ý
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Nevada
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46-5027260
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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Title of each class
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Common Stock,$0.001 Par Value
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Large accelerated filer
☐
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Accelerated filer
ý
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Non-accelerated filer
☐
(Do not check if a smaller reporting company)
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Smaller reporting company
☐
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Emerging growth company
ý
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Page
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PART I
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Item 1.
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Business.
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2
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Item 1A.
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Risk Factors.
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14
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Item 1B.
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Unresolved Staff Comments.
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23
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Item 2.
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Properties.
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23
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Item 3.
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Legal Proceedings.
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23
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Item 4.
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Mine Safety Disclosures
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23
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PART II
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Item 5.
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Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
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23
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Item 6.
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Selected Financial Data.
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23
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Item 7.
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Management's Discussion and Analysis of Financial Condition and Results of Operations.
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23
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Item 7A.
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Quantitative and Qualitative Disclosures About Market Risk.
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29
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Item 8.
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Financial Statements and Supplementary Data.
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F-1
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Item 9.
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Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
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30
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Item 9A.
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Controls and Procedures.
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30
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Item 9B.
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Other Information.
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31 |
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PART III
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Item 10.
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Directors, Executive Officers and Corporate Governance.
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32
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Item 11.
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Executive Compensation.
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35
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Item 12.
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Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
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36
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Item 13.
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Certain Relationships and Related Transactions, and Director Independence.
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37
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Item 14.
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Principal Accountant Fees and Services.
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37
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PART IV
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Item 15.
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Exhibits, Financial Statement Schedules.
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38
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· |
a web-server accessible by physicians and diabetes professionals to track the condition remotely, thereby reducing healthcare costs and managing the condition more effectively;
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· |
a complete virtual doctor that monitors a person's vital signs and transmits results via the web; and
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· |
other patches using the BEAT technology platform to measure alternative analytes, including lactate, uric acid, lithium and drugs. This would be a step-change in the monitoring of conditions, particularly in the hospital setting. Lactate monitoring is currently used to determine the relative fitness of professional athletes.
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Milestone
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Target Start Date
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Target Completion Date
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Completion of clinical studies in Type 1 and Type 2 diabetic subjects to define final device claims and for submission for CE Mark approval with final device claims.
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July 2017
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Completed
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Scale up of commercial sensor/patch manufacturing
(Scale up means we have started looking at larger scales - sufficient for product launch in the UK. It refers to the manufacturing process for sensors.)
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January 2017
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Completed
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Scale up of device (transmitter) manufacturing
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January 2017
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Ongoing
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CE Mark for body worn transmitter device
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April 2018
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December 2018
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Commercial launch in the UK, followed by major territories in Europe
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Q4 2018
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Staggered launch
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Commence clinical trial to support U.S. PMA submission
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To be determined
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To be determined
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2013
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2035
|
|
Adult population
(20-79 years, millions)
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659
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669
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Diabetes (20 – 79 years)
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||
Regional prevalence (%)
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8.5
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10.3
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Comparative prevalence (%)
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6.8
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7.1
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Number of people with diabetes
(millions)
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56.3
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68.9
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Impaired Glucose Tolerance (20 – 79 years)
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||
Regional prevalence (%)
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9.2
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11.0
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Comparative prevalence (%)
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8.1
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8.9
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Number of people with IGT (millions)
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60.6
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73.7
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Type 1 diabetes (0 – 14 years)
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||
Number of children with Type 1
diabetes (thousands)
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129.4
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-
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Number of newly diagnosed cases per year (thousands)
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20.0
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-
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Countries/Territories
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Millions
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Russian Federation
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10.9
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Germany
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7.6
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Turkey
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7.0
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Spain
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3.8
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Italy
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3.6
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· |
Completion of the technical dossier, documenting the entire design process including the industrial design, electronic design and software design for the final commercial product, incorporating the final aesthetics and materials for product launch.
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· |
Completion of human clinical studies in Type I and Type II diabetic patients against a defined clinical protocol, the outcome of which must support the claims for the device; additional ethics committee approvals and regulatory body approvals will be required if the device is to be tested in clinics other than those where ethics approval has already been obtained, or if clinical studies are planned in other countries, respectively.
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· |
CE approval in Europe and subsequent regulatory approvals in other territories with new claims; and
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· |
Prepare the body worn transmitter, and sensor-electrode system for manufacturing for commercial sales, i.e., in large volumes. The patches (containing the sensors) and the device have been manufactured in small batches sufficient for clinical studies and laboratory testing. The scale up of the processes will be undertaken to mass-produce the sensors and patches and the devices in a scale that allows large volume batches to be produced cost effectively. This is necessary to ensure that the manufacturing costs of our products are minimized in order to effectively meet market demands.
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IP: Patent (Core Claim), Know-how, Trademark
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Expiration Date
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Jurisdictions in which Granted/ Issued
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Jurisdictions in which
Pending |
Ongoing Royalty or Milestone Payments
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||
Patent: Cumulative Measurement of an Analyte*.
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May 20, 2032
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Australia, France, Germany, Italy, Poland, Spain, Netherlands, UK
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Brazil, Canada, China, India, Japan, Qatar, United Arab Emirates, U.S.
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None
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||
Patent: Patches for Reverse Iontophoresis**
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July 1, 2029
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Australia, Germany, France, UK, Italy, Netherlands, Switzerland, China, Hong Kong, Japan.
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None
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None
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||
Know-how: Sensor Formulation
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N/A
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Trade Secret
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N/A
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N/A
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Patent: Patch Application to the skin: Device for applying the sugarBEAT to the skin in a single step, to eliminate multiple manual steps.
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To be filed
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N/A
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N/A
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N/A
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Trademark: BEAT
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Renewal due in 2026
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UK, China, EU, India, Japan
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Canada
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N/A
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Trademark: sugarBEAT
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Renewal due in 2025
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UK, Australia, Switzerland, China, Egypt, EU, Israel, India, Iran, Japan, North Korea, Morocco, Mexico, Norway, New Zealand, Russia, Singapore, Tunisia, Turkey, USA
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Canada
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N/A
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- |
Manufacturing agreements for the sensor manufacture
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- |
Manufacturing agreements for the patch manufacture
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- |
Manufacturing agreements for the CGM watch device and transmitter device manufacture
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● |
Class I devices present a low risk and are not life-sustaining or life-supporting. The majority of Class I devices are subject only to "general controls" (e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. General controls are baseline requirements that apply to all classes of medical devices.)
