LSA
THIS Agreement is made this 15th day of May 2002, between The University of
Texas M.D. Xxxxxxxx Cancer Center, 0000 Xxxxxxxx Xxxxxxxxx, Xxxxxxx, Xxxxx 00000
("Institution"), a component of The University of Texas System ("System"), and
BIOCELL INNOVATIONS, INC. 000 XXXXXXXX XXXXXX, XXXXXXX, XXXXX, 00000,
("Sponsor"), to conduct a laboratory study and evaluation ("Study"). Institution
and Sponsor agree as follows:
1. PROTOCOL
1.1 Institution agrees to use its best efforts to conduct the Study, as an
independent contractor, in accordance with Institutional policy, applicable laws
and regulations and the Project, "The use of patented processes and procedures
as described in Appendix I for the making, using, selling, proliferating,
transferring and/or making other disposition of bone marrow cells and tissues,
and bone-marrow derived peripheral blood cells and applications thereof,
including but not limited to growth and commercialization of bone marrow blood
cell cultures, growth and transplantation of blood cells and bone marrow; and
the use of blood cells and bone marrow for commercial growth of bone
marrow-derived biological products, including but not limited to red blood
cells, white blood cells, platelets, cellular growth factors, and intercellular
communication factors, and processes for making such products. The sources of
testing and commercialization materials shall be derived from sources such as
living donor biopsies, harvested from cadaver donors, living donor biopsies,
bone marrow aspirates, peripheral blood cells and other sources. Specifically
excluded as a source of bone marrow are human embryonic, fetal or neonatal cells
and tissues." as described in Exhibit A attached hereto and incorporated herein.
The Study will be supervised by Xx. Xxxx Xxxxxx, M.D., (Principal
Investigator"), at Institution, with assistance from associates and colleagues
as required.
1.2 Sponsor agrees to engage the services of Institution to conduct the
Study and further agrees to provide at no cost to Institution the materials and
equipment for the conduct of the Study.
2. AWARD
2.1 In consideration for performance of the Study by Institution, Sponsor
shall pay Institution $Three Hundred Seventy-Five Thousand and No/100 Dollars
($375,000.00) for Study expenses and other related costs. This amount, shown by
approximate category of expense in Exhibit B attached hereto for information
only, is payable in twenty-four monthly installments in the amount of $Fifteen
Thousand Six Hundred Twenty-five and NO/100 Dollars ($15,625.00) each. The first
payment is payable within thirty (30) days of the date herein above the final
payment will be due upon completion of the study.
3. TERM
3.1 This Agreement shall continue in force until the earlier of
completion of the Study as mutually agreed upon by the parties or twenty-four
(24) months from the date set forth above; provided, however, that either party
may terminate the Agreement by giving thirty (30) days advance notice to the
other.
3.2 Upon early termination of this Agreement, Sponsor shall be liable
for all reasonable costs incurred or obligated by Institution at the time of
such termination, subject to the maximum amount specified in Article 2. Sponsor
shall pay Institution for such costs within thirty (30) days of receipt of an
invoice for same.
3.3 Upon termination of this Agreement, Institution shall return Sponsor's
materials and equipment to Sponsor.
4. INDEMNIFICATION
4.1 Institution shall, to the extent authorized under the Constitution
and laws of the State of Texas, indemnify and hold Sponsor harmless from
liability resulting from the negligent acts or omissions of Institution, its
agents or employees pertaining to the activities to be carried out pursuant to
the obligations of this Agreement; provided, however, that Institution shall not
hold Sponsor harmless from claims arising out of the negligence or willful
malfeasance of Sponsor, its officers, agents, or employees, or any person or
entity not subject to Institution's supervision or control.
4.2 Sponsor shall indemnify and hold harmless System, Institution, their
Regents, officers, agents and employees from any liability or loss resulting
from judgments or claims against them arising out of the activities to be
carried out pursuant to the obligation of this Agreement, including but not
limited to the use by Sponsor of the results of the Study; provided, however,
that the following is excluded from Sponsor's obligation to indemnify and hold
harmless:
a. the negligent failure of Institution to comply with any applicable
governmental requirements or to adhere to the terms of the Protocol; or
b. the negligence or willful malfeasance by a Regent, officer, agent, or
employee of Institution or System.
