2. Contents (will be edited upon document completion)
SummaryPage 3
. Products and ServicesPage 4
. Intellectual PropertyPage 4
. Using Microgravity in Space to research biology
. Accelerated Evolution
. Plants, animals and humans
. Company Status & Plan OverviewPage 6
. MarketingPage 6
. Initial Plans
. Market Development
. Potential ZGI ApplicationsPage 7
. Licensing, Sale, or ManufacturingPage 8
. Barriers to Market Entry by Competitors Page 8
. Company Personnel and ResourcesPage 9
. Company Operations Plan Page 16
. Organizational Authorities & Responsibilities
. Principle Functions
. Marketing
. Research & Development
. Intellectual Property SpecificsPage 19
. Investment RequirementsPage 20
. Return On InvestmentPage 20
. Exit StrategyPage 21
Appendices Page 22
I. Overview, Figures & Notes
II. Budget Details
III. Notes on Technology Validation
EXECUTIVE SUMMARY
Biology and evolution on Earth have developed over nearly 3.8 billion years. In that time, life has
developed from very simple amino acids and pseudo-proteins, to multi-cellular mammals, as
complex as the one now reading this document.
3. In all of these eons of time, almost everything about the environment on Planet Earth has changed;
it has been alternatively hot, cold, wet and dry, as well as having to adapt to other changes, such as
the chemical constitution of our atmosphere. We say almost everything has changed because there
has always been one constant during life’s long development on Earth; gravity or more commonly,
1G. Take away gravity and life systems change quite drastically, at the cellular and even molecular
level.
Our founder, John W. Kennedy, realized some time ago that, in microgravity, some of the changes
that occur, in living systems, might change in ways advantageous to humans. He pursued this idea
by acquiring a Space Act Agreement with NASA, which led to six successful flights into space on
the Space Shuttle and to the International Space Station. In conjunction with the most qualified
scientists at the University of Florida, John was able to prove his hypothesis that, evolution of cells
could be accelerated in space, and that plant and then animal cells, could be “pushed” toward
characteristics that would be both useful and advantageous to humans back on Earth.
Kennedy’s umbrella patent pending application has since grown to become five patents pending,
potentially highly profitable to the agriculture and energy industries (to visualize the technologies
capabilities imagine an orange tree, frost resistant, so that it might flourish in colder climes, like
Virginia, or perhaps rice, able to be harvested from sea water, potentially tripling the global crop).
Each new variety developed can be patented.
The second part of our umbrella patent involves the ability to stop stem cell differentiation,
resulting in large scale replication of both plant and animal stem cells; this process again, only
possible in the microgravity environment. Scientific proof of concept, bearing out all of JWK’s
hypotheses, is about to be published as a scientific paper, by Dr. Wagner Vendrame, of the
University of Florida.
Our proposal describes the plan for ZGI technology, development and marketing, aimed at
technology licensing – our baseline approach -- or the possibility of founding a stem cell or viable
plant sales company, eventually to evolve to animal cells, then human stem cells, to support the
revolution in regenerative medicine.
In order to complete all of our IP development, produce our first commercial stem cells in bulk,
ready for sale, and move forward toward identifying new commercial candidate cells for
commercialization, we seek funding, over two years; first year at $1,500,000, second at $2,500,000.
ZGI Inc. / John Wayne Kennedy is a certified NASA ISS-National Lab "Pathfinder" firm. A
Virginia based C Corp, incorporated in Delaware 2006, by John W. Kennedy.
I. PRODUCTS AND SERVICES
ZGI is the recipient of a NASA Space Act Agreement and as such has been designated a NASA
“ISS Pathfinder” company. Armed with this and its intellectual property in the form of an umbrella
Patent Pending, as well as a working relationship with the University of Florida and a sponsoring
commercial partner, through six flights on board the Space Shuttle, it has been able to prove the
hypothesis postulated by John Kennedy that, in space, ZGI can accelerate the evolution of plant
cells toward attributes both useful and profitable to humans. Our first candidate cell is the Jatropha
Curcas plant; a well known candidate crop for bio-fuel, particularly suited to producing jet fuel.
4. Currently, the Jatropha plant grows well in most wet or dry climates, however only in the tropics
and sub tropics, to date, as it is sensitive to cold.
First, our experiments have proven that our new patentable Jatropha variety, developed on the ISS,
is not only capable of growing in colder climates (possibly West Texas) but has a substantially
increased oil yield, in the seeds. This is our first, potentially very valuable, new, patentable plant
variety and we’re currently identifying other candidate cash crop cells, to be accelerated toward
higher yield or cold resistant, disease resistant or other useful attributes.
Jatropha Curcas seeds, high oil yield suitable for bio-fuel production.
