ITEM 1. BUSINESS
Overview
We hold a license to plant cell replication technology and related proprietary equipment, processes, and formulations to produce, manufacture, and sell cannabis-related byproducts—sometimes referred in the industry as cannabinoids—exclusively in North and Central America and the Caribbean for medical, food additive, and recreational uses. Upon successful completion of a full-scale demonstration of the commercial viability of the technology, which we refer to as the “Efficacy Demonstration,” we intend to exploit this intellectual property through sublicenses with third parties that will incorporate the cell replication technology into production plants they fund and build to produce medical, food additive, and recreational cannabis-related products.
The licensed intellectual property is based on established bioscience principles and practices and has been bench-tested in the laboratory. However, it has not been scaled-up to produce cannabinoids in commercial quantities. Accordingly, our right to exploit the intellectual property through sublicenses is dependent on successful completion of the Efficacy Demonstration meeting requisite technical specifications, including equipment, processes, and formulations, for production in batches of a sufficient size in bioreactors in which specific cells are grown in a biologically active controlled and monitored environment within the proprietary production pods that could be replicated routinely to produce commercial quantities.
Our license was granted to us by Cell Science Holding Ltd., a corporation organized under the laws of the Republic of Cyprus (“Cell Science”), We issued 210,000,000 shares of common stock, which constituted about 69.97% of our issued stock as of July 31, 2020, to Cell Science in consideration of the original license agreement on December 20, 2018, which has subsequently been revised as discussed below. The number of shares issued is subject to reduction if the results of the Efficacy Demonstration show less than targeted results. In September 2020, we released 20,000,000 shares from possible reduction. Under our license as currently revised, we are obligated to pay to Cell Science a one-time fee of $3.5 million, less certain adjustments and credits, on a successful Efficacy Demonstration of the technology for an exclusive, fully paid license until the expiration of any patent rights included in the licensed technology for all of North America, including the Caribbean. See “Our Amended Restated License” below for a more complete discussion of the terms of our license from Cell Science.
The licensed technology describes a process to mirror, or replicate, precisely and predictably, the cannabinoid flavor, aroma, and CBD and THC potency qualities of the source plant’s cells without growing the plant. We do not now, and do not intend to, produce, transport, or sell cannabis or cannabinoids.
During 2019, all efforts to advance the Efficacy Demonstration were adversely affected due to the novel COVID-19 pandemic, which has caused and continues to cause delays, increased costs, and interrupted travel and, in general, to negatively impact testing efforts.
Our Amended Restated License
On December 20, 2018, we entered into Patent and Technology License Agreement, which was amended and restated effective December 31, 2019, which in turn was further amended on September 22, 2020 (the “Amended Restated License”) to license, with the right to sublicense, the described cell-extraction and replication technology and related proprietary equipment, processes, and medium formulations to be used in a commercially-sized bioreactor laboratory to produce, manufacture, and sell cannabis-related byproducts—sometimes referred in the industry as cannabinoids—exclusively in North and Central America, including the Caribbean for medical, food additive, and recreational uses. As consideration for the grant of the license, we issued 210,000,000 shares of common stock, subject to adjustment, and agreed to a one-time payment of $3.5 million, less amounts paid in the interim to Dr. Peter Whitten, the inventor, upon completion of the Efficacy Demonstration achieving target results. As a result of the issuance of these shares, Cell Science became our largest stockholder. See Item 12. Security Ownership of Beneficial Owners and Management Related Stockholder Matters and Item 13. Certain Relationships and Related Transactions.
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Under the Amended Restated License, we have an exclusive right to sublicense, on such terms as may be acceptable to us, the technology and the methods and processes, whose practice or use is covered by any of the valid claims set forth in a valid, unexpired patent for: (a) producing and manufacturing cannabinoids from a particular subspecies of cannabis plants and their byproducts for sale for food additives, edibles, and hemp variations; (b) cannabis-related research, teaching, and education for medical and recreational uses; and (c) all medical uses and applications. See “Patents” below for a description of the patents underlying the licensed technology. Cell Science retained the rights to publish scientific findings from our research, use the licensed science of medical care and research, and use the technology outside North America. We are obligated, either directly or through sublicensees, to use reasonably diligent efforts to produce, distribute, and sell cannabinoids using the licensed technology.
Our right to enter into sublicenses becomes effective under the Amended Restated License on the successful completion of an Efficacy Demonstration, under specified protocols and procedures, to assure the commercial viability of the technology in accordance with specified standards. The 190,000,000 of the 210,000,000 shares of common stock initially issued and the $3.5 million one-time payment will be reduced in proportion to the extent by which the Efficacy Demonstration falls short of the specified standards that the identified quantity of cannabis cells produced, harvested, and dried during the full production cycle contain at least 90% of the levels of THC and CBD as the donor cell and that the result is achieved at a projected utility and supplies cost of $0.10 per gram.
Any improvements to the licensed technology during the term of the Amended Restated License will be owned by Cell Science and will be included in our license. Cell Science may request that we negotiate a separate agreement to license any improvements that we develop to Cell Science.
We are responsible for developing and advancing costs for a patent prosecution, maintenance, defense, and protection strategy to maximize protection for the technology, including improvements, in North America. Cell Science is required to reimburse us for related costs incurred.
The technology license continues in effect for patented technology until the expiration of all issued patents and for technology not covered by patents in perpetuity, all unless terminated by either party for cause.
The above description is a summary only and is qualified in its entirety by the specific terms and conditions of the Amended Restated License, which is included and incorporated by reference as an exhibit to this report.
The Efficacy Demonstration Requirement
The Efficacy Demonstration is designed to confirm Cell Science’s claims that the licensed intellectual property can be used to produce a specified quantity of product with a specified quality at a specified cost. More specifically, the demonstration will seek to confirm that the proprietary science underlying the licensed intellectual property can be used routinely by qualified personnel in accordance with the prescribed specification for specialized equipment, suitable facilities, formulations, and processes to consistently, predictably, repeatedly, and economically produce commercial quantities of measurable THC (tetrahydrocannabinol) and CBD (cannabidiol) percentage levels over a combined cycle of 18 to 24 weeks. The process begins by dissecting from a cannabis plant donor cells with laboratory tested and third party verified THC and CBD levels. Those donor cells are then reproduced, first in flask volume and subsequently in a larger volume, to serve as a seed culture that can be loaded for the production cycle into a group of five 1,000-liter bioreactors that are:
(a)loaded from the same seed culture batch over a period not to exceed seven days;
(b)operated under the same temperatures, lighting, ventilation, vacuum, equipment calibration, drying times, temperature, and all other material specifications;
(c)harvested via membrane filtration to produce a liquid product concentrate;
(d)producing, after filtering and drying, at least 18 kilograms (approximately 39 pounds) of concentrate cells and media culture food and nutrients per bioreactor and 90 kilograms (approximately 198 pounds) for the five-bioreactor group;
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(e)with further processing, producing the volume of cannabinoids in kilograms per bioreactor harvest that mirror the same percentage of THC and CBD as the donor cell; and
(f)at a predictable cost of consumables, disposables, and utilities (excluding capital expenditures, labor, administrative, and operational expenses not directly related to the Cell Science process) of $0.10 per gram.
Tests are being conducted for successive groups of five bioreactors in the aggregate and separately for each bioreactor in the group. The testing process and commercial production, if testing is successful, require laboratory cleanroom conditions comparable to requirements applicable to medical device manufacturers and similar industries. Testing is conducted under the supervision of Dr. Peter Whitton, the inventor, and his associated technical team.
Possible Adjustment to License Consideration
Our obligation under the Amended Restated License to pay a one-time cash payment of $3.5 million, subject to certain credits, and release 190,000,000 shares of our common stock previously issued to Cell Science is subject to adjustment if the results of the Efficacy Demonstration fail to meet the agreed following standards:
(a)a quantity standard of harvested and dried cell concentrate equaling or exceeding both 90 kilograms (approximately 198 pounds) for two successive groups of five bioreactors each and 18 kilogram (approximately 39 pounds) of cells and media culture for each bioreactor in the group;
(b)a quality standard of cells produced, harvested, and dried during the full cycle of the process from each bioreactor harvest contain the targeted volume of cannabinoids expressed in kilogram that mirror the same levels of THC and CBD as the donor cells utilizing the formula: 18 times original THC/CBD percentage of donor plant equals the end product expressed in kilogram, with this result from each bioreactor and all five bioreactors of two successive groups of five reactors each affirmed by a third-party testing laboratory; and
(c)a cost standard of projected utilities and supplies plus actual material costs per bioreactor and for two successive groups of five bioreactors, excluding administrative and labor expenses, capital expenditures, or prorated leasehold expenses, of $0.10 per gram of THC/CBD.
Any shortfall in the achieving the quantity or quality standard or an overage above the cost standard will trigger a pro-rata reduction in the cash and common stock license consideration from us, recognizing that the failure to meet any standard may substantially reduce the commercial viability of the licensed intellectual property or render it commercially valueless.
The amount of the cash and common stock license consideration will be adjusted as follows: (i) the actual quantity produced in the test will be divided by 90 kilograms and the result weighted 10%; (ii) the actual concentration of the cannabinoids produced will be measured in kilogram, and this amount will be determined by the formula: 18 times original THC/CBD percentage of donor plant equals the end product of cannabinoids expressed in kilogram, for each bioreactor, and this efficacy target for concentration will be weighted 75%; and (iii) $0.10 per gram will be subtracted from the calculated cost per gram of the particular test and the difference divided by $0.10, weighted 15%. Test results will be verified by a third-party laboratory. The percentage resulting from arithmetic average of the above weighted results will yield the results for that test, and the resulting percentage of the cash and common stock license consideration will be adjusted as follows:
Percentage achievement of at least:
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100%
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90%
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80%
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70%
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60%
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50%
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Percent of cash and Common Stock:
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100%
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100%
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90%
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80%
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70%
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60%
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In applying the above, each bioreactor separately and all five bioreactors in a particular group as a whole must meet or exceed at least 50% of the applicable standard.