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● |
Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety and effectiveness. Devices in Class II are subject to both general controls and "special controls" (e.g., special labeling, compliance with performance standards, and post market surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification (510(k)) process.)
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● |
Class III devices present the highest risk. These devices generally are life-sustaining, life-supporting, or for a use that is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls, by themselves, are insufficient and for which there is insufficient information to determine that application of special controls would provide a reasonable assurance of safety and effectiveness. Class III devices are subject to general controls and typically require FDA approval of a premarket approval ("PMA") application before marketing.
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● |
Establishment registration and device listing requirements;
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● |
Quality System Regulation ("QSR"), which governs the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of finished devices;
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● |
Labelling requirements, which mandate the inclusion of certain content in device labels and labelling, and generally require the label and package of medical devices to include a unique device identifier ("UDI"), and which also prohibit the promotion of products for uncleared or unapproved, i.e., "off-label," uses;
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● |
Medical Device Reporting ("MDR") regulation, which requires that manufacturers and importers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; and
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● |
Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to the FDA recalls (i.e., corrections or removals) if undertaken to reduce a risk to health posed by the device or to remedy a violation of the Federal Food, Drug and Cosmetic Act that may present a risk to health; manufacturers and importers must keep records of recalls that they determine to be not reportable.
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● |
Untitled letters or warning letters;
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● |
Fines, injunctions and civil penalties;
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● |
Recall or seizure of our products;
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● |
Operating restrictions, partial suspension or total shutdown of production;
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● |
Refusing our request for 510(k) clearance or premarket approval of new products;
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Withdrawing 510(k) clearance or premarket approvals that are already granted; and
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● |
Criminal prosecution.
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- |
Processed lawfully, fairly and in a transparent manner in relation to the data subject.
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- |
Collected for a specified, explicit and legitimate purpose and not further processed in a manner that is incompatible with those purposes.
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- |
Adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed.
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- |
Kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed.
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- |
Processed in a manner that ensures appropriate security of the personal data, including protection against unauthorised or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organisational measures.
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- |
Maintained accurately and up to date and that every reasonable step is taken to ensure that personal data that are inaccurate, having regard to the purposes for which they are processed, are erased or rectified without delay.
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Fiscal Year 2017
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High Bid
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Low Bid
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||||||
First Quarter
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1.99
|
1.50
|
||||||
Second Quarter
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1.95
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1.90
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||||||
Third Quarter
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1.90
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1.50
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||||||
Fourth Quarter
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2.50
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1.40
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Fiscal Year 2018
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High Bid
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Low Bid
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||||||
First Quarter
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9.00
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2.00
|
||||||
Second Quarter
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6.99
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4.04
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||||||
Third Quarter
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6.49
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4.20
|
||||||
Fourth Quarter*
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6.80
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4.50
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Fiscal Year 2019
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High Bid
|
Low Bid
|
||||||
First Quarter (through June 1, 2018)
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4.95
|
2.76
|
Year Ended March 31,
|
2018
|
2017
|
2016
|
2015
|
2014
|
|||||||||||||||
Net loss
|
$
|
(1,820,449
|
)
|
$
|
(1,551,266
|
)
|
$
|
(1,539,637
|
)
|
$
|
(1,319,840
|
)
|
$
|
(586,233
|
)
|
|||||
Diluted loss per share
|
$
|
(0.01
|
)
|
$
|
*
|
$
|
*
|
$
|
*
|
*
|
||||||||||
Cash, cash equivalents, and short-term investments
|
$
|
5,733,886
|
$
|
2,779,309
|
$
|
9,403,965
|
$
|
354,749
|
$
|
1,873,141
|
||||||||||
Total assets
|
$
|
6,255,402
|
$
|
7,401,906
|
$
|
9,732,783
|
$
|
913,108
|
$
|
2,049,774
|
||||||||||
Long-term obligations
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
(170,000
|
)
|
$
|
-
|
|||||||||
Deferred Revenue
|
$
|
1,333,128
|
$
|
1,183,035
|
$
|
1,396,005
|
$
|
1,538,300
|
$
|
1,667,200
|
||||||||||
Stockholders’ equity/(deficit)
|
$
|
4,110,965
|
$
|
5,366,500
|
$
|
7,678,765
|
$
|
(917,411
|
)
|
$
|
373,900
|
|||||||||
|
●
|
obtaining regulatory approval for the sugarBEAT device: CE mark review and approval in Europe is anticipated in 2018, and FDA clinical program and PMA submission timing is yet to be determined.
|
●
|
pursuing additional capital raising opportunities;
|
●
|
exploring licensing opportunities; and
|
●
|
undertaking manufacturing development and scale-up of the sugarBEAT device for commercialization.