Second, our research is not limited to plant cells; animal cells also are sensitive to the microgravity
environment. We foresee the ability to “stress” animal stem cells by the same method as we are
currently doing with plant cells, thus allowing useful, accelerated hybridization of commercial
livestock (cattle, pigs, chickens, etc.).
Third, we can attest that within a relatively short period of time, our stem cell replication
intellectual property will enable us to produce large quantities of pluripotent, human stem cells on
orbit, to support the revolution in human regenerative medicine.
II. INTELLECTUAL PROPERTY
ZGI possesses multiple patents pending that contain claims covering biological processes in
microgravity, including the growth of cellular plant and animal tissues on-orbit, the 3-Dimensional
growth of biologics on-orbit, the enhanced gene expression of biologics in microgravity, stem cell
replication and related processes.
A. Accelerated Evolution
Life on Earth has always and only developed within the confines of 1G. About 50% of the energy
expended by terrestrial-bound plants is dedicated to structural support, to overcome gravity. Take
gravity away and plant cells have an excess of energy, which allows them to express their genes in a
variety of new ways. Some such expressions are of great interest to humans. We are actively
moving forward with plans for new, patentable varieties such as frost and disease resistant citrus
fruit trees, rice that can grow in brackish water and corn that grows with less irrigation. There are
far too many possible candidates (hundreds), to list in this document.
At this point, it’s important to state that, our new varieties are not genetically modified. Our
technology only accelerates evolution of the genes that already exist, but that are dormant within the
plant’s genome. Thus, our new, patentable varieties, are not subject to the same common, often
negative misconceptions, concerning Genetic Modification (GM). We have merely accelerated
hybridization, something that mankind has done for over 15,000 years, albeit slowly, up until now.
B. Stressing or “Pushing” gene expression of candidate stem cells
5. We’ve recently proven in space the concept of accelerated evolution, with our Jatropha stem cell
experiments. In partnership with the University of Florida and a sponsoring commercial
corporation, we have been able to prove our hypothesis of accelerated evolution, by flying our stem
cells in space (five times on the Space Shuttle to the ISS). We have been able to stress the cell in
space, so that it produces a substantially higher yield of oil in its seeds and enhancing it, to be frost
resistant, thus allowing the plant to be cultivated in areas that are potentially highly advantageous
and profitable (like West Texas). Lands currently “scrub land”, in the West Texas oil fields, could
become highly cultivated areas producing just short of 3 tons of oil, per hectare sown, five years
after planting. The oil from the Jatropha plant has been identified as exceptional for producing jet
fuels. We therefore consider it to be our first potential revenue generator, through several avenues:
patent royalty basis, licensing IP or selling the stem cells or even young full grown plants. There are
myriad options for monetizing this technology.
C. Mass replication of new pluripotent stem cells in space
The second part of our unique space technology IP pertains to the mass replication of stem cells in
space, something that can be done on Earth but at much slower rates than in space. Again, our five
space missions prove our concept; we have been able to stop pluripotent stem cells from
differentiating into their many different cell types, instead causing them to replicate en masse. This
is a very valuable process that will allow us to produce large quantities of the required stem cells in
short order. In fact, orders of magnitude quantities in much shorter times than on Earth. This
segment of the IP should be of particular interest from a profit standpoint when we start to produce
individual human stem cells in large quantities for organ and other tissue regeneration or
replacement. We should point out that billions of viable cells can be contained in a small receptacle,
perhaps the size of a coffee cup. This means that our very valuable cells are high value, yet low
volume products, a very attractive attribute when considering the current costs of transport to and
from space.
III. COMPANY STATUS & PLAN OVERVIEW
The ability to take advantage and utilize long term microgravity has only been available to us for
little more than 50 years; or since the advent of the space age. Most of that first 50 years, has been
spent creating the engineering systems, which allow access to space regularly and thence to be able
to work and survive, in the hostile environment that is outer space. Most of the nation’s efforts, to
this point, have been expended in creating the engineering and delivery systems that now exist in
the form of the International Space Station (ISS), a multi-nation orbiting laboratory, as well as the
myriad transport systems that allow transport from the ground to Low Earth Orbit. (LEO) ISS was
very recently awarded National Laboratory status, by the U.S. Congress, under the aegis of a
business friendly, not-for-profit organization, the Center for the Advancement of Science in Space
(CASIS).
