
Cancer Sample, or (ii) if based on that inspection the Cancer Sample
deviates from the specifications set forth in Appendix A, Lixte may
request that University provide to it a Section of a Cancer Sample
from
the same patient or another patient with the same type of cancer.
Lixte
may repeat the request of part (ii) of this Paragraph until University
is
able to provide Lixte with a Cancer Sample which meets the specifications
set forth in Appendix A, provided that Lixte may not repeat the request
of
part (ii) of this Paragraph more than two (2) times.
|
| 2.4 |
Within
sixty (60) days after receiving Lixte’s request for a Cancer Sample
pursuant to part (i) of Paragraph 2.3, University shall provide Lixte
with
that Cancer Sample.
|
-
3 -
| 2.5 |
Along
with each Cancer Sample which University provides to Lixte pursuant
to
Paragraph 2.4, University shall also provide to Lixte two (2) Serum
Samples taken from the same patient from whom the Cancer Sample was
obtained, wherein the first Serum Sample is obtained within four
weeks
before Surgery, and the second Serum Sample is obtained one to six
weeks
after Surgery.
|
| 2.6 |
Along
with each renal and bladder Cancer Sample which University provides
to
Lixte pursuant to Paragraph 2.4, University shall also provide to
Lixte
(i) a first Urine Sample taken from the same patient from whom the
Cancer
Sample was obtained, wherein the first Urine Sample is obtained within
four weeks before Surgery, and (ii) if feasible for the University,
a
second Urine Sample taken from the same patient from whom the Cancer
Sample was obtained, wherein the second Urine Sample is obtained
one to
six weeks after Surgery.
|
| 2.7 |
University
agrees that all Materials will be obtained under informed consent
meeting
all the regulations of University and those of all applicable
jurisdictions in Germany. Lixte is aware of each patient’s right to
withdraw informed consent. In each instance where a patient withdraws
consent, University will inform Lixte of such withdrawal and Lixte,
once
so informed, will not thereafter use any Material obtained from the
patient who withdrew consent. All Materials provided to Lixte must
be
obtained as part of a clinically indicated procedure and must not
be
needed for clinical management, that is, all Materials should be
“waste”
tissue released by the responsible pathologist after taking all material
needed for diagnosis and management.
|
| 2.8 |
The
parties agree that any Material provided to Lixte which is obtained
from a
given patient will be accompanied by information about that patient
and
the method by which the Material was obtained, according to the procedures
set forth in Appendix A, with the proviso that no information will
be
provided to Lixte which would reveal the identity of any patient
from whom
Material has been obtained.
|
| 2.9 |
The
parties agree that Xx. Xxxxx Xxxxxxxx, Institute of Pathology, University
of Regensburg, will act as Supervisor. Should Xx. Xxxxxxxx become
unable
or unwilling to perform such role, University will promptly select
another
individual to act as Supervisor, subject to Lixte’s approval. If a
suitable Supervisor is not identified by the University, the parties
acknowledge that Lixte may terminate this Agreement pursuant to Paragraph
6.2.
|
| 2.10 |
At
Lixte’s request and expense, University will continue to store all or
portions of all Materials for up to two (2) years after termination
or
expiration of this Agreement.
|
| 2.11 |
Lixte
has the right to review the quality of Material selection,
characterization and storage at any time during the term of this
Agreement. If the quality is less than that required for Lixte’s purposes,
Lixte will notify Supervisor who will work with Lixte to achieve
the
desired level of quality.
|
| 2.12 |
Lixte
reserves the right to request in writing one or more minor changes
in the
procedures set forth in Appendix A without incurring additional cost
provided the changes are no more demanding with respect to University’s
time and supplies than the requirements specified in Appendix A as
of the
Effective Date, and provided that the changes are in compliance with
applicable German laws and regulations. In each instance where Lixte
requests a change pursuant to this Paragraph, Lixte will inform University
in writing of such request, specifying the change requested. University,
once so informed, will thereafter implement the requested change.
