General Development of Business
The Company was organized
in the State of Nevada on April 24, 2008 under the name Planet Resources, Corp. The Company’s initial business model was
the re-processing of mine tailings from previous mining operations. We did not generate any revenues because we were not successful
in implementing our business plan. Various business alternatives were considered to ensure the viability and solvency of the Company;
however, the Company went dormant from April 30, 2011 to June 2018, and in Case Number A-14-720990-C, Nevada's 8th Judicial District
appointed Robert Stevens as Receiver for the Company on August 20, 2015. Subsequent to Mr. Stevens being released as the court-appointed
receiver in July 2018, the Company embarked on its new business plan.
On December 20, 2018, the Company entered into
a License Agreement (the “License Agreement”) in the cell-extraction sector with Cell Science Holdings Ltd. (“Licensor”).
Pursuant to the License Agreement, the Licensor granted to the Company an exclusive license, with respect to the Licensed Science
and process, for, among other things, the production, manufacturing and sale of cannabis and byproducts thereof where permitted
within the United States of America, Canada, Mexico, all countries in the Caribbean Sea and all other countries north of the Panama/Columbia
border, including the entire nation of Panama (the “Territory”).
We currently conduct our business activities
at our offices at One World Trade Center, Suite 130, Long Beach, California 90831.
Our common stock is currently trading on the
OTC Markets Pinksheets under the symbol BKUH.
Financial Information
The audited financial statements for the fiscal
year ended July 31, 2019 are attached hereto as Item 8 in this annual report.
Business of Issuer
On December 20, 2018, the Company entered into
a License Agreement in the cell-extraction sector. Pursuant to the License Agreement, the Licensor granted to the Company an exclusive
license, with respect to the use of the Licensed Science and process, for (i) the production, manufacturing and sale of cannabis
and byproducts thereof where permitted, (ii) Cannabis-related research, teaching and education for both medical and other purposes,
and (iii) all medical uses and applications of Cannabis, within the Territory, as defined in the License Agreement.
The Company business plan is to sublicense the
rights acquired under the License Agreement to third parties in various market verticals for an initial payment and an ongoing
royalty stream.
The value of the potential licenses will be
dependent on the ability for third parties to scale the application of the technology and trade secret processes in production
laboratories at the same or lesser capital costs and operating costs than approaches common to the industry verticals for CBD and
or THC concentrate.
For commercial and licensing purposes, which
is the basis the License Agreement, in simplistic terms, the Licensor has represented to the Company that the Licensed Science
and processes may be utilized to dissect a specific cell (the “Donor Cell”) of a cannabis donor plant that has a measurable
percentage level of Tetrahydrocannabinol (“THC”) and Cannabidiol (“CBD”), and using the Licensed Science
and process, thereafter grow duplicate cells in a laboratory commercial application so that each 5000 liter grow process
will produce approximately 90 kilos or approximately 187 pounds of cells containing identical measurable percentage levels of THC
and CBD.
Under the terms of the License Agreement, the
Company and Licensor have agreed that a commercial scaled demonstration of the Licensed Science (the “Efficacy Testing”)
is necessary to validate the representations and claims of Licensor, to establish the value of License Agreement. The standard
result (the “Standard Result”) claim by the Licensor and which will be considered acceptable by the Company is a result
in which (a) the cells produced, harvested and dried during a full cycle of the Licensed Science process contain at least 90% of
the measurable percentage levels of THC and CBG as the Donor Cell, and (b) this result is achieved at a project utility, production
and supplies cost of $0.10 per gram or roughly $100 per kilo.
To date, our efforts have been devoted primarily
to start-up and development activities, which include developing our business plan and finalizing the License Agreement with the
Licensor and developing a method to market and sublicense the rights granted under said License Agreement. With the intent of,
and in furtherance of engaging in the sublicense of the rights granted under the License Agreement, the Company has, and continues
to (i) monitor the required Efficacy Testing being conducted under the License Agreement; (ii) research and define, with the assistance
of Licensor, the equipment and staffing requirements to scale the technology process to a commercial scale operation, (iii) explore
with experts and companies in the cannabis industry the current costs to cultivate and process end products with either a THC or
CBD concentrate, and (v) research the regulatory requirements in the Territory as they pertain to the ability to sublicense the
rights of the Company under the License Agreement.
The Company is currently preparing for Efficacy
Testing to validate the License Science and processes in a scientific laboratory setting, prove-up the efficiencies and scalability
of the grow process, to evaluate and determine the market value of the process and then enter into sublicenses for cash consideration
and royalty payments.
Subsidiary - Cell Science CBD International, Inc.
On August 9, 2019, the Company formed a wholly
owned subsidiary, Cell Science CBD International, Inc., a California corporation (“CS CBD”). The Company formed CS
CBD with the specific intent of separating the business operations and opportunities relating to THC which sub-licensing shall
be conducted through the Company, from the business operations and opportunities relating to CBD which will be conducted through
CS CBD. In this regard, the Company is in the process of facilitating the sublicensing of all rights under the License Agreement
that pertain to CBD, including without limitation utilizing the Licensed Science and the process as it applies to CBD, and the
subsequent grant of sublicenses to third parties that are legally engaged in the business of producing and manufacturing CBD derived
products and byproducts for sale and use where permitted. The Company intends that any additional licenses acquired by the Company
that pertains to CBD will also be sublicensed to CS CBD.
Licensor’s Approach.
In laymen’s terms, the Licensor’s
approach is as follow:
Rather than producing a pound of end product
of with predictable measurable percentage level of THC and or CBD by growing plants that produce flowers that are then either ground
or distilled using solvents to get the concentrate of cells which have THC and or CBD, the Licensor’s approach is to select
a targeted Donor Cell from a donor plant that has all the characteristics desired in the end concentrate product and harvest that
specific cell (“Donor Cell”). That Donor Cell is then duplicated in a clean lab environment to millions of cells which
becomes a “Seed Culture” batch of desired cells contained in a ten or twenty liter proprietary container. That batch
of “seed culture” cells is then added to a proprietary medium culture in a larger proprietary container generically
referred to as a “Bioreactor,” sized at 1,000 liters. The bioreactor is then operated for 40 to 42 days inside a proprietary
“pod” environment, in which light, oxygen, CO2, and other factors are controlled. At the end of the growth cycle, the
medium culture and the multiplied cells are “harvested,” and the raw product is put through two proprietary finishing
processes which removes moisture and unwanted cells. The end product, a dry concentrate, can then be sized in powder grind size
for various uses, including those in the medical or food industry, according to set specifications. The end product has the exact
identity of the Donor Cell, in terms of THC and CBD as well as the other attributes of the Donor Cell.
The general efficiencies of cell growth process
using the Licensed Science are that it can produce the active ingredient from the host organic substance, specifically the Donor
Cell, in mandated quantities while assuring purity levels and concentrations as opposed to the inconsistencies and waste found
in the cultivation, harvest, processing, storage, packaging, shipping, and limited shelf-life of typical cannabis plant cultivation
and processing.
Products and Services
The Company does not produce any products and
has no current intent on engaging in the cultivation, production, manufacturing or sale of cannabis derived products.
Rather, if the Licensed Science is proven and
validated, the Company intends to undertake the sublicense of the Licensed Science to such third parties, consistent with the terms
of the License Agreement, that are legally engaged in the business of producing and manufacturing cannabis derived products and
byproducts for sale and use where permitted, including, a cannabis concentrate powder product for the medical, food additive, and
recreational cannabis consumption market verticals.
If validated and scalable as claimed by the
Licensor, the Company believes that an end user (i.e. third parties and companies legally engaged in the cultivation, production,
manufacturing or sale of cannabis derived products) would value and prefer this method (using the Licensed Science and process)
to produce an end product concentrate, with identifiable consistent quality at a reduced cost. The potential for reduced capital
expense, reduced costs to grow and harvest, reduced labor, reduced testing costs, and importantly, the avoidance of contaminants,
pests, blights, and varied “flower” harvests, common to the current industry approaches in inside grow and greenhouse
outdoor grow operations, are compelling reasons for using the Licensed Science and process.
To conduct the Efficacy Testing required under
the License Agreement and establish the business and science ratios for the production of the end product, the OZ Corporation on
behalf of the Licensor has engaged and is working with V O Leasing Corp., to build a 5,600 square foot research and development
lab in Van Nuys, California (the “Van Nuys Lab”). V O Leasing Corp., holds provisional California issued Cannabis Cultivation,
Manufacturing and Distribution licenses that become full licenses with the completion of the renovation of the Van Nuys lab and
final inspection by the regulatory committee. V O leasing Corp has experience in, and is a respected consultant to, the cannabis
industry, and in addition to the provisional licenses in Van Nuys, holds a cannabis cultivation and processing licenses in Chatsworth
and Hollywood, California, and has created their own brand of cannabis products which are currently carried in over 600 dispensaries
including MedMen dispensaries, and are currently expanding their operations and brand to other states. In addition to assisting
with the licensed and regulatory compliance pertaining to the Efficacy Testing of the Licensed Science and process, VO Leasing
Corp., with the consent of the Company as the license holder, has the option to utilize concentrate produced as part of the Efficacy
Testing from the Van Nuys lab, in V O Leasing’s medical and recreational consumables after third party certification of the
Efficacy Test results of the Licensed Science and certification that the product concentrate meets the California cannabis regulatory
quality testing.
The Van Nuys Lab will attempt to replicate,
utilizing ten 1,000-liter bioreactors, the previous laboratory tests and results of the technology and processes that were conducted
in one-liter test runs and memorialize the projected cost of goods ratios for production of the concentrate. The business objective
is to verify that the Licensed Science and the process can produce a desired concentrate at or below current competitive market
approaches.
Permitting, design, and engineering work began
in March of 2019, and the Van Nuys Lab is expected to be operational by end of November of 2019. The first scaled Efficacy Test,
scheduled to begin in December of 2019, will utilize ten 1,000-liter bioreactors (approximately 260 US gallons in each reactor)
and three differing original seed cultures (targeted seed cells from three different donor plants). Licensor has advised the Company
that it anticipates that the first scaled production Efficacy Test will be completed in late January or February 2020, at which
time the results will be sent to an accredited third-party lab for verification of purity, potency, and compliance with California
cannabis and CBD regulations. Assuming the Licensed Science process is successful and verified through both the Efficacy Test and
third-party verification, the Company will begin seeking to enter into sublicense agreements.
The Company intends to sublicense its rights
under the License Agreement to financially qualified and appropriately licensed third-party cannabis companies that will either
build their own commercial production laboratories, or convert existing laboratories to utilize the Licensed Science process and
production approach. The potential licensees must be qualified by possessing both the regulatory licensure, as well as the financial
capability to acquire a sublicense to the License Science and finance a 12,000 square foot production lab.
Thus, the Company plans to only be burdened
with research and development costs, and creating a licensing sales and support operation, without the attendant operational expenses
of building production facilities, acquiring compliant cannabis licensing in various states and provinces, or bringing products
to the marketplace.
Our research and product development sequence
involves:
Patent filings for process, and customized
proprietary equipment all necessary to facilitate the use and implementation of the Licensed Science process
·
|
Sample test in the research and development “limited run,” including:
|
|
•
|
efficacy of harvest product matching targeted seed culture cells;
|
|
•
|
percent concentration yields; and
|
|
•
|
costs per unit produced.
|
|
·
|
Third-party laboratory verification of the Efficacy Test results including production ratios;
|
|
·
|
Legal research and analysis into patent protection.
|
Support Services to Sublicensees
The Company’s business model is to create
a licensing program, including marketing, sales, business and technical support to sublicensees to help the sublicensees permit
and build a commercial production laboratory utilizing the Company’s proprietary production processes, proprietary concentrate
finishing process and the Company’s proprietary equipment and process designs and medium culture formulations.
