Item
1. Business
Overview
NutraLife
BioSciences, Inc., a Florida corporation (“us,” “we,” “our” or the “Company”) was founded
in 2010 by Edgar Ward, the Company’s Chief Executive Officer, President & sole Director to engage in the development, manufacturing
and distribution of nutritional and dietary nutritional supplement products. Since then, the Company has evolved into a branded and private
label developer, manufacturer and distributor of a wide range of nutraceutical, wellness, and CBD products.
Amid
the COVID-19 global pandemic, in 2020, the Company made a strategic pivot from our then-current nutraceutical manufacturing business
by adding the manufacture of consumer sanitizer products utilizing the Company’s existing manufacturing capabilities and the Company’s
ability to retrofit its operations and accommodate production due to the shortage of supply and increased demand for sanitizer products.
The
Company’s manufacturing facility has been registered with the Food and Drug Administration and its manufacturing facility has operated
in accordance with the Good Manufacturing Processes Standard (GMP) for more than five years. Our products adhere to high manufacturing
standards throughout every step of the manufacturing and extraction process. Our products are formulated, developed, manufactured and
produced under the supervision of Edgar Ward, our Chief Executive Officer, President and sole Director. Once produced, our products are
tested by our in-house and third party laboratory chemists. We believe that our nutraceutical and industrial CBD products are of the
highest-quality and are laboratory tested for strength, purity and contaminants such as microbials, heavy metals, pesticides, and solvents.
We
offer a number of different core formulations which we modify to meet the specifications of our private label customers. We provide many
different variations of our core formulations. Our private label ingestible and skincare products include CBD-infused oral sprays, tinctures,
pet drops, pain balms, and face creams.
Our
products are available in various formulations and strengths and are available for purchase online directly from the Company through
its website at www.nutralifebiosciences.com, as well as through numerous other private label distributors, online retailers and
retail outlets. Information available on, or accessible through the foregoing website is not a part of this Annual Report on Form 10-K
and is not incorporated herein by reference.
Our
financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of
liabilities and commitments in the normal course of business. We sustained a net loss of approximately $5.8 and $2.9 million for the
years ended December 31, 2021 and 2020, respectively, negative cash flows from operations for both years and had an accumulated deficit
of approximately $47.6 million at December 31, 2021. These conditions raise substantial doubt about our ability to continue as
a going concern. The independent auditors’ report on our financial statements for the years ended December 31, 2021 and 2020 contain
explanatory paragraphs expressing substantial doubt as to our ability to continue as a going concern.
In
December 2019, a novel strain of coronavirus was reported to have surfaced in China and spread to the U.S. in early 2020. The spread
of this virus caused various business disruptions including temporary closures to the Company’s offices and facilities.
The
Company is currently in the process of raising capital to complete and finalize the build-out of its facility in Deerfield Beach for
the purpose of consolidating its operations. The structure of the capital raise is currently in development. The Company is seeking to
continue its path to profitability through increased business development, marketing and sales of the Company’s multiple lines
of topical, ingestible and skincare health and wellness products. The Company is also focused on completing an efficacy clinical study
on its patented mosquito bug patch with plans upon a successful conclusion to launch globally in the future, adding to the Company’s
suite of wellness products. However, there can be no assurance that the foregoing can occur as planned, or at all.
Failure
to successfully continue to grow operational revenues could harm our profitability and adversely affect our financial condition and results
of operations. We face all of the risks inherent in a new business, including the need for significant additional capital, management’s
potential underestimation of initial and ongoing costs, and potential delays and other problems in connection with establishing sales
channels.
We
are continuing our plan to further grow and expand operations and seek sources of capital to pay our contractual obligations as they
come due. Management believes that its current operating strategy will provide the opportunity for us to continue as a going concern
as long as we are able to obtain additional financing; however, there is no assurance this will occur. The accompanying consolidated
financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
Corporate
History
The
Company was formed as a limited liability company in the state of Florida on April 1, 2010. On December 3, 2012, we converted from a
limited liability company to a Florida corporation.
We
have four wholly owned subsidiaries:
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Precision
Analytic Testing, LLC, a Florida limited liability company (“PAT”) formed on May 11, 2019; |
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NutraDerma
Technologies, Inc., (“NutraDerma”) a Florida corporation formed on January 28, 2019; |
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PhytoChem
Technologies, Inc., a Florida corporation (“PhytoChem”) formed on February 4, 2019; and |
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TransDermalRX,
Inc., a Florida corporation (“TransDermal”) formed on February 8, 2019. |
Smaller
Reporting Company
The
Company is a “smaller reporting company” as defined in Rule 12b-2 under the Exchange Act. There are certain exemptions available
to us as a smaller reporting company, including: (1) not being required to comply with the auditor attestation requirements of Section
404(b) of the Sarbanes Oxley Act; (2) scaled executive compensation disclosures; and (3) the requirement to provide only two years of
audited financial statements, instead of three years. As long as we maintain our status as a “smaller reporting company,”
these exemptions will continue to be available to us.
Bankruptcy,
Receivership or Similar Proceedings
We
have not been involved in a bankruptcy receivership or similar proceeding. Additionally, we have not been involved in a reclassification,
merger, consolidation, or purchase or sale of a significant amount of assets not in the ordinary course of business.
Our
Business
We
are a manufacturer and distributor of nutraceutical, dietary, wellness and other products, such as skincare and sanitizer products. Our
products are sold to private label distributors who sell the products we manufacture under their own brand names as well as under our
own brand names. We generate revenues from the sales of our products.
For
the years ending on December 31, 2021 and 2020, we generated revenues of $626,619 and $1,255,784, respectively, from the sale of our
products.
In
March 2017, we began selling CBD products. For the years ending on December 31, 2021 and 2020, we generated revenues of $516,747 and
$66,807 respectively, from the sale of our CBD products, representing 98% and 5.65% of our revenues for such periods.
Our
Products and Services
We
manufacture and distribute private label and branded products. In both of the years ended December 31, 2021 and 2020, private label sales
represented 82% of our revenue.
Our
Products
Our
CBD products are derived from the seeds and mature stalks of the Cannabis Sativa plant which includes all parts and varieties of the
cannabis sativa plant also known as hemp, which contain a tetrahydrocannabinol concentration (“THC”) that does not exceed
0.3 percent on a dry-weight basis. In December of 2018, the U.S. Food and Drug Administration completed an evaluation of three generally
recognized as safe (GRAS) notices for hemp seed-derived food ingredients. The FDA stated that hulled hemp seed (GRN765), hemp seed protein
powder (GRN771), and hemp seed oil (GRN778) are GRAS under their intended conditions of use.
Our
CBD products are made from seeds and mature stalks of hemp and contain only trace amounts of THC which are far below 0.3 percent, and
we believe they qualify as GRAS products.
Our
CBD products include:
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Cannabinoid-rich
hemp oil derived from industrial hemp; |
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Tinctures; |
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Topical
lotions and oils applied directly to the skin designed to treat pain or inflammation; |
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Face
creams; |
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Massage
oils; |
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Nutraceutical
Sprays with CBD as an added ingredient; and |
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Pet
products taken internally. |
Our
other products include:
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Eddie’s
Clean Hands |
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Eddie’s
Immune Boost |
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INVISIPatch
Bug Patch |
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PCR-
Pure |
Recent
Developments
In
November of 2018, PAT began providing bulk material analytical, identity, potency and purity testing of raw industrial hemp.
In
January of 2019, NutraDerma acquired the patent for a natural dermal skin patch that is designed to prevent mosquito and other insect
bites.
In
February of 2019, Phytochem entered into an agreement with Owen Morgan, an individual, whereby Mr. Morgan agreed to provide certain know
how and services to Phytochem for the commercialization of certain technologies to separate and/or process the components of hemp to
remove and/or modify, purify, dilute and extract bioactive ingredients and/or remove unwanted substances to produce finished products
for a variety of applications. This agreement is further described under the heading “Material Agreements” below.
In
March of 2019, we licensed our technology for a unique system for pharmaceutical grade delivery of testosterone into the human body to
licensed pharmacist, Orlando Pharmacy, as further described under the heading “Material Agreements” below.
In
March of 2019, we entered into an agreement with NewLeaf Assets, LLC, a Delaware Limited Liability Company (“NewLeaf”) as
amended, (the “Agreement”) whereby NewLeaf invested an aggregate of $1,380,000 (the “Investment”) in our securities.
This Agreement is further described under the heading “Material Agreements” below.
On
June 7, 2019, the Company granted a bonus to its Chief Executive Officer and President, Edgar Ward, of ten percent (10%) of the future
gross revenue generated by PhytoChem for a period of seven (7) years from the date that PhytoChem receives its first revenue.
In
June 2019, and as amended in November 2019, we entered into an investment agreement, note, Security Agreement, Purchase Royalty Agreement,
Pledge Agreement, Pledgor Royalty Agreement with PhytoChem Technologies, Inc., Kahn Family Limited PT II., and Brenda Hamilton as the
pledgor, which were subsequently amended in November of 2019. The foregoing agreements are further described under the heading “Material
Agreements” below.
Amid
the COVID-19 global pandemic, in 2020, the Company made a strategic pivot from our then-current nutraceutical manufacturing business
by adding the manufacture of consumer sanitizer products utilizing the Company’s existing manufacturing capabilities and the Company’s
ability to retrofit its operations and accommodate production due to the shortage of supply and demand for sanitizer products. To do
so, consistent with Food and Drug Administration (FDA) requirements, the Company registered and obtained a labeler code as an over-the-counter
(OTC) manufacturing facility and began manufacturing and distributing a line of liquid-based multi-use sanitizer spray products under
the Company’s in-house brand, “Eddie’s Clean Hands,” packaged as a multi-use sanitizer spray, formulated per
the CDC’s recommendation of containing at least 60-95% ethanol or isopropanol alcohol to be effective.
In
May 2020, we secured a supplier agreement with Grainger, and began drop-shipping its sanitizer products that include a 10-pack of Eddie’s
Clean Hands 2 oz. sanitizer spray along with a larger 8 oz. sanitizer spray directly to Grainger and its customers. Grainger is a broad
line, business-to-business distributor of maintenance, repair, and operating (MRO) products and services with operations primarily in
North America, Japan, and Europe.
On
September 30, 2020, the Company filed Articles of Amendment (the “Amendment”) to its Articles of Incorporation with the Florida
Department of State that contained a Certificate of Designations to designate one hundred and ten (110) shares of the preferred stock
of the Company, par value $0.0001 as Series B Convertible Preferred Stock (the “Series B Preferred Stock”). The Amendment
was effective on September 30, 2020.
On
November 2, 2020, the Company entered into a Stock Purchase Agreement with Lord Global Corporation and its wholly owned subsidiary, 27
Health Inc., and also entered into a Manufacturing, Distribution and Sales Agreement (the “MDS”) with 27 Health Inc. The
MDS is a multi-year production, fulfillment, and distribution agreement with 27 Health Inc. to launch its patent-pending Oral Sanitizer
mouth spray which we hope will provide some protection from viruses by reducing viral transmission. The foregoing agreements are further
described under the heading “Material Agreements” below.
On
December 18, 2020, the Company received its product registration number from the Food and Drug Administration (FDA) and completed its
first production run of Oral Shield antiseptic protection mouth spray. The Company along with its partners plans to market and distribute
the product on a global scale and seeks to provide a convenient, travel-size, quality, multi-functioning antiseptic mouth spray for consumers
to use throughout the day. We believe that mouthwash products can be effective at killing viruses, reducing the viral load within the
mouth essentially supporting the reduction of virus transmissions.
In
September 2021, the Company entered a strategic partnership with KOR Medical to produce an initial order for a line of cannabinoid-based
wellness products. The initial products produced under this venture is a line of four ingestible items formulated to help improve overall
health, including helping consumers sleep better, feel better, be calmer, and improve their quality of life.
In November 20, 2021 the Company executed
a definitive agreement with Cookie Retail Products, LLC (“CRP”) for a strategic partnership with Cookies (branded)
Retail Products. Under the terms of the agreement, CRP will provide the Company with branding and marketing guidance while the
Company becomes a preferred research and development profit participant and partner of CRP. The Company will utilize its nutraceutical
and research resources to design, create, and provide options for non-regulated, federally legal for sale, innovative product introductions
to be used for the parent Cookies brand. Cookies is an iconic billion-dollar brand with retail, ecommerce, and direct-to-consumer verticals
across multiple channels of trade.
Our
Operating Strategy
The
Company manufactures and distributes unique dietary
supplements, sold directly to consumers, as well as through retail and wholesale outlets. We are dedicated to bringing the highest quality,
most beneficial, effective nutrients and delivery systems to the market. With over 35 years’ experience in nutritional supplementation,
we know the importance of products that are natural and highly effective in maintaining one’s healthy lifestyle.
The
Company’s products are formulated to cater
to the daily health needs of men and women, and feature revolutionary nutrient delivery systems, such as oral sprays, tincture droppers,
blast caps and nutritional drinking straws. These methods are approved for pharmaceutical and nutraceutical use and have been hailed
for their convenience and precision.
The Company entered into strategic partnership
with Cookies (branded) Retail Products (CRP). Under the terms of the agreement, CRP will provide the Company with branding and
marketing guidance while the Company becomes a preferred research and development profit participant and partner of CRP. The
Company will utilize its nutraceutical and research resources to design, create, and provide options for non-regulated, federally
legal for sale, innovative product introductions to be used for the parent Cookies brand. Cookies is an iconic billion-dollar brand with
retail, ecommerce, and direct-to-consumer verticals across multiple channels of trade.
In
conjunction with recent private-label agreements, the Company is in the process of expanding its manufacturing operations and capabilities
to accommodate the production of several new products expected to be released in the near future. These products include an immune booster
drink shot infused with CBDA. CBDA along with CGBA have been found to “bind to the SARS-CoV-2 spike protein, blocking a critical
step in the process the virus uses to infect people.” Steve Lundeberg, Oregon State University.
The
Company is also preparing an application for a planned
uplisting to the OTCQB, with the objectives of increasing its visibility and exposure within the North American financial community,
and creating additional value for shareholders.
We
plan to continue the development, manufacturing and distribution of nutritional dietary and skincare products and we believe a
number of current industry trends will increase demand for private label products particularly in the industrial hemp CBD market.
