Exhibit 10.3
* INDICATES A PORTION OF THIS EXHIBIT THAT WAS OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THIS EXHIBIT INCLUDING SUCH OMITTED INFORMATION WAS
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION ON A CONFIDENTIAL
BASIS.
University of Louisville Research Foundation
Sponsored Research Agreement
THIS AGREEMENT made and effective as of the last date of signature below
("Effective Date"), by and between the University of Louisville Research
Foundation, Inc. (hereinafter "ULRF") a Kentucky non-profit corporation having
an office at MedCenter One, 000 X. Xxxxxxxx, Xxxxx 000, Xxxxxxxxxx, XX
00000-0000 as the agent of the University of Louisville (hereinafter "UofL") for
receiving grants and research agreements from external funding sources and which
owns and controls intellectual property on behalf of UofL (collectively
"Institution") and NeoStem, Inc. with a principal place of business at 000
Xxxxxxxxx Xxxxxx, Xxxxx 000, Xxx Xxxx, XX 00000 (hereinafter "SPONSOR").
WHEREAS, the research program contemplated by this Agreement is of mutual
interest and benefit to the ULRF and SPONSOR and will further the instructional,
research and public service objectives of the UofL in a manner consistent with
its status as a non-profit, tax-exempt, educational institution; and
WHEREAS, SPONSOR desires to provide research funding in support of the research
program in return for receiving certain rights in the research results.
NOW, THEREFORE, the parties hereto agree as follows:
1. DEFINITIONS
As used herein, the following terms shall have the following meanings:
1.1 "Principal Investigator" shall mean the investigator under whose
supervision the Research is performed and shall mean Xx. Xxxxxxx Xxxxxxxxx,
Department of Medicine, Division of Hematology/Oncology.
1.2 "Research Period" commences with the date after the Effective Date of this
Agreement on which (i) all Approvals (as defined in Section 2.1) are
obtained, and (ii) the Principal Investigator has received the specimens
needed for the conduct of the Research, and continuing for two and one-half
years thereafter.
1.3 "Research" shall mean the description of the research in the Research Plan
which is attached hereto as Appendix "A" and hereby made a part of this
Agreement. Appendix A describes a collaborative effort between SPONSOR and
Institution, with specified portions of Institution's Research contingent
upon SPONSOR's activities.
1.4 "ULRF Intellectual Property" shall mean individually and collectively all
inventions, improvements, modifications and/or discoveries which are
conceived, invented, authored and/or first reduced to practice by one or
more employees of UofL in performance of the Research, and all United
States and foreign patent and copyright applications which may be filed at
any time thereon. ULRF Intellectual Property shall not include "Traditional
Works" as defined in Section 1.g. of Institution's Intellectual Property
Policy (xxxx://xxxxxxxxxx.xxx/xxxxxxx/xxx-xxxxxxx-xxx-xxxxx/xx-xxxxxx.xxxx)
not specifically commissioned by Institution.
1.5 "JOINT Intellectual Property" shall mean individually and collectively all
inventions, improvements, modifications and/or discoveries which are
conceived, invented, authored and/or first reduced to practice jointly by
one or more employees of UofL and by one or more employees, consultants or
advisors of SPONSOR in performance of the Research, and all United States
and foreign patent and copyright applications which may be filed at any
time thereon. JOINT Intellectual Property shall not include "Traditional
Works" as defined in Section 1.g. of Institution's Intellectual Property
Policy (xxxx://xxxxxxxxxx.xxx/xxxxxxx/xxx-xxxxxxx-xxx-xxxxx/xx-xxxxxx.xxxx)
not specifically commissioned by Institution.
Page 1
2. RESEARCH
2.1 ULRF and SPONSOR have executed this Agreement prior to all approvals
("Approvals") required by Institution and/or Federal regulation (e.g.
