ITEM
1. BUSINESS
Business
Overview
Novo
Integrated Sciences, Inc. (“Novo Integrated”) was incorporated in Delaware on November 27, 2000, under the name Turbine Truck
Engines, Inc. On February 20, 2008, the Company was re-domiciled to the State of Nevada. Effective July 12, 2017, the Company’s
name was changed to Novo Integrated Sciences, Inc. When used herein, the terms the “Company,” “we,” “us”
and “our” refer to Novo Integrated and its consolidated subsidiaries.
The
Company owns Canadian and U.S. subsidiaries which provide, or intend to provide, essential and differentiated solutions to the delivery
of multidisciplinary primary care and related wellness products through the integration of medical technology, interconnectivity, advanced
therapeutics, diagnostic solutions, unique personalized product offerings, and rehabilitative science.
We
believe that “decentralizing” healthcare, through the integration of medical technology and interconnectivity, is an essential
solution to the rapidly evolving fundamental transformation of how non-catastrophic healthcare is delivered both now and in the future.
Specific to non-critical care, ongoing advancements in both medical technology and inter-connectivity are allowing for a shift of the
patient/practitioner relationship to the patient’s home and away from on-site visits to primary medical centers with mass-services.
This acceleration of “ease-of-access” in the patient/practitioner interaction for non-critical care diagnosis and subsequent
treatment minimizes the degradation of non-critical health conditions to critical conditions as well as allowing for more cost-effective
healthcare distribution.
The
Company’s decentralized healthcare business model is centered on three primary pillars to best support the transformation of non-catastrophic
healthcare delivery to patients and consumers:
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First Pillar: Service Networks.
Deliver multidisciplinary primary care services through (i) an affiliate network of clinic facilities, (ii) small and micro footprint
sized clinic facilities primarily located within the footprint of box-store commercial enterprises, (iii) clinic facilities operated
through a franchise relationship with the Company, and (iv) corporate operated clinic facilities. |
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Second Pillar: Technology.
Develop, deploy, and integrate sophisticated interconnected technology, interfacing the patient to the healthcare practitioner thus
expanding the reach and availability of the Company’s services, beyond the traditional clinic location, to geographic areas
not readily providing advanced, peripheral based healthcare services, including the patient’s home. |
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Third Pillar: Products.
Develop and distribute effective, personalized health and wellness product solutions allowing for the customization of patient preventative
care remedies and ultimately a healthier population. The Company’s science-first approach to product innovation further emphasizes
our mandate to create and provide over-the-counter preventative and maintenance care solutions. |
Innovation
through science combined with the integration of sophisticated, secure technology assures us of continued cutting edge advancement in
patient first platforms.
First
Pillar – Service Networks for Hands-on Patient Care
Our
clinicians and practitioners provide certain multidisciplinary primary health care services, and related products, beyond the medical
doctor first level contact identified as primary care. Our clinicians and practitioners are not licensed medical doctors, physicians,
specialist, nurses or nurse practitioners. Our clinicians and practitioners are not authorized to practice primary care medicine and
they are not medically licensed to prescribe pharmaceutical based product solutions.
Our
team of multidisciplinary primary health care clinicians and practitioners provide assessment, diagnosis, treatment, pain management,
rehabilitation, education and primary prevention for a wide array of orthopedic, musculoskeletal, sports injury, and neurological conditions
across various demographics including pediatric, adult, and geriatric populations through our 17 corporate-owned clinics, a contracted
network of affiliate clinics, and eldercare related long-term care homes, retirement homes, and community-based locations in Canada.
Our
specialized multidisciplinary primary health care services include physiotherapy, chiropractic care, manual/manipulative therapy, occupational
therapy, eldercare, massage therapy (including pre- and post-partum), acupuncture and functional dry needling, chiropody, stroke and
traumatic brain injury/neurological rehabilitation, kinesiology, vestibular therapy, concussion management and baseline testing, trauma
sensitive yoga and meditation for concussion-acquired brain injury and occupational stress-PTSD, women’s pelvic health programs,
sports medicine therapy, assistive devices, dietitian, holistic nutrition, fall prevention education, sports team conditioning programs
including event and game coverage, and private personal training.
Additionally,
we continue to expand our patient care philosophy of maintaining an on-going continuous connection with our current and future patient
community, beyond the traditional confines of brick-and-mortar facilities, by extending oversight of patient diagnosis, care and monitoring,
directly through various Medical Technology Platforms either in-use or under development.
The
occupational therapists, physiotherapists, chiropractors, massage therapists, chiropodists and kinesiologists contracted, by NHL, to
provide occupational therapy, physical therapy and fall prevention assessment services are registered with the College of Occupational
Therapists of Ontario, the College of Physiotherapists of Ontario, College of Chiropractors of Ontario, College of Massage Therapists
of Ontario, College of Chiropodists of Ontario, and the College of Kinesiologists of Ontario regulatory authorities.
Our
strict adherence to public regulatory standards, as well as self-imposed standards of excellence and regulation, have allowed us to navigate
with ease through the industry’s licensing and regulatory framework. Compliant treatment, data and administrative protocols are
managed through a team of highly trained, certified health care and administrative professionals. We and our affiliates provide service
to the Canadian property and casualty insurance industry, resulting in a regulated framework governed by the Financial Services Commission
of Ontario.
Affiliate
Clinics
In
order to strengthen our position within the Canadian Preferred Provider Network (“PPN”), we’ve built a contracted affiliate
relationship with 115 clinics across Canada with 85 affiliate clinics in Ontario province and 30 affiliate clinics located throughout
Alberta, Nova Scotia and Newfoundland.
The
PPN is a network of three major insurance companies and their subsidiaries, totaling 16 insurance companies. PPN member insurance companies,
in need of specific multidisciplinary primary health care solutions for their patients, send referrals to specific clinics registered
through the PPN. We, as one of five major providers to the PPN, receive referrals through the PPN. This subset of business is a continuous
source of referrals, from the insurance company payer to the approved group of clinics meeting the insurance companies’ pre-determined
set of criteria for what they believe to be an appropriate clinical setting. Affiliate clinics pay us a mix of a flat fee and a percentage-based
fee upon receipt of a payment for a service referred through the PPN.
The
services provided by our affiliate clinics are consistent with the multidisciplinary primary health care services provided by our own
corporate clinics. While each affiliate clinic may provide additional unique health care solutions, all affiliate clinics must meet specific
criteria established under the PPN, creating a single standard of excellence across all clinics within our network.
LA
Fitness U.S. and Canada Micro Clinics
In
September 2019, through its U.S. subsidiary Novomerica Health Group, Inc. (“Novomerica”) and its Canadian subsidiary, Novo
Healthnet Limited, the Company entered into exclusive Master Facility License Agreements (“License Agreement”) to establish
and operate reduced footprint clinics, or “micro-clinics”, to provide outpatient physical and/or occupational therapy services
and related products within LA Fitness facilities in both the U.S. and Canada. In March 2020, as a result of guidelines issued by local,
state, federal, and provincial authorities due to the COVID-19 pandemic, LA Fitness U.S. and Canada closed all facilities nationwide.
As a result, all contractual terms and conditions of both our U.S. and Canada Master Facility License Agreements were placed on hold
through fiscal year 2021 with all parties expressing the intent to amend both the U.S. and Canada License Agreements and related timelines
to launch our LA Fitness micro-clinic facilities as “normal” activity resumes in the LA Fitness U.S. and Canada facilities.
On
December 15, 2021, NHL entered into an Amended and Restated Master Facility License Agreement (the “Amended and Restated Canada
License Agreement”) with LAF Canada Company (“LA Fitness Canada”). The Amended and Restated Canada License Agreement
had the effect of (i) removing NHL’s obligation to develop and open a certain number of facilities within certain designated time
periods; and (ii) revising the default provisions such that certain defaults will result only in termination with respect to a specific
facility, rather than of the license itself. As a result of the Amended and Restated Canada License Agreement, NHL may continue to develop
and open additional facilities for business.
We
cannot guarantee that the U.S. License Agreement will be amended to allow for an extension of its timeline. Currently, under both government
and internal corporate directives, LA Fitness continues to both open and expand operations, access and services offered in both its U.S.
and Canada facilities. Opening of our micro-clinic facilities may vary from state to state and province-to-province; however, our model
plan to partner and sub-license with existing local clinic ownership to launch and operate each of our LA Fitness micro-clinic facilities
remains intact. Due to the ever-changing conditions surrounding the operations of both U.S. and Canada based LA Fitness facilities, we
are unable to verify our schedule to commence opening our micro-clinics, but we are tentatively planning on a target of the latter part of 2023.
Eldercare
The
Company’s eldercare related operations provide physiotherapy (“PT”), occupational therapy (“OT”), assessment
and application assistance for assistive devices, fall prevention programs, community-based strengthening and general flexibility exercise
classes, rehabilitative strategies and continuing education to eldercare clients, including caregivers and family members as applicable,
in various long-term care homes, retirement homes and community-based locations across the province of Ontario, Canada.
As
a result of NHL’s September 2013 asset acquisition of Peak Health LTC Inc, an Ontario corporation formed in 2006, NHL has more
than 15-years’ experience of providing certain multidisciplinary related healthcare services and products to the eldercare community.
In 2017, based on the philosophical overlap and synchronicity between PT and OT, NHL launched its occupational therapy sector of services
for our eldercare clients. NHL’s eldercare focused OT and PT services and product are in direct competition with the top providers
in this sector. We offer one of the most extensive rosters of OT and PT clinicians certified by the Ministry of Health for assistive
device assessment under the Assistive Device Program which, when the individual meets the criteria, allows our eldercare clients access
to significant funding subsidies to purchase varying mobility aids (such as walkers, wheelchairs, seating, and power wheelchairs/scooters).
Additionally,
our proprietary Electronic Rehabilitation Record and Management Reporting software solution provides us the ability to deliver each eldercare
location with a wide-array of detailed PT and OT reports that include, among other things: (i) client specific treatment details, (ii)
identifying cost and optimization possibilities, (iii) outlining a wide variety of client outcome measurements, (iv) analyzing overall
contract effectiveness, and (v) producing indicators which assist the NHL team to target opportunities for improved team efficiency.
This software comes with an ability to provide a graphically illustrated ‘report card’ for contribution to annual, interdisciplinary
care conferences with staff and family members, as well as fall reporting capacities, which are central to many homes’ fall prevention
committee meetings. Additionally, data generated by the software allows members from both the NHL team and the eldercare facility team
to identify residents who fall frequently and allow for the inter-disciplinary team to put strategies in place to better reduce a resident’s
“fall-risk”.
NHL
has created and delivers, through online virtual technology, a variety of eldercare related educational in-service programs which include
topics such as nursing restorative education, back education and other eldercare-relevant topics such as osteoporosis, fall prevention,
wheelchair positioning, and least restraints. NHL has designed its virtual online education in-service programs and modules to be presented
in a variety of formats to facilitate the different capacity and styles of learning common to senior-aged individuals.
Our
eldercare PT services are provided as follows:
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Long-Term Care Homes.
NHL contracts with long-term care homes to provide individualized, onsite PT and group exercise classes for its residents. Registered
physiotherapists are assisted by on-site support personnel to deliver individualized care, based on assessed needs, and with a goal
of assisting each resident to attain and maintain their highest level of function possible with their activities of daily living.
These services are primarily funded by the Ontario Ministry of Long-Term Care (“MLTC”). The NHL team assists in providing
assistive device assessments allowing residents access to funding assistance for varying mobility aids (such as walkers, wheelchairs,
seating, and power wheelchairs/scooters). In addition to providing PT services, our team assists the long-term care home’s
interdisciplinary team in the homes’ annual care conferences with its residents. Through the provision of education regarding
nursing restorative programming, our team assists the long-term care home’s team in back education, fall prevention and many
other subjects related to PT or physical health and wellness. The NHL team works together with the interdisciplinary team to assist
with mandatory coding of Canada’s Resident Assessment Instrument Minimum Data Set (“RAI-MDS”) which is the standardized
assessment tool required for the home to access payment from the MLTC for each resident. Additionally, through NHL’s proprietary
software, the homes have access to abundant reporting solutions to help provide objective and quantitative measures for their continuous
quality improvement program. NHL’s proprietary software provides our eldercare client locations with the unique ability to
login and access multiple data points related to a multitude of therapy services provided to its residents, allowing for detailed,
rapid reporting and accountability. |
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Retirement Homes.
We contract with client retirement homes to provide individualized PT and group exercise classes to the retirement homes’ residents.
Registered physiotherapists are assisted by the onsite support personnel to deliver individualized care based on assessed needs,
again with a goal of assisting the residents participating in therapy to attain and maintain their level of function related to the
activities of daily living. These services are partially funded by the individual and partly funded by the MLTC. Similar to the long-term
care sector, our team assists with education of the nursing/interdisciplinary team, provides in depth service reports to the homes
to measure desired service delivery and our proprietary software allows for the retirement home to have the same unique login capacity.
In addition to the services above, some of the residents in the retirement homes, and as applicable the resident’s family members,
can request and authorize receiving an increased level of physiotherapy related services available privately on a fee-for-service
basis paid by the individual. In addition, access to Registered Massage Therapists and Speech Language Pathologists is also offered
on a fee-for-service basis. |
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Community Based Home
Care Physiotherapy. Throughout the province of Ontario, the MLTC operates 14 Home and Community Care Support Services organizations
(“HCCSS”) which are health authorities responsible for regional administration of public health care services. The HCCSS’s
serve as contact points, information clearing houses, referral resources, and assessment / care coordinators for eligible residents
who need health care assistance at home or a safer place to live through aging at home strategies that can be put in place by health
care providers. Through service contracts, the HCCSS’s engage “cluster providers” to provide services to clients
living in the community, clients living at-home or clients living in a retirement home. These service contracts are funded by the
MLTC. |
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NHL is a “cluster
provider” sub-contractor for home care physiotherapy in the Northeast HCCSS which encompasses more than 565,000 people across
400,000 square kilometers and five sub-regions. Through this subcontract arrangement, we provide one-on-one physiotherapy assessment
and treatment to clients who cannot easily access outpatient services due to mobility challenges. Primarily, these clients are elderly
with multiple co-morbidities, although some clients are not elderly and are instead simply post-operative with mobility challenges. |
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Community Based Group
Exercise Classes & Fall Prevention Programs. NHL has contracted with 2 “cluster providers” to provide group exercise
classes and fall prevention programs (consisting of an assessment accompanied by education and group exercise classes) in 3 separate
HCCSS’s (Central, Toronto Central and Central East) which encompass the Greater Toronto area with an estimated aggregate population
of 4.4 million people. In 2013, the MLTC introduced several initiatives designed to assist seniors in maintaining an active and healthy
lifestyle while still living at home. Under the 2013 initiative, exercise instructors under contract with NHL, deliver group exercise
classes over a 48-week period each year. |
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In addition, another component
of the 2013 MLTC initiative is the delivery of fall prevention programs with entry and exit assessments completed by specialized
registered providers such as kinesiologists and physiotherapists with the assistance of exercise instructors for the group class
and education portion of the program. The goal of these classes is to assess seniors’ general health status, identify defined
levels of risk pertaining to balance and falling, and educate seniors about fall prevention through a combination of increased knowledge
and teaching exercises designed to improve strength and balance. |
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Community-based Outpatient
Clinics. NHL provides outpatient physiotherapy, chiropractic, and laser technology services through a community-based clinic
in the province of Ontario. The services provided at the clinic are funded by Motor Vehicle Accident treatment plans, extended health
benefits insurance coverage, or private payment. A portion of the services provided at the clinic are funded by the MLTC in the form
of Episodes of Care and these services are specifically targeted to be delivered to clients who meet the following criteria: |
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Aged 65 years of age and
older or aged 18 years of age and younger, and |
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Are post-operative, or |
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Have just been discharged
from a hospital, or |
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Are receiving services
from the Ontario Disability Services Program or Ontario Works. |
Our
eldercare OT services are provided, through two separate sectors, as follows:
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Long-Term Care Sector.
We contract with client homes to provide the following OT services: |
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Assessments and interventions
to support maintenance and restoration of function related to seating, mobility, positioning for self-care, prevention of pressure
ulcers, falls and use of restraints, |
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Speech language pathology
services, including evaluation and treatment, |
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Swallowing and eating assessments
and interventions, |
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Cognitive behavioral assessments
and care planning, |
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Our occupational therapists
have specialized training in mobility providing assistive device assessments when required. This service is funded primarily by the
MLTC. |
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Retirement Home &
Community. We provide the following OT services through individual contracts with private payers: |
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Home safety assessments, |
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Functional assessments, |
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In-home activities of daily living assessments, |
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Assessment and completion of applications for assistive
devices (mobility aids), |
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Custom seating and mobility consultations, |
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Case management services, and |
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Speech language pathology services, including evaluation
and treatment. |
Second
Pillar – Interconnected Technology for Virtual Ecosystem of Services, Products and Digital Health Offerings
Decentralization
through the integration of interconnected technology platforms has been adopted and is thriving in a variety of sectors and industries
such as transportation (Uber, Lyft), real estate (Zillow, Redfin, Airbnb, VRBO), used car sales (Carvana, Vroom), stock and financial
markets (Robinhood, Acorns, Webull) and so many other sectors. Yet decentralization of the non-critical primary care and wellness sector
of healthcare is lagging significantly in capability and benefit for patient access and delivery of services and products. The COVID
pandemic has taught both patients and healthcare providers the viability, importance, and benefits of decentralized access to primary
care simply through the rapid adoption of telehealth/telemedicine.
The
Company’s focus on a holistic approach to patient-first health and wellness, through innovation and decentralization, includes
maintaining an on-going continuous connection with our current and future patient community, beyond the traditional confines of brick-and-mortar
facilities, by extending oversight of patient evaluation, diagnosis, treatment solutions, and monitoring, directly through various Medical
Technology Platforms and periphery tools either in-use or under development. Through the integration and deployment of sophisticated
and secure technology and periphery diagnostic tools, the Company is working to expand the reach of our non-critical primary care services
and product offerings, beyond the traditional clinic locations, to geographic areas not readily providing advanced primary care service
to date, including the patient’s home.
Novo
Connect
The
Company believes the healthcare industry is in the early stages of a fundamental transformation of the patient-practitioner-health insurer
relationship whereby the patient is demanding greater control and care collaboration for their health and wellness needs while the practitioner
desires dramatic improved efficiency in the delivery of their expertise to the patient. Novo Connect, the Company’s proprietary
mobile application, is a secure, cloud-based health and commerce web application intended to assist patients as they explore, connect,
manage, and have direct control of their personalized health and wellness needs. Novo Connect is designed to integrate the Company’s
interconnected technology and provide the patient a single platform with a robust healthcare ecosystem of services, products and digital
health offerings.
The
current system for delivery and access to primary care is fragmented, requiring patients to use multiple access points, portals, and
applications to track various practitioner and health plan interactions for which each practitioner and health plan maintains separate
records. Too many times, as a patient ages, the current systems make it almost impossible to have a central data set of a patients’
health history, many times losing various time periods of health history. Novo Connect is intended to empower the patient by providing
a single platform that offers the care services, tracking, and secure recordkeeping to better navigate care choices.
Specific
to non-critical care, the patient-practitioner relationship is shifting away from on-site visits to primary medical centers with mass-services
and to the patient’s home and micro-clinics. Novo Connect is intended to provide “ease-of-access” in the patient/practitioner
interaction for non-critical care diagnosis and subsequent treatment minimizing the degradation of non-critical health conditions to
critical conditions as well as allowing for more cost-effective healthcare distribution. The services and products available through
Novo Connect may be provided either directly by the Company or an affiliated network of service or product providers across a variety
of specialties.
Novo
Connect is intended to provide a suite of secure, reliable engagement features including, but not limited to,
| ● | Connect
Now: a real-time scheduling solution to connect with our affiliate practitioners and
physicians |
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Storage: Secure Document storage |
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Community: a community chat forum to share and discuss various conditions to include
curated “channels” offering health and wellness solutions and insight |
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CarePlan – a patient-specific care plan developed by providers, augmented with
product and service solutions, to address various conditions |
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bill pay |
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patient monitoring interface |
As
of August 31, 2022, Novo Connect is in limited commercialization through certain of the Company’s corporate owned clinics with
expanded commercialization intended to launch in the latter part of 2023.
Telemedicine/Telehealth
The
pandemic has taught both patients and healthcare providers the viability, importance, and benefits of telemedicine technology for non-catastrophic
primary care. Telemedicine is transforming traditional approaches to healthcare by providing ease of access and reduced costs for patients,
particularly in areas with limited access to both clinicians and medically licensed providers. In a post-pandemic global environment,
telemedicine is more readily being adopted by patients, practitioners, clinicians, medical licensed providers, and health insurers for
limited diagnostic and treatment solutions. We believe to date, telehealth technology usage is one dimensional and limiting in comfort
for practitioners to provide in-depth diagnosis and treatment solutions.
Through
both internal development and partnerships, the Company is working to provide the next generation of telehealth technology to offer the
patient and the practitioner a sophisticated and enhanced telehealth interaction using an interface of sophisticated periphery based
diagnostic tools, such as a blood pressure reading device, a derma scope, an ophthalmoscope, otoscope, and other add-ons operated by
skilled support workers in the patient’s remote location. This enhanced telehealth experience allows for the practitioner and patient
to have a much higher level of ability and comfort to provide a uniquely comprehensive evaluation, diagnosis, and treatment solution
thus dramatically elevating the effectiveness of virtual visits that are more resource efficient and as effective as a physical visit.
Remote
Patient Monitoring (“RPM”)
Through
our licensing agreement with Cloud DX, our RPM platform empowers a patient to have direct control of collecting and monitoring real-time
vital sign information while maintaining a direct technology link from patient to clinician or medical practitioner. The transfer of
vital information from home to clinic or patient to clinician allows for the delivery of high quality, non-redundant diagnostic based
proactive healthcare. The implementation of in-clinic patient metrics equivalent to those derived via a remote application in the home
environment is the first step in engaging patient retention to remote review. The Cloud DX platform allows us to further expand on our
patient-first care philosophy of maintaining an on-going connection with our patient community, beyond the traditional confines of a
clinic, extending oversight of patient care and monitoring directly into the patient’s home.
Third
Pillar – Health and Wellness Products
We
believe our science first approach to product offerings further emphasizes the Company’s strategic vision to innovate, evolve,
and deliver over-the-counter preventative and maintenance care solutions as well as therapeutics and personalized diagnostics that enable
individualized health optimization.
As
the Company’s patient base grows through the expansion of its corporate owned clinics, its affiliate network, its micro-clinic
facility openings, its interconnected technology platforms, and other growth initiatives, the development and distribution of high-quality
wellness product solutions is integral to (i) offering effective product solutions allowing for the customization of patient preventative
care remedies and ultimately a healthier population, and (ii) maintaining an on-going relationship with our patients through the customization
of patient preventative and maintenance care solutions.
The
Company’s product offering ecosystem is being built through strategic acquisitions and engaging in licensing agreements with partners
that share our vision to provide a portfolio of products that offer an essential and differentiated solution to health and wellness globally.
Acenzia
Inc.
Acenzia
Inc. (“Acenzia”), was acquired by the Company’s wholly-owned subsidiary, Novo Healthnet Limited in June 2021. Acenzia
is in the business of providing nutraceutical health solutions through advanced bio-science research and development, proprietary manufacturing,
and personalized diagnostics. In addition, Acenzia has developed a multiple international jurisdiction patented technology platform,
using zebra fish, which enables rapid analysis of cancer cells, offering cancer patients and their healthcare providers prediction of
early metastasis and drug sensitivity thereby providing important information for diagnosis and treatment (“Zgraft”)
Acenzia,
founded in 2015, is licensed by multiple international government agencies including Health Canada, the U.S. FDA and the European Union
for Good Manufacturing Practices (GMP) for over-the-counter and dietary supplement manufacturing. In addition, Acenzia maintains multiple
third-party licenses including from the National Sanitation Foundation International (NSF) for meeting the required public health standards
for manufacturing food, nutrition, and supplements. Acenzia is dedicated to the creation of innovative therapeutics and diagnostics that
enables individualized health optimization.
Acenzia’s
36,000 square foot facility is located in Windsor Ontario Canada and includes Class 100 pharmaceutical grade cleanrooms and certified
laboratories from which Acenzia creates and manufactures evidenced-based dietary, nutraceutical, and food products that can be validated
through personalized diagnostics.
PRO-DIP,
LLC
PRO-DIP,
LLC (“PRO-DIP”), founded in 2015 and based in San Jose, California, was acquired by the Company in May 2021. PRO-DIP has
developed and commercialized its proprietary, patent-pending ION Energy oral pouch that delivers flavorful bursts of vitamins and natural
energy supplements through small, semi-permeable sachets placed in the mouth, between the gum and cheek or lip. The initial burst of
supplements is followed by extended absorption of the nutrients, providing long-lasting energy, even at high-exertion levels. With its
hand-free ease of consumption, the ION energy-rich pouch is an alternative to traditional sports supplements. On March 15, 2022, PRO-DIP
was issued U.S. Patent No. 11,273,965 by the U.S. Patent and Trademark Office on March 15, 2022. The ‘965 patent relates to PRO-DIP’s
novel technology for manufacturing its oral supplement pouches.
In
addition to the ION Energy oral pouch, PRO-DIP is developing other pouch types for applications such as hydration, immunity, multi-vitamin,
antioxidants, creatine, and sleep.
The
PRO-DIP oral pouch delivery system offers broad market applications related to (i) nutritionally focused products and, (ii) medicinal
based formulations. The dissolvable oral pouch as the delivery mechanism for certain medications, normally swallowed in pill or tablet
format, between the cheek and gum for buccal absorption into the mouth’s small blood vessels.
PRO-DIP’s
current distribution chain includes ADS, Inc., a leading value-added logistics and supply chain solutions provider that serves all branches
of the U.S. Military, federal, state, and local government organizations, law enforcement agencies, first responders, partner nations
and the defense industry. In addition, PRO-DIP is working to expand its distribution network to include convenience store chains in North
America.
Terragenx
Inc. and Iodine Micro-nutrient
On
November 17, 2021, NHL acquired a 91% controlling interest in Terragenx Inc. and the Company acquired the intellectual property portfolio
for the unique formulation and manufacturing capability to produce a water-soluble iodine micro-nutrient that is FDA and Health Canada
approved for over-the-counter and e-commerce distribution (“IoNovo”).
Iodine
is a naturally occurring element and essential nutrient used by the thyroid gland to manufacture necessary hormones in the human body.
Iodine is recognized as a world class disinfectant and is one of nature’s finest microbial killers of bacteria and virus deactivators.
Iodine is an essential micronutrient required for the human body to produce specific thyroid hormones (T3/T4) that activate and strengthen
our immune system.
While
iodine alone cannot be ingested, through the acquisition of Terragenx and the Iodine IP, Novo has acquired the intellectual property
for iodine in an aqueous form that can be safely ingested and has been proven to kill viruses, bacteria and protozoa when sprayed onto
your mucous membranes, the entry points for various airborne viruses.
The
Company has been granted Natural Product Numbers (NPN) by Health Canada for each of IoNovo GO Iodine, IoNovo Pure Iodine, IoNovo Iodide,
and IoNovo for Kids pure iodine oral spray. An NPN is a product license assessed and granted by Health Canada to commercialize a product
that is found to be safe, effective, and of high quality.
The
IoNovo line of oral sprays are 100% pure and natural with no chemicals, no plastics, and no alcohol.
Intellectual
Property and Patents
The
Company has acquired intellectual property, including patents, related to health sciences, personal diagnostics, and product applications
which include:
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U.S.
Patent No. 11,273,965 issued by the U.S. Patent and Trademark Office on March 15, 2022 for oral and/or buccal delivery pouch and
the method of making same. The ‘965 patent relates to PRO-DIP’s novel technology for manufacturing its oral supplement
pouches. PRO-DIP’s innovative, patented oral supplement pouch delivery system technology provides for broad market applications
related to nutritionally focused products and medicinal based formulations. PRO-DIP’s initial oral pouch commercial product
offering, the ION Energy pouch, is designed for the delivery of flavorful bursts of vitamins and natural energy supplements through
small, semi-permeable sachets placed in the mouth, between the gum and cheek or lip. The initial burst of supplements is followed
by extended absorption of the nutrients, providing long-lasting energy, even at high-exertion levels. With its hands-free ease of
consumption, the energy-rich pouches are an alternative to traditional sports supplements and deliver a daily serving of natural
vitamins and nutrients. The invention of the pouch delivery system for nutraceuticals continues to gain mainstream interest from
health product manufacturers, medical organizations, big pharma, the military, space organizations, CBD/hemp companies, humanitarian
aid groups and the list goes on. |
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U.S.
Patent No. 10,760,060B2, issued by the U.S. Patent and Trademark Office on September 1, 2020 for injection and incubation of circulating
tumor cells from a cancer biopsy in zebrafish for accelerated prediction of cancer progression and response to treatment (“Zgraft”).
Zgraft is a multiple international jurisdiction patented personalized diagnostic technology platform which , using zebra fish, enables
rapid analysis of cancer cells, offering cancer patients and their healthcare providers prediction of early metastasis and drug sensitivity
thereby providing important information for diagnosis and treatment. The Zgraft platform models tumor progression and analyzes a
cancer cell’s response to various treatment by transplanting human tumor tissue into a zebrafish allowing researchers to test
an individual’s tumor cells under various conditions to see how they might respond to certain drug combinations and how the
cancer progresses — all without exposing patients to the adverse effects of trying drug combinations that, ultimately, aren’t
effective for their cases. Essentially, by taking a sample of cancer cells from a patient’s own tumors and studying them in
a variety of conditions, doctors can now provide a more accurate prognosis of that individual’s case. More importantly, we
believe doctors can now test a variety of possible drug combinations to see how that articular patient’s cancer will respond
to them. |
|
|
|
|
3. |
Intellectual
property for generic primary and sub-primary drug formulations (known as bioequivalence) of name brand pharmaceutical reference products
related to usage as injectables, ophthalmic, and topical applications. |
|
|
|
|
4. |
Intellectual
property for proprietary designs for a cannabis dosing device, TruDose, which provides real-time analysis for the amount of THC/CBD
in the smoke/vapor stream, after the heat point, allowing that once the device has detected the medically prescribed pre-set amount
of THC/CBD has been detected, the device shuts off the flow of smoke/vapor so that only the pre-determined dose can be inhaled. The
TruDose device is designed and intended to create assurance to delivered doses potentially allowing for broader medical application
adoption. |
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|
5. |
Iodine
and IoNovo related Intellectual Property and patent pending as follows: |
|
a. |
Canada
patent pending for spray devices for dispensing aqueous iodine, and methods of making and using spray devices that dispense aqueous
iodine |
|
b. |
U.S.
patent pending for controlled gaseous iodine sublimation from solid iodine for atmospheric iodine nutrition, disinfection and therapeutic
uses |
|
c. |
U.S.
patent pending for an apparatus to produce atmospheric nutritional & disinfectant iodine |
|
d. |
U.S.
patent pending for automated high output aqueous iodine production and bottling system |
Recent
Developments
Coronavirus
(COVID-19)
While
all of the Company’s business units are operational at the time of this filing, any future impact of the COVID-19 pandemic on the
Company’s operations remains unknown and will depend on future developments, which are highly uncertain and cannot be predicted
with confidence, including the duration of the COVID-19 outbreak, new information which may emerge concerning the severity of the COVID-19
pandemic, and any additional preventative and protective actions that governments, or the Company, may direct, which may result in an
extended period of continued business disruption, reduced patient traffic and reduced operations. For more information regarding the
impact of COVID-19 on the Company, see “—Liquidity and Capital Resources—Financial Impact of COVID-19” of this
annual report on Form 10-K.
MiTelemed+
Joint Venture Agreement
On
October 8, 2021, the Company and NHL completed a Joint Venture Agreement (the “MiTelemed+ JV”) with EK-Tech Solutions Inc.
(“EK-Tech”) to establish the joint venture company MiTelemed+ Inc., an Ontario province Canada corporation (“MiTelemed+”),
to operate, support, and expand access and functionality of EK-Tech’s enhanced proprietary Telehealth platform. At closing, EK-Tech
contributed all intellectual property, source code, and core data of the iTelemed platform, valued at CAD$1,500,000, and NHL issued to
EK-Tech, non-voting NHL Exchangeable Special Shares, free and clear of all liens and encumbrances, which are issued solely for the purpose
of EK-Tech to exchange, for 185,000 restricted shares of Company’s common stock solely upon EK-Tech meeting terms and conditions
for exchange of the NHL Exchangeable Special Shares as defined in the MiTelemed+ JV. The net profits and net losses of the JV will be
split 50/50 between NHL and EK-Tech. As of August 31, 2022, the terms and conditions for the exchange of the NHL Exchangeable Special
Shares had not been met.
Terragenx
Share Exchange Agreement
On
November 17, 2021, the Company and NHL, a wholly owned subsidiary of the Company, entered into that certain Share Exchange Agreement
(the “Terra SEA”), dated as of November 17, 2021, by and among the Company, NHL, Terragenx Inc. (“Terra”), TMS
Inc. (“TMS”), Shawn Mullins, Claude Fournier, and The Coles Optimum Health and Vitality Trust (“COHV” and collectively
with TMS, Mr. Mullins and Mr. Fournier, the “Terra Shareholders”). Collectively, the Terra Shareholders owned 91% of the
outstanding shares of Terra (the “Terra Purchased Shares”).
Pursuant
to the terms of the Terra SEA, NHL agreed to purchase from the Terra Shareholders, and the Terra Shareholders agreed to sell to NHL,
the Terra Purchased Shares on the closing date, in exchange for payment by NHL of the purchase price (the “Purchase Price”)
of CAD$500,000 (approximately $398,050) (the “Exchange”). The Purchase Price was to be paid with the issuance, by NHL to
the Terra Shareholders, of certain non-voting NHL special shares exchangeable into restricted shares of the Company’s common stock
(the “NHL Exchangeable Shares”). The total shares of Company common stock allotted in favor of the Terra Shareholders was
calculated at a per share price of $3.35.
The
Exchange closed on November 17, 2021. At the closing of the Exchange, (i) the Terra Shareholders transferred to NHL a total of 910 shares
of Terra common stock, representing 91% of Terra’s outstanding shares, and (ii) a total of 100 NHL Exchangeable Shares were issued
to the Terra Shareholders, which NHL Exchangeable Shares are exchangeable into a total of 118,821 restricted shares of the Company’s
common stock. As a result of the Exchange, NHL has 91% ownership of Terra and full control of the Terra business.
Mullins
Asset Purchase Agreement
On
November 17, 2021, the Company entered into that certain Asset Purchase Agreement (the “Mullins APA”), dated as of November
17, 2021, by and between the Company and Terence Mullins. Pursuant to the terms of the Mullins APA, Mr. Mullins agreed to sell, and the
Company agreed to purchase, all of Mr. Mullins’ right, title and interest in and to certain assets directly and indirectly related
to any and all iodine-based related products and technologies as specified in the Mullins APA (the “Mullins IP Assets”),
in exchange for a purchase price of CAD$2,500,000 (approximately $1,990,250) which is to be paid as follows:
|
(a) |
CAD$2,000,000 (approximately
$1,592,200) is to be issued or allotted to Mr. Mullins only after patent-pending status, in the U.S. or internationally, is designated
for all Mullins IP Assets (the “Mullins IP Assets CAD$2m Shares”), as either restricted shares of Company common stock
or NHL Exchangeable Shares, as determined by Mr. Mullins. Once issued or allotted, the Mullins IP Assets CAD $2m Shares will be held
in escrow pending registration and approval for all Mullins IP Assets, and |
|
|
|
|
(b) |
CAD$500,000 (approximately
$398,050) is to be issued in the form of 118,821 restricted shares of Company common stock, free and clear of all liens, pledges,
encumbrances, charges, or known claims of any kind, nature, or description, upon closing of the Mullins APA |
All
shares issued or allotted under the terms and conditions of the Mullins APA are calculated at a value of $3.35 per share.
In
addition, the Company will pay a royalty equal to 10% of net revenue (net profit) of all iodine related sales reported through the Company
or any of its wholly owned subsidiaries for a period equal to the commercial validity of the intellectual property.
Jefferson
Street Capital Stock Purchase Agreement, Secured Convertible Promissory Note, Partial Payment and Extension of the Jefferson Note
On
November 17, 2021, the Company and Terragenx Inc., a majority owned subsidiary of the Company (“Terra”), entered into
that certain securities purchase agreement (the “Jefferson SPA”), dated as of November 17, 2021, by and among the
Company, Terra and Jefferson Street Capital LLC (“Jefferson”). Pursuant to the terms of the Jefferson SPA, (i) the
Company agreed to issue and sell to Jefferson the Jefferson Note (as hereinafter defined); (ii) the Company agreed to issue to
Jefferson the Jefferson Warrant (as hereinafter defined); and (iii) the Company agreed to issue to Jefferson 1,000,000 restricted
shares of Company common stock (the “Collateral Shares”), as collateral on the Jefferson Note, which is being held by the escrow agent and subject to return
to the Company upon full payment of the Jefferson Note; and (iv) Jefferson agreed to pay to the Company $750,000 (the
“Jefferson Purchase Price”).
Pursuant
to the terms of the Jefferson SPA, on November 17, 2021, Terra issued to Jefferson a secured convertible promissory note (the “Jefferson
Note”) with a maturity date of May 17, 2022 (the “Maturity Date”), in the principal amount of $937,500. The Company
acted as guarantor on the Jefferson Note. Pursuant to the terms of the Jefferson Note, Terra agreed to pay to Jefferson $937,500 (the
“Principal Amount”), with a purchase price of $750,000 plus an original issue discount in the amount of $187,500 (the “OID”),
and to pay interest on the Principal Amount at the rate of 1% per annum.
Any
amount of principal, interest or other amount due on the Jefferson Note that is not paid when due will bear interest at the rate of the
lesser of (i) 12%, or (b) the maximum rate allowed by law.