The recently completed ISS National Laboratory
6. Historically, access to the space environment was monopolized by NASA. Flying experiments on
the space shuttle or to the ISS, was a highly coveted, bureaucratized and time consuming process. A
confluence of new commercial capabilities in the space sector just this year, have allowed ZGI to
take advantage of ground to orbit access and other capabilities. In previous years transport to space
required being manifested on perhaps four space shuttle missions per year, many of which were ISS
construction missions, not science or R&D flights. The paradigm shift that has occurred with the
advent of the ISS being “construction complete” and new U.S. commercial carriers such as SpaceX
and Orbital Technologies coming online, means that in 2013 we have 15 to 18 “up flight”
opportunities and as many as eight “down” or return flights. This, in conjunction with CASIS and
the new National Laboratory status, is a new and unprecedented capability, of which ZGI is in pole
position to take advantage.
As already detailed, ZGI holds a current Space Act Agreement with NASA. We also have R&D
agreements with the USDA Agriculture Research Services laboratories in Beltsville, Maryland, as
well as a currently operating R&D agreement with the University of Florida. These relationships
have allowed us to be the key component in flying six missions to space, five of which are pertinent
to our accelerated evolution intellectual property.
Our previous experience of flying applied research experiments in space along with our current and
developing relationships with governmental, academia and corporate entities, as well as our
developing IP, conceivably put us years ahead of any possible challengers to our business model.
Regarding ISS being a single point failure criticality for our business plans, we are already in
discussions with several vehicle operators, including SpaceX, to allow us automated, unmanned
access to low earth orbit on other already existing vehicles should a catastrophic event lead to the
ISS demise. Low Earth Orbit (LEO) is now commercially open to businesses, such as ZGI.
Company in good standing (input needed from Robert Fritzges here)
IV. MARKETING & COMMERCIALIZATION
Jatropha Curcas crop
A. Initial Plans
At this time, ZGI's business plans define ZGI's position as: an owner of the intellectual property
directed at on-orbit, microgravity processes used to manufacture stem cells (human, animal, and
plant) in space. ZGI's business extends along a span or segment of the end-to-end stem cell
creation-to-market value-chain.
We anticipate early marketing efforts, to identify the possible opportunities that exist with our
current R&D corporate sponsor, who initially funded most of the space flight experiments on the
Space Shuttle, to date. This company is very interested in the capabilities of the new Jatropha
variety as a bio-fuel crop. We are actively in discussions with them to commercialize our first
cultivar seed crop. We are also actively engaged in discussions with other NGO Agricultural bodies,
who represent industries and individual states, with regard to developing specific attributes within
valuable cash crops. Our marketing and revenue growth plans will include
7. • Methods of improving plant, animal and human biology, growth and health in conjunction with
strategic corporate and other partners
• Licenses to patents and know-how as well as outright sale of proven organisms
• Funded R&D with equity and royalty participation
• Government grants
B. Plant Market Development
Once our scientific findings are published, we anticipate considerable publicity for our technology.
Our ongoing relationship with the USDA Agriculture Research Services in Beltsville, Maryland
will lead to development of new candidate cells and partners interested in developing attributes of
identified crops, whether it be climate adaptation, yield or disease resistance. This will be an
ongoing relationship providing myriad new target cells of opportunity.
C. Animal Market Development
Once we have our first crop being developed commercially in the field and after our next raft of
plant cells being developed in space, we will turn our R&D attention to animal stem cells and which
animal stock and management resources need access to our research, development and
commercialization services. ZGI's initial animal R&D target market was the pig liver cell
application for human liver dialysis with strategic partner HepaLife Technologies, Inc. The new
source of "pure" 3-D pig liver cells in volume from ZGI will change the entire market. The purity of
the cells will be superior to any on the market and at reduced cost. The flight studies showed that
we need to extend space flight duration in the future to 90 days as opposed to what we recently flew
which was 17 days.
V. POTENTIAL ZGI CANDIDATE OPPORTUNITIES
The replication of undifferentiated cells of both plant and animals en masse for the following
purposes:
1. Replication of animal organ tissues in a "3-D" matrix to produce artificial livers, kidneys, lung
tissues, or human stem cells, etc.
2. Plant replication of "Specimen" plants that would take many more years using conventional
methods.
3. The "Stressing" of undifferentiated tissues on orbit to produce plants with a greater range of
climatic condition on Earth. Commercial users are already anxious to participate in determination of
possible yields in the "Up-Down" of mass in undifferentiated tissues, and realize that the cost
factors will improve with time.
4. Further research on animal tissues in the primordial stage for gene expression and possible
"forcing" of such tissues toward developing a wider range for such species.
5. Animal stem cells (including humans) for repair of injured tissues.
6. Gene expression experiments that will accelerate the understanding of the genes and the role each
gene plays in the genome.
8. 7. Expansion of the range of bio-fuels that have the potential for production of fuel for jet liners by
increase the productivity of land not utilized for other purposes.