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If each bioreactor separately and all five bioreactors in a particular group meet or exceed at least 50% of the applicable tests, Cell Science may request the adjusted cash payment and share release and elect to extend the testing period for up to two successive 20-week periods to order to attempt to improve results.
All tests will be subject to verification by a qualified third-party testing laboratory selected by us, and we will supervise and bear the costs of verification.
Status of Efficacy Testing
The licensed intellectual property has been bench-tested in the laboratory but has not been scaled-up to produce cannabinoids in commercial quantities. Accordingly, our rights to exploit the intellectual property through sublicenses is dependent on successful completion of an Efficacy Demonstration meeting requisite technical specifications, including equipment, processes, and formulations, for production in batches of a sufficient size in bioreactors within the proprietary production pods that could be replicated routinely to produce commercial quantities.
OZ Corporation, an indirect principal stockholder of Cell Science, initiated the laboratory efficacy testing in early 2019 in a leased third-party laboratory that is licensed to handle cannabis in a facility in Van Nuys, California.
Dr. Peter Whitton, the technology’s principal inventor and our director, is supervising the testing and demonstration.
Initially, completion of the full-scale laboratory and launch of the testing process were hindered by logistical delays in sequential state inspection and permitting steps resulting from the COVID-19 pandemic. As a result, the laboratory did not become fully operational until October 2020.
Our filtration and drying systems have been tested and upgraded in capacity and are fully functional. Additionally, we have 10 fully functional proprietary bioreactors and growth pods that we are using for ongoing commercialization testing. While we will need ongoing retesting and fine-tuning of the variables involved, we are now able to trust the process and the accuracy of the results and make adjustments on the basis of those results without the need to account for non-sterile environmental conditions impacting the process, which we encountered initially. Specifically, the accomplishments made to our commercialization laboratory since our last update are as follows:
·Completed the laboratory and required parking lot improvements and passed all final inspections, a total of about 38 clearances.
·Completed and furnished the clean laboratory.
·Completed and finished the sterile laboratory.
·Completed the laboratory security system, alarm, and fire alarm systems.
·Upgraded the security barriers.
·Installed the back-up generator.
·Successfully negotiated the installation of a gas line feed, completing a five-month effort.
·Installed the medical air resource for the entire facility, switching from portable medical air supply to system-wide medical air with variable air feed pressure for each bioreactor.
·Redesigned the proprietary lid for the bioreactor.
·Completed 10 bioreactors, including temperature controls and related instrumentation.
·Upgraded the filtration capacity of the membrane filtration equipment.
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·Fine-tuned the concentrate drying process in the vacuum-assisted drying ovens.
·Completed three full-scale runs of the bioreactors.
·Sourced the chemicals for the media culture batches for the next 40 bioreactor tests, which were unable to be obtained at the onset of COVID-19 because they had not been classified as essential.
·Updated the Efficacy Demonstration to include an extra process step to reduce bioreactor output to pure cannabinoid concentrate.
·Successfully created and grew seed cultures in quantity to “seed” the first phase of the efficacy tests.
·Began preparation of the U.S. and Canadian licensing compliance documents.
Once the testing and production results are complete, we will seek verification of the results by a third-party accredited laboratory.
In the course of the laboratory work on the efficacy testing, features of new proprietary equipment, processes, and medium formulations may have been created that may be suitable for patent protection are included in the licensed intellectual property. Appropriate international patent applications are now being prepared in the name of Cell Science. In addition to patent protection, where applicable, these patentable features and know-how will be covered under our Amended Restated License.
Proposed Sublicensing Program
As noted, upon a successful Efficacy Demonstration, we intend to sublicense third parties to use the licensed technology and related proprietary equipment, processes, and medium formulations to produce, manufacture, and sell cannabinoids. We do not now, and do not intend to, produce, distribute, or market cannabis or cannabis products.
We intend to sublicense the licensed technology only to third parties that are legally engaged in the business of producing and manufacturing cannabis-derived products and byproducts for sale and use where permitted, including a cannabis concentrate powder product for the medical, food additive, and recreational cannabis consumption markets. The tested licensed technology is designed to produce both THC and CBD concentrates that mirror the “seed cell” with potency, after the final processing step of 90% pure cannabinoids.
We will seek sublicensees that have the requisite cannabinoid handling licenses and financial ability to scale-up commercially sized bioreactor labs capable of producing 60,000 pounds per annum of a predictable harvested cell product concentrate with reliable qualities and quantities.
We will be responsible for ongoing research and development costs and creating a licensing sales and support operation. Sublicensees will be required to fund production facilities construction, staffing, and operation. Thereafter, sublicensees will also be responsible for regulatory licensing, sales, and product distribution.
Sublicenses and Royalty Agreements
General
Upon successful completion of the Efficacy Demonstration, we will have the right to commercialize the technology for the commercial production of cannabinoids through sublicenses or joint ventures that will enable cannabis producers, distributors, and retailers to market a variety of cannabis-related products to medical and recreational markets. These sublicensing activities will be conducted either directly or through our subsidiary, CBD Biotech, Inc.
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Except for the initial sublicense discussed below, we are now screening a number of inquiries for possible sublicense arrangements for multiple locations in the United States and Canada, but are deferring negotiating definitive terms until the efficacy testing more nearly approaches completion on the expectation that we may be able to obtain terms more advantageous to us.
Sublicense with ICS
On April 17, 2020, through our subsidiary, we entered into a Strategic Alliance Agreement with Integrity Cannabis Solutions, Inc., a Florida corporation, or ICS, to collaborate: (i) to facilitate the building and operation of a commercial-scale production facility in Florida; and (ii) to enter into a sublicense.
We entered into the Sublicense Agreement on April 22, 2020, under which we granted to ICS the right to use the sublicensed technology to produce, manufacture, market, and sell CBD and related byproducts and derivatives having less than 3.0% measurable THC on a dry weight basis. The sublicense will become effective when the Efficacy Demonstration is complete with confirmed results demonstrating that: (a) the cannabinoid concentrates produced, harvested, and dried during a full cycle of the licensed technology process contain at least 90% of the measurable percentage levels of THC and CBD as the donor cells; and (b) this result is achieved at a project utility, production, and supplies cost of $0.10 per gram, or roughly $100 per kilogram.
ICS advises that it is proceeding to establish a clean production laboratory designed to produce 5,000 pounds of cannabinoid concentrate monthly in an 18,000-square-foot facility central Florida.
Under the sublicense, ICS is obligated to pay to us a continuing royalty equal to 8% of the wholesale product price sales revenue from the production of CBD raw product concentrate in the production facility using the sublicensed technology. The royalty payments are payable quarterly in arrears, beginning after the first quarter of commercial production. The production laboratory has not been completed, so we have not received royalties to date.
Sublicensee Support Services
We intend to provide our sublicensees with business and technical support to help them permit and build a commercial production laboratory to use our cell-extraction and replication technologies and related proprietary equipment, processes, and medium formulations. Our technical support will include component planning, such as:
·build out requirements—plans, permits, regulatory compliance, utilities;
·staffing plans, including in-house sales, science officer, compliance, pre-build advisory assistance, build-out advisory, equipment set-up, initial testing and laboratory certification advisory, first production cycle support;
·introduction to external resources—consultants, engineers, compliance, shipping/packing, distribution;
·installation of bioreactors and all support equipment;
·seed culture harvest from donor plants;
·seed culture growth cycle training;
·cell growth cultivation cycle training;
·filtering cycle training;
·drying equipment operation;
·concentrate distillation training;
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·initial product harvest and packaging training;
·internal and third-party laboratory testing contract review of services;
·sublicensees product to market options; and
·introduce “take away” contract candidates; and/or
·consulting to utilize the product in proprietary products under regulatory compliance.
Sources and Availability of Raw Materials
The completion of the Efficacy Demonstration is dependent on the availability of standard biological laboratory equipment and supplies. In some cases, existing available equipment has been significantly modified and customized to perform required tasks and procedures. Similarly, medium formulations have been developed from raw materials commercially available from multiple suppliers. The efficacy testing has not been materially impacted by the shortages or unavailability of equipment or supplies with the exception of the first four months of the pandemic. The lab currently has supplies in sufficient quality for over 40 individual bioreactor cycles.
Our sublicense of the cell-extraction and replication technology will not require the Company to obtain raw materials. We anticipate that sublicensees will be able to readily acquire or build the equipment and obtain the supplies necessary to construct and operate a commercial cannabinoid production facility to employ our sublicensed cell-extraction and replication technology without unusual costs or delays.
Patents
We license the following patent applications under our Amended Restated License. We do not currently own any other intellectual property.
Patents:
Application No.
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Title
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Filing Date
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Jurisdiction
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1717554.8
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A method of production of phytocannabinoids for use in medical treatments
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10/25/2017
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United Kingdom
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|
|
|
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16/290,708
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A method of production of phytocannabinoids for use in medical treatments
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3/1/2019
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United States
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Patents Cooperation Treaty Filing:
Application No.
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Title
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Filing Date
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Jurisdiction
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2018/077149
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A method of production of phytocannabinoids for use in medical treatments
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10/5/2018
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PCT
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The protection of proprietary rights relating to our licensed cell-extraction and replication technology is critical for the business. We intend to file additional patent applications to protect certain technology and improvements considered important to the development of the licensed technology and our business. We also intend to rely upon trade secrets, know-how, continuing technological innovation and licensing opportunities, and a comprehensive and robust confidentiality and nondisclosure discipline.