Jefferson
may, at any time, convert all or any portion of the then outstanding and unpaid principal amount and interest into shares of the Company’s
common stock at a conversion price of $3.35 per share. The Jefferson Note has a 4.99% equity blocker; provided, however, that the 4.99%
equity blocker may be waived (up to 9.99%) by Jefferson, at Jefferson’s election, on not less than 61 days’ prior notice
to the Company.
On
November 17, 2021, Jefferson paid the Jefferson Purchase Price of $750,000 in exchange for the Jefferson Note. Terra intends to use the
proceeds for the acquisition of the certain assets directly and indirectly related to any and all iodine-based related products and technologies
as specified in the Asset Purchase Agreement (the “Mullins APA”), dated as of November 17, 2021, by and between the Company
and Terence Mullins (the “Mullins IP”) and thereafter for working capital and other general purposes.
Terra
may prepay the Jefferson Note at any time in accordance with the terms of the Jefferson Note.
Except
as related to the next transaction after the issue date of the Jefferson Note conducted on the Company’s behalf by the Maxim Group
LLC (“Maxim”), Terra and the Company agreed to pay to Jefferson on an accelerated basis, any outstanding Principal Amount
of the Jefferson Note, along with all unpaid interest, and fees and penalties, if any, from the sources of capital below, at Jefferson’s
discretion, it being acknowledged and agreed by Jefferson that the Company and Terra have the right to make bona fide payments to vendors
with Company common stock:
|
● |
At Jefferson’s option,
15% of the net cash proceeds of any future financings by the Company, Terra or any subsidiary, whether debt or equity, or any other
financing proceeds such as cash advances, royalties or earn-out payments. |
|
● |
All net proceeds from any
sale of assets of the Company, Terra or any subsidiaries other than sales of inventory in the ordinary course of business or receipt
by the Company or any subsidiaries of any tax credits or collections pursuant to any settlement or judgement. |
|
● |
Net proceeds resulting
from the sale of any assets outside of the ordinary course of business or securities in any subsidiary. |
On
June 1, 2022, the Company made a partial payment of $192,188 towards principal and interest owed on the Jefferson Note. On June 1,
2022, the Company and the note holder agreed to extend the maturity date to November 29, 2022 with a principal amount face value of
$937,500 and interest rate that shall accrue at a rate equal to 1% per annum. Effective February 16, 2023, the Jefferson Note has
been paid in full. See Financial Note 19 – Subsequent Events for additional information regarding the Jefferson
Note.
Platinum
Point Capital Stock Purchase Agreement, Secured Convertible Promissory Note, and Full Payment of the Platinum Note
On
November 17, 2021, the Company and Terra entered into that certain securities purchase agreement (the “Platinum SPA”), dated
as of November 17, 2021, by and among the Company, Terra and Platinum Point Capital LLC (“Platinum”). Pursuant to the terms
of the Platinum SPA, (i) the Company agreed to issue and sell to Platinum the Platinum Note (as hereinafter defined); (ii) the Company
agreed to issue to Platinum the Platinum Warrant (as hereinafter defined); and (iii) the Company agreed to issue to Platinum 1,000,000
restricted shares of the Company common stock, as collateral on the Platinum Note, which is being held by the escrow agent and subject
to return to the Company upon full payment of the Platinum Note; and (iv) Platinum agreed to pay to the Company $750,000 (the “Platinum
Purchase Price”).
Pursuant
to the terms of the Platinum SPA, on November 17, 2021, Terra issued to Platinum a secured convertible promissory note (the “Platinum
Note”) with a maturity date of May 17, 2022 (the “Maturity Date”), in the principal amount of $937,500. The Company
acted as guarantor on the Platinum Note. Pursuant to the terms of the Platinum Note, Terra agreed to pay to Platinum $937,500 (the “Platinum
Principal Amount”), with a purchase price of $750,000 plus an original issue discount in the amount of $187,500 (the “OID”),
and to pay interest on the Principal Amount at the rate of 1% per annum.
Any
amount of principal, interest or other amount due on the Platinum Note that is not paid when due will bear interest at the rate of the
lesser of (i) 12%, or (b) the maximum rate allowed by law.
Platinum
may, at any time, convert all or any portion of the then outstanding and unpaid principal amount and interest into shares of the Company’s
common stock at a conversion price of $3.35 per share. The Platinum Note has a 4.99% equity blocker; provided, however, that the 4.99%
equity blocker may be waived (up to 9.99%) by Platinum, at Platinum’s election, on not less than 61 days’ prior notice to
the Company.
On
November 17, 2021, Platinum paid the Platinum Purchase Price of $750,000 in exchange for the Platinum Note. Terra intends to use the
proceeds for the acquisition of the Mullins IP and thereafter for working capital and other general purposes.
Terra
may prepay the Platinum Note at any time in accordance with the terms of the Platinum Note.
Except
as related to the next transaction after the issue date of the Platinum Note conducted on the Company’s behalf by the Maxim, Terra
and the Company agreed to pay to Platinum on an accelerated basis, any outstanding Principal Amount of the Platinum Note, along with
all unpaid interest, and fees and penalties, if any, from the sources of capital below, at Platinum’s discretion, it being acknowledged
and agreed by Platinum that the Company and Terra have the right to make bona fide payments to vendors with Company common stock:
|
● |
At Platinum’s option,
15% of the net cash proceeds of any future financings by the Company, Terra or any subsidiary, whether debt or equity, or any other
financing proceeds such as cash advances, royalties or earn-out payments. |
|
● |
All net proceeds from any sale of assets of the Company, Terra
or any subsidiaries other than sales of inventory in the ordinary course of business or receipt by the Company or any subsidiaries of
any tax credits or collections pursuant to any settlement or judgement. |
|
● |
Net proceeds resulting
from the sale of any assets outside of the ordinary course of business or securities in any subsidiary |
On
June 1, 2022, the Company made an aggregated payment of $948,874, including all principal and interest owed, on the Platinum Note.
December
2021 Registered Direct Offering
On
December 14, 2021, the Company entered into a Securities Purchase Agreement with an accredited institutional investor (the “Purchaser”)
pursuant to which the Company agreed to issue to the Purchaser and the Purchaser agreed to purchase (the “Purchase”), in
a registered direct offering, (i) $16,666,666 aggregate principal amount of the Company’s senior secured convertible notes, which
notes are convertible into shares of the Company’s common stock, under certain conditions (the “Notes”); and (ii) warrants
to purchase up to 5,833,334 shares of the Company’s common stock (the “Warrants”). The securities, including up to
68,557,248 shares of common stock issuable upon conversion under the Notes and up to 5,833,334 shares of common stock issuable upon exercise
of the Warrants, are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-254278),
which was declared effective by the SEC on March 22, 2021. The Purchase closed on December 14, 2021.
The
Notes have an original issue discount of 10%, resulting in gross proceeds to the Company of $15,000,000. The Notes bear interest of 5%
per annum and mature on June 14, 2023, unless earlier converted or redeemed, subject to the right of the Purchaser to extend the date
under certain circumstances. The Company will make monthly payments on the first business day of each month commencing on the calendar
month immediately following the sixth month anniversary of the issuance of the Notes through June 14, 2023, the maturity date, consisting
of an amortizing portion of the principal of each Note equal to $1,388,888 and accrued and unpaid interest and late charges on the Notes.
All amounts due under the Notes are convertible at any time, in whole or in part, at the holder’s option, into common stock at
the initial conversion price of $2.00, which conversion price is subject to certain adjustments; provided, however, that the Notes have
a 9.99% equity blocker. If an event of default occurs, the holder may convert all, or any part, of the principal amount of a Note and
all accrued and unpaid interest and late charge at an alternate conversion price, as described in the Notes. Subject to certain conditions,
the Company has the right to redeem all, but not less than all, of the remaining principal amount of the Notes and all accrued and unpaid
interest and late charges in cash at a price equal to 135% of the amount being redeemed.
The
Warrants are exercisable at an exercise price of $2.00 per share and expire on the fourth anniversary of December 14, 2021, the initial
issuance date of the Warrants.
As
of August 31, 2022, the principal balance owed on the December 14, 2021 Notes is approximately $11,230,555. See Financial Note 19—Subsequent Events for additional information regarding the December 14, 2021 Notes.
LA
Fitness Canada Amended and Restated License Agreement & Amended and Restated Guaranty
On
December 15, 2021, NHL entered into an Amended and Restated Master Facility License Agreement (the “Amended and Restated Canada
License Agreement”) with LAF Canada Company (“LA Fitness Canada”). The Amended and Restated Canada License Agreement
had the effect of (i) removing NHL’s obligation to develop and open a certain number of facilities within certain designated time
periods; and (ii) revising the default provisions such that certain defaults will result only in termination with respect to a specific
facility, rather than of the license itself. As a result of the Amended and Restated Canada License Agreement, NHL may continue to develop
and open additional facilities for business.
Pursuant
to the terms of the Amended and Restated Canada License Agreement, the Company entered into that certain Guaranty Agreement (the “Canada
Guaranty”) dated December 15, 2021 by and between the Company, Fitness International, LLC and LA Fitness Canada, pursuant to which
the Company irrevocably guaranteed the full, unconditional, and prompt payment and performance of all of NHL’s obligations and
liabilities under the Amended and Restated Canada License Agreement.
Consulting
Services Agreement
On
December 20, 2021, the Company executed a Consulting Services Agreement for financial and corporate consulting services over a 3-month
term. As consideration for payment of services, the Company paid (i) 50,000 restricted shares of common stock, and (ii) $25,000 per month
for the 3-month term. On December 20, 2021, the Company issued 50,000 shares of restricted common stock. On January 24, 2022, the Company
issued 50,000 restricted shares of common stock. On February 24, 2022, the Company issued 50,000 restricted shares of common stock.
Stock
Option Grant to Independent Directors
On
February 23, 2022, the Company granted, pursuant to the Company’s 2021 Equity Incentive Plan (the “2021 Plan”), a stock
option to purchase 93,955 shares of common stock at an exercise price of $1.33 to each of the Company’s then-independent directors,
Alex Flesias, Robert Oliva and Michael Pope. Effective June 30, 2022, Mr. Oliva resigned as a member of the Board of Directors. Each
stock option vests, and becomes exercisable, (i) with respect to 7,833 shares each month, beginning on the date of grant, until December
23, 2022, and (ii) with respect 7,832 shares on January 23, 2023. Each stock option expires on February 23, 2027. The stock option grants
were previously approved by the Company’s Board of Directors on January 26, 2021 and are consistent with the letter agreements
dated January 26, 2021, between the Company and Messrs. Flesias, Oliva and Pope.
Share
Exchange Agreement to Acquire 50.1% of 12858461 Canada Corp.
On
March 1, 2022, the Company and NHL completed a Share Exchange Agreement (the “1285 SEA”) with 12858461 Canada Corp. (“1285”),
a Canada federal corporation in the business of providing clinic-based physiotherapy and related ancillary services and products, and
Prashant A. Jani, a Canadian citizen and sole shareholder of 1285 (the “1285 Shareholder”) to acquire 50.1% ownership of
1285 for a purchase price of $68,000 (the “1285 Purchase Price”) paid with the issuance, by NHL to the 1285 Shareholder,
of certain non-voting NHL Exchangeable Special Shares which can only be utilized for the purpose of exchange into an allotment of 17,000
restricted shares of the Company’s common stock (the “Parent 1285 SEA Shares”) at the determination of the 1285 Shareholder.
The number of Parent 1285 SEA Shares was calculated by dividing the 1285 Purchase Price by $4.00 per share.
Asset
Purchase Agreement with Poling Taddeo Hovius Physiotherapy Professional Corp., operating as Fairway Physiotherapy and Sports Injury Clinic
On
March 1, 2022, the Company and NHL completed an Asset Purchase Agreement (the “PTHPC APA”) with Poling Taddeo Hovius Physiotherapy
Professional Corp. (“PTHPC”), operating a clinic-based physiotherapy, rehabilitative, and related ancillary services and
products business known as Fairway Physiotherapy and Sports Injury Clinic (“FAIR”), and Jason Taddeo, a Canadian citizen
and the sole shareholder of PTHPC (the “PTHPC Shareholder”), Under the terms and conditions of the PTHPC APA, PTHPC agreed
to sell, assign and transfer to NHL, free and clear of all encumbrances, other than permitted encumbrances, and NHL agreed to purchase
from PTHPC all of PTHPC’s right, title and interest in and to all of its assets related to FAIR and the FAIR Business, with the
exception of certain limited exclusions, and the rights, privileges, claims and properties of any kind whatsoever that are related thereto,
whether owned or leased, real or personal, tangible or intangible, of every kind and description and wheresoever situated. Under the
terms and conditions of the PTHPC APA, the purchase price is $627,000 (the “FAIR Purchase Price”) paid with the issuance,
by NHL to the PTHPC Shareholder, of certain non-voting NHL Exchangeable Special Shares which can only be utilized for the purpose of
exchange into an allotment of 156,750 restricted shares of the Company’s common stock (the “Parent PTHPC APA Shares”)
at the determination of the PTHPC Shareholder. The number of Parent PTHPC APA Shares was calculated by dividing the FAIR Purchase Price
by $4.00 per share.
Clinical
Consultants International LLC Acquisition
On
March 17, 2022, the Company entered into a Membership Interest Purchase Agreement (the “CCI Agreement”) by and among the
Company, Clinical Consultants International LLC (“CCI”), each of the members of CCI (the “Members”), and Dr.
Joseph Chalil as the representative of the Members.
Pursuant
to the terms of the CCI Agreement, among other things, the CCI Members will sell and assign to the Company all of their membership interests
of CCI, in exchange for a total of 800,000 restricted shares of the Company’s common stock (the “Exchange Shares”) (“CCI
Acquisition”). The Exchange Shares will be apportioned among the Members pro rata based on their respective membership interest
ownership percentage of CCI. Following the closing of the CCI Acquisition (the “Closing”), the Company will own 100% of the
issued and outstanding membership interests of CCI, and the CCI Members or their designees will collectively own 800,000 restricted shares
of the Company’s common stock. The restricted shares were issued on April 7, 2022.
Pursuant
to the terms of the CCI Agreement, the Company agreed to (i) name, at the Closing, Dr. Chalil as the Chief Medical Officer of the Company
and the President of Novomerica Healthcare Group, Inc., which is a wholly owned subsidiary of the Company, (ii) enter into an employment
agreement with Dr. Chalil, and (iii) name Dr. Chalil to the Company’s Board of Directors.
On
April 5, 2022, the CCI Acquisition closed. As a result, immediately after the Closing on April 5, 2022, the Company owned 100% of the
issued and outstanding membership interests of CCI. On April 7, 2022, the Company issued an aggregate of 800,000 restricted shares of
the Company’s common stock to the Members in connection with the CCI Acquisition and pursuant to the terms of the CCI Agreement.
Appointment
of Dr. Chalil as the Company’s Chief Medical Officer and President of Novomerica Healthcare Group, Inc.
On
April 5, 2022, in connection with the closing of the CCI Acquisition and pursuant to the terms of the CCI Agreement, the Company named
Dr. Chalil as the Company’s Chief Medical Officer, and the President of Novomerica Healthcare Group, Inc., a wholly owned subsidiary
of the Company formed for expansion of certain medically related business in the U.S. (“NHG”). Pursuant to the terms of the
CCI Agreement, the Company expects to appoint Dr. Chalil as a member of the Company’s Board of Directors in the near future.
Chalil
Employment Agreement
In
connection with Dr. Chalil’s appointment as the Company’s Chief Medical Officer and NHG’s President, the Company entered
into an executive agreement (the “Chalil Agreement”) with Dr. Chalil on April 5, 2022. Pursuant to the terms of the Chalil
Agreement, the Company agreed to pay Dr. Chalil an annual base salary of $400,000. In addition, the Company agreed to pay Dr. Chalil
an amount equal to 10% of the net income of CCI in excess of $450,000 for each calendar year during the term of the Chalil Agreement
(the “Revenue Share Payment”).
Dr.
Chalil will also receive bonuses based on increases in the Company’s market cap valuation (“MCV”) from the date of
the Chalil Agreement, with the following milestone bonus parameters:
|
(a) |
For each and every $50
million Company MCV increase sustained for a period of not less than 30 days (the “50M Bonus Event”), Dr. Chalil will
receive $250,000, or 0.5% of $50 million, in Company common stock. For the sake of clarity, Dr. Chalil will only be issued compensation
based on $50 million MCV increments; there will be no compensation issued for anything above $50 million until the subsequent $50
million MCV milestone is achieved. This bonus will be capped at a Company MCV of $1 billion. The 50M Bonus Event stock will be issued
as (i) 50% restricted shares within 30 days of the respective 50M Bonus Event or at a later date as requested by Dr. Chalil, and
held as an allocation to Dr. Chalil, until the requisition date as provided in writing, by Dr. Chalil, to the Company, and (ii) 50%
registered shares from the Company’s current active incentive plan within 30 days of the respective 50M Bonus Event. |
|
(b) |
Upon the Company sustaining
a MCV of $2 billion for no less than 30 days (the “2B Bonus Event”), Dr. Chalil will receive $20 million, or 1% of $1
billion, in restricted shares of Company common stock. The 2B Bonus Event stock will be issued within 30 days of the 2B Bonus Event
or at a later date as requested by Dr. Chalil, and held as an allocation to Dr. Chalil, until Dr. Chalil provides the Company with
written instructions requesting the specific stock issuance date. |
|
(c) |
For each additional $1
billion MCV, beyond the 2B Bonus Event and commencing when the Company MCV reaches $3 billion sustained for no less than 30 days,
Dr. Chalil will receive $10 million, or 1% of $1 billion, in restricted shares of the Company’s common stock. Dr. Chalil may
choose to have this stock issued within 30 days of each additional $1 billion MCV event or at a later date as requested by Dr. Chalil,
and held as an allocation to Dr. Chalil, until Dr. Chalil provides the Company with written instructions requesting the specific
stock issuance date. |
The
Company may also issue to Dr. Chalil equity awards as determined by the Board of Directors.
The
term of the Chalil Agreement ends on the earlier of (i) April 5, 2025, and (ii) the time of the termination of Dr. Chalil’s employment
pursuant to the terms of the Chalil Agreement. The term of the Chalil Agreement will be automatically extended for one or more additional
terms of one year each unless either party provided notice to the other party of their desire to not renew at least 30 days prior to
expiration of the then-current term.
The
Company may terminate the Chalil Agreement at any time for Cause (as defined in the Chalil Agreement) or without Cause, and Dr. Chalil
may terminate the Chalil Agreement at any time with or without Good Reason (as defined in the Chalil Agreement. If the Company terminates
the Chalil Agreement without Cause or Dr. Chalil terminates the Chalil Agreement with Good Reason, (i) the Company will pay to Dr. Chalil
any base salary, bonuses, and benefits then owed or accrued, and any unreimbursed expenses incurred by Dr. Chalil in each case through
the termination date; (ii) the Company will pay to Dr. Chalil, in one lump sum, an amount equal to the greater of (1) the base salary
that would have been paid to Dr. Chalil for the remainder of the then-current term, and (2) the total base salary that would have been
paid to Dr. Chalil for a one year period based on the base salary as of the date of termination, and the Revenue Share Payment for the
calendar year in which such termination occurs; and (iii) any equity grant already made to Dr. Chalil will, to the extent not already
vested, be deemed automatically vested.
Shelf
Registration Statement
On
April 28, 2022, the SEC declared effective the Company’s shelf registration statement on Form S-3 (File No. 333-264360) (the “Form
S-3”) originally filed on April 18, 2022. The Form S-3 is a shelf registration statement relating to the sale of 223,880 shares
of our common stock issuable to Jefferson Street Capital and Platinum Point Capital, under the terms and conditions of both the Jefferson
SPA and the Platinum SPA, upon exercise of certain warrants, currently held by the respective selling stockholders, with an exercise
price of $3.35 which expire on November 17, 2024.
Promissory
Note Amortization Payment
On
June 14, 2022, the Company made a cash payment in the aggregate amount of $1,391,589 for the monthly Amortization Payment pursuant to
the terms and conditions of the $16.66m+ convertible notes.
Dalcourt
and Gaynor Board of Directors Compensation
On
June 29, 2022, the Board granted Pierre Dalcourt and Michael Gaynor 250,000 and 50,000 shares of common stock, respectively, pursuant
to the 2021 Plan as consideration for over 5-years of service to the Board without having received compensation.
Board
of Directors Changes
Effective
June 30, 2022, Robert Oliva, Michael Gaynor and Pierre Dalcourt resigned as members of the Board of Directors. Also, effective June 30,
2022, (i) Sarfaraz Ali was appointed as an independent member of the Board of Directors; (ii) the size of the Board of Directors was
reduced from seven to five members. As a result, effective June 30, 2022, following the aforementioned Board changes, a majority of the
Company’s Board of Directors is independent. As compensation for Mr. Ali’s services as a director, on August 9, 2022, the
Company granted, pursuant to the Company’s 2021 Equity Incentive Plan, a stock option to purchase 39,480 shares of common stock
at an exercise price of $1.90. Mr. Ali’s stock options vests, and becomes exercisable, (i) with respect to 6,580 shares on the
date of grant, and (ii) with respect to 3,290 shares monthly, beginning on September 9, 2022 until July 9, 2023. Each stock option expires
on August 9, 2027. The stock option grants were previously approved by the Company’s Board of Directors on June 30, 2022, and are
consistent with the letter agreement, dated June 27, 2022, between the Company and Mr. Ali.
Promissory
Note Payment
On
June 30, 2022, the Company paid the balance owed on an Acenzia promissory note for an aggregate payment of $5,300,000, including all
principal and interest owed.
Promissory
Note Amortization Payment
On
July 14, 2022, the Company made a cash payment in the aggregate amount of $1,474,496 for the monthly Amortization Payment pursuant to
the terms and conditions of the $16.66m+ convertible notes.
Promissory
Note Amortization Payment
On
August 14, 2022, the Company made a cash payment in the aggregate amount of $1,441,470 for the monthly Amortization Payment pursuant
to the terms and conditions of the $16.66m+ convertible notes.
Registration
Statement on Form S-1
On
September 13, 2022, the Company filed a registration statement on Form S-1 (File No. 333-267401) (as amended, the “Registration
Statement”). The Registration Statement relates to the Company’s proposed offer of up to 19,138,756 units (“Units”),
with each Unit consisting of (i) one share of common stock, (ii) one warrant with a three-year term to purchase one share of common stock
at an exercise price of $1.045 per share (100% of the offering price per Unit) (“Three-Year Warrant”), and (iii) one warrant
with a five-year term to purchase one share of common stock at an exercise price of $1.045 per share (100% of the offering price per
Unit) (“Five-Year Warrant”) on a best-efforts basis. The assumed public offering price is $1.045 per Unit. Each Three-Year
Warrant and Five-Year Warrant will be immediately exercisable for one share of common stock at an assumed exercise price of $1.045 per
share (not less than 100% of the public offering price of each Unit sold in the offering). The actual public offering price per Unit
will be determined between the Company, Maxim Group LLC and the investors in the offering, and may be at a discount to the current market
price of the Company’s common stock.
As
indicated in the Registration Statement, the Company also proposes to offer to each purchaser of Units that would otherwise result in
the purchaser’s beneficial ownership exceeding 4.99% of the Company’s outstanding common stock immediately following the
consummation of the offering, the opportunity to purchase Units consisting of one pre-funded warrant to purchase one share of common
stock (“Pre-Funded Warrant”) (in lieu of one share of common stock), one Three-Year Warrant and one Five-Year Warrant. Subject
to limited exceptions, a holder of Pre-Funded Warrants will not have the right to exercise any portion of its Pre-Funded Warrants if
the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of the holder, such limit may
be increased to up to 9.99%) of the number of shares of common stock outstanding immediately after giving effect to such exercise. Each
Pre-Funded Warrant will be exercisable for one share of common stock. The purchase price of each Unit including a Pre-Funded Warrant
will be equal to the price per Unit including one share of common stock, minus $0.01, and the remaining exercise price of each Pre-Funded
Warrant will equal $0.01 per share. The Pre-Funded Warrants will be immediately exercisable (subject to the beneficial ownership cap)
and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. For each Unit including a Pre-Funded Warrant
sold (without regard to any limitation on exercise set forth therein), the number of Units including a share of common stock offered
will be decreased on a one-for-one basis. The common stock and Pre-Funded Warrants, if any, can each be purchased in the offering only
with the accompanying Three-Year Warrant and Five-Year Warrant as part of a Unit, but the components of the Units will immediately separate
upon issuance. The Company also proposes to register the common stock issuable from time to time upon exercise of the Pre-Funded Warrants,
Three-Year Warrants and Five-Year Warrants included in the Units.
There
is no minimum number of Units or minimum aggregate amount of proceeds for the offering to close.
The
Company expects to commence the sale of the securities as of the date on which the Registration Statement is declared effective by the
SEC. No sales will be made prior to effectiveness of the Registration Statement. There can be no assurance that the Registration Statement
will be declared effective by the SEC.
Promissory
Note Amortization Payment
On
September 14, 2022, the Company made a cash payment in the aggregate amount of $1,435,683 for the monthly Amortization Payment pursuant
to the terms and conditions of the $16.66m+ convertible notes.
CVI
Investments, Inc. Waiver and Amendment
On
October 13, 2022, the Company entered into a Waiver and Amendment (the “CVI Waiver and Amendment”) with CVI Investments,
Inc. (“CVI”). Pursuant to the terms of the CVI Waiver and Amendment, (i) the Company obtained a limited waiver from CVI with
respect to certain provisions of a Warrant to Purchase Common Stock, dated as of December 14, 2021, issued by the Company to CVI (the
“CVI Warrant”); (ii) the Company and CVI amended certain provisions of the CVI Warrant; (iii) the Company obtained a limited
waiver from CVI with respect to certain provisions of a Senior Secured Convertible Note, dated as of December 14, 2021, issued by the
Company to CVI (the “CVI Note”); and (iv) the Company and CVI amended certain provisions of the CVI Note, all as more fully
described below and as set forth in the CVI Warrant and the CVI Note, as applicable.
Pursuant
to the terms of the CVI Waiver and Amendment, the Company obtained a limited waiver from CVI with respect to the provisions of the CVI
Warrant that would have reduced the exercise price of the CVI Warrant upon the closing of the sale of the Company’s common stock
by the Company (the “Offering”) to be conducted as set forth in and pursuant to the prospectus contained in the Registration
Statement on Form S-1 (File No. 333-267401) filed by the Company on September 13, 2022, as subsequently amended and as declared effective
on October 13, 2022. In addition, the Company and CVI agreed to amend the CVI Warrant to provide that the exercise price of the CVI Warrant
shall be the price at which the Company’s common stock is offered for sale in the Offering.
Also
pursuant to the terms of the CVI Waiver and Amendment, the Company obtained a limited waiver from CVI with respect to the provisions
of the CVI Note that would have reduced the conversion price of the CVI Note upon the closing of the Offering. CVI also agreed to extend
the date on which the Amortization Redemption Amount (as defined in the CVI Note) may be paid from October 14, 2022 to October 19, 2022.
In addition, the Company and CVI agreed to amend the CVI Note to provide that the conversion price set forth in the CVI Note shall be
the price at which the Company’s common stock is being offered for sale in the Offering.
Hudson
Bay Master Fund Ltd. Waiver and Amendment
Also
on October 13, 2022, the Company entered into a Waiver and Amendment (the “Hudson Bay Waiver and Amendment”) with Hudson
Bay Master Fund Ltd. (“Hudson Bay”). Pursuant to the terms of the Hudson Bay Waiver and Amendment, (i) the Company obtained
a limited waiver from Hudson Bay with respect to certain provisions of a Warrant to Purchase Common Stock, dated as of December 14, 2021,
issued by the Company to Hudson Bay (the “Hudson Bay Warrant”); (ii) the Company and Hudson Bay amended certain provisions
of the Hudson Bay Warrant; (iii) the Company obtained a limited waiver from Hudson Bay with respect to certain provisions of a Senior
Secured Convertible Note, dated as of December 14, 2021, issued by the Company to Hudson Bay (the “Hudson Bay Note”); and
(iv) the Company and Hudson Bay amended certain provisions of the Hudson Bay Note, all as more fully described below and as set forth
in the Hudson Bay Warrant and the Hudson Bay Note, as applicable.
Pursuant
to the terms of the Hudson Bay Waiver and Amendment, the Company obtained a limited waiver from Hudson Bay with respect to the provisions
of the Hudson Bay Warrant that would have reduced the exercise price of the Hudson Bay Warrant upon the closing of the Offering. In addition,
the Company and Hudson Bay agreed to amend the Hudson Bay Warrant to provide that the exercise price of the Hudson Bay Warrant shall
be the price at which the Company’s common stock is offered for sale in the Offering.
Also
pursuant to the terms of the Hudson Bay Waiver and Amendment, the Company obtained a limited waiver from Hudson Bay with respect to the
provisions of the Hudson Bay Note that would have reduced the conversion price of the Hudson Bay Note upon the closing of the Offering.
Hudson Bay also agreed to extend the date on which the Amortization Redemption Amount (as defined in the Hudson Bay Note) may be paid
from October 14, 2022 to October 19, 2022. In addition, the Company and Hudson Bay agreed to amend the Hudson Bay Note to provide that
the conversion price set forth in the Hudson Bay Note shall be the price at which the Company’s common stock is being offered for
sale in the Offering.
Unit
Offering
On
October 18, 2022 (the “Closing Date”), the Company sold an aggregate of 4,000,000 units (the “Units”) for an
aggregate of $2,000,000, at a purchase price $0.50 per Unit (the “Offering”), consisting of (i) 4,000,000 shares (the “Shares”)
of the Company’s common stock, (ii) warrants with a three-year term to purchase 4,000,000 shares of common stock at an exercise
price of $0.50 per share (the “Three Year Warrants”), and (iii) warrants with a five-year term to purchase 4,000,000 shares
of common stock at an exercise price of $0.50 per share (the “Five Year Warrants” and together with the Three Year Warrants,
the “Warrants”).
On
October 13, 2022, the Company entered into a Placement Agency Agreement (the “Placement Agency Agreement”) with Maxim Group
LLC, as exclusive placement agent thereunder (the “Placement Agent”), pursuant to which the Placement Agent agreed to act
as the Company’s exclusive placement agent to solicit offers to purchase the Units, and the Common Stock and Warrants forming part
of the Units, offered by the prospectus (“Prospectus”) contained in the Registration Statement on Form S-1 (File No. 333-267401)
declared effective by the Securities and Exchange Commission on October 13, 2022 (the “Registration Statement”). The Placement
Agent did not purchase or sell any securities, nor was it required to arrange for the purchase and sale of any specific number or dollar
amount of securities, other than to use its “reasonable best efforts” to arrange for the sale of the securities by the Company.
Accordingly, there was no minimum amount of proceeds that was a condition to closing of the Offering.
The
Offering resulted in gross proceeds to the Company of approximately $2,000,000 before deducting the Placement Agent fees and related
offering expenses, and excluding proceeds to the Company, if any, that may result from the future exercise of Warrants issued in the
Offering which formed part of the Units. Pursuant to the terms of the Placement Agency Agreement, the Company paid the Placement Agent
a cash fee of $140,000 equal to 7.0% of the gross proceeds of the Offering as well as reimbursed the Placement Agent for its accountable
expenses, resulting in net proceeds to the Company of $1,795,000.
Under
the Placement Agency Agreement, the Company agreed to certain restrictions on future stock offerings, including that during the 90-day
period following the Closing Date, the Company will not issue (or enter into any agreement to issue) any shares of common stock or common
stock equivalents, subject to certain exceptions, and will not file any registration statements. In addition, during the 180-day period
following the Closing Date and subject to certain exceptions, the Company is prohibited from entering into (i) a transaction that would
result in the Company issuing common stock that has a variable conversion price, exercise price, or exchange rate, or such a price that
would reset upon the occurrence of specified or contingent events; or (ii) a transaction in which the Company agrees to issue securities
at a future determined price. Each of the Company’s officers, directors, and any holder of 10% or more of the outstanding common
stock has agreed to a three-month “lock-up” with respect to their shares of common stock, including securities that are convertible
into, or exchangeable or exercisable for, shares of common stock. Subject to certain exceptions, during such lock-up period these holders
may not offer, sell, pledge or otherwise dispose of these securities, without the prior written consent of the Placement Agent. The Placement
Agency Agreement provides that the Placement Agent’s obligations were subject to conditions contained in the Placement Agency Agreement.
Each
Warrant had an exercise price of $0.50 per share and is exercisable upon issuance. As a result of the Company’s entry, on November 14, 2022, into the CVI Exchange Offer and Amendment (as hereinafter
defined) and the Hudson Bay Exchange Offer and Amendment (as hereinafter defined), the exercise price of each Warrant was reduced to $0.10
per share. The Three Year Warrants and the Five Year Warrants
will expire three years and five years from the date of issuance, respectively.
Each
Warrant is exercisable for one share of common stock, subject to adjustment in the event of stock dividends, stock splits, stock combinations,
reclassifications, reorganizations or similar events affecting the common stock as described in the Prospectus. Subject to certain exemptions
outlined in the Three Year Warrants and Five Year Warrants, if the Company sells, enters into an agreement to sell, or grants any option
to purchase, or sell, enters into an agreement to sell, or grants any right to reprice, or otherwise disposes of or issues (or announces
any offer, sale, grant or any option to purchase or other disposition) any shares of common stock or Common Stock Equivalents (as defined
in the Three Year Warrants and Five Year Warrants), at an effective price per share less than the exercise price of the Three Year Warrants
or Five Year Warrants then in effect, the exercise price of the Three Year Warrants and Five Year Warrants will be reduced to equal the
effective price per share in such dilutive issuance; provided, however, in no event will the exercise price of the Three Year Warrants
and Five Year Warrants be reduced to an exercise price lower than $0.10. Additionally, on the date that is 60 calendar days immediately
following the initial issuance date of the Three Year Warrants and Five Year Warrants, the exercise price will be reduced to the Reset
Price (as hereinafter defined), provided that the Reset Price is less than the exercise price in effect on that date. The “Reset
Price” is equal to the greater of (a) 50% of the initial exercise price or (b) 100% of the lowest daily volume weighted average
price per share of common stock (“VWAP”) occurring during the 60 calendar days following the issuance date of the Three Year
Warrants and Five Year Warrants.
On
October 13, 2022, the (i) conversion price of the Senior Secured Convertible Notes, and the (ii) exercise price per share of common stock
under the warrants to purchase common stock, issued by the Company and held by CVI Investments, Inc. and Hudson Bay Master Fund Ltd.
(the “Holders”) was reduced to $0.50 per share of common stock based on the offering price of each Unit in the Offering and
in accordance with waivers by the Holders, as further described in the Company’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on October 14, 2022.
The
terms of the Three Year Warrants and Five Year Warrants are governed by a Warrant Agency Agreement (the “Warrant Agency Agreement”),
dated as of the Closing Date, by and between the Company and Pacific Stock Transfer Company (the “Warrant Agent”). Pursuant
to the terms of the Warrant Agency Agreement, the Company agreed to indemnify the Warrant Agent in its roles as transfer agent and warrant
agent, its agents and each of its stockholders, directors, officers and employees against all liabilities, including judgments, costs
and reasonable counsel fees that may arise out of acts performed or omitted for its activities in that capacity, except for any liability
due to any gross negligence, willful misconduct or bad faith of the indemnified person or entity.
Promissory
Note Amortization Payment
On
October 19, 2022, the Company made a cash payment in the aggregate amount of $1,429,896 for the monthly Amortization Payment pursuant
to the terms and conditions of the $16.66m+ convertible notes.
Restricted Stock Issuance
On October 26, 2022, the Company issued 36,222 restricted shares of common
stock for NHL Exchangeable Shares under the terms and conditions of a Share Exchange Agreement
which closed on June 24, 2021.
CVI
Investments, Inc. Exchange Offer and Amendment
On November 14, 2022, the
Company entered into an exchange offer and amendment (the “CVI Exchange Offer and Amendment”) with CVI. Pursuant to the terms
of the CVI Exchange Offer and Amendment, (i) the Company exchanged one share of the Company’s common stock, for each share of common
stock (the “CVI Warrant Exchange”) underlying the warrant to purchase common stock, dated as of December 14, 2021, issued
by the Company to CVI (the “CVI Warrant”); and (ii) the Company and CVI amended certain provisions of the senior secured convertible
note, dated as of December 14, 2021, issued by the Company to CVI (the “CVI Note”), all as more fully described below and
as set forth in the CVI Warrant and the CVI Note, as applicable. On November 15, 2022 and January 5, 2023, 1,757,319 and 1,159,348 shares
of common stock were issued under the terms and conditions of the CVI Warrant Exchange.
Pursuant
to the terms of the CVI Exchange Offer and Amendment, the Company and CVI agreed to amend the CVI Note such that (i) the Company shall
pay the interest originally payable in November 2022 and December 2022 upon execution of the CVI Exchange Offer and Amendment, (ii) the
Company shall pay a $50,000 extension fee to CVI ($10,000 on January 15, 2023, $10,000 on February 14, 2023, $10,000 on March 14, 2023,
$10,000 on April 14, 2023, and $10,000 on May 15, 2023), (iii) the payment dates for the principal originally payable in November 2022
and December 2022 shall be extended such that 1/5 of such respective principal amount shall instead be paid on each Amortization Date
(as defined in the CVI Note) during January 2023, February 2023, March 2023, April 2023, and May 2023, in addition to the Amortization
Redemption Amounts (as defined in the CVI Note) (the “Amortization Redemption Amounts”) due on the aforementioned dates in
2023.