Our operating strategy for such products consists of the following key elements:
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We
purchase raw materials and produce goods only upon receipt of a firm commitment from our private label customers and we require payment
in full prior to shipping. Once a product is shipped to a customer, we generally do not accept returns unless the product is defective
or delivered late. These practices minimize our need to carry unsold inventories. |
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We
regularly update our product line to keep up with consumer trends and industry developments. |
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We
provide superior customer service by controlling the entire production process of our products. By controlling the production process,
we have the ability to tailor products to a customer’s specific needs, offer customers rapid order turnaround time, maintain
flexible scheduling and maintain higher standards of quality control. |
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We
seek to add value to customers’ overall merchandising effort. We work closely with our customers to develop distinctive product
lines at their particular price points. We believe that this process allows our customers to achieve a degree of differentiation
from their retail competitors. We believe our ability to develop, manufacture and offer high quality, all-natural products is a competitive
advantage and will lead to increased orders. |
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We
emphasize the development of long-term relationships with our customers by providing a high level of customer service through our
sales force. We seek to capitalize on our knowledgeable and experienced sales force by maintaining regular interaction with our customers
which provides us with an understanding of which products will meet their particular needs. |
Our
Growth Strategy
We
intend to grow our business by pursuing the following strategies:
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We
plan to continue to expand our manufacture of consumer products. |
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We
also plan to continue to brand ourselves as a High Quality GMP Compliant manufacturer of industrial hemp CBD products. Many manufacturers
of CBD based products do not operate in compliance with GMP standards. All of our CBD products are tested at multiple stages of the
production process to ensure product quality and a THC content of less than 0.3%. |
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We
will seek to increase sales to our existing customers by expanding sales of additional products. Certain of our customers began their
relationship with us by purchasing only one of our products. Since these initial purchases, we have been able to expand our sales
to such customers to multiple products. This strategy has enabled us to expand our product sales to our existing customers over time.
We aggressively pursue these cross-selling opportunities. Our range of products enables us to pursue many of these cross-selling
opportunities. |
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We
seek to increase sales to customers by offering products in categories outside of our traditional product offerings. |
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We
plan to leverage our sales, reputation for quality all-natural products to expand our customer base to other private label customers
within the industrial hemp CBD and Nutraceutical markets. |
Our
Customers
Our
customers for our consumer sanitizer products include Grainger, Riverhead Chamber of Commerce and ecommerce direct to consumer consumers.
Our
private label sales represent several different brands of products manufactured by us. Sales to private label customers represented approximately
82% and 99% of our revenues for the years ended December 31, 2021 and 2020, respectively. Our industrial hemp CBD products represented
98% and 100% of private label sales in the years ended December 31, 2021and 2020, respectively.
We
do not enter into long term contracts with our private label distributors and all sales are made by purchase order. Our private label
customers are not obligated to order a minimum amount of product from us and can discontinue purchasing our product at any time.
We
believe our private label products offer numerous benefits to our customers:
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Our
private label products are premium products. |
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Our
private label products offer the opportunity for higher profit margins than brand name products. |
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Distributing
private label products builds brand recognition for the retail as well as the wholesale customer. |
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We
are registered with the FDA and follow GMP in the manufacturing process ensuring high quality products and consistent standards for
our private label customers. |
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Businesses
using our private label products avoid the additional expense of manufacturing and creating the finished product. |
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Our
private label customers are able to focus their attention and resources on their business and not on manufacturing a final product. |
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We
believe that we offer high quality unique products with enhanced delivery systems that are effective and appealing to consumers. |
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We
offer a wide range of private label products providing our customers with a variety of options. |
Manufacturing
As noted above, the Company
entered into strategic partnership with Cookies (branded) Retail Products (CRP). Under the terms of the agreement, CRP will provide
the Company with branding and marketing guidance while the Company becomes a preferred research and development profit
participant and partner of CRP. The Company will utilize its nutraceutical and research resources to design, create, and provide
options for non-regulated, federally legal for sale, innovative product introductions to be used for the parent Cookies brand. Cookies
is an iconic billion-dollar brand with retail, ecommerce, and direct-to-consumer verticals across multiple channels of trade.
Also
noted above, in 2020, the Company made a strategic pivot from our then-current nutraceutical manufacturing business by adding the manufacture
of consumer sanitizer products utilizing the Company’s existing manufacturing capabilities and the Company’s ability to retrofit
its operations and accommodate production due to the shortage of supply and demand for sanitizer products. To do so, consistent with
FDA requirements, the Company registered and obtained a labeler code as an OTC manufacturing facility and began manufacturing and distributing
a line of liquid-based multi-use sanitizer spray products under the Company’s in-house brand, “Eddie’s Clean Hands,”
packaged as a multi-use sanitizer spray, formulated per the CDC’s recommendation of containing at least 60-95% ethanol or isopropanol
alcohol to be effective. We plan to continue manufacturing and distributing liquid-based multi-use sanitizer spray products under the
Company’s in-house brand, “Eddie’s Clean Hands”.
Also,
as discussed above, on December 18, 2020, the Company received its product registration number from the FDA and completed its first production
run of Oral Shield antiseptic protection mouth spray. The Company along with its partners plans to market and distribute the product
on a global scale and seeks to provide a convenient, travel-size, quality, multi-functioning antiseptic mouth spray for consumers to
use throughout the day. We believe that mouthwash products can be effective at killing viruses, reducing the viral load within the mouth
essentially supporting the reduction of virus transmissions.
Once
developed, our products are manufactured at our facility in Coconut Creek, Florida. We obtain all raw materials and ingredients for our
products from third party suppliers. For all orders we receive, we manufacture, package, label and ship the product to the customer.
We lease an aggregate of six thousand four hundred (6,400) square feet of office and warehouse space at 6601 Lyons Rd, Suites L-6&7,
Coconut Creek, Florida 33073. Approximately five thousand eight hundred (5,800) square feet at this location is used for manufacturing,
storage and distribution of our products.
On
June 6, 2017, we entered into an agreement to lease nineteen thousand eight hundred and thirty-one (19,831) square feet in Deerfield
Beach, FL 33441. We plan to use seventeen thousand eight hundred (17,800) square feet of the new Deerfield Beach location for manufacturing,
storage and distribution of our products. We expect to begin manufacturing at this location in July of 2022.
By
manufacturing our own products, we believe that we maintain better control over product quality and availability while also reducing
production costs. Our manufacturing process generally consists of the following operations: (a) sourcing ingredients for products, (b)
warehousing raw ingredients, (c) efficacy testing and measuring ingredients for inclusion in products, and (d) blending using automatic
equipment. The next step, bottling and packaging, involves filling, capping, coding, labeling and placing the product in packaging with
appropriate tamper-evident features then sending the packaged product to our customers.
The
FDA requires companies manufacturing homeopathic medicines to have their facilities certified as Good Manufacturing Practices (“GMPs”).
Our manufacturing facility is registered with the FDA and is compliant with its GMP certification. Our quality control program seeks
to ensure the superior quality of our products and that they are manufactured in accordance with current GMP. Our processing methods
are monitored closely to ensure that only quality ingredients are used and to ensure product purity. Periodically, we retain the services
of outside GMP audit firms to assist us in our efforts to comply with GMPs.
Sources
and Availability of Raw Materials
The
raw materials for our industrial hemp CBD products consist of Cannabidiol rich oil and isolate. We obtain the raw materials for our industrial
hemp CBD products from state licensed suppliers. We obtain the raw materials for our other non-CBD based products from several ingredient
suppliers located in the U.S. These raw materials consist of naturally derived vitamins and nutrients. The raw materials used by us are
available from a variety of suppliers. We maintain a good relationship with our suppliers and do not anticipate that any of our suppliers
will terminate their relationship with us in the near term. We have ongoing relationships with secondary and tertiary suppliers. In the
event we are unable to obtain any of our raw materials from our suppliers; we believe that we could obtain alternative sources of any
raw materials from other suppliers. We do not have contracts with our suppliers and we order our raw materials on an as needed basis.
We have not experienced any material adverse effects on our business as a result of shortages of raw materials or packaging materials
used in the manufacturing of our products. An unexpected interruption or a shortage in supply of raw materials could adversely affect
our business derived from these products.
Shipping
and Delivery of Finished Products
Upon
completion of the manufacturing process, our products are shipped directly to customers. Private label products are packaged by us in
the packaging provided by each customer. All shipping, bills of lading and invoices are generated by us from our Coconut Creek, Florida
facility.
We
ship the product ordered within forty-five (45) days to our private label distributors, thirty (30) days to retail customers and within
thirty (30) days to wholesale and third party (non-private label) distributors. All orders are shipped by freight delivery at the cost
of the customer. We require a deposit of fifty percent (50%) upon an order being placed from our private label customers and the balance
prior to shipping. Our retail customers must pay for their order at the time that the order is placed.
Product
Development & Quality
We
have in place comprehensive quality control procedures seeking to ensure that raw materials and finished goods meet our exacting quality
standards. Each product we offer is based upon the research of Mr. Ward, with the assistance of our team and in-house chemists. Our products
are and, in the future, will continue to be identified by Mr. Ward based upon suggestions from customers, and from industry and market
research he conducts on an ongoing basis. We do not employ medical professionals and our management does not have experience in the healthcare
industry or in the treatment of disease. Our products have not been confirmed in any respect by the FDA or any other governmental agency
and may not produce the results intended. In developing products, we require:
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ingredients
that are supported with a certificate of analysis, publicly available scientific research and references which our Chief Executive
Officer reviews with our in-house chemists who assist in developing our final products; |
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ingredients
that are combined so that their effectiveness is not impaired; |
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the
THC contained in our products is less than 0.3% and all other ingredients are in dosage levels that fall within tolerable upper intake
levels established for healthy people by the Institute of Medicine of the National Academies and products with hemp; |
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our
products do not contain adulterated ingredients such as ephedra, androstenedione, aspartame, steroids, or human growth hormones;
and |
Sales
and Marketing
Mr.
Ward actively participates in the planning of our marketing and selling efforts. We employ 1 in house sales representative and use the
services independent sales representatives on a commission basis. We believe that this sales structure enables us to effectively control
our costs and sales efforts.
We
believe that our marketing mix of social media promotions and search engine optimization is an optimal strategy to increase sales for
both our private label and branded products. We use web-based marketing to promote our brands and products including social media and
promotion of our website at www.nutralifebiosciences.com. The information available on or accessible through our website is not a part
of and is not incorporated by reference into this Annual Report. Our website provides useful information about our industry, new developments
and our products and allows visitors to order our retail and wholesale wellness, nutraceutical and CBD products. We use Search Engine
Optimization (SEO) on an ongoing basis to drive traffic to our website and social media pages and enhance our presence on major search
engines such as Google, Bing and Yahoo.
We
aim to emphasize the development of long-term relationships with our customers. We believe that we have established strong relationships
with individual buyers at each of our private label customers, and more importantly we have also established relationships with senior
management of our key private label customers.
A
key component of our ability to achieve long-term relationships is the high level of services that we provide to our customers. Each
salesperson is responsible for all aspects of a customer’s needs, including product samples, obtaining orders, coordinating product
selection, monitoring production and delivering finished products. During the production process, such salesperson is responsible for
informing the customer about the progress of an order, including any difficulties that might affect delivery time. In this way, we and
our customer can make appropriate arrangements regarding any delay or other change in the order. Further, we seek to ensure that multiple
salespersons are familiar with each customer account so that they can work cooperatively to assist one another on a reciprocal basis.
We believe that this sales management technique provides an advantage over our competitors because it ensures that our customers always
have a knowledgeable salesperson available to discuss product orders and related issues.
Our
sales force is in constant contact with our customers to develop an understanding of the customers’ retail strategies and production
requirements. We use this information to provide our customers with products that meet their particular requirements efficiently. We
require that our sales force be knowledgeable about all aspects of our products. We believe our knowledgeable sales force enables it
to provide our customers immediate feedback as to the various costs and availability of various raw materials, and production times.
Employees
As
of the date hereof, we have approximately 12 full-time and part-time employees. 1 employee is a chemist engaged in product development
and testing, 3 are engaged in executive or administrative capacities, 7 employees are engaged in manufacturing, packaging, or distribution
and 1 is engaged in sales.
From
time to time, we employ temporary employees which provides us with flexibility to adjust staffing levels in response to demand.
None
of our employees are employed under a collective bargaining agreement. We believe we have an excellent relationship with our employees
and independent contractors.
Return
and Refund Policy
We
will exchange any product found to be defective. A written exchange request must be submitted when a customer returns defective or damaged
products. Purchasers can apply for a refund in the full amount of purchased products within ten (10) days of purchase. All shipping fees
for product exchanges or returns must be paid by the purchaser. Historically, product returns as a percentage of our net sales have been
nominal.
Patents
and Trademarks
NutraDerma
holds patent number 7,754,237 from the U.S. Patent and Trademark office, for an all-natural dermal patch designed to prevent mosquito
and other insect bites. We plan to begin to test, manufacture and distribute this product in the near future.
Backlog
of Orders
We
have no backlog of orders.
Seasonal
Aspect of our Business
None
of our products are affected by seasonal factors.
Status
of any Publicly Announced New Product or Service
As noted above, the Company entered into a strategic
partnership with Cookies (branded) Retail Products (CRP). Under the terms of the agreement, CRP will provide the Company with
branding and marketing guidance while the Company becomes a preferred research and development profit participant and partner
of CRP. The Company will utilize its nutraceutical and research resources to design, create, and provide options for non-regulated,
federally legal for sale, innovative product introductions to be used for the parent Cookies brand. Cookies is an iconic billion-dollar
brand with retail, ecommerce, and direct-to-consumer verticals across multiple channels of trade.
In
September 2021, the Company entered a strategic partnership with KOR Medical to produce an initial order for a line of cannabinoid-based
wellness products. The initial products produced under this venture is a line of four ingestible items formulated to help improve overall
health, including helping consumers sleep better, feel better, be calmer, and improve their quality of life.
As
noted above, in 2020, the Company made a strategic pivot from our then-current nutraceutical manufacturing business by adding the manufacture
of consumer sanitizer products utilizing the Company’s existing manufacturing capabilities and the Company’s ability to retrofit
its operations and accommodate production due to the shortage of supply and demand for sanitizer products. To do so, consistent with
FDA requirements, the Company registered and obtained a labeler code as an OTC manufacturing facility and began manufacturing and distributing
a line of liquid-based multi-use sanitizer spray products under the Company’s in-house brand, “Eddie’s Clean Hands,”
packaged as a multi-use sanitizer spray, formulated per the CDC’s recommendation of containing at least 60-95% ethanol or isopropanol
alcohol to be effective. We plan to continue manufacturing and distributing liquid-based multi-use sanitizer spray products under the
Company’s in-house brand, “Eddie’s Clean Hands”.