The Company and the Licensor have created proprietary
equipment designs necessary to the cell production process and the product finishing process, all of which are in process of being
filed as Intellectual Property. Additionally the Company has proprietary formulations for the medium growing culture which will
be sold at cost to the Licensees.
In support of the sublicensees, the Company
will provided advisory consulting services, as required, with regard to:
Bioreactor laboratory planning, including;
|
·
|
build out requirements – plans, permits, regulatory compliance, utilities;
|
|
·
|
staffing plans, including in house sales, science officer, compliance, pre-build advisory assistance,
build out advisory, equipment set up, initial testing and lab certification advisory, first production cycle support;
|
|
·
|
introduction to external resources - consultants, engineers, legal, compliance, shipping/packing,
distribution;
|
|
·
|
installation of bioreactors and all support equipment;
|
|
·
|
seed culture growth cycle training;
|
|
·
|
cell growth cultivation cycle training;
|
|
·
|
filtering cycle training;
|
|
·
|
drying equipment operation;
|
|
·
|
initial product harvest and packaging training;
|
|
·
|
internal and third-party laboratory testing contract review of services;
|
|
·
|
sublicensees product to market options; and,
|
|
·
|
introduce “take away” contract candidates; and/or consulting to utilize the product
in proprietary products under regulatory compliance.
|
In August 2018, the Licensor completed third-party
lab test through Evio Labs-Berkley (C3 Labs, LLC), a subsidiary of Evio Inc., in Berkley, California confirming the efficacy of
cells grown in petri dishes using the Licensed Science. Specifically, Evio labs tested and confirmed that the THC and CBD potency
of the concentrate produced by the Licensed Science process matching the THC and CBD potency of the donor plant.
One of the inventors, Dr. Peter Whitton, completed
in house efficacy testing of a research laboratory simulation of the proprietary filtering and drying process in July of 2019 in
Van Nuys, California. These tests, conducted in a VO Leasing “clean lab,” by Dr. Whitton, confirmed the type of filtration
process required to identify and separate the targeted production cells, and, the size of the filtration membranes, at the planned
1000 liter bioreactor product scale, to be utilized in the proposed lab scaling efficacy tests. Additionally, Dr. Whitton was able
to use the same experiments to determine the drying process and rightly size the drying ovens and the moisture ratios of the cell
concentrate product before and after filtering.
As stated above, as part of the Efficacy Testing
requirements under the License Agreement, the OZ Corporation on behalf of the Licensor, has contracted to build and operate a 5,600
square foot research and development lab in Van Nuys, California, under a State of California issued Cannabis Cultivation and Manufacturing
license, held by VO Leasing Corp. The Company expects the Van Nuys Lab to be completed and the Efficacy Test, directed by Dr. Whitton,
to begin in December 2019 or January 2020. The first test cycle will take approximately six (6) weeks from initial loading of the
Seed Culture into the proprietary medium culture in the Bioreactors, until the batch of desired cells is mature for harvest, filtering
and drying.
The only business of the Company will be the
sub-licensing of the Licensed Science. The rights under the License Agreement are perpetual, contingent on the Company staying
in compliance on terms of the License Agreement and the potential sublicensees being in compliance with the terms of any sublicense
agreements.
Patents, Trademarks, Licenses and Royalty Agreements
The following patent applications are licensed
by the Company subject to the terms of the License Agreement. The Company does not currently own any other intellectual property
outside of the License Agreement.
Patents:
Application No.
|
Title
|
Filing Date
|
Jurisdiction
|
1717554.8
|
A method of production of phytocannabinoids for use in medical treatments
|
10/25/2017
|
United Kingdom
|
|
|
|
|
16/290,708
|
A method of production of phytocannabinoids for use in medical treatments
|
3/1/2019
|
United States
|
Patents Cooperation Treaty Filing:
Application No.
|
Title
|
Filing Date
|
Jurisdiction
|
2018/077149
|
A method of production of phytocannabinoids for use in medical treatments
|
10/5/2018
|
PCT
|
|
|
|
|
The protection of proprietary rights relating
to Licensed Science is critical for the business. The Company intends to file additional patent applications to protect certain
technology and improvements considered important to the development of the Company’s business. The Company, through its subsidiary,
further intends to license the rights under a recently filed patent application with regard to patent rights to produce a non-toxic
CBD product and thereafter to specifically grant sublicenses to utilize the process for CBD based products as opposed to THC products.
The Company also intends to rely upon trade secrets, know-how, continuing technological innovation and licensing opportunities
to develop and maintain its competitive position.
Although the Company intends to seek patent
protection for additionally developed proprietary technology, the patent positions of our products are generally uncertain and
involve complex legal and factual questions. Consequently, we do not know whether any of the patent applications that we have and
will consider filing will result in the issuance of any patents or whether such patent applications will be circumvented or invalidated.
There can be no assurance that all United States patents that may pose a risk of infringement can or will be identified. If we
are unable to obtain licenses where we may have infringed on other patents, we could encounter delays in market introductions while
attempting to design around such intellectual property rights, or we could find that the development, manufacture or sale of products
requiring such licenses could be prevented. In addition, we could incur substantial costs in defending suits brought against us
on such intellectual property rights or prosecuting suits which the Company brings against other parties to protect its intellectual
property rights. Competitors or potential competitors may have filed applications for, or have received patents and may obtain
additional patents and proprietary rights relating to, compounds or processes competitive with those of covered under the License
Agreement.
The Company relies on the patented and unpatented
trade secrets under the License Agreement its business, and there can be no assurance that others will not independently develop
substantially equivalent proprietary information and techniques, or otherwise gain access to our trade secrets or disclose such
technology, or that the Company can meaningfully protect its rights to its unpatented trade secrets. We intend to require each
of our employees, consultants and advisors to execute confidentiality agreements either upon the commencement of an employment
or consulting relationship with the Company or at a later time. There can be no assurance, however, that these agreements will
provide meaningful protection for the Licensed Science utilized by the Company or trade secrets in the event of unauthorized use
or disclosure of such information.
We do not believe that any of our patents or
other proprietary rights infringe upon the rights of third parties. However, there can be no assurance that others may not assert
infringement claims against the Licensor or the Company in the future and we recognize that any such assertion may require us to
incur legal and other defense costs, enter into compromise royalty arrangements, or terminate the use of some technologies. Further,
we may be required to incur legal and other costs to protect our proprietary rights against infringement by third parties.
Additional Intellectual Property and Processes in Development
Early testing of the proprietary technology
and trade secret process claimed in the Licensor’s subsequent process patent application filed on October 11, 2019 indicates
that CBD produced cells in a concentrate from the Licensed Science proprietary process hold promise, when treated in a secondary
process defined in the patent filing, to avoid the potential harmful toxicity side effects to liver and kidney that have recently
emerged in consumers that ingest or apply topically, CBD products. This toxicity results from the current industry wide lab approach
to refining and producing CBD distillate oils which are then utilized in numerous unregulated products experiencing a rapid growth
for health and diet consumption of humans and animals
In this regard, the Licensor is currently undertaking
to enter into an agreement to have an FDA accredited lab conduct a series of tests utilizing the Licensed Science for creating
a CBD product versus products from multiple current suppliers.
The intended first FDA reviewed test protocol
will focus on the safety issues of CBD product processing and distillation that is known to cause initial and cumulative toxicity
in the human and animal liver. The test protocol will require liver cells from multiple single donors from accredited lab sources
for a comparative test impact analysis of the current market offerings vis a vis the Licensed Science approach to making a CBD
concentrate.
Lab testing will measure the initial and cumulative
toxicity impact on human liver cells of each of at least six commercial public CBD selected suppliers, and then compare, utilizing
the same protocols, the impact on the liver cells utilizing the product created using the Licensed Science and treated using the
proprietary process.
The first multi-purpose test will seek to demonstrate,
utilizing human liver tissue, the impact of consuming or applying topically, CBD products that are sourced from CBD high concentrate
distillate, in the doses and frequencies, proposed by the various manufacturers of topical or consumable products, to create immediate
and cumulative toxicity in the liver of humans.
In the same test protocols, the CBD product
utilizing the licensed process will be tested on human liver cells demonstrating that the licensed process created CBD concentrate
will have limited or zero initial and or cumulative toxicity in the same source liver cells utilized in the tests. The Company
intends to begin the first FDA reviewed test in November of 2019 for current CBD manufactured products, whether topical or consumable,
creating human liver cell toxicity.
Pursuant to Efficacy Testing of the commercial
scaling of the process using the Licensed Science, the Licensor intends to seek a full FDA approval of its commercially scaled
production process to yield a concentrate product that may be utilized, by food or Pharmaceutical companies, as directed, in topicals
and consumables that will not create toxicity in the liver. The Company currently intends to enter those FDA trials in February
or March of 2020 utilizing the same test protocols already utilized by the FDA in the first FDA review planned for November of
2019. The Company believes the receipt of FDA approval by the Licensor would enhance value and credibility of the Licensed Science
under the License Agreement held by the Company.
The Company does not intend to seek FDA approval
to create or license derivative products of its CBD concentrate, nor to focus on specific use cases or claims medically for using
CBD. Rather it seeks to demonstrate, in the affirmative, that the CBD concentrate that is created by its patented pending process
will not cause toxicity in the liver of humans or animals if consumed or utilized in topicals to deliver CBD.
The Company believes that the opioid health
crisis creates the necessity of substitutes for opioid based products which may potentially be sourced from Sativa Cannabis derivatives.
The Company believes that an FDA published recognition from their sponsored testing protocols that the Company process and methodology
for producing a CBD concentrate that does not create toxicity in the liver will remove one more “roadblock” from other
companies offering topical and consumable cannabis based alternatives to opioid offerings based on CBD source products and could
add significant value to the Company’s rights under the License Agreement.
Sources and Availability of Raw Materials
The Company does not utilize any raw materials
as the Company does not produce any products and has no current intent on engaging in the cultivation, production, manufacturing
or sale of cannabis derived products. There are various materials required when using the Licensed Science processes, all of which
are readily available. Provided that a sublicensee possesses the proper required licenses which differs from state to state, including
without limitation, by way of example in California, a Cannabis Cultivation and Manufacturing license, the Company is not aware
of any existing or future problem that will materially affect the source and availability of any materials which would be required
of a sublicenses of the Licensed Science.
Sublicenses and Royalty Agreements
To date we have not entered into any sublicense
or royalty agreements which have resulted in royalty payments.
Market
According to the Brightfield Group, the global
medical cannabis market is expected to grow from its current 7.7 billion dollars to 31.4 billion by 2021. The US market currently
drives 90 percent of global cannabis sales, but with Canada and other western nations reassessing medical cannabis, the US percentage
of the market share is expected to decrease to below 60%. Decreased government regulation, and the lack of political will to enforce
federal cannabis laws also plays an important role in the growth and expansion of the cannabis industry as a whole. We believe
that the Company’s development plan will allow us to build the relationships, experience, resources and services to be successful
in sub-licensing the Licensed Science in the medical cannabis industry, the CBD industry, and provide net stockholder value through
the initial license fees, as well as royalty earnings.
The Company intends to sublicense to both public
and private companies in the medical cannabis, the recreational cannabis (where permitted) and those companies that are choosing
to focus on CBD market for topicals, and edibles, and to stay out of THC content above 3% market.
The Company believes that the recent focused
interest of the FDA on safety issues for medical, recreational and topical applications of all cannabis-based products will only
intensify. Further, the Company believes that the patents filed by inventors/scientists and possessed by the Licensor will protect
for many years, others attempting to duplicate the approach using the Licensed Science, to creating a predictable quality cannabis
concentrate. It should be noted however, that any FDA approval of medical cannabis and cannabis related products contain THC and
CBD, may come with FDA restrictions and regulations that could affect the Licensed Science.