Also,
pursuant to the terms of the CVI Exchange Offer and Amendment, the Company agreed to hold an annual or special meeting of stockholders
on or prior to the date that is 90 calendar days after November 14, 2022, for the purpose of obtaining shareholder approval (“Shareholder
Approval”) to amend the CVI Note as follows:
(i)
the definition of Conversion Price (as defined in the CVI Note) (the “Conversion Price”) shall be amended such that, as
to the first $1,000,000 of principal amount of the CVI Note converted after the date that the Shareholder Approval is obtained, the
Conversion Price shall be the lower of (i) the Conversion Price in effect at such time and (ii) 82.0% of the lowest VWAP (as defined
in the CVI Note) during the five trading days immediately prior to the applicable conversion date (the “Adjusted Conversion
Price”), provided, however, that the portion of the first $1,000,000 of principal amount of the CVI Note that is converted
pursuant to a voluntary conversion by CVI shall reduce each of the remaining Amortization Redemption Amounts proportionately on a
pro rata basis;
(ii)
CVI may accelerate up to four Amortization Redemption Amounts (as defined in the Notes) provided that CVI agrees to accept shares of
Common Stock instead of cash for such payments at a price per share equal to the Adjusted Conversion Price as calculated on the
immediately preceding Amortization Date (as defined in the CVI Note)); and
(iii)
upon mutual consent by the Company and CVI, CVI may elect to utilize the Adjusted Conversion Price for the balance of the
Notes.
The
CVI Exchange Offer and Amendment further provides that from November 14, 2022 until 30 days following November 14, 2022, neither the
Company nor any of its subsidiaries shall (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance
of any Common Stock or any securities convertible or exchangeable into Common Stock, or (ii) enter into any agreement to amend, exchange
or otherwise provide any incentive to exercise any of the warrants originally issued together with the Exchange Warrants or any other
warrants of the Company that are outstanding on November 14, 2022, in each such case except with respect to certain exempt issuances.
Hudson
Bay Master Fund Ltd. Exchange Offer and Amendment
Also, on November 14, 2022,
the Company entered into an exchange offer and amendment (the “Hudson Bay Exchange Offer and Amendment”) with Hudson Bay.
Pursuant to the terms of the Hudson Bay Exchange Offer and Amendment, (i) the Company exchanged one share of the Company’s common
stock, for each share of common stock (the “Hudson Bay Warrant Exchange”) underlying the warrant to purchase common stock,
dated as of December 14, 2021, issued by the Company to Hudson Bay (the “Hudson Bay Warrant”); and (ii) the Company and Hudson
Bay amended certain provisions of the senior secured convertible note, dated as of December 14, 2021, issued by the Company to Hudson
Bay (the “Hudson Bay Note”), all as more fully described below and as set forth in the Hudson Bay Warrant and the Hudson Bay
Note, as applicable. On November 15, 2022, 2,916,667 shares of common stock were issued under
the terms and conditions of the Hudson Bay Warrant Exchange.
Pursuant
to the terms of the Hudson Bay Exchange Offer and Amendment, the Company and Hudson Bay agreed to amend the Hudson Bay Note such that
(i) the Company shall pay the interest originally payable in November 2022 and December 2022 upon execution of the Hudson Bay Exchange
Offer and Amendment, (ii) the Company shall pay a $50,000 extension fee to Hudson Bay ($10,000 on January 15, 2023, $10,000 on February
14, 2023, $10,000 on March 14, 2023, $10,000 on April 14, 2023, and $10,000 on May 15, 2023), (iii) the payment dates for the principal
originally payable in November 2022 and December 2022 shall be extended such that 1/5 of such respective principal amount shall instead
be paid on each Amortization Date (as defined in the Hudson Bay Note) during January 2023, February 2023, March 2023, April 2023, and
May 2023, in addition to the Amortization Redemption Amounts (as defined in the Hudson Bay Note) (the “Amortization Redemption
Amounts”) due on the aforementioned dates in 2023.
Also,
pursuant to the terms of the Hudson Bay Exchange Offer and Amendment, the Company agreed to hold an annual or special meeting of stockholders
on or prior to the date that is 90 calendar days after November 14, 2022, for the purpose of obtaining shareholder approval (“Shareholder
Approval”) to amend the Hudson Bay Note as follows:
(i)
the definition of Conversion Price (as defined in the Hudson Bay Note) (the “Conversion Price”) shall be amended such
that, as to the first $1,000,000 of principal amount of the Hudson Bay Note converted after the date that the Shareholder Approval
is obtained, the Conversion Price shall be the lower of (i) the Conversion Price in effect at such time and (ii) 82.0% of the lowest
VWAP (as defined in the Hudson Bay Note) during the five trading days immediately prior to the applicable conversion date (the
“Adjusted Conversion Price”), provided, however, that the portion of the first $1,000,000 of principal amount of the
Hudson Bay Note that is converted pursuant to a voluntary conversion by Hudson Bay shall reduce each of the remaining Amortization
Redemption Amounts proportionately on a pro rata basis;
(ii)
Hudson Bay may accelerate up to four Amortization Redemption Amounts (as defined in the Notes) provided that Hudson Bay agrees to
accept shares of Common Stock instead of cash for such payments at a price per share equal to the Adjusted Conversion Price as
calculated on the immediately preceding Amortization Date (as defined in the Hudson Bay Note)); and
(iii)
upon mutual consent by the Company and Hudson Bay, Hudson Bay may elect to utilize the Adjusted Conversion Price for the balance of
the Notes.
The
Hudson Bay Exchange Offer and Amendment further provides that from November 14, 2022 until 30 days following November 14, 2022, neither
the Company nor any of its subsidiaries shall (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance
of any Common Stock or any securities convertible or exchangeable into Common Stock, or (ii) enter into any agreement to amend, exchange
or otherwise provide any incentive to exercise any of the warrants originally issued together with the Exchange Warrants or any other
warrants of the Company that are outstanding on November 14, 2022, in each such case except with respect to certain exempt issuances.
Promissory Note Amortization and Extension Fee
Payments
On
November 14, 2022, as provided in the CVI Exchange Offer and Amendment, the Company made a cash payment, in the amount of $37,384, for
the monthly interest owed on the CVI Note outstanding principal balance. On November 14, 2022, as provided in the Hudson Bay Exchange
Offer and Amendment, the Company made a cash payment, in the amount of $33,056, for the monthly interest owed on the Hudson Bay Note
outstanding principal balance.
On January 17, 2023, March 2, 2023, and March 14,
2023, the Company made an interest payment on the Hudson Bay Note, to Hudson Bay, in the amount of $8,333, $625, and $208, respectively.
On January 17, 2023, March 2, 2023, and March 14, 2023, pursuant to the terms of the Hudson Bay Exchange Offer and Amendment, the Company
paid, to Hudson Bay, extension fees in the amount of $10,000, $10,000, and $10,000, respectively. On March 24, 2023, the Company paid to Hudson Bay an aggregate of $70,069, representing the remaining principal balance
on the Hudson Bay Note ($50,000), interest on the Hudson Bay Note ($69), and extension fees ($20,000). As of March 24, 2023, the Hudson
Bay Note was paid in full and no amounts remain due and outstanding in respect of the Hudson Bay Note.
On March 14, 2023, the Company made a principal
payment on the CVI Note, to CVI, in the amount of $6,111 and an interest payment on the CVI Note, to CVI, in the amount of $77. Also
on March 14, 2023, pursuant to the terms of the CVI Exchange Offer and Amendment, the Company paid, to CVI, an extension fee in the
amount of $30,000. On March 24, 2023, the Company paid to CVI an extension fee in the amount
of $20,000. As of March 24, 2023, the CVI Note was paid in full and no amounts remain due and outstanding in respect of the CVI Note.
Share
Issuances in Connection with Warrant Exercises
Subsequent to the fiscal year ended August 31, 2022,
the Company issued an aggregate of 3,910,000 shares of common stock to certain warrant holders upon exercise of their warrants related
to the Company’s Registration Statement on Form S-1 (File No. 333-267401) declared effective by the Securities and Exchange Commission
on October 13, 2022.
Share
Issuances in Connection with Note Conversions
Subsequent
to the fiscal year ended August 31, 2022, the Company issued an aggregate of 94,185,340 shares of common stock to certain note holders
upon conversion of their notes. As of March 31, 2023, (i) the principal balance owed by the Company to Hudson Bay pursuant to
the senior secured convertible note, dated as of December 14, 2021, as amended, issued by the Company to Hudson Bay is $0, (ii)
the principal balance owed by the Company to CVI pursuant to the senior secured convertible note, dated as of December 14, 2021, as amended,
issued by the Company to CVI is $0; and (iii) the principal balance owed by the Company to Jefferson pursuant to the secured convertible
note, dated as of November 17, 2021, as amended, issued by the Company to Jefferson is $0.
Share
Issuance in Exchange for Certain NHL Non-Voting Special Shares
Subsequent
to the fiscal year ended August 31, 2022, the Company issued 3,202,019 shares of common stock in exchange for certain non-voting special
shares of NHL, previously issued in connection with NHL’s acquisition of Acenzia that closed on June 24, 2021.
Nasdaq
Notification—Minimum Bid Price Requirement
On
November 21, 2022, the Company received a notification letter (the “November Notification Letter”) from The Nasdaq Stock
Market, LLC (“Nasdaq”) that it is not in compliance with the minimum bid price requirements set forth in Nasdaq Listing
Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities to
maintain a minimum bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum
bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid
price of the Company’s common stock between October 10, 2022 and November 11, 2022, the Company no longer meets the minimum
bid price requirement. The November Notification Letter has no immediate effect on the listing or trading of the Company’s
common stock on The Nasdaq Capital Market and, at this time, the common stock will continue to trade on The Nasdaq Capital Market
under the symbol “NVOS.”
The
November Notification Letter provides that the Company has 180 calendar days, or until May 22, 2023, to regain compliance with
Nasdaq Listing Rule 5550(a)(2). To regain compliance, the bid price of the Company’s common stock must have a closing bid
price of at least $1.00 per share for a minimum of 10 consecutive business days. If the Company does not regain compliance by May
22, 2023, an additional 180 days may be granted to regain compliance, so long as the Company meets The Nasdaq Capital Market
continued listing requirements (except for the bid price requirement) and notifies Nasdaq in writing of its intention to cure the
deficiency during the second compliance period. If the Company does not qualify for the second compliance period or fails to regain
compliance during the second 180-day period, then Nasdaq will notify the Company of its determination to delist the Company’s
common stock, at which point the Company will have an opportunity to appeal the delisting determination to a hearings
panel.
The
Company intends to monitor the closing bid price of its common stock and will consider implementing available options to regain compliance
with the minimum bid price requirement under the Nasdaq Listing Rules.
Information
Statement on Schedule 14C
On
January 4, 2023, the Company filed with the SEC a definitive information statement on Schedule 14C (the “14C”). The 14C relates
to the notice to stockholders concerning the approval by written consent of stockholders holding a majority of the Company’s issued
and outstanding voting securities (the “Majority Stockholders”) of the effectuation of the transactions provided for in each
exchange offer and amendment entered into on November 14, 2022 by the Company (the “Exchange Offers and Amendments”) with
CVI and Hudson Bay, including but not limited to the following amendments to the senior secured convertible notes, dated as of December
14, 2021, issued by the Company to CVI and Hudson (the “Notes”):
(i)
the definition of Conversion Price (as defined in the Notes) (the “Conversion Price”) shall be amended such that, as to the
first $1,000,000 of principal amount of each of the Notes converted after the date that shareholder approval is obtained, the Conversion
Price shall be the lower of (i) the Conversion Price in effect at such time and (ii) 82.0% of the lowest VWAP (as defined in Notes) during
the five trading days immediately prior to the applicable conversion date (the “Adjusted Conversion Price”), provided, however,
that the portion of the first $1,000,000 of principal amount of each of the Notes that is converted pursuant to a voluntary conversion
by the holders of each of the Notes shall reduce each of the remaining Amortization Redemption Amounts proportionately on a pro rata
basis;
(ii)
Each of the holders of the Notes may accelerate up to four Amortization Redemption Amounts (as defined in the Notes) provided that such
holder agrees to accept shares of Common Stock instead of cash for such payments at a price per share equal to the Adjusted Conversion
Price as calculated on the immediately preceding Amortization Date (as defined in the Notes)); and
(iii)
upon mutual consent by the Company and each of the holders of the Notes, such holder may elect to utilize the Adjusted Conversion Price
for the balance of the Notes.
Accordingly,
the Majority Stockholders approved, by written consent, the issuance of the total number of shares of Company common stock of the Company
necessary to effectuate the Exchange Offers and Amendments, which is currently an indeterminate number due to the methodology of the
conversion pricing as described herein and in the Exchange Offers and Amendments.
Stockholder
approval of the Exchange Offers and Amendments was required by Rule 5635(d) of The Nasdaq Stock Market, which requires stockholder approval
prior to a 20% issuance of securities at a price that is less than the Minimum Price (as defined in the information statement) in a transaction
other than a public offering. A 20% issuance is a transaction, other than a public offering, involving the sale, issuance or potential
issuance by the company of common stock (or securities convertible into or exercisable for common stock), which alone or together with
sales by officers, directors or substantial stockholders of the company, equals 20% or more of the common stock or 20% or more of the
voting power outstanding before the issuance.
Such
approval and consent by the Majority Stockholders constitute the approval and consent of a majority of the total number of shares of
the Company’s outstanding voting stock and is sufficient under the Nevada Revised Statutes, the Company’s Amended and Restated
Articles of Incorporation, as amended, and the Company’s Bylaws to approve the Exchange Offers and Amendments. Accordingly, the
actions will not be submitted to the other stockholders of the Company for a vote, and the information statement has been furnished to
such other stockholders to provide them with certain information concerning the actions in accordance with the requirements of the Exchange
Act, and the regulations promulgated under the Exchange Act, including Regulation 14C.
Jefferson
Street Letter Agreement
As
previously disclosed, on June 1, 2022, the Company and Jefferson agreed to extend the maturity date of the Jefferson Note to November
29, 2022 with a principal amount face value of $937,500 and interest rate that shall accrue at a rate equal to 1% per annum. On December
2, 2022, the Company made a partial payment of $199,980 toward principal and interest owed on the Jefferson Note, leaving a balance of
$746,875. On December 13, 2022, the Company, Terra and Jefferson entered into a letter agreement. Pursuant to the terms of the letter
agreement, Jefferson agreed to forbear from entering an event of default under the terms of the Jefferson Note and related transaction
documents until December 29, 2022. In addition, the parties agreed to release the Collateral Shares to Jefferson. Effective February 16, 2023, the Jefferson Note has been paid in full.
Nasdaq
Notification—Delinquent Form 10-K and Form 10-Q Filings
On
December 15, 2022, the Company received a notification letter (the “December Notification Letter”) from Nasdaq that it is
not in compliance with Nasdaq’s continued listing rules due to its failure to timely file its Annual Report on Form 10-K for the
fiscal year ended August 31, 2022 (the “2022 10-K”). On January 25, 2023, the Company received a notification letter (the
“January Notification Letter”) from Nasdaq advising the Company that it was not in compliance with Nasdaq’s continued
listing requirements as a result of its failure to timely file the 2022 10-K and its Quarterly Report on Form 10-Q for the fiscal quarter
ended November 30, 2022 (the “Form 10-Q”). On February 13, 2023, the Company submitted a plan to regain compliance with Nasdaq’s
continued listing rules with the respect to the Form 10-K and the Form 10-Q. If Nasdaq accepts the Company’s plan, then Nasdaq
may grant an exception of up to 180 calendar days from the due date of the Form 10-K, or until June 12, 2023, to regain compliance.
SwagCheck
Agreement
On
December 23, 2022, the Company, SwagCheck Inc. (“SWAG”), and all SWAG shareholders (collectively, the “SWAG Shareholders”)
entered into that certain Share Purchase Agreement (the “SWAG Agreement”). Pursuant to the terms of the SWAG Agreement, the
Company agreed to purchase, and the SWAG Shareholders agreed to sell to the Company, 100% of the outstanding shares of SWAG in exchange
for $1.00 (the “SWAG Purchase”). SWAG holds a specific right of purchase of a precious gem collection (the “Gems”)
as provided for in an agreement between SWAG and a Court-appointed Successor Receiver for the United States District Court for the Central
District of California (the “Receiver”).
The
parties have made customary representations, warranties and covenants in the SWAG Agreement. In addition to certain customary closing
conditions, the obligations of SWAG and the SWAG Shareholders to consummate the closing of the SWAG Purchase are subject to the satisfaction
(or waiver by any of SWAG or the SWAG Shareholders), at or before the closing date, of certain conditions, including that (i) the Company
will have received a financing commitment of at least $90 million by December 27, 2022, with a closing date no later than December 30,
2022, (ii) $60 million will be distributed directly to a Receiver for the purchase of the Gems by SWAG, and (iii) $30 million is a Mark-up
to be distributed for the benefit of the outgoing SWAG Shareholders.
In
addition to certain customary closing conditions in the SWAG Agreement, the obligations of SWAG and the SWAG Shareholders to consummate
the closing of the SWAG Purchase were subject to the satisfaction (or waiver by any of SWAG or the SWAG Shareholders), at or before the
closing date, of certain conditions, including that (i) the Company will have provided SWAG with a binding letter of intent (a “LOI”)
by a competent financing party for financing in the amount of at least $90 million by December 27, 2022 with a closing date no later
than December 30, 2022, (ii) $60 million will be distributed directly to the Receiver for the purchase of the Gems by SWAG, and (iii)
$30 million is a mark-up to be distributed for the benefit of the outgoing SWAG Shareholders.
On
December 30, 2022, the Company, SWAG and the SWAG Shareholders entered into Amendment No. 1 to the SWAG Agreement (the “SWAG Amendment”).
Pursuant to the terms of the SWAG Amendment, the parties agreed as follows:
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The closing
of the SWAG Purchase will occur no later than January 10, 2023, with all contemplated extensions being subject to the Receiver’s
stipulations, conditions, and limitations. |
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The condition for the Company
to provide SWAG with a binding LOI has been deleted. |
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A total of $92 million
will be distributed as follows: (i) $60 million will be distributed to the Receiver for the purchase of the Gems by SWAG, and (ii)
a $32 million mark-up will be distributed directly for the benefit of the outgoing SWAG Shareholders. |
Although
the SWAG Agreement has not yet closed, the parties continue to work together with the intention of closing the transaction. Following
the closing of SWAG Purchase, SWAG will be a wholly owned subsidiary of the Company and will own title to the Gems, which the Company
intends to either collateralize or sell to raise capital.
Mast Hill Securities Purchase
Agreement & Note
On February 23, 2023, the
Company entered into a securities purchase agreement (the “Mast Hill SPA”) with Mast Hill Fund, L.P. (“Mast Hill”),
pursuant to which the Company issued an 12% unsecured promissory note (the “Mast Hill Note”) with a maturity date of February
23, 2024 (the “Mast Hill Maturity Date”), in the principal sum of $573,000 (the “Mast Hill Principal Sum”). In
addition, the Company issued a common stock purchase warrant for the purchase of up to 1,000,000 shares of the Company’s common
stock (the “Mast Hill Warrant”) to Mast Hill pursuant to the Mast Hill SPA. Pursuant to the terms of the Mast Hill Note, the
Company agreed to pay the Mast Hill Principal Sum to Mast Hill and to pay interest on the principal balance at the rate of 12% per annum.
The Mast Hill Note carries an OID of $57,300. Accordingly, on the closing date, Mast Hill paid the purchase price of $515,700 in exchange
for the Mast Hill Note and the Mast Hill Warrant. Mast Hill may convert the Mast Hill Note into shares of the Company’s common stock
at any time at a conversion price equal to $0.175 per share, subject to adjustment as provided in the Mast Hill Note (including but not
limited to certain price protection provisions in case of future dilutive offerings, subject to certain customary exempt transactions)
as well as certain beneficial ownership limitations.
Pursuant to the terms of
the Mast Hill Note, the Company agreed to pay accrued interest monthly as well as the Mast Hill Principal Sum as follows: (i) $57,300
on August 23, 2023, (ii) 57,300 on September 23, 2023, (iii) $57,300 on October 23, 2023, (iv) $100,000 on November 23, 2023, (v) $100,000
on December 23, 2023, (vi) $100,000 on January 23, 2023, and (vii) all remaining amounts owed under the Mast Hill Note on the Mast Hill
Maturity Date (each of the aforementioned payments are an “Amortization Payment”). If the Company fails to make any Amortization
Payment, then Mast Hill shall have the right to convert the amount of such respective Amortization Payment into shares of common stock
as provided in the Mast Hill Note at the lesser of (i) the then applicable conversion price under the Mast Hill Note, or (ii) 85% of the
lowest VWAP of the Company’s common stock on any trading day during the five trading days prior to the respective conversion date.
The Company may prepay the
Mast Hill Note at any time prior to the date that an Event of Default (as defined in the Mast Hill Note) occurs at an amount equal to
the Mast Hill Principal Sum then outstanding plus accrued and unpaid interest (no prepayment premium) plus $750 for administrative fees.
The Mast Hill Note contains customary events of default relating to, among other things, payment defaults, breach of representations and
warranties, and breach of provisions of the Mast Hill Note, Mast Hill Warrant, or Mast Hill SPA.
Upon the occurrence of any
Event of Default, the Mast Hill Note shall become immediately due and payable and the Company shall pay to Mast Hill, in full satisfaction
of its obligations hereunder, an amount equal to the Mast Hill Principal Sum then outstanding plus accrued interest multiplied by 125%.
Upon the occurrence of an Event of Default, additional interest will accrue from the date of the Event of Default at the rate equal to
the lower of 16% per annum or the highest rate permitted by law.
The Mast Hill Warrant is
exercisable for five years from February 23, 2023, at an exercise price of $0.25 per share, subject to adjustment as provided in the Mast
Hill Warrant. The Mast Hill Warrant also contains certain cashless exercise provisions as well as price protection provisions providing
for adjustment of the number of shares of the Company’s common stock issuable upon exercise of the Mast Hill Warrant and the exercise
price in case of future dilutive offerings, subject to certain customary exempt transactions.
As additional
consideration for the purchase of the Mast Hill Note and pursuant to the terms of the Mast Hill SPA, on February 24, 2023, the
Company issued 955,000 restricted shares of common stock (the “Commitment Shares”) to Mast Hill at closing. The Mast
Hill SPA contains customary representations, warranties, and covenants of the Company, including, among other things and subject to
certain exceptions, piggy-back registration rights with respect to the Commitment Shares as well as the shares of common stock
underlying the Mast Hill Note and the Mast Hill Warrant. In addition to the beneficial ownership limitations provided in the Mast
Hill Note and the Mast Hill Warrant, the sum of the number of shares of common stock that may be issued under the Mast Hill SPA
(including the Commitment Shares), the Mast Hill Note, and the Mast Hill Warrant shall be limited to 19.99% of the issued and
outstanding common stock on the closing date (equal to 27,720,448 shares) as further described in the Mast Hill SPA, unless
shareholder approval to exceed such limitation is obtained by the Company.
On March 23, 2023, the Company made a monthly interest-only
payment to Mast Hill in the amount of $5,086.
March
2023 FirstFire Securities Purchase Agreement, Note & Warrant
On
March 21, 2023, the Company entered into a securities purchase agreement (the “SPA”) with FirstFire, pursuant to which the
Company issued an 12% unsecured promissory note (the “2023 FirstFire Note”) with a maturity date of March 21, 2024, in the
principal sum of $573,000 (the “Principal Sum”). In addition, the Company issued a common stock purchase warrant for the
purchase of up to 1,000,000 shares of the Company’s common stock (the “2023 FirstFire Warrant”) to FirstFire pursuant
to the SPA. Pursuant to the terms of the 2023 FirstFire Note, the Company agreed to pay the Principal Sum to FirstFire and to pay interest
on the principal balance at the rate of 12% per annum. The 2023 FirstFire Note carries an OID of $57,300. Accordingly, on the closing
date, FirstFire paid the purchase price of $515,700 in exchange for the 2023 FirstFire Note and the 2023 FirstFire Warrant. FirstFire
may convert the 2023 FirstFire Note into the Company’s common stock at any time at a conversion price equal to $0.175 per share,
subject to adjustment as provided in the 2023 FirstFire Note (including but not limited to certain price protection provisions in case
of future dilutive offerings, subject to certain customary exempt transactions) as well as certain beneficial ownership limitations.
Pursuant
to the terms of the 2023 FirstFire Note, the Company agreed to pay accrued interest monthly as well as the Principal Sum as follows:
(i) $57,300 on September 21, 2023, (ii) 57,300 on October 21, 2023, (iii) $57,300 on November 21, 2023, (iv) $100,000 on December 21,
2023, (v) $100,000 on January 21, 2024, (vi) $100,000 on February 21, 2024, and (vii) all remaining amounts owed under the 2023 FirstFire
Note on the maturity date (each of the aforementioned payments are an “Amortization Payment”). If the Company fails to make
any Amortization Payment, then FirstFire shall have the right to convert the amount of such respective Amortization Payment into shares
of common stock as provided in the 2023 FirstFire Note at the lesser of (i) the then applicable conversion price under the 2023 FirstFire
Note or (ii) 85% of the lowest VWAP of the Company’s common stock on any trading day during the five trading days prior to the
respective conversion date.
The
Company may prepay the 2023 FirstFire Note at any time prior to the date that an event of default (as provided in the 2023 FirstFire
Note) occurs at an amount equal to the Principal Sum then outstanding plus accrued and unpaid interest (no prepayment premium) plus $750
for administrative fees. The 2023 FirstFire Note contains customary events of default relating to, among other things, payment defaults,
breach of representations and warranties, and breach of provisions of the 2023 FirstFire Note, the 2023 FirstFire Warrant, or SPA.
Upon
the occurrence of any event of default, the 2023 FirstFire Note shall become immediately due and payable and the Company shall pay to
FirstFire, in full satisfaction of its obligations hereunder, an amount equal to the Principal Sum then outstanding plus accrued interest
multiplied by 125% (the “Default Amount”). Upon the occurrence of an Event of Default, additional interest will accrue from
the date of the Event of Default at the rate equal to the lower of 16% per annum or the highest rate permitted by law.
The
2023 FirstFire Warrant is exercisable for five years from March 21, 2023, at an exercise price of $0.25 per share, subject to adjustment
as provided in the 2023 FirstFire Warrant. The 2023 FirstFire Warrant also contains certain cashless exercise provisions as well as price
protection provisions providing for adjustment of the number of shares of common stock issuable upon exercise of the 2023 FirstFire Warrants
and the exercise price in case of future dilutive offerings, subject to certain customary exempt transactions.
As
additional consideration for the purchase of the 2023 FirstFire Note and pursuant to the terms of the SPA, on March 22, 2023, the
Company issued 955,000 restricted shares of the Company’s common stock (the “Commitment Shares”) to FirstFire at
closing. The SPA contains customary representations, warranties, and covenants of the Company, including, among other things and
subject to certain exceptions, piggy-back registration rights with respect to the Commitment Shares as well as the shares of common
stock underlying the 2023 FirstFire Note and the 2023 FirstFire Warrant. In addition to the beneficial ownership limitations
provided in the 2023 FirstFire Note and the 2023 FirstFire Warrant, the sum of the number of shares of common stock that may be
issued under the SPA (including the Commitment Shares), the 2023 FirstFire Note, and 2023 FirstFire Warrant shall be limited to
10,000,000 shares as further described in the SPA, unless shareholder approval to exceed such limitation is obtained by the
Company.
Business
Growth Initiatives
The
Company’s mission is to provide excellence in multidisciplinary primary health care evaluation, assessment, diagnosis, treatment,
pain management and prevention through the integration of medical technology, advanced therapeutics, and rehabilitative science combined
with the development and distribution of high-quality health and wellness product solutions. Key elements of our business growth initiatives
include:
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Increase Market Share
in Canada through Organic Growth, Asset Acquisition and Affiliate Network Expansion for both our Clinic and Eldercare Operations.
Specific to our clinic operations, the Company has an ongoing initiative to expand our Canadian market share through organic
growth, increasing our affiliate network of clinics, as well as strategic acquisitions and Joint Ventures of operating multidisciplinary
primary health care clinics in markets in which we currently operate as well as new geographic markets. Specific to our eldercare
based operations, we intend to increase our Canada market share of providing contracted-occupational therapy and physiotherapy services
to eldercare centric homes through network affiliation growth, new contract awards, and increased usage of telemedicine. |
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Expand Operations into
the United States through: |
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the introduction and deployment
of our various interconnected technology platforms to deliver the Company’s array of primary care services and products. |
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Establish micro clinics
in existing facilities through partnerships with existing U.S. based operators of healthcare related services and products such as
pharmacies and big-box retail outlets. |
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The strategic acquisition
of targeted U.S. operating clinics in key geographical areas. |
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The strategic acquisition
of targeted U.S. operating pharmacies in key geographical areas. |
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Establishment of strategic
affiliations, alliances and partnerships with existing U.S. health care provider facilities allowing us immediate access to their
client base. |
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Open Micro-Clinic Facilities
through our U.S. and Canada LA Fitness Master Facility License Agreements. Micro-clinic facilities are reduced footprint clinics,
primarily located within the footprint of box-store commercial enterprises, focused on providing both (i) multidisciplinary primary
care and medical technology related services, and (ii) health and wellness products. Under the terms of our agreements with LA Fitness
(U.S. and Canada), we are planning to operate micro-clinic facilities within the footprint of LA Fitness facilities throughout both
the U.S. and Canada. Each micro-clinic exists through either third-party sub-license agreements or corporate sponsored arrangement.
The Company’s LA Fitness based micro-clinic facilities will primarily provide outpatient physiotherapy and occupational therapy
services. |
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Further Development
and Usage of Novo Connect and Telemedicine/Telehealth Medical Technology Platform. |
The
Company’s focus on a holistic approach to patient-first health and wellness, through innovation and decentralization, includes
maintaining an on-going continuous connection with our current and future patient community, beyond the traditional confines of brick-and-mortar
facilities, by extending oversight of patient evaluation, diagnosis, treatment solutions, and monitoring, directly through various Medical
Technology Platforms and periphery tools either in-use or under development. Through the integration and deployment of sophisticated
and secure technology and periphery diagnostic tools, the Company is working to expand the reach of our non-critical primary care services
and product offerings, beyond the traditional clinic locations, to geographic areas not readily providing advanced primary care service
to date, including the patient’s home.
The
Company believes the healthcare industry is in the early stages of a fundamental transformation of the patient-practitioner-health insurer
relationship whereby the patient is demanding greater control and care collaboration for their health and wellness needs while the practitioner
desires dramatic improved efficiency in the delivery of their expertise to the patient. Through both internal development and partnerships,
the Company is working to provide the next generation of telehealth technology capability to offer the patient and the practitioner a
sophisticated and enhanced telehealth interaction through laptop, desktop or the Company’s Novo Connect mobile application.
Novo
Connect is the Company’s proprietary mobile application designed and built to be a secure, cloud-based health and commerce web
application intended to assist patients as they explore, connect, manage, and have direct control of their personalized health and wellness
needs. Novo Connect is designed to integrate the Company’s interconnected technology and provide the patient a single platform
with a robust healthcare ecosystem of services, products and digital health offerings.
Through
the interface of sophisticated peripheral based diagnostic tools, such as a blood pressure reading device, a derma scope, an ophthalmoscope
otoscope, and other add-ons operated by skilled support workers in the patient’s remote location, the practitioner’s ability
and comfort to provide a uniquely comprehensive evaluation, diagnosis, and treatment solution is dramatically elevated creating virtual
visits that are intended to be as real and as effective as a physical visit.
Specific
to our eldercare operations, prior to COVID-19 our Telemedicine Medical Technology Platform was primarily focused on providing physiotherapy
related “virtual-care” services to both smaller and remote eldercare focused facilities to ensure access to service providers,
when needed; and continuity of care to eldercare patients without service providers in their area. With the profound impact COVID-19
has had on the delivery of healthcare services sector wide, we expanded our eldercare related Telemedicine Medical Technology Platform
to include non-critical resident reviews, exercise related activity and additional physiotherapy sessions, ensuring continuity of service
for our long-term care and retirement home clients.
Specific
to our Clinic based operations, the success of telemedicine has always depended on the adoption of virtual technology by clinicians,
medically licensed providers and the patient. A basic checklist approach to results allows both multidisciplinary clinicians and medically
licensed providers to remotely determine if direct medical attention is required rather than remote or virtual guidance to care. The
patient friendly telemedicine platform removes the traditional barrier represented by intimidating peripherals along with necessary precision
use and application of the peripherals to obtain accurate data necessary for appropriate diagnosis. A patient can now feel certain of
their role in the assessment process without sophisticated and exhaustive training.
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Develop and Launch our
Remote Patient Monitoring Medical Technology Platform. Beyond the traditional confines of in-clinic visits, our Remote Patient
Monitoring Medical Technology Platform (“RPM platform” or “RPM”) provides clinicians and practitioners the
ability to maintain an on-going continuous connection with their patient community extending patient care directly into the patient’s
home. Through our licensing agreement with Cloud DX, our RPM platform empowers a patient to have direct control of collecting and
monitoring real-time vital sign information while maintaining a direct technology link from patient to clinician or medical practitioner.
The transfer of vital information from home to clinic or patient to clinician allows for the delivery of high quality, non-redundant
diagnostic based proactive healthcare. The implementation of in-clinic patient metrics equivalent to those derived via a remote application
in the home environment is the first step in engaging patient retention to remote review. |
Effective
with the re-opening of NHL’s corporate clinics post COVID-19 lockdown, we have launched Phase 1 of our Remote Patient Monitoring
Medical Technology Platform. Using the Cloud DX technology, at the time of our clinic staff initiating patient check-in, NHL’s
staff is collecting pertinent vital sign data for on-going analysis, comparison, and observation under the RPM license application. Our
clinic staff are actively working to educate our patients regarding the benefits of participating in our RPM Platform. In Canada, third
party insurance coverage for RPM related devices is now being reviewed for implementation nationwide. Currently, as documented and requested
by the clinician, insurance coverage is being approved on a case-by- case basis.
Additionally,
the Company is implementing a marketing and sales program to sub-license the Cloud DX technology to our Canadian affiliate clinic network
as well as other clinics and medically licensed providers throughout both Canada and the United States.
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Build
an Intellectual Property and Patent Portfolio. In addition to the Company’s current portfolio of Intellectual Property
(IP), patent-pending and patent assets, we intend to acquire or obtain licensing rights for IP and patents related to health sciences,
health and wellness products, and nano-formulation.
When
considering nano-formulation patent and IP assets, one specific area we intend to pursue relates to medical cannabis related medicines,
beverages and foods infused with dry powder, liquid or oil with further formulation into creams and gels, allowing for oral, intravenous
and/or transdermal delivery. |
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Expand our Posture,
Stride, and Kinetic Body Movement Scanning Technologies and Protocols. When combined with decades of data harvesting and analysis,
we believe these specialized technologies and protocols provide our clinics with the ability to deliver better healthcare, through
early diagnosis and preventative health care strategies, to both our patients and patients under the care of other providers. |
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Launch our Exclusive
Medicinal Cannabidiol (“CBD”) Product Platform based in Canada. As we continue to build our health science platform
of services and products through the integration of technology and rehabilitative science, one component of our lateral business
growth strategy includes developing business units centered on the direct control of the cultivation, processing, and manufacturing
of CBD products in Canada, and the sale and distribution of medicinal CBD products in Canada and authorized U.S. states. We expect
our prospective medicinal CBD products will be specifically focused on CBD for use (i) as a treatment aid; (ii) to provide relief
for a large array of neurological and musculoskeletal system disorders; and (iii) as an alternative option for health care providers
in place of prescribing opioids to patients. |
Offering
our patients access to non-hallucinogenic and non-addictive natural remedies, under required clinical oversight policies and procedures
as they relate to medicinal CBD, combined with our existing clinic-based treatment protocols, allows us to enter this market segment
with a unique integration model not readily available in the marketplace.
LA
Fitness U.S. and Canada License Agreement & Guaranty for Micro Clinics
In
September 2019, through its U.S. subsidiary Novomerica Health Group, Inc. (“Novomerica”) and its Canadian subsidiary, Novo
Healthnet Limited, the Company entered into exclusive Master Facility License Agreements (“License Agreement”) to establish
and operate reduced footprint clinics, or “micro-clinics”, to provide outpatient physical and/or occupational therapy services
and related products within LA Fitness facilities in both the U.S. and Canada. In March 2020, as a result of guidelines issued by local,
state, federal, and provincial authorities due to the COVID-19 pandemic, LA Fitness U.S. and Canada closed all facilities nationwide.
As a result, all contractual terms and conditions of both our U.S. and Canada Master Facility License Agreements were placed on hold
through fiscal year 2021 with all parties expressing the intent to amend both the U.S. and Canada License Agreements and related timelines
to launch our LA Fitness micro-clinic facilities as “normal” activity resumes in the LA Fitness U.S. and Canada facilities.
On
December 15, 2021, NHL entered into an Amended and Restated Master Facility License Agreement (the “Amended and Restated Canada
License Agreement”) with LAF Canada Company (“LA Fitness Canada”). The Amended and Restated Canada License Agreement
had the effect of (i) removing NHL’s obligation to develop and open a certain number of facilities within certain designated time
periods; and (ii) revising the default provisions such that certain defaults will result only in termination with respect to a specific
facility, rather than of the license itself. As a result of the Amended and Restated Canada License Agreement, NHL may continue to develop
and open additional facilities for business.
We
cannot guarantee that the U.S. License Agreement will be amended to allow for an extension of its timeline. Currently, under both government
and internal corporate directives, LA Fitness continues to both open and expand operations, access and services offered in both its U.S.
and Canada facilities. Opening of our micro-clinic facilities may vary from state to state and province-to-province; however, our model
plan to partner and sub-license with existing local clinic ownership to launch and operate each of our LA Fitness micro-clinic facilities
remains intact. Due to the ever-changing conditions surrounding the operations of both U.S. and Canada based LA Fitness facilities, we
are unable to verify our schedule to commence opening our micro-clinics, but we are tentatively planning on a target of the latter part of 2023.
Cloud
DX
On
February 26, 2019, the Company entered into a Software License Agreement with Cloud DX, Inc., a medical device company, operating in
the United States and Canada that develops both hardware and related software for Remote Patient Monitoring Medical Technology Platform
and Chronic Care, that provides NHL with perpetual licensing rights to the Bundled Pulsewave PAD-1A USB Blood Pressure Device, related
software and up-to-date product releases. Additionally, the License Agreement provides NHL with conditional exclusive rights, over the
initial 5-year period, to sub-license and re-sell Bundled Pulsewave Devices and related software pursuant to the terms of the Software
License Agreement.