Institutional Review Board ("IRB") approval if human subjects are involved
in the Research, Institutional Animal Care and Use Committee ("IACUC")
approval for use of live vertebrate animals in the Research) having been
obtained for the Research described in Appendix A. Sponsor, Principal
Investigator and Institution, as applicable, shall cooperate in preparing
and fiing these documents, as applicable. ULRF shall commence the
performance of its activities as set forth in Appendix A promptly after the
start date of the Research Period as set forth in Section 1.2 above. ULRF
and/or SPONSOR, as applicable, shall use its best reasonable efforts to
obtain the Approvals promptly after the Effective Date of the Agreement.
ULRF shall use reasonable best efforts to perform the Research
substantially in accordance with the terms and conditions of this
Agreement, subject to SPONSOR's performance of the activities assigned to
it under Appendix A. Specimens from human subjects shall initially be
provided to ULRF for the Research by Sponsor; provided that in the event
the specimens are to be collected by the Xxxxx Xxxxxx Xxxxx Cancer Center
of University Hospital located in Louisville, Kentucky, for use in the
Research, then this Agreement shall be amended as appropriate in order to
reflect such arrangement.
2.2 SPONSOR will obtain the informed written consent and separate authorization
under HIPAA of each human subject from which a specimen is collected by
SPONSOR for the purpose of the Research such that collection and use of
Protected Health Information ("PHI") shall comply with all United States
and international privacy laws, regulations, rules, opinions or other
governmental and/or self-regulatory group requirements or statements of
position currently existing or later enacted during the term of this
Agreement. SPONSOR shall not provide any PHI to Institution or the
Principal Investigator.
2.3 If for any reason the Principal Investigator becomes unable to continue the
Research, and a successor acceptable to both parties is not available, ULRF
and/or SPONSOR shall have the option to terminate this Agreement pursuant
to Section 10 hereof.
2.4 If the nature of the Research is such that Institution and/or SPONSOR is
required to have approval of a review committee(s) (e.g. conflict of
interest, IRB, IACUC), Principal Investigator or SPONSOR investigator(s),
as appropriate, shall prepare and file the applicable protocol/outline of
work, and/or other required information and documents with the appropriate
review committee(s), including any (re)submissions to such review
committee(s) subsequently made necessary due to revision of Appendix A by
the parties.
2.5 Both parties acknowledge that each reserves the right to terminate this
Agreement and the Research if the applicable review committee(s) does not
approve or subsequently suspends or withdraws its approval of the specimen
collection protocol or Research.
3. REPORTING
3.1 The Principal Investigator will produce a brief progress report for each
Aim described in Appendix A, outlining the accomplishments and results of
the Research. Both parties agree to meet as may be necessary to discuss
progress of the Research and the results of each Aim and may agree to
modify future efforts based upon progress to date. In addition, Principal
Investigator shall provide written technical reports on the Research to
SPONSOR every six (6) months, and a final written technical report shall be
submitted by the Principal Investigator within sixty (60) days of the
conclusion of the Research Period. ULRF shall maintain records of the use
of the funds provided by SPONSOR and shall make such records available to
SPONSOR upon reasonable notice during regular ULRF business hours, but not
more frequently than once each calendar year.
3.2 Subject to the provisions for (i) non-use and non-disclosure of ULRF's
Confidential Information under Section 5 (CONFIDENTIALITY), (ii) the
prerogative of Research personnel to first publish Research results in
accordance with Section 7 (PUBLICATIONS), and (iii) filing of
application(s) for statutory protection of Intellectual Property prior to
enabling disclosure thereof in accordance with Section 8 (INTELLECTUAL
PROPERTY) herein, SPONSOR may use the information provided in written
technical reports submitted pursuant to this Section 3 and disclose such
information to any third party. Information contained in such written
technical reports which remains subject to the terms and conditions of
Section 5, Section 7, and/or Section 8 herein shall not be disclosed by
SPONSOR except on an "as needed" basis (a) to those parties with whom
SPONSOR has entered into written confidentiality agreements at least as
restrictive as the terms of Section 5 herein, or (b) in a submission to the
United States Food & Drug Administration or a similar foreign agency that
regulates approval of new drugs, provided that SPONSOR gives ULRF sixty
(60) days prior written notice of such disclosure and receives ULRF's prior
written permission, which shall not be unreasonably withheld.