|
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
|
Page
|
|||
Reports of Independent Registered Public Accounting Firm
s
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F-2
|
|||
Consolidated Balance Sheets as of March 31, 2018 and 2017
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F-4
|
|||
Consolidated Statements of Comprehensive Loss for the years ended March 31, 2018, 2017 and 2016
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F-5
|
|||
Consolidated Statements of Changes of Stockholders’ Equity for the years ended March 31, 2018, 2017 and 2016
|
F-6
|
|||
Consolidated Statement of Cash Flows for the years ended March 31, 2018, 2017 and 2016
|
F-7
|
|||
Notes to Consolidated Financial Statements
|
F-8-15
|
|
As of March 31,
|
As of March 31,
|
||||||
|
2018
($)
|
2017
($)
|
||||||
|
||||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash
|
822,335
|
911,359
|
||||||
Fixed rate cash account
|
4,911,551
|
1,867,950
|
||||||
Prepaid expenses and other receivables
|
187,139
|
51,086
|
||||||
Accrued interest receivable
|
77,508
|
-
|
||||||
Total current assets
|
5,998,533
|
2,830,395
|
||||||
|
||||||||
Other assets:
|
||||||||
Property and equipment, net
|
5,770
|
9,161
|
||||||
Intangible assets, net of accumulated amortization
|
251,099
|
203,800
|
||||||
|
256,869
|
212,961
|
||||||
|
||||||||
Long term assets:
|
||||||||
Fixed rate cash account
|
-
|
4,358,550
|
||||||
Total assets
|
6,255,402
|
7,401,906
|
||||||
|
||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities
|
||||||||
Accounts payable
|
49,912
|
77,530
|
||||||
Liability due to related party
|
613,818
|
687,609
|
||||||
Other liabilities and accrued expenses
|
147,579
|
87,232
|
||||||
|
||||||||
Total current liabilities
|
811,309
|
852,371
|
||||||
|
||||||||
Deferred revenue
|
1,333,128
|
1,183,035
|
||||||
1,333,128
|
1,183,035
|
|||||||
|
||||||||
Total liabilities
|
2,144,437
|
2,035,406
|
||||||
|
||||||||
Commitments and contingencies
|
||||||||
|
||||||||
Stockholders’ equity:
|
||||||||
Convertible Series A preferred stock, $0.001 par value, 200,000 shares authorized and 137,324 outstanding at March 31, 2018
|
137
|
-
|
||||||
Common stock, $0.001 par value, 420,000,000 shares authorized and 67,676,000 shares issued and outstanding at March 31, 2018 (205,000,000 issued and outstanding at March 31, 2017)
|
67,676
|
205,000
|
||||||
|
||||||||
Additional paid in capital
|
13,056,859
|
12,919,672
|
||||||
Accumulated deficit
|
(8,973,082
|
)
|
(7,152,633
|
)
|
||||
Accumulated other comprehensive loss
|
(40,625
|
)
|
(605,539
|
)
|
||||
Total stockholders’ equity
|
4,110,965
|
5,366,500
|
||||||
Total liabilities and stockholders’ equity
|
6,255,402
|
7,401,906
|
|
Year Ended March 31,
|
|||||||||||
|
2018
($)
|
2017
($)
|
2016
($)
|
|||||||||
Revenues
|
||||||||||||
Total revenues
|
-
|
-
|
-
|
|||||||||
|
||||||||||||
|
||||||||||||
Operating expenses:
|
||||||||||||
Research and development
|
993,833
|
1,034,605
|
1,028,224
|
|||||||||
General and administrative
|
915,132
|
516,661
|
511,413
|
|||||||||
Total operating expenses
|
1,908,965
|
1,551,266
|
1,539,637
|
|||||||||
|
||||||||||||
Loss from operations
|
(1,908,965
|
)
|
(1,551,266
|
)
|
(1,539,637
|
)
|
||||||
|
||||||||||||
Interest income
|
88,516
|
-
|
-
|
|||||||||
Net loss
|
(1,820,449
|
)
|
(1,551,266
|
)
|
(1,539,637
|
)
|
||||||
|
||||||||||||
|
||||||||||||
Other comprehensive income/ (loss)
|
||||||||||||
Foreign currency translation adjustment
|
564,914
|
(760,999
|
)
|
135,813
|
||||||||
Comprehensive loss
|
(1,255,535
|
)
|
(2,312,265
|
)
|
(1,403,824
|
)
|
||||||
|
||||||||||||
Loss per share
|
||||||||||||
Basic and diluted
|
(0.01
|
)
|
*
|
*
|
||||||||
|
||||||||||||
Weighted average number of shares outstanding
|
150,070,400
|
205,000,000
|
201,726,027
|
|
Common Stock
($)
|
Convertible preferred stock
($)
|
Additional Paid in Capital
($)
|
Accumulated Deficit
($)
|
Accumulated
Other Comprehensive Income
($)
|
Total Stockholders’ Equity
($)
|
||||||||||||||||||
|
||||||||||||||||||||||||
Balance at April 1, 2015
|
200,000
|
-
|
2,924,672
|
(4,061,730
|
)
|
19,647
|
(917,411
|
)
|
||||||||||||||||
|
||||||||||||||||||||||||
Common stock issued for cash
|
5,000
|
-
|
9,995,000
|
-
|
-
|
10,000,000
|
||||||||||||||||||
Net loss
|
-
|
-
|
(1,539,637
|
)
|
-
|
(1,539,637
|
)
|
|||||||||||||||||
Other comprehensive income - foreign currency translation gain
|
-
|
-
|
-
|
-
|
135,813
|
135,813
|
||||||||||||||||||
Balance at March 31, 2016
|
205,000
|
12,919,672
|
(5,601,367
|
)
|
155,460
|
7,678,765
