UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-K

 

(Mark One)

 

[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the fiscal year ended December 31, 2017

 

OR

 

[  ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO

 

Commission File Number 001-54856

 

OWC Pharmaceutical Research Corp.

(Exact name of Registrant as specified in its Charter)

 

 

 

Delaware   98-0573566
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)
     
2 Ben Gurion st, Ramat Gan, Israel   5257334
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: +972-72-260-8004

 

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Name of Each Exchange on Which Registered

 

Securities registered pursuant to Section 12(g) of the Act:

Common Stock, $0.0001 par value

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES [  ] NO [X]

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES [  ] NO [X]

 

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 [X] NO [  ]

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, 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 [X] NO [  ]

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405) is not contained herein, and will not be contained, to the best of 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. [  ]

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   [  ]   Accelerated filer   [  ]
Non-accelerated filer   [  ](Do not check if a small reporting company)   Small reporting company   [X]
Emerging growth company   [  ]        

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES [  ] NO [X]

 

The aggregate market value of common stock held by non-affiliates of the registrant as of June 30, 2017, the last business day of the registrant’s most recently completed second quarter, was $89 million, computed based on the closing price of $0.62 per share on June 30, 2017.

 

As of April 16, 2018 there were 147,758,908 shares of the registrant’s common stock, par value $0.001 per share, outstanding.

 

DOCUMENTS INCORPORATED BY REFERENCE

 

The following documents (or parts thereof) are incorporated by reference into the following parts of this Form 10-K: Certain information required in Part III of this Annual Report on Form 10-K is incorporated from our definitive proxy statement for the 2018 annual meeting of stockholders to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of our fiscal year ended December 31, 2017.

 

 

 

 

 

 

TABLE OF CONTENTS

 

Item   Description   Page
     
    PART I   4
         
ITEM 1A.   RISK FACTORS   20
ITEM 1B.   UNRESOLVED STAFF COMMENTS   41
ITEM 2.   PROPERTIES   41
ITEM 3.   LEGAL PROCEEDINGS   41
ITEM 4.    MINE SAFETY DISCLOSURES   41
         
    PART II   41
     
ITEM 5.   MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF SECURITIES   41
ITEM 6.   SELECTED FINANCIAL DATA   44
ITEM 7.   MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATION   44
ITEM 7A.   QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK   46
ITEM 8.   FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA   46
ITEM 9.   CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE   75
ITEM 9A.   CONTROLS AND PROCEDURES   75
ITEM 9B.   OTHER INFORMATION   76
         
    PART III   76
     
ITEM 10.   DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE   76
ITEM 11.   EXECUTIVE COMPENSATION   76
ITEM 12.   SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS   76
ITEM 13.   CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTORS INDEPENDENCE   76
ITEM 14.   PRINCIPAL ACCOUNTING FEES AND SERVICES   76
         
    PART IV   76
         
ITEM 15.   EXHIBITS AND FINANCIAL STATEMENT SCHEDULES   76
ITEM 16.   10-K SUMMARY   77

 

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Cautionary Statement regarding Forward-Looking Statements

 

This Annual Report on Form 10-K contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve risks and uncertainties, principally in the sections entitled “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” All statements other than statements of historical fact contained in this Annual Report on Form 10-K, including statements regarding future events, our future financial performance, business strategy and plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate” and “continue,” or the negative of such terms or other similar expressions. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we caution you that these statements are based on our good faith projections of the future that are subject to known and unknown risks and uncertainties and other factors that may cause our actual results, level of activity, performance or achievements expressed or implied by these forward-looking statements, to differ materially. The description of our Business set forth in Item 1, the Risk Factors set forth in Item 1A and our Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth in Item 7 as well as other sections in this report, discuss some of the factors that could contribute to these differences. These forward-looking statements include, among other things, statements about:

 

  our ability to continue as a going concern;
  our ability to generate revenue or achieve profitability;
  our ability to obtain additional financing on acceptable terms, if at all;
  our ability to obtain insurance coverage;
  performance of our information technology and storage systems;
  a disruption of breach of our information technology systems;
  our dependence on the success of cannabinoid technology;
  our ability to keep pace with technological advances;
  legal and regulatory developments in the United States and foreign countries;
  the success and timing of our preclinical and clinical trials;
  our ability to secure Israeli licenses to use cannabis for medical research;
  the rate and degree of market acceptance of cannabis-based medical products;
  the success of competing products or therapies that become available;
  our dependence on third parties;
  the performance of third parties upon which we depend;
  our ability to obtain and maintain protection for our intellectual property;
  our ability to protect and defend against litigation, including intellectual property claims;
  our ability to obtain licenses, if necessary, on commercially reasonable terms or at all;
  our ability to attract and retain key personnel;
  risks related to operating in Israel;
  the volatility of the price of our Common Stock;
  the marketability of our Common Stock;
  our broad discretion to invest or spend the proceeds from our financings in ways with which our stockholders may not agree and may have limited ability to influence; and
  other risks and uncertainties, including those listed in Item 1A, “Risk Factors.”

 

Moreover, we operate in a highly competitive and rapidly changing environment. New risks emerge from time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements.

 

You should not place undue reliance on any forward-looking statement, each of which applies only as of the date of this Annual Report on Form 10-K. Before you invest in our securities, you should be aware that the occurrence of the events described in the section entitled “Risk Factors” and elsewhere in this Annual Report on Form 10-K could negatively affect our business, operating results, financial condition and stock price. All forward-looking statements included in this document are based on information available to us on the date hereof, we undertake no obligation to publicly update or revise any of the forward-looking statements after the date of this Annual Report on Form 10-K, whether as a result of new information, future events otherwise, except as required by law.

 

As used in this Annual Report on Form 10-K, unless the context indicates or otherwise requires, “our Company”, “the Company”, “OWC,” “we,” “us,” and “our” refer to OWC Pharmaceutical Research Corp., a Delaware corporation, and its consolidated subsidiary, One World Cannabis Ltd., a company organized under the laws of Israel.

 

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PART I

 

ITEM 1. DESCRIPTION OF BUSINESS

 

Overview

 

We are an early stage medical cannabis research and development company that applies conventional pharmaceutical research protocols and disciplines to the field of medical cannabis with the objective of establishing a leadership position in the research and development of medical cannabis therapies, products and delivery technologies. We are currently engaged in the research and development and have conducted trials on the efficacy of cannabis-based medical products (the “Cannabis-Based Medical Products”) commencing with our cannabis-based topical cream for the treatment of psoriasis. In addition, we also are pursuing the use of our Cannabis-Based Medical Products for the treatment of multiple myeloma, post-traumatic stress disorder (“PTSD”), chronic pain and fibromyalgia, and have made significant advancements in the development of a cannabis soluble tablet delivery system that could have applications for other indications. We are also capable of providing consulting and advisory services to governmental and private entities to assist them with developing and implementing tailor-made, comprehensive medical cannabis programs, although we have not generated any revenues from such services to date.

 

We have been engaged in research and development and consulting and advisory activities through our wholly-owned Israeli subsidiary, One World Cannabis Ltd since July 2014. To date, we have entered into binding agreements with major hospitals and medical research facilities in Israel for the purpose of conducting research studies and trials related to the development and use of Cannabis-Based Medical Products for the treatment of multiple myeloma, psoriasis, PTSD, chronic pain and fibromyalgia, and for the development of a cannabis soluble tablet delivery system. We recently announced promising clinical results from the testing of our cannabis-based topical cream for the treatment of psoriasis, an autoimmune disease that causes red, scaly patches to appear on the skin. Skin cells in patients with psoriasis grow at an abnormally fast rate, causing a buildup of lesions that tend to burn and itch. While the real cause of psoriasis is not known, genetics are believed to play a major role in its development. According to the American Academy of Dermatology, psoriasis affects about 3% of the world’s population and 7.5 million people in the United States.

 

History and Former Operations

 

In 2008, we acquired a patent relating to our electromagnetic percussion device (the “Device”). In March 2013, we entered into a manufacturing and distribution agreement with GUMI Tel Aviv Ltd. (“GUMI”), a technology company engaged in the manufacture and sale of industrial equipment, to develop, manufacture and market the Device. To date, we have not derived any revenues from GUMI’s marketing efforts. We abandoned this line of business in 2015 and in February 2016 terminated our agreement with GUMI, executing mutual general releases.

 

We were incorporated in Delaware on March 7, 2008 under the name Dynamic Applications Corp. We changed our name to OWC Pharmaceutical Research Corp. on December 9, 2014. We formed our wholly owned subsidiary One World Cannabis Ltd in Israel on July 6, 2014. Our principal executive offices are located at 2 Ben Gurion St. Ramat Gan, Israel 5257334 and our telephone number is 972 (0) 72-260-8004.

 

Recent Developments

 

On September 28, 2016, we entered into a loan agreement (the “Loan Agreement”) with Medmar LLC (“Medmar”), pursuant to which Medmar agreed to loan us a total of $300,000 (the “Loan”) on a non-interest bearing basis, with no conversion rights. The Loan is due in 36 months from September 22, 2016 (the “Effective Date”), and repayment would have been made only by a set off of royalties payable by Medmar to us as follows: (i) prior to the full repayment of the Loan, which we may prepay at any time, if and to the extent Medmar is required to pay any royalties to us under a License Agreement dated March 17, 2016, Medmar shall set off such royalties from the outstanding principal balance of the Loan; (ii) we shall not be required to pay the Loan other than through the set off from the royalties; and (iii) the Loan is a non-recourse loan, meaning that if and to the extent that the royalties are insufficient for any reason in order to fully repay the Loan, Medmar waived any right and/or claim to any deficiency.

 

In addition, the Loan Agreement also provided that: (i) subject to Medmar funding the entire Loan, Medmar shall receive the exclusive right to manufacture, produce, publicize, promote and market our Licensed Products (as defined in the above-referenced License Agreement) in any state in the U.S., subject to a new license agreement to be negotiated and signed between the parties with respect to each and every state; (ii) the rights to be granted to Medmar under (i) above shall expire within three (3) years subject to certain conditions and limitations; and (iii) the right of first refusal agreement between the parties that was executed on February 8, 2016 providing Medmar certain rights in connection with the commercialization of Licensed Products in the States of Hawaii and Pennsylvania be terminated.

 

On April 21, 2017, we provided written notice to Medmar regarding our determination to prepay the loan in the principal amount of $300,000. Pursuant to Sections 4 and 5.3 of the Loan Agreement and based upon the full repayment of the non-recourse, non-interest bearing and non-convertible loan, we have elected to exercise what we believes is our absolute right to terminate certain distribution rights granted to Medmar under the loan agreement.

 

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On November 27, 2016, we entered into a license agreement (the “License Agreement”) with Emilia Cosmetics Ltd. (“Emilia”), a world-leading company in the field of development, production, manufacturing and packaging of health and beauty products including for treatment of human skin disease.

 

Prior to entering into the License Agreement, Emilia and the Company (the “Parties”) conducted a “Development and Evaluation Program” (as defined in the License Agreement) for the development of a specific product comprising Emilia’s formulation with certain medical cannabis extract provided by us for topical treatment of psoriasis.

 

Pursuant to the License Agreement, Emilia granted a limited license to us with respect to Emilia’s licensed intellectual property (the “Emilia Intellectual Property”) to be developed and commercialized worldwide in the topical treatment of psoriasis in humans with our product and upon the successful achievement of the trial, Emilia will grant us an exclusive, worldwide, transferable, royalty-bearing license, with the right to grant sublicenses, to use, sell and commercially exploit the Emilia Intellectual Property (the “Emilia License”). In consideration for the Emilia License, from and after the first commercial sales of our product, we shall pay to Emilia a royalty at the rate of ten (10%) percent of net sales during a ten-year term beginning upon the first commercial sale. In the event the sale of the Licensed Product during the royalty term reaches the minimum sales targets mutually agreed by the Parties as set forth in the License Agreement, the royalty term will extend to an additional five (5) year term. The trial was completed in May 2016 and as a result we became the exclusive licensee of the Emilia Intellectual Property.

 

On December 29, 2016, we entered into a research agreement (the “Research Agreement”) with the Medical Research Infrastructure Development and Health Services Fund of the Chaim Sheba Medical Center, a non-profit organization incorporated under the laws of the State of Israel (the “Fund”).

 

Pursuant to the Research Agreement, the Fund shall perform a Phase I, placebo controlled, maximal dose study (the “Study”) to determine the safety, tolerability of topical cream containing Medical Grade Cannabis (“MGC” or the “Study Drug”) in healthy volunteers, employing the services of Dr. Aviv Barzilay, Director of the Department of Dermatology at Chaim Sheba Medical Center, to lead the Study (the “Investigator”). The Study shall be conducted in compliance with the following, as defined in the Research Agreement: (1) the Protocol; (2) the Ministry Guidelines; (3) the instructions and terms specified in the Helsinki Committee’s approval; (4) the ICH-GCP; (5) the Helsinki Declarations; (6) the applicable laws, rules and regulations regulating such studies which are applicable in Israel (the “Applicable Laws”); and (7) written instructions and prescriptions issued by us and governing the administration of the Study Drug.

 

We have undertaken to pay the Fund the amounts specified in the payment schedule set forth in the Research Agreement.

 

On February 1, 2017, following encouraging results that have been achieved at the mid-point of the psoriasis-related study conducted by us with an Israeli research institute, our Board of Directors and our management and scientific personnel have determined to extend the size and scope of the Study for the purpose of, among other things, checking the biological markers that have been generated to date with respect to the treatment of psoriasis (proliferation/inhibition and several interleukins).

 

On March 20, 2017, we announced the promising preliminary results from the pre-clinical efficacy testing of our cannabinoid-based topical cream for treating psoriasis, reporting significant reduction of several inflammation markers specific to psoriasis. We anticipated that the topical cream will be market-ready during the second fiscal quarter of 2017 and, subject to regulatory approvals from applicable jurisdictions and the Study completion, the topical cream should be available for use by those who suffer from psoriasis in the near term. We expect to complete the Phase I study for our topical cream during the next three to six months and start looking for strategic partners in different countries.

 

On April 5, 2017, we announced that as a result of the promising preliminary results from the preclinical efficacy testing of its cannabinoid-based topical cream for treating psoriasis, reporting significant reduction of several inflammation markers specific to psoriasis, we have received expressions of scientific and medical interest, world-wide, for its cannabinoid-based topical cream for treating psoriasis. We have expanded the size and scope of our clinical studies and, as previously announced, anticipates that subject to pending regulatory approvals from applicable jurisdictions, the topical cream should be available for use by those who suffer from psoriasis in the near term.

 

On May 3, 2017, we published a press release titled “OWC Pharmaceutical Research Announces Update on Multiple Myeloma Study,” reporting our intention to continue our testing and study of our cannabinoid-based therapies on the treatment of multiple myeloma.

 

The next phase of the study, which is based upon the promising results of our earlier in-vitro studies of our unique formula of cannabinoid-based therapies targeting cells, is to investigate the doses and diverse delivery systems, to best determine the most effective dosages for the future planned study on human patients, pending receipt of regulatory approvals. We completed a preclinical study during the third fiscal quarter of 2017. The study was conducted under a service agreement with the Fund. We are currently negotiating a license and research agreement with the Fund for further studies. We are evaluating the preclinical results and expects to resume the study during third fiscal quarter of 2018, subject to sufficient capital funding.

 

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Dr. Yehuda Baruch, our Chief Medical Officer and Director of Research and Regulatory Affairs, stated that this unique study, which we designed to pursue and secure orphan designation status from the United States Food and Drug Administration (the “FDA”), will hopefully open ways to improve the quality of life of multiple myeloma patients while at the same time potentially enhance response to various multiple myeloma treatment regimes.

 

On May 31, 2017, we announced that we signed an agreement with Mediq Innovation Partners (“Mediq”), a German-based company with extensive experiences, knowledge and a successful track record in enabling Israel-based companies to penetrate the European markets. We engaged Mediq to consult in marketing our products and conduct research in Germany. Mediq prepared a “road map” that will guide us in our penetration to the European Union market.

 

On June 26, 2017, we announced that we had filed a patent application with the United States Patent and Trademark Office (the “USPTO”) for our active cannabinoid-based topical cream. This new patent application follows the previously filed “provisional” patent application. The added protection that this patent application should provide that our intellectual property will enable us to accelerate our ongoing discussions and negotiations regarding scientific, medical and commercial collaboration, based upon the fact that our topical cream is ready for marketing and commercial exploitation. To date, we have not yet received a response to our patent application.

 

On August 1, 2017 we entered into a service agreement with PharmItBe Ltd (“PharmItBe”) for the development process of the second generation of our cannabis soluble tablet delivery system and preparing the tablet for clinical trials. The development cost amounted to approximately $100,000.

 

On November 8, 201 7 , we granted a Certificate of Patent, #2015101908 (the “Innovation Patent”) from the Commissioner of Patents, Commonwealth of Australia, for the our proprietary cream for the treatment of skin disorders. Pre-clinical results of our skin cream strongly indicate that it may lower various inflammatory markers by up to 70% and inhibit Keratocytes proliferation, a manifestation of various skin disorders, especially psoriasis. A human safety study for our cream is currently ongoing. We believe that the Innovation Patent granted in Australia, valid for a term of 8 years, should be followed by additional patent grants in other jurisdictions and should afford protection and competitive advantage to us, subsequent to efficacy trials to be performed in 2018, to manufacture, distribute and sell our Cannabis-Based Medical Products wherever there exists a lawful medical cannabis market.

