Exhibit 10.48
Research Agreement
The University of Miami
This Research Agreement (the "Agreement") is entered into as of this 1/31/2008
(the "Effective Date"), by and between The University of Miami, located at 0000
Xxxxxxx Xxxxxx, Xxxxx Xxxxxx, Xxxxxxx 00000 (the "Institution"), and National
Stem Cell, a corporation organized under the laws of the State of a Delaware
having an address at 0000 Xxxxx 00 Xxxx, Xxxxxxxxxxxx, XX (the "Sponsor").
WHEREAS, Sponsor wishes that Institution conduct research studies as described
in the Statement of Work, attached hereto as Exhibit A.
NOW, THEREFORE, in consideration of the following mutual promises, covenants,
and conditions and any sums to be paid, the parties hereto agree as follows:
1. STATEMENT OF WORK
The Institution agrees to conduct in collaboration with Sponsor the research
studies entitled: Ex Vivo Expansion of Cord Blood Cells (Research Project), as
described in the Statement of Work for this study (attached as Exhibit A). The
Institution represents that to the best of its knowledge that it has, or by the
commencement of the Research Project will have, the experience, capability, and
resources, including, but not limited to, sufficient personnel and equipment, to
efficiently and expeditiously perform the Research Project in a professional and
competent manner, and in strict adherence to the protocol. Institution
represents and warrants that it will use reasonable efforts to ensure that the
Research Project will be in accordance with all federal, state and local
regulatory laws, rules and practices. Sponsor is providing certain technology
and biological materials for the Study. Investigator shall not co-mingle funding
that might incur obligations to third parties; and shall not co-mingle materials
of the study or of Sponsor with those of third parties which might incur
obligations to third parties.
2. INVESTIGATOR
This Research Project will be conducted under the direction of Xxx XxXxxxx, PhD
(the "Investigator"). The Investigator shall be responsible for performing this
Research Project and for direct supervision of any individual performing
portions of this study. In the event the Investigator becomes unwilling or
unable to perform the duties required for the Research Project conducted under
this Agreement, the Institution and Sponsor shall attempt to agree on a mutually
agreeable replacement. In the event a mutually acceptable replacement is not
available, then the Research Project may be terminated by either party hereto in
accordance with Section 8 of this Agreement.
3. PAYMENT
(a) In consideration of conducting the Research Project hereunder, Sponsor
shall pay Institution in accordance with the budget attached as Exhibit B of
this Agreement. The Direct Costs shown in Exhibit B are subject to University
Indirect Costs of $23,612 for a total payment of $118,060.
Payments shall be made as follows: 50% of the budget will be due within 90 days
of the execution of this agreement, 25% will be due on the completion date and
the final 25% due upon delivery of the final report.
(b) Payments shall be addressed to the University's central lockbox account,
referencing the Contract No. and the Investigator.
Payable to: The University of Miami Tax I.D. Number.
University of Miami
Sponsored Programs
X.X. Xxx 000000
Xxxxx, XX 00000-0000
The check should indicate the University account number. A copy of the payment
transmittal shall be sent to the Principal Investigator
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It is expected that grant funds will be expended in general accordance with the
budget attached as Exhibit B. Actual expenditures may vary at the discretion of
the University.
4. RECORDKEEPING, REPORTING, ACCESS
Authorized representatives of Sponsor or its designee shall have the right, at
mutually agreed upon times, and during regular business hours, to examine and
inspect the Institution's and applicable Investigator's facilities and records
associated with this Study and inspect records relating to this Research
Project.
Institution shall advise Sponsor of the results of the Research Project at least
once in every two-week period during the term of this Agreement, and provide
Sponsor with semi-annual informal written progress reports concerning the
details of the progress of the Research Project. A final written report setting
forth the results achieved under and pursuant to the Research Project, including
the Study Results and the Subject Inventions, shall be submitted by to Sponsor
within thirty (30) days of the completion of the Research Project or the
termination of this Agreement, whichever is earlier. Such final report shall
include, but may not be limited to, a complete summary of the activities carried
out, including: design details, prototypes, testing protocols and detailed
results.
5. PROPRIETARY INFORMATION AND CONFIDENTIALITY
Neither party shall disclose to any third party or use for any purposes other
than the performance of this Research Project, any and all compositions, data,
information, materials, methods, processes, trade secrets, privileged records,
or other proprietary information disclosed to one party by the other party
pursuant to this Agreement (collectively, "Proprietary Information"), without
providing the party's prior written consent, except as otherwise specified in
this Agreement. The receiving party shall treat the Proprietary Information as
it would treat its own proprietary information, but in no event shall it use
less than a reasonable degree of care. The obligation of non-disclosure and non-
use shall not apply to the following.