University’s obligation to implement changes requested under this
Paragraph shall not apply retroactively to procedures followed prior
to
such request.
|
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4 -
| 2.13 |
Lixte
is free to use any Material provided under this Agreement for the
purpose
of analyzing markers (e.g., morphological, molecular and metabolic
markers) in tumors, cancer cells, serum and urine which may have
use in
the development of methods for understanding carcinogenesis, for
detecting
and assessing cancer behavior, for assessing the efficacy of cancer
treatments, and for developing improved cancer treatments.
|
| 2.14 |
Lixte
has no obligation during or after the term of this Agreement to provide
or
otherwise disclose to University or any third party any material
or
information which Lixte or its Affiliates produce or derive using
any
Material or information provided by University under this Agreement.
|
| 2.15 |
Neither
Lixte nor any of its Affiliates shall have any obligation during
or after
the term of this Agreement to contribute, directly or otherwise,
to the
treatment or care of any patient in the care of the University,
particularly any patient from whom any Material is
obtained.
|
| 2.16 |
The
parties hereto acknowledge their respective obligations to comply
with all
applicable laws and regulations in connection with the services provided
under this Agreement.
|
| 2.17 |
University
shall retain all laboratory notebooks containing data generated during
the
performance of its obligations under this Agreement. Subject to the
provisions of Paragraph 2.8, Lixte shall have access to these laboratory
notebooks during business hours upon request, and shall have the
right to
use the data therein for any purpose whatsoever. University shall
not
destroy or discard these laboratory notebooks without prior written
approval from Lixte. University’s obligations under this Paragraph shall
remain in effect for a period of five (5) years after the expiration
or
termination of this Agreement.
|
| 2.18 |
University
shall ensure that Supervisor and other scientists and technicians
who are
to perform the University’s obligations under this Agreement are willing
and capable of doing so, and shall ensure that they perform their
respective obligations with all due care and diligence, in a professional
and ethical manner, and in accordance with this Agreement and any
other
guidelines agreed upon from time to time by the
parties.
|
| 2.19 |
In
order to facilitate University's performance of its obligations under
this
Agreement, each party shall appoint a principal contact who shall
represent the views of his or her respective party. As of the Effective
Date, the principal contact for University shall be Xx. Xxxxx Xxxxxxxx,
and the principal contact for Lixte shall be Dr. Xxxx Xxxxxx. Each
party
hereto shall be free to change its principal contact by notice in
accordance with Paragraph 9.1.
|
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5 -
ARTICLE
III
PAYMENTS
| 3.1 |
In
consideration for the Services provided under this Agreement, Lixte
shall
pay University a total of €72,000. The €72,000 shall be paid to University
in two (2) installments of €36,000 each. The first installment shall be
made within sixty (60) days after the Effective Date. The second
installment shall be made within sixty (60) days after the earlier
of (i)
the first anniversary of the Effective Date or (ii) University’s
fulfillment of its obligations under Paragraphs 2.2 and 2.4 of this
Agreement. Invoices will be made by University’s Office of Knowledge and
Technology Transfer (Referat IV/6). The parties to this Agreement
acknowledge that payments made under this Paragraph are exempt from
German
value added tax according to § 4 Nr. 1 a German Value Added Tax Act
(Umsatzsteuergesetz). Should payments be subject to any tax such
as, but
not limited to, sales tax according to applicable United States tax
law,
such tax will be borne and paid by Lixte in addition to other payments
due
under this Paragraph.
|
| 3.2 |
Lixte
will make checks payable to the Department of Pathology, University
of
Regensburg. Lixte will send all checks to the University by a method
specified by the University.
|
| 3.3 |
Subject
to the provisions of Paragraph 2.10, Lixte shall not be obligated
to pay
University any fee other than that specified in Paragraph 3.1, and
shall
not be obligated to pay any fee (including, without limitation, shipping
costs and compensation to patients) to any third party in connection
with
this Agreement.