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(1,551,266
|
)
|
-
|
(1,551,266
|
)
|
||||||||||||||||
Other comprehensive income - foreign currency translation loss
|
-
|
-
|
-
|
-
|
(760,999
|
)
|
(760,999
|
)
|
||||||||||||||||
Balance at March 31, 2017
|
205,000
|
-
|
12,919,672
|
(7,152,633
|
)
|
(605,539
|
)
|
5,366,500
|
||||||||||||||||
Cancellation of ordinary stock and issue of convertible preferred stock
|
(137,324
|
)
|
137
|
137,187
|
-
|
-
|
-
|
|||||||||||||||||
Net loss
|
-
|
-
|
-
|
(1,820,449
|
)
|
-
|
(1,820,449
|
)
|
||||||||||||||||
Other comprehensive income - foreign currency translation gain
|
-
|
-
|
-
|
-
|
564,914
|
564,914
|
||||||||||||||||||
Balance at March 31, 2018
|
67,676
|
137
|
13,056,859
|
(8,973,082
|
)
|
(40,625
|
)
|
4,110,965
|
|
Year Ended March 31
|
|||||||||||
|
2018
($)
|
2017
($)
|
2016
($)
|
|||||||||
Cash Flows from Operating Activities:
|
||||||||||||
Net loss
|
(1,820,449
|
)
|
(1,551,266
|
)
|
(1,539,637
|
)
|
||||||
|
||||||||||||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||
Depreciation and amortization
|
29,256
|
20,433
|
17,404
|
|||||||||
Changes in assets and liabilities:
|
||||||||||||
Prepaid expenses and other receivables
|
(138,859
|
)
|
85,367
|
224,392
|
||||||||
Prepayment to related party for clinical trials
|
-
|
-
|
249,459
|
|||||||||
Accounts payable
|
(31,247
|
)
|
2,522
|
(31,279
|
)
|
|||||||
Liability due to related party
|
(162,644
|
)
|
270,975
|
-
|
||||||||
Accrued expenses
|
60,407
|
(20,859
|
)
|
(129,704
|
)
|
|||||||
Accrued interest receivable
|
(73,441
|
)
|
-
|
-
|
||||||||
Net cash used in operating activities
|
(2,136,977
|
)
|
(1,192,828
|
)
|
(1,209,365
|
)
|
||||||
|
||||||||||||
Cash Flows from Investing Activities:
|
||||||||||||
Decrease in restricted cash
|
-
|
-
|
-
|
|||||||||
Purchase of intangible assets
|
(45,260
|
)
|
(73,070
|
)
|
(78,197
|
)
|
||||||
Purchase of property and equipment
|
-
|
(6,519
|
)
|
(9,367
|
)
|
|||||||
Fixed rate savings account
|
1,994,475
|
(6,226,500
|
)
|
-
|
||||||||
Net cash provided by/ (used in) investing activities
|
1,949,215
|
(6,306,089
|
)
|
(87,564
|
)
|
|||||||
|
||||||||||||
Cash Flows from Financing Activities:
|
||||||||||||
Net proceeds from issuance of common stock
|
-
|
-
|
10,000,000
|
|||||||||
Net advances from related party
|
-
|
-
|
299,434
|
|||||||||
Net cash provided by financing activities
|
-
|
-
|
10,299,434
|
|||||||||
Net (decrease)/increase in cash
|
(187,762
|
)
|
(7,498,917
|
)
|
9,002,505
|
|||||||
Effect of exchange rate changes on cash
|
98,738
|
(993,689
|
)
|
46,711
|
||||||||
Cash at beginning of year
|
911,359
|
9,403,965
|
354,749
|
|||||||||
Cash at end of year
|
822,335
|
911,359
|
9,403,965
|
Supplemental disclosure of cash flow information:
|
||||||||||||
|
||||||||||||
Schedule of non-cash investing and financing transactions:
|
||||||||||||
Transfer of property and equipment and intangible assets to related party
|
-
|
-
|
23,428
|
|
2018
|
2017
|
2016
|
Year end GBP : US$ exchange rate
|
1:1.4033
|
1:1.2453
|
1:1.4318
|
Average period/yearly GBP : US$ exchange rate
|
1:1.3305
|
1:1.3146
|
1:1.5224
|
|
March 31, 2018
($)
|
March 31, 2017
($)
|
||||||
Fixtures and fittings
|
18,213
|
16,163
|
||||||
Less accumulated depreciation
|
(12,443
|
)
|
(7,002
|
)
|
||||
|
5,770
|
9,161
|
|
March 31, 2018
($)
|
March 31, 2017
($)
|
||||||
Patents and licenses
|
323,987
|
244,457
|
||||||
Less accumulated amortization
|
(72,888
|
)
|
(40,657
|
)
|
||||
|
251,099
|
203,800
|
|
Year Ended March 31,
2018
($)
|
Year Ended March 31,
2017
($)
|
Year Ended March 31,
2016
($)
|
|||||||||
Balance due from Pharma and NDM at beginning of period
|
(687,609
|
)
|
(494,145
|
)
|
192,484
|
|||||||
Amounts advanced to Pharma
|
-
|
-
|
58,197
|
|||||||||
Amounts received from Pharma
|
(145,214
|
)
|
(2,480
|
)
|
(228,361
|
)
|
||||||
Reduction in prepayments to Pharma for clinical trials
|
-
|
-
|
(247,596
|
)
|
||||||||
Amounts invoiced by Pharma to DDL, NM and TCL (1)
|
(842,739
|
)
|
(577,481
|
)
|
(331,714
|
)
|
||||||
Amounts invoiced by DDL to Pharma
|
-
|
15,305
|
16,307
|
|||||||||
Amounts repaid by DDL to Pharma
|
1,096,767
|
249,060
|
-
|
|||||||||
Amounts paid by DDL on behalf of Pharma
|
19,889
|
42,403
|
-
|
|||||||||
Sale of fixed and intangible assets to Pharma and NDM
|
-
|
-
|
17,775
|
|||||||||
Foreign exchange differences
|
(54,912
|
)
|
79,729
|
28,763
|
||||||||
Net balance due to Pharma and NDM at end of the period
|
(613,818
|
)
|
(687,609
|
)
|
(494,145
|
)
|
(1) |
These amounts are included primarily in research and development expenses.
