Exhibit 10.10
Confidential portions of this Agreement have been omitted pursuant to an order
granting confidential treatment issued by the Commission on May 11, 2005,
pursuant to Rule 406 of the Securities Act of 1933, as amended.
[GRAPHIC OMITTED]
TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER
School of Medicine
Department of Surgery
xxxx://xxx.xxxxxx.xxx/xxxxx/xxxxxxx/xxxxxxx.xxxx
0000 0xx Xxxxxx XXXX 0000
Xxxxxxx, Xxxxx 00000-0000
(000) 000-0000
(000) 000-0000 - Fax
Xxxxxx X. Xxxxxx, Ph.D.
Chairman & CEO
HemoBioTech, Inc.
0000 Xxxxxxxx Xxx, Xxxxx 000
Xxxxxx, XX 00000
Tel: (000) 000-0000; Fax: (000) 000-0000; E-mail: xxxxxxx@xxxxx.xxx
Re: Phase II of the Texas Tech-HemoBioTech Joint Blood Substitute Project.
Date: December 13, 2004
Dear Xx. Xxxxxx:
Texas Tech Administration Officials and I acknowledge the receipt of the funds
for Phase II of the Texas Tech-HemoBioTech Joint Research Project. This week the
account will be established and after a few days actual work on the project will
begin.
We would like to thank you for hosting HemoBioTech's Board of Directors Meeting
at Texas Tech. We are pleased with the results of this important meeting. We are
glad that Xx. Xxxxx, a new member of the Board of Directors, was pleased with
the scientific and technical capability of the Texas Tech Blood Substitute R&D
Team. We are confident that other members of your Board of Directors, Drs.
Mittemeyer and Xxxxxxxxx will ensure the success of the project.
As we discussed earlier I am including new FDA Guidance for the Blood Substitute
Industry: "Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as
Red Blood Cell Substitutes" which will supercede the 1990 "Points to Consider on
the Safety Evaluation of Hb-Based Oxygen Carriers" and replaces the 1997 draft
"Guidance for Industry: Efficacy Evaluation of Hb- and Perfluorocarbon-Based
Oxygen carriers." We can confer this document on Wednesday.
Xx. Xxxxxx we are certain that under your leadership the blood substitute
project will be a commercial success.
Regards,
Jan
/s/ Xx. Xxx Xxxxxx
-----------------------------------------------
Xx. Xxx Xxxxxx
P.I. of Sponsored Research Agreement
Associate Research Professor of Surgery and Internal Medicine
Texas Tech University Health Sciences Center
Xxxxxxx, XX 00000
Tel: 806-743-2460 ext. 246
Fax: 000-000-0000
Cc:
Xx. Xxxxxxx X. Xxxxx, Professor and Associate VP for Research and Xxxx of the
Graduate School, TTUHSC, Xxxxxxx, XX 00000
Xx. Xxxxxxx X. Xxxxxxxxxx, Professor and HemoBioTech's Board of Directors
Member, TTUHSC, Xxxxxxx, XX 00000
Xx. Xxxx Xxxxxx, Director, Office of Sponsored Programs, TTUHSC, Xxxxxxx, XX
00000
Dr. K. Xxxxx Xxxxxxxx, Director, Office of Technology Transfer and Intellectual
Properties, TTU & TTUHSC, Xxxxxxx, XX 00000
PROJECT TITLE: TEXAS TECH-HEMOBIOTECH JOINT BLOOD SUBSTITUTE PROJECT.
PHASE II: U.S. PATENT EXTENSION AND INITIAL IND STAGE.
PROJECT DIRECTOR (AT HEMOBIOTECH, INC.):
Xxxxxx X. Xxxxxx, PhD, Chairman & CEO
HemoBioTech, Inc.