(a) Information, which at the time of disclosure hereunder, is generally
available to the public;
(b) Information, which after disclosure hereunder, becomes generally available
to the public, except through breach of this Agreement;
(c) Information that a party can demonstrate was in its possession at the time
of disclosure by the other party and that was not acquired, directly or
indirectly, from such other party;
(d) Information that becomes available to a party from a third party that is
not legally prohibited from disclosing such information, provided such
information was not acquired directly or indirectly from a party to this
agreement
(e) Information that is independently developed by a party without reference
to the Proprietary Information, as documented by written evidence; or
(f) Information required by any law, regulation, or order of court to be
disclosed. Prior to disclosing proprietary or confidential information of the
other party, the disclosing party shall first notify the providing party and
provide it an opportunity to prevent disclosure if practicable.
In addition, the terms of this Agreement supersede any previous non-disclosure
agreements or any other preliminary representations or understandings that have
been entered into by the parties to this Agreement with regard to the subject
Research Project.
The obligations of nonuse and confidentiality set forth herein shall extend for
a period of five (5) years from the date of disclosure.
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6. RESULTS AND INTELLECTUAL PROPERTY
Any and all study data, information, inventions, compositions, discoveries,
materials, methods, processes, and/or technology generated by performing this
Research Project, including all study results ("Study Results") as well as all
potentially patentable results, information, ideas, inventions, developments or
discoveries first conceived and/or reduced to practice in the course of
performance of this Agreement ("Subject Inventions") shall be the sole and
exclusive property of the Sponsor. Sponsor and the Investigator hereby delivers,
assigns, and will deliver and assign the Study Results and the Subject
Inventions and all of its rights, title and interest in and to the Study
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Results and the Subject Inventions to Sponsor and agrees to execute and have
executed by relevant personnel and individuals all oaths, assignments, and other
relevant documentation (at Sponsor's reasonable expense) reasonably necessary to
effect the transfer of ownership contemplated under this Section.
7. PUBLICATION
The Institution and the Investigator are free to publish, present, or use any
results arising out of this Research Project for their own instructional,
research, or publication objectives, provided that such publication does not
disclose any of Sponsor's Proprietary Information, as defined in this Agreement.
Institution agrees to submit the draft of any proposed publication to Sponsor at
least sixty (60) days prior to submission for publication, presentation, and
agrees, at the request of Sponsor, to withhold any such submission for an
additional period, not to exceed sixty (60) days in order to file any patent
applications at the request of Sponsor.
8. TERM AND TERMINATION
(a) Unless earlier terminated in accordance with the provisions of this
Agreement, the term of this agreement shall commence on the Effective Date and
shall terminate six months after the Effective Date. This Agreement may be
terminated by Sponsor or institution upon at least sixty (60) days prior written
notice to the other party.
(b) In addition, the Agreement may be terminated by either party if the
Investigator conducting the Research Project is unwilling or unable to continue
performing the study and a successor to both Sponsor and Institution is not
available.
If this Agreement is terminated prior to the original termination date and
Sponsor has not yet remitted the full estimated project total to Institution,
Sponsor shall still be held responsible for all non-cancelable Institution
expenses and shall remit such total within thirty (30) days of Institution's
written request for final payment.
Sections 4, 5, 6, 9, 10 and ii of this Agreement shall survive any termination
or expiration of this Agreement.
9. WARRANTIES
UNIVERSITY MAKES NO WARRANTIES, EXPRESS OR IMPLIED AND HEREBY DISCLAIMS ALL SUCH
WARRANTIES DEVELOPED UNDER THIS AGREEMENT; OR THE OWNERSHIP, MERCHANTABILITY, OR
FITNESS FOR A PARTICULAR PURPOSE OF THE RESEARCH OR ANY SUCH INVENTION OR
PRODUCT. UNIVERSITY SHALL NOT BE LIABLE FOR ANY DIRECT, CONSEQUENTIAL, OR OTHER
DAMAGES SUFFERED BY ANY LICENSEE OR ANY THIRD PARTIES RESULTING FROM THE USE OF
THE RESEARCH OR ANY SUCH INVENTION OR PRODUCT.