|
|
Year ended March 31,
|
|||||||||||
|
2018
|
2017
|
2016
|
|||||||||
$ | $ | $ | ||||||||||
Loss before income taxes arising in UK
|
(1,353,243
|
)
|
(1,251,870
|
)
|
(1,300,468
|
)
|
||||||
Loss before income taxes arising in United States
|
(467,206
|
)
|
(299,396
|
)
|
(239,169
|
)
|
||||||
Total loss before income tax
|
(1,820,449
|
)
|
(1,551,266
|
)
|
(1,539,637
|
)
|
|
Year ended March 31,
|
|||||||||||||||||||||||
2018 | 2017 | 2016 | ||||||||||||||||||||||
$ | $ | $ | ||||||||||||||||||||||
Loss before income taxes
|
(1,820,449
|
)
|
(1,551,266
|
)
|
(1,539,637
|
)
|
||||||||||||||||||
Expected tax benefit
|
(561,000
|
)
|
(31
|
%)
|
(527,000
|
)
|
(34
|
%)
|
(523,000
|
)
|
(34
|
%)
|
||||||||||||
Foreign tax differential
|
36,000
|
2
|
%
|
217,000
|
14
|
%
|
216,000
|
14
|
%
|
|||||||||||||||
Enhanced research and development
|
(215,000
|
)
|
(12
|
%)
|
(198,000
|
)
|
(13
|
%)
|
(177,000
|
)
|
(11
|
%)
|
||||||||||||
Other
|
35,000
|
2
|
%
|
-
|
- |
-
|
- | |||||||||||||||||
Change in valuation allowance
|
705,000
|
39
|
%
|
455,000
|
29
|
%
|
484,000
|
31
|
%
|
|||||||||||||||
Actual income tax benefit
|
- | - | - | - | - | - |
|
As of March 31,
|
|||||||
|
2018
|
2017
|
||||||
$ | $ | |||||||
Net operating tax loss carried forwards
|
2,229,000
|
1,818,000 | ||||||
Valuation allowance
|
(2,229,000
|
)
|
(1,818,000 | ) | ||||
Net deferred tax assets
|
-
|
- |
|
Quarter Ended
|
|||||||||||||||
2018
|
June 30
|
Sept. 30
|
Dec. 31
|
March 31
|
||||||||||||
Total revenue
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
||||
Loss from operations
|
|
$
|
(417,320
|
)
|
|
$
|
(447,516
|
)
|
|
$
|
(476,353
|
)
|
|
$
|
(567,776
|
)
|
Net loss
|
|
$
|
(407,787
|
)
|
|
$
|
(393,031
|
)
|
|
$
|
(466,365
|
)
|
|
$
|
(553,266
|
)
|
Basic and diluted loss per share
|
|
$
|
*
|
|
$
|
*
|
|
$
|
*
|
|
$
|
*
|
||||
Weighted average number of shares outstanding
|
205,000,000
|
205,000,000
|
121,411,478
|
150,070,400
|
||||||||||||
|
Quarter Ended
|
|||||||||||||||
2017
|
June 30
|
Sept. 30
|
Dec. 31
|
March 31
|
||||||||||||
Total revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||
Loss from operations
|
$
|
(494,183
|
)
|
$
|
(322,482
|
)
|
$
|
(375,366
|
)
|
$
|
(359,235
|
)
|
||||
Net loss
|
$
|
(494,183
|
)
|
$
|
(322,482
|
)
|
$
|
(375,366
|
)
|
$
|
(359,235
|
)
|
||||
Basic and diluted loss per share
|
$
|
*
|
$
|
*
|
$
|
*
|
$
|
*
|
||||||||
Weighted average number of shares outstanding
|
205,000,000
|
205,000,000
|
205,000,000
|
205,000,000
|
||||||||||||
· |
Our size has prevented us from being able to employ sufficient resources to enable us to have an adequate level of supervision and segregation of duties within our internal control system
.
This has resulted in a number of internal control deficiencies. Specifically,
|
· |
there is a lack of segregation of duties in the processing of financial transactions which could result in inappropriate initiation, processing and review of transactions and the financial reporting of such transactions whether due to errors or fraud;
|
· |
there is a lack of review and approval of journal entries which could result in the improper initiation and reporting of transactions; and
|
· |
there is a lack of access controls over the Company’s IT applications which could result in the improper initiation and reporting of significant transactions.
|
· |
Management has identified that there is a lack of adequate financial expertise related to the assessment of complex transactions and a lack of adequate resources to review out of the ordinary transactions and arrangements of the Company.
This could result in the improper reporting of significant transactions or arrangements.
|
· |
Related party transactions
.
Specifically, there are limited policies and procedures to ensure that financial statement disclosures reconcile fully to the underlying accounting records and that Board approval of these transactions is not documented.
|
· |
Assembling a team from our finance department to be responsible for the preparation of financial statements under U.S. Securities laws, including hiring additional qualified personnel such as a CFO with US listed company experience. In assembling this team, the Company will put in place controls to segregate duties in the processing of key transactions, controls to ensure the review and approval of journal entries and controls to ensure that access to IT systems is limited to authorized users based on the applications and their functions within the organization.
|
· |
Engaging a third party consulting firm to assist in assessing, designing, implementing, and monitoring controls related to financial statement preparation, IT general controls, journal entries, and significant operating processes.
|
· |
Organizing regular training sessions on US GAAP for our finance department in the form of workshops, seminars and newsletters as well as requiring our finance personnel to participate in annual in-house or public US GAAP training courses; and
|
· |
Implementing stronger internal controls and processes over related party transactions including segregating reviews and approvals, as well as continuing efforts to reduce the amount and volume of related party transactions; and
|
· |
Establishing an audit committee with an “audit committee financial expert” within the definition of the applicable Securities and Exchange Commission. The committee will be helped by an outsourced internal audit department to review our internal control processes, policies and procedures to ensure compliance with the Sarbanes-Oxley Act.
|
· |
Ongoing assessment of our current Internal Control Over Financial Reporting against COSO 2013 and the requirements set forth by Sarbanes-Oxley Act section 404. This task will be conducted by an independent expert.
|
· |
Continued testing of the operating effectiveness of the controls that have been identified and implemented in order to prevent misstatement of the financial statements. In addition, the company will focus on the design and implementation of Key Performance Indicators (KPIs) in order to measure the quality of the processes in place, and the efficiency of the controls.
|
· |
We have continued to engage with a third party consulting firm to help us assess our current internal control over financial reporting against COSO 2013, as well as identifying a gap analysis, suggest improvements in controls, and assist us in testing our control systems. Further testing has occurred of certain controls, including purchasing processes, payment processes, and month end closing procedures. In addition, an initial assessment of IT general controls has been conducted, with a view to assessing the current situation and strengthening these controls where deemed necessary. The Company has set a target to design and implement controls that will address the material weaknesses by March 31, 2019. The independent advisers have agreed a table of work to complete all controls reviews, implementation and testing in this timeframe and the Company has committed to meeting this timeframe. However, as this process is ongoing and there will need to be sufficient time to ensure implemented controls are operating effectively, there is no assurance that all material weaknesses will be fully remediated by March 31, 2019.