4. PAYMENT OF COSTS
4.1 In consideration of ULRF's performance hereunder, SPONSOR agrees to support
costs incurred in performance of the Research in the amount of Three
Hundred Seventy Five Thousand U.S. Dollars (US$375,000), inclusive of
applicable Facilities & Administrative Costs calculated at Institution's
rate which is in effect as of the Effective Date of this Agreement. Unless
the funding total is subsequently increased by written amendment to this
Agreement made in accordance with Section 17.1, total costs to SPONSOR
shall not exceed said amount. SPONSOR shall make interim payments as set
forth in Appendix A provided this Agreement has not been terminated.
Payment will be due upon SPONSOR's receipt of invoice. Payment by SPONSOR
shall be sent to the address specified on the invoice. Invoices not paid
within thirty (30) days of the later of invoice date or receipt date of
invoice are subject to 1% per month interest on the unpaid balance for any
amounts not in dispute. ULRF reserves the right to discontinue the Research
if SPONSOR fails to make payments within thirty (30) days of the dates
specified in the invoice except for amounts which are in dispute and
subject to a thirty (30) day opportunity to resolve.
4.2 ULRF shall retain title to any equipment purchased with funds provided by
SPONSOR under this Agreement.
4.3 The determination of allowable cost for ULRF's activities will be made in
accordance with the applicable Federal Cost Principle inclusive of all
amendments in effect as of the date of this Agreement, and any subsequent
amendments: Institutions of Higher Education (OMB Circular A-21).
4.4 In the event of termination of this Agreement pursuant to Section 10,
SPONSOR shall reimburse ULRF for all costs incurred and non-cancelable
obligations made up to and including the effective date of such notice of
termination; provided, the total funding provided by SPONSOR to ULRF
hereunder shall not exceed the total funding amount set forth in Section
4.1.
5. CONFIDENTIALITY
5.1 In performance of the Research, either party may disclose information to
the other party which it considers to be proprietary and confidential
(hereinafter Confidential Information). All such information shall be
designated confidential at the time of disclosure by the disclosing party
either orally or in writing. If designated confidential orally, the
disclosing party shall within thirty (30) days of the date of disclosure
confirm in writing the confidential nature of such information. The
receiving party shall use reasonable efforts to ensure said Confidential
Information is kept confidential and shall promptly return or destroy all
originals and copies of Confidential Information at the written request of
the disclosing party. Except as otherwise provided herein, for a period of
five (5) years following the date of such disclosure, the receiving party
will not disclose the Confidential Information without the consent of the
disclosing party and shall use such Confidential Information only for the
purposes of this Agreement. Notwithstanding the foregoing, the receiving
party may transfer the disclosing party's Confidential Information to those
of receiving party's employees, students, officers, directors and agents as
may be reasonably necessary to carry out the performance of this Agreement.
Information shall not be subject to the aforementioned restrictions where
the:
(a) information was possessed by receiving party prior to receipt from
disclosing party other than through prior disclosure by the disclosing
party as evidenced by receiving party's business records;
(b) information published or available to the general public otherwise
than through a breach of this Agreement;
(c) information obtained by receiving party from a third party with a
valid right to disclose it, provided that said third party is not
under a confidentiality obligation to the disclosing party;
(d) information was independently developed by employees, agents or
consultants of receiving party who had no knowledge of or access to
the information as evidenced by receiving party's business records;
(e) information for which the receiving party obtains the disclosing
party's prior written permission to publish or which is disclosed in
the necessary course of the prosecution of patent applications upon
intellectual property developed pursuant to this Agreement; or
(f) information required to be disclosed by operation of law, regulation,
Attorney General decisions that carry the force of law, or court
order.
