Item
1. Business.
Overview
We
develop hemp-derived, cannabidiol-based products, each formulated to address key segments of the health and wellness market. Through
our subsidiaries and strategic partnerships, we sell high-end, full-spectrum oils, extracts, topicals, and pet products, all with the
shared purpose of supporting the potential of relief of pain and inflammation for humans and pets through our e-commerce site www.cbdunlimited.com,
as well as other online and in-store retailers. Our products are built upon three key fundamentals: targeted-delivery, controlled-dosing,
and dual-therapy applications. Our products have been formulated with input from nutrition experts, cosmetic specialists, and Doctors
of Podiatric Medicine; use American-sourced hemp-derived materials; and use the highest quality natural ingredients. Each product undergoes
rigorous quality control checks to ensure that the final product is of the highest possible quality and is tested and verified by independent
laboratories. (See, “Government Regulation.”) We continue to invest in research and development in order to develop
new products and delivery methods. We plan to scale our production to meet growing consumer demand by entering into new joint ventures
and securing commitments from large retailers with national presence.
In
addition to our consumer products, our Gorilla-Tek division offers a state-of-the art automated dispensing system providing a secure
method of distributing hemp-based products. The proprietary system enables retailers to increase sales channels without opening a physical
storefront location. Complementing our retail products and Gorilla-Tek divisions, we also own and operate a number of wholly-owned subsidiaries
that offer technology and consulting solutions to the hemp and hemp-derived product industry, including an easy to use “Seed-to-Shelf”
compliance and inventory tracking and process management system for regulated products in a front of counter pharmacy support platform.
We
are led by a management team and advisory group that has decades of experience in the pharmacy, medical, hemp-derived products, nutraceutical,
and health supplement industries. Our strategic partnerships include leading regulated hemp farms, manufacturers, marketers, and retailers
with national presence, all supporting the development and sale of our hemp-derived products. We are based in Cave Creek, Arizona.
Historical
Overview
The
Company was incorporated in the State of Nevada on September 5, 1997 as Micron Solutions, Inc. (“Micron Solutions”), in order
to complete a merger with Shillelagh Ventures Chartered, a Utah corporation (“Shillelagh”). In November 1997, Shillelagh
merged with and into Micron Solutions, with Micron Solutions as the surviving entity.
In
2002, Micron Solutions entered into an Exchange Agreement (the “Exchange Agreement”) with PanaMed, Inc., a California corporation,
formerly known as PanaMed Africa, Inc., and all of its shareholders, pursuant to which they transferred and assigned their common shares
to Micron Solutions in exchange for an equal number of shares of common stock of Micron Solutions, thereby causing PanaMed, Inc. to become
a wholly-owned subsidiary of Micron Solutions. In connection with the Exchange Agreement, Micron Solutions (i) changed its name to PanaMed
Corporation (“PanaMed Corporation”), (ii) effected a 1-for-10 reverse stock split, such that every ten shares of PanaMed
Corporation’s common stock became one share of its common stock, and (iii) amended its Articles of Incorporation similarly to decrease
the number of its authorized shares of capital stock by the same ratio as the reverse stock split ratio. From 2002 to 2005, PanaMed Corporation
operated as a biotech service and licensing company, investing capital into biotechnologies and conducting therapeutic treatment programs
in the Ivory Coast, Africa.
In
June 2005, we filed a Certificate of Amendment to our Articles of Incorporation with the Secretary of State of the State of Nevada to
change our name to Endexx Corporation. At that time, we adopted our current trading symbol, “EDXC.” In September 2005, we
acquired Visual Board Books, Inc. (“VBB”), a Software-as-a-Service (“SaaS”) developer, through a merger, whereby
VBB merged with and into us, and we were the surviving entity. Subsequently, we operated as a diversified technology and SaaS and compliance
and tracking systems company until we shifted our focus to the hemp-derived product industry in August 2014. In October 2018, we changed
our name to CBD Unlimited, Inc., and in May 2020, we changed our name back to Endexx Corporation, with CBD Unlimited, Inc., becoming
our wholly-owned subsidiary. On January 25, 2021, we filed our Amended and Restated Articles of Incorporation.
Operating
Subsidiaries
We
currently have two primary operating subsidiaries:
Go
Green Global Enterprises, Inc.
We
acquired Go Green Global Enterprises, Inc., a Nevada corporation (“Go Green Global”), pursuant to a Common Stock Share Exchange
Agreement (the “GG Share Exchange Agreement”), dated May 1, 2018, with Go Green Global, as subsequently amended by the First
Amended Common Stock Share Exchange Agreement, dated July 10, 2018 (the “Amendment”; and, together with the GG Share Exchange
Agreement, the “Amended Exchange Agreement”). Pursuant to the Amended Exchange Agreement, we issued 10,000,000 restricted
shares of our Common Stock to the two former equity owners of Go Green Global in exchange for 20,000,000 restricted shares of Go Green
Global’s common stock, which constituted all of its post-closing issued and outstanding shares of common stock, and resulted in
Go Green Global becoming our wholly-owned subsidiary. The GG Share Exchange Agreement was the first step in our proposed entry into the
Jamaican cannabis market.
In
June 2018, Go Green Global entered into an Agreement for the Assignment and Assumption of Contracts, Intellectual Property, Trade Secrets,
and Business Opportunities (the “Go Green Global and Jamaica Assignment”) with Go Green Global Enterprises Limited, a Jamaican
corporation (“Go Green Jamaica”), in furtherance of Go Green Global’s business strategy to commence operations in Jamaica.
As a result of the Go Green Global and Jamaica Assignment, Go Green Global now owns 49% of the ordinary shares of Go Green Jamaica. The
remaining 51% of the ordinary shares are held by Go Green Jamaica’s legacy equity owners (including one of its directors, Kent
Gammon), each of whom is otherwise unaffiliated with the Company. Our Chief Executive Officer, Todd Davis, serves as one of the three
directors of Go Green Jamaica and as its President.
Pursuant
to the Go Green Global and Jamaica Assignment, Go Green Jamaica assigned to Go Green Global certain assets, including (i) two consulting
agreements, (ii) a lease for approximately 1,200 square feet of retail space to be operated as a “retail herb house” to be
located in Ocho Rios, Jamaica, now that a “Retailer Licence” has been obtained from the Cannabis Licensing Authority of Jamaica
(the “Jamaica CLA”), (iii) a lease for approximately one acre to be used to grow cannabis once the relevant license for growing
operations has been obtained from the Jamaica CLA, and (iv) license applications to grow, cultivate, process, package, and sell medical
cannabis in Jamaica. As of June 17, 2021, Go Green Global has become licensed by the Jamaica CLA for retail sales and, prior to the date
of this Annual Report on Form 10-K, the Jamaica CLA granted a provisional license for cultivation. We expect to commence retail operations
on or about September 1, 2021. We expect that the cultivation license process will be completed in approximately six months, which will
allow Go Green Jamaica then to commence its cultivation operations in Jamaica.
Together
One Step Closer, LLC
We
acquired Together One Step Closer, LLC, an Arizona limited liability company, doing business as Holistic Earth Remedies (“Holistic
Earth Remedies”), pursuant to a Stock Purchase Agreement (the “Holistic SPA”), dated November 8, 2017, entered into
between Holistic Earth Remedies and us. Pursuant to the Holistic SPA, we acquired all of the issued and outstanding equity interests
in Holistic Earth Remedies and, in consideration thereof, we issued 1,000,000 restricted shares of our Common Stock to its then-sole
member, who was otherwise unaffiliated with us. Holistic Earth Remedies specializes in the formulation, production, and sales of a full
line of topical lotions, gels, salves, balms, and spray applications for the potential natural relief of pain, inflammation, stress,
and mild skin irritation. Holistic Earth Remedies currently has limited operations. It distributes third-party manufactured hemp-derived
products that are sold at select health spas, fitness centers and alternative medicine outlets.
Additionally,
we recently completed three acquisitions in connection with our business plan:
Kush
Inc.
On
February 1, 2020, we entered into a Stock Purchase Agreement with Kush Inc. (aka Kushwear; “Kush”), pursuant to which agreement
we acquired all of the issued and outstanding shares of capital stock of Kush. In consideration thereof, at the closing of the transaction,
we issued 500,000 restricted shares of our Common Stock to Charles Mohr, the sole shareholder of Kush, and are obligated to issue up
to an additional 500,000 restricted shares of our Common Stock upon meeting certain milestones. One hundred twenty-five thousand of such
additional restricted shares of our Common Stock will be issued upon the occurrence of each of the following events: (i) Kush clients
generating $150,000 in gross sales revenue, (ii) 3,000 points of distribution being established, (iii) a positive return on investment
being established in the first year of the agreement (which event did not occur), and (iv) the achievement of 200,000 “likes or
engagements” (in any combination) in social media. We purchased Kushwear for rebranding purposes to reach a younger demographic
with our clothing line and hemp-derived products. As of the date of this Amended Registration Statement, the website has been completed,
but we have not launched our sales activities.
CBD
Life Brands, Inc.
On
March 1, 2020, we entered into a term sheet with CBD Life Brands, Inc. (“CBDLB”), for the purchase of all of CBDLB’s
digital and social assets, intellectual property, and formulas/recipes for its cannabidiol (“CBD”)-infused beverages for
which we paid $100,000. In connection with this transaction, the key employees of CBDLB agreed to enter into standard three-year non-competition
agreements for our benefit. We are still in the process of developing CBD-infused beverage formulations, and expect to launch new products
in late-2023.
Khode,
LLC
On
October 1, 2020, we entered into an LLC Operating Agreement of Khode, LLC (“Khode”) and, in May of 2021, we entered into
a Membership Interest Purchase Agreement that resulted in a minor adjustment to the holdings of the parties thereto. By virtue of that
agreement, we now own 70.01% of the membership interests of Khode and, pursuant to the provisions of the Khode Operating Agreement, are
required to make a capital contribution of $3,500,000. As of the date of this Annual Report on Form 10-K, we have made a partial capital
contribution in the amount of approximately $1,500,000 and expect to raise the balance through limited, private sales of our debt and
equity securities. We cannot provide any assurance that such financing will be available on terms acceptable to us, at times required
by us, if at all. If we fail to make the entire capital contribution, we will be in breach of our obligations under the Khode Operating
Agreement. In the event of such a breach, the 24.99% interest holder in Khode, a Florida corporation known as Serious Promotions, Inc.,
will have the right, exercisable by written notice given at any time on or before the date which is twenty Business Days following the
occurrence of such event of default, to terminate the Endorsement Agreement (as described in the second paragraph, below), with Khode
having a ten-month sell-off period with respect to all Branded Products (as defined in the Khode Operating Agreement) then manufactured
but not yet sold.
Effective
January 22, 2021, we entered into a Percentage Payment Agreement with a third party that is not otherwise affiliated with Khode, pursuant
to which we are obligated to pay to that third party an amount equivalent to 2.1% of all cash received by Khode from its net sales of
certain products during the term of that Percentage Payment Agreement, which will terminate when Khode has been dissolved. As of the
date of this Amended Registration Statement, Khode has not generated any revenues and we cannot provide any assurance that it will generate
any revenues.
During
October 2020, Khode entered into a five-year Endorsement and License Agreement with Serious Promotions, Inc., a Florida corporation,
f/s/o Khaled, professionally known as DJ Khaled, who is an American artist, record executive and producer, and media personality. Pursuant
to that agreement, Khode is to create a custom line of hemp-derived-infused oils, creams, and other beauty products under DJ Khode’s
brand and he is to promote the products through personal appearances, the use of social media platforms, participation in presentation
videos, video, and audio “drops,” and media quotes. In connection with DJ Khaled’s services, Khode is obligated to
make quarterly payments totaling an aggregate of $5,000,000 by July 1, 2025, of which aggregate amount, as of the date of this Annual
Report on Form 10-K, Khode has tendered $750,000 and expects to finance the balance of the quarterly payments through cash flow from
operations of Khode. As of the date of this Annual Report on Form 10-K, Khode has not generated any positive cash flow from operations
and we cannot provide any assurance that it will generate any cash flow from operations in the future in an amount sufficient to, among
other things, make such quarterly payments.