0000 Xxxxxxxx Xxx, Xxxxx 000, Xxxxxx, XX 00000
Tel: 000-000-0000; Fax: 000-000-0000
Email: xxxxxxx@xxxxx.xxx
Web: xxxx://xxx.xxxxxxxxxxx.xxx
PROJECT PRINCIPAL INVESTIGATOR (AT TTUHSC):
Xxx Xxxxxx, DVM, PhD
Co-Inventor of Texas Tech Blood Substitute
Associate Research Professor of Surgery and Internal Medicine
Texas Tech University Health Sciences Center
School of Medicine
0000 0xx Xxxxxx, Xxxxxx 0X000X, Xxxxxxx, XX 00000
Tel: 000-000-0000 x 000; Fax: 000-000-0000
Email: xxx.xxxxxx@xxxxxx.xxx
DATES OF THE ENTIRE PROPOSED PERIOD:
December 1, 2004 - November 30, 2005
TOTAL DIRECT COST REQUESTED FOR THE PROJECT:
$230,503
PERFORMANCE SITES: Department of Surgery
Texas Tech University Health Sciences Center
0000 0xx Xxxxxx, Xxxxxxx, XX 00000, and
Texas Tech Xxx Xxxx Xxxx
Xxxx xx Xxx Xxxx, XX 00000
APPLICANT ORGANIZATION:
Texas Tech University Health Sciences Center
Xxxxxxx, XX 00000
TYPE OF ORGANIZATION:
State
ORGANIZATIONAL COMPONENT TO RECEIVE CREDIT FOR GRANT:
School of Medicine
OFFICIAL SIGNING FOR APPLICANT ORGANIZATION:
Xxxxxxx X. Xxxxx, PhD, Assoc. Xxxx/Assoc. VP
Office of Research and Graduate School
Texas Tech University Health Sciences Center
0000 0xx Xxxxxx, XX 112; Xxxxxxx, XX 00000
Tel: 000-000-0000; Fax: 000-000-0000
Email: Xxxxxxx.Xxxxx@xxxxxx.xxx
Signature: /s/ Xxxxxxx X. Xxxxx Date: 11/19/04
OFFICIAL IN BUSINESS OFFICE TO BE NOTIFIED ABOUT THIS FUNDING:
Xxxx Xxxxxx, Director
Office of Sponsored Program, TTUHSC
0000 0xx Xxxxxx, Xxxxxx 0X000, Xxxxxxx, XX 00000
Tel: 000-000-0000; Fax: 000-000-0000
Signature: /s/ Xxxx Xxxxxx Date: 11/19/04
PRINCIPAL INVESTIGATOR SIGNATURE:
Signature: /s/ Xxx Xxxxxx Date: 11/18/04
Texas Tech-HemoBioTech Joint Blood Substitute Project.
Phase II: U.S. Patent Extension and Initial IND Stage
Page 2
1. PROJECT DESCRIPTION:
The proposed project represents a joint effort between Texas Tech University
Health Sciences Center (TTUHSC) and HemoBioTech, Inc. with an objective to
commercialize the Texas Tech developed blood substitute product. The legal basis
for such an activity is the Sponsored Research Agreement and License Agreement
between Texas Tech University Health Sciences Center (a licensor) and
HemoBioTech, Inc (a licensee).
After active participation in Phase I of the project including:
o creation of a company structure;
o development of the business plan; and
o intellectual/scientific/technical support during the process of
searching for an initial venture capital,
the Texas Tech Blood Substitute R&D team led by Xx. Xxxxxx, was asked to provide
further assistance to the company. As requested by Xx. Xxxxxx X. Xxxxxx,
Chairman & CEO of HemoBioTech, Inc., during the October 28 meeting, new services
provided by Texas Tech to the company will include:
o completion and submission to the U.S. Patent and Trademark Office a
new patent on the method for stimulating erythropoiesis with the Texas Tech
developed blood substitute (Project I),
o transfer of the *, pre-clinical and clinical research data into
digital pdf format (Project II),
o analysis and summarization of the CMC, pre-clinical and clinical
research data for IND application (Project III),
o renovation and sanitation of the Texas Tech Blood Substitute
Production Facility (Project IV), and
o establishment of the animal blood donor facility (Project V).
Each project will be done at Texas Tech University using the Texas Tech
intellectual and technical resources and be paid in advance by HemoBioTech, Inc.