VI. LICENSING, SALE, OR MANUFACTURING
This is considered disruptive and enabling technology and as a consequence there are numerous
potential markets and strategic partners. ZGI intends to commercialize selected aspects of its
science, technology, unique processes, and intellectual property to create product, provide value to
its customers, and generate sustained revenues with profitably. This will be done through patent
licenses spread over several fields of use, strategic partnerships, with current market leaders,
provision of research materials and consultation, and eventually by direct marketing of ZGI
products and services.
VII. BARRIERS TO MARKET ENTRY BY COMPETITORS
ZGI has over six years already invested substantially in its technology, whether this be through our
current Patents Pending; our NASA Space Act Agreement, our partnership with the University of
Florida and our excellent working relationships with the USDA Agriculture Research Services and
other organizations involved in working with stem cell technologies; OR our already completed
R&D experience which includes a total of six experimental missions to space on board the Space
Shuttle and ISS. Through the University of Florida we are about to publish our proven scientific
findings concerning the Jatropha seeds that pertain to our Intellectual Property. Our team also
includes management with extensive space engineering and transportation knowledge, especially
with regard to the new commercial entities that are offering regular access to LEO.
We therefore believe that ZGI is not only protected from an IP standpoint, but that our professional
relationships and our proven scientific findings and experience put us years ahead of any potential
competition in the arena of stem cell evolution in space and microgravity replication of pluripotent
stem cells.
VIII. COMPETITIVE ADVANTAGES
ZGI / John Wayne Kennedy is a certified NASA ISS-National Lab "Pathfinder" firm. We have
proprietary technology with patents pending, regular access to space through our Space Act
Agreement with NASA, as well as our lead scientist’s Bio-Space experience over the past six years.
We enjoy a close working relationship with the USDA Agriculture Research Services Laboratories.
We expect to increase our intellectual property exponentially as we develop new varieties of cells.
We have an experienced management team with many years in industry, building businesses. We
have uniquely experienced expertise and strong patent prosecution, licensing and enforcement
skills.
As well as all this ZGI's has other Competitive Advantages:
1.ZGI is currently the only biotech firm that is pursuing science, processes, product development
and manufacturing of on-orbit production directed at a Return On Investment (ROI).
9. 2. ZGI is the only biotech firm that has been awarded a NASA Space Act Agreement to pursue on
orbit science and process development on orbit for plant and animal undifferentiated cells.
3.ZGI is one of the only firms that has filed patents that address the subjects discussed concerning
processing and manufacture of plants and animal undifferentiated cells in space under weightless
conditions.
4.ZGI has a World-Class science team that has already performed to accomplish STS-118 science
(August 2007) and STS- 126 and subsequent flights that continued to execute stem cell science on
the Shuttle, ISS-National Lab missions and advanced and veterinary science.
IX. COMPANY PERSONNEL
The Company’s team includes people with experience in agricultural research, plant and animal
stem cell research, spaceflight transportation and payload processing management and business
startups and development. In addition, the Company will utilize a Board of Advisors that will
provide capability second to none in all aspects of stem cell technologies.
Brief biographies are as follows:
John W. Kennedy, ZGI Founder and Chief Scientist: Forty years experience in applied research,
botany, biology, physics, nutrition, biochemistry and discoveries associated with health, disease,
plant and biological sciences and technologies. Author, International consulting scientist and
science consultant. Research and discovery of novel chemistries, processes, and materials to
diagnose, treat, cure, and prevent disease. Expertise and research in the biological principals
governing the bio-availability of nutrients essential to living organisms.
John Kennedy after 18 years with USDA founded John Wayne Kennedy Consultants and has
represented and supported programs of over 90 companies in 19 countries worldwide. Kennedy
represented The Government of Mexico on Avocado crop importation into the U.S., the National
Agricultural Chemical Association, the US Forest Service, and other agricultural groups on
pesticide issues. He introduced GPS aerial application technologies for guidance of aircraft on spray
programs to the USDA and was contracted by the State of California to author manuals on GPS and
Sat-Loc spray system use. Work with satellite imaging technologies via connections to NASA and
private satellite builders, with application for inventory and classification of vegetation, land and
aquatic species. Federal Inspector in New York, Chicago and Hoboken, New Jersey in USDA
before being promoted to the Assistant Director of the Methods Laboratory, USDA that conducted
research concerning treatments for insect and plant diseases. He authored several publications
including the "Plant Protection and Quarantine Treatment Manual" on insect and plant treatments
for all imported products. Promoted to Hyattsville (now Riverdale) as a Staff Officer in charge of
Gypsy Moth, Japanese beetle and working on the Med. Fly, etc. Staff Officer in charge of the
eradication of isolated infestations of the gypsy moth around the country including California (San
Jose). Author of the original Japanese and Med Fly Environmental Impact Statement with
contributions to the Gypsy Moth EIS, Bio-control, and Boll Weevil Eradication Statements.