|
ARTICLE
IV
INTELLECTUAL
PROPERTY
| 4.1 |
All
data, information, results and materials that are developed by Lixte
using
Materials during or after the term of this Agreement shall be solely
owned
by Lixte. Notwithstanding the foregoing, University shall be free
to
independently perform work using any Material, so long as such work
does
not involve the use of any data, information, results or materials
owned
by Lixte pursuant to this Paragraph 4.1.
|
ARTICLE
V
CONFIDENTIALITY
| 5.1 |
It
is understood that during the term of this Agreement, University
and its
employees may be exposed to information that is confidential and
proprietary to Lixte. All such information (hereinafter “Lixte
Confidential Information”),
whether written or oral, tangible or intangible, that is made available,
disclosed, or otherwise made known to University and its employees
by
Lixte or its employees under this Agreement shall be considered
confidential and shall be considered the sole property of Lixte.
It is
also understood that during the term of this Agreement, Lixte and
its
employees may be exposed to information that is confidential and
proprietary to University. All such information (hereinafter “University
Confidential Information”),
whether written or oral, tangible or intangible, that is made available,
disclosed, or otherwise made known to Lixte and its employees by
University or its employees under this Agreement shall be considered
confidential and the sole property of University. University Confidential
Information together with the Lixte Confidential Information shall
constitute “Confidential
Information.”
Confidential Information shall be (a) marked as confidential, or
(b)
otherwise represented by the disclosing party as confidential either
before or within a reasonable time after its disclosure to the receiving
party. The Confidential Information shall be used by the receiving
party
and its employees only for purposes of performing the receiving party's
obligations hereunder. This obligation of confidentiality, non-disclosure
and non-use shall remain in effect for a period of five (5) years
after
the expiration or termination of this
Agreement.
|
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6 -
| 5.2 |
The
obligations of confidentiality, non-disclosure and non-use set forth
in
Paragraph 5.1 shall not apply to any information
that:
|
| 5.2.1 |
is
or hereafter becomes generally available to the public other than
by
reason of any default with respect to a confidentiality obligation
under
this Agreement; or
|
| 5.2.2 |
was
already known to the recipient as evidenced by prior written documents
in
its possession; or
|
| 5.2.3 |
is
disclosed to the recipient by a third party who is not in default
of any
confidentiality obligation to the disclosing party hereunder;
or
|
| 5.2.4 |
is
developed by or on behalf of the receiving party, without reliance
on
confidential information received hereunder as evidenced by written
documents in its possession; or
|
| 5.2.5 |
is
used with the consent of the disclosing party (which consent shall
not be
unreasonably withheld) in patent applications under the terms of
this
Agreement; or
|
| 5.2.6 |
has
been approved in writing by one party for publication by the other
party;
or
|
| 5.2.7 |
is
required to be disclosed in compliance with applicable laws or regulations
in connection with the development, approval, manufacture or sale
of
products derived from services performed pursuant to this
Agreement.
|
| 5.3 |
Subject
to the provisions of Paragraphs 5.4 and 10.1, Lixte shall be free
during
and after the term of this Agreement to make public, or discard,
any data,
information, results or materials that are developed by Lixte using
Materials.
|
| 5.4 |
Except
as required by law, neither party shall release to any third party
or
publish via press release or otherwise any non-public information
relating
to this Agreement without the prior written consent of the other
party,
which consent shall not be unreasonably
withheld.
|
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ARTICLE
VI
TERM
AND TERMINATION
| 6.1 |
The
term of this Agreement shall extend from the Effective Date until
the
second anniversary of the Effective Date, subject to the other provisions
of this Article.
|
| 6.2 |
Lixte
may terminate this Agreement for any reason by giving sixty (60)
days’
prior written notice to University. In the event of termination under
this
Paragraph, Lixte will not be obligated to pay any installment under
Paragraph 3.1 which is due more than sixty (60) days after written
notice
of termination is given to University.