6. PUBLICITY
6.1 SPONSOR will not use the name of the ULRF, UofL, nor of any employee,
student, trustee or officer thereof, in advertising or publicity, including
news releases, without the prior written consent of the ULRF, which shall
not be unreasonably withheld; and ULRF will not use the name of the
SPONSOR, nor any employee of SPONSOR, in any advertising or publicity,
including news releases, without the prior written approval of SPONSOR,
which shall not be unreasonably withheld.
6.2 Nothwithstanding anything to the contrary in this Agreement, (i) the ULRF
may disclose the identity of the SPONSOR, the title of the Research, the
name of the Investigator, the Contract Period, and the amount being paid by
the SPONSOR for the Research, and (ii) the SPONSOR may disclose such
information as required by law or regulation.
7. PUBLICATIONS
7.1 SPONSOR recognizes that under UofL policies, the results of the Research
must be publishable and agrees that UofL and UofL investigators have the
right to publish and otherwise publicly disclose any information gained in
the course of the Research; provided, SPONSOR retains the right to preclude
publication or other public disclosure of SPONSOR's Confidential
Information. In order to permit SPONSOR an opportunity to determine if
patentable inventions or SPONSOR's Confidential Information are disclosed
therein, the Principal Investigator will provide SPONSOR with copies of any
proposed publication or presentation by project investigators no less than
thirty (30) days prior to submission for publication. Whenever possible,
efforts will be made by the Principal Investigator to provide copies of
drafts of intended articles or abstracts as soon as they reach a stage
suitable for distribution. SPONSOR shall have thirty (30) days after
receipt of said copies to object to such proposed presentation or proposed
publication because there is patentable subject matter which needs
protection and/or discloses SPONSOR's Confidential Information. In the
event that SPONSOR makes an objection because its Confidential Information
is disclosed in the proposed presentation or publication, such Confidential
Information will be deleted from the proposed presentation or publication
by the Principal Investigator and other Research personnel before
proceeding with publication or presentation. In the event that SPONSOR
makes an objection because potentially patentable subject matter is
disclosed in the proposed publication or presentation, the Principal
Investigator and other project investigators shall refrain from making such
publication or presentation for a reasonable time, not to exceed three (3)
months from the date of receipt of such objection, in order for the ULRF or
SPONSOR to file a patent application(s) directed to the patentable subject
matter contained in the proposed publication or presentation, in accordance
with Article 8 (INTELLECTUAL PROPERTY) below.
8. INTELLECTUAL PROPERTY
8.1 For the purposes of this Section 8, right and title to any intellectual
property, whether patented, copyrighted or maintained as know-how, shall be
determined in accordance with the provisions for determining authorship and
inventorship under Titles 17 and 35 of the United States Code,
respectively.
8.2 All rights and title to ULRF Intellectual Property shall belong to the ULRF
and shall be subject to the terms and conditions of this Agreement.
8.3 All rights and title to JOINT Intellectual Property shall jointly belong to
ULRF and SPONSOR, and shall be subject to the terms and conditions of this
Agreement.
8.4 ULRF will promptly notify SPONSOR of any ULRF Intellectual Property or
JOINT Intellectual Property and will supply SPONSOR with a copy of any
invention disclosure received from the Principal Investigator describing
said ULRF Intellectual Property or JOINT Intellectual Property. Likewise,
SPONSOR will promptly notify ULRF of any ULRF Intellectual Property or
JOINT Intellectual Property and will supply ULRF with a copy of any
invention disclosure thereon received from SPONSOR employee(s) describing
said ULRF Intellectual Property or JOINT Intellectual Property. SPONSOR
shall have thirty (30) days from the date of disclosure to decide whether a
patent application or application for other intellectual property
protection should be sought. If SPONSOR decides that a patent application
or application for other intellectual property protection should be filed
on ULRF Intellectual Property, the ULRF shall promptly prepare, file and
prosecute such U.S. and foreign application(s) in ULRF's name. If SPONSOR
decides that a patent application or application for other intellectual
property protection should be filed on JOINT Intellectual Property, then
SPONSOR shall direct ULRF to promptly prepare, file and prosecute such U.S.