Also,
as discussed above, on December 18, 2020, the Company received its product registration number from the FDA and completed its first production
run of Oral Shield antiseptic protection mouth spray. The Company along with its partners plans to market and distribute the product
on a global scale and seeks to provide a convenient, travel-size, quality, multi-functioning antiseptic mouth spray for consumers to
use throughout the day. We believe that mouthwash products can be effective at killing viruses, reducing the viral load within the mouth
essentially supporting the reduction of virus transmissions.
Material
Agreements
Cookies
Retail Products
As noted above, the Company entered into strategic
partnership with Cookies (branded) Retail Products (CRP). Under the terms of the agreement, CRP will provide the Company with
branding and marketing guidance while the Company becomes a preferred research and development profit participant and partner
of CRP. The Company will utilize its nutraceutical and research resources to design, create, and provide options for non-regulated,
federally legal for sale, innovative product introductions to be used for the parent Cookies brand. Cookies is an iconic billion-dollar
brand with retail, ecommerce, and direct-to-consumer verticals across multiple channels of trade.
NewLeaf
Assets LLC
On
March 10, 2019, we entered into an agreement with NewLeaf as amended, (the “Agreement”) whereby NewLeaf invested an aggregate
of $1,380,000 (the “Investment”) in our securities (the “Securities”) as follows:
(a) |
NewLeaf
invested the sums of $250,000, $130,000 and $1,000,000 on July 31, 2018, August 31, 2018 and March 15, 2019, respectively; |
(b) |
On
July 31, 2018 NewLeaf was granted 2,000,0000 shares of our common stock and warrants to purchase 625,000 shares at the price of $.20
per share at any time for a period of three (3) years; |
(c)
|
On
August 31, 2018 NewLeaf received warrants to purchase 325,000 shares of our common stock at the price of $.20 per share at any time
for a period of three (3) years; |
(d)
|
On
March 15, 2019, NewLeaf invested the sum of $1,000,000; and |
(e) |
On
March 15, 2019, we issued 13,764,705 common shares, warrants to purchase an additional 10 million common shares at the price of $.20
per share at any time until March 4, 2022 and an option to purchase an aggregate of 7,647,058 common shares at the aggregate
price of $650,000 at any time prior to April 8, 2019. This option was not exercised prior to such date. |
As
of the date of the filing of this report, NewLeaf holds an aggregate of 15,764,705 of our common shares. The warrants to purchase an
additional 10,950,000 common shares for an aggregate price of $2,190,000 at any time until March 4, 2022 and the option to purchase an
additional 7,647,058 common shares for an aggregate price of $650,000 at any time prior to April 8, 2019, were not exercised prior to
such dates.
The
Company paid a finder’s fee of 10% in connection with the Investment to Mitchell Pasin. Under the terms of the Agreement, if NewLeaf
sells, assigns, gifts or otherwise transfers any portion of the Securities to any other person or entity (the “Transferees”),
the aggregate amount of the Securities that may be sold by all NewLeaf and the Transferees in the aggregate shall be 1% of the Company’s
then outstanding common shares every ninety (90) days.
June
2019 Investment Agreement, Note, Security Agreement, Purchase Royalty Agreement, Pledge Agreement, Pledgor Royalty Agreement and November
2019 Amendments Thereto
June
2019 Investment Agreement
On
June 6, 2019, the Company entered into that and Investment Agreement (the “June 2019 Investment Agreement” and collectively
with the June 2019 Note, the June 2019 Purchaser Royalty Agreement, the June 2019 Security Agreement, the June 2019 Pledgor Royalty Agreement
and the June 2019 Mortgage, each as hereinafter defined, the “Transaction Documents” by and among the Company, PhytoChem
and Kahn Family Limited PT II (the “Purchaser”). Pursuant to the terms of the June 2019 Investment Agreement, the Company
agreed to issue and sell, and the Purchaser agreed to purchase, a full recourse secured convertible promissory note bearing interest
at the rate of 8.5% per annum in the principal amount (the “Principal Amount”) of $1,000,000 (the “June 2019 Note”).
In addition to repayment of the June 2019 Note and the payment of interest as set forth in the June 2019 Note, the Company agreed to
pay the following consideration to the Purchaser: (i) 500,000 shares of the Company’s common stock, and (ii) 8.5% of the revenue
generated from the first four of the Ennea Processors monetized and/or commercialized by the Company pursuant to an agreement by and
between Owen J. Morgan and the Company dated February 4, 2019 (the “Collateral Processors”) while the Principal Amount of
the June 2019 Note is outstanding and 5.0% thereafter as set forth in that certain Royalty Participation Agreement dated June 6, 2019
by and among the Company, PhytoChem and the Purchaser (the “June 2019 Purchaser Royalty Agreement”).
Pursuant
to the terms of the June 2019 Investment Agreement, the Principal Amount of the June 2019 Note is secured by the Collateral Processors
in accordance with the terms of the June 2019 Note and that certain Security Agreement (the “June 2019 Security Agreement”)
dated June 6, 2019 by and among the Company, PhytoChem and the Purchaser. The Principal Amount of the June 2019 Note is also secured
by certain real property (the “Real Property”) owned by Brenda Hamilton (the “Pledgor”) pursuant to the terms
of that certain Pledge Agreement (the “June 2019 Pledge Agreement”) dated June 6, 2019 by and among NutraLife, PhytoChem,
the Pledgor and the Purchaser. Pursuant to the terms of the June 2019 Investment Agreement and the mortgage on the Real Property (the
“June 2019 Mortgage”), the June 2019 Mortgage will be reduced by any and all consideration of any nature that is paid to
the Purchaser by the Company under the Transaction Documents.
The
June 2019 Investment Agreement provides that any controversy or claim arising out of or relating to the June 2019 Investment Agreement
will be settled by binding arbitration and judgment on the award entered in any court having jurisdiction.
The
Agreement contains customary representations, warranties and conditions.
June
2019 Note
On
June 6, 2019, the Company issued the June 2019 Note in the Principal Amount of $1,000,000. Pursuant to the terms of the June 2019 Note,
the entire outstanding principal balance of the June 2019 Note matures on December 7, 2020. The June 2019 Note provides that until such
time as the Principal Amount of the June 2019 Note has been paid in full, interest will accrue at the fixed rate of 8.5% per annum. Beginning
July 7, 2019 and through December 7, 2019, the Company agreed to make interest only payments at a fixed rate of 8.5% per annum on the
Principal Amount of the June 2019 Note. Beginning on January 7, 2020 and continuing until the maturity date, the Company agreed to make
equal monthly installment payments of principal and interest at the fixed rate of 8.5% per annum in an amount sufficient to fully amortize
the Principal Amount of the June 2019 Note and all accrued interest over an amortization period of 12 months, until the amounts due under
the June 2019 Note are paid in full.
Pursuant
to the terms of the June 2019 Note, all payments made by the Company to the Purchaser under the Transaction Documents, including but
not limited to the June 2019 Note, will be first applied to the Principal Amount then to accrued interest outstanding. Any and all consideration
paid by the Company to the Purchaser under the Transaction Documents will reduce the amounts secured by the June 2019 Mortgage without
affecting the amounts owed by the Company to the Purchaser under the Transaction Documents. The June 2019 Note is secured by the Collateral
Processors pursuant to the terms of the June 2019 Investment Agreement and the June 2019 Security Agreement. The Company agreed to deliver
a pledge of the Real Property to secure the Principal Amount pursuant to the terms of the June 2019 Pledge Agreement and June 2019 Mortgage,
and the June 2019 Mortgage will be reduced from time to time by the consideration paid by the Company to the Purchaser. Simultaneously
with the payment of consideration equal to the Principal Amount of the June 2019 Note, the Purchaser will record with the Palm Beach
County Property Appraiser’s Officer a Satisfaction of the Mortgage releasing the Purchaser’s June 2019 Mortgage on the Real
Property.
In
the event of a default of the June 2019 Note, Purchaser has full recourse to all the assets of the Company and the Purchaser will be
required to proceed against or exhaust all remedies against both the Company and PhytoChem’s assets prior to proceeding against
the June 2019 Mortgage and/or commencing an action to foreclose the June 2019 Mortgage.
At
any time while the June 2019 Note is outstanding, the Purchaser will have the option of converting the Principal Amount and accrued interest
due on the June 2019 Note into common stock of the Company at a price of $1.00 per share. Upon conversion of the Principal Amount and/or
interest, the Company will be forever released from all of its obligations and liabilities under the June 2019 Note. In the event Purchaser
converts less than all principal and interest outstanding, the amount converted under the June 2019 Note will be first applied to reduce
the principal until it is paid in full. Additionally, upon conversion of all outstanding principal at the time of conversion, the June
2019 Mortgage will be released as security for the obligations and liabilities under the June 2019 Note.
For
purposes of the June 2019 Note, an event of default means that the Company has failed to make any payment required under the June 2019
Note within 15 days after the date the payment is due. If the Company is in default under the June 2019 Note, the unpaid principal and
accrued interests and any other unpaid amounts and costs due will bear interest at the rate of 10% (the “Default Rate”) until
the event of default is cured. From and after the Maturity Date any unpaid principal and interest and any other unpaid amounts and costs
under the June 2019 Note will bear interest at the Default Rate. Additionally, and without limitation, all amounts owed under any judgment
obtained by Purchaser against the Company with respect to the June 2019 Note will bear interest at the Default Rate. The June 2019 Note
provides that any controversy or claim arising out of or relating to the June 2019 Note will be settled by binding arbitration and judgment
on the award entered in any court having jurisdiction.
June
2019 Security Agreement
Pursuant
to the terms of the June 2019 Security Agreement, the Company assigned and granted to the Purchaser a continuing lien on and security
interest in the Collateral. The Company agreed that it would not sell or offer to sell or otherwise transfer or grant or allow the imposition
of a lien or security interest upon the Collateral or use any portion thereof in any manner inconsistent with the June 2019 Security
Agreement or with the terms and conditions of any policy of insurance thereon. The Company also irrevocably authorized Purchaser at any
time and from time to time to file in any Uniform Commercial Code (“UCC”) jurisdiction any initial financing statements and
amendments thereto relating to the Collateral as provided in the June 2019 Security Agreement.
The
Company will, at the Purchaser’s option, be in default under the June 2019 Security Agreement upon the happening of any of the
following events or conditions (each, a “June 2019 Security Agreement Event of Default”): (a) a failure to pay any amount
due under the June 2019 Note or the June 2019 Security Agreement within 15 days after the due date; (b) failure by the Company to perform
any of its other obligations under the June 2019 Security Agreement within 30 days of notice from Purchaser of the same; (c) falsity,
inaccuracy or material breach by the Company or any written warranty, representation or statement made or furnished to the Purchaser
by or on behalf of the Company; (d) an uninsured material loss, theft, damage, or destruction to any of the Collateral, or the entry
of any judgment against the Company or any lien against or making of any levy, seizure or attachment of or on the Collateral; or (e)
the failure of the Purchaser to have a perfected first priority security interest in the Collateral.
Upon
the occurrence of any June 2019 Security Agreement Event of Default and at any time thereafter, the Purchaser may declare all obligations
secured by the June 2019 Security Agreement immediately due and payable and will have, in addition to any remedies provided in the June
2019 Security Agreement or by any applicable law or in equity, all the remedies of a secured party under the UCC. The June 2019 Security
Agreement provides that any controversy or claim arising out of or relating to the June 2019 Security Agreement will be settled by binding
arbitration and judgment on the award entered in any court having jurisdiction.
If
the Company is in default under the June 2019 Note, the unpaid principal and accrued interests and any other unpaid amounts and costs
due will bear interest at the rate of 10% (the “Default Rate”) until the event of default is cured. From and after the Maturity
Date any unpaid principal and interest and any other unpaid amounts and costs under the June 2019 Note will bear interest at the Default
Rate. Additionally, and without limitation, all amounts owed under any judgment obtained by Purchaser against the Company with respect
to the June 2019 Note will bear interest at the Default Rate.
June
2019 Purchaser Royalty Agreement
Pursuant
to the terms of the June 2019 Purchaser Royalty Agreement, which has a 10-year term, commencing upon the fiscal quarter in which revenue
is derived directly or indirectly from any of the Collateral Processors, the Company will pay to the Purchaser non-refundable royalty
payments consisting of 8.5% of all Net Revenue (as defined in the June 2019 Purchaser Royalty Agreement) received by the Company as a
result of the commercialization and/or monetization of the Collateral Processors until such time as the Principal Amount has been paid.
At such time as the Principal Amount has been paid to the Purchaser, Purchaser will receive non-refundable royalty payments consisting
of 5.0% of Net Revenue received by the Company as a result of the commercialization and/or monetization of the first two processors of
the Collateral Processors. The royalty payments will be paid by the Company to the Purchaser within 15 days after the end of the quarter
in which the Company receives payment for any Net Revenue from the Collateral Processors. The June 2019 Purchaser Royalty Agreement provides
that any controversy or claim arising out of or relating to the June 2019 Purchaser Royalty Agreement will be settled by binding arbitration
and judgment on the award entered in any court having jurisdiction.
June
2019 Pledge Agreement
Pursuant
to the terms of the Pledge Agreement, to induce Brenda Hamilton (the “Pledgor”) to enter into the June 2019 Pledge Agreement
and the Mortgage, the Company represented and warranted to the Pledgor and the Purchaser that the Company will timely pay all amounts
owing to the Purchaser, and that it will deliver full and timely payment of all and any amounts due and/or which may become due to the
Purchaser from the Company from time to time in connection with the Transaction Documents without limitation. Purchaser agreed that it
understood that all consideration delivered to the Purchaser by the Company pursuant to the Transaction Documents will be applied to
the Principal Amount and as a result, the Mortgage will be reduced by any and all payments of consideration of any type made by the Company
to the Purchaser under the Transaction Documents.
In
addition, under the terms of the June 2019 Pledge Agreement, based upon the representations of the Company and the Purchaser that they
will perform and comply with their obligations and duties under the Transaction Documents, the Pledgor agreed to provide the Purchaser
with the June 2019 Mortgage which will secure the Company’s payment of the Principal Amount pursuant to the Transaction Document.