The Company believes that the potential medical
and food-based inclusion of pure grade cannabis products, as well as providing product for the CBD rapidly expanding markets has
potential to drive adoption of Licensed Science.
Distribution Plan
The Company’s near-term plan, upon validation
and certification of the Efficacy Testing, scalability and costs using the Licensed Science, which the Company anticipates being
completed in the first or second quarter of 2020, is to begin qualifying candidates which will sublicense the Licensed Science
to produce concentrate products for medical and recreational markets via cell growth technology in multiple bioreactor facilities.
Cell growth in research applications and commercial
bioreactor labs has achieved efficacy in recent years in terms of operational viability. While the technology works, the economics
for certain applications, outside of a science experiment, have not proven to be economically feasible. The Company believes cell
culturing is commercially viable if growing highly valued, and relatively difficult to find in nature, certain plant or animal
cells that are utilized in medicine and food additive products to add viability to the host product. A cost to grow targeted cells
of $200 to $2,000 per pound is economically viable when you are selling the product by the gram or for extremely high multiples.
Applications of the science for tissue and or
cell culturing for the cannabis industry has been hampered by the federal mandate of cannabis containing more than 3% THC to be
a controlled substance. As the minimum investment is several million dollars for a commercially scaled laboratory, and those assets
are all subject to seizure under federal law, most finance sources were not willing to advance the funds for experimentation. Additionally,
a cannabis plant, at the cell and molecular level has attributes that make it very difficult, if not impossible, to utilize “big
Ag” bioreactor (bioreactors sized from 3,000 gallon to 500 cubic meters (130,000 gallon) science to grow the cells. All experiments
known to the inventors to date, of applied bio science protocols by third parties to grow THC and CBD products in traditional bioscience
approaches, have failed to produce a predictable cannabis end product that mirrors the subject donor plant.
One of the reasons the Licensor has secured
its first patent on the Licensed Science proprietary process is that its process has actually worked, utilizing a “bioreactor”
science approach, but with a proprietary bioreactor design, a differing proprietary environmental control which was not achieved
with traditional (dark or limited light) bioreactor commercial offerings and proprietary medium culture formulations. And, importantly,
the final filtering process, also of proprietary design, is able to separate the desired cells without damaging or destroying them.
The Licensed Science is a holistic approach that begins with the idea that you can grow cells but requires all the processes and
equipment to be specifically and uniquely designed for the targeted cannabis cell.
According to trade journals, business news following
the cannabis industry worldwide, and public company information available for Canadian companies and US companies domiciling in
Canada, the cost, average, reported by the industry, of both private and public companies to grow cannabis flower and trim in an
inside grow facility in California is approximately $800 to $950 a pound without capital expenses or taxes and approximately $420
a pound in a typical California greenhouse grow. The end product flower, before taxation, depending on the state and the strain,
is selling for between $1,200 a pound to over $4,000 a pound.
The Company believes that the combination of
the Licensed Science and process holds promise to deliver a high-quality cell culture concentrate at costs below $250 per pound
in a commercially scaled laboratory that is one third the cap ex cost of a greenhouse grow facility.
The Company plans to sublicense the Licensed
Science process to third parties who have the requisite licenses and financial ability to scale-up commercially sized bioreactor
labs capable of producing 60,000 pounds per annum of a predictable harvested cell product with reliable qualities and quantities
in the product at lower costs per pound to deliver than any current market alternative.
Sales and Marketing
The Company’s plan is offer to sublicense
the Licensed Science to qualified cannabis licensed operators in those states with the US in which the Licensed Science may legally
be used as well as all the provinces of Canada, specifically limiting the number of licenses in a given market for cannabis THC
based products. The number of sublicenses to be sold will depend on size of potential market in that specific state, estimated
future consumption of products in that market, and whether the state is medical consumption only, or both, medical and recreational.
Additionally, the Company, through its subsidiary CS CBD, plans to sublicense the Licensed Science, with regard to CBD based products,
to qualified licensed operators in those states within the United States, and all the provinces of Canada, in which the Licensed
Science may legally be used or where national or international trade agreements currently in place allow the cross border trade
of CBD concentrate or CBD based products.
Competition
The Company believes the Licensed Science, requiring
less capitalization than inside grow or outside grow without the attendant challenges of such operations, and delivering a competitive
product at a lower cost per pound, will drive adoption by sublicenses in the market. The medical cannabis industry in the United
States is highly competitive. Our prospective licensees face competition from traditional cultivation and processing facilities
already with market share. Additionally, there are many public and private companies with large cash reserves waiting to enter
the market when the regulations change. In the states where cannabis is legal, others have enjoyed a first mover advantage. Past
spending on traditional grow methods may limit sublicensing opportunities, which could create a significant barrier to entry in
the medical cannabis and recreational cannabis market. We will compete with a variety of companies, many of which have substantially
greater technical, financial, marketing and other resources than we do, allowing them to compete more effectively than we can.
The Company considers anyone that is engaged
in the business of producing THC and CBD by growing plants and extracting the THC and CBD from the plant to be a competitor. MedMen
and Curaleaf, for example, have first mover advantage. Medmen, headquartered in Culver City, California is engaged in the Clone-to-Product
cannabis business with operations for cultivation and retail paired up in California and eight other US states. Curaleaf, a Connecticut
company, backed by Blackstone Partners and other investors, is the third largest cultivator and dispensary owner in the US market.
It recently acquired Grass Roots for US$875 million and Cura Partners for over $1 billion. These companies have been in the market
for many years and have significant resources and market share. However, assuming successful results from the Efficacy Testing
and third party certification of the Licensed Science, it is believed that products can be produced using the Licensed Science
at significant cost saving, making adoption of the Licensed Science attractive. The Company has initiated conversations with executives
at Med Men about potentially licensing the Licensed Science after efficacy testing.
Dependence on few/many customers
The Company has no current customers and intends
to limit the number of sublicenses in a given market for cannabis THC based products. However, the company will determine, after
completion of the Efficacy Test and certification, if the Licensed Science can be optimized by selling hundreds of licenses or
limiting the number of sublicenses to certain large producers and distributors.
The
Company intends to focus on potential sub-licensees that have the financial wherewithal to pay an initial license fee of $500,000
or more, have the ability to build out a lab with an estimated cost of $5.5 million, and will sign a guaranteed royalty agreement
beginning within six months of operational start-up. We believe that this is the starting point, but we have not sold the first
license. In contrast, to produce what can be produced in a 12,000 square feet lab using the Licensed Science at an estimated capital
cost of $5.5 million, it is estimated that it would cost over $12 million to build a 280,000 square foot greenhouse grow, an outdoor
operation on at least ten acres, requiring labor, significant water and utility power, and suffer waste/loss on average of 15%
to grow a third party lab tested pound of flower at around $425. We believe that an apples to apples comparison of capital expense,
cost to grow, and risk mitigation utilized in the Licensed Science approach will attract operators and investors in this industry
willing take this financial risk. Additionally, the Company believes those operators planning on expansion will have to evaluate
the opportunity to license the Licensed Science from the Company before committing more expansion dollars to their traditional
approaches to grow product for the projected growing demand of the cannabis market.
Government approvals and regulation in the United States Cannabis
Industry
Cannabis is a Schedule I controlled substance
under the Controlled Substances Act of 1970 (the “CSA”). Even in those jurisdictions in which the manufacture and use
of medical cannabis has been legalized at the state level, the possession, use and cultivation all remain violations of federal
law that are punishable by imprisonment, substantial fines and forfeiture. Moreover, individuals and entities may violate federal
law if they intentionally aid and abet another in violating these federal controlled substance laws or conspire with another to
violate them. The U.S. Supreme Court has ruled in United States v. Oakland Cannabis Buyers' Coop. and Gonzales v. Raich that it
is the federal government that has the right to regulate and criminalize the sale, possession and use of cannabis, even for medical
purposes. We would likely be unable to execute our business plan if the federal government were to strictly enforce federal law
regarding cannabis, and the chemically active compounds contained within.
In January 2018, the Department of Justice (the
“DOJ”) rescinded certain memoranda, including the so-called “Cole Memo” issued on August 29, 2013 under
the Obama Administration, which had characterized enforcement of federal cannabis prohibitions under the CSA to prosecute those
complying with state regulatory systems allowing the use, manufacture and distribution of medical cannabis as an inefficient use
of federal investigative and prosecutorial resources when state regulatory and enforcement efforts are effective with respect to
enumerated federal enforcement priorities under the CSA. The impact of the DOJ's rescission of the Cole Memo and related memoranda
is unclear but may result in the DOJ increasing its enforcement actions against the state-regulated cannabis industry generally.
Congress previously enacted an omnibus spending
bill that includes a provision prohibiting the DOJ (which includes the Drug Enforcement Agency (the “DEA”)) from using
funds appropriated by that bill to prevent states from implementing their medical-use cannabis laws. This provision, however, expired
on December 7, 2018, and must be renewed by Congress. In USA vs. McIntosh, the U.S. Court of Appeals for the Ninth Circuit held
that this provision prohibits the DOJ from spending funds from relevant appropriations acts to prosecute individuals who engage
in conduct permitted by state medical-use cannabis laws and who strictly comply with such laws. However, the Ninth Circuit's opinion,
which only applies to the states of Alaska, Arizona, California, Hawaii, and Idaho, also held that persons who do not strictly
comply with all state laws and regulations regarding the distribution, possession and cultivation of medical-use cannabis have
engaged in conduct that is unauthorized, and in such instances the DOJ may prosecute those individuals.
Additionally, financial transactions involving
proceeds generated by cannabis-related conduct can form the basis for prosecution under the federal money laundering statutes,
unlicensed money transmitter statutes and the Bank Secrecy Act. The penalties for violation of these laws include imprisonment,
substantial fines and forfeiture. Prior to the DOJ's rescission of the “Cole Memo,” supplemental guidance from the
DOJ issued under the Obama administration directed federal prosecutors to consider the federal enforcement priorities enumerated
in the “Cole Memo” when determining whether to charge institutions or individuals with any of the financial crimes
described above based upon cannabis-related activity. With the rescission of the “Cole Memo,” there is increased uncertainty
and added risk that federal law enforcement authorities could seek to pursue money laundering charges against entities or individuals
engaged in supporting the cannabis industry.
Federal prosecutors have significant discretion
and no assurance can be given that the federal prosecutor in each judicial district where our sublicensees operate will not choose
to strictly enforce the federal laws governing cannabis or cannabis-related activities production or distribution. Any change in
the federal government's enforcement posture with respect to state-licensed cultivation of cannabis or its chemical components,
including the enforcement postures of individual federal prosecutors in judicial districts where our sublicensees operate, would
result in our inability to execute our business plan, and we would likely suffer significant losses, which would adversely affect
the trading price of our securities. We have not requested or obtained any opinion of counsel or ruling from any authority to determine
if our operations are in compliance with or violate any state or federal laws or whether we are assisting others to violate a state
or federal law. In the event that our operations are deemed to violate any laws or if we are deemed to be assisting others to violate
a state or federal law, any resulting liability could cause us to modify or cease our operations.
Should
the federal government legalize cannabis for medical use, it is possible that the U.S. Food and Drug Administration ("FDA")
would seek to regulate it under the Food, Drug and Cosmetics Act of 1938. Additionally, the FDA may issue rules and regulations
including CGMPs (“Certified Good Manufacturing Practices) related to the growth, cultivation, harvesting and processing of
medical cannabis. Clinical trials may be needed to verify efficacy and safety. It is also possible that the FDA would require that
facilities where medical cannabis is grown be registered with the FDA and comply with certain federally prescribed regulations.