and foreign application(s) in ULRF and SPONSOR's name. SPONSOR shall bear
all costs incurred in connection with such preparation, filing, prosecution
and maintenance of U.S. and foreign applications directed to said ULRF
Intellectual Property or JOINT Intellectual Property but may elect to
discontinue its financial support of such prosecution and/or maintenance,
provided, SPONSOR notifies ULRF in writing of such decision to discontinue
reasonably in advance of ULRF's need to respond to any statutory deadlines
of which SPONSOR has been made aware. SPONSOR and ULRF shall ensure that
such application(s) to the best of their knowledge, cover all items of
commercial interest and significance. With regard to all applications for
which SPONSOR is reimbursing ULRF for or directly paying the patent-related
expenses, SPONSOR shall be given reasonable opportunity to review and
contribute to the content of said ULRF Intellectual Property application(s)
being managed by ULRF. ULRF shall keep SPONSOR advised as to all
developments with regard to said application(s) and shall promptly provide
to SPONSOR copies of all documents received and/or filed in connection with
the filing, prosecution or maintenance thereof in reasonable time, subject
to statutory deadlines, for the SPONSOR to comment and contribute thereto.
Following execution of an exclusive license to ULRF Intellectual Property
or JOINT Intellectual Property, then prosecution responsibility of all
licensed ULRF Intellectual Property or JOINT Intellectual Property shall be
governed by the terms of such license, which shall be no less favorable to
Sponsor than the terms set forth in the license being entered into
concurrently with this Agreement.
8.5 If the SPONSOR elects not to support the filing of a patent application or
other intellectual property protection for any ULRF Intellectual Property
or Joint Intellectual Property disclosed to the SPONSOR or decides to
discontinue the financial support of the prosecution or maintenance of any
applications, ULRF shall have no further obligation to SPONSOR under this
Agreement with regard to such applications and the subject ULRF
Intellectual Property or JOINT Intellectual Property, and ULRF shall be
free to file or continue prosecution or maintain any such application(s),
and to maintain any issued patents thereon in the U.S. and any foreign
country at ULRF's expense. Such patent applications and issued patents
shall be excluded from SPONSOR's option under Section 9 hereof, however,
SPONSOR shall retain all of its own rights in Joint Intellectual Property.
9. GRANT OF RIGHTS
9.1 ULRF grants the SPONSOR the first option, at the SPONSOR's sole election,
to negotiate for an exclusive, worldwide commercial license to ULRF's
interest in any ULRF Intellectual Property or JOINT Intellectual Property.
Such license shall be for fair and valuable consideration and shall include
a reasonable royalty rate and, subject to ULRF's policies, shall include
other such terms as are typical in licenses of similar technology from
not-for-profit organizations to for-profit organizations. The option shall
extend for an option time period of * from the date of disclosure of the
ULRF Intellectual Property or JOINT Intellectual Property to SPONSOR.
9.2 If SPONSOR elects not to exercise its option pursuant to this Section or
fails to negotiate a license agreement to ULRF Intellectual Property or
Joint Intellectual Property during said * option period, then:
(a) ULRF shall have no further obligation and SPONSOR shall have no
further right to ULRF Intellectual Property and ULRF may license its
interest in ULRF Intellectual Property to any party upon terms ULRF
deems appropriate;
(b) SPONSOR shall pay to ULRF a royalty on any product that is covered by
JOINT Intellectual Property, such rate to be determined during the
option time period, or, if the parties fail to arrive at an agreement
on this point, shall be set at * the rate of the relevant industry
standard;
(c) ULRF and SPONSOR each shall be free to exploit the JOINT Intellectual
Property as it wishes, whether directly and/or through licensing under
its ownership interests to any third party(ies). ULRF and SPONSOR each
shall fully account to the other for compensation derived from such
exploitation, such accounting to be determined during the option time
period, or, if the parties fail to arrive at an agreement on this
point, shall be with * of the compensation to the licensing party and
* to the non-licensing party.