The
Cloud DX platform allows NHL to further expand on its patient care philosophy of maintaining an on-going continuous connection with its
patient community, beyond the traditional confines of a clinic, extending oversight of patient care and monitoring directly into the
patient’s home through Remote Patient Monitoring Medical Technology Platform. The Cloud DX technology empowers a patient with real-time
vital sign information while maintaining a direct technology link from patient to clinician or medical practitioner. The transfer of
vital information from home to clinic or patient to clinician further allows our clinicians and practitioners to deliver non-redundant
diagnostic based proactive multidisciplinary primary health care.
Effective
with the re-opening of NHL’s corporate clinics post COVID-19 lockdown, we have launched Phase 1 of our Remote Patient Monitoring
Medical Technology Platform. Using the Cloud DX technology, at the time of our clinic staff initiating patient check-in, NHL’s
staff is collecting pertinent vital sign data for on-going analysis, comparison, and observation under the RPM license application. Our
clinic staff are actively working to educate our patients regarding the benefits of participating in our RPM Platform. In Canada, third
party insurance coverage for RPM related devices is now being reviewed for implementation nationwide. Currently, as documented and requested
by the clinician, insurance coverage is being approved on a case-by- case basis.
Additionally,
the Company is implementing a marketing and sales program to sub-license the Cloud DX technology to our Canadian affiliate clinic network
as well as other clinics and medically licensed providers throughout both Canada and the United States.
Contracts
Certain
contracts held with client homes and client companies follow standard formats and include generally accepted terms of reference. Specific
clauses within the NHL contracts for services contain language intended to (1) clarify which entity is the health information custodian
of the medical files (usually held by the client home or company), (2) define release of liability, (3) ensure privacy and confidentiality
of proprietary information or private health information, (4) define provisions of worker’s compensation clearance or benefits
for employees and/or contractors, (5) detail provisions of value-added items, services or programs, (6) set out terms and conditions
of the contract (often for a set number of years with an option to a renew), (7) provide for termination conditions, and (8) detail invoicing
and billing procedures.
Employees
As
of August 31, 2022, we employed 115 full-time employees and 91 part-time employees across all Company subsidiaries. Specific to our clinic
and eldercare services, approximately 90% of our clinicians and practitioners are contracted as independent contractors. We believe that
a diverse workforce is important to our success. We will continue to focus on the hiring, retention and advancement of women and underrepresented
populations, and to cultivate an inclusive and diverse corporate culture. In the future, we intend to continue to evaluate our use of
human capital measures or objectives in managing our business such as the factors we employ or seek to employ in the development, attraction
and retention of personnel and maintenance of diversity in our workforce.
The
success of our business is fundamentally connected to the well-being of our people. Accordingly, we are committed to the health, safety
and wellness of our employees. We provide our employees and their families with access to a variety of innovative, flexible and convenient
health and wellness programs, including benefits that provide protection and security so they can have peace of mind concerning events
that may require time away from work or that impact their financial well-being; that support their physical and mental health by providing
tools and resources to help them improve or maintain their health status and encourage engagement in healthy behaviors; and that offer
choice where possible so they can customize their benefits to meet their needs and the needs of their families.
We
also provide robust compensation and benefits programs to help meet the needs of our employees. We believe that we maintain a satisfactory
working relationship with our employees and have not experienced any labor disputes.
Competition
In
both Canada and the U.S., the primary healthcare service sector in which we operate is highly competitive. Specific to both our clinic
and eldercare operations, with a finite number of patients and corporate clients, companies providing multidisciplinary primary health
care services operate within an overlapping patient and client landscape.
Our
principal competitors include other multidisciplinary primary healthcare providers, clinics, pharmacies, other micro clinic-oriented
facilities, hospitals, and general primary care facilities. An important part of our business strategy is to continue making targeted
acquisitions of other multidisciplinary primary healthcare providers. However, reduced capacity, the passage of healthcare parity legislation,
and increased demand for multidisciplinary primary healthcare related services and products are likely to attract other potential buyers,
including diversified healthcare companies, other pure-play multidisciplinary primary healthcare providers, companies, and private equity
firms.
In
addition to the competition we face for acquisitions, we must also compete for patients. Patients are referred to our multidisciplinary
primary healthcare facilities through a number of different sources, including healthcare practitioners, public programs, other treatment
facilities, insurance providers, legal practitioners, and word of mouth from previously treated patients and their families, among others.
These referral sources may instead refer patients to other providers of services similar to ours.
There
is additional competition from non-traditional healthcare providers, such as holistic and Eastern medicine-based clinics. We believe
we can successfully compete based on providing high-quality specialized multidisciplinary primary health care services, products, meaningful
interconnected technology applications, competitive pricing, building and maintaining a solid reputation and our caregiver’s devotion
to maintaining the highest quality patient satisfaction.
The
health and wellness product industry is highly competitive. Our ability to remain competitive depends on many factors, including having
relevant products that meet consumer needs, enhanced education and tools, innovation in our products and services, competitive pricing,
a strong reputation, and a financially viable company.
Health
Insurance Plans
Additionally,
our ability to effectively compete for patients is impacted by commercial and managed care payor programs that influence patient choice
by offering health insurance plans that restrict patient choice of provider.
Canadian
Health Care System
Our
competition will also be the Canadian health care system which is a government sponsored system that began in 1957, when Parliament approved
the Hospital Insurance and Diagnostics Services Act. The Act provided free acute hospital care, laboratory and radiological diagnostic
services to Canadians. By 1961, agreements were in place with all the provinces and 99% of Canadians had free access to the health care
services covered by the legislation. The Act was followed by the Medical Care Act of 1966 that provided free access to physician services.
By 1972, each province had established its own system of free access to physician services. The federal government shared in the funding.
In 1984, the Government of Canada passed the Canada Health Act (CHA). The Canada Health Act created a publicly administered health care
system that is comprehensive, universal and accessible. All medically necessary procedures are provided free of charge. The system provides
diagnostic, treatment and preventive services regardless of income level or station in life. Access to care is not based on health status
or ability to pay. Coverage is portable between provinces and territories. We can give no assurance that we will be able to effectively
compete in this market.
Government
Regulation and Health Care Regulation
Canada
In
Canada, some health care services are public, some are private and there are a number of different entities involved in regulating and
providing their delivery. While there is a perception that all health care in Canada is publicly funded, the publicly funded system is
generally restricted to “medically necessary” hospital and physician services, and provincial or territorial drug plans that
provide access to prescription drugs to residents over the age of 65 or those residents who rely on social assistance programs. Publicly
funded services are delivered through a combination of public and private providers and funding comes from the Canadian federal government,
which sets national standards, and the provincial and territorial governments, which regulates the delivery of services and determines
those services that are deemed “medically necessary” (i.e., publicly funded) within the context of their own unique fiscal
and political environment. In addition, there are a wide array of health products and services that are not subject to coverage under
the public health insurance plans that are provided on a private payer basis. See “Risks Related to our Multidisciplinary Primary
Health Care Business”.
Federal/Provincial
Government Division of Power
As
is the case for many important industries and economic sectors, neither the federal, nor the provincial/territorial level of government
has exclusive jurisdiction over health. Instead, the Constitution Act, 1867, divides the legislative powers relevant to the regulation
of the delivery of health products and services between the federal and provincial levels of government.
The
federal government is responsible for regulating important aspects of various health industries or sectors including the regulation of
selling, importing, distributing and marketing of drugs and medical devices and maintains significant influence over health policy and
national objectives through the use of its spending power.
The
provincial/territorial level of government has comprehensive authority over the delivery of health care services. Other examples of provincial
responsibility include the regulation of hospitals and other health facilities, administration of health insurance plans, distribution
of prescription drugs and regulation of health professionals.
However,
many health industry sectors are subject to at least some degree of regulation or oversight by both levels of government.
Canada’s
National Health Insurance Program
Canada’s
“national” health insurance program, a publicly funded single-payer system often referred to as “Medicare,” is
designed to ensure that all Canadian residents have universal access to medically necessary hospital and physician services through the
provincial and territorial health care insurance plans.
The
Canada Health Act
The
Canada Health Act is the federal legislation that provides the foundation for the Canadian health care system. The Act is administered
by Health Canada, the federal department with primary responsibility for maintaining and improving the health of Canadians. However,
neither the Canada Health Act nor Health Canada have direct authority to regulate the health insurance plans that give effect to the
publicly funded health insurance system that is in place across the country. Instead, the Act establishes certain values and principles
and sets out criteria and conditions that each publicly funded health insurance plan is required to meet in order to qualify for federal
funding through the Canada Health Transfer. As federal funding is critical to the ability to fund “medically necessary” hospital
and physician services, each provincial and territorial health insurance plan must satisfy the requirements of public administration;
universality; portability; comprehensiveness; and accessibility.
Notably,
these requirements relate only to funding and administration and establish broad principles rather than a prescriptive code. In addition,
the Canada Health Act is silent with respect to the delivery of health services and does not prohibit or discourage the delivery of insured
health services by the private sector. As a result, there is significant variation in the funding and administration of health insurance
plans from one jurisdiction to another. However, most provinces permit the delivery of a broad range of publicly funded health services
through a combination of both public and private providers. Indeed, many publicly funded services in Canada are privately delivered.
The
requirement that publicly funded health insurance plans be comprehensive requires that “medically necessary” hospital and
physician services be covered. If a service is determined to be “medically necessary” then the full cost of the service must
be covered by the public plan. However, the term is not defined and the services that must be covered are intentionally and broadly defined
in order to accommodate the ability of each province and territory to make its own coverage decisions within the context of its unique
fiscal and political environment. Typically, such decisions are made in consultation with the relevant medical associations in the jurisdiction.
However, determining whether a particular service is “medical necessary” is a determination that has both a fiscal and political
dimension. Ultimately, these coverage decisions are decisions about the allocation of scarce public resources.
The
products and services available to Canadians through the publicly funded health insurance system are supplemented by a wide array of
health products and services that are not, as a general matter, subject to coverage under the public health insurance plans. For example,
prescription drug coverage, dental services and vision care are generally provided on a private payer basis. However, many jurisdictions
provide coverage for these types of services to seniors and those who face financial or other barriers to privately funded health care.
There are also a growing number of providers that offer non-medically necessary ancillary health services. Examples include elective
surgical or cosmetic procedures.
Regulation
of Health Professionals and Health Facilities
Health
professionals and health care facilities are subject to federal laws of general application, but the regulation of such matters is largely
a matter of provincial jurisdiction.
Health
Professionals
Through
legislation, the provinces have delegated the regulation of health professionals to self-governing professional bodies (with varying
degrees of discretion). Such legislation generally seeks to protect the public through a combination of “input regulations”
that focus on who is entitled to provide a particular health service and “output regulations” that focus on the quality and
delivery of the service being provided. Such regulations also generally include conflict of interest (or anti-kickback) provisions, as
such matters are generally dealt with as part of the regulation of health professions rather than the regulation of health facilities.
Health
industry participants that offer a particular service need to understand how the service is regulated. If the service involves the performance
of a regulated or controlled act (i.e., acts that can only be performed by a particular category or categories of regulated health professionals
or their delegates) then the involvement of one or more duly qualified health professionals will likely be required. Also, it may be
necessary to implement certain protocols and procedures in order to comply with the requirements of the regulatory colleges that govern
the practices of any such professionals. Complying with such requirements can have significant commercial implications.
Health
Facilities
Operating
a regulated health facility can be challenging and often involves a degree of regulatory risk.
Residential
health care facilities other than hospitals, such as nursing homes, long-term care facilities, pharmacies, laboratories and specimen
collection clinics are, in most jurisdictions, privately owned and operated pursuant to provincial licenses and oversight. However, the
degree to which such health facilities and other providers are regulated generally depends on the nature of the products and services
being provided.
The
operation of health facilities by private sector entities still typically involves some element of reimbursement through public funds.
Where public funds are being used to acquire goods and services, additional accountability measures such as procurement requirements
often apply.
Regulation
of Drugs
The
process of obtaining marketing authorizations and approvals of prescription drugs is administered by Health Canada’s Therapeutic
Products Directorate (“TPD”).
The
TPD applies the Food and Drugs Act and the regulations applicable to prescription drugs to ensure that drug products sold in Canada are
safe and effective. No drug product can be offered for sale in Canada unless and until, after review, it is issued a marketing authorization
by Health Canada.
In
addition to its review of drug products, Health Canada is responsible for the ongoing monitoring of drug products being sold in Canada,
as well as the regulation of good manufacturing practices and establishment licenses, which are required in connection with the import,
manufacture, distribution and/or sale of drug products.
The
Patented Medicines Prices Review Board
The
Patented Medicines Prices Review Board (“PMPRB”) is an independent quasi-judicial body created in 1987 under amendments to
the Patent Act. The PMPRB is responsible for regulating the prices that patentees charge for prescription and non-prescription patented
drugs sold in Canada. Based on a review of the information required to be filed by a patentee, the PMPRB considers whether the price
of a medicine appears excessive based on certain factors including: (i) the prices that the patented medicine is sold in the Canadian
market; (ii) the prices at which other medicines in the same therapeutic class are sold in the Canadian market; and (iii) the prices
at which the medicine and other medicines in the same therapeutic class have been sold in other countries other than Canada. If the PMPRB
considers the price of a medicine appears excessive, revised pricing is the usual outcome.
Public
Market Access
Each
province has a provincial drug plan that allows certain individuals to access drugs at a reduced cost. Products that will be paid for
by the provincial government (in some provinces, for all residents, while in others for certain prescribed individuals such as seniors
and individuals receiving social assistance), are typically listed on provincial formularies. For innovator products, the manufacturer
negotiates the pricing for inclusion on the provincial formulary with the provincial government. For generic products, the price to be
paid for the generic product is determined by a sliding scale of fixed prices related to when such products enter the market and the
price of the innovator product (i.e., a percent of the price of the innovator pharmaceutical product depending on whether they are first,
second or third entry products). If a drug is a generic product and listed as interchangeable on the provincial formulary, a pharmacist
is permitted to dispense the interchangeable product for the innovator product. Under most provincial benefit plans, interchanging a
generic product for the innovator product by pharmacists is mandatory and generally most provinces will only reimburse the pharmacist
for the lowest cost interchangeable product. Government drug plans account for approximately 50% of all sales of prescription drugs in
Canada.
The
scope and enforcement of each of these laws is uncertain and subject to constant change. Federal and provincial enforcement entities
have significantly increased their scrutiny of health care companies and providers which has led to investigations, prosecutions, convictions
and large settlements. Although we conduct our business in compliance with all applicable federal and provincial fraud and abuse laws,
many of these laws are broadly worded and may be interpreted or applied in ways that cannot be predicted with any certainty. Therefore,
we cannot assure you that our arrangements or business practices will not be subject to government scrutiny or that they will be found
to be in compliance with applicable fraud and abuse laws. Further, responding to investigations can be time consuming and result in significant
legal fees and can potentially divert management’s attention from the Company.
Client
Information Privacy
In
Canada, under the Personal Information Protection and Electronic Documents Act and under various provincial laws, comprehensive privacy
laws have been introduced to protect the privacy of individuals from the undisclosed or non-consensual sharing of sensitive information
for commercial purposes. As the gathering and use of information is such an integral component of our business, we must always be alert
for and respond to changes in the information regulatory environment.
Protection
of Environment and Human Health and Safety
We
are subject to various federal, state and local and regulations relating to the protection of the environment and human health and safety,
including those governing the management and disposal of hazardous substances and wastes, the cleanup of contaminated sites and the maintenance
of a safe workplace. Some of our operations include the use, generation and disposal of hazardous materials. We also plan to acquire
ownership in new facilities and properties, some of which may have had a history of commercial or other operations. We may, in the future,
incur liability under environmental statutes and regulations with respect to contamination of sites we own or operate, including contamination
caused by prior owners or operators of such sites, abutters or other persons, and the off-site disposal of hazardous substances. Violations
of these laws and regulations may result in substantial civil penalties or fines.
United
States
The
United States health care industry is subject to extensive regulation by federal, state and local governments. Government regulation
affects our businesses in several ways, including requiring licensure or certification of facilities, regulating billing and payment
for certain of our services, regulating how we maintain health-related information and patient privacy, and regulating how we pay and
contract with our physicians. Our ability to conduct our business and to operate profitability depends in part upon obtaining and maintaining
all necessary licenses and other approvals; and complying with applicable healthcare laws and regulations. See “Risk Factors —
Risks Related to Health Care Regulation.”
State
Law Regulation of Construction, Acquisition or Expansion of Healthcare Facilities
Thirty-six
states have certificate of need programs that require some level of prior approval for the construction of a new facility, acquisition
or expansion of an existing facility, or the addition of new services at various healthcare facilities. Following the acquisition of
one or more clinics or staffing primary healthcare practitioners in the United States, states where we may seek to operate may require
a certificate of need to acquire or operate our clinics.
State
Licensure
Only
a few states may require the licensure of multidimensional primary health care clinics and clinics such as ours. This absence of a uniform
licensing process leads to inconsistencies in the nature and scope of services offered at our care clinics. To effectively control both
the nature of services rendered and the environment in which services are offered, state legislators or regulators may attempt to regulate
the urgent care industry in a manner similar to hospitals and freestanding emergency rooms. Following the acquisition of one or more
clinics or staffing primary healthcare practitioners in the United States, such regulations could have a material impact on our growth
strategy and expansion plans.
Laws
and Rules Regarding Billing
Following
the intended acquisition, or opening, of one or more multidisciplinary primary healthcare clinics or the staffing of multidisciplinary
primary healthcare clinics, affiliate clinics or eldercare centric homes with clinicians and practitioners in the United States, numerous
state and federal laws may apply to our claims for payment, including but not limited to (i) “coordination of benefits” rules
that dictate which payor must be billed first when a patient has coverage from multiple payors, (ii) requirements that overpayments be
refunded within a specified period of time, (iii) “reassignment” rules governing the ability to bill and collect professional
fees on behalf of other providers, (iv) requirements that electronic claims for payment be submitted using certain standardized transaction
codes and formats, and (v) laws requiring all health and financial information of patients in a manner that complies with applicable
security and privacy standards.
Additionally,
on January 16, 2009, the United States Department of Health and Human Services (“HHS”), released the final rule (implemented
on October 1, 2015) mandating that providers covered by the Administrative Simplification Provisions of the Health Insurance Portability
and Accountability Act of 1996 (“HIPAA”), including our clinics, comply with ICD-10. Following the acquisition of one or
more clinics or staffing primary healthcare practitioners in the United States, we will incur additional compliance related costs.
Medicare
and Medicaid
Following
the intended acquisition, or opening, of one or more multidisciplinary primary healthcare clinics or the staffing of multidisciplinary
primary healthcare clinics, affiliate clinics or eldercare centric homes with clinicians and practitioners in the United States, our
clinics and multidisciplinary primary healthcare clinicians and practitioners, including any staffing we might pursue in affiliate clinics
or eldercare centric homes in the United States, might participate in the federal Medicare and/or Medicaid programs.
Since
1992, Medicare has paid for the “medically necessary” services of physicians, non-physician practitioners, clinicians and
certain other suppliers under a physician fee schedule, a system that pays for covered physicians’ services furnished to a person
with Medicare Part B coverage. Under the physician fee schedule, relative values are assigned to each of more than 7,000 services to
reflect the amount of work, the direct and indirect (overhead) practice expenses, and the malpractice expenses typically involved in
furnishing that service. Each of these three relative value components is multiplied by a geographic adjustment factor to adjust the
payment for variations in the costs of furnishing services in different localities. Relative value units, or RVUs, are summed for each
service and then are multiplied by a fixed-dollar conversion factor to establish the payment amount for each service. The higher the
number of RVUs assigned to a service, the higher the payment. Under the Medicare fee-for-service payment system, an individual can choose
any licensed physician enrolled in Medicare and use the services of any healthcare provider or facility certified by Medicare.
On
November 2, 2017, the Clinics for Medicare & Medicaid Services (“CMS”) issued a final rule updating the Quality Payment
Program (“QPP”) under the Medicare and CHIP Reauthorization Act of 2015 (“MACRA”). MACRA was signed into law
on April 16, 2015, ending the Sustained Growth Rate (“SGR”) formula for determining Medicare spending on physician services.
MACRA created two provider payment tracks—the Medicare Incentive Payment System (“MIPS”) and the Advanced Alternative
Payment Models (“A-APM”) track. Under MIPS, clinicians receive an annual composite score, which drives either an upward or
downward rate adjustment two years after the performance period. Under the A-APM track, participants in Medicare Alternative Payment
Models that exceed specified levels of clinician risk become MIPS-exempt and receive special bonuses equivalent to 5% of their annual
Part B revenue. MACRA requirements on clinicians are already in effect for calendar year 2017, with payment adjustments under the new
system due to start in 2019. However, in rulemaking last year, CMS significantly scaled back MIPS requirements for Performance Year 2017
to address concerns about physician buy-in and participation. Under the Final Rule, CMS would continue this “go slow” trajectory
for MIPS, notably by increasing MIPS exemptions and once again scaling back potential downside payment adjustments through design of
the MIPS scoring system. Reductions in Medicare payments could have a material adverse effect on our business.
CMS’s
RAC Program
The
Medicare Prescription Drug Improvement and Modernization Act of 2003 (“MMA”) introduced on a trial basis the use of Recovery
Audit Contractors (“RACs”) for the purpose of identifying and recouping Medicare overpayments and underpayments. Any overpayment
received from Medicare is considered a debt owed to the federal government. In October 2008, CMS made the RAC program permanent. RACs
review Medicare claims to determine whether such claims were appropriately reimbursed by Medicare. RACs engage in an automated review
and in a complex review of claims. Automated reviews are conducted when a review of the medical record is not required and there is certainty
that the service is not covered or is coded incorrectly. Complex reviews involve the review of all underlying medical records supporting
the claim and are generally conducted where there is a high likelihood, but not certainty, that an overpayment has occurred. RACs are
paid a contingency fee based on overpayments they identified and collected.
A
Medicare administrative contractor, or MAC, may suspend Medicare payments to a provider if it determines that an overpayment has occurred.
When a Medicare claim for payment is filed, the MAC will notify the patient and the provider of its initial determination regarding reimbursement.
The MAC may deny the claim for one of several reasons, including the lack of necessary information or lack of medical necessity for the
services rendered. Providers may appeal any denials for claim payment.
Anti-Kickback
Statute
Following
the intended acquisition, or opening, of one or more multidisciplinary primary healthcare clinics or the staffing of multidisciplinary
primary healthcare clinics, affiliate clinics or eldercare centric homes with clinicians and practitioners in the United States, if we
are participants in the Medicare program, we will be subject to the Anti-kickback Statute. The Anti-Kickback Statute prohibits the knowing
and willful offer, payment, solicitation or receipt of remuneration, directly or indirectly, in return for the referral of patients or
arranging for the referral of patients, or in return for the recommendation, arrangement, purchase, lease or order of items or services
that are covered, in whole or in part, by a federal healthcare program such as Medicare or Medicaid. The term “remuneration”
has been broadly interpreted to include anything of value such as gifts, discounts, rebates, waiver of payments or providing anything
at less than its fair market value. The ACA amended the intent requirement of the Anti-Kickback Statute such that a person or entity
can be found guilty of violating the statute without actual knowledge of the statute or specific intent to violation the statute. Further,
the ACA now provides that claims submitted in violation of the Anti-Kickback Statute constitute false or fraudulent claims for purposes
of the civil False Claims Act (“FCA”) including the failure to timely return an overpayment. Many states have adopted similar
prohibitions against kickbacks and other practices that are intended to influence the purchase, lease or ordering of healthcare items
and services reimbursed by a governmental health program or state Medicaid program. Some of these state prohibitions apply to remuneration
for referrals of healthcare items or services reimbursed by any third-party payor, including commercial payors.
Following
the intended acquisition, or opening, of one or more multidisciplinary primary healthcare clinics or the staffing of multidisciplinary
primary healthcare clinics, affiliate clinics or eldercare centric homes with clinicians and practitioners in the United States, if we
accept funds from governmental health programs, we will be subject to the Anti-Kickback Statute. Violations of the Anti-Kickback Statute
can result in exclusion from Medicare, Medicaid or other governmental programs as well as civil and criminal penalties, such as $25,000
per violation and up to three times the remuneration involved. If in violation, we may be required to enter into settlement agreements
with the government to avoid such sanctions. Typically, such settlement agreements require substantial payments to the government in
exchange for the government to release its claims, and may also require entry into a corporate integrity agreement, or CIA. Any such
sanctions or obligations contained in a CIA could have a material adverse effect on our business, financial condition and results of
operations.
False
Claims Act
The
federal civil FCA prohibits providers from, among other things, (1) knowingly presenting or causing to be presented, claims for payments
from the Medicare, Medicaid or other federal healthcare programs that are false or fraudulent; (2) knowingly making, using or causing
to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the federal government; or (3)
knowingly making, using or causing to be made or used, a false record or statement to avoid, decrease or conceal an obligation to pay
money to the federal government. The “qui tam” or “whistleblower” provisions of the FCA allow private individuals
to bring actions under the FCA on behalf of the government. These private parties are entitled to share in any amounts recovered by the
government, and, as a result, the number of “whistleblower” lawsuits that have been filed against providers has increased
significantly in recent years. Defendants found to be liable under the FCA may be required to pay three times the actual damages sustained
by the government, plus mandatory civil penalties ranging between $5,500 and $11,000 for each separate false claim.
There
are many potential bases for liability under the FCA. The government has used the FCA to prosecute Medicare and other government healthcare
program fraud such as coding errors, billing for services not provided, and providing care that is not medically necessary or that is
substandard in quality. The ACA also provides that claims submitted in connection with patient referrals that results from violations
of the Anti-Kickback Statute constitute false claims for the purpose of the FCA with some courts determining that a violation of the
Stark law can result in FCA liability as well. In addition, a number of states have adopted their own false claims and whistleblower
provisions whereby a private party may file a civil lawsuit in state court. Following the acquisition of one or more clinics or staffing
primary healthcare practitioners in the United States, we will be required to provide information to our employees and certain contractors
about state and federal false claims laws and whistleblower provisions and protections.
Civil
Monetary Penalties Statute
The
federal Civil Monetary Penalties statute prohibits, among other things, the offering or giving of remuneration to a Medicare or Medicaid
beneficiary that the person or entity knows or should know is likely to influence the beneficiary’s selection of a particular provider
or supplier of items or services reimbursable by a federal or state healthcare program.
Electronic
Health Records
As
required by the American Recovery and Reinvestment Act of 2009, the Secretary of HHS has developed and implemented an incentive payment
program for eligible healthcare professionals that adopt and meaningfully use electronic health record, or EHR, technology. HHS uses
the Provider Enrollment, Chain and Ownership System, or PECOS, to verify Medicare enrollment prior to making EHR incentive program payments.
If our employed professionals are unable to meet the requirements for participation in the incentive payment program, including having
an enrollment record in PECOS, we will not be eligible to receive incentive payments that could offset some of the costs of implementing
EHR systems. Further, healthcare professionals that fail to demonstrate meaningful use of certified EHR technology are subject to reduced
payments from Medicare. System conversions to comply with EHR could be time consuming and disruptive for physicians and employees. Failure
to implement EHR systems effectively and in a timely manner could have a material adverse effect on our financial position and results
of operations.
Following
the intended acquisition, or opening, of one or more multidisciplinary primary healthcare clinics or the staffing of multidisciplinary
primary healthcare clinics, affiliate clinics or eldercare centric homes with clinicians and practitioners in the United States, we will
convert certain of our clinical and patient accounting information system applications to newer versions of existing applications or
altogether new applications. In connection with our implementation and conversions, we will likely incur capitalized costs and additional
training and implementation expenses.
Privacy
and Security Requirements of Our Business Lines
Following
the intended acquisition, or opening, of one or more multidisciplinary primary healthcare clinics or the staffing of multidisciplinary
primary healthcare clinics, affiliate clinics or eldercare centric homes with clinicians and practitioners in the United States, numerous
federal and state laws and regulations, including HIPAA and the Health Information Technology for Economic and Clinical Health Act, as
amended (“HITECH”) will govern the collection, dissemination, security, use and confidentiality of patient-identifiable health
information. As required by HIPAA, HHS has adopted standards to protect the privacy and security of this health-related information.
The HIPAA privacy regulations contain detailed requirements concerning the use and disclosure of individually identifiable health information
and the grant of certain rights to patients with respect to such information by “covered entities.” We believe that all or
substantially all of our entities qualify as covered entities under HIPAA. We will take actions to comply with the HIPAA privacy regulations
including the creation and implementation of policies and procedures, staff training, execution of HIPAA-compliant contractual arrangements
with certain service providers and various other measures. Although we believe we will be in substantial compliance, ongoing implementation
and oversight of these measures involves significant time, effort and expense.
In
addition to the privacy requirements, HIPAA covered entities must implement certain administrative, physical, and technical security
standards to protect the integrity, confidentiality and availability of certain electronic health-related information received, maintained,
or transmitted by covered entities or their business associates. Although we have taken actions in an effort to be in compliance with
these security regulations, a security incident that bypasses our information security systems causing an information security breach,
loss of PHI, or other data subject to privacy laws or a material disruption of our operational systems could have a material adverse
effect on our business, along with fines. Furthermore, ongoing implementation and oversight of these security measures involves significant
time, effort and expense.
Further,
HITECH, as implemented in part by an omnibus final rule published in the Federal Register on January 25, 2013, further requires that
patients be notified of any unauthorized acquisition, access, use, or disclosure of their unsecured protected health information, or
PHI, that compromises the privacy or security of such information. HHS has established the presumption that all unauthorized uses or
disclosures of unsecured PHI constitute breaches unless the covered entity or business associate establishes there is a low probability
that the information has been compromised. HITECH and implementing regulations specify that such notifications must be made without unreasonable
delay and in no case later than 60 calendar days after discovery of the breach. Breaches affecting 500 patients or more must be reported
immediately to HHS, which will post the name of the breaching entity on its public website. Furthermore, breaches affecting 500 patients
or more in the same state or jurisdiction must also be reported to the local media. If a breach involves fewer than 500 people, the covered
entity must record it in a log and notify HHS of such breaches at least annually. These breach notification requirements apply not only
to unauthorized disclosures of unsecured PHI to outside third parties but also to unauthorized internal access to or use of such PHI.
The
scope of the privacy and security requirements under HIPAA was substantially expanded by HITECH, which also increased penalties for violations.
Penalties for violations of these laws vary. For instance, penalties for failure to comply with a requirement of HIPAA and HITECH vary
significantly, and include significant civil monetary penalties and, in certain circumstances, criminal penalties with fines up to $250,000
per violation and/or imprisonment. In addition, numerous breach incidents could lead to possible penalties in excess of $1.68 million.
A person who knowingly obtains or discloses individually identifiable health information in violation of HIPAA may face a criminal penalty
of up to $50,000 and up to one-year imprisonment. The criminal penalties increase if the wrongful conduct involves false pretenses or
the intent to sell, transfer or use identifiable health information for commercial advantage, personal gain or malicious harm. The amount
of penalty that may be assessed depends, in part, upon the culpability of the applicable covered entity or business associate in committing
the violation. Some penalties for certain violations that were not due to “willful neglect” may be waived by the Secretary
of HHS in whole or in part, to the extent that the payment of the penalty would be excessive relative to the violation. HITECH also authorized
state attorneys general to file suit on behalf of residents of their states. Applicable courts may be able to award damages, costs and
attorneys’ fees related to violations of HIPAA in such cases. HITECH also mandates that the Secretary of HHS conduct periodic compliance
audits of a cross-section of HIPAA covered entities and business associates. Every covered entity and business associate is subject to
being audited, regardless of the entity’s compliance record.
State
laws may impose more protective privacy restrictions related to health information and may afford individuals a private right of action
with respect to the violation of such laws. Both state and federal laws are subject to modification or enhancement of privacy protection
at any time. We are subject to any federal or state privacy-related laws that are more restrictive than the privacy regulations issued
under HIPAA. These statutes vary and could impose additional requirements on us and more severe penalties for disclosures of health information.
If we fail to comply with HIPAA, similar state laws or any new laws, including laws addressing data confidentiality, security or breach
notification, we could incur substantial monetary penalties and substantial damage to our reputation.
States
may also impose restrictions related to the confidentiality of personal information that is not considered PHI under HIPAA, including
certain identifying information and financial information of our patients. Theses state laws may impose additional notification requirements
in the event of a breach of such personal information. Failure to comply with such data confidentiality, security and breach notification
laws may result in substantial monetary penalties.
HIPAA
and HITECH also include standards for common healthcare electronic transactions and code sets, such as claims information, plan eligibility
and payment information. Covered entities such as the Company and each of our clinics will be required to conform to such transaction
set standards.
Telemedicine
Medical Technology Platform, Remote Patient Monitoring Medical Technology Platform and Novo Connect Medical Technology Platform (collectively,
“Medical Technology Platforms”)
Both
our Telemedicine Medical Technology Platform and Remote Patient Monitoring Medical Technology Platform are operational in Canada on a
limited usage basis; but are primarily in development. Our Novo Connect Medical Technology Platform is under development and limited
commercialization. All of our Medical Technology Platforms are subject to governmental health care regulations in Canada including, but
not limited to, the Canada Health Act. While our Medical Technology Platforms are not currently operational in the United States, once
operational our Medical Technology Platforms’ usage will be subject to United States laws, regulations, and directives such as,
but not limited to, Medicare, Medicaid, RAC, Anti-Kick Back Statute, False Claims Act, Civil Monetary Penalties Statute, HIPAA, and HITECH.
In addition, we will be subject to data privacy, security and breach notification requirements of United States federal, state, and local
statutes and other data privacy and security laws.
Our
Medical Technology Platforms are intended to collect and transmit a patient’s personal data, vital statistics and other medical
history information, and both are subject to governmental health care regulations, data privacy, security and breach notification requirements
of United States federal, state, and local statutes and other data privacy and security laws.
Stark
Law
Our
Medical Technology Platforms, once fully operational in the United States, will provide patients with real-time access to third-party
primary care medically licensed physicians, specialists, nurses and nurse practitioners in various medical disciplines as well as multidisciplinary
primary care clinicians. Because we will participate through our Medical Technology Platforms in the Medicare program, we will also be
subject to the Stark Law. Unlike the Fraud and Abuse Law, the Stark Law is a strict liability statute. Proof of intent to violate the
Stark Law is not required. Physical therapy services are among the “designated health services”. Further, the Stark Law has
application to the Company’s management contracts with individual physicians, physician groups, multidisciplinary primary care
clinicians, as well as any other financial relationship between us and referring physicians, specialists, nurses and nurse practitioners
in various medical disciplines as well as multidisciplinary primary care clinicians, including any financial transaction resulting from
a clinic acquisition. The Stark Law also prohibits billing for services rendered pursuant to a prohibited referral. Several states have
enacted laws like the Stark Law. These state laws may cover all (not just Medicare and Medicaid) patients. Many federal healthcare reform
proposals in the past few years have attempted to expand the Stark Law to cover all patients as well. As with the Fraud and Abuse Law,
we consider the Stark Law in operating our Medical Technology Platforms and intend to operate our Medical Technology Platforms in compliance
with the Stark Law. If we violate the Stark Law, our financial results and operations could be adversely affected. Penalties for violations
include denial of payment for the services, significant civil monetary penalties, and exclusion from the Medicare and Medicaid programs.
E-Commerce
We
are subject to general business regulations and laws as well as Federal and provincial regulations and laws specifically governing the
Internet and e-commerce. Existing and future laws and regulations may impede the growth of the use of the Internet, availability of economic
broadband access, or other online services, and increase the cost of providing our digital delivery of content and services. These regulations
and laws may cover taxation, tariffs, user privacy, data protection, pricing, content, copyrights, distribution, electronic contracts
and other communications, consumer protection, broadband internet access and the characteristics and quality of services. It is not clear
how existing laws which govern issues such as property ownership, sales, use and other taxes, libel and personal privacy apply to the
internet and e-commerce. Unfavorable resolution of these issues may harm our business and results of operations.
Medical
Cannabidiol Product Offering (Future Growth Initiative)
As
discussed in the Business Growth Initiative section above, we plan to expand our business to include the cultivation, processing, and
manufacturing of CBD products in Canada, and the sale and distribution of medicinal CBD products in Canada and authorized U.S. states.
We expect our prospective medicinal CBD products will be specifically focused on CBD for use (i) as a treatment aid; (ii) to provide
relief for a large array of neurological and musculoskeletal system disorders; and (iii) as an alternative option for health care providers
in place of prescribing opioids to patients.
Offering
our patients access to non-hallucinogenic and non-addictive natural remedies, under required clinical oversight policies and procedures
as they relate to medicinal cannabis and medicinal CBD, combined with our existing clinic-based treatment protocols, allows us to enter
this market segment with a unique integration model not readily available in the marketplace.
Cannabis
Versus Hemp
While
hemp and cannabis are both derived from the same species (Cannabis sativa), there are major differences in the characteristics of the
respective plant strains that produce industrial hemp on the one hand, and cannabis products on the other. In short, hemp is a strain
of the Cannabis sativa plant that is grown primarily for use in industrial applications. It has been specifically cultivated to produce
a low tetrahydrocannabinol (“THC”) content and a high cannabidiol content. THC is the psychoactive constituent of cannabis
and is responsible for producing the effects of the drug. CBD is another active ingredient present in Cannabis sativa plants, and it
largely acts to neutralize the psychoactive effects of THC. Since hemp strains have extremely low levels of THC and high levels of CBD,
they do not produce psychoactive effects when ingested.
Canada
Cannabis
is legal in Canada for both recreational and medicinal purposes. Medicinal use of cannabis was legalized nationwide on July 30, 2001
under conditions outlined in the Marijuana for Medical Purposes Regulations, later superseded by the Access to Cannabis for Medical Purposes
Regulations, issued by Health Canada and seed, grain, and fiber production was permitted under license by Health Canada. The federal
Cannabis Act came into effect on October 17, 2018 and made Canada the second country in the world to formally legalize the cultivation,
possession, acquisition and consumption of cannabis and its by-products.