In the event that some or all of these regulations are imposed, we do not know what the impact would be on the cannabis industry
and what costs, requirements and possible prohibitions may be enforced. If our sublicensees are unable to comply with the regulations
and/or registration as prescribed by the FDA, such sublicensees may be unable to continue to operate our business in the US markets.
Local
and state marijuana laws and regulations are broad in scope and subject to evolving interpretations, which could require us to
incur substantial costs associated with compliance or alter our business plan. In addition, violations of these laws, or allegations
of such violations, could disrupt our business and result in a material adverse effect on our operations. In addition, it is possible
that regulations may be enacted in the future that will be directly applicable to our proposed business. We cannot predict the
nature of any future laws, regulations, interpretations or applications, nor can we determine what effect additional governmental
regulations or administrative policies and procedures, when and if promulgated, could have on our business.
Financial transactions involving proceeds generated
by cannabis-related conduct can form the basis for prosecution under the federal money laundering statutes, unlicensed money transmitter
statute and the U.S. Bank Secrecy Act. Guidance issued by the Financial Crimes Enforcement Network, or FinCen, a division of the
U.S. Department of the Treasury, clarifies how financial institutions can provide services to cannabis-related businesses consistent
with their obligations under the Bank Secrecy Act. Furthermore, supplemental guidance from the DOJ directs federal prosecutors
to consider the federal enforcement priorities enumerated in the Cole Memo when determining whether to charge institutions or individuals
with any of the financial crimes described above based upon cannabis-related activity. Banks remain hesitant to offer banking services
to cannabis-related businesses. Consequently, those businesses involved in the cannabis industry continue to encounter difficulty
establishing banking relationships. Our inability to maintain our current bank accounts would make it difficult for us to operate
our business, increase our operating costs, and pose additional operational, logistical and security challenges and could result
in our inability to implement our business plan.
The Bank Secrecy Act, enforced by FinCEN, requires
us to report currency transactions in excess of $10,000, including identification of the customer by name and social security number,
to the IRS. This regulation also requires us to report certain suspicious activity, including any transaction that exceeds $5,000
that we know, suspect or have reason to believe involves funds from illegal activity or is designed to evade federal regulations
or reporting requirements and to verify sources of funds. Substantial penalties can be imposed against us if we fail to comply
with this regulation. If we fail to comply with these laws and regulations, the imposition of a substantial penalty could have
a material adverse effect on our business, financial condition and results of operations.
Employees
As of July 31, 2019, we had employees other
than our Chief Executive Officer, Thomas K. Emmitt. We intend to hire additional personnel as we grow and develop our business.
National unemployment rates remain low relative to historical averages, and there exists a significant amount of competition for
skilled personnel in the medical cannabis industry. Nevertheless, we expect to be able to attract and retain such additional employees
as are necessary, commensurate with the anticipated future expansion of our business. Further, we expect to continue to use consultants,
contract labor, attorneys and accountants as necessary.
Available Information
The public may read and copy any materials the
Company files with the SEC at the SEC’s public reference room at 100 F Street, NE, Washington D.C. 20549, on official business
days during the hours of 10 a.m. to 3 p.m. Eastern Time. Information may be obtained on the operation of the public reference room
by calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet site that contains reports, proxy and information statements,
and other information regarding issuers that file electronically with the SEC at http://www.sec.gov.
FORWARD-LOOKING STATEMENTS
This report contains statements that constitute
“forward-looking statements.” These forward-looking statements can be identified by the use of predictive, future-tense
or forward-looking terminology like “believes,” “anticipates,” “expects,” “estimates,” “envision”
or similar terms. These statements appear in a number of places in this report and include statements regarding our intent, belief
or current expectations and those of our directors or officers with respect to, among other things: (i) trends affecting our financial
condition or results of operations, (ii) our business and growth strategies, and (iii) our financing plans. You are cautioned that
any forward-looking statements are not guarantees of future performance and involve significant risks and uncertainties, and that
actual results may differ materially from those projected in the forward-looking statements as a result of various factors. Factors
that could adversely affect actual results and performance include, among others, the effect of inflation and other negative economic
trends and developments on the business of our customers and other barriers, government regulation and competition. All forward-looking
statements attributable to us are expressly qualified in their entirety by the foregoing cautionary statement. The Company undertakes
no obligation to publicly update or revise any forward-looking statements, whether as the result of new information, future events
or otherwise.
Investment in our common stock involves significant risk.
You should carefully consider the information described in the following risk factors, together with the other information appearing
elsewhere in this Current Report and our other SEC Filings, before making an investment decision regarding our common stock. If
any of the events or circumstances described in these risks actually occur, our business, financial conditions, results of operations
and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price of our
common stock could decline, and you may lose all or a part of your investment in our common stock.
Risks Associated with our Company
We have not generated any revenue since
our inception and we may never achieve profitability.
We are a development stage company and we have
not generated any revenue. As the OZ Corporation, on behalf of the Licensor, in conjunction with VO Leasing Corp builds the research
and development facility to conduct the Efficacy Test and we undertake further research and development of our licensing strategy
and identification of potential sublicensees, our expenses are expected to increase significantly before we can begin selling sublicenses.
Accordingly, we will need to generate significant revenue to achieve profitability. Even as we begin to market and sublicense the
Licensed Science we expect our losses to continue as a result of ongoing research and development expenses, as well as increased
costs in seeking patent protection, FDA approval, and sales and marketing expenses for the sublicenses. These losses, among other
things, have had and will continue to have an adverse effect on our working capital, total assets and stockholders’ equity.
Because of the numerous risks and uncertainties associated with the Efficacy Test of the Licensed Science and commercialization
efforts, we are unable to predict when we will become profitable, and we may never become profitable. Even if we do achieve profitability,
we may not be able to sustain or increase profitability on a quarterly or annual basis. If we are unable to achieve and then maintain
profitability, our business, financial condition and results of operations will be negatively affected and the market value of
our common stock will likely decline.
Reliance on Licenses
The Company’s ability to sublicense the
Licensed Science is dependent on maintaining its existing licenses, and any and all other future licenses through its various partners.
Failure to comply with the requirements of the License Agreement, or any failure to maintain the License Agreement may have a material
adverse impact on the Company’s business, financial condition and results of operations. The License is perpetual but maintaining
the license is subject to performance covenants. There can be no guarantees that the Company will be able to extend or renew the
license as necessary or, if it extended or renewed, that the licenses will be extended or renewed on the same or similar terms.
Should the License Agreement not be extended or renewed, or should they renew on different terms, the Company’s business,
financial condition and results of operations may be materially adversely affected.
Reliance of Successful Efficacy Test
There is no guarantee that the Efficacy Test
will be successful in validating the Licensed Science and processes and in achieving the results claimed by the Licensor. The failure
of the Efficacy Test or in obtaining third- party certification of the Efficacy Test could materially and adversely affect benefits,
value and demand for use of the Licensed Science and process and operations of the Company’s intended sublicensing business
model.
Expansion Strategy
There is no guarantee that the Company’s
expansion strategy, and marketing and sales initiatives, to sublicense the Licensed Science, to third parties that are legally
engaged in the business of producing and manufacturing THC and CBD derived products and byproducts for sale and use, in jurisdictions
where it is legally permitted, will be successful or completed in the currently proposed form, if at all, nor is there any guarantee
that the Company will be able to expand into additional jurisdictions. There is also no guarantee that such sublicensees will be
able to acquire and/or construct production and manufacturing facilities for use of the Licensed Science and thereafter produce
and sell any products produced using the Licensed Science. Any such activities will require, among other things, various regulatory
approvals, licenses and permits and there is no guarantee that all required approvals, licenses and permits will be obtained in
a timely fashion or at all.
The Company’s failure to successfully
execute its expansion strategy and marketing and sales initiatives to sublicense the Licensed Science, could adversely affect the
Company’s business, financial condition and results of operations and may result in the Company failing to meet anticipated
or future demand for the Licensed Science.
The use of the Licensed Science and thus the
Company’s expansion into jurisdictions outside of the United States, is subject to additional business risks, including new
or unexpected risks or could significantly increase the Company’s exposure to one or more existing risk factors, including
economic instability, changes in laws and regulations and the effects of competition. In addition, international expansion could
subject the Company’s business to certain risks relating to fluctuating exchange rates or require a number of up-front expenses,
including those associated with obtaining regulatory approvals, as well as additional ongoing expenses, including those associated
with infrastructure, staff and regulatory compliance. These factors may limit the Company’s ability to successfully expand
its operations into such jurisdictions and may have a material adverse effect on the Company’s business, financial condition
and results of operations.
Highly Regulated Industry
The laws, regulations and guidelines generally
applicable to the cannabis industry domestically and internationally may change in ways currently unforeseen. There are a variety
of laws, regulations and guidelines relating to the cultivation, production, manufacturing, management, transportation, disposal,
storage, distribution,
sales, use, health
and safety of THC and CBD derived products and byproducts that may be produced using the Licensed Science by the intended sublicensees.
In addition, the Company is subject to a variety of applicable federal and state securities regulations and stock exchange rules
and regulations. Any amendment to or replacement of existing laws, or new law, may cause adverse effects to the Company’s
operations. The risks to the Company’s business represented by subsequent regulatory changes could reduce demand and market
to sublicense the Licensed Science and could materially and adversely affect the Company’s business, financial condition,
results of operations and prospects. To the knowledge of management, the Company is currently in compliance with all such laws.
Achievement of the Company’s business objectives is contingent, upon the successful Efficacy Testing, and with regulatory
requirements enacted by governmental authorities and, where necessary, obtaining regulatory approvals. The impact of the United
States’ compliance regime, any delays of the sublicensees in obtaining, or failure to obtain regulatory approvals required
may significantly delay or impact the development of the Company’s business and operations and could have a material adverse
effect on the Company’s business, financial condition, results of operations and prospects. Any potential non-compliance
could cause the Company’s business, financial condition, results of operations and prospects to be adversely affected. Further,
any amendment to or replacement of the applicable rules and regulations governing the Company’s business activities may
cause adverse effects on the Company’s business, financial conditions and results of operations.
The Company will incur ongoing costs and obligations
related to regulatory compliance. Failure to comply with applicable laws and regulations could subject the Company to regulatory
or agency proceedings or investigations and may result in enforcement actions thereunder, including orders issued by regulatory
or judicial authorities causing operations to cease or be curtailed, and may include damage awards, fines, penalties or corrective
measures requiring capital expenditures or remedial actions. Parties may be liable for civil or criminal fines or penalties imposed
for violations of applicable laws or regulations. The outcome of any regulatory or agency proceedings, investigations, audits,
and other contingencies could harm the Company’s reputation and no assurance can be given that any pending or future regulatory
or agency proceedings, investigations and audits will not result in substantial costs or a diversion of management’s attention
and resources. Amendments to current laws, regulations and permitting requirements, or more stringent application of existing laws
or regulations, may have a material adverse impact on the Company’s business, resulting in increased capital expenditures
or production costs, reduced levels of production or abandonment or delays in the development of facilities.
In addition, the introduction of new tax laws,
regulations or rules, or changes to, or differing interpretation of, or application of, existing tax laws, regulations or rules
in any of the jurisdictions in which the Company operates could result in an increase in taxes, or other governmental charges,
duties or impositions. No assurance can be given that new tax laws, regulations or rules will not be enacted or that existing tax
laws, regulations or rules will not be changed, interpreted or applied in a manner which could result in the Company’s profits
being subject to additional taxation or which could otherwise have a material adverse effect. Due to the complexity and nature
of the Company’s operations, various legal and tax matters may be outstanding from time to time. If the Company is unable
to resolve any of these matters favorably, it may have a material adverse effect on the Company.
