UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-K
(Mark One)
þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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| | For the year ended December 31, 20122015 |
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| ¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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| | For the transition period from __________ to ____________ |
Commission File Number: 2-93277-D
MEDIZONE INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
| Nevada | | 87-0412648 |
| (State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| 4000 Bridgeway, Suite 401, Sausalito, California | | 94965 |
| (Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code: (415) 331-0303
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes o No þ
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þ No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. oþ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer o | | Accelerated filer o |
Non-accelerated filer o | | Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No þ
The aggregate market value of common stock held by non-affiliates of the registrant as of June 29, 201230, 2015, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $35,224,150,$43,934,237, computed by reference to the average bid and asked price of the common stock on such date of $0.15$0.129 per share.
There were 299,104,559369,934,068 shares of the registrant’s common stock outstanding as of March 18, 2013.3, 2016.
Documents incorporated by reference. None
FORM 10-K
For the year ended December 31, 20122015
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| Part I |
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| Item 1 | | 3 |
| Item 1A | | 11 |
| Item 2 | | 1615 |
| Item 3 | | 1615 |
| Item 4 | Mine Safety Disclosures (omitted) | |
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| Part II |
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| Item 5 | | 1716 |
| Item 6 | Selected Financial Data (omitted) | |
| Item 7 | | 1817 |
| Item 7A | Quantitative and Qualitative Disclosures About Market Risk (omitted) | |
| Item 8 | | 2019 |
| Item 9 | | 2019 |
| Item 9A | | 2119 |
| Item 9B | | 2120 |
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| Part III |
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| Item 10 | | 2221 |
| Item 11 | | 24 |
| Item 12 | | 26 |
| Item 13 | | 2726 |
| Item 14 | | 27 |
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| Part IV |
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| Item 15 | | 29 |
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| 30 |
PART I
The statements contained in this reportThis Annual Report on Form 10-K that are not purely historical are considered to be “forward-looking statements”contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 19951995. All statements contained in this Annual Report on Form 10-K other than statements of historical fact, including statements regarding our future results of operations and Section 21Efinancial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part I. Item 1A. “Risk Factors,” in this Annual Report on Form 10-K. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the Securities Exchange Actimpact of 1934, as amended (the “Exchange Act”). Theseall factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements represent our expectations, beliefs, anticipations, commitments, intentions,we may make. In light of these risks, uncertainties and strategies regardingassumptions, the future events and include, but aretrends discussed in this Annual Report on Form 10-K may not limited to, the risksoccur and uncertainties outlined in Item 1A Risk Factors and Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations. Readers are cautioned that actual results could differ materially and adversely from those anticipated or implied in the anticipatedforward-looking statements.
We undertake no obligation to revise or publicly release the results or other expectations that are expressed inof any revision to these forward-looking statements, within this report. Theexcept as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements includedstatements.
Unless expressly indicated or the context requires otherwise, the terms “Medizone,” “Company,” “we,” “us,” and “our” in this report speak only as of the date hereof.
document refer to Medizone International, Inc., a Nevada corporation, and, where appropriate, its affiliate. In this Annual Report on Form 10-K,addition, unless indicated otherwise, references to “dollars” and “$” are to United States dollars.
We own or have rights to trademarks, service marks or trade names that we use in connection with the operation of our business, including, without limitation, “Medizone,“Medizone” and “AsepticSure®.” “AsepticSure” and the stylized logos “Medizone,” “O3”“O3” and “AsepticSure” logos.“AsepticSure®”. Solely for convenience, some of the copyrights, trademarks, service marks and trade names referred to in this report are listed without the ©, ®®, and ™ symbols, but we will assert, to the fullest extent under applicable law, our rights to our copyrights, trademarks, service marks, trade names and domain names. The trademarks, service marks and trade names of other companies appearing in this report are, to our knowledge, the property of their respective owners.
Introduction
Medizone International, Inc. and its subsidiaries (collectively, “Medizone,” the “Company,” “we,” “us,” “our”) has been a development stage company conducting research into the use of ozoneWe were incorporated in January 1986. Our focus is in the disinfectionfield of surgical and other medical treatment facilities and in other applications.hospital disinfection. During the year ended December 31, 2012, we emergedgenerated our first significant revenues from the development stage assale of our AsepticSure® hospital disinfection system. We cannot predict when or if we beganwill generate sufficient cash flows from operating activities to sellfund continuing or planned operations. If we fail to obtain additional funding, we will be forced to suspend or permanently cease operations, and may need to seek protection under U.S. bankruptcy laws.
AsepticSure® is the name of our patented ozone disinfectant system AsepticSure.for hospitals, long-term care facilities and other critical infrastructure. In the AsepticSure® system, oxygen atoms are misted into the environment with a hydrogen peroxide vapor. The AsepticSure® formula creates Trioxidane, which separates our system from other ozone systems. AsepticSure® has repeatedly demonstrated a 6-log (99.9999%) bactericidal kill inside an enclosed space without residual damage to the room contents.
By way of explanation, “log reduction” is a mathematical term (as is “log increase”) used to show the relative number of live microbes eliminated from a surface by disinfecting or cleaning. For example, a “5-log reduction” means lowering the number of microorganisms by 100,000-fold, that is, if a surface has 100,000 pathogenic microbes on it, a 5-log reduction would reduce the number of microorganisms to one, as follows:
| · | 1 log reduction means the number of germs is 10 times smaller |
| · | 2 log reduction means the number of germs is 100 times smaller |
| · | 3 log reduction means the number of germs is 1000 times smaller |
| · | 4 log reduction means the number of germs is 10,000 times smaller |
| · | 5 log reduction means the number of germs is 100,000 times smaller |
| · | 6 log reduction means the number of germs is 1,000,000 times smaller |
| · | 7 log reduction means the number of germs is 10,000,000 times smaller |
Ozone is a gas composed of three oxygen atoms (O3) in an unstable and highly reactive form. Ozone naturally tends to seek its normal state, exhibiting a short half-life as it reverts back to oxygen (O2) fairly rapidly. There are many uses of ozone as a disinfecting agent. Although ozone does react with organic matter, it leaves no residue in water or on thea treated product. Ozone also does not form any toxic byproducts. When used in water, no change in color or flavor results from ozone treatment, unlike chlorine treatment. Ozone can be generated onsite from ambient air or from oxygen. Each method has its advantages and unique challenges. It has been demonstrated that ozone can be economically produced and is effectively used as an agent in food processing and equipment sanitizing, and in water treatment facilities globally. Ozone technology is replacing conventional sanitation techniques such as chlorine, steam, or hot water.
Development of Our Business
Prior to 2008, our research and development activity had been dedicated to (i) seeking regulatory approval of a precise mixture of ozone and oxygen, and the process of inactivating lipid-enveloped viruses for the intended purpose of decontaminating blood and blood products and assisting in the treatment of certain diseases; (ii) developing or acquiring the related technology and equipment for the medical application of our products, including a drug production and delivery system; and, (iii) applying our novel technology to the problem of nosocomial infections world-wide.
Early in 2008, we began to consider other applications of our core technologies and new technologies with lower development costs with the objective of moving us to revenue production in the shortest period of time. This new direction included re-positioning the Company to pursue an initiative in the field of hospital disinfection. Following laboratory results with Bacillus subtilis, an internationally recognized surrogate for anthrax, that produced 7 log reductions (sterilization), we have expanded our research and business plan to include bio-terrorism countermeasures as well as hospital disinfection and critical infrastructure de-contamination.
By way of explanation, “log reduction” is a mathematical term (as is “log increase”) used to show the relative number of live microbes eliminated from a surface by disinfecting or cleaning. For example, a “5-log reduction” means lowering the number of microorganisms by 100,000-fold, that is, if a surface has 100,000 pathogenic microbes on it, a 5-log reduction would reduce the number of microorganisms to one, as follows:
·1 log reduction means the number of germs is 10 times smaller
·2 log reduction means the number of germs is 100 times smaller
·3 log reduction means the number of germs is 1000 times smaller
·4 log reduction means the number of germs is 10,000 times smaller
·5 log reduction means the number of germs is 100,000 times smaller
·6 log reduction means the number of germs is 1,000,000 times smaller
·7 log reduction means the number of germs is 10,000,000 times smaller
Corporate Operations
This change in our research and development focus was based, in part, on a review of published data on hospital-derived infections, an area of rapidly growing concern in the medical community. We identified an opportunity to build on our experience with ozone technologies and ozone’s bio-oxidative qualities in pursuing this initiative and shifted our near term efforts towards one of our founding tenets, namely that under the right conditions, ozone can be extremely effective at sterilizing biological fluids (blood, serum, and plasma and plasma fractionates) as well as biologically contaminated equipment, surfaces, and spaces.
We expect our unique ozone generating technologies will play a vital role in addressing what public health officials and surgeons world-wide are beginninghave referred to recognize as “the silent epidemic” (American Academy of Orthopedic Surgeons, May 2008, copy on file with the Company (“AAOS Study”)), a reference tospecifically referencing Methicillin-resistant Staphylococcus aureus (“MRSA”) infection. This is a strain of Staphylococcus aureus bacteria (“staph”) that is resistant to the broad-spectrum antibiotics commonly used to treat it. MRSA can be fatal. According to the AAOS Study, “the number of hospital admissions for MRSA has exploded in the past decade. By 2005, admissions were triple the number in 2000 and 10-fold higher than in 1995. In 2005, in the United States, 368,600 hospital admissions for MRSA — including 94,000 invasive infections — resulted in 18,650 deaths. The number of MRSA fatalities in 2005 surpassed the number of fatalities from hurricane Katrina and AIDS combined and is substantially higher than fatalities at the peak of the U.S. polio epidemic.” Indeed, biological contamination of medical treatment areas such as hospitals and chronic care facilities has recently been identified by several world renowned public health institutions, including the United States Centers for Disease Control or “CDC” (“CDC Report,” 17 Oct, 2007, copy on file with the Company), as one of the greatest threats to public health and safety in the industrial world. This concern was reflected in an article published in the journal Science (18 July 2008, Vol. 321, pp 356-361, copy on file with the Company) which estimated that hospital-based infections in 2006 accounted for almost 100,000 deaths in the United States. We expect that current data, if available, would indicate that deaths in the United States from hospital-acquired MRSA infections exceed 100,000 per year.
In response to this situation, we have developed AsepticSure®, a highly portable, low-cost, ozone-based technology (“AsepticSure”) specifically for the purpose of decontaminating and sterilizing hospital surgical suites, emergency rooms, intensive care units and other enclosed spaces such as gym locker rooms, laboratories and veterinary clinics. Since this technology is not considered a medical treatment or a diagnostic device, its development pathway is not subject to a stringent and expensive regulatory review process. We anticipate that the development pathway will be based on independent peer-reviewed science and engineering excellence. Our team is also developing a variant of AsepticSureAsepticSure® for governmental use with bio-terrorism countermeasures.
During May 2009, we commencedWe took delivery in January 2013 of the first of a series of trials designed to confirm thatAsepticSure® system constructed by our AsepticSure hospital disinfection system can rapidly eliminate hospital-based bacterial pathogens known to be responsible for the growing number of deaths and serious infections currently plaguing the healthcare system. We engaged an internationally recognized expert in medical microbiology and hospital infections to lead these trials.
We commenced a second series of laboratory trials in early June 2009, after the first series produced results that our researchers deemed to have demonstrated significant bactericidal effects against C. difficile, E. coli, Pseudomonas aeruginosa, MRSA and Vanocomycin-resistant Enterococci (“VRE”), the main causative agents of hospital derived nosocomial infections. This second series of laboratory trials resulted in what are estimated to be levels of bactericidal action necessary to achieve our commercial objectives.
In October 2009, we began a third series of laboratory trials to establish the precise protocols necessary to obtain maximum bactericidal action in combination with minimum turn-around times in keeping with normal hospital flow patterns. This third series of laboratory trials was completed during January 2010 and demonstrated predictably greater than 6 logs (99.9999%) of bacterial “kill” across the full spectrum of hospital contaminants including MRSA, C difficile, E coli, Pseudomonas aeruginosa and VRE in addition to the internationally accepted surrogate for anthrax, Bacillus subtilis. Our research has shown that the technology can now achieve a level of bacterial decontamination heretofore unseen in open space settings using conventional means. We expect that this development will significantly expand the utility and acceptance or our AsepticSure technology.
In connection with our trials described above, we also designed and produced a development prototype which has demonstrated that it can reach both the charge time and saturation requirements of its design criteria. In January 2010, we started mock-up trials for both public (hospital) and government (bio-terrorism countermeasures) applications of our system. Results obtained during early February 2010 demonstrated that every full-scale test run completed in our hospital room mock-up facility had resulted in the total elimination of all bacteria present in the room. Additional testing was designed to confirm in a more realistic hospital setting these laboratory findings indicating extremely high antibacterial efficacy for our novel technology (6-7.2 log reductions) against the primary causative agents of hospital acquired infections (“HAIs”), sometimes referred to as “Super Bugs.” We completed multiple runs with very high concentrations of MRSA, VRE and E. coli samples that were distributed throughout the test room. In every instance, the AsepticSure system produced greater than 6 log (99.9999%) reductions, which by definition, is sterilization. We have now systematically collected empirically verifiable scientific data on all of the remaining causative agents of HAIs. We have also disinfected Bacillus subtilis, the recognized surrogate for anthrax in full-sized room settings to a sterilization standard of >6 log, which we interpret as a positive indicator that AsepticSure could play a vital role in the government arena of bio-terrorism countermeasures.
We started hospital beta-testing of a prototype system utilizing the original technology during the summer of 2010, with the initial phases successfully completed during early October 2010. The first round of in-hospital beta-testing for the AsepticSure hospital disinfection system was completed on October 9, 2010, at the Hotel Dieu hospital in Kingston, Ontario, Canada. The targeted hospital space was artificially contaminated with high concentrations of MRSA and C. difficile, using both regulatory compliant stainless steel discs and carpet samples typically found in many health care facilities. One hundred percent of the MRSA and C. difficile was eliminated from the discs (7.1 logs for MRSA and 6.2 logs for C difficile). The pathogens were also completely eliminated from all contaminated carpet samples, something we believe to be unachievable with any other technology. Testing further indicated that beyond the test samples artificially introduced, all pre-occurring pathogens present before testing were also eliminated on all surfaces by the AsepticSure hospital disinfection system.
In addition to the hospital disinfection system, we employ an ozone-destruct unit which is used following disinfection of the treated infrastructure to reverse the O3 gas in the space, and turn it back into O2 in a short period of time. We have initially targeted the treatment of a typically sized surgical suite including disinfection followed by ozone destruct to habitable standards in 90 minutes or less. This short turn-around period is considered of great importance for commercialization of the technology.
In addition, work completed by the Company at Queen’s Universitycontract manufacturer, Transformix Engineering, located in Kingston, Ontario, Canada demonstrated that the AsepticSure system can reliably eliminate in excess of 6 logs (99.99999%(“Transformix”) reductions of Listeria monocytogenes and Salmonella typhium with 30-minute exposure to our unique and patented gas mixture, which provides an additional application of the AsepticSure technology, beyond that of hospital acquired infections for the food processing industry.
Importantly, the AsepticSure system is proving equally effective in disinfecting carpets and drapes as well as hard surfaces to greater than 6 log kill (6-log is generally recognized within the scientific community as the standard for sterilization). We have four units in inventory as of December 31, 2015, which are not aware of any other system in the world capable of making this claim that utilizes green technology and allows content to remain in the room during disinfection.
available for sale. During January 2012, technology transfer of the production design was completed from ADA Innovations (“ADA”), our production development partner, to SMTC Corporation in Toronto, Canada, our original contract manufacturing partner. An initial order was placed for five production validation units to be built. The production validation units were intended to be used for regulatory compliance and licensing validation, additional testing and early delivery positions.
In February 2012, SMTC reported that certain supply-side and tooling delays set back the anticipated delivery date for the initial units by a number of weeks, although the first unit had been delivered. Electrical testing requirements for the unit have been met. The remaining four validation units were delivered in September 2012 and used to fill early delivery positions.
In June 2012,2015 we announced that we had achieved 100% kill rates with tuberculosis in three successive trials. This represents another important milestone in our understanding of the antimicrobial limits of our recently launched disinfection technology, AsepticSure.sold two units.
According to Dr. Michael E. Shannon, our President, approximately one-third of the world’s population is currently infected with tuberculosis and a new Extreme Drug Resistant Strain of tuberculosis is now sweeping across Asia, central Europe and parts of Africa. These factors drove the Company to evaluate the efficacy of AsepticSure against this daunting bacterium. With a small increase in treatment time (beyond our standard 90 minute protocol, start to finish) we demonstrated that AsepticSure consistently produces greater than 6 log reductions of Mycobacterium terrae, a well-established surrogate organism for Mycobacterium tuberculosis. These findings expand upon our ground-breaking research already published in the field of HAI control, with implications not just of academic or scientific interest but of significant public health importance as well. There are over 200,000 clinical laboratories in the United States and until now, there has been no cost effective way to address their contamination problems. We believe, based on our testing, that AsepticSure offers an extremely effective and surprisingly inexpensive disinfection and decontamination solution, not only for laboratory contamination problems, but environmental contamination problems worldwide.
During the second quarter of 2012, we also announced the appointment of Queen’s University Professor Dr. Dick Zoutman as our new Chief Medical Officer. In this new role, as well as continuing to provide direct microbiology support to Dr. Shannon, Dr. Zoutman reports to both the President and the Chief Executive Officer regarding his responsibilities, which include providing:
· | input into the design, planning, initiation and analysis of all beta test and post market surveillance programs worldwide; and |
· | support as a direct liaison with clinical investigators, and maintaining professional awareness of our many scientific accomplishments through the preparation of peer-reviewed articles and the preparation of presentations at medical conferences. |
We also obtained the services of Mr. Glen Balzer during 2012 to lead our management team in the building of both a distributor network and supply side management and manufacturing oversight team. Mr. Balzer is a recognized expert in both supply side and distribution side team building.
In September 2012, we changed manufacturers and entered into a contract with Transformix Engineering (“Transformix”) to manufacture our devices. Transformix is a specialty engineering and manufacturing company located in Kingston, Ontario, Canada. This change in manufacturers was necessitated to address delays in product delivery and quality control issues encountered earlier in 2012. We believe that Transformix has a depth of engineering experience in its workforce to appropriately meet the needs of the Company. We took delivery of the first AsepticSure system built by Transformix at the end of January 2013. Delivery was followed by two days of product evaluation testing at our Queen’s University laboratories. Transformix expects to ramp up production in order to meet estimated sales orders of the AsepticSure system for the second quarter of 2103. At this time, based on the number of inquiries we are receiving, and the fact that the HAI problem continues to grow worse globally based on frequent media reports, we expect to see significant product demand as we increase production. We currently anticipate we will have delivered or have on order approximately 40 units by the end of the second quarter of 2013. Nine of the 40 units have already been built with three delivered to customers. We have received deposits for two additional units.
While our intention is to expand distribution in the North American market first, we have already undertaken significant seed work with potential corporate distribution partners in Europe, parts of Asia and Brazil. Distribution into those markets is not anticipated to commence until after we have more fully developed distribution into the North American market.
Recent Developments
We took delivery of the first Transformix-built AsepticSure system at the end of January 2013 and the remaining three units from the initial build order during February 2013. Performance confirmation testing of the units at our Innovation Park laboratories proved satisfactory. The build quality of the system appears to be very good. We believe we now have a manufacturing source that is capable of meeting our anticipated production requirements.
After the year endedOn December 31 2012, Singapore issued us our Health Care Patent (P-no.: 176977 ‒ Healthcare Facility Disinfecting Process and System with Oxygen/Ozone Mixture). We consider this significant for our business growth in Asia. According to published reports, the treatment of non-resident and foreign patients (the “medical tourism market”) in Singapore has been growing rapidly and as reported by the Singapore press holdings on-line portal, AsiaOne, there were approximately 850,000 foreign patients treated in Singapore medical facilities during 2012, producing revenues of about $3.5 billion. We believe Singapore could become a lucrative market for AsepticSureAsepticSure® sales as the medical system there seeks to distinguish itself with the safest hospitals possible in order to promote continued growth in the expanding medical tourism market.
In January 2013, we completed successful safety and preliminary operational trials of the AsepticSureAsepticSure® system at the Belleville General Hospital site of Quinte Health Care in Canada (“QHC”) in collaboration with Contamination Control Company (C3), an Ontario-based provider of AsepticSure® services in Canada. Belleville General is a medium-sized community hospital affiliated with Queen’s University in Ontario, Canada. In collaboration with Contamination Control Company (C3), an Ontario-based provider of AsepticSure services in Canada,We believe that these trials are believed to unequivocally demonstrate the safety and ease of operation of the AsepticSureAsepticSure® disinfection system in a functioning health care setting. During the tests, the turnaround time for disinfection and reoccupation of the hospital rooms was less than 90 minutes.
In April 2013, we entered into an agreement with Wood Wyant Canada (“Wood Wyant”), a subsidiary of Sanimarc Group, to become a National Hospital Distributor of AsepticSure® in Canada. Wood Wyant is national in scope and regional in focus, serving Canada from 16 diverse locations across all 10 provinces, providing both sales and service to the hospital market. We delivered an order of five systems to Wood Wyant for proceeds totaling $375,000.
In June 2013, QHC’s Belleville General Hospital in Ontario, Canada suffered a severe outbreak of MRSA on a 14-bed ward. According to Dr. Dick Zoutman, Chief of Staff for the hospital (and a consultant to Medizone), “On average we have had one or two new MRSA cases per month on the ward. This is in keeping with averages being reported within the health care system nationally. In June we noted a rapidly spreading MRSA problem on the ward that reached seven rooms over a short period of time.” At that time, the hospital began using the AsepticSure® room disinfection system. The results were immediate, and all traces of MRSA were immediately and entirely eliminated from the ward, based on cultures of 120 surfaces of the treated rooms conducted before and after the AsepticSure® system was used.
In addition to full room disinfection, all support equipment associated with each contaminated room was also disinfected using AsepticSure® in virtually eliminating MRSA from the ward. These mobile pieces of patient care equipment are notoriously hard to clean by hand. The ease of the use of AsepticSure® was also noted in the process. The longer term effects of the treatments were more fully appreciated after a six-month follow-up completed in January 2014 indicated that no further illness related to MRSA was reported by the hospital. We believe that our experience in the practical application of AsepticSure® at QHC’s Belleville General Hospital demonstrates a new standard for clean hospitals and will lead to saving thousands of lives, while reducing the overall cost of hospital care by avoiding the cost of treating these largely preventable infections, estimated by the CDC to be approximately $25,000 per new infection.
In May 2014, at the Infection Prevention and Control Association of Canada (“IPAC”) Annual Scientific Meeting in Halifax, Nova Scotia, Canada, Dr. Zoutman further reported that each of the rooms disinfected with AsepticSure® at Belleville in June 2013 had now gone a full year without another case of MRSA.
In January 2015, a senior official at QHC informed Medizone that following the use of AsepticSure® to treat the MRSA outbreak at Belleville and a C-difficile outbreak at QHC’s Trenton Memorial Hospital, the hospitals reported no further cases of illness related to MRSA or C-difficile, citing the use of AsepticSure® as a significant factor in this achievement. As reported by Dr. Zoutman at the IPAC meeting in Victoria, B.C. in June 2015, there had been no further cases of C-difficile at Trenton Memorial Hospital as of the meeting date.
Using the Belleville example of reporting an historical average of one to two new MRSA infections per month on the ward, to go a full year without a new infection would appear to have prevented approximately 18 new cases of hospital acquired MRSA infections. The projected savings to the hospital is estimated at approximately $450,000 for cleaning each room one time.
We believe that this extraordinary demonstration of disinfection efficacy by AsepticSure® underscores the importance of obtaining 100% kill of infective pathogens in health care settings if the re-infection cycle is to be broken. At Medizone’s research laboratories located at Innovation Park, Queen’s University in Kingston, Ontario, Canada, Dr. Michael Shannon, the Company’s President and Director of Medical Affairs has demonstrated the requirement to obtain 100% kill in laboratory. Using a 5-log control of MRSA Dr. Shannon intentionally obtained a partial kill of 3-log (99.9% kill of the bacteria.) The importance of demonstrating with a 3-log kill is that 3-log is a greater kill than any current hospital double cleaning practice or other technology has proven capable of disinfecting surfaces throughout an entire room. Only AsepticSure® has demonstrated the ability to obtain 100% kill in both laboratory and real world settings.