5. PUBLICATION AND CONFIDENTIALITY
5.1 The parties reserve the right to publish or otherwise make public the
data resulting from the Study. The party so wishing to publish or make public
shall submit any such manuscript or release to the other party for comment
thirty (30) days prior to publication or release.
5.2 Except as otherwise required by law or regulation, neither party shall
release or distribute any materials or information containing the name of the
other party or any of its employees without prior written approval by an
authorized representative of the non-releasing party, but such approval shall
not be unreasonably withheld.
5.3 Each party shall hold in confidence for three (3) years after the
termination of this Agreement any confidential information identified as
confidential and obtained from the other party during the course of this Study.
Nothing herein, however, shall prevent Institution or any other component of
System from using any information generated hereunder for ordinary research and
educational purposes of a university.
6. INTELLECTUAL PROPERTY
6.1 Title to all inventions and discoveries made by Institution resulting
from the research performed hereunder shall reside in Institution; title to all
inventions and discoveries made by Sponsor resulting from the research performed
hereunder shall reside in Sponsor; title to all inventions and discoveries made
jointly by Institution and Sponsor resulting from the research performed
hereunder shall reside jointly in Institution and Sponsor. Inventorship shall be
determined in accordance with U.S. Patent law.
6.2 After consultation with Sponsor regarding the advisability of filing
patent applications, Institution shall file appropriate United States and
foreign patent applications for wholly or jointly owned Institution inventions.
Institution will provide Sponsor, on a confidential basis, a copy of any such
application filed and any documents received or filed during prosecution thereof
and will provide Sponsor the opportunity to comment thereon. On any application
on which an employee of Sponsor is named as a co-inventor, Sponsor will
cooperate in obtaining execution of any necessary documents by its employees.
6.3 Institution agrees to grant to Sponsor an exclusive, worldwide,
royalty-bearing license to make, use, or sell under any invention or discovery
owned wholly or partly by Institution and made or conceived and reduced to
practice during the term of this Agreement or within twelve (12) months
thereafter and directly resulting from the performance of the research
hereunder, with right to sublicense with accounting to University. Sponsor shall
have six (6) months from disclosure of any invention or discovery to notify
Institution of its desire to enter into such a license agreement, and a license
agreement shall be negotiated in good faith within a period not to exceed twelve
(12) months from Sponsor's notification to Institution of its desire to enter
into a license agreement, or such period of time as to which the parties shall
mutually agree.
6.4 If Sponsor and Institution fail to enter into an agreement during that
period of time, Sponsor shall have a right of first refusal with respect to any
terms generally more favorable offered by Institution to a third party for a
period of one (1) year thereafter.
6.5 In the event Sponsor elects to exercise its option to negotiate a
license in accordance with the procedures detailed above, it shall be obligated
to pay all expenses, including attorney's fees, incurred in searching prior art,
obtaining search opinions, preparing applications, filing, prosecuting,
enforcing or maintaining a patent or patent application with respect to the
licensed invention in any country in which the patent or application is filed.
7. GENERAL
7.1 This Agreement, including the attached Exhibit A and B, constitutes
the entire and only Agreement between the parties relating to the Study, and all
prior negotiations, representations, agreements, and understandings are
superseded hereby. No agreements altering or supplementing the terms hereof,
including the exhibits attached hereto, may be made except by a written document
signed by the duly authorized representatives of the parties.
7.2 Any conflicts between the Protocol and this Agreement are controlled by
this Agreement.
7.3 This Agreement shall be construed and enforced in accordance with the
laws of the State of Texas.
7.4 This Agreement anticipates educational training and may involve health
science postgraduates and other students of the Institution.