The provision of this paragraph shall continue beyond the termination of this
Agreement
10. INDEMNIFICATION
Sponsor agrees to release, indemnify and hold harmless the Principal
Investigator, University, its Trustees, officers, faculty, employees and
students (University) against any and all losses, expenses, claims, damages,
actions, lawsuits and judgments thereon (including attorney fees through the
appellate levels), which may be brought against the University, arising out of
or reasonably attributable to 1) the activities to be carried out in this
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research and development study, 2) any negligent act or omission of Sponsor, its
agents or employees or any product or equipment supplied by Sponsor, or 3) the
use, possession or operation by the Sponsor or any third party of any Invention
or Discovery developed under this Agreement.
Sponsor, its agents and employees agree to release, hold harmless and indemnify
the University from and against any and all loss, claims, or damages, including
bodily injury or death or property damage, and including attorney fees, suffered
by Sponsor, and its agents and employees while on the University premises,
provided that such loss, claim or damage does not arise out of University
negligence.
Except as otherwise provided in this Agreement, University agrees to release,
indemnify and hold harmless Sponsor, its officers, directors and employees for
any and all losses, expenses, claims, damages, actions, lawsuits and judgments
therein (including attorney fees through the appellate levels) which may be
brought against
Sponsor, its officers, directors and employees arising out of any negligent act
or omission of University, its faculty, employees or agents.
In the event any such claim is made or lawsuit is initiated, the persons or
party against whom such lawsuit is brought or claim is made shall promptly
notify the other party in writing, and shall cooperate fully in the defense of
such lawsuit and permit the indemnifying party or its insurance carrier to
defend such a claim or lawsuit.
The provisions of this paragraph shall continue beyond the termination of this
Agreement.
11. INSURANCE
Sponsor and University each agree to carry and keep in force, each at its
expense, general liability insurance with limits not less than $1,000,000 per
person and $3,000,000 aggregate to cover liability for damages on account of
bodily or personal injury or death to any person, or damage to property of any
person. Sponsor shall keep in force product liability insurance with limits not
less than $5,000,000 prior to commencement of human subject testing. Such
insurance shall not be cancelled for any cause without at least 30 days prior
written notice to the other party. Such cancellation shall be cause for
termination.
Sponsor's insurance shall contain an endorsement naming the University as an
additional insured with respect to this Agreement Sponsor shall provide a
certificate of insurance or a self-insurance letter (if Sponsor is self-insured)
stating the limits of coverage. Such insurance shall be written to cover claims
incurred, discovered, manifested or made during or after the expiration of this
Agreement. Insurance Certificates should be sent to the University of Miami,
attention Xx. Xxxx Xxxxxxxx, Director, Office of Technology Transfer, 0000
Xxxxxxxxx 00xx Xxxxxx, Xxxx 0000, Xxxxx, Xxxxxxx 00000.
12. FEDERAL REGULATIONS
No human subject testing shall be conducted under this Agreement. Any studies
involving the use of vertebrate animals shall comply with all state and federal
statutes, rules and regulations governing animal care and use. Any studies
involving isotopes must comply with any and all applicable state and federal
rules, regulations and statutes. Recombinant DNA research shall be performed in
accordance with regulations promulgated as Guidelines for Research Involving
Recombinant DNA Molecules, U.S. Department of Health and Human Services, Public
Health Service, National Institutes of Health.
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13. NOTICES
With the exception of study funds paid by Sponsor pursuant to Section 3 hereof,
all notices required or permitted to be given under this Agreement shall be in
writing and shall be sent as follows:
If to Sponsor: National Stem Cell
000 Xxxx Xxxx Xxxxxxxxxxxx, XX Attn: Xxxxxxx Xxxxx
Chief Executive Officer
With a copy to:
Xxxxx Xxxxx Zedek Xxxxxx, LLP
00 Xxxxxxxxxxx Xxxxx,
Xxxxx 0000 Xxx Xxxx, Xxx
Xxxx, 00000 Telephone 000-000-0000
Facsimile 000-000-0000
Attn: Xxxx X. Xxxxx
If to Institution:
Xx. Xxxx Xxxx-Xxxxxx
Controller
Office of Controller
212 Xxx Xxxxxxx Bldg.
0000 Xxxxxxx Xxxxxx
Xxxxx Xxxxxx, XX 00000-0000
Xx. Xxxx X. Xxxx
Vice President
Business Services
327 Xxx Xxxxxxx Bldg.
0000 Xxxxxxx Xxxxxx
Xxxxx Xxxxxx, XX 00000-0000
Xx. Xxxxxxx Xxxxxxx
Vice Xxxxxxx for Research
X.X. Xxx 000000 (X-00)
Xxxxx,Xxxxxxx 00000
Copy to: Investigator
14. INDEPENDENT CONTRACTORS
The relationship of Sponsor to Institution and its Investigator shall be that of
an Independent Contractor and none of the parties shall hold itself out to third
parties as purporting to act as, or on behalf of, the other party hereto.
