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 oral spray 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 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 heavy metals, pesticides,
and solvents.
We
offer 13 different core formulations which we modify to meet the specifications of our private label customers. We provide approximately
50 different variations of our core formulations. Our private label products include CBD-infused oral sprays, tinctures, pet drops,
pain balms, and face creams, and nutraceutical oral spray products for sleep support and weight loss packaged under the customer’s
brand names.
Our
spray products and tinctures 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 $4.0 and $2.0 million
for the years ended December 31, 2019 and 2018, respectively, and have an accumulated deficit of approximately $38.8 million at
December 31, 2019. These conditions raise substantial doubt about our ability to continue as a going concern. The independent
auditors’ reports on our financial statements for the years ended December 31, 2019 and 2018 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. The spread of this virus caused various business
disruptions including temporary closures to the Company’s offices and facilities. While these disruptions are currently
expected to be temporary, there is considerable uncertainty around the duration. Therefore, the Company expects this matter to
negatively impact its operating results. The related financial impact and duration cannot be reasonably estimated at this time.
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 very
near 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
NutraLife
BioSciences, Inc, 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, 2017;
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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.
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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 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, of 2018 and 2019, we generated revenues of approximately $3,700,000 and $2,100,000, respectively
from the sale of our products.
In
March of 2017, we began selling CBD products. Since that time, revenues from sales of our CBD products decreased from $2,400,000
for the year ended December 31, 2018 to $1,800,000 for the year ended December 31, 2019 representing 78% and 100% of
our revenues for such periods.
Our
Products and Services
We
manufacture and distribute private label and branded products. In the years ended December 31, 2018 and 2019, private label sales
represented 99% and 99% of our revenue, respectively.
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.
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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
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PCR-
Pure
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Recent
Developments
In
November of 2018, our wholly owned subsidiary PAT began providing bulk material analytical, identity, potency and purity testing
of raw industrial hemp.
In
January of 2019, our wholly owned subsidiary, NutraDerma acquired the patent for a natural dermal skin patch that is designed
to prevent mosquito and other insect bites.
In
February of 2019, our wholly owned subsidiary 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 the Company’s wholly owned subsidiary, 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 the Company, 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.
Our
Operating Strategy
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 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. 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 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.
We
also plan to continue the development, manufacturing and distribution of nutritional and dietary oral spray 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.
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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 sanitizer products.
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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”.
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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.
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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 7 different brands of products manufactured by us. Sales to private label customers represented
approximately 99% and 99% of our revenues for the years ended December 31, 2018 and 2019, respectively. Our industrial hemp
CBD products represented 78% and 100% of private label sales in the year ended December 31, 2018 and 2019.
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 as less expensive than brand name products, but of equal or better quality.
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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.
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Private
label customers have the convenience of ordering our products online.
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Manufacturing
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 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. 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 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.
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 August of 2021.
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
Food and Drug Administration (“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 Edgar Ward, our Chief Executive Officer, President, and
sole Director, with the assistance of our in-house chemists. Our products are and, in the future, will continue to be identified
by Mr. Ward based upon suggestions from our 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 U.S. Food and Drug Administration 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
CBD 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
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our
formulations have a minimum of one-year shelf life.
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Sales
and Marketing
Our
Chief Executive Officer, President and sole Director, Edgar 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 14 full-time and part-time employees. 1 employee is a chemist engaged in product development
and testing, 4 are engaged in executive or administrative capacities, 10 employees are engaged in manufacturing, packaging, or
distribution and 1is 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
We
received federal trademark registration for the expression “Spray your way to a healthier day!” that we use, or intend
to use, to distinguish ourselves from others. All trademark registrations are protected for an initial period of five (5) years
and then are renewable after five (5) years, if still in use, and every ten (10) years thereafter. We hold the following trade
names from the U.S. Patent and Trademark office:
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OralPro
NutraSpray
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NutraSpray
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NRG
X Spray
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Micro
Blast Body Slim
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Micro
Blast
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Body
Slim
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NutraHemp
CBD
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Spray
your way to a healthier day!
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Our
wholly owned subsidiary, 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 test, manufacture and distribute this product in
2021.
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, 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. 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 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.
Material
Agreements
Owen
Morgan
On
February 4, 2019, our wholly owned subsidiary known as Phytochem Technologies, Inc. (“Phytochem) entered into an agreement
(the “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 (the “Technology”) 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.
Mr.
Morgan agreed to provide services to Phytochem for a period of one (1) year. In exchange for his services, Mr. Morgan received
$65,520 upon execution of the Agreement and agreed to be compensated $15,000 monthly. Mr. Morgan’s services include overseeing
all aspects of the manufacturing which shall be done in the United Kingdom. Phytochem is obligated to pay up to $10,000 to manufacture
a demo unit (“Demo Unit”) using the Technology and $400,000 plus enhancement costs, shipping and installation to manufacture
one commercial units using the Technology.
Phytochem
was obligated to pay Mr. Morgan 40% of net revenues derived from the commercialization of the Technology. In addition, Mr. Morgan
was to receive shares of the Company’s Common Stock upon certain milestones. Upon receipt of the Demo Unit and Commercial
Unit, Mr. Morgan shall receive 500,000 and 1,500,000 shares, respectively. If the commercialization of the Technology results
in revenues of $1,000,000, $5,000,000 and $10,000,000, Mr. Morgan was to receive 2,000,000 shares upon each milestone. If the
commercialization of the Technology results in revenues of $25,000,000, $50,000,000, and $100,000,000, Mr. Morgan shall receive
4,000,000, 5,000,000 and 5,000,000 shares, respectively, upon each milestone.