Education: University of Wisconsin - Madison – Natural Sciences (degree Botany) and advanced
studies at New York City (Entomology, Plant Pathology, Nematology.) concerning quarantine
pests. As Founder of ZGI - Holds multiple patents pending for on-orbit processing of plant, animal,
and human undifferentiated cells on orbit.
10. Harvey Kaye: Chairman of the Board (Bio needed)
Richard Godwin, CEO, ZGI: Richard has been a serial entrepreneur, since his high school days in
the UK. He has founded, built, and successfully sold companies in the UK, Canada and the U.S.
over the past 30 years. Notable achievements in the UK include the creation of a small restaurant
chain in the late 70’s, which he quickly grew and sold for a profit. At the age of 26, Godwin
purchased a 24-bedroom country manor estate, increased the business revenues by a factor of 40,
and sold the business only a year later. He next purchased a small division of Thorn EMI, Plc, in
London. Again, he grew and sold the company for substantial profit in just three years. After
moving to America in 1987, while appointed senior, exclusive broker for one of Mitsubishi
Corporation’s Divisions, he identified and developed another niche industry. He founded a
compact disc import company in the Chicago area; he developed and grew this organization, which
rapidly became the largest import distributor of recorded music in the U.S. with annual sales of over
thirty million dollars ($30,000,000.00US). From there, he was able to create several sub-companies,
as a part of a small conglomerate, including three record labels and a book publishing company,
which he still owns today. Richard has been very active in the U.S. Space Exploration field and is
considered an expert on national space policy; to that end he has testified at a U.S. Senate
Roundtable. He was called to attend a high-level national policy group to assist in the design of
America’s space policy in the wake of the Columbia Space Shuttle disaster. Most recently, Richard
has been sub-contracted as a business development consultant for SpaceX, working on their nascent
DragonLab program. His consultancy company clients include businesses in Bio-Tech, online
publishing, science, STEM education, space and alternative energy engineering as well as a variety
of marketing arenas.
Dr. Wagner Vendrame: Senior Plant R&D Scientist: Dr. Vendrame is an Associate Professor at the
Environmental Horticulture Department, of the Institute of Food and Agricultural Sciences (IFAS),
University of Florida, working at the Tropical Research and Education Center (TREC), in
Homestead, Florida. Dr. Vendrame has a 60% teaching and 40% research appointment in the areas
of ornamental horticulture and biotechnology. His research program has focused in production and
conservation of ornamental plants using tissue culture, molecular biology, and cryo-preservation
techniques. More recently Dr. Vendrame expanded his research program to include studies on
plants with potential for medicinal use and/or bio-fuel production. Studies are under way to assess
Jatropha Curcas as a potential alternative energy crop for South Florida. In 2007 Dr. Vendrame
partnered with Zero Gravity, Inc., BioServe, and Spacehab, Inc. to develop a project to evaluate the
growth of undifferentiated plant cells under microgravity. An experiment with cell suspensions was
sent on board of space shuttle Endeavour in August 2007, remaining for three months at the
International Space Station, and returning in November 2007 on board of the Discovery. Results are
currently being evaluated and should represent a first step into further research in space biology. Dr.
Vendrame obtained his B.S. in Agricultural Sciences and M.Sc. in Plant Physiology and
Biochemistry from the University of São Paulo, Brazil, and his Ph.D. in Horticulture from the
University of Georgia.
Patrick Kennedy: Board Member: Mr. Kennedy is a consultant, currently managing public relations
coordination, data, websites and collateral material for The Williams Investment Companies. From
May 2000 to June 2007 Mr. Kennedy was the President of American Natural Technology Sciences,
11. Inc.; Mr. Kennedy has forty-five years of business experience involving a wide range of skills,
including business development, trade, finance, marketing and sales. He has negotiated, marketed
and consummated over one billion dollars of sales volume. Patrick has experience with industry
contracts; negotiations/structuring of marketing and product distribution. Other skills include
creative application, writing capabilities including; corporate collateral materials, critical letters and
advertising/media approaches. Mr. Kennedy is well versed in; corporate issues, military & industry
form requirements and he is capable of writing and presenting business plans, marketing plans,
spreadsheet projections etc. Mr. Kennedy has completed international trade/financial instrument
course work with Orient Pacific Shipping and with the Chase Manhattan Bank. From 1977 to 2000
Mr. Kennedy successfully owned and operated oil companies.