For this test following a 3-log, 99.9% kill of the MRSA bacteria, the test dish was simply set aside and observed. In five hours the remaining 0.1% of surviving bacteria began to regenerate. In five days it had grown back to full strength. All current cleaning practices known, with the exception of AsepticSure®, have failed to demonstrate 100% kill. The regeneration of infective pathogens is a major contributing factor to reinfection, commonly experienced as healthcare-associated infections (“HAI”) or infections that are acquired in hospitals. AsepticSure® has now demonstrated the ability to break that reinfection cycle both in laboratory and at Belleville General Hospital.
On November 22, 2011, the Canadian Patent Office issued Canadian Patent No. 2,735,739 titled “Healthcare Facility Disinfecting Process and System with Oxygen/Ozone Mixture.” On October 8, 2013, the United States Patent and Trademark Office (“U.S. PTO”) issued U.S. Patent Number 8,551,399 titled “Healthcare Facility Disinfecting Process and System with Oxygen/Ozone Mixture.” On November 25, 2015, the Chinese State Intellectual Property Office issued Patent No. ZL201080030657.2 – “Healthcare Facility Disinfecting Process and System with Oxygen/Ozone Mixture.” Our healthcare patent applications have now been granted in the Canada, United States, China and Singapore. Applications are also pending in the 38 member countries that are parties to the European Union (“EU”) Patent Treaty, as well as Korea, Japan, India, Brazil and Mexico.
During September 2015, we sold two AsepticSure systems to a purchaser in Jeddah, Saudi Arabia. The purchaser, Al-Hidaya International RecognitionMedical Services Company (Al-Hidaya), has also signed a non-binding letter of intent to become the Company’s exclusive distributor of the system in the Kingdom of Saudi Arabia, subject to the completion and execution of a binding distribution agreement. Pursuant to the letter of intent, Al-Hidaya sponsored the travel of a Medizone team to Saudi Arabia led by Dr. Shannon, to introduce the system to interested medical and government representatives in Saudi Arabia and to provide initial training to Al-Hidaya personnel. A subsequent Al-Hidaya-sponsored trip by a senior Medizone technician to continue the training of Al-Hidaya technicians took place in October 2015. Al-Hidaya worked with Saudi regulatory authorities through system demonstrations both in-hospital and in Al-Hidaya offices in these two training sessions. Once an agreement has been executed, we expect Al-Hidaya to introduce a service model to the medical community throughout Saudi Arabia. In addition, the distribution agreement will provide that if Al-Hidaya is successful in establishing sales of the system and related services in Saudi Arabia, we will consider granting future distribution rights to Al-Hidaya for other countries in the Middle East on a country-by-country basis. Al-Hidaya has represented that it is in regular and frequent contact with the Saudi regulatory authorities and that it believes it will soon obtain full regulatory approval to import additional AsepticSure systems and operate them providing disinfection services. Following Saudi regulatory approval, it is anticipated the formal contract for future distribution and service rights will be finalized and executed. The distribution agreement will include additional system orders for production. Al-Hidaya has established office, supply and training space to support AsepticSure activities and has hired service technicians in preparation for a broader launch following receipt of regulatory approval. As of the date of this report, final Saudi regulatory approval is pending and the final distribution agreement with the proposed distributor had not been signed.
During November 2015, we entered into an agreement for the introduction and distribution of AsepticSure® in South America with GYD S.A. (GYD). Medizone granted GYD exclusive distribution rights for the AsepticSure® system in Chile, Brazil, Colombia and Peru. GYD will lead the regulatory approval process throughout South America and exclusive distribution rights will be expanded to other countries in South America on a country-by-country basis as GYD achieves regulatory approvals and establishes channels of distribution. In connection with the negotiation and execution of this agreement, GYD and three other investors in Chile invested $1 million in Medizone through the purchase of 10,000,000 shares of common stock at a price of $0.10 per share and warrants exercisable for one year to purchase an additional $1 million of common stock. The exercise price of the warrant shares is fixed at a 40% discount to market at the time of the exercise, however, in the event the warrants are exercised on or before March 30, 2016, the exercise price per share will be capped at the lesser of 40% discount to market or $0.25 per share. There is a one-year lock up on the shares acquired in the initial stock purchase.
During December 2015, we participated in the creation of and acquired a minority stake in Medizone Canada Inc., a Canadian National corporation, a corporation that will focus on research, development, manufacturing and Canadian employee compliance. The initial incorporating director is Dr. Michael Shannon.
In May 2011,January 2016, we finalized an agreement with a prestigious peer review medical journal, The American Journal of Infection Control (“AJIC”), e-published a peer-reviewed article onconsultant to obtain the science of AsepticSureknow-how necessary to source the UV ozone-generating bulbs and its unprecedented micro microbial disinfection ability (> 6 log kill for all pathogens tested), titled: “Effectiveness of a novel ozone-based system for the rapid high-level disinfection of health care spaces and surfaces,” authored by Dr. Zoutman, MD, FRCPC, Dr. Shannon, M.A., M.Sc., M.D., and Arkady Mandel, M.D., Ph.D., D.Sc., Kingston, and Ottawa, Ontario, Canada. The review was based onmanufacturing expertise used in the work completed at our laboratories located at Innovation Park, Queen’s University, in Kingston, Ontario, Canada. The print editionconstruction of the article appearedgenerators. In exchange, we issued 500,000 common shares at $0.08 per share to this consultant. In February 2016, we terminated the agreement as to future payments to the consultant.
While our intention is to expand distribution in the December 2011 issueNorth American market first, we have also undertaken seed work with potential corporate distribution partners in Europe and parts of Asia. With the exception of Chile, Peru, Columbia and Brazil, where our new distribution partner GYD S.A. is actively seeking regulatory approvals, distribution into those markets is not anticipated to commence until after we have more fully developed distribution into the North American market. In the United States, we have experienced increasing levels of interest from hospital administrators and infectious disease experts within hospitals. Many have contacted us directly following their review of the AJIC.results of our experience at Belleville General Hospital and Trenton Memorial. We expect that we will be able to sell devices directly to hospitals as a result of this interest and that this will help us penetrate the United States market more quickly than if we are required to establish other distribution channels. We continue to explore potential distributor arrangements and expect that may become another means of distribution as demand for AsepticSure® grows.
In July 2011, canadaNOW, a bi-annual national magazine of the Canadian university research parks, featured AsepticSure in an article titled, “Taking on the ‘silent epidemic.” Also in July 2011, AsepticSure was awarded one of three Awards for Innovation at the First International Conference on Prevention and Infection Control ('ICPICP') sponsored by the World Health Organization in Geneva, Switzerland.
Canadian Foundation for Global Health (“CFGH”) – Consolidated Variable Interest Entity
In 2008, we assisted in the formation of CFGH, a not-for-profit foundation based in Ottawa, Canada. We helped establish CFGH for two primary purposes: (1) to establish an independent not-for-profit foundation intended to have a continuing working relationship with us for research purposes that is best positioned to attract the finest scientific, medical and academic professionals possible to work on projects deemed to be of social benefit, and (2) to provide a means for us to use a tiered pricing structure for services and products in emerging economies and extend the reach of our technology to as many in need as possible.
CFGH may not contract for research or other services on our behalf without our prior approval. In addition, our understanding with the CFGH provides that all intellectual property, including but not limited to, scientific results, patents and trademarks that are derived from work done on our behalf or at our request by CFGH or parties contracted by CFGH with our prior approval will be our sole and exclusive property.
The CFGH is registered as a not-for-profit corporation under Canadian Federal Charter. Dr. Michael Shannon M.A., M.Sc., M.D. is President of CFGH and maintains offices at the CFGH. Mr. Brad Goble, President of TDVGlobal, Inc., is also a board member of CFGH and serves as the Secretary-Treasurer for that organization. According to its website, TDVGlobal, Inc. “is a strategic management consulting company” focusing on the public sector. It is based in Ottawa, Ontario, Canada. Other members of the CFGH board are Edwin G. Marshall (our Chief Executive Officer and Chairman), Daniel D. Hoyt (one of our directors), Dr. Jill C. Marshall, NMD, (Mr. Marshall’s wife and a former corporate officer of the Company), and Dr. Ron St. John.
Variable interest entities (“VIE”) must be consolidated by a company if that company absorbs a majority of the VIE’s expected losses and/or receives a majority of the VIE’s expected residual returns as a result of holding variable interests, which are the ownership, contractual, or other financial interests in the VIE. In addition, a legal entity is considered to be a VIE, if it does not have sufficient equity at risk to finance its own activities without relying on financial support from other parties. If the legal entity is a VIE, then the reporting entity determined to be the primary beneficiary of the VIE must consolidate it. We have determined that the CFGH meets the requirements of a VIE, effective upon the first advance to CFGH on February 12, 2009. Accordingly, the financial position and operations of CFGH have been consolidated with our financial results in our consolidated financial statements included within this annual report.Annual Report.
Regulatory Affairs
The regulatory arm of Health Canada has given us an opinion letter stating that our AsepticSureAsepticSure® disinfection system will not be regulated in Canada as a disinfectant, as there is no surface residual following room treatment. In addition, AsepticSureAsepticSure® will not be regulated in Canada as a medical device. As a result of this very favorable ruling, we are now free to market AsepticSurebegan marketing and selling AsepticSure® in the Canadian market.market during 2013.
New Zealand regulatory authorities have taken a similar position to the Canadian authorities, making New Zealand the second country in which we are authorized to sell the AsepticSureAsepticSure® hospital disinfection system.
We anticipate that the United States will become the third country approvingto approve the sale of AsepticSure.AsepticSure®. The United States Food and Drug Administration (“FDA”) has ruled that AsepticSureAsepticSure® is a Class I medical device.device (Code LRJ, Class I Disinfectant, Medical Devices; covered under 880.6890 General Purpose Disinfectants). This was expected by our developmentis the lowest and regulatory team. safest medical device class. According to FDA 21 CFR Parts 862-892, the technology is exempted from pre-market authorization, so FDA approval need only be sought when the technology is mature, validated and market-ready.
Interaction with both the FDA andUnited States Environmental Protection Agency (“EPA”) in the United Statesunfortunately has progressed well and we currently anticipate obtaining approval for sale into the United States market early in 2013.
Government Regulation
much more slowly. The EPA allows the use of ozone with no reporting or record keeping requirements. The FDA approved ozone in bottled water in 1982EPA appears to accept that from an environmental perspective, the room is safe to occupy following an AsepticSure® disinfection. The EPA has been provided with an independent environmental report titled “Ozone and granted a petition for use with fruits, vegetables, meatHydrogen Peroxide Industrial Hygiene Environmental Monitoring” that confirms the safety of the room following disinfection. The report was done by two highly reputable firms. The levels of both O3 and poultry in June 2000. TheH2O2 following disinfection, when the door was opened, were demonstrated as being well below all international regulatory requirements including the U.S. DepartmentOccupational Safety and Health Administration (OSHA) and the EPA.
Results were compared to the following occupational exposure limits and environmental criteria: the Ontario Regulation respecting Control of AgricultureExposure to Biological or Chemical Agents (O. Reg. 833) Time‐Weighted Average (“USDA”TWA”), Short‐Term Exposure Limit (“STEL”), and Excursion Limit; OSHA; Permissible Exposure Limit TWA (“PEL‐TWA”); the American Conference of Governmental Industrial Hygienists (“ACGIH®”) approved ozone as organic underThreshold Limit Value TWA (“TLV®‐TWA”) and Excursion Limits; the USDA Organic Rule in 2000.Ontario Ambient Air Quality Criteria (“AAQC”); Health Canada’s published Lowest Observed Adverse Effect Level (“LOAEL”); and the EPA National Ambient Air Quality Standards (“NAAQS”).
Ozone can damage the lungs if it is inhaled. Inhaling ozone may cause respiratory problems in healthy individuals and may worsen chronic respiratory diseases. Because of these risks, it is important to follow proper procedures when using ozone technology. Along with technology development and scientific testing of our hospital disinfection system, we are developing protocols for room sealing during the treatment period, followed by ozone-destruct to habitable standards prior to re-entry and returning the space to service. We utilize appropriate detection equipment and have taken countermeasures in design and in the test lab environment to reduce the risk of exposure to these substances in levels that would be harmful to personnel employing the technology. The correct use of our equipment will not expose a human to any toxic gas levels that would exceed EPA standards. The EPA also requires proof of efficacy data, done to EPA protocols.
We have established and recently expandedThe AsepticSure® system’s technology does not fit easily in the existing EPA protocols. The EPA refers to AsepticSure® as a “fogger”, which falls under the agency’s Pesticides Products Division. While internally we do not consider AsepticSure® a pesticide, the Pesticides Products Division of the EPA is the organization within the EPA from which we must gain regulatory consulting teamapproval. The EPA requires pesticides to determine the applicationgo through rigorous testing to demonstrate efficacy as well as safety. The EPA does not consider data generated outside of government regulation on our technology and its use onown approved protocols, such as peer reviewed journal literature or real world results, in considering a region by region basisproduct’s efficacy.
The Company continues to work with the objectiveEPA to satisfy final requirements for approval of achieving global approvals for the implementationsystem. The unique characteristics of the AsepticSure® method have resulted in more protracted review and testing associated with EPA clearance than originally anticipated by our systems. In connectiontechnical advisors. The most recent meetings with the agency and Company representatives in February 2016 resulted in our assessment of applicable regulations, we have determined that our ozone-based technology will be assessedagreement to provide additional test results with multiple-assayed diluted peroxide mixtures to standards requested by the EPA. In certain applications, itThose tests, once completed, will be submitted to the EPA by our advisors. This process may be considered a pesticide used for decontamination (as would berequire that we withdraw our previous application and submit the case in anti-terrorism applications). In that event, submission of safety and effectiveness data may be required. The precedent technology is vaporized hydrogen peroxide. The EPA may be most interested in bactericidal and sporicidal activity and ozone destruction and residual ozone levels. According to our data, residual ozone levels achieved are a safe level of <0.02 ppm. As a result, we do not anticipate any EPA-related regulatory issues. In some countries we will seek regulatory approval of AsepticSurenew results as a medical device, as noted below. In the United States for example, obtaining approval as an FDA Class I medical device will allow us to make claims regarding the level of disinfection achieved (> 6-log), that we would not otherwise be allowed to claim. Achieving approval as a Class I device is not considered onerous and should not be confusednew filing with the expenseagency, as directed by our legal and time typically required to obtain drug approvals from the FDA. By following this regulatory path, we expect to clearly separate our system from any perceived competing technologies that simply do not achieve the same level of disinfection (i.e.: 100% kill).technical team in Washington, D.C.
In addition, our ozone-based technology should be considered a Class I medical device by the FDA (Code LRJ, Class I Disinfectant, Medical Devices; covered under 880.6890 General Purpose Disinfectants). This is the lowest and safest medical device class. According to FDA 21 CFR Parts 862-892, the technology is exempted from pre-market authorization, so FDA approval need only be sought when the technology is mature, validated and market-ready. The standard FDA Class I device marketing application will apply. As a result, we do not anticipate any FDA-related regulatory issues adversely affecting our products or their use.
The manufacturing and marketing of our AsepticSureAsepticSure® system is subject to the standards of Good Manufacturing Practices. We dohave not anticipatehad any difficulty or unreasonable expense in meeting these standards.
For the foreseeable future, we have suspended our efforts to seek FDA approval of our precise mixture of ozone and oxygen (the “Drug”), which previously was part of our principal focus and business plans. In the future, should we obtain substantial additional funding or generate revenues sufficient to support a return to our viral disease treatment program, and should we choose to do so, we may resume the testing, manufacturing and marketing of the Drug and related drug delivery technology, as well as our related research and development activities, all of which are subject to regulation for safety, efficacy and quality by numerous governmental authorities in the United States and other countries. At this time, because we believe that complying with these regulations would involve a considerable amount of time, expense and uncertainty, we intend to direct our efforts of the AsepticSure system. We project that the AsepticSure system, because it does not fall under the FDA description of a drug or treatment, will provide a much more cost-effective path for us to generate revenues in a reasonable period of time and at greatly reduced cost when compared to the development of a drug, advanced level medical device or treatment protocol. At this time we anticipate that our AsepticSure disinfection technology will actually save more lives and alleviate more suffering than our previously pursued medical treatment programs would have. One thing that is very exciting about AsepticSure is that its employment in the medical sector should not only greatly reduce human suffering and improve mortality, but that it will do so while reducing overall medical costs.
Intellectual Property
Trademarks
Trademarks.We have developed and we use trademarks in our business, particularly relating to our corporate and product names. We own one trademark that is registered with the United States Patent and Trademark Office (“PTO”)U.S. PTO and we have filed an application on another. Federal registration of a trademark enables the registered owner of the mark to bar the unauthorized use of the registered mark in connection with a similar product in the same channels of trade by any third-party anywhere in the United States, regardless of whether the registered owner has ever used the trademark in the area where the unauthorized use occurs. We have registered the mark AsepticSure® as a trademark for the system with the U.S. PTO. The mark is used to describe a portable decontamination and disinfection system for hospitals, government buildings, schools and other functionally critical environments that might currently require, or need to be prepared for countermeasures capability from contamination by infectious biological agents such as C. difficile, E. coli, Pseudomonas aeruginosa, MRSA and VRE. We intend to register additional trademarks in countries where our products are or may be used or sold in the future. Protection of registered trademarks in some jurisdictions may not be as extensive as the protection in the United States.
We also claim ownership and protection of certain product names, unregistered trademarks, and service marks under common law. Common law trademark rights do not provide the same level of protection that is afforded by the registration of a trademark. In addition, common law trademark rights are limited to the geographic area in which the trademark is actually used. We believe these trademarks, whether registered or claimed under common law, constitute valuable assets, adding to recognition of our Company and the effective marketing of our products and technology. Trademark registration once obtained is essentially perpetual, subject to the payment of a renewal fee. We therefore believe that these proprietary rights have been and will continue to be important in enabling us to compete.
Trade Secrets.
We own certain intellectual property, including trade secrets that we seek to protect, in part, through confidentiality agreements with employees and other parties. Even where these agreements exist, there can be no assurance that these agreements will not be breached, that we would have adequate remedies for any breach, or that our trade secrets will not otherwise become known to or independently developed by competitors. Our proprietary product formulations are generally considered trade secrets, but are not otherwise protected under intellectual property laws.
Patents
PatentsOriginal Patents. In addition to the patent applications filed in connection with our AsepticSure® system described below, in prior years we filed the following patent applications and were issued patents related to our original ozone technologies:
| · | U.S. equipment patent (U.S. Patent No. 5,052,382) entitled “Apparatus for the Controlled Generation and Administration of Ozone” (“Patent No. 1”); |
| · | U.S. patent (U.S. Patent No. 6,073,627) entitled “External Application of Ozone/Oxygen for Pathogenic Conditions, a process patent for the treatment of external afflictions.” This patent also describes equipment evolutions and treatment envelope design for external medical applications (“Patent No. 2”); |
| · | U.S. Provisional Patent Application serial no. 10/002943, for “Method and Apparatus for Ozone Decontamination of Biological Liquids.” This application deals with protocols for biological liquid decontamination as well as the devices for conducting decontamination; and |
| · | Process U.S. patent (U.S. Patent No. 4,632,980) entitled “Ozone Decontamination of Blood and Blood Products,” covering a procedure for ozone decontamination of blood and blood products through the treatment of blood and blood components. This patent expired in February 2003. Many of the claims and primary aspects of the technology covered by this patent are assumed by or incorporated in Patent Nos. 1 and 2 described above. |
AsepticSure® Patents. On July 6, 2009, we filed U.S. patent application (US 61/223,219) titledentitled “Healthcare Facility Disinfecting System”Process and System with Oxygen/Ozone Mixture” for the AsepticSureAsepticSure® technology. This patent application hasPatents have now been granted in SingaporeCanada, the United States, China and Canada.Singapore. The patent covers disinfection for rooms and their contents within all healthcare facilities, mobile or stationary, and other critical infrastructure such as schools and government buildings.
During the third round of trials, additional technologies were added to the AsepticSureAsepticSure® system, each having their own antimicrobial effects, which in combination, were shown not to be additive, but multiplicative. The unprecedented results obtained of 6-log reductions or greater with all HAI associated pathogens provided us with valuable inventive information that resulted in a second patent filing made on January 20, 2010.
This second patent filing (U.S. patent application US 61/295,851) was made in January 2010 to protect improvements in our basic procedure and protocol achieved by combining it with another procedure, resulting in a significant increase in disinfecting capabilities demonstrated during the third round of laboratory trials against a wide variety of bacteria and on a range of different surfaces commonly found in healthcare and other essential facilities. Both patent applications currently afford international protection for this technology, and can be expanded into full international patent applications, in countries of our choice.
On July 5, 2010, we filed an international patent application (PCT/CA 2010/000998) under the auspices of the Patent Co-operation Treaty (“PCT”) to secure international patent protection for our AsepticSureAsepticSure® technology. The international patent application consolidates the two previously filed patent applications described above and expands the technical evidence, both laboratory scale and practical scale, supporting the effectiveness of the technology in clearing healthcare and other critical infrastructure of bacterial infections such as C. difficile, E. coli, Pseudomonas aeruginosa, MRSA and VRE down to complete sterilization standards. After the international patent application has been searched and examined by the International Patent Office authorities, we can register it in any or all countries of the world that have ratified the PCT (over 120 countries, which include all major industrialized countries except Taiwan), and secure grant of patents on the application in countries of our choice.
During September 2010, we filed an additional international patent application (PCT/CA2010/001364) covering recent developments in our variant of AsepticSure,AsepticSure®, designed for government use in bio-terrorism countermeasures.
(The U.S. patent (US 8,636,951) was granted on January 28, 2014, entitled Bio-Terrorism Counteraction Using Ozone and Hydroperoxide).
An additional U.S. provisional patent application (US 61/380,758) was filed covering the use of AsepticSureAsepticSure® in food processing plants and related facilities for the sterilization of food-borne pathogens such as Listeria, Salmonella, and other human harmful, food-poisoning-causing bacteria.
Also during September 2010, we filed a U.S. provisional patent application (US 61/380,825) covering the use of AsepticSureAsepticSure® for disinfecting sports equipment and training facilities including those associated with professional, college and high school level teams. Recent investigations indicate a broad range of bacteria at high concentration actually resides within unclean sports equipment which tend to be covered in mucus, sweat, dead skin, and occasionally blood; ideal culture media for bacteria, fungi and mold. (The U.S. patent (US 8,992,829) was granted on March 31, 2015, entitled Sports Equipment and Facility Disinfection).
During September 2010, we filed U.S. provisional patent application (US 61/380,763) entitled “Combating Insect Infestations.” Additional research is needed to prove the effectiveness of the AsepticSureAsepticSure® technology with this application. A related application was filed under the PCT on September 20, 2011 (PCT/CA2011/050576). Based on results thus far produced at both Purdue University and from within our own laboratories at Innovation Park, Queen’s University, it appears AsepticSureAsepticSure® is capable of eradicating both bed bugs and their larvae in one treatment. However, results using the same formula as that used to kill bacteria and viruses take approximately 37 hours to achieve. On-going research using revised treatment formulas is now underway in an effort to decrease the overall treatment time required for 100% kill with a single treatment.
During late September 2010, we filed a fourth U.S. provisional patent application (61/384,495) involving “Advanced Oxidative Sterilization Processes.” In conjunction with this filing, we are now exploring a new development in the field of oxidative chemistry which we estimate will have a significant impact on our future technology and the ease with which we can effectively decontaminate equipment, surfaces and space in hospitals, chronic care facilities, veterinary facilities, hotels, cruise ships, and sports facilities. Our research to date demonstrates that the combination of modest levels of ozone and low concentrations of peroxide, properly delivered at the right temperature and humidity, will reliably eliminate bacteria loads of at least 6 logs (sterilization standard) on a broad range of surface materials. Research is now underway at our laboratories on a parallel track with our hospital beta-testing program to evaluate the merits of a multifactorial decontamination system which appears to further increase the potency of our AsepticSureAsepticSure® technology, while dramatically reducing the exposure time, both of which are believed to have significant implications for certain applications. Research has confirmed that combining low concentrations of ozone and hydrogen peroxide produces a unique highly potent free radical in the polyoxide family known as Trioxidane. It is this combination when introduced into a contaminated space at a specific humidity and temperature that generates green killing power unique to AsepticSure.AsepticSure®. The degradation products of this process are water and oxygen, so AsepticSureAsepticSure® can be highly efficacious yet friendly to the environment. This advanced process is protected in our issued patents and our patent applications.