Although we intend to seek patent protection for additionally developed proprietary technology, the patent positions of our products are generally uncertain and involve complex legal and factual questions. Consequently, we do not know whether any current or possible future patent applications will result in the issuance of any patents or
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whether such patent applications will be circumvented or invalidated. We cannot assure that all U.S. patents that may pose a risk of infringement can or will be identified. If we are unable to obtain licenses where we may have infringed on other patents, we could encounter delays in product market introductions while attempting to design around the intellectual property rights, or we could find that the development, manufacture, or sale of products requiring the licenses could be prevented. In addition, we could incur substantial costs in defending suits brought against us on important intellectual property rights or prosecuting suits that we bring against other parties to protect our intellectual property rights. Competitors or potential competitors may have filed applications for, or received, patents and obtained additional patents and proprietary rights relating to, compounds or processes competitive with those covered under the Amended Restated License.
We rely on the patented and unpatented trade secrets, and we cannot assure that we can meaningfully protect our rights to them or that others will not independently develop substantially equivalent proprietary information and techniques or otherwise gain access to or disclose our trade secrets and technology. We routinely require each of our personnel, consultants, and advisors to execute confidentiality agreements. We cannot assure, however, that these agreements will provide meaningful protection in the event of unauthorized use or disclosure of such information.
We do not believe that any of patents or other proprietary rights that we license infringe upon the rights of third parties. However, we cannot assure that others may not assert infringement claims against us in the future, and we recognize that any such assertion may require us to incur legal and other defense costs, enter into compromise royalty arrangements, or terminate the use of some technologies. Further, we may be required to incur legal and other costs to protect our proprietary rights against infringement by third parties.
Research and Development
We had no research and development expenditures during the fiscal the years ended July 31, 2020 and 2019, respectively.
Market
According to trade journals, business news following the cannabis industry worldwide, and public company information available for Canadian companies and U.S. companies domiciling in Canada, the average cost, reported by the industry, including both private and public companies, to grow cannabis flower and trim in an inside-grow facility in California is approximately $800 to $950 a pound, without capital expenses or taxes, and approximately $420 a pound in a typical California greenhouse grow. The end-product flower, before taxation, depending on the state and the strain, is selling for $1,200 a pound to over $4,000 a pound.
We believe that the combination of the licensed technology and process holds promise to deliver a high-quality cell culture concentrate at costs below $250 per pound in a commercially scaled laboratory, which is approximately one-third the capital expense cost of a comparable greenhouse grow facility.
Competition
We believe that competition in the commercial cannabinoid industry is based primarily on price per unit and predictable and replicable quality in terms of taste, aroma, and CBD or THC concentration.
Cost is a function of both amortization of required capital costs and operating expenses. Based on the efficacy testing to date, we believe that capital costs for our cell-extraction and replication production facilities will compare favorably to capital costs required for an open-grow greenhouse or inside grow or hydroponic production facility of similar capacity. Similarly, we project lower per unit of production operating costs for cell-replicated production than open-grow greenhouse or hydroponic production facilities. Our estimates are financial approximations of the economic effects derived during the efficacy testing and we cannot assure their accuracy.
Another principal competitive factor is the replicable and predictable ability of our cell-extraction and replication technology to produce cannabinoids with flavor, aroma, and CBD or THC concentration that accurately mirrors the source cells.
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These criteria are part of the technical requirements that must be satisfied for a successful Efficacy Demonstration. A part of this quality consistence and assurance is that laboratory-produced cannabinoids are free of pests, blights, and varied “flower potency” harvests common to the current live grow industry.
We believe the value to potential sublicenses will be dependent on their ability to scale the application of the technology and trade secret processes in production laboratories at the same or lower capital and operating costs than approaches common to the industry for outside, greenhouse, inside or hydroponic grown live plants.
We consider anyone producing THC and CBD to be a competitor. MedMen and Curaleaf, for example, have first-mover advantage. MedMen, headquartered in Culver City, California, is engaged in the Clone-to-Product cannabis business with operations for cultivation and retail paired up in California and eight other U.S. states. Curaleaf, a Connecticut company, backed by Blackstone Partners and other investors, is the third largest cultivator and dispensary owner in the U.S. market. It recently acquired Grass Roots for $875 million and Cura Partners for over $1 billion. These companies have been in the market for many years and have significant resources and market share. There are numerous small, new entrants into the cannabis growing industry that, together with the industry leaders, present a large, diversified, well-funded, and capably managed array of competitors. Many of the firms with which we will compete have large financial and management resources and established positive industry reputations, distribution channels, customer relationships, operating histories, and reputations. We cannot assure that we will be able to compete effectively.
Government Approvals and Regulation in the U.S. Cannabis Industry
Legislation and Interpretation
Thirty-three states and the District of Columbia currently have laws broadly legalizing cannabis in some form for either medicinal or recreational use. However, cannabis is a Schedule I drug under the Controlled Substances Act of 1970, or CSA, and is therefore illegal under federal law. The U.S. Supreme Court has ruled that the federal government has the right to regulate and criminalize the sale, possession, and use of cannabis, even for medical purposes. Thus, even where cannabis has been legalized under state law, its use, possession, or cultivation remains a violation of federal law.
The U.S. Department of Justice, or DOJ, stated that Schedule I controlled substances are “the most dangerous drugs” with “potentially severe psychological or physical dependence.” If the federal government decides to enforce the CSA, those charged with distributing, possessing with intent to distribute, or growing cannabis could be subject to fines of up to $50 million or prison sentences up to life, even if they are in compliance with state law. Further, individuals and entities may violate federal law if they intentionally aid and abet another violator or conspire to do so.
We have not requested or obtained any opinion of counsel or authority ruling to determine whether our operations are in compliance with any state or federal laws or if we are assisting others to violate said laws. If our operations are deemed to violate any state or federal laws or if we are deemed to be assisting others in violating said laws, any resulting liability could cause us to modify or cease our operations.
In light of the conflict between federal and state cannabis laws, in August 2013, under the Obama administration, DOJ Deputy Attorney General James M. Cole issued the Cole Memorandum to U.S. Attorneys providing guidance concerning marijuana enforcement under the CSA. It effectively stated it was not an efficient use of federal resources to direct federal law enforcement agencies to prosecute individuals following state laws that allow medical cannabis. The Cole Memorandum stated that when states have implemented strong and effective regulatory and enforcement systems to control the cultivation, distribution, sale, and possession of cannabis, conduct in compliance with those laws is less likely to threaten federal priorities and that state and local law enforcement and regulatory bodies should remain the primary means of addressing cannabis-related activity.
In January 2018, under the Trump administration, the DOJ issued a policy memorandum on federal marijuana enforcement announcing a return to the rule of law and rescinding previous guidance documents, including the Cole Memorandum. In this memorandum, Attorney General Jeff Sessions directed U.S. Attorneys to determine whether to pursue prosecution of cannabis activity based upon the seriousness of the crime, the deterrent effect of criminal prosecution, and the cumulative impact of particular crimes on the community. The DOJ claims this is a return of trust
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and local control to federal prosecutors who know where and how to deploy federal resources most effectively to reduce violent crime, stem the tide of the drug crisis, and dismantle criminal gangs. Mr. Sessions reiterated that the cultivation, distribution, and possession of marijuana continues to be a crime under the CSA, that “it is the mission of the DOJ to enforce the laws of the United States,” and that all U.S. Attorneys should use previously established prosecutorial principles to disrupt criminal organizations, tackle the growing drug crisis, and thwart violent crime across our country. Notwithstanding the change in guidance, year-end reports on the federal judiciary indicate that federal marijuana prosecutions dropped in both 2018 and 2019, even as the total number of defendants charged with drug crimes increased. Nevertheless, the DOJ could decide to strongly enforce the federal laws applicable to cannabis, causing us significant or irreparable financial damage.
Congress possesses broad authority to change the status of cannabis under the CSA and related federal laws. In each budget cycle since 2014, Congress has passed an appropriations rider, known as the “Rohrabacher-Blumenauer Amendment,” barring the DOJ from using taxpayer funds to prevent states from implementing their own laws that authorize the use, distribution, possession, or cultivation of medical marijuana. This amendment does not change the legal status of cannabis, prevent criminal liability, or effect recreational marijuana. It must be renewed each fiscal year in order to remain in effect, and if Congress repealed the rider, the DOJ could prosecute CSA violations retroactively while the rider was in effect. On October 1, 2020, the amendment was renewed and is effective through December 11, 2020. The U.S. Court of Appeals for the Ninth Circuit held in 2016 that the Rohrabacher-Blumenauer Amendment, in the opinion of the court, also prohibits the DOJ from spending funds from other relevant appropriations acts to prosecute individuals who engage in conduct permitted by state medical-use cannabis laws and who strictly comply with said state laws. This opinion applies only to states within the Ninth Circuit in the western United States.
On December 20, 2018, President Trump signed the Agriculture Improvement Act that removes hemp, a member of the cannabis family, from being considered a Schedule I controlled substance under the CSA if it contains less than 0.3 percent THC. Hemp cultivation is now broadly permitted. It is unknown however if other cannabis derivatives will be federally legalized.
If the federal government were to strictly enforce federal law regarding cannabis and its chemically active compounds, we would likely be unable to execute our business plan. Even if our activities do not interfere with any of the enforcement priorities of the DOJ, we could be seen as violating federal law and be unable to conduct our business.
Financial Transactions and Future Laws
Financial transactions involving cannabis-related proceeds may trigger prosecution under federal money laundering statutes, unlicensed money transmitter statutes, and the Bank Secrecy Act, or “BSA.” The penalties for violations of these laws include imprisonment, substantial fines, and forfeiture. With the rescission of the Cole Memorandum, there is increased uncertainty and added risk that federal law enforcement authorities could seek to pursue money laundering charges against entities or individuals engaged in supporting the cannabis industry.
In response to the Cole Memorandum, in February 2014, the Financial Crimes Enforcement Network, a division of the U.S. Department of the Treasury, issued guidance regarding how financial institutions can provide services to cannabis-related businesses consistent with their obligations under the BSA. In August 2014, the DOJ further directed federal prosecutors to consider the federal enforcement priorities in the Cole Memorandum when determining whether to charge institutions or individuals with financial crimes based upon cannabis-related activity. Nevertheless, banks remain hesitant to offer banking services to cannabis-related businesses. Thus, it is difficult for businesses in the cannabis industry to establish banking relationships. Although we do not produce, transport, or sell cannabis or its products, financial institutions may refuse to do business with us based on their conclusion that our activities are intertwined with the cannabis industry. Our inability to maintain our current bank accounts would make it difficult for us to operate our business, increase our operating costs, and pose additional operational, logistical, and security challenges that could result in our inability to implement our business plan.