|
| 6.3 |
Either
Party (the “Non-Breaching
Party”)
may, without prejudice to any other remedy available to it at law,
terminate this Agreement for reasonable cause, such as in the event
the
other party (the “Breaching
Party”)
shall have materially breached or defaulted in the performance of
any of
its material obligations hereunder, and such breach or default shall
have
continued for sixty (60) days after written notice thereof was provided
to
the Breaching Party by the Non-Breaching Party (or, if such breach
or
default cannot be cured within such 60-day period, if the Breaching
Party
does not commence and diligently continue actions to cure such breach
or
default during such 60-day period). Any such termination shall become
effective at the end of such 60-day period unless the Breaching Party
has
cured any such breach or default prior to the expiration of such
60-day
period (or, if such breach or default cannot be cured within such
60-day
period and the Breaching Party has commenced and diligently continued
actions to cure such breach or default, then such termination shall
become
effective at such time as the Breaching Party ceases to diligently
continue actions to cure such breach or default prior to cure). The
right
of either party to terminate this Agreement as provided in this Paragraph
shall not be affected in any way by its waiver or failure to take
action
with respect to any previous breach or
default.
|
| 6.4 |
Neither
expiration nor termination of this Agreement shall affect (i) any
right or
obligation of either party which has accrued as of the date of expiration
or termination, or (ii) any right or obligation which expressly survives
the expiration or termination of this
Agreement.
|
ARTICLE
VII
ASSIGNMENT
| 7.1 |
Neither
this Agreement, nor any of the rights and obligations created herein,
shall be assigned or transferred, in whole or in part, by any party
hereto
without the prior written consent of the other party hereto provided,
however, that Lixte shall have the right to assign this Agreement
to its
Affiliates, or to a successor to that part of its business to which
this
Agreement relates, without such prior written consent. Any attempted
assignment or transfer of such rights or obligations without such
prior
written consent, except as provided herein, shall be void.
|
| 7.2 |
In
the event Lixte assigns this Agreement or any right or obligation
created
herein pursuant to Paragraph 7.1 of this Agreement, Lixte will inform
University within twenty (20) days of such assignment. Once informed
by
Lixte of such assignment, and notwithstanding the provisions of Paragraph
6.3 of this Agreement, University shall have the right to terminate
this
Agreement by giving sixty (60) days’ prior written notice to Lixte in the
event such assignment conflicts with University’s obligations under German
law and regulations.
|
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ARTICLE
VIII
FORCE
MAJEURE
| 8.1 |
No
failure or omission by either party hereto in the performance of
any
obligation of this Agreement shall be deemed a breach of this Agreement
or
create any liability if the same shall have arisen from any cause
or
causes beyond the control of the party provided, in each case, that
such
failure or omission is cured as soon as is practicable following
the
occurrence of such event. Causes beyond the control of a party shall
include, without limitation, any act or omission of any government;
any
rule, regulation or order issued by any governmental authority or
by any
officer, department, agency or instrumentality thereof; a fire; a
storm; a
flood; an earthquake; an accident; a war; a rebellion; a terrorist
act; an
insurrection; a riot; an invasion; a strike; and a
lockout.
|
ARTICLE
IX
NOTICES
| 9.1 |
Any
notice or other communication required or permitted to be given under
this
Agreement shall be in writing and shall be deemed to have been given
if
(a) personally delivered or sent by facsimile, internationally-recognized
air courier or first class certified or registered mail, postage
prepaid,
return receipt requested, and (b) addressed as
follows:
|
| (i) |
If
to University:
|
|
Prof. Xx. Xxxxx Xxxxxxxx
Institute of Pathology
University of Regensburg D-93042 Regensburg Germany |
| (ii) |
If
to Lixte:
|
|
Dr. Xxxx Xxxxxx
000 Xxxxx 00X #0
Xxxx Xxxxxxxx
Xxx Xxxx 00000
Xxxxxx Xxxxxx of
America
|
or
to
such other address as the party to whom such communication is to be given may
have furnished to the other party in writing. Any such communication shall
be
deemed to have been received when delivered, if personally delivered, or sent
by
certified or registered mail, return receipt requested; or when sent by
facsimile or by internationally-recognized air courier.