In addition to the patent applications filed in connection with our AsepticSure system, in prior years we filed patent applications and were issued patents related to our original ozone technologies, as follows:
· | U.S. equipment patent (U.S. Patent No. 5,052,382) entitled “Apparatus for the Controlled Generation and Administration of Ozone” (“Patent No. 1”); |
· | U.S. patent (U.S. Patent No. 6,073,627) entitled “External Application of Ozone/Oxygen for Pathogenic Conditions, a process patent for the treatment of external afflictions.” This patent also describes equipment evolutions and treatment envelope design for external medical applications (“Patent No. 2”); |
· | U.S. Provisional Patent Application serial no. 10/002943, for “Method and Apparatus for Ozone Decontamination of Biological Liquids.” This application deals with protocols for biological liquid decontamination as well as the devices for conducting decontamination; and |
· | Process U.S. patent (U.S. Patent No. 4,632,980) entitled “Ozone Decontamination of Blood and Blood Products,” covering a procedure for ozone decontamination of blood and blood products through the treatment of blood and blood components. This patent expired in February 2003. Many of the claims and primary aspects of the technology covered by this patent are assumed by or incorporated in Patent Nos. 1 and 2 described above. |
Advances in Patent Protection for AsepticSure
On November 22, 2011, our Canadian national patent application for our foundational patent was approved (Canadian Patent No. 2735739). International application filings of that issued patent haveare now been filedbeing processed in the United States, Mexico, Singapore, Japan, Korea, China and the 3738 member countries of the European Union,EU Patent Treaty, including the United Kingdom. A patent was issued in Singapore after December 31, 2012.in January 2013.
In January 2012, we also received a formal report from the Patent Corporation TreatyPCT Examiners on both our Medical Countermeasures Application and our application for treating pests such as bed bugs. The PCT Examiners reported they had found no prior art of which we were not previously aware. In respect to both cases all claims have been ruled to “possess both novelty and inventive step, so they can proceed without further amendment or argument.”
On October 8, 2013, the U.S. PTO issued U.S. Patent Number 8,551,399 entitled “Healthcare Facility Disinfecting Process and System with Oxygen/Ozone Mixture.” Our healthcare patent has now been granted in the Canada, United States, Singapore and China (see below). An application is also pending in the 38 member countries that are parties to the EU Patent Treaty, as well as Korea, Japan, India, Brazil and Mexico. We expect that this ruling by the US Examiner will prove favorable for us in connection with other pending applications. As an example, the application for our government variant of AsepticSure® (designed for building remediation following biological attack), was originally challenged by the US Examiner, stating many of the same objections as originally stated for our Health Care application. Now that we’ve received a grant of the health care patent, we anticipate that the successful approach to overcoming those same objections for the government variant is likely to be accepted.
In January 2014, the U.S. PTO issued U.S. Patent Number 8,636,951 titled “Bio-Terrorism Counteraction Using Ozone and Hydrogen Peroxide.” We believe we now have significant intellectual property protection in place for both the health care related applications of our technology, and the government variant. We believe this protection positions us strongly for market entry into the United States.
In November 2015, the Chinese State Intellectual Property Office issued Patent Certificate No. ZL 201080030657.2: “Healthcare Facility Disinfecting Process and System with Oxygen/Ozone Mixture.” This patent will remain in force for a term of 20 years from the filing date (i.e., until July 5, 2030), subject to payment of renewal fees.
Competition
The market for hospital disinfection is extremely competitive. We are aware of one company, for example, that has commenced research into the use of ozone as a sterilization product for the food industry that might eventually compete with us in the sterilization market for hospitals and other medical infrastructure. Other companies, foundations, research laboratories or institutions may also be conducting similar investigations into the use of ozone for this application of which we are not aware.
Employees
As of December 31, 2012,2015, we had fourthree employees, including two full-time employees. We also engageemployees in the services of over 10 part-time consultants.United States and one full-time employee in Canada.
Additional Available Information
We maintain executive offices and principal facilities at 4000 Bridgeway, Suite 401, Sausalito, California 94965. Our telephone number is (415) 331-0303. We maintain a World Wide Website at http://medizoneint.com. The information on our website should not be considered part of this report on Form 10-K.
We make available, free of charge at our corporate web site, copies of our annual reportsAnnual Reports on SEC Form 10-K, quarterly reportsQuarterly Reports on SEC Form 10-Q, current reportsCurrent Reports on SEC Form 8-K, proxy statements, and all amendments to these reports, as soon as reasonably practicable after such material is electronically filed with or furnished to the SECSecurities and Exchange Commission (“SEC”) pursuant to Section 13(a) or 15(d) of the Securities Exchange Act. This informationAct of 1934, as amended (the “Exchange Act”). The public may also be obtained fromread and copy materials we file with the SEC at the SEC’s on-line database, which is locatedPublic Reference Room at 100 F Street, NE, Washington, D.C. 20549, on official business days during the hours of 10 a.m. to 3 p.m. You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet site that contains reports, proxy and information statements and other information regarding issuers, including the Company, at http://www.sec.gov.
Forward-Looking Statements and Certain Risks
StatementsCertain factors may have a material adverse effect on our business, financial condition, and results of operations. You should consider carefully the risks and uncertainties described below, in addition to other information contained in this report that are not purely historical are “forward-looking statements” within the meaning of Section 21E of the Exchange Act. These statements relate to our expectations, hopes, beliefs, commitments, intentions, and strategies regarding the future. They may be identified by the use of words or phrases, such as “believe,” “expect,” “anticipate,” “should,” “plan,” “estimate,” and “potential,” among others. Forward-looking statements include, but are not limited to, statements contained in “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding our financial performance, revenue and expense levels in the future, and the sufficiency of our existing assets to fund future operations and capital spending needs. Actual results could differ materially from the anticipated results or other expectations expressed in these forward-looking statements for the reasons discussed below. The forward-looking statements in this Annual Report on Form 10-K, including our consolidated financial statements and related notes. The risks and uncertainties described below are made as ofnot the date of this report, andonly ones we assume no obligation to update them or to update the reasons why our actual results could differ from those that we have projected in these forward-looking statements.
We encounter substantial risks in our business, any one of which may adversely affect our business, results of operations or financial condition. The fact that some of these risk factors may be the same or similar to those that we have filed with the SEC in past reports, means only that the risks are present in multiple periods. We believe that many of the risks that are described here are part of doing business in the industry in which we operate or intend to operate and will likely be present in all periods. The fact that certain risks are endemic to the industry does not lessen their significance. These risk factors should be read together with the other items in this report, including Item 1, “Business,” and Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Among others,face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business. If any of the following risks actually occurs, our business, financial condition, performance, development, and results of operations, include those listed in this Item 1A.
our common stock could decline, and you could lose part or all of your investment.
Risks Related to Our Business
We have a history of losses and have a substantial accumulated deficit, which raise substantial doubt about our ability to continue as a going concern. We have incurredOur significant losses since inception which resulted in anand accumulated deficit of $30,084,992$35,398,346 as of December 31, 2012. These losses and this significant deficit2015 raise substantial doubt about our ability to continue as a going concern. The accompanying audited consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result from the outcome of this uncertainty.
As a development stage company we incurred significant accumulated deficits, and we canWe expect losses to continue for the foreseeable future. We have only recently begun to generate revenues from operations. No assurance can be given that our business activities will ever generate substantial revenues. Even with funding to continue our research and development activities, as well as revenues from our initial sales, we expect to continue to incur substantial losses for the foreseeable future.
We currently have limited financing to meet our operating expenses. We will require additional financing in the future to cover our operating costs. If we are unable to obtain additional financing or generate significant revenues from sales of our disinfection systems, we may be required to take outfile for bankruptcy or liquidate the Company.liquidate. We have financed our operations since inception primarily by the sale of common stock in small private placements to accredited investors and drawdowns under a private equity line of credit. There is no assurance we will successfully accomplish our objectives or that necessary additional financing will be obtained in a timely manner or on terms that are favorableacceptable to the Company.
Our net operating losses and our lack of revenues will require that we finance our operations through the sale of our securities for the foreseeable future. Our strategy for financing operations includes the sale of our common stock. The sale of equity securities or of securities that are convertible to our common stock will result in possibly significant dilution to our stockholders and may adversely affect the trading prices of our common stock. We will require substantial additional capital to meet our obligations and to commercialize our technology. The lack of assets and borrowing capacity makemakes it most likely that such funding, if obtained, will be through sales of common stock or other securities. The sale of equity securities or of securities that are convertible to our common stock will result in possible significant dilution to our stockholders and may adversely affect the trading prices of our common stock. No assurances can be given that we will be able to obtain sufficient additional capital to continue our intended research program, or that any additional financing will be sufficient to satisfy our ongoing administrative and operating expenses for any significant period of time.
While we have historically raised capital through the sale of our common stock, we are approaching our common stock authorized limit. Our Articles of Incorporation authorize us to issue up to a total of 395,000,000 shares of common stock and 50,000,000 shares of preferred stock. As of the date of this report, we have issued and outstanding 369,934,068 shares of common stock. There are no shares of preferred stock issued and outstanding. In addition, we have granted options or common stock purchase warrants for the purchase of up to 20,965,000 shares of common stock, of which 19,890,000 are presently exercisable, although most of those options and warrants are not in the money, meaning their exercise prices exceed the current market price of the Company’s common stock. If all outstanding options and warrants were exercised immediately, we would have issued and outstanding 390,899,068 shares. This means that the Company will be limited or perhaps precluded from raising additional equity capital, pursuing strategic partnership arrangements and acquisitions, or other similar transactions in which the Company is required to issue shares of common stock unless the price of the common stock significantly rises or the Company eventually increases the number of shares we are authorized to issue by an amendment to the Articles of Incorporation or effects a reverse split of the outstanding shares. In such events, our operations and financial condition will be materially and adversely affected. Moreover, even if we were to negotiate additional merger, acquisition, or other transactions on terms acceptable to the Company, we likely would not be able to complete such transactions without an increase in authorized capital.
General economic conditions may affect our revenue and harm our business. As widely reported, financial markets in the United States, Europe and Asia have been experiencing extreme disruption in the past two years. Unfavorable changes in economic conditions, including declining consumer confidence, inflation, recession or other changes, may lead our customers to delay or reduce purchases of our products and services, adversely affecting our results of operations and financial condition. Challenging economic conditions also may impair the ability of our customers or distributors to pay for products or services they have purchased and asAs a result, any reserves for doubtful accounts and write-offs of accounts receivable could become necessary. Our cash flows may be adversely affected by delayed payments or underpayments by our customers. We are unable to predict the duration and severity of the current disruption in financial markets and adverse economic conditions in the United States and other countries.
We currently have a limited sales, marketing and distribution organization. If we are unable to develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners, we will not be successful in commercializing our products. We intend to establish our sales and marketing organization with technical expertise and supporting distribution capabilities to commercialize our products and product candidates, which will be expensive and time-consuming. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of our products. We intend tomay also distribute our products through our own sales and marketing organization and through independent contractor and distribution agreements with companies possessing established sales and marketing operations in the medical device industry, but there can be no assurance that we will be able to build a successful sales and marketing infrastructure or be able to enter into independent contractor and distribution agreements on terms acceptable to us or at all. To the extent that we enter into co-promotion or other licensing arrangements, our product revenue is likely to be lower than if we directly marketed or sold our products. In addition, any revenue we receive willwould depend in whole or in part upon the efforts of such third parties, which may not be successful and are generally not within our control. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to successfully commercialize our disinfection system. If we are not successful in commercializing our existing and future products, either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we may incur significant additional losses.
Our reliance on patented technology may limit the scope of our protection and may increase the cost of doing business if we are required to enforce our rights under existing and future patents. Our success will depend, in large part, on our ability to obtain and enforce patents, maintain our trade secrets and operate without infringing on the proprietary rights of others, both in the United States and in other countries. The patent positions of companies can be uncertain to some extent and involve complex legal and factual questions, and, therefore, the scope and enforceability of claims allowed in patents are not systematically predictable with absolute accuracy. Our rights depend in part upon the breadth and scope of protection provided by our patents and the validity of those patents. Any failure to maintain the issued patents also could adversely affect our business. We intend to file additional patent applications (both U.S. and foreign), when appropriate, relating to our technologies, improvements to the technologies and for specific products. There can be no assurance that any issued patents or pending patent applications will not be challenged, invalidated or circumvented. There can also be no assurance that the rights granted under patents will provide us with adequate proprietary protection or competitive advantages.
Our commercial success will also depend in part, on our ability to avoid infringing patents issued to others or breaching any technology licenses upon which our products and services are based. It is uncertain whether any third partythird-party patents will require us to alter our products or processes, obtain licenses or cease certain activities. In addition, if patents have been issued to others, which contain competitive or conflicting claims and such claims are ultimately determined to be valid, we may be required to obtain licenses to those patents or to develop or obtain alternative technology. If any licenses are required, there can be no assurance we will be able to obtain necessary licenses on commercially favorable terms, if at all. The breach of an existing license or the failure to obtain a license to any technology that we may require in order to commercialize our products may have a material adverse impact on our business, results of operations and financial condition. Litigation in those events or to enforce patents licensed or issued to us or to determine the scope or validity of third partythird-party proprietary rights would be costly and time consuming. If competitors prepare and file patent applications in the United States that claim technology also claimed by us, we may have to participate in interference proceedings declared by the U.S. PTO to determine priority of invention, which could result in substantial costs, even if the eventual outcome is favorable to us. An adverse outcome could subject us to significant liabilities to third parties, require disputed rights to be licensed from third parties or require that we stop using such technology.
We also rely on secrecy to protect portions of our technology for which patent protection has not yet been pursued or which is not believed to be appropriate or obtainable in addition to any information of a confidential and proprietary nature relating to us, including but not limited to our know-how, trade secrets, methods of operation, names and information relating to existing or potential vendors or suppliers and customer names and addresses.
We intend to protect our patents, unpatentable and unpatented proprietary technology and processes, in addition to other confidential and proprietary information in part, by confidentiality agreements with employees, collaborative partners, consultants and certain contractors. There can be no assurance that these agreements will not be breached, that we will have adequate remedies for any breach, or that our trade secrets and other confidential and proprietary information will not otherwise become known or be independently discovered or reverse-engineered by competitors.
Our testing and business activities may involve the use of hazardous substances. Our research and development activities, and the application of our technology, may involve the controlled use of materials or substances that may, if used or employed improperly, prove hazardous to the respiratory system. Although we have designed our system to employ such potentially hazardous or toxic materials and substances in a manner that minimizes their adverse effects, there is a potential risk to those working with and around the substances if they fail to follow the measures we have adopted for their proper use. The injury or illness resulting from the use of our system may subject us to legal claims and possible liability.
We may face significant competition, including competition from larger and better funded enterprises. We expect to face competition in some of our markets from well-funded and significantly larger companies, some of which enjoy significant name recognition or market share in the sterilization and decontamination industries. We may not be successful in our efforts to compete with these companies. There can be no assurance that our technology will have advantages over those of competitors which will be significant enough to cause users to use it. The products in which our technology may be incorporated will compete with products currently marketed, and competition from such products is expected to increase.
Many of the companies currently producing products or using disinfectant or sterilization techniques have significantly greater financial resources and expertise in research and development, marketing, manufacturing, pre-clinical and clinical testing, obtaining regulatory approvals and marketing. Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large third parties. Academic institutions, governmental agencies and public and private research organizations also conduct research, seek patent protection and establish collaborative arrangements for product and clinical development and marketing. Many of these competitors have products or techniques approved or in development and operate large, well-funded research and development programs. Moreover, these companies and institutions may be in the process of developing technology that could be developed more quickly or ultimately proved safer or more effective than our technology.
Our proposed business may subject us to the potential for product liability claims. Although we intend to insure for this liability, the claims might in some cases exceed the amount of coverage available to us. The testing, marketing, sale and use of medical or clinical products and other products using our technology involve unavoidable risks. The use of any of our potential products in clinical or other tests or as a result of the sale of our products, or the use of our technology in products, may expose us to potential liability resulting from the use of such products. That liability may result from claims made directly by consumers or by regulatory agencies, companies or others selling such products. We currently have product liability insurance coverage. We anticipate maintaining appropriate insurance coverage as products continue to be manufactured. We cannot assure that the insurance can be acquired at a reasonable cost or in sufficient amounts to protect us against all potential liability. The obligation to pay any product liability claim in excess of insurance coverage or the recall of any products incorporating our technology could have a material adverse effect on our business, financial condition and future prospects.
If we are to succeed in implementing our business plan, we will need to engage and retain trained and qualified staff.While thus far we have been able to engage and maintain qualified staff, particularly for research and development of our system, there is no assurance that we will succeed in retaining the personnel needed to meet our needs as operations expand. Even if additional financing is obtained, there can be no assurance we will be able to attract and retain such individuals on acceptable terms, when needed, and to the degree required. We anticipate that any clinical development or other approval tests in which we participate will be augmented by agreements with universities and/or medical institutions or other personnel. It is likely that our academic collaborators will not become our employees. As a result, we will have limited control over their activities and can expect that only limited amounts of their time will be dedicated to our business activities. Our academic collaborators also may have relationships with other commercial entities, some of which could compete with us.
We do not own manufacturing capability. We currently must rely on third parties to manufacture the devices required for our hospital disinfection system. This arrangement decreases our control over the manufacturing process and may result in problems relating to costs, quality control and warranty issues. Although we might build or acquire our own manufacturing facility in the future, at this time we have no manufacturing capability or capacity to produce any products utilizing our disinfection technology, including any products to be used in any required clinical or other tests. We initially intend to develop relationships with other companies to manufacture those components and/or products, as we have already done, and we will act as specification developer and final assembly manufacturer for selected products only. The products currently being developed and sold by us have never been manufactured on a commercial scale and there can be no assurance that such products can be manufactured at a cost or in quantities necessary to make them commercially viable. Any delay in availability of products may result in a delay in the submission of products for any required regulatory approval or market introduction, subsequent sales of such products, which could have a material adverse effect on our business, financial condition, or results of operations. Our manufacturing processes may be labor intensive and, if so, significant increases in production volume would likely require changes in both product and process design in order to facilitate increased automation of our then-current production processes. There can be no assurance that any such changes in products or processes or efforts to automate all or any portion of our manufacturing processes would be successful, or that manufacturing or quality problems will not arise as we initiate production of any products we might develop.
Market Risks
There is only a volatile, limited market for our common stock.Recent history relating to the market prices of public companies indicates that, from time to time, there may be periods of extreme volatility in the market price of securities because of factors unrelated to the operating performance of, or announcements concerning, the issuers of the affected stock, and especially for stock traded on the OTCOver-the-Counter Bulletin Board.Board (“OTCQB”). During the year ended December 31, 2012, the2015, our common stock traded on the OTC Bulletin BoardOTCQB from a high closing price of $0.27$0.15 to a low of $0.07$0.05 per share. See “Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.” General market price declines, market volatility, especially for low priced securities, or factors related to the general economy or to our business in the future could adversely affect the price of the common stock. With the low price of our common stock, any securities placement by us would be very dilutive to existing stockholders, thereby limiting the nature of future equity placements.
If we are unable to maintain effective internal control over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports and the trading price of our common stock may be negatively affected. We are subject to Section 404 of the Sarbanes-Oxley Act (SOX), which requires us to maintain internal controls over financial reporting and to report any material weaknesses in such internal controls. We have consumed and will continue to consume management resources and incur expenses for SOX compliance on an ongoing basis. If we identify material weaknesses in our internal control over financial reporting, or if we are unable to comply with the requirements of Section 404 in a timely manner or assert that our internal control over financial reporting is effective, investors may lose confidence in the accuracy and completeness of our financial reports and the trading price of our common stock could be negatively affected, and we could become subject to investigations by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities, which could require additional financial and management resources.
We have never paid dividends, and there can be no assurance that we will pay dividends in the future.Although our Board of Directors has determined that if we were to become profitable in the future, a dividend may be declared from earnings legally available for such a distribution, there is no assurance that we will become profitable or that we will have distributable income that might be distributed to stockholders as a dividend or otherwise in the foreseeable future. As a result, until such time, if ever, that dividends are declared with respect to our common stock, an investor would only realize income from an investment in our shares if there is an increase in the market price of our common stock, which is uncertain and unpredictable.
Our Board of Directors may authorize the issuance of preferred stock and designate rights and preferences that will dilute the ownership and voting interests of existing stockholders without their approval. Our Articles of Incorporation authorize us to issue preferred stock. The Board of Directors is authorized to designate, and to determine the rights and preferences of any series or class of preferred stock. The Board of Directors may, without stockholder approval, issue shares of preferred stock with dividend, liquidation, conversion, voting or other rights which are senior to the common stock or which could adversely affect the voting power or other rights of the existing holders of outstanding shares of preferred stock or common stock. Additionally, the issuance of preferred stock may have the effect of decreasing the market price of the common stock and reduce the likelihood that common stockholders will receive dividend payments and payments upon liquidation. The issuance of additional shares of preferred stock may also adversely affect an acquisition or change in control of the Company.
Our continued sale of equity securities will dilute existing stockholders and may adversely affect the market price for our common stock. Given our current business and operating needs, we will require additional financing, which will require the issuance of additional shares of our equity or debt securities convertible into equity securities. We expect to continue our efforts to acquire financing in the future to fund additional growth, product manufacturing and development expenses, and administrative expenses, among other expenses, which will result in future and possibly significant dilution to existing stockholders.
Our common stock is subject to the “Penny Stock” rules of the SEC. Our common stock is currently traded on the OTC Markets and is considered a “penny stock.” The OTC Markets are generally regarded as a less efficient trading market for our securities is limited, which makes transactions in our stock cumbersome and may reducethan the value of an investment in our stock.NASDAQ Capital Market. The SEC has adopted Rule 15g-9 which establishes the definition ofrules that regulate broker-dealer practices in connection with transactions in “penny stocks.” Penny stocks generally are equity securities with a “penny stock,” for the purposes relevant to us, as any equity security that has a market price of less than $5.00 per share(other than securities registered on certain national securities exchanges or quoted on the NASDAQ system, provided that current price and volume information with an exercise price of less than $5.00 per share, subjectrespect to certain exceptions. For any transaction involving atransactions in such securities is provided by the exchange or system). The penny stock unless exempt, the rules require:
· | that a broker or dealer approve a person’s account for transactions in penny stocks; and |
· | the broker or dealer receive from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased. |
In order to approverequire a person’s account for transactions in penny stocks, the broker or dealer must:
· | obtain financial information and investment experience objectives of the person; and |
· | make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks. |
The broker or dealer must also deliver,broker-dealer, prior to anya transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure schedule prescribeddocument prepared by the SEC, relating towhich specifies information about penny stocks and the nature and significance of risks of the penny stock market. The broker-dealer also must provide the customer with bid and offer quotations for the penny stock, the compensation of the broker-dealer and any salesperson in the transaction, and monthly account statements indicating the market which,value of each penny stock held in the customer’s account. In addition, the penny stock rules require that, prior to a transaction in a penny stock not otherwise exempt from those rules, the broker-dealer must make a special written determination that the penny stock is highlighteda suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the trading activity in form as follows:
· | sets forth the basis on which the broker or dealer made the suitability determination; and |
· | that the broker or dealer received a signed, written agreement from the investor prior to the transaction. |
the secondary market for our common stock. Generally, brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more difficult for investors to dispose of our common stock and cause a decline in the market value of our stock.
Disclosure also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies available to an investor in cases of fraud in penny stock transactions. Finally, monthly statements have to be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks.
FINRA sales practice requirements may also limit a stockholder’s ability to buy and sell our stock. In addition to the “penny stock” rules described above, the Financial Industry Regulatory Authority (“FINRA”) has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low priced securities will not be suitable for at least some customers. The FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit your ability to buy and sell our stock and which will have an adverse effect on the market for our shares.
Our principal executive offices are located in leased premises at 4000 Bridgeway, Suite 401, Sausalito, California. The lease term was extended for a year,runs through December 31, 20132016 with monthly lease payments of $2,200.approximately $2,500. Also, we lease a certified laboratory located at Innovation Park, Queen’s University in Kingston, Ontario, Canada, which has provided a primary research and development platform as we proceed toward commercialization of our products. The lease term expired on June 30, 2012, and is now month-to-monthmonth to month with monthlya lease paymentspayment of $1,375 Canadian Dollars (“CD”) $1,350 plus the applicable Goodsgoods and Services Taxservices tax (“GST”). A second laboratory space for full scale room testing and a storage unit are also expiredleased on June 30, 2012, and is now month–to-montha month-to-month basis with monthly lease payments of CD$1,250,1,375 and CD$475, respectively, plus the applicable GST. We estimate that our current facilities are sufficient to meet our needs for at least the next 12 months.