The BSA requires us to report currency transactions over $10,000 to the IRS, including identification of customers by name and social security number. The BSA also requires us to report certain suspicious activity, including any transaction over $5,000 that we suspect may involve funds from illegal activity or is designed to evade federal regulations or reporting requirements, and to verify sources of funds. Substantial penalties can be imposed
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against us if we fail to comply with this regulation, which could have a material adverse effect on our business, financial condition, and results of operations. These BSA requirements may adversely affect us because many of the firms with which we may do business rely on cash transactions because of their inability to establish regular banking relationships.
Federal prosecutors have significant discretion, and we cannot ensure that federal prosecutors in the judicial districts in which we operate will not choose to strictly enforce federal cannabis laws. Any change in the federal government’s enforcement posture respecting state-licensed cultivation of cannabis or its chemical components, including the postures of individual federal prosecutors, may result in our inability to execute our business plan, and we would likely suffer significant losses, which would adversely affect our securities.
Should the federal government legalize cannabis for medical use, it is possible that the U.S. Food and Drug Administration, or “FDA,” would seek to regulate it under the Food, Drug and Cosmetics Act of 1938. Additionally, the FDA may issue rules and regulations including requirements to use certified good manufacturing practices related to the growth, cultivation, harvesting, and processing of medical cannabis. Clinical trials may be needed to verify efficacy and safety. It is also possible that the FDA would require that facilities where medical cannabis is grown be registered with the FDA and comply with certain federally prescribed regulations. If these regulations were imposed, we do not know what the impact would be on the cannabis industry generally and on us specifically and what costs, requirements, and prohibitions may be enforced. If our sublicensees are unable to comply with the regulations or registration as prescribed by the FDA, such sublicensees may be unable to continue to operate their businesses in the U.S. markets.
Local and state marijuana laws and regulations are broad in scope and subject to evolving interpretations, which could require us or our sublicensees to incur substantial costs associated with compliance or altering our business plan. Allegations or findings that we have violated these laws could disrupt our business and result in a material adverse effect on our operations. In addition, future regulations may be enacted that are directly applicable to our proposed business. We cannot predict the nature of any future laws, regulations, interpretations, or applications, nor can we determine what effect they may have on our business.
Costs and Effects of Compliance with Environmental Laws
We do not anticipate that our future business activities will subject us to any environmental compliance regulations.
However, the operations of our sublicensees may be subject to environmental regulation in the various jurisdictions in which they operate. These regulations mandate, among other things, the maintenance of air and water quality standards and land reclamation. They also set forth limitations on the generation, transportation, storage, and disposal of solid and hazardous waste. The processes and media formulations that are parts of our licensed technology must be applied, used, and discarded in accordance with these requirements. Environmental legislation is evolving in a manner that will require stricter standards and enforcement, increased fines and penalties for noncompliance, more stringent environmental assessments of proposed projects, and a heightened degree of responsibility for companies and their officers, directors, and employees. We cannot assure that future changes in environmental regulation, if any, will not adversely affect the operations of a sublicensee, which in turn will affect our operations.
Government approvals and permits are currently and may in the future be required in connection with the operations of our sublicensees. To the extent such approvals are required and not obtained, our sublicensees may be curtailed or prohibited from production of adult-use or medical cannabis-related products, delaying the development of our operations as currently proposed.
Failure to comply with applicable environmental laws and regulations could subject our sublicensees to regulatory or agency proceedings or investigations and may result in enforcement actions thereunder, including orders issued by regulatory or judicial authorities causing operations to cease or be curtailed, and may include damage awards, fines, penalties, or corrective measures requiring capital expenditures or remedial actions. Our sublicensees may be required to compensate those suffering loss or damage by reason of their operations using our technology and civil or criminal fines or penalties may be imposed for violations of applicable laws or regulations.
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Employees
As of July 31, 2020, our president and director was our only employee, although we intend to hire additional personnel as we grow and develop our business. National unemployment has recently spiked and is currently at rates far in excess of historic national averages; however, a significant amount of competition still exists for skilled personnel in the medical cannabis-related industry. Nevertheless, we expect to be able to attract and retain additional employees as necessary, commensurate with the anticipated future expansion of our business. Further, we expect to continue to use consultants, contract labor, attorneys, and accountants as necessary.
Our Organization
We were organized in Nevada on April 24, 2008, under the name Planet Resources, Corp., to reprocess mine tailings from previous mining operations. We were not successful in implementing this business plan. Previous management considered various alternatives to ensure our viability and solvency, but those efforts were unsuccessful, and we had no activities between April 2011 and June 2018. In order to revive our company, a receiver was appointed in a Nevada state court proceeding in August 2015. We were released from receivership in July 2018.
On May 15, 2018, we privately sold 335,000 shares of restricted common stock, which constituted about 56% of our issued common stock, at $1.00 per share to OZ Corporation for consulting services. OZ Corporation appointed new management and directors. Further, on August 8, 2018, we issued four shares of newly authorized Series A Preferred stock to OZ Corporation in consideration of consulting services. On November 6, 2020 the four shares of Series A Preferred stock were transferred to Cell Science Holdings Ltd. This shares of Series A Preferred Stock has super voting rights that enable the holder to control the election of our board of directors and, ultimately, our direction. See Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Following the above change in control, we embarked on a new business plan to license and commercialize cell-extraction and replication technologies, primarily for medical products for pain relief and insomnia. These efforts lead to our initial license agreement with Cell Science that we entered in December 2018 for exclusive rights to certain patents and intellectual property and associated technical information respecting the production of cannabinoids for use in medical treatments in North America, including the Caribbean. In consideration of the grant of this license, we agreed to issue 210,000,000 shares of our common stock to Cell Science. As discussed in this report, that original license agreement has since been amended and revised as the Amended Restated License.
ITEM 1A. RISK FACTORS
Investment in our common stock involves significant risk. You should carefully consider the information described in the following risk factors, together with the other information appearing elsewhere in this report, before making an investment decision regarding our common stock. If any of the events or circumstances described in these risks actually occur, our business, financial conditions, results of operations, and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price of our common stock could decline, and you may lose all or a part of your investment in our common stock.
Risks Related to the COVID-19 Pandemic
The COVID-19 global pandemic has had an adverse effect on our operations and the potential commercialization of the licensed intellectual property.
On March 11, 2020, the World Health Organization characterized COVID-19 as a global pandemic. We are monitoring the situation closely and our response to the COVID-19 pandemic continues to evolve. Our current principal responsive measures include implementing a mandatory work from home policy when possible, restricting airplane travel, rescheduling inspections and clearances for required regulatory clearances and permits at the commercialization laboratory, delaying sublicense marketing efforts, and updating our planning for future events in recognition of the fact that potential sublicensees are likely experiencing similar operating difficulties. We are also evaluating the impact of the pandemic on required equipment, components, and supplies that we and potential sublicensees will require. We actively monitor COVID-19-related developments and may take further actions that
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alter our business operations as may be required by federal, state, or local authorities or that we determine are in the best interests of our personnel, sublicensees, vendors, and stockholders. The effects of these operational modifications will be reflected in current and future reporting periods.
For us, the COVID-19 pandemic substantially delayed the efforts to put the Efficacy Testing laboratory in full service as we worked to complete regulatory inspections and clearances, obtain necessary equipment and supplies, and assemble required international technical expertise, consultants, and personnel. These delays resulted in additional costs and delays in completing the planned testing and, in turn, submitting applications for required regulatory approvals. We are unable to launch our sublicensing program until the Efficacy Demonstration is substantially complete and required regulatory clearances are obtained.
The duration and magnitude of the COVID-19 pandemic impact on our business operations and overall financial performance are unknown at this time and will depend on numerous circumstances outside our control or the ability of anyone to predict accurately. The secondary and tertiary unpredictable economic effects on our business and on the worldwide economy could be quite adverse. The probability of reoccurrences of widespread or localized virus outbreaks is high and may continue for many months, likely resulting in further government-ordered lockdowns, stay-home or shelter-in-place orders and social distancing; restrictions on travel; and other extensive measures. Effective treatments for those infected by the virus and a possible preventive vaccine have not been developed and may not be widely accepted if they are developed in the future. We cannot predict the effect of these circumstances on us and our vendors, suppliers, and potential sublicensees; the global economy and political conditions; and the health of our personnel, consultants, and their families; all of which will affect how quickly and to what extent normal economic and operating activities can resume.
Even after the COVID-19 pandemic has subsided, we may continue to experience an adverse effect on our business as a result of its global economic impact, including any resulting and ongoing recession. All of these circumstances likely exert similar hardships on those with which we deal, such as vendors, shippers, distributors, and sublicensees. As a result, we have made adjustments to, and will need to continue to adjust, our business and expenditures in an effort to correlate our activities with business exigencies, including restrictions of executive and employee travel, hiring freezes or delays, and limitations on marketing. The ultimate financial impact and duration of all of the foregoing cannot now be predicted and may well exceed our expectations or our ability to cope with them.
Risks Related to our Business
Our entire business relies on the commercial-scale validation of our licensed cell-extraction and replication technology.
We plan to exploit our licensed cell-extraction and replication technology for the commercial production of cannabinoids through sublicenses to third-parties. Our ability to do so is conditional on a satisfactory Efficacy Demonstration. Therefore, our ability to launch our sublicensing efforts are dependent on an acceptable Efficacy Demonstration. If there is an acceptable Efficacy Demonstration and we timely pay the one-time cash payment and release the issued shares, as to be determined based on the results of the Efficacy Demonstration for our fully paid license in order to offer sublicenses, we cannot assure that the substantive results of the Efficacy Demonstration or their scientific credibility will be accepted by prospective sublicensee. Our sublicensing efforts will be dependent on our ability to convince prospective sublicensees that our licensed cell-extraction and replication technology warrants the required commitment or capital, expertise, and other resources. Even after a successful Efficacy Demonstration, initially there will be no established commercially operating facility using this technology successfully to support our sublicensing efforts.