PROJECT I: The recently developed a new mechanism of erythropoietic activity of
Texas Tech's blood substitute will be patented. This patent will indirectly
protect the previously patented composition (U.S. Patent No. 5,439,882) and will
extend legal protection for the Texas Tech invented blood substitute product.
The Texas Tech R&D Blood Substitute Team,
* The information omitted is confidential and has been filed separately with the
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Texas Tech-HemoBioTech Joint Blood Substitute Project.
Phase II: U.S. Patent Extension and Initial IND Stage
Page 3
led by Xx. Xxxxxx established that the Texas Tech blood substitute product
effectively stimulates erythropoietic responses *. Using the intramural and
private funds, Xx. Xxxxxx has established that the Texas Tech blood substitute
has erythropoietic activity under *. To submit the successful patent application
it is believed that such a response should also be tested under * conditions.
To speed up the process, HemoBioTech, Inc. has agreed to provide the financial
resources to complete this study.
As requested by Xx. Xxxxxx, this study should be completed in * after receiving
the necessary funds. This project will also require that Xx. Xxxxxx will
prepare, in the next *, a complete patent application.
This project will also include additional * (i.e., detection of * level in the
HemoTech(TM) preparations; additional * tests; additional * tests; evaluation of
a new method for *, etc.). This project will be completed in * after completion
of the * study. Some elements of this project will continue through the entire
funding period.
The detailed budget is presented as ATTACHMENT 1.
PROJECT II: The transfer of the * pre-clinical and clinical data into a pdf file
will require manual handling of ca. * different documents. This work will be
done by the Electron Microscopy and Medical Photography Center of TTUHSC. The
entire process will be coordinated by Xx. Xxxxxx, and is required by the FDA.
The detailed budget and timetable of completion is presented as ATTACHMENT 2.
PROJECT III: Analysis and summarization of the *, pre-clinical and clinical
research data will require evaluation of ca. different documents. This work will
be done by Xx. Xxxxxx * and Xx. Xxxxx Xxxxx, an employee of HemoBioTech, Inc.
(pre-clinical and clinical data). This project (Xx. Xxxxxx'x part) will be
completed in * days after completion of the * study. Xx. Xxxxx'x part will be
completed in *
The detailed budget is presented in ATTACHMENT 1.
* The information omitted is confidential and has been filed separately with the
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Texas Tech-HemoBioTech Joint Blood Substitute Project.
Phase II: U.S. Patent Extension and Initial IND Stage
Page 4
PROJECT IV: The remodeling and sanitation of the Blood Substitute Production
Facility will be done by the Texas Tech's Facilities Planning and Construction
Department and the Blood Substitute's R&D Team under the direction of Xx.
Xxxxxx. This project can be completed in * days after receiving the necessary
funds.
The detailed budget is presented as ATTACHMENT 3.
PROJECT V: The establishment of the animal blood donor facility will be done in
cooperation with the Department of Animal Sciences at TTU. This facility will be
located at * in * and supervised by Xx. Xxxxxx. The remodeling/renovation part
of this project can be completed in * days after receiving the necessary funds.
This project will continue through the entire funding period.
The detailed budget and timetable of completion is presented as ATTACHMENT 4.
2. TECHNICAL AND MANAGERIAL RESOURCES. Texas Tech University Health Sciences
Center with twenty years of experience in the blood substitute field has all
intellectual and technical resources to successfully complete Phase II of the
project.
All the personnel involved are highly qualified, well recognized experts in the
blood substitute field. The proposed structure for the management team was
presented to Xx. Xxxxxx during the October 28 meeting.
3. FUNDING REQUESTS: The total funds requested for Phase II (projects I, III, IV
and V) of the project are $230,502. This amount includes 25% overhead that will
cover use of the TTUHSC facilities during the funding period.
This budget is not yet related to the *. From this budget, however, certain *
activities will be conducted (i.e., additional * tests, evaluation of a new
method for *, detection of * in HemoTech(TM), etc.).
The detailed budget for each project is presented as attachments 1, 3 and 4.