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9 -
ARTICLE
X
PUBLICITY
| 10.1 |
The
text of any press release relating to this Agreement or the transactions
contemplated herein shall be reviewed in advance by both parties
and may
not, except as required by law, be issued without the prior written
approval of both parties.
|
ARTICLE
XI
INDEMNIFICATION
| 11.1 |
Lixte
assumes all liability for damages which may arise from Lixte’s use,
storage or disposal of Material. University shall not be liable for
any
loss, claim or demand made by Lixte, or made against Lixte by any
party,
due to or arising from the use of Material by Lixte, except to the
extent
set forth by mandatory law when caused by University’s gross negligence or
willful misconduct.
|
| 11.2 |
The
statutory remedies for defects of Material and services rendered
by
University shall be limited to the rights set forth in Paragraph
2.3 of
this Agreement. Any further warranty claims are excluded. In particular,
there is no warranty, express or implied, as to the fitness of Material
for any purpose. There also is no warranty to the extent that any
defects
result from the biological nature of Material.
|
| 11.3 |
University
shall be liable for claims for damages, whether based on contract
theory
or any other legal theory, only to the extent that the damage was
caused
by gross negligence or willful misconduct imputable to University.
In the
event of (i) bodily injury to an individual or (ii) nonperformance
regarding a fundamental duty under this Agreement, University also
shall
be liable for negligence, such liability being limited (i) to such
damage
as University could have reasonably foreseen as of the Effective
Date or
(ii) to two times the amount billed for services to Lixte under this
Agreement, whichever amount is lower. University’s liability shall not
cover damage caused by use of Material or services which could have
been
prevented by Lixte’s examination of such Material or services at regular
intervals. Any liability under applicable mandatory product liability
laws
or other mandatory laws shall remain unaffected.
|
ARTICLE
XII
GOVERNING
LAW AND ARBITRATION
| 12.1 |
All
matters affecting the interpretation, validity and performance of
this
Agreement shall be governed by the laws applicable to agreements
made in,
and to be performed in, Germany, Regensburg, without regard to its
conflict of law principles.
|
| 12.2 |
Any
controversy or claim arising out of or relating to this Agreement,
or the
parties’ decision to enter into this Agreement, or the breach thereof
which cannot be settled amicably shall be finally settled by (i)
mediation
if both parties to this Agreement consent thereto, or (ii) arbitration
by
one or more arbitrators at the International Chamber of Commerce
in
Geneva, Switzerland in accordance with that institution’s rules governing
arbitrations by one or more arbitrators to be appointed under the
terms of
those rules. In any arbitration in which there are three arbitratrors,
the
chairperson shall be of judicial education. The award of the arbitration
will be final and binding upon the parties to this Agreement. As
provided
in Paragraph 12.1 of this Agreement, the arbitrator(s) shall apply
the
substantive law of Germany, Regensburg. No punitive damages shall
be
awarded to either party in the arbitration, and the parties shall
be
deemed to have waived any right to such damages. Further, the
arbitrator(s) shall be bound by the express terms of this
Agreement.
|
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ARTICLE
XIII
INTEGRATION
| 13.1 |
This
Agreement constitutes the entire agreement between the parties hereto
with
respect to the subject matter hereof, and supercedes all prior agreements,
understandings and arrangements, whether oral or written, of the
parties
with respect thereto.
|
| 13.2 |
Any
amendment to, or modification of, this Agreement must be made in
writing
and signed by both parties.
