NEURALSTEM INC NON EXCLUSIVE LIMITED LICENSE AND MATERIAL TRANSFER AGREEMENT
NEURALSTEM
INC
NON
EXCLUSIVE LIMITED LICENSE AND MATERIAL TRANSFER AGREEMENT
This
Non exclusive Limited License and Material Transfer Agreement ("Agreement")
is
entered into as of 12/22,
2004 (the "Effective Date") by and among Neuralstem, Inc., ("Neuralstem"),
a
company incorporated under the laws of the State of Maryland, having an address
at 0000 Xxxxx Xxxxxx Xxxxxxx, Xxxxx 000, Xxxxxxxxx, Xxxxxxxx 00000 on the one
side, and A-T Children's Project ("A-TCP"), having an address at 000
X. Xxxxxxxx Xxxxx, Xxxxxxxxx Xxxxx, Xxxxxxx 00000 .
Whereas,
Neuralstem is the owner of certain patented and proprietary technology relating
to production and use of human CNS stem cells, and has created a cerebellar
stem
cell line designated HCB576 (hereinafter the "cells");
Whereas,
Neuralstem desires to provide such cells to A-TCP for research purposes
only;
Whereas,
A-TCP desires to use said cells in a research project to study
Ataxia-Telangiectasia ("the disease"); and to develop suitable assay(s) for
screening compounds to treat the disease. (`the research"); and
The
parties therefore agree as follows:
Article
1.0 Definitions
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1.1
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"Research
Materials" means
the Materials, the know-how provided by Neuralstem to PI, and any
Progeny
and Unmodified or modified Derivative thereof "Materials"
means
the materials provided by Neuralstem to PT listed in Article 2 below.
"Progeny" means an unmodified or modified descendant from the Materials,
such as a virus from virus, cell from cell, or organism from
organism.
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1.2
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"Research
Uses" means
experimental in vitro research conducted by A-TCP in its own laboratories
and for its own internal use in the performance of the research program
described in Article 2.1 (the "Research Program"). No other use of
the
cells by PI is anticipated or allowed under this
agreement.
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1.3
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"Research
Results" means
the data or records, whether compiled in electronic, written or other
form, arising from the use by A-TCP of Research Materials as Limited
to
the work product as result of the Research
Program.
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1.4
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"Neuralstem
Patents" means
any patents or patent applications together with all patents resulting
therefrom in any and all jurisdictions which cover the manufacture,
use or
sale of human CNS stem cells, and any progeny, derivative, improvement
or
modification thereof, which are owned or controlled by NeuralStem
at the
Effective Date, including all licensed patents or patent applications
that
Neuralstem has the right to sublicense at the Effective
Date:
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Isolation,
Propagation, and Directed Differentiation of Stem Cells from Embryonic and
Adult
Central Nervous System of Mammals (U.S. Patent 5,753,506 issued May 19, 1998,
patents pending in Canada and Europe)
In
Vitro Generation of Differentiated Neurons from Cultures of Mammalian
Multipotential CNS Xxxxx Cells (U,S. Patent 6,040,180 issued March 21, 2000—
continuation-in-part of U,S, Patent 5,753,506, patents pending in Canada and
Europe)
Stable
Neural Stem Cell Lines (U.S. patent pending—continuation-in-part of U.S. Patent
5,753,506, patents pending in Canada, Europe and Japan, patent issued in New
Zealand)
Article
2. 0 Research Program
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2.1
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The
Research Program shall involve the use of HCB576 cell line by A-TCP
for
the growth and use of the cell line to study the disease
ataxia-telangiectasia and to create an assay suitable for screening
compounds for treatment of the
disease.
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2.2
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A-TCP
will designate a principal investigator ("PI") to conduct the research.
The designated P1 is Dr. Xxxxx Xxxxxx at Tel Aviv University. In
the event
that Dr. Shiloh is unwilling or unable to conduct the research, the
A-TCP
has the right to designate a different PI. A-TCP and PI collectively
referred to herein as "Recipients".