Item 3. Legal Proceedings
From time to time, we may become involved in lawsuits and legal proceedings that arise in the ordinary course of business. Litigation is subject to inherent uncertainties and an adverse result in these or other matters may arise from time to time that may have an adverse effect on our business, financial condition, or operating results. We are not aware of any legal proceedings or claims that will have, individually or in the aggregate, a material adverse effect on our business, financial condition or operating results.
Several years ago, a former consultant brought an action against the Company styled Rakas vs. Medizone International, Inc., in the Supreme Court of New York, Westchester County (Index No. 08798/00) claiming we had failed to pay consulting fees under a consulting agreement. We deny that we owe any fees to the consultant. In September 2001, the parties agreed to settle the matter for $25,000. Our lack of funds prevented us from consummating the settlement, and the plaintiff moved the court to enter a default judgment in the amount of $143,000 in January 2002. On May 8, 2002, the court vacated the default judgment and ordered that we post a bond of $25,000 to cover the settlement previously entered into by the parties. We have not posted thisThe Company has been unable to post the required bond and we have accrued the entire amount as of the date of this report. Therefore, the Company has recorded a liability (included in accounts payable) for the original default judgment of $143,000, plus fees totaling $21,308, as of $21,308.December 31, 2015 and 2014. The Company intends to contest the judgment when it is able to do so in the future.
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market Information
Our common stock is traded on the OTC Bulletin BoardOTCQB market under the symbol MZEI.OB.MZEI.
The following table sets forth the range of the high and low bid quotations of the common stock for the past two years in the over-the-counter (“OTC”)OTCQB market, as reported by the OTC Bulletin Board.OTCQB (see www.otcmarkets.com). The quotations reflect inter-dealer prices without retail mark-up, mark-down or commission, and may not represent actual transactions.
| Fiscal Year 2011 | | High | | Low | | |
| Fiscal Year 2014 | | | High | | Low | |
First Quarter Ended March 31 | | | | | | | | | | | | | | |
Second Quarter Ended June 30 | | | | | | | | | | | | | | |
Third Quarter Ended September 30 | | | | | | | | | | | | | | |
Fourth Quarter Ended December 31 | | | | | | | | | | | | | | |
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First Quarter Ended March 31 | | | | | | | | | | | | | | |
Second Quarter Ended June 30 | | | | | | | | | | | | | | |
Third Quarter Ended September 30 | | | | | | | | | | | | | | |
Fourth Quarter Ended December 31 | | | | | | | | | | | | | | |
Holders
As of December 31, 2012, there were2015, we had approximately 2,6002,350 holders of record of theour common stock and 288,771,227369,434,068 shares of common stock outstanding.
Dividend Policy
We have had minimal revenues to date, and we have never declared dividends or paid cash dividends on our common stock. In the future, if we become profitable, our Board of Directors has stated its intention to declare a dividend from our surplus earnings.
Transfer Agent and Registrar
The transfer agent and registrar for theour common stock is American Stock Transfer & Trust Company, 6201 15th15th Avenue, Brooklyn, New York 11219.
Issuer Purchases of Equity Securities
The CompanyWe did not purchase any of itsour own securities during the year ended December 31, 2012.2015.
Securities Authorized for Issuance Under Equity Compensation Plans
The following table and discussion provides certain information as of December 31, 2015 with respect to compensation plans (including individual compensation arrangements) under which equity securities of the Company are authorized for issuance.
Equity Compensation Plan Information
| Plan category | | Number of securities to be issued upon exercise of outstanding options, warrants and rights | | | Weighted-average exercise price of outstanding options, warrants and rights | | | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) | |
| | | (a) | | | (b) | | | (c) | |
Equity compensation plans approved by security holders | | | | | | | | | | | | |
Equity compensation plans not approved by security holders (1) | | | | | | | | | | | | |
| | | | | | | | | | | | |
| (1) Includes shares subject to awards granted or available for grant under consulting agreements as well as the following plans: 2008 Equity Compensation Plan, 2009 Incentive Stock Plan, 2012 Equity Incentive Award Plan, and 2014 Equity Incentive Plan. |
Recent Sales of Unregistered Securities
The following information is furnished regarding our sale of securities without registration under the Securities Act of 1933, as amended (the “Securities Act”) during the period covered by this report that has not previously been included in a Quarterly Report on Form 10-Q or in a Current Report on Form 8-K filed by the Company.
During October, November and December 2012, the Company2015, we sold an aggregatea total of 2,234,30010,000,000 restricted shares of common stock to six accredited investors not otherwise affiliated with the Company, for cash proceeds of $135,858 at prices ranging from $0.06 to $0.078 per share. There were no underwriters involved.
During January, February and March 2013, the Company sold an aggregate of 10,333,332 restricted shares of common stock to ninefour accredited investors for cash proceeds of $310,000 at a price of $0.03totaling $1,000,000, or $0.10 per share. There were no underwriters involved.
These sales were made without registration under the Securities Act in reliance upon exemptions from registration provided under Section 4(2)4(a)(2) of the Securities Act and related SEC regulations promulgated thereunder.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
This Management’s DiscussionYou should read the following discussion of our financial condition and Analysisresults of Financial Conditionoperations in conjunction with our consolidated financial statements and Resultsthe related notes included in Part II, Item 8, “Financial Statements and Supplementary Data” of Operationsthis Annual Report on Form 10-K. In addition to our historical consolidated financial information, the following discussion contains forward-looking statements within the meaning of Section 21E of the Exchange Actthat reflect our plans, estimates, and Section 27A of the Securities Act. All statements contained in this report other than statements of historical fact are forward-looking statements. When used in this report or elsewhere by management from time to time, the words “believe,” “anticipate,” “intend,” “plan,” “estimate,” “expect,” “may,” “will,” “should,” “seeks” and similar expressions are forward-looking statements. Such forward-looking statements are based on current expectations, but the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual events orbeliefs. Our actual results maycould differ materially from those discussed in the forward-looking statements as a result of various factors. For a more detailed discussion of such forward-looking statementsstatements. Factors that could cause or contribute to these differences include those discussed below and the potential risks and uncertainties that may impact upon their accuracy, seeelsewhere in this Annual Report on Form 10-K, particularly in Part I, Item 1A, “Risk Factors.” These forward-looking statements reflect our view only as of the date of this report. Except as required by law, we undertake no obligations to update any forward-looking statements. Accordingly, you should also carefully consider the factors set forth in other reports or documents that we file from time to time with the SEC.
Results of Operations
Year Ended December 31, 20122015 Compared to Year Ended December 31, 2011
We were incorporated in January 1986. Until 2012, we operated as a development stage company primarily engaged in research into the medical uses of ozone. Our current work is in the field of hospital disinfection, not human therapies. During the year ended December 31, 2012, we generated our first significant revenues from the sale of our AsepticSure hospital disinfection system. We cannot predict when or if we will generate sufficient revenues or cash flows from sales to fund continuing or planned operations. As a consequence, if we fail to obtain additional funding, we will be forced to suspend or permanently cease operations, and may need to seek protection under U.S. bankruptcy laws.2014
For the year ended December 31, 2012,2015, we had a net loss of $3,343,694,$2,035,922, compared to a net loss for the year ended December 31, 20112014 of $1,940,217.$1,940,440. The primary reasonreasons for the significant increase in the net loss from the prior year is the issuance of restricted common stock andhigher stock-based compensation expense in 2015 for options granted to directors, officers, employees and consultants during 2012, as discussed below.consultants. Our primary expense isexpenses are payroll and consulting fees, research and development expenses, office expenses, together with interest expense and additionalcompensation expense recorded as a result of restricted commonour granting of stock issuances and options granted by the Company.options. Net loss per common share was $0.01 per share($0.01) in 2012 which was the same in 2011.2015 and 2014.
During 2012, we exited the development stage as we commenced planned principal operations. DuringFor the year ended December 31, 2012,2015, we delivered units and finalizedhad sales totaling $225,000 with relatedof $197,000 compared to no sales for the year ended December 31, 2014. Related cost of goods sold totaling $144,404.totaled $114,811 for the year ended December 31, 2015. As of December 31, 2012,2015, we holdrecognized as revenue deposits from customers totaling $30,000 for units to be delivered in the first quarter of 2013 totaling $34,554.2015.
General and administrative expenses in 2012for 2015 were $2,726,989,$1,737,175, compared to $946,833 in 2011.$1,445,049 for 2014. The majority of thesekey expenses include payroll and consulting fees, professional fees, director fees, and performance bonuses.compensation expense recorded as a result of granting of stock options. The significant increase in expenses from the prior year was due primarily the result of the Company recognizing expense from the issuance of restricted shares of common stockto higher stock-based compensation for services performed by itsoptions granted to directors, officersemployees and employees valued at approximately $1,733,000 during 2012.consultants. The remaining general and administrative expenses include rent, office expenses and travel expenses.
Research and development expenses in 2012for 2015 were $635,685,$299,649, compared to $945,848 in 2011. We continue$420,945 for 2014. The decrease from the prior year was primarily due to incur less research and development costs, as a result of less need for prototype development,lower consulting and other research activities.engineering costs. Research and development expenses include prototypes, consultant fees, interface development costs, prototypes, and research stage ozone generator and instrument development.
Principal amounts owed on notesNotes payable totaled $298,536$372,396 as of December 31, 2012,2015, and $283,249$298,241 as of December 31, 2011.2014. Interest expense on these obligations totaled $24,425 in 2012$27,872 for 2015 and $23,848 in 2011.$25,176 for 2014. The applicable interest rates on this debt ranged from 7.75 percent4.63% to 10 percent12.00% per annum.
At this time, basedBased on the number of inquiries we are receiving, and the fact that the HAI problem continues to grow worse globally based on frequent media reports, we expect to see significant product demand as we increase production. We have four units currently anticipate we will have delivered or have on order approximately 40 machines by the end of the second quarter of 2013.
available for sale and held in inventory.
Liquidity and Capital Resources
As of December 31, 2012,2015, our working capital deficiency was $3,307,973$2,675,007 compared to $3,264,298 at$3,235,007 as of December 31, 2011.2014. The total stockholders’ deficit as of December 31, 2012,2015 was $3,314,099$2,569,234 compared to $3,334,561 at$3,021,832 as of December 31, 2011.2014.
InDuring 2012, we emerged from the development stage and began to generate revenues with the salegenerated initial sales of our AsepticSureAsepticSure® disinfection system in the latter half of the year.system. We will continue to require additional financing to fund operations and to undertake our new business plans, to further the ongoing testing, and to market our hospital and medical disinfection system. We believe that we will need approximately $1.5 million$1,000,000 during the next 12 months for continued production manufacturing, research, development, marketing, product manufacturing and relatedmarketing activities, as well as for general corporate purposes.
During 2012,2015, we raised a total of $1,420,793$1,676,000 through the sale of 16,729,27823,400,000 shares of common stock at prices ranging from $0.050$0.05 to $0.165$0.10 per share, which funds have beenshare. We used the proceeds from these securities issuances to keep us current in our reporting obligations under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and to pay certain other corporate obligations including the costs related to sales of our hospital disinfection system. Subsequent to December 31, 2012, through the date of this report, we have raised a total of $69,000 through the sale of 3,200,000 shares of common stock at a price of $0.03 per share.obligations.
Our consolidated financial statements included in this report have been prepared on the assumption that the Companywe will continue as a going concern. Since inception, it has been necessary for us to rely upon financing from the sale of our equity securities to sustain operations as indicated above.operations. Additional financing will be required if we are to continue as a going concern. If we do not obtain additional financing in the near future, we may be required to curtail or discontinue operations or possibly to seek protection under the bankruptcy laws.
Critical Accounting Policies and Estimates
We have identified the policies below as critical to our business operations and the understanding of our results of operations.
The preparation of consolidated financial statements requires our management to make significant estimates and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses. By their nature, these judgments are subject to an inherent degree of uncertainty. On an on-going basis, we evaluate these estimates, including those related to intangible assets, revenues, expenses, and income taxes. We base our estimates on historical experience and other facts and circumstances that are believed to be reasonable, and the results form the basis for making judgments about the carrying valuevalues of assets and liabilities. The actual results may differ from these estimates under different assumptions or conditions.
We account for equity securitiesrecord compensation expense in connection with the granting of stock options and their vesting periods based on their fair values. We estimate the fair values of stock option awards issued for services renderedto employees at the fair valuegrant date by using the Black-Scholes option-pricing model. For stock options issued to consultants and other non-employees, we estimate the related expense using the Black-Scholes option-pricing model. For stock options with a service condition, the expense is measured at the grant date and expensed over the vesting period. For stock options with a performance condition, the expense is measured when it is probable that the performance condition will be met, subsequently re-measured at each reporting date, and trued up upon the final completion of the securities on the date of issuance.performance condition.
Recent Accounting Pronouncements
Recent Accounting Pronouncements
In 2011,May 2014, the Financial Accounting Standards Board (“FASB”)(FASB) issued two Accounting Standard Updates (“ASU”); namely,Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers, which supersedes nearly all existing revenue recognition guidance under US GAAP. The core principle of ASU No. 2011-05 and2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU No. 2011-12, which amend2014-09 defines a five-step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing US GAAP. The standard is effective for annual reporting periods beginning after December 15, 2016, and interim periods therein. Early adoption is not permitted. We are currently assessing the impact, if any, of implementing this guidance on our consolidated financial position, results of operations and liquidity.
In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This standard sets forth management’s responsibility to evaluate, each reporting period, whether there is substantial doubt about the entity’s ability to continue as a going concern, and if so, to provide related footnote disclosures. The standard is for annual reporting periods beginning after December 15, 2016, and interim periods within annual periods ending after December 15, 2016. We are currently assessing the impact, if any, of implementing this guidance will have on the Company.
In April 2015, the FASB issued ASU No. 2015-03, “Interest – Imputation of Interest (Subtopic 835-30), Simplifying the Presentation of Debt Issuance Costs.” To simplify presentation of debt issuance costs, the amendments in this ASU require that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected by the presentationamendments in this ASU. For public companies, the ASU is effective for financial statements issued for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. Early adoption of comprehensive income.the ASU is permitted for financial statements that have not been previously issued. The amendedCompany is assessing the impact, if any, of implementing this guidance requires an entity to present components of net income and other comprehensive income in one continuous statement, referred to as the statement of comprehensive income, or in two separate, but consecutive statements. The option to report other comprehensive income andon its components in the statement of stockholders’ equity has been eliminated. Although the new guidance changes the presentation of comprehensive income, there are no changes to the components that are recognized in net income or other comprehensive income under existing guidance. We adopted these ASUs using one continuous statement for the years presented.financial reporting.
Off-Balance Sheet Arrangements
We have not entered into any financial guarantees or other commitments to guarantee the payment obligations of any third parties. We have not entered into any derivative contracts that are indexed to our shares and classified as stockholders’ equity (deficit)deficit or that are not reflected in our consolidated financial statements. Furthermore, we do not have any retained or contingent interest in assets transferred to an unconsolidated entity that serves as credit, liquidity or market risk support to such entity. We do not have any variable interests in any unconsolidated entity that provides financing, liquidity, market risk or credit support to us or engages in leasing, hedging or research and development services with us.
Outlook
The following discussion is intended to provide a brief overview of management’s plan moving forward with our AsepticSure product line as we transition our operations from research and development to production and sales. The achievement of these plans is subject to risks. Those risks include, but are not limited to the results of ongoing clinical studies, economic conditions, product and technology development, production efficiencies, product demand, the existence of competitive products, an increasingly competitive environment for our technologies, successful testing and government regulatory issues as well as the outcome of various relationships with other companies that are still in the development stage at the time of filing of this report.
The AsepticSure production design targets a lead-free, high level green content and system design intended to be globally acceptable to the most stringent regulatory and import licensing bodies. Our original market penetration plan, initially targeted North America exclusively. However, that could be subject to change if market demand from other sectors, such as Asia, justifies an earlier expansion into those regions than originally planned. In any case, should we decide to pursue sales outside of North America this year, we expect that this would not occur until the latter half of the year.
Item 8. Financial Statements and Supplementary Data
Our Consolidated Financial Statementsconsolidated financial statements and the related notes are set forth beginning on page 3231 of this report.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
On December 3, 2012, we dismissed HJ Associates & Consultants, LLP (“HJA”) as our independent registered public accounting firm. The Company has no audit committee. The decision to change accountants was made by our Board of Directors.
The reports of HJA on the Registrant’s consolidated financial statements for the year ended December 31, 2011 did not contain an adverse opinion or disclaimer of opinion and were not modified as to uncertainty, audit scope, or accounting principles, except the reports did contain an explanatory paragraph related to substantial doubt about our ability to continue as a going concern.
During the year ended December 31, 2011, and the subsequent period through December 3, 2012, as indicated in the Company’s report on Form 8-K filed with the SEC on December 5, 2012, disclosing the change (the “Current Report”), there were (i) no disagreements with HJA on any matter of accounting principles or practices, consolidated financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of HJA would have caused HJA to make reference to the subject matter of the disagreements in connection with the Current Report, and (ii) no “reportable events” as that term is defined in Item 304(a)(1)(v) of Regulation S-K.
We provided HJA with a copy of the disclosures made in the Current Report and requested that HJA furnish the Company with a letter addressed to the SEC stating whether or not it agrees with the statements therein and, if not, stating the respects in which it does not agree. A copy of the letter furnished by HJA was furnished with the Current Report as an exhibit.
On December 3, 2012, we engaged Tanner LLC (“Tanner”) as our new independent registered public accounting firm. The appointment of Tanner was approved by the Board of Directors. During the two most recent years ended December 31, 2011 and 2010, and the subsequent period through December 3, 2012, we did not consult with Tanner on (i) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that may be rendered on our consolidated financial statements, and Tanner did not provide either a written report or oral advice to the Company that was an important factor considered by our Board of Directors in reaching a decision as to any accounting, auditing, or financial reporting issue; or (ii) the subject of any disagreement, as defined in Item 304 (a)(1)(iv) of Regulation S-K and the related instructions, or a reportable event within the meaning set forth in Item 304(a)(1)(v) of Regulation S-K.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness, as of December 31, 2012,2015, of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. The purpose of this evaluation was to determine whether as of the evaluation date our disclosure controls and procedures were effective to provide reasonable assurance that the information we are required to disclose in our filings with the SEC, under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. Based on their evaluation, our management has concluded that our disclosure controls and procedures were effective as of December 31, 2012. 2015.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Exchange Act Rule 13a-15(f). Our internal control system was designed to provide reasonable assurance to our management regarding the reliability of financial reporting and the preparation of the Company’s consolidated financial statements for external purposes in accordance with U.S. Generally Accepted Accounting Principles (U.S.(US GAAP). Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2012.2015. In conducting the evaluation, our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control-Integrated Framework (the(1992), or the COSO criteria).criteria. Based on our evaluation under the COSO criteria, our management concluded that our controls over financial reporting as of December 31, 20122015 were effective.
This report does not include an attestation report of the Company’s independent registered public accounting firm regarding internal control over financial reporting. Management’s reportOur internal control over financial reporting was not subject to attestation by the Company’s independent registered public accounting firm pursuant to the rules of the SEC that permit the Company to provide only management’s report in this report.Annual Report on Form 10-K.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the quarter ended December 31, 20122015 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitation on the Effectiveness of Internal Controls
The effectiveness of any system of internal control over financial reporting, including ours, is subject to inherent limitations, including the exercise of judgment in designing, implementing, operating, and evaluating the controls and procedures, and the inability to completely eliminate misconduct. Accordingly, any system of internal control over financial reporting, including ours, no matter how well designed and operated, can only provide reasonable, not absolute assurances.assurance. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. We intend to continue to monitor and upgrade our internal controls as necessary or appropriate for our business, but cannot assure you that such improvements will be sufficient to provide us with effective internal control over financial reporting.
Item 9B. Other Information
None.
PART III
Item 10. Directors, Executive Officers and Corporate Governance
Directors and Executive Officers
The following table contains information concerning our directors and executive officers as of December 31, 2012.2015.
| Name | | Age | | Position |
| | 70 | | Chairman of the Board, Chief Executive Officer |
| | 70 | | |
| | 73 | | |
| | 64 | | Director, President, and Director of Medical Affairs, President of CFGH |
| | | | |
| | | | |
| | | | |
| | 43 | | |
Following is a brief summary of the background and experience of each of our directors and executive officers:
Edwin G. Marshall became Chairman of the Board in June 1997. He was appointed Chief Executive Officer in April 1998. Mr. Marshall attended the College of Marin, with a double major in business and fire science. From 1964 to 1978, Mr. Marshall worked in the fire service in a city with a major chemical industrial complex, leaving with the rank of Captain. He then pursued various business interests including ownership of a real estate brokerage firm and part-ownership of a number of other small businesses in other fields. He has been a private investor in real estate, precious metals, and stocks since 1973. Mr. Marshall serves both as our Chairman and as our Chief Executive Officer. The Board of Directors has determined that it is most efficient at this time while the Company emerges from the development stage for Mr. Marshall to serve as both Chairman and Chief Executive Officer of the Company.
Richard G. Solomon is a director. Mr. Solomon has been one of our stockholders since 1992. He was a director in 1996 and 1997 and was reappointed to the Board of Directors in May 2000. Mr. Solomon received a Bachelor of Commerce degree (University of Otago, NZ), and a Diploma of Business and Industrial Administration (University of Auckland). He is an Associate Chartered Accountant. Mr. Solomon’s career has been in business and investment. For 20 years he developed and operated a private hospital operating company, Haven Care Hospitals Limited. He was a long-standing board member and president of the New Zealand Hospitals Association and he was instrumental in the establishment of the New Zealand Council of Healthcare Standards, Inc., now known as Quality Health New Zealand. He has been retired from active business since 1996.
Daniel D. Hoyt became a director in January 2002. Mr. Hoyt is a graduate of the University of Indiana, where he received a Bachelor of Science degree in Business Administration. Over the past 25 years, he has become a recognized leader in the life insurance industry, working as a career agent for American United Life Insurance Company. Mr. Hoyt’s clients have ranged from large public companies to small private businesses. In recent years he has spent most of his time in public speaking and relationship building in the insurance industry. His previous work experience includes seven years with Merrill Lynch as well as serving as the Chief Executive for the Chamber of Commerce in three Indiana communities. From June 1996 until June 2010, Mr. Hoyt was the Chairman of the Board of Biological Systems, Inc., a privately held corporation involved with bio-cleansing remediation systems for animal fats and oil-based materials. He also serves on the Development Board of the Indiana University Simon Cancer Center (since January 2000) and on the Board of the St. Vincent Foundation in Indianapolis, Indiana.
Dr. Michael E. Shannon M.A., M.Sc., M.D., became a director on August 18, 2008 and President of the Company in 2011. He also serves as Director of Medical Affairs.Affairs since 2002 and in October 2008 was appointed President of CFGH. Dr. Shannon received his medical degree from Queen’s University in Canada, which included advanced training in surgery and sports medicine. He also holds post-graduate degrees in neurochemistry and physiology. He has been actively engaged in applied medical research within these areas for over 2728 years. He served in the Canadian Forces for 31 years retiring at the rank of Commodore (Brigadier General equivalent) as Deputy Surgeon General for Canada. During the first Gulf War, Dr. Shannon served as the senior medical liaison officer for all of the Canadian forces. In 1996 he assumed responsibilities within Health Canada for re-organizing the Canadian blood system. Working with both the provincial and federal governments, he oversaw the development of a new corporate entity dedicated exclusively to the management of blood services in Canada. He was then appointed Director General for the Laboratory Centre for Disease Control, a position he held for three years. In December 2000, Dr. Shannon left the Canadian federal government to pursue a new career in industry. In that capacity, he simultaneously directed a phase III clinical trial in Canada, the United States and Great Britain for an artificial blood substitute product. Following completion of that work, he was asked to accept a special assignment with the Canadian Federal Government Auditor General’s office, his assignment being to conduct a cost benefit analysis of all government sponsored pharmacare programs and make recommendations directly to the Parliament of Canada. His assignment and presentation to Parliament was completed in November 2004. Dr. Shannon then served on a special assignment to the Canadian Public Health Agency (Centers for Disease Control equivalent in the United States) as Senior Medical Advisor. His responsibility was to direct the rebuilding of the Emergency Medical Response Capacity for Canada. In this regard and under his direction, the largest emergency medical response exercise in the history of the country, involving the overnight construction of a mobile hospital, hundreds of doctors and thousands of patients, was successfully held in Toronto in December 2007. Dr. Shannon has been actively engaged in medical bio-oxidative (O3) based research since 1987 and was directly responsible for the first human clinical trial to have ever been approved in North America which examined the efficacy of O3 delivered via minor autohemotherapy in the treatment of AIDS. He was also responsible for several primate studies utilizing O3 involving scientists from various departments within the Canadian Federal Government, as well as senior investigators from the Company and Cornell University. Dr. Shannon
Daniel D. Hoyt became a director in January 2002. Mr. Hoyt is a graduate of the University of Indiana, where he received a Bachelor of Science degree in Business Administration. Over the past 38 years, he has become a recognized leader in the life insurance industry, working as a career agent for American United Life Insurance Company. Mr. Hoyt’s clients have ranged from large public companies to small private businesses. In recent years he has spent most of his time in public speaking and relationship building in the insurance industry. His previous work experience includes seven years with Merrill Lynch as well as serving as the Chief Executive for the Chamber of Commerce in three Indiana communities. From June 1996 until June 2010, Mr. Hoyt was the Chairman of the Board of Biological Systems, Inc., a privately held corporation involved with bio-cleansing remediation systems for animal fats and oil-based materials. He also serves on the Development Board of the Indiana University Simon Cancer Center (since January 2000) and is the Vice-Chair of the Board of the St. Vincent Foundation in Indianapolis, Indiana. Mr. Hoyt serves on our Audit and Compensation Committees.