We cannot accurately predict when a satisfactory Efficacy Demonstration can be completed.
We cannot accurately predict when the Efficacy Demonstration, which is critical to our continuity, can be completed. In addition to past and unforeseeable delays resulting from the ongoing COVID-19 pandemic, testing delays may result from scaling the previous laboratory work undertaken by the inventor to commercial size, transferring the inventor’s proprietary knowledge to testing personnel, refining processes and mediums, and fine-tuning other details of this complicated process we do not now foresee. Any delay in completing the Efficacy Demonstration or in meeting the applicable specifications would postpone the commencement of our business and our
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potential for revenue, which may require us to obtain additional capital to meet expenditures to sustain our operations. If an Efficacy Demonstration satisfactory to our board of directors cannot be completed timely, we may have to abandon efforts involving the cell-extraction and replication technology for cannabinoid production and seek other business opportunities or suspend operations. Consequently, we would be unable to recover previous costs related to these abandoned activities. We have no other technology or know-how to exploit commercially.
Our license from Cell Science may be terminated by it if we fail to meet certain covenants, which could adversely affect our sublicensing program and third-party sublicensees.
Under our Amended Restated License, after we pay the cash and release the common stock to obtain a fully paid license, we will continue to be obligated to pay certain patent prosecution and other intellectual property protection costs that could be substantial. We do not plan to establish or maintain any deposits or reserves in order to pay these costs. If we fail to meet these obligations, Cell Science could terminate our license. Under our Amended Restated License, Cell Science would then have the right to assume any outstanding sublicenses. If Cell Science assumed outstanding licenses, it would step into our position as licensee, precluding us from participating in further revenue from that sublicensee, notwithstanding our potential continuing liability for our sublicensee obligations to the sublicensee. The possibility that Cell Science, a foreign entity, may assume our obligations to our sublicensees may be a risk to potential sublicensees that has a material adverse effect on our sublicensing efforts. If Cell Science refused to assume our obligations to a sublicensee, the rights of the sublicensee would be subject to dispute, which would likely result in damages that the sublicensee would seek to recover from us. The existence of the right of Cell Science to terminate our license on which our sublicenses will be based may be considered a substantial risk to potential sublicensee and correspondingly impair the success of our sublicensing effort.
Acceptable completion of the Efficacy Demonstration will require us to pay to Cell Science a one-time payment of $3.5 million, subject to certain adjustments and credits, which we do not have.
If the Efficacy Demonstration is completed with results meeting prescribed criteria, we will be required to pay $3.5 million, subject to certain adjustments and credits, to Cell Science to obtain a fully paid, royalty-free license to the cell-extraction and replication technology. We do not currently have funds with which to pay this amount and do not have arrangements in place or commitments for such funding from any source. Our inability to make the payment would enable Cell Science to terminate the license on 60 days’ notice. In the event of termination, we would be unable to recover related costs incurred to date and would have to pursue other business opportunities or cease operations.
Our ability to attract and enter into sublicenses with producers, distributors, and sellers is uncertain.
Following an acceptable Efficacy Demonstration, we will need to identify and attract qualified, interested third parties to sublicense our cell-extraction and replication technology for cannabinoid production. We cannot assure that we will be able to successfully sublicense our new technology. We estimate that a new facility designed to produce about 5000 pounds of dry cannabinoid concentrate per month using our licensed technology for cannabinoid production will require a capital investment of from $3.9M to $4.6M by a sublicensee. We expect to encounter third-party reluctance to commit substantial capital to use our technology, which will at least initially be commercially untried by others. Accordingly, we cannot predict when or the pace at which we may be able to enter into sublicenses in order to generate revenue. We may be forced to delay anticipated business growth, seek other commercialization strategies, or obtain additional capital to continue.
We cannot assure that we will be able to transfer the required technical know-how respecting our licensed technology to enable sublicensees to commercially produce cannabinoids.
Our licensed cell-extraction and replication technology for cannabinoid production is relatively sophisticated and complex and requires scientific expertise in sterile production facility plant construction and operation, particularly as compared to traditional open-grown, greenhouse, or hydroponic production. We cannot assure that the licensed technology transfer and consulting strategies we plan to use will be effective in successful production facility operation by our sublicensees.
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Our long-term success will depend on the profitability of our sublicensees, which we cannot control or predict.
Our long-term success will depend on the success of our sublicensees and their ability to construct and operate commercial cannabinoid production facilities, market their products competitively, and achieve an overall, sustainable profit. The degree of commercial success and profitability of our sublicensees will affect our success in attracting sublicensees and the economic terms of our sublicenses. We cannot assure that our sublicensees will be successful, and so we may be required to adjust the terms of our existing or new sublicenses to include terms less favorable to us.
Others may challenge the validity and enforceability of the licensed patents, know-how, and related intellectual property.
Our future success is dependent on the validity and enforceability of the licensed patents, trade secrets, intellectual property, and related rights. Unauthorized parties may attempt to replicate or otherwise obtain and use the licensed intellectual property granted to us. Policing the unauthorized use of our current or future patents, trade secrets, intellectual property, or licensed rights and enforcing these rights against unauthorized use by others could be difficult, expensive, time-consuming, and unpredictable, as may be enforcing these rights against unauthorized use by others. Identifying unauthorized use of these rights is difficult as we may be unable to effectively monitor and evaluate the products being distributed by our competitors, including parties such as unlicensed dispensaries, and the processes used to produce such products. In addition, in any infringement proceeding, some or all of our trademarks, patents, other intellectual property rights, licensed rights, or other proprietary know-how, or arrangements or agreements seeking to protect the same for our benefit, may be found invalid, unenforceable, anticompetitive, or not infringed. An adverse result in any litigation or defense proceedings could put one or more of our trademarks, patents, other intellectual property, or licensed rights at risk of being invalidated or interpreted narrowly and could put existing intellectual property applications for patent protection at risk of not being issued. Any or all of these events could materially and adversely affect our business, financial condition, and results of operations.
In addition, other parties may claim that our products infringe on their proprietary and perhaps patent-protected rights. Such claims, whether or not meritorious, may subject us to significant financial and managerial resources, legal fees, injunctions, temporary restraining orders, or an award of damages. We may need to obtain licenses from third parties that allege that we have infringed on their lawful rights, which may not be available on terms acceptable to us or at all. In addition, we may not be able to use or obtain licenses or other rights for intellectual property that we do not own on terms that are favorable to us or at all.
Under our Amended Restated License with Cell Science, we are obligated to defend the licensed technology against third-party infringement. Therefore, we may be obligated to incur substantial legal, expert witness, and related litigation costs in any litigation that may be involved, whether initiated by us or a third party. We cannot assure that we would be able to recover any costs incurred by us.
The markets for cannabinoid products may not grow at the rate projected by industry market data or at all.
We partially base our long-term business model on the anticipated growth of demand for cannabis and cannabis-related products demand in North America, particularly in the United States, as a result of regulatory liberalization and growing social acceptance and use. We cannot assure that our projections, based on numerous assumptions and projected effects of future events, will materialize. Limitations or slowness in the increase of demand for cannabis and cannabis-related products in the United States would also limit our possible growth.
Our ability to successfully implement a sublicensing strategy does not assure our profitability.
We cannot assure that our strategy of sublicensing our technology to third-party cannabinoid producers, even if we enter into several or multiple sublicenses, will generate sufficient revenue to meet related costs and result in a profit. We will incur operating costs in marketing our technology, completing sublicense arrangements, providing technical and operational support to our sublicensees, and otherwise operating our business. We cannot assure that our sublicense revenue will offset these costs. We may not be profitable.
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The auditor’s reports for the years ended July 31, 2020 and 2019, contain an explanatory paragraph about our ability to continue as a going concern.
We have not generated revenue and have limited capital. We have incurred losses since inception resulting in an accumulated deficit of $15,724,678 as of July 31, 2020. Our auditors stated in their report on our audited financial statements that they have substantial doubt that we will be able to continue as a going concern without further financing. Our ability to continue as a going concern is dependent upon our ability to successfully accomplish our business plan and eventually attain profitable operations and obtain acceptable financing in the interim period.
We anticipate that any additional funding that we obtain will be in the form of equity financing from the sale of our common stock. However, we cannot assure that we will be able to raise sufficient funding from the sale of our common stock. The risky nature of our business enterprise places debt financing beyond the creditworthiness required by most banks or typical investors of corporate debt until such time as our products are available on the market. We do not have any arrangements in place for any future equity financing. If we are unable to secure additional funding, we will cease or suspend operations. We have no plans, arrangements, or contingencies in place in the event that we cease operations.
We have a limited operating history.
We were incorporated in 2008, but had little or no activity until we obtained license rights to cell-extraction and replication technology for commercial cannabinoid production in late 2018. However, its commercial efficacy has not been demonstrated, so we have not commenced sublicensing this technology to generate revenue. Therefore, we are subject to the risks common to early-stage enterprises, including undercapitalization, few personnel, limited financial and other resources, and lack of revenues. We cannot assure that we will be successful in achieving a return on our stockholders’ investments. Our likelihood of success must be considered in the light of our early stage of operations.
We have not generated any revenue since our inception, and we may never achieve profitability.
We are a development-stage company that has not generated any revenue. If the Efficacy Demonstration meets prescribed standards so we can launch our sublicensing effort, our expenses are expected to increase significantly before we can begin granting sublicenses and generating revenue. Even as we begin to market and sublicense our licensed technology, we expect our losses to continue as a result of ongoing sales and marketing expenses for the sublicenses, technology transfer costs, research and development expenses, and other operating expenses. These losses, among other things, have had and will continue to have an adverse effect on our working capital, total assets, and stockholders’ equity. Because of the numerous risks and uncertainties that we will encounter, we are unable to predict if or when we will become profitable. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. If we are unable to achieve and then maintain profitability, our business, financial condition, and results of operations will be negatively affected, and the market value of our common stock will likely decline.