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Article
3. 0 Material Transfer and
Use
Limitations
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3.1
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Upon
the execution of this Agreement, Ncuralstem shall provide to A-TCP
the
cerebellar cell line licensed under this agreement, designated: "HCB576".
NISI will transfer no less than 12 frozen vials, each containing
approximately 2 million cells of passage 8 to PI in order to allow
P1 to
establish its own stock, and no more than 15 vials, at NS1 cost.
NS1 will
also provide necessary protocols and know-how, as deemed necessary
by
mutual agreement by the parties to expand and maintain the cell line.
Neuralstem hereby grants to A-TCP a limited, non exclusive license
to use
the cells and related Neuralstem technology for the term of this
license,
for research uses, under the terms and conditions of this
agreement.
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3.2
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The
Recipients hereby agree that Research Materials will be used under
suitable containment conditions in compliance with all government
laws and
regulations and for approved uses only and recipient agrees to the
restrictions provided for in this
agreement.
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3.3
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The
Recipients agree that Research Materials will remain the sole property
of
Neuralstem.
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3.4
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The
Recipients agree that they will retain control over and will assume
all
responsibility for the custody of Research Materials. The Recipients
further agree that they will return any unused Research Materials
to
Neuralstem at Neuralstem's expense, should Neuralstem so request,
along
with a record of all used or spent Research Materials or will dispose
of
any unused Research Materials as otherwise directed by
Neuralstem.
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3.5
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The
Recipients agree they will not transfer, sell, give, or otherwise
convey
in any form whatsoever, Research Materials to any other person or
entity,
including without limitation any of PI's commercial, non-commercial,
joint
venture partners or aliases, without the prior, express written permission
of Neuralstem. Recipient hereby assigns to Neuralstem any materials
and
inventions (as defined below) made outside of the permitted research
uses.
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3.6
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Neuralstem
agrees to render a reasonable amount of technical assistance as may
be
required by Pl. The determination of what constitutes a reasonable
amount
of technical assistance will he mutually agreed to by the
Parties.
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3.7
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The
parties agree that nothing in this Agreement shall be construed in
any way
as restricting or interfering with Neuralstem's right to distribute
Research Materials to any other person or
entity.
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Article
4.0 Payments
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4.1
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In
entire consideration for the delivery of the Materials and the License
grant from Neuralstem to A-TCP, A-TCP shall pay a single fixed fee
payment
to Neuralstem in the amount of $37,500. This amount shall be payable
within l5 days from the execution of this agreement by both
Parties.
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Article
5.0 Reports And
Publication
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5.1
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PI
shall keep a record of its use of Research Materials and shall provide
a
copy of this record upon request to
Neuralstem.
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5.2
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I
will provide Neuralstem on a regular basis For the duration of the
Research Program, but not less than semi-annually, the Research Results
in
the form of a written report.
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Article
6.0 Representations And
Warranties
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6.1
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Neuralstem
represents and warrants to the Recipients that, as of the Effective
Date,
it has the right to transfer Research Materials for the Research
Uses to
PI under this Agreement.
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6.2
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While
Neuralstem confirms that Research Materials are covered under Neuralstem
Patents, A-TCP and Neuralstem agree that nothing hereunder shall
be
construed to represent any license or right under Neuralstem Patents
to
the Recipients, other than those rights expressly granted under this
Agreement.
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6.3
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The
Recipients represent to Neuralstem that they have the right to accept
the
terms and obligations of this Agreement and that they will maintain
compliance with all applicable laws in carrying out their obligations
under this Agreement.
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6.4
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Each
party represents that it has the full right and authority to enter
into
this Agreement and that the individual executing this Agreement on
its
behalf has the authority to do so.
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6.5
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The
Recipients represent to Neuralstem that they are acting on their
own
behalf under this Agreement and are not acting in their capacity
as a
contractor or agent of the United States
Government.