 

On December 20, 2017, we announced that we received a new permit from the Israel Medical Cannabis Agency (“IMCA”) to proceed with the safety study of our cannabis soluble tablet delivery system. The study protocol has been submitted and approved by the Institutional Review Board (“IRB”) at Tel Aviv Sourasky Medical Center (“Sourasky”) and has been approved by them. We are now waiting for the approval by the central Israeli Review Board. The study is scheduled to start in the second fiscal quarter of 2018.

 

Our goal is to become a leader in the research and development of cannabis-based medical drugs and treatments. To achieve our goal, we plan to focus our activities on the following areas:

 

Our Research and Development Activities

 

Since 2014, our focus has been on researching and developing cannabis-based formulations for the treatment of multiple myeloma, psoriasis, PTSD, chronic pain and fibromyalgia, as well as developing a cannabis soluble tablet delivery system. We believe a significant need remains for novel oral and safe drugs for patients who do not respond to existing therapies or for whom these therapies are unsuitable. Our research and development is focused primarily on exploring several formulations containing active compounds from the cannabis plant, including (but not limited to) the cannabinoids cannabidiol (“CBD”) and tetrahydrocannabinol (“THC”), and identifying potential therapeutic applications of the synergistic effects of these active compounds. The synergistic contributions of our formulations have not yet been fully-researched and scientifically demonstrated and that is the purpose of the studies we have been conducting in collaboration with major Israeli health institutions as discussed more fully below.

 

We aim to standardize the formulations of our Cannabis-Based Medical Products across the extracts as a whole, not simply by reference to their key active components (CBD and/or THC). Although there are existing reports and studies on CBD and THC, our formulations upon completion are expected to possibly contain several additional active compounds from the cannabis plant that have not been as well studied to date by others. Our formulations must be fully-researched and documented in order to verify their efficacy at treating indications, the appropriate dosage levels and the appropriate methods of administration. As we continue to experience promising results through research and development, we intend to produce pharmaceutical-grade cannabinoid-based products and treatments standardized in composition, formulation and dose, administered by means of an appropriate and efficient delivery system, and tested in properly controlled pre-clinical and clinical studies. During the years ended December 31, 201 7 and 201 6 , we spent $441,203 and $141,858 on research and development, respectively.

 

We are continuing to conduct our research, led by internationally renowned investigators, at the facilities of leading Israeli hospitals and scientific institutions. Dr. Yehuda Baruch, our Chief Medical and Regulatory Affairs Officer, Dr. Oron Yacoby Zeevi, our newly-appointed Chief Science Officer, and Alon Sinai, our Chief Operating Officer, will monitor the studies. Our team of specialists also includes Dr. Miri Sani our regulatory adviser and Dr. Sharon Rozenblat, who is a Senior Science Advisor to the Scientific Advisory Board and Dr. Merav Leiba, also our Senior Science Advisor.

 

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We acquire the cannabis needed for our research activities from G.K. Medical Cannabis Ltd, Canndoc Ltd or IMC Medical Cannabis Ltd, all government-licensed Israeli medical cannabis growers.

 

Research and Development

 

Our research and development continues to be focused primarily on exploring several formulations containing active compounds from the cannabis plant, including but not limited to the cannabinoids CBD and THC, and identifying potential therapeutic applications of the synergistic effects of these active compounds. The synergistic contributions of our formulations have not been scientifically researched and demonstrated in a preclinical model concerning our topical cream formulation. We aim to standardize the formulations across the extracts as a whole, not simply by reference to their key active components (CBD and/or THC). In addition, we are developing unique delivery systems for our pharmaceutical grade products.

 

Although there are existing reports and studies on CBD and THC, our formulations will contain several other active compounds from the cannabis plant, that must be fully researched and documented in order to verify their effectiveness in specific indications, at what doses and which method of administration will be the most appropriate and effective.

 

We plan to produce pharmaceutical-grade cannabinoid-based products and treatments that will be standardized in composition, formulation and dose, administered by means of an appropriate and efficient delivery system, and tested in properly controlled pre-clinical and clinical studies. We plan to conduct our research, led by internationally renowned investigators, at the facilities of leading Israeli hospitals and scientific institutions. We will adhere to legislation, rules and guidelines regarding the investigations.

 

To date, we have signed three research collaboration and license agreements as well as service agreements with Sheba Academic Medical Center in Tel Hashomer, Israel (“Sheba”), with respect to two potential indications. Sheba is a university-affiliated hospital that serves as Israel’s national medical center and is one of the leading integrated medical centers in the Middle East. Within the framework of the abovementioned agreements with Sheba, as well as other potentially negotiated agreements, we intend to initiate two studies at the Sheba facilities to explore the effect of two formulations, all based on active ingredients in the cannabis extracts, on multiple myeloma and psoriasis.

 

Pursuant to the Research Agreement, the Fund is performing the Study to determine the safety and tolerability of topical cream containing MGC in healthy volunteers. Dr. Aviv Barzilay is leading the Study. The Study, as defined in the Research Agreement is conducted in compliance with the following: (1) the Protocol; (2) the Ministry Guidelines; (3) the instructions and terms specified in the IRB approval; (4) the ICH-GCP; (5) the IRB Declarations; (6) the Applicable Laws; and (7) written instructions and prescriptions issued by us and the governing the administration of the Study Drug.

 

On February 1, 2017, following the very encouraging results that we achieved at the mid-point of a psoriasis-related study conducted by us with an Israeli research institute, we are determined to extend the size and scope of the study for the purpose, among other parameters, of checking the biological markers that have been generated to date with respect to the treatment of psoriasis (proliferation/ inhibition and several interleukins) which was conducted by such institute. Such trial results concluded that application of our unique active cannabinoid-based topical cream formulation, indicated up to 70% improvement in a variety of inflammation markers directly associated with Psoriasis and inhibition of proliferation.

 

The Study of our topical Psoriasis ointment is ongoing at the dermatologic department at Sheba’s hospital and should be completed during the second fiscal quarter of 2018.

 

To date, our intellectual property portfolio comprises nine patent families and includes 31 filings in selected domains at various stages from the Patent Cooperation Treaty (“PCT”) filings, National Phase filings and Continuations in Part (CIP). Two of the patent families are in the field of Multiple Myeloma and the other families are in the fields of pharmaceutical emulsions, fibromyalgia, migraine, sexual function and skin disorders. These filings encompass pharmaceutical compositions and devices in these fields.

 

The national phase is the second of the two main phases of the PCT procedure. It follows the international phase and consists in the processing of the international application before each office of or acting for a contracting state of the PCT that has been designated in the international application. Assuming the successful completion of the clinical trials, of which there can be no assurance, we believe that we will be able to retain the intellectual property rights and secure patent protection for our proprietary developments.

 

While we retain full ownership on our intellectual property rights that we conceived prior to the signing of the research collaboration and license agreements with Sheba Academic Medical Center, the psoriasis agreement with Sheba provide that all intellectual property that is conceived during the course of the research is to be jointly owned by Sheba and us.

 

Pursuant to a collaboration agreement, we were expected to pay Sheba $170,000 for conducting the multiple myeloma trial between the third fiscal quarter of 2015 and the second fiscal quarter of 2016. As of December 31, 2017, we have paid Sheba $65,669 as per Sheba’s payment requests. Pursuant to a collaboration agreement, we are obliged to pay Sheba $170,000 throughout 2017 and 2018 for conducting the Study for the cream for treatment of psoriasis. As of December 31, 2017, we have paid Sheba $13,903 as per Sheba’s payment requests and in January 2018, we paid an additional sum of $29,163.

 

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At present, we use our available working capital to fund these studies. However, we expect that we will need to raise additional funding prior to or when our clinical studies are commenced.

 

Research and Development Status

 

The following table summarizes the stages of development for each of our current Cannabis-Based Medical Products prospects:

 

Target Indication Collaborator Status
Multiple Myeloma Sheba

1.     Entered into a research agreement for in vitro and in vivo studies.

 

2.     Completed initial in vitro studies.

 

3.     Drafted a clinical trial protocol synopsis to assist in preparing an application for orphan drug status designation.

 

4.     Expect to negotiate agreement and submit a clinical trial protocol to the IRB and receive its approval to commence a clinical study.

 

5.     Intend to commence a clinical study referred to in (4) above in the second half of 2018.

 

Psoriasis Sheba

Entered into the Research Agreement.

 

Received IRB approval for the Sheba Study.

 

Phase I safety study has started

 

Psoriasis Emilia

1.     Entered into a nonbinding Memorandum of Understanding for the development, manufacture and marketing of the Psoriasis Cream.

 

2.     Completed the development of the Psoriasis Cream in the first fiscal quarter of 2016.

 

3.     Entered into the License Agreement, Emilia granted a limited license to us with respect to Emilia’s licensed intellectual property to be developed and commercialized worldwide in the topical treatment of psoriasis in humans with ours and the Emilia Product.

 

Fibromyalgia  

1.       Drafted a clinical trial protocol synopsis.

 

New delivery system – cannabis soluble tablet G.C. Group Ltd.

1.     Completed a proof of concept of a soluble tablet to test the fabric, durability, solidification and other features of the tablet.

 

  PharmItBe 2.     Develop a second generation of our soluble tablet, preparing the tablet for clinical studies expected in the second fiscal quarter of 2018

 

Our Investigation on Multiple Myeloma

 

Dr. Merav Leiba, Head of Multiple Myeloma Outpatient Clinic and Multiple Myeloma Research Lab at Sheba’s Hematology Institute, led the in vitro tests on multiple myeloma. Dr. Leiba, a specialist in Internal Medicine and Hematology, was a postdoctoral fellow at the Jerome Lipper Multiple Myeloma Center at Dana Farber Cancer Institute, Boston, Massachusetts (2006-2008). Dr. Leiba has participated in numerous clinical and investigational studies aimed at developing novel drugs for multiple myeloma.

 

Our test results on multiple myeloma cells studied in vitro, which we announced on June 17, 2015, led us to proceed with further pre-clinical studies (safety and toxicity, PK, PD) of our formulation, to assess the scientific merit for further development as an investigational new drug. Whilst we are encouraged by the results of the limited in vitro tests, there can be no assurance that any clinical trial will result in commercially viable products or treatments.

 

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Clinical trials are expensive, time consuming and difficult to design and implement. We, as well as the regulatory authorities in Israel and elsewhere, such as an IRB committee), Israel Medical Cannabis Unit (the “IMCU”), or the FDA, may suspend, delay or terminate our clinical trials at any time, may require us, for various reasons, to conduct additional clinical trials, or may require a particular clinical trial to continue for a longer duration than originally planned, including, among others:

 

  lack of effectiveness of any formulation or delivery system during clinical trials;
  discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues;
  slower than expected rates of subject recruitment and enrollment rates in clinical trials;
  delays or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing constraints;
  delays in obtaining regulatory authorization to commence a trial, including IRB approvals, licenses required for obtaining and using cannabis for research, either before or after a trial is commenced;
  unfavorable results from ongoing pre-clinical studies and clinical trials.
  patients or investigators failing to comply with study protocols;
  patients failing to return for post-treatment follow-up at the expected rate;
  sites participating in an ongoing clinical study withdraw, requiring us to engage new sites;
  third-party clinical investigators decline to participate in our clinical studies, do not perform the clinical studies on the anticipated schedule, or act in ways inconsistent with the established investigator agreement, clinical study protocol, good clinical practices, and other IRB requirements;
  third-party entities do not perform data collection and analysis in a timely or accurate manner or at all;
  regulatory inspections of our clinical studies require us to undertake corrective action or suspend or terminate our clinical studies;

 

Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.

 

Consulting Services

 

We believe that the complexity of the medical cannabis programs has created a demand for consulting and advisory services in different aspects of the medical cannabis industry. Our services are designed to help government officials, policy-makers and regulatory agencies develop and implement tailor-made comprehensive medical cannabis programs. In addition, we offer medical cannabis regulatory compliance services and patient-care consultancy services.

 

Our initial activities to secure consulting contracts will be in member states of the European Union and states of the United States that allow for public medical cannabis programs in compliance with applicable laws.

 

Our management has the expertise in designing training programs for physicians, caregivers, and researches that are essential to the establishment of a successful, patient-focused medical cannabis program. By working with policy-makers, government officials, public agencies, and privately-owned businesses, we believe we can also raise the public’s awareness of the benefits of cannabis-based treatments and products.

 

Market Opportunity

 

According to the American Academy of Dermatology, psoriasis affects about 3% of the world’s population and 7.5 million people in the United States. In addition, according to 2014 edition of the Marijuana Business Factbook, U.S. retail sales of medical cannabis are expected to rise significantly over the next five years from an estimated $2.2 billion in 2014 to $8.2 billion in 2018. We believe that cannabis-based formulations have the potential to effectively treat multiple myeloma, psoriasis, PTSD, chronic pain and fibromyalgia.

 

Controlled substance legislation differs between countries (and jurisdictions within those countries) and legislation in certain countries may restrict or limit our ability to distribute or sell our products. We believe that the United States will represent a major market for our Cannabis-Based Medical Product prospects due, in large part, to state level legislation allowing comprehensive public medical cannabis programs. A total of 28 states, the District of Columbia and Guam now allow for comprehensive public medical cannabis programs. Recently approved efforts in 16 states allow use of “low THC, high CBD” products for medical reasons in limited situations.

 

In Europe, medical cannabis programs regulatory frameworks exist in several countries, such as the Netherlands, Italy, Germany, Finland and the Czech Republic. It can also be expected that there will be policy changes in the member countries of the European Union concerning the medical use of cannabis and cannabis-based products. We believe that there will be rising demand for cannabis derived medical products and that future growth is expected to be driven by favorable changes in legislation and demographic factors.

 

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Multiple myeloma is a hematological (blood) cancer that develops in the plasma cells found in bone marrow. Plasma cells are a type of white blood cell responsible for producing antibodies (immunoglobulins) which are critical for maintaining the body’s immune system. Through a complex, multi-step process, healthy plasma cells transform into malignant myeloma cells. Myeloma cells result in the production of abnormal antibodies, or M proteins. The M proteins offer no benefit to the body, and as the amount of M protein increases, it crowds out normally functioning immunoglobulins. This ultimately causes multiple myeloma symptoms such as bone damage or kidney problems. Multiple myeloma is considered to be incurable but treatable. Remissions may be induced with steroids, chemotherapy, proteasome inhibitors, immunomodulatory drugs such as thalidomide or lenalidomide, and stem cell transplants. Radiation therapy is sometimes used to reduce pain from bone lesions. According to the American Cancer Society, in the United States the lifetime risk of getting multiple myeloma is 1 in 143 and it is estimated that 30,330 new cases will be diagnosed in 2016.

 

Fibromyalgia is a chronic health problem that causes pain throughout the body and other symptoms such as fatigue and cognitive (memory or thought) problems. According to the National Fibromyalgia Association the disorder affects an estimated ten million people in the United States and an estimated 3 to 6% of the world population. There is no known cure and a variety of prescription medications are often used to reduce pain levels and improve sleep. On June 21, 2007, the FDA approved Lyrica (pregabalin) as the first drug to treat fibromyalgia. Cymbalta (duloxetine HCl) was approved in June 2008 and Savella (milnacipranHCl) was approved in January 2009, both of which are now generic formulations no longer under patent protection.

 

Psoriasis is a skin condition that affects 2% to 3% of the general population according to the National Psoriasis Foundation. The disease is manifested by scaly plaques on the skin and in the severe form has a major effect on the physical and emotional well-being of the patients. Topical agents are typically used for mild disease, phototherapy for moderate disease, and systemic agents for severe disease. For moderate to severe cases, systemic biologic drugs, delivered via IV, have dominated the market. According to the National Psoriasis Foundation, common side effects of biologics include respiratory infections, flu-like symptoms, and injection site reactions while rare side effects include serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes, blood disorders, and certain types of cancer. According to Global Data, the psoriasis treatment market was worth $3.6 billion in 2010 and is forecast to grow to $6.7 billion by 2018. The current common treatments for psoriasis include topical and systemic drugs, steroids, immunosuppressive drugs such as Cyclosporine A (by Novartis), methotrexate or MTX and biological drugs such as Enbrel (by Amgen), Amevive (by Biogen but whose patent expired in 2013) and Ustakinumabn (by Janssen Immunology).

 

Our Medmar Agreements

 

On October 11, 2015, we entered into a memorandum of understanding with Medmar for the purpose of granting an exclusive, non-transferable, royalty-bearing license, to manufacture, produce, publicize, promote and market the licensed products described therein in the State of Hawaii and the State of Pennsylvania, pursuant to which Medmar has paid us $100,000. On February 8, 2016, we entered into a right of first refusal agreement with Medmar II, an affiliate of Medmar, granting Medmar certain rights in connection with the commercialization of our Cannabis-Based Medical Products in other states in the USA, pursuant to which Medmar has paid $50,000.

 

On March 17, 2016, we entered into a consulting and license agreement with Medmar pursuant to which we granted to Medmar an exclusive, non-transferable, royalty-bearing license, to manufacture, produce, publicize, promote and market the certain of our products (as defined in the license agreement) in the State of Maryland, against payment by Medmar to us of a royalty.

 

On September 28, 2016, we entered into a non-recourse loan agreement with Medmar pursuant to which Medmar agreed to loan us a total of $300,000 in installments of $50,000 each on a non-interest bearing basis with no conversion rights. The loan, which was made on a non-recourse basis, which permitted prepayment at any time, was due 36 months from the date of the loan and the obligation to repay shall be made only by the set-off of royalties payable by Medmar to us, if and only to the extent Medmar is required to pay any royalties to us under the March 17, 2016 license agreement referenced above. To the extent that the royalties payable to us under the license agreement shall be insufficient to repay the loan, for any reason whatsoever, Medmar agreed to waive any repayment rights and/or any claim for any such deficiency. $250,000 of the loan proceeds were funded before the year-ended December 31, 2016 and the last tranche of $50,000 was funded in February 2017 by Medmar.