We are a smaller reporting company, which reduces our reporting obligations.
We are currently a “smaller reporting company,” meaning that we are not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent company that is not a smaller reporting company and have a public float of less than $75 million and had annual revenues of less than $50 million during the most recently completed fiscal year. Because we are a smaller reporting company, the disclosure required in our SEC filings is less than it would be if we were not considered to be a smaller reporting company. Specifically, smaller reporting companies are able to provide simplified executive compensation disclosures in their filings; are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal control over financial reporting; are required to provide only two years of audited financial statements in annual reports; and have certain other decreased disclosure obligations in their SEC filings. Decreased disclosures in our SEC filings due to our status as a smaller reporting company may make it harder for investors to analyze our results of operations and financial prospects.
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Unsolicited takeover proposals may detract management and adversely affect our business.
The review and consideration of any takeover proposal may be a significant distraction for our management and personnel and could require the expenditure of significant time and resources by us. Moreover, any unsolicited takeover proposal may create uncertainty for our personnel that may adversely affect our ability to retain key personnel and to hire new talent. Management and employee distractions related to any such takeover proposal also may adversely impact our ability to optimally conduct our sublicensing program and otherwise advance our business and pursue our strategic objectives. An unsolicited takeover proposal may also create uncertainty for our sublicensees, suppliers, and other business partners, which may cause them to terminate, or not to renew or enter into, arrangements with us. The uncertainty arising from unsolicited takeover proposals and any related costly litigation may disrupt our business, which could result in an adverse effect on our business, financial condition, and results of operations.
We have, and may continue to have, a number of relationships with direct and indirect principal stockholders and their affiliates that are not, and will not be, the result of arm’s-length negotiations.
Our principal asset on which our business is based is a license for technology from Cell Science, our principal common stockholder. The efficacy testing is being undertaken on behalf of Cell Science by OZ Corporation, an indirect principal stockholder. Certain of our executive officers and directors have business or personal relationships with our direct and indirect principal stockholders. See Item 13. Certain Relationships and Related Transactions, and Director Independence. As a result of these relationships, the terms of the license on which our business is based, as well as other agreements or arrangements, between these parties and us were not the result of arm’s-length negotiations. However, by resolution adopted by our board of directors in September 2020, our board is required in the future to refrain from approving any transaction that is not in our best interests and is not on terms at least as favorable to us as could be obtained as a result of arm’s-length negotiations between unrelated parties in a similar situation. We have not adopted any other policy respecting decisions involving conflicts of interest and cannot assure that any such issues will be resolved solely in our favor.
We rely on key personnel and consultants.
Our success is dependent upon the ability, expertise, judgment, discretion, and good faith of our executive management and consultants and our ability to continue to attract, develop, motivate, and retain highly qualified and skilled personnel and consultants. Qualified individuals such as our president, Thomas Emmitt, and our principal technical consultants, Donald Clark, are in high demand, and we may incur significant costs to retain them. We rely on scientific advice from Dr. Peter Whitton, the inventor of the cell-extraction and replication technology on which our business is based, who has numerous other commitments and demands on his attention. The loss of the services of our executive management or consultants, or an inability to attract other suitably qualified persons when needed, could have a material adverse effect on our ability to execute our business plan and strategy, and we may be unable to find adequate replacements on a timely basis or at all.
We may incur product liability claims related to the application of the intellectual property we sublicense to cannabinoid producers.
As sublicensor of intellectual property for the commercial production of cannabinoids, we will face an inherent risk of exposure to third-party product liability claims, regulatory action, and litigation if our processes, procedures, or medium formulations are alleged to have caused significant loss or injury. In addition, the sale of products produced by a sublicensee using the sublicensed intellectual property involves the risk of injury to consumers due to product contamination or tampering by unauthorized third parties. Previously unknown adverse reactions could occur resulting from human consumption of such products alone or in combination with other medications or substances. We may be subject to various third-party product liability claims, including claims that the products produced using the licensed technology caused injury or illness, that such products did not include adequate warnings concerning possible side effects or interactions with other substances, or that the use of the licensed technology did not include adequate instructions for use.
A product liability claim or regulatory action against us could result in increased costs, adversely affect our reputation generally with existing or potentially new sublicensees, and have a material adverse effect on our results of operations and financial condition. We cannot assure that we will be able to obtain or maintain product liability
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insurance on acceptable terms or with adequate coverage against potential liabilities. Such insurance is expensive and may not be available in the future on acceptable terms or at all. The inability to obtain sufficient insurance coverage on reasonable terms or to otherwise protect against potential product liability claims could prevent or inhibit the commercialization of the sublicensees’ production of potential products and, therefore, the commercialization of the licensed technology.
Subsequent clinical or laboratory research on the characteristics of cannabinoids or their effect on the human body could adversely affect the commercialization of our licensed technology.
A variety of institutions worldwide are continuing clinical and laboratory research of the use and effects of cannabinoids. Future research, studies, and clinical trials may lead to conclusions that dispute or conflict with the current understanding and belief regarding the medical or recreational benefits, viability, safety, efficacy, dosing, and social acceptance of cannabinoids and the demand for the products produced by our sublicensees. Research in the United States and internationally regarding the medical benefits, viability, safety, efficacy, and dosing of cannabis or isolated cannabinoids such as CBD and THC remains in relatively early stages.
We cannot assure that the insurance coverage we obtain will be adequate.
We have or intend to obtain insurance to protect our assets, operations, directors, and personnel. While we believe our insurance coverage addresses and will address all material risks to which we are exposed and is adequate and customary for our operations, such insurance is subject to coverage limits and exclusions and may not be available for the risks and hazards to which we are exposed. In addition, we cannot assure that such insurance will be adequate to cover our liabilities or will be generally be available in the future or, if available, that premiums will be commercially justifiable. If we were to incur substantial liability and the damages were not covered by insurance or were in excess of policy limits, or if we were to incur liability at a time when we were not able to obtain liability insurance, there could be a material adverse effect on our business, financial condition, and results of operations.
We are also currently pursuing additional insurance coverage over our product liability claims and for business interruption. We cannot assure that we will be able to obtain desired insurance coverage on acceptable terms or at all. Any insurance coverage we maintain will be subject to coverage limits and exclusions and may not be available for the risks and hazards to which we are exposed.
As a technology provider for the cannabinoid industry, we would be adversely affected by negative public attitudes and consumer perception.
We believe the cannabinoid industry is highly dependent upon consumer perception regarding the safety, efficacy, and quality of cannabis and related products distributed to consumers. Consumer perception of the products produced by sublicensees using our licensed technology can be significantly influenced by scientific research or findings, regulatory investigations, litigation, media attention, informal social media exchanges, and other publicity regarding the consumption or use of cannabinoid products. We cannot assure that future scientific research, reports, findings, regulatory proceedings, litigation, media attention, or other publicity will be favorable to the cannabis market or any particular product or consistent with earlier publicity. Future research reports, findings, regulatory proceedings, litigation, media attention, informal social media exchanges, or other publicity that is perceived as less favorable than, or that questions, earlier research reports, findings, or publicity could have a material adverse effect on the demand for use of the licensed technology and consequently, our business, results of operations, financial condition, and cash flows. Negative publicity or public opinion may adversely affect consumer demand for cannabinoids produced and sold by our sublicensees, which would also adversely affect our ability to increase sublicenses that generate royalty revenues from sublicensees and our business, results of operations, financial condition, and cash flows.
Unfavorable publicity reports or other media attention regarding the safety, efficacy, and quality of cannabis and related products produced using the licensed technology or associating the consumption of cannabis or related products with illness or other negative effects or events could also have such a material adverse effect. Negative publicity reports or other media attention could arise even if the adverse effects associated with such products resulted from a sublicensee’s failure to use the licensed technology correctly or a consumer’s failure to consume or use the products appropriately or as directed. The increased usage of social media and other web-based tools to generate, publish, and discuss user-generated content and to connect with other users has made it significantly easier for
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individuals and groups to communicate and share opinions and views about us, our activities, or our licensed technology, whether true or not. Although we believe that we operate in a manner that is respectful to all stakeholders and that we take care in protecting our image and reputation, we do not ultimately have direct control over how we are perceived by others. Reputational loss may result in decreased investor confidence, increased challenges in developing and maintaining community relations, and an impediment to our overall ability to advance our projects, thereby having a material adverse effect on our financial performance, financial condition, cash flows, and growth prospects.
Third parties may refuse to do business with us if they perceive that we are too closely connected to the cannabis industry, with which they do not want to be associated.
Some firms with which we may want to transact business may perceive that we are too closely connected to the objectionable cannabis industry and refuse to deal with us. These third parties may perceive that doing business with us exposes them to reputational risk as a result of our business activities relating to cannabis, even though we are not engaged in the cultivation, production, manufacturing, or sale of cannabis-derived products. Failure to establish or maintain business relationships could have a material adverse effect on us.
Our business will be subject to failures or interruptions of information technology systems and cyber-attacks.
Our business will depend on information technology hardware, software, telecommunications, and other services and systems we obtain from third parties. Therefore, our operations depend, in part, on how well we and our suppliers protect networks, equipment, information technology systems, and software against damage from a number of threats, including damage to physical facilities, capacity limitations, natural disasters, intentional damage and destruction, fire, power loss, hacking, computer viruses, vandalism, and theft. Our operations also depend on the timely maintenance, upgrade, and replacement of networks, equipment, information technology systems, and software, as well as preemptive expenses to mitigate the risks of failures. Any of these and other events could result in information system failures and delays or increased capital expenses. The failure of information systems or a component of information systems could, depending on the nature of any failure, adversely impact our reputation and results of operations.
