EXHIBIT 10.4
LICENSE AGREEMENT
This License Agreement, made and entered into this 16th day of
December, 2002, ("Agreement Date") is by and between IMMUNEREGEN BIOSCIENCES,
INC., a Delaware corporation with its principal offices at 8665 E. ▇▇▇ ▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇ ("the Company") on the
one hand, and ▇▇▇▇ ▇. ▇▇▇▇▇▇, Ph.d., an individual having his principal address
at ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇ ("▇▇▇▇▇▇") and ▇▇▇▇▇ ▇▇▇▇▇▇,
Ph.d., an individual having its principal address at ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ ▇▇▇,
▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇ ("▇▇▇▇▇▇"), on the other hand (▇▇▇▇▇▇ and ▇▇▇▇▇▇ are
together the "Licensors").
W I T N E S S E T H :
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WHEREAS, Licensors have developed medical applications using Licensed
and other technologies (as hereinafter defined, "Licensed Technology"), and
holds certain patents and/or other rights with respect to such applications of
Licensed Technology as set forth on Schedule A attached hereto (such rights are
sometimes hereinafter referred to as the "Licensed Proprietary Rights"); and
WHEREAS, the Company desires to obtain the exclusive license to use
and sublicense the Licensed Proprietary Rights to develop methods, procedures
and products that utilize the Licensed Technology; and
WHEREAS, the Company and Licensors wish to enter into an agreement
pursuant to which Licensors will grant to the Company an exclusive license to
the Licensed Proprietary Rights subject to the terms set forth herein;
NOW, THEREFORE, for and in consideration of the promises set forth
herein and other good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the parties hereto expressly agree as follows:
SECTION 1. DEFINITIONS.
1.1 "Affiliate" shall mean, with respect to any person, any other person that,
directly or indirectly, through one or more intermediaries, controls, is
controlled by, or is under common control with such person. For purposes of this
definition, "control" means the possession, directly or indirectly, of the power
to direct or cause the direction of management and policies of a person, whether
by ownership or voting securities, by contract, or otherwise.
1.2 "Licensed Product(s)" shall mean any product or medical application which
incorporates or utilizes the Licensed Proprietary Rights, including, but not
limited to, the Company Products (as hereinafter defined).
1.3 "The Company Application Ideas" shall mean ideas for products or medical
applications incorporating or utilizing the Licensed Technology initially
conceived by the Company.
1.4 "The Company Products" shall mean any product or medical application which
incorporates or utilizes the Licensed Technology arising from the Company
Application Ideas.
1.5 "Licensed Technology" shall mean all patents held by the Licensors relating
to the utilization of Sar9, Met(o2)11-substance P, a naturally occurring
immunomodulaor and or Homspera in the applications of revitalizing and
stimulating the immune system with regards to acute respiratory disease
syndrome, cigarette smoking, AIDS and anti-aging as contemplated in the
Investment Overview attached hereto as Schedule B.
1.6 "Sublicensee(s)" shall mean any person that is not an Affiliate of the
Company to which the Company grants a sublicense to the Licensed Proprietary
Rights or any part thereof to make, have made, use, market or sell Licensed
Products for human or animal use.
1.7 "Sublicense Agreement" shall mean any agreement between the Company and a
third party in which the Company grants the third party a right to the Licensed
Proprietary Rights or any part thereof to make, have made, use, market or sell
Licensed Products for human or animal use.
SECTION 2. LICENSE.
2.1 In consideration for the issuance to the Licensors of an aggregate of
9,250,000 shares of the Company's Common Stock, and subject to all of the terms
and conditions of this License Agreement, Licensors hereby grants to the Company
an exclusive royalty-free, license to the Licensed Proprietary Rights throughout
the United States and the world, with the right to make, have made, use, market,
and sell Licensed Products and to grant sublicenses pursuant to Sublicense
Agreements.
SECTION 3. SUBLICENSEES.
3.1 The Company shall give Licensors prompt notification of the identity and
address of each Sublicensee with whom it concludes a Sublicense Agreement and
shall supply Licensors with a copy of each Sublicense Agreement.
3.2 The Company shall not grant any rights which are inconsistent with the
rights to and obligations of the Company hereunder.
3.3 No Sublicense Agreement shall contain any provision which would cause it to
extend beyond the term of this License Agreement.
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SECTION 4. COMPANY'S AND LICENSORS' DUTIES.
4.1 BEST EFFORTS. The Company shall use reasonable efforts to protect any
patents issued with respect to the Licensed Proprietary Rights and/or Licensed
Products. The Company shall be responsible for all regulatory affairs,
financing, pilot manufacturing, clinical studies and licensing in connection
with the Licensed Proprietary Rights and/or Licensed Products.