IN WITNESS WHEREOF, Institution and Sponsor hereby enter into this
Agreement, effective as of the date first set forth above, and execute two (2)
original counterparts.
SPONSOR THE UNIVERSITY OF TEXAS
M.D. XXXXXXXX CANCER CENTER
By: /s/ Xxxxxxx Xxxx By:/s/
Xxxxxxx X. Xxxxxxxx, M.D., M.B.A
Title: CEO Vice President for Research Administration
Date: May 15, 2002 Date: May 15, 2002
I ACKNOWLEDGE THAT I HAVE READ THIS AGREEMENT IN ITS ENTIRETY AND THAT I SHALL
USE REASONABLE EFFORTS TO UPHOLD MY INDIVIDUAL OBLIGATIONS AND RESPONSIBILITIES
SET FORTH HEREIN:
By: /s/ Zeev Extrov
Principal Investigator
By: /s/ Moseh Talzez
Chair
By: Xxxx Ki Hong
Head, Division of Cancer Medicine
Make Payment to:
The University of Texas
M.D. Xxxxxxxx Cancer Center
Attn: Manager, Grants & Contracts Accounting
X.X. Xxx 000000
Xxxxxxx, XX 00000
Tax I.D. 74 6001118 A1
APPENDIX I
NASA CASE NUMBER TITLE PATENT STATUS
------------------ ----- --------------
MSC-21560-1 "THREE-DIMENSIONAL CO-CULTURE PROCESS" U.S. XXX NO. 5,153,132
ISSUED OCTOBER 6, 1992
ABSTRACT
--------
Laboratory process provides environmental conditions favoring simultaneous
growth of cocultures of mammalian cells of more than one type. Cultures become
three-dimensional tissue-like assemblies serving as organoid models of
differentiation of cells. Process used, for example, to study growth of human
colon cancers, starting from mixtures of normal colonic fibroblasts and
partially differentiated colon adenocarcinoma cells.
MSC-21294-2 "METHOD FOR CULTURING MAMMALIAN CELLS U.S. XXX NO. 5,153,133
IN A HORIZONTALLY ROTATED BIOREACTOR" ISSUED OCTOBER 6, 1992
ABSTRACT
A bio-reactor system where cell growth microcarrier beads are suspended in a
zero head space fluid medium by rotation about a horizontal axis and where the
fluid is continuously oxygenated from a tubular membrane which rotates on a
shaft together with rotation of the culture vessel. The oxygen is continuously
throughput through the membrane and disbursed into the fluid medium along the
length of the membrane.
MSC-21559-1 "THREE-DIMENSIONAL CELL TO TISSUE U.S. XXX NO. 5,155,034
ASSEMBLY PROCESS" ISSUED OCTOBER 13, 1992
ABSTRACT
The present invention relates to a 3-dimensional cell to tissue and maintenance
process, more particularly to methods of culturing cells in a culture
environment, either in space or in a gravity field, with minimum fluid shear
stress, freedom for 3-dimensional spatial orientation of the suspended particles
and localization of particles with differing or similar sedimentation properties
in a similar spatial region.
MSC-21293-2 "METHOD FOR CULTURING MAMMALIAN CELLS U.S. XXX.XX. 5,155,035
PERFUSED BIOREACTOR ISSUED OCTOBER 13, 1992
ABSTRACT
A bio-reactor system wherein a tubular housing contains an internal circularly
disposed set of blade members and a central tubular filter all mounted for
rotation about a common horizontal axis and each having independent rotational
support and rotational drive mechanisms. The housing, blade members and filter
preferably are driven at a constant slow speed for placing a fluid culture
medium with discrete microbeads and cell cultures in a discrete spatial
suspension in the housing. Replacement fluid medium is symmetrically input and
fluid medium is symmetrically output from the housing where the input and the
output are part of a loop providing a constant or intermittent flow of fluid
medium in a closed loop.