Cannabis and the chemically active compounds contained therein
(i.e. THC and CBD), remain illegal under US federal law, and therefore, strict enforcement of federal laws regarding cannabis would
likely result in our inability and the inability of our Licensees to execute our respective business plans.
Cannabis is a Schedule I controlled substance
under the Controlled Substances Act of 1970 (the “CSA”). Even in those jurisdictions in which the manufacture and use
of medical cannabis has been legalized at the state level, the possession, use and cultivation all remain violations of federal
law that are punishable by imprisonment, substantial fines and forfeiture. Moreover, individuals and entities may violate federal
law if they intentionally aid and abet another in violating these federal controlled substance laws or conspire with another to
violate them. The U.S. Supreme Court has ruled in United States v. Oakland Cannabis Buyers' Coop. and Gonzales v. Raich that it
is the federal government that has the right to regulate and criminalize the sale, possession and use of cannabis, even for medical
purposes. We would likely be unable to execute our business plan if the federal government were to strictly enforce federal law
regarding cannabis, and the chemically active compounds contained within.
In January 2018, the Department of Justice
(the “DOJ”) rescinded certain memoranda, including the so-called “Cole Memo” issued on August 29,
2013 under the Obama Administration, which had characterized enforcement of federal cannabis prohibitions under the CSA to
prosecute those complying with state regulatory systems allowing the use, manufacture and distribution of medical cannabis as
an inefficient use of federal investigative and prosecutorial resources when state regulatory and enforcement efforts are
effective with respect to enumerated federal enforcement priorities under the CSA. The impact of the DOJ's rescission of the
Cole Memo and related memoranda is unclear but may result in the DOJ increasing its enforcement actions against the
state-regulated cannabis industry generally.
Congress previously enacted an omnibus spending
bill that includes a provision prohibiting the DOJ (which includes the Drug Enforcement Agency (the “DEA”)) from using
funds appropriated by that bill to prevent states from implementing their medical-use cannabis laws. This provision, however, expired
on December 7, 2018, and must be renewed by Congress. In USA vs. McIntosh, the U.S. Court of Appeals for the Ninth Circuit held
that this provision prohibits the DOJ from spending funds from relevant appropriations acts to prosecute individuals who engage
in conduct permitted by state medical-use cannabis laws and who strictly comply with such laws. However, the Ninth Circuit's opinion,
which only applies to the states of Alaska, Arizona, California, Hawaii, and Idaho, also held that persons who do not strictly
comply with all state laws and regulations regarding the distribution, possession and cultivation of medical-use cannabis have
engaged in conduct that is unauthorized, and in such instances the DOJ may prosecute those individuals.
Additionally, financial transactions involving
proceeds generated by cannabis-related conduct can form the basis for prosecution under the federal money laundering statutes,
unlicensed money transmitter statutes and the Bank Secrecy Act. The penalties for violation of these laws include imprisonment,
substantial fines and forfeiture. Prior to the DOJ's rescission of the “Cole Memo,” supplemental guidance from the
DOJ issued under the Obama administration directed federal prosecutors to consider the federal enforcement priorities enumerated
in the “Cole Memo” when determining whether to charge institutions or individuals with any of the financial crimes
described above based upon cannabis-related activity. With the rescission of the “Cole Memo,” there is increased uncertainty
and added risk that federal law enforcement authorities could seek to pursue money laundering charges against entities or individuals
engaged in supporting the cannabis industry.
Federal prosecutors have significant discretion
and no assurance can be given that the federal prosecutor in each judicial district where our sublicensees operate will not choose
to strictly enforce the federal laws governing cannabis or cannabis-related activities production or distribution. Any change in
the federal government's enforcement posture with respect to state-licensed cultivation of cannabis or its chemical components,
including the enforcement postures of individual federal prosecutors in judicial districts where our sub-licencees operate, would
result in our inability to execute our business plan, and we would likely suffer significant losses, which would adversely affect
the trading price of our securities. We have not requested or obtained any opinion of counsel or ruling from any authority to determine
if our operations are in compliance with or violate any state or federal laws or whether we are assisting others to violate a state
or federal law. In the event that our operations are deemed to violate any laws or if we are deemed to be assisting others to violate
a state or federal law, any resulting liability could cause us to modify or cease our operations.
We and our customers may have difficulty accessing the service
of banks, which may make it difficult to sell our products and services.
Financial transactions involving proceeds generated
by cannabis-related conduct can form the basis for prosecution under the federal money laundering statutes, unlicensed money transmitter
statute and the U.S. Bank Secrecy Act. Guidance issued by the Financial Crimes Enforcement Network (“FinCen”), a division
of the U.S. Department of the Treasury, clarifies how financial institutions can provide services to cannabis-related businesses
consistent with their obligations under the Bank Secrecy Act. Furthermore, supplemental guidance from the DOJ directs federal prosecutors
to consider the federal enforcement priorities enumerated in the Cole Memo when determining whether to charge institutions or individuals
with any of the financial crimes described above based upon cannabis-related activity. Nevertheless, banks remain hesitant to offer
banking services to cannabis-related businesses. Consequently, those businesses involved in the cannabis industry continue to encounter
difficulty establishing banking relationships. Our inability to maintain our current bank accounts would make it difficult for
us to operate our business, increase our operating costs, and pose additional operational, logistical and security challenges and
could result in our inability to implement our business plan.
We are subject to certain federal regulations relating to
cash reporting.
The Bank Secrecy Act, enforced by FinCEN, requires
us to report currency transactions in excess of $10,000, including identification of the customer by name and social security number,
to the IRS. This regulation also requires us to report certain suspicious activity, including any transaction that exceeds $5,000
that we know, suspect or have reason to believe involves funds from illegal activity or is designed to evade federal regulations
or reporting requirements and to verify sources of funds. Substantial penalties can be imposed against us if we fail to comply
with this regulation. If we fail to comply with these laws and regulations, the imposition of a substantial penalty could have
a material adverse effect on our business, financial condition and results of operations.
Laws and Regulations Governing Cannabis in Foreign Jurisdictions
The Company’s ability to achieve its business
objectives in foreign jurisdictions is contingent, in part, upon compliance with regulatory requirements enacted by governmental
authorities, which are applicable to the Company’s business of sublicensing the Licensed Science, the Company obtaining all
required regulatory approvals. The Company cannot predict the impact of the compliance regime countries such as Jamaica are
implementing and the method in which their governmental authorities will implement the adult-use or medical cannabis industry and
how such regulations effect a sublicensee’s use of the Licensed Science in producing and manufacturing THC and CBD derived
products and byproducts such jurisdictions. Similarly, the Company cannot predict how long it will take to for any sublicensee
to secure all appropriate regulatory approvals, if any, for producing and manufacturing THC and CBD derived products and byproducts
using the Licensed Science and process, or the extent of testing and documentation that may be required by governmental authorities.
The impact of the various compliance regimes, any delays in obtaining, or failure to obtain regulatory approvals may significantly
delay or impact the development of markets using the Licensed Science and could have a material adverse effect on the Company’s
business, financial condition, results of operations and prospects.
The Company anticipates it will incur ongoing
costs and obligations related to regulatory compliance. A failure on the Company’s part to comply with regulations may result
in additional costs for corrective measures, penalties or in restrictions on its operations. In addition, changes in regulations,
more vigorous enforcement thereof or other unanticipated events could require extensive changes to the Company’s operations,
increased compliance costs or give rise to material liabilities, which could have a material adverse effect on the Company’s
business, financial condition, results of operations and prospects.
Foreign Investment in Cannabis Companies
Certain jurisdictions may prohibit or restrict
its citizens or residents from investing in or transacting with companies involved in the cannabis industry, even if such companies
only conduct business in jurisdictions where cannabis is legal, and even if the Company is not engaged in the cultivation, production,
manufacturing or sale of cannabis derived products and is only a sub-licensor of the Licensed Science. For example, if an investor
in the United Kingdom profits from an investment in cannabis producer or supplier, or the use of technology is used in the production,
such investment may technically violate the United Kingdom Proceeds of Crime Act 2002. Similar prohibitions or restrictions
may apply in other jurisdictions where cannabis has not been legalized. In the United States, there have been certain instances
of US Customs and Border Protection preventing citizens of foreign countries from entering the United States for reasons related
to the cannabis industry.
Operations in Foreign Jurisdictions
The Company may have operations in certain emerging
markets in the future. Such operations may expose the Company to the socioeconomic conditions as well as the laws governing the
cannabis industry in such countries. Inherent risks with conducting foreign operations include, but are not limited to: high rates
of inflation; extreme fluctuations in currency exchange rates, military repression; war or civil war; social and labor unrest;
organized crime; hostage taking; terrorism; violent crime; expropriation and nationalization; renegotiation or nullification of
existing licenses, approvals, permits and contracts; changes in taxation policies; restrictions on foreign exchange and repatriation;
and changing political norms, banking and currency controls and governmental regulations that favor or require us to award contracts
in, employ citizens of, or purchase supplies from, the jurisdiction.
Governments in certain foreign jurisdictions
intervene in their economies, sometimes frequently, and occasionally make significant changes in policies and regulations. Changes,
if any, in cannabis industry or investment policies pertaining to the sublicensing or use of the Licensed Science to produce and
manufacture THC and CBD derived products and byproducts or shifts in political attitude in the countries in which the Company operates
may adversely affect its operations or profitability. Operations may be affected in varying degrees by government regulations with
respect to, but not limited to, restrictions on production, price controls, export controls, currency remittance, importation of
product and supplies, income and other taxes, royalties, the repatriation of profits, expropriation of property, foreign investment,
maintenance of concessions, licenses, approvals and permits, environmental matters, land use, land claims of local people, water
use and workplace safety. Failure to comply strictly with applicable laws, regulations and local practices could result in loss,
reduction or expropriation of licenses, or the imposition of additional local or foreign parties as joint venture partners with
carried or other interests.
The Company continues to monitor developments
and policies in the emerging markets in which it operates and assess the impact thereof to our operations; however, such developments
cannot be accurately predicted and could have an adverse effect on the Company’s business, financial condition and results
of operations.
Corruption and Fraud in Emerging Markets
There are uncertainties, corruption and fraud
relating to title ownership of real property in certain emerging markets in which the Company operates or may operate. Property
disputes over title ownership are frequent in emerging markets, and, as a result, there is a risk that errors, fraud or challenges
could adversely affect the Company’s ability to operate in such jurisdictions. Any of the foregoing risks and uncertainties
could have a material adverse effect on the Company’s business, financial condition, results of operations and prospects.
Inflation in Emerging Markets
In the past, high levels of inflation have adversely
affected emerging economies and financial markets, and the ability of government to create conditions that stimulate or maintain
economic growth. Moreover, governmental measures to curb inflation and speculation about possible future governmental measures
have contributed to the negative economic impact of inflation and have created general economic uncertainty. The emerging markets
in which the Company operates or may operate may experience high levels of inflation in the future. Inflationary pressures may
weaken investor confidence in such countries and lead to further government intervention in the economy. If countries in which
the Company operates experience high levels of inflation in the future and/or price controls are imposed, the Company may not be
able to adjust the rates the Company charges its customers to fully offset the impact of inflation on the Company’s cost
structures, which could adversely affect the Company’s business, financial condition and results of operations.
Acquisition or Use of Properties in Foreign Jurisdictions
Non-resident individuals and non-domiciled foreign
legal entities may be subject to restrictions on the acquisition or lease of properties in certain emerging markets. Limitations
also apply to legal entities domiciled in such countries which are controlled by foreign investors, such as the entities through
which the Company operates in certain countries. Accordingly, the Company’s current and future operations may be impaired
as a result of such restrictions on the acquisition or use of property, and the Company’s ownership or access rights in respect
of any property it owns or leases in such jurisdictions may be subject to legal challenges, all of which could result in a material
adverse effect on the Company’s business, financial condition, results of operations and cash flows.