4.2 CONFIDENTIALITY. The Company agrees to use reasonable efforts (which shall
be at least as great as the efforts it uses to maintain the confidentiality of
its own confidential information) to maintain the Licensed Proprietary Rights in
confidence, and to use the Licensed Proprietary Rights only in accordance with
this License Agreement. Such obligation of confidentiality shall not apply to
information which the Company can demonstrate: (i) was at the time of disclosure
in the public domain; (ii) has come into the public domain after disclosure
through no fault of the Company or its Affiliates; (iii) was known to the
Company or its Affiliates prior to disclosure thereof by Licensors; or (iv) was
lawfully disclosed to the Company or its Affiliates without obligation of
confidence by a third party which was not under an obligation of confidence to
Licensors with respect thereto. The foregoing obligations of confidentiality
shall survive termination of this License Agreement.
4.3 INSURANCE. Upon the granting by the FDA to the Company of the first PMA to
market a Licensed Product, the Company and/or its Affiliates as applicable,
shall, for so long as the Company or its Affiliates sell any Licensed Products,
maintain in full force and effect policies of general liability insurance (with
Broad Form General Liability and Product Liability endorsements) with limits of
not less than one million dollars ($1,000,000) per occurrence and one million
dollars ($1,000,000) annual aggregate. Upon request by Licensors, the Company
shall provide a certificate evidencing the coverage maintained which shall also
provide that Licensors receive no less than thirty (30) days prior written
notice of any change in or cancellation of such coverage.
4.4 LICENSORS' BEST EFFORTS. Licensors shall be responsible for concept, proof
of concept, preclinical studies, successful prosecution of pending patent
applications, scientific knowledge and presence in connection with development
and promotion of the Licensed Proprietary Rights and/or Licensed Products and
shall use its reasonable best efforts to affect said responsibilities.
SECTION 5. PATENTS AND INFRINGEMENT.
5.1 WARRANTY. Licensors warrants that they are the owners of the Licensed
Proprietary Rights, that they have the right to convey the license set forth in
Section 2.1 hereof, and that the Company's use of such Licensed Proprietary
Rights in accordance with the terms of this License Agreement shall not infringe
upon any U.S. or foreign patents, trade secrets, or other proprietary right of
any third party according to the Licensors' present knowledge.
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5.2 INDEMNIFICATION. Licensors agree, jointly and severally, to defend,
indemnify and hold harmless the Company from and against any claim, suit, demand
or action alleging that the Company' use of the Licensed Proprietary Rights
infringes upon a U.S. or foreign patent, trade secret, or other proprietary
right of any third party according to the Licensors' present knowledge, and
Licensors shall, jointly and severally, indemnify the Company against all costs,
expenses, and damages arising from any such claim, suit, demand or action;
provided, however, that (1) the Company shall have given Licensors prompt
written notice of such claim, suit, demand, or action; (2) the Company shall
cooperate with Licensors in the defense and settlement thereof; and (3)
Licensors shall have control of the defense of such claim, suit, demand or
action and the settlement or compromise thereof.
5.3 INFRINGEMENT BY THIRD PARTY. If it is believed in good faith that the
Licensed Proprietary Rights are infringed by a third party, the party to this
License Agreement first having knowledge of such infringement shall promptly
notify the other in writing, which notice shall set forth the facts of such
infringement in reasonable detail. The Company shall have the right, but not the
obligation, to institute and prosecute at its own expense any infringement of
the Licensed Proprietary Rights. If the Company fails to bring such action or
proceedings within a period of three (3) months after receiving written notice
or otherwise having knowledge of such infringement, then Licensors shall have
the right, but not the obligation, to prosecute at their own expense any
infringement of the Licensed Proprietary Rights. Any recovery of damages and
costs in such suits shall be the property of the party bringing action or
proceeding.
SECTION 6. LICENSED PRODUCTS.
6.1 DISCLAIMER OF RESPONSIBILITY. Neither of the Licensors nor any of their
trustees, officers, employees, or agents assume any responsibility for the
manufacture, product specifications, or use of the Licensed Products which are
manufactured by or for, or sold by, the Company, its Affiliates or its
Sublicensees. All warranties in connection with the Licensed Products shall be
made by the Company or the particular Affiliate or Sublicensee as the
manufacturer or seller thereof and none of such warranties shall directly or by
implication in any way obligate Licensors or its employees, or agents.
6.2 DISCLAIMER OF WARRANTY. Neither of the Licensors makes any warranties or
representations, expressed or implied, regarding Licensed Products, including,
but not limited to, warranties of fitness and merchantability.