Ed Cowles: Board member: (Bio needed)
Deworth Williams: Board member: (Bio needed)
Michael Weiner: Senior VP Business Development: (Bio needed)
Robert Fritzges: Board Member: (Bio needed)
12. IX. COMPANY OPERATIONS PLAN
A. Organization Authority and Responsibilities
As CEO of the Company, Mr. Godwin will have overall responsibility for operations, marketing,
and day-to-day business affairs, including disbursements. As Chief Technology Officer, Mr.
Kennedy will have responsibility for research and development to be largely conducted in
conjunction with Dr. Vendrame, as well as intellectual property filing and patent enhancement.
Other personnel will be utilized as necessary. Authorization for significant expenditures will be
Mr. Godwin’s responsibility with Mr. Kaye’s concurrence and under Board advisement.
Company personnel live in various parts of the country. Mr. Godwin is located in the metropolitan
Chicago area. John Kennedy and USDA ARS are located in Maryland, Mr. Kaye, Mr. Weiner and
Dr. Vendrame are all located in Florida.
On routine matters, telephone, email, and Skype will suffice. Periodic meetings at Mr. Kaye’s
offices in Florida will allow for detailed business and technical discussions. Marketing will
necessarily involve travel, initially within the U.S. until otherwise authorized. Periodic investor
meetings are envisioned to take place at Mr. Kaye’s offices in Boca Raton Florida.
A CFO will be appointed to oversee financial transactions and to verify proper use of finances as
soon as funds allow.
B. Principle Functions
The Company’s principle activity will include ongoing research and development and filing of new
intellectual property pertaining to both plant and animal candidate cells; licensing of developed cell
technology and other intellectual property; sale of pluripotent stem cells developed and grown in
space; possible sale of fully formed plants.
1. Marketing & Business Development
As indicated, Mr. Weiner will manage the Company’s ongoing business development planning. At
the outset, he along with Mr. Kennedy and Mr. Godwin will survey optional markets for ZGI,
Our revenues will come from:
a) Methods of improving plant, animal and human biology, growth and health.
b) Licenses to patents and know-how.
c) Funded R&D with equity and royalty participation.
d) Government grants.
e) Utilizing our Space Act agreement with NASA to conduct other experiments in Space.
f) Sale of new varieties of plants and animal cells or adult organisms.
By the end of the two-year period, the Company is expected to be self-supporting with related and
additional income flowing back to Company investors.
2. Research & Development
a. Overview
13. Mr. Kennedy and Dr Vendrame, will be responsible for the development of ZGI technology and
system development pertaining to increasing the content and scope of our intellectual property. It is
envisaged that each plant or animal stem cell developed on orbit will become a new patentable
variety that can be commercialized.
b. Develop strategic partnerships with corporate, academic and Governmental entities.
The company will nurture partnerships with all forms of strategic entities in order to identify new
candidate cell opportunities as well as acquiring funding partners who will assist in financing each
flight manifest and experiment. Partners will be assessed on their need for new varietals as well as
their ability to fund the R&D needed for each new cell. Funding of this nature will be considered
regular income.
c. Test business model efficacies to identify most profitable pathways and markets.
We will be assessing the most profitable business models for each target market including licensing
of our IP, or outright sale of cells or plants.
d. ZGI pushing the boundaries of regenerative medicine.
Once we have established the efficacy of our plant and animal experiments we will be actively
moving our operations towards development of large quantity production of human stem cells to
support the revolution in regenerative medicine.
e. Regulatory costs and similar issues.
We expect to enjoy an advantage in the normally high risk and long term business that requires
FDA and other regulatory approvals which we do not anticipate as a substantial cost of doing
business. Expensive clinical trials are the work of our customers, who will fund them. We will be
structured similar to a biotech boutique via milestone transactions involving monies up front,
monies on milestones, and post launch revenues from royalties. This is a model similar to ILEX
oncology, a small start up which was sold to Genzyme for $1.3 billion.
X. INTELLECTUAL PROPERTY
ZGI's patents claim processes that are based on 3-D volumetric cellular processing and culturing.
Volumetric, 3-D culturing will result in yield increases on the order of 10x or more. Consequently,
certain cellular product lines moved to on-orbit manufacturing environments will provide much
greater product yields than on-earth counterparts.
U. S. Provisional Application No.: 60/867,582
Title: Replication of Undifferentiated Cells in Plants (Apical Cells) and Animals (Stem Cells) in a
Weightless Environment and a Facility for Such Replication
There are very specific differentials that exist between the majority of existing stem cell and cellular
process IP and Patent filings made by other firms versus the Patent filings made by ZGI. ZGI's
patents predominately involve the processing, storage, and manufacture of stem cells, plant, animal,
14. and human, on-orbit, in space, in microgravity environments. Therefore, most competitor Patents
may be viewed in a different plane.