 

On April 21, 2017, we provided written notice on Medmar of its determination to prepay the loan by Medmar in the principal amount of $300,000. Reference is made to our Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on May 3, 2017 as well as to the Forms 8-K filed September 30, 2016 and to the loan agreement between us and Medmar, filed as Exhibit 10.9 to the September 30, 2016 Form 8-K. Pursuant to Sections 4 and 5.3 of the loan agreement and based upon the full repayment of the non-recourse, non-interest bearing and non-convertible loan, we exercised our absolute right to terminate distribution rights granted to Medmar under the loan agreement .

 

Marketing and Sales

 

We do not currently have any marketing or sales capabilities. We intend to license to, or enter strategic alliances with, larger companies in the pharmaceutical business, which are equipped to market and/or sell our products, if any, through their well-developed marketing capabilities and distribution networks. We intend to out-license some or all our patent rights to more than one party to achieve the fullest development, marketing and distribution of any products we develop.

 

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Our Strengths

 

Notwithstanding the fact that we have only commenced our cannabis-based medical research, we believe that we offer the following key characteristics in our approach to developing our Cannabis-Based Medical Product prospects:

 

  Our leading medical professionals are recognized leaders in medical cannabis treatments
  We received approval from the Israeli IRB for an in vitro clinical study for the treatment of multiple myeloma;
  We have already filed 9 patent families and includes 31 filings in selected domains;
  We have entered into three research and license agreements with Sheba to conduct research on two indicators;
  Understanding governmental regulation is a prerequisite for success in our industry and our team has substantial knowledge and experience with respect to the rules of drug development and medical cannabis programs; and
  Our scientific team has many years of experience in diverse but relevant disciplines, including medical research and regulatory affairs, as well as extensive cannabis-related issues experience.

 

Intellectual Property

 

Our success depends in significant part on our ability to protect the proprietary nature of our Cannabis-Based Medical Product prospects, technology and know-how, to operate without infringing on the proprietary rights of others, and to defend challenges and oppositions from others and prevent others from infringing on our proprietary rights, including our provisional patents described below. We have not acquired any intellectual property from Dr. Baruch or Mr. Sinai. Rather, they have brought to us their wealth of know-how in matters related to medical cannabis, based upon their many years of experience in the medical field as well as Dr. Baruch’s service leading the Medical Cannabis Unit of the Israeli Ministry of Health.

 

We plan to continue to seek patent protection in the United States and other countries for our proprietary technologies. To date, our intellectual property portfolio comprises 9 patent families and includes 31 filings in selected domains at various stages from PCT filings, National Phase filings and CIP. Two of the patent families are in the field of multiple myeloma and the other families are in the fields of pharmaceutical emulsions, fibromyalgia, migraine, sexual function and skin disorders. These filings encompass pharmaceutical compositions and devices in these fields.

 

We anticipate that we will file additional patent applications in conjunction with our research, testing, and development of our Cannabis-Based Medical Product prospects.

 

Our policy is to seek patent protection for the technology, inventions and improvements that we consider important to the development of our business, but only in those cases where we believe that the costs of obtaining patent protection is justified by the commercial potential of the technology, and typically only in those jurisdictions that we believe present significant commercial opportunities.

 

Competition

 

We face competition from larger companies that are or may be in the process of offering similar products to ours. Many of our current and potential competitors have longer operating histories, significantly greater financial, marketing and other resources than we may be expected to have.

 

Competitors may include major pharmaceutical and biotechnology companies and public and private research institutions. Management cannot be certain that we will be able to compete against current or future competitors or that competitive pressure will not seriously harm our business prospects. These competitors may be able to react to market changes, respond more rapidly to new regulations or allocate greater resources to the development and promotion of their products than we can.

 

Furthermore, some of these competitors may make acquisitions or establish collaborative relationships among themselves to increase their ability to rapidly gain market share. Large pharmaceutical companies may eventually enter the market.

 

Given the rapid changes affecting the global, national, and regional economies in general and cannabis-related medical research and development in particular, we may not be able to create and maintain a competitive advantage in the marketplace. Time-to-market is an important factor and our success will depend on our ability to develop innovative products that will be accepted by patients.

 

Our success will also depend on our ability to respond quickly to, among other things, changes in the economy, market conditions, and competitive pressures. Any failure to anticipate or respond adequately to such changes could have a material effect on our financial condition, operating results, liquidity, cash flow and our operational performance.

 

There can be given no assurance that any of our on Cannabis-Based Medical Products will obtain regulatory approval in the US or in other markets that we intent to market such products.

 

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Employees

 

We presently have no full-time employees. Our Chief Executive Officer and Chief Operating Officer are employed under service agreements with us. Our officers and directors are expected to dedicate approximately 60% of their professional time to our business until such time that we receive regulatory approval of any Cannabis-Based Medical Product prospects. Our subsidiary currently have five employees and conduct our medical research through collaboration agreements with third parties.

 

Government Laws and Regulations Relating to the Cannabis Industry

 

Israel

 

To date, our research and development activities have been conducted in and limited to Israel. The cannabis-based products we are developing contain controlled substance (cannabis) as defined in the Israeli Dangerous Drugs Ordinance [New Version], 5733 - 1973. In Israel, licenses to cultivate, possess and to use cannabis for medical research are granted by the Ministry of Health, IMCA - Israel Medical Cannabis Ajency, on an ad-hoc basis. We obtained necessary IMCA licenses in order to carry out the research in collaboration with Sheba Academic Medical Center, G.C. Group, Emilia, Dead Sea Labs and the Technion Israel Institute of Technology (“Technion”). We are acquiring the cannabis needed for our research activities from G.K. Medical Cannabis, Canndoc or IMC, all government-licensed Israeli medical cannabis growers. Currently we have licenses in order to continue our activities in collaboration with Sheba Academic Medical Center, PharmItBe, Pharmaceed and the Technion. We have applied for additional license for a phase I study we are starting in the second fiscal quarter in Sourasky hospital for the safety of our cannabis soluble tablet delivery system.

 

Although we have been successful in obtaining a license to use cannabis for medical research, there can be no assurance that we will be able to continue to maintain this license in the future.

 

United States

 

In the event that we seek to conduct any product-related activities in the United States in the future, the research and development, manufacturing, distribution and sale of our product prospects will become subject to the United States’ Federal Controlled Substances Act of 1970 (the “CSA”) and regulations promulgated thereunder. Under the CSA, Cannabis sativa, or botanical marijuana, is a Schedule I controlled substance, meaning that it has no medical use and is subject to the highest level of Drug Enforcement Agency (DEA) restrictions and enforcement. However, the FDA has the authority to review drugs derived from botanical marijuana to determine whether they are safe and effective for a legitimate medical use. If the FDA approves a drug derived from a substance appearing on the controlled substance schedules, the FDA may provide scientific guidance as to the schedule on which the ultimate drug product should be placed. The CSA requires FDA to consider the following eight factors when making a scheduling recommendation (21 U.S.C. § 811(c)):

 

  1. Actual or relative potential for abuse
  2. Scientific evidence of pharmacological effect
  3. Current scientific knowledge regarding the substance
  4. History and current pattern of abuse
  5. Scope, duration, and significance of abuse
  6. Risk to public health
  7. Psychic or physiological dependence liability
  8. Immediate precursor of a substance already controlled

 

In general, FDA approval of a new drug application, or NDA, for a substance is considered adequate evidence of an “accepted medical use” under the CSA. However, United States case law dictates that substances without an FDA-approved new drug application, or NDA, must meet the following criteria to have a “currently accepted medical use” making such substances eligible for listing on Schedules II-V (57 Fed. Reg. 10,499, 10,504-06 (Mar. 26, 1992):

 

  1. The drug product’s chemistry is known and reproducible
  2. There are adequate studies demonstrating the drug’s safety
  3. There are adequate and well-controlled studies proving the drug’s efficacy
  4. The drug is accepted by qualified experts
  5. Relevant scientific evidence on the drug is widely available

 

The FDA has not approved marijuana for any medical indication and has not yet approved any drug product derived or isolated from botanical marijuana. However, the FDA has previously approved two drug products containing a chemically synthesized version of a substance present in the marijuana plant and one drug product containing a synthetic substance that is not found in the marijuana plant but that has chemical activity similar to compounds derived from marijuana.

 

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If approved by the FDA, we anticipate that our products will be listed by the DEA as a Schedule II or III controlled substance. Consequently, the manufacture, importation, exportation, domestic distribution, storage, sale and legitimate use of our future products will very likely be subject to a significant degree of regulation by the DEA.

 

In addition to federal scheduling and control, individual states have enacted controlled substance laws and regulations. Although state-controlled substances laws often mirror federal law, because the states are separate jurisdictions, they may separately schedule certain products. In the case of marijuana, while United States federal law totally prohibits the use, distribution, growing, and possession of marijuana, individual states have enacted laws permitting the use and distribution of marijuana for medical purposes. To date, a total of 29 states, the District of Columbia, Guam, and Puerto Rico have laws allowing medical use of marijuana and 20 states, Guam, and Puerto Rico have enacted comprehensive public medical cannabis programs, meaning that they (1) provide protection from criminal penalties related to medical use of marijuana, (2) provide access to marijuana via home cultivation, dispensaries, or other system, (3) allow a variety of marijuana strains, and (4) permits smoking or vaporization of the marijuana plant or an extract therefrom. In addition, 17 states allow use of “low THC, high cannabidiol (CBD)” products for medical reasons in limited situations. Each state that has established a medical marijuana program (with the exception of California) has also enacted laws restricting participation to patients with specific medical conditions who have received an explicit recommendation or referral for treatment of the condition with medical marijuana from one or more physicians. Common restrictions include patients with cancer, glaucoma, HIV, AIDS, or any chronic disease causing cachexia, severe pain, severe nausea, seizures, or persistent muscle spasms (including treatment for such diseases which may cause any of these conditions). In addition, while state laws authorize qualified individuals to smoke or vaporize marijuana for medical purposes, it is not clear that other uses of marijuana or its extracts or derivatives (e.g., topical or edible) are permitted for medical use.

 

As of the date of this filing, we have provided consulting services to a medical marijuana program with locations in Hawaii and Pennsylvania. We do not grow or distribute cannabis. However, our providing of ancillary products and services to state-approved programs could be deemed to be aiding and abetting illegal activities, a violation of federal law. Where applicable, we will apply for state licenses that are necessary to conduct our business in compliance with local laws.

 

Enforcement of United States Federal Laws

 

We intend to conduct rigorous due diligence to verify the legality of all activities that we engage in. We realize that there is a discrepancy between the laws in some states, which permit the distribution and sale of marijuana for medical purposes, from federal law that prohibits any such activities. As discussed above, the CSA makes it illegal under federal law to manufacture, distribute, or dispense cannabis. Many states impose and enforce similar prohibitions. Notwithstanding the federal ban, as of the date of this filing, 29 states, the District of Columbia, Guam, and Puerto Rico have legalized certain cannabis-related activity. However, with respect to our products, compliance with state laws provides little protection from prosecution under federal laws at the discretion of the various United States Attorney offices, which are part of the U.S. Department of Justice (DOJ).

 

From 2009 to 2014, the DOJ issued a series of official memoranda setting the agency’s enforcement policies relative to state programs legalizing medical use of marijuana. The most prominent of these documents was issued by Deputy Attorney General James Cole on August 29, 2013 (the Cole Memo), which reiterated DOJ’s authority to prosecute violations of federal laws relating to marijuana and outlined specific marijuana enforcement priorities, such as preventing distribution to minors and preventing revenues from marijuana sales from reaching criminal organizations. The Cole Memo also outlined a general policy that DOJ would defer on ordinary enforcement matters if a state had established regulatory and enforcement systems addressing potential risks and other law enforcement interests related to marijuana.

 

However, on January 4, 2018, the DOJ rescinded all marijuana enforcement memoranda issued by the agency between 2009 and 2014, including the Cole Memo. The January 4 memorandum states that the CSA prohibits cultivation, distribution, and possession of marijuana and that such activities can also lead to prosecution under the money laundering statutes (18 U.S.C. §§ 1956-57), the unlicensed money transmitter statute (18 U.S.C. § 1960), and the Bank Secrecy Act or BSA (31 U.S.C. § 5318). In addition, the memorandum directs all United States Attorneys to enforce federal law and to “weigh all relevant considerations, including federal law enforcement priorities set by the Attorney General, the seriousness of the crime, the deterrent effect of criminal prosecution, and the cumulative impact of particular crimes on the community” (Office of the Attorney General, Memorandum for All United States Attorneys RE: Marijuana Enforcement (Jan. 4, 2018)).

 

The January 4 memorandum demonstrates that DOJ’s current enforcement policy puts all companies with operations relating to the cultivation, distribution, and sale of marijuana and products derived from marijuana at risk of prosecution, even if such companies comply with state laws allowing these activities. However, it is still unclear whether United States Attorneys will aggressively pursue companies operating in states that have legalized certain distribution and sale of marijuana, or how the DOJ’s policy will affect any drug derived from botanical marijuana that is approved by FDA.

 

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FinCEN

 

Since the use of cannabis is illegal under federal law, we or our consulting clients may have difficulty acquiring or maintaining bank accounts in the United States. The Financial Crimes Enforcement Network (“FinCEN”) provided guidance on February 14, 2014 about how financial institutions can provide services to cannabis-related businesses consistent with their obligations under the BSA. In general, a financial institutions decision to open, close, or refuse any account or relationship should be based on multiple factors specific to that institution. These factors may include business objectives, an evaluation of the risks associated with offering particular products or services, and capacity to manage those risks effectively. The FinCEN guidance describes thorough due diligence as a critical aspect of this assessment for customers with marijuana-related business.

 

FinCEN advises financial institutions to conduct customer due diligence for cannabis-related businesses that includes: (1) verifying with the appropriate state authorities whether the business is duly licensed and registered; (2) reviewing the license application (and related documentation) submitted by the business for obtaining a state license to operate its cannabis-related business; (3) requesting from state licensing and enforcement authorities available information about the business and related parties; (4) developing an understanding of the normal and expected activity for the business, including the types of products to be sold and the type of customers to be served (e.g., medical versus recreational customers); (5) ongoing monitoring of publicly available sources for adverse information about the business and related parties; (6) ongoing monitoring for suspicious activity, including for any of the red flags described in the FinCEN guidance; and (7) refreshing information obtained as part of customer due diligence on a periodic basis and commensurate with the risk. With respect to information regarding state licensure obtained about such customer due diligence, a financial institution may reasonably rely on the accuracy of information provided by state licensing authorities, where states make such information available.

 

Europe

 

Approximately 250 substances, including cannabis, are listed in the Schedules annexed to the United Nations Single Convention on Narcotic Drugs (New York, 1961, amended 1972), the Convention on Psychotropic Substances (Vienna, 1971) and the Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (introducing control on precursors) (Vienna, 1988). The purpose of these listings is to control and limit the use of these drugs according to a classification of their therapeutic value, risk of abuse and health dangers, and to minimize the diversion of precursor chemicals to illegal drug manufacturers. The 1961 UN Single Convention on Narcotic Drugs, as amended in 1972 classifies cannabis as Schedule I (“substances with addictive properties, presenting a serious risk of abuse”) and as Schedule IV (“the most dangerous substances, already listed in Schedule I, which are particularly harmful and of extremely limited medical or therapeutic value”) narcotic drug. The 1971 UN Convention on Psychotropic Substances classifies THC - the principal psychoactive cannabinoid of cannabis - as schedule I psychotropic substance (Substances presenting a high risk of abuse, posing a particularly, serious threat to public health which are of very little or no therapeutic value).

 

Most countries in Europe are parties to these conventions, which govern international trade and domestic control of these substances, including cannabis. They may interpret and implement their obligations in a way that creates a legal obstacle to our obtaining manufacturing and/or marketing approval for our products in those countries or to providing consulting services in those countries. These countries may not be willing or able to amend or otherwise modify their laws and regulations to permit our products to be manufactured and/or marketed, or for us to provide consulting services, or achieving such amendments to the laws and regulations may take a prolonged period. While some countries in Europe such as the United Kingdom, Germany, the Czech Republic, France, Romania, and Finland have decriminalized cannabis or permit its use for medical purposes, no country has completely legalized it.

 

Regulations Related to the Drug Regulatory Process

 

We operate in a highly controlled regulatory environment. Stringent regulations establish requirements relating to analytical, toxicological and clinical standards and protocols in respect of the testing of pharmaceuticals. Regulations also cover research, development, manufacturing and reporting procedures, both pre- and post-approval. Failure to comply with regulations can result in stringent sanctions, including product recalls, withdrawal of approvals, seizure of products and criminal prosecution. Further, many countries have stringent regulations relating to the possession and use of cannabis.

 

Before obtaining regulatory approvals for the commercial sale of our future product candidates, we must demonstrate through preclinical studies and clinical trials that our product candidates are safe and effective. Historically, the results from preclinical studies and early clinical trials often have not accurately predicted results of later clinical trials. In addition, a number of pharmaceutical products have shown promising results in clinical trials but subsequently failed to establish sufficient safety and efficacy results to obtain necessary regulatory approvals. We expect to incur substantial expense for, and devote a significant amount of time to, preclinical studies and clinical trials. Many factors can delay the commencement and rate of completion of clinical trials, including the inability to recruit patients at the expected rate, the inability to follow patients adequately after treatment, the failure to manufacture sufficient quantities of materials used for clinical trials, and the emergence of unforeseen safety issues and governmental and regulatory delays. If a product candidate fails to demonstrate safety and efficacy in clinical trials, this failure may delay development of other product candidates and hinder our ability to conduct related preclinical studies and clinical trials. Additionally, as a result of these failures, we may also be unable to obtain additional financing.