Effective
August 31, 2022, we closed a transaction contemplated by an Agreement (the “Hyla August Agreement”) with HYLA UK Holdco Limited,
a United Kingdom limited company (“Hyla UK”). Pursuant to the terms thereof, we, through our specially formed transaction
subsidiary, purchased (the “Hyla Transaction”) 51% of the issued and outstanding capital stock of Hyla US Holdco Limited,
a Delaware corporation (“Hyla”), a wholly-owned operating subsidiary of Hyla UK. We are holding that 51% as an investment.
(See Item 9b.)
Present
and Future State of Operations
Among
our subsidiaries, acquisitions, and partnerships, CBD Unlimited, Inc., Phytobites Inc., Holistic Earth Remedies, Go Green Global Enterprises,
and our operating agreement with Khode, LLC are operational and in full effect. Over the coming months and years, we intend to: (i) launch
Go Green Global’s retail operation in Jamaica; (ii) re-brand Kushwear’s line-up of sustainable clothing and hemp-derived
products; and (iii) develop CBDLB’s formula of hemp-derived and infused beverages, and integrate them into our product offering.
Overview
of the Hemp-Derived Product Industry
The
Difference Between Hemp and Marijuana
Both
marijuana and hemp come from the same species of plant called “Cannabis.” Hemp is a unique strain or species known as “Cannabis
Sativa L,” which, by dry weight, contains less than 0.3% THC concentration. Cannabis Sativa L plants contain unique compounds called
cannabinoids and terpenoids. CBD is one of approximately 66 cannabinoids found in the Cannabis Sativa L plant and shares many properties
with cannabis (i.e., marijuana). Unlike CBD derived from marijuana, CBD derived from the aerial parts of the hemp plant contains
less than three-tenths of one percent (0.3%) of THC, the component that causes the psychoactive side-effects commonly associated with
marijuana. In general, hemp CBD-based products that have a THC concentration of less than 0.3% is generally considered “legal”
in the United States, and yields a product that some consumers believe contains the observed medicinal benefits of traditional cannabis,
without inducing its “high” in consumers. Notwithstanding the beliefs of many consumers, the FDA has not recognized any medical
benefits derived from CBD. CBD is available in several forms, such as isolates, distillates, and oil extracts, including (i) hemp seed
oil, which has no CBD, (ii) full-spectrum CBD, which contains phyto-cannabinoids, such as THC, CBN, THCA, CBC, and CBG in variable concentrations,
and is considered the most natural form of CBD, and (iii) broad-spectrum CBD, which contains less-to-non-detectable THC than full-spectrum
CBD.
Market
Opportunity
We
believe that, with recent regulatory changes, the hemp-derived product industry is poised for growth. Recent projections from BDS Analytics
Inc. and Arcview Market Research project that the collective market for hemp-derived product sales is poised to exceed $20 billion in
the United States by 2024. This forecast takes into account products sold through licensed dispensaries, pharmaceuticals, and in the
general retail market.
Many
believe this current and prospective growth is driven by education and shifting attitudes towards hemp-derived Products. According to
a January 2019 Consumer Reports survey, an estimated 64 million Americans have tried CBD in the preceding 24 months. A June 2019 Harris
Poll reported that 86% of the survey takers had some awareness of CBD and 56% of the survey takers indicated that they support using
CBD as a potential replacement for traditional pain killers. The June 2019 Harris Poll also indicated that CBD users tend to be younger,
with over 10% of Americans between the ages of 18 and 44 years old using CBD regularly. Overall, males are more likely to have tried
CBD and are more likely to use it regularly: 10% of males responded that they used CBD on a regular basis, as compared to just 4% of
female respondents.
Our
Products
The
hemp-derived product industry is still largely underserved against the demand for natural and nutritional supplements and topicals. With
the industry poised for growth in the coming years, our established portfolio of products and industry solutions can serve multiple market
segments. Our current products and service offerings consist of two groups: (i) consumer products and (ii) technology solutions.
Our
Current Consumer Products
Our
focus is on the development, manufacture, and distribution of nutritional supplements and delivery systems for healthy living for the
nutraceutical consumer market in the form of hemp-based, non-psychoactive cannabinoids and terpenoid extracts that are infused into products.
Our current products encompass hemp-derived oils, topicals, extracts, drinks, premium chocolates, and a newly launched premium blue line
of hemp-derived health and beauty care products. Our Phyto-bites are hemp-derived soft chews for animal use that are formulated to promote
health and potentially support an improved quality of life.
According
to the National Institutes of Health, a “dietary supplement” is a product that is intended to supplement the diet. A dietary
supplement contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other
substances) or their components; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is identified on the front
label of the product as being a dietary supplement. None of our products is a dietary supplement.
We
have built a network of reliable suppliers of high-quality, hemp-derived products and provide pharmacy-grade delivery systems with consistent
and precise dosages. The derived and finished products are tested at the point of origin and retested in the certified labs for contaminants,
trace elements, potency, and purity. All products are developed and produced in ISO 9000 and GMP and OTC-certified facilities in collaboration
with our distribution partners throughout the United States and established licensed medical hemp manufacturing and processing facilities.
We
believe that our product line is establishing a new standard in quality, transparency, consistency, and accuracy. Using current extraction
technologies and sustainable cultivation practices, our ultimate goal is to improve the safety, quality, and bioavailability of hemp-derived
products to our customers. All of our products are sold on our e-commerce site, www.cbdunlimited.com, which seamlessly brings
together our products, marketing content, and education into a single platform. The Premium Blue Line is marketed to the mass pharmacy,
mass retail, and mass food markets.
Our
existing consumer products include energy drinks, water products, tea bags, and K-Cup Pods and hemp-derived creams and mists.
Products
Under Development and Implementation
Gorilla-Tek
We
have developed and, subject to manufacturing, are implementing “Gorilla-Tek,” a secure automated inventory control and dispensing
system developed for managing high value items. The technology has been re-engineered for the hemp-derived product and pharmacy industries
and offers retailers a new venue for selling hemp-derived products in a safe and secure manner. The dispensing system is a kiosk that
comes in multiple forms and is no larger than traditional vending machines. We also recently launched a propriety application as an “end
cap” machine designed to service, educate, and advertise hemp-derived products as a self-contained full-service store within in
a store.
Gorilla-Tek
was acquired in connection with our acquisition of Dispense Labs LLC in 2013 and uses proprietary software that is specifically designed
to secure and control compliant transactions and manage inventory. We believe this will significantly improve profitability, accountability,
security, and customer satisfaction. Gorilla-Tek is specifically designed and configured to dispense hemp-derived products, regulated
products, and prescription refills, while also managing the supply chain, providing up-to-the-minute accounting details, and protecting
the security of the product, as well as the consumer and/or patient accessing the system. Gorilla-Tek has been tested in high-risk one
in each of three geographically dispersed locations: Santa Ana, California; Denver, Colorado; and Kingston, Jamaica in licensed dispensaries.
Originally known as “Autospense,” Gorilla-Tek was rebranded to reflect automated retail and remote retail applications better,
where additional security, age compliance, and tracking are required. The Gorilla-Tek machines were strategically positioned at high-traffic
areas in order to promote easy access and significant use. Initial results were promising, as retailers saw increased sales, reduced
theft of products, and stronger inventory control. Subsequent to completion of testing, one of the machines is currently located at the
manufacturing facility in California, the second is located at a retail establishment in Kingston, Jamaica, and the third is located
at the retail facility in Kingston, Jamaica that we will operate now that we have received our license for retail sales from the Jamaica
CLA. We expect to release Gorilla-Tek to the broader market in late-2022 and 2023, where we intend to partner with national retailers
interested in selling hemp-derived products.
Dudad
“Dudad”
is an Acoustic Fingerprint Audio Ad Capture and advertising application platform. Development of the base operating system has been finalized.
Additional investments will be required to commercialize the technology, and there can be no assurance that we will expend the resources
necessary for commercialization, that we will have available resources, or that the technology can even be commercialized successfully.
In order to commercialize Dudad, we will need to update the software app to current Python integration capabilities and then we will
need to market it to the advertising industry. Python is an open-source programming language managed by the Python Software Foundation.
WE believe that third-party programmers will be able to update the software for an expenditure of not more than $100,000. We do not currently
know the economic extent of the marketing required for Dudad. When ready, as to which there can be no assurance, we expect to promote
Dudad through advertisements in Advertising Age and other industry outlets.
Distribution
Methods
All
of our products are currently sold online through our e-commerce platform www.cbdunlimited.com, select distributors, specialty
sales groups, and brick-and-mortar retailers.
We
distribute our products throughout the United States, and now that the Cannabis Licensing Authority of Jamaica has granted Go Green Jamaica
a “Retailer Licence,” we expect to commence the distribution of our products on a limited basis in Jamaica through Go Green
Global and Go Green Jamaica commencing on or about September 1, 2021. Our product offerings to be sold in Jamaica through Go Green Global
are expected to include medical cannabis products regulated by the Jamaica CLA, hemp-derived products, clothing, and other shop-related
products. A portion of our sales comes through our e-commerce platform, and orders are fulfilled at our fulfillment center, which is
located at our headquarters in Cave Creek, Arizona. Demand for our products is generally increasing and we are contemplating a transition
of our distribution to a third-party fulfillment center.
In
addition to our e-commerce website, several distributors carry our products and sell them into mass pharmacy, retail stores, food chains,
convenience stores, gas station stores, and specialty shops. Our current retail strategy entails targeting accounts and regions throughout
the United States where we believe our products, including our hemp-derived creams and mists, are most likely to succeed with retail
shoppers. Our distribution and retail strategy aims to increase our brand exposure and drive follow-on purchases at retail locations
that carry our products and through our e-commerce platform. We intend to utilize social media, print, radio, and digital marketing,
as well as broad distribution agreements. We currently have distribution agreements with:
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Southern
Glazer’s Wine and Spirits, LLC: we entered into a 10-year (subject to successive automatic five-year renewals) Master Distribution
Agreement, dated March 27, 2020, pursuant to which we appointed SGWS as our sole and exclusive distributor of certain of our products
(as defined in the Agreement) to retail accounts that are licensed to sell alcoholic beverages in the territory (as defined in the
Agreement), subject our rights to sell our products to end-users in the territory through electronic commerce. |
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Impulse
Health LLC: we entered into a two-year (subject to successive automatic two-year renewals) Sales Representative Agreement, dated
April 1, 2020, pursuant to which pursuant to which we appointed Impulse Health as our exclusive sales representative of certain of
our products (as defined in the Agreement) to certain accounts (as defined in the Agreement). |
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Beauty
Strategy Group, LLC: we entered into a 12-month (subject to extension mutually agreeable to the parties) Brand Consulting Agreement,
dated April 21, pursuant to which we granted Beauty Strategy the right to act as our consultant and the authorization to solicit
orders from Ulta and Sephora in accordance with our regular terms of sale and prices then in effect. |
Effective
on October 9, 2020, Khode entered into a Master Service Agreement with Impact Brokers, LLC, for a term that continues for the duration
of the transactions contemplated by the Khode Operating Agreement. During the term of that agreement, Impact Brokers will provide to
Khode strategic, creative, and operational support for those transactions.