David A. Esposito became a director in February 2014. Mr. Esposito is the President and CEO of Armune BioScience, Inc., an early stage medical diagnostics company focused on developing and commercializing unique technology for diagnostic and prognostic tests for prostate, lung, and breast cancers. From 2011 to 2013, Mr. Esposito was Vice President, Commercial Operations, at Thermo Fisher Scientific. Before joining Thermo Fisher Scientific, he was President and General Manager of Phadia US Inc., a specialty diagnostics company from 2009 until its acquisition by Thermo Fisher Scientific in 2011. He was employed in various positions by Merck & Co., Inc. from 1996 to 2009, including stints as Executive Director of the Respiratory Marketing Team (2006-2007), New Commercial Model (2007-2008), and US Commercial Strategy (2008-2009). He was a combat infantry officer (Lt., US Army Infantry, 101st Airborne Division) from 1990-1993 and served in Operation Desert Storm in 1991, where he was awarded the Bronze Star Medal for combat action in Iraq. He received a BS degree in civil engineering at the United States Military Academy (West Point), and an MBA from Syracuse University. He also completed an executive education program, Competitive Marketing Strategy Program, at The Wharton School (University of Pennsylvania). Mr. Esposito chairs our Audit Committee and is a member of the Compensation Committee.
Vincent C. Caponi became a director in October 2014. Mr. Caponi currently serves as the Executive Chairman of the Board of St. Vincent Health and as a Senior Vice President of Ascension Health Alliance. Until July 2013, Mr. Caponi served as the Senior Medical AdvisorChief Executive Officer of St. Vincent Health. He grew the St. Vincent Health ministry to a 22-hospital system serving central and southern Indiana. St. Vincent Health is one of Indiana’s largest employers. Ascension Health of St. Louis, Missouri – the Company since 2002. In Augustsponsor of 2008, he accepted a position onSt. Vincent Health – is the Board of Directorsnation’s largest Catholic non-profit health system with 130 hospitals located in eight states. Mr. Caponi is the chair of the CompanyCompensation Committee at Welch Allyn and assumed responsibility for Medical Affairs. In October 2008, he wasis also appointeda member of their Audit Committee. Mr. Caponi is the Presidentchair of the CFGH.our Compensation Committee and serves on our Audit Committee.
Thomas (Tommy) E. Auger joined us as our Chief Financial Officer in December 2010. Since August 2010, Mr. Auger has been engaged as a consultant on accounting and financial operations for private companies and senior management through Advanced CFO Solutions, L.C., in Salt Lake City, Utah.management. From August 2008 until August 2010, he was the Chief Financial Officer of Red Ledges Land Development, Inc., a private developer of recreational and vacation properties in Utah. From September 2004 until August 2008, he was vice president of finance and administration for Talisker Corporation, a private company engaged in developing, owning and operating recreation properties and resorts in North America. From 1994 until 2004, Mr. Auger was an accountant with the international accounting firms Deloitte and Touche (1994-1995), KPMG LLP (1995 to 1999(1995-1999 and 2002 to 2004)2002-2004) and Arthur Andersen (1999 to 2002)(1999-2002). Mr. Auger is a CPA licensed in Utah and Oklahoma and a member of the American Institute of Certified Public Accountants and the Utah Association of Certified Public Accountants (“UACPA”). He is a member of the UACPA Leadership Council, and also served as committee chair of the ProNet councilCouncil for many years. He received an MS in Accounting in 1994 and a BS in Accounting in May 1993 from Oklahoma City University.
Meetings of the Board of Directors
The Board of Directors is elected by and is accountable to the stockholders. The Board of Directors establishes policy and provides strategic direction, oversight, and control of the Company. The Board of Directors met fiveseven times during the year ended December 31, 2012.2015. All directors participated in at least 80 percentall of the meetings held by the Board.Board of Directors. The Board of Directors has no standing audit, compensation, nominating or other committees.committees except for audit and compensation committees established in January 2015.
Code of Ethics
We have adopted a formal, written code of conduct (“Code of Ethics”) within the specific guidelines promulgated by the SEC. This document can be found on our website at http://medizoneint.com. The Code of Ethics applies to our named executive officers, as well as all employees and consultants. We have communicated the high level of ethical conduct expected from all of our employees, including our officers and our consultants. We will disclose any changes or amendments to or waivers from the Code of Ethics applicable to the named executive officers by posting such changes or waivers to our website.
Board’s Role in Risk Oversight
Because we do not have an Audit Committee at this time as explained below, the full Board of Directors is responsible for the assessment and oversight of our financial risk exposures. The Board of Directors plays an active role in our risk oversight and is responsible for overseeing the processes established to report and monitor systems that mitigate material risks applicable to our Company. These risks include financial, technological, competitive and operational risks. Committees
The Board of Directors assesses the risks affecting or potentially affecting the business on an ongoing basis at its regularhas determined that Mr. Hoyt, Mr. Esposito and special meetings. The Board of Directors dedicates time at each of these meetings to review and consider these risks. As we begin to bring our technology to market and our operations become more complex, we expect to increase the number ofMr. Caponi are independent directors as defined by the rules of the NASDAQ Stock Market, as discussed below. Our common stock is currently traded on our Boardthe OTCQB. This market does not impose definitions or standards relating to director independence or the composition of Directors and to organize the committees described below to assist management in assessing and overseeing our management of risks affecting our business.with independent directors. We have not appointed a “lead independent director.”
The Board of Directors and Committees
Currently, Mr. Hoyt and Mr. Solomon are independent directors as defined by the rules of any securities exchange or inter-dealer quotation system. Our common stock is currently traded on the OTC Bulletin Board. These markets do not impose definitions or standards relating to director independence or the makeup of committees with independent directors. The Company does not have a “lead independent director.”
No Board Committees
As of the date of this report,During January 2015, our Board of Directors does not haveformed an Audit Committee and a standing Compensation Committee.
Audit Committee. Having emerged at the end of 2012 from the development stage and commencing to generate revenue through the sale of our hospital disinfecting system, we intend to establish anCommittee. The Audit Committee of the Board of Directors during(the “Audit Committee”) is a standing committee of the next year. ThisBoard, which has been established as required by Section 3(a) of the Exchange Act. Members of the Audit Committee are Mr. Esposito, Chairman, and Mr. Hoyt and Mr. Caponi. The Board has determined that Mr. Caponi is an “audit committee will consist of independent directors, of which at least one director will qualify as a qualified financial expert,” as defined inby the applicable regulations promulgated by the SEC under the Exchange Act. The Board also believes that each member of the SEC.Audit Committee meets stock exchange requirements regarding financial literacy. The Audit Committee’s duties would be to recommend toresponsibilities include: (i) appointing the independent registered public accounting firm of the Company, (ii) reviewing, approving and monitoring the scope and cost of any proposed audit and non-audit services that are provided by, as well as the qualifications and independence of, the independent registered public accounting firm, (iii) reviewing and monitoring with the independent registered public accounting firm, and any internal audit staff, the results of audits, any recommendations from the independent registered public accounting firm and the status of management’s actions for implementing such recommendations, as well as the quality and adequacy of our Board of Directors the engagement of independent auditors tointernal financial controls and any internal audit staff, and (iv) reviewing and monitoring our consolidatedannual and quarterly financial statements and to review our accountingthe status of material pending litigation and auditing principles.regulatory proceedings. The Audit Committee would review the scope, timing and fees for the annual audit and the results of audit examinations performed by the internal auditors, if any, and independent public accountants, including their recommendations to improve the system of accounting and internal control. The Audit Committee would at allmet three times be composed exclusively of directors who are, in the opinion of our Board of Directors, free from any relationship that would interfere with the exercise of independent judgment as a committee member and who possess an understanding of financial statements and U.S. GAAP.2015.
As of the date of this report, we do not have a standing Compensation Committee. We intend to establish aCommittee. The Compensation Committee of the Board of Directors during the next year. Once established,(the “Compensation Committee”) includes as members Mr. Caponi, Chairman, Mr. Hoyt and Mr. Esposito. All members of the Compensation Committee would revieware outside directors as defined by Rule 162(m) of the Internal Revenue Code and approveare non-employee directors as defined by the applicable regulations promulgated by the SEC under the Exchange Act. The Compensation Committee’s responsibilities include: (i) reviewing and recommending to the full Board of Directors the salaries, bonuses, and other forms of compensation and benefit plans for management and (ii) administering our salaryequity compensation plans. The duties of the Compensation Committee as the administrator of those plans include, but are not limited to, determining those persons who are eligible to receive awards, establishing terms of all awards, authorizing officers of the Company to execute grants of awards, and benefits policies, includinginterpreting the provisions of the equity compensation of executive officers.plans and grants that are made under those plans. The Compensation Committee would also administer any stock option plans that we may adopt and recommend and approve grants of stock options under such plans.met one time in 2015.
As of the date of this report, we do not have a standing Nominating and Corporate Governance Committee. We intend to establish a Nominating and Corporate Governance Committee of the Board of Directors duringin the next yearfuture to assist in the selection of director nominees, approve director nominations to be presented for stockholder approval at ouran annual meeting of stockholders, and fill any vacancies on our Board of Directors, consider any nominations of director candidates validly made by stockholders, and review and consider developments in corporate governance practices.
Risk Oversight and Management
Our Board of Directors is actively involved in the oversight and management of the material risks that could affect the Company. Historically, our Board of Directors has carried out its risk oversight and management responsibilities by monitoring risk directly as a full board. The Board’s direct role in our risk management process includes receiving regular reports from our executive officers and other members of senior management on areas of material risk to the Company, including operational, strategic, financial, legal and regulatory risks.
With the formation of an Audit Committee and a Compensation Committee in January 2015, the Board delegated the oversight and management of certain risks to the Audit Committee and Compensation Committee. The Audit Committee is responsible for the oversight of Company risks relating to accounting matters, financial reporting and related-party transactions. To satisfy these oversight responsibilities, the Audit Committee meets regularly with and receives reports from the Company’s Chief Financial Officer and the Company’s independent registered public accounting firm.
The Compensation Committee is responsible for the oversight of risk relating to the Company’s compensation and benefits programs. To satisfy these oversight responsibilities, the Compensation Committee meets regularly with and receives reports from the Company’s Chief Executive Officer and Chief Financial Officer to understand the financial, human resources and shareholder implications of compensation and benefits decisions.
Board Committee Charters
A written charter has been adopted for each of the Audit Committee and the Compensation Committee. Copies of the Audit Committee Charter and the Compensation Committee Charter are available, free of charge, on the Company’s website at http://medizoneint.com under the “Corporate Governance” tab. The information contained on the website is not incorporated by reference in, or considered part of, this report.
Item 11. Executive Compensation
The following table summarizes information concerning the compensation of our Chief Executive Officer (principal executive officer) during the years ended December 31, 20122015 and 2011,2014, and our two other highest paid executive officers for services rendered in all capacities with(with the principal executive officer collectively, the “Named Executive Officers”) who were serving in such capacities as of December 31, 2012.2015.
Summary Compensation Table
| Name and principal position | | Year | | Salary ($) | | Stock awards ($) | | Option awards ($) | | Total ($) | | | Year | | Salary | | Option Awards | | Total |
| (a) | | (b) | | (c) | | (d) | | (e) | | (f) | | | (b) | | (c) | | (e) | | (f) |
| | | | | | | | | | | | | | | | | | | | | |
Edwin G. Marshall (1) (2) | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Chairman and Chief Executive Officer | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
Director of Medical Affairs | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Thomas (“Tommy”) E. Auger (4) | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| (1) | No other cash paymentsstock awards were made or accrued during the years indicated.these periods and therefore Column (d) is omitted from this table. Amount in column (e) represents the fair value on the date of grant of compensation paid Mr. Marshall in the form of stock options granted as compensation for Mr. Marshall’s service as a member of our Board of Directors (see “Director Compensation” following this section). Cash payments of salary made to Dr. Jill Marshall (Mr. Marshall’s wife), an employee of the Company, were both $67,000$82,000 in 20122015 and 2011. Those payments2014, respectively, and are not included in the table. |
| (2) | AggregateNot included in the table are aggregate accrued and unpaid wages owed Mr. Marshall for prior periods as of December 31, 2012,2015 for periods prior to 2009, totaled $1,090,630. Aggregated$1,065,189. Not included in the table are aggregated accrued and unpaid wages and consulting fees owed as of December 31, 2015 to Dr. Jill Marshall for periods prior periods as of December 31, 2012,to 2009, totaled $448,483.$441,583. |
| (3) | Dr. Shannon is President of Medizone and of the CFGH, and serves as the Director of Medical Affairs Directorand President of the Company. His salary (column (c)) is paid by the CFGH in Canadian dollars.CD. Base salary is CD$240,000 per year. The above amounts have been converted to U.S. dollars using the average exchange rate between the Canadian and the U.S. dollar for each year. The average exchange raterates for 2012 was 0.991147. The average exchange rate for 2011 was 0.991057.2015 and 2014 were 0.7924465 and 0.8887995, respectively. Column (e) represents the fair value on the date of grant of compensation paid to Dr. Shannon in the form of stock options granted as compensation for Dr. Shannon’s service as a member of our Board of Directors (see “Director Compensation”). Not included in the table are accrued and unpaid consulting fees owed to Dr. Shannon for periods prior to 2011, which totaled $111,109 as of December 31, 2012.2015. |
| (4) | Mr. Auger became our Chief Financial Officer on December 30, 2010. Mr. Auger’s services are provided to the Company under a consulting agreement with Advanced CFO Solutions, which employs Mr. Auger. Mr. Auger’s salary is paid by Advanced CFO Solutions from the fee paid by the Company under the consulting agreement. The fee paid to Advanced CFO SolutionsMr. Auger was $60,000 for both 20122015 and 2011.2014. Column (e) represents the fair value on the grant date of grants offor options granted by the Company in 2012 and 2011 to Mr. Auger to purchase 250,000 and 150,000 shares of common stock at an exercise price of $0.23 and $0.14 per share, respectively. These options are fully vested as of December 31, 2012.Company. |
We do not have any written employment agreements with any employee. Our Board of Directors doesdid not have a compensation committee or audit committee. Thecommittee until January 2015. Through January 2015, the Board determinesof Directors determined matters concerning the compensation of executive officers.
Compliance with Section 16(a) of the Exchange Act
Section 16(a) of the Exchange Act requires our officers, directors, and persons who beneficially own more than 10 percent10% of our common stock to file reports of ownership and changes in ownership with the SEC and to furnish us with copies of all Section 16(a) forms that they file.
Based solely upon a review of the copies of such forms furnished to the Company or written representations that no Forms 5 were required, we believe that all reports required to be filed by these individuals and persons under Section 16(a) were filed during the year ended December 31, 2012,2015, and that such filings were timely.
Outstanding Equity Awards as of Fiscal Year-End 20122015
The following table summarizes the outstanding equity awards held by our Named Executive Officers as of December 31, 2012:
| | Option Awards | | | Stock Awards | |
Name
(a)
| | Number of securities underly-ing unexer-cised options
(#) exercise-able
(b)
| | | Number of securities underly-ing unexer-cised options
(#)
Unexer-cisable
(c)
| | | Equity incentive plan awards: number of securities underly-ing unexer-cised unearned options
(#)
(d)
| | | Option exercise price
($)
(e)
| | | Option expiration date(f)
| | | Number of
shares
or units of stock that
have
not vested (#)
(g)
| | | Market value of shares or units of stock that have not vested ($)
(h)
| | | Equity incentive plan awards: number of unearned shares, units, or other rights that have not vested
(#)
(i)
| | | Equity incentive plan awards: market or payout value of unearned shares, units, or other
rights
that have not
vested
($)
(j)
| |
Edwin G. Marshall
Principal Executive Officer
| | | 2,000,000 | | | | - | | | | - | | | Various | | | Various | | | | - | | | | - | | | | - | | | | - | |
Michael E. Shannon
President
| | | 4,500,000 | | | | - | | | | - | | | Various | | | Various | | | | - | | | | - | | | | - | | | | - | |
2015:
| | | Option Awards |
| Name | | Number of securities underlying unexercised options (#) exercisable | | | Number of securities underlying unexercised options (#) unexercisable | | | Equity incentive plan awards: number of securities underlying unexercised unearned options (#) | | | Option exercise price ($) | | Option expiration date |
| (a) | | (b) | | | (c) | | | (d) | | | (e) | | (f) |
| | | | | | | | | | | | | | |
| Edwin G. Marshall | | | | | | | | | | | | | |
| Principal Executive Officer | | | 1,000,000 | | | | - | | | | - | | | $ | 0.23 | | 2/21/17 |
| | | | 250,000 | | | | - | | | | - | | | $ | 0.163 | | 4/30/19 |
| | | | 1,500,000 | | | | - | | | | - | | | $ | 0.087 | | 8/18/20 |
| | | | | | | | | | | | | | | | | | |
| Michael E. Shannon | | | | | | | | | | | | | | | | | |
| President | | | 1,000,000 | | | | - | | | | - | | | $ | 0.23 | | 2/21/17 |
| | | | 250,000 | | | | - | | | | - | | | $ | 0.163 | | 4/30/19 |
| | | | 1,000,000 | | | | - | | | | - | | | $ | 0.13 | | 8/15/19 |
| | | | 1,500,000 | | | | - | | | | - | | | $ | 0.087 | | 8/18/20 |
| | | | | | | | | | | | | | | | | | |
| Thomas (“Tommy”) E. Auger | | | | | | | | | | | | | | | | | |
| Principal Accounting and Financial Officer | | | 150,000 | | | | - | | | | - | | | $ | 0.14 | | 3/17/16 |
| | | | 250,000 | | | | - | | | | - | | | $ | 0.23 | | 2/21/17 |
| | | | 100,000 | | | | - | | | | - | | | $ | 0.163 | | 4/30/19 |
| | | | 350,000 | | | | - | | | | - | | | $ | 0.087 | | 8/18/20 |
Director Compensation
The following table summarizes the compensation paid during the year ended December 31, 20122015 to our directors. During 2015 there was no cash compensation paid to our directors. We made no stock awards and we paid no non-equity incentive plan compensation, nonqualified deferred compensation earnings, or other compensation to the directors anddirectors; those columns are therefore omitted from the table.
Name (a) | | Fees earned or paid in cash ($) (b) | | | Stock awards ($) (c) | | | Option awards ($) (d) | | | Total ($) (h) | |
| Daniel D. Hoyt | | | - | | | | - | | | $ | 209,426 | | | $ | 209,426 | |
| Edwin G. Marshall | | | - | | | | - | | | $ | 209,426 | | | $ | 209,426 | |
| Michael E. Shannon | | | - | | | | - | | | $ | 209,426 | | | $ | 209,426 | |
| Richard G. Solomon | | | - | | | | - | | | $ | 209,426 | | | $ | 209,426 | |
| (1) | As of December 31, 2015 and 2014, Mr. Hoyt had 2,750,000 and 1,250,000 vested shares, respectively, subject to purchase under options that have vested. |
| (2) | As of December 31, 2015 and 2014, Mr. Esposito had 1,750,000 and 1,000,000 vested shares, respectively, subject to purchase under options that have vested. Does not include additional unvested options for the purchase of 1,000,000 shares of common stock granted February 26, 2014. |
| (3) | As of December 31, 2015 and 2014, Mr. Caponi had 1,750,000 and 0 vested shares, respectively, subject to purchase under options that have vested. |
In February 2012,August 2015, in lieu of other compensation, each director of the Company wasdirectors were awarded stock options for the purchase of 1,000,0006,000,000 shares of common stock, exercisable at a price of $0.23$0.0877 per share, which was the closing price of the Company’s common stock reported on the OTC Bulletin BoardOTCQB on February 21, 2012,August 18, 2015, the date of grant. The members of the Board of Directors had not previously been compensated for their service since July 2010.2014. The amount indicated in column (d) represents the fair value of these options on the date of grant.grant for Mr. Hoyt, Mr. Esposito and Mr. Caponi. Options granted to Mr. Marshall and Dr. Shannon for service as directors are included in the Summary Compensation Table above.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The following tables contain information as of March 18, 20133, 2016 (the “Table Date”) with respect to beneficial ownership of shares of our common stock, for (1) all persons known to be holders of more than 5 percent5% of our voting securities based solely on the Company’s review of SEC filings, (2) each director, (3) each Named Executive Officer in the Summary Compensation Table of this report holding office on the Table Date, and (4) all executive officers and directors as a group. As of the Table Date, 299,104,559 369,934,068 shares of the Company’s common stock were issued and outstanding.
Except as otherwise noted, the persons named in the table have sole voting and dispositive power with respect to all shares beneficially owned, subject to community property laws where applicable.
| Title of class | | Name and Address of beneficial owner (1) | | Amount and nature of beneficial ownership | | | Percentage of class | | | Name and Address of beneficial owner (1) | | Amount and nature of beneficial ownership | | Percentage of class |
| | Edwin G. Marshall, Director and Chief Executive Officer (2) | | | 14,982,597 | | | | 5.0 | % | | Edwin G. Marshall, Director and Chief Executive Officer (2) | | | | |
| | Richard G. Solomon, Director (3) | | | 14,102,345 | | | | 4.6 | % | | Michael E. Shannon, Director and President (3) | | | | |
| | Daniel D. Hoyt, Director (4) | | | 10,001,988 | | | | 3.2 | % | | Daniel D. Hoyt, Director (4) | | | | |
| | Michael E. Shannon, Director (5) | | | 6,989,000 | | | | 2.3 | % | | David A. Esposito, Director (5) | | | | |
| | | | | 400,000 | | | | * | | | Vincent C. Caponi, Director (6) | | | | |
| | All Officers and Directors As a Group (5 persons) (7) | | | 46,475,930 | | | | 15.5 | % | | Thomas (“Tommy”) E. Auger, Chief Financial Officer (7) | | | | | |
| | | All Officers and Directors As a Group (6 persons) (8) | | | | |
___________
* Less than one percent of the issued and outstanding common stock.
| | (1) | Except as otherwise indicated, the address of the stockholder is: c/o Medizone International, Inc., 4000 Bridgeway, Suite 401, Sausalito, California 94965. |
| | (2) | Amount indicated includes (i) 2,670,000 shares owned of record by Mr. Marshall’s wife, (ii) 9,759,729 shares owned directly by Mr. Marshall, and (iii) 52,868 shares held by Mr. and Mrs. Marshall as joint tenants. Also includes 2,500,0003,575,000 shares subject to purchase under options that have vested, which are held in the names of Mr. Marshall (for 2,000,0002,750,000 shares) and his wife, Dr. Jill Marshall (for 500,000825,000 shares). |
| | (3) | Amount indicated includes (i) 5,633,844Includes 2,489,000 shares held directly by Mr. Solomon, (ii) 42,000owned of record and 3,750,000 shares held by immediate family members of Mr. Solomon, (iii) 7,426,501 shares held by Solomon Family Trust, an entity of which Mr. Solomon is a trustee, and (iv) 1,000,000 shares issuable upon the exercise ofsubject to purchase under options held by Mr. Solomon that have vested. |
| | (4) | Includes 8,501,988 shares owned directly by Mr. Hoyt and 1,500,0002,750,000 shares subject to purchase under options that have vested. |
| | (5) | Includes 2,489,0001,000,000 shares owned of record and 4,500,0001,750,000 shares subject to purchase under options that have vested. Does not include additional unvested options for the purchase of 1,000,000 shares of common stock granted February 26, 2014. |
| (6) | Includes 1,750,000 shares subject to purchase under options that have vested. |
| | (6)(7) | Options to purchase 400,000850,000 shares of common stock that have vested. |
| | (7)(8) | Based on a total of 299,104,559369,934,068 shares outstanding atas of the Table Date, plus 9,900,00019,890,000 shares that may be issued upon the exercise of options that have vested. vested, totaling 389,824,068 shares. |
Item 13. Certain Relationships and Related Transactions, and Director Independence
Transactions with Related Parties
We owe accrued and unpaid compensation to our Chairman and Chief Executive Officer.Officer for periods prior to December 31, 2009. We also owe accrued and unpaid compensation for those prior periods to former officers, including Mr. Marshall’s wife, Dr. Jill Marshall. See “Executive Compensation.” Except as disclosed herein, we have not entered into any other transactions with related persons during the last two completed fiscal years that resulted in indebtedness or otherwise involved amounts in excess of the lesser of $120,000 or one percent of the average of our total assets at year endas of year-end for the last two years.