 

Governmental authorities in all major markets require that a new pharmaceutical product be approved or exempted from approval before it is marketed, and have established high standards for technical appraisal, which can result in an expensive and lengthy approval process. The time to obtain approval varies by country and some products are never approved. The lengthy process of conducting clinical trials, seeking approval and the subsequent compliance with applicable statutes and regulations, if approval is obtained, are very costly and require the expenditure of substantial resources.

 

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A summary of the Israeli, U.S. and EU regulatory processes follow below:

 

Israel

 

In order to conduct clinical testing on humans in Israel, special authorization must first be obtained from the ethics committee and general manager of the institution in which the clinical studies are scheduled to be conducted, as required under the Guidelines for Clinical Trials in Human Subjects implemented pursuant to the Israeli Public Health Regulations (Clinical Trials in Human Subjects), as amended from time to time, and other applicable legislation. These regulations also require authorization from the Israeli Ministry of Health, except in certain circumstances, and in the case of genetic trials, special fertility trials and similar trials, an additional authorization of the overseeing institutional ethics committee. The institutional ethics committee must, among other things, evaluate the anticipated benefits that are likely to be derived from the project to determine if it justifies the risks and inconvenience to be inflicted on the human subjects, and the committee must ensure that adequate protection exists for the rights and safety of the participants as well as the accuracy of the information gathered in the course of the clinical testing. Since, at this time, we intend to perform all of the clinical studies in Israel, we will be required to obtain authorization from the ethics committee and general manager of each institution in which we intend to conduct our clinical trials, and in most cases, from the Israeli Ministry of Health.

 

Israel’s Ministry of Health, which regulates medical testing, has adopted protocols that correspond, generally, to those of the FDA and the European Medicines Agency (the “EMA”), making it comparatively straightforward for studies conducted in Israel to satisfy FDA and the EMA requirements, thereby enabling medical technologies subjected to clinical trials in Israel to reach U.S. and EU commercial markets in an expedited fashion. Many members of Israel’s medical community have earned international prestige in their chosen fields of expertise and routinely collaborate, teach and lecture at leading medical centers throughout the world. Israel also has free trade agreements with the United States and the European Union.

 

Currently we do not conduct any product-related activities such as research, development, manufacturing or marketing activities outside of Israel, nor do we expect to for the foreseeable future.

 

United States

 

In the United States, the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder, and other federal and state statutes and regulations govern, among other things, the safety and effectiveness standards for our products and the raw materials and components used in the production of, testing, manufacture, labeling, storage, record keeping, approval, advertising and promotion of product candidates on a product-by-product basis.

 

Preclinical tests include in vitro and in vivo evaluation of the product candidate, its chemistry, formulation and stability, and animal studies to assess potential safety and efficacy. Certain preclinical tests must be conducted in compliance with good laboratory practice regulations. Violations of these regulations can, in some cases, lead to invalidation of the studies, requiring them to be replicated. After laboratory analysis and preclinical testing, testing, a sponsor files an Investigational New Drug application, or IND, to begin human testing. Typically, a manufacturer conducts a three-phase human clinical testing program which itself is subject to numerous laws and regulatory requirements, including adequate monitoring, reporting, record keeping and informed consent. In Phase 1, small clinical trials are conducted to determine the safety and proper dose ranges of product candidates. In Phase 2, clinical trials are conducted to assess safety and gain preliminary evidence of the efficacy of product candidates. In Phase 3, clinical trials are conducted to provide sufficient data for the statistically valid evidence of safety and efficacy. The time and expense that will be required for us to perform this clinical testing can vary and is substantial. We cannot be certain that we will successfully complete Phase 1, Phase 2 or Phase 3 testing within any specific period, if at all. Furthermore, the FDA, the Institutional Review Board responsible for approving and monitoring the clinical trials at a given site, the Data Safety Monitoring Board, where one is used, or we may suspend the clinical trials at any time on various grounds, including a finding that subjects or patients are exposed to unacceptable health risk.

 

If the clinical data from these clinical trials (Phases 1, 2 and 3) are deemed to support the safety and effectiveness of the candidate product for its intended use, then we may proceed to seek to file with the FDA, a New Drug Application, or NDA, seeking approval to market a new drug for one or more specified intended uses. We have not completed our clinical trials for any candidate product for any intended use and therefore, we cannot ascertain whether the clinical data will support and justify filing an NDA. Nevertheless, if and when we are able to ascertain that the clinical data supports and justifies filing an NDA, we intend to make such appropriate filings.

 

The purpose of the NDA is to provide the FDA with sufficient information so that it can assess whether it ought to approve the candidate product for marketing for specific intended uses. The fact that the FDA has designated a drug as an orphan drug for a particular intended use does not mean that the drug has been approved for marketing. Marketing and commercialization of a drug is permitted only after FDA approves an NDA for the drug. A request for orphan drug status must be filed before the NDA is filed. The orphan drug designation, though, provides certain benefits, including a seven-year period of market exclusivity subject to certain exceptions.

 

The NDA normally contains, among other things, sections describing the chemistry, manufacturing, and controls, non-clinical pharmacology and toxicology, human pharmacokinetics and bioavailability, microbiology, the results of the clinical trials, and the proposed labeling which contains, among other things, the intended uses of the candidate product.

 

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We cannot take any action to market any new drug or biologic product in the United States until our marketing application has been approved by the FDA. The FDA has substantial discretion over the approval process and may disagree with our interpretation of the data submitted. The process may be significantly extended by requests for additional information or clarification regarding information already provided. As part of this review, the FDA may refer the application to an appropriate advisory committee, typically a panel of clinicians. Satisfaction of these and other regulatory requirements typically takes several years, and the actual time required may vary substantially based upon the type, complexity and novelty of the product. Government regulation may delay or prevent marketing of potential products for a considerable period and impose costly procedures on our activities. We cannot be certain that the FDA or other regulatory agencies will approve any of our products on a timely basis, if at all. Success in preclinical or early stage clinical trials does not assure success in later-stage clinical trials. Even if a product receives regulatory approval, the approval may be significantly limited to specific indications or uses and these limitations may adversely affect the commercial viability of the product. Delays in obtaining, or failures to obtain regulatory approvals, would have a material adverse effect on our business.

 

Even after we obtain FDA approval, we may be required to conduct further clinical trials (i.e., Phase 4 trials) and provide additional data on safety and effectiveness. We are also required to gain separate approval for the use of an approved product as a treatment for indications other than those initially approved. In addition, side effects or adverse events that are reported during clinical trials can delay, impede or prevent marketing approval. Similarly, adverse events that are reported after marketing approval can result in additional limitations being placed on the product’s use and, potentially, withdrawal of the product from the market. Any adverse event, either before or after marketing approval, can result in product liability claims against us.

 

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition—generally a disease or condition with a prevalence of fewer than 200,000 individuals in the United States. Orphan drug designation must be requested before submitting an NDA. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. The first NDA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the United States for that product candidate, for that indication. During the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug for the same disease, except in limited circumstances, such as a showing of clinical superiority to the product candidate with orphan drug exclusivity. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA application user fee.

 

Although we currently have no approvals to market our products from the FDA, if we obtain regulatory approval for any of our product prospects, we will be required to comply with post-approval regulatory requirements, including any post-approval requirements that the FDA may have imposed as a condition of approval. We will be required to report certain adverse reactions and production problems to the FDA, provide updated safety and efficacy information and comply with requirements concerning advertising and promotional labeling requirements. We, as well as certain of our partners or subcontractors, will be required to register our facilities with the FDA and certain state agencies, and will be subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including current good manufacturing, or cGMP, regulations, which impose certain procedural and documentation requirements upon drug manufacturers. Accordingly, we must continue to expend time, money and effort in the areas of production and quality control to maintain compliance with cGMP regulations and other regulatory requirements.

 

Our products may also be subject to official lot release, meaning that we will be required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to official release, we must submit samples of each lot, together with a release protocol showing a summary of the history of manufacture of the lot and the results of all tests performed on the lot, to the FDA. The FDA may in addition perform certain confirmatory tests on lots of some products before releasing the lots for distribution. Finally, the FDA will conduct laboratory research related to the safety, purity, potency, and effectiveness of pharmaceutical products.

 

Once an approval is granted, the FDA may withdraw the approval if we do not maintain compliance with regulatory requirements and standards or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a Risk Evaluation and Mitigation Strategy, or REMS, program. Other potential consequences include, among other things:

 

  restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
  fines, warning letters or holds on post-approval clinical trials;
  refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product license
  approvals;
  product seizure or detention, or refusal to permit the import or export of products; or
  injunctions or the imposition of civil or criminal penalties.

 

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The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

 

We may also be subject to various federal, state and international laws pertaining to health care “fraud and abuse,” including anti-kickback laws and false claims laws. The federal Anti-kickback law, which governs federal healthcare programs (e.g., Medicare, Medicaid), makes it illegal to solicit, offer, receive or pay any remuneration in exchange for, or to induce, the referral of business, including the purchase or prescription of a particular drug. Many states have similar laws that are not restricted to federal healthcare programs. Federal and state false claims laws prohibit anyone from knowingly and willingly presenting, or causing to be presented for payment to third party payers (including Medicare and Medicaid), claims for reimbursement, including claims for the sale of drugs or services, that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services. If the government or a whistleblower were to allege that we violated these laws there could be a material adverse effect on us, including our stock price. Even an unsuccessful challenge could cause adverse publicity and be costly to respond to, which could have a materially adverse effect on our business, results of operations and financial condition. A finding of liability under these laws can have significant adverse financial implications for us and can result in payment of large penalties and possible exclusion from federal healthcare programs. We will consult counsel concerning the potential application of these and other laws to our business and our sales, marketing and other activities and will make good faith efforts to comply with them. However, given their broad reach and the increasing attention given by law enforcement authorities, we cannot assure you that some of our activities will not be challenged or deemed to violate some of these laws.

 

European Economic Area

 

Although we are not currently seeking regulatory approval in the EU, we or our potential future licensees may do so in the future. As such, a summary of the EU regulatory processes follows below.

 

A medicinal product may only be placed on the market in the European Economic Area (the “EEA”), composed of the 27 EU member states, plus Norway, Iceland and Lichtenstein, when a marketing authorization has been issued by the competent authority of a member state pursuant to Directive 2001/83/EC (as recently amended by Directive 2004/27/EC), or an authorization has been granted under the centralized procedure in accordance with Regulation (EC) No. 726/2004 or its predecessor, Regulation 2309/93. There are essentially three community procedures created under prevailing European pharmaceutical legislation that, if successfully completed, allow an applicant to place a medicinal product on the market in the EEA.

 

Centralized Procedure

 

Regulation 726/2004/EC now governs the centralized procedure when a marketing authorization is granted by the European Commission, acting in its capacity as the European Licensing Authority on the advice of the EMA. That authorization is valid throughout the entire community and directly or (as to Norway, Iceland and Liechtenstein) indirectly allows the applicant to place the product on the market in all member states of the EEA. The EMA is the administrative body responsible for coordinating the existing scientific resources available in the member states for evaluation, supervision and pharmacovigilance of medicinal products. Certain medicinal products, as described in the Annex to Regulation 726/2004, must be authorized centrally. These are products that are developed by means of a biotechnological process in accordance with Paragraph 1 to the Annex to the Regulation. Medicinal products for human use containing a new active substance for which the therapeutic indication is the treatment of acquired immune deficiency syndrome, or AIDS, cancer, neurodegenerative disorder or diabetes must also be authorized centrally. Starting on May 20, 2008, the mandatory centralized procedure was extended to autoimmune diseases and other immune dysfunctions and viral diseases. Finally, all medicinal products that are designated as orphan medicinal products pursuant to Regulation 141/2000 must be authorized under the centralized procedure. An applicant may also opt for assessment through the centralized procedure if it can show that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization centrally is in the interests of patients at the community level. For each application submitted to the EMA for scientific assessment, the EMA is required to ensure that the opinion of the Committee for Medicinal Products for Human Use (the “CHMP”), is given within 210 days after receipt of a valid application. This 210 days period does not include the time that the applicant to answer any questions raised during the application procedure, the so-called ‘clock stop’ period. If the opinion is positive, the EMA is required to send the opinion to the European Commission, which is responsible for preparing the draft decision granting a marketing authorization. This draft decision may differ from the CHMP opinion, stating reasons for diverging for the CHMP opinion. The draft decision is sent to the applicant and the member states, after which the European Commission takes a final decision. If the initial opinion of the CHMP is negative, the applicant is afforded an opportunity to seek a re-examination of the opinion. The CHMP is required to re-examine its opinion within 60 days following receipt of the request by the applicant. All CHMP refusals and the reasons for refusal are made public on the EMA website. Without a centralized marketing authorization it is prohibited to place a medicinal product that must be authorized centrally on the market in the EU.

 

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Mutual Recognition and Decentralized Procedures

 

With the exception of products that are authorized centrally, the competent authorities of the member states are responsible for granting marketing authorizations for medicinal products placed on their national markets. If the applicant for a marketing authorization intends to market the same medicinal product in more than one member state, the applicant may seek an authorization progressively in the community under the mutual recognition or decentralized procedure. Mutual recognition is used if the medicinal product has already been authorized in a member state. In this case, the holder of this marketing authorization requests the member state where the authorization has been granted to act as reference member state by preparing an updated assessment report that is then used to facilitate mutual recognition of the existing authorization in the other member states in which approval is sought (the so-called concerned member state(s)). The reference member state must prepare an updated assessment report within 90 days of receipt of a valid application. This report together with the approved Summary of Product Characteristics (“SmPC”) (which sets out the conditions of use of the product), and a labeling and package leaflet are sent to the concerned member states for their consideration. The concerned member states are required to approve the assessment report, the SmPC and the labeling and package leaflet within 90 days of receipt of these documents. The total procedural time is 180 days.

 

The decentralized procedure is used in cases where the medicinal product has not received a marketing authorization in the EU at the time of application. The applicant requests a member state of its choice to act as reference member state to prepare an assessment report that is then used to facilitate agreement with the concerned member states and the grant of a national marketing authorization in all of these member states. In this procedure, the reference member state must prepare, for consideration by the concerned member states, the draft assessment report, a draft SmPC and a draft of the labeling and package leaflet within 120 days after receipt of a valid application. As in the case of mutual recognition, the concerned member states are required to approve these documents within 90 days of their receipt.

 

For both mutual recognition and decentralized procedures, if a concerned member state objects to the grant of a marketing authorization on the grounds of a potential serious risk to public health, it may raise a reasoned objection with the reference member state. The points of disagreement are in the first instance referred to the Co-ordination Group on Mutual Recognition and Decentralized Procedures, to reach an agreement within 60 days of the communication of the points of disagreement. If member states fail to reach an agreement, then the matter is referred to the EMA and CHMP for arbitration. The CHMP is required to deliver a reasoned opinion within 60 days of the date on which the matter is referred. The scientific opinion adopted by the CHMP forms the basis for a binding European Commission decision.

 

Irrespective of whether the medicinal product is assessed centrally, de-centrally or through a process of mutual recognition, the medicinal product must be manufactured in accordance with the principles of good manufacturing practice as set out in Directive 2003/94/EC and Volume 4 of the rules governing medicinal products in the European community. Moreover, community law requires the clinical results in support of clinical safety and efficacy based upon clinical trials conducted in the European community to be in compliance with the requirements of Directive 2001/20/EC, which implements good clinical practice in the conduct of clinical trials on medicinal products for human use. Clinical trials conducted outside the European community and used to support applications for marketing within the EU must have been conducted in a way consistent with the principles set out in Directive 2001/20/EC. The conduct of a clinical trial in the EU requires, pursuant to Directive 2001/20/EC, authorization by the relevant national competent authority where a trial takes place, and an ethics committee to have issued a favorable opinion in relation to the arrangements for the trial. It also requires that the sponsor of the trial, or a person authorized to act on his behalf in relation to the trial, be established in the community.

 

National Procedure

 

This procedure is available for medicinal products that do not fall within the scope of mandatory centralized authorization and are intended for use in only one EU member state. Specific procedures and timelines differ between member states, but the duration of the procedure is generally 210 days and based on a risk/efficacy assessment by the competent authority of the member state concerned, followed by determination of SmPC, package leaflet and label text/layout and subsequently grant of the marketing authorization. Marketing authorizations granted on this basis are not mutually recognized by other member states.

 

There are various types of applications for marketing authorizations:

 

Full Applications. A full application is one that is made under any of the community procedures described above and “stands alone” in the sense that it contains all of the particulars and information required by Article 8(3) of Directive 2001/83 (as amended) to allow the competent authority to assess the quality, safety and efficacy of the product and in particular the balance between benefit and risk. Article 8(3)(l) in particular refers to the need to present the results of the applicant’s research on (i) pharmaceutical (physical-chemical, biological or microbiological) tests, (ii) preclinical (toxicological and pharmacological) studies and (iii) clinical trials in humans. The nature of these tests, studies and trials is explained in more detail in Annex I to Directive 2001/83/EC. Full applications would be required for products containing new active substances not previously approved by the competent authority, but may also be made for other products.

 

Abridged Applications. Article 10 of Directive 2001/83/EC contains exemptions from the requirement that the applicant provide the results of its own preclinical and clinical research. There are three regulatory routes for an applicant to seek an exemption from providing such results, namely (i) cross-referral to an innovator’s results without consent of the innovator, (ii) well established use according to published literature and (iii) consent to refer to an existing dossier of research results filed by a previous applicant.