The
above summary description of each of the four agreements is not intended to be comprehensive. For a more complete understanding of each
of the agreements, please see Exhibits 10.27, 10.28, 10.29, and 10.30 to this Annual Report on Form 10-K.
During
our 2022 fiscal year, we did not have any significant customer concentrations.
Marketing
The
key goal of our sales and marketing campaign is to provide broad exposure of our products and their demonstrated potential effectiveness
to our target markets. We have adopted a multi-pronged approach to market our products and build brand awareness, encompassing digital,
social, educational, and affiliate marketing:
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Social
Media Marketing: We are capitalizing on the reach of social media platforms, including Facebook, Instagram, and Twitter, to work
with social media influencers to increase our brand awareness. |
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Digital
Ads and Search Engine Optimization: We are developing personalized digital advertisements to target different consumer segments
and explain the potential benefits of our products. Additionally, we intend to work with our partners and public relations team to
optimize search engine results for our brand in the hemp-derived product category.
We
expect that our future marketing campaign will include: |
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Affiliate
Marketing: We are in the process of adopting an affiliate marketing campaign, where our sales teams and social media influencers
will market and sell our products through their network of contacts and followers. We expect that our affiliate marketing campaign
will offer commissions on sales and referrals that should enable the growth of our sales and brand awareness. |
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Television
and Radio Content: We intend to make regular appearances on radio stations and news segments to discuss our Company and its brands,
and the hemp-derived product industry as a whole. |
Competition
The
hemp-derived product industry is subject to significant competition and is comprised of thousands of businesses, ranging from growers,
extractors, and manufacturers to distributors and retailers, and this number is expected to grow substantially in the coming years. We
directly compete with small-to-mid-sized manufacturers with annual revenues between $2 million and $20 million. However, if we are successful
in achieving our future growth targets, of which there can be no assurance, we would compete with much larger companies that generate
annual revenues in excess of $50 million. Some of our key competitors include Alternate Health Corp., Charlotte’s Web Holdings,
Inc., Cresco Labs, Inc., Curaleaf Holdings Inc., CV Sciences, Inc., Elixinol Global Ltd., Eviana Health Corp., KannaLife, Inc., Ovation
Science Inc., and Zynerba Pharmaceuticals, Inc.
Competition
against these brands is fierce, with each manufacturer offering a host of hemp-derived products directly competing with us. This can
over-populate the market with indistinguishable products and brands, forcing customers to buy products with little information. With
so many brands in the market, having a competitive differentiator is essential to attract customers. We believe our products are superior
to those of many of our competitors because we have established formulations with controlled dosing and delivery systems, and have tested
this platform within the healthcare industry with physicians, pharmacists, healthcare service providers, and veterinarians through clinical
trials or other pharmacy collaborations. Additionally, we believe that providing good customer service to our customers, through transparency
and education, will set us apart from our competitors. However, it is possible that one or more of our competitors could develop significant
research or marketing advantages over us that allows them to provide superior products or pricing, respectively, which could put us at
a competitive disadvantage.
Suppliers
We
have a network of suppliers and third-party service providers, including state-certified hemp suppliers, manufacturers, and distributors.
We source all of our hemp from certified American growers, and manufacture all of our products in CGMP, OTC, Cosmetic, and ISO-certified
facilities. Additionally, all of our ingredients and finished goods are tested for purity and quality by ISO-certified third-party laboratories:
Delta Verde Laboratories, DB Labs, LLC, and a division of Eurofins Scientific SE. We make available to our customers copies of the laboratories’
certificates of analysis, which disclose THC concentration, presence of metals, pesticides, or any other harmful contaminants. We continuously
manage the risks associated with third-party suppliers and service providers by continuously evaluating our supply chain for any quality
or manufacturing problems, and are continually identifying alternative solutions to any potential issues.
Our
Customers
We
are not dependent on any single customer for a significant portion of our sales. However, we have customers who purchase our products
on a regular basis. We believe this loyalty is an essential factor that will help differentiate our brand and products from our competition.
Our goal is to continue to build this loyalty from our customers by offering the highest quality products and best customer service in
the hemp-derived product industry.
In
addition to the customers who visit our e-commerce platform, we have strong relationships with wholesalers, distributors, and retailers.
Our products are now in approximately 6,400 retail locations .
Government
Regulation
In
2014, Congress enacted Section 7606 of the Agriculture Act of 2014 (the “2014 Farm Bill”), which provides for the domestic
cultivation of industrial hemp as part of agricultural pilot programs adopted by individual states for the purposes of research by state
departments of agriculture and institutions of higher education. The 2014 Farm Bill provides for the domestic cultivation of industrial
hemp in these pilot programs, notwithstanding other federal laws, such as the Controlled Substances Act (the “CSA”). The
2014 Farm Bill governed any current domestic production of industrial hemp.
The
2014 Farm Bill’s provisions require states that choose to adopt agricultural pilot programs to study the growth, cultivation, or
marketing of industrial hemp to do so in a manner that (i) ensures that only institutions of higher education and state agriculture departments
are used to grow or cultivate industrial hemp; (ii) requires that sites used for growing or cultivating industrial hemp be certified
with, and registered by, the states; and (iii) authorizes state agriculture departments to regulate the pilot programs. Within those
parameters, the 2014 Farm Bill gives significant discretion to states to determine whether to adopt an industrial hemp pilot program,
and to adopt regulations governing industrial hemp (including marketing research involving products derived from industrial hemp) under
those pilot programs. Many of the states that have adopted pilot programs have registered private companies to participate in the pilot
program. We worked with farms and extraction facilities that were registered under Arizona’s agricultural pilot program.
Under
the 2014 Farm Bill, any cannabis plant, plant part, or plant product that contains a higher concentration of THC than permitted in industrial
hemp is considered a Schedule I substance under the CSA and is not protected by the 2014 Farm Bill. In addition, any industrial hemp
plant, plant part, or plant product that is produced outside of a state agricultural pilot program may be considered unlawful but not
a controlled substance.
In
December 2018, the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”) was signed into law. Prior to its passage,
hemp, a member of the cannabis family, and hemp-derived products were classified as Schedule I controlled substances, and so were considered
illegal under the CSA. With the passage of the 2018 Farm Bill, hemp cultivation is broadly permitted outside of the state agricultural
pilot programs. The 2018 Farm Bill explicitly allows the transfer of hemp-derived products across state lines for commercial or other
purposes. It also puts no restrictions on the sale, transport, or possession of hemp-derived products, so long as those items are produced
in a manner consistent with the law.
Additionally,
there will be significant, shared state-federal regulatory power over hemp cultivation and production. Pursuant to the 2018 Farm Bill,
state agriculture departments must consult with the state’s governor and chief law enforcement officer to devise a plan that must
be submitted to the Secretary of the United States Department of Agriculture (the “USDA”). A state’s plan to license
and regulate hemp can only commence once the Secretary of the USDA approves the state’s plan. In states opting not to devise a
hemp regulatory program, the USDA will construct a regulatory program under which hemp cultivators in those states must apply for licenses
and comply with a federally-run program. This system of shared regulatory programming is similar to options states had in other policy
areas, such as health insurance marketplaces under the Affordable Care Act, or workplace safety plans under the Occupational Health and
Safety Act – both of which had federally-run systems for states opting not to set up their own systems. The USDA has deferred review
and approval of state plans, establishing its umbrella plan for hemp production in states without approved plans, and issuing federal
licenses to producers in such states until the agency promulgates final implementing regulations. Until such time as the USDA issues
such final regulations, commercial hemp production under the 2018 Farm Bill cannot legally begin. However, research-related activities
involving industrial hemp under the more-restrictive 2014 Farm Bill may continue. The USDA has expressed an intention to issue such final
regulations in time for producers to cultivate hemp for commercial purposes during the 2020 growing season; however, the timing and content
of the USDA’s final implementing regulations cannot be assured. Moreover, the 2018 Farm Bill permits states to establish additional
restrictions on hemp production and hemp products than required under federal law, although states may not interfere with the interstate
transportation of hemp or hemp products produced in compliance with the 2018 Farm Bill.
Even
though the 2018 Farm Bill removed industrial hemp from the Schedule I list, the 2018 Farm Bill preserved the regulatory authority of
the Food and Drug Administration (the “FDA”) over cannabis and cannabis-derived compounds used in food and pharmaceutical
products pursuant to the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”) and Section 351 of the Public Health Service
Act. The FDA has stated that it intends to treat products containing cannabis or cannabis-derived compounds as it treats any other FDA-regulated
products. The FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with
any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce.
The
FDA has also stated that it is unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce,
or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. Even though products
containing cannabis and cannabis-derived compounds remain subject to the FDA’s regulatory authority, there are methods available
for those companies who seek to lawfully introduce these products into interstate commerce. For example, a company can seek approval
from the FDA to market a human or animal drug that is derived from cannabis with therapeutic claims. In June 2018, the FDA approved Epidiolex,
which is a CBD-derived drug approved to treat epilepsy. The approval was based on adequate and well-controlled clinical studies, which
gives prescribers confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for
treating patients with epilepsy. The FDA’s position leaves a great deal of uncertainty in interpreting the legal standing of CBD
– the 2018 Farm Bill legalizes the interstate commerce of hemp, but the FDA has made statements indicating its desire to regulate
CBD products, which could significantly limit interstate commerce of CBD products.
Additionally,
the Federal Trade Commission (“FTC”) regulates advertising of all products, including for FDA-regulated articles made from
hemp and CBD derived from hemp.
Accumulated
Deficit
We
have incurred operating losses since inception and have negative cash flow from operations. As of September 30, 2022, we had an accumulated
deficit of $43,642,790 and incurred a net loss of $4,128,946 for the year then ended. Additionally, as of September 30, 2021 we had an accumulated
deficit of $39,513,844 and incurred a net loss of $6,808,154 for our 2021 fiscal year.
Our continuation as a going
concern is dependent on our ability to obtain additional financing until we can generate sufficient cash flow from operations to meet
our obligations. We intend to continue to seek additional debt or equity financing to continue our operations, but there can be no assurance
that such financing will be available on terms acceptable to us, if at all.
Intellectual
Property
We
do not hold, nor have we applied for, any patents. As of the date of this Annual Report on Form 10-K, we have one service mark for “Endexx.”
Additionally, we have applied for several trademarks of our products’ names and logos, including “CBD Unlimited,” “Khode,”
and “Phyto-Bites.” As of the date of this Annual Report on Form 10-K, the US Patent and Trademark Office (USPTO) has not
approved any CBD-related trademarks, and, accordingly, our applications are still pending.
Research
and Development
Our
research and development expenses for the years ended September 30, 2022 and 2021 totaled $27,067 and $10,145, respectively, and relate
to the development of our products. None of these costs was borne directly by our customers.
Employees
As
of January 12, 2023, we have approximately ten full-time employees. None of our employees is covered by any collective bargaining
agreements and we have never experienced a major work stoppage, strike, or dispute. We consider our relationship with our employees to
be outstanding.
Reports
to Security Holders
We
are not currently required to file periodic reports with the Commission, nor are we required to deliver an annual report to our stockholders.
However, in compliance with OTC Markets Group Inc. (the “OTCM”) Alternative Reporting Standards, we file alternate annual
and interim reports, all of which can be found on the disclosure tab of our company profile on the OTCM’s website at https://www.otcmarkets.com/stock/EDXC/disclosure.
Because
our class of Common Stock is now registered pursuant to Section 12(g) of the Exchange Act, we are subject to the requirements of Section
13(a) thereunder, which will require us to file Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form
8-K, and are required to comply with all other obligations of the Exchange Act applicable to issuers pursuant to Section 12(g). Further,
our directors and named executive officers and beneficial owners of five percent (5%) or more of our Common Stock will be subject to
certain disclosure obligations under the Exchange Act.