In December 2011 and February 2012, Richard Solomon, a director of the Company, purchased a total of 1,500,000 shares of common stock from the Company in a private placement at the offering price of $0.10 per share, or an aggregate purchase price of $150,000 paid in cash to the Company. Mr. Solomon’s purchase of these shares was on the same terms and conditions as those applicable to purchases made by unaffiliated investors in the private placement.
Any future transactions between us and our officers, directors, principal stockholders or affiliates will be on terms no less favorable to us than could be obtained from an unaffiliated third party, and will be approved by the Audit Committee or by a majority of disinterested directors.
Director Independence
WeThe NASDAQ Stock Markets (“NASDAQ”) and New York Stock Exchange (“NYSE”) have twoestablished rules and regulations which generally require companies listed on these exchanges to have a board of directors with a majority of independent directors as defined by the rules of any securities exchange or inter-dealer quotation system.directors. Our common stock is currently traded on the OTC Bulletin Board,OTCQB, which does not impose standards relating to director independence or the makeupcomposition of committees with independent directors, or provide definitions of independence. However, a majority of the members of our Board of Directors are independent under NASDAQ Marketplace Rules.
OurTo assist the Board in making its determination regarding director independence, the Board has adopted independence standards that conform to the independence requirements of the NASDAQ Stock Market. In addition to evaluating each director’s independence, the Board considers all relevant facts and circumstances in making its independence determination. We assess director independence on an annual basis. The Board has determined, after careful review, that Mr. Esposito, Mr. Caponi and Mr. Hoyt are independent based on the rules of the NASDAQ Stock Market and applicable regulations of the SEC. In particular, the Board noted that each of these directors (1) is not an officer or employee of the Company, and (2) has no direct or indirect relationship with the Company that would interfere with the exercise of his independent judgment in carrying out his responsibilities of a director. As a result, the Board of Directors has determined duringthat we have a majority of independent directors. The Board also has determined that each independent director also qualifies as “independent” as the year ended December 31, 2012 that Daniel Hoyt and Richard Solomon were “independent”term is used in accordance with standards for independence set forth in the Sarbanes-Oxley ActItem 407 of 2002. There were no transactions, relationships or arrangements not disclosed pursuant to Item 404(a) that were consideredRegulation S-K as promulgated by the BoardSEC and as that term is defined under NASDAQ Rule 4200(a)(15). In addition, each member of Directorsthe Audit Committee is independent as required under Section 10A(m)(3) of the applicable independence definitionsExchange Act.
Involvement in determining that Messrs. Hoyt and Solomon are independent.Certain Legal Proceedings
During the past 10 years, none of our directors has been:
| (i) | involved in any bankruptcy petition filed by or against such person or any business of which such person was a general partner or executive officer, either at the time of the bankruptcy or within two years prior to that time; |
| (ii) | named as a defendant or counter-claimant in any civil litigation; |
| (iii) | convicted or plead nolo contendere in any criminal proceeding or is subject to a pending criminal proceeding (excluding traffic violations and other minor offences); |
| (iv) | subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoined, barred, suspended or otherwise limited from involvement in any type of business, securities, futures, commodities or banking activities; |
| (v) | found by a court of competent jurisdiction (in a civil action), the Securities and Exchange Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated; |
| (vi) | involved in any judicial or administrative proceeding resulting from involvement in mail or wire fraud or fraud in connection with any business entity; |
| (vii) | involved in any judicial or administrative proceedings based on violations of federal or state securities, commodities, banking or insurance laws and regulations, or any settlement to such actions (other than settlements of civil proceedings among private parties); |
| (viii) | involved in any disciplinary sanction or orders imposed by a stock, commodities or derivatives exchange or other similar self- regulatory organization. |
Item 14. Principal Accounting Fees and Services.Services
Policy on Pre-Approval of Audit and Permissible Non-Audit Services
TheFor the year ended December 31, 2015, the Board of Directors approvesapproved the engagement of our independent registered public accounting firm and hashad the ultimate authority and responsibility to select, evaluate and where appropriate, replace the independent registered public accounting firm and nominate an independent registered public accounting firm for stockholder approval. Going forward, the selection of the independent registered public accounting firm will be performed by the Audit Committee of the Board of Directors.
Prior to the performance of any services, the Board of Directors approvesAudit Committee will approve all audit and non-audit services to be provided by the Company’s independent registered public accounting firm and the fees to be paid therefor. AlthoughWe also expect that the Sarbanes-Oxley Act of 2002 permits the audit committee of a board of directors toAudit Committee will pre-approve some types or categories ofcertain services to be provided by the independent registered public accounting firm, in the absence of an audit committee, it is the current practice of our Board of Directors to specifically approve all services provided by the independent registered public accounting firm in advance, rather than to pre-approve any type of service. firm.
In connection with this practice,2015, the Board of Directors has considered whether the provisionperformance of non-audit services iswas compatible with maintaining the independence of our independent registered public accounting firm, Tanner and, historically, HJA.
Independence
Tanner has advised us that it has no direct or indirect financial interest in the Company or in any of its subsidiariesaffiliate and that it has had, during the last three years, no connection with the Company or any of its subsidiaries,affiliate, other than as the Company’s independent auditorsregistered public accounting firm or in connection with certain other activities, as described below.
Services
Subsequent to the year ended December 31, 2012, Tanner performed services consisting of the audit of the annual consolidated financial statements of the Company and its subsidiariesaffiliate for 2012.2015 and 2014. Tanner did not perform any financial information systems design and implementation services for the Company.
During years ended December 31, 2012 and 2011, HJA provided services consisting ofThe following table summarizes the audit of the annual consolidated financial statements of the Company for 2011,fees (which include quarterly reviews of the quarterly consolidated financial statements for the year 2012 (quarters ended March 31, June 30, and September 30) and 2011 (all quarters), and accounting consultations, consents, and other services relatedperiodic filings) paid to SEC filings and registration statements that were filed by the Company and its subsidiaries. HJA did not perform any financial information systems design and implementation services for the CompanyTanner for the years ended December 31, 2012 or 2011.
2015 and 2014. The following table summarizes thealso includes tax compliance fees that were paid to Tanner and HJA by the Company for the years ended December 31, 2012 and 2011:indicated:
| | | Years Ended December 31, | | |
| | | 2012 | | | 2011 | | | Years Ended December 31, | |
| | | Tanner | | | HJA | | | 2015 | | 2014 | |
| Audit Fees | | $ | 12,500 | | | $ | 22,500 | | | | | | | | |
| Audit Related Fees | | | - | | | | | | | | | | |
| Tax Fees | | | 2,000 | | | | - | | | | | | |
| All Other Fees | | | - | | | | 4,000 | | | | - | | | | |
| Total Fees | | $ | 14,500 | | | $ | 26,500 | | | | | | | | |
PART IV
Item 15. Exhibits, Financial Statement Schedules
| (a) | The following documents are filed as part of this report: |
(1) Financial Statements |
| |
ReportsReport of Independent Registered Public Accounting FirmsFirm |
| |
Consolidated Financial Statements:Balance Sheets as of December 31, 2015 and 2014 |
| |
Consolidated Balance Sheets, December 31, 2012 and 2011 |
|
Consolidated Statements of Comprehensive Loss for the years endedYears Ended December 31, 20122015 and 20112014 |
| |
Consolidated Statements of Stockholders’ Deficit for the years endedYears Ended December 31, 20122015 and 20112014 |
| |
Consolidated Statements of Cash Flows for the years endedYears Ended December 31, 20122015 and 20112014 |
| |
| Notes to the Consolidated Financial Statements |
(2) Schedules – None
(3) Exhibits:
| Exhibit No. | | Description |
| 2 | | Agreement and Plan of Reorganization, March 12, 1986 (1) |
| 3(i)(a) | | Articles of Incorporation (1) |
| 3(i)(b) | | Articles of Amendment to Articles of Incorporation (2) |
| 3(i)(c) | | Articles of Amendment to Articles of Incorporation (3) |
| 3(ii) | | Bylaws (1) |
| 10(a) | | Letter of UnderstandingDistribution Agreement (4) |
10(b) | | Termination of Joint Venture (5) |
10(c) | | Stock Purchase Agreement (6) |
21 | | Subsidiaries of Registrant (7) |
| 31.1* | | |
| 31.2* | | |
| 32.1* | | |
| 32.2* | | |
101.INS** | | XBRL Instance Document |
101.SCH** | | XBRL Taxonomy Extension Schema |
101.CAL** | | XBRL Taxonomy Extension Calculation Linkbase |
101.DEF** | | XBRL Taxonomy Extension Definition Linkbase |
101.LAB** | | XBRL Taxonomy Extension Label Linkbase |
101.PRE** | | XBRL Taxonomy Extension Presentation Linkbase |
* Filed herewith.
** Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933 or Section 18 of the Securities Exchange Act of 1934 and otherwise are not subject to liability.
| (1) | Incorporated by reference to Registration Statement on Form S-18 (no. 2-93277-D), May 14, 1985. |
| (2) | Incorporated by reference to Annual Report on Form 10-KSB for period ended December 31, 1986. |
| (3) | Incorporated by reference to Quarterly Report on Form 10-Q for period ended September 30, 2009. |
| (4) | Incorporated by reference to Annual Report on Form 10-KSB for the period ended December 31, 2008. |
(5) | Incorporated by reference to Annual Report on Form 10-K for the period ended December 31, 2009. |
(6) | Incorporated by reference to Current Report on Form 8-K datedfiled November 23, 2010. |
(7) | Incorporated by reference to Exhibit 21, Registration Statement on Form S-1, effective January 27, 2011.17, 2015. |
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, Medizone International, Inc. has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| | MEDIZONE INTERNATIONAL, INC. | |
| | | |
Dated: March 18, 20133, 2016 | By: | /s/ Edwin G. Marshall | |
| | | Edwin G. Marshall, Chief Executive Officer | |
| | | | |
| | | |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
| Name | | Title | | Date |
| | | | | |
| /s/ Edwin G. Marshall | | Chief Executive Officer (Principal Executive Officer) and Director | | March 18, 20133, 2016 |
| Edwin G. Marshall | | | | |
| | | | | |
| /s/ Michael E. Shannon | | President and Director | | March 18, 20133, 2016 |
| Michael E. Shannon | | | | |
| | | | | |
| /s/ Daniel D. Hoyt | | Director | | March 18, 20133, 2016 |
| Daniel D. Hoyt | | | | |
| | | | | |
/s/ Richard G. SolomonDavid A. Esposito | | Director | | March 18, 20133, 2016 |
Richard G. SolomonDavid A. Esposito | | | | |
| | | | |
| /s/ Vincent C. Caponi | | Director | | March 3, 2016 |
| Vincent C. Caponi | | | | |
| | | | | |
| /s/ Tommy E. Auger | | Chief Financial Officer (Principal Accounting | | March 18, 20133, 2016 |
| Tommy E. Auger | | Financial and AccountingFinancial Officer) | | |
| | | | | |
EXHIBITS TO
ANNUAL REPORT ON FORM 10-K
FOR THE YEAR ENDED DECEMBER 31, 2012
Exhibits Filed Herewith
Exhibit
Number
| | Description
|
| | |
31.1 | | |
31.2 | | |
32.1 | | |
32.2 | | |
101.INS** | | XBRL Instance Document |
101.SCH** | | XBRL Taxonomy Extension Schema |
101.CAL** | | XBRL Taxonomy Extension Calculation Linkbase |
101.DEF** | | XBRL Taxonomy Extension Definition Linkbase |
101.LAB** | | XBRL Taxonomy Extension Label Linkbase |
101.PRE** | | XBRL Taxonomy Extension Presentation Linkbase |
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
| | Page |
| | |
| 33 |
| |
| 3432 |
| | |
| 3533 |
| | |
| 3634 |
| | |
| 3735 |
| | |
| 3836 |
| | |
| 3937 |
To the Board of Directors and Stockholders
Medizone International, Inc.
We have audited the accompanying consolidated balance sheetsheets of Medizone International, Inc. and subsidiariesaffiliate (collectively, the Company) as of December 31, 20122015 and 2014, and the related consolidated statements of comprehensive loss, stockholders'stockholders’ deficit, and cash flows for the yearyears then ended. These consolidated financial statements are the responsibility of the Company'sCompany’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit.audits.
We conducted our auditaudits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the auditaudits to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2012, and the consolidated results of its operations and its cash flows for the year then ended in conformity with U.S. generally accepted accounting principles.
The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 10 to the consolidated financial statements, the Company has incurred significant recurring losses which have resulted in a significant accumulated deficit and deficit in stockholders’ equity. Additionally, the Company has minimal cash and negative working capital as of December 31, 2012. These matters, among others, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 10. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/ Tanner LLC
Salt Lake City, Utah
March 18, 2013
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMThe Board of Directors
Medizone International, Inc. and Subsidiaries
Sausalito, California
We have audited the accompanying consolidated balance sheet of Medizone International, Inc. and Subsidiaries as of December 31, 2011, and the related consolidated statements of comprehensive loss, stockholders’ deficit, and cash flows for the year then ended. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform an audit of its internal control over financial reporting. Our auditaudits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall consolidated financial statement presentation. We believe that our audit providesaudits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Medizone International, Inc. and Subsidiariesthe Company as of December 31, 2011,2015 and 2014, and the consolidated results of theirits operations and theirits cash flows for the yearyears then ended in conformity with U.S. generally accepted accounting principles.
The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 10 to the consolidated financial statements, the Company has incurred significant recurring losses which have resulted in a significant accumulated deficit accumulated during the development stage and a deficit in stockholders’ equity. This raisesAdditionally, the Company has minimal cash and negative working capital as of December 31, 2015. These matters, among others, raise substantial doubt about itsthe Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 10. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/HJ Associates & Consultants, LLP Tanner LLC
HJ Associates & Consultants, LLP
Salt Lake City, Utah
February 28, 2012March 3, 2016
MEDIZONE INTERNATIONAL, INC. AND AFFILIATE Consolidated Balance Sheets
| ASSETS | |
| | | December 31, | |
| | | 2015 | | | 2014 | |
| Current assets: | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Property and equipment, net | | | | | | | | |
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Trademark and patents, net | | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
| | | | | | | | | |
| | | | | | | | |
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Accounts payable – related parties | | | | | | | | |
| | | | | | | | |
Accrued expenses – related parties | | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Total current liabilities | | | | | | | | |
Notes payable, net of current portion | | | | | | | | |
| | | | | | | | |
Commitments and contingencies (Notes 5 and 10) | | | | | | | | |
| | | | | | | | | |
| | | | | | | | |
Preferred stock, $0.00001 par value 50,000,000 authorized: no shares outstanding | | | | | | | | |
Common stock, $0.001 par value 395,000,000 authorized: 369,434,068 and 346,034,068 shares outstanding, respectively | | | | | | | | |
Additional paid-in capital | | | | | | | | |
Accumulated other comprehensive loss | | | | | | | | |
| | | | | | | | |
Total stockholders’ deficit | | | | | | | | |
Total liabilities and stockholders’ deficit | | | | | | | | |
The accompanying notes are an integral part of these consolidated financial statements.
MEDIZONE INTERNATIONAL, INC. AND AFFILIATE Consolidated Statements of Comprehensive Loss
| | | For the Years Ended December 31, | |
| | | 2015 | | | 2014 | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
General and administrative | | | | | | | | |
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Depreciation and amortization | | | | | | | | |
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Other comprehensive loss: | | | | | | | | |
Gain (loss) on foreign currency translation | | | | | | | | |
| | | | | | | | |
Basic and diluted net loss per common share | | | | | | | | |
Weighted average number of common shares outstanding | | | | | | | | |
The accompanying notes are an integral part of these consolidated financial statements.
MEDIZONE INTERNATIONAL,, INC. AND SUBSIDIARIESAFFILIATE Consolidated Balance Sheets
Statements of Stockholders’ Deficit
| ASSETS | |
| | | December 31, | |
| | | 2012 | | | 2011 | |
| Current Assets: | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Property and Equipment, Net | | | | | | | | |
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Trademark and patents, net | | | | | | | | |
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| | | | | | | | |
| | | | | | | | |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
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Accounts payable – related parties | | | | | | | | |
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Accrued expenses – related parties | | | | | | | | |
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Total Current Liabilities | | | | | | | | |
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Commitments and Contingencies (Notes 5 and 10) | | | | | | | | |
| | | | | | | | | |
| | | | | | | | |
Preferred stock, 50,000,000 shares authorized of $0.00001 par value, no shares issued or outstanding | | | | | | | | |
Common stock, 395,000,000 shares authorized of $0.001 par value, 288,771,227 and 272,041,949 shares issued and outstanding, respectively | | | | | | | | |
Additional paid-in capital | | | | | | | | |
Accumulated other comprehensive loss | | | | | | | | |
| | | | | | | | |
Total Stockholders’ Deficit | | | | | | | | |
Total Liabilities and Stockholders’ Deficit | | | | | | | | |
| | | | | | | | | | | | Accumulated | | | | | | | |
| | | Common Stock | | | Additional Paid-in | | | Other Comprehensive | | | Accumulated | | | Total Stockholders’ | |
| | | Shares | | | Amount | | | Capital | | | Loss | | | Deficit | | | Deficit | |
| | | | | | | | | | | | | | | | | | | |
| Balance, December 31, 2013 | | | 322,055,496 | | | $ | 322,055 | | | $ | 28,018,398 | | | $ | (26,269 | ) | | $ | (31,421,984 | ) | | $ | (3,107,800 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Common stock issued for cash ranging from $0.05 to $0.085 per share | | | 23,978,572 | | | | 23,979 | | | | 1,580,271 | | | | - | | | | - | | | | 1,604,250 | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Stock-based compensation | | | - | | | | - | | | | 453,987 | | | | - | | | | - | | | | 453,987 | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Loss on foreign currency translation | | | - | | | | - | | | | - | | | | (31,829 | ) | | | - | | | | (31,829 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Net loss | | | - | | | | - | | | | - | | | | - | | | | (1,940,440 | ) | | | (1,940,440 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Balance, December 31, 2014 | | | 346,034,068 | | | | 346,034 | | | | 30,052,656 | | | | (58,098 | ) | | | (33,362,424 | ) | | | (3,021,832 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Common stock issued for cash ranging from $0.05 to $0.10 per share | | | 23,400,000 | | | | 23,400 | | | | 1,652,600 | | | | - | | | | - | | | | 1,676,000 | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Stock-based compensation | | | - | | | | - | | | | 791,390 | | | | - | | | | - | | | | 791,390 | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Gain on foreign currency translation | | | - | | | | - | | | | - | | | | 21,130 | | | | - | | | | 21,130 | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Net loss | | | - | | | | - | | | | - | | | | - | | | | (2,035,922 | ) | | | (2,035,922 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Balance, December 31, 2015 | | | 369,434,068 | | | $ | 369,434 | | | $ | 32,496,646 | | | $ | (36,968 | ) | | $ | (35,398,346 | ) | | $ | (2,569,234 | ) |
The accompanying notes are an integral part of these consolidated financial statements.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIESAFFILIATE
| | | For the Years Ended December 31, | |
| | | 2012 | | | 2011 | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
General and administrative | | | | | | | | |
| | | | | | | | |
Depreciation and amortization | | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Other Comprehensive Loss: | | | | | | | | |
Loss on foreign currency translation | | | | | | | | |
| | | | | | | | | |
| | | | | | | | |
Basic and Diluted Loss Per Common Share | | | | | | | | |
Weighted Average Number Of Common Shares Outstanding | | | | | | | | |
| | | For the Years Ended December 31, | |
| | | 2015 | | | 2014 | |
| Cash flows from operating activities: | | | | | | |
| | | | | | | | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | |
Depreciation and amortization | | | | | | | | |
| | | | | | | | |
Changes in operating assets and liabilities: | | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Accounts payable and accounts payable – related parties | | | | | | | | ) |
Accrued expenses and accrued expenses – related parties | | | | | | | | |
Net cash used in operating activities | | | | | | | | |
| | | | | | | | | |
Cash flows from investing activities: | | | | | | | | |
Purchases of trademark and patents | | | | | | | | |
Net cash used in investing activities | | | | | | | | |
| | | | | | | | | |
Cash flows from financing activities: | | | | | | | | |
Principal payments on notes payable | | | | | | | | |
Issuance of notes payable | | | | | | | | |
Issuance of common stock for cash | | | | | | | | |
Net cash provided by financing activities | | | | | | | | |
Effects of foreign currency exchanges rates | | | | | | | | |
| | | | | | | | |
Cash as of beginning of the year | | | | | | | | |
Cash as of end of the year | | | | | | | | |
| | | | | | | | | |
Supplemental cash flow information: | | | | | | | | |
| | | | | | | | |
Non-cash financing activities: | | | | | | | | |
Financing of insurance premiums | | | | | | | | |
The accompanying notes are an integral part of these consolidated financial statements.
Consolidated Statements of Stockholders’ Deficit
| | | Common Stock | | | Additional Paid-in | | | | | | Accumulated | | | Total Stockholders’ | |
| | | Shares | | | Amount | | | Subscribed | | | Capital | | | Loss | | | Deficit | | | Deficit | |
| | | | | | | | | | | | | | | | | | | | | | |
| | | 259,362,171 | | | $ | 259,362 | | | $ | - | | | $ | 21,593,448 | | | $ | (8,519 | ) | | $ | (24,801,081 | ) | | $ | (2,956,790 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Common stock issued for cash ranging from $0.08 to $0.192 per share | | | 11,554,778 | | | | 11,555 | | | | - | | | | 1,404,351 | | | | - | | | | - | | | | 1,415,906 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | - | | | | - | | | | - | | | | (4,300 | ) | | | - | | | | - | | | | (4,300 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Common shares subscribed for ranging from $0.08 to $0.12 per share | | | - | | | | - | | | | 1,125 | | | | 128,875 | | | | - | | | | - | | | | 130,000 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | - | | | | - | | | | - | | | | 33,403 | | | | - | | | | - | | | | 33,403 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Common stock issued previously subscribed | | | 1,125,000 | | | | 1,125 | | | | (1,125 | ) | | | - | | | | - | | | | - | | | | - | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Loss on foreign currency translation | | | - | | | | - | | | | - | | | | - | | | | (12,563 | ) | | | - | | | | (12,563 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss for the year ended December 31, 2011 | | | - | | | | - | | | | - | | | | - | | | | - | | | | (1,940,217 | ) | | | (1,940,217 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance, December 31, 2011 | | | 272,041,949 | | | | 272,042 | | | | - | | | | 23,155,777 | | | | (21,082 | ) | | | (26,741,298 | ) | | | (3,334,561 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Common stock issued for cash ranging from $0.05 to $0.165 per share | | | 16,729,278 | | | | 16,729 | | | | - | | | | 1,404,064 | | | | - | | | | - | | | | 1,420,793 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | - | | | | - | | | | - | | | | 1,946,725 | | | | - | | | | - | | | | 1,946,725 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Loss on foreign currency translation | | | - | | | | - | | | | - | | | | - | | | | (3,362 | ) | | | - | | | | (3,362 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss for the year ended December 31, 2012 | | | - | | | | - | | | | - | | | | - | | | | - | | | | (3,343,694 | ) | | | (3,343,694 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance, December 31, 2012 | | | 288,771,227 | | | $ | 288,771 | | | $ | - | | | $ | 26,506,566 | | | $ | (24,444 | ) | | $ | (30,084,992 | ) | | $ | (3,314,099 | ) |
The accompanying notes are an integral part of these consolidated financial statements.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIESAFFILIATEConsolidated Statements of Cash Flows| | | For the Years Ended December 31, | |
| | | 2012 | | | 2011 | |
| Cash Flows From Operating Activities: | | | | | | |
| | | | ) | | | | |
Adjustments to reconcile net loss to net cash Used in operating activities: | | | | | | | | |
Depreciation and amortization | | | | | | | | |
Amortization of deferred consulting fees | | | | | | | | |
| | | | | | | | |
Changes in operating assets and liabilities: | | | | | | | | |
| | | | ) | | | | |
| | | | ) | | | | |
| | | | ) | | | | |
Accounts payable and accounts payable – related parties | | | | ) | | | | |
Accrued expenses and accrued expenses – related parties | | | | | | | | |
Net Cash Used in Operating Activities | | | | ) | | | | |
| | | | | | | | | |
Cash Flows From Investing Activities: | | | | | | | | |
Purchases of trademarks and patents | | | | ) | | | | |
Purchases of property and equipment | | | | ) | | | | |
Net Cash Used in Investing Activities | | | | ) | | | | |
| | | | | | | | | |
Cash Flows From Financing Activities: | | | | | | | | |
Principal payments on notes payable | | | | ) | | | | |
Repayment of stockholders advances | | | | | | | | |
| | | | | | | | |
Issuance of common stock for cash | | | | | | | | |
Net Cash Provided by Financing Activities | | | | | | | | |
Effects of Foreign Currency Exchanges Rates | | | | ) | | | | |
| | | | | | | | |
| | | | ) | | | | |
Cash at Beginning of Year | | | | | | | | |
| | | | | | | | |
| | | | | | | | | |
Supplemental Cash Flow Information: | | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Non-Cash Financing Activities: | | | | | | | | |
Financing of insurance policy | | | | | | | | |
The accompanying notes are an integral part of these consolidated financial statements.