The budget for Project 2 (transfer of the * pre-clinical and clinical data into
pdf format) * is presented separately (SEE ATTACHMENT 2). The funds for Project
2 ($8,000 - $12,000) will be transferred directly from HemoBioTech, Inc. to EM
Center at TTUHSC (w/o 25% overhead). Xx. Xxxxxx and other members of his Blood
Substitute R&D Team are not HemoBioTech employees and should be reimbursed by
the company for their services. Moreover, Xx. Xxxxxx does not own any
HemoBioTech's stock.
* The information omitted is confidential and has been filed separately with the
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Texas Tech-HemoBioTech Joint Blood Substitute Project.
Phase II: U.S. Patent Extension and Initial IND Stage
Page 5
Since Xx. Xxxxxx and his team members will provide services to the company on a
regular basis, therefore the salaries for the personnel are for 12 months. After
completion of the proposed Phase II of the project the personnel will be
assigned to the next phase of the program.
Xx. Xxxxx Xxxxx, however, as a full time HemoBioTech's employee and no longer
employed by the Texas Tech University System, should not be reimbursed for his
services through this Sponsored Research Agreement.
SUBMITTED BY:
XXX XXXXXX, DVM, PhD
Associate Research Professor of Surgery and Internal Medicine
P.I. of Sponsored Research Agreement
TTUHSC, School of Medicine
Xxxxxxx, XX 00000
SIGNATURE: /s/ Xxx Xxxxxx DATE: 11/18/04
APPROVED BY:
XXXXXXX X. XXXXX, Ph.D.
Associate Vice President for Research and
Associate Xxxx for Research and the Graduate School
Office of Research and the Graduate School, TTUHSC, Xxxxxxx, XX 00000
Signature: /s/ Xxxxxxx X. Xxxxx DATE: 11/19/04
XX. XXXX XXXXXX
Director, Office of Sponsored Programs
TTUHSC, Xxxxxxx, XX 00000
SIGNATURE: /s/ Xxxx Xxxxxx DATE: 11/19/04
XXXXX XXXXXXXX, JD
Director, Office of Technology Transfer and Intellectual Properties
TTU & TTUHSC, Xxxxxxx, XX 00000
SIGNATURE: /s/ Xxxxx Xxxxxxxx DATE: 11/19/04
PROJECT II
ATTACHMENT 1
PROJECT TITLE: The Texas Tech-HemoBioTech Joint Blood Substitute Project.
Phase II: U.S. Patent Extension and Initial IND Stage.
PROJECT DIRECTOR (at HemoBioTech, Inc.): Xx. Xxxxxx X. Xxxxxx
PROJECT PRINCIPAL INVESTIGATOR (at TTUHSC): Xx. Xxx Xxxxxx
DETAILED BUDGET FOR PHASE II OF THE PROJECT
FROM: December 1, 2004 THROUGH: November 30, 2005/(1)
SALARY:
NAME ROLE ON TYPE % DOLLAR AMOUNT REQUESTED
PROJECT APPT EFF SALARY SALARY FRINGE TOTAL
(mo) BASE REQUESTED
SOMONI, Jan P.I. * *% * * * *
XXXXXXX, Xxxx X. Post-doc * *% * * * *
XXXXXX, Xxxxx Med. Res. * *% * * * *
To be hired Animal Tech. * *% * * * *
SALARY SUBTOTALS: * * *
CONSULTANTS * * *
EQUIPMENT (Itemize): *
Phase II of this project will not require any equipment above $*.