6.3 INDEMNITY. Each party shall notify the other of any claim, lawsuit or other
proceeding related to the Licensed Products. Subject to the provisions of the
last sentence of this Section and Section 6.2, the Company agrees that it will
defend, indemnify and hold harmless Licensors, and each of their employees,
officers, directors, and agents (the "Indemnified Parties"), from and against
any and all claims, causes of action, lawsuits or other proceedings filed or
otherwise instituted against the Indemnified Parties by third parties related
directly or indirectly to Licensed Products produced by the Company or its
Affiliates. The Company will also assume
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responsibility for all costs and expenses related to such claims and lawsuits
for which it is obligated to indemnify the Indemnified Parties pursuant to this
Section, including, but not limited to, the payment of all reasonable attorneys'
fees and costs of litigation or other defense. Each of the Licensors shall
promptly notify the Company of any such claim or action related to the Licensed
Products and the Company shall have the right to control the defense, settlement
or compromise thereof.
SECTION 7. TERMINATION OF LICENSE AGREEMENT.
7.1 TERM OF LICENSE AGREEMENT. Unless earlier terminated as hereinafter provided
in Section
7.2, this License Agreement shall terminate ten (10) years after the date of the
expiration of the last patent issued or issuing with respect to the Licensed
Proprietary Rights.
7.2 EARLY TERMINATION. In the event of the default or failure by either party to
perform any of the terms, covenants or provisions of this License Agreement to
be done and performed by such party, the non-performing party shall have sixty
(60) days after the giving of written notice by the performing party of such
default within which to correct such default. If such default is not corrected
within the said cure period, the performing party shall have the right, at its
option, to cancel and terminate this License Agreement. In the event of
termination of this License Agreement all rights licensed by Licensors to the
Company hereunder shall revert to Licensors.
7.3 NO WAIVER. Termination of this License Agreement shall not constitute a
termination or a waiver of any rights of either party against the other party
accruing at or prior to the time of such termination.
SECTION 8. AUTHORITY TO ENTER LICENSE AGREEMENT.
8.1 LICENSOR. Each of the Licensors has full power and authority to enter into
this License Agreement, and has duly authorized by all necessary action its
execution and delivery of this License Agreement. The execution, delivery and
performance of this License Agreement by each of the Licensors will not result
in a breach of or constitute a default under any governing document, or any
agreement, instrument, order or law applicable to each Licensor or by which it
is bound or require the consent of any person or entity.
8.2 THE COMPANY. The Company is duly incorporated, organized and existing in
good standing under the laws of its jurisdiction of incorporation, has full
power and authority to enter into this License Agreement, and has duly
authorized by all necessary corporate action its execution and delivery of this
License Agreement. The execution, delivery and performance of this License
Agreement by the Company will not result in a breach of or constitute a default
under any corporate governing document, or any agreement, instrument, order or
law applicable to the Company or by which it is bound or require the consent of
any person or entity.
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SECTION 9. MISCELLANEOUS PROVISIONS.
9.1 NO WAIVER. The failure of any party to enforce at any time or times any of
the provisions of this License Agreement or any rights in respect thereto, or to
exercise any election herein provided, shall in no way be a waiver of such
provision, right or election, or in any way affect the validity of this License
Agreement. Exercise by any party of any of its rights herein or any of its
elections under the terms and covenants herein shall not preclude any party from
exercising the same or any other rights in this License Agreement irrespective
of any previous action or proceeding taken by any party hereunder. The waiver by
any of the parties of any breach of any provision hereof shall not be construed
to be a waiver of any succeeding breach of such provision or a waiver of the
provision itself.
9.2 SEVERABILITY. If any provision of this License Agreement is determined
judicially or in an arbitration proceeding to be void or unenforceable, such
provision shall be deemed to be severable from the other provisions of this
License Agreement which shall remain in full force and effect. Any party may
request that a provision otherwise void or unenforceable be reformed so as to be
valid and enforceable to the maximum extent permitted by law.
9.3 FORCE MAJEURE. No liability hereunder shall result to a party by reason of
delay in performance caused by circumstances beyond the reasonable control of
the party, sometimes referred to as force majeure, including without limitation,
acts of God, fire, flood, war, civil unrest, labor unrest, or shortage of or
inability to obtain material or equipment.
9.4 ENTIRE AGREEMENT. The terms and conditions herein constitute the entire
License Agreement between the parties relating to the Licensed Proprietary
Rights and shall supersede all previous agreements, either oral or written,
between the parties hereto with respect to the subject matter hereof.