|
· |
During the quarter ended September 30, 2017, the Board of Directors (“Board”) appointed three independent directors to serve on our Board, each of whom meet the definition of “independent” as set forth under The Nasdaq Stock Market rules. The Board has established an audit committee with each of the independent directors serving as members of the audit committee. The Board has also designated one of the independent directors to serve as Chair of the audit committee who meets the definition of an “audit committee financial expert.”.
|
· |
During the year, members of our accounting department have attended training courses relating to US accounting practice and changes in taxation laws.
|
Name
|
Age
|
Position
|
Date of Appointment
|
|||
Dewan Fazlul Hoque Chowdhury
|
45
|
Chief Executive Officer, President and Director
|
December 24, 2013
|
|||
Bashir Timol
|
43
|
Director
Chief Business Officer
|
December 24, 2013
April 9, 2018 |
|||
Iain Anderson
|
58
|
Chief Financial Officer
|
December 12, 2016
|
|||
Thomas Moore
|
54
|
Independent Director
|
August 3, 2017
|
|||
Dr. Salim Natha
|
51
|
Independent Director
|
July 26, 2017
|
|||
Timothy Johnson
|
34
|
Independent Director
|
July 17, 2017
|
Name
|
Form
|
Transaction
|
|||
Dewan F.H. Chowdhury
|
4
|
Cancellation of
87,537,000
shares of common stock; Acquisition of
87,537
shares of preferred stock
|
|||
Bashir Timol
|
4
|
Cancellation of
27,082,000
shares of common stock; Acquisition of
27,082
shares of preferred stock
|
|||
Sufyan Ismail
|
4
|
Cancellation of
22,705,000
shares of common stock; Acquisition of
22,705
shares of preferred stock
|
|||
Timothy Johnson
|
3
|
Appointment as a director owning
-0- shares
|
|||
Salim Natha
|
3
|
Appointment as a director owning
4,006,389 shares
|
|||
Thomas J. Moore
|
3
|
Appointment as a director owning
-0- shares
|
Named Executive Officer
and Principal Position |
Year
|
Salary
($)
|
Bonus
($)
|
All Other Compensation
($)
|
Total
($)
|
||||||||||||
|
|
||||||||||||||||
Dewan Fazlul Hoque Chowdhury
|
2018
|
106,440
|
-
|
390
|
106,830
|
||||||||||||
Chief Executive Officer (Principal Executive Officer)
|
2017
|
105,168
|
-
|
-
|
105,168
|
||||||||||||
Iain Anderson
|
2018
|
57,938
|
-
|
297
|
58,235
|
||||||||||||
Chief Financial Officer (Principal Financial Officer) |
2017
|
34,761
|
-
|
-
|
34,761
|
Name
|
Fees Earned or paid in Cash
($US) (1)
|
Non-Equity Incentive Plan Compensation
($US)
|
All other Compensation
($US) |
Total
($US)
|
||||||||||||
Timothy Johnson
|
4,726
|
-0-
|
-0-
|
4,726
|
||||||||||||
Salim Natha
|
4,568
|
-0-
|
-0-
|
4,568
|
||||||||||||
Thomas Moore
|
4,387
|
-0-
|
-0-
|
4,387
|
Name of Beneficial Owner
|
Shares Beneficially Owned
|
Percentage Total Voting Power
1
|
||||||
Chowdhury, Dewan F.H.
|
87,537,000
|
43
|
%
|
|||||
Timol, Bashir
|
27,082,100
|
13
|
%
|
|||||
Iain Anderson
|
0
|
-
|
||||||
Timothy Johnson
|
0
|
-
|
||||||
Salim Natha
|
4,006,389
|
2
|
%
|
|||||
Thomas Moore
|
0
|
- | ||||||
Total Officers and Directors as a Group
|
118,625,489
|
58
|
%
|
|||||
Holders of 5% or more of our Common Stock
|
||||||||
Ismail, Sufyan
|
22,705,250
|
11
|
%
|
|
Year Ended
March 31,
2018
($)
|
|||
Balance due from Pharma and NDM at beginning of period
|
(687,609
|
)
|
||
Amounts advanced to Pharma
|
-
|
|||
Amounts received from Pharma
|
(145,214
|
)
|
||
Reduction in prepayments to Pharma for clinical trials
|
-
|
|||
Amounts invoiced by Pharma to DDL, NM and TCL (1)
|
(842,739
|
)
|
||
Amounts invoiced by DDL to Pharma
|
-
|
|||
Amounts repaid by DDL to Pharma
|
1,096,767
|
|||
Amounts paid by DDL on behalf of Pharma
|
19,889
|
|||
Sale of fixed and intangible assets to Pharma and NDM
|
-
|
|||
Foreign exchange differences
|
(54,912
|
)
|
||
Net balance due to Pharma and NDM at end of the period
|
(613,818
|
)
|
(1) |
These amounts are included primarily in research and development expenses.
|
ITEM 14.
|
PRINCIPAL ACCOUNTANT FEES AND SERVICES
|
|
2018
|
2017
|
||||||
Audit Fees
|
$
|
106,000
|
$
|
84,000
|
||||
Audit Related Fees
|
-
|
-
|
||||||
Tax Fees
|
$
|
6,765
|
$
|
6,000
|
||||
Other Fees
|
-
|
-
|
||||||
Totals
|
$
|
112,765
|
$
|
90,000
|
ITEM 15.
|
EXHIBITS, FINANCIAL STATEMENT SCHEDULES.
|
||
(a)
|
Exhibits:
|
Exhibit No.
|
Description
|
|
3.1
|
||
3.1(a)*
|
||
3.2*
|
||
3.3*
|
||
4.1
|
||
4.2
|
||
10.1
|
||
10.2
|
||
10.3
|
||
10.4
|
||
10.5+
|
||
10.6
|
||
10.7
|
||
10.8+
|
||
14.1
|
||
21.1
*
|
||
23.1*
|
||
31.1 | ||
31.2 | ||
32.1 | ||
32.2 | ||
101 | Interactive data files pursuant to Rule 405 of Regulation S-T: (i) the Balance Sheets, (ii) the Statements of Comprehensive Loss, (iii) Statements of Stockholders Equity, (iv) the Statement of Cash Flows and (v) the Notes to the Financial Statements |
· |
*Filed herewith
|
· |
+Portions of this Exhibit have been omitted pursuant to a request for confidential treatment.