This
agreement is in default since Mr. Morgan failed to deliver the commercial units.
Orlando
Pharmacy
On
March 10, 2019, we entered into an agreement (the “Agreement”) with Orlando Pharmacy Inc., a Florida corporation (the
“Pharmacy”) whereby we granted a limited exclusive license to the Pharmacy for a unique process for a delivery system
to deliver testosterone into the human body using an oral spray. Under the terms of the Agreement, the Pharmacy was obligated
to pay royalties to us of sixty-six and two thirds percent (66 2/3%) of its net sales of the “Product” within fifteen
(15) days after the close of each calendar month. The Agreement had a term of five (5) years unless earlier terminated. The Agreement
l automatically terminates upon:
(a)
|
Upon
the Pharmacy’s failure to use best efforts to market the product;
|
(b)
|
Within
three (3) months after execution, if the Pharmacy fails to have net revenues of at least $10,000 from the sale of the Product;
|
(c)
|
Within
one year after execution, if the Pharmacy fails to have net revenues of at least $500,000 from the sale of the Product;
|
(d)
|
Within
two years after execution, if the Pharmacy fails to have net revenues of at least $2,000,000 from the sale of the Product;
|
(e)
|
Within
three years after execution, if the Pharmacy fails to have net revenues of at least $3,000,000 from the sale of the Product;
|
(f)
|
Within
four years after execution, if the Pharmacy fails to have net revenues of at least $4,000,000 from the sale of the Product;
or
|
(g)
|
Within
five years after execution, if the Pharmacy fails to have net revenues of at least $5,000,000 from the sale of the Product.
|
This
Agreement was terminated pursuant to clause (b) above upon three (3) months after execution, as the Pharmacy failed to have net
revenues of at least $10,000 from the sale of the Product.
NewLeaf
Assets LLC
On
March 10, 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 (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 anytime 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
a result of the Investment, NewLeaf holds an aggregate of 15,764,705 of our common shares, warrants to purchase an additional
10,950,000 common shares for an aggregate price of $2,190,000 and an had an 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, which was not exercised prior to such date.
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 a wholly owned subsidiary of the Company “PhytoChem” and together with NutraLife, the “Company”)
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
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|
(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 installment 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 defenses 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 United States Food and Drug Administration’s (“FDA”) 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 Federal Trade Commission (“FTC”), and, to a lesser extent,
the Consumer Product Safety Commission (“CPSC”), the United States Department of Agriculture (“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 Federal Food, Drug, and Cosmetic Act, (“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, 2018 and, December 31, 2019, we received $618,000 and $2,800,000, from the sale of our
securities. For the years ended December 31, 2018 and December 31, 2019, our revenues were approximately $3,700,000 and
$2,100,000, respectively from the sale of our products. Our operating expenses are presently approximately $330,000 per month
or $3,960,000 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 $590,000 which is sufficient to pay our operating expenses for
approximately 2 months. We do not have any arrangements for future financing. We 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, 2018 and December 31, 2019, we incurred net losses of approximately $2,100,000 and $4,000,000
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 favorable 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, 2018 and December 31, 2019, our revenues were $3,700,000 and $2,130,000, respectively, from
the sale of our products. For the years ended December 31, 2018 and December 31, 2019, we incurred net losses of $2,100,000
and $4,000,000.
Because
we lack historical financial data, including revenue data, our future revenues are unpredictable.
Our
operating expenses are presently approximately $330,000 per month or $3,960,000 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 $590,000 which is sufficient
to pay our operating expenses for approximately 2 months. 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, 2019, our total liabilities were approximately $2,900,000. 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. The Company now believes that it may
have defenses 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. However, if the Purchaser does seek to proceed against the Collateral, the Company’s
financial condition will be negatively affected and we may have to curtail our cease our operations altogether.
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 $1,800,000, $3,700,000 and
$2,100,000 for the years ended December 31, 2017, 2018 and 2019, 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;
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satisfying
existing customers and attracting new customers of our products and services;
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introducing
new products and services;
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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.
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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 four private label distributors, which represented 25%, 22%, 16%, and 10%, of our revenues
for the year December 31, 2019 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 four (4) private label customers which represented 25%, 22%, 16%,
and 10%, of our revenues for the year ended December 31, 2019. 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 $2,130,000 in 2019. 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 United States Food and Drug Administration’s (“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 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 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, 2019, product returns represented 1% 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 15.23% 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. Wards 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
The
Company is currently delinquent in its Reporting Obligations with the SEC and accordingly the Company currently has a “Pink
No Information” Stop Sign Symbol on OTC Markets.
Our
common stock is quoted on the OTC Pink No Information Tier of OTC Markets under the symbol, “NLBS” We are currently
labeled as “Delinquent SEC Reporting” and have a red stop sign next to our name on OTC Markets because the Company
has not filed all of its required periodic reports since we filed our Quarterly Report for the Quarter ended September 30, 2019,
which was filed with the SEC on November 14, 2019. We plan to make up all of our required periodic reports and become current
with our reporting obligations with the SEC so that our profile on OTC Markets can be updated accordingly to reflect Current Information
and remove the stop sign as well as the “Delinquent SEC Reporting” label. However, there can be no assurance
that we’ll be able to accomplish the foregoing as planned or at all.
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 March 19, 2021, we had 160,740,190 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 15.23% 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 March 19, 2021, we had 160,740,190 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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that
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.
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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.
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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.