9.5 MODIFICATION. No party shall be bound by any agreement, covenant or warranty
made by its agents or employees, or any other persons, unless such agreements,
covenants and warranties shall be reduced to writing and signed by a duly
authorized officer or representative of each party and shall expressly refer to
this License Agreement.
9.6 GOVERNING LAW. This License Agreement shall be construed according to the
laws of the State of Delaware and any and all disputes arising hereunder shall
be resolved in the courts of the State of Delaware; provided, however, that any
patent question or controversy shall be resolved in the court having
jurisdiction over such patent or patents and in accordance with the laws
applicable to such patent or patents.
9.7 NOTICES. All notices, requests, instructions, consents and other
communications relating to this License Agreement shall be in writing and shall
be deemed delivered when personally delivered, received by telex, telecopier or
other means of facsimile transmission, or three (3) days after such notice was
deposited in the mail, certified, first class or airmail postage pre-paid,
addressed to the receiving party at the address specified on the first page of
this License
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Agreement, or at such other address as the receiving party has previously
notified the other party hereto in the manner required for delivery of notices
under this Section.
9.8 HEADINGS. The headings of sections and subsections have been included for
convenience only and shall not be considered in interpreting this License
Agreement.
9.9 COUNTERPARTS. This License Agreement may be executed in one or more
counterparts, each of which shall be deemed to be original, and all of which
together shall constitute one and the same License Agreement.
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IN WITNESS WHEREOF, the parties hereto have caused this License
Agreement to be executed by their duly authorized corporate officers as of the
Agreement Date.
"LICENSORS"
/S/ ▇▇▇▇ ▇. ▇▇▇▇▇▇ 12-20-02
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▇▇▇▇ ▇. ▇▇▇▇▇▇, Ph.d.
/S/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇, PHD 12/20/02
-------------------------------------------
▇▇▇▇▇ ▇▇▇▇▇▇, Ph.d.
IMMUNEREGEN BIOSCIENCES, INC.
By: /S/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
--------------------------------------
Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Title: President
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SCHEDULE A
Licensed Proprietary Rights
-------------- ------------ ----------------- ------------ --------------- ------------- ------------ ----------------
Docket No. Country Title Status Application No. Filing Date Grant No. Grant Date
-------------- ------------ ----------------- ------------ --------------- ------------- ------------ ----------------
00003 U.S. Amelioration of Filed 60/406036 8/27/02
effects of
cigarette
-------------- ------------ ----------------- ------------ --------------- ------------- ------------ ----------------
05299 U.S. Substance P Granted 08/829445 3/28/97 5944508 8/31/99
treatment
-------------- ------------ ----------------- ------------ --------------- ------------- ------------ ----------------
U.S. Substance P Filed 12/18/02
Enduces Hair
Growth
-------------- ------------ ----------------- ------------ --------------- ------------- ------------ ----------------
73958 U.S. Substance P Granted 09/028003 2/23/98 5998376 12/07/99
treatment
-------------- ------------ ----------------- ------------ --------------- ------------- ------------ ----------------
78273 AU Substance P Granted 4064/97 7/08/97 73721 06/29/01
treatment (acceptance)
-------------- ------------ ----------------- ------------ --------------- ------------- ------------ ----------------
78274 CA Substance P Filed 2261885 7/08/97
treatment
-------------- ------------ ----------------- ------------ --------------- ------------- ------------ ----------------
78275 EP Substance P Filed 979380490 7/08/97
treatment
-------------- ------------ ----------------- ------------ --------------- ------------- ------------ ----------------
SCHEDULE B
Investment Overview
IMMUNEREGEN BIOSCIENCES, INC.
▇▇▇▇ ▇. ▇▇▇ ▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇-▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
(▇▇▇) ▇▇▇-▇▇▇▇
(▇▇▇) ▇▇▇-▇▇▇▇
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ImmuneRegen BioSciences, Inc. ("we," "us," or ----------------------------
the "Company"), a Delaware corporation, is a INITIAL USES FOR SUBSTANCE P
biotechnology company engaged in the research REVERSING LUNG DAMAGE
and development of applications utilizing TREATMENT FOR ARDS
substance P, a naturally occurring TREATMENT FOR CANCER
immunomodulator. Over the past 11 years, we TREATMENT FOR FOOD POISONING
have achieved significant breakthroughs SLOWING THE AGING PROCESS
relating to the use of substance P in the TREATMENT FOR AIDS
reversal of lung damage and the stimulation of ANTI-TERRORISM
suppressed or failing immune systems. We ----------------------------
currently hold 2 patents and 1 provisional
patent in the United States. Additionally, we hold a patent with the European
Union and Australia and are seeking to extend our patents into Canada and,
possibly, Japan.