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6.6
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THESE
RESEARCH MATERIALS ARE PROVIDED "AS IS" WITHOUT WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR ANY OTHER WARRANTY
EXPRESS OR IMPLIED. NEURALSTEM MAKES NO REPRESENTATION OR WARRANTY
REGARDING THE VALIDITY OR SCOPE OF NEURALSTEM PATENTS NOR THAT THE
RESEARCH MATERIALS OR THEIR USE WILL NOT INFRINGE ANY PATENT OR ANY
OTHER
PROPRIETARY RIGHT OF ANY THIRD PARTY. IN NO EVENT, OTHER THAN BREACH
OF
ITS REPRESENTATIONS OR WARRANTIES IN THIS ARTICLE, WILL NEURALSTEM
BE
LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING
FROM
THE EXERCISE OF THIS AGREEMENT OR THE USE OF RESEARCH
MATERIALS.
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Article
7.0 Confidentiality
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7.1
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As
used herein, "Confidential Information" shall mean (a) all trade
secrets
or confidential or proprietary information which is designated in
writing
as confidential or proprietary by the disclosing party prior to or
at the
time of the disclosure thereof; (b) information without such designation
if it would be apparent to a reasonable person, familiar with the
disclosing party's business and the industry, that such information
is of
a confidential or proprietary nature; and (c) information disclosed
without such designation, if the disclosing party, within thirty
(30) days
after such disclosure. informs the receiving party in writing of
the
confidential or proprietary nature of the disclosed information,
describing such information and referencing the place and date of
the
oral, visual or written disclosure and the names of the employees
or
officers of the receiving party to whom such disclosure was
made.
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7.2
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During
the term of this Agreement and for a period of five (5) years from
any
termination or expiration hereof, the parties agree to keep Confidential
Information of the other party in confidence, not to disclose Confidential
Information of the other party to any third party and not to use
Confidential Information of the other party for any purpose, other
than as
permitted in this Agreement.
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7.3
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The
restrictions on the disclosure and use of Confidential Information
shall
not apply to any Confidential Information which: (i) was known by
the
receiving party (as evidenced by the receiving party's written records)
prior to disclosure by the disclosing party hereunder; (ii) is or
becomes
part of the public domain through no fault of the receiving party;
(iii)
is disclosed to the receiving party by a third party having a legal
right
to make such a disclosure; or (iv) is independently developed by
employees
or consultants of the receiving party without use or access to the
Confidential Information of the disclosing
party.
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7.4
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This
Agreement shall supersede any other prior agreements regarding the
protection of confidential information, and any confidential information
disclosed to the other party under such other prior agreements shall
be
subject to the terms of this Section
7.
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Article
8.0 Intellectual Property
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8.1
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"Inventions"
shall mean Sole Inventions and Joint Inventions based on US patent
law.
"Sole
Invention(s)"
shall mean any new and useful invention or discovery conceived by
employees or consultants of the Recipients alone in the course of
performing the Research Program. "Joint
Invention(s)"
shall mean any new or useful invention or discovery conceived jointly
by
an employee or consultant of a Recipient and an employee or consultant
of
Neuralstem in the course of performing the Research Program. All
Inventions shall be owned by A-TCP. Neuralstem shall assign and does
hereby assign to A-TCP all right, title and interest in its Sole
and Joint
Inventions. Neuralstem shall reasonably cooperate in perfecting and
enforcing Such rights at A-TCP's expense, including without limitation,
by
executing any documents necessary for Neuralstem to support the Filing
of
patent applications.
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8.2
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A-TCP
hereby grants to Neuralstem the tight to negotiate within a 60-day
period
a non-exclusive, perpetual license to Recipients' Sole Inventions
and the
Recipients' interest in Joint Inventions that are conceived during
the
performance of the Research Program. In addition the Recipients hereby
grant to Neuralstem the first right to negotiate an exclusive license
to
Recipients' Sole Inventions and Recipients' rights in any Joint Inventions
for which Neuralstem has paid and/or has agreed to pay patent expenses.