15. USE OF OTHER PARTIES' NAMES
Neither the Sponsor nor the Institution shall use directly or by implication the
names of the other party, nor any of the other party's affiliates or
contractors, nor any abbreviations thereof, or of any staff member, faculty
member, student, or employee of the other party in connection with any products,
promotion, advertising, or other public disclosure without the prior written
permission of the other party. Sponsor is permitted to state that Sponsor has
entered into a Research Agreement with Institution, for factual purposes, but
not for marketing or promotion purposes. The Institution herby acknowledges that
the Sponsor is allowed to disclose this agreement to potential investors without
any further notification to the Institution. The Sponsor agrees to notify and
request the permission of the Institution prior to the use of its name,
employees name or its affiliates name prior to any publication that the Sponsor
may publish. The institution shall respond to the Sponsors notification within 5
business days. Institution may use Sponsor's name in its Research Notes.
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16. WAIVERS; SEVERABILITY
No waiver of any term or provision of this Agreement whether by conduct or
otherwise in any one or more instances shall be deemed to be, or construed as, a
further or continuing waiver of any such term or provision, or of any other term
or provision, of this Agreement.
17. CONTINUING OBLIGATION
Except as otherwise specifically provided herein, termination of this Agreement
shall not relieve either party hereto from any obligation under this Agreement
that accrued or arose from facts or circumstances in existence prior thereto.
18. ASSIGNMENT.
This Agreement shall be binding upon and shall inure to the benefits of the
parties hereto and the successors to substantially the entire business and
assets of the respective parties hereto. This Agreement shall not be assignable
by either party without the prior written consent of the other party.
19. ENTIRE AGREEMENT
This Agreement embodies the entire understanding between Institution and the
Sponsor for or this project, and any prior or contemporaneous representations,
either oral or written, are hereby superseded. No amendments or changes to this
Agreement, including without limitation, changes in the statement of work, total
cost, and period of performance, shall be effective unless made in writing and
signed by authorized representatives of the parties.
20. HEADINGS
The headings in this Agreement are for the convenience of reference only and are
not substantive parts of this Agreement nor shall they affect its
interpretation.
21. COUNTERPARTS
This Agreement and any amendments hereto may be executed in counterparts and all
such counterparts taken together shall be deemed to constitute one and the same
instrument.
In Witness Whereof, the parties have caused this Agreement to be executed by
their duly authorized representatives as of the Effective Date.
NATIONAL STEM CELL, INC
By: /s/Xxxxxxx Xxxxx
---------------------
XxxxxxX Xxxxx
Chief Executive Officer
Date: 11/20/07
THE UNIVERSITY OF MIAMI
By: /s/ Xxx Xxxx
-----------------
XXX XXXX
DIRECTOR OF RESEARCH
Date:
Read and Agreed to:
/s/ Xxx XxXxxxx
----------------
Investigator
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EXHIBIT A
SCOPE OF WORK
Cord Blood (CB) products have become a standard hematopoietic cell graft as
support for cancer patients undergoing high dose chemotherapy. However, the
number of cells available in a CB product is limited and the use of CB products
for adult patients has been limited. Therefore a number of Investigators have
explored ex vivo expansion of CB products as a means to provide increased cell
numbers. The research to be undertaken in this project will evaluate approaches
for isolation of subpopulations of hematopoietic cells from CB products for
optimal expansion of total nucleated cells.
In previous research studies XxXxxxx and colleagues have demonstrated that ex
vivo culture of CB mononuclear cells (MNC) results in minimal expansion of total
cells. This led to the use of CD34 selection of CB products, however, in
clinical trials where frozen CB products were required the recovery of CD34+
cells and the purity of the final selected cells was highly variable resulting
in minimal efficacy. In further studies we have identified selection approaches
that result in passive removal of "inhibitor)," cells from the MNC enabling
optimal recovery of CD34+ cells and providing a cell population that can be
effectively expanded in culture.
The goal of this research is to evaluate the preparation of CB products using
rosette technology which will generate a starting cell population capable of
optimal expansion in culture. We will perform separation of 10 CB products and
identify the optimal processing procedure. These experiments will compare
different antibody to cell ratios and different cell concentrations of the
labeled cells on density gradient separation. Subsequently the separated cell
populations will be expanded for 14 to 21 day periods and evaluated for
expansion of various cell populations including CD34+ cells, total nucleated
cells, myeloid progenitor cells (GM-CFC) and primitive progenitor cells (HPP-
CFC).