Notes to the Consolidated Financial Statements
December 31, 20122015 and 20112014
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
a. Organization
The consolidated financial statements presented are those of Medizone International, Inc. (Medizone), and its wholly owned subsidiary, Medizone International, Inc. Delaware (Medizone-Delaware). The consolidated financial statements presented also include the accounts of the Canadian Foundation for Global Health (CFGH), a not-for-profit foundation based in Ottawa, Canada, considered to be a variable interest entity (VIE) as described below. Collectively, they are referred to herein as the “Company”. The Company is in the business of designing, manufacturing and selling a patented system using ozone in the disinfection of surgical and other medical treatment facilities and in other applications. Historically, the Company has been considered a development stage company. During 2012, the Company commenced its planned operations, generated significant revenues, and is no longer considered a development stage company.
In late 2008, the Company assisted in the formation of the CFGH, a not-for-profit foundation based in Ottawa, Canada.foundation. The Company helped establish the CFGH for two primary purposes: (1) to establish an independent not-for-profit foundation intended to have a continuing working relationship with the Company for research purposes that is best positioned to attract the finest scientific, medical and academic professionals possible to work on projects deemed to be of social benefit; and (2) to provide a means for the Company to use a tiered pricing structure for services and products in emerging economies and extend the reach of its technology to as many in need as possible.
Accounting standards require a VIE to be consolidated by a company if that company absorbs a majority of the VIE’s expected losses and/or receives a majority of the VIE’s expected residual returns as a result of holding variable interests (ownership, contractual, or other financial interests) in the VIE. In addition, a legal entity is considered to be a VIE, if it does not have sufficient equity at risk to finance its own activities without relying on financial support from other parties. If the legal entity is a VIE, then the reporting entity determined to be the primary beneficiary of the VIE must consolidate it. The Company determined that the CFGH meetsfinancial results of the requirements of a VIE effective upon the first advance to the CFGH on February 12, 2009.with it. Accordingly, the financial conditionposition and results of operations of the CFGH are being consolidated with Medizone as of and for the periodsyears ended December 31, 20122015 and 2011.2014.
The Company’s objective is to pursue an initiative in the field of hospital disinfection. The Company is working on the development ofhas developed an ozone-based technology, specifically for the purpose of decontaminating and disinfecting hospital surgical suites, emergency rooms, and intensive care units.
The Company’s consolidated financial statements are prepared using the accrual method of accounting.
d. Basic and Diluted Net Loss Per Common Share
The computations of basic and diluted net loss per common share are based on the weighted average number of common shares outstanding during the year as follows:
| | | For the Years Ended December 31, | |
| | | 2012 | | | 2011 | |
| Numerator | | | | | | |
| | | | | | | | |
| | | | | | | | | |
Denominator (weighted average number of common shares outstanding) | | | | | | | | |
| | | | | | | | | |
Basic and diluted loss per common share | | | | | | | | |
| | | For the Years Ended December 31, | |
| | | 2015 | | | 2014 | |
| | | | | | | |
| | | | | | | | |
| | | | | | | | | |
Denominator (weighted average number of common shares outstanding) | | | | | | | | |
| | | | | | | | | |
Basic and diluted net loss per common share | | | | | | | | |
Common stock equivalents, consisting of 20,965,000 options, have not been included in the calculation as their effect is antidilutive for the years presented.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIESAFFILIATE
Notes to the Consolidated Financial Statements
December 31, 20122015 and 20112014
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)(continued)
e.d. Property and Equipment
Property and equipment are recorded at cost. Any major additions and improvements are capitalized. The cost and related accumulated depreciation of equipment retired or sold are removed from the accounts and any differences between the undepreciated amount and the proceeds from the sale are recorded as gain or loss on sale of property and equipment. Depreciation is computed using the straight-line method over a period of: (1) three years for computers and software, and (2) five years for office equipment and furniture and (3) two years for leasehold improvements.
furniture.
f.e. Provision for Income Taxes
The Company estimates income taxes in each of the jurisdictions in which it operates. This process involves estimating the Company’s actual current income tax exposure together with assessing temporary differences resulting from differing treatment of items for income tax and financial reporting purposes. These temporary differences result in deferred income tax assets and liabilities, the net amount of which is included in the Company’s consolidated balance sheets. When appropriate, the Company records a valuation allowance to reduce its deferred income tax assets to the amount that the Company believes is more likely than not to be realized. Key assumptions used in estimating a valuation allowance include potential future taxable income, projected income tax rates, expiration dates of net operating loss and tax credit carry forwards, and ongoing prudent and feasible tax planning strategies.
As of December 31, 2012,2015, the Company had net operating loss (“NOL”) carryforwards of approximately $8,940,000$11,066,000 that may be offset against future taxable income, if any, and expire in years 2013 through 2033.2034. If substantial changes in the Company’s ownership should occur, there would also be an annual limitation of the amount of the NOL carryforwards which could be utilized. No tax benefit hadhas been reported in the consolidated financial statements as, in the opinion of management, it is more likely than not that all of the deferred income tax assets will not be realized and the NOL carryforwards will expire unused. Deferred income tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. If the Company were to determine that it would be able to realize its deferred income tax assets in the future in excess of the net recorded amount, an adjustment to reduce the valuation allowance would increase net income or decrease net loss in the period such determination was made.
Interest and penalties associated with unrecognizedany underpayment of income taxes would be classified as income tax benefits are classified as additional income taxesprovision in the statements of comprehensive loss.
A company may adopt a policy of presenting taxes assessed by a governmental authority on revenue-producing transactions either on a gross basis or a net basis within revenues. The Company has elected to present revenues net of any tax collected.
Deferred income tax assets as of December 31, 20122015 and 2011 are2014 comprised of the following:
| | | 2012 | | | 2011 | |
| | | | | | | |
Net operating loss carryforwards | | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | | |
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
December 31, 2012 and 2011
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
f. Provision for Income Taxes (continued)
| | | 2015 | | | 2014 | |
| | | | | | | |
Net operating loss carryforwards | | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | | |
The income tax provision differs from the amount of income tax determined by applying the U.S. federal income tax rate to pretax income for the years ended December 31, 20122015 and 20112014 due to the following:
| | | 2012 | | 2011 | | | 2015 | | 2014 | |
| | | | | | | | | | | |
| | | | | | | | | |
Income tax benefit based on U.S. statutory rate of 34% | | | | | | | | | |
Stock issued for expenses | | | | | | | | | | |
| | | | | | | | | | |
Change in valuation allowance | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
MEDIZONE INTERNATIONAL, INC. AND AFFILIATE
Notes to Consolidated Financial Statements
December 31, 2015 and 2014
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
e. Provision for Income Taxes (continued)
The Company had no uncertain income tax positions as of December 31, 20122015 and 2011. As of December 31, 2012, the Company has approximately $9,826,600 of NOL carryforwards, which expire beginning in 2016 through 2032.
The Company files income tax returns in the U.S. federal and California jurisdictions. With few exceptions, the Company is no longer subject to U.S. federal, state and local tax examinations for years before 2009.
2012.
g.f. Principles of Consolidation
TheThe consolidated financial statements include the accounts of Medizone and its wholly owned inactive subsidiary, Medizone-Delaware. The consolidated financial statements presented also include the accounts of the CFGH, a VIE.
All material intercompany accounts and transactions have been eliminated.
g. Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting principles (U.S. GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of the contingent assets and liabilities atas of the datedates of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period.periods. Actual results could differ from those estimates.
i.h. Advertising
The Company expenses the costs of advertising as incurred.
j.i. Stock Options
TheThe Company records compensation expense in connection with the granting of stock options and their vesting periods based on their fair values. The Company estimates the fair valuevalues of each stock option awards issued to employees at the grant date by using the Black-Scholes option-pricing model.
For stock options issued to consultants and other non-employees, the Company estimates the related expense using the Black-Scholes option-pricing model. For stock options with a service condition, the expense is measured at the grant date and expensed over the vesting period. For stock options with a performance condition, the expense is measured when it is probable that the performance condition will be met, subsequently re-measured at each reporting date, and trued up upon the final completion of the performance condition.
k. Trademarksj. Trademark and Patents
TrademarksTrademark and patents are recorded at cost. Amortization is computed using the straight-line method over a period of seven years. The Company evaluates the recoverability of intangibles and reviews the amortization period on a continual basis. Several factors are used to evaluate intangibles, including management’s plans for future operations, recent operating results, and projected, undiscounted net cash flows.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
December 31, 2012 and 2011
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
l.k. Revenue Recognition Policy
The Company commenced sales and emerged from the development stage in 2012. The Company recognizes revenue when it ships its products, title and risk of loss passes to customers, payment from the customer is reasonably assured and the price is fixed or determinable. The Company records customer deposits that have not yet been earnedreceived in advance of shipping products as unearned revenue. Revenue is recognized only when title and risk of loss passes to customers.
a liability.
m.l. Inventory
The Company’s inventory consists of its AsepticSureAsepticSure® product and is valued on a “specificspecific identification basis”.basis. The Company purchases its inventory as a finished product from unrelated manufacturing companies. The Company writes off 100% of the cost of inventorydetermined that it specifically identifies and considersthere was no obsolete or excessive to fulfill future sales estimates. The Company did not deem anyexcess inventory obsolete or excessive as of December 31, 2012.2015 and 2014.
n.MEDIZONE INTERNATIONAL, INC. AND AFFILIATE
Notes to Consolidated Financial Statements
December 31, 2015 and 2014
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
m. Fair Value of Financial Instruments
The Company’s financial instruments consist of cash, accounts payable, and notes payable. The carrying amounts of cash and accounts payable approximate their fair values because of the short-term nature of these items.instruments. The carrying amounts of the notes payable approximate fair values as the individual borrowings bear interest at rates that approximate market interest rates for similar debt instruments.
o.n. Recent Accounting Pronouncements
In 2011,May 2014, the Financial Accounting Standards Board (“FASB”)(FASB) issued two Accounting Standards Updates (“ASU”), namely,Update (ASU) No. 2014-09, Revenue from Contracts with Customers, which supersedes nearly all existing revenue recognition guidance under US GAAP. The core principle of ASU No. 2011-05 and2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU No. 2011-12 which amend2014-09 defines a five-step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing US GAAP. This ASU is effective for annual reporting periods beginning after December 15, 2016, and interim periods therein. Early adoption is not permitted. The Company is currently assessing the impact, if any, of implementing this guidance on its consolidated financial position, results of operations and liquidity.
In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This ASU sets forth management’s responsibility to evaluate, each reporting period, whether there is substantial doubt about the entity’s ability to continue as a going concern, and if so, to provide related footnote disclosures. This ASU is for annual reporting periods beginning after December 15, 2016, and interim periods within annual periods ending after December 15, 2016. The Company is currently assessing the impact, if any, of implementing this guidance on the Company’s financial reporting.
In April 2015, the FASB issued Accounting Standards Update (ASU) No. 2015-03, “Interest – Imputation of Interest (Subtopic 835-30), Simplifying the Presentation of Debt Issuance Costs.” To simplify presentation of debt issuance costs, the amendments in this ASU require that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected by the presentationamendments in this ASU. For public companies, the ASU is effective for financial statements issued for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. Early adoption of comprehensive income. The amended guidance requires an entity to present components of net income and other comprehensive income or loss in one continuous statement, referred to as the statement of comprehensive income or loss, or in two separate, but consecutive statements. The option to report other comprehensive income or loss and its components in the statement of stockholders’ deficit hasASU is permitted for financial statements that have not been eliminated. Although the new guidance changes the presentation of comprehensive income or loss, there are no changes to the components that are recognized in net income or loss or other comprehensive income or loss under existing guidance.previously issued. The Company adopted these ASUs using one continuous statement for all years presented.is assessing the impact, if any, of implementing this guidance on its financial reporting.
p.o. Concentration of Credit Risk
The Company maintains its cash in bank deposit accounts which cash, at times, exceeds federally insured limits. The Emergency Economic Stabilization Act of 2008 temporarily increased FDIC deposit insurance from $100,000 to $250,000 per depositor through December 31, 2009. The Dodd-Frank Wall Street Reform and Consumer Protection Act, signed into law in July 2010, made this $250,000 per depositor coverage limit permanent. As of December 31, 2012 and 2011,2015, the Company had noapproximately $212,000 of cash balances that exceeded federally insured limits. To date, the Company has not experienced a material loss or lack of access to its cash; however, no assurance can be provided that access to the Company’s cash will not be impacted by adverse conditions in the financial markets.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
December 31, 2012 and 2011
NOTE 2 - PROPERTY AND EQUIPMENT
Property and equipment consist of the following as of December 31, 20122015 and 2011:2014:
| | | 2012 | | 2011 | | | 2015 | | 2014 | |
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| | | | | | |
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Property and equipment, net | | | | | | | | | | | | | | |
MEDIZONE INTERNATIONAL, INC. AND AFFILIATE
Notes to Consolidated Financial Statements
December 31, 2015 and 2014
NOTE 2 - PROPERTY AND EQUIPMENT (continued)
Depreciation expense for the years ended December 31, 20122015 and 20112014 was $2,320$415 and $1,770,$787, respectively.
NOTE 3 - TRADEMARKSTRADEMARK AND PATENTS
TrademarksTrademark and patents consist of the following as of December 31, 20122015 and 2011:2014:
| | | 2012 | | 2011 | | | 2015 | | 2014 | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | |
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Trademark and patents, net | | | | | | | | | | | | | | |
Amortization expense for the years ended December 31, 20122015 and 20112014 was $34,437$53,027 and $20,771,$48,483, respectively. The future amortization as of December 31, 2015 is as follows: 2016-$53,910; 2017-$46,569; 2018-$34,028; 2019-$20,368; 2020-$14,090; and 2021-$7,121.
NOTE 4 - ACCRUED EXPENSES AND ACCRUED EXPENSES – RELATED PARTIES
Accrued expenses and accrued expenses – related parties consist of the following as of December 31, 20122015 and 2011:
2014:
| | | 2012 | | 2011 | | | 2015 | | 2014 | |
Accrued payroll and consulting – related parties | | | | | | | | | | | | | | |
| | | | | | | | | | |
Accrued payroll taxes – related parties | | | | | | | | | | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Accrued expenses – related parties relate toconsist of accrued but unpaid prior payroll and consulting fees (and associated taxes) for certain of the Company’s employees and consultants who are also directors, officers or stockholders.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
December 31, 2012 and 2011
NOTE 5 - COMMITMENTS AND CONTINGENCIES
Litigation
The Company is subject to certain claims and lawsuits arising in the normal course of business. In the opinion of management, uninsured losses, if any, resulting from the ultimate resolution of these matters will not have a material effect on the Company’s consolidated financial position, results of operations, or cash flows.
Rakas vs. Medizone International, Inc. - A former consultant brought this action against the Company claiming the Company had failed to pay consulting fees under a consulting agreement. In September 2001, the parties agreed to settle the matter for $25,000. The Company, however, did not have the funds to pay the settlement and the plaintiff moved the court to enter a default judgment in the amount of $143,000 in January 2002. On May 8, 2002, the court vacated the default judgment and requested that the Company post a bond of $25,000 to cover the settlement previously entered into by the parties. The Company has been unable to post the required bond amount as of the date of this report. Therefore, the Company has recorded, as part of accounts payable, the original default judgment in the amount of $143,000, plus fees totaling $21,308, as of December 31, 20122015 and 2011.2014. The Company intends to contest the judgment if and when it is able to do so in the future.
As of December 31, 20122015 and 2011,2014, the Company has recorded other payables totaling $224,852 related to certain past due payables for which the Company has not received invoices or demands for over 10 years. Although management of the Company does not believe that the amounts will be paid, the amounts have been recorded as other payables until such time as the Company is certain that no liability exists and until the statute of limitations has expired.
exists.
MEDIZONE INTERNATIONAL, INC. AND AFFILIATE
Notes to Consolidated Financial Statements
December 31, 2015 and 2014
NOTE 5 - COMMITMENTS AND CONTINGENCIES (continued)
Operating Leases
The Company operates a certified laboratory located at Innovation Park, Queen’s University in Kingston, Ontario, Canada, which provides a primary research and development platform. The lease term expired on June 30, 2012, and is now operated on a month–to-month basismonth to month with a monthly lease payment of $1,350$1,375 Canadian dollars (“CD”) plus the applicable goods and services tax (“GST”).
A lease Leases for a second laboratory space for full scale room testing also expired on June 30, 2012, and is now operateda storage unit are on a month-to-month basis with a monthly lease payment of $1,250 CD,CD$1,375 and CD$475, respectively, plus the applicable GST.
In March 2011, the Company entered into a lease agreement and established its corporate offices in California that includes a monthly lease payment of $2,500 and was renewable on a month–to-month basis following the initial lease term that ended in May 2011. The Company elected to terminate thishas a non-cancelable lease for office space located in December 2011 and enter into a new corporate office lease effective January 1, 2012 through December 31, 2012California, with monthly payments of $2,100. The lease term was extended for another year,approximately $2,300 through December 31, 2013, with monthly lease payments increasing from $2,100 to $2,200. 2015 and $2,500 through December 31, 2016.
NOTE 6 - EQUITY TRANSACTIONS
Unless otherwise stated, allthe following equity transactions shown below were with unrelated parties and the securities issued were restricted.
Common Stock for Cash – 2011
During February 2011, the Company issued 582,065 shares of common stock to Mammoth, an accredited investor (as part of the Equity Line), for cash proceeds of $59,000 (net of $4,300 of stock issuance costs) at a price of $0.10875 per share. There were no underwriters involved.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
December 31, 2012 and 2011
NOTE 6 - EQUITY TRANSACTIONS (Continued)
The Company sold an aggregate of 1,000,000 restricted shares of common stock that were subscribed for as of March 31, 2011 and issued in April 2011. The purchasers of these shares were two accredited investors, not otherwise affiliated with the Company. The Company received cash proceeds of $120,000, or $0.12 per share. There were no underwriters involved.
During April and May 2011, the Company issued 3,649,867 shares of common stock to Mammoth (as part of the Equity Line) for cash proceeds of $658,012. The sales were made pursuant to two separate “Draw Down Notices” issued by the Company under the Stock Purchase Agreement. The first notice was effective May 18, 2011, for 1,583,771 shares and proceeds of $261,322, or approximately $0.165 per share. The second notice was effective June 16, 2011, for 2,066,096 shares and proceeds of $396,690, or approximately $0.192 per share. There were no underwriters involved.
During April, May and June 2011, the Company sold an aggregate of 4,625,000 restricted shares of common stock to accredited investors, not otherwise affiliated with the Company, for cash proceeds of $370,000 at a price of $0.08 per share. There were no underwriters involved.
The Company entered into a transaction, with an accredited investor, not otherwise affiliated with the Company, for 125,000 restricted shares of common stock that were subscribed for as of June 30, 2011 and issued in July 2011 for cash proceeds of $10,000 at a price of $0.08 per share. There were no underwriters involved.
During September 2011, the Company issued 1,147,846 shares of common stock to Mammoth (as part of the Equity Line) for cash proceeds of $169,594, at a price of $0.14775 per share. There were no underwriters involved.
During November and December 2011, the Company sold an aggregate of 1,550,000 restricted shares of common stock to eight accredited investors, not otherwise affiliated with the Company, for cash proceeds of $155,000 at a price of $0.10 per share. There were no underwriters involved.
Common Stock for Cash – 20122014
During January, February and February 2012,March 2014, the Company sold an aggregate of 6,653,0009,000,000 restricted shares of common stock to approximately 30five accredited investors for cash proceeds of $665,300 at a price of $0.10totaling $450,000, or $0.05 per share. There were no underwriters involved.
During January 2012, the Company issued 903,089 shares of common stock to Mammoth (as part of the Equity Line) for cash proceeds of $149,010 at a price of $0.165 per share. There were no underwriters involved.
During June 2012, the Company issued 500,000 shares of common stock to Mammoth (as part of the Equity Line) for cash proceeds of $65,625 at a price of $0.131 per share. There were no underwriters involved.
During June 2012,March 2014, the Company sold an aggregate of 1,205,5567,050,000 restricted shares of common stock to two16 accredited investors for cash proceeds of $108,500 at a price of $.09totaling $599,250, or $0.085 per share. There were no underwriters involved.
During July 2012,September 2014, the Company sold an aggregate of 250,0002,471,429 restricted shares of common stock to five accredited investors for cash proceeds totaling $173,000, or $0.07 per share.
During November 2014, the Company sold 2,907,143 restricted shares of common stock to five accredited investors for cash proceeds totaling $203,500, or $0.07 per share.
During December 2014, the Company sold 2,550,000 restricted shares of common stock to an accredited investor for cash proceeds of $22,500 at a price of $0.09totaling $178,500, or $0.07 per share. There were no underwriters involved.
Common Stock for Cash – 2015
During August 2012,February 2015, the Company sold 300,000 restricted shares of common stock to an accredited investor for cash proceeds totaling $21,000, or $0.07 per share.
During February and March 2015, the Company sold an aggregate of 2,500,000 restricted shares of common stock to three accredited investors for cash proceeds of $125,000 at a price of $0.05 per share. There were no underwriters involved.
During September 2012, the Company sold an aggregate of 2,483,3333,000,000 restricted shares of common stock to seven accredited investors for cash proceeds of $149,000 at a price of $0.06totaling $150,000, or $0.05 per share. There were no underwriters involved.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
December 31, 2012 and 2011
NOTE 6 - EQUITY TRANSACTIONS (Continued)
During October, NovemberApril, May and December 2012,June 2015, the Company sold an aggregate of 2,234,3007,500,000 restricted shares of common stock to sixeight accredited investors for cash proceeds of $135,858 at prices ranging from of $0.06 to $0.078totaling $375,000, or $0.05 per share. There were no underwriters involved.
During August 2015, the Company sold an aggregate of 2,600,000 restricted shares of common stock to five accredited investors for cash proceeds totaling $130,000, or $0.05 per share.
During November 2015, the Company sold 10,000,000 restricted shares of common stock to an accredited investor for cash proceeds totaling $1,000,000, or $0.10 per share.
Recapitalization
The Company’s amended Articles of Incorporation (“AOI”) include a class of preferred stock, par value $0.00001, with authorized shares of 50,000,000. To date, no shares of preferred stock have been issued. The rights and preferences of the authorized preferred shares will be determined by the Company’s Board of Directors.
MEDIZONE INTERNATIONAL, INC. AND AFFILIATE
Notes to Consolidated Financial Statements
December 31, 2015 and 2014
NOTE 6 - EQUITY TRANSACTIONS (continued)
The amended AOI authorize 395,000,000 shares of common stock, par value $0.001.