 

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Cross-referral to Innovator’s Data

 

Articles 10(1) and 10(2)(b) of Directive 2001/83/EC provide the legal basis for an applicant to seek a marketing authorization on the basis that its product is a generic medicinal product (a copy) of a reference medicinal product that has already been authorized, in accordance with community provisions. A reference product is, in principle, an original product granted an authorization on the basis of a full dossier of particulars and information. This is the main exemption used by generic manufacturers for obtaining a marketing authorization for a copy product. The generic applicant is not required to provide the results of preclinical studies and of clinical trials if its product meets the definition of a generic medicinal product and the applicable regulatory results protection period for the results submitted by the innovator has expired. A generic medicinal product is defined as a medicinal product:

 

  having the same qualitative and quantitative composition in active substance as the reference medicinal product;
  having the same pharmaceutical form as the reference medicinal product; and
  whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.

 

Applications in respect of a generic medicinal product cannot be made before the expiry of the protection period. Where the reference product was granted a national marketing authorization pursuant to an application made before October 30, 2005, the protection period is either 6 years or 10 years, depending upon the election of the particular member state concerned. Where the reference product was granted a marketing authorization centrally, pursuant to an application made before November 20, 2005, the protection period is 10 years. For applications made after these dates, Regulation 726/2004 and amendments to Directive 2001/83/EC provide for a harmonized protection period regardless of the approval route utilized. The harmonized protection period is in total 10 years, including eight years of research data protection and two years of marketing protection. The effect is that the originator’s results can be the subject of a cross-referral application after eight years, but any resulting authorization cannot be exploited for a further two years. The rationale of this procedure is not that the competent authority does not have before it relevant tests and trials upon which to assess the efficacy and safety of the generic product, but that the relevant particulars can, if the research data protection period has expired, be found on the originator’s file and used for assessment of the generic medicinal product. The 10-year protection period can be extended to 11 years where, in the first eight years, post-authorization, the holder of the authorization obtains approval for a new indication assessed as offering a significant clinical benefit in comparison with existing products.

 

If the copy product does not meet the definition of a generic medicinal product or if certain types of changes occur in the active substance(s) or in the therapeutic indications, strength, pharmaceutical form or route of administration in relation to the reference medicinal product, Article 10(3) of Directive 2001/83/EC provides that the results of the appropriate preclinical studies or clinical trials must be provided by the applicant.

 

Well-Established Medicinal Use

 

Under Article 10a of Directive 2001/83/EC, an applicant may, in substitution for the results of its own preclinical and clinical research, present detailed references to published literature demonstrating that the active substance(s) of a product have a well-established medicinal use within the community with recognized efficacy and an acceptable level of safety. The applicant is entitled to refer to a variety of different types of literature, including reports of clinical trials with the same active substance(s) and epidemiological studies that indicate that the constituent or constituents of the product have an acceptable safety/efficacy profile for a particular indication. However, use of the published literature exemption is restricted by stating that in no circumstances will constituents be treated as having a well-established use if they have been used for less than 10 years from the first systematic and documented use of the substance as a medicinal product in the EU. Even after 10 years’ systematic use, the threshold for well-established medicinal use might not be met. European pharmaceutical law requires the competent authorities to consider among other factors the period over which a substance has been used, the amount of patient use of the substance, the degree of scientific interest in the use of the substance (as reflected in the scientific literature) and the coherence (consistency) of all the scientific assessments made in the literature. For this reason, different substances may reach the threshold for well-established use after different periods, but the minimum period is 10 years. If the applicant seeks approval of an entirely new therapeutic use compared with that to which the published literature refers, additional preclinical and/or clinical results would have to be provided.

 

Informed Consent

 

Under Article 10c of Directive 2001/83/EC, following the grant of a marketing authorization the holder of such authorization may consent to a competent authority utilizing the pharmaceutical, preclinical and clinical documentation that it submitted to obtain approval for a medicinal product to assess a subsequent application relating to a medicinal product possessing the same qualitative and quantitative composition with respect to the active substances and the same pharmaceutical form.

 

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Law Relating to Pediatric Research

 

Regulation (EC) 1901/2006 (as amended by Regulation (EC) 1902/2006) was adopted on December 12, 2006. This Regulation governs the development of medicinal products for human use in order to meet the specific therapeutic needs of the pediatric population. It requires any application for marketing authorization made after July 26, 2008 in respect of a product not authorized in the European Community on January 26, 2007 (the time the Regulation entered into force), to include the results of all studies performed and details of all information collected in compliance with a pediatric investigation plan agreed by the Pediatric Committee of the EMA, unless the product is subject to an agreed waiver or deferral or unless the product is excluded from the scope of Regulation 1902/2006 (generics, hybrid medicinal products, biosimilars, homeopathic and traditional (herbal) medicinal products and medicinal products containing one or more active substances of well-established medicinal use). Waivers can be granted in certain circumstances where pediatric studies are not required or desirable. Deferrals can be granted in certain circumstances where the initiation or completion of pediatric studies should be deferred until appropriate studies in adults have been performed. Moreover, this regulation imposes the same obligation from January 26, 2009 on an applicant seeking approval of a new indication, pharmaceutical form or route of administration for a product already authorized and still protected by a supplementary protection certificate granted under Regulation EC 469/2009 and its precursor (EEC) 1768/92 or by a patent that qualifies for the granting of such a supplementary protection certificate. The pediatric Regulation 1901/2006 also provides, subject to certain conditions, a reward for performing such pediatric studies, regardless of whether the pediatric results provided resulted in the grant of a pediatric indication. This reward comes in the form of an extension of six months to the supplementary protection certificate granted in respect of the product, unless the product is subject to orphan drug designation, in which case the 10-year market exclusivity period for such orphan products is extended to 12 years. If any of the non-centralized procedures for marketing authorization have been used, the six-month extension of the supplementary protection certificate is only granted if the medicinal product is authorized in all member states.

 

Post-authorization Obligations

 

In the pre-authorization phase the applicant must provide a detailed pharmacovigilance plan that it intends to implement post-authorization. An authorization to market a medicinal product in the EU carries with it an obligation to comply with many post-authorization organizational and behavioral regulations relating to the marketing and other activities of authorization holders. These include requirements relating to post-authorization efficacy studies, post-authorization safety studies, adverse event reporting and other pharmacovigilance requirements, advertising, packaging and labeling, patient package leaflets, distribution and wholesale dealing. The regulations frequently operate within a criminal law framework and failure to comply with the requirements may not only affect the authorization, but also can lead to financial and other sanctions levied on the company in question and responsible officers. As a result of the currently on-going overhaul of EU pharmacovigilance legislation the financial and organizational burden on market authorization holders will increase significantly, such as the obligation to maintain a pharmacovigilance system master file that applies to all holders of marketing authorizations granted in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004. Marketing authorization holders must furthermore collect data on adverse events associated with use of the authorized product outside the scope of the authorization. Pharmacovigilance for biological products and medicines with a new active substance will be strengthened by subjecting their authorization to additional monitoring activities. The EU is currently in the process of issuing implementing regulations for the new pharmacovigilance framework.

 

Any authorization granted by member state authorities, which within three years of its granting is not followed by the actual placing on the market of the authorized product in the authorizing member state ceases to be valid. When an authorized product previously placed on the market in the authorizing member state is no longer actually present on the market for a period of three consecutive years, the authorization for that product shall cease to be valid. The same two three year periods apply to authorizations granted by the European Commission based on the centralized procedure.

 

ITEM 1A. RISK FACTORS

 

Risks Related to Our Business, Financial Position and Capital Requirements

 

We are an early-stage biopharmaceutical medical cannabis research and development company with a history of losses, and we expect to continue to incur losses for the foreseeable future, and we may never achieve or maintain profitability.

 

We are an early-stage biopharmaceutical medical cannabis research and development company focused on the research and development of medical cannabis therapies, products and delivery technologies and we have incurred significant operating losses since we commenced our present operations in July 2014. Our net loss was approximately $4.5 million and $2.4 million for the fiscal years ended December 31, 2017 and 2016, respectively. As of December 31, 2017, we had an accumulated deficit of approximately $14.5 million. To date, we have not generated any product revenue. Substantially all of our losses have resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We have no products on the market and expect that it will be many years, if ever, before we have a product candidate ready for commercialization.

 

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We have not generated, and may not generate, any product revenue for the foreseeable future, and we expect to continue to incur significant operating losses for the foreseeable future due to the cost of research and development, preclinical studies and clinical trials, the regulatory review process for product prospects, and the development of manufacturing and marketing capabilities for any product prospects approved for commercial sale. The amount of our potential future losses is uncertain. To achieve profitability, we must successfully develop product prospects, obtain regulatory approvals to market and commercialize product prospects, manufacture any approved product prospects on commercially reasonable terms, establish a sales and marketing organization or suitable third-party alternatives for any approved product prospects and raise sufficient funds to finance our business activities. We may never succeed in these activities and, even if we do, may never generate revenues that are significant or large enough to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease our value and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in our value could also cause our stockholders to lose all or part of their investment.

 

Since we have a limited operating history in our business, it is difficult for potential investors to evaluate our business.

 

Our business involves two distinct operations: (i) conducting scientific research and development in collaboration with leading universities and institutions in Israel on the use of cannabis for medical treatment and (ii) providing consulting services to assist clients with establishing their own medical cannabis treatment programs. We commenced operations as a medical cannabis research and development company in July 2014, and therefore have a relatively short operating history upon which an evaluation of our future success or failure can objectively be made. Our business is a highly speculative undertaking and involves a substantial degree of risk. We have not demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by early-stage companies in new and rapidly evolving competitive fields, including under-capitalization, cash shortages, limitations with respect to personnel, financial, and other resources and lack of revenue. The likelihood of our success must be considered in light of the early stage of our operations. There is no assurance that our business will ever be successful or that we will be able to attain profitability. Any failure by us to report profits may adversely affect the price of our Common Stock.

 

We will need to raise additional capital to meet our business requirements in the future, which may be costly or difficult to obtain and could dilute our stockholders’ ownership interests.

 

We have not yet generated significant revenue and will require additional capital to continue our research and development activities, conduct clinical trials, commercialize our products and otherwise fund our operations. Our ability to secure required financing will depend in part upon investor perception of our ability to create a successful business. Capital market conditions and other factors beyond our control may also play important roles in our ability to raise capital. There can be no assurance that debt or equity financing will be available or sufficient for our requirements or for other corporate purposes, or if debt or equity financing is available, that it will be on terms acceptable to us. Moreover, future activities may require us to alter our capitalization significantly. Our inability to access sufficient capital for our operations could have a material adverse effect on our financial condition, results of operations and prospects. If we are unable to obtain additional funding as needed, we may be required to reduce the scope of our research and development activities, which could harm our business plan, financial condition and operating results, or we may be required to cease our operations entirely, in which case, our investors will lose all of their investment.

 

Any additional capital raised through the sale of equity or equity-backed securities may dilute our stockholders’ ownership percentages and could also result in a decrease in the market value of our equity securities. The terms of any securities issued by us in future capital transactions may be more favorable to new investors, and may include preferences, superior voting rights and the issuance of warrants or other derivative securities, which may have a further dilutive effect on the holders of our securities then outstanding. Any debt financing secured in the future could involve restrictive covenants relating to capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities. In addition, we may incur substantial costs in pursuing future capital financing, including investment banking fees, legal fees, accounting fees, securities law compliance fees, printing and distribution expenses and other costs. We may also be required to recognize non-cash expenses in connection with certain securities we issue, such as convertible notes and warrants, which may have an adverse impact on our financial condition.

 

Our involvement in the cannabis industry may make it difficult to obtain insurance coverage.

 

In the event that we decide to commence business operations in the U.S., of which there can be no assurance, obtaining and maintaining necessary insurance coverage, for such things as workers compensation, general liability, product liability and directors and officers insurance, may be more difficult and/or expensive for us to find because we are involved in the cannabis industry. There can be no assurance that we will be able to find such insurance in the near future, if needed, or that the cost of coverage will be affordable or cost-effective. If, either because of unavailability or cost prohibitive reasons, we are compelled to operate without insurance coverage, we may be prevented from entering certain business sectors, experience inhibited growth potential and/or be exposed to additional risks and financial liabilities.

 

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Our independent registered public accounting firm has expressed substantial doubt as to our ability to continue as a going concern.

 

The audited financial statements included in this annual report have been prepared assuming that we will continue as a going concern and do not include any adjustments that might result if we cease to continue as a going concern. We believe that in order to continue as a going concern, including the costs of being a public company, we will need approximately $260,000 per year simply to cover our administrative, legal and accounting fees. We have incurred significant losses since our inception. We have funded these losses primarily through the sale of restricted shares of our Common Stock, grant of restricted shares for services and the issuance of convertible notes, which have subsequently been converted into restricted shares of Common Stock.

 

Based on our financial history and other factors described in the audited financial statements as of and for the year ended December 31, 2017, our independent registered public accounting firm has expressed substantial doubt as to our ability to continue as a going concern in its report on the financial statements and elsewhere in the financial statements. To date, we have not generated significant revenues and we do not anticipate generating any significant revenues in 2018.

 

Notwithstanding our success in raising $1.9 million from the sale of our securities in 2017, there can be no assurance that we will be able to continue to raise equity and/or debt capital from investors on terms and conditions satisfactory to us, or otherwise, and/or have adequate capital resources required by us to fund our current and future planned operations. If we are unable to obtain adequate capital resources to fund operations, we may be required to delay, scale back or eliminate some or all of our plan of operations, which may have a material adverse effect on our business, results of operations and ability to continue as a going concern.

 

Our proprietary information, or that of our customers, suppliers and business partners, may be lost or we may suffer security breaches.

 

In the ordinary course of our business, we collect and store sensitive data, including intellectual property, clinical trial data, our proprietary business information and that of our suppliers and business partners, and personally identifiable information of our employees, in our data centers and on our networks. The secure processing, maintenance and transmission of this information is critical to our operations. Despite our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Although to our knowledge we have not experienced any such material security breach to date, any such breach could compromise our networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, regulatory penalties, disrupt our operations, damage our reputation, and cause a loss of confidence in our products and our ability to conduct clinical trials, which could adversely affect our business and reputation and lead to delays in gaining regulatory approvals for our Cannabis-Based Medical Product prospects. Although we maintain business interruption insurance coverage, our insurance might not cover all losses from any future breaches of our systems.

 

Significant disruptions of information technology systems or security breaches could adversely affect our business.

 

We are increasingly dependent upon information technology systems, infrastructure and data to operate our business. In the ordinary course of business, we collect, store and transmit large amounts of confidential information (including, among other things, trade secrets or other intellectual property, proprietary business information and personal information). It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. We also have outsourced elements of our operations to third parties, and as a result we manage a number of third-party vendors who may or could have access to our confidential information. The size and complexity of our information technology systems, and those of third-party vendors with whom we contract, and the large amounts of confidential information stored on those systems, make such systems vulnerable to service interruptions or to security breaches from inadvertent or intentional actions by our employees, third-party vendors, and/or business partners, or from cyber-attacks by malicious third parties. Cyber-attacks are increasing in their frequency, sophistication and intensity, and have become increasingly difficult to detect. Cyber-attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information.

 

Significant disruptions of our information technology systems, or those of our third-party vendors, or security breaches could adversely affect our business operations and/or result in the loss, misappropriation and/or unauthorized access, use or disclosure of, or the prevention of access to, confidential information, including, among other things, trade secrets or other intellectual property, proprietary business information and personal information, and could result in financial, legal, business and reputational harm to us. For example, any such event that leads to unauthorized access, use or disclosure of personal information, including personal information regarding our patients or employees, could harm our reputation, require us to comply with federal and/or state breach notification laws and foreign law equivalents, and otherwise subject us to liability under laws and regulations that protect the privacy and security of personal information. Security breaches and other inappropriate access can be difficult to detect, and any delay in identifying them may lead to increased harm of the type described above. While we have implemented security measures to protect our information technology systems and infrastructure, there can be no assurance that such measures will prevent service interruptions or security breaches that could adversely affect our business.

 

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The estimates and judgments we make, or the assumptions on which we rely, in preparing our consolidated financial statements could prove inaccurate.

 

Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP). The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of our assets, liabilities, revenues and expenses, the amounts of charges accrued by us and related disclosure of contingent assets and liabilities. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. We cannot assure, however, that our estimates, or the assumptions underlying them, will not change over time or otherwise prove inaccurate. For example, our estimates as they relate to anticipated timelines and milestones for our clinical trials or preclinical development or other financial measurements may prove to be inaccurate. If this is the case, we may be required to re-estimate our plans or restate our consolidated financial statements, which could, in turn, subject us to securities class action litigation. Defending against such potential litigation relating to a restatement of our consolidated financial statements would be expensive and would require significant attention and resources of our management. Moreover, our insurance to cover our obligations with respect to the ultimate resolution of any such litigation may be inadequate. As a result of these factors, any such potential litigation could have a material adverse effect on our financial results, harm our business, and cause our share price to decline.

 

Risks Related to Our Product Development, Our Services and the Medical Cannabis Industry

 

We are highly dependent on the success of cannabinoid technology, and we may not be able to develop the technology, successfully obtain regulatory or marketing approval for, or successfully commercialize, our products or product candidates.

 

Our business is focused upon the research and development of medical cannabis therapies, products and delivery technologies. Our success is dependent upon the viability of the development of medical cannabis therapies, products and delivery technologies.

 

Neither we nor any other company has received regulatory approval from the FDA to market any therapeutics, products or delivery technologies based on botanical cannabinoids, though the FDA has approved two drugs that contain a synthetic substance that acts similarly to cannabis compounds but is not present in the cannabis plant. Further, the scientific evidence underlying the feasibility of developing medical cannabis therapies, products and delivery technologies is both preliminary and limited.