MSC-21560-2 "MULTI-CELLULAR THREE-DIMENSIONAL U.S. XXX NO. 5,308,764
LIVING MAMMALIAN TISSUE" ISSUED MAY 3, 1994
ABSTRACT
The present invention relates to a multicellular, three-dimensional, living
mammalian tissue. The tissue is produced by a co-culture process wherein two
distinct types of mammalian cells are co-cultured in a rotating bioreactor which
is completely filled with culture media and cell attachment substrates. As the
size of the tissue assemblies formed on the attachment substrates changes, the
rotation of the bioreactor is adjusted accordingly.
MSC-21984-1 "CULTURED NORMAL MAMMALIAN TISSUE U.S. XXX NO. 5,496,722
AND PROCESS" ISSUED MARCH 5, 1996
ABSTRACT
Normal mammalian tissue and the culturing process has been developed for the
three groups of organ, structural and blood tissue. The cells are grown in vitro
under microgravity culture conditions and form three dimensional cells
aggregates with normal cell function. The microgravity culture conditions may be
microgravity or simulated microgravity created in a horizontal rotating wall
culture vessel.
MSC-21560-3 "MULTI-CELLULAR, THREE-DIMENSIONAL U.S. XXX NO. 5,627,021
LIVING MAMMALIAN TISSUE" ISSUED MAY 6, 1997
ABSTRACT
The process of the present invention relates to a three dimensional co-culture
process.
MSC-21984-2 "MEDIA COMPOSITIONS FOR THREE- U.S. XXX NO. 5,846,807
DIMENSIONAL MAMMALIAN TISSUE ISSUED DECEMBER 8, 1998
GROWTH UNDER
ABSTRACT
Normal mammalian tissue and the culturing process has been developed for the
three groups of organ, structural and blood tissue. The cells are grown in vitro
under microgravity culture conditions and form three dimensional cells
aggregates with normal cell function. The microgravity culture conditions may be
microgravity or simulated microgravity created in a horizontal rotating wall
culture vessel.
MSC-21984-3 "PRODUCTION OF NORMAL MAMMALIAN ORGAN U.S. XXX NO. 5,858,783
CULTURE USING A MEDIUM CONTAINING ISSUED JANUARY 12, 1999
MEM- ALPHA, LEIBOVITZ X-00, XXXXXXX
XXXXXXXXX FRUCTOSE
ABSTRACT
Normal mammalian tissue and the culturing process has been developed for the
three groups of organ, structural and blood tissue. The cells are grown in vitro
under micro-gravity culture conditions and form three dimensional cells
aggregates with normal cell function. The microgravity culture conditions may be
microgravity or simulated micro-gravity created in a horizontal rotating wall
culture vessel. The medium used for culturing the cells, especially a mixture of
epithelial and mesenchymal cells contains a mixture of Mem-alpha and Xxxxxxxxx
X00 supplemented with glucose, galactose and fructose.
MSC-22119-1 "CULTURED HIGH-FIDELITY U.S. XXX NO. 5,851,816
THREE DIMENSIONAL HUMAN UROGENITAL ISSUED DEC. 22, 1998
TRACT CARCINOMAS AND PROCESS"
ABSTRACT
Artificial high-fidelity three-dimensional human urogenital tract carcinomas are
propagated under in vitro-microgravity conditions from carcinoma cells.
Artificial high-fidelity three-dimensional human urogenital tract carcinomas are
also propagated from a coculture of normal urogenital tract cells inoculated
with carcinoma cells. The microgravity culture conditions may be microgravity or
simulated microgravity created in a horizontal rotating wall culture vessel.
MSC-22122 "HORIZONTAL ROTATING-WALL VESSEL U.S. XXX NO. 6,117,674
PROPAGATION IN VITRO HUMAN TISSUE ISSUED SEPT. 12, 2000
MODELS"
ABSTRACT
A process for propagating a pathogen in a three-dimensional tissue mass cultured
at microgravity conditions in a culture vessel containing culture media and a
culture matrix is provided. The three-dimensional tissue mass is inoculated with
a pathogen and pathogen replication in the cells of the tissue mass achieved.