You
may read and copy this Annual Report on Form 10-K and any future reports we file with the Commission free of charge through the Commission’s
website at www.sec.gov. You may obtain further information about us on our websites at https://endexx.com/ and www.cbdunlimited.com.
We caution the reader that none of the information contained on such websites is incorporated into this Annual Report on Form 10-K.
Item
1A. Risk Factors.
Investing
in our securities involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together
with all of the other information contained in this Annual Report on Form 10-K or in any other documents incorporated by reference into
this Annual Report on Form 10-K, in light of your particular investment objectives and financial circumstances. Moreover, the risks so
described are not the only risks we face. Additional risks not presently known to us or that we currently perceive as immaterial may
ultimately prove more significant than expected and impair our business operations. Any of these risks could adversely affect our business,
financial condition, results of operations, or prospects. The quoted price of the Common Stock could decline due to any of these risks
and you may lose all or part of your investment.
Risks
Related to Our Business
We
have a limited operating history on which to judge our new business prospects and management. We commenced operations in the
hemp-derived product industry in 2014 in the same year as the 2014 Farm Bill became law and four years prior to the passage of the 2018
Farm Bill. Accordingly, we have only a limited operating history upon which to have to base an evaluation of our business and prospects.
Operating results for future periods are subject to numerous uncertainties and we cannot assure you that we will achieve or sustain profitability.
Our prospects must be considered in light of the risks encountered by companies in the early stage of development, particularly companies
in new and rapid evolving markets. We cannot assure you that we will successfully address any of these risks.
We
have incurred significant net losses and cannot assure you that we will achieve or maintain profitable operations. Our net losses
were $9,163,000 for the year ended September 30, 2020 and $8,276,000 for the year ended September 30, 2019. As of September 30, 2020,
we had a stockholders’ deficit of $11,654,000. The increase in net losses was the result of the sum of certain positive results
in the 2020 fiscal year compared to the 2019 fiscal year (nominally increased revenues, enhanced by a $422,000 decrease in cost of revenues,
a $378,000 decrease in inventory impairment, a $342,000 decrease in professional fees-related party, a $1,480,000 decrease in combined
financing costs, interest expenses, and default penalties, and a $2,510,000 non-cash gain in fair value of derivative liability) offset
by certain negative results between the years (a $200,000 increase in advertising and promotion expenses, a $100,000 increase in payroll
expenses, a $70,000 increase in professional fees, a $255,000 increase in general and administrative expenses, and a net 428,000 loss
on acquisition and unrealized loss on investments). We may continue to incur significant losses in the future for a number of reasons,
including unforeseen expenses, difficulties, complications, and delays, and other unknown events.
Accordingly,
we cannot assure you that we will achieve sustainable operating profits as we continue to expand our product line and otherwise implement
our growth initiatives. Any failure to achieve and maintain profitability would have a materially adverse effect on our ability to implement
our business plan, our results and operations, and our financial condition, and could cause the value of our Common Stock to decline,
resulting in a significant or complete loss of your investment.
Our
independent registered public accounting firm’s reports for the fiscal years ended September 30, 2022 and 2021 have raised substantial
doubt as to our ability to continue as a “going concern.” Our independent registered public accounting firm indicated
in its reports on our audited consolidated financial statements as of and for the years ended September 30, 2022 and 2021 that there
is substantial doubt about our ability to continue as a going concern. A “going concern” opinion indicates that the financial
statements have been prepared assuming we will continue as a going concern and do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets, or the amounts and classification of liabilities that may result if
we do not continue as a going concern. Therefore, you should not rely on our consolidated balance sheet as an indication of the amount
of proceeds that would be available to satisfy claims of creditors, and potentially be available for distribution to stockholders, in
the event of liquidation. The presence of the going concern note to our financial statements may have an adverse impact on the relationships
we are developing and plan to develop with third parties as we continue the commercialization of our products and could make it challenging
and difficult for us to raise additional financing, all of which could have a material adverse impact on our business and prospects and
result in a significant or complete loss of your investment.
Our
ability to grow and compete in the future will be adversely affected if adequate capital is not available to us or not available on terms
favorable to us. We have limited capital resources. To date, we have financed our operations through a mix of equity and debt
investments by investors, and we expect to continue to do so in the foreseeable future. Our ability to continue our normal and planned
operations, to grow our business, and to compete in our industry will depend on the availability of adequate capital.
We
cannot assure you that we will be able to obtain additional funding from those or other sources when or in the amounts needed, on acceptable
terms, or at all. If we raise capital through the sale of equity, or securities convertible into equity, it would result in dilution
to our then-existing stockholders, which could be significant depending on the price at which we may be able to sell our securities.
If we raise additional capital through the incurrence of additional indebtedness, we would likely become subject to further covenants
restricting our business activities, and holders of debt instruments may have rights and privileges senior to those of our then-existing
stockholders. In addition, servicing the interest and principal repayment obligations under debt facilities could divert funds that would
otherwise be available to support development of new programs and marketing to current and potential new clients. If we are unable to
raise capital when needed or on attractive terms, we could be forced to delay, reduce, or eliminate development of new products or future
marketing efforts, or reduce or discontinue our operations. Any of these events could significantly harm our business, financial condition,
and prospects.
The
COVID-19 pandemic could have a material adverse impact on our business, results of operations, and financial condition. In December
2019, a novel strain of coronavirus was reported to have surfaced in Wuhan, China. In January 2020, the WHO declared the COVID-19 outbreak
a “Public Health Emergency of International Concern.” This worldwide outbreak has resulted in the implementation of significant
governmental measures, including lockdowns, closures, quarantines, and travel bans intended to control the spread of the virus. Companies
are also taking precautions, such as requiring employees to work remotely, imposing travel restrictions, and temporarily closing businesses
and facilities. These restrictions, and future prevention and mitigation measures, have had an adverse impact on global economic conditions
and have had an adverse impact on consumer confidence and spending on certain products and services, which could materially adversely
affect the supply of, as well as the demand for, our products. Uncertainties regarding the economic impact of COVID-19 are likely to
result in sustained market turmoil, which could also negatively impact our business, financial condition, and cash flow. As of the date
of this Annual Report on Form 10-K, many of the governmental restrictions are in the process of being lessened or lifted, which actions
we expect should have a positive impact on consumer confidence and spending and a related positive impact on our business and, thereafter,
our financial condition and cash flow.
Our
co-packers source raw materials used in our products from suppliers located in the United States. The impact of COVID-19 on these suppliers,
or any of our other suppliers, distributors, and resellers, or transportation or logistics providers, has negatively affected the price
(through increases) and the availability of our ingredients and/or packaging materials (through longer lead times) and has accordingly
negatively impacted our supply chain. As these disruptions caused by COVID-19 have continued for an extended period of time, our ability
to meet the demands of our consumers has been and may be further materially impacted. To date, we have not experienced any reduction
in the available supply of our products. Additionally, many of our employees, including members of our management team, have been working
remotely as a result of the closure of our offices and warehouses in compliance with local and state regulations in response to the COVID-19
pandemic. If our operations or productivity continue to be impacted by the COVID-19 outbreak and government-mandated closures, those
occurrences will continue to impact our business, financial condition, and cash flow, all in a negative manner. The extent to which the
COVID-19 pandemic will further impact our business will depend on future developments and, given the uncertainty around the extent and
timing of the potential future spread or mitigation and around the imposition or relaxation of protective measures, we cannot reasonably
estimate the impact to our business at this time. However, we expect that, during our current fiscal year, the adverse impact of COVID-19
on our business will slowly abate, as the positivity rate in tests for COVID-19 continues to decrease along with the new infection and
mortality rates and the number of people becoming vaccinated continues to increase.
Nevertheless,
the extent of the effect of COVID-19 on our operational and financial performance will continue to depend on future developments of the
outbreak, which remain uncertain and difficult to predict, considering the rapidly evolving landscape, including the spread of the new
Delta variant of COVID-19. As a result, it is not currently possible to ascertain the short- and medium-term impact of COVID-19 on our
business. However, as the pandemic has continued for a prolonged period, it has had a material adverse effect on our business, results
of operations, financial condition, and cash flow and may have contributed to the volatility in the quoted price of our Common Stock
on the OTCM.
The
2018 Farm Bill passed in December 2018, along with undeveloped shared state-federal regulations over hemp cultivation and production
that may impact our business. The 2018 Farm Bill was signed into law on December 20, 2018. Pursuant to the terms of the 2018
Farm Bill, state agriculture departments must consult with the state’s governor and chief law enforcement officer to devise a plan
that must be submitted to the Secretary of the USDA. A state’s plan to license and regulate hemp can only commence once the Secretary
of the USDA approves the state’s plan. In states opting not to devise a hemp regulatory program, the USDA will need to construct
a regulatory program under which hemp cultivators in those states must apply for licenses and comply with a federally-run program. The
details and scopes of each state’s plans are not known as of the date of this Registration Statement and may contain varying regulations
that may impact our business. Even if a state creates a plan in conjunction with its governor and chief law enforcement officer, the
Secretary of the USDA must approve it. There can be guarantee that any state plan will be approved. Review times may be extensive. There
may be amendments and the ultimate plans, if approved by states and the USDA, may materially limit our business depending upon the scope
of the regulations.
Laws
and regulations affecting our industry to be developed under the 2018 Farm Bill are in development. As a result of the 2018 Farm
Bill’s recent passage, there will be constant evolution of laws and regulations affecting the hemp industry could detrimentally
affect our operations. Local, state, and federal hemp laws and regulations may be broad in scope and subject to changing interpretations.
These changes may require us to incur substantial costs associated with legal and compliance fees and ultimately require us to alter
our business plan. Furthermore, violations of these laws, or alleged violations, could disrupt our business and result in a material
adverse effect on our operations. In addition, we cannot predict the nature of any future laws, regulations, interpretations, or applications,
and it is possible that regulations may be enacted in the future that will be directly applicable to our business.
The
possible FDA regulation of hemp and industrial hemp-derived products, and the possible registration of facilities where hemp is grown
and hemp-derived products are produced, if implemented, could negatively affect the cannabis industry generally, which could directly
affect our financial condition. The 2018 Farm Bill established that hemp containing less than 0.3% THC was no longer under the
CSA. Previously, the FDA had not approved cannabis, industrial hemp, or CBD derived from cannabis or industrial hemp as a safe and effective
drug for any indication. The FDA considered hemp and hemp-derived CBD as illegal Schedule I drugs. As of the date of this Annual Report
on Form 10-K, we have not, and do not intend to file an investigational new drug (“IND”) application with the FDA, concerning
any of our products that may contain cannabis, industrial hemp, or CBD derived from industrial hemp. Further, the FDA concluded that
products containing hemp or CBD derived from hemp are excluded from the dietary supplement definition of the FD&C Act. However, as
a result of the passage of the 2018 Farm Bill, at some indeterminate future time, the FDA may choose to change its position concerning
products containing hemp, or CBD derived from hemp, and may choose to enact regulations that are applicable to such products, including,
but not limited to, the growth, cultivation, harvesting, and processing of hemp; regulations covering the physical facilities where hemp
is grown; and possible testing to determine efficacy and safety of hemp-derived CBD. In such event, our products could be subject to
regulation. However, we do not know what impact would be on the hemp industry in general, and what costs, requirements, and possible
prohibitions may be enforced in the future. If we are unable to comply with the conditions and possible costs of such regulations and/or
registrations, we may be unable to continue to operate our business.