 

If our Cannabis-Based Medical product prospects are found to be ineffective or unsafe in humans, or if the never receive regulatory approval for commercialization, we may never be able bring our Cannabis-Based Medical Products prospects to market and may never become profitable. Further, our current business strategy, including all of our research and development, is primarily focused on utilizing cannabinoid technology to develop medical cannabis therapies, products and delivery technologies. This lack of diversification increases the risk associated with the ownership of our Common Stock. If we are unsuccessful in developing and commercializing our Cannabis-Based Medical product prospects, we may be required to alter our scope and direction and steer away from the intellectual property we have developed as well as the core capabilities of our management team and advisory board. Without successful commercialization of our Cannabis-Based Medical product prospects, we may never become profitable, which would have a material adverse effect on our business, results of operations and financial condition.

 

Laws and regulations affecting therapeutic uses of marijuana are constantly evolving.

 

The constant evolution of laws and regulations affecting the research and development of cannabis-based medical products and treatments could detrimentally affect our business. Laws and regulations related to the therapeutic uses of marijuana are subject to changing interpretations. These changes may require us to incur substantial costs associated with legal and compliance fees and ultimately require us to alter our business plan. Furthermore, violations or alleged violation of these laws could disrupt our business and result in a material adverse effect on our operations. In addition, we cannot predict the nature of any future laws, regulations, interpretations or applications of laws and regulations and it is possible that new laws and regulations may be enacted in the future that will be directly applicable to our business.

 

The FDA has not approved the whole-plant extract of cannabis as a safe and effective drug for any indication.

 

Although the FDA has not approved any drug product containing or derived from botanical cannabis, the FDA is aware that there is considerable interest in its use to attempt to treat a number of medical conditions. Before conducting testing in humans of a drug that has not been approved by the FDA, we will need to submit an investigational new drug (IND) application, which is reviewed by the FDA. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending NDAs, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution. We cannot predict how FDA would regulate any drug based on or derived from botanical cannabis or what restrictions would apply once approved.

 

Clinical trials of cannabis-based medical products and treatments are novel terrain with very limited or non-existing clinical trials history; we face a significant risk that the trials will not result in commercially viable products and treatments.

 

At present, there is no documented history of clinical trials from which we can derive any scientific conclusions, or prove that our present assumptions for the current and planned research are scientifically compelling. The results from our 2015 in vitro studies on the effect of a formulation comprised of Cannabidiol (CBD) and tetrahydrocannabinol (THC) on multiple myeloma cells studied outside their normal biological context indicated a 100% mortality rate of myeloma cells in 60% of the cultured cells within a 24 to 48 hour period, and highlight the potential abilities of cannabis oil extract to successfully fight multiple myeloma cancer cells and, hopefully treat multiple myeloma in patients, when and if approved. While we are encouraged by the results of the limited in vitro tests, there can be no assurance that any clinical trial will result in commercially viable products or treatments.

 

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Clinical trials are expensive, time consuming and difficult to design and implement. Failure can occur at any time during the clinical study process. The results of preclinical studies and early clinical studies of our product candidates may not be predictive of the results of later-stage clinical studies. Product candidates that have shown promising results in early-stage clinical studies may still suffer significant setbacks in subsequent advanced clinical studies. There is a high failure rate for drugs proceeding through clinical studies, and product candidates in later stages of clinical studies may fail to show the desired safety and efficacy traits despite having progressed satisfactorily through preclinical studies and initial clinical studies. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical studies due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier studies. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses. We do not know whether any Phase I, Phase II, Phase III or other clinical studies we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain regulatory approval to market our product candidates. We, as well as the regulatory authorities in Israel and elsewhere, such as an IRB (Helsinki committee), IMCU - Israel Medical Cannabis Unit, or the FDA, may suspend, delay or terminate our clinical trials at any time, may require us, for various reasons, to conduct additional clinical trials, or may require a particular clinical trial to continue for a longer duration than originally planned, including, among others:

 

  lack of effectiveness of any formulation or delivery system during clinical trials;
  discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues;
  slower than expected rates of subject recruitment and enrollment rates in clinical trials;
  delays or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing constraints;
  delays in obtaining regulatory authorization to commence a trial, including IRB approvals, licenses required for obtaining and using cannabis for research, either before or after a trial is commenced;
  unfavorable results from ongoing pre-clinical studies and clinical trials.
  patients or investigators failing to comply with study protocols;
  patients failing to return for post-treatment follow-up at the expected rate;
  sites participating in an ongoing clinical study withdraw, requiring us to engage new sites;
  third-party clinical investigators decline to participate in our clinical studies, do not perform the clinical studies on the anticipated schedule, or act in ways inconsistent with the established investigator agreement, clinical study protocol, good clinical practices, and other Institutional Review Board requirements;
  third-party entities do not perform data collection and analysis in a timely or accurate manner or at all; or
  regulatory inspections of our clinical studies require us to undertake corrective action or suspend or terminate our clinical studies.

 

Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.

 

We may find it difficult to enroll patients in our clinical studies. Difficulty in enrolling patients could delay or prevent clinical studies of our product candidates.

 

Identifying and qualifying patients to participate in clinical studies of our product prospects is critical to our success. The timing of our clinical studies depends in part on the speed at which we can recruit patients to participate in testing our product prospects, and we may experience delays in our clinical studies if we encounter difficulties in enrollment.

 

Additionally, the process of finding patients may prove costly. We also may not be able to identify, recruit and enroll a sufficient number of patients to complete our clinical studies because of the perceived risks and benefits of the product prospects under study, the availability and efficacy of competing therapies and clinical studies, the proximity and availability of clinical study sites for prospective patients and the patient referral practices of physicians. If patients are unwilling to participate in our studies for any reason, the timeline for recruiting patients, conducting studies and obtaining regulatory approval of potential product prospects will be delayed.

 

If we experience delays in the completion or termination of any clinical study of our product prospects, the commercial prospects of our product prospects will be harmed, and our ability to generate revenue from any of these product prospects could be delayed or prevented. In addition, any delays in completing our clinical studies will increase our costs, slow down our product candidate development and approval process and jeopardize our ability to commence product sales and generate revenue. Any of these occurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical studies may also ultimately lead to the denial of regulatory approval of our product prospects.

 

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In respect of our product candidates targeting rare indications, orphan drug exclusivity may afford limited protection, and if another party obtains orphan drug exclusivity for the drugs and indications we are targeting, we may be precluded from commercializing our product candidates in those indications during that period of exclusivity.

 

We are seeking to obtain an orphan designation for some of our product candidates in the United States and in Europe. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, defined, in part, as a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In the European Union, the EMA’s Committee for Orphan Medicinal Products (COMP), grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the European Union community. Additionally, designation is granted for products intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing the drug.

 

In the United States, the first NDA applicant with an orphan drug designation for a particular active moiety to treat a specific disease or condition that receives FDA approval is entitled to a seven-year exclusive marketing period in the United States for that product candidate, for that indication. In the European Union, orphan drug designation also entitles a party to financial incentives such as reduction of fees or fee waivers and 10 years of market exclusivity is granted following drug approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.

 

There is no assurance that we will successfully obtain orphan drug designation for any rare disease or condition indications or that we will receive the full benefit of orphan exclusivity upon approval of any of our product prospects for which we obtain orphan drug designation.

 

Failure to secure the necessary Israeli licenses to use cannabis for medical research could limit our ability to execute our research and development activities, delay the launch of our products and adversely affect the results of our business operations.

 

To date, we are only conducting our research in Israel and, in fact, have limited our activities to Israel. The medical products we are developing contain cannabis, a “controlled substance” as defined in the Israeli Dangerous Drugs Ordinance [New Version], 5733 - 1973. In Israel, licenses to cultivate, possess and to use cannabis for medical research are granted by the IMCA, on an ad-hoc basis. We acquire the cannabis needed for our research activities from G.K. Medical Cannabis Ltd, Canndoc Ltd or IMC Medical Cannabis Ltd, all government-licensed Israeli medical cannabis growers. We obtained necessary IMCA licenses in order to carry out the research in collaboration with Sheba, G.C. Group, Emilia, Dead Sea Labs and the Technion. Currently we have licenses in order to continue our activities in collaboration with Sheba Academic Medical Center, PharmItBe, Pharmaceed Ltd and the Technion R&D Foundation Ltd. We have applied for additional license for a phase I study we are starting in the second fiscal quarter of 2018 in Sourasky hospital for the safety of our cannabis soluble tablet delivery system.

 

Although we have an established track record of successfully obtaining the requisite licenses as required, there can be no assurance that we will continue to be able to secure licenses in the future. If we fail to comply with Israeli rules and regulations related to the licensing of cannabis, we may not be able to research and develop our product prospects as we intend or at all. If we are unsuccessful in obtaining the requisite licenses, we may never become profitable, which would have a material adverse effect on our business, results of operations and financial condition.

 

Our failure to comply with controlled substance legislation could restrict or harm our ability to develop and commercialize our products.

 

Our business is, and will be, subject to wide-ranging laws and regulations of Israel, the United States (federal and state), the European Community and other governments in each of the countries where we may develop and market our products. We must comply with all regulatory requirements if we expect to be successful.

 

Most countries are parties to the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol, which governs international trade and domestic control of narcotic substances, including cannabis extracts. Countries may interpret and implement their treaty obligations in a way that creates a legal obstacle to us obtaining marketing approval in those countries for any cannabinoid-based products we develop. These countries may not be willing or able to amend or otherwise modify their laws and regulations to permit our products to be marketed, or achieving such amendments to the laws and regulations may take a prolonged period of time. In the case of countries with similar obstacles, we would be unable to market our product prospects in countries in the near future or perhaps at all if the laws and regulations in those countries do not change.

 

Any cannabinoid-based product prospect that we may develop for use in the United States, will be subject to U.S. controlled substance laws and regulations that will require us, along with our collaborators and licensees, to expend time, money and effort in all areas of regulatory compliance, including, if applicable, manufacturing, production, quality control and assurance and clinical trials. Any failure to comply with these laws and regulations, or the cost of compliance with these laws and regulations, could adversely affect the results of our business operations and our financial condition.

 

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The constant evolution of laws and regulations affecting the research and development of medical cannabis therapies, products and delivery technologies could detrimentally affect our business. Laws and regulations related to the therapeutic uses of cannabis are subject to changing interpretations. These changes may require us to incur substantial costs associated with legal and compliance fees and ultimately require us to alter our business plan. Furthermore, violations or alleged violation of these laws could disrupt our business and result in a material adverse effect on our operations, including our ability to conduct clinical trials that are prerequisite to our ability to commercialize our Cannabis-Based Medical Products. We cannot predict the nature of any future laws, regulations, interpretations or applications of laws and regulations and it is possible that new laws and regulations may be enacted in the future that will be directly applicable to our business.

 

Cannabis remains illegal under U.S. federal law, and any change in the enforcement priorities of the federal government could render our current and planned future operations unprofitable or even prohibit such operations.

 

We are a biotechnology company focused on the research and development of medical cannabis therapies, products and delivery technologies. The commercial viability of our medical cannabis therapies, products and delivery technologies in the United States depends, in part, on state laws and regulations; however, Cannabis remains illegal under federal law.

 

The United States federal government regulates drugs through the Controlled Substances Act, which places controlled substances, including cannabis, on one of five schedules. Cannabis is currently classified as a Schedule I controlled substance, which is viewed as having a high potential for abuse and no currently accepted medical use in treatment in the United States. No prescriptions may be written for Schedule I substances, and such substances are subject to production quotas imposed by the United States Drug Enforcement Administration. Because of this, doctors may not prescribe cannabis for medical use under federal law, although they can recommend its use under the First Amendment.

 

Currently, twenty-eight U.S. states and the District of Columbia allow the use of medical cannabis. Eight states and the District of Columbia also allow its recreational use. Because cannabis is a Schedule I controlled substance, however, the development of a legal cannabis industry under the laws of these states is in conflict with the Federal Controlled Substances Act, which makes cannabis use and possession illegal on a national level. The United States Supreme Court has confirmed that the federal government has the right to regulate and criminalize cannabis, including for medical purposes, and that federal law criminalizing the use of cannabis pre-empts state laws that legalize its use.

 

In 2014, the United States House of Representatives passed an amendment (the “Rohrabacher-Farr Amendment”) to the Commerce, Justice, Science, and Related Agencies Appropriations Bill, which funds the United States Department of Justice (the “DOJ”). The Rohrabacher-Farr Amendment prohibits the DOJ from using funds to prevent states with medical cannabis laws from implementing such laws. In August 2016, a Ninth Circuit federal appeals court ruled in United States v. McIntosh that the Rohrabacher-Farr Amendment bars the DOJ from spending funds on the prosecution of conduct that is allowed by state medical cannabis laws, provided that such conduct is in strict compliance with applicable state law. In March 2015, bipartisan legislation titled the Compassionate Access, Research Expansion, and Respect States Act (the “CARERS Act”) was introduced, proposing to allow states to regulate the medical use of cannabis by changing applicable federal law, including by reclassifying cannabis under the Controlled Substances Act to a Schedule II controlled substance and thereby changing the plant from a federally-criminalized substance to one that has recognized medical uses.

 

Although these developments have been met with a certain amount of optimism in the scientific community, the CARERS Act has not yet been adopted, and the Rohrabacher-Farr Amendment, being an amendment to an appropriations bill, must be renewed annually. On March 23, 2018, President Trump signed the Consolidated Appropriations Act of 2018 into law, which included the Rohrabacher-Blumenthal Amendment, an extension of the Rohrabacher-Farr Amendment, and will be in effect through September 30, 2018. The federal government could at any time change its enforcement priorities against the cannabis industry. We do not grow or distribute cannabis, but our current and planned business operations involve licensing cannabinoid-based products and technology. Any change in enforcement priorities could render such operations unprofitable or even prohibit such operations.

 

If we choose to distribute our future products in the United States, we will be subject to controlled substance laws and regulations; failure to receive necessary approvals may delay the launch of our products and failure to comply with these laws and regulations may adversely affect the results of our business operations.

 

Our future products will contain controlled substances as defined in the CSA. Controlled substances that are pharmaceutical products are subject to a high degree of regulation under the CSA, which establishes, among other things, certain registration, manufacturing quotas, security, recordkeeping, reporting, import, export and other requirements administered by the DEA. The DEA classifies controlled substances into five schedules: Schedule I, II, III, IV or V substances. Schedule I substances by definition have a high potential for abuse, have no currently “accepted medical use” in the United States, lack accepted safety for use under medical supervision, and may not be prescribed, marketed or sold in the United States. Pharmaceutical products approved for use in the United States may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk of abuse among such substances. Schedule I and II drugs are subject to the strictest controls under the CSA, including manufacturing and procurement quotas, security requirements and criteria for importation. In addition, dispensing of Schedule II drugs is further restricted. For example, they may not be refilled without a new prescription.

 

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While Cannabis is a Schedule I controlled substance, products approved for medical use in the United States that contain Cannabis or Cannabis extracts would likely be placed in Schedules II - V, depending on FDA’s scheduling recommendation. If and when our product prospects receive FDA approval, the DEA will make a scheduling determination based on FDA’s scientific guidance and place it in a schedule other than Schedule I in order for it to be prescribed to patients in the United States. If approved by the FDA, we expect the finished dosage forms of our product prospects to be listed by the DEA as a Schedule II or III controlled substance. Consequently, their manufacture, importation, exportation, domestic distribution, storage, sale and legitimate use will be subject to a significant degree of regulation by the DEA. The scheduling process may take one or more years beyond FDA approval, thereby significantly delaying the launch of our product prospects. Furthermore, if the FDA, DEA or any foreign regulatory authority determines that product prospects may have potential for abuse, it may require us to generate more clinical data than that which is currently anticipated, which could increase the cost and/or delay the launch of our product prospects.

 

We expect that our product prospects will be scheduled as Schedule II or III, as a result of which we will also need to identify wholesale distributors with the appropriate DEA registrations and authority to distribute the products to pharmacies and other healthcare providers, and these distributors would need to obtain Schedule II or III distribution licenses. The failure to obtain, or delay in obtaining, or the loss of any of those registrations could result in increased costs to us. If a product prospect is a Schedule II drug, pharmacies would be required to, among other things, maintain enhanced security with alarms and monitoring systems and they must adhere to recordkeeping and inventory requirements. This may discourage some pharmacies from carrying the product. Furthermore, state and federal enforcement actions, regulatory requirements, and legislation intended to reduce prescription drug abuse, such as the requirement that physicians consult a state prescription drug monitoring program, may make physicians less willing to prescribe, and pharmacies to dispense, Schedule II products.

 

We may manufacture the commercial supply of our product prospects outside of the United States. If a Product Prospect is approved by the FDA and classified as a Schedule II or III substance, an importer can import for commercial purposes if it obtains from the DEA an importer registration and files an application with the DEA for an import permit for each import. The DEA provides annual assessments/estimates to the International Narcotics Control Board which guides the DEA in the amounts of controlled substances that the DEA authorizes to be imported. The failure to identify an importer or obtain the necessary import authority, including specific quantities, could affect the availability of a Product Prospect and have a material adverse effect on our business, results of operations and financial condition. In addition, an application for a Schedule II importer registration must be published in the Federal Register, and there is a waiting period for third party comments to be submitted.

 

Individual states have also established controlled substance laws and regulations. Though state-controlled substance laws often mirror federal law, because the states are separate jurisdictions, they may separately schedule our product candidates as well. While some states automatically schedule a drug based on federal action, other states schedule drugs through rulemaking or a legislative action. State scheduling may delay commercial sale of any product for which we obtain federal regulatory approval and adverse scheduling could have a material adverse effect on the commercial attractiveness of such product. We, our potential future partners, and future distributors would also need to obtain separate state registrations, permits or licenses in order to be able to obtain, handle, and distribute controlled substances for clinical trials or commercial sale, and failure to meet applicable regulatory requirements could lead to enforcement and sanctions by the states in addition to those from the DEA or otherwise arising under federal law.