|
NEMAURA MEDICAL INC. | |||
|
By:
|
/s/ Dewan F. H. Chowdhury | |
Dewan F. H. Chowdhury | |||
President, Chief Executive Officer (Principal Executive Officer) | |||
|
By:
|
/s/ Iain S Anderson | |
Iain S Anderson | |||
Chief Financial Officer (Principal Financial Officer) | |||
Name
|
Position
|
Date
|
|
/s/ Dewan F.H. Chowdhury
|
President, Chief Executive Officer (Principal Executive Officer) Chief Financial Officer
|
June 12, 2018
|
|
Dewan F.H, Chowdhury
|
|||
/s/ Bashir Timol
|
Director
|
June 12, 2018
|
|
Bashir Timol
|
|||
/s/ Timothy Johnson
|
Independent Director
|
June 12, 2018
|
|
Timothy Johnson
|
|||
/s/ Salim Natha
|
Independent Director
|
June 12, 2018
|
|
Salim Natha
|
|||
/s/ Thomas Moore
|
Independent Director
|
June 12, 2018
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Thomas Moore |
Date of Conversion:
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Number of Preferred Shares to be converted:
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Stock certificate no(s). of Preferred Shares to be converted:
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Please confirm the following information:
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Conversion Price:
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Number of shares of Common Stock to be issued:
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Number of shares of Common Stock beneficially owned or deemed beneficially owned by the Holder on the Date of Conversion:
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1. |
PLACE OF MEETINGS
. Meetings of the Stockholders shall be held at the principal office of the corporation or at such place within or without the State of Nevada as the Board shall authorize.
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2. |
ANNUAL MEETING
. The annual meeting of Stockholders shall be held on the first Monday of each year in the month of February; however, if such day falls on a legal holiday, then on the next business day following at the same time. At the annual meeting of Stockholders, the Stockholders shall elect the Board of Directors and transact such other business as may properly come before the meeting.
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3. |
SPECIAL MEETINGS
. Special meetings of the Stockholders may be called by the Board or by the President or at the written request of Stockholders owning a majority of the stock entitled to vote at such meeting. A meeting requested by the Stockholders shall be called for a date not less than ten (10) nor more than sixty (60) days after a request is made. The Secretary shall issue the call for the meeting unless the President, the Board or the Stockholders shall designate another to make said call.
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4. |
NOTICE OF MEETINGS
. Written Notice of each meeting of Stockholders shall state the purpose of the meeting and the time and place of the meeting. Notice shall be mailed to each Stockholder having the right and entitled to vote at such meetings to their last address as it appears on the records of the corporation, not less than ten (10) nor more than sixty (60) days before the date set for such meeting. Such notice shall be sufficient for the meeting and any adjournment thereof. If any Stockholder shall transfer his stock after notice, it shall not be necessary to notify the transferee. Any Stockholder may waive notice of any meeting before, during or after the meeting.
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5. |
RECORD DATE
. The Board may fix a record date not more than forty (40) days prior to the date set for a meeting of Stockholders as the date of which the Stockholders of record who have the right to and are entitled to notice of and to vote at such meeting and any adjournment thereof shall be determined. Notice that such date has been fixed may be published in the city, town or county where the principal office of the corporation is located and in each city or town where a transfer agent of the stock of the corporation is located.
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6. |
VOTING.
Every Stockholder shall be entitled at each meeting and upon each proposal presented at each meeting to one vote for each share of voting stock recorded in her name on the books of the corporation on the record date as fixed by the Board. If no record date was fixed, on the date of the meeting the book of records of Stockholders shall be produced at the meeting upon the request of any Stockholder. Upon demand of any Stockholder, the vote for Directors and the vote upon any question before the meeting shall be by ballot. All elections for Directors shall be decided by plurality vote; all other questions shall be decided by majority vote.
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7. |
QUORUM.
The presence, in person or by proxy, of Stockholders holding a majority of the stock of the corporation entitled to vote shall constitute a quorum at all meetings of the Stockholders. In case quorum shall not be present at any meeting, a majority in interest of the Stockholders entitled to vote thereat present in person or by proxy, shall have power to adjourn the meeting from time to time, without notice other than announcement at the meeting, until the requisite amount of stock entitled to shall be present. At any such adjourned meeting at which the requisite amount of stock entitled to vote be represented, any business may be transacted which might have been transacted at the meeting as originally noticed; but only those Stockholders entitled to vote at the meeting shall be entitled to vote at any adjournment or adjournments thereof.
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8. |
PROXIES
. At any Stockholders' meeting or any adjournment thereof, any Stockholder of record having the right and entitled to vote thereat may be represented and vote by proxy appointed in an instrument. No such proxy shall be voted after three years from the date of the instrument unless the instrument provides for a longer period. In the event that any such instrument provides for or more persons to act as proxies, a majority of such persons present at the meeting, or if only one is present, that one, shall have all the powers conferred by the instrument upon all persons so designated unless the instrument shall otherwise provide.
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9. |
STOCKHOLDER LIST.
After fixing a record date for a meeting, the corporation shall prepare an alphabetical list of the names of all its Stockholders who are entitled to notice of a Stockholders' meeting. Such list shall be arranged by voting group with the names and addresses of, and the number class and series if any, of shares held by each. This list shall be available for inspection by any Stockholder for a period of ten days prior to the meeting.
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10. |
ACTION BY CONSENT
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Any action required or permitted by law or by the Articles of Incorporation to be taken at any meeting of the stockholders may be taken without a meeting, without prior notice, and without a vote, if a written consent, setting forth the action so taken, shall be signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting by less than unanimous written consent shall be given to those stockholders who have not consented in writing thereto
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1. |
BOARD OF DIRECTORS.