ZGI has performed due-diligence on the fewer number of patents filed that involve cellular
processing in space, in microgravity. Generally, none assert claims of the type and nature that
ZGI's patent state. [For further information, reference ZGI Patent of Nov 2006 and additions of
Nov 2007, which contain specific referenced patents of others]
XI. INVESTMENT REQUIREMENTS
ZGI INC. is seeking investment partners interested in development and sale of new varieties of
plants and animals that can be commercialized in ways undreamt of before this time, with potential
for worldwide gains in agricultural crop yields and mitigation of disease for cash crops and
livestock. We project a need for $1.5 million in year one continuing to $2.5million in year two, as
outlined in this proposal. At the end of that period, we anticipate licensing and other income to
create positive cash flow, which we anticipate to grow dramatically thereafter.
We will provide monthly progress reports to investors and project a a description of the most
attractive ZGI markets at the one year anniversary of the program initiation. Accordingly, we
request a full two-year financial commitment of $4.0million.
We welcome the opportunity of working with an engaged partner who shares our vision of a
worldwide marketplace for our products and services. An investor need not have a background in
bio-technologies or spaceflight. However, an investor who can and is willing to assist in the
worldwide development of the various types of new plant and animal varieties we create would be
desirable.
XII. INVESTOR RETURN ON INVESTMENT
The company team envisions a wide array of attractive markets for its technology, as indicated
elsewhere in this document. Until we perform careful analyses of the most attractive of those
opportunities, we cannot in good conscience make reasonable estimates of ZGI’s specific potential
market penetration. Therefore, we cannot accurately estimate an ROI at this time.
Our planned program includes initial market estimates at the outset. Those estimates will be firmed
up as we collect more data from our experimental programs and upgrade our findings.
Accordingly, we believe that we will be in good a position to generate a strongly-based ROI
estimate at the end of the first year.
XIII. EXIT STRATEGY
(Harvey, Ed or Deworth input needed here if necessary)
15. Appendices
I. Overview, Figures & Notes
What is the overall size of the potential market?
ZGI's business and products address multiple markets. Since there are opportunities to deliver
products for human uses as well as for animal / veterinary and for plant and agricultural purposes,
"addressable market" characterization and sizing is speculative but huge.
a.ZGI's intellectual property holds claims to the processes that relate to 3-D volumetric cellular
growth on-orbit, in microgravity. Currently, many existing ground-based cellular manufacturing,
culturing, and harvesting processes are constrained to 2-D (planar) growth and culturing processes,
albeit there are 'clever' efforts to enhance these 2-D manufacturing methodologies.
b. ZGI's patents claim processes that are based on 3-D volumetric cellular processing and culturing.
Volumetric, 3-D culturing will result in yield increases on the order of 10x or more. Consequently,
certain cellular product lines moved to on-orbit manufacturing environments will provide much
greater product yields than on-earth counterparts.
c.There are entire additional "addressable markets" as associated product families for ZGI in the
plant, horticultural and agricultural industries. ZGI's patent claims include the creation,
development, processing, and manufacture of primordial plant cells on-orbit, in microgravity.
Claims, rights, and outcomes are multifold:
d.Specific ZGI claims are directed at the rapid, high-volume production of primordial cells for
specific plant types, e.g. corn, wheat, soy, rice, and other crops, as well as orchids, citrus, of
herbaceous and woody plants and other species. Existing ground-based science and processes for
plant development requires years (typically 7 – 10 years) to produce volumes of a new or variant
plant type. ZGI's processes enable rapid development and volume production, on-orbit. ZGI's
products are therefore of higher intrinsic value and enable product to be provided in substantially
less time, and at competitive or lower prices. The size and character of the "addressable market" for
these products is considerable in ZGI's current assessment, but a rigorous market sizing and analysis
has not been performed yet. Suffice it to say, the general assessment is that the "addressable
market" for these products is well into the $ multi-billion dollar revenue per year range.
e. ZGI patents contain claims directed at the development of new and variant plant species (and of
HOLBS – of higher-order-living-biological-systems). ZGI patents claim on-orbit processes that
are tied to microgravity processing conditions (forcing functions) that result in "enhanced gene
expression". Consequently, plants and organisms processed in microgravity exhibit gene-
expressions are accelerated and "forced" into conforming with an existence outside the normal
range of the plant. It takes Centuries to accomplish the same effects in the normal path of evolution
on Earth. ZGI's cellular and plant processing takes advantage of the enhanced gene-expression, to
create new and variant plant, crop, vegetation, and species that are tailored for specific purposes and
environments, e.g. – citrus that grows viably only in Florida, may be tailored to grow robustly in the
colder and altered environments of Maryland. The technology may someday be the key to feeding
the Earth if dramatic shifts in the climate should occur.