Based on our initial research findings, we believe that we can use substance P
to provide viable and exciting applications for: 1) dramatically lessening lung
damage caused by cigarette smoking; 2) the treatment of widespread illnesses
including acute respiratory disease syndrome (ARDS), AIDS and food poisoning; 3)
the treatment of lung and other cancers; 4) slowing the aging process; and, 5)
protecting against and treating the effects of weapons of terrorism.
We are currently seeking funding to continue our research and development,
obtain additional patents and perform the required FDA trials of our current and
proposed products and applications.
INVESTMENT HIGHLIGHTS
o WE HAVE PERFORMED EXTENSIVE RESEARCH STUDIES USING SUBSTANCE P TO TREAT
DAMAGE CAUSED TO THE LUNGS AND THE IMMUNE SYSTEM FROM JET FUEL EXPOSURE.
WE HAVE APPLIED THE SAME PRINCIPLES AND PROCEDURES TO LUNG DAMAGE CAUSED
BY CIGARETTE SMOKE AND HAVE HAD SIMILAR POSITIVE RESULTS. WE CURRENTLY
HAVE A PROVISIONAL PATENT IN EFFECT COVERING THESE EXCITING FINDINGS AND,
DEPENDING ON RESULTS, EXPECT TO FILE FOR A FULL PATENT WITHIN THE YEAR.
o WE HAVE OBTAINED GLOBAL PATENTS BASED ON USING SUBSTANCE P AS AN
INHALATION AEROSOL THERAPY FOR THE STIMULATION OF THE IMMUNE SYSTEM. WE
EXPECT TO BUILD UPON THESE PATENTS, LEADING TO THE DEVELOPMENT OF A WIDE
ARRAY OF NEW APPLICATIONS, INCLUDING TREATMENTS FOR REVERSING LUNG DAMAGE
CAUSED BY CIGARETTE SMOKE, ARDS, AIDS, CANCER, FOOD POISONING AND SLOWING
THE AGING PROCESS.
o THE FDA "FAST-TRACK" APPROVAL OF SUBSTANCE P USE FOR THE TREATMENT OF ARDS
IS EXPECTED WITHIN 6 TO 12 MONTHS AFTER FUNDING. THE APPROVAL OF OTHER
USES FOR SUBSTANCE P, INCLUDING AIDS AND CANCER TREATMENT, TO FOLLOW
SHORTLY THEREAFTER.
o WE HAVE BEEN AND CONTINUE TO WORK WITH THE DEPARTMENT OF DEFENSE TO
CONDUCT STUDIES ON THE EFFECTS OF SUBSTANCE P AS A COUNTERMEASURE AGAINST
BIOLOGICAL, CHEMICAL AND RADIOACTIVE WARFARE AGENTS.
o WITH A POTENTIAL WORLDWIDE MARKET OF OVER 4 BILLION PEOPLE, REVENUES COULD
EXCEED $100 MILLION WITHIN 5 YEARS.
o REVENUE STREAMS FROM LICENSE AGREEMENTS IN EUROPE ARE EXPECTED TO BEGIN
WITHIN 6-12 MONTHS. DOMESTIC REVENUES TO BEGIN SHORTLY AFTER FDA APPROVAL.
o WE HAVE A STRONG MANAGEMENT TEAM WITH EXTENSIVE EXPERIENCE IN RESEARCHING,
DEVELOPING AND DESIGNING NEW APPLICATIONS IN BIOTECHNOLOGY.
SUBSTANCE P
[GRAPHIC OMITTED] [GRAPHIC OMITTED]
Substance P is an 11-amino acid neurotransmitter found in central and peripheral
nerves. Substance P has been extensively studied by scientists because of its
many general physiological effects, such as smooth muscle contraction,
inflammation, neurotransmission, blood vessel dilation, histamine release and
immune system growth factor properties.
Our patents and continued substance P research are derived from discoveries made
during research funded by the Air Force Office of Scientific Research in the
early 1990s. During this research ImmueRegen founders, Drs. ▇▇▇▇▇▇ and ▇▇▇▇▇▇,
observed that exposure of animals to jet fuels resulted in pathological changes
in the lung and immune systems of the exposed animals. It was also observed that
the jet fuel exposure resulted in depletion of substance P from the lungs of the
animals. Studies showed that substance P prevented and reversed the effects of
jet fuel exposure in the lungs as well as protected and regenerated the immune
system. The surprising immune findings led to early research on reversal of lung
damage caused by cigarette smoke and the anti-cancer effects of substance P
therapy, with similar positive results.