9.3 Any license granted to SPONSOR by ULRF shall be subject, if applicable, to
the rights of the United States government reserved under Public Laws
96-517, 97-256 and 98-620, codified at 35 U.S.C. 200-212, and any
regulations issued thereunder, and shall include a perpetual, paid-up,
royalty-free, non-exclusive license in favor of the ULRF and the Principal
Investigator(s) to use the inventions and/or discoveries for noncommercial,
educational and research purposes, including authorizing other entities to
use such ULRF Intellectual Property and JOINT Intellectual Property for
academic and non-commercial research purposes. For ULRF Intellectual
Property and JOINT Intellectual Property subject to SPONSOR's exclusive
option period as specified in Section 9.1 or to a subsequently executed
exclusive commercial license agreement between ULRF and SPONSOR, ULRF shall
notify SPONSOR of each other entity's use of such ULRF Intellectual
Property or JOINT Intellectual Property and include appropriate
restrictions (e.g., prohibit the third party from transferring the subject
ULRF Intellectual Property or JOINT Intellectual Property to any third
party, prohibit use of the subject ULRF Intellectual Property or JOINT
Intellectual Property by the third party for any commercial purposes) in
any such grant of research use rights to third parties. Unless restricted
during the term of SPONSOR's exclusive option period specified in Section
9.1 or unless subject to a subsequently executed exclusive commercial
license agreement between ULRF and SPONSOR, ULRF also reserves the right to
use ULRF Intellectual Property and JOINT Intellectual Property for any
purpose, including licensing ULRF Intellectual Property and JOINT
Intellectual Property to third parties, without any further obligation to
SPONSOR except as otherwise set forth herein (so long as such use does not
disclose SPONSOR Confidential Information).
10. TERMINATION
10.1 This Agreement shall become effective upon the date first hereinabove
written and shall continue in effect for the full duration of the Research
Period unless sooner terminated pursuant to this Section. Sponsor may
terminate this agreement upon ninety (90) days prior written notice to
ULRF.
10.2 In the event that either party hereto shall commit any breach of or default
in any of the terms or conditions of this Agreement, and also shall fail to
remedy such default or breach within thirty (30) days after receipt of
written notice thereof from the other party hereto, the party giving notice
may, at its option and in addition to any other remedies which it may have
at law or in equity, terminate this Agreement by sending notice of
termination in writing to the other party to such effect and such
termination shall be effective as of the date of receipt of such notice.
10.3 Termination of this agreement by either party for any reason shall not
affect the rights and obligations of the parties accrued prior to the
effective date of termination of this Agreement. No termination of this
Agreement, however effectuated, shall release either party from their
rights and obligations under Sections 5, 6, 7, 8 and 11.
11. INDEPENDENT PARTIES
11.1 For the purposes of this Agreement, the parties shall be independent
contractors. Nothing contained herein shall be deemed or construed to
create between the parties hereto a partnership or joint venture or the
relationship of agent and principal.
12. DISCLAIMER OF WARRANTIES, INDEMNIFICATION
12.1 ULRF makes no warranties, express or implied, as to any matter whatsoever,
including without limitation, warranties with respect to the conduct,
completion, success or particular results of the Research, or the
condition, ownership, merchantability, or fitness for a particular purpose
of the Research or any ULRF Intellectual Property or JOINT Intellectual
Property. ULRF shall not be liable for any direct, indirect, consequential,
punitive or other damages suffered by SPONSOR or any other person resulting
from the Research or use of the results of the Research or any ULRF
Intellectual Property or JOINT Intellectual Property.