 

Our ability to provide consulting services in the United States is dependent on additional states legalizing medical marijuana.

 

While continuing with scientific investigations into medical effects and benefits of cannabis, we anticipate that it will begin generating revenue through providing consulting services related to medical marijuana programs. As of the date of this filing, we have provided consulting services to a medical marijuana program with locations in Hawaii and Pennsylvania, but has no other agreements, arrangements, or understandings, either written or oral, to provide consulting services related to public or private medical marijuana programs. We have little information on the potential market for or commercial viability of such consulting services or the entities that would compete with us for provision of such services.

 

Continued development of the medical marijuana market is dependent upon continued legislative authorization of marijuana at the state level for medical purposes and, in certain states, including California, based on the specifics of the legislation passed in that state. Any number of factors could slow or halt the progress. Furthermore, progress, while encouraging, is not assured, and the process normally encounters set-backs before achieving success. While there may be ample public support for legislative proposals, key support must be created in the legislative committee or a bill may never advance to a vote. Numerous factors impact the legislative process. Any one of these factors could slow or halt the progress and adoption of marijuana for medical purposes, which would limit the market for our services and products and negatively impact our business and revenues.

 

If we choose to engage in research and development in the United States, controlled substance legislation may restrict or limit our ability to research, manufacture and develop a commercial market for our products.

 

Clinical research with cannabis involving human subjects is heavily regulated in the US and involves coordination with multiple federal agencies, including the FDA, the DEA, and the National Institute on Drug Abuse (NIDA). All cannabis supplies for clinical research must be obtained through the NIDA, which limits the amounts and strains of cannabis available for research. Although the DEA published a notice in August 2016 that it would consider applications from independent cannabis growers to supply cannabis for clinical research, the DEA has not yet approved any additional suppliers.

 

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As of the date of this filing, we do not have any ongoing research studies involving cannabis or any of the product prospects in the US.

 

If we choose to engage in research and development or consulting activities in Europe, controlled substance legislation may restrict or limit our ability to provide consulting services or to research, manufacture and develop a commercial market for our products.

 

Approximately 250 substances, including cannabis, are listed in the Schedules annexed to the United Nations Single Convention on Narcotic Drugs (New York, 1961, amended 1972), the Convention on Psychotropic Substances (Vienna, 1971) and the Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (introducing control on precursors) (Vienna, 1988). The purpose of these listings is to control and limit the use of these drugs according to a classification of their therapeutic value, risk of abuse and health dangers, and to minimize the diversion of precursor chemicals to illegal drug manufacturers. The 1961 UN Single Convention on Narcotic Drugs, as amended in 1972 classifies cannabis as Schedule I (“substances with addictive properties, presenting a serious risk of abuse”) and as Schedule IV (“the most dangerous substances, already listed in Schedule I, which are particularly harmful and of extremely limited medical or therapeutic value”) narcotic drug. The 1971 UN Convention on Psychotropic Substances classifies THC - the principal psychoactive cannabinoid of cannabis - as schedule I psychotropic substance (Substances presenting a high risk of abuse, posing a particularly, serious threat to public health which are of very little or no therapeutic value). Most countries in Europe are parties to these conventions, which govern international trade and domestic control of these substances, including cannabis. They may interpret and implement their obligations in a way that creates a legal obstacle to our obtaining manufacturing and/or marketing approval for our products in those countries. These countries may not be willing or able to amend or otherwise modify their laws and regulations to permit our products to be manufactured and/or marketed, or achieving such amendments to the laws and regulations may take a prolonged period of time.

 

Changes in legislation or regulation in the health care systems in the United States and foreign jurisdictions may affect us.

 

Our ability to successfully commercialize our cannabis-based medical products and treatments may depend on how Israel, the US and other respective governments and/or health administrations provide coverage and/or reimbursements for our cannabis-based product prospects and treatments. The ongoing efforts of governments, insurance companies, and other participants in the health care services industry to trim health care costs may adversely affect our ability to achieve profitability.

 

In the US to date, the FDA has not approved a drug product based on botanical marijuana or a derivative or extract from botanical marijuana. In addition, the US federal government has maintained strict prohibitions on the use, cultivation, distribution, sale, and possession of marijuana and products derived from marijuana. While 29 states have enacted laws permitting medical use of marijuana for qualified patients, states laws do not necessarily allow use of medical products derived from marijuana unless otherwise approved by FDA for specific medical indications. If the laws, regulations, and enforcement policies at the federal and state level do not change, we may not be able to market our products in the US without significant risk of enforcement action.

 

In certain foreign markets, including major markets in the European Union, pricing of prescription pharmaceuticals is subject to governmental control. Price negotiations with governmental authorities may range from 6 to 12 months or longer after the receipt of regulatory marketing approval for a product. Our business could be detrimentally effected if reimbursements of our cannabis-based products is unavailable or limited if pricing is set at unacceptable levels.

 

Changes in consumer preferences and acceptance of cannabis-based medical products and treatments and any negative trends will adversely affect our business.

 

We are substantially dependent on continued market acceptance and proliferation of cannabis-based medical products and treatments. We believe that as cannabis-based products and treatments become more widely accepted by the medical/scientific communities and the public at large, the stigma associated with cannabis-based medical products and treatments will moderate and, as a result, consumer demand will likely continue to grow. However, we cannot predict the future growth rate and size of the market, assuming that the regulatory climate permits, of which there can be no assurance. Any negative outlook on cannabis-based medical products will adversely affect our business prospects.

 

In addition, we believe that large, well-funded pharmaceutical and other related businesses and industries may have a strong economic reasons to be in strong opposition to cannabis-based medical products. We believe that the pharmaceutical industry may not easily surrender control of any product, such as cannabis-based products, that could generate significant revenue. The pharmaceutical industry is well-funded with a strong and experienced lobby presence at both the federal and state levels as well as internationally, that surpasses financial resources of the current group of medical cannabis research and development companies. Any effort the pharmaceutical lobby could or might undertake to halt or delay the newly developing medical cannabis industry could have a detrimental impact on our business.

 

These pressures could also limit or restrict the introduction and marketing of any such product. Adverse publicity from cannabis misuse or adverse side effects from cannabis or other cannabinoid products may adversely affect the commercial success or marketability. The nature of our business attracts and may be expected to continue to attract a high level of public and media interest and, in the event of any related adverse publicity, we may not succeed in monetizing our products.

 

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We are entering a potentially highly competitive market.

 

Demand for medical cannabis-based products is dependent on a number of social, political and economic factors that are beyond our control. While we believe that demand for such medical products will continue to grow, there is no assurance that such increase in demand will happen, that we will benefit from any demand increase or that our business, in fact, will ever become profitable.

 

The emerging markets for cannabis-related medical research and development is and will likely remain both competitive and evolve into becoming even more so. In particular, we face strong competition from larger and better funded companies that may be in the process of offering similar products and treatments that we intend to offer. Many of our current and potential competitors have longer operating histories, significantly greater financial, marketing and other resources than we may be expected to have for the foreseeable future.

 

These competitors may be able to react to market changes quicker, respond more rapidly to new regulations and/or allocate greater resources to the development and promotion of their products than we can. Furthermore, some of these competitors may make acquisitions or establish collaborative relationships among themselves or with third parties to increase their ability to rapidly gain market share.

 

Given the rapid changes affecting the cannabis-related medical research and development industry, we may not be able to create and maintain a competitive advantage in the marketplace. Our success will depend on our ability to develop innovative cannabis-related products and treatments working with our university and institutional partners that will be accepted, especially with ever-changing legal and regulatory environment. Our success will depend on our ability to respond to, among other things, changes in the economy, market conditions, and competitive pressures. Any failure by us to anticipate or respond adequately to such changes could have a material adverse effect on our financial condition, operating results, liquidity, cash flow and our operational performance.

 

Our failure to comply with existing and potential future laws and regulations relating to drug development could harm our plan of operations.

 

Our business is, and will be, subject to wide-ranging, existing laws and regulations of the State of Israel, the U.S. (federal and states), and other governments in each of the countries we may develop and market our product prospects. We must comply with as many regulatory requirements as possible if we expect to be successful.

 

If any of our cannabis-based product prospects and treatments is approved in the United States, it will be subject to ongoing regulatory requirements including federal and state requirements. As a result, we and our collaborators and/or joint venture partners must continue to expend time, money and effort in all areas of regulatory compliance, including, if applicable, manufacturing, production, quality control and assurance and, of upmost importance, clinical trials. To date, the FDA has not approved cannabis as a safe and effective drug for any indication and has not approved a drug based on botanical cannabis or a derivative or extract from botanical cannabis. We cannot predict how FDA would regulate such a drug or what restrictions would apply once approved. It is very likely that the DEA would add any such drug product to a controlled substance schedule which carries significant restrictions. We will also be required to report certain adverse reactions and production problems, if any and applicable, to the FDA, and to comply with advertising and promotion requirements for our cannabis-based product prospects and treatments.

 

Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to conduct clinical trials, which are prerequisite to our ability to commercialize our cannabis-based medical products and related treatments. If regulatory sanctions are applied or if regulatory approval, once obtained, is for any reason withdrawn, the value of our business and our operating results could be materially adversely affected.

 

State and municipal governments in which we provide consulting services or seek to provide consulting services may have, or may adopt laws that adversely affect our ability to do business.

 

While the federal government has the right to regulate and criminalize marijuana, which it has in fact done, state and municipal governments may adopt additional laws and regulations that further criminalize or negatively affect marijuana businesses. States that currently have laws that decriminalize or legalize certain aspects of marijuana, such as medical marijuana, could in the future, reverse course and adopt new laws that further criminalize or negatively affect marijuana businesses. Additionally, municipal governments in these states may have laws that adversely affect marijuana businesses, even though there are no such laws at the state level. For example, municipal governments may have zoning laws that restrict where marijuana operations can be located and the manner and size of which they can expand and operate. These municipal laws, like the federal laws, may adversely affect our ability to do business, and adverse enforcement actions under these laws may lead to costly litigation and a closure of the businesses with which we have contracts or royalty-fee structures in place, in turn, affecting our own business. Moreover, if additional states do not adopt laws that legalize certain aspects of the marijuana industry, we may not be able to expand our business in the manner in which we prefer.

 

Also, given the complexity and rapid change of the federal, state and local laws pertaining to marijuana, we may incur substantial legal costs associated with complying with these laws and in acquiring the necessary state and local licenses required by our business endeavors. For example, some states permit entities to enter into joint venture relationships with individual license holders that provide for revenue sharing arrangements. In other states, revenue sharing is not permitted, and we will accept fee-for-service arrangement on a cost-plus basis for our services. State and municipal governments may also limit the number of specialized licenses available or apply stringent compliance requirements necessary to maintain the license. These developments may limit our ability to expand our negatively affect our business model.

 

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The businesses for which we plan to provide consulting services may have difficulty accessing the services of banks in the United States, which may make it difficult for them to purchase our products and services.

 

As discussed above, the use of marijuana is illegal under federal law. Therefore, there is a strong argument that banks cannot accept for deposit funds from the drug trade and therefore cannot do business with our clients that operate medical marijuana programs. On February 14, 2014, the U.S. Department of the Treasury, FinCEN released guidance to banks “clarifying Bank Secrecy Act (“BSA”) expectations for financial institutions seeking to provide services to marijuana-related businesses.” In addition, U.S. Rep. Jared Polis (D-CO) has stated he will seek an amendment to banking regulations and laws in order to allow banks to transact business with state-authorized medical marijuana treatment programs. While these are positive developments, there can be no assurance this legislation will be successful, or that, even with the FinCEN guidance, banks will decide to do business with medical marijuana retailers, or that, in the absence of actual legislation, state and federal banking regulators will not strictly enforce current prohibitions on banks handling funds generated from an activity that is illegal under federal law. The inability of potential clients in our target markets to open accounts and otherwise use the services of banks may make it difficult for such potential clients to purchase our products and services and could materially harm our business.

 

Risks Related to Our Dependence on Third Parties

 

We depend substantially on collaboration with our research and development partners.

 

We do not have in-house research facilities and, as a consequence, we must rely on collaboration agreements with industry partners, as well as leading academic medical centers, in order to develop, research, produce and commercialize our novel cannabinoid-based therapies targeting a variety of different indications and effectively help patients in need.

 

Dr. Yehuda Baruch, our Chief Medical and Regulatory Affairs Officer and our Director of Research and Regulatory Affairs, who is highly qualified by both training and experience, is monitoring the progress of the investigation and research of our medical cannabis development. We are also dependent upon Dr. Oron Yacoby Zeevi, our newly-appointed Chief Scientific Officer, who has more than 20 years of extensive scientific experience with both private and publicly listed companies in the biopharmaceutical industry. In addition, Alon Sinai, our Chief Operating Officer, serves as our key liaison with our collaboration partners at the major Israeli hospitals and medical centers.

 

To date, we have signed three research collaboration and license agreements with Sheba. Sheba is a university-affiliated hospital that serves as one of Israel’s national medical centers and is one of the leading integrated medical centers in the Middle East. Within the framework of the agreements with Sheba, we will initiate two studies at the Sheba facilities to explore the effect of three formulations, all based on active ingredients in the cannabis extracts, on multiple myeloma and psoriasis.

 

On April 5, 2017, we announced that as a result of the promising preliminary results from the preclinical efficacy testing of its cannabinoid-based topical cream for treating psoriasis, reporting significant reduction of several inflammation markers specific to psoriasis, we have received expressions of scientific and medical interest, world-wide, for its cannabinoid-based topical cream for treating psoriasis. We have expanded the size and scope of its clinical studies and, as previously announced, anticipates that subject to pending regulatory approvals from applicable jurisdictions, the topical cream should be available for use by those who suffer from psoriasis in the near term. The study had been done by the Dead Sea Labs.

 

In August 6, 2015, we signed a nonbinding Memorandum of Understanding with Emilia, for the development, manufacture and marketing of a cannabinoid-based topical cream to treat psoriasis. We entered into a binding agreement with Emilia Cosmetics, which set forth all terms, in the fourth fiscal quarter of 2016. We completed the development process in the fourth fiscal quarter of 2016 and then initiated a phase I Study at the Sheba facilities to explore the efficacy of the topical cream on psoriasis. However, we do not know if our expectations with respect to the development process will be fulfilled in a timely manner, if at all, or if the costs of development will exceed our anticipation.

 

While we retain full ownership of our intellectual property, or other proprietary rights and trade secrets that were conceived prior to entry into the agreements with Sheba, our psoriasis- and fibromyalgia-related research agreements with Sheba provide that all intellectual property and other rights that are conceived during the collaboration will be jointly owned by Sheba and us.

 

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Collaboration agreements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize cannabis-based medical products.

 

We may also enter into collaboration agreements with pharmaceutical companies and/or biotechnology institutions for the development or commercialization of our cannabis-based medical product prospects and treatments, which agreements may contain provisions based upon, among other things, the merits of retaining certain rights. We will face significant competition in seeking appropriate collaborators and in negotiating agreements at acceptable terms, if at all. We may not be successful in our efforts to enter, implement and maintain collaboration agreements. Disagreements stemming from collaboration agreements concerning development, intellectual property, regulatory or commercialization matters can lead to delays and, in some cases, termination of our collaboration agreements or otherwise result in the potentially significant costs and fees in seeking to enforce or protect our rights, if any. Any such disagreements can be difficult if, in fact, neither of the parties has final decision making authority. The resulting outcome of any disputes and/or disagreements would in all likelihood adversely affect our business.

 

Data provided by collaborators and others upon which we rely that has not been independently verified could turn out to be false, misleading, or incomplete.

 

We rely on third-party vendors, scientists, and collaborators to provide us with significant data and other information related to our projects, clinical trials, and our business. If such third parties provide inaccurate, misleading, or incomplete data, our business, prospects, and results of operations could be materially adversely affected.

 

We depend on a limited number of suppliers for materials and components required to manufacture our product prospects. The loss of these suppliers, or their failure to supply us on a timely basis, could cause delays in our current and future capacity and adversely affect our business.

 

We depend on a limited number of suppliers for the materials and components required to manufacture our product prospects. As a result, we may not be able to obtain sufficient quantities of critical materials and components in the future. A delay or interruption by our suppliers may also harm our business, results of operations and financial condition.

 

In addition, the lead time needed to establish a relationship with a new supplier can be lengthy, and we may experience delays in meeting demand in the event we must switch to a new supplier. The time and effort to qualify for and, in some cases, obtain regulatory approval for a new supplier could result in additional costs, diversion of resources or reduced manufacturing yields, any of which would negatively impact our operating results. Our dependence on single-source suppliers exposes us to numerous risks, including the following: our suppliers may cease or reduce production or deliveries, raise prices or renegotiate terms; our suppliers may become insolvent or cease trading; we may be unable to locate a suitable replacement supplier on acceptable terms or on a timely basis, or at all; and delays caused by supply issues may harm our reputation, frustrate our customers and cause them to turn to our competitors for future needs.

 

We rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates.