International Expansion
In addition to the jurisdictions described elsewhere
in this current report, the Company may in the future expand into other geographic areas, which could increase the Company’s
operational, regulatory, compliance, reputational and foreign exchange rate risks. The failure of the Company’s operating
infrastructure to support such expansion could result in operational failures and regulatory fines or sanctions. Future international
expansion could require the Company to incur a number of up-front expenses, including those associated with obtaining regulatory
approvals, as well as additional ongoing expenses, including those associated with infrastructure, staff and regulatory compliance.
The Company may not be able to successfully identify suitable acquisition and expansion opportunities or integrate such operations
successfully with the Company’s existing operations.
Reliance on International Advisors and Consultants
The legal and regulatory requirements in the
foreign countries in which the Company operates or will operate with respect to the use of the Licensed Science, the cultivation,
production, manufacturing and sale of cannabis by intended sublicensees, banking systems and controls, as well as local business
culture and practices are different from those in the US. The Company must rely, to a great extent, on local legal counsel, consultants
and advisors retained by it in order to keep apprised of legal, regulatory and governmental developments as they pertain to and
affect the Company’s business, and to assist the Company with its governmental relations. The Company must rely, to some
extent, on those members of management and the Board who have previous experience working and conducting business in these countries,
if any, in order to enhance its understanding of and appreciation for the local business culture and practices. The Company also
relies on the advice of local experts and professionals in connection with current and new regulations that develop in respect
to the use of the Licensed Science by intended sublicensees as well as in respect of banking, financing, labor, litigation and
tax matters in these jurisdictions. Any developments or changes in such legal, regulatory or governmental requirements or in local
business practices are beyond the Company’s control. The impact of any such changes may adversely affect the Company’s
business, financial condition and results of operations.
Anti-Money Laundering Laws and Regulation Risks
The Company is subject to a variety of domestic
and international laws and regulations pertaining to money laundering, financial recordkeeping and proceeds of crime, and the rules
and regulations thereunder, the Criminal Code and any related or similar rules, regulations or guidelines, issued,
administered or enforced by governmental authorities internationally.
In the event that any of the Company’s
operations or investments, any proceeds thereof, any dividends or distributions therefrom, or any profits or revenues accruing
from such operations or investments were found to be in violation of money laundering legislation or otherwise, such transactions
may be viewed as proceeds of crime under one or more of the statutes noted above or any other applicable legislation. This could
restrict or otherwise jeopardize the Company’s ability to declare or pay dividends, effect other distributions or subsequently
repatriate such funds back to the US. Furthermore, while the Company has no current intention to declare or pay dividends in the
foreseeable future, in the event that a determination was made that proceeds obtained by the Company could reasonably be shown
to constitute proceeds of crime, the Company may decide or be required to suspend declaring or paying dividends without advance
notice and for an indefinite period of time.
Corruption and Anti-Bribery Law Violations
The Company’s business is subject to US
laws which generally prohibit companies and employees from engaging in bribery or other prohibited payments to foreign officials
for the purpose of obtaining or retaining business. In addition, the Company is subject to the anti-bribery laws of any other countries
in which it conducts business now or in the future. The Company’s employees or other agents may, without its knowledge and
despite its efforts, engage in prohibited conduct under the Company’s policies and procedures and anti-bribery laws for which
the Company may be held responsible. The Company’s policies mandate compliance with these anti-corruption and anti-bribery
laws. However, there can be no assurance that the Company’s internal control policies and procedures will always protect
it from recklessness, fraudulent behavior, dishonesty or other inappropriate acts committed by its affiliates, employees, contractors
or agents. If the Company’s employees or other agents are found to have engaged in such practices, the Company could suffer
severe penalties and other consequences that may have a material adverse effect on its business, financial condition and results
of operations.
Legislative or Regulatory Reform and Compliance
The commercial cannabis industry is a new industry,
and we anticipate that such regulations will be subject to change as the federal government and each state monitors both legal
and commercial activity. The Company’s operations are subject to a variety of laws, regulations, guidelines and policies,
whether in the US or elsewhere, relating to the cultivation, manufacture, import, export, management, packaging/labelling, advertising
and promotion, sale, transportation, storage and disposal of cannabis but also including laws and regulations relating to drugs,
controlled substances, health and safety, the conduct of operations and the protection of the environment. The Company is not engaged
in the cultivation, production, manufacturing or sale of cannabis derived products. While to the knowledge of management, the Company,
whose business is only the sublicensing of the Licensed Science, is currently in compliance with all such laws, any changes to
such laws, regulations, guidelines and policies due to matters beyond the Company’s control may cause adverse effects to
the Company’s operations.
Environmental Regulations and Risks
The Company’s operations and the operations
of the sublicensee may be subject to environmental regulation in the various jurisdictions in which it operates. These regulations
mandate, among other things, the maintenance of air and water quality standards and land reclamation. They also set forth limitations
on the generation, transportation, storage and disposal of solid and hazardous waste. Environmental legislation is evolving in
a manner which will require stricter standards and enforcement, increased fines and penalties for non-compliance, more stringent
environmental assessments of proposed projects and a heightened degree of responsibility for companies and their officers, directors
and employees. There is no assurance that future changes in environmental regulation, if any, will not adversely affect the Company’s
operations or the operations of a sublicensee.
Government approvals and permits are currently
and may in the future be required in connection with operation of the Company or the sublicensees. To the extent such approvals
are required and not obtained, the operations of the Company and/or the sublicensees may be curtailed or prohibited from its proposed
production of adult-use or medical cannabis or from proceeding with the development of its operations as currently proposed.
Failure to comply with applicable laws, regulations
and permitting requirements may result in enforcement actions thereunder, including orders issued by regulatory or judicial authorities
causing operations to cease or be curtailed, and may include corrective measures requiring capital expenditures, installation of
additional equipment, or remedial actions. The Company may be required to compensate those suffering loss or damage by reason of
its operations and may have civil or criminal fines or penalties imposed for violations of applicable laws or regulations.
Amendments to current laws, regulations and
permits governing the production of medical cannabis, or more stringent implementation thereof, could have a material adverse impact
on the company and cause increases in expenses, capital expenditures or production costs or reduction in levels of production or
require abandonment or delays in development.
Reliance on Key Personnel
The success of the Company is dependent upon
the ability, expertise, judgment, discretion and good faith of its executive management. The Company’s future success depends
on its continuing ability to attract, develop, motivate and retain highly qualified and skilled employees. Qualified individuals
are in high demand, and the Company may incur significant costs to attract and retain them. The loss of the services of member
of the Company’s executive management, or an inability to attract other suitably qualified persons when needed, could have
a material adverse effect on the Company’s ability to execute on its business plan and strategy, and the Company may be unable
to find adequate replacements on a timely basis, or at all.
Limited Operating History
The Company, while incorporated in 2008, has
not generated revenue from the intended sublicensing of the Licensed Science. The Company is therefore subject to many of the risks
common to early-stage enterprises, including under-capitalization, cash shortages, limitations with respect to personnel, financial
resources, and other resources and lack of revenues. There is no assurance that the Company will be successful in achieving a return
on stockholders’ investment and the likelihood of success must be considered in light of the early stage of operations.
Product Liability
While the Company is not engaged in the cultivation,
production, manufacturing or sale of cannabis derived products, the intended sublicensees will be engaged in the cultivation, production,
manufacturing, packaging and sale of cannabis derived products. As manufacturing and distribution of products designed to be ingested
by humans, will be produced by others using the Licensed Science, the Company faces an inherent risk of exposure to third-party
product liability claims, regulatory action and litigation if such products produced using the Licensed Science are alleged to
have caused significant loss or injury. In addition, the sale of products produced by a sublicensee using the Licensed Science,
involves the risk of injury to consumers due to tampering by unauthorized third parties or product contamination. Previously unknown
adverse reactions resulting from human consumption of such products alone or in combination with other medications or substances
could occur. The Company may be subject to various third- party product liability claims, including, among others, that the products
produced using the Licensed Science caused injury or illness, that such products produced using the Licensed Science did not include
adequate warnings concerning possible side effects or interactions with other substances, or that the use of the Licensed Science
did not include adequate instructions for use.
A product liability claim or regulatory action
against the Company could result in increased costs, could adversely affect the Company’s reputation with its clients and
consumers generally, and could have a material adverse effect on our results of operations and financial condition of the Company.
There can be no assurances that the Company will be able to obtain or maintain product liability insurance on acceptable terms
or with adequate coverage against potential liabilities. Such insurance is expensive and may not be available in the future on
acceptable terms, or at all. The inability to obtain sufficient insurance coverage on reasonable terms or to otherwise protect
against potential product liability claims could prevent or inhibit the commercialization of the sublicensees’ production
of potential products, and therefore the commercialization of the Licensed Science.
Results of Future Clinical Research
To date, there is limited standardization in
the research of the effects of cannabis, and future clinical research studies may lead to conclusions that dispute or conflict
with the current understanding and belief regarding the medical benefits, viability, safety, efficacy, dosing and social acceptance
of cannabis. Research in the United States and internationally regarding the medical benefits, viability, safety, efficacy and
dosing of cannabis or isolated cannabinoids (such as CBD and THC) remains in relatively early stages. Future research and clinical
trials may draw opposing conclusions or could reach different or negative conclusions regarding the medical benefits, viability,
safety, efficacy, dosing or other facts and perceptions related to cannabis, which could adversely affect social acceptance of
cannabis and the demand for the products produced by sublicensees of the Licensed Science.
Insurance Coverage
The Company intends to obtain insurance to protect
its assets, operations, directors and employees. While the Company believes its insurance coverage addresses all material risks
to which it is exposed and is adequate and customary in its current state of operations, such insurance is subject to coverage
limits and exclusions and may not be available for the risks and hazards to which the Company is exposed. In addition, no assurance
can be given that such insurance will be adequate to cover the Company’s liabilities or will be generally available in the
future or, if available, that premiums will be commercially justifiable. If the Company were to incur substantial liability and
such damages were not covered by insurance or were in excess of policy limits, or if the Company were to incur such liability at
a time when it is not able to obtain liability insurance, there could be a material adverse effect on the Company’s business,
financial condition and results of operations.
The Company is also currently pursuing additional
insurance coverage over its product liability claims and for business interruption. While the Company believes the insurance coverage
addresses all material risks to which it is exposed and is adequate and customary in the current state of operations, such insurance
is subject to coverage limits and exclusions and may not be available for the risks and hazards to which the Company is exposed.
Unfavorable Publicity or Consumer Perception
The Company believes the cannabis industry is
highly dependent upon consumer perception regarding the safety, efficacy and quality of cannabis and related products distributed
to such consumers. Consumer perception of the products produced by sublicensees using the Company’s Licensed Science can
be significantly influenced by scientific research or findings, regulatory investigations, litigation, media attention and other
publicity regarding the consumption of cannabis products. There can be no assurance that future scientific research, findings,
regulatory proceedings, litigation, media attention or other research findings or publicity will be favorable to the cannabis market
or any particular product, or consistent with earlier publicity. Future research reports, findings, regulatory proceedings, litigation,
media attention or other publicity that are perceived as less favorable than, or that question, earlier research reports, findings
or publicity could have a material adverse effect on the demand for use of the Licensed Science and the business, results of operations,
financial condition and cash flows of the Company. While the Company is not engaged in the cultivation, production, manufacturing
or sale of cannabis derived products, the Company’s dependence upon consumer perceptions means that adverse scientific research
reports, findings, regulatory proceedings, litigation, media attention or other publicity, whether or not accurate or with merit,
could have a material adverse effect on the demand for use of the Licensed Science and consequently on the Company’s business,
results of operations, financial condition and cash flows of the Company.