12.2 SPONSOR shall defend, indemnify and hold harmless ULRF, UofL, the Principal
Investigator and any of ULRF or UofL's faculty, students, employees,
trustees, officers, affiliates and agents and their respective successors,
heirs and assigns (hereinafter referred to collectively as the " ULRF
Indemnified Persons") from and against any and all liability, claims,
lawsuits, losses, damages, costs or expenses (including attorney's fees)
(collectively "Losses") which the ULRF Indemnified Persons may hereafter
incur, or be required to pay as a result of SPONSOR's use of the results of
the Research or any ULRF Intellectual Property or Joint Intellectual
Property or any act or omission of SPONSOR, its employees, affiliates,
contractors, licensees or agents. Nothwithstanding the foregoing, SPONSOR's
indemnification obligations under this Section shall not apply to any
Losses to the extent such Losses are attributable to the gross negligence
or willful misconduct of any of the ULRF Indemnified Persons. ULRF shall
notify SPONSOR upon learning of the institution or threatened institution
of any such liability, claims, lawsuits, losses, damages, costs and
expenses.
12.3 SPONSOR hereby assumes any risks of personal injury and property damage
attributable to the negligent acts or omissions of SPONSOR in the
performance of the Research and SPONSOR's officers, employees, and agents
thereof. To the extent permitted by applicable law and its insurance
coverage, ULRF hereby assumes any risks of personal injury and property
damage attributable to the negligent acts or omissions of ULRF in the
performance of the Research and ULRF's officers, employees and agents
thereof.
13. ASSIGNMENT
13.1 This Agreement may not be assigned or delegated, in whole or in part, by
SPONSOR or ULRF without the prior written consent of the other party, which
shall not be unreasonably withheld. A change in control shall not be
considered an assignment for purposes of this Section 13.1 unless such
change in control causes SPONSOR or its Affiliates to engage in any morally
objectionable activities including: activities designed to defame,
embarrass, harm, abuse, threaten, slander or harass third parties;
activities prohibited by the laws of the United States and/or foreign
territories in which SPONSOR conducts business; activities designed to
encourage unlawful behavior by others, such as hate crimes, terrorism and
child pornography; activities that are tortuous, vulgar, obscene, invasive
of the privacy of a third party, racially, ethnically, or otherwise
objectionable; activities designed to harm minors in any way. Any attempted
assignment in violation of this Section 13.1 shall be void and of no
effect. "Affiliate" shall mean any corporation or other legal entity which
directly or indirectly controls, is controlled by, or is under common
control with SPONSOR as of the Effective Date of this Agreement. For the
purpose of this Agreement, "control" shall mean the direct or indirect
ownership of greater than fifty percent (50%) of the outstanding shares on
a fully diluted basis or other voting rights of the subject entity to elect
directors, or if not meeting the preceding, any entity owned or controlled
by or owning or controlling at the maximum control or ownership right
permitted in the country where such entity exists. For clarity, a party's
status as an Affiliate of SPONSOR shall terminate if and when such control
ceases to exist.
14. GOVERNING LAW
14.1 This Agreement shall be governed and construed in accordance with the laws
of the Commonwealth of Kentucky without giving effect to the conflict of
laws provisions.
15. NOTICES
15.1 Notices, invoices, communications and payments hereunder shall be deemed
made if given in writing and addressed to the party to receive such notice,
invoice, communication or payment at the address given below, or such other
address as may hereafter be designated by notice in writing. Notices shall
be delivered by certified or registered first class mail (airmail if not
domestic) or by commercial courier service, and shall be deemed to have
been given or made (a) when delivered personally; (b) when sent by
confirmed facsimile; (c) three (3) days after having been sent by
registered or certified mail, return receipt requested, postage prepaid; or
(d) two (2) days after deposit with a commercial overnight carrier with
confirmed verification of receipt.. All communications will be sent to the
addresses set forth below or to such other address as may be designated by
a party by giving written notice to the other party pursuant to this
Section.