Such licenses shall be negotiated in good faith with terms considered
reasonable and customary in the field for like inventions. Such license
shall also provide for the reimbursement by Neuralstem
of
any future patent expenses incurred by Recipients. The rights to
negotiate
granted pursuant to this paragraph 8.2 shall be exercisable for a
period
of thirty (30) days from the date of A-TCP' s notification to Neuralstem
of such Sole or Joint Invention. The parties shall enter into a written
agreement for each license within sixty (60) days following the
notification from Neuralstem to A-TCP of its interest in obtaining
the
license to the Invention(s). If the parties are unable to agree to
terms
for the licenses within the stipulated time period, or if Neuralstem
ceases to pay patent expenses, A-TCP shall be free to license to
others
and shall have no further obligations to Neuralstem with respect
to such
inventions. Invention disclosures and related correspondence shall
be
directed to the following
people:
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For
PI:
Xxxxx
Xxxxxx, PhD Tel Aviv University
For
Recipient:
Xxxxxxxx
Xxxxxxxx Executive Director
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For
Neuralstem:
Xxxxxxx
Xxxx
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Article
9 Term and Termination
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9.1
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The
term of this Agreement shall go into effect on the date the last
party
hereto executes this Agreement and shall continue until ten years
from the
effective date. The terms of Articles 7, 8 and 10 shall survive the
termination of this Agreement.
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Article
10.0 Miscellaneous Provisions
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10.1
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The
Recipients shall be excused for failure or delay in performing any
of
their respective obligations under this Agreement if failure or delay
is
caused by force majeure, to the extent such failure or delay is caused
by
said force majeure.
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10.2
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All
notices, requests and other communications regarding the terms or
performance of this Agreement shall be in writing, shall refer
specifically to this Agreement and shall be. personally delivered
or sent
by registered mail, overnight courier or certified mail, return receipt
requested, postage prepaid, or by facsimile or electronic mail, in
each
case to the address specified below, or as to other such address
as may be
specified in writing to the other
party.
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Neuralstem:
0000
Xxxxx Xxxxxx Xxxxxxx, Xxxxx 000 Xxxxxxxxx, Xxxxxxxx 00000
e-mail:
xxxxxx@xxxxxxxxxx.xxx
Attention:Xxxxxxx
Xxxx
Recipients:
A-T
Children's Project
000
X. Xxxxxxxx Xxxxx
Xxxxxxxxx
Xxxxx, XX 00000
e-mail:
xxxxxxxx@xxxx.xxx
Attention:
Xxxxxxxx Xxxxxxxx
Such
notices shall be deemed received on the next business day after dispatched
in
the case of overnight courier or live (5) business days after deposit in the
U.S. mail.
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10.3
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The
rights and obligations under this Agreement are not assignable by
A-TCP
without the prior written consent of
Neuralstem.
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10.4
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This
Agreement constitutes the entire agreement between the parties and
no
provision of this Agreement shall be varied or contradicted by any
oral
agreement. All prior or contemporaneous
understandings or agreements, whether written or oral, between the
parties
with respect to the subject matter herein are hereby superseded in
their
entirety by this Agreement. No amendment shall be effective unless
made in
writing specifically identifying this Agreement and the provision
to be
amended and signed by the parties.
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10.5
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This
Agreement shall be construed and enforced in accordance with the
laws
of
the State of Delaware and all parties
hereto,
specifically including
P1
agree to such jurisdiction.
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10.6
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If
any
provision
of this Agreement is held unenforceable in any jurisdiction, all
other
provisions shall remain in full force and effect in such jurisdictions
and
such unenforceability will not affect the enforceability of the provision
in other jurisdictions. To the extent permitted
by
applicable law, the parties hereby waive
any
provision of law that would render
any provision hereof prohibited or unenforceable in any respect.
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10.7
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This
Agreement may be executed in
counterparts.
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Neither
party shall use the name of the other or any contraction or
derivative thereof
or the
name(s)
of the other party's faculty members, employees,
or
students,
as applicable, in any advertising,
promotional, or sales literature without prior written consent
from
the other party.
IN
WITNESS WHEREOF, the parties have executed this Agreement effective as of the
date first stated above.
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A-TCP
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By:
/s/
I. Xxxxxxx Xxxx
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By:
/s/
Xxxxxxxx Xxxxxxxx
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I.
Xxxxxxx Xxxx
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Xxxxxxxx
Xxxxxxxx
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President
& CEO
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Executive
Director
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