The business of the corporation shall be managed and its corporate powers exercised by a Board each of whom shall be of full age. It shall not be necessary for Directors to be Stockholders. The number of Director(s) shall be determined by the Stockholders at their annual meeting. There shall be no less than one (1) director and no more than fifteen (15) directors.
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2. |
ELECTION AND TERM OF DIRECTORS.
Directors shall be elected at the annual meeting of stockholders and each Director elected shall hold office until her successor has been elected and qualified, or until the Director's prior resignation or removal.
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3. |
VACANCIES.
If the office of any Director, member of a committee or other office becomes vacant the remaining Directors in office, by a majority vote, may appoint any qualified person to fill such vacancy, who shall hold office for the unexpired term and until a successor shall be duly chosen.
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4. |
REMOVAL OF DIRECTORS.
Any or all of the Directors may be removed with or without cause by a vote of a majority of all the stock outstanding and entitled to vote at a special meeting of Stockholders called for that purpose.
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5. |
NEWLY CREATED DIRECTORSHIPS
. The number of Directors may be increased by amendment of these Bylaws by the affirmative vote of a majority of the Directors, though less than a quorum, or, by the affirmative vote of a majority in interest of the Stockholders, at the annual meeting or at a special meeting called for that purpose, and by like vote the additional Directors may be chosen at such meeting to hold office until the next annual election and until their successors are elected and qualify.
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RESIGNATION.
A Director may resign at any time by giving written notice to the Board, the President or the Secretary of the Corporation. Unless otherwise specified in the notice, the resignation shall take effect upon receipt thereof by the Board or such officer, and the acceptance of the resignation shall not be necessary to make it effective.
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7. |
QUORUM OF D1RECTORS.
A majority of the Directors shall constitute a quorum for the transaction of business. If at any meeting of the Board there shall be less than a quorum present, a majority of those present may adjourn the meeting until a quorum is obtained and no further notice thereof need be given other than by announcement at the meeting which shall be so adjourned.
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PLACE AND TIME OF BOARD MEETINGS.
The Board may hold its meetings at the office of the corporation or at such other places either within or without the State of Nevada as it may from time to time determine. There shall be semi-annual meetings of the Board of Directors to conduct a review of the business and policies of the corporation and to conduct any business that may be brought forward.
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9. |
REGULAR ANNUAL MEETING.
A regular meeting of the Board shall be held immediately following the annual meeting of the Stockholders at the place of such annual meeting of Stockholders.
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10. |
CONDUCT OF BUSINESS WITHOUT MEETINGS.
Any action of the Directors or committees may be taken without a meeting if consent in writing, setting forth the action so taken, shall be signed by all persons who would be entitled to vote on such action at a meeting and filed with the Secretary of the corporation as part of the proceedings of the Directors or committees as the case may be.
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NOTICE OF MEETINGS OF THE BOARD.
Regular meetings of the Board may be held without notice at such time and place as it shall from time to time determine. Special meetings of the Board shall be held upon notice to the Directors and may be called by the President upon three days’ notice to each Director either personally or by mail or by wire or by facsimile; special meetings shall be called by the President or by the Secretary in a like manner on written request by two Directors. Notice of a meeting need not be given to any Director who submits a Waiver of Notice whether before or after the meeting or who attends the meeting without protesting prior thereto or at its commencement, the lack of notice to him.
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EXECUTIVE AND OTHER COMMITTEES.
The Board, by resolution, may designate two or more of their number to one or more committees, which, to the extent provided in said resolution or these Bylaws may exercise the powers of the Board in the management of the business of the corporation.
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13. |
COMPENSATION.
Directors, as such may receive, pursuant to a resolution of the Board of Directors, fees and other compensation for their services as directors, including without limitation their services as members of committees of the Board of Directors.
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1. |
OFFICERS. ELECTION AND TERM
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1.1 |
The Board may elect or appoint a Chairman, a President, one or more Vice-Presidents, a Secretary, an Assistant Secretary, a Treasurer and an Assistant Treasurer and such other officers as it may determine who shall have duties and powers as hereinafter provided.
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1.2 |
All officers shall be elected or appointed to hold office until the meeting of the Board following the next annual meeting of Stockholders and until their successors have been elected or appointed and qualified.
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2. |
REMOVAL. RESIGNATION. SALARY. ETC.
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2.1 |
Any officer elected or appointed by the Board may be removed by the Board with or without cause.
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2.2 |
In the event of the death, resignation or removal of an officer, the Board in its discretion may elect or appoint a successor to fill the unexpired term.
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2.3 |
Any two or more offices may be held by the same person.
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2.5 |
The Directors may require any officer to give security for the faithful performance of her duties.
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4.2. |
any date upon which Stockholders shall be called upon to have a right to take action without a meeting, or
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4.3. |
any date fixed for the payment of a dividend or any other form of distribution, and only those Stockholders of record at the time the transfer books are closed, shall be recognized as such for the purpose of
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1. |
These Bylaws may be altered or repealed at any annual meeting of the Stockholders or at any special meeting thereof if notice of the proposed alteration or repeal to made is contained in the notice of such special meeting, by the affirmative vote of a majority of the stock issued and outstanding and entitled to vote thereat.
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2. |
These Bylaws may amended or repealed by the affirmative vote of a majority of the Board except the Board may not amend or repeal any Bylaw which expressly provides that the Board may not amend or repeal that Bylaw provision.
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Date: June 12, 2018
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By:
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/s/ Dewan F.H. Chowdhury | |
Name: Dewan F.H. Chowdhury | |||
Title: Chief Executive Officer (Principal Executive Officer) | |||
Date: June 12, 2018
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By:
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/s/ Iain S. Anderson | |
Name: Iain S. Anderson | |||
Title: Chief Financial Officer (Principal Financial and Accounting Officer) | |||
Dated: June 12, 2018
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By:
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/s/ Dewan F H Chowdhury |
Name:
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Dewan F H Chowdhury
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Title:
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Chief Executive Officer (Principal Executive Officer)
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Dated: June 12, 2018
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By:
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/s/ Iain S Anderson |
Name:
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Iain S Anderson
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Title:
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Chief Financial Officer (Principal Financial Officer)
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