If to SPONSOR:
NeoStem, Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxx 000
Xxx Xxxx, XX 00000
Attention: General Counsel
If to ULRF:
For administrative notice:
Director, Office of Industry Contracts
University of Louisville Research Foundation, Inc.
XxxXxxxxx Xxx, Xxxxx 000
000 Xxxx Xxxxxxxx
Louisville, KY 40202-1798
For technical notice: For U.S. Postal Service:
Dr. Xxxxxxx Ratajcak
Dept. of Medicine-Oncology
University of Louisville
Xxxxxxxxxx, XX 00000
16. ADDITIONAL PROVISIONS
16.1 In the event any part, article, section, subsection, clause, paragraph or
subparagraph of this Agreement shall be held to be indefinite, invalid,
illegal or otherwise voidable or unenforceable, the entire Agreement shall
not fail on account thereof, and the balance of the Agreement shall
continue in full force and effect.
16.2 A waiver by either party of a breach or violation of any provision of this
Agreement will not constitute or be construed as a waiver of any subsequent
breach or violation of that provision or as a waiver of any breach or
violation of any other provision of this Agreement.
16.3 No exercise of a specific right or remedy by any party precludes it from or
prejudices it in exercising another remedy or maintaining an action to
which it may otherwise be entitled either at law or in equity.
16.4 During the performance of this Agreement, SPONSOR and ULRF shall not
discriminate against any employee or applicant for employment because of
race, color, sex, sexual preference, age, religion, national or ethnic
origin, handicap, or because he or she is a disabled veteran or veteran of
the Vietnam era.
16.5 Each party shall comply with all laws, regulations and other legal
requirements applicable to them in connection with this Agreement.
17. AGREEMENT MODIFICATION
17.1 This Agreement is the final and complete understanding of the parties with
respect to the subject matter hereof superseding all prior agreements,
understandings and discussions relating thereto. No amendments or changes
to this Agreement including, without limitation, changes to the field of
Research, total cost or Research Period, shall be valid unless the change
is made in writing and signed by authorized representatives of the parties
hereto. The appendices will be binding upon the parties hereto except to
the extent they may conflict with the terms and conditions contained within
this Agreement, in which case the terms and conditions of the Agreement
will govern.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
date first above written.
THE UNIVERSITY OF LOUISVILLE NEOSTEM, INC.
RESEARCH FOUNDATION, INC.
Signature: /s/ Xxxxx Xxxx Signature: /s/ Xxxxx Xxxxx
Printed Name: Xxxxx X. Xxxx Printed Name: Xxxxx Xxxxx
------------- -----------
Title: Director, Office of Industry Contracts Title: Chairman and CEO
-------------------------------------- ----------------
Date: November 12, 2007 Date: November 13, 2007
----------------- -----------------
Principal Investigator, while not a party to this
Agreement, by his/her signature acknowledges that
he/she: (1) has read and agrees to abide by the terms
and conditions that apply to the Principal Investigator,
(2) agrees to conduct/perform the research as outlined
in the Research Statement of Work, and (3) if applicable,
will see that the work within the scope of this agreement
is performed in accordance with an approved University/
Institution management plan.(1)
Name: Xxxxxxx X. Xxxxxxxxx, M.D., Ph.D.
---------------------------------
Signature: /s/ Xxxxxxx Xxxxxxxxx
Title: Professor, Medical Oncology
---------------------------
Date: November 12, 2007
-----------------
---------------
(1) "Management Plan" means a written plan for the management, reduction or
elimination of a potential financial conflict of interest relating to
research. It relies upon, and is therefore limited by, good faith
disclosures about significant financial interests made, and other
information provided by, a covered individual to the University.