As
set out in the Cannabis Regulations:
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Licenses are required for: |
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cultivating and processing
cannabis, |
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sale of cannabis for medical
purposes or recreational purposes, and |
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analytical testing of and
research with cannabis. |
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Permits are required to
import or export: |
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cannabis for scientific
or medical purposes, and |
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industrial hemp. |
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License holders are subject
to strict physical and personnel security requirements. |
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Plain packaging is required
for cannabis products. |
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The regulations set out
strict requirements for logos, colors and branding. |
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Cannabis products must
also be labeled with mandatory health warnings, a standardized cannabis symbol, and specific information about the product. |
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Access to cannabis for
medical purposes continues to be provided for patients who need it. |
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Manufacturers of prescription
drugs containing cannabis, while primarily subject to the Food and Drugs Act and its Regulations, are also subject to certain regulatory
requirements set out in the Cannabis Regulations. |
Patients
authorized by their health care provider are still able to access cannabis for medical purposes by:
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buying directly from a
federally licensed seller, |
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registering with Health
Canada to produce a limited amount of cannabis for their own medical purposes, or |
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designating someone to
produce it for them. |
Under
the new regulations, there are improvements for patients accessing cannabis for medical purposes from federally licensed sellers. These
improvements include:
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the ability to request
the return of their medical document from a federally licensed seller, |
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the ability to request
the transfer of their medical document to a different federally licensed seller, |
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that the effective date
on the registration document will be the day it is issued, rather than the day the medical document was signed by the health care
provider, |
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removal of the 30-day limitation
period for buying cannabis from a federally licensed seller (to ensure no break in a patient’s supply), |
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a broader range of permitted
products, and |
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access to an increasing
number of licensed producers and sellers (Health Canada has licensed more producers in the last year than in the four previous years
combined), which enables: |
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competitive prices, |
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more supply of cannabis,
and |
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an increased availability
of a range of products. |
United
States
Until
2014, when 7 U.S. Code §5940 became federal law as part of the Agricultural Act of 2014 (the “2014 Farm Act”), products
containing oils derived from hemp, notwithstanding a minimal or non-existing THC content, were classified as Schedule I illegal drugs.
The 2014 Farm Act expired on September 30, 2018, and was thereafter replaced by the Agricultural Improvement Act of 2018 on December
20, 2018 (the “2018 Farm Act “), which amended various sections of the U.S. Code, thereby removing hemp, defined as cannabis
with less than 0.3% of THC, from Schedule 1 status under the Controlled Substances Act (“CSA”), and legalizing the cultivation
and sale of hemp at the federal level, subject to compliance with certain federal requirements and state law, amongst other things. THC
is the psychoactive component of plants in the cannabis family generally identified as marihuana or marijuana. We anticipate that our
prospective medicinal CBD products will be federally legal in the United States in that they will contain less than 0.3% of THC in compliance
with the 2018 Farm Bill guidelines and will have no psychoactive effects on our patients’ and customers’ bodies. Notwithstanding,
there is no assurance that the 2018 Farm Act will not be repealed or amended such that our prospective products containing hemp-derived
CBD would once again be deemed illegal under federal law.
The
2018 Farm Bill also shifted regulatory authority from the Drug Enforcement Administration to the Department of Agriculture. The 2018
Farm Bill did not change the United States Food and Drug Administration’s (“FDA”) oversight authority over CBD products.
The 2018 Farm Act delegated the authority to the states to regulate and limit the production of hemp and hemp derived products within
their territories. Although many states have adopted laws and regulations that allow for the production and sale of hemp and hemp derived
products under certain circumstances, no assurance can be given that such state laws may not be repealed or amended such that our intended
products containing hemp-derived CBD would once again be deemed illegal under the laws of one or more states now permitting such products,
which in turn would render such intended products illegal in those states under federal law even if the federal law is unchanged. In
the event of either repeal of federal or of state laws and regulations, or of amendments thereto that are adverse to our prospective
medical CBD products, we may be restricted or limited with respect to those products that we may sell or distribute, which could adversely
impact our intended business plan with respect to such intended products.
Additionally,
the FDA has indicated its view that certain types of products containing CBD may not be permissible under the United States Federal Food,
Drug and Cosmetic Act (“FDCA”). The FDA’s position is related to its approval of Epidiolex, a marijuana-derived prescription
medicine to be available in the United States. The active ingredient in Epidiolex is CBD. On December 20, 2018, after the passage of
the 2018 Farm Bill, FDA Commissioner Scott Gottlieb issued a statement in which he reiterated the FDA’s position that, among other
things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with
any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce and that
the FDCA prohibits introducing into interstate commerce food products containing added CBD, and marketing products containing CBD as
a dietary supplement, regardless of whether the substances are hemp-derived. Although we believe our prospective medicinal CBD product
offering will comply with applicable federal and state laws and regulations, legal proceedings alleging violations of such laws could
have a material adverse effect on our business, financial condition and results of operations.
We
do not intend to offer and we do not intend to compete with companies that offer cannabis products containing high levels of psychoactive
THC. Although legal in some states, and in Canada, we do not intend to enter into this market. We may offer prospective medicinal CBD
(hemp-based) products to patients and customers but will not compete with any medical or recreational marijuana sellers of products for
high THC content sales due to legal and regulatory restrictions and uncertainty in the United States. Because of regulatory challenges
facing marijuana companies in the United States, the vast majority of the companies focused on THC are Canadian and foreign, although
several have begun to pursue domestic activities in states that permit marijuana sales. Federal law does not generally recognize marijuana
(or hemp that exceeds 0.3% THC) as lawful, although that may change in the future.
Corporate
History
Novo
Integrated Sciences, Inc. was incorporated in Delaware on November 27, 2000, under the name Turbine Truck Engines, Inc. On February 20,
2008, Novo Integrated was re-domiciled to the State of Nevada. Effective July 12, 2017, the Company’s name was changed to Novo
Integrated Sciences, Inc.
Since
inception and through May 9, 2017, our activities and business operations were limited to raising capital, organizational matters and
the implementation of our business plan related to research, development, testing and commercialization of various alternative energy
technologies.
On
September 5, 2013, NHL was incorporated under the laws of Ontario province Canada. On September 16, 2013, Novo Assessments Inc., Novo
Community Care Inc, and Novo Healthnet Rehab Limited were formed, under the laws of Ontario province Canada, as wholly owned subsidiaries
of NHL. On September 20, 2013, Novo Community Care Inc.’s name was changed to Novo Peak Health Inc. On September 30, 2013, NHL
acquired substantially all the assets of the following operational Ontario Canada based entities, (i) Peak Health LTC Inc.; (ii) ICC
Healthnet Canada Inc. and its related companies; and (iii) Michael Gaynor Physiotherapy Professional Corporation, operating as Back on
Track. On November 18, 2014, Novo Healthnet Kemptville Centre, Inc., was formed under the laws of Ontario province Canada, with NHL owning
an 80% interest. On April 1, 2017, NHL purchased substantially all of the assets of APKA Health, an occupational therapy entity operating
in Ontario province Canada.
Acquisition
of Novo Healthnet Limited
On
April 25, 2017 (the “Effective Date”), the Company entered into a Share Exchange Agreement (the “Share Exchange Agreement”)
by and between (i) the Company; (ii) NHL; (iii) ALMC-ASAP Holdings Inc. (“ALMC”); (iv) Michael Gaynor Family Trust (the “MGFT”);
(v) 1218814 Ontario Inc. (“1218814”); and (vi) Michael Gaynor Physiotherapy Professional Corp.; and collectively ALMC, MGFT
and 1218814 herein referred to as “the NHL Shareholders”). Pursuant to the terms of the Share Exchange Agreement, the Company
agreed to acquire, from the NHL Shareholders, all of the shares of both common and preferred stock of NHL, held by the NHL Shareholders,
in exchange for the issuance by the Company, to the NHL Shareholders, shares of the Company’s common stock, such that following
the closing of the Share Exchange Agreement, the NHL Shareholders would own 16,779,741 restricted shares of Company common stock, representing
85% of the issued and outstanding Company common stock, calculated including all granted and issued options or warrants to acquire the
Company common stock as of the Effective Date, but to exclude shares of Company common stock that are subject to a then-current Regulation
S Offering that was undertaking by the Company (the “Exchange”).
On
May 9, 2017, the Exchange closed and, as a result, NHL became a wholly owned subsidiary of Novo Integrated Sciences, Inc.
Acquisition
of Executive Fitness Leaders
On
December 1, 2017, the Company, NHL and Executive Fitness Leaders, located in Ottawa Ontario Canada, entered into an Asset Purchase Agreement,
pursuant to which NHL acquired substantially all of the assets of Executive Fitness Leaders in exchange for the issuance, by the Company,
of 38,411 restricted shares of its common stock.
Formation
of Novomerica Health Group, Inc. in U.S.
On
November 3, 2017, Novomerica Health Group, Inc. was incorporated, under the laws of the state of Nevada, as a wholly owned subsidiary
of Novo Integrated Sciences, Inc. for the purpose of expanding the Company’s operations into the United States.
Novo
Peak Health Inc. Amalgamated with NHL
On
September 25, 2018, Novo Peak Health, Inc. was amalgamated with Novo Healthnet Limited.
Assignment
of Joint Venture Agreement
On
January 7, 2019, 2478659 Ontario Ltd. (“247”) and Kainai Cooperative (“Kainai”) entered into a Joint Venture
Agreement (the “Joint Venture Agreement”) for the purpose of developing, managing and arranging for financing of greenhouse
and farming projects involving hemp and cannabis cash crops on Kainai related lands, and developing additional infrastructure projects
creating jobs and food supply to local communities. On January 8, 2019, we and 247 entered into an Agreement of Transfer and Assignment,
pursuant to which 247 agreed to sell, assign and transfer to the Company all rights, contracts, contacts and any and all other assets
related in any way to the Joint Venture Agreement. Pursuant to the terms of the Joint Venture Agreement, as assigned to us, the parties
will work in a joint venture relationship with the Company providing the finance, development and operation of the project, including
sales, and Kainai providing the land and approvals for the development of the projects.
The
joint venture will distribute to the Company and Kainai all net proceeds after debt and principal servicing and repayment allocation,
as well as operating capital allotment, on a ratio equal to 80% to the Company and 20% to Kainai.
The
Joint Venture Agreement has an initial term of 50 years and Kainai may renew the Joint Venture Agreement within five years of the expiry
of the initial term upon mutual agreement.
On
January 30, 2019, pursuant to the terms of the Joint Venture Agreement, the Company issued 1,200,000 restricted common shares to 247
with a value of $21,600,000.
Acquisition
of Societe Professionnelle de Physiotherapie M Dignard, carrying on business as Action Plus Physiotherapy Rockland
On
July 22, 2019, the Company and Societe Professionnelle de Physiotherapie M Dignard, carrying on business as Action Plus Physiotherapy
Rockland and providing physiotherapy and related ancillary services (“APPR”), entered into an Asset Purchase Agreement (“APA”)
pursuant to which APPR agreed to sell, assign and transfer to the Company, free and clear of all encumbrances, other than permitted encumbrances,
and the Company agreed to purchase from APPR all of APPR’s right, title and interest in and to all of its assets, with the exception
of certain limited exclusions, and the rights, privileges, claims and properties of any kind whatsoever that are related thereto, whether
owned or leased, real or personal, tangible or intangible, of every kind and description and wheresoever situated.
Pursuant
to the terms of the APA, the purchase price is determined as six times APPR’s purported EBITDA, equaling CAD$300,000, of which,
APPR (1) received a cash payment of CAD$175,000; and (2) was issued CAD$125,000 worth of the Company’s common stock, par value
$0.001, as restricted common shares pursuant to an exemption from registration as set forth in Regulation S under the Securities Act
of 1933, as amended (the “Securities Act”). Pursuant to the terms of the APA, APPR was issued 8,456 restricted common shares
of the Company’s common stock as consideration for the CAD$125,000 payment owed to APPR. On the business day immediately preceding
the closing date of the APA, determined as July 19, 2019, the CAD-to-USD conversion rate, per x-rates.com, was 0.7644 which converts
CAD$125,000 to $95,550 rounded to the nearest whole number dollar amount. Based on the determined 30-trading day closing average price
per share of $11.30, the calculated number of the Company’s restricted common shares issued to APPR was 8,456, which includes rounding
the calculation up to the nearest whole number of shares.
The
transaction closed on July 22, 2019. The purchase of these assets was not considered significant for accounting purposes; therefore,
pro forma financial statements were not presented.
Intellectual
Property Asset Purchase Agreement
On
December 17, 2019, the Company entered into that certain Intellectual Property Asset Purchase Agreement (the “APA”) by and
between the Company and 2731861 Ontario Corp. (the “Seller”), pursuant to which the Company agreed to purchase, and Seller
agreed to sell (the “Acquisition”), proprietary designs for an innovative cannabis dosing device, in addition to designs,
plans, procedures, and all other material pertaining to the application, construction, operation, and marketing of a cannabis business
under the regulations of Health Canada (the “Intellectual Property”). Pursuant to the terms of the APA, the purchase price
of the Intellectual Property is 800,000 shares of restricted common stock of the Company. The Acquisition closed on December 17, 2019.
Joint
Venture Agreement
On
December 19, 2019, the Company entered into that certain Joint Venture Agreement (the “JV Agreement”) between the Company
and Harvest Gold Farms Inc. (“HGF”) relating to the development, management and arrangement of medicinal farming projects
involving hemp and cannabis cash crops (the “Project”). Pursuant to the terms of the JV Agreement, the parties agreed to
work in a joint venture relationship, with the Company providing the development and operation of the Project, including sales, and HGF
providing the land, farming expertise, biomass and necessary approvals for the development of the Project.
The
initial term of the JV Agreement will, unless sooner terminated by consent of all parties, expire in five years from the effective date
of the JV Agreement. The Company and HGF may renew the JV Agreement within two years of the expiration of the initial term upon mutual
understanding.
Each
of the parties agreed to contribute to the start-up of the joint venture (the “JV”) as follows:
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Complete and finalize a
business plan and layout plans, a detailed procurement project binder and an implementation and roll-out plan. |
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Make arrangements for construction
and financing options of any facilities required for the profitable farming of medicinal crops or related facilities. |
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Direct project finance
model and selection of engineering, procurement, construction contracts and management service providers. |
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Arrange for product purchase
contracts. |
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Provide the land and approvals
for greenhouse (if necessary), open field farming and other facilities as required. |
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Arrange for all required
titled land for greenhouses and outdoor agriculture platforms. |
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Arrange for all building
permits, environmental approvals and HGF internal approvals including confirmation of tax-free JV status for the duration of the
proposal (if possible). |
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Provide elite farming expertise
for the purposes of maximizing potential profits, inclusive of harvesting techniques and process flow and engineering. |
Pursuant
to the terms of the JV Agreement, the Company agreed to maintain all financial records (in U.S. GAAP) of the JV, to provide quarterly
and annual reporting to all JV stakeholders, and to assign and direct operational staff from onset to agreement termination. The Company
agreed to pay HGF 30% of net JV income on an annual basis commencing 12 months after the first full 12-month revenue period, and to purchase
product from the JV at a price of cost plus 5%.
In
addition, the Company agreed to issue 200,000 shares of Company common stock upon achievement of $25,000,000 of net profit by the JV
each fiscal year. Such common stock will be delivered to HGF via Novo Healthnet Limited exchangeable preferred shares. Any Company common
stock issued to HGF will be subject to pro-rata adjustment in the event that the Company approves, prior to the issuance date, any forward
stock split, reverse stock split or other capitalization restructure.
HGF
agreed, among other things, to grow medicinal agriculture crop at the highest standard, subject to independent third party biomass testing,
in the most profitable manner while maintaining the standards of excellence required to maintain elite status, and to provide a minimum
of 7,000 acres for the Primary Project. All staffing, including but not limited to, management, specialized or general labor requirements
for farming will be the sole responsibility of HGF.
Asset
Purchase Agreement to Acquire Generic Primary and Sub-primary Drug Formulations
On
December 11, 2020, the Company and 2794512 Ontario Ltd., an Ontario Canada corporation, entered into an Asset Purchase Agreement pursuant
to which the Company acquired generic primary and sub-primary drug formulations (known as bioequivalence) of name brand pharmaceutical
reference products related to usage as injectables, ophthalmic, and topical applications. In consideration, the Company issued 240,000
restricted shares of common stock that were valued at $876,000.
Acquisition
of PRO-DIP, LLC
On
May 24, 2021, the Company completed the acquisition of PRO-DIP, a New York state limited liability company in the business of providing
nutritional oral energy and medicinal supplement pouches through a proprietary process, under the terms and conditions of a Share Exchange
Agreement, dated May 11, 2021, resulting in PRO-DIP being a wholly owned subsidiary of the Company. The Company issued 189,796 restricted
shares of common stock and $10,000 in cash as full consideration for the transaction.
Acquisition
of Acenzia Inc.
On
May 28, 2021, the Company and NHL entered into a Share Exchange Agreement (the “ACZ SEA”) by and among the Company and NHL,
on the one hand, and Acenzia Inc., Avec8 Holdings Inc., Ambour Holdings Inc., Indrajit Sinha, Grant Bourdeau and Derrick Bourdeau, on
the other hand (collectively the “ACZ Shareholders”). On June 24, 2021, pursuant to the terms of the ACZ SEA, the acquisition
of Acenzia by NHL closed. The closing purchase price may be adjusted within 90 days of the closing date pending completion of an audit
and working capital requirement provisions (the “Post-Closing Purchase Price Adjustment”). On October 22, 2021, the parties
(i) set the final Purchase Price, as determined by the Post-Closing Purchase Price Adjustment, at a value of $14,162,795, and (ii) agreed
to the issuance of that number of NHL Exchangeable Shares (as defined in the ACZ SEA) exchangeable into 3,622,199 restricted shares of
Company common stock at an agreed upon price of $3.91 allotted for the ACZ Shareholders as provided for in the ACZ SEA. The price of
the Company’s common stock on the closing date was $2.55; therefore the purchase price for accounting purposes was $9,236,607.
Joint
Venture Agreement with EK-Tech Solutions Inc. to Form MiTelemed+ Inc.
On
October 8, 2021, the Company and NHL completed a Joint Venture Agreement (the “MiTelemed+ JV”) with EK-Tech Solutions Inc.
(“EK-Tech”) to establish the joint venture company MiTelemed+ Inc., an Ontario province Canada corporation (“MiTelemed+”),
to operate, support, and expand access and functionality of EK-Tech’s enhanced proprietary Telehealth platform. At closing, EK-Tech
contributed all intellectual property, source code, and core data of the iTelemed platform, valued at CAD$1,500,000, and NHL issued to
EK-Tech, non-voting NHL Exchangeable Special Shares, free and clear of all liens and encumbrances, which are issued solely for the purpose
of EK-Tech to exchange, for 185,000 restricted shares of Company’s common stock solely upon EK-Tech meeting terms and conditions
for exchange of the NHL Exchangeable Special Shares as defined in the MiTelemed+ JV. Additionally, MiTelemed+ is contracted with EK-Tech
to operate, maintain, support, provide software hosting, and for further development of iTelemed’s capabilities. NHL is responsible
for global commercialization as well as fulfilling all administrative functions for the JV. The net profits and net losses of the JV
will be split 50/50 between NHL and EK-Tech.
Terragenx
Share Exchange
On
November 17, 2021, the Company and NHL entered into that certain Share Exchange Agreement (the “Terra SEA”), dated as of
November 17, 2021, by and among the Company, NHL, Terragenx Inc. (“Terra”), TMS Inc. (“TMS”), Shawn Mullins,
Claude Fournier, and The Coles Optimum Health and Vitality Trust (“COHV” and collectively with TMS, Mr. Mullins and Mr. Fournier,
the “Terra Shareholders”). Collectively, the Terra Shareholders own 91% of the outstanding shares of Terra (the “Terra
Purchased Shares”).
Pursuant
to the terms of the Terra SEA, NHL agreed to purchase from the Terra Shareholders, and the Terra Shareholders agreed to sell to NHL,
the Terra Purchased Shares on the closing date, in exchange for payment by NHL of the purchase price (the “Purchase Price”)
of CAD$500,000 (approximately $398,050) (the “Exchange”). The Purchase Price was to be paid with the issuance, by NHL to
the Terra Shareholders, of certain non-voting NHL special shares exchangeable into restricted shares of the Company’s common stock
(the “NHL Exchangeable Shares”). The total shares of Company common stock allotted in favor of the Terra Shareholders was
calculated at a per share price of $3.35.
The
Exchange closed on November 17, 2021. At the closing of the Exchange, (i) the Terra Shareholders transferred to NHL a total of 910 shares
of Terra common stock, representing 91% of Terra’s outstanding shares, and (ii) a total of 100 NHL Exchangeable Shares were issued
to the Terra Shareholders, which NHL Exchangeable Shares are exchangeable into a total of 118,821 restricted shares of the Company’s
common stock. As a result of the Exchange, NHL has 91% ownership of Terra and full control of the Terra business.
The
Terra SEA contains customary representations, warranties and closing conditions.
Mullins
Asset Purchase Agreement
On
November 17, 2021, the Company entered into that certain Asset Purchase Agreement (the “Mullins APA”), dated as of November
17, 2021, by and between the Company and Terence Mullins. Pursuant to the terms of the Mullins APA, Mr. Mullins agreed to sell, and the
Company agreed to purchase, all of Mr. Mullins’ right, title and interest in and to certain assets directly and indirectly related
to any and all iodine-based related products and technologies as specified in the Mullins APA (the “Mullins IP Assets”),
in exchange for a purchase price of CAD$2,500,000 (approximately $1,990,250) which is to be paid as follows:
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(a) |
CAD$2,000,000 (approximately
$1,592,200) is to be issued or allotted to Mr. Mullins only after patent-pending status, in the U.S. or internationally, is designated
for all Mullins IP Assets (the “Mullins IP Assets CAD$2m Shares”), as either restricted shares of Company common stock
or NHL Exchangeable Shares, as determined by Mr. Mullins. Once issued or allotted, the Mullins IP Assets CAD $2m Shares will be held
in escrow pending registration and approval for all Mullins IP Assets, and |
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(b) |
CAD$500,000 (approximately
$398,050) is to be issued in the form of 118,821 restricted shares of Company common stock, free and clear of all liens, pledges,
encumbrances, charges, or known claims of any kind, nature, or description, upon closing of the Mullins APA |
All
shares issued or allotted under the terms and conditions of the Mullins APA are calculated at a value of $3.35 per share.
In
addition, the Company will pay a royalty equal to 10% of net revenue (net profit) of all iodine related sales reported through the Company
or any of its wholly owned subsidiaries for a period equal to the commercial validity of the intellectual property.
The
Mullins APA includes customary representations and warranties and closing conditions.
Share
Exchange Agreement to Acquire 50.1% of 12858461 Canada Corp.
On
March 1, 2022, the Company and NHL completed a Share Exchange Agreement (the “1285 SEA”) with 12858461 Canada Corp. (“1285”),
a Canada federal corporation in the business of providing clinic-based physiotherapy and related ancillary services and products, and
Prashant A. Jani, a Canadian citizen and sole shareholder of 1285 (the “1285 Shareholder”) to acquire 50.1% ownership of
1285 for a purchase price of $68,000 (the “1285 Purchase Price”) paid with the issuance, by NHL to the 1285 Shareholder,
of certain non-voting NHL Exchangeable Special Shares which can only be utilized for the purpose of exchange into an allotment of 17,000
restricted shares of the Company’s common stock (the “Parent 1285 SEA Shares”) at the determination of the 1285 Shareholder.
The number of Parent 1285 SEA Shares was calculated by dividing the 1285 Purchase Price by $4.00 per share.
Asset
Purchase Agreement with Poling Taddeo Hovius Physiotherapy Professional Corp., operating as Fairway Physiotherapy and Sports Injury Clinic
On
March 1, 2022, the Company and NHL completed an Asset Purchase Agreement (the “PTHPC APA”) with Poling Taddeo Hovius Physiotherapy
Professional Corp. (“PTHPC”), operating a clinic-based physiotherapy, rehabilitative, and related ancillary services and
products business known as Fairway Physiotherapy and Sports Injury Clinic (“FAIR”), and Jason Taddeo, a Canadian citizen
and the sole shareholder of PTHPC (the “PTHPC Shareholder”), Under the terms and conditions of the PTHPC APA, PTHPC agreed
to sell, assign and transfer to NHL, free and clear of all encumbrances, other than permitted encumbrances, and NHL agreed to purchase
from PTHPC all of PTHPC’s right, title and interest in and to all of its assets related to FAIR and the FAIR Business, with the
exception of certain limited exclusions, and the rights, privileges, claims and properties of any kind whatsoever that are related thereto,
whether owned or leased, real or personal, tangible or intangible, of every kind and description and wheresoever situated. Under the
terms and conditions of the PTHPC APA, the purchase price is $627,000 (the “FAIR Purchase Price”) paid with the issuance,
by NHL to the PTHPC Shareholder, of certain non-voting NHL Exchangeable Special Shares which can only be utilized for the purpose of
exchange into an allotment of 156,750 restricted shares of the Company’s common stock (the “Parent PTHPC APA Shares”)
at the determination of the PTHPC Shareholder. The number of Parent PTHPC APA Shares was calculated by dividing the FAIR Purchase Price
by $4.00 per share.
Membership
Interest Purchase Agreement with Clinical Consultants International LLC
On
March 17, 2022, the Company entered into a Membership Interest Purchase Agreement (the “CCI Agreement”) by and among the
Company, Clinical Consultants International LLC (“CCI”), each of the members of CCI (the “Members”), and Dr.
Joseph Chalil as the representative of the Members.
Pursuant
to the terms of the CCI Agreement, among other things, the CCI Members will sell and assign to the Company all of their membership interests
of CCI, in exchange for a total of 800,000 restricted shares of the Company’s common stock (the “Exchange Shares”)
(“CCI Acquisition”). The Exchange Shares will be apportioned among the Members pro rata based on their respective membership
interest ownership percentage of CCI. Following the closing of the CCI Acquisition (the “Closing”), the Company will own
100% of the issued and outstanding membership interests of CCI, and the CCI Members or their designees will collectively own 800,000
restricted shares of the Company’s common stock. The restricted shares were issued on April 7, 2022.
This CCI Acquisition was accounted
for as an asset acquisition, as substantially all of the fair value of the assets being acquired under the arrangement was concentrated
in the customer. Accordingly, the $1,704,000 purchase price was primarily allocated to the customer relationships intangible asset, for
$1,701,814, and amortized over an estimated useful life of 5 years. The remaining purchase price was allocated to cash and cash equivalents.
Pursuant
to the terms of the CCI Agreement, the Company agreed to (i) name, at the Closing, Dr. Chalil as the Chief Medical Officer of the Company
and the President of Novomerica Healthcare Group, Inc., which is a wholly owned subsidiary of the Company, (ii) enter into an employment
agreement with Dr. Chalil, and (iii) name Dr. Chalil to the Company’s Board of Directors.
The
CCI Agreement may be terminated under certain customary and limited circumstances prior to the Closing, including by either party if
the conditions to Closing of an opposing party have not been satisfied or waived by the applicable party on or prior to April 15, 2022.
The CCI Acquisition closed on April 5, 2022. See “—Closing of CCI Acquisition” below.
On
April 5, 2022, the CCI Acquisition closed. As a result, immediately after the Closing on April 5, 2022, the Company owned 100% of the
issued and outstanding membership interests of CCI. On April 7, 2022, the Company issued an aggregate of 800,000 restricted shares of
the Company’s common stock to the Members in connection with the CCI Acquisition and pursuant to the terms of the CCI Agreement.
ITEM
1A. RISK FACTORS
Our
business is subject to numerous risks and uncertainties. These risks represent challenges to the successful implementation of our strategy
and to the growth and future profitability of our business. These risks include, but are not limited to, the following:
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We have a history of operating
losses; |
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We may not be able to implement
successfully our growing our multidisciplinary primary health care business by opening and acquiring new clinics and expanding the
staffing of multidisciplinary primary health care clinicians to affiliate clinics and eldercare centric homes; |
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Public health epidemics
or outbreaks (such as the novel strain of coronavirus (COVID-19)) could adversely impact our business |
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We may not be able to increase
our market share in existing eldercare services, occupational therapy services, physiotherapy services and speech language pathology
services through network affiliation growth and new contracts; |
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We may be unable to attract
sufficient demand for and obtain acceptance of our multidisciplinary primary health care services and our medical cannabidiol products
by both multidisciplinary primary health care clinicians and patients; |
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The clinics that we acquire
or open may not meet our expectations; |
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If we open new clinics
in existing markets, revenue at our existing clinics may be affected negatively; |
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The multidisciplinary primary
health care market is highly competitive, including competition for patients, strategic relationships, and commercial payor contracts,
each of which could adversely affect our contract and revenue base; |
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We may be unable to obtain
reimbursement for our multidisciplinary primary health care services from the government or third-party health care insurers of our
patients; |
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We may not be able to successfully
make acceptable financial arrangements for patients who desire treatment but cannot afford to pay in full or part, and for whom third-party
insurance coverage is either limited or non-existent; |
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Prospective patients may
be unwilling to pay out-of-pocket for certain of our multidisciplinary primary health care and primary care services, in the absence
of reimbursement from the government or third-party health care insurers for such multidisciplinary primary health care and services; |
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The success of alternative
treatments, therapies and medical products as opposed to the multidisciplinary primary health care services, therapies and prospective
medical CBD products that we might offer in the future could adversely affect us; |
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We may not be able to recruit
and retain qualified multidisciplinary primary health care clinicians for our multidisciplinary primary health care clinics and staffing
of affiliate clinics and eldercare centric homes; |
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We may not be able to prohibit
or limit our multidisciplinary primary health care clinicians from competing with us in our local markets; |
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We may be unable to enter
into or maintain contracts for our multidisciplinary primary health care services on favorable terms with commercial payors in Canada
and the United States; |
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Government health care
programs may reduce reimbursement rates; |
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The health care industry
is heavily regulated, and if we fail to comply with these laws and governmental regulations, we could incur penalties or be required
to make significant changes to our operations; |
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Our multidisciplinary primary
health care clinics are and will be subject to numerous statutes and regulations in the Canadian provinces in which we operate or
intend to operate and states in the United States in which we intend to operate. Failure to comply with these laws and regulations
could result in civil or criminal sanctions; |
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Past and future health
care reform legislation and other changes in the health care industry could adversely affect our business, financial condition and
results of operations; |
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We are subject to the Canada
Health Act, Canada’s National Health Insurance Program and Food and Drugs Act and analogous provisions of applicable federal,
provincial, state and local laws and could face substantial penalties if we fail to comply with such laws; |
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If the Company acquires
one or more multidisciplinary primary health care clinics or primary care facilities in the United States, we will be subject to
the Anti-Kickback Statute, FCA, Civil Monetary Penalties statute and analogous provisions of applicable state laws and could face
substantial penalties if we fail to comply with such laws; |
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We will be subject to the
data privacy, security and breach notification requirements of Canadian and United States federal statutes and other data privacy
and security laws, and the failure to comply with these rules, or allegations that we have failed to do so, could result in civil
or criminal sanctions; |
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Our Telemedicine Medical
Technology Platform is currently in early-stage roll-out and we may be unsuccessful in the commercialization of the Telemedicine
Medical Technology Platform; |
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Our success with the Telemedicine
Medical Technology Platform will highly be dependent upon our ability to develop relationships with primary care physicians, specialists
and clinicians; |
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Our Telemedicine Medical
Technology Platform may not be accepted in the marketplace; |
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Our Remote Patient Monitoring
Medical Technology Platform is currently in early-stage roll-out and development and we may be unsuccessful in the commercialization
of the RPM platform; |
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Our success with the Remote
Patient Monitoring Medical Technology Platform will highly be dependent upon our ability to develop relationships with primary care
physicians and specialists; |
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Our Remote Patient Monitoring
Medical Technology Platform may not be accepted in the marketplace; |
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Our Novo Connect Medical
Technology Platform is currently in early-stage roll-out and development and we may be unsuccessful in the commercialization of the
Novo Connect Medical Technology Platform; |
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Our success with the Novo
Connect Medical Technology Platform will highly be dependent upon our ability to develop relationships with primary care physicians
and specialists; |
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Our Novo Connect Medical
Technology Platform may not be accepted in the marketplace; |
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Government regulation of
the internet and e-commerce is evolving, and unfavorable changes could substantially harm our business and results of operations; |
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We may be unable to attract
sufficient demand for and obtain acceptance of our medical CBD products by both multidisciplinary primary health care clinicians
and patients; |
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Possible yet unanticipated
changes in federal and state law could cause any products that we intend to launch, containing hemp-derived CBD oil to be illegal,
or could otherwise prohibit, limit or restrict any of our products containing CBD; |
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Risks associated with the
CBD products industry; |
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FDA regulation could negatively
affect the hemp industry, which would directly affect our financial condition; |
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Sources of hemp-derived
CBD depend upon legality of cultivation, processing, marketing, and sales of products derived from those plants under state law of
the United States; |
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Because our distributors
may only sell and ship our products containing hemp-derived CBD in states that have adopted laws and regulations qualifying under
the 2018 Farm Act, a reduction in the number of states having such qualifying laws and regulations could limit, restrict or otherwise
preclude the sale of intended products containing hemp-derived CBD; |
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There may be unanticipated
delays in the development and introduction of our prospective medicinal CBD products and/or our inability to control costs; |
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If needed, we may be unable
to consistently retain or hire third-party manufacturers, suppliers, or other service providers to produce our prospective medicinal
CBD products; |
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We do not have control
over all third parties involved in the manufacturing of our products and their compliance with government health and safety standards.
Even if our products meet these standards, they could otherwise become contaminated; |
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The sale of our products
involves product liability and related risks that could expose us to significant insurance and loss expenses; |
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Confusion between legal
CBD and illegal cannabis; |
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Seasonal fluctuations in
revenue; |
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Our failure to promote
and maintain a strong brand; |
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Failure to achieve or sustain
profitability; |
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Our failure to successfully
or cost-effectively manage our marketing efforts and channels, and the failure of such efforts and channels to be effective in generating
leads and business for the Company or any of its affiliated providers; |
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Significant competition;
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Adequate protection of
confidential information; |
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The business risks of United
States and international operations; |
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Our vulnerability to changes
in consumer preferences and economic conditions; |
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Potential litigation from
competitors and health related claims from patients and customers; |
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A limited market for our
common stock; |
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Our ability to adequately
protect the intellectual property used to produce our prospective medicinal CBD products; and |
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Our ability to stay abreast
of modified or new laws and regulations applying to our business. |
History
of operating losses and negative cash flow.
For
the fiscal years ended August 31, 2022 and 2021, we reported net losses attributed to Novo Integrated Sciences of $32,849,215 and
$4,462,147, respectively, and negative cash flow from operating activities of $5,884,145 and $1,024,802, respectively. As of August 31,
2022, we had an aggregate accumulated deficit of $53,818,489.
Such
losses have historically required us to seek additional funding through the issuance of debt or equity securities. Our long-term success
is dependent upon among other things, achieving positive cash flows from operations and if necessary, augmenting such cash flows using
external resources to satisfy our cash needs. There can be no assurance that we will be able to obtain additional funding, if needed,
on commercially reasonable terms, or of all.
Our
consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. These adjustments
would likely include substantial impairment of the carrying amount of our assets and potential contingent liabilities that may arise
if we are unable to fulfill various operational commitments. In addition, the value of our securities would be greatly impaired. Our
long-term success is dependent upon generating sufficient cash flow from operations and obtaining additional capital and financing. If
our ability to generate cash flow from operations is delayed or reduced and we are unable to raise additional funding from other sources,
we may be unable to continue in business.
Novo
Integrated Sciences, Inc. is a parent company and depends upon our subsidiaries for our cash flows.
We
are a parent company. All of our operations are conducted, and some of our assets are owned, by our subsidiaries. Consequently, our cash
flows and our ability to meet our obligations depend upon the cash flows of our subsidiaries and the payment of funds by these subsidiaries
to us in the form of dividends, distributions or otherwise. The ability of our subsidiaries to make any payments to us depends on their
earnings, the terms of their indebtedness, including the terms of any credit facilities and legal restrictions. Any failure to receive
dividends or distributions from our subsidiaries when needed could have a material adverse effect on our business, results of operations
or financial condition.
Future
acquisitions or strategic investments could disrupt our business and harm our business, results of operations or financial condition.
We
may in the future explore potential acquisitions of companies or strategic investments to strengthen our business. Even if we identify
an appropriate acquisition candidate, we may not be successful in negotiating the terms or financing of the acquisition, and our due
diligence may fail to identify all of the problems, liabilities or other shortcomings or challenges of an acquired business.
Acquisitions
involve numerous risks, any of which could harm our business, including:
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straining our financial
resources to acquire a company; |
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anticipated benefits may
not materialize as rapidly as we expect, or at all; |
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diversion of management
time and focus from operating our business to address acquisition integration challenges; |
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retention of employees
from the acquired company; |
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cultural challenges associated
with integrating employees from the acquired company into our organization; |
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integration of the acquired
company’s accounting, management information, human resources and other administrative systems; |
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the need to implement or
improve controls, procedures and policies at a business that prior to the acquisition may have lacked effective controls, procedures
and policies; and |
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litigation or other claims
in connection with the acquired company, including claims from terminated employees, former stockholders or other third parties. |
Failure
to appropriately mitigate these risks or other issues related to such strategic investments and acquisitions could result in reducing
or eliminating any anticipated benefits of transactions and harm our business generally. Future acquisitions could also result in dilutive
issuances of our equity securities, the incurrence of debt, contingent liabilities, amortization expenses or the impairment of goodwill,
any of which could have a material adverse effect on business, results of operations or financial condition.
We
may require additional funding for our growth plans, and such funding may result in a dilution of your investment.