However, modern computer (laptop) is needed for data collection and acquisition:
SUPPLIES: (Itemize by category):
* *
* *
* *
* *
* *
* *
* *
* *
* *
* *
* *
TOTAL (including computer)
ALTERATIONS AND RENOVATIONS:
Renovation and sanitation the Texas Tech Blood Substitute Production Facility: *
(the exact cost will be determined later)
Renovation/remodeling of the Animal Blood Donor Facility (New Deal Farm): *
(Cattle Facility Option 2)
OTHER EXPENSES:
Photocopying, postage, phone, secretarial, e-mail/internet connection: *
(Cost of the CMC, pre-clinical, clinical research data transfer into the pdf
file presented separately as Attachment 2)
TRAVEL: For P.I. and co-investigators to travel to company headquarter,
FDA, etc.: *
SUBTOTAL DIRECT COST FOR PHASE II OF THE PROJECT: *
TTUHSC OVERHEAD (25% of 158,002 base-excluding alterations/renovations) *
TOTAL FOR PHASE II: 230,503
/(1) THIS BUDGET REFLECTS THE PROJECT I, III, IV AND V AND IS NOT YET RELATED
TO *
FROM THIS BUDGET, HOWEVER, CERTAIN * ACTIVITIES WILL BE CONDUCTED (I.E.,
ADDITIONAL * TESTS, EVALUATION OF A NEW METHOD FOR *, DETECTION OF * IN
HEMOTECH(TM), ETC). THE EXACT COST OF THE PROJECT II (TRANSFER OF THE *,
PRE-CLINICAL AND CLINICAL RESEARCH DATA INTO PDF FORMAT) IS PRESENTED AS
ATTACHMENT 2 AND FUNDS WILL BE TRANSFERRED DIRECTLY FROM HEMOBIOTECH, INC. TO
EM CENTER AT TTUHSC(W/O OVERHEAD).
* The information omitted is confidential and has been filed separately with the
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
PROJECT II
ATTACHMENT II
DOCUMENT SCANNING AND CONVERSION TO PDF
BASED ON AN ANTICIPATED VOLUME OF * PAGES:
The department of Medical Photography and Electron Microscopy will scan and
convert documents of PDF at the rate of $* to $* per page ($8,000.00 to
$18,000.00). Rate applied will be based on the complexity of scanning and
converting individual documents. We do not believe that actual cost will be the
maximum figure due to the fact that a large majority of the documents will not
be highly complex. However, the final cost will be established after the project
has been completed.
As we discussed during the meeting, Oct 28, 2004; Medical Photography can
provide other services relating to the presentation of IND research data as
required by the FDA. Our unit can also help in the preparation of clinical and
research data during phase one of clinical trial. Such activities will require
the development of a supplemental budget. We are open to other request relating
to electronic documentation, presentation and secure transfer of data generated
through activities at Texas Tech University Health Sciences Center Sponsored
Research Agreement or directly to HemoBio Tech Inc.
DOCUMENT SCANNING/CONVERSION TIMETABLE:
Medical Photography and Electron Microscopy estimates it will take approximately
* to properly scan and convert the anticipated volume, * pages. All documents
will be prepared according to Guidance for Industry Providing Regulatory
Submission is Electronic Format -- General Considerations, U.S. Department of
Health and Human Services Food and Drug Administration.
ADDENDUM: BID ACCEPTANCE, NOVEMBER 18, 2004
IN REFERENCE TO THE HEMOBIO TECH LETTER SENT TO XX. XXX XXXXXX, DATED NOVEMBER
6, 2004.
The department of Medical Photography and Electron Microscopy will perform the
transfer of information to a digital format at the rate of $* to $* per page,
not to exceed $8,000 to $12,000 for documents required to complete Phase II.
Work will begin only after billing and payment procedures have been established
between the department of Medical Photography and Electron Microscopy and
HemoBio Tech. To set up these procedures, please contact:
Xxxx Xxxxxx
Manager -- Medical Photography and Electron Microscopy
Texas Tech University Health Sciences Center
0000 0xx Xxxxxx XXXX 0000
Xxxxxxx, Xxxxx 00000-0000
(000) 000-0000 Office
(000) 000-0000 FAX
xxxx.xxxxxx@xxxxxx.xxx
* The information omitted is confidential and has been filed separately with the
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
PROJECT II
ATTACHMENT 3
RENOVATION AND SANITATION OF THE TEXAS TECH BLOOD SUBSTITUTE
PRODUCTION FACILITY.
The cost should not exceed *.
The renovation and sanitation of the Texas Tech Blood Substitute Production
facility will include:
1) *
2) Replacement of the * chamber
3) Replacement of the * chamber
4) Replacement of * chamber
5) Replacement of * chamber
6) Replacement of the * chamber
7) Replacement of *
8) Replacement of *
9) Replacement of *
The replacement of * and replacement of * * will be included in the HemoTech's
production budget.
* The information omitted is confidential and has been filed separately with the
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