The
FDA limits companies’ ability to discuss the medical benefits of hemp-derived products. Under FDA rules, it is illegal
for companies to make “health claims” or any claim that a product has a specific medical benefit without first getting FDA
approval for such claim. The FDA has not recognized any medical benefits resulting from the consumption of hemp-derived products, which
means that no companies are legally permitted to advertise any health claims related to hemp-derived products. Because of the perception
among many consumers that hemp-derived CBD is a health/medicinal product, our inability to make health claims about the hemp-derived
materials in our products may limit our ability to market and sell the products to consumers, which would negatively impact our revenues
and profits.
The
FDA has recently called into question the legality of products containing hemp-derived ingredients sold as dietary supplements. In
November 2019, the FDA issued warning letters to 15 companies for selling products that contain CBD in ways that violate the FD&C
Act and stated therein that products containing CBD cannot be sold as dietary supplements. In a series of letters in 2016 and 2017, the
FDA stated that, “based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement
definition (the “IND Preclusion”) under Section 201(ff)(3)(B)(ii) of the FD&C Act.” Under that provision, if a
substance (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted
and for which the existence of such investigations has been made public, the products containing that substance are excluded from the
Section 201(ff)(3)(B)(ii) definition of a dietary supplement. There is an exception to the IND Preclusion if the substance was “marketed
as” a dietary supplement or as a conventional food before substantial clinical investigations were instituted pursuant to an authorization
for investigation of a new drug and made public, as further discussed below; however, based on available evidence, the FDA concluded
that this is not the case for cannabidiol, as it has not concluded that CBD is generally recognized as safe (GRAS) among qualified experts
for its use in human or animal food. The FDA has not instituted any rulemaking procedures or provided an opportunity for public comment
in arriving at its conclusion regarding CBD in dietary supplements.
The
IND preclusion language from Section 201(ff) of the FD&C Act includes several requirements that must be met for a certain ingredient
to be precluded from the definition of a dietary supplement. First, the ingredient must have been authorized by FDA for investigation
as a new drug. Next, substantial clinical investigations must have been instituted. These substantial clinical investigations must also
be made public. Lastly, all of the above must have occurred prior to the marketing of the ingredient as a dietary supplement or food.
That is, all of these conditions must be met before the article can be precluded from the definition of a dietary supplement under Section
201(ff)(3)(B)(ii) of the FD&C Act.
According
to the National Institutes of Health, a “dietary supplement” is a product that is intended to supplement the diet. A dietary
supplement contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other
substances) or their components; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is identified on the front
label of the product as being a dietary supplement. None of our products is a dietary supplement.
We
believe that CBD has been marketed as a dietary supplement prior to commencement and public notice of any substantial clinical investigations
instituted on CBD, as the investigations that were publicized were not substantial and they were limited in number and preliminary in
nature, thereby rendering the IND Preclusion inapplicable.
U.S.
federal and foreign regulation and enforcement may adversely affect the implementation of cannabis laws and regulations and may negatively
impact our revenue, or we may be found to be violating the CSA or other federal, state, or foreign laws. Even though we do not
cultivate, process, market, or distribute cannabis or any products that contain cannabis, some of our customers do engage in such activities.
Cannabis, though not strictly defined in the 2018 Farm Bill, is a Schedule I controlled substance and is illegal under federal law. Even
in those states where the use of cannabis has been legalized, its use remains a violation of federal law. A Schedule I controlled substance
is defined as a substance that has no currently accepted medical use in the United Stated, a lack of safety for use under medical supervision
and a high potential for abuse. The Department of Justice defines Schedule I controlled substances as “the most dangerous drugs
of all the drug schedules with potentially severe psychological or physical dependence.”
At
present, numerous states and the District of Columbia allow their citizens to use medical cannabis. Additionally, many states have approved
legalization of cannabis for adult recreational use. The laws of these states relative to cannabis are in conflict with the CSA, which
makes cannabis use and possession illegal on a national level. If the federal government decides to enforce the CSA with respect to cannabis,
persons that are charged with distributing, possessing with intent to distribute, or growing cannabis could be subject to fines and imprisonment.
Any such change in the federal government’s enforcement of current federal laws could cause significant financial damage to us.
Cannabis
and cannabis products remain illegal under federal law. Cannabis and CBD containing in excess of 0.3% THC are Schedule I controlled
substances and are illegal under federal law, specifically the CSA. Even in those states in which the use of marijuana has been legalized,
its use remains a violation of federal law. CBD and cannabinoids derived from industrial hemp are not distinguishable. Although our hemp-derived
products contain less than 0.3% THC, if there were mistakes in processing or mislabeling and THC in excess of 0.3% were found in our
products, we could be subject to enforcement and prosecution, which would have a negative impact on our business and operation.
Variations
in state and local regulation, and enforcement in states that have legalized cannabis, may restrict cannabis-related activities, which
may negatively impact our revenues and prospective profits. Individual state laws do not always conform to the federal standard
or to other states’ laws. States that have decriminalized cannabis have created legal regimes, structures, and rules related to
the use, cultivation, manufacture, distribution, transportation, and sale of medical cannabis and related products. These legal regimes
often require companies to apply for and be awarded a license in order to operate a cannabis business operation. Although our products
contain less than 0.3% THC, if there were mistakes in processing or mislabeling and THC in excess of 0.3% was found in our products,
we could be found to be in violation of these states laws and regulations for not obtaining required licenses.
State
laws and regulations are also still in flux as states figure out how best to regulate new products. State laws may change in unexpected
ways that could result in our partners losing their licenses, being forced to change their products or services, or raise prices, all
of which could impact our revenues and prospective profits.
Laws
regarding the transportation of cannabis may change, which may negatively impact our business. Transportation of cannabis is
governed by both state and federal law. The interaction between these two legal regimes creates legal and practice difficulties in getting
products to market. Changes in state law related to the transportation of cannabis may significantly impact our ability to get products
to market or may raise the cost of doing so, which would impact our revenue and potential profits. Although federal law now allows the
transportation of products derived exclusively from industrial hemp, both state and federal law make it illegal to transport cannabis
products across state lines. Any accidental or intentional transportation of cannabis in our products across state lines could, therefore,
result in significant consequences including loss of a state issued license or permit, financial penalties, seizure of our products,
and prosecution for the illegal transportation of a Schedule I substance. These consequences may impact our revenues, potential profits,
or ability to continue operating in this line of business.
The
approach in the enforcement of cannabis laws may be subject to change, which creates uncertainty for our business. As a result
of the conflicting views between state legislatures and the federal government regarding cannabis, investments in, and the operations
of, cannabis businesses in the United States are subject to inconsistent laws and regulations. Laws and regulations affecting the cannabis
industry are constantly changing, which could detrimentally affect our operations. Local, state, and federal cannabis 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 material adverse effect on our operations. It is also possible that regulations may be enacted in the future that will be directly
applicable to our business. Since the passage of the 2018 Farm Bill, there has been little other legislation passed at the federal level
pertaining to the cultivation, transportation, and sale of CBD products. Conversely, numerous laws and guidance have passed on the state
and local levels, providing for non-standardized legal standing throughout the US. These ever-changing regulations could even affect
federal tax policies that may make it difficult to claim tax deductions on our returns. In light of these changes and to the best of
our knowledge, we are in compliance with all existing regulations.
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.
Because
our business is dependent upon continued market acceptance by consumers, any negative trends will adversely affect our business operations.
We are substantially dependent on continued market acceptance and proliferation of consumers of hemp and hemp-derived products.
We believe that, as hemp and hemp-derived products become more accepted as a result of the passage of the 2018 Farm Bill, the stigma
associated with hemp and hemp-derived products will diminish and, as a result, consumer demand will continue to grow. While we believe
that the market and opportunity in the hemp space continues to grow, we cannot predict the future growth rate and size of the market.
Any negative outlook on the hemp industry will adversely affect our business operations.
We
face intense competition and many of our competitors have greater resources that may enable them to compete more effectively. We
are involved in a highly competitive industry where we may compete with numerous other companies who offer alternative methods or approaches,
who may have far greater resources, more experience, and personnel perhaps more qualified than we. Our competitors may devote their resources
to developing and marketing products that will directly compete with our product lines. Due to this competition, there is no assurance
that we will not encounter difficulties in obtaining revenues and market share or in the positioning of our products and services. There
are no assurances that competition in our respective industries will not lead to reduced prices for our products. If we are unable to
successfully compete with existing companies and new entrants to the hemp market, this will have a negative impact on our business and
financial condition.
Our
products and services are new, and our industry is rapidly evolving. Due consideration must be given to our prospects in light
of the risks, uncertainties, and difficulties frequently encountered by companies in their early stage of development, particularly companies
in the rapidly evolving legal hemp industry. To be successful in this industry, we must, among other things:
|
● |
develop
and introduce functional and attractive product and service offerings; |
|
● |
attract
and maintain a large base of consumers; |
|
● |
increase
awareness of our brands and develop consumer loyalty; |
|
● |
establish
and maintain strategic relationships with distribution partners and service providers; |
|
● |
respond
to competitive and technological developments; and |
|
● |
attract,
retain, and motivate qualified personnel. |
We
cannot guarantee that we will succeed in achieving any or all of these goals, and our failure to do so would have a material adverse
effect on our business, prospects, financial condition, and operating results.
Some
of our products and services are new and are only in early stages of commercialization. We are not certain that these products and services
will function as anticipated or be desirable to its intended market. Also, some of our products may have limited functionalities, which
may limit their appeal to consumers and put us at a competitive disadvantage. If our current or future products and services fail to
function properly or if we do not achieve or sustain market acceptance, we could lose customers or could be subject to claims that could
have a material adverse effect on our business, financial condition, and operating results.
As
is typical in a new and rapidly evolving industry, demand, and market acceptance for recently introduced products and services are subject
to a high level of uncertainty and risk. Because our market is new and evolving, it is difficult to predict with any certainty the size
of this market and its growth rate, if any. We cannot guarantee that a market for our products and services will develop or that a demand
for our products and services will emerge or be sustainable. If the market fails to develop, develops more slowly than expected, or becomes
saturated with competitors, our business, financial condition, and operating results would be materially adversely affected.
Federal
intellectual property laws may limit our ability to protect our trademarks, names, logos, and other intellectual property. U.S.
trademark law makes it unlawful to trademark any product that cannot legally be sold across state lines. Because the sale and transportation
of cannabis and cannabis products is still prohibited under federal law, this may limit our ability to secure trademark protection for
our products. We applied for trademark protection with the understanding that our products are derived from industrial hemp and other
legal sources; however, because of the current state of cannabis law, the U.S. Patent and Trademark Office may reject our current or
future applications. This would negatively impact our ability to protect our intellectual property, which could negatively impact our
revenues and prospective profits.
If
we fail to protect our intellectual property, our business could be adversely affected. Our viability will depend, in part, on
our ability to develop and maintain the proprietary aspects of our intellectual property to distinguish our products from our competitors’
products. We rely on trade secrets and confidentiality provisions to establish and protect our intellectual property, including our proprietary
formulas and manufacturing techniques. We may not be able to enforce some of our intellectual property rights because cannabis is illegal
under federal law.
Any
infringement or misappropriation of our intellectual property or proprietary formulations could damage its value and limit our ability
to compete. We may have to engage in litigation to protect the rights to our intellectual property, which could result in significant
litigation costs and require a significant amount of our time. In addition, our ability to enforce and protect our intellectual property
rights may be limited in certain countries outside the United States, which could make it easier for competitors to capture market position
in such countries by utilizing technologies that are similar to those developed or licensed by us.
Competitors
may also harm our sales by designing products that mirror our products or processes without infringing on our intellectual property rights.
If we do not obtain sufficient protection for our intellectual property, or if we are unable to effectively enforce our intellectual
property rights, our competitiveness could be impaired, which would limit our growth and future revenue.