We
have estimated our funding requirements in order to implement our growth plans. If the costs of implementing such plans should exceed
these estimates significantly or if we come across opportunities to grow through expansion plans which cannot be predicted at this time,
and our funds generated from our operations prove insufficient for such purposes, we may need to raise additional funds to meet these
funding requirements.
These
additional funds may be raised by issuing equity or debt securities or by borrowing from banks or other resources. We cannot assure you
that we will be able to obtain any additional financing on terms that are acceptable to us, or at all. If we fail to obtain additional
financing on terms that are acceptable to us, we will not be able to implement such plans fully if at all. Such financing even if obtained,
may be accompanied by conditions that limit our ability to pay dividends or require us to seek lenders’ consent for payment of
dividends, or restrict our freedom to operate our business by requiring lender’s consent for certain corporate actions.
Further,
if we raise additional funds by way of a rights offering or through the issuance of new shares, any shareholders who are unable or unwilling
to participate in such an additional round of fund raising may suffer dilution in their investment.
Most
of our executive officers do not reside in the United State.
Our
U.S. stockholders would face difficulty in:
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Effecting service of process
within the United States on most of our executive officers, if considered necessary. |
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Enforcing judgments obtained
in U.S. courts based on the civil liability provisions of the U.S. federal securities laws against the executive officers. |
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Enforcing judgments of
U.S. courts based on civil liability provisions of U.S. federal securities laws in foreign courts against the executive officers. |
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Bringing an original action
in foreign courts to enforce liabilities based on the U.S. federal securities laws against the executive officers. |
Accordingly,
persons contemplating an investment in our common stock should seriously consider these factors before making an investment decision.
Our
future success depends on the continuing efforts of our key employees and our ability to attract, hire, retain and motivate highly skilled
and creative employees in the future.
Our
future success depends on the continuing efforts of our executive officers, our founders and other key employees, in particular Robert
Mattacchione, our Chief Executive Officer, Christopher David, our Chief Operating Officer/President and Jim Zsebok, our Principal Financial
Officer. We rely on the leadership, knowledge and experience that our executive officers, founders and key employees provide. They foster
our corporate culture, which we believe has been instrumental to our ability to attract and retain new talent. Any failure to attract
new or retain key creative talent could have a material adverse effect on our business, financial condition, and results of operations.
The
market for talent in our key areas of operations is intensely competitive, which could increase our costs to attract and retain talented
employees. As a result, we may incur significant costs to attract and retain employees, including significant expenditures related to
salaries and benefits and compensation expenses related to equity awards, and we may lose new employees to our competitors or other companies
before we realize the benefit of our investment in recruiting and training them.
Employee
turnover, including changes in our management team, could disrupt our business. The loss of one or more of our executive officers, founders
or other key employees, or our inability to attract and retain highly skilled and creative employees, could have a material adverse effect
on our business, results of operations or financial condition.
We
believe our corporate culture has contributed to our success and, if we are unable to maintain it as we grow, our business could be harmed.
We
believe our corporate culture has been a key element of our success. However, as our organization grows, it may be difficult to maintain
our culture, which could reduce our ability to attract and maintain new talent and operate effectively. The failure to maintain the key
aspects of our culture as our organization grows could result in decreased employee satisfaction, increased difficulty in attracting
top talent and increased turnover and could compromise the quality of our client service, all of which are important to our success and
to the effective execution of our business strategy. Accordingly, if we are unable to maintain our corporate culture as we grow our business,
this could have a material adverse effect on our business, results of operations or financial condition.
We
may not have sufficient insurance coverage and an interruption of our business or loss of a significant amount of property could have
a material adverse effect on our financial condition and operations.
We
currently do not maintain any insurance policies against loss of key personnel. We do maintain insurance coverage for business interruption
as well as product liability claims. In addition, we do maintain director and officer insurance coverage. If any event were to occur
which required our insurance coverage to be applicable as well as a loss of key personnel, our business, financial performance, and financial
position may be materially and adversely affected.
We
could become involved in claims or litigations that may result in adverse outcomes.
From
time-to-time we may be involved in a variety of claims or litigations. Such proceeding may initially be viewed as immaterial but could
prove to be material. Litigations are inherently unpredictable and excessive verdicts do occur. Given the inherent uncertainties in litigation,
even when we can reasonably estimate the amount of possible loss or range of loss and reasonably estimable loss contingencies, the actual
outcome may change in the future due to new developments or changes in approach. In addition, such claims or litigations could involve
significant expense and diversion of management’s attention and resources from other matters.
We
may be unable to adequately safeguard our intellectual property or we may face claims that may be costly to resolve or that limit our
ability to use such intellectual property in the future.
Where
litigation is necessary to safeguard our intellectual property, or to determine the validity and scope of the proprietary rights of others,
this could result in substantial costs and diversion of our resources and could have a material adverse effect on our business, financial
condition, operating results or future prospects.
We
are unable to assure you that third parties will not assert infringement claims against us in respect of our intellectual property or
that such claims will not be successful. It may be difficult for us to establish or protect our intellectual property against such third
parties and we could incur substantial costs and diversion of management resources in defending any claims relating to proprietary rights.
If any party succeeds in asserting a claim against us relating to the disputed intellectual property, we may need to obtain licenses
to continue to use the same. We cannot assure you that we will be able to obtain these licenses on commercially reasonable terms, if
at all. The failure to obtain the necessary licenses or other rights could cause our business results to suffer.
We
could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar international anti-bribery and anti-kickback
laws with respect to our activities outside the United States.
We
anticipate rendering multidisciplinary primary health care services through our clinics and distributing our medical cannabidiol products
to locations in Canada and United States as well as operate our business in Canada and United States. The U.S. Foreign Corrupt Practices
Act, and other similar anti-bribery and anti-kickback laws and regulations, generally prohibit companies and their intermediaries from
making improper payments to non-U.S. officials for the purpose of obtaining or retaining business. We cannot assure you that we will
be successful in preventing our agents from taking actions in violation of these laws or regulations. Such violations, or allegations
of such violations, could disrupt our business and result in a material adverse effect on our financial condition, results of operations
and cash flows.
We
are subject to a number of risks related to credit card and debit card payments we accept.
We
accept payments through credit card and debit card transactions. For credit card and debit card payments, we pay interchange and other
fees, which may increase over time. An increase in those fees would require us to either increase the prices we charge for our services
which could cause us to lose clients or suffer an increase in our operating expenses, either of which could harm our operating results.
If we or any of our processing vendors have problems with our billing software, or the billing software malfunctions, it could have an
adverse effect on our customer satisfaction and could cause one or more of the major credit card companies to disallow our continued
use of their payment products. In addition, if our billing software fails to work properly and, as a result, we do not automatically
charge our clients’ credit cards, debit cards or bank accounts on a timely basis or at all, we could lose revenues, which would
harm our operating results. If we fail to adequately control fraudulent credit card and debit card transactions, we may face civil liability,
diminished public perception of our security measures and significantly higher credit card and debit card related costs, each of which
could adversely affect our business, financial condition and results of operations. The termination of our ability to process payments
on any major credit or debit card would significantly impair our ability to operate our business.
Security
breaches of confidential customer information, in connection with our electronic processing of credit and debit card transactions, or
confidential employee information may adversely affect our business.
Our
business requires the collection, transmission and retention of large volumes of customer and employee data, including credit and debit
card numbers and other personally identifiable information, in various information technology systems that are maintained internally
and by third parties with whom we contract to provide services. The integrity and protection of that customer and employee data is critical
to us. Our customers and employees have a high expectation that we and our service providers will adequately protect their personal information.
The information, security and privacy requirements imposed by governmental regulation are increasingly demanding. Our systems may not
be able to satisfy these changing requirements and customer and employee expectations or may require significant additional investments
or time in order to do so. Efforts to hack or breach security measures, failures of systems or software to operate as designed or intended,
viruses, operator error or inadvertent releases of data all threaten our information systems and records. A breach in the security of
our service providers’ information technology systems could lead to an interruption in the operation of our systems, resulting
in operational inefficiencies and a loss of profits. A significant theft, loss or misappropriation of, or access to, customers’
or other proprietary data or other breach of our information technology systems could result in fines, legal claims or proceedings, including
regulatory investigations and actions, or liability for failure to comply with privacy and information security laws, which could disrupt
our operations, damage our reputation and expose us to claims from customers and employees, any of which could have a material adverse
effect on our financial condition and results of operations.
We
rely on third parties to provide services in connection with our business, and any failure by these third parties to perform their obligations
could have an adverse effect on our business, financial condition and results of operations.
We
have entered into agreements with third parties that include, but are not limited to, information technology systems (including hosting
our website, mobile application and our point-of-sale system), select marketing services, and employee benefits servicing. Services provided
by third-party suppliers could be interrupted as a result of many factors, such as acts of nature or contract disputes. Accordingly,
we are subject to the risks associated with the third parties’ abilities to provide these services to meet our needs. Any failure
by a third party to provide services for which we have contracted on a timely basis or within expected service level and performance
standards could result in a disruption of our business and have an adverse effect on our business, financial condition, and results of
operations.
Our
amended and rested articles of incorporation provide the that state or federal court located within the state of Nevada will be the sole
and exclusive forum for substantially all disputes between us and our shareholders, which could limit its stockholders’ ability
to obtain a favorable judicial forum for disputes with us or our directors, officers, or other employees.
Our
amended and restated articles of incorporation provide that “[u]nless the Corporation consents in writing to the selection of an
alternative forum, the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the Corporation, (ii)
any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Corporation to the
Corporation or the Corporation’s stockholders, (iii) an action asserting a claim arising pursuant to any provision of the NRS,
or (iv) any action asserting a claim governed by the internal affairs doctrine, shall be a state or federal court located within the
state of Nevada, in all cases subject to the court’s having personal jurisdiction over the indispensable parties named as defendants.
This exclusive forum provision is intended to apply to claims arising under Nevada state law and would not apply to claims brought pursuant
to the Exchange Act of 1934, as amended (the “Exchange Act”) or Securities Act of 1933, as amended (the “Securities
Act”), or any other claim for which the federal courts have exclusive jurisdiction. The exclusive forum provision in our amended
and restated articles of incorporation will not relieve us of our duty to comply with the federal securities laws and the rules and regulations
thereunder, and shareholders will not be deemed to have waived compliance with these laws, rules and regulations.
Public
health epidemics or outbreaks could adversely impact our business.
While
all of the Company’s business units are operational at the time of this filing, any future impact of the COVID-19 pandemic or any
other public health epidemic on the Company’s operations remains unknown and will depend on future developments, which are highly
uncertain and cannot be predicted with confidence, including the duration of the COVID-19 or other potential public health epidemic,
new information which may emerge concerning the severity of the COVID-19 pandemic or public health epidemic, and any additional preventative
and protective actions that governments, or the Company, may direct, which may result in an extended period of continued business disruption,
reduced patient traffic and reduced operations. For more information regarding the impact of COVID-19 on the Company, see “—Liquidity
and Capital Resources—Financial Impact of COVID-19” of this annual report on Form 10-K.
Risks
Related to our Multidisciplinary Primary Health Care Business
We
may not be able to successfully implement our business growth initiatives for our multidisciplinary primary health care business on a
timely basis or at all, which could harm our business, financial performance, financial position, and results of operations.
The
growth of our multidisciplinary primary health care business depends on our ability to open and acquire new clinics and expand our roster
of clinicians and staff to best service our multidisciplinary primary health care clinics and eldercare centric homes.
A
component of our growth strategy is to increase the number of our multidisciplinary primary health care clinics through both the acquisition
of existing clinics and the opening of new clinics while also engaging new contracts with new affiliate clinics and elder centric homes.
Our ability to acquire and open profitable clinics and expand our clinician and staffing requirements depends on many factors, including
our ability to:
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access capital to fund
future acquisitions and preopening expenses; |
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achieve brand awareness
in new and existing markets; |
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manage costs, which could
give rise to delays or cost overruns; |
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recruit, train, and retain
qualified multidisciplinary primary health care clinicians and other staff in our local markets; |
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obtain favorable reimbursement
rates for services rendered at the clinics; |
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successfully staff and
operate new clinics and affiliated clinics and elder centric homes; |
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obtain all required governmental
approvals, certificates, licenses and permits on a timely basis; |
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manage delays in the acquisition
or opening of clinics; |
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compete for appropriate
sites in new markets against other multidisciplinary primary health care competitors and clinics; and |
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maintain adequate information
systems and other operational system capabilities. |
Further,
additional federal or state legislative or regulatory restrictions or licensure requirements could negatively impact our ability to operate
both new and existing clinics.
Accordingly,
we may not be able to achieve our planned growth or, even if we are able to grow our clinic base as planned, any new clinics may not
be profitable or otherwise perform as planned. Failure to implement successfully our growth strategy would likely have an adverse impact
on our business, financial condition or results of operations.
The
long-term success of our multidisciplinary primary health care business is highly dependent on our ability to successfully identify and
acquire target clinics and identify and secure staffing opportunities.
To
achieve our business growth initiative, we will need to acquire and open new clinics and operate them on a profitable basis. We expect
this to be the case for the foreseeable future. In addition, we will need to identify and secure staffing opportunities as well. We consider
numerous factors in identifying target markets where we can enter or expand and staffing opportunities that we can secure.
The
number and timing of new clinics acquired and opened during any given period may be negatively impacted by a number of factors including,
without limitation:
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the identification and
availability of attractive sites for new clinics and the ability to negotiate suitable lease terms; |
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our ability to successfully
identify and address pertinent risks during acquisition due diligence; |
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the preparation of target
clinics’ financial statements on methods of accounting other than generally accepted accounting principles, or GAAP; |
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the proximity of potential
sites to one of our or our competitors’ existing clinics; |
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our ability to obtain required
governmental licenses, permits and authorizations on a timely basis; and |
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our ability to recruit
qualified clinicians and other personnel to staff our clinics. |
If
we are unable to find and secure attractive target clinics to expand in existing markets or enter new markets, our revenues and profitability
may be harmed, we may not be able to implement our business growth initiatives and our financial results may be negatively affected.
Our
intended acquisition and opening of clinics and increase in staffing in new markets exposes us to various risks and may require us to
develop new business models.
Our
growth and profitability depend on our ability to implement our business growth initiatives by expanding the number of clinics we operate
and the amount of staffing in both new and existing markets. We cannot assure you our efforts to expand into new markets, particularly
where we do not currently operate, will succeed. To operate in new markets, we may be required to modify our existing business model
and cost structure to comply with local regulatory or other requirements, which may expose us to new operational, regulatory or legal
risks.
We
may be unable to acquire target clinics within our current price ranges. This may reduce the pace of our growth and increase the need
for additional debt and equity capital. The patient population of clinics we acquire may be loyal to existing ownership, making it difficult
to maintain pre-closing revenue and profit levels. The re-branding of acquired clinics may have an adverse market effect in local communities,
and our brand may not be received as favorably in the local communities as we anticipate.
The
process of integration of an acquired clinic may subject us to a number of risks, including:
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Failure to successfully
manage relationships with multidisciplinary primary health care clinicians and other staff of the acquired clinic; |
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Demands on management related
to the increase in size of our Company after the acquisition; |
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Diversion of management
attention; |
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Potential difficulties
integrating and harmonizing financial reporting systems; |
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Difficulties in the assimilation
and retention of employees; |
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Inability to retain the
multidisciplinary primary health care clinicians and other staff of the acquired clinic; |
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Inability to establish
uniform standards, controls, systems, procedures and policies; |
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Inability to retain the
patients of the acquired clinic; |
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Exposure to legal claims
for activities of the acquired clinic prior to acquisition; and |
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Incurrence of additional
expenses in connection with the integration process. |
If
the acquired clinic is not successfully integrated into our Company, our business, financial condition and results of operations could
be materially adversely affected, as well as our reputation. Furthermore, if we are unable to successfully integrate the acquired clinic
or if there are delays in combining the businesses, the anticipated benefits of the acquisition may not be realized fully or at all or
may take longer to realize than expected.
Growing
our business through acquisitions will require additional personnel. There can be no assurance that these demands will not have a material
adverse effect on our business, financial condition, and results of operations, nor can there be any assurance that we will be able to
attract or retain competent personnel and improve our operational systems sufficiently to support the expansion of our operations.
Also
important to our success will be our ability to achieve additional economies of scale in order to improve operating margins. There can
be no assurance that we will be able to achieve such economies of scale, and the failure to do so could have a material adverse effect
on our business, financial condition, and results of operations.
Clinics
we open in new markets may take longer to reach expected revenue and profit levels on a consistent basis. The cost of opening and operating
new clinics may exceed our budget, thereby affecting our overall profitability. New markets may have competitive conditions, consumer
preferences, and health care spending patterns that are more difficult to predict, identify or satisfy than our existing markets. We
may need to make greater investments than we originally planned in advertising and promotional activity in new markets and after closing
acquisitions to build brand awareness. We may find it more difficult in new markets to hire, and we may not be able to retain and motivate
qualified multidisciplinary primary health care clinicians and other personnel. We may need to augment our labor model to meet regulatory
requirements and the overall cost of labor may increase or be higher than anticipated.
As
a result, any new or acquired clinics may be less successful and may not achieve target profit margins at the same rate or at all. If
any steps taken to expand our existing business model into new markets are unsuccessful, we may not be able to achieve our growth objectives
and our business, financial condition and results of operations could be adversely affected.
We
will require additional capital to fund our operating and expansion costs, and our inability to obtain such capital will likely harm
our business.
Although
we currently operate 16 corporate owned multidisciplinary primary health care clinics, our administrative, corporate, and general organizational
infrastructure is designed to support numerous additional clinics. Consequently, we expect that our monthly expenses will continue to
exceed our monthly cash receipts until we significantly increase the number of our multidisciplinary primary health care clinics. Depending
on the results of our operations, we may need to raise additional capital to cover our operating and expansion costs.
To
support our expansion strategy, we must have sufficient capital to continue making investments in new and existing clinics. Current funding
sources and cash generated by our operations may not be sufficient to allow us to sustain our expansion efforts. If this is the case,
we may need additional equity or debt financing to provide the funds required to operate and expand our business. If such financing is
not available on satisfactory terms or at all, we may be unable to expand our business or acquire new clinics at our projected rate and
our operating results may suffer. Debt financing increases expenses and must be repaid regardless of operating results and may impose
restrictions on the manner in which we operate our business. Equity financing, or debt financing that is convertible into equity, could
result in additional dilution to our existing stockholders. Furthermore, if we are unable to obtain adequate capital, whether in the
form of equity or debt, to fund our business and growth strategies we may be required to delay, scale back or eliminate some or all of
our expansion plans, which may have a material adverse effect on our business, operating results, financial condition, or prospects.
The
clinics that we intend to acquire or open may not meet our expectations.
In
general, our business growth initiatives involve the acquisition and opening of strategically located clinics. Clinics that we intend
to acquire and open may not meet our revenue or profit targets or may take longer than anticipated to do so. If our acquired or new clinics
do not perform as planned, our business and future prospects could be harmed. If we are unable to manage successfully the potential difficulties
associated with acquiring and opening new clinics, we may not be able to capture the efficiencies and opportunities that we expect from
our expansion strategy. Our inability to capture expected efficiencies of scale, maintain patient volumes, improve our systems and equipment,
continue our cost discipline, and retain appropriate physician and overall labor levels, could have a material adverse effect on our
business, financial condition and results of operations.
If
we open new clinics in existing markets, revenue at our existing clinics may be affected negatively.
The
catchment area of our clinics varies by location and depends on a number of factors, including population density, other available convenient
medical or multidimensional primary health care services, area demographics and geography. As a result, the opening of a new clinic in
or near markets in which we already have clinics could adversely affect the revenues of those existing clinics. Existing clinics could
also make it more difficult to build our patient base for a new clinic in the same market. We may selectively open new clinics in and
around areas of existing clinics that are operating at or near capacity to serve effectively our patients, but revenue cannibalization
between our clinics may become significant in the future as competition increases and as we continue to expand our operations. This could
adversely affect our revenue growth, which could, in turn, adversely affect our business, financial condition, or results of operations.
We
may be required to make capital expenditures in connection with our acquisitions to implement our growth strategy.
In
order to maintain brand consistency across our multidimensional primary health care clinics, we may need to make significant capital
expenditures to the interior and exterior of our clinics. This may include making real property improvements and upgrading our medical
equipment to serve our patients and remain competitive. Changing competitive conditions or the emergence of significant advances in medical
technology could require us to invest significant capital in additional equipment or capacity in order to remain competitive. Along these
lines, if the systems and technology of our target clinics differ from those we have chosen to utilize, we may be required to invest
significant capital to either convert, terminate, or integrate the varying medical technology platforms. If we are unable to fund any
such investment or otherwise fail to make necessary capital expenditures, our business, financial condition, or results of operations
could be materially and adversely affected.
Damage
to our reputation or our brand in existing or new markets could negatively impact our business, financial condition and results of operations.
We
must grow the value of our brand to be successful. We intend to further develop our reputation and brand of providing patients with high
quality effective multidisciplinary primary health care services, and related products, delivered by respected clinicians and well-trained
operational staff. Additionally, we place high-value on building and maintaining a patient-centered culture. If we do not make investments
in areas such as marketing and advertising, as well as the day-to-day investments required for clinic operations, equipment upgrades,
and personnel training, the value of our brand may not increase or may be diminished. Any incident, real or perceived, regardless of
merit or outcome, that adversely affects our brand, such as, but not limited to, patient disability or death due to malpractice or allegations
of malpractice, failure to comply with federal, provincial or local regulations, including allegations or perceptions of non-compliance
or failure to comply with ethical and operational standards, could significantly reduce the value of our brand, expose us to negative
publicity and damage our overall business and reputation.
Our
marketing activities may not be successful.
We
incur costs and expend other resources in our marketing efforts to attract and retain patients. Our marketing activities are principally
focused on increasing brand awareness in the communities in which we provide services. As we open and acquire new clinics, we expect
to undertake aggressive marketing campaigns to increase community awareness about our presence and our service capabilities. We plan
to conduct our targeted marketing efforts in neighborhoods through channels such as direct mail, billboards, radio advertisements, physician
open houses, community sponsorships and various social media. If we are not successful in these efforts, we will have incurred expenses
without materially increasing revenue.
The
multidisciplinary primary health care market is highly competitive, including competition for patients, strategic relationships, and
commercial payor contracts, each of which could adversely affect our contract and revenue base.
The
market for providing multidisciplinary primary health care services, and related products, is highly competitive, and all of our clinics
and staffing opportunities face and will face competition, in varying degrees, from existing multidisciplinary primary health care providers.
Walk-in clinics, hospital emergency rooms, private doctors’ offices, freestanding emergency clinics, independent laboratories,
hospital- and payor-supported urgent care facilities, and occupational medicine clinics. We compete with national, regional, and local
enterprises, some of which have greater financial and other resources available to them, greater access to clinicians, medically licensed
physicians and other medical professionals or greater access to potential patients. Our clinics and staffing compete on the basis of
accessibility, including evening and weekend hours, walk-in care, as well as varying appointment opportunities. We also compete on the
basis of our multi-provinces, regional footprint, which we believe will be of value to both employers and third-party payors. As a result
of the differing competitive factors within the markets in which we operate and will operate, the individual results of our clinics may
be volatile. If we are unable to compete effectively with any of these entities or groups, we may be unable to implement our business
strategies successfully, which could have a material adverse effect on our business, prospects, results of operations and financial condition.
We
may not be able to recruit and retain qualified multidisciplinary primary health care clinicians for our multidisciplinary primary health
care clinics and staffing of affiliate clinics and eldercare centric homes.
Our
success depends upon our ability to recruit and retain qualified multidisciplinary primary health care clinicians and other staff. There
is currently a national shortage in Canada and United States of certain of these health care professionals. To the extent a significant
number of multidisciplinary primary health care clinicians within an individual community or market decide to partner with competing
multidisciplinary primary health care providers or hospitals and not with us, we may not be able to operate our clinics in such community.
We face competition for such personnel from existing operators, hospital systems, entrepreneurial start-ups, and other organizations.
This competition may require us to enhance wages and benefits to recruit and retain qualified personnel. Our inability to recruit and
retain these professionals could have a material adverse effect on our ability to grow or be profitable.
We
may not be able to prohibit or limit our multidisciplinary primary health care clinicians from competing with us in our local markets.
In
certain provinces in Canada in which we operate or intend to operate and states in the United States in which we intend to operate, non-compete,
non-solicitation, and other negative covenants applicable to employment or ownership are judicially or statutorily limited in their effectiveness
or are entirely unenforceable against multidisciplinary primary health care professionals. As a result, we may not be able to protect
our operational processes, procedures, and general trade secrets or limit insiders from using competitive information against us or competing
with us, which could have a material adverse effect on our ability to remain competitive.
With
respect to our operations in Canada, we may be unable to enter into or maintain contracts for our affiliate multidisciplinary primary
health care clinics and eldercare focused facilities or services on favorable terms with commercial payors.
In
Canada, a significant portion of our net patient service revenue is derived from nongovernmental, extended health insurers which provide
reimbursement based on a pre-allocated amount disbursed as a cash payment for services, and related products, provided to the patient.
With
respect to our anticipated expansion of our operations into the United States, we may be unable to enter into or maintain contracts for
our multidisciplinary primary health care clinics and services on favorable terms with commercial payors in the United States.
With
respect to our anticipated expansion of our operations into the United States, we anticipate that a significant portion of our net patient
service revenue will be derived from nongovernmental, third-party payors, or commercial payors, such as managed care organizations, commercial
insurance providers and employer-sponsored health care plans. These commercial payors use a variety of methods for reimbursement depending
on the arrangement involved. These arrangements include fee-for-service, PPOs and health maintenance organizations, as well as prepaid
and discounted medical service packages and capitated, or fixed fee, contracts. Rates for health maintenance organization benefit plans
are typically lower than those for PPOs or other benefit plans that offer broader provider access.
Frequently,
commercial payors classify or may reclassify our multidisciplinary primary health care services differently. Such distinctions may result
in different payment and reimbursement structure. Such differences may affect costs to the patient through increased copayments, deductibles
and other cost-sharing mechanisms and, accordingly, patient choice of provider.
There
is often pressure to renegotiate reimbursement levels, particularly in connection with changes to Medicare. Typically, commercial payors
reimburse us based upon contracted discounts to our established base rates. If managed care organizations and other commercial payors
reduce their rates or we were to experience a significant shift in our revenue mix toward Medicare or Medicaid reimbursements, then our
revenue and profitability would be adversely affected and our operating margins would be reduced. Commercial payors often demand discounted
fee structures, and the trend toward consolidation among commercial payors tends to increase their bargaining power over fee structures.
Because some commercial payors rely on all or portions of Medicare fee schedules to determine payment rates, changes to government health
care programs that reduce payments under these schedules may negatively impact payments from commercial payors. Other health care providers
may impact our ability to negotiate increases and other favorable terms in our reimbursement arrangements with commercial payors. For
example, some of our competitors may negotiate exclusivity provisions with commercial payors or otherwise restrict the ability of commercial
payors to contract with us. We may be excluded from participating in commercial payor networks, making it more expensive for certain
patients to receive treatment at our clinics. Our results of operations will depend, in part, on our ability to retain and renew managed
care contracts as well as enter into new managed care contracts on terms favorable to us. Our inability to maintain suitable financial
arrangements with commercial payors could have a material adverse impact on our business.
As
various provisions of the Patient Protection and Affordable Care Act, or the ACA, are implemented, commercial payors may increasingly
demand fee reductions. In addition, there is a growing trend for commercial payors to take steps to shift the primary cost of care to
the plan participant by increasing co-payments, co-insurance and deductibles, and these actions could discourage such patients from seeking
treatment at our clinics. Patient volumes could be negatively impacted if we are unable to enter into or maintain acceptable contracts
with such commercial payors, which could have a material adverse effect on our business, prospects, results of operations and financial
condition.
Government
health care programs may reduce reimbursement rates.
Our
competition will also be the Canadian health care system which is a government sponsored system that began in 1957, when Parliament approved
the Hospital Insurance and Diagnostics Services Act. The Act provided free acute hospital care, laboratory and radiological diagnostic
services to Canadians. By 1961, agreements were in place with all the provinces and 99% of Canadians had free access to the health care
services covered by the legislation. The Act was followed by the Medical Care Act of 1966 that provided free access to physician services.
By 1972, each province had established its own system of free access to physician services. The federal government shared in the funding.
In 1984, the Government of Canada passed the Canada Health Act (CHA). The Canada Health Act created a publicly administered health care
system that is comprehensive, universal and accessible. All medically necessary procedures are provided free of charge. The system provides
diagnostic, treatment and preventive services regardless of income level or station in life. Access to care is not based on health status
or ability to pay. Coverage is portable between provinces and territories. We can give no assurance that we will be able to effectively
compete in this market.
In
recent years, in the United States, new legislation has been proposed and adopted at both the federal and state level that is effecting
major changes in the health care system. Any change in the laws, regulations, or policies governing the health care system could adversely
affect reimbursement rates and our operations and financial condition. Enacted in March 2010, the ACA seeks to expand health care coverage,
while increasing quality and limiting costs. The ACA substantially changes the way health care is financed by both governmental and commercial
payors. As a result of the ACA or the adoption of additional federal and state health care reforms measures there could be limits to
the amounts that federal and state governments will pay for health care services, which could result in reduced demand or profitability
of our services.
Furthermore,
if due to an allegation of fraud or any other reason one or more of our multidisciplinary primary health care clinicians or practitioners
is no longer entitled to bill and receive payment for services rendered to patients whose treatment is paid in whole or in part by a
governmental payor, our revenue may be negatively impacted, which could have a material adverse effect on our business, prospects, results
of operations and financial condition.
If
payments from commercial or governmental payors are significantly delayed, are reduced or eliminated, our business, prospects, results
of operations and financial condition could be adversely affected.
We
depend upon compensation from third-party payors for the services provided to patients by our multidisciplinary primary health care clinicians
and practitioners in our clinics, affiliate clinics and eldercare centric homes serviced by our clinicians. The amount that we receive
through our clinics in payment for their services may be adversely affected by factors we do not control, including federal, provincial,
or local regulatory changes, cost-containment decisions, and changes in reimbursement schedules of third-party payors and legislative
changes. Any reduction or elimination of these payments could have a material adverse effect on our business, prospects, results of operations
and financial condition.
Additionally,
the reimbursement process is complex and can involve lengthy delays. Although we recognize revenue when multidisciplinary primary health
care services are provided, there can be delays before we receive payment. In addition, third-party payors may disallow, in whole or
in part, requests for reimbursement based on determinations that certain amounts are not reimbursable under plan coverage, that services
provided were not medically necessary, or that additional supporting documentation is necessary. Retroactive adjustments by third-party
payors may be difficult or cost prohibitive to appeal, and such changes could materially reduce the actual amount we receive from those
payors. Delays and uncertainties in the reimbursement process may be out of our control and may adversely affect us.
Significant
changes in our payor mix resulting from fluctuations in the types of patients seen at our clinics could have a material adverse effect
on our business, prospects, results of operations and financial condition.
Our
results may change from period to period due to fluctuations in payor mix or other factors relating to the type of treatment performed
by clinicians at our clinics. Payor mix refers to the relative amounts we receive from the mix of persons or entities that pay or reimburse
us for health care services. Because we generally receive relatively higher payment rates from commercial payors than from governmental
payors or self-pay patients, a significant shift in our payor mix toward a higher percentage of self-pay or patients whose treatment
is paid in whole or part by a governmental payor, which could occur for reasons beyond our control, could have a material adverse effect
on our business, prospects, results of operations and financial condition.
Failure
to bill timely or accurately for our services could have a negative impact on our net revenues, bad debt expense and cash flow.
Billing
for our services is often complex and time consuming. The practice of providing multidisciplinary primary health care services, and related
products, in advance of payment or prior to assessing a patient’s ability to pay for such services may have a significant negative
impact on our patient service revenue, bad debt expense and cash flow. We bill numerous and varied payors, including self-pay patients,
various forms of commercial payors, government payors and insurance payors. Billing requirements that must be met prior to receiving
payment for services rendered often vary by payor. Self-pay patients and third-party payors may fail to pay for services even if they
have been properly billed. Reimbursement is typically dependent on our providing the proper procedure and diagnosis codes.
Additional
factors that could affect our collections for the services we render include:
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disputes among payors as
to which party is responsible for payment; |
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variations in coverage
among various payors for similar services; |
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the difficulty of adherence
to specific compliance requirements, coding and various other procedures mandated by responsible parties; |
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the institution of new
coding standards; and |
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failure to properly credential
our providers to enable them to bill various payors. |
The
complexity associated with billing for our services causes many delays in our cash collections, resulting in increased carrying costs
associated with the aging of our accounts receivable as well as the increased potential for bad debt expense.
We
are dependent on our third-party revenue cycle managers for billing and collection of our claims.
We
submit our claims for services rendered to commercial payors and governmental payors electronically through our third-party revenue cycle
managers. We are dependent on our revenue cycle managers for the timely billing and collections of our claims. Any delay by or failure
of our revenue cycle managers to timely bill and collect our claims could have a material adverse effect on our business, results of
operations and financial condition.
We
may incur costs resulting from security risks in connection with the electronic data processing by our partner banks.
Because
we accept electronic payment cards for payments at our facilities, we may incur costs resulting from related security risks in connection
with the electronic processing of confidential information by our partner banks. Recently, several of the large national banks have experienced
potential or actual breaches in which similar data has been or may have been stolen. Such occurrences could cause patient dissatisfaction
resulting in decreased visits or could also distract our management team from the management of the day-to-day operations.
With
respect to our Canadian operations and our anticipated expansion of our operations into the United States, a successful challenge by
tax authorities to our treatment of certain multidisciplinary primary health care clinicians and practitioners as independent contractors
or the elimination of an existing safe harbor could materially increase our costs relating to these multidimensional primary health care
clinicians and practitioners.
With
respect to our Canadian operations and our anticipated expansion of our operations into the United States, certain of our multidisciplinary
primary health care clinicians and practitioners may be engaged as independent contractors by our state-level operating subsidiaries.
If these personnel are treated as independent contractors rather than as employees, our state-level operating subsidiaries will not (i)
withhold federal, state or local or state income or other employment related taxes from their compensation, (ii) make federal, provincial,
state or local federal or state unemployment tax or Federal Insurance Contributions Act payments with respect to them, (iii) provide
workers compensation insurance with respect to them (except in states where they are required to do so for independent contractors),
or (iv) allow them to participate in benefits and retirement programs available to employees. Although we will have contracts with these
licensed multidisciplinary primary health care clinicians obligating them to pay these taxes and other costs, if a challenge to our treatment
of these licensed multidisciplinary primary health care clinicians and practitioners as independent contractors by federal, state, or
local authorities were successful and they were treated as employees instead of independent contractors, we could be liable for taxes,
penalties, and interest. In addition, there are currently, and have been in the past, proposals made to eliminate an existing safe harbor
that would potentially protect us from the imposition of taxes in these circumstances, and similar proposals could be made in the future.
If such a challenge were successful or if the safe harbor were eliminated, this could cause a material increase in our costs relating
to these personnel and, have a material adverse effect on our business, financial condition, and results of operations.
Currently,
our corporate owned clinics and affiliate clinics are located in the Canadian provinces of Ontario, Alberta, Nova Scotia and Newfoundland
making us particularly sensitive to regulatory, economic, and other conditions in those states.
Our
clinics and affiliate clinics are located in the Canadian provinces of Ontario, Alberta, Nova Scotia and Newfoundland. If there were
an adverse regulatory, economic, or other development in any of those states, our patient volume could decline, our ability to operate
our clinics under our existing business model could be impacted, or there could be other unanticipated adverse impacts on our business
that could have a material adverse effect on our business, financial condition, and results of operations.
Our
business is seasonal, which impacts our results of operations.
Our
clinics’ patient and staffing volumes are sensitive to seasonal fluctuations. Typically, winter months see a higher occurrence
of motor vehicle and winter weather related accidents, such as falling, however; the timing and severity of these can vary dramatically.
Additionally, in the United States as consumers shift toward high deductible insurance plans, they are responsible for a greater percentage
of their bill, particularly in the early months of the year before other health care spending has occurred, which may lead to lower than
expected patient volume or an increase in bad debt expense during that period. Our quarterly operating results may fluctuate significantly
in the future depending on these and other factors.
We
could be subject to lawsuits for which we are not fully insured.
Medical
professionals, including multidisciplinary primary health care clinicians and practitioners, have become subject to an increasing number
of lawsuits alleging medical malpractice and related legal theories such as negligent hiring, supervision and credentialing. In Canada,
our clinicians and practitioners, whether an employee or independent contractor, are responsible for their own professional liability
insurance coverage. As provided in Canadian rules and regulations, our liability insurance coverage is not required to cover our clinicians
and practitioners. As we expand in the United States, we anticipate procuring insurance coverage for our affiliated multidimensional
primary health care clinicians, practitioners, and corporate entities. In addition, as we expand our menu of services and related products
through our various Medical Technology Platforms or possible acquisition of a medical licensed primary care practice, we will be subject
to lawsuits alleging medical malpractice and related legal theories such as negligent hiring, supervision, and credentialing.
We
are currently insured under policies in amounts management deems appropriate, based upon the nature and risk of our business. Nevertheless,
there are exclusions and exceptions to coverage under each insurance policy that may make coverage for any claim unavailable, future
claims could exceed the limits of available insurance coverage, existing insurers could become insolvent and fail to meet their obligations
to provide coverage for such claims, and such coverage may not always be available with sufficient limits and at reasonable cost to insure
us adequately and economically in the future. One or more successful claims against us not covered by, or exceeding the coverage of,
our insurance could have a material adverse effect on our business, prospects, results of operations and financial condition. Moreover,
in the normal course of our business, we may be involved in other types of lawsuits, claims, audits and investigations, including those
arising out of our billing and marketing practices, employment disputes, contractual claims and other business disputes for which we
may have no insurance coverage. The outcome of these matters could have a material adverse effect on our financial position, results
of operations, and cash flows.
Some
of these lawsuits may involve large claim amounts and substantial defense costs.
Insurance
coverage for some of our losses may be inadequate and may be subject to the credit risk of commercial insurance providers.