A synthesized version of substance P is readily available at low cost from
several life science and technology companies that provide biochemical and
organic chemical products and kits used in scientific and genomic research,
biotechnology, pharmaceutical development and the diagnosis of disease and
chemical manufacturing. One such company is Sigma Chemical Company.
PRODUCTS
Our products will use substance P for the treatment of various high-profile
diseases and provide methods for:
o Preventing the pathological effects of cigarette smoking on the lungs
(e.g., cancer and emphysema);
o Reducing the risk of cancer development;
o Prevention of the spread and metastasis of cancer;
o Enhancing an immune response to a bacterial infection (e.g., food
poisoning by salmonella);
o A prophylactic method for preventing a decrease in activity of an
individual's immune system (e.g., anti-aging);
o Stimulating the immune system of those with depleted or depressed immune
systems (e.g., AIDS); and,
o Enhancing an immune response to a viral infection.
Our products will use an inhaler (puffer) device to deliver substance P to the
user. To develop, manufacture and test an inhaler device we will partner with a
full-service drug development and chemical services company that offers services
ranging from pre-clinical and toxicology studies to clinical trial support and
manufacturing services. Such a partnership will enable us to decrease the
time-to-market for our products and to increase our productivity.
Furthermore, we anticipate entering into strategic partnerships with identified
industry leaders in the pharmaceutical and medical device industries for
application-specific sales and distribution of our techniques and products. Our
aim is to establish relationships with industry leaders, both domestic and
international, which represent the broadest market appeal for our specific
products and techniques. This will have the effect of generating revenues in
under twelve months after funding in the form of license agreements with
companies in Europe and other countries, while awaiting FDA approval for sales
in the United States to begin.
We are investigating obtaining a fast track status for substance P though the
FDA process as a treatment for ARDS. The "FAST TRACK" designation is an
important accelerated phase in the nation's drug review and approval process,
which signifies that the FDA can expedite the review and development of a drug
candidate considered a breakthrough to treat a deadly disease. Once substance P
has been approved by the FDA for the treatment of ARDS, approval for additional
uses can be obtained much more quickly and at less cost.
MARKET
We believe that there is a potential market of over 4 billion people worldwide
for substance P treatments. We estimate that there are (i) 1.5 billion people
suffering from induced lung damage due to smoking and polluted air conditions;
(ii) 750 million people each for cancer and Salmonella food poising; (iii) 1.5
billion people at risk of influenza-induced lung injury; (iv) 250 million people
with AIDS; and, (v) 10 million people with ARDS. Furthermore, we anticipate that
a majority of these potential markets for substance P analog therapy can be
realized within the next 3 to 5 years. The revenue potential for the ImmuneRegen
BioSciences could exceed $100 million over the next 5 years and accelerate
rapidly thereafter.
MANAGEMENT
We have assembled an experienced management team and advisory board to guide us
through our first stage of development.
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, CHIEF EXECUTIVE OFFICER & FOUNDER.
▇▇. ▇▇▇▇▇▇▇ has been in the financial industry since 1990. Initially, ▇▇.
▇▇▇▇▇▇▇ established his career as a broker and financial advisor. Shortly
thereafter, ▇▇. ▇▇▇▇▇▇▇ accepted management positions for firms such as ▇▇▇▇▇▇
Securities where he was involved in opening and managing branch offices. While
raising money through private placements and initial public offerings at these
firms, ▇▇. ▇▇▇▇▇▇▇ became frustrated in not having the ability to gain a true
understanding of the various companies, their products, management and industry.
This led to his eventual departure from the brokerage business and since 1994
has effectively worked with early stage companies. ▇▇. ▇▇▇▇▇▇▇ eventually formed
Foresight Capital Partners. At Foresight Capital Partners ▇▇. ▇▇▇▇▇▇▇ has
enjoyed much success in identifying early stage companies with above average
growth potential and helping them reach the next stage of development. In
working with these companies, ▇▇. ▇▇▇▇▇▇▇ provides advisory services, often
taking a seat on the board of directors, and financing, occasionally incubating
the company. Furthermore, ▇▇. ▇▇▇▇▇▇▇ has been successful in facilitating the
raise of several million dollars through private financings for these companies,
including Isolagen Technologies, Inc. (OTCBB: ISLG), a biotechnology company. In
working with Isolagen, ▇▇. ▇▇▇▇▇▇▇ was a critical asset in turning the company
around, obtaining the necessary advisory and capital commitments to allow FDA
clinical trials to begin on their product.
▇▇▇▇ ▇. ▇▇▇▇▇▇, PH.D., DIRECTOR, FOUNDER & RESEARCH SCIENTIST.