The June 2019 Mortgage will be reduced from time to time by any and all payments made by the Company to the Purchaser under the Transaction
Documents. In exchange for providing the Real Property collateral, the Pledgor agreed to receive:
|
(i) |
500,000
shares of the Company’s common stock, |
|
|
|
|
(ii) |
Commencing
on December 5, 2019, monthly payments equal to the interest paid by the Company to the borrower under the June 2019 Note accruing
from time of the Purchaser’s delivery of the Principal Amount to the Company until the June 2019 Note is paid in full, and |
|
|
|
|
(iii) |
8.5%
of the Net Revenue while the Principal Amount is outstanding and 5.0% thereafter on the first two processors of the Collateral Processors
as set forth in that certain Royalty Participation Agreement dated as of June 6, 2019 by and among the Company, PhytoChem and the
Pledgor (the “June 2019 Pledgor Royalty Agreement”). |
As
set forth in the June 2019 Pledge Agreement, the terms including payment due dates and maturity dates of the June 2019 Note may not be
extended by the Purchaser and the Company without the express written consent of the Pledgor. In the event that the June 2019 Note is
amended or modified including to extend a payment due date or the maturity date of the June 2019 Note, without the Pledgor’s written
consent, then Pledgor’s obligation to provide security under the June 2019 Pledge Agreement will automatically cease, and the June
2019 Mortgage will be deemed satisfied and released in full as security for the Principal Amount of the Amended Note, and (iii) the Purchaser
will immediately record with the Palm Beach County Property Appraiser’s Officer a Satisfaction of Mortgage releasing the Purchaser’s
lien on the Real Property.
Pursuant
to the terms of the June 2019 Pledge Agreement, a default means that the Company has failed to make any payment required under the June
2019 Note, within 15 days after the date the payment is due. If after exhaustion of all other remedies, including enforcement of the
lien against the Collateral and collection of all amounts due from the Company, there remains a default, then the Purchaser will provide
written notice to the Pledgor of the default and the Pledgor will have the option but not the obligation to cure the default. In such
event, the amounts paid by the Pledgor will bear interest at the highest rate allowed under Florida law. So long as the Company is in
default of its obligations under the June 2019 Note, then the Company will pay the Pledgor interest on the amounts outstanding under
the June 2019 Note at a rate of 10%.
If
the Company defaults on its obligations under the June 2019 Note, the June 2019 Pledge Agreement or any of the other Transaction Agreements,
the Company will reimburse the Pledgor on demand for (i) payments made by the Pledgor to Purchaser to cure a default by the Company under
the June 2019 Investment Agreement and/or the June 2019 Note, and (ii) all costs and expenses, including attorneys’ fees and disbursements
that the Pledgor incurs in exercising any right, power, or remedy provided by the June 2019 Note, the June 2019 Purchaser Royalty Agreement,
the June 2019 Security Agreement, the June 2019 Pledgor Royalty Agreement, the June 2019 Mortgage or by law or defending any action arising
out of the June 2019 Note, the June 2019 Purchaser Royalty Agreement, the June 2019 Security Agreement, the June 2019 Pledgor Royalty
Agreement or the June 2019 Mortgage. Additionally, in the event of a default by the Company, all costs incurred and paid by the Pledgor
will bear interest at the highest rate allowed under Florida law. The June 2019 Pledge Agreement provides that any controversy or claim
arising out of or relating to the June 2019 Pledge Agreement will be settled by binding arbitration and judgment on the award entered
in any court having jurisdiction.
June
2019 Pledgor Royalty Agreement
Pursuant
to the terms of the June 2019 Pledgor Royalty Agreement, which has a 10-year term, commencing upon the fiscal quarter in which revenue
is derived directly or indirectly from any of the Collateral Processors, the Company will pay to the Pledgor non-refundable royalty payments
consisting of 8.5% of all Net Revenue received by the Company as a result of the commercialization and/or monetization of the Collateral
Processors until such time as the Principal Amount has been paid. At such time as the Principal Amount has been paid to the Purchaser,
the Pledgor will receive non-refundable royalty payments consisting of 5.0% of Net Revenue received by the Company as a result of the
commercialization and/or monetization of the first two processors of the Collateral Processors. The royalty payments will be paid by
the Company to the Pledgor within 15 days after the end of the quarter in which the Company receives payment for any Net Revenue from
the Collateral Processors. The June 2019 Pledgor Royalty Agreement provides that any controversy or claim arising out of or relating
to the June 2019 Pledgor Royalty Agreement will be settled by binding arbitration and judgment on the award entered in any court having
jurisdiction.
Amended
Investment Agreement
On
November 13, 2019, the Company entered into an amended Investment Agreement (the “Amended Investment Agreement” and collectively
with the Amended Note, the Amended Purchaser Royalty Agreement, the Amended Security Agreement, the Amended Pledgor Royalty Agreement
and the Amended Mortgage, each as hereinafter defined, the “Amended Transaction Documents”) by and among the Company and
the Purchaser. Pursuant to the terms of the Amended Investment Agreement, the Principal Amount of the Amended Note is secured by the
current assets and future assets of the Company and its subsidiaries (the “Collateral”), including the Collateral Processors
in accordance with the terms of provisions of the Amended Note and the Amended Security Agreement. Except as set forth herein, the terms
of the Amended Investment Agreement are substantially similar to the terms of the June 2019 Investment Agreement.
Amended
Note
Pursuant
to the terms of the Amended Note dated November 13, 2019 from the Company to the Purchaser (the “Amended Note”), the entire
outstanding principal balance of the Amended Note matured on December 7, 2020. The Amended Note provides that the Company make the first
interest only payment on December 7, 2019 at the fixed rate of 5.75% per annum. Beginning January 7, 2020 and continuing until the maturity
date, the Company agreed to make equal monthly instalment payments of principal and interest at the fixed rate of 5.75% per annum in
an amount sufficient to fully amortize the Principal Amount of the Amended Note and all accrued interest over an amortization period
of 18 months, until all amounts due under the Amended Note are paid in full. Interest will accrue from June 6, 2019 at the rate of 5.75%
per annum until the maturity date of the Amended Note.
Pursuant
to the terms of the Amended Note, all payments made by the Company to the Purchaser under the Transaction Documents, including but not
limited to the Amended Note, will be first applied to the Principal Amount then to accrued interest outstanding. Any and all consideration
paid by the Company to the Purchaser under the Transaction Documents will reduce the amounts secured by the Amended Mortgage without
affecting the amounts owed by the Company to the Purchaser under the Transaction Documents.
The
Amended Note is secured by the Collateral Processors, including the Collateral Processors. A pledge of the Real Property secures the
Principal Amount pursuant to the terms of the Amended Pledge Agreement and Amended Mortgage, and the Amended Mortgage will be reduced
from time to time by the consideration paid by the Company to the Purchaser. Simultaneously with the payment of consideration (whether
interest, royalty and/or securities, as provided in the Amended Note and the Amended Investment Agreement) equal to the Principal Amount
of the Amended Note, the Purchaser will record with the Palm Beach County Property Appraiser’s Officer a Satisfaction of the Mortgage
releasing the Purchaser’s Amended Mortgage on the Real Property.
Pursuant
to the terms of the Amended Note, Purchaser has full recourse to the Collateral and the Purchaser will be required to proceed against
and exhaust all remedies against the Collateral prior to proceeding against the Amended Mortgage and/or commencing an action to foreclose
the Amended Mortgage. Except as set forth herein, the terms of the Amended Note are substantially similar to the terms of the June 2019
Note.
Amended
Security Agreement
Pursuant
to the terms of an amended security agreement dated November 13, 2019 by and between the Company and the Purchaser (the “Amended
Security Agreement”), the Company assigned and granted to the Purchaser a continuing lien on and security interest in the Collateral,
including the Collateral Processors. Except as set forth herein, the terms of the Amended Security Agreement are substantially similar
to the terms of the June 2019 Security Agreement.
Amended
Purchaser Royalty Agreement
On
November 13, 2019, the Company entered into that certain purchaser royalty agreement dated November 13, 2019 by and between the Company
and the Purchaser (the “Amended Purchaser Royalty Agreement”). Aside from certain conforming changes, the terms of the Amended
Purchaser Royalty Agreement are substantially similar to the terms of the June 2019 Purchaser Royalty Agreement.
Amended
Pledge Agreement
On
November 13, 2019, the Company entered into an amended pledge agreement by and among the Company, the Pledgor and the Purchaser (the
“Amended Pledge Agreement”). Pursuant to the terms of the Amended Pledge Agreement, to induce Pledgor to enter into the Amended
Pledge Agreement and the Mortgage, the Company and the Purchaser represented and warranted to the Pledgor that each of the Company and
the Pledgor will timely comply with all requirements and obligations under the Transaction Documents and the Company will pay all amounts
owing to the Purchaser, and that it will deliver full and timely payment of all and any amounts due and/or which may become due to the
Purchaser from the Company from time to time in connection with the Transaction Documents without limitation. Purchaser agreed that it
understood that all consideration delivered to the Purchaser by the Company pursuant to the Transaction Documents will be applied to
reduce the Principal Amount secured by the Amended Mortgage and as a result, the Amended Mortgage will be reduced by any and all payments
of consideration of any type (including cash or securities) made by the Company to the Purchaser under the Transaction Documents and
the June 2019 Investment Agreement and June 2019 Note.
Pursuant
to the terms of the Amended Pledge Agreement, based upon the representations of the Company and the Purchaser that they will perform
and comply with their obligations and duties under the Transaction Documents, the Pledgor agreed to provide the Purchaser with the Amended
Mortgage which will secure the Company’s payment of the Principal Amount pursuant to the Transaction Document. The Amended Mortgage
will be reduced from time to time by any and all payments of any nature (including cash or securities) made by the Company to the Purchaser
under the Transaction Documents. In exchange for providing the Real Property collateral, the Company agreed to pay to Pledgor:
|
(i) |
500,000
shares of the Company’s common stock, which were issued upon execution of the June 2019 Pledge Agreement, |
|
|
|
|
(ii) |
Commencing
on December 7, 2019 and ending on the maturing date of the Amended Note, monthly payments equal to 5% interest on the Principal Amount
accruing on the Principal Amount and accrued interest from June 6, 2019 until the maturity date of the Amended Note, and |
|
|
|
|
(iii) |
8.5%
of the Net Revenue so long as any portion of the Principal Amount is outstanding and 5.0% thereafter on the first two processors
of the Collateral Processors as set forth in that certain Amended Royalty Participation Agreement dated as of November 13, 2019 by
and among NutraLife, PhytoChem and the Pledgor (the “Amended Pledgor Royalty Agreement”). |
As
set forth in the Amended Pledge Agreement, the terms set forth in the Transaction Documents may not be extended by the Purchaser and
the Company without the express written consent of the Pledgor so long as any portion of the Principal Amount is outstanding. In the
event that any of the Transaction Documents is amended and/or modified in any respect without the Pledgor’s written consent while
any portion of the Principal Amount is outstanding then (i) Pledgor’s obligation to provide security under the Amended Pledge Agreement
will automatically cease, (ii) the Amended Mortgage will be deemed satisfied and released in full as security for the Principal Amount
of the Amended Note, and (iii) the Purchaser will immediately record with the Palm Beach County Property Appraiser’s Officer a
Satisfaction of Mortgage releasing the Purchaser’s lien on the Real Property at the cost of the Company.
Pursuant
to the terms of the Amended Pledge Agreement, a default means that the Company has failed to make any payment required under the Amended
Note, within 15 days after the date the payment is due. If after exhaustion of all other remedies, including enforcement of the lien
against the Collateral and collection of all amounts due from the Company, there remains a default owed to the Purchaser, then the Purchaser
will provide written notice to the Pledgor of the default and the Pledgor will have the option but not the obligation to cure the default.
In such event, the amounts paid by the Pledgor to enforce its rights under the Amended Pledge Agreement will bear interest at the highest
rate allowed under Florida law. So long as the Company is in default of its obligations under the Transaction Documents, then the Company
will pay the Pledgor interest on the Principal and accrued interest outstanding under the Amended Note at the highest rate allowed under
Florida law.
If
the Company defaults on its obligations under the Amended Note, the Amended Pledge Agreement or any of the other Transaction Agreements,
the Company will reimburse the Pledgor on demand for (i) payments made by the Pledgor to Purchaser to cure a default by the Company under
the Amended Investment Agreement and/or the Amended Note, and (ii) all costs and expenses, including attorneys’ fees and disbursements
that the Pledgor incurs in exercising any right, power, or remedy provided by the Amended Note, the Amended Purchaser Royalty Agreement,
the Amended Security Agreement, the Amended Pledgor Royalty Agreement, the Amended Mortgage or by law or defending any action arising
out of the Amended Note, the Amended Purchaser Royalty Agreement, the Amended Security Agreement, the Amended Pledgor Royalty Agreement
or the Amended Mortgage. Additionally, in the event of a default by the Company, all costs incurred and paid by the Pledgor including
but not limited to attorney fees and any amounts Pledgor pays to cure a default by the Company of the Amended Note will bear interest
at the highest rate allowed under Florida law. Except as set forth herein, the terms of the Amended Pledge Agreement are substantially
similar to the terms of the June 2019 Pledge Agreement.
Amended
Pledgor Royalty Agreement
On
November 13, 2019, the Company entered into the Amended Pledgor Royalty Agreement. Aside from certain conforming changes, the terms of
the Amended Pledgor Royalty Agreement are substantially similar to the terms of the June 2019 Pledgor Royalty Agreement.
Company
Default
The
Company has not made the principal and interest payments on the Amended Note as of the date of this Annual Report. The Company now believes
that it may have defences to the enforcement of the Transaction Documents as written, however this may not be the case. Additionally,
the Purchaser has not indicated to the Company that it will seek to enforce its rights under the Transaction Documents or that it will
proceed against the Collateral.
Stock
Purchase Agreement
On
November 2, 2020 (the “Closing Date”), the Company entered into a Stock Purchase Agreement (the “SPA”) by and
between the Company, Lord Global Corporation, a Nevada corporation (the “Lord Global”) and 27 Health, Inc., a wholly-owned
subsidiary of Lord Global (“27 Health”). Pursuant to the SPA, the Company acquired from Lord Global 250 shares of Series
X Convertible Preferred Stock of Lord Global (the “Series X Stock”) in exchange for the issuance by the Company to 27 Health
of 12,500,000 shares of common stock, par value $0.0001 per share, of the Company (the “NutraLife Common Stock”). The transactions
pursuant to the SPA closed on the Closing Date.