Stock Purchase Agreement
On November 17, 2010, the Company entered into a Common Stock Purchase Agreement (the “Stock Purchase Agreement”), with Mammoth Corporation (“Mammoth”) providing for a financing arrangement that is sometimes referred to as a committed equity line financing facility (or “Equity Line”). The Stock Purchase Agreement provided that, upon the terms and subject to the conditions in the Stock Purchase Agreement, Mammoth was committed to purchase up to $10,000,000 of shares of common stock over the 24-month term of the Stock Purchase Agreement. Furthermore, in no event could Mammoth purchase any shares of the Company’s common stock which, when aggregated with all other shares of common stock then beneficially owned by Mammoth, would result in the beneficial ownership by Mammoth of more than 4.9 percent of the then outstanding shares of the Company’s common stock. These maximum share and beneficial ownership limitations could not be waived by the parties.
Under the terms of the Stock Purchase Agreement, the Company had the opportunity for a 24-month period, commencing on the date on which the SEC first declares effective the registration statement, to require Mammoth to purchase up to $10,000,000 in shares of common stock. For each share of common stock purchased under the Stock Purchase Agreement, Mammoth would pay to the Company a purchase price equal to 75 percent of the lowest closing bid price during the five consecutive trading day period (the “Draw Down Pricing Period”) preceding the date a draw down notice (the “Draw Down Notice”) is delivered to Mammoth (the “Draw Down Date”) in a manner provided by the Stock Purchase Agreement. Subject to the limitations outlined below, the Company could, at its sole discretion, issue a Draw Down Notice to Mammoth, and Mammoth would then be irrevocably bound to purchase such shares.
Each Draw Down Notice must specify the lowest purchase price during the Draw Down Pricing Period at which the Company would sell the shares to Mammoth, which could not be less than 75 percent of the lowest closing bid price during the Draw Down Pricing Period. Furthermore, the number of shares to be issued was limited by multiplying by five the average daily trading volume for the 30 trading days immediately preceding the delivery of the Draw Down Notice. The Draw Down Notice also included the aggregate dollar amount of the Draw Down, which could not be less than $25,000 and not more than $500,000 in any Draw Down Notice. There must be a minimum of 15 trading days between each Draw Down Notice. Regardless of the maximum amount indicated in the Draw Down Notice, Mammoth was not obligated to purchase shares under any Draw Down Notice in an amount which, when added to the number of shares of common stock then beneficially owned by Mammoth, would result in Mammoth owning more than 4.9 percent of the outstanding shares of the Company’s common stock.
The Company agreed to pay up to $5,000 of reasonable attorneys’ fees and expenses (of which the Company paid $4,300 during the year ended December 31, 2011 to fully satisfy this obligation) incurred by Mammoth in connection with the preparation, negotiation, execution and delivery of the Stock Purchase Agreement and related transaction documentation.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
December 31, 2012 and 2011
NOTE 6 - EQUITY TRANSACTIONS (Continued)
Further, if the Company issued a Draw Down Notice and failed to deliver the shares to Mammoth on the applicable settlement date, and such failure continued for 10 trading days, the Company agreed to pay Mammoth, in addition to all other remedies available to Mammoth under the Stock Purchase Agreement, an amount in cash equal to $100 for each $5,000 of the Draw Down Amount for the first 10 days such delivery is late, and $350 for each $5,000 of the Draw Down Amount for each trading day beyond 10 trading days that such delivery is late.
In connection with the Stock Purchase Agreement, the Company granted registration rights to Mammoth, and agreed to register the resale of shares issued to Mammoth in connection with Draw Downs made in connection with the Stock Purchase Agreement. In January 2011, the Company filed a registration statement to cover the resale by Mammoth of up to 66,666,667 shares of common stock under the Stock Purchase Agreement. The Company was not permitted to make Draw Downs under the Stock Purchase Agreement at any time there was not an effective registration statement registering the resale of shares of common stock by Mammoth. On January 25, 2011, the registration statement was made effective by the SEC. As previously mentioned, the Company made four Draw Down requests under the Stock Purchase Agreement during the year ended December 31, 2011 as well as two requests during the year ended December 31, 2012. The Stock Purchase Agreement terminated automatically by its terms on January 25, 2013, the 24-month anniversary of the effective date of the registration statement.
ADA Innovations
In December 2010, the Company reached a Services Agreement with ADA Innovations (“ADA”) for final development and production manufacturing of portable versions (the Projects) of the Company’s AsepticSure™ disinfection systems. A contract containing the terms of the agreement and detailed development plan was executed by the parties in January 2011, and amended in January 2012. Any and all notes, reports, information, inventions, sketches, plans concepts, data or other works created by ADA on its behalf under the Services Agreement will be the sole and exclusive property of the Company.
The term of the Services Agreement continued until the completion of the development and design projects contemplated by the Services Agreement. Deliverables included: (1) the pre-production prototype designed and manufactured to the Company’s specifications, (2) design and device content compliant with all North America, Europe and United Kingdom regulatory and licensing agency regulations, (3) a soft launch program managed by ADA and the Company, intended to be followed by increased production, and (4) additional outsourced macro-manufacturing capacity as required, supervised by the parties. The Company paid ADA as services were provided. During the year ended December 31, 2012 and 2011, the Company incurred expenses totaling approximately $212,000 and $607,000, respectively, for services provided under the Services Agreement. Of these amounts, approximately $204,000 and $569,000, respectively, were recorded as research and development expenses.
NOTE 7 - COMMON STOCK OPTIONS
On August 26, 2009, the Company granted options for the purchase of a total of 1,000,000 shares of common stock to a Company director with an exercise price of $0.10 per share, exercisable for up to five years. On the same date, the Company granted options for the purchase of an additional 1,500,000 shares of common stock to an outside consultant for services rendered, with an exercise price of $0.10 per share, exercisable for up to five years, but including vesting provisions as follows: i) options for purchase of 500,000 shares vested immediately on the date of grant, ii) options for 500,000 shares will vest on the date certified by the Company as the date the Company’s hospital disinfection program completes its beta-testing (completed in 2012), and iii) the remaining options will vest on the date certified by the Company as the date that the Company’s process has been commercialized and a minimum of 50 units or devices have been sold to third parties by the Company. During the year ended December 31, 2012, 500,000 options vested for which the Company recognized $48,699 of expense. As of December 31, 2012, options for the purchase of 500,000 of the 1,500,000 shares had not yet vested.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
December 31, 2012 and 2011
NOTE 7 - COMMON STOCK OPTIONS (Continued)
In July 2010, the Company granted options for the purchase of up to 3,500,000 shares (of which 250,000 were cancelled in 2011) of common stock to certain board members and employees of the Company as additional compensation for work performed. These options are exercisable at $0.20 per share, are exercisable for five years, but do not vest until the Company has achieved commercial sales (completed in 2012). During the year ended December 31, 2012, these 3,250,000 options vested for which the Company recognized $659,822 of expense.
In September 2010, the Company granted options for the purchase of up to 250,000 shares of common stock to an outside consultant in connection with extending his consulting agreement with the Company through September 2011. These options are exercisable at $0.275 per share, are exercisable for five years, but do not vest until the Company has achieved commercialization and sales of the AsepticSure product. During the year ended December 31, 2012, these options vested for which the Company recognized $65,067 of expense.
In March 2011, the Company granted options for the purchase of 150,000 shares of common stock to an individual for accounting related services to be performed through December 30, 2011. The options have an exercise price of $0.14 per share, and are exercisable for up to five years. The Company recognized $20,042 of expense during the year ended December 31, 2011 for these options.
In March 2011, the Company granted options for the purchase of 100,000 shares of common stock to an individual for web and press support services to be performed through December 30, 2011. The options have an exercise price of $0.14 per share, and are exercisable for up to five years. The Company recognized $13,361 of expense, during the year ended December 31, 2011 for these options.
In February 2012, the Board of Directors approved the 2012 Equity Incentive Award Plan (the “2012 Plan”) and authorized up to 10,000,000 shares of common stock to be available for awards under the 2012 Plan. On February 21, 2012, each of four directors of the Company was awarded stock options for the purchase of 1,000,000 shares of common stock, exercisable at a price of $0.23 per share, which was the closing price of the Company’s common stock reported on the over-the-counter Bulletin Board on the date of grant. In addition, certain officers, consultants and employees of the Company were awarded in the aggregate options in the aggregate for the purchase of 1,050,000 shares of stock at an exercise price of $0.23 per share. The value of these options granted, totaling $1,057,600, was recognized as expense during the year ended December 31, 2012 as each of the options granted was fully vested on the date of grant.
In May 2012, the Company granted options for the purchase of 1,000,000 shares of common stock to an individuala consultant for distribution channel related services to be performed. Options for 100,000 sharesThe options have vested as of December 31, 2012 and the remaining options will vest on the date certified by the Company as the date that the other milestones are achieved.2015. The options have an exercise price of $0.17 per share, and are exercisable for up to five years. The Company recognized $69,300 of expense during the year ended December 31, 2015.
In August 2013, the Company granted options for the purchase of 250,000 shares of common stock to a consultant. These options are exercisable at $0.10 per share for five years from the date of grant with 50,000 options vesting immediately and the other 200,000 options vesting upon the achievement of certain milestones, which were met in 2015. The Company recognized the remaining expense of $17,659 during the year ended December 31, 2015.
On February 26, 2014, the Company granted to a new director options for the purchase of 2,000,000 shares of common stock, with an exercise price of $0.1095 per share. Of these options, 1,000,000 vested February 26, 2015 and the remaining 1,000,000 options will vest upon the successful achievement of certain milestones. Unvested options vest immediately in the event of a change in control of the Company. The options are exercisable for five years. The Company recognized $16,017 and $80,075 during the years ended December 31, 2015 and 2014, respectively, in connection with the options that vested February 26, 2015. The Company will measure and begin recognizing the remaining expense when the achievement of the required milestones becomes probable.
On February 26, 2014, the Company granted options to six consultants and service providers for the purchase of a total of 250,000 shares of common stock at an exercise price of $0.1095 per share. Options for 200,000 shares vested immediately upon grant and options for the remaining 50,000 shares vested January 9, 2015. The options are exercisable for five years. The grant date fair value of these options was $153,997 in connection with which the$24,023. The Company recognized $15,399 forexpense of $800 and $23,223 during the yearyears ended December 31, 2012. The Company will recognize the remaining expense upon achievement of the required milestones.2015 and 2014, respectively.
In May 2012,On April 30, 2014, the Company granted options for the purchase of 1,000,000a total of 1,350,000 shares of common stock for services rendered, as follows: 250,000 shares to each of four directors of the Company, 100,000 shares to each of two consultants, and 75,000 shares each to a consultant and an individual for medical consulting support services already performed (vested immediately onemployee of the Company. All options vested upon grant, date) and to be performed in the future, which do not vest until completion of certain milestones. The options have an exercise price of $0.17$0.163 per share, and are exercisable for up to five years. The total value of these options at the date of grant was $193,234, which the Company recognized as an expense during the year ended December 31, 2014.
On May 6, 2014, the Company granted options to a consultant for the purchase of 100,000 shares of common stock at an exercise price of $0.19 per share. Options for 50,000 shares vested immediately upon grant and options for the remaining 50,000 vested during 2015. The options are exercisable for five years. The Company recognized expense of $8,342 and $8,342 during the years ended December 31, 2015 and 2014, respectively.
On August 15, 2014, the Company granted options to a consultant for the purchase of 75,000 shares of common stock at an exercise price of $0.13 per share. The shares will vest when certain required milestones are achieved. The options are exercisable for five years. The Company will measure and begin recognizing an expense when the achievement of the required milestones becomes probable.
On August 15, 2014, the Company granted options for services rendered to a director of the Company for the purchase of 1,000,000 shares of common stock at an exercise price of $0.13 per share. These options vested immediately upon grant. The Company recognized expense of $114,069 during the year ended December 31, 2014, which was the grant date fair value of these options was $149,460. During 2012,options.
On October 7, 2014, the Company granted to a new board member options for the purchase of 670,000 of the 1,000,000 shares had vested and the Company recognized expense of $100,138 during the year ended December 31, 2012. The Company will recognize the remaining expense upon achievement of the required milestones.
In August 2012, the Company granted options for the purchase of 2,500,000 shares of common stock, to three individuals in connection with the purchase of restricted stock, exercisable at aan exercise price of $0.05$0.16 per share. No expense was recordedThese options vested October 7, 2015. The options are exercisable for these options as anyfive years. The grant date fair value associated with theseof the options was recorded as part of$140,178. The Company recognized $105,133 and $35,045 during the stock transactions.years ended December 31, 2015 and 2014, respectively.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIESAFFILIATE
Notes to the Consolidated Financial Statements
December 31, 20122015 and 20112014
NOTE 7 - COMMON STOCK WARRANTS AND OPTIONS (Continued)(continued)
On December 4, 2014, the Company granted options to four consultants for the purchase of 140,000 shares of common stock at an exercise price of $0.11 per share. The Company estimatedrequired milestones have been met and the fairshares are fully vested. The options are exercisable for five years. The total value of the stockthese options at the date of grant was $13,461, which the Company recognized as an expense during the year ended December 31, 2015.
.
In August 2015, the Company granted options for the purchase of a total of 7,150,000 shares of common stock for services rendered, as follows: 6,000,000 shares total to five directors of the Company, 650,000 shares total to four consultants, and 500,000 shares to an employee of the Company. All options vested upon grant, based onhave an exercise price of $0.088 per share, and are exercisable for up to five years. The total value of these options at the following weighted average assumptions:date of grant was $541,687, which the Company recognized as an expense during the year ended December 31, 2015.
| | | | | 2.46 | % |
| Expected life | | | | | 5 years | |
| | 185.59% | | to | | % |
| | | | | 0.00 | % |
A summaryThe Company’s 2014 Equity Compensation Plan (the “2014 Plan”) was adopted on April 30, 2014 by the Board of Directors. The Company filed a registration statement on Form S-8 on July 17, 2014, to register 6,000,000 shares of common stock that may be issued under awards made pursuant to the status of the Company’s outstanding options as2014 Plan. As of December 31, 20122015, the Company had 4,935,000 options available for grant under the 2014 Plan and changes during the year then ended is presented below:
previously adopted plans.
| | | Shares | | | Weighted Average Exercise Price | |
Outstanding, January 1, 2012 | | | | | | | | |
| | | 9,550,000 | | | | 0.17 | |
| | | | | | | | |
| | | | | | | | |
Outstanding, December 31, 2012 | | | 17,300,000 | | | | 0.19 | |
| | | 15,570,000 | | | | | |
The Company estimates the fair value of each stock award by using the Black-Scholes option pricingoption-pricing model, which model requires the use of exercise behavior data and the use of a number of assumptions including expected volatility of the Company’s stock price, the weighted average risk-free interest rate, and the weighted average expected life of the options. Because the Company does not pay dividends, the dividend rate variable in the Black-Scholes option-pricing model is zero. Expense of $1,946,725$791,390 and $33,403$453,987 was recorded for the years ended December 31, 20122015 and 2011, respectively, using the Black-Scholes option-pricing model. As2014, respectively. Excluding options whose performance condition is not yet deemed probable as of December 31, 2012,2015, the Company had various unvested outstanding options which have not vested totaling approximately $237,000.with related unrecognized expense of $104,647. The Company will recognize suchthis expense if such individualwhen achievement of the required milestones become probable.
The Company estimated the fair value of the stock options vest over their remaining useful lives which range from 20at the date of the grant, based on the following weighted average assumptions:
| Risk-free interest rate | | | 1.52 | % | to | | | 1.60 | % |
| Expected life | | | | | | | | 5 years | |
| | | | | | | | | |
| | | | | | | | | |
A summary of the status of the Company’s outstanding options as of December 31, 2015 and changes during the year then ended is presented below:
| | | Shares | | | Weighted Average Exercise Price | |
Outstanding, January 1, 2015 | | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Outstanding, December 31, 2015 | | | | | | | | |
| | | | | | | | |
MEDIZONE INTERNATIONAL, INC. AND AFFILIATE
Notes to 52 monthsConsolidated Financial Statements
December 31, 2015 and 2014
NOTE 8 - ACCOUNTS PAYABLE – RELATED PARTIES
As of December 31, 20122015 and 2011,2014, the Company owed $234,572 and $229,669, respectively,$233,109 to certain consultants for services. These consultants are stockholders of the Company and are classified as related parties.
NOTE 9 - NOTES PAYABLE
Notes payable consist of the following as of December 31, 20122015 and 2011:2014:
| | | 2012 | | | 2011 | |
Unsecured notes payable to ten stockholders, due on demand, plus interest at 10% per annum (principle and accrued interest in arrears as of report date). The Company is obligated to accept the rate at face value plus accrued interest as partial payment for shares the lenders may purchase from the Company upon exercise of the lenders’ option to acquire shares from the Company. | | $ | 60,815 | | | $ | 60,815 | |
| | | | | | | | | |
Unsecured notes payable to directors totaling $28,000 and a note payable to a third party in the amount of $9,000, due on April 22, 1995 (principal and accrued interest in arrears as of report date), plus interest at 8% per annum. Each lender has the right to convert any portion of the principal and interest into common stock at a price per share equal to the price per share under a prior private placement transaction. | | | 37,000 | | | | 37,000 | |
| | | | | | | | | |
Unsecured notes payable to former directors and a family member of a former director, due at various dates in 1995, 1996 and 1997 (principal and accrued interest in arrears as of report date), plus interest at 8% per annum. The Company has the right to repay the loans with restricted stock at $0.10 per share if alternative financings do not occur. | | | 182,676 | | | | 182,676 | |
| | | 2015 | | | 2014 | |
| Unsecured notes payable to former directors and a family member of a former director, due at various dates in 1995, 1996 and 1997 (principal and accrued interest as of December 31, 2015), interest at 8%. The Company has the right to repay the loans with restricted stock at $0.10 per share if alternative financings do not occur. These notes payable are in default. | | $ | 182,676 | | | $ | 182,676 | |
| Unsecured notes payable to a third party in the amount of $50,000, due on September 8, 2018 (principal as of December 31, 2015), interest at 12%. Accrued interest due semi-annually, January 5 and July 5 of each year. The note holder has the right to convert 20% of the then outstanding principal into common shares at $0.10 per share. | | | 50,000 | | | | - | |
| Unsecured notes payable to 10 stockholders, due on demand, interest at 10% (principal and accrued interest as of December 31, 2015). The Company is obligated to accept the principal rate at face value plus accrued interest as partial payment for shares the lenders may purchase from the Company upon exercise of the lenders’ option to acquire shares from the Company. | | | 60,815 | | | | 60,815 | |
| Unsecured notes payable to a third party in the amount of $25,000, due on September 17, 2018 (principal as of December 31, 2015), interest at 12%. Accrued interest due semi-annually, January 5 and July 5 of each year. The note holder has the right to convert 20% of the then outstanding principal into common shares at $0.10 per share. | | | 25,000 | | | | - | |
| Unsecured notes payable to directors totaling $28,000 and a note payable to a third party in the amount of $9,000, due on April 22, 1995 (principal and accrued interest as of December 31, 2015), interest at 8%. Each lender has the right to convert any portion of the principal and interest into common stock at a price per share equal to the price per share under a prior private placement transaction. These notes payable are in default. | | | 37,000 | | | | 37,000 | |
| Unsecured notes payable to a financing company, payable in nine monthly installments, interest ranging from 4.63% to 6.43%m, mature in April, July and November 2016. | | | 16,905 | | | | 17,750 | |
| Total notes payable | | | 372,396 | | | | 298,241 | |
| Less notes payable current portion | | | (297,396 | ) | | | (298,241 | ) |
| Total notes payable long term | | $ | 75,000 | | | $ | - | |
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIESAFFILIATE
Notes to the Consolidated Financial Statements
December 31, 20122015 and 2011
NOTE 9 - NOTES PAYABLE (Continued)
| | | 2012 | | | 2011 | |
| | | | | | | |
Unsecured note payable to a financing company, payable in nine monthly installments, interest at 6.23% per annum, matures on July 15, 2013. | | $ | 18,045 | | | $ | 2,758 | |
| | | | | | | | | |
| | | 298,536 | | | | 283,249 | |
| | | (298,536 | ) | | | (283,249 | ) |
| | $ | - | | | $ | - | |
The notes payable balances as of December 31, 2012 have been classified as short term as each note payable is due on or before December 31, 2013.2014
NOTE 10 - GOING CONCERN
The Company’s consolidated financial statements are prepared using U.S.in accordance with US GAAP which assumes an entity is a going concern and contemplates the realization of assets and liquidationthe settlement of liabilities in the normal course of business. The Company has incurred significant recurring losses from its inception through December 31, 2012,2015, which have resulted in an accumulated deficit of $30,084,992$35,398,346 as of December 31, 2012.2015. The Company has minimal cash, has a working capital deficit of approximately $3,307,973,$2,675,007, and a total stockholder’sstockholders’ deficit of $3,314,099$2,569,234 as of December 31, 2012.2015. The Company has relied almost exclusively on debt and equity financing to sustain its operations. Accordingly, there is substantial doubt about its ability to continue as a going concern.
Continuation of the Company as a going concern is dependent upon obtaining additional capital and ultimately, upon the Company’sCompany attaining profitable operations. The Company will require a substantial amount of additional funds to complete the continued development ofcontinue to develop its products, product manufacturing, and to fund additional losses, until revenues are sufficient to cover the Company’s operating expenses. If the Company is unsuccessful in obtaining the necessary additional funding, noted below, it will most likely be forced to substantially reduce or cease operations.
TheThe Company believes that it will need approximately $1,500,000$1,000,000 during the next 12 months for continued production manufacturing research, development, and development, marketing and related activities, as well as for general corporate purposes, including manufacturing and sales.
purposes.
During 2012,During 2015, the Company raised a total of $1,420,793$1,676,000 through the sale of 16,729,27823,400,000 shares of common stock at prices ranging from $0.05 to $0.165$0.10 per share, which funds have been used to keep the Company current in its public reporting obligations and to pay certain other corporate obligations including the initial costs of development for its hospital sterilizationdisinfection system. Subsequent to December 31, 2012, through the date of this report, the Company raised a total of $310,000 through the sale of 10,333,332 shares of common stock at a price of $0.03 per share.
The Company believes it can raise additional funds from some of the samecertain investors who have purchased shares from 2009 to 2012,through 2015, although there is no guaranteeassurance that these investors will purchase additional shares.
The ability of the Company to continue as a going concern is dependent on its ability to successfully accomplishaccomplishing the plan described in the preceding paragraphs and eventually attainattaining profitable operations. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result from the outcome of this uncertainty.
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
December 31, 2012 and 2011
NOTE 11 – CUSTOMER DEPOSITS
In November 2011, the Company entered into a production manufacturing contract with SMTC Corporation (SMTC), headquartered in Toronto, Canada. SMTC maintains manufacturing facilities in Canada, the United States, Mexico and China. In January 2012, the Company initiated its first purchase order for five production validation units to be manufactured. The production validation units were used for regulatory compliance and licensing validation, additional testing and early delivery purposes.
As of December 31, 2011,2014, the Company received two purchase orders and related customer deposits totaling $40,000$30,000 to purchase the AsepticSureAsepticSure® hospital disinfection systems. The Company took delivery of its first disinfection systems early in 2012. As ofand related equipment. During the year ended December 31, 2011,2015, these customer deposits were reflectedapplied toward the purchase of these units and were recognized as current liabilities.revenue.
In September 2012, the Company changed manufacturers and entered into a contract with Transformix Engineering (Transformix) to manufacture the Company’s devices. Transformix is a specialty engineering and manufacturing company located in Kingston, Ontario, Canada. This change in manufacturers was necessitated to address delays in product delivery and quality control issues encountered under the earlier agreement. The Company took delivery of the first AsepticSure systems built by Transformix in December 2012. Transformix expects to ramp up production in order to meet estimated sales orders of the AsepticSure system for the second quarter of 2013.
NOTE 12 – SUBSEQUENT EVENTS
The Company has evaluated subsequent events through the filing date of this reportAnnual Report on Form 10-K and has determined it appropriate to disclose the following event.
During January February and March 2013,2016, the Company soldfinalized an aggregateagreement with a consultant to obtain the know-how necessary to source the UV ozone-generating bulbs and the manufacturing expertise used in the construction of 10,333,332 restrictedgenerators used in the AsepticSure® hospital disinfection systems. In exchange, the Company issued 500,000 common shares of common stockat $0.08 per share to nine accredited investors for cash proceeds of $310,000 at a price of $0.03 per share.this consultant. In February 2016, the Company terminated the agreement as to future payments to the consultant.