▇▇. ▇▇▇▇▇▇ is a Research Professor and Director of the ▇▇▇▇ ▇. and ▇▇▇▇▇▇ ▇.
▇▇▇▇▇▇▇ Lung Injury Laboratory in the Department of Pediatrics at the University
of Arizona College of Medicine. ▇▇. ▇▇▇▇▇▇ obtained his Ph.D. degree
from Indiana University in 1983 with a double major in physiology and exercise
physiology. He conducted a post-doctoral fellowship in Respiratory Sciences at
The University of Arizona College of Medicine from 1983 to 1988. He then spent 2
years as an Assistant Biologist at Massachusetts General Hospital and Instructor
in Medicine at Harvard Medical School. He returned to The University of Arizona
College of Medicine in 1990. He has authored over 200 published manuscripts,
book chapters and abstracts
▇▇▇▇▇ ▇. ▇▇▇▇▇▇, PH.D., DIRECTOR, FOUNDER & RESEARCH SCIENTIST.
▇▇. ▇▇▇▇▇▇ is a Professor in the Department of Microbiology and Immunology in
the College of Medicine at The University of Arizona. ▇▇. ▇▇▇▇▇▇ obtained his
Ph.D. degree from Wake Forest University in 1982 with a major in microbiology
and immunology. After 3 years of post-doctoral fellowship (1982-1985) in
immunology at the ▇▇▇▇▇▇ Institute for Cancer Research in Lausanne, Switzerland,
▇▇. ▇▇▇▇▇▇ became a Research Assistant Professor in the College of Medicine at
the University of North Carolina-Chapel Hill. In 1989, ▇▇. ▇▇▇▇▇▇ moved to The
University of Arizona College of Medicine. ▇▇. ▇▇▇▇▇▇ is also Director of the
Stem Cell Bank and Chief Science Officer for Cord Blood Registry, Inc. He is
also Head of the Gene Therapy Group. ▇▇. ▇▇▇▇▇▇ is a co-inventor with Dr, ▇▇▇▇▇▇
on the substance P patents and also holds 3 additional U.S. patents. ▇▇. ▇▇▇▇▇▇
has authored more than 200 published papers, book chapters and abstracts. ▇▇.
▇▇▇▇▇▇ has extensive experience in start-up biotechnology companies, having
established the first stem cell bank in the world in 1992. That company,
initially started at the University of Arizona, was "spun-off" in 1996 into what
is now known as Cord Blood Registry, Inc. Cord Blood Registry is the largest
for-profit, private stem cell bank in the world with annual revenues exceeding
$20 million annually and has successfully completed a $20 million second round
of private financing. ▇▇. ▇▇▇▇▇▇ remains the Chief Science Officer and Member of
the Scientific Advisory Board. Furthermore, ▇▇. ▇▇▇▇▇▇ has extensively consulted
for a number of biotechnology companies.
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇, PHD, FACMG, CHIEF SCIENCE OFFICER.
▇▇. ▇▇▇▇▇▇▇▇▇▇ has been an Associate Professor at the University of New Mexico
in the Department of Pathology since 1997. ▇▇. ▇▇▇▇▇▇▇▇▇▇ obtained her Ph.D.
degree in animal physiology from Kent State University. ▇▇. ▇▇▇▇▇▇▇▇▇▇ has
received certification from the American Board of Medical Genetics, Diplomate in
Clinical Cytogenetics (1987; #870107) and the New York State Department of
Health, Certificate of Qualification as Laboratory Director in Cytogenetics. ▇▇.
▇▇▇▇▇▇▇▇▇▇ has had several professional appointments in clinical cytogenetics
including Laboratory Director of University of New Mexico/TriCore Reference
Laboratories, Laboratory Director for Genzyme Genetics, Laboratory Director for
the Laboratory for Genetic Services, and Laboratory Director for Vivigen, Inc.
She has authored numerous published manuscripts, book chapters and abstracts.
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, SECRETARY.
▇▇. ▇▇▇▇▇▇▇ has worked in the investment banking sector of the financial
services industry since 1993, specializing in public financings and private
placements, including institutional 144 and non-arbitrage Regulation D private
placements of debt and equity for private and public companies. Currently, ▇▇.
▇▇▇▇▇▇▇ is the lead investment banker for First Financial Equity Corporation.
His corporate finance experience has focused on generating, analyzing,
structuring and placing middle-market based finance transactions. Previously,
▇▇. ▇▇▇▇▇▇▇ was a Vice President of WestPark Capital, Inc., a specialized
investment banking firm based in Southern California. Prior to his work with
WestPark Capital, he was an equity analyst and investment banker for ▇▇▇▇▇▇
▇▇▇▇▇▇▇ & Associates, Inc. and EBI Securities, Inc.