Each
share of Series X Stock is convertible into shares of common stock, par value $0.001 per share, of Lord Global (the “Lord Global
Common Stock”) at the rate of 1,000 shares of Lord Global Common Stock per share of Series X Stock, subject to customary adjustments
for stock splits, stock dividend, stock combinations, recapitalizations or other similar transactions. The conversion of the Series X
Stock is subject to a customary beneficial limitation such that the Company may not convert the Series X Stock into Lord Global Common
Stock if such conversion would result in the Company and its affiliates having beneficial ownership of in excess of 4.99% of the outstanding
shares of Lord Global Common Stock, provided that the Company may elect to waive this limitation on 61 days’ notice to Lord
Global.
In
addition to the Series X Stock issued to the Company, in the event that, on the first business day following the 180-day anniversary
of the Closing Date, the average volume weighted average price of the Lord Global Common Stock for the 10 trading day period prior to
that date is less than $4.00 (subject to customary adjustments), then Lord Global will issue to the Company, for no additional consideration
payable by the Company, a number of shares of Lord Global Common Stock equal to (i) $1,000,000, divided by (ii) the share price as of
such date, minus 250,000 (the “First Adjustment Shares”). A second such adjustment shall be completed on the first business
day following the one-year anniversary of the Closing Date, provided that at this adjustment the number of First Adjustment Shares will
also be deducted from any additional shares to be issued to the Company.
Manufacturing,
Distribution and Sales Agreement
In
connection with the SPA and the transactions as set forth therein, on the Closing Date the Company also entered into a Manufacturing,
Distribution and Sales Agreement (the “MDS Agreement”) by and between the Company and 27 Health. 27 Health, together with
Lord Global (referred to in this section jointly as “27 Health”) has developed and currently manufactures and markets certain
products related to the testing and treatment of COVID-19 (the “Coviguard Products”).
Pursuant
to the MDS Agreement, 27 Health engaged the Company to manufacture the Coviguard Products and granted the Company the right, on a non-exclusive
basis, to sell and distribute the Coviguard Products manufactured by the Company though all channels of distribution on a worldwide basis
and to undertake advertising and marketing as determined to be necessary by the Company, with written notice, in connection therewith.
During
the term of the Agreement, the Company has the exclusive right to manufacture the Coviguard Products, subject to the Company’s
continued ability to meet in all material respects the production requirements of 27 Health for the Coviguard Products. In the event
that the Company is unable, in the sole determination of 27 Health, to meet the production requirements, 27 Health may seek other sources
for the manufacturing of the Coviguard Products or may terminate the MDS Agreement.
Pursuant
to the MDS Agreement, the Company may elect to market the Coviguard Products directly, without any requirement of an order for the manufacturing
of the products being supplied by 27 Health or accepted by the Company. All such direct sales will be made by the Company to the recipient
of the products, and the Company will pay to 27 Health a set distributor price for the products, and retain the balance paid by the buyer.
In
the event that the Company identifies a potential third-party customer for the Coviguard Products, but does not elect to sell the Coviguard
Products directly to the customer as set forth above, the Company may refer such potential customer to 27 Health. If the customer is
a not a current customer of 27 Health, then for any and all sales of Coviguard Products to such new customers, 27 Health will pay to
the Company 15% commissions on these sales. No commissions would be paid for sales to customers who were already customers of 27 Health
at the time.
The
MDS Agreement has an initial term of 5 years, with automatic extensions of 1 year each, subject to earlier expiration or termination
as set forth therein.
Competitive
Business Conditions
The
nutritional, dietary supplement and industrial hemp CBD industries, as well as the sanitizer products industry, are highly competitive.
Numerous manufacturers and distributors compete with us for customers throughout the United States selling products to private label
customers and retailers such as mass merchandisers, drug store chains, independent pharmacies and health food stores. We are also vulnerable
to competition from companies that can manufacture similar products to our products and compete for private label customers. The markets
for our products are highly competitive. We seek to compete on the basis of customer service, product quality, pricing and marketing
support.
We
compete with major private label and broadline brand manufacturers many of which are larger and have access to greater resources than
us. Among other factors, competition among private label manufacturers is based upon price. If one or more private label or broadline
brand manufacturers significantly reduce their prices in an effort to gain market share, our results of operations or market position
could be adversely affected. We also compete with manufacturers of nationally advertised brand name products which are larger and have
resources substantially greater than us. In the future, one or more of these companies could seek to compete more directly with us by
manufacturing private label products or by significantly lowering the prices of their national brand products.
Many
of our indirect competitors are substantially larger, have more experience than us, have longer operating histories, and have materially
greater financial and other resources than us.
Costs
and Effects of Compliance with Environmental Laws
We
are in a business that involves the use of raw materials in a manufacturing process, however, we believe that it is unlikely that such
materials are likely to result in the violation of any existing environmental rules and/or regulations. Further, we do not own any real
property that could lead to liability as a landowner. Therefore, we do not anticipate that there will be any material costs associated
with compliance with environmental laws and regulations.
Product
Liability Insurance
We
maintain commercial liability, including product liability coverage, and property insurance. Our policy provides for a general liability
of five million dollars ($5,000,000) per occurrence, and five million dollars ($5,000,000) annual aggregate coverage which includes our
main corporate facility. We carry property coverage on our main office facility to cover our legal liability, tenant’s improvements,
business property, and inventory.
Regulation
of our Hemp Finished Products
The
sale of our Hemp Finished Products is potentially subject to a complex web of federal and state regulations that are evolving at a rapid
rate. The formulation, manufacturing, packaging, labeling, advertising, and distribution of our products are subject to regulation by
one or more federal agencies, principally the Food and Drug Administration (“FDA”), the Federal Trade Commission (“FTC”),
and, to a lesser extent, the Consumer Product Safety Commission (“CPSC”), the United States Department of Agriculture (“USDA”),
Drug Enforcement Agency (“DEA”) and the Environmental Protection Agency (“EPA”). Our activities are also regulated
by various governmental agencies for the states and localities in which our products are sold, as well as by governmental agencies in
certain countries outside the United States in which our products are sold. These agencies can change their rules at any time. Should
we become subject to FDA, DEA or other enforcement proceedings we would have to cease operations.
The
FDA under the Federal Food, Drug, and Cosmetic Act regulates the formulation, manufacturing, packaging, labeling, distribution and sale
of drugs, food, including dietary supplements, and over-the-counter drugs.
Until
2014, when 7 U.S. Code §5940 became federal law as part of the Agricultural Act of 2014 (the “2014 Farm Act”), products
containing oils derived from hemp, notwithstanding a minimal or non-existing THC content, were classified as Schedule I illegal drugs.
The 2014 Farm Act expired on September 30, 2018, and was thereafter replaced by the Agricultural Improvement Act of 2018 on December
20, 2018 (the “2018 Farm Act”), which amended various sections of the U.S. Code, thereby removing hemp, defined as cannabis
with less than 0.3% of THC, from Schedule 1 status under the Controlled Substances Act (“CSA”), and legalizing the cultivation
and sale of hemp at the federal level, subject to compliance with certain federal requirements and state law, amongst other things. THC
is the psychoactive component of plants in the cannabis family generally identified as marihuana or marijuana. We believe that our hemp
products are and will continue to be federally legal in the United States in that they contain and will continue to contain less than
0.3% of THC in compliance with the 2018 Farm Bill guidelines and will have no psychoactive effects on our customers’ bodies. Notwithstanding,
there is no assurance that the 2018 Farm Act will not be repealed or amended such that our products containing hemp-derived CBD would
once again be deemed illegal under federal law.
The
2018 Farm Bill also shifted regulatory authority from the Drug Enforcement Administration to the Department of Agriculture. The 2018
Farm Bill did not change the FDA’s oversight authority over hemp products. The 2018 Farm Act delegated the authority to the states
to regulate and limit the production of hemp and hemp derived products within their territories. Although many states have adopted laws
and regulations that allow for the production and sale of hemp and hemp derived products under certain circumstances, no assurance can
be given that such state laws may not be repealed or amended such that our hemp products would once again be deemed illegal under the
laws of one or more states now permitting such products, which in turn would render such products illegal in those states under federal
law even if the federal law is unchanged. In the event of either repeal of federal or of state laws and regulations, or of amendments
thereto that are adverse to our hemp products, we may be restricted or limited with respect to those products that we may sell or distribute,
which could adversely impact our operations with respect to such products.
Additionally,
the FDA has indicated its view that certain types of hemp products may not be permissible under the United States Federal Food, Drug
and Cosmetic Act (“FDCA”). The FDA’s position is related to its approval of Epidiolex, a marijuana-derived prescription
medicine to be available in the United States. The active ingredient in Epidiolex is CBD. On December 20, 2018, after the passage of
the 2018 Farm Bill, FDA Commissioner Scott Gottlieb issued a statement in which he reiterated the FDA’s position that, among other
things, 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 and that
the FDCA prohibits introducing into interstate commerce food products containing added hemp, and marketing products containing hemp as
a dietary supplement, regardless of whether the substances are hemp-derived. Although we believe our hemp product offerings comply with
applicable federal and state laws and regulations, legal proceedings alleging violations of such laws could have a material adverse effect
on our business, financial condition and results of operations.
We
do not intend to offer and do not compete with companies that offer cannabis products containing high levels of psychoactive THC in the
United States. Although legal in some states in the United States, we are not in, and do not intend to enter into this market.
We offer hemp-based products to customers in the United States but do not compete with any medical or recreational marijuana sellers
of products for high THC content sales due to legal and regulatory restrictions and uncertainty in the United States.
The
FDA under the Federal Food, Drug, and Cosmetic Act regulates the formulation, manufacturing, packaging, labeling, distribution and sale
of drugs, food, including dietary supplements, and over-the-counter drugs and any inclusion of cannabis or cannabis-derived compounds,
like CBD, in such products would be regulated by the FDA regardless of the source of the cannabis substance, be it hemp or marijuana.
Our
CBD products are derived from the seeds and mature stalks of the Cannabis Sativa plant which includes all parts and varieties of the
cannabis sativa plant also known as hemp, which contain a tetrahydrocannabinol concentration (“THC”) that does not exceed
0.3 percent on a dry-weight basis. In December of 2018, the U.S. Food and Drug Administration completed an evaluation of three generally
recognized as safe (GRAS) notices for hemp seed-derived food ingredients. The FDA stated that hulled hemp seed (GRN765), hemp seed protein
powder (GRN771), and hemp seed oil (GRN778) are GRAS under their intended conditions of use. Some of the intended uses for these ingredients
include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based
alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked
goods, cereals, snacks and nutrition bars. Our CBD products are made from seeds and mature stalks of hemp and contain only trace amounts
of THC, we believe they qualify as GRAS products.
We
have not obtained and do not plan to obtain FDA approval of our CBD products. As a result, we could be subject to enforcement proceedings
by the FDA. We do not believe that FDA enforcement proceedings are likely since our products only contain trace elements of THC and do
not cause the “high” associated with the THC in marijuana. Additionally, Hemp Finished Products like those sold by us are
sold by large retailers online including Whole Foods, Publix, Wal-Mart and others. Despite the foregoing, should we become subject to
FDA or other enforcement proceedings we could have to cease operations.
Other
Regulations Impacting our Hemp Finished - CBD Products
Some
states are considering various taxation of marijuana-related products including hemp finished products. These considerations seem to
range from routine sales taxes to taxes similar to those imposed on tobacco products. Though, for the reasons described above, we do
not believe the Hemp Finished Products to be subject to any marijuana-related taxation schemes, it is unclear whether Hemp Finished Products
would fall under these tax plans if and when they are imposed.
IRS
section 280(E) prevents cannabis companies from deducting expenses from their income, except for those considered cost of goods sold.
No deduction or credit is allowed for any amount paid or incurred during the taxable year in carrying on any trade or business if such
trade or business (or the activities which comprise such trade or business) consists of trafficking in controlled substances (within
the meaning of schedule I and II of the Controlled Substances Act) which is prohibited by federal law or the law of any State in which
such trade or business is conducted. Though, for the reasons described above, we do not believe the Hemp Finished Products to be appropriately
treated as a controlled substance, if IRC 280(E) is enforced against us relating to deductions concerning our Hemp Finished Products,
such tax treatment could create operating and cash flow problems in the future.
Cannabis
versus Hemp
While
hemp and cannabis are both derived from the same species (Cannabis sativa), there are major differences in the characteristics of the
respective plant strains that produce industrial hemp on the one hand, and cannabis products on the other. In short, hemp is a strain
of the Cannabis sativa plant that has been grown primarily for use in industrial applications and has been specifically cultivated to
produce a low tetrahydrocannabinol (“THC”) content and a high cannabidiol (“CBD”) content. THC is the psychoactive
constituent of cannabis and is responsible for producing the psychoactive effects of the drug. CBD is another active ingredient present
in Cannabis sativa plants, and it largely acts to neutralize the psychoactive effects of THC and is not associated with psychoactive
effects. Since hemp strains have very little THC and a lot of CBD, they do not produce psychoactive effects when ingested.
Regulation
of our Products not Containing CBD
The
formulation, manufacturing, packaging, labeling, advertising, and distribution of our non-hemp based products are subject to regulation
by one or more federal agencies, principally the FDA, the FTC, and, to a lesser extent, the CPSC, the USDA, and the Environmental Protection
Agency “EPA”. Our activities are also regulated by various governmental agencies for the states and localities in which our
products are sold, as well as by governmental agencies in certain countries outside the United States in which our products are sold.
Among other matters, regulation by the FDA and FTC are concerned with product safety and claims made with respect to a product’s
ability to provide health-related benefits. Specifically, the FDA, under the FDCA, regulates the formulation, manufacturing, packaging,
labeling, distribution and sale of food, including dietary supplements, and over-the-counter drugs. The FTC regulates the advertising
of these products. The National Advertising Division (“NAD”) of the Council of Better Business Bureaus oversees an industry
sponsored, self-regulatory system that permits competitors to resolve disputes over advertising claims. The NAD has no enforcement authority
of its own, but may refer matters that appear to violate the Federal Trade Commission Act or the FDCA to the FTC or the FDA for further
action, as appropriate.