We
may also find it necessary to bring infringement or other actions against third parties to seek to protect our intellectual property
rights. Litigation of this nature, even if successful, is often expensive and time-consuming to prosecute and there can be no assurance
that we will have the financial or other resources to enforce our rights or be able to enforce our rights or prevent other parties from
developing similar products or processes or designing around our intellectual property.
Although
we believe that our products and processes do not and will not infringe upon the patents or violate the proprietary rights of others,
it is possible such infringement or violation has occurred or may occur, which could have a material adverse effect on our business.
We are not aware of any infringement by us of any person’s or entity’s intellectual property rights. In the event
that products we sell or processes we employ are deemed to infringe upon the patents or proprietary rights of others, we could be required
to modify our products or processes or obtain a license for the manufacture and/or sale of such products or processes or cease selling
such products or employing such processes. In such event, there can be no assurance that we would be able to do so in a timely manner,
upon acceptable terms and conditions, or at all, and the failure to do any of the foregoing could have a material adverse effect upon
our business.
There
can be no assurance that we will have the financial or other resources necessary to enforce or defend a patent infringement or proprietary
rights violation action. If our products or processes are deemed to infringe or likely to infringe upon the patents or proprietary rights
of others, we could be subject to injunctive relief and, under certain circumstances, become liable for damages, which could also have
a material adverse effect on our business and our financial condition.
Tax
laws related to cannabis may impact our ability to generate revenue or potential profits. Section 280E of the Internal Revenue
Code prohibits cannabis businesses from deducting their ordinary and necessary business expenses, forcing us to pay higher effective
federal tax rates compared to similar companies in other industries. With the passage of the 2018 Farm Bill, we believe that Section
280E of the Internal Revenue Code will not apply to us. However, if we inadvertently produce or sell products that are considered cannabis,
or are deemed to engage in a cannabis business despite the passage of the 2018 Farm Bill, we may be subject to Section 280E of the Internal
Revenue Code, which would prohibit us from deducting our ordinary and necessary business expenses. In such instance, our business may
be less profitable than it could otherwise be.
State
tax laws are also changing. Even though state taxes are already high, many local jurisdictions are imposing heavy additional taxes either
as a disincentive for cannabis companies to operate there or in order to cash in on the growing number of cannabis companies paying taxes.
It is unknown how states will treat companies engaging in the hemp-derived product industry from a tax perspective. High taxes could
overwhelm our partner companies causing them to go out of business or raise prices for their services, which in turn may impact our revenues
and profits by forcing us to find different partners in more tax friendly areas or pay higher prices.
We
may not be able to obtain the necessary permits and authorizations to operate our business in the future. We may not be able
to obtain or maintain the necessary licenses, permits, authorizations, or accreditations for our business, or may only be able to do
so at great cost. In addition, we may not be able to comply fully with the wide variety of laws and regulations applicable to the cannabis
and hemp-derived product industries. Failure to comply with or to obtain the necessary licenses, permits, authorizations, or accreditations
could result in restrictions on our ability to operate, which could have a material adverse effect on our business.
Changes
in the regulations governing cannabis outside of the United States may adversely impact our prospects. Our growth strategy with
respect to international expansion of the new business lines continues to evolve as regulations governing the cannabis and hemp-derived
product industries in foreign jurisdictions become more fully developed. Interpretation of these laws, rules, and regulations and their
application is ongoing. Amendments to current laws, regulations, and guidelines, more stringent implementation, or enforcement thereof,
enactment of new laws, the adoption of new regulations, or other unanticipated events, including changes in political regimes and attitudes
toward cannabis and hemp-derived products are beyond our control and could material adverse effect on our international growth prospects.
We
cannot assure you that we will be able to expand our operations into legal jurisdictions outside of the United States, and any such expansion
will be subject to risks. There can be no assurance that any market for cannabis products to be offered by us will develop in
any jurisdiction outside of the United States. Laws, regulations, and perceptions pertaining to cannabis and hemp-derived products vary
widely internationally, and the scope or pace of legalization of cannabis and hemp-derived products cannot be predicted or assured. If
and when additional legal markets for cannabis and hemp-derived products develop, our pursuit of such markets may expose it to new or
unexpected risks or significantly increase its exposure to one or more existing risk factors, including economic instability, changes
in laws and regulations, and the effects of competition. These factors may limit our capability to successfully expand our operations
into such jurisdictions and may have a material adverse effect on our business, financial condition, and results of operations.
We
will become subject to further laws and regulations as we expand internationally. In addition to initiating business operations
in Jamaica, we plan on expanding our business internationally. If and as this international expansion occurs, we will become subject
to the laws and regulations of (as well as international treaties among) the foreign jurisdictions in which we operate or import or export
products or materials. In addition, we may avail ourselves of proposed legislative changes in certain jurisdictions to expand our product
portfolio, which expansion may include business and regulatory compliance risks as yet undetermined. Failure by us to comply with the
current or evolving regulatory framework in any jurisdiction could have a material adverse effect on our business, financial condition,
and results of operations. There is the possibility that any such international jurisdiction could determine that we were not or is not
compliant with applicable local regulations. If our historical or current sales or operations were found to be in violation of such international
regulations, we may be subject to enforcement actions in such jurisdictions including, but not limited to civil and criminal penalties,
damages, fines, the curtailment or restructuring of our operations or asset seizures and the denial of regulatory applications, each
of such circumstances could have a material adverse effect on our business, financial condition, and results of operations.
Reliance
on third-party suppliers, service providers, manufacturers, and distributors may result in disruption to our business lines’ supply
chains. Suppliers, service providers, and distributors of our products may elect, at any time, to breach or otherwise cease to
participate in supply, service, or distribution agreements, or other relationships, on which the operations of our business rely. The
loss of suppliers, service providers, manufacturers, or distributors would have a material adverse effect on the business and operational
results of our business.
Industrial
hemp is vulnerable to specific agricultural risks that could have a material adverse effect on the availability of hemp to be purchased
by us for use in our products. Our suppliers may grow their industrial hemp outdoors. As such, the risks inherent in engaging
in outdoor agricultural businesses apply. Agricultural production by its nature contains elements of risk and uncertainty that may adversely
affect our business and operations, including but not limited to the following: (i) any future climate change with a potential shift
in weather patterns leading to droughts and associated crop losses; (ii) potential insect, fungal, and weed infestations resulting
in crop failure and reduced yields; (iii) wild and domestic animals damaging the crops; and (iv) crop raiding, sabotage, or
vandalism, all of which could affect the availability of hemp that we can purchase for use in our products. If hemp is not readily available,
our business and financial condition would be materially adversely effected.
Loss
of key contracts with our suppliers, renegotiation of such agreements on less favorable terms or other actions these third parties may
take could harm our business. Most of our agreements with suppliers of our industrial hemp, including our key supplier contract,
may be subject to cancellation or non-renewal. The loss of these agreements, or the renegotiation of these agreements on less favorable
economic or other terms, could limit our ability to procure raw material to manufacture our products. This could negatively affect our
ability to meet consumer demand for our products. Upon expiration or termination of these agreements, our competitors may be able to
secure industrial hemp from our existing suppliers which will put us at a competitive disadvantage in the market.
We
have a limited number of supply sources and depend solely on United States-based suppliers, which may subject us to additional risks.
We believe that our continued success will depend upon the availability of raw materials that permit us to meet labeling claims
and quality control standards. The supply of our industrial hemp is subject to the same risks normally associated with agricultural production,
such as climactic conditions, insect infestations, and availability of manual labor or equipment for harvesting. Any significant delay
in or disruption of the supply of raw materials could substantially increase the cost of such materials, could require product reformulations,
the qualification of new suppliers, and repackaging and could result in a substantial reduction or termination by us of our sales of
certain products, any of which could have a material adverse effect upon us. Accordingly, there can be no assurance that the disruption
of our supply sources will not have a material adverse effect on us.
We
also exclusively obtain our raw product from United States’ suppliers. Therefore, our business is subject to the risks generally
associated with a lack of geographic diversity in our suppliers poses, including the potential for enforcement activity, natural disasters
affecting key geographic locations where our ingredients are grown, and possible challenges with exporting our products abroad.
The
market for industrial hemp and hemp-derived products in the United States is relatively new and is subject to risks associated with an
emerging industry. This industry and market may not continue to exist or grow as anticipated or we may ultimately be unable to succeed
in this industry or market. The hemp and hemp-derived product industry in the United States is highly speculative and is a relatively
new industry that appears to be rapidly expanding but ultimately may not be successful. We face inherent challenges associated with being
in a new market, including establishing reliable agricultural supply chains and processing and manufacturing to compete with producers
in other countries where industrial hemp cultivation has already been established. Therefore, we are subject to all of the business risks
associated with a new business in a niche market, including risks of unforeseen capital requirements, failure of widespread market acceptance
of hemp products, failure to establish business relationships, and competitive disadvantages as against larger and more established competitors.
Laws
governing our access to banking services are uncertain and are in a state of flux. Since the commerce in cannabis is illegal
under federal law, most federally chartered banks will not accept funds for deposit from businesses involved with cannabis. Consequently,
businesses involved in the cannabis industry often have difficulty finding a bank willing to accept their business. With the passage
of the 2018 Farm Bill, we expect the banking industry will be more open to doing business with compliant hemp business. However, banks
may still refuse to open bank accounts, make loans, or initiate currency transactions with us. Additionally, major credit card processors
also may be hesitant to do business with us and, as a result, we may be forced to find less reputable credit card processing solutions
abroad, or pay higher transaction fees.
The
House of Representatives approved the Secure and Fair Enforcement Banking Act in September 2019 and its provisions were included in the
HEROES Act relief bill that it approved in May 2020. Those provisions are designed to protect banks that service the cannabis industry
from being penalized by federal regulators as well as to protect ancillary business that work with the cannabis industry from being charged
with money laundering and other financial crimes. However, whether the provisions of this bill will be introduced again and ultimately
passed is unknown and, even if it is passed, it may not result in a more open banking climate. Our inability to open and maintain 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. Similarly, many of our suppliers, partners,
and customers are involved in cannabis and/or hemp businesses and further restriction to their ability to access banking services may
make it difficult for them to purchase our products, which could have a material adverse effect on our business, financial condition,
and results of operations.
Banking
regulations in our business are costly and time consuming, which may negatively impact our business. In assessing the prospective
risk of providing services to hemp-related business, financial institutions may conduct customer due diligence that includes: (i) verifying
with the appropriate state authorities whether the business is duly licensed and registered; (ii) reviewing the license application (and
related documentation) submitted by the business for obtaining a state license to operate its cannabis-related or hemp-related businesses;
(iii) requesting from state licensing and enforcement authorities available information about the business and related parties; (iv)
developing an understanding of the normal and expected activity for the business, including the types of products to be sold; (v) ongoing
monitoring of publicly available sources for adverse information about the business and related parties; (vi) ongoing monitoring for
suspicious activity, including for any of the red flags described in this guidance; and (vii) refreshing information obtained as part
of customer due diligence on a periodic basis and commensurate with the risk. With respect to information regarding state licensure obtained
in connection with such customer due diligence, a financial institution may reasonably rely on the accuracy of information provided by
state licensing authorities, where states make such information available. These regulatory reviews may be time consuming and costly.
Due
to our involvement in the hemp industry, we may have a difficult time obtaining the various insurances that are desired to operate our
business, which may expose us to additional risk and financial liability. Insurance that is otherwise readily available, such
as general liability and product liability, may be more difficult for us to obtain and has been more expensive, because of our involvement
in the hemp industry. There are no guarantees that we will be able to find such insurance in the future, or that the cost will be affordable
to us. If we are forced to go without such insurance, it may prevent us from entering into certain business sectors, may inhibit our
growth, and may expose us to additional risk and financial liability.