Further, adverse publicity reports or other
media attention regarding the safety, efficacy and quality of cannabis and related products in general, or products produced using
the Licensed Science and process, specifically, or associating the consumption of cannabis or related products with illness or
other negative effects or events, could have such a material adverse effect. Such adverse publicity reports or other media attention
could arise even if the adverse effects associated with such products resulted from a sublicensee’s failure to use the Licensed
Science correctly, or a consumers’ failure to consume such products appropriately or as directed. The increased usage of
social media and other web-based tools used to generate, publish and discuss user-generated content and to connect with other users
has made it increasingly easier for individuals and groups to communicate and share opinions and views in regard to the Company
and its activities, whether true or not. Although the Company believes that it operates in a manner that is respectful to all stakeholders
and that it takes care in protecting its image and reputation, it does not ultimately have direct control over how it is perceived
by others. Reputational loss may result in decreased investor confidence, increased challenges in developing and maintaining community
relations and may be an impediment to the Company’s overall ability to advance its projects, thereby having a material adverse
impact on its financial performance, financial condition, cash flows and growth prospects.
Reputational Risk to Third Parties
The parties outside of the cannabis industry
with which the Company does business may perceive that they are exposed to reputational risk as a result of the Company’s
business activities relating to cannabis, even though the Company is not engaged in the cultivation, production, manufacturing
or sale of cannabis derived products. Failure to establish or maintain business relationships could have a material adverse effect
on the Company.
Our Principal Stockholder will Continue to Control us in the
Foreseeable Future
The OZ Corporation is currently the beneficial
owner of 17,679,081 shares of Common Stock representing 6.14% of outstanding shares of Common Stock of the Company, and 4 shares
of Series A Preferred Stock of the Company representing 100% of outstanding shares of Series A Preferred Stock. Each share of Series
A Preferred Stock has super-voting rights equal to 4 times the total number of shares of common stock issued and outstanding plus
the total number of votes of all other classes of preferred stock issued and outstanding, divided by the number of shares of Series
A Preferred Stock issued and outstanding. See “Security Ownership of Certain Beneficial Owners and Management.” Accordingly,
by virtue of its ownership the shares of Class A Common Stock and Series A Preferred, the OZ Corporation will effectively have
the ability to influence significant corporate actions, for the foreseeable future. Such actions include the election of our directors
and the approval or disapproval of fundamental corporate transactions, including mergers, the sale of all or substantially all
of our assets, liquidation, and the adoption or amendment of provisions in our articles of incorporation and bylaws. Such actions
could delay or prevent a change in our control. See “Security Ownership of Certain Beneficial Owners and Management”
and “Description of Securities.”
Additional Financing
There is no guarantee that the Company will
be able to achieve its business objectives. The continued development of the Company will require additional financing. The failure
to raise such capital could result in the delay or indefinite postponement of current business objectives or the Company ceasing
to carry on business. There can be no assurance that additional capital or other types of financing will be available if needed
or that, if available, the terms of such financing will be favorable to the Company. In addition, from time to time, the Company
may enter into transactions to acquire assets or the shares of other corporations. These transactions may be financed wholly or
partially with debt, which may increase the Company’s debt levels. Any debt financing secured in the future could involve
restrictive covenants relating to capital raising activities and other financial and operational matters, which may make it more
difficult for the Company to obtain additional capital and to pursue business opportunities, including potential acquisitions.
Debt financings may also contain provisions which, if breached, may entitle lenders or their agents to accelerate repayment of
loans and/or realize through security covenants, control over the assets of the Company, and there is no assurance that the Company
would be able to repay such loans in such an event or prevent the enforcement of security granted controls pursuant to such debt
financing.
Future Acquisitions or Dispositions
Although there is no present intention to undertake
any of the following transactions, material acquisitions, dispositions and other strategic transactions involve a number of risks,
including: (i) potential disruption of the Company’s ongoing business; (ii) distraction of management; (iii) the Company
may become more financially leveraged; (iv) the anticipated benefits and cost savings of those transactions may not be realized
fully or at all or may take longer to realize than expected; (v) increasing the scope and complexity of the Company’s operations;
and (vi) loss or reduction of control over certain of the Company’s assets.
The presence of one or more material liabilities
of an acquired company that are unknown to the Company at the time of acquisition could have a material adverse effect on the results
of operations, business prospects and financial condition of the Company. A strategic transaction may result in a significant change
in the nature of the Company’s business, operations and strategy. In addition, the Company may encounter unforeseen obstacles
or costs in implementing a strategic transaction or integrating any acquired business into the Company’s operations.
Conflicts of Interest
The Company may be subject to various potential
conflicts of interest because of the fact that some of its officers and directors may be engaged in a range of business activities.
The Company’s executive officers and directors may devote time to their outside business interests, so long as such activities
do not materially or adversely interfere with their duties to the Company. In some cases, the Company’s executive officers,
directors and consultants may have fiduciary obligations associated with these business interests that interfere with their ability
to devote time to the Company’s business and affairs and that could adversely affect the Company’s operations.
In addition, the Company may also become involved
in other transactions which conflict with the interests of its directors and officers who may from time to time deal with persons,
firms, institutions or corporations with which the Company may be dealing, or which may be seeking investments similar to those
the Company desires. The interests of these persons could conflict with the Company’s interests. In addition, from time to
time, these persons may be competing with the Company for available investment opportunities. Conflicts of interest, if any, will
be subject to the procedures and remedies provided under applicable laws. In particular, in the event that such a conflict of interest
arises at a meeting of the Board, a director who has such a conflict will abstain from voting for or against the approval of such
participation or such terms. In accordance with applicable laws, the Company’s directors are required to act honestly, in
good faith and in the Company’s best interests.
Litigation
From time to time, the Company may become involved
in legal proceedings or be subject to claims, some of which arise in the ordinary course of the Company’s business. Litigation
is inherently uncertain, and any adverse outcomes could negatively affect the Company’s business, results of operations,
financial condition, brand and/or the trading price of its securities. In addition, litigation can involve significant management
time and attention and be expensive, regardless of outcome. During the course of litigation, there may be announcements of the
results of hearings and motions and other interim developments related to the litigation. If securities analysts or investors regard
these announcements as negative, the trading price of the Company’s securities may decline. In addition, the Company evaluates
these litigation claims and legal proceedings to assess the likelihood of unfavorable outcomes and to estimate, if possible, the
amount of potential losses. Based on these assessments and estimates, the Company may establish reserves or disclose the relevant
litigation claims or legal proceedings, as appropriate. These assessments and estimates are based on the information available
to management at the time and involve a significant amount of management judgment. Actual outcomes or losses may differ materially
from the Company’s current assessments and estimates.
Intellectual Property
The ownership and protection of trademarks,
patents, trade secrets, intellectual property and any licensed rights are significant aspects of the Company’s future success.
Unauthorized parties may attempt to replicate or otherwise obtain and use the Licensed Science and rights granted to the Company.
Policing the unauthorized use of the Company’s current or future trademarks, patents, trade secrets, intellectual property
or licensed rights could be difficult, expensive, time-consuming and unpredictable, as may be enforcing these rights against unauthorized
use by others. Identifying unauthorized use of such rights is difficult as the Company may be unable to effectively monitor and
evaluate the products being distributed by its competitors, including parties such as unlicensed dispensaries, and the processes
used to produce such products. In addition, in any infringement proceeding, some or all of the Company’s trademarks, patents,
other intellectual property rights, licensed rights, or other proprietary know-how, or arrangements or agreements seeking to protect
the same for the benefit of the Company, may be found invalid, unenforceable, anti-competitive or not infringed. An adverse result
in any litigation or defense proceedings could put one or more of the Company’s trademarks, patents, other intellectual property
or licensed rights at risk of being invalidated or interpreted narrowly and could put existing intellectual property applications
at risk of not being issued. Any or all of these events could materially and adversely affect the Company’s business, financial
condition and results of operations.
In addition, other parties may claim that the
Company’s products infringe on their proprietary and perhaps patent protected rights. Such claims, whether or not meritorious,
may result in the expenditure of significant financial and managerial resources, legal fees, result in injunctions, temporary restraining
orders and/or require the payment of damages. As well, the Company may need to obtain licenses from third parties who allege that
the Company has infringed on their lawful rights. However, such licenses may not be available on terms acceptable to the Company
or at all. In addition, the Company may not be able to obtain or utilize on terms that are favorable to it, or at all, licenses
or other rights with respect to intellectual property that it does not own.
Customer Acquisitions
The Company’s success depends on its ability
to attract and retain customers (i.e. sublicensees of the Licensed Science). There are many factors which could impact the Company’s
ability to attract and retain customers, including but not limited to the Company’s brand awareness, its ability for the
Licensed Science to continually produce desirable and effective cannabis products and the successful implementation of customer-acquisition
plans. The failure to acquire and retain customers could have a material adverse effect on the Company’s business, financial
condition and results of operations.
Fraudulent or Illegal Activity
The Company is exposed to the risk that its
employees, independent contractors and consultants may engage in fraudulent or other illegal activity. Misconduct by these parties
could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to the Company that violates:
(i) government regulations; (ii) manufacturing standards; (iii) federal healthcare fraud and abuse laws and regulations; or (iv)
laws that require the true, complete and accurate reporting of financial information or data. It is not always possible for the
Company to identify and deter misconduct by its employees and other third parties, and the precautions taken by the Company to
detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting the
Company from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws
or regulations. If any such actions are instituted against the Company, and it is not successful in defending itself or asserting
its rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative
penalties, damages, monetary fines, contractual damages, reputational harm, diminished profits and future earnings, and curtailment
of the Company’s operations, any of which could have a material adverse effect on the Company’s business, financial
condition and results of operations.
Information Technology Systems and Cyber-Attacks
The Company has entered into agreements with
third parties for hardware, software, telecommunications and other information technology services in connection with its operations.
The Company’s operations depend, in part, on how well it and its suppliers protect networks, equipment, information technology
systems and software against damage from a number of threats, including, but not limited to, cable cuts, damage to physical plants,
natural disasters, intentional damage and destruction, fire, power loss, hacking, computer viruses, vandalism and theft. The Company’s
operations also depend on the timely maintenance, upgrade and replacement of networks, equipment, information technology systems
and software, as well as pre-emptive expenses to mitigate the risks of failures. Any of these and other events could result in
information system failures, delays and/or increase in capital expenses. The failure of information systems or a component of information
systems could, depending on the nature of any such failure, adversely impact the Company’s reputation and results of operations.
The Company has not experienced any material
losses to date relating to cyber-attacks or other information security breaches, but there can be no assurance that the Company
will not incur such losses in the future. The Company’s risk and exposure to these matters cannot be fully mitigated because
of, among other things, the evolving nature of these threats. As a result, cyber security and the continued development and enhancement
of controls, processes and practices designed to protect systems, computers, software, data and networks from attack, damage or
unauthorized access is a priority. As cyber threats continue to evolve, the Company may be required to expend additional resources
to continue to modify or enhance protective measures or to investigate and remediate any security vulnerabilities.
Security Risks
Given the nature of the products which may be
produced by sublicensees using the Company’s Licensed Science and its lack of legal availability outside of channels approved
by the government, there remains a risk of shrinkage as well as theft at a sublicensee’s facility. A security breach at one
of the Company’s or its sublicensee’s facilities could expose the Company to additional liability and to potentially
costly litigation, increase expenses relating to the resolution and future prevention of these breaches and may deter potential
patients from choosing the Company’s products.
A privacy breach may occur through procedural
or process failure, information technology malfunction, or deliberate unauthorized intrusions. Theft of data for competitive purposes
is an ongoing risk whether perpetrated via employee collusion or negligence or through deliberate cyber-attack. Any such theft
or privacy breach would have a material adverse effect on the Company’s business, financial condition and results of operations.