We
maintain insurance coverage for specific liability for our clinic facilities through various third-party insurers. To the extent we hold
policies to cover certain groups of claims or rely on insurance coverage obtained by third parties to cover such claims, we may be responsible
for those losses if the insurance coverage is inadequate or the insurer rejects our claim for payment. Furthermore, for our losses that
are insured or reinsured through commercial insurance providers, we are subject to the financial viability of those insurance companies.
Although we believe our commercial insurance providers are currently creditworthy, they may not remain so in the future.
Risks
Related to Health Care Regulation
The
health care industry is heavily regulated, and if we fail to comply with these laws and government regulations, we could incur penalties
or be required to make significant changes to our operations.
The
health care industry is heavily regulated and closely scrutinized by federal, state, provincial and local governments. Comprehensive
statutes and regulations govern the manner in which we provide and bill for services and products, our contractual relationships with
our clinicians, vendors, patients and our marketing activities and other aspects of our operations. If we fail to comply with these laws
and regulations, we could be exposed to civil and criminal penalties such as fines, damages, overpayment recoupment, loss of enrollment
status and exclusion from government health care programs. Any action against us for violation of these laws or regulations, even if
successfully defended, could cause us to incur significant legal expenses and divert our management’s attention from the operation
of our business. Our clinicians and practitioners are also subject to ethical guidelines and operating standards of professional and
private accreditation agencies.
The
laws, regulations and standards governing the provision of health care service, and related products, may change significantly in the
future, and these changes may materially and adversely affect our business. Furthermore, a review of our business by regulatory or accreditation
authorities could result in determinations that could adversely affect our operations.
Our
Canadian clinics are and will be subject to numerous statutes and regulations. Additionally, given our intention to expand and begin
operations in the United States, we will be subject to numerous U.S. statutes and regulations. Failure to comply with these laws and
regulations could result in civil or criminal sanctions.
The
operation of our clinics in Canada subjects us, and will subject us, to many provincial laws and regulations, following the projected
expansion of our Company’s operations to the United States, federal and state laws in the United States. In general, whether directly
or through boards, agencies, or other delegated authorities, regulating the ownership and dispensing of controlled substances, the retention
and storage of medical records, patient privacy and protection of health information, the licensure of multidisciplinary primary health
care providers, including clinicians, and the clinical supervision, by physicians, of nurse practitioners and physician assistants, among
other aspects of our operations are regulated. All such laws and regulations, and the applicable interpretations of such laws and regulations,
are subject to change.
Additional
regulation of clinics such as ours has been proposed in several Canadian provinces and the United States. The adoption of any such regulations
in the provinces in Canada, or states in the United States in which we operate or intend to operate, could force us to change our operational
or transactional approach or lead to a finding by regulators that our primary care clinics and clinics do not meet legal requirements.
We may be subject to criminal prosecution, regulatory fines, penalties, or other sanctions if our operations or clinics are found to
not comply with applicable laws and regulations. In addition, we may be required to refund all funds received from patients and third-party
payors during the period of noncompliance.
With
respect to our anticipated expansion of our operations into the United States, state regulation of the expansion of multidisciplinary
primary health care clinics could prevent us from reaching our expansion objectives.
In
the United States, many states have certificate of need programs that require some level of prior approval for the development, acquisition,
or expansion of health care sector related facilities. With respect to our anticipated expansion of our operations into the United States,
in the event we choose to acquire or open clinics in a state that does require such approval, we may be required to obtain a certificate
of need before the acquisition or opening occurs. If we are unable to obtain such approvals, we may not be able to move forward with
the planned activity.
Only
a few states currently require the licensure of multidisciplinary primary health care clinics such as ours. The lack of a specific licensure
process for our clinics in the vast majority of states may lead state legislators or regulators to regulate aggressively the growth of
our industry, potentially seeking to treat our industry in a manner similar to hospitals or freestanding emergency departments. Further,
the growing number of urgent care clinics and freestanding emergency departments may lead to legislation or regulations requiring us
to change substantially our operations or cease our operations in that state entirely. Any such requirements could have a material adverse
effect on our prospects and growth strategy.
Our
services, and related products, are subject to comprehensive laws and regulations that govern the manner in which we bill and are paid
for our services by third-party payors, and the failure to comply with these requirements can result in civil or criminal sanctions,
including exclusion from federal and state health care programs.
A
substantial portion of our services, and related products, are paid for by commercial payors and governmental payors. These third-party
payors typically have differing and complex billing and documentation requirements. If we fail to meet these requirements, we may not
be paid for our services or payment may be substantially delayed or reduced.
Numerous
federal, provincial and local laws also apply to our claims for payment, including but not limited to (i) “coordination of benefits”
rules that dictate which payor must be billed first when a patient has coverage from multiple payors, (ii) requirements that overpayments
be refunded within a specified period of time, (iii) “reassignment” rules governing the ability to bill and collect professional
fees on behalf of other providers, (iv) requirements that electronic claims for payment be submitted using certain standardized transaction
codes and formats, and (v) laws requiring all health and financial information of patients in a manner that complies with applicable
security and privacy standards.
Third-party
payors carefully monitor compliance with these and other applicable rules. Our failure to comply with these rules could result in our
obligation to refund amounts previously paid for such services or non-payment for our services.
If
we are found to have violated any of these or any of the other laws or regulations which govern our activities, the resulting penalties,
damages, fines or other sanctions could adversely affect our ability to operate our business and our financial results.
Changes
in coverage and the rates or methods of third-party reimbursements may adversely affect our revenue and operations.
A
substantial portion of our revenue is derived from direct billings to patients and third-party payors. As a result, any changes in the
rates or methods of reimbursement for the services and products we provide could have a material adverse effect on our revenue and financial
results. Reimbursement rates can vary depending on whether our clinic is an in-network or out-of-network provider. Each of our clinics
may be out-of-network for some patients. When acting as an out-of-network provider, reimbursement rates may be lower, co-payments and
deductibles may be higher and we may have difficulties complying with the billing requirements of certain third-party payors.
Past
and future legislation related to the health care industry and other changes in the health care industry could adversely affect our business,
financial condition, and results of operations.
The
health care industry is subject to legislative and regulatory changes, as well as changes from other influences. The government may continue
reviewing and assessing health care delivery and payment systems and may in the future adopt legislation making additional fundamental
changes in the health care system. There is no assurance that such changes will not have a material adverse effect on our business, financial
condition, or results of operations. Continued efforts to shift health care costs to the patient (through co-payments, deductibles, and
other mechanisms) could adversely affect our business, financial condition, and results of operations.
We
are subject to the Canada Health Act, Canada’s National Health Insurance Program and Food and Drugs Act and analogous provisions
of applicable state laws and could face substantial penalties if we fail to comply with such laws.
In
Canada, some health care services are public, some are private with a number of different entities involved in regulating and providing
their delivery. While there is a perception that all health care in Canada is publicly funded, the publicly funded system is generally
restricted to “medically necessary” hospital and physician services, and provincial or territorial drug plans that provide
access to prescription drugs to residents over the age of 65 or those residents who rely on social assistance programs. Publicly funded
services are delivered through a combination of public and private providers and funding comes from the Canadian federal government,
which sets national standards, and the provincial and territorial governments, which regulates the delivery of services and determines
those services that are deemed “medically necessary” (i.e., publicly funded) within the context of their own unique fiscal
and political environment. In addition, there are a wide array of health products and services that are not subject to coverage under
the public health insurance plans that are provided on a private payer basis.
Federal/Provincial
Government Division of Power in Canada
As
is the case for many important industries and economic sectors, neither the federal, nor the provincial/territorial level of government
has exclusive jurisdiction over health. Instead, the Constitution Act, 1867, divides the legislative powers relevant to the regulation
of the delivery of health products and services between the federal and provincial levels of government.
The
federal government is responsible for regulating important aspects of various health industries or sectors including the regulation of
selling, importing, distributing, and marketing drugs and medical devices and it maintains significant influence over health policy and
national objectives through the use of its spending power.
The
provincial/territorial level of government has comprehensive authority over the delivery of health care services. Other examples of provincial
responsibility include the regulation of hospitals and other health facilities, administration of health insurance plans, distribution
of prescription drugs and regulation of health professionals.
However,
many health industry sectors are subject to at least some degree of regulation or oversight by both levels of government.
Canada’s
National Health Insurance Program
Canada’s
“national” health insurance program, a publicly funded single-payer system often referred to as “Medicare,” is
designed to ensure that all Canadian residents have universal access to medically necessary hospital and physician services through the
provincial and territorial health care insurance plans.
The
Canada Health Act
The
Canada Health Act is the federal legislation that provides the foundation for the Canadian health care system. The Act is administered
by Health Canada, the federal department with primary responsibility for maintaining and improving the health of Canadians. However,
neither the Canada Health Act nor Health Canada have direct authority to regulate the health insurance plans that give effect to the
publicly funded health insurance system that is in place across the country. Instead, the Act establishes certain values and principles
and sets out criteria and conditions that each publicly funded health insurance plan is required to meet in order to qualify for federal
funding through the Canada Health Transfer. As federal funding is critical to the ability to fund “medically necessary” hospital
and physician services, each provincial and territorial health insurance plan must satisfy the requirements of public administration;
universality; portability; comprehensiveness; and accessibility.
Notably,
these requirements relate only to funding and administration and establishing broad principles rather than a prescriptive code. In addition,
the Canada Health Act is silent with respect to the delivery of health services and does not prohibit or discourage the delivery of insured
health services by the private sector. As a result, there is significant variation in the funding and administration of health insurance
plans from one jurisdiction to another. However, most provinces permit the delivery of a broad range of publicly funded health services
through a combination of both public and private providers. Indeed, many publicly funded services in Canada are privately delivered.
The
requirement that publicly funded health insurance plans be comprehensive requires that “medically necessary” hospital and
physician services be covered. If a service is determined to be “medically necessary” then the full cost of the service must
be covered by the public plan. However, the term is not defined and the services that must be covered are intentionally and broadly defined
in order to accommodate the ability of each province and territory to make its own coverage decisions within the context of its unique
fiscal and political environment. Typically, such decisions are made in consultation with the relevant medical associations in the jurisdiction.
However, determining whether a particular service is “medical necessary” is a determination that has both a fiscal and political
dimension. Ultimately, these coverage decisions are decisions about the allocation of scarce public resources.
The
products and services available to Canadians through the publicly funded health insurance system are supplemented by a wide array of
health products and services that are not, as a general matter, subject to coverage under the public health insurance plans. For example,
prescription drug coverage, dental services and vision care are generally provided on a private payer basis. However, many jurisdictions
provide coverage for these types of services to seniors and those who face financial or other barriers to privately funded health care.
There are also a growing number of providers that offer ancillary healthcare services. Examples include elective surgical or cosmetic
procedures.
Regulation
of Health Professionals and Health Facilities
Health
professionals and health care facilities are subject to federal laws of general application, but the regulation of such matters is largely
a matter of provincial jurisdiction.
Health
Professionals
Through
legislation, the provinces have delegated the regulation of health professionals to self-governing professional bodies (with varying
degrees of discretion). Such legislation generally seeks to protect the public through a combination of “input regulations”
that focus on who is entitled to provide a particular health service and “output regulations” that focus on the quality and
delivery of the service being provided. Such regulations also generally include conflict of interest (or anti-kickback) provisions, as
such matters are generally dealt with as part of the regulation of health professions rather than the regulation of health facilities.
Health
industry participants that offer a particular service need to understand how the service is regulated. If the service involves the performance
of a regulated or controlled act (i.e., acts that can only be performed by a particular category or categories of regulated health professionals
or their delegates) then the involvement of one or more duly qualified health professionals will likely be required. Also, it may be
necessary to implement certain protocols and procedures in order to comply with the requirements of the regulatory colleges that govern
the practices of any such professionals. Complying with such requirements can have significant commercial implications.
Health
Facilities
Operating
a regulated health facility can be challenging and often involves a degree of regulatory risk.
Residential
health care facilities other than hospitals, such as nursing homes, long-term care facilities, pharmacies, laboratories and specimen
collection clinics are, in most jurisdictions, privately owned and operated pursuant to provincial licenses and oversight. However, the
degree to which such health facilities and other providers are regulated generally depends on the nature of the products and services
being provided.
The
operation of health facilities by private sector entities still typically involves some element of reimbursement through public funds.
Where public funds are being used to acquire goods and services, additional accountability measures such as procurement requirements
often apply.
Regulation
of Drugs
The
process of obtaining marketing authorizations and approvals of prescription drugs is administered by Health Canada’s Therapeutic
Products Directorate (TPD).
The
TPD applies the Food and Drugs Act and the regulations applicable to prescription drugs to ensure that drug products sold in Canada are
safe and effective. No drug product can be offered for sale in Canada unless and until, after review, it is issued a marketing authorization
by Health Canada.
In
addition to its review of drug products, Health Canada is responsible for the ongoing monitoring of drug products being sold in Canada,
as well as the regulation of good manufacturing practices and establishment licenses, which are required in connection with the import,
manufacture, distribution and/or sale of drug products.
The
Patented Medicines Prices Review Board
The
Patented Medicines Prices Review Board (PMPRB) is an independent quasi-judicial body created in 1987 under amendments to the Patent Act.
The PMPRB is responsible for regulating the prices that patentees charge for prescription and non-prescription patented drugs sold in
Canada. Based on a review of the information required to be filed by a patentee, the PMPRB considers whether the price of a medicine
appears excessive based on certain factors including: (i) the prices that the patented medicine is sold in the Canadian market; (ii)
the prices at which other medicines in the same therapeutic class are sold in the Canadian market; and (iii) the prices at which the
medicine and other medicines in the same therapeutic class have been sold in other countries other than Canada. If the PMPRB considers
the price of a medicine appears excessive, revised pricing is the usual outcome.
Public
Market Access
Each
province has a provincial drug plan that allows certain individuals to access drugs at a reduced cost. Products that will be paid for
by the provincial government (in some provinces, for all residents, while in others for certain prescribed individuals such as seniors
and individuals receiving social assistance), are typically listed on provincial formularies. For innovator products, the manufacturer
negotiates the pricing for inclusion on the provincial formulary with the provincial government. For generic products, the price to be
paid for the generic product is determined by a sliding scale of fixed prices related to when such products enter the market and the
price of the innovator product (i.e., a percent of the price of the innovator pharmaceutical product depending on whether they are first,
second or third entry products). If a drug is a generic product and listed as interchangeable on the provincial formulary, a pharmacist
is permitted to dispense the interchangeable product for the innovator product. Under most provincial benefit plans, interchanging a
generic product for the innovator product by pharmacists is mandatory and generally most provinces will only reimburse the pharmacist
for the lowest cost interchangeable product. Government drug plans account for approximately 50% of all sales of prescription drugs in
Canada.
The
scope and enforcement of each of these laws is uncertain and subject to constant change. Federal and provincial enforcement entities
have significantly increased their scrutiny of health care companies and providers which has led to investigations, prosecutions, convictions
and large settlements. Although we conduct our business in compliance with all applicable federal and provincial fraud and abuse laws,
many of these laws are broadly worded and may be interpreted or applied in ways that cannot be predicted with any certainty. Therefore,
we cannot assure you that our arrangements or business practices will not be subject to government scrutiny or will be found to be in
compliance with applicable fraud and abuse laws. Further, responding to investigations can be time consuming and result in significant
legal fees and can potentially divert management’s attention from the Company.
We
are subject to the data privacy and security laws of Canada, and the failure to comply with these rules, or allegations that we have
failed to do so, could result in civil or criminal sanctions.
In
Canada, under the Personal Information Protection and Electronic Documents Act and under various provincial laws, comprehensive privacy
laws have been introduced to protect the privacy of individuals from the undisclosed or non-consensual sharing of sensitive information
for commercial purposes. As the gathering and use of information is such an integral component of our business, we must always be alert
for and respond to changes in the information regulatory environment. The failure to comply with these rules, or allegations that we
have failed to do so, could result in civil or criminal sanctions against us.
Following
the intended acquisition, or opening, of one or more clinics or staffing primary healthcare practitioners in the United States, our centers
may participate in the federal Medicare program and, as a result, we will need to comply with a number of additional federal regulatory
requirements.
Following
the intended acquisition, or opening, of one or more multidisciplinary primary healthcare clinics or the staffing of multidisciplinary
primary healthcare clinics, affiliate clinics or eldercare centric homes with clinicians and practitioners in the United States, our
clinics and multidisciplinary primary healthcare clinicians and practitioners, including any staffing we might pursue in affiliate clinics
or eldercare centric homes in the United States, might participate in the federal Medicare and/or Medicaid programs.
Since
1992, Medicare has paid for the “medically necessary” services of physicians, non-physician practitioners, clinicians and
certain other suppliers under a physician fee schedule, a system that pays for covered physicians’ services furnished to a person
with Medicare Part B coverage. Under the physician fee schedule, relative values are assigned to each of more than 7,000 services to
reflect the amount of work, the direct and indirect (overhead) practice expenses, and the malpractice expenses typically involved in
furnishing that service. Each of these three relative value components is multiplied by a geographic adjustment factor to adjust the
payment for variations in the costs of furnishing services in different localities. Relative value units, or RVUs, are summed for each
service and then are multiplied by a fixed-dollar conversion factor to establish the payment amount for each service. The higher the
number of RVUs assigned to a service, the higher the payment. Under the Medicare fee-for-service payment system, an individual can choose
any licensed physician enrolled in Medicare and use the services of any healthcare provider or facility certified by Medicare.
CMS
is required to limit the growth in spending under the physician fee schedule by a predetermined sustained growth rate, or SGR. If implemented
as mandated, the SGR would result in significant payment reductions under the physician fee schedule. Every year since 2003, Congress
has delayed application of the SGR, but we cannot predict with certainty whether it will continue to do so. Congress most recently delayed
application of the SGR in the Protecting Access to Medicare Act of 2014, or PAMA, which became effective on April 1, 2014. In March of
2014 (prior to the passage of PAMA), CMS announced that the estimated physician fee schedule update for 2014 would be reduced by 20.9%
due to the SGR formula. PAMA provides for the continuation of the 0.5% reimbursement increase to the physician payment schedule through
December 31, 2014 (originally provided under the Pathway for SGR Reform Act of 2013), and it also provides for no change to the physician
fee schedule through March 31, 2015. Although several recent legislative proposals have sought to impose permanent or semi-permanent
solutions to the SGR reductions, we cannot predict with certainty whether the SGR will be repealed or if another formula would be substituted
and what form that might take. Repeal of the SGR could be offset by further reductions in Medicare payments, and any such reductions
could have a material adverse effect on our business.
Furthermore,
the ACA reduces annual payment updates for certain providers and reduces Medicare payments for certain procedures, and the Budget Control
Act of 2011, or BCA, requires automatic spending reductions for each fiscal year through 2021. As a result of the BCA and subsequent
activity in Congress, a $1.2 trillion sequester (across-the-board spending cuts) in discretionary programs took effect in 2013. In particular,
a 2% reduction in Medicare payments took effect on April 1, 2013 which has recently been extended for an additional two years beyond
the original expiration date of 2021.
Following
the intended acquisition, or opening, of one or more clinics or staffing primary healthcare practitioners in the United States, we will
be subject to CMS’ RAC program.
The
Medicare Prescription Drug, Improvement and Modernization Act of 2003, or MMA, introduced on a trial basis the use of RACs for the purpose
of identifying and recouping Medicare overpayments and underpayments. Any overpayment received from Medicare is considered a debt owed
to the federal government. In October 2008, CMS made the RAC program permanent. RACs review Medicare claims to determine whether such
claims were appropriately reimbursed by Medicare. RACs engage in an automated review and in a complex review of claims. Automated reviews
are conducted when a review of the medical record is not required and there is certainty that the service is not covered or is coded
incorrectly. Complex reviews involve the review of all underlying medical records supporting the claim; and are generally conducted where
there is a high likelihood, but not certainty, that an overpayment has occurred. RACs are paid a contingency fee based on overpayments
identified and collected.
A
Medicare administrative contractor, or MAC, may suspend Medicare payments to a provider if it determines that an overpayment has occurred.
When a Medicare claim for payment is filed, the MAC will notify the patient and the provider of its initial determination regarding reimbursement.
The MAC may deny the claim for one of several reasons, including the lack of necessary information or lack of medical necessity for the
services rendered. Providers may appeal any denials for claim payments.
Following
the intended acquisition, or opening, of one or more clinics or staffing primary healthcare practitioners in the United States, any such
reviews under the RAC program or denials by the MAC could have a material adverse effect on our results of operations.
Following
the intended acquisition, or opening, of one or more clinics or staffing primary healthcare practitioners in the United States, we will
be subject to the Anti-Kickback Statute, FCA, Civil Monetary Penalties statute and analogous provisions of applicable state laws and
could face substantial penalties if we fail to comply with such laws.
Anti-Kickback
Statute
Following
the intended acquisition, or opening, of one or more clinics or staffing primary healthcare practitioners in the United States, if we
are participants in the Medicare program, we will be subject to the Anti-kickback Statute. The Anti-Kickback Statute prohibits the knowing
and willful offer, payment, solicitation or receipt of remuneration, directly or indirectly, in return for the referral of patients or
arranging for the referral of patients, or in return for the recommendation, arrangement, purchase, lease or order of items or services
that are covered, in whole or in part, by a federal healthcare program such as Medicare or Medicaid. The term “remuneration”
has been broadly interpreted to include anything of value such as gifts, discounts, rebates, waiver of payments or providing anything
at less than its fair market value. The ACA amended the intent requirement of the Anti-Kickback Statute such that a person or entity
can be found guilty of violating the statute without actual knowledge of the statute or specific intent to violation the statute. Further,
the ACA now provides that claims submitted in violation of the Anti-Kickback Statute constitute false or fraudulent claims for purposes
of the civil False Claims Act, or FCA, including the failure to timely return an overpayment. Many states have adopted similar prohibitions
against kickbacks and other practices that are intended to influence the purchase, lease or ordering of healthcare items and services
reimbursed by a governmental health program or state Medicaid program. Some of these state prohibitions apply to remuneration for referrals
of healthcare items or services reimbursed by any third-party payor, including commercial payors.
Following
the intended acquisition, or opening, of one or more clinics or staffing primary healthcare practitioners in the United States, if we
accept funds from governmental health programs, we will be subject to the Anti-Kickback Statute. Violations of the Anti-Kickback Statute
can result in exclusion from Medicare, Medicaid or other governmental programs as well as civil and criminal penalties, such as $25,000
per violation and up to three times the remuneration involved. If in violation, we may be required to enter into settlement agreements
with the government to avoid such sanctions. Typically, such settlement agreements require substantial payments to the government in
exchange for the government to release its claims, and may also require entry into a corporate integrity agreement, or CIA. Any such
sanctions or obligations contained in a CIA could have a material adverse effect on our business, financial condition and results of
operations.
False
Claims Act
The
federal civil FCA prohibits providers from, among other things, (1) knowingly presenting or causing to be presented, claims for payments
from the Medicare, Medicaid or other federal healthcare programs that are false or fraudulent; (2) knowingly making, using or causing
to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the federal government; or (3)
knowingly making, using or causing to be made or used, a false record or statement to avoid, decrease or conceal an obligation to pay
money to the federal government. The “qui tam” or “whistleblower” provisions of the FCA allow private individuals
to bring actions under the FCA on behalf of the government. These private parties are entitled to share in any amounts recovered by the
government, and, as a result, the number of “whistleblower” lawsuits that have been filed against providers has increased
significantly in recent years. Defendants found to be liable under the FCA may be required to pay three times the actual damages sustained
by the government, plus mandatory civil penalties ranging between $5,500 and $11,000 for each separate false claim.
There
are many potential bases for liability under the FCA. The government has used the FCA to prosecute Medicare and other government healthcare
program fraud such as coding errors, billing for services not provided, and providing care that is not medically necessary or that is
substandard in quality. The ACA also provides that claims submitted in connection with patient referrals that results from violations
of the Anti-Kickback Statute constitute false claims for the purpose of the FCA, and some courts have held that a violation of the Stark
law can result in FCA liability, as well. In addition, a number of states have adopted their own false claims and whistleblower provisions
whereby a private party may file a civil lawsuit in state court. Following the acquisition of one or more clinics or staffing primary
healthcare practitioners in the United States, we will be required to provide information to our employees and certain contractors about
state and federal false claims laws and whistleblower provisions and protections.
Civil
Monetary Penalties Statute
The
federal Civil Monetary Penalties statute prohibits, among other things, the offering or giving of remuneration to a Medicare or Medicaid
beneficiary that the person or entity knows or should know is likely to influence the beneficiary’s selection of a particular provider
or supplier of items or services reimbursable by a federal or state healthcare program.
The
scope and enforcement of each of these laws is uncertain and subject to constant change. Federal and state enforcement entities have
significantly increased their scrutiny of healthcare companies and providers which has led to investigations, prosecutions, convictions
and large settlements. Following the acquisition of one or more clinics or staffing primary healthcare practitioners in the United States,
although we intend to conduct our business in compliance with all applicable United States federal and state fraud and abuse laws, many
of these laws are broadly worded and may be interpreted or applied in ways that cannot be predicted with any certainty. Therefore, we
cannot assure you that our arrangements or business practices will not be subject to government scrutiny or will be found to be in compliance
with applicable fraud and abuse laws. Further, responding to investigations can be time consuming and result in significant legal fees
and can potentially divert management’s attention from the Company.
Following
the intended acquisition, or opening, of one or more clinics or staffing primary healthcare practitioners in the United States, we will
be subject to the data privacy, security and breach notification requirements of HIPAA, HITECH and other data privacy and security laws,
and the failure to comply with these rules, or allegations that we have failed to do so, could result in civil or criminal sanctions.
Following
the intended acquisition, or opening, of one or more multidisciplinary primary healthcare clinics or the staffing of multidisciplinary
primary healthcare clinics, affiliate clinics or eldercare centric homes with clinicians and practitioners in the United States, numerous
federal and state laws and regulations, including HIPAA and HITECH, will govern the collection, dissemination, security, use and confidentiality
of patient-identifiable health information. As required by HIPAA, HHS has adopted standards to protect the privacy and security of this
health-related information. The HIPAA privacy regulations contain detailed requirements concerning the use and disclosure of individually
identifiable health information and the grant of certain rights to patients with respect to such information by “covered entities.”
The Company and each of our clinics is considered a covered entity under HIPAA. We will take actions to comply with the HIPAA privacy
regulations including the creation and implementation of policies and procedures, staff training, execution of HIPAA-compliant contractual
arrangements with certain service providers and various other measures. Although we believe we will be in substantial compliance, ongoing
implementation and oversight of these measures involves significant time, effort and expense.
In
addition to the privacy requirements, HIPAA covered entities must implement certain administrative, physical, and technical security
standards to protect the integrity, confidentiality and availability of certain electronic health-related information received, maintained,
or transmitted by covered entities or their business associates. Although, we will take actions in an effort to be in compliance with
these security regulations, a security incident that bypasses our information security systems causing an information security breach,
loss of PHI or other data subject to privacy laws or a material disruption of our operational systems could have a material adverse effect
on our business, along with fines. Furthermore, ongoing implementation and oversight of these security measures involves significant
time, effort and expense.
Further,
HITECH, as implemented in part by an omnibus final rule published in the Federal Register on January 25, 2013, further requires that
patients be notified of any unauthorized acquisition, access, use, or disclosure of their unsecured PHI that compromises the privacy
or security of such information. HHS has established the presumption that all unauthorized uses or disclosures of unsecured PHI constitute
breaches unless the covered entity or business associate establishes that there is a low probability the information has been compromised.
HITECH and implementing regulations specify that such notifications must be made without unreasonable delay and in no case later than
60 calendar days after discovery of the breach. Breaches affecting 500 patients or more must be reported immediately to HHS, which will
post the name of the breaching entity on its public website. Furthermore, breaches affecting 500 patients or more in the same state or
jurisdiction must also be reported to the local media. If a breach involves fewer than 500 people, the covered entity must record it
in a log and notify HHS of such breaches at least annually. These breach notification requirements apply not only to unauthorized disclosures
of unsecured PHI to outside third parties but also to unauthorized internal access to or use of such PHI.
The
scope of the privacy and security requirements under HIPAA was substantially expanded by HITECH, which also increased penalties for violations.
Penalties for violations of these laws vary. For instance, penalties for failure to comply with a requirement of HIPAA and HITECH vary
significantly, and include significant civil monetary penalties and, in certain circumstances, criminal penalties with fines up to $250,000
per violation and/or imprisonment. In addition, numerous breach incidents could lead to possible penalties in excess of $1.68 million.
A person who knowingly obtains or discloses individually identifiable health information in violation of HIPAA may face a criminal penalty
of up to $50,000 and up to one-year imprisonment. The criminal penalties increase if the wrongful conduct involves false pretenses or
the intent to sell, transfer or use identifiable health information for commercial advantage, personal gain or malicious harm. The amount
of penalty that may be assessed depends, in part, upon the culpability of the applicable covered entity or business associate in committing
the violation. Some penalties for certain violations that were not due to “willful neglect” may be waived by the Secretary
of HHS in whole or in part, to the extent that the payment of the penalty would be excessive relative to the violation. HITECH also authorized
state attorneys general to file suit on behalf of residents of their states. Applicable courts may be able to award damages, costs and
attorneys’ fees related to violations of HIPAA in such cases. HITECH also mandates that the Secretary of HHS conduct periodic compliance
audits of a cross-section of HIPAA covered entities and business associates. Every covered entity and business associate is subject to
being audited, regardless of the entity’s compliance record.
State
laws may impose more protective privacy restrictions related to health information and may afford individuals a private right of action
with respect to the violation of such laws. Both state and federal laws are subject to modification or enhancement of privacy protection
at any time. We are subject to any federal or state privacy-related laws that are more restrictive than the privacy regulations issued
under HIPAA. These statutes vary and could impose additional requirements on us and more severe penalties for disclosures of health information.
If we fail to comply with HIPAA, similar state laws or any new laws, including laws addressing data confidentiality, security or breach
notification, we could incur substantial monetary penalties and substantial damage to our reputation.
States
may also impose restrictions related to the confidentiality of personal information that is not considered PHI under HIPAA, including
certain identifying information and financial information of our patients. Theses state laws may impose additional notification requirements
in the event of a breach of such personal information. Failure to comply with such data confidentiality, security and breach notification
laws may result in substantial monetary penalties.
HIPAA
and HITECH also include standards for common healthcare electronic transactions and code sets, such as claims information, plan eligibility
and payment information. Covered entities such as the Company and each of our centers will be required to conform to such transaction
set standards.
Following
the intended acquisition, or opening, of one or more multidisciplinary primary healthcare clinics or the staffing of multidisciplinary
primary healthcare clinics, affiliate clinics or eldercare centric homes with clinicians and practitioners in the United States, if we
fail to effectively and timely implement electronic health record systems, our operation could be adversely affected.
As
required by the American Recovery and Reinvestment Act of 2009, the Secretary of HHS has developed and implemented an incentive payment
program for eligible healthcare professionals that adopt and meaningfully use electronic health record, or EHR, technology. HHS uses
the Provider Enrollment, Chain and Ownership System, or PECOS, to verify Medicare enrollment prior to making EHR incentive program payments.
If our employed professionals are unable to meet the requirements for participation in the incentive payment program, including having
an enrollment record in PECOS, we will not be eligible to receive incentive payments that could offset some of the costs of implementing
EHR systems. Further, healthcare professionals that fail to demonstrate meaningful use of certified EHR technology are subject to reduced
payments from Medicare. System conversions to comply with EHR could be time consuming and disruptive for physicians and employees. Failure
to implement EHR systems effectively and in a timely manner could have a material adverse effect on our financial position and results
of operations.
Following
the intended acquisition, or opening, of one or more clinics or staffing primary healthcare practitioners in the United States, we will
convert certain of our clinical and patient accounting information system applications to newer versions of existing applications or
altogether new applications. In connection with our implementation and conversions, we will likely incur capitalized costs and additional
training and implementation expenses.
If
we fail to comply with laws and regulations related to the protection of the environment and human health and safety, we could incur
substantial penalties and fines.
We
are subject to various federal, state and local and regulations relating to the protection of the environment and human health and safety,
including those governing the management and disposal of hazardous substances and wastes, the cleanup of contaminated sites and the maintenance
of a safe workplace. Some of our operations include the use, generation and disposal of hazardous materials. We also plan to acquire
ownership in new facilities and properties, some of which may have had a history of commercial or other operations. We may, in the future,
incur liability under environmental statutes and regulations with respect to contamination of sites we own or operate, including contamination
caused by prior owners or operators of such sites, abutters or other persons, and the off-site disposal of hazardous substances. Violations
of these laws and regulations may result in substantial civil penalties or fines.
Risks
Related to our Telemedicine Medical Technology Platform, Remote Patient Monitoring Medical Technology Platform and Novo Connect Medical
Technology Platform
We
may be unsuccessful in the development, usage, application and commercialization of each or all of our Medical Technology Platforms
Our
Telemedicine Medical Technology Platform, which is currently operating with limited usage and remains primarily under development, is
intended to provide patients with real-time access to third-party primary care medically licensed physicians and specialists in various
disciplines as well as multidisciplinary health care clinicians. Telemedicine is transforming traditional approaches to all components
of the health industry by providing ease of access and reduced costs for patients, particularly in areas with limited access to primary
care licensed physicians, nurses, nurse practitioners, specialists and multidisciplinary primary care clinicians. Our advanced Telemedicine
Medical Technology Platform intends to integrate certain medical devices, such as a blood pressure reading device, a derma scope and
an ophthalmoscope otoscope, each of which can provide the doctor with real-time diagnostic data, greatly enhancing the doctor’s
ability to provide the patient with an accurate diagnosis. Our Telemedicine Medical Technology Platform is intended to allow any type
of health care clinic or location to install and utilize our Telemedicine Medical Technology Platform at a relatively low-cost point
of entry.
Our
Remote Patient Monitoring Medical Technology Platform, which is currently operating with limited usage and remains primarily under development,
is intended to empower a patient with real-time vital sign information while maintaining a direct technology link from patient to clinician
or medical practitioner. The transfer of vital information from home to clinic or patient to clinician allows for the delivery of high
quality, non-redundant diagnostic based proactive healthcare. We intend to expand our RPM Platform to not only our Canadian clinics and
affiliate clinics but to clinics and medically licensed providers throughout Canada and the United States.
Our
Novo Connect Medical Technology Platform is currently in development and limited commercialization. Novo Connect is intended to be a
cloud-based app designed as a secure patient-centered portal which will allow the integration of numerous source systems for patient
interface by facilitating communication between the patient and the patient’s provider. The Novo Connect app will be developed
for Web, iOS and Android application to optimize communication between source systems. Novo Connect is being designed to allow patients
to have direct control of their overall healthcare and wellness by providing a suite of secure, reliable engagement features
The
success of our Medical Technology Platforms will highly be dependent upon our ability to develop relationships with both Canadian based
and United States based medically licensed primary care providers and specialist in addition to multidisciplinary primary health care
clinicians.
Our
success will highly be dependent upon our ability to develop relationship with our patients, primary care medically licensed physicians,
nurse practitioners, and specialists in addition to multidisciplinary primary health care clinicians and practitioners. If we cannot
generate relationships with these medical professionals to translate into service contracts or licensing agreements for our Medical Technology
Platforms, we may need to cease the development and commercialization of each or all Medical Technology Platform.
Our
Medical Technology Platforms may not be accepted in the Canadian and United States marketplace.
Uncertainty
exists as to whether our Medical Technology Platforms will be accepted by potential users; including, but not limited to third-party
Canadian based and United States based primary care medically licensed physicians and specialists in various medical disciplines, multidisciplinary
primary care clinicians and practitioners; as well as patients. A number of factors may limit the market acceptance of our Medical Technology
Platforms including the price relative to other product offerings. There is a risk that primary care medically licensed physicians and
specialists, multidisciplinary primary health care clinicians or patient acceptance will be encouraged to continue to use other products
and/or methods instead of ours. We are assuming that, notwithstanding the fact that our Medical Technology Platforms will be new in the
market, primary care medically licensed physicians and specialists, multidisciplinary health care clinicians, or patient acceptance will
elect not to use each or all of our Medical Technology Platforms simply because it will provide ease of access and reduced costs for
patients.
Primary
care medically licensed physicians and specialists, multidisciplinary health care clinicians and patients need to be persuaded that our
Medical Technology Platform services are justified for the anticipated benefit, but there is no assurance that sufficient numbers of
patients will be convinced to enable a successful market to develop for each or all of our Medical Technology Platforms.
In
the event that we are not able to market and significantly increase the number of primary care medically licensed physicians and specialists,
multidisciplinary health care clinicians, or patients that use our Medical Technology Platforms, or if we are unable to charge the necessary
prices, we may need to cease operating each or all of our Medical Technology Platforms.
Defects
or malfunctions in our Medical Technology Platforms could hurt our reputation, sales and profitability.
The
acceptance of our Medical Technology Platforms will depend upon their effectiveness and reliability. Each of our Medical Technology Platforms
will be complex and will be continually modified and improved, and as such may contain undetected defects or errors when first introduced
or as new versions are released. To the extent that defects or errors cause each or all of our Medical Technology Platforms to malfunction
and our customers’ use of our Medical Technology Platforms is interrupted, our reputation could suffer, and our potential revenues
could decline or be delayed while such defects are remedied. We may also be subject to liability for the defects and malfunctions.
There
can be no assurance that, despite our testing, errors will not be found in each or all of our Medical Technology Platforms or new releases,
resulting in loss of future revenues or delay in market acceptance, diversion of development resources, damage to our reputation, adverse
litigation, or increased service, any of which would have a material adverse effect upon our business, operating results and financial
condition.
Software
failures, breakdowns in the operations of our servers and communications systems or the failure to implement system enhancements could
harm our business.