Federal
agencies, primarily the FDA and the FTC, have a variety of procedures and enforcement remedies available to them including initiating
investigations, issuing warning letters and cease and desist orders, requiring corrective labeling or advertising, requiring consumer
redress (for example, requiring that a company offer to repurchase products previously sold to consumers), seeking injunctive relief
or product seizures, imposing civil penalties, or commencing criminal prosecution. In addition, certain state agencies have similar authority.
These federal and state agencies have in the past used these remedies in regulating participants in the food, dietary supplement and
over-the-counter drug industries, including the imposition of civil penalties in the millions of dollars against a few industry participants.
The
Dietary Supplement Health and Education Act (“DSHEA”) was enacted in 1994, amending the FDCA. We believe DSHEA is generally
favorable to consumers and to the dietary supplement industry. DSHEA establishes a statutory class of “dietary supplements”,
which includes vitamins, minerals, herbs, amino acids and other dietary ingredients for human use to supplement the diet. Dietary ingredients
marketed in the United States before October 15, 1994 may be marketed without the submission of a “new dietary ingredient”
(“NDI”) premarket notification to the FDA. Dietary ingredients not marketed in the United States before October 15, 1994
may require the submission, at least seventy-five (75) days before marketing of an NDI notification containing information establishing
that the ingredient is reasonably expected to be safe for its intended use. Among other things, DSHEA prevents the FDA from regulating
dietary ingredients in dietary supplements as “food additives” and allows the use of statements of nutritional support on
product labels and in labeling. The FDA has issued final regulations under DSHEA and has issued draft guidance on NDI notification requirements.
Further guidance and regulations are expected. Several bills to amend DSHEA in ways that would make this law less favorable to consumers
and industry have been proposed in Congress.
The
Nutrition Labeling and Education Act of 1990 (“NLEA”) amended the FDCA to establish additional requirements for ingredient
and nutrition labeling and labeling claims for foods. If the NLEA labeling requirements change at a future time, we may need to revise
our product labeling. Our non-CBD products are classified as dietary supplements. The FDA has concluded that THC and CBD products are
excluded from the definition of a dietary supplement. The FDA issued a Final Rule on GMPs for dietary supplements on June 22, 2007. The
GMPs cover manufacturers and holders of finished dietary supplement products, including dietary supplement products manufactured outside
the United States that are imported for sale into the United States. Among other things, the new GMPs: (a) require identity testing on
all incoming dietary ingredients, call for a “scientifically valid system” for ensuring finished products meet all specifications,
(b) include requirements related to process controls, including statistical sampling of finished batches for testing and requirements
for written procedures, and (c) require extensive recordkeeping.
We
have reviewed the GMPs and have taken steps to ensure compliance. While we believe we are in compliance, there can be no assurance that
our operations or those of our suppliers will be in compliance in all respects at all times. Additionally, there is a potential risk
of increased audits as the FDA and other regulators seek to ensure compliance with the GMP’s.
On
December 22, 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which went into effect on
December 22, 2007. The law requires, among other things, that companies that manufacture or distribute nonprescription drugs or dietary
supplements report serious adverse events allegedly associated with their products to the FDA and institute recordkeeping requirements
for all adverse events (serious and non-serious). There is a risk that consumers, the press and government regulators could misinterpret
reported serious adverse events as evidence of causation by the ingredient or product complained of, which could lead to additional regulations,
banned ingredients or products, increased insurance costs and a potential increase in product liability litigation, among other things.
The
Consumer Product Safety Improvement Act of 2008 (“CPSIA”) primarily addresses children’s product safety but also improves
the administrative process of the CPSC. Among other things, the CPSIA requires testing and certification of certain products and enhances
the CPSC’s authority to order recalls.
The
FDA Food Safety Modernization Act (“FSMA”), enacted January 4, 2011, amended the FDCA to significantly enhance the FDA’s
authority over various aspects of food regulation. The FSMA granted the FDA mandatory recall authority when the FDA determines if there
is reasonable probability that a food is adulterated or misbranded and that the use of, or exposure to, the food will cause serious adverse
health consequences or death to humans or animals. Other changes include the FDA’s expanded access to records; the authority to
suspend food facility registrations and require high risk imported food to be accompanied by a certification; stronger authority to administratively
detain food; the authority to refuse admission of an imported food if it is from a foreign establishment to which a U.S. inspector is
refused entry for an inspection; and the requirement that importers verify that the foods they import meet domestic standards.
One
of the FSMA’s more significant changes is the requirement of hazard analysis and risk-based preventive controls (“HARBPC”)
for all food facilities required to register with the FDA, except dietary supplement facilities in compliance with both GMPs and the
serious adverse event reporting requirements. Although dietary supplement facilities are exempt from the HARBPC requirements, dietary
ingredient facilities might not qualify for the exemption. The HARBPC requirements, which the FDA has yet to propose, are expected to
be onerous because facilities will have to develop and implement preventive controls to assure that identified hazards are significantly
minimized or prevented, monitor the effectiveness of the preventive controls and maintain numerous records related to the HARBPC. The
HARBPC requirements may increase the costs of dietary ingredients and/or affect our ability to obtain dietary ingredients.
As
required by Section 113(b) of the FSMA, the FDA published in July 2011, a draft guidance document clarifying when the FDA believes a
dietary ingredient is an NDI, when a manufacturer or distributor must submit an NDI premarket notification to the FDA, the evidence necessary
to document the safety of an NDI and the methods for establishing the identity of an NDI. The draft guidance, if implemented as proposed,
could have a material impact on our operations. Although our industry has strongly objected to several aspects of the draft guidance,
it is unclear whether the FDA will make changes to the final guidance. In addition, it is possible that the FDA will begin taking enforcement
actions consistent with the interpretations in the draft guidance before issuing a final version. The new FSMA requirements, as well
as the FDA enforcement of the NDI guidance as written, could require us to incur additional expenses, which could be significant, and
negatively impact our business in several ways, including, but not limited to, the detention and refusal of admission of imported products,
the injunction of manufacturing of any dietary ingredients or dietary supplements until the FDA determines that such ingredients or products
are in compliance and the potential imposition of fees for re-inspection of noncompliant facilities. Each of these events would increase
our liability and could have a material adverse effect on our financial condition, results of operations or cash flows.
The
FTC and the FDA have pursued a coordinated effort to challenge what they consider to be unsubstantiated and unsafe weight-loss products,
and have also coordinated enforcement against dietary supplement claims in other areas, including children’s products. Their efforts
to date have focused on manufacturers and marketers as well as media outlets, and have resulted in a significant number of investigations
and enforcement actions, some resulting in civil penalties of several million dollars under the Federal Trade Commission Act. We expect
that the FTC and the FDA will continue to focus on health-related claims for dietary supplements and foods which could cause our non-CBD
products to be the subject of an FTC/FDA inquiry.
Item
1A. Risk Factors
YOU
SHOULD CAREFULLY CONSIDER THE RISKS AND UNCERTAINTIES DESCRIBED BELOW AND THE OTHER INFORMATION CONTAINED OR INCORPORATED BY REFERENCE
IN THIS ANNUAL REPORT ON FORM 10-K BEFORE DECIDING WHETHER TO INVEST IN THE COMPANY’S COMMON STOCK. ADDITIONAL RISKS AND UNCERTAINTIES
NOT PRESENTLY KNOWN TO THE COMPANY OR THAT THE COMPANY CURRENTLY DEEMS IMMATERIAL MAY ALSO IMPAIR THE COMPANY’S BUSINESS OPERATIONS.
IF ANY OF THE FOLLOWING RISKS ACTUALLY OCCUR, THE COMPANY’S BUSINESS, FINANCIAL CONDITION OR OPERATING RESULTS COULD BE MATERIALLY
ADVERSELY AFFECTED. IN SUCH CASE, THE TRADING PRICE OR THE COMPANY’S COMMON STOCK COULD DECLINE AND YOU MAY LOSE PART OR ALL OF
YOUR INVESTMENT. THIS ANNUAL REPORT ON FORM 10-K ALSO CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE RISKS AND UNCERTAINTIES. PLEASE
SEE “CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS”.
Risks
Related to our Financial Condition
We
are dependent on the sale of our securities to fund our operations.
During the years ended December 31, 2021 and 2020,
we received $348,000 and $125,000 from the sale of our securities. For the years ended December 31, 2021 and 2020, our revenues
were approximately $600,000 and $1,300,000, respectively from the sale of our products. Our operating expenses are presently approximately
$380,000 per month or $4,600,000 annually which consist of rent, advertising, salaries and other general and administrative expenses.
Our cash on hand as of the date of this Annual Report on Form 10-K is $135,769 which is not sufficient to pay our operating expenses.
We are in the process of obtaining future financing and are dependent on the sale of our securities to help fund our operations. There
is no assurance we will be able to obtain future funding for our operations from the sale of our securities. The future issuance of our
securities will result in substantial dilution in the percentage of our common stock held by our then existing stockholders, and would
likely have an adverse effect on any trading market for our common stock. Obtaining financing would be subject to a number of factors,
including investor acceptance. These factors may adversely affect the timing, amount, terms, or conditions of any financing that we may
obtain or make any additional financing unavailable to us. If we do not obtain additional financing to fund our future operations, our
business could fail and you could lose your investment.
There
is substantial doubt about our ability to continue as a going concern as a result of our limited operating history and financial resources,
and if we are unable to generate significant revenue or secure financing we may be required to cease or curtail our operations.
For
the years ended December 31, 2021 and 2020, we incurred net losses of approximately $5,800,000 and $2,900,000. As a result,
our auditor has rendered an opinion that we may be unable to continue as a going concern. Our limited operating history and financial
resources raises substantial doubt about our ability to continue as a going concern and our financial statements contain a going concern
qualification. Our financial statements do not include adjustments that might result from the outcome of this uncertainty and if we are
unable to generate significant revenue or secure financing we may be required to cease or curtail or completely suspend our operations.
We
will need additional capital to fund our operations, which, if obtained, could result in substantial dilution or significant debt service
obligations. Our inability to procure additional financing, if required, may have a material adverse effect on us. We may not be able
to obtain additional capital on commercially reasonable terms, which could adversely affect our liquidity and financial position.
We
require additional equity and/or debt financing to continue our operations. There can be no assurance that we will be able to obtain
funds on commercially acceptable terms, if at all. We expect to have ongoing needs for working capital in order to fund operations and
to continue to expand our operations. To that end, we may be required to raise additional funds through equity or debt financing. In
order to continue operating, we may need to obtain additional financing, either through borrowings, private offerings, public offerings,
or some type of business combination, such as a merger, or buyout, and there can be no assurance that we will be successful in such pursuits.
We may be unable to acquire the additional funding necessary to continue operating. However, there can be no assurance that we will be
successful in securing additional capital. If we are unsuccessful, we may need to (a) initiate cost reductions; (b) forego business development
opportunities; (c) seek extensions of time to fund liabilities, or (d) seek protection from creditors. Our inability to obtain any additional
financing could have a material adverse effect upon us. We may not be able to secure any additional financing we may need on terms favorable
to us, or at all. These conditions raise substantial doubt about our ability to continue as a going concern for at least one year from
the date of this filing.
In
addition, if we are unable to generate adequate cash from operations, and if we are unable to find sources of funding, it may be necessary
for us to sell one or more lines of business or all or a portion of our assets, enter into a business combination, or reduce or eliminate
operations. These possibilities, to the extent available, may be on terms that result in significant dilution to our investors or that
result in our investors losing all of their investment in our Company.
If
we are able to raise additional capital, we do not know what the terms of any such capital raising would be. In addition, any future
sale of our equity securities could be at prices substantially below prices at which our shares are currently valued. To the extent we
require additional financing and cannot raise it, we may have to limit our then-current operations, curtail all or certain portions of
our business objectives and plans or terminate our operations. We may seek to increase our cash reserves through the sale of additional
equity or debt securities. The sale of convertible debt securities or additional equity securities could result in additional and potentially
substantial dilution to our investors. The incurrence of indebtedness would result in increased debt service obligations and could result
in operating and financing covenants that would restrict our operations and liquidity. In addition, our ability to obtain additional
capital on acceptable terms is subject to a variety of uncertainties. We cannot assure you that financing will be available in amounts
or on terms acceptable to us, if at all. Any failure to raise additional funds on favourable terms could have a material adverse effect
on our liquidity and financial condition.
If
we are unable to generate sufficient revenues for our operating expenses we will need financing, which we may be unable to obtain; should
we fail to obtain sufficient financing, our potential revenues will be negatively impacted.
For the years ended December 31, 2021 and 2020, our
revenues were $626,619 and $1,255,784 respectively, from the sale of our products. For the years ended December 31, 2021 and 2020, we
incurred net losses of $5,827,507 and $2,889,940.
Because
we lack historical financial data, including revenue data, our future revenues are unpredictable.
Our
operating expenses are presently approximately $380,000 per month or $4,600,000 annually which consist of rent, advertising, salaries
and other general and administrative expenses. Our cash on hand as of the date of this Form 10-K is $135,769 which is not sufficient
to pay our operating expenses. In the future, we may require additional debt or equity funding to continue our operations. We intend
to raise additional funds from an offering of our stock in the future; however, this offering may never occur, or if it occurs, we may
be unable to raise the required funding. Further new offerings of our common shares will dilute our existing shareholders and your investment
in our common shares. We do not have any plans or specific agreements for new sources of funding and we have no agreements for financing
in place.
Our
liabilities could adversely affect our ability to raise additional capital to fund our operations, limit our ability to react to changes
in the economy or our industry and prevent us from meeting our obligations under our indebtedness.
As
of December 31, 2021, our total liabilities were $5,563,655. Our liabilities could have important consequences for our investors, including:
making it more difficult for us to make payments on indebtedness; increasing our vulnerability to general economic and industry conditions;
requiring a substantial portion of cash flow from operations to be dedicated to the payment of principal and interest on indebtedness
when our indebtedness become due. This reduces our ability to use our cash flow to fund our operations, capital expenditures and future
business opportunities; limiting our ability and the ability of our subsidiaries to obtain additional financing for working capital,
capital expenditures, product development, debt service requirements, acquisitions and general corporate or other purposes; and limiting
our ability to adjust to changing market conditions and placing us at a competitive disadvantage compared to our competitors which have
fewer liabilities. We may incur substantial additional indebtedness in the future. If new indebtedness is added to our current debt levels,
the related risks that we face could increase.
We
are currently in default on certain secured debt obligations which could negatively affect our financial condition and may cause us to
curtail or cease our operations.
As
discussed above, the Company has not made the principal and interest payments on the Amended Note as of the date of this Annual Report.