We
are dependent on the popularity of consumer acceptance of our product lines and service offerings. Our ability to generate revenue
and be successful in the implementation of our business plan is dependent on consumer acceptance and demand of our product lines and
service offerings. Acceptance of our products and services will depend on several factors, including availability, cost, ease of use,
familiarity of use, convenience, effectiveness, safety, and reliability. If customers do not accept our products, or if we fail to meet
customers’ needs and expectations adequately, our ability to continue generating revenues could be reduced. Due to the changing
consumer preferences, it is also difficult to forecast demand for hemp-derived products. There is a high risk that hemp-derived products’
ultimate popularity will decline, leading to lower revenues.
A
drop in the retail price of hemp-derived products may negatively impact our business. The demand for our products depends in
part on the price of commercially grown hemp. Fluctuations in economic, market, and agricultural conditions that impact the prices of
commercially grown hemp, such as increases in the supply of such hemp and the decrease in the price of products using commercially grown
hemp, could cause the demand for hemp-derived products to decline, which would have a negative impact on our business.
We
could suffer reputational and financial damage in the event of injury from our products or product recalls. As a manufacturer
and distributor of products intended for human consumption or use, we are subject to product liability claims if the use of our products
by others is alleged to have resulted in harm or injury. Our products consist of hemp-derived oils, creams, lotions, extracts, and other
ingredients that are not subject to pre-market regulatory approval in the United States or internationally, as well as snacks and health,
but not dietary, supplements. Previously unknown adverse reactions resulting from human consumption or use of these ingredients could
occur, which would likely result in product liability claims against us, and which would increase our costs and adversely affect our
reputation and harm our business. We may be held liable if any illness or injury caused by any product we develop, manufacture, or distribute,
if any such product is found to be unsuitable for use. In addition to any reputational damage we would suffer, we cannot guarantee that
our product liability insurance or that of any of our suppliers would fully cover potential liabilities. In the event of litigation,
any adverse judgments against us would have a material adverse effect on our financial condition, including our cash balances, and results
of operations.
The
presence of THC in our hemp-derived products may cause adverse consequences to users of such products that will expose us to the risk
of liability and other consequences. Our products are made from industrial hemp, which contains THC, though typically at a low
level. As a result of the variability of agricultural products, certain of our products contain varying levels of THC. THC is an illegal
or controlled substance in many jurisdictions. Whether or not ingestion of THC (at low levels or otherwise) is permitted in a particular
jurisdiction, there may be adverse consequences to end users who test positive for THC attributed to use of our products through unintentional
presence in its products of THC, even if only in trace amounts. In addition, certain metabolic processes in the body may negatively affect
the results of drug tests. Positive tests may adversely affect the end user’s reputation, ability to obtain or retain employment,
and participation in certain athletic or other activities. A claim or regulatory action against us based on such positive test results
could materially adversely affect our reputation, potentially expose us to material liability, and potentially require us to recall our
products.
Our
future success depends on our key executive officers and our ability to attract, retain, and motivate qualified personnel. Our
future success largely depends upon the continued services of our executive officers and management team. If one or more of our executive
officers are unable or unwilling to continue in their present positions, we may not be able to replace them readily, if at all. Additionally,
we may incur additional expenses to recruit and retain new executive officers. If any of our executive officers joins a competitor or
forms a competing company, we may lose some or all of our customers. Finally, we do not maintain “key person” life insurance
on any of our executive officers. Because of these factors, the loss of the services of any of these key persons could adversely affect
our business, financial condition, and results of operations, and thereby an investment in our stock.
Our
continuing ability to attract and retain highly qualified personnel will also be critical to our success because we will need to hire
and retain additional personnel as our business grows. There can be no assurance that we will be able to attract or retain highly qualified
personnel. We face significant competition for skilled personnel in our industries. In particular, if the hemp industry continues to
grow, demand for personnel may become more competitive. This competition may make it more difficult and expensive to attract, hire, and
retain qualified managers and employees. Because of these factors, we may not be able to manage or grow our business effectively, which
could adversely affect our financial condition or business. As a result, the value of your investment could be significantly reduced
or completely lost.
We
may not be able to manage our growth or improve our operational, financial, and management information systems effectively, which would
impair our results of operations. In the near term, we intend to expand the scope of our operations activities significantly,
including the launch of our new brand Blesswell, in conjunction with the Khode LLC Joint Venture, expanding our existing sales and distribution
channels, along with the future launch of Go Green Global’s operations in Jamaica, re-branding of Kushwear’s product line-up,
and developing and launching CBDLB’s line-up of beverages. If we are successful in executing our business plan, we will experience
growth in our business that could place a significant strain on our business operations, finances, management, and other resources. The
factors that may place strain on our resources include, but are not limited to, the following:
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The
need for continued development of our financial and information management systems; |
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need to manage strategic relationships and agreements with manufacturers, customers, and partners; and |
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Difficulties
in hiring and retaining skilled management, technical, and other personnel necessary to support and manage our business. |
Additionally,
our strategy envisions a period of rapid growth that may impose a significant burden on our administrative and operational resources.
Our ability to manage growth effectively will require us to substantially expand the capabilities of our administrative and operational
resources and to attract, train, manage, and retain qualified management and other personnel. There can be no assurance that we will
be successful in recruiting and retaining new employees or retaining existing employees.
We
cannot provide assurances that our management will be able to manage this growth effectively. Our failure to successfully manage growth
could result in our sales not increasing commensurately with capital investments or otherwise materially adversely affecting our business,
financial condition, or results of operations.
If
we are unable to continually innovate and increase efficiencies, our ability to attract new customers may be adversely affected. In
the area of innovation, we must be able to develop new technologies and products that appeal to our customers. This depends, in part,
on the technological and creative skills of our personnel and on our ability to protect our intellectual property rights. We may not
be successful in the development, introduction, marketing, and sourcing of new technologies or innovations, that satisfy customer needs,
achieve market acceptance, or generate satisfactory financial returns.
If
we incur substantial liability from litigation, complaints, or enforcement actions, our financial condition could suffer. Our
participation in the hemp-derived product industry may lead to litigation, formal or informal complaints, enforcement actions, and inquiries
by various federal, state, or local governmental authorities against us. Litigation, complaints, and enforcement actions could consume
considerable amounts of financial and other corporate resources, which could have a negative impact on our sales, revenue, profitability,
and growth prospects. We have not been, and are not currently, subject to any material litigation, complaint, or enforcement action regarding
cannabis or hemp (or otherwise) brought by any federal, state, or local governmental authority.
Risks
Relating to Our Common Stock
The
market price of our Common Stock may fluctuate significantly, which could negatively affect us and the holders of our Common Stock. The
trading price of our Common Stock may fluctuate significantly in response to a number of factors, many of which are beyond our control.
For instance, if our financial results are below the expectations of securities analysts and investors, the market price of our Common
Stock could decrease, perhaps significantly. Other factors that may affect the market price of our Common Stock include:
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volatility
in the trading markets generally and in our particular market segment; |
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trading of our Common Stock; |
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actual
or anticipated fluctuations in our results of operations; |
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the
financial projections we may provide to the public, any changes in those projections, or our failure to meet those projections; |
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announcements
regarding our business or the business of our customers or competitors; |
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changes
in accounting standards, policies, guidelines, interpretations, or principles; |
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actual
or anticipated developments in our business or our competitors’ businesses or the competitive landscape generally; |
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developments
or disputes concerning our intellectual property or our offerings, or third-party proprietary rights; |
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announced
or completed acquisitions of businesses or technologies by us or our competitors; |
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new
laws or regulations or new interpretations of existing laws or regulations applicable to our business; |
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any
major change in our board of directors (our “Board”) or management; |
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sales
of shares of our Common Stock by us or by our stockholders; |
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lawsuits
threatened or filed against us; and |
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other
events or factors, including those resulting from war, incidents of terrorism, or responses to these events. |
Statements
of, or changes in, opinions, ratings, or earnings estimates made by brokerage firms or industry analysts relating to the markets in which
we operate or expect to operate could have an adverse effect on the market price of our Common Stock. In addition, the stock market as
a whole, as well as our particular market segment, has from time to time experienced extreme price and volume fluctuations, which may
affect the market price for the securities of many companies, and which often have appeared unrelated to the operating performance of
such companies. Any of these factors could negatively affect our stockholders’ ability to sell their shares of Common Stock at
the time and price they desire.
We
may issue additional shares of Common Stock or preferred stock in the future, which could cause significant dilution to all stockholders.
We are authorized to issue up to 1,000,000,000 shares of Common Stock and 10,000,000 shares of preferred stock, par value $0.0001
per share, of which 505,157,952 shares of Common Stock and 4,878,048.8 shares of Series
H Convertible Preferred Stock (the “Series H Stock”) are currently issued and outstanding as of January 9, 2023. The number
of shares of Common Stock issued and outstanding excludes the shares of Common Stock underlying the shares of Series H Stock and shares
underlying common stock purchase warrants. We expect to seek additional financing in order to provide working capital to our business
or may issue additional shares of Common Stock as compensation. Our Board has the power to issue any or all of such authorized but unissued
shares of our Common Stock at any price and, in respect of the preferred stock, at any price and with any attributes, our Board considers
sufficient, without stockholder approval. The issuance of additional shares of Common Stock in the future will reduce the proportionate
ownership and voting power of current stockholders and may negatively impact the market price of our Common Stock.
We
may issue additional securities with rights superior to those of our Common Stock, which could materially limit the ownership rights
of our stockholders. We may offer additional debt or equity securities in private and/or public offerings in order to raise working
capital or to refinance our debt. Our Board has the right to determine the terms and rights of any debt securities and preferred stock
without obtaining the approval of our stockholders. It is possible that any debt securities or preferred stock that we sell would have
terms and rights superior to those of our Common Stock and may be convertible into shares of our Common Stock. Any sale of securities
could adversely affect the interests or voting rights of the holders of our Common Stock, result in substantial dilution to existing
stockholders, or adversely affect the market price of our Common Stock.
Quotation
on the OTCM’s Pink® Open Market may be volatile and sporadic. Currently, our Common Stock is quoted on the
OTCM’s Pink Open Market. Trading in stock quoted on over-the-counter markets is often thin and characterized by wide fluctuations
in trading prices, due to many factors that may have little to do with our operations or business prospects. This volatility could depress
or inflate the market price of our Common Stock for reasons unrelated to operating performance. Moreover, the OTCM is not a stock exchange,
and trading of securities on this market is often more sporadic than the trading of securities listed on a national securities exchange,
i.e., the New York Stock Exchange, the NYSE American, or The Nasdaq Stock Market.
The
Holders of our Series H Stock control more than half of our voting securities; they can exert significant control over our business and
affairs and have actual or potential interests that may depart from those of investors. The holders of our Series H Preferred
Stock control in excess of 50% of our total voting power. As a result, they will have significant influence and control over all corporate
actions requiring stockholder approval, irrespective of how our other stockholders may vote, including the following actions:
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elect or defeat the election of our directors; |
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amend or prevent an amendment to our Articles of Incorporation or Bylaws; |
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effect or prevent a merger, sale of assets, or other corporate transaction; and |
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control the outcome of any other matter submitted to our stockholders for a vote. |
This
concentration of ownership by itself may have the effect of impeding a merger, consolidation, takeover, or other business consolidation,
or discouraging a potential acquirer from making a tender offer for our Common Stock, which in turn could reduce our stock price or prevent
our stockholders from realizing a premium over our stock price.