GOAL OF STUDIES:
The minimal cell dose required for transplantation of CB products is 1 x 107
TNC/kg, we will target a minimal cell increase of 5 fold which would result in a
cell dose of expanded cells of 5 x 107 TNC/kg. Ideally, a level of 10 fold
expansion would be desired to account for CB products with an even lower cell
dose of around 5 x 106 TNC/kg, therefore also resulting a cell dose of 5 x 107
TNC/kg. Therefore the goal of these studies is to determine if a reproducible ex
vivo expansion of at least 5 fold can be achieved with an optima/result being
10 fold expansion.
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EXHIBIT B
BUDGET FOR STUDY
DETAILED BUDGET FOR INITIAL BUDGET PERIOD
DIRECT COSTS ONLY
PERSONNEL (Applicant organization only)%
FROM THROUGH
01/01/08 06/30/08
DOLLAR AMOUNT REQUESTED
(omit cents)
---------------------------------------------------------------------------------------------
ROLE ON TYPEE FFORT INST.
PROJECT APPT. ON BASE SALARY FRINGE
NAME (months) PROJ. SALARY REQUESTED BENEFITS TOTAL
----------------------------------------------------------------------------------------------
Xxx XxXxxxx, PhD Principal 12 10% 350,000 17,500 4,848 22,348
TBD Technician 12 100% 40,000 20,000 6,840 26,840
SUBTOTALS 37,500 11,688 49,188
CONSULTANT COSTS 0
EQUIPMENT (Itemize) 0
SUPPLIES (Itemize by category)
Ficoll, buffers, FCS: $3,000
Plastic disposables for tissue culture $5,000
Antibodies $7,500
Selection reagents $10,000
Growth Factors $10,000
Methylcellulose $3,000
------------------------------
$38,500
TRAVEL 0
PATIENT CARE COSTSI INPATIENT 0
OUTPATIENT 0
ALTERATIONS AND RENOVATIONS (Itemize by category) 0
OTHER EXPENSES (Itemize by category)
FACS analysis ($65/hr x 4 his per week x 26 weeks) $6,760 $6,760
SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD $94,448
CONSORTIUM/CONTRACT DIRECT COSTS
TOTAL
COSTS FACILITIES AND ADMINISTRATIVE COSTS
TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 7a, Face Page) $94,448
Indirect costs $23,612
---------
Grand Total $118,060
=========
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PROTEONOMIX
000 Xxxx Xxxx
Xxxxxxxxxxxx, XX 00000
February 12, 2009
Xxx Xxxx
Director of Administration University of Miami
212 Max Orvitz Building
0000 Xxxxxxx Xxxxxx
Xxxxx Xxxxxx, XX 00000-0000
Re: Sponsored Research agreement by National Stem Cell Holding, Inc. (renamed
Proteonomix, Inc.)
Dear Xx. Xxxx,
Enclosed please find a copy of sponsored research agreement to be conducted at
the University of Miami. Please be advised that National Stem Cell Holding, Inc.
has changed its name to Proteonomix, Inc. (the "Company") but continues as the
same corporate entity. Further, because of corporate constraints the Company
could not effectuate the research agreement in 2008 but would like to initiate
the research as soon as possible.
The Company would like to amend the agreement as follows:
a) New effective date - February 9, 2009
b) Name on the agreement - Proteonomix, Inc.
c) Address of the Company - 000 Xxxx Xxxx, Xxxxxxxxxxxx, XX 00000
d) Telephone and fax numbers - phone 000-000-0000 and fax 000-000-0000
e) Copy notice to Xxxx Xxxxxxx Attorney at Law, 000 Xxxxxxxxxxx Xxxx, Xxxxxxx XX
00000 phone: 000-000-0000 fax 000-000-0000 email: xxxxxxxx@xxxxx.xxx'
The Company respectfully requests this letter constitute an amendment to the
existing agreement as of the date above. Please review and accept this letter at
your convenience.
Thank you in advance for your assistance with this matter. If you should have
any questions or requests, please feel free to contact me anytime.
Sincerely,
Accepted:
Proteonomix, Inc. University of Miami
/s/Xxxxxxx Xxxxx CEO /s/Mr. Xxx Xxxx
-------------------- -------------------------
Director of Administration
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