|
ARTICLE
XIV
GENERAL
| 14.1 |
It
is understood and agreed that University and Lixte shall each have
the
status of an independent contractor under this Agreement and that
nothing
in this Agreement shall be construed as authorization for either
party to
act as an agent for the other.
|
| 14.2 |
University
represents and warrants to Lixte that it is not a party to any agreement
that would prevent it from fulfilling its obligations under this
Agreement.
|
| 14.3 |
The
waiver by either party hereto, whether express or implied, of any
provision of this Agreement, or of any breach or default of either
party
hereto, shall not be construed to be a continuing waiver of such
provision, a waiver of any succeeding breach or default, or a waiver
of
any other provision of this
Agreement.
|
| 14.4 |
Should
any part or provision of this Agreement be held unenforceable or
in
conflict with the law of any jurisdiction by a court or other tribunal
of
competent jurisdiction, all other provisions, rights and obligations
shall
remain in force.
|
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11 -
IN
WITNESS WHEREOF, each of the parties hereto has caused this Agreement to be
executed on its behalf as of the Effective Date.
| UNIVERSITY OF REGENSBURG | ||
| |
|
|
| By: | /s/ | |
|
Name: Xx. Xxxxxxxxx Xxxxxxxx |
||
| Title: Head of Administration | ||
| |
|
|
| By: | /s/ | |
|
Name: Prof. Xx. Xxxxx Xxxxxxxx |
||
| Title: Project Coordinator | ||
| LIXTE BIOTECHNOLOGY, INC. | ||
| |
|
|
| By: | /s/ | |
|
Name: Xxxx X. Xxxxxx |
||
| Title: President | ||
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12 -
APPENDIX
A
Cancer
Sample and Section Preparation and Storage
1. Each
Cancer Sample will be obtained from a specimen of a primary cancer of
the
pancreas, stomach, breast, prostate, colon, ovary, bladder or
kidney.
2. After
using a cancer specimen for all indicted clinical purposes, a representative
5—8
micron frozen section of the specimen (Section) stained with hematoxylin
and
eosin (H & E) will be obtained and a color photomicrograph made
and sent as a color image via email to Lixte for documentation of the
presence
of the desired cancer type. The original H & E-stained frozen
section will be saved by University along with the cancer specimen.
3. Each
Cancer Sample will be placed in a snap—top tissue cassette having specifications
and source as agreed to by the parties, the closed cassette “snap frozen” by
immersion in a slurry of isopentane and dry ice or in liquid nitrogen,
and
stored at minus 80 degrees Celsius until shipped to Lixte. Each Cancer
Sample
sent to Lixte will be sent frozen on dry ice.
Serum
Sample and Urine Sample Collection and Storage
1. Each
Serum Sample will be obtained by withdrawal of venous blood into a glass
serum
separator tube without activator. After clotting but within six hours
of venous
puncture, the serum (approximately four milliliters) will be removed
and
subdivided into about 2 milliliter aliquots in two snap—top cryotubes, labeled,
and frozen at minus 80 degrees Celsius.
2. For
each
Urine Sample, approximately 10 milliliters of urine will be collected
before and
after removal of the primary bladder tumor. Each sample will be subdivided
into
each of two snap-top cryovials having specifications and source as agreed
to by
the parties, with about 5 milliliters of urine in each, labeled, and
frozen at
minus 80 degrees Celsius.
Medical
and Demographic Information
The
following patient information should be provided with each Cancer Sample,
Serum
Sample and Urine Sample:
1. Age
at
the time of surgery;
2. Sex;
3. Ethnicity
(country of birth, country of birth of parents);
4. Family
history regarding the same cancer for which treatment is being provided,
if such
history is available;
5. Histologic
diagnosis of present cancer including cell type and grade; and
6. History
of tobacco use (for cigarette smokers, indicate number of packs per day
and
number of years of smoking) , if such history is available.