ADVISORY BOARD
▇▇▇▇▇ ▇. ▇▇▇▇▇▇, PH.D.
▇▇. ▇▇▇▇▇▇ is a Professor in the Department of Pharmacology and Experimental
Therapeutics at the Boston University School of Medicine. ▇▇. ▇▇▇▇▇▇ obtained
her Ph.D. degree in physiology from Radcliffe College in 1958. ▇▇. ▇▇▇▇▇▇ was
the first scientist to isolate substance P in the central nervous and
gastrointestinal systems. ▇▇. ▇▇▇▇▇▇ has authored over 150 peer-viewed
manuscripts and book chapters. ▇▇. ▇▇▇▇▇▇ was elected to the National Academy of
Sciences in 1991.
▇▇▇▇▇▇ ▇. ▇▇▇▇, M.D.
▇▇. ▇▇▇▇ is a Professor of Internal Medicine and Associate Head of the
Deptartment of Internal Medicine in the College of Medicine at the University of
Arizona. ▇▇. ▇▇▇▇ is also the Past-President of the American Academy of Sleep
Medicine. ▇▇. ▇▇▇▇ obtained his M.D. degree at the University of California-San
Francisco in 1974. He has authored more than 90 peer-reviewed manuscripts and
book chapters. ▇▇. ▇▇▇▇ has also served on the board of directors of other
early-stage biotechnology companies.
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇, M.D.
▇▇. ▇▇▇▇▇ is a Professor of Medicine at Harvard University Medical School and
Head of the Pulmonary & Critical Care Medicine Unit at Massachusetts General
Hospital. ▇▇. ▇▇▇▇▇ has authored more than 125 peer-reviewed manuscripts and
book chapters, and is an internationally recognized expert in pulmonary and
critical care medicine.
▇▇▇▇▇ ▇. ▇▇▇▇▇, ▇.▇., PH.D.
▇▇▇▇▇ ▇▇▇▇▇ is a partner in the Banner & Witcoff, Ltd. Intellectual property
legal firm in Washington, D.C. She holds a Ph.D. degree in molecular biology
from the University of Wisconsin (1981) and a ▇.▇. degree from ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
University (1988). Her professional memberships include the American Bar
Association, Women's Bar Association of the District of Columbia, and the
American Intellectual Property Law Associations.
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇, B.A.
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ is the former Director of Federal Relations for The University
of Arizona for the past 15 years. Before she held her position at The University
of Arizona, she was Chief of Staff for Congressman ▇▇▇▇▇▇▇ ▇▇▇▇ of Michigan for
20 years. ▇▇. ▇▇▇▇▇▇▇▇▇▇ has many contacts within the state of Arizona and on
Capital Hill that will facilitate the development of the corporation.
USE OF PROCEEDS
Our initial fund raising efforts will be focused on raising approximately
$500,000.00. We anticipate that such proceeds will be used to perform additional
testing on substance P and our current projects, salaries and professional fees
and general working capital needs. Investors are advised that the Board of
Directors has sole discretion as to the actual use of proceeds received. The
following table provides additional detail regarding the use of proceeds.
Costs associated with our research and development within the first 12 months.
We plan to undertake the following initiatives simultaneously:
Finalize our current studies and perform additional studies relating to the
use of substance P to treat ARDS. We expect to submit our findings to the
FDA within 6 to 12 months of funding.
Perform additional testing on the effects of substance P used in conjunction
with damaged lungs due to cigarette smoke. Tests will be performed on
damaged lung tissue to demonstrate pre- versus post-exposure to substance
P. We currently have a provisional patent in effect and depending on
results, we expect to file for a full patent within the year.
Complete the study (approximately six months) on substance P and the effects
of slowing of the aging process by boosting the immune system to combat
internal breakdowns.
Further refine the administration of substance P, analyzing the effects of
differing doses and concentrations over varying periods of time using
various delivery methods.
Complete studies on the toxicity of substance P in terms of maximum tolerated
dosage in conjunction with route of delivery. Studies to be performed to
show the effects on normal individuals, as well as on those who suffer from
allergies, asthma and other common ailments.
Further the current study on the effects of
substance P on cancerous cells. $ 175,000
Salaries and professional consulting fees. The funds will
be used to pay for a CEO, CFO, FDA Consultant, COO/CSO
Lab Director, two lab technicians, founder research,
legal costs, marketing, web presence and office related
expenses. 275,000
Marketing-presentations and related travel expenses 25,000
Working capital 25,000
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Total Use of Proceeds $ 500,000