Accordingly, the Company is currently in default on these secured debt obligations.
We
are subject to the periodic reporting requirements of the Exchange Act that require us to perform accounting and reporting obligations
with limited resources.
We
are subject to the reporting requirements of the Exchange Act and are required to file periodic reports with the Securities and Exchange
Commission (the “SEC”) pursuant to the Exchange Act and the rules and regulations promulgated thereunder. The reporting obligations
require additional staff or consulting expenses. In addition, we have limited resources to allocate to such compliance functions, which
increase the possibility of non-compliance.
Risks
Related to Our Business
We
have been growing rapidly and expect to continue to invest in our growth for the foreseeable future. If we are unable to manage our growth
effectively, our revenue and profits could be adversely affected.
We
have experienced rapid growth in a relatively short period of time. Our revenues were approximately $600,000 and $1,300,000 for the years
ended December 31, 2021 and 2020, respectively. We plan to continue to expand our operations, and we anticipate that further significant
expansion will place additional demands on our resources and operations. We presently operate our manufacturing and distribution from
a 6,400 square foot facility. We plan to begin manufacturing at a second facility consisting of 20,000 square feet in addition to our
existing facility. Our future operating results depend to a large extent on our ability to manage this expansion and growth successfully.
Sustaining our growth will place significant demands on our management as well as on our administrative, operational, and financial resources.
To manage our growth, we must continue to improve our sales and manage our operational systems. If we are unable to manage our growth
successfully, our revenue and profits could be harmed. Risks that we face in undertaking future expansion include but are not limited
to:
|
●
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effectively
recruiting, integrating, training, and motivating new employees, including our sales force, while retaining existing private label
distributors and effectively executing our new business plan focusing on the processing, extraction and sale of CBD products; |
|
● |
satisfying
existing customers and attracting new customers of our products and services; |
|
● |
introducing
new products and services; |
|
● |
increasing
our private label customers; |
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● |
controlling
expenses and investments in expanded operations including our new manufacturing facility; |
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● |
implementing
and enhancing our administrative, operational, and financial infrastructure, systems, and processes; and |
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addressing
new products to meet consumer preferences. |
A
failure to manage our growth effectively could harm our business, operating results and/or financial condition. Further, due to our recent
rapid growth, we have limited experience operating at our current scale and potentially at a larger scale, and as a result, it may be
difficult for us to fully evaluate future prospects and risks. Our recent and historical growth should not be considered indicative of
our future performance. We have encountered in the past, and will encounter in the future, risks and uncertainties frequently experienced
by growing companies in rapidly changing industries. If our assumptions regarding these risks and uncertainties, which we use to plan
and operate our business, are incorrect or change, or if we do not address these risks successfully, our financial condition and operating
results could differ materially from our expectations, our growth rates may slow and our business would by adversely impacted.
Our
revenues are highly dependent upon two private label distributors, which represented 58%, and 24%, of our revenues for the year December
31, 2021 and should these distributors reduce their orders from us or should we lose these distributors; our revenues and results of
operations would be negatively affected which could cause you to lose your investment.
Our
revenues are concentrated and highly dependent on two (2) private label customers which represented 58%, and 24%, of our revenues for
the year ended December 31, 2021. All sales made under a private label relationship are made on a purchase order basis and there are
no long-term contracts with respect to any private label relationships. There can be no assurance that existing private label relationships
will continue in the future or that we will be able to obtain new private label relationships on an ongoing basis, if at all. Our private
label customers can reduce the products they order from us or cease ordering products from us at any time without notice. There can be
no assurance that these private label customers will continue to place orders with us, that orders by such customers will continue at
their previous levels or that we can replace any such lost business. Should this occur, our revenues and results of operations will be
negatively affected which could cause you to lose your investment in our common shares.
As
a result of our evolving business model, we have a limited operating history in our lines of business and, therefore, we may not be able
to correctly estimate our future operating expenses, which could lead to cash shortfalls.
Since
our inception, our business model has evolved significantly. In 2017, we began selling CBD products and as a result our revenues increased
from approximately $1,800,000 in 2017 to approximately $3,700,000 in 2018 and then decreased to $2,130,000 in 2019 and $1,300,000 in
2020, and 600,000 in 2021. CBD became our main source of income, and we focused on generating revenue through private label manufacturers.
As a result of the change in our business model, our revenues have significantly increased from prior periods. We have a limited operating
history for our CBD products from which to evaluate our business. Additionally, amid the COVID-19 global pandemic, in 2020, the Company
made a strategic pivot from our then-current nutraceutical manufacturing business by adding the manufacture of consumer sanitizer products
utilizing the Company’s existing manufacturing capabilities and the Company’s ability to retrofit its operations and accommodate
production due to the shortage of supply and demand for sanitizer products. We also have a limited operating history for our sanitized
products from which to evaluate our business. Our failure to successfully execute our business plan would have a material adverse effect
on our ability to continue operating. Accordingly, our prospects must be considered in light of the risks, expenses, and difficulties
frequently encountered by companies in an early stage of development. We may not be successful in addressing such risks, and the failure
to do so could have a material adverse effect on our business, operating results and financial condition.
Our
quarterly and annual expenses are likely to increase substantially over the next several years depending upon the level of capital spending
required to grow our revenues. Our operating results in future quarters may fall below expectations. Any of these events could adversely
impact our business prospects and make it more difficult to raise additional equity capital at an acceptable price per share.
We
do not have many written contracts with our customers. This allows such customers to use other companies instead of us which may negatively
impact on our sales.
Because
we do not have many written contracts with our customers who are free to purchase products from other suppliers, our customers can choose
to use other companies instead. If a significant number of our customers began to use competing companies instead of us, our sales would
decrease significantly.
An
unexpected interruption or shortage in the supply or significant increase in the cost of components could limit our ability to manufacture
any products, which could reduce our sales and margins.
An
unexpected interruption of supply or a significant increase in the cost of components, for any reason, such as regulatory requirements,
import restrictions, loss of certifications, disruption of distribution channels as a result of weather, terrorism or acts of war, fire,
earthquake, or other national disaster, a work stoppage or other labor-related disruption, failure in supply or other logistical channels,
electrical outages, or other events, could result in significant cost increases and/or shortages of our products. Our inability to obtain
a sufficient amount of products or to pass through higher cost of products we offer could have a material adverse effect on our business,
financial condition or results of operations.
The
COVID-19 pandemic has already begun to adversely affect the Company’s business and the ultimate effect of the COVID-19 pandemic
on the Company’s operations and financial condition will depend on future developments, which are highly uncertain and cannot be
predicted.
The
effects of the COVID-19 pandemic, including actions taken by businesses and governments, have adversely affected the global economy,
disrupted global supply chains and created significant volatility in the financial markets. As a result, the Company’s business
operations have been limited due to government actions or other restrictions in connection with the COVID-19 pandemic and may also be
effected if Company’s personnel is unable to work effectively due to illness, quarantines, or other restrictions in connection
with the COVID-19 pandemic. The COVID-19 pandemic has also already hindered the Company’s ability to raise capital and stay current
in its reporting obligations with the SEC. If the COVID-19 pandemic continues for a prolonged period, the Company’s business, financial
condition, results of operation and liquidity may be materially and adversely affected. The extent of the ultimate impact of the pandemic
on the Company’s operational and financial performance will depend on various developments, including the duration and spread of
the outbreak, and its impact on potential customers, employees, and vendors, all of which cannot be reasonably predicted at this time.
These future developments will also include, but are not limited to, the actions taken by governmental authorities and other third parties
in response to the pandemic. Disruptions and/or uncertainties related to the COVID-19 pandemic for a sustained period of time could result
in delays or modifications to the Company’s strategic plans and initiatives and hinder the Company’s ability to achieve its
goals.
Possible
yet unanticipated changes in federal and state law in the U.S. could cause our products containing hemp to be illegal, or could otherwise
prohibit, limit or restrict any of our products containing hemp.
Until
2014, when 7 U.S. Code §5940 became federal law as part of the Agricultural Act of 2014 (the “2014 Farm Act”), products
containing hemp, notwithstanding a minimal or non-existing THC content, were classified as Schedule I illegal drugs. The 2014 Farm Act
expired on September 30, 2018, and was thereafter replaced by the Agricultural Improvement Act of 2018 on December 20, 2018 (the “2018
Farm Act”), which amended various sections of the U.S. Code, thereby removing hemp, defined as cannabis with less than 0.3% of
THC, from Schedule 1 status under the Controlled Substances Act (“CSA”), and legalizing the cultivation and sale of hemp
at the federal level, subject to compliance with certain federal requirements and state law, amongst other things. THC is the psychoactive
component of plants in the cannabis family generally identified as marihuana or marijuana. We anticipate that our hemp-based products
are and will continue to be federally legal in the United States in that they do, and will contain less than 0.3% of THC in compliance
with the 2018 Farm Bill guidelines and will have no psychoactive effects on our customers’ bodies. Notwithstanding, there is no
assurance that the 2018 Farm Act will not be repealed or amended such that our products containing hemp would once again be deemed illegal
under federal law.
The
2018 Farm Bill also shifted regulatory authority from the Drug Enforcement Administration to the Department of Agriculture. The 2018
Farm Bill did not change the FDA oversight authority over hemp-based products. The 2018 Farm Act delegated the authority to the states
to regulate and limit the production of hemp and hemp derived products within their territories. Although many states have adopted laws
and regulations that allow for the production and sale of hemp and hemp derived products under certain circumstances, no assurance can
be given that such state laws may not be repealed or amended such that our products containing hemp would once again be deemed illegal
under the laws of one or more states now permitting such products, which in turn would render such products illegal in those states under
federal law even if the federal law is unchanged. In the event of either repeal of federal or of state laws and regulations, or of amendments
thereto that are adverse to our hemp-based products, we may be restricted or limited with respect to those products that we may sell
or distribute, which could adversely impact our business operations with respect to such products.
Additionally,
the FDA has indicated its view that certain types of products containing hemp may not be permissible under the FDCA. The FDA’s
position is related to its approval of Epidiolex, a marijuana-derived prescription medicine to be available in the United States. The
active ingredient in Epidiolex is hemp-derived CBD. On December 20, 2018, after the passage of the 2018 Farm Bill, FDA Commissioner Scott
Gottlieb issued a statement in which he reiterated the FDA’s position that, among other things, 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 and that the FDCA prohibits introducing into interstate
commerce food products containing added hemp, and marketing products containing hemp-derived ingredients, including, but not limited
to CBD, as a dietary supplement, regardless of whether the substances are hemp-derived. Although we believe our planned hemp-based product
offerings do and will continue to comply with applicable federal and state laws and regulations, legal proceedings alleging violations
of such laws could have a material adverse effect on our business, financial condition and results of operations.
FDA
regulation could negatively affect the hemp industry, which would directly affect our financial condition.
The
FDA may seek expanded regulation of hemp under the FDCA. Additionally, the FDA may issue rules and regulations, including certified good
manufacturing practices, or cGMPs, related to the growth, cultivation, harvesting and processing of hemp. Clinical trials may be needed
to verify efficacy and safety. It is also possible that the FDA would require that facilities where hemp is grown register with the FDA
and comply with certain federally prescribed regulations. In the event that some or all of these regulations are imposed, we do not know
what the impact would be on the hemp industry, including what costs, requirements and possible prohibitions may be enforced. If we or
our partners are unable to comply with the regulations or registration as prescribed by the FDA, we and or our partners may be unable
to continue to operate our and their business in its current or planned form or at all.
Confusion
between legal hemp and illegal cannabis.
There
is risk that confusion or uncertainty surrounding our products with regulated cannabis could occur on the state or federal level and
impact us. We may have difficulty with establishing banking relationships, working with investment banks and brokers who would be willing
to offer and sell our securities or accept deposits from stockholders, and auditors willing to certify our financial statements if we
are confused with businesses that are in the cannabis business. Any of these additional factors, should they occur, could also affect
our business, prospects, assets or results of operation could have a material adverse effect on the business, prospects, results of operations
or financial condition of the Company.
Because
we are subject to numerous laws and regulations we could incur substantial costs.
The
manufacture, labeling and distribution of our products is regulated by various federal, state and local agencies. These governmental
authorities may commence regulatory or legal proceedings, which could restrict the permissible scope of our product claims or the ability
to sell our products in the future. The FDA regulates our nutraceutical and wellness products to ensure that the products are not adulterated
or misbranded.
We
are subject to additional regulation as a result of our CBD products. The shifting compliance environment and the need to build and maintain
robust systems to comply with different compliance in multiple jurisdictions increase the possibility that we may violate one or more
of the requirements. If our operations are found to be in violation of any of such laws or any other governmental regulations that apply
to us, we may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or
restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.
Failure
to comply with FDA requirements may result in, among other things, injunctions, product withdrawals, recalls, product seizures, fines
and criminal prosecutions. Our advertising is subject to regulation by the FTC under the FTCA. In recent years, the FTC has initiated
numerous investigations of dietary and nutrition supplement products and companies. Additionally, some states also permit advertising
and labeling laws to be enforced by private attorney generals, who may seek relief for consumers, seek class action certifications, seek
class wide damages and product recalls of products sold by us. Any actions against us by governmental authorities or private litigants
could have a material adverse effect on our business, financial condition and results of operations.
Adverse
publicity or consumer perception of our products and any similar products distributed by others could harm our reputation and adversely
affect our sales and revenues.
We
are highly dependent upon positive consumer perceptions of the safety and quality of our products as well as similar products distributed
by other wellness, nutraceutical and CBD companies. Consumer perception of nutrition supplements and our products, in particular, can
be substantially influenced by scientific research or findings, national media attention and other publicity about product use. Adverse
publicity from these sources regarding the safety, quality or efficacy of nutritional supplements and our products could harm our reputation
and results of operations. The mere publication of news articles or reports asserting that such products may be harmful or questioning
their efficacy could have a material adverse effect on our business, financial condition and results of operations, regardless of whether
such news articles or reports are scientifically supported or whether the claimed harmful effects would be present at the dosages recommended
for such products.
If
the products we sell do not have the healthful effects intended, our business may suffer.
In
general, our products contain food, nutritional supplements which do not currently require approval from the FDA or other regulatory
agencies prior to sale. Many of our products contain innovative ingredients or combinations of ingredients. There is little long term
experience with human or other animal consumption of certain of these ingredients or combinations thereof in concentrated form. Our products
could have certain side effects if not taken as directed or if taken by a consumer that has certain medical conditions. Furthermore,
there can be no assurance that any of the products, even when used as directed, will have the effects intended or will not have harmful
side effects. Should our products cause unwanted side effects or not have the results intended, it could have a material adverse effect
on our business, financial condition and results of operations.