We are also subject to cyber-attacks or other information security breaches, and we cannot assure that we will not incur such losses in the future. Our risk and exposure to these matters cannot be fully mitigated because of, among other things, the evolving nature of these threats. As a result, we will prioritize cyber security and the continued development and enhancement of controls, processes, and practices designed to protect systems, computers, software, data, and networks from attack, damage, or unauthorized access. As cyber threats continue to evolve, we may be required to expend additional resources to continue to modify or enhance protective measures or to investigate and remediate any security vulnerabilities.
Ongoing domestic and international financial conditions will adversely affect our business and operations, the business and operations of our prospective sublicensees, the cannabinoid industry, and the world generally.
In recent years, global commercial and financial markets have experienced significant reoccurring disruptions, including severely diminished liquidity and credit availability, levels of sovereign and individual indebtedness, increased trade tariffs and barriers, declines in consumer confidence, declines in economic growth, increased unemployment, and uncertainty about economic stability. We cannot assure that significant deterioration in credit and financial markets, international trade, and confidence in economic conditions will not occur in the future. Any such economic downturn, volatile business environment, or continued unpredictable and unstable market conditions could have a material adverse effect on our business, financial condition, and results of operations.
Further, global credit and financial markets have displayed arguably increased volatility in response to global economic or political events. Future crises may be precipitated by any number of causes, including natural disasters, geopolitical instability, changes to energy prices or sovereign defaults. These factors may impact our ability to obtain equity or debt financing in the future and, if obtained, on terms favorable to us. Increased levels of volatility and market turmoil can adversely impact our operations and value, and the price of the common stock could be adversely affected.
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We cannot assure that we will be able to compete successfully.
We expect significant competition from other companies. We believe that competition in the commercial cannabinoid industry is based primarily on price per unit and predictable and replicable product flavor, aroma, and CBD or THC concentration. Price per unit of production will be based on the cost of amortizing capital expenditures and covering production and operating costs, and we cannot assure that production using our licensed technology will enable sublicensees to compete on these terms. Our principal known competitors include MedMen and Curaleaf, both of which have first-mover advantage and are well capitalized with experienced management and technical resources. A large number of companies appear to be applying for cultivation, processing, and sale licenses, some of which may have significantly greater financial, technical, marketing, and other resources than we have. These competitors may be able to devote greater resources to the development, promotion, sale, and support of their products and services, and may have more extensive customer bases and broader customer relationships. Our future success depends upon our ability to sublicense the licensed technology and generate an initial and continuing royalty stream. To the extent that we are not able to market and enter into enough sublicenses, our business, financial condition, and results of operations could be materially and adversely affected.
Risks of Related to Significant Regulation
The activities of our potential sublicensees are highly regulated by extensive and complex federal and state regulatory schemes that make maintaining compliance difficult and challenging.
The commercial cannabis industry is a relatively new industry, and we anticipate that regulations will constantly be changing as the federal government and each state monitors the applicable regulatory regime and commercial activity. Our technology sublicensees will be subject to a variety of laws, regulations, and guidelines relating to the production, manufacturing, management, transportation, disposal, storage, distribution, sales, use, health, and safety of cannabis and derived products and byproducts as well as laws and regulations relating to drugs, controlled substances, health, and safety. In addition, publicly held cannabinoid producers may be subject to other federal and state securities laws and the rules and regulations of self-regulatory organizations such as the exchanges on which their securities are traded.
Laws, regulations, and guidelines generally applicable to the cannabis industry domestically and internationally may change in unforeseen ways. New laws and changes to existing laws or regulatory schemes may adversely affect our sublicensees directly and us indirectly. Regulatory changes could reduce demand for cannabis-derived products and byproducts, decreasing the market for our sublicenses or potential royalty revenue, which would adversely affect our financial condition, results of operations, and prospects. Amendments to current laws, regulations, and permitting requirements, or more stringent application of existing laws or regulations, may have a material adverse effect on our sublicensees or us and our business, resulting in increased capital expenditures or production costs, reduced levels of production, or abandonment or delays in the development of facilities.
Our ability to sublicense our technology will depend on the ability of our sublicensees to maintain compliance with these laws and regulations. Delays of our sublicensees in obtaining, or failing to obtain, and maintaining the requisite regulatory approvals may significantly delay or negatively impair our sublicensing program.
We may incur ongoing costs and obligations related to regulatory compliance or assisting our sublicensees in their regulatory compliance. Failure to comply with applicable laws and regulations could result in regulatory or agency proceedings, investigations, and enforcement actions, including orders causing operations to cease or be curtailed and levying damage awards, fines, penalties, or corrective measures, all of which will require unanticipated capital expenditures or remedial actions. Parties may be liable for civil or criminal fines or penalties imposed for violations of applicable laws or regulations. The outcome of any regulatory or agency proceedings, investigations, audits, and enforcement actions could harm our sublicensees directly and us indirectly.
Strict enforcement of federal laws regarding cannabis would likely severely restrict our ability to execute our business plan.
Cannabis remains illegal under U.S. federal law. Even in those jurisdictions in which the manufacture and use of medical cannabis has been legalized at the state level, the interstate production, transportation, possession, sale,
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and use remain violations of federal law that are punishable by imprisonment, substantial fines, and forfeiture. Our sublicensees will be directly subject to these laws and regulations. Companies that are not engaged directly in the cultivation, production, manufacturing, or sale of cannabis or cannabis-derived products nevertheless may violate federal law if they intentionally aid and abet another in violating these federal controlled substance laws. Therefore, strict enforcement of federal laws regarding cannabis would likely result in our inability and the inability of our sublicensees to execute our respective business plans.
We and our sublicensees may have difficulty accessing the service of banks, which may make it difficult to sell our products and services.
Federal and federally insured state banks currently do not do business with those that grow and sell cannabis products on the stated ground that growing and selling cannabis is illegal under federal law. Financial transactions involving proceeds generated by cannabis-related activities can form the basis for prosecution under the federal statutes and the U.S. Bank Secrecy Act. Guidance issued by the Financial Crimes Enforcement Network, a division of the U.S. Department of the Treasury, clarifies how financial institutions can provide services to cannabis-related businesses consistent with their obligations under the Bank Secrecy Act. Furthermore, supplemental guidance from the U.S. Department of Justice (“DOJ”) directs federal prosecutors to consider the enforcement priorities enumerated in the so-called “Cole Memo,” issued on August 29, 2013, under the Obama Administration, when determining whether to charge institutions or individuals with any of the financial crimes based upon cannabis-related activity. However, in January 2018, under the Trump Administration, the DOJ issued a policy memorandum on federal marijuana enforcement announcing a return to the rule of law and rescinding previous guidance documents, including the Cole Memorandum. In this memorandum, Attorney General Jeff Sessions directed U.S. Attorneys to determine whether to pursue prosecution of cannabis activity based upon the seriousness of the crime, the deterrent effect of criminal prosecution, and the cumulative impact of particular crimes on the community. Understandably, banks remain hesitant to offer banking services to cannabis-related businesses, and those businesses involved in the cannabis industry continue to encounter difficulty establishing banking relationships. We cannot assure that we will be able to avoid being considered by financial institutions to be engaged in the cannabis industry, which would adversely affect our banking relationships. Our inability to maintain bank accounts would make it difficult for us to operate our business, increase our operating costs, and pose additional operational, logistical, and security challenges that could result in our inability to implement our business plan.
We are subject to certain federal regulations relating to cash reporting.
The Bank Secrecy Act requires us to report currency transactions in excess of $10,000, including identification of the customer by name and social security number, to the IRS. This regulation also requires us to report certain suspicious activity, including any transaction that exceeds $5,000 that we know, suspect, or have reason to believe involves funds from illegal activity or is designed to evade federal regulations or reporting requirements, and to verify sources of funds. We may be pressured by sublicensees to accept cash payments in view of the federal regulation of banks that restricts sublicensees’ access to banks. If we fail to comply with these laws and regulations, the imposition of substantial penalties could have a material adverse effect on our business, financial condition, and results of operations. Increasingly, foreign jurisdictions in which we may do business have similar regulatory schemes.
We or our sublicensees may be subject to compliance with laws and regulations governing cannabis in foreign jurisdictions.
Our ability to achieve our business objectives in foreign jurisdictions may be contingent, in part, upon our prospective sublicensees obtaining approval and complying with applicable regulatory requirements enacted by those governmental authorities. We cannot predict the effect to our business of foreign compliance regulations on our sublicensees in producing and manufacturing cannabis and derived products and byproducts; the length of time to secure appropriate regulatory approvals to use our licensing technology and process; or the extent of testing and documentation that may be required in those jurisdictions. Delays in obtaining, or failing to obtain, regulatory approvals may negatively affect the development of markets for our sublicenses and could have a material adverse effect on our business, financial condition, results of operations, and prospects.
We anticipate that we and our sublicensees will incur ongoing costs and obligations related to regulatory compliance. Failure by us or our sublicensees to comply with regulations may result in additional costs for corrective
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measures, penalties, or restrictions on our operations. In addition, changes in regulations, more vigorous enforcement thereof, or other unanticipated events could require extensive changes to our operations, increase compliance costs, or give rise to material liabilities, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
Prohibitions or restrictions from investing in or transacting business with companies in the cannabis industry may have an adverse effect on our operations.
Certain jurisdictions may prohibit or restrict their citizens or residents from investing in or transacting business with companies involved in the cannabis industry, even if such companies only conduct business in jurisdictions where cannabis is legal or the companies are not directly engaged in the cultivation, production, manufacturing, or sale of cannabis-derived products. For example, if an investor in the United Kingdom profits from an investment in a cannabis producer or supplier, or the use of technology is used in the production, the investment may technically violate the United Kingdom Proceeds of Crime Act 2002. Similar prohibitions or restrictions may apply in other jurisdictions where cannabis has not been legalized. In the United States, there have been certain instances of the U.S. Customs and Border Protection preventing citizens of foreign countries from entering the United States for reasons related to the cannabis industry.