Challenging Global Financial Conditions
In recent years, global credit and financial
markets have experienced extreme disruptions, including with respect to, at times, severely diminished liquidity and credit availability,
declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability.
There can be no assurance that significant deterioration in credit and financial markets and confidence in economic conditions
will not occur in the future. Any such economic downturn, volatile business environment or continued unpredictable and unstable
market conditions could have a material adverse effect on the Company’s business, financial condition and results of operations.
Further, global credit and financial markets
have displayed arguably increased volatility in response to global events. Future crises may be precipitated by any number of causes,
including natural disasters, geopolitical instability, changes to energy prices or sovereign defaults. These factors may impact
the ability of the Company to obtain equity or debt financing in the future and, if obtained, on terms favorable to the Company.
Increased levels of volatility and market turmoil can adversely impact the Company’s operations and the value, and the price
of the Common Shares could be adversely affected.
In addition, there is a risk that one or more
of the Company’s current service providers may themselves be adversely impacted by difficult economic circumstances, which
could have a material adverse effect on the Company’s business, financial condition and results of operations.
History of Losses
The Company incurred losses in prior periods.
The Company may not be able to achieve or maintain profitability and may continue to incur significant losses in the future. In
addition, the Company expects to continue to increase operating expenses as it implements initiatives to continue to grow its business.
If the Company’s revenues do not increase to offset these expected increases in costs and operating expenses, the Company
will not be profitable.
Competition
The Company expects significant competition
from other companies. A large number of companies appear to be applying for cultivation, processing and sale licenses, some of
which may have significantly greater financial, technical, marketing and other resources than the Company. These competitors may
be able to devote greater resources to the development, promotion, sale and support of their products and services, and may have
more extensive customer bases and broader customer relationships. The Company’s future success depends upon its ability to
sublicense the Licensed Science and generate an initial and continuing royalty stream. To the extent that the Company is not able
to market and enter into enough sublicenses, the Company’s business, financial condition and results of operations could
be materially and adversely affected.
Should the size of the cannabis market increase
as projected the overall demand for products and number of competitors will increase as well, and in order for demand for the Company’s
Licensed Science to be competitive it will need to invest significantly in research and development, market development, marketing,
production expansion, new client identification, distribution channels and client support. If the Company is not successful in
obtaining sufficient resources to invest in these areas, the Company’s ability to compete in the market may be adversely
affected, which could materially and adversely affect the Company’s business, financial condition and results of operations.
Difficulty to Forecast
The Company must rely largely on its own market
research to forecast sales as detailed forecasts are, with certain exceptions, not generally available from other sources at this
early stage of the cannabis industry. A failure in the demand for the sub-licensing and use of the Licensed Science, or products
produced by third parties using the Licensed Science, to materialize as a result of competition, technological change, change in
the regulatory or legal landscape or other factors could have a material adverse effect the Company’s business, financial
condition and results of operations.
Unsolicited Takeover Proposals
The review and consideration of any takeover
proposal may be a significant distraction for the Company’s management and employees and could require the expenditure of
significant time and resources by the Company.
Moreover, any unsolicited takeover proposal
may create uncertainty for the Company’s employees and this uncertainty may adversely affect the Company’s ability
to retain key employees and to hire new talent. Any such takeover proposal may also create uncertainty for the Company’s
customers, suppliers and other business partners, which may cause them to terminate, or not to renew or enter into, arrangements
with the Company. The uncertainty arising from unsolicited takeover proposals and any related costly litigation may disrupt the
Company’s business, which could result in an adverse effect on its business, financial condition and results of operations.
Management and employee distraction related to any such takeover proposal also may adversely impact the Company’s ability
to optimally conduct its business and pursue its strategic objectives.
Risks Related to the Company’s Common Shares
Volatile Market Price of the Common Shares
The market price of the Common Shares may be
volatile and subject to wide fluctuations in response to numerous factors, many of which are beyond the Company’s control.
This volatility may affect the ability of holders of Common Shares to sell their securities at an advantageous price.
Market price fluctuations in the Common Shares
may be due to the Company’s results of operations failing to meet expectations of securities analysts or investors in any
period, downward revision in securities analysts’ estimates, adverse changes in general market conditions or economic trends,
acquisitions, dispositions or other material public announcements by the Company or its competitors, along with a variety of additional
factors. These broad market fluctuations may adversely affect the market price of the Common Shares. Financial markets historically
at times experienced significant price and volume fluctuations that have particularly affected the market prices of equity securities
of companies and that have often been unrelated to the operating performance, underlying asset values or prospects of such companies.
Accordingly, the market price of the Common Shares may decline even if the Company’s results of operations, underlying asset
values or prospects have not changed. Additionally, these factors, as well as other related factors, may cause decreases in asset
values that are deemed to be other than temporary, which may result in impairment losses. There can be no assurance that continuing
fluctuations in price and volume will not occur. If such increased levels of volatility and market turmoil continue, the Company’s
operations could be adversely impacted, and the trading price of the Common Shares may be materially adversely affected.
Risks Related to Dilution
The Company may issue Common Shares in the future,
which may dilute a stockholder’s holdings in the Company. The Company’s articles permit the issuance of Common Shares,
and stockholders will have no pre-emptive rights in connection with such further issuance. The Board has discretion to determine
the price and the terms of issue of further issuances. Issuances of the Company’s securities may involve the issuance of
a significant number of Common Shares at prices less than the current market price for the Common Shares. Issuances of substantial
numbers of Common Shares, or the perception that such issuances could occur, may adversely affect prevailing market prices of the
Common Shares. Any transaction involving the issuance of previously authorized but unissued Common Shares, or securities convertible
into Common Shares, would result in dilution, possibly substantial, to security holders. Moreover, additional Common Shares will
be issued by the Company on the exercise of options under the Company’s stock option plan and upon the exercise of outstanding
warrants.
The Company may sell equity securities in offerings
(including through the sale of securities convertible into equity securities). The Company cannot predict the size of such issuances
of equity securities or the size and terms of future issuances of debt instruments or other securities convertible into equity
securities or the effect, if any, that future issuances and sales of the Company’s securities will have on the market price
of the Common Shares.
Sales of substantial amounts of the Company’s
securities by the Company or its existing stockholders, or the availability of such securities for sale, could adversely affect
the prevailing market prices for the Company’s securities and dilute investors’ earnings per Common Share. Exercises
of presently outstanding share options or warrants, if any, may also result in dilution to security holders. A decline in the market
prices of the Company’s securities could impair the Company’s ability to raise additional capital through the sale
of securities should the Company desire to do so.
Dividends
The Company has not paid any dividends on the
outstanding Common Shares, and the Company has no current intention to declare dividends on the Common Shares in the foreseeable
future. Any decision to pay dividends on the Common Shares in the future will be at the discretion of the Board and will depend
on, among other things, the Company’s results of operations, current and anticipated cash requirements and surplus, financial
condition, any future contractual restrictions and financing agreement covenants, solvency tests imposed by corporate law and other
factors that the Board may deem relevant. As a result, investors may not receive any return on an investment in the Common Shares
unless they are able to sell their Common Shares for a price greater than that which such investors paid for them.
Regulated Nature of the Company’s Business May Impede
or Discourage a Takeover
The Company requires and holds various licenses
to operate its business, which would not necessarily continue to apply to an acquiror of the Company’s business following
a change of control. These licensing requirements could impede a merger, amalgamation, takeover or other business combination involving
the Company or discourage a potential acquirer from making a tender offer for Common Shares, which, under certain circumstances,
could reduce the market price of the Common Shares.
Liquid Trading Market
The Company’s stockholders may be unable
to sell significant quantities of Common Shares into the public trading markets without a significant reduction in the price of
their Common Shares, or at all. There can be no assurance that there will be sufficient liquidity of the Common Shares on the trading
market, and that the Company will continue to meet the listing requirements of any public listing exchange.
Risks Related to Changes in Laws, Regulations and Guidelines
The Company’s operations are subject to
various laws, regulations and guidelines relating to the manufacture, management, packaging/labelling, advertising, sale, transportation,
storage and disposal of adult-use or medical cannabis but also including laws and regulations relating to drugs, controlled substances,
health and safety, the conduct of operations and the protection of the environment. Changes to such laws, regulations and guidelines
due to matters beyond the control of the Company may cause adverse effects business, financial condition and results of operations
of the Company. The Company endeavors to comply with all relevant laws, regulations and guidelines. To the best of the Company’s
knowledge, the Company is in compliance or in the process of being assessed for compliance with all such laws, regulations and
guidelines.
Emerging Growth Company
The Company is an “emerging growth company,”
as defined in the US Jumpstart Our Business Start-ups Act, and it uses the exemption provided to emerging growth companies
from the auditor attestation requirements of Section 404(b) of the Sarbanes Oxley Act of 2002 (“SOX”).
Therefore, the Company’s internal controls over financial reporting (“ICOFR”) will not receive the level of review
provided by the process relating to the auditor attestation included in annual reports of issuers that are not using an exemption.
Emerging Growth Company Status
We are an “emerging growth company,”
as defined in the Jumpstart our Business Startups Act of 2012 (“JOBS Act”), and we may take advantage of certain exemptions
from various reporting requirements that are applicable to other public companies, including, but not limited to, not being required
to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations
regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding
a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors
find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock
price may be more volatile.
Section 107 of the JOBS Act provides that an
“emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the
Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company”
can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have
elected not to opt out of the transition period pursuant to Section 107(b).
We could remain an “emerging growth company”
for up to five years, or until the earliest of (i) the last day of the first fiscal year in which our annual gross revenues exceed
$1 billion, (ii) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act,
which would occur if the market value of our common stock that is held by non-affiliates exceeds $700 million as of the last business
day of our most recently completed second fiscal quarter, or (iii) the date on which we have issued more than $1 billion in non-convertible
debt during the preceding three-year period.
Smaller Reporting Company
We are currently a “smaller reporting
company”, meaning that we are not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent
company that is not a smaller reporting company and have a public float of less than $75 million and annual revenues of less than
$50 million during the most recently completed fiscal year. In the event that we are still considered a “smaller reporting
company,” at such time are we cease being an “emerging growth company,” the disclosure we will be required to
provide in our SEC filings will increase, but will still be less than it would be if we were not considered either an “emerging
growth company” or a “smaller reporting company.” Specifically, similar to “emerging growth companies,”
“smaller reporting companies” are able to provide simplified executive compensation disclosures in their filings; are
exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting
firms provide an attestation report on the effectiveness of internal control over financial reporting; and have certain other decreased
disclosure obligations in their SEC filings, including, among other things, only being required to provide two years of audited
financial statements in annual reports. Decreased disclosures in our SEC filings due to our status as an “emerging growth
company” or “smaller reporting company” may make it harder for investors to analyze our results of operations
and financial prospects.
We do not anticipate earning revenues until
such time as we able to fully market sublicenses. For these reasons, our auditors stated in their report on our audited financial
statements that they have substantial doubt that we will be able to continue as a going concern without further financing. The
ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish its plan of operations
described herein and eventually attain profitable operations, and source acceptable financing in the interim period.
We anticipate that any additional funding that
we require will be in the form of equity financing from the sale of our common stock. However, there is no assurance that
we will be able to raise sufficient funding from the sale of our common stock. The risky nature of our business enterprise
places debt financing beyond the creditworthiness required by most banks or typical investors of corporate debt until such time
as our products are available on the market. We do not have any arrangements in place for any future equity financing. If
we are unable to secure additional funding, we will cease or suspend operations. We have no plans, arrangements or contingencies
in place in the event that we cease operations.