We
will be a “controlled company” within the meaning of the Nasdaq rules and the NYSE rules and, as a result, will qualify for,
and will rely on, exemptions from certain corporate governance requirements that provide protection to the stockholders of companies
that are subject to such corporate governance requirements. Because the holders of our Series H Preferred Stock control in excess
of 50% of our total voting power, we will be a “controlled company” within the meaning of the corporate governance standards
of the Nasdaq rules and the NYSE rules. Under these rules, a listed company of which more than 50% of the voting power is held by an
individual, group, or another company is a “controlled company” and may elect not to comply with certain of the exchange’s
corporate governance requirements. As of the date of this Annual Report on Form 10-K, our Common Stock is not listed on the New York
Stock Exchange, the NYSE American, or the Nasdaq Stock Market and there cannot be any assurance that it ever will be listed on a national
securities exchange. If our Common Stock qualifies to be listed on a national securities exchange and if we choose to initiate the listing
process, we will then determine whether we characterize ourselves as a “controlled company” for corporate governance requirements.
As a company, whose Common Stock is currently quoted on the OTCM’s Pink Open Market, we are not required to abide by the corporate
governance rules of a national securities exchange and accordingly, do not have a fully independent series of board committees. Thus,
as a consequence of our reliance on certain exemptions from the Nasdaq standards provided to “controlled companies,” you
will not have the same protections afforded to stockholders of companies that are subject to all of the corporate governance requirements
of a national securities exchange.
We
are not subject to the rules of a national securities exchange requiring the adoption of certain corporate governance measures and, as
a result, our stockholders do not have the same protections. Separately from the “controlled company” analysis of
the previous risk factor, we are not subject to the rules of a national securities exchange, such as the New York Stock Exchange, the
NYSE American, or The Nasdaq Stock Market. National securities exchanges generally require more rigorous measures relating to corporate
governance that are designed to enhance the integrity of corporate management. The requirements of the OTCM’s Pink®
Open Market afford our stockholders fewer corporate governance protections than those of a national securities exchange. Until we comply
with such greater corporate governance measures, even though such compliance is not required by the OTCM for quotations of shares of
our Common Stock on the OTCM’s Pink Open Market, our stockholders will have fewer protections, such as those related to director
independence, stockholder approval rights, and governance measures that are designed to provide oversight of a corporation’s management
by its board of directors.
A
decline in the price of our Common Stock could affect our ability to raise working capital, which could adversely impact our ability
to continue our operations. A prolonged decline in the price of our Common Stock could result in a reduction in the liquidity
of our Common Stock and a reduction in our ability to raise capital. We may attempt to acquire a significant portion of the funds we
need in order to conduct our planned operations through the sale of equity securities; thus, a decline in the price of our Common Stock
could be detrimental to our liquidity and our operations because the decline may adversely affect investors’ desire to invest in
our securities. If we are unable to raise the funds we require for all of our planned operations, we may be forced to reallocate funds
from other planned uses and may suffer a significant negative effect on our business plan and operations, including our ability to develop
new products or services and continue our current operations. As a result, our business may suffer, and we may be forced to reduce or
discontinue operations. We also might not be able to meet our financial obligations if we cannot raise enough funds through the sale
of our Common Stock and we may be forced to reduce or discontinue operations.
Because
we do not intend to pay any cash dividends on our shares of Common Stock in the near future, our stockholders will not be able to receive
a return on their shares unless and until they sell them. We intend to retain any future earnings to finance the development
and expansion of our business. We do not anticipate paying any cash dividends on our Common Stock in the near future. The declaration,
payment, and amount of any future dividends will be made at the discretion of our Board, and will depend upon, among other things, the
results of operations, cash flow, and financial condition, operating and capital requirements, and other factors as our Board considers
relevant. There is no assurance that future dividends will be paid, and, if dividends are paid, there is no assurance with respect to
the amount of any such dividend. Unless our Board determines to pay dividends, our stockholders will be required to look to appreciation
of our Common Stock to realize a gain on their investment. There can be no assurance that this appreciation will occur.
If
we are unable to establish appropriate internal financial reporting controls and procedures, it could cause us to fail to meet our reporting
obligations, result in the restatement of our financial statements, harm our operating results, possibly subject us to regulatory scrutiny
and sanctions, cause investors to lose confidence in our reported financial information, and have a negative effect on the market price
for shares of our Common Stock. Effective internal controls are necessary for us to provide reliable financial reports and effectively
to prevent fraud. We maintain a system of internal controls over financial reporting, which is defined as a process designed by, or under
the supervision of, our principal executive officer and principal financial officer, or persons performing similar functions, and effected
by our Board, management, and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles (“GAAP”).
Because
our class of Common Stock is now registered pursuant to Section 12(g) of the Exchange Act, we will have significant requirements for
enhanced financial reporting and internal controls. We are required to document and test our internal control procedures in order to
satisfy the requirements of Section 404 of the Sarbanes-Oxley Act of 2002, which requires annual management assessments of the effectiveness
of our internal controls over financial reporting. The process of designing and implementing effective internal controls is a continuous
effort that requires us to anticipate and react to changes in our business and economic and regulatory environments, and to expend significant
resources to maintain a system of internal controls that is adequate to satisfy our reporting obligations as a public company.
We
cannot assure you that we will, in the future, identify areas requiring improvement in our internal control over financial reporting.
We cannot assure you that the measures we will take to remediate any areas in need of improvement will be successful or that we will
implement and maintain adequate controls over our financial processes and reporting in the future as we continue to grow. If we are unable
to establish appropriate internal financial reporting controls and procedures, it could cause us to fail to meet our reporting obligations,
result in the restatement of our financial statements, harm our operating results, subject us to regulatory scrutiny and sanction, cause
investors to lose confidence in our reported financial information, and have a negative effect on the market price for shares of our
Common Stock.
We
lack sufficient internal controls over financial reporting and implementing acceptable internal controls will be difficult with a limited
number of management personnel, which will make it difficult to ensure that information required to be disclosed in our future reports
filed and submitted under the Exchange Act is recorded, processed, summarized, and reported as and when required. As of the date
of this Annual Report on Form 10-K, we currently lack certain internal controls over our financial reporting. We have a limited number
of management personnel, which may make it difficult to implement such controls at this time. The lack of such controls makes it difficult
to ensure that information required to be disclosed in our reports to be filed and submitted under the Exchange Act (now that our class
of Common Stock is registered pursuant to Section 12(g) thereof) will be recorded, processed, summarized, and reported, as and when required.
The
reasons we believe that our disclosure controls and procedures are not fully effective are because:
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there
is a lack of segregation of duties necessary for a good system of internal control due to insufficient accounting staff due to our
size; |
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the
staffing of our accounting department is weak due to the lack of qualifications and training, and the lack of formal review process; |
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our
control environment is weak due to the lack of an effective risk assessment process, the lack of internal audit function, and insufficient
documentation and communication of the accounting policies; and |
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failure
in the operating effectiveness over controls related to recording revenue. |
We
cannot assure you that we will be able to develop and implement the necessary internal controls over financial reporting. The absence
of such internal controls may inhibit investors from purchasing our shares and may make it more difficult for us to raise debt or equity
financing.
Our
Common Stock is categorized as “penny stock,” which may make it more difficult for investors to sell their shares of Common
Stock due to suitability requirements. Our Common Stock is categorized as “penny stock.” The Commission adopted Rule
15g-9, which generally defines “penny stock” to be any equity security that has a market price (as defined) of less than
$5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. The price of our Common Stock is significantly
less than $5.00 per share and we did not qualify for any of the other exceptions; therefore, our Common Stock is considered “penny
stock.” This designation imposes additional sales practice requirements on broker-dealers who sell to persons other than established
customers and “accredited investors.” The term “accredited investor” refers generally to institutions with assets
in excess of $5,000,000 or individuals with a net worth in excess of $1,000,000 or annual income exceeding $200,000, or $300,000 jointly
with his or her spouse. The penny stock rules require a broker-dealer buying our securities, prior to a transaction in a penny stock
not otherwise exempt from the rules, to deliver a standardized risk disclosure document in a form prepared by the Commission that provides
information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the customer
with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction
and monthly account statements showing the market value of each penny stock held in the customer’s account. The bid and offer quotations,
and the broker-dealer and salesperson compensation information, must be given to the customer orally or in writing prior to effecting
the transaction and must be given to the customer in writing before or with the customer’s confirmation. In addition, the penny
stock rules require that, prior to a transaction in a penny stock not otherwise exempt from these rules, the broker-dealer must make
a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written
agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary
market for the stock that is subject to these penny stock rules. Consequently, these penny stock rules may affect the ability and/or
willingness of broker-dealers to trade our securities, either directly or on behalf of their clients, may discourage potential investor’s
from purchasing our securities, or may adversely affect the ability of our stockholders to sell their shares.
The
Financial Industry Regulatory Authority, Inc. (“FINRA”) has adopted sales practice requirements that may limit a stockholder’s
ability to buy and sell our Common Stock, which could depress the price of our Common Stock. In addition to the “penny
stock” rules described above, FINRA has adopted rules that require that, in recommending an investment to a customer, a broker-dealer
must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low-priced
securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s
financial status, tax status, investment objectives, and other information. Under interpretations of these rules, FINRA believes that
there is a high probability that speculative low-priced securities will not be suitable for at least some customers. Thus, the FINRA
requirements may make it more difficult for broker-dealers to recommend that their customers buy our Common Stock, which could limit
your ability to buy and sell our Common Stock, have an adverse effect on the market for our shares, and thereby depress our price per
share of Common Stock.
The
elimination of monetary liability against our directors, officers, and employees under Nevada law and the existence of indemnification
rights for our obligations to our directors, officers, and employees may result in substantial expenditures by us and may discourage
lawsuits against our directors, officers, and employees. Our Articles of Incorporation contain a provision limiting the personal
liability of our directors and officers to our stockholders and to us for damages for the breach of a fiduciary duty as a director or
officer except with respect to (i) acts or omissions that involve intentional misconduct, fraud, or a knowing violation of the law or
(ii) the payment of dividends in violation of Nevada law. We also previously entered into employment agreements with each of our officers
pursuant to which we have contractual indemnification obligations. The foregoing indemnification obligations could result in us incurring
substantial expenditures to cover the cost of settlement or damage awards against directors and officers, which we may be unable to recoup.
These provisions and the resulting costs may also discourage us from bringing a lawsuit against directors and officers for breaches of
their fiduciary duties, and may similarly discourage the filing of derivative litigation by our stockholders against our directors and
officers even though such actions, if successful, might otherwise benefit our stockholders and us.
Anti-takeover
effects of certain provisions of Nevada state law hinder a potential takeover of us. Nevada has a business combination law that
prohibits certain business combinations between Nevada corporations and “interested stockholders” for three years after an
“interested stockholder” first becomes an “interested stockholder,” unless the corporation’s board of directors
approves the combination in advance. For purposes of Nevada law, an “interested stockholder” is any person who is (i) the
beneficial owner, directly or indirectly, of ten percent or more of the voting power of the outstanding voting shares of the corporation
or (ii) an affiliate or associate of the corporation and at any time within the three previous years was the beneficial owner, directly
or indirectly, of ten percent or more of the voting power of the then-outstanding shares of the corporation. The definition of the term
“business combination” is sufficiently broad to cover virtually any kind of transaction that would allow a potential acquirer
to use the corporation’s assets to finance the acquisition or otherwise to benefit its own interests rather than the interests
of the corporation and its other stockholders.
The
potential effect of Nevada’s business combination law is to discourage parties interested in taking control of us from doing so
if these parties cannot obtain the approval of our Board. Both of these provisions could limit the price investors would be willing to
pay in the future for shares of our Common Stock.