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, we are subject to product liability claims if the use of our
products for others is alleged to have resulted in injury. Our products consist of vitamins, minerals, herbs, lotions and other ingredients
that are not subject to pre-market regulatory approval in the United States or internationally. Previously unknown adverse reactions
resulting from human consumption of these ingredients could occur which would likely result in product liability claims against us 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.
Our
insurance coverage may not be sufficient to cover our legal claims or other losses that we may incur in the future.
We
maintain insurance, including property, general and product liability, and workers’ compensation to protect ourselves against potential
loss exposures. There is no assurance that our insurance will be sufficient to cover any claims that are asserted against us. In the
future, insurance coverage may not be available at adequate levels or on adequate terms to cover potential losses, including on terms
that meet our customer’s requirements. If insurance coverage is inadequate or unavailable, we may face claims that exceed coverage
limits or that are not covered, which could increase our costs and adversely affect our operating results.
Our
intellectual property rights are valuable, and any inability to protect them could reduce the value of our products and brand.
We
manufacture products primarily for third parties who sell the products under their own brand names. We also sell products under our own
brand names. Our product formulations are not patented and there are numerous companies selling similar products. As such, third parties
could copy our products or sell similar products to our distributors and/or customers.
Our
competitors may have or develop equivalent or superior manufacturing and design skills, and may develop an enhancement to our formulations
that will be patentable or otherwise protected from duplication by others. Further, we may be unable or unwilling to strictly enforce
our intellectual property rights, including our trademarks, from infringement. Our inability to obtain and/or failure to enforce our
intellectual property rights could diminish the value of our product offerings and have a material adverse effect on our business, prospects,
results of operations, and financial condition.
If
we are unable to obtain and maintain protection of our intellectual property, the value of our products may be adversely affected.
Our
business is dependent in part upon our ability to use intellectual property rights to protect our products from competition. To protect
our products, we rely on a combination of patent and other intellectual property laws, employment, confidentiality and invention assignment
agreements with our employees and contractors, and confidentiality agreements and protective contractual provisions with our partners,
licensors and other third parties. These methods, however, afford us only limited protection against competition from other products.
We
attempt to protect our intellectual property position, in part, by filing patent applications related to our proprietary technology,
inventions and improvements that are important to our business. However, our patent position is not likely by itself to prevent others
from commercializing products that compete directly with our products. In addition, the patent owned by us or issued to us could be challenged,
invalidated, or held to be unenforceable. We also note that any patent granted may not provide a competitive advantage to us. Our competitors
may independently develop technologies that are substantially similar or superior to our technologies. Further, third parties may design
around our patented or proprietary products and technologies.
We
rely on certain trade secrets and we may not be able to adequately protect our trade secrets even with contracts with our personnel and
third parties. Also, any third party could independently develop and have the right to use, our trade secret, know-how and other proprietary
information. If we are unable to protect our intellectual property rights, our business, prospects, financial condition and results of
operations could suffer materially.
We
may be involved in lawsuits or proceedings to protect or enforce our intellectual property rights or to defend against infringement claims,
which could be expensive and time consuming.
Our
success depends in part on our products not infringing on the patents and proprietary rights of other parties. For instance, in the United
States, patent applications filed in recent years are confidential for 18 months, while older applications are not published until the
patent issues. As a result, there may be patents and patent applications of which we are unaware, and avoiding patent infringement may
be difficult. Litigation may be necessary to enforce our intellectual property rights, protect our trade secrets or determine the validity
and scope of the proprietary rights of others. Interference proceedings conducted by a patent and trademark office may be necessary to
determine the priority of inventions with respect to our patent applications. Litigation or interference proceedings could result in
substantial costs and diversion of resources and management attention. In addition, in an infringement proceeding, a court may decide
that a patent of ours is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the
grounds that our patents do not cover the technology. An adverse determination of any litigation or defense proceedings could put one
or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.
In addition, we may be enjoined from marketing one or more of our products if a court finds that such products infringe the intellectual
property rights of a third party. During litigation, we may not be able to prevent the confidentiality of certain of our proprietary
rights because of the substantial amount of discovery required in connection with intellectual property litigation. In addition, during
the course of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments.
If investors or customers perceive these results to be negative, it could have a material adverse effect on our business, prospects,
financial condition and results of operations.
Our
business is highly competitive, and our failure to compete effectively could adversely affect our market share, financial condition and
future growth.
The
nutritional supplement, wellness and CBD industries are highly competitive with respect to price, brand and product recognition and new
product introductions. Many of our competitors are larger, more established and possess greater financial, personnel, distribution and
other resources. We face competition (a) in the health food channel from a limited number of large nationally known manufacturers, private
label brands and many smaller manufacturers of dietary and nutrition supplements; and (b) in the mass-market distribution channel from
manufacturers, major private label manufacturers and others. Private label brands at mass-market chains represent substantial sources
of income for these merchants and the mass-market merchants often support their own labels at the expense of other brands. As such, the
growth of our brands within food, drug, and general mass-market merchants are highly competitive and uncertain. If we cannot compete
effectively, we may not be profitable.
We
may experience greater than expected product returns, which might adversely affect our sales and results of operations.
In
the year ended December 31, 2021, product returns represented 2% of our sales. Products may be returned for various reasons, including
expiration dates or lack of sufficient sales volume. Any increase in product returns could reduce our results of operations.
The
purchase of many of our products is discretionary and may be negatively impacted by adverse trends in the general economy and make it
more difficult for us to generate revenues.
Our
business is affected by general economic conditions since our products are discretionary and we depend, to a significant extent, upon
a number of factors relating to discretionary consumer spending. These factors include economic conditions and perceptions of such conditions
by consumers, employment rates, the level of consumers’ disposable income, business conditions, interest rates, consumer debt levels
and availability of credit. Consumer spending on our products may be adversely affected by changes in general economic conditions.
We
may not be able to anticipate consumer preferences and trends within the diet and nutritional industry, which could negatively affect
acceptance of our products by retailers and consumers and result in a significant decrease in our revenues.
Our
products must appeal to a broad range of consumers, whose preferences cannot be predicted with certainty and are subject to rapid change.
Our products will need to successfully meet constantly changing consumer demands. If our products are not successfully received by our
private label distributors and their customers, our business, financial condition, results of operations and prospects may be harmed.
Risks
Related to Our Management
Should
we lose the services of Edgar Ward, our founder, Chief Executive Officer, President and sole Director, our financial condition and proposed
expansion may be negatively impacted.
Our
future depends on the continued contributions of Edgar Ward, our founder, Chief Executive Officer, President and sole Director who would
be difficult to replace. The services of Mr. Ward are critical to the management of our business and operations. Additionally, we do
not maintain key man life insurance on Mr. Ward. Should we lose the services of Mr. Ward, and be unable to replace his services with
equally competent and experienced personnel, our operational goals and strategies would likely be adversely affected, which will negatively
affect our revenues.
Edgar
Ward, our founder, Chief Executive Officer, President and sole Director has voting control of the Company.
Edgar
Ward, our founder, Chief Executive Officer, President and sole Director holds voting and dispositive control over 13.87% of our
issued and outstanding common stock shares. Further he holds 100% of our issued and outstanding Series A Preferred stock. Each share
of Series A Preferred Stock is entitled to 500,000 votes per share or an aggregate of 500,000,000 votes. Therefore, Edgar Ward effectively
has voting control over the Company, which could lead to a conflict of interest where Mr. Ward’s interests do not align
with those of ordinary shareholders of the Company.
Because
we do not have an audit or compensation committee, shareholders will have to rely on the one member of our board of directors who is
not independent to perform these functions.
We
do not have an audit or compensation committee or board of directors as a whole that is composed of independent directors. These functions
are performed by our sole director. Because our sole Director is not independent, there is a potential conflict between their or our
interests and our shareholders’ interests since Edgar Ward, our sole Board Member, is also our Chief Executive Officer and President
who will participate in discussions concerning management compensation and audit issues that may affect management decisions. Until we
have an audit committee or independent directors, there may less oversight of management decisions and activities and little ability
for minority shareholders to challenge or reverse those activities and decisions, even if they are not in the best interests of minority
shareholders.
Our
Vice-President devotes limited time to our business, which may negatively impact our plan of operations, implementation of our business
plan and our potential profitability.
Neil
Catania, our Vice-President currently devotes only ten (10) hours to our business each month. Our Chief Executive Officer and President,
Edgar Ward, devotes full time to our business however, there is no assurance he will be able to do so in the future. Management time
devoted to our business activities in the future may be inadequate to implement our plan of operations and develop a profitable business.
Risks
Related to Our Common Stock
Our
Chief Executive Officer, President and sole Director has voting control over all matters submitted to a vote of our common stockholders,
which will prevent our minority shareholders from having the ability to control any of our corporate actions.
As
of the date hereof, we had 174,968,516 shares of our common stock outstanding, each entitled to one vote per common share. Our Chief
Executive Officer, President and sole Director, Edgar Ward, held 13.87% of our issued and outstanding common stock and 1,000 Series
A Preferred which provide 500,000 votes per share or an aggregate of 500,000,000 votes on all matters submitted to our stockholders.
As a result, Mr. Ward has voting control of the Company and has the ability to determine the outcome of all matters submitted to our
stockholders for approval, including the election of directors. Mr. Ward’s control of our voting securities may make it impossible
to complete some corporate transactions without his support and may prevent a change in our control. In addition, this ownership could
discourage the acquisition of our common stock by potential investors and could have an anti-takeover effect, possibly depressing the
trading price of our common stock.
We
will, in the future, issue additional securities which would reduce investors’ percent of ownership and will cause dilution to
our existing shareholders.
Our
Articles of Incorporation authorize us to issue 499,990,000 shares of common stock. As of the date hereof, we had 174,968,516 shares
of common stock outstanding. Accordingly, we may issue additional shares of common stock. The future issuance of common stock may result
in substantial dilution in the percentage of our common stock held by our then existing shareholders. We may value any common stock issued
in the future on an arbitrary basis including for services or acquisitions or other corporate actions that may have the effect of diluting
the value of the shares held by our stockholders, and might have an adverse effect on any trading market for our common stock. Additionally,
we are authorized to issue 10,000 shares of preferred stock, of which we currently have 1,000 shares of our Series A Preferred stock
issued and outstanding and 20 shares of Series B Preferred stock issued and outstanding. Further, our board of directors may designate
the rights, terms and preferences of our authorized but unissued preferred shares at our discretion including conversion and voting preferences
without notice to our shareholders.
The
sale of the additional shares of common stock could cause dilution as well as the value of our common stock to decline.
The
sale of a substantial number of shares of our common stock, or anticipation of such sales, could make it more difficult for us to sell
equity or equity-related securities in the future at a time and at a price that we might otherwise wish. Further, if we do sell or issue
more common stock, any investors’ investment in the Company will be diluted. Dilution is the difference between what you pay for
your stock and the net tangible book value per share immediately after the additional shares are sold by us. If dilution occurs, any
investment in the Company’s common stock could seriously decline in value.
Our
common stock is subject to the application of the “penny stock” rules which could adversely affect the market price of our
common stock and increase transaction costs to sell those shares.
The
SEC has adopted rule 3a51-1 which establishes the definition of a “penny stock,” for the purposes relevant to us, as any
equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject
to certain exceptions. For any transaction involving a penny stock, unless exempt, Rule 15g-9 requires:
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a broker or dealer approve a person’s account for transactions in penny stocks, and |
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the
broker or dealer receive from the investor a written agreement to the transaction, setting forth the identity and quantity of the
penny stock to be purchased. |
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In
order to approve a person’s account for transactions in penny stocks, the broker or dealer must: |
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obtain
financial information and investment experience objectives of the person, and |
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make
a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge
and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks. |
The
broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to
the penny stock market, which, in highlight form:
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sets
forth the basis on which the broker or dealer made the suitability determination and |
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that
the broker or dealer received a signed, written agreement from the investor prior to the transaction. |
Generally,
brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more
difficult for investors to dispose of our common stock and cause a decline in the market value of our stock.
The
market price for our common stock is particularly volatile which could lead to wide fluctuations in our share price. You may be unable
to sell your common stock shares at or above your purchase price, or at all, which may result in substantial losses to you.
The
market for our common stock is characterized by significant price volatility when compared to seasoned issuers, and we expect that our
share price will continue to be more volatile than a seasoned issuer for the indefinite future. As a consequence of this enhanced risk,
more risk-adverse investors may, under the fear of losing all or most of their investment in the event of negative news or lack of progress,
be more inclined to sell their shares on the market more quickly and at greater discounts than would be the case with the stock of a
seasoned issuer. Many of these factors are beyond our control and may decrease the market price of our common stock regardless of our
operating performance. We cannot make any predictions or projections as to what the prevailing market price for our common stock shares
will be at any time, or as to what effect the sale of shares or the availability of common stock shares for sale at any time will have
on the prevailing market price.
FINRA
sales practice requirements may also limit a stockholder’s ability to buy and sell our stock.
In
addition to the “penny stock” rules described above, FINRA has adopted FINRA Rule 2111 that requires a broker-dealer to have
reasonable grounds for believing that an investment is suitable for a customer before recommending the investment. 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. The FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which
may limit your ability to buy and sell our stock and have an adverse effect on the market for our shares.
We
do not intend to pay dividends for the foreseeable future.
We
have never declared or paid any cash dividends on our stock and do not intend to pay any cash dividends in the foreseeable future. We
anticipate that we will retain all of our future earnings for use in the development of our business and for general corporate purposes.
Any determination to pay dividends in the future will be at the discretion of our Board of Directors.
If
we are unable to comply with the financial reporting requirements mandated by the SEC’s regulations, investors may lose confidence
in our financial reporting and the price of our common stock, if a market ever does develop for it, could decline.
If
we fail to maintain effective internal controls over financial reporting, our ability to produce timely, accurate and reliable periodic
financial statements could be impaired. If we do not maintain adequate internal control over financial reporting, investors could lose
confidence in the accuracy of our periodic reports filed under the Exchange Act. Additionally, our ability to obtain additional financing
could be impaired or a lack of investor confidence in the reliability and accuracy of our public reporting could cause our stock price
to decline.