16. The "addressable market" for this product-family has not been assessed. The number of potential
products is considerable, and may be well into the hundreds (100's). It is likely that entire new
industries will result from this on-orbit processing and production activity. Therefore "addressable
market" characterization is beyond the current scope of ZGI at this time. Suffice it to say that
ZGI's general assessment is that the "addressable market" for these products is well into the $ multi-
billion dollar revenue per year range. ZGI will enable the development of many of these markets
through patent license agreements. This will generate initial, maintenance, and royalty payments to
ZGI.
How do we plan to make money?
ZGI's plans to commercialize the products and services and are described in part in Section 2 above.
ZGI's commercialization plans are to perform high-volume, mass-manufacture of stem cells and
undifferentiated parenchyma on-orbit. Undifferentiated cells include stem cell manufacturing and
apical meristem tissues from plants.
ZGI's space-based cellular manufacturing is predicated on the fact that weightless conditions on-
orbit are mandatory for the specific stem cell processing required. In other words, stem cell
biotech firms that are performing cell development and manufacture on Earth, will not be able to
produce cellular products properly or as effectively in a gravity/weight environment. Today, there
are numerous firms that produce adult and pluripotent stem cells, on Earth. And they will continue
to do so. But these Earth-based processes are limited, in the type of cells produced and the volume
of cells produced over time. ZGI's processes must be done in a weightless environment to yield
effective product with near exponential cell replication in a 3-D structure. At this time, this
requirement is poorly understood by biotech competitors and will present a considerable market
barrier to entry for these firms, even when they do understand it.
ZGI will make money in high-volume undifferentiated cell product sales that are directed at animal,
and plant market sectors, and eventually the human stem cell sector.
Highlights of the University of Florida ISS Experiments & Analysis
Among the U of F conclusions: (John and/or Wagner input needed here)
1
2
3
17. The Jatropha Experiments in Space
(John & Or Wagner input)
II. Budget Details (if necessary)
A. Cost Estimates Two Years
1. Market Analysis & Development
Participants in corporate management, licensing and sales
2. Technology Development
Participants in technology development are as follows:
• John W Kennedy, two years to direct and guide all technology R & D, innovation, and Candidate
development ………..……….$n
• Wagner Vendrame plus lab one technician for two years + expenses for device fabrication and
necessary instrumentation .……..$n
• Other consultants as needed…………………………………..…….…….….$n
• Travel……………………………………………………………..……….……..$n
•
Total……………………….…..…$n
3. Patent & Intellectual Property Development:
18. Prepare and file process improvement patents in the U.S., help evaluate the value of international
patents based on market analysis, and file patents in selected countries.
• Attorney costs……………………..…………………………………….……..$n
• Filing costs (best guess)………………..………………………………..$n
Total…………………..$n
4. Administration
• Bookkeeping, disbursements, misc. …………………………………….…...$n
Contingency to be managed within and between activities
Two Year Cost Summary Total
• Market Analysis & Development …………………………………………...….$n
• Technology Development……………………………………………………..$n
• Patent & Intellectual Property Development……………………….…$n
• Administration……………………………………………………………….……...$n
•
Total……..……………………….$3n
Round to $n
B. First Year Costs:
• Market Analysis & Development ……………………………………...……….$n
• Technology Development……………………………………………………..$n
• Patent & Intellectual Property Development….……………………………….$n
• Administration………………………………………………………………….…...$n
Total……………………………………….……$n
III. Notes on Technology Validation
The literature provides a range of definitions for the term “Technology Validation,” a topic often
included in technology development proposals and plans. In a few cases, the term may narrowly
apply simply to validation of technological feasibility. At the other extreme, it may apply to the
whole process of research, development, and demonstration, up to validating that a concept is ready
to enter the commercial marketplace.
In the case of this ZGI proposal we can say the following:
1. The feasibility of the ZGI as a means to accelerate cell evolution is based on John Kennedys
patent pending, which shows valid results after five flights in space. In addition, the experiments at
partner-funded University of Florida project demonstrated proof of concept bearing out Mr.
Kennedy’s IP.
19. 2. Additional research is needed to develop the database necessary to continue to develop and
improve the underlying technology.
The results of these steps will provide the substance needed to pursue one of the following Investor
profit-generating options:
. Licensing varietals of ZGI’s stem cells to appropriate existing market participants, our baseline
goal,
. Selling new varietal stem cells for plants or animals.
. Selling complete grown plants
. Growing quantities of individual human stem cells in space for sale within the regenerative
medicine marketplace.