The
operational success of our Medical Technology Platforms will depend on the efficient and uninterrupted operation of our servers and communications
systems. A failure of our network or data gathering procedures could impede services and could result in the loss of primary care medically
licensed physician and specialists, multidisciplinary primary care clinicians or patients. While all our operations will have disaster
recovery plans in place, they might not adequately protect us. Despite any precautions we take, damage from fire, floods, hurricanes,
power loss, telecommunications failures, computer viruses, break-ins and similar events at our computer facilities could result in interruptions
in the flow of data to our servers and from our servers to our clients. In addition, any failure by our computer environment to provide
our required data communications capacity could result in interruptions in our service. In the event of a server failure, we could be
required to transfer our client data collection operations to an alternative provider of server hosting services. Such a transfer could
result in delays in our ability to deliver our products and services to our clients.
Additionally,
significant delays in the planned delivery of system enhancements, improvements, and inadequate performance of the systems once they
are completed could damage our reputation and harm our business. Long-term disruptions in the infrastructure caused by events such as
natural disasters, the outbreak of war, the escalation of hostilities and acts of terrorism, particularly involving cities in which we
have offices, could adversely affect our businesses. Although, we plan to carry property and business interruption insurance for our
business operations, our coverage might not be adequate to compensate us for all losses that may occur.
We
face risks related to the storage of customers’ and their end users’ confidential and proprietary information.
Our
Medical Technology Platforms are being designed to maintain the confidentiality and security of our patients’ confidential and
proprietary data stored on our server systems, which may include sensitive personal data. However, any accidental or willful security
breaches or other unauthorized access to these data could expose us to liability for the loss of such information, time-consuming and
expensive litigation and other possible liabilities as well as negative publicity. Techniques used to obtain unauthorized access or to
sabotage systems change frequently and generally are difficult to recognize and react to. We may be unable to anticipate these techniques
or implement adequate preventative or reactionary measures.
We
might incur substantial expense to further develop each or all of our Medical Technology Platforms which may never become sufficiently
successful.
Our
business growth initiatives include the successful development, launch and operations of each and all of our Medical Technology Platforms.
Although management will take every precaution to ensure that our Medical Technology Platforms will, with a high degree of likelihood,
achieve commercial success, there can be no assurance that this will be the case. The causes for failure of each or all of our Medical
Technology Platforms, once commercialized, can be numerous, including:
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market demand for each
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further each or all of
our Medical Technology Platform’s development (i) turns out to be costlier than anticipated or takes longer; (ii) requires
significant adjustment post commercialization, rendering the each or all of our Medical Technology Platforms uneconomic or extending
considerably the likely investment return period; (iii) additional regulatory requirements may increase the overall costs of the
development; patent conflicts or unenforceable intellectual property rights; and (iv) primary care medically licensed physicians
and specialists and clients may be unwilling to adopt and/or use each or all of our Medical Technology Platforms. |
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Compliance with changing
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We
cannot be certain that we will obtain patents for each or all of our Medical Technology Platforms or that such patent will protect us
from competitors.
We
believe that our success and competitive position will depend in part on our ability to obtain and maintain patents for each or all of
our Medical Technology Platforms, which is both costly and time consuming. We still are in the process to evaluate the patent potential
of each and all of our Medical Technology Platforms. The Patent Office typically requires 12-24 months or more to process a patent application.
There can be no assurance that any of our potential patent applications will be approved. There can be no assurance that any potential
patent issued or licensed to us will provide us with protection against competitive products, protect us against changes in industry
trends which we have may not have anticipated or otherwise protect the commercial viability of each or all of our Medical Technology
Platforms, or that challenges will not be instituted against the validity or enforceability of any of our future patents or, if instituted,
that such challenges will not be successful. The cost of litigation to uphold the validity of a patent and enforce it against infringement
can be substantial. Even issued patents may later be modified or revoked by the Patent and Trademark Office or in legal proceedings.
Patent applications in the United States and Canada are maintained in secrecy until the patent issues and, since publication of patents
tends to lag actual discoveries, we cannot be certain that if we obtain patents for our product, we were the first creator of the inventions
covered by a pending patent applications or the first to file patent applications on such inventions.
Government
regulation of the Internet and e-commerce is evolving, and unfavorable changes could substantially harm our business and results of operations.
We
are subject to general business regulations and laws as well as federal, state and provincial regulations and laws specifically governing
the internet and e-commerce. Existing and future laws and regulations may impede the growth of the use of the internet, availability
of economic broadband access, or other online services, and increase the cost of providing our digital delivery of content and services.
These regulations and laws may cover taxation, tariffs, user privacy, data protection, pricing, content, copyrights, distribution, electronic
contracts and other communications, consumer protection, broadband internet access and the characteristics and quality of services. It
is not clear how existing laws governing issues such as property ownership, sales, use and other taxes, libel and personal privacy apply
to the internet and e-commerce. Unfavorable resolution of these issues may harm our business and results of operations.
Risks
Related to the United States Regulatory System as to Medicinal CBD Products
Possible
yet unanticipated changes in federal and state law could cause any products that we intend to launch, containing hemp-derived CBD oil
to be illegal, or could otherwise prohibit, limit or restrict any of our prospective products containing CBD.
Until
2014, when 7 U.S. Code §5940 became federal law as part of the Agricultural Act of 2014 (the “2014 Farm Act”), products
containing oils derived from hemp, notwithstanding a minimal or non-existing THC content, were classified as Schedule I illegal drugs.
The 2014 Farm Act expired on September 30, 2018, and was thereafter replaced by the Agricultural Improvement Act of 2018 on December
20, 2018 (the “2018 Farm Act “), which amended various sections of the U.S. Code, thereby removing hemp, defined as cannabis
with less than 0.3% of THC, from Schedule 1 status under the Controlled Substances Act (“CSA”), and legalizing the cultivation
and sale of hemp at the federal level, subject to compliance with certain federal requirements and state law, amongst other things. THC
is the psychoactive component of plants in the cannabis family generally identified as marihuana or marijuana. We anticipate our prospective
medical CBD products will be federally legal in the United States in that they will contain less than 0.3% of THC in compliance with
the 2018 Farm Bill guidelines and will have no psychoactive effects on our patients and customers bodies. Notwithstanding, there is no
assurance that the 2018 Farm Act will not be repealed or amended such that our products containing hemp-derived CBD would once again
be deemed illegal under federal law.
The
2018 Farm Bill also shifted regulatory authority from the Drug Enforcement Administration to the Department of Agriculture. The 2018
Farm Bill did not change the United States Food and Drug Administration’s (“FDA”) oversight authority over CBD products.
The 2018 Farm Act delegated the authority to the states to regulate and limit the production of hemp and hemp derived products within
their territories. Although many states have adopted laws and regulations that allow for the production and sale of hemp and hemp derived
products under certain circumstances, no assurance can be given that such state laws may not be repealed or amended such that our intended
products containing hemp-derived CBD would once again be deemed illegal under the laws of one or more states now permitting such products,
which in turn would render such intended products illegal in those states under federal law even if the federal law is unchanged. In
the event of either repeal of federal or of state laws and regulations, or of amendments thereto that are adverse to our prospective
medicinal CBD products, we may be restricted or limited with respect to those products that we may sell or distribute, which could adversely
impact our intended business plan with respect to such intended products.
Additionally,
the FDA has indicated its view that certain types of products containing CBD may not be permissible under the United States Federal Food,
Drug and Cosmetic Act (“FDCA”). The FDA’s position is related to its approval of Epidiolex, a marijuana-derived prescription
medicine to be available in the United States. The active ingredient in Epidiolex is CBD. On December 20, 2018, after the passage of
the 2018 Farm Bill, FDA Commissioner Scott Gottlieb issued a statement in which he reiterated the FDA’s position that, among other
things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with
any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce and that
the FDCA prohibits introducing into interstate commerce food products containing added CBD, and marketing products containing CBD as
a dietary supplement, regardless of whether the substances are hemp-derived. Although our prospective medicinal CBD product offerings
will comply with applicable federal and state laws and regulations, legal proceedings alleging violations of such laws could have a material
adverse effect on our business, financial condition and results of operations.
FDA
regulation could negatively affect the hemp industry, which would directly affect our financial condition.
The
FDA may seek expanded regulation of hemp under the FDCA. Additionally, the FDA may issue rules and regulations, including certified good
manufacturing practices, or cGMP’s, related to the growth, cultivation, harvesting and processing of hemp. Clinical trials may
be needed to verify efficacy and safety. It is also possible that the FDA would require that facilities where hemp is grown register
with the FDA and comply with certain federally prescribed regulations. In the event some or all of these regulations are imposed, we
do not know what the impact would be on the hemp industry, including what costs, requirements and possible prohibitions may be enforced.
If we or our partners are unable to comply with the regulations or registration as prescribed by the FDA, we and or our partners (including
C2M) may be unable to continue to operate their and our business in its current or planned form or at all.
Sources
of hemp-derived CBD depend upon legality of cultivation, processing, marketing and sales of products derived from those plants under
state law of the United States.
Hemp-derived
CBD can only be legally produced in states that have laws and regulations that allow for such production and that comply with the 2018
Farm Act, apart from state laws legalizing and regulating medical and recreational cannabis or marijuana, which remains illegal under
federal law and regulations. Initially, we intend to use hemp-derived CBD from growers and processors in Canada where such production
is legal to produce our prospective medicinal CBD products. Although hemp and hemp seeds may legally be imported into the United States,
the importation of products containing THC, including CBD products, into the United States may be illegal if the CBD products cause THC
to enter the human body. In that case, we will be required to purchase all our hemp-derived prospective medicinal CBD products from licensed
growers and processors in states in the United States where such production is legal. In addition, as described in the preceding risk
factor, in the event of repeal or amendment of laws and regulations which are now favorable to the cannabis/hemp industry in such states,
we would be required to locate new suppliers in states with laws and regulations that qualify under the 2018 Farm Act. If we were to
be unsuccessful in arranging new sources of supply of our raw ingredients, or if our raw ingredients were to become legally unavailable,
our intended business plan with respect to such products could be adversely impacted.
Because
our distributors may only sell and ship our products containing hemp-derived CBD in states that have adopted laws and regulations qualifying
under the 2018 Farm Act, a reduction in the number of states having such qualifying laws and regulations could limit, restrict or otherwise
preclude the sale of intended products containing hemp-derived CBD.
The
interstate shipment of hemp-derived CBD from one state to another is legal only where both states have laws and regulations that allow
for the production and sale of such products and that qualify under the 2018 Farm Act. Therefore, the marketing and sale of our intended
products containing hemp-derived CBD is limited by such factors and is restricted to such states. Although we believe we may lawfully
sell any of our finished products, including those containing CBD, in a majority of states, a repeal or adverse amendment of laws and
regulations that are now favorable to the distribution, marketing and sale of finished products we intend to sell could significantly
limit, restrict or prevent us from generating revenue related to our products that contain hemp-derived CBD. Any such repeal or adverse
amendment of now favorable laws and regulations could have an adverse impact on our business plan with respect to such products.
Due
to projected expansion into the CBD industry, we may have a difficult time obtaining the various insurances that are desired to operate
our business, which may expose us to additional risk and financial liability.
Insurance
that is otherwise readily available, such as general liability, and directors and officer’s insurance, may become more difficult
for us to find, and more expensive, due to our intended launch of certain medically related products containing hemp-derived CBD. There
are no guarantees that we will be able to find such insurances in the future, or that the cost will be affordable to us. If we are forced
to go without such insurances, it may prevent us from entering into certain business sectors, may inhibit our growth, and may expose
us to additional risk and financial liabilities.
Our
products may not meet health and safety standards or could become contaminated.
We
have adopted various quality, environmental, health and safety standards. We do not have control over all the third parties involved
in the manufacturing of our products and their compliance with government health and safety standards. Even if our products meet these
standards, they could otherwise become contaminated. A failure to meet these standards or contamination could occur in our operations
or those of our manufacturers, distributors, or suppliers. This could result in expensive production interruptions, recalls and liability
claims. Moreover, negative publicity could be generated from false, unfounded, or nominal liability claims or limited recalls. Any of
these failures or occurrences could negatively affect our business and financial performance.
The
sale of our products involves product liability and related risks that could expose us to significant insurance and loss expenses.
We
face an inherent risk of exposure to product liability claims if the use of our products results in, or is believed to have resulted
in, illness or injury. Our products contain combinations of ingredients, and there is little long-term experience with the effect of
these combinations. In addition, interactions of these products with other products, prescription medicines and over-the-counter drugs
have not been fully explored or understood and may have unintended consequences. While our third-party manufacturers perform tests in
connection with the formulations of our products, these tests are not designed to evaluate the inherent safety of our products.
Any
product liability claim may increase our costs and adversely affect our revenue and operating income. Moreover, liability claims arising
from a serious adverse event may increase our costs through higher insurance premiums and deductibles and may make it more difficult
to secure adequate insurance coverage in the future. In addition, our product liability insurance may fail to cover future product liability
claims, which, if adversely determined, could subject us to substantial monetary damages.
Confusion
between legal CBD and illegal Cannabis
There
is the risk that confusion or uncertainty surrounding products that are offered with regulated cannabis could occur on the state or federal
level and impact us. We may have difficulty with establishing banking relationships, working with investment banks and brokers who would
be willing to offer and sell our securities or accept deposits from shareholders, and auditors willing to certify our financial statements
if we are confused with businesses that are in the cannabis business. Any of these additional factors, should they occur, could also
affect our business, prospects, assets or results of operation could have a material adverse effect on the business, prospects, results
of operations or financial condition of the Company.
Risks
Related to our Common Stock and our Status as a Public Company
As
a result of being a public company, we are subject to additional reporting and corporate governance requirements that will require additional
management time, resources, and expense.
As
a public company we are obligated to file with the SEC annual and quarterly information and other reports that are specified in the Securities
Exchange Act of 1934, as amended (the “Exchange Act”). We are also subject to other reporting and corporate governance requirements
under the Sarbanes-Oxley Act of 2002, as amended, and the rules and regulations promulgated thereunder, all of which impose significant
compliance and reporting obligations upon us and require us to incur additional expense in order to fulfill such obligations.
Our
stock price is likely to be highly volatile because of several factors, including a limited public float.
The
market price of our common stock has been volatile in the past and the market price of our common stock is likely to be highly volatile
in the future. You may not be able to sell shares of our common stock following periods of volatility because of the market’s adverse
reaction to volatility.
Other
factors that could cause such volatility may include, among other things:
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in our operating results; |
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analysts covering us and distributing research and recommendations about us; |
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we may have a low trading
volume for a number of reasons, including that a large portion of our stock is closely held; |
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overall stock market fluctuations; |
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announcements concerning
our business or those of our competitors; |
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actual or perceived limitations
on our ability to raise capital when we require it, and to raise such capital on favorable terms; |
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conditions or trends in
the industry; |
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litigation; |
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changes in market valuations
of other similar companies; |
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or failure to hire key personnel; and |
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Any
of these factors could have a significant and adverse impact on the market price of our common stock and/or warrants. In addition, the
stock market in general has at times experienced extreme volatility and rapid decline that has often been unrelated or disproportionate
to the operating performance of particular companies. These broad market fluctuations may adversely affect the trading price of our common
stock and/or warrants, regardless of our actual operating performance.
Our
common stock is a “penny stock” under SEC rules. It may be more difficult to sell securities classified as “penny stock.”
Our
common stock is a “penny stock” under applicable SEC rules (generally defined as non-exchange traded stock with a per-share
price below $5.00). Unless we successfully list our common stock on a national securities exchange, or maintain a per-share price above
$5.00, these rules impose additional sales practice requirements on broker-dealers that recommend the purchase or sale of penny stocks
to persons other than those who qualify as “established customers” or “accredited investors.” For example, broker-dealers
must determine the appropriateness for non-qualifying persons of investments in penny stocks. Broker-dealers must also provide, prior
to a transaction in a penny stock not otherwise exempt from the rules, a standardized risk disclosure document that provides information
about penny stocks and the risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer
quotations for the penny stock, disclose the compensation of the broker-dealer and its salesperson in the transaction, furnish monthly
account statements showing the market value of each penny stock held in the customer’s account, provide a special written determination
that the penny stock is a suitable investment for the purchaser, and receive the purchaser’s written agreement to the transaction.
Legal
remedies available to an investor in “penny stocks” may include the following:
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If a “penny stock”
is sold to the investor in violation of the requirements listed above, or other federal or states securities laws, the investor may
be able to cancel the purchase and receive a refund of the investment. |
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If a “penny stock”
is sold to the investor in a fraudulent manner, the investor may be able to sue the persons and firms that committed the fraud for
damages. |
These
requirements may have the effect of reducing the level of trading activity, if any, in the secondary market for a security that becomes
subject to the penny stock rules. The additional burdens imposed upon broker-dealers by such requirements may discourage broker-dealers
from effecting transactions in our securities, which could severely limit the market price and liquidity of our securities. These requirements
may restrict the ability of broker-dealers to sell our common stock and may affect your ability to sell our common stock.
Many
brokerage firms will discourage or refrain from recommending investments in penny stocks. Most institutional investors will not invest
in penny stocks. In addition, many individual investors will not invest in penny stocks due, among other reasons, to the increased financial
risk generally associated with these investments.
For
these reasons, penny stocks may have a limited market and, consequently, limited liquidity. We can give no assurance at what time, if
ever, our common stock will not be classified as a “penny stock” in the future.
If
we fail to maintain effective internal control over financial reporting, the price of our securities may be adversely affected.
Our
internal control over financial reporting may have weaknesses and conditions that could require correction or remediation, the disclosure
of which may have an adverse impact on the price of our common stock. We are required to establish and maintain appropriate internal
control over financial reporting. Failure to establish those controls, or any failure of those controls once established, could adversely
affect our public disclosures regarding our business, prospects, financial condition or results of operations. In addition, management’s
assessment of internal control over financial reporting may identify weaknesses and conditions that need to be addressed in our internal
control over financial reporting or other matters that may raise concerns for investors. Any actual or perceived weaknesses and conditions
that need to be addressed in our internal control over financial reporting or disclosure of management’s assessment of our internal
control over financial reporting may have an adverse impact on the price of our common stock.
We
are required to comply with certain provisions of Section 404 of the Sarbanes-Oxley Act and if we fail to continue to comply, our business
could be harmed and the price of our securities could decline.
Rules
adopted by the SEC pursuant to Section 404 of the Sarbanes-Oxley Act require an annual assessment of internal control over financial
reporting, and for certain issuers an attestation of this assessment by the issuer’s independent registered public accounting firm.
The standards that must be met for management to assess the internal control over financial reporting as effective are evolving and complex,
and require significant documentation, testing, and possible remediation to meet the detailed standards. We expect to incur significant
expenses and to devote resources to Section 404 compliance on an ongoing basis. It is difficult for us to predict how long it will take
or costly it will be to complete the assessment of the effectiveness of our internal control over financial reporting for each year and
to remediate any deficiencies in our internal control over financial reporting. As a result, we may not be able to complete the assessment
and remediation process on a timely basis. In the event that our Chief Executive Officer or Principal Financial Officer determines that
our internal control over financial reporting is not effective as defined under Section 404, we cannot predict how regulators will react
or how the market prices of our securities will be affected; however, we believe that there is a risk that investor confidence and the
market value of our securities may be negatively affected.
Shares
eligible for future sale may adversely affect the market.
From
time to time, certain of our stockholders may be eligible to sell all or some of their shares of common stock by means of ordinary brokerage
transactions in the open market pursuant to Rule 144 promulgated under the Securities Act, subject to certain limitations. In general,
pursuant to Rule 144, non-affiliate stockholders may sell freely after six months, subject only to the current public information requirement.
Affiliates may sell after six months, subject to the Rule 144 volume, manner of sale (for equity securities), current public information,
and notice requirements. Of the approximately 144,257,518 shares of our common stock outstanding as of March 31, 2023, approximately
116,741,592 shares are tradable without restriction. Given the limited trading of our common stock, resale of even a small number of shares
of our common stock pursuant to Rule 144 or an effective registration statement may adversely affect the market price of our common stock.
Substantial
future sales of shares of our common stock could cause the market price of our common stock to decline.
The
market price of shares of our common stock could decline as a result of substantial sales of our common stock, particularly sales by
our directors, executive officers and significant stockholders, a large number of shares of our common stock becoming available for sale
or the perception in the market that holders of a large number of shares intend to sell their shares.
Provisions
of our amended and restated articles of incorporation and bylaws may delay or prevent a takeover which may not be in the best interests
of our stockholders.
Provisions
of our amended and restated articles of incorporation and our bylaws, as amended, may be deemed to have anti-takeover effects, which
include when and by whom special meetings of our stockholders may be called, and may delay, defer or prevent a takeover attempt. Further,
our amended and restated articles of incorporation authorize the issuance of up to 1,000,000 shares of preferred stock with such rights
and preferences as may be determined from time to time by our board of directors in their sole discretion. Our board of directors may,
without stockholder approval, issue series of preferred stock with dividends, liquidation, conversion, voting or other rights that could
adversely affect the voting power or other rights of the holders of our common stock.
We
do not expect to pay dividends in the foreseeable future.
We
do not intend to declare dividends for the foreseeable future, as we anticipate that we will reinvest any future earnings in the development
and growth of our business. Therefore, investors will not receive any funds unless they sell their common stock, and stockholders may
be unable to sell their shares on favorable terms. We cannot assure you of a positive return on investment or that you will not lose
the entire amount of your investment in our common stock.
Risk
Factors Related to Product Manufacturing
We
may be unable to obtain raw materials for our current and planned products due to unexpected shortages, lack of availability, increased
costs and price fluctuations, which could limit our ability to manufacture any products and could adversely affect our sales and results
of operations.
We
currently manufacture nutraceutical products that we sell to private label customers, and we also plan to begin manufacturing and selling
our own branded nutraceutical products. The principal raw materials used in the manufacturing process in the Company’s current
and planned nutraceutical business include vitamins and minerals both of natural and synthetic source, herbal ingredients and vegetable/fruit
powders/extracts either natural or certified organic, other nutritional supplements such as soft-gel, capsules and tablets in bulk form,
powdered proteins either regular, plant or certified organic, powdered amino acid and energy/muscle building ingredients, vegetable and
gelatin capsules, processing excipients, coating materials, and the necessary components for packaging the finished products.
The
raw materials are available from numerous sources within the United States, Canada and abroad as are the vegetable and gelatin capsules,
coating materials and packaging materials. However, the availability of such raw materials is subject to change. For example an unexpected
interruption of supply or a significant increase in the cost of raw materials we need, for any reason, such as regulatory requirements,
changes in governmental trade and agricultural programs, increased global competition for resources and consumer demand, import restrictions,
loss of certifications or licenses, disruption of distribution channels as a result of weather, terrorism or acts of war, fire, earthquake,
or other natural or man-made disaster, a work stoppage or other labor-related disruption, failure in supply or other logistical channels,
electrical outages, or other events, could result in significant cost increases and/or shortages of our current and planned products.
Additionally, the prices of packaging materials and freight are subject to fluctuations which would cause the Company’s costs to
increase and would also cause the Company to increase our prices. If our competitors do not also increase their prices, customers and
consumers may choose to purchase competing products or may shift purchases to lower-priced private label or other value offerings which
may adversely affect the Company’s results of operations. Further, we currently use, as well as plan to use pouches which are prepared
by third parties in the manufacturing of our current and planned products, and such pouches may either become unavailable or may become
damaged by the third parties that prepare them. Our inability to obtain adequate supplies of raw materials in a timely manner or a material
increase in the price of the raw materials used in our products due to any of the foregoing, could limit our ability to manufacture any
products and could have a material adverse effect on our business, financial condition and results of operations.
Our
planned acquisition of raw materials from international sources subjects us to risk from currency fluctuations.
We
plan in part to acquire raw materials from international sources, which subjects us to risks from currency fluctuations, such as changes
in foreign exchange rates. For example, if the value of a foreign currency used to purchase from an international supplier were to increase
compared to the value of the U.S. dollar, we could receive less value for purchases of raw materials when purchasing in such other country,
which could force us to increase our prices, or settle for lower margins on our product sales. If either of these outcomes occur, our
results of operations may be harmed.
Our
business is subject to inherent risks relating to product liability and personal injury claims, our quality control processes may fail
to detect issues in the ingredients we use to make our products and our product liability insurance may be insufficient to cover possible
claims against us which would adversely affect our operating results.
Our
Company, like other manufacturers, wholesalers and distributors of nutraceutical products, faces an inherent risk of exposure to product
liability and personal injury claims if, among other things, the use or ingestion of our products, results in sickness or injury. Our
current products consist of tablets, powdered beverages, dietary supplements, pain creams, liquids, gels, minerals, herbs and other ingredients
that are classified as foods or dietary supplements. If the materials that we use to create these current products or our planned products
are contaminated and if our quality control processes fail to detect issues in these materials, we may be obligated to recall affected
products, and if we are found liable for product liability or personal injury claims, we could be required to pay substantial monetary
damages. Further, even if we successfully defend ourselves against this type of claim, we could be required to spend significant management,
financial and other resources, which could disrupt our business and harm our reputation. We currently maintain a product liability insurance
policy that provides up to CAD$5 million in product liability coverage. However, there can be no assurance that our existing or future
insurance coverage will be sufficient to cover any possible product liability risks or that such insurance will continue to be available
to us on economically feasible terms. In the event that any of the foregoing occurs, we risk the loss of net revenues, increased administrative
costs and will likely suffer an adverse effect on our operating results.
We
do not have any long-term contracts with our suppliers or with our customers, and we do not have many written contracts with our customers,
and if we can’t maintain these relationships or if we or our suppliers experience manufacturing problems or delays, our financial
results will be negatively affected.
We
do not have any long-term contracts with our suppliers or with our customers for our current or planned products. We also do not have
many written contracts with our customers. There can be no assurance that these suppliers will continue to sell to us on prior or current
terms, or at all and likewise there can also be no assurance that our customers will continue to purchase from us or that we can obtain
customers to purchase our planned products. We may not be able to maintain our relationships with our suppliers and customers, or we
may be unable to find alternate suppliers or customers in a timely fashion. Should this occur, our revenues and results of operations
will be negatively affected. Additionally, we or our suppliers may encounter unforeseen delays or shortfalls in manufacturing, and our
suppliers’ production processes may have to change to accommodate any significant future expansion of our manufacturing capacity,
which may increase our or our suppliers’ manufacturing costs, delay production of our current and planned products, reduce our
product gross margin and adversely impact our business. If we are unable to keep up with demand for our current and planned products
by maintaining our relationships with our suppliers or successfully manufacturing and shipping our products in a timely manner, our revenue
could be impaired, market acceptance for our current and planned products could be adversely affected and our customers might instead
purchase our competitors’ products. In addition, developing manufacturing procedures for new products may require developing specific
production processes for those products. Developing such processes could be time consuming and any unexpected difficulty in doing so
can delay the introduction of a product.
Our
revenues are highly dependent upon two private label distributor customers.
Our
revenues are concentrated and highly dependent on two private label distributor customers which comprise most of our revenues from our
current manufacturing operations. All sales made under a private label relationship are made on a purchase order basis and there are
no long-term contracts with respect to any private label relationships. There can be no assurance that our existing private label relationships
will continue in the future or that we will be able to obtain new private label relationships on an ongoing basis, if at all. Our private
label customers can reduce the products they order from us or cease ordering products from us at any time without notice. There can be
no assurance that these private label customers will continue to place orders with us, that orders by such customers will continue at
their previous levels or that we can replace any such lost business. Should this occur, our revenues and results of operations will be
negatively affected.
Our
business is subject to numerous laws and regulations and compliance with existing, as well as new laws and regulations, could increase
our costs significantly and adversely affect our financial results.
The
processing, formulation, manufacturing, packaging, labeling, advertising, sale and distribution of our current and planned nutraceutical
products are subject to regulation by several U.S. federal agencies, including the Food and Drug Administration (“FDA”),
the Federal Trade Commission (“FTC”), the Consumer Product Safety Commission, the Department of Agriculture and the Environmental
Protection Agency, as well as various state, local and international laws and agencies of the localities in which our current and planned
products are, and will be, manufactured and sold. For example, the FDA regulates our products to ensure that the products are not adulterated
or misbranded. Failure to comply with FDA requirements may result in, among other things, injunctions, product withdrawals, recalls,
product seizures, fines and criminal prosecutions. Additionally, once we begin direct sales and marketing of our planned Company branded
products, our advertising will be subject to regulation by the FTC. In recent years, the FTC has initiated numerous investigations of
dietary and nutrition supplement products and companies. Further some states also permit advertising and labeling laws to be enforced
by attorney generals, who may seek relief for consumers, seek class action certifications, seek class wide damages and product recalls
of products sold by us. Compliance with these government regulations may prevent or delay the introduction, or require the reformulation,
of our current and planned products, and additionally these governmental authorities may commence regulatory or legal proceedings against
us which could restrict the permissible scope of our current or planned product or the ability to sell our products in the future. Additionally,
any such government actions would result in costs to us, including lost revenues from any additional products that we are required to
remove from the market, which additional costs could be material. Any such government actions also could lead to liability and reduced
growth prospects. Moreover, there can be no assurance that new laws or regulations imposing more stringent regulatory requirements on
the nutraceutical industry will not be enacted which could require reformulation of certain products to meet new standards, recalls or
discontinuance of certain products that cannot be reformulated, additional record-keeping requirements, increased documentation of the
properties of certain products, additional or different labeling, additional scientific substantiation, adverse event reporting or other
new requirements. If our operations are found to be in violation of any laws or any other governmental regulations that apply to us,
or if we are unable to keep up with changing laws and regulations, we may be subject to penalties, including, without limitation, civil
and criminal penalties, damages, fines, the curtailment or restructuring of our operations, any of which could adversely affect our ability
to operate our business and our financial results.
We
may be involved in lawsuits or proceedings to protect or enforce our intellectual property rights or to defend against infringement claims,
which could be expensive and time consuming. Additionally, our inability to protect our intellectual property rights could reduce the
value or our current and planned products.
Our
business is dependent in part upon our ability to use intellectual property rights to protect our current and planned products from competition
and on our products not infringing on the patents and proprietary rights of other parties. To protect our current and planned products,
we rely, and intend to rely on a combination of trade secrets, patent and other intellectual property laws, employment, confidentiality
and invention assignment agreements with our employees and contractors, and confidentiality agreements and protective contractual provisions
with our partners, licensors and other third parties. These methods, however, afford us only limited protection against competition from
other products. Also, we cannot ensure that our formulas and proprietary information, are not leaked to other parties by anyone that
obtains access to same. To date, none of our current or planned formulas are patented, although we maintain manufacturing trade secrets,
we believe that most competent manufacturers have the skillset necessary to replicate such formulas. As such, third parties could copy
our products or sell similar products to our distributors and/or customers. Our competitors may have or develop equivalent or superior
manufacturing and design skills and may develop an enhancement to our formulations that will be patentable or otherwise protected from
duplication by others. We may also infringe on the patents of other parties. Litigation may be necessary to enforce our intellectual
property rights, protect our trade secrets or determine the validity and scope of the proprietary rights of others. Litigation or interference
proceedings could result in substantial costs and diversion of resources and management attention. In addition, in an infringement proceeding,
a court may decide that a patent of ours, if we obtain any patents in the future, is not valid or is unenforceable or may refuse to stop
the other party from using the technology at issue on the grounds that our patents do not cover the technology. An adverse determination
of any litigation or defense proceedings could put one or more of our patents, if we acquire any in the future, at risk of being invalidated
or interpreted narrowly and could put our patent applications at risk of not issuing. In addition, we may be enjoined from marketing
one or more of our current or planned products if a court finds that such products infringe the intellectual property rights of a third
party. Further, we may be unable or unwilling to strictly enforce our intellectual property rights, including our trademarks, from infringement.
Our inability to obtain and/or failure to enforce our intellectual property rights could diminish the value of our current and planned
product offerings and have a material adverse effect on our business, prospects, results of operations, and financial condition.
The
commercial success of our planned products is dependent, in part, on factors outside our control.
We
currently manufacture nutraceutical products that we sell to private label customers, and we also plan to begin manufacturing and selling
our own branded nutraceutical products. The commercial success of our planned products is dependent upon unpredictable and volatile factors
beyond our control, such as the success of our competitors’ products. Our failure to attract market acceptance and a sustainable
competitive advantage over our competitors would materially harm our business.
If
we fail to increase our brand recognition, we may face difficulty in obtaining customers for our planned products.
Because
we have not yet started selling our own branded products, we currently do not have strong brand identity or brand loyalty. We believe
that establishing and maintaining brand identity and brand loyalty is critical to attracting customers once we have commercially viable
branded products. Maintaining and enhancing our brand recognition in a cost-effective manner is critical to achieving widespread acceptance
of future products and is an important element in our effort to obtain and increase our customer base. Successful promotion of our brand
will depend largely on our ability to maintain a sizeable and active customer base, our marketing efforts and our ability to provide
reliable and useful products at competitive prices. Brand promotion activities may not yield increased revenue, and even if they do,
any increased revenue may not offset the expenses we will incur in building our brand. If we fail to successfully promote and maintain
our brand, or if we incur substantial expenses in an unsuccessful attempt to promote and maintain our brand, we may fail to attract enough
new customers or retain our existing customers to the extent necessary to realize a sufficient return on our brand-building efforts,
in which case our business, operating results and financial condition, would be materially adversely affected.
If
our products do not have the healthful effects intended, or if there is adverse publicity or consumer perception of our products and
any similar products distributed by others, our reputation could be harmed and our business may suffer.
Many
of our current and planned products contain innovative ingredients or combinations of ingredients. There is little long-term experience
with human or other animal consumption of certain of these ingredients or combinations thereof in concentrated form. Our current and
planned products could have certain side effects if not taken as directed or if taken by a consumer that has certain medical conditions.
Furthermore, there can be no assurance that any of the products, even when used as directed, will have the effects intended or will not
have harmful side effects. Should our current or planned products cause unwanted side effects or not have the results intended, it could
have a material adverse effect on our business, financial condition, and results of operations. Additionally, we believe we are, and
will be, highly dependent upon positive consumer perceptions of the safety and quality of our current and planned products as well as
similar products distributed by other nutraceutical companies. Consumer perception of nutraceutical and our current and planned products,
as well as the products sold by our private label customers, in particular, can be substantially influenced by scientific research or
findings, national media attention and other publicity about product use. Adverse publicity from these sources regarding the safety,
quality or efficacy of nutraceuticals could have a negative effect on us. The mere publication of news articles or reports asserting
that such products may be harmful or questioning their efficacy could have a material adverse effect on our business, financial condition
and results of operations, regardless of whether such news articles or reports are scientifically supported or whether the claimed harmful
effects would be present at the dosages recommended for such products.
The
nutraceuticals industry is highly competitive, and our failure to compete effectively could adversely affect our market share, financial
condition, and future growth.
The
industry of nutraceutical and wellness-related supplements and products we produce as well as intend to produce is highly competitive
with respect to price, brand and product recognition and new product introductions. Several of our competitors are larger, more established
and possess greater financial, personnel, distribution and other resources. We face competition (a) from large nationally known manufacturers,
private label brands and many smaller manufacturers of dietary and nutrition supplements; and (b) in the mass-market distribution channel
from manufacturers, major private label manufacturers and others. Private label brands at mass-market chains represent substantial sources
of income for these merchants and the mass-market merchants often support their own labels at the expense of other brands. As such, the
growth of our current and planned products within the nutraceutical industry are highly competitive and uncertain. If we cannot compete
effectively, we may not be profitable.
The
purchase of many of our planned and current products are discretionary and may be negatively impacted by adverse trends in the general
economy and make it more difficult for us to generate revenues.
Our
business is affected by general economic conditions since our current and planned products are discretionary and we depend, to a significant
extent, upon a number of factors relating to discretionary consumer spending. These factors include economic conditions and perceptions
of such conditions by consumers, employment rates, the level of consumers’ disposable income, business conditions, interest rates,
consumer debt levels and availability of credit. Consumer spending on our current and planned products may be adversely affected by changes
in general economic conditions. Our operating results are impacted by the health of the North American economies. Our business and financial
performance may be adversely affected by current and future economic conditions, such as a reduction in the availability of credit, financial
market volatility or recession. Additionally, we may experience difficulties in scaling our operations to react to economic pressures
in the United States.
We
may not be able to anticipate consumer preferences and trends within the nutraceutical industry, which could negatively affect acceptance
of our planned and current products by retailers and consumers and result in a significant decrease in our revenues.
We
currently manufacture nutraceutical products that we sell to private label customers, and we also plan to begin manufacturing and selling
our own branded nutraceutical products. Our planned and current products must appeal to a broad range of consumers, whose preferences
cannot be predicted with certainty and are subject to rapid change. Our products will need to successfully meet constantly changing consumer
demands. If our products are not successfully received by our customers, our business, financial condition, results of operations and
prospects may be harmed.
We
may experience greater than expected product returns, which might adversely affect our sales and results of operations.
We
currently manufacture nutraceutical products that we sell to private label customers, and we also plan to begin manufacturing and selling
our own branded nutraceutical products. Once we start selling our own branded products, such products may be returned for various reasons,
including expiration dates. Any increase in product returns could reduce our results of operations.
An
unexpected interruption in our warehousing facilities or if there is a lack of capacity at our warehousing facilities, it could reduce
our sales and margins.
We
store products in our warehouses that we then ship to other retailers and serve as fulfilling distribution hubs to other retailers. If
we run out of capacity, we won’t be able to store as many products and may not be able to maintain all products in an efficient
manner. Additionally, if there is any unexpected interruption to our warehousing facilities, for any reason, such as loss of certifications
or licenses, as a result of weather, terrorism or acts of war, fire, earthquake, or other national disaster, a work stoppage or other
labor-related disruption, electrical outages, or other events, it could result in significant reductions to our sales and margins and
could have a material adverse effect on our business, financial condition or results of operations.
Any
interruption to our distribution channels for our planned products could adversely affect our sales and results of operations.
We
currently manufacture nutraceutical products that we sell to private label customers, we also intend to manufacture and sell our own
branded products and distribute those products through various distribution channels. Any interruption to our distribution channels for
our planned products for any reason, such as disruption of distribution channels as a result of weather, terrorism or acts of war, fire,
earthquake, or other national disaster, a work stoppage or other labor-related disruption, could adversely affect our sales and results
of operations.