We will rely on foreign advisors and consultants respecting local legal, regulatory, or governmental requirements or business practices.
The legal and regulatory requirements in the foreign countries in which we operate, or may operate, respecting the cultivation, production, manufacturing, and sale of cannabis and cannabis-related products by our intended sublicensees, as well as banking systems and controls and local business culture and practices, are different from those in the United States. Although members of our management may have previous experience working and conducting business in these countries, we may retain and rely on local consultants, advisors, legal counsel, and other expert professionals in order to keep apprised of legal, regulatory, and governmental developments as they pertain to our business, banking, financing, labor, litigation, and tax matters in these jurisdictions. Any changes in the local legal, regulatory, or governmental requirements or business practices are beyond our control and may adversely affect our business, financial condition, and results of operations.
We would suffer severe penalties and other consequences if our agents or personnel are found to be corrupt or to violate anti-bribery laws.
Our business is subject to U.S. laws that generally prohibit companies and personnel from engaging in bribery or other prohibited payments to foreign officials for the purpose of obtaining or retaining business. In addition, we are subject to the anti-bribery laws of any other countries in which we may conduct business. Even though our policies and procedures mandate compliance with these anti-corruption and anti-bribery laws, our personnel or other agents may, without our knowledge and despite our efforts, engage in prohibited conduct for which we may be held responsible. We cannot assure that our internal control policies and procedures will always protect us from recklessness, fraudulent behavior, dishonesty, or other inappropriate acts committed by our affiliates, personnel, contractors, or agents. If our personnel or other agents are found to have engaged in such practices, we could suffer severe penalties and other consequences that may have a material adverse effect on our business, financial condition, and results of operations.
Anticipated relaxation of regulatory restraints may not materialize.
Currently the market for THC cannabinoids in the United States is severely restricted by the federal regulatory position listing cannabis as a Schedule I controlled substance, which prohibits cannabis in interstate commerce, with attendant secondary and tertiary adverse effects. Accordingly, intrastate production, transportation, and sale of cannabis and cannabis-related products are regulated on a state-by-state basis. Although in recent years several states have changed their laws to legalize and tax cannabis and cannabis-related products for medical or recreational use, we cannot predict whether this trend will continue or whether the federal government will take similar action. We expect the disparity between federal and state cannabis legalization and regulation will continue. The continuation of the current regulatory regime may limit the commercialization of our licensed technology.
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Our business may be adversely affected by the environmental regulations and compliance related to the businesses of our sublicensees.
We do not anticipate that our future business activities will subject us to any direct environmental compliance regulations.
However, the operations of our sublicensees may be subject to environmental regulation in the various jurisdictions in which they operate. These regulations mandate, among other things, the maintenance of air and water quality standards and land reclamation. They also set forth limitations on the generation, transportation, storage, and disposal of solid and hazardous waste. The processes and media formulations that are parts of our licensed technology must be applied, used, and discarded in accordance with these requirements. Environmental legislation is evolving in a manner that may require stricter standards and enforcement, increased fines and penalties for noncompliance, more stringent environmental assessments of proposed projects, and a heightened degree of responsibility for companies and their officers, directors, and employees. We cannot assure that future changes in environmental regulation, if any, will not adversely affect the operations of a sublicensee, which in turn will affect our operations.
Government approvals and permits are currently and may in the future be required in connection with the operations of our sublicensees. To the extent such approvals are required and not obtained, our sublicensees may be curtailed or prohibited from production of adult-use or medical cannabis-related products, delaying the development of our operations as currently proposed.
Failure to comply with applicable environmental laws and regulations could subject our sublicensees to regulatory or agency proceedings or investigations and may result in enforcement actions thereunder, including orders issued by regulatory or judicial authorities causing operations to cease or be curtailed, and may include damage awards, fines, penalties, or corrective measures requiring capital expenditures or remedial actions. Our sublicensees may be required to compensate those suffering loss or damage by reason of their operations using our technology and civil or criminal fines or penalties may be imposed for violations of applicable laws or regulations.
We will be subject to Federal Trade Commission and state regulation of business opportunities in connection with our sublicensing activities.
We must comply with regulations adopted by the U.S. Federal Trade Commission, or FTC, and several state laws that regulate the offer and sale of business opportunities. The FTC and certain state laws require that we furnish prospective sublicensees with a business opportunity disclosure document containing information prescribed by the FTC rules and applicable state laws and regulations, including, for example:
·whether legal action has ever been taken against us;
·whether there is a cancellation or refund policy for the business transaction;
·any claims that the buyer (sublicensee) will earn a specific amount of money through the business opportunity; and
·references for our company.
We cannot assure that any disclosure document that we prepare and use will comply with the FTC rules and applicable state disclosure requirements. Our failure to meet applicable business opportunity requirements may expose us to regulatory sanctions and business interruptions while we bring disclosure into regulatory compliance and civil liability to sublicensees.
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Risks Related to our Common Stock
The market for our common stock is volatile.
The market price of our common stock may be volatile and subject to wide fluctuations in price and trading volume in response to numerous factors, many of which are beyond our control. This volatility may affect the ability of holders of our common stock to sell their securities at an advantageous price or at all.
Market price fluctuations in our common stock may be due to our results of operations or public releases failing to meet market expectations, negative news about us or the cannabis industry, adverse changes in general market conditions or economic trends, social media activity outside our control, or other material public announcements by us or others. Financial markets for the stock of smaller capitalized companies historically has experienced significant price and volume fluctuations that have often been unrelated to the operating performance, underlying asset values, or prospects of such companies. Accordingly, the market price of our common stock may decline even if our results of operations, underlying asset values, or prospects have not changed. We cannot assure that continuing fluctuations in price and volume of our common stock will not occur. If increased levels of volatility and market turmoil continue, our ability to obtain capital from external sources, the trading price of our common stock, and our operations could be adversely affected.
We will continue to be controlled by our principal stockholders.
Inter-M Traders FZ, LLE is currently the beneficial owner of 120,000,000 shares of common stock, representing 39.98% of our outstanding common stock, Mentone Ltd., is currently the beneficial owner of 90,000,000 shares of common stock, representing 29.99% of our outstanding common stock and OZ Corporation is currently the beneficial owner of 11,378,397 shares of common stock, representing 3.79% of our outstanding common stock. Cell Science, which is owned 40% by Inter-M Traders FZ, LLE, 30% by OZ Corporation and 30% by Mentone Ltd., owns four shares of Series A Preferred Stock, representing 100% of our outstanding Series A Preferred Stock. The super voting rights of the Series A Preferred Stock entitle it to voting power equivalent to four times the aggregate voting power of all other outstanding common and preferred stock outstanding, or 12,200,455,000 votes. Based on the number of shares currently outstanding, the holders of the Preferred Stock have 80% of all votes on all matters submitted to the stockholders for consideration, voting together as a single class, which enables Cell Science directly, and its controlling stockholders indirectly, to control the election of our directors and the approval or disapproval of all other matters, including mergers, the sale of all or substantially all of our assets, liquidation, and the adoption or amendment of provisions in our articles of incorporation and bylaws. See Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
We may issue common stock in the future, which may dilute a stockholder’s holdings in our company, including the investors in this offering, or have a negative effect on the market price of our stock.
We may sell equity securities (including convertible securities) in offerings, which may dilute a stockholder’s holdings in our company. Our articles of incorporation grant our board of directors’ discretion to issue, sell, and determine the price and terms of, additional common stock, including at prices less than the current market price per share. Our stockholders do not have preemptive rights. Moreover, additional common stock will be issued by us on the exercise of options under our stock option plan. Any transaction involving the issuance of common stock, or securities convertible into common stock, would result in dilution, possibly substantial, to our security holders, including the investors in this offering.
Sales of substantial amounts of our securities by us or our existing stockholders, or the availability of such securities for sale, could adversely affect the prevailing market prices for our securities and dilute an investor’s per-share earnings, if any. A decline in the market prices of our securities could also impair our ability to raise additional capital through the sale of securities should we desire to do so.
Limited trading volumes for our common stock may limit the ability of our stockholders to obtain liquidity.
Due to the limited trading volume for our common stock, our stockholders may be unable to sell any or large quantities of our common stock into the public trading market without a significant reduction in the price of their
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common stock. We cannot assure that there will be sufficient liquidity of the common stock on the trading market, and that we will continue to meet the listing requirements of any public listing exchange or quotation medium.
We do not anticipate paying dividends.
We do not have earnings from which to pay dividends and have no current intention to declare dividends, even if we were to become profitable. If we were to achieve earnings, any discretionary decision to pay dividends would depend on, among other things, our results of operations, current and anticipated cash requirements and surplus, financial condition, future contractual restrictions and financing agreement covenants, solvency tests imposed by corporate law, and other factors that our board of directors may deem relevant. Rather than pay dividends, we anticipate that we will retain earnings to fund expansion and growth.
The regulated nature of our business may impede or discourage a takeover.
Our business is subject to direct and indirect regulatory or licensing requirements that may not necessarily continue to apply to an acquirer of our business following a change of control. These licensing requirements could impede a merger, amalgamation, takeover, or other business combination involving us or discourage a potential acquirer from making a tender offer for common stock, which under certain circumstances could reduce the market price of the common stock.
Our status as a prior shell company adversely affects our stockholders under Rule 144.
On June 12, 2020, we filed a Current Report on Form 8-K reporting that we were no longer a “shell company,” as that term is defined in Rule 405 of the Securities Act of 1933, as amended (“Securities Act”) and Rule 12b-2 of the Securities Exchange Act of 1934, as amended (“Exchange Act”). On filing that Form 8-K, we completed our “Form 10 Information” showing that we had material assets and operations. This has a number of consequences, including making Rule 144 available to our stockholders for the resale of stock owned by them commencing June 12, 2021 (i.e. one year after Form 10 information was filed). Thus, until that date, Rule 144 will not be available for the resale of the securities issued before June 12, 2021.