 

We rely on contract research organizations (“CROs”), clinical data management organizations and consultants to design, conduct, supervise and monitor our preclinical studies and clinical trials. We and our CROs are required to comply with various regulations, including Good Clinical Practice (“GCP”) requirements, which are enforced by regulatory agencies, including the FDA, and guidelines of the Competent Authorities of Member States of the EEA and comparable foreign regulatory authorities to ensure that the health, safety and rights of patients are protected in clinical development and clinical trials, and that trial data integrity is assured. Regulatory authorities ensure compliance with these requirements through periodic inspections of trial sponsors, principal investigators and trial sites. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. If we or any of our CROs fail to comply with applicable requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, the European Commission or other comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with such requirements. In addition, our clinical trials must be conducted with products produced under current Good Manufacturing Practices (“cGMP”) requirements, which mandate, among other things, the methods, facilities and controls used in manufacturing, processing and packaging of a drug product to ensure its safety and identity. Failure to comply with these regulations may require us to repeat preclinical studies and clinical trials, which would delay the regulatory approval process.

 

Our CROs are not our employees, and except for remedies available to us under our agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our ongoing clinical and preclinical programs. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed or reduced. In addition, operations of our CROs could be affected by earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics, terror attacks and other natural or man-made disasters or business interruptions. If their facilities are unable to operate because of an accident or incident, even for a short period of time, some or all of our research and development programs may be harmed or delayed and our operations and financial condition could suffer.

 

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Because we have relied on third parties, our internal capacity to perform these functions is limited. Outsourcing these functions involves risk that third parties may not perform to our standards, may not produce results in a timely manner or may fail to perform at all. In addition, the use of third-party service providers requires us to disclose our proprietary information to these parties, which could increase the risk that this information will be misappropriated. We currently have a small number of employees, which limits the internal resources we have available to identify and monitor our third-party providers. To the extent we are unable to identify and successfully manage the performance of third-party service providers in the future, our business may be adversely affected. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

 

We rely on third-party manufacturers to produce preclinical and clinical supplies, and intend to rely on third-party manufacturers for commercial supplies, of our approved product prospects, if approved.

 

We rely on third parties to manufacture our product prospects. We do not own manufacturing facilities. Any replacement of our manufacturers could require significant effort and expertise because there may be a limited number of qualified manufacturers.

 

The manufacturing process for our product prospects is subject to review by the FDA, EMA, DEA and other foreign regulatory authorities. Manufacturers must meet applicable manufacturing requirements and undergo rigorous facility and process validation tests required by regulatory authorities in order to comply with regulatory standards such as cGMP. In addition, our manufacturers must ensure consistency among batches, including preclinical, clinical and, if approved, marketing batches. Demonstrating such consistency may require typical manufacturing controls as well as clinical data. Our manufacturers must also ensure that our batches conform to complex release specifications. Further, manufacturers of controlled substances must obtain and maintain necessary DEA and state registrations and registrations with applicable foreign regulatory authorities, and must establish and maintain processes to ensure compliance with DEA and state requirements and requirements of applicable foreign regulatory authorities governing, among other things, the storage, handling, security, recordkeeping and reporting for controlled substances. In the event that any of our manufacturers fails to comply with such requirements or to perform its obligations to us in relation to quality, timing or otherwise, or if their operations become limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves, for which we currently do not have the capabilities or resources, or enter into an agreement with another third party, which we may not be able to do on reasonable terms, if at all. In some cases, the technical skills or technology required to manufacture our product prospects may be unique or proprietary to the original manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills or technology to another third party and a feasible alternative may not exist. These factors would increase our reliance on such manufacturer or require us to obtain a license from such manufacturer in order to have another third party manufacture our product candidates. If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. The delays associated with the verification of a new manufacturer could negatively affect our ability to develop product prospects in a timely manner or within budget.

 

We expect to continue to rely on third-party manufacturers if we receive regulatory approval for any product prospect. To the extent that we have existing, or enter into future, manufacturing arrangements with third parties, we will depend on these third parties to perform their obligations in a timely manner consistent with contractual and regulatory requirements, including those related to quality control and assurance. If we are unable to obtain or maintain third-party manufacturing for product prospects, or to do so on commercially reasonable terms, we may not be able to develop and commercialize our product prospects successfully. Our or a third party’s failure to execute on our manufacturing requirements could adversely affect our business in a number of ways, including:

 

  an inability to initiate or continue preclinical studies or clinical trials of product prospects under development;
  delay in submitting regulatory applications, or receiving regulatory approvals, for product prospects;
  loss of the cooperation of a collaborator;
  subjecting our product prospects to additional inspections by regulatory authorities; and
  in the event of approval to market and commercialize a product prospect, the withdrawal of such approval and/or an inability to meet commercial demands for our products.

 

In addition, our ability to obtain materials from these manufacturers could be disrupted if the operations of these manufacturers are affected by earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics, terror attacks and other natural or man-made disasters or business interruptions. If their facilities are unable to operate because of an accident or incident, even for a short period of time, some or all of our research and development programs may be harmed or delayed and our operations and financial condition could suffer. Our third-party manufacturers also may use hazardous materials, including chemicals and compounds that could be dangerous to human health and safety or the environment, and their operations may also produce hazardous waste products. In the event of contamination or injury, our third-party manufacturers could be held liable for damages or be penalized with fines in an amount exceeding their resources, which could result in our clinical trials or regulatory approvals being delayed or suspended.

 

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If we are unable to develop sales, marketing and distribution capabilities or enter into agreements with third parties to perform these functions on acceptable terms, we may be unable to generate revenue.

 

We do not currently have any sales, marketing or distribution capabilities. If any of our Cannabis-Based Medical Products prospects are approved, we will need to develop internal sales, marketing and distribution capabilities to commercialize such products, which would be expensive and time-consuming, or enter into collaborations with third parties to perform these services. If we decide to market our products directly, we will need to commit significant financial and managerial resources to develop a marketing and sales force with technical expertise and supporting distribution, administration and compliance capabilities. If we rely on third parties with such capabilities to market our products or decide to co-promote products with collaborators, we will need to establish and maintain marketing and distribution arrangements with third parties, and there can be no assurance that we will be able to enter into such arrangements on acceptable terms or at all. In entering into third-party marketing or distribution arrangements, any revenue we receive will depend upon the efforts of the third parties and there can be no assurance that such third parties will establish adequate sales and distribution capabilities or be successful in gaining market acceptance of any approved product. If we are not successful in commercializing any product approved in the future, either on our own or through third parties, our business, financial condition and results of operations could be materially adversely affected.

 

Risks Related to Intellectual Property

 

If we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products would be negatively affected.

 

Our success will depend in part on our ability to protect our intellectual property. This is done, in part, by obtaining patents and trademarks and then maintaining adequate protection of our technologies, tradenames and products. If we do not adequately protect our intellectual property, competitors may be able to use our technologies to produce and market products in direct competition with us and erode our competitive advantage. Some foreign countries lack rules and methods for defending intellectual property rights and do not protect proprietary rights to the same extent as the United States. Many companies have had difficulty protecting their proprietary rights in these foreign countries. We may not be able to prevent misappropriation of our proprietary rights.

 

We are currently seeking patent protection for several processes and products prospects. However, the patent process is subject to numerous risks and uncertainties, and there can be no assurance that we will be successful in protecting our product prospects by obtaining and defending patents. These risks and uncertainties include the following:

 

  patents that may be issued or licensed may be challenged, invalidated, or circumvented, or otherwise may not provide any competitive advantage;
  our competitors, many of which have substantially greater resources than us and many of which have made significant investments in competing technologies, may seek, or may already have obtained, patents that will limit, interfere with, or eliminate our ability to make, use, and sell our products and product candidates either in the United States or in international markets;
  there may be significant pressure on the United States government and other international governmental bodies to limit the scope of patent protection both inside and outside the United States for treatments that prove successful as a matter of public policy regarding worldwide health concerns;
  countries other than the United States may have less restrictive patent laws than those upheld by United States courts, allowing foreign competitors the ability to exploit these laws to create, develop, and market competing products.

 

Any patents issued to us may not provide us with meaningful protection, and third parties may challenge, circumvent or narrow them. Third parties may also independently develop products similar to our products or product candidates, duplicate our unpatented product or product candidates, and design around any patents on product candidates we may develop.

 

Additionally, extensive time is required for development, testing and regulatory review of product candidates. While extension of a patent term due to regulatory delays may be available, it is possible that before any of our product candidates can be commercialized, any related patent, even with an extension, may expire or remain in force for only a short period following commercialization, thereby reducing any advantages of the patent.

 

In addition, the USPTO, and patent offices in other jurisdictions have often required that patent applications concerning biotechnology-related inventions be limited or narrowed substantially to cover only the specific innovations exemplified in the patent application, thereby limiting the scope of protection against competitive challenges. Thus, even if we or our licensors are able to obtain patents, the patents may be substantially narrower than anticipated.

 

In addition to patents, we rely on a combination of trade secrets, confidentiality, nondisclosure and other contractual provisions, and security measures to protect our confidential and proprietary information. These measures may not adequately protect our trade secrets or other proprietary information. If they do not adequately protect our rights, third parties could use our technology, and we could lose any competitive advantage we may have. In addition, others may independently develop similar proprietary information or techniques or otherwise gain access to our trade secrets, which could impair any competitive advantage we may have.

 

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Costly litigation may be necessary to protect our intellectual property rights and we may be subject to claims alleging the violation of the intellectual property rights of others.

 

We may face significant expense and liability as a result of litigation or other proceedings relating to patents and other intellectual property rights of others. In the event that another party has also filed a patent application or been issued a patent relating to an invention or technology claimed by us in pending applications, we may be required to participate in an interference proceeding declared by the USPTO to determine priority of invention, which could result in substantial uncertainties and costs for us, even if the eventual outcome were favorable to us. We, or our licensors, also could be required to participate in interference proceedings involving issued patents and pending applications of another entity. An adverse outcome in an interference proceeding could require us to cease using the technology or to license rights from prevailing third parties.

 

The cost to us of any patent litigation or other proceeding relating to our licensed patents or patent applications, even if resolved in our favor, could be substantial. Our ability to enforce our patent protection could be limited by our financial resources, and may be subject to lengthy delays.

 

A third party may claim that we are using inventions claimed by their patents and may go to court to stop us from engaging in our normal operations and activities, such as research, development and the sale of any future products. Such claims, whether or not meritorious, may result in the expenditure of significant financial and managerial resources, legal fees, result in injunctions, temporary restraining orders and/or require the payment of damages. There is a risk that the court will decide that we are infringing the third party’s patents and will order us to stop the activities claimed by the patents, redesign our products or processes to avoid infringement or obtain licenses (which may not be available on commercially reasonable terms). In addition, there is a risk that a court will order us to pay the other party damages for having infringed their patents.

 

Moreover, there is no guarantee that any prevailing patent owner would offer us a license so that we could continue to engage in activities claimed by the patent, or that such a license, if made available to us, could be acquired on commercially acceptable terms. In addition, third parties may, in the future, assert other intellectual property infringement claims against us with respect to our product candidates, technologies or other matters.

 

We rely on confidentiality agreements that could be breached and may be difficult to enforce, which could result in third parties using our intellectual property, trade secrets and/or proprietary information to compete against us.

 

Although we believe that we take reasonable steps to protect our intellectual property, including the use of agreements relating to the non-disclosure of confidential information to third parties, as well as agreements that purport to require the disclosure and assignment to us of the rights to the ideas, developments, discoveries and inventions of our employees and consultants while we employ them, the agreements can be difficult and costly to enforce. Although we seek to obtain these types of agreements from our contractors, consultants, advisors and research collaborators, to the extent that employees and consultants utilize or independently develop intellectual property in connection with any of our projects, disputes may arise as to the intellectual property rights associated with our products. If a dispute arises, a court may determine that the right belongs to a third party. In addition, enforcement of our rights can be costly and unpredictable.

 

We also rely on trade secrets to protect our proprietary know-how and technologies, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our current and former employees, consultants, outside scientific collaborators, sponsored researchers, contract manufacturers, vendors and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, we cannot guarantee that we have executed these agreements with each party that may have or have had access to our trade secrets. Any party with whom we or they have executed such an agreement may breach that agreement and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.

 

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they disclose such trade secrets, from using that technology or information to compete with us. If any of our trade secrets or proprietary information were to be disclosed to or independently developed by a competitor or other third-party, our competitive position would be harmed.

 

We may desire to, or be forced to, seek additional licenses to use intellectual property owned by third parties, and such licenses may not be available on commercially reasonable terms or at all.

 

Third parties may also hold intellectual property, including patent rights that are important or necessary to the development of our drug candidates, in which case we would need to obtain a license from that third party or develop a different formulation of the product that does not infringe upon the applicable intellectual property, which may not be possible. Additionally, we may identify drug candidates that we believe are promising and whose development and other intellectual property rights are held by third parties. In such a case, we may desire to seek a license to pursue the development of those drug candidates. Any license that we may desire to obtain or that we may be forced to pursue may not be available when needed on commercially reasonable terms or at all. Any inability to secure a license that we need or desire could have a material adverse effect on our business, financial condition and prospects.

 

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Risks Related to Management and Personnel

 

If we are unable to hire and retain key personnel, we may not be able to implement our business plan and our business may fail.

 

Our future success depends, to a significant extent, on our ability to attract, train and retain capable scientists and physicians, enter into collaboration agreements for our research and managerial personnel. Recruiting and retaining capable personnel, particularly those with expertise with medical research, is vital to our success. If we are unable to attract and retain qualified employees, our business may fail and our investors could lose their entire investment.

 

At present, we believe to have the necessary key personal to carry out our business plans but there can be no assurance that our beliefs prove unfounded. If we are unable to hire and retain key personnel, our business will be materially adversely affected.

 

Our future success is dependent, in part, on the performance and continued service of Dr. Yehuda Baruch, our Chief Medical and Regulatory Affairs Officer and Alon Sinai, our Chief Operating Officer.

 

We are dependent to a great deal on Dr. Yehuda Baruch, our Chief Medical and Regulatory Affairs Officer, to conduct and oversee our clinical studies. Dr. Baruch is expected to handle all aspects of our medical and research related to developing our product prospects and regulatory affairs. We are also dependent on the services of Alon Sinai, our Chief Operating Officer, in negotiating and serving as our liaison with our collaboration partners at major Israeli medical centers. The loss of Dr. Baruch’s services and those of Mr. Sinai could have a material adverse effect on our operations and prospects. At this time, we do not currently have “key man” life insurance for Dr. Baruch, Dr. Yacobi-Zeevi or Mr. Sinai.

 

Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could subject us to significant liability and harm our reputation.

 

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with applicable manufacturing standards, comply with other federal and state laws and regulations, report information or data accurately or disclose unauthorized activities to us. Employee misconduct could also involve the improper use of information, including information obtained in the course of clinical trials, or illegal appropriation of drug product, which could result in government investigations and serious harm to our reputation. We have not yet adopted a code of business conduct and ethics and it is not always possible to identify and deter employee misconduct. The precautions we take to detect and prevent these prohibited activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

 

Risks Related to Operating in Israel

 

We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business.

 

A significant portion of our intellectual property has been developed by our Israeli employees in the course of their employment for us. Under the Israeli Patent Law, 5727-1967 (the “Israeli Patent Law”), inventions conceived of by an employee during the term and as part of the scope of his or her employment with a company are regarded as “service inventions,” which belong to the employer, absent a specific agreement between the employee and employer giving the employee service invention rights. The Israeli Patent Law also provides that if there is no such agreement between an employer and an employee, the Israeli Compensation and Royalties Committee (the “C&R Committee”), a body constituted under the Israeli Patent Law, shall determine whether the employee is entitled to remuneration for his or her inventions. The C&R Committee (decisions of which have been upheld by the Israeli Supreme Court) has held that employees may be entitled to remuneration for their service inventions despite having specifically waived any such rights. Further, the C&R Committee has not yet set specific guidelines regarding the method for calculating this remuneration or the criteria or circumstances under which an employee’s waiver of his or her right to remuneration will be disregarded. We generally enter into intellectual property assignment agreements with our employees pursuant to which such employees assign to us all rights to any inventions created in the scope of their employment or engagement with us. Although our employees have agreed to assign to us service invention rights and have specifically waived their right to receive any special remuneration for such assignment beyond their regular salary and benefits, we may face claims demanding remuneration in consideration for assigned inventions. As a consequence of such claims, we could be required to pay additional remuneration or royalties to our current or former employees, or be forced to litigate such claims, which could negatively affect our business.

 

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It may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers.

 

The majority of our assets are located outside the United States. In addition, certain of our officers are nationals or residents of countries other than the United States, and all or a substantial portion of such persons’ assets are located outside the United States. As a result, it may be difficult for investors to enforce within the United States any judgments obtained against us or any of our non-U.S. officers, including judgments predicated upon the civil liability provisions of the securities laws of the United States or any state thereof. It may also be difficult to assert claims under United States securities law in actions originally instituted outside of the United States. Moreover, Israeli courts may refuse to hear a United States securities law claim because Israeli courts may not be the most appropriate forums in which to bring such a claim. Even if an Israeli court agrees to hear a claim, it may determine that Israeli law, and not U.S. law, is applicable to the claim. Further, if U.S. law is found to be applicable, certain content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process, and certain matters of procedure would still be governed by Israeli law. Consequently, our investors may be effectively prevented from pursuing remedies under U.S. federal and state securities laws against us or any of our non-U.S. directors or officers.

 

If there are significant shifts in the political, economic and military conditions in Israel and its neighbors, it could have a material adverse effect on our business relationships and profitability.

 

All of our research facilities and certain of our key personnel are located in Israel. Our business is directly affected by the political, economic and military conditions in Israel and its neighbors. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its Arab neighbors. A state of hostility, varying in degree and intensity, has caused security and economic problems in Israel. Although Israel has entered into peace treaties with Egypt and Jordan, and various agreements with the Palestinian Authority, there has been a marked increase in violence, civil unrest and hostility, including armed clashes, between the State of Israel and the Palestinians since September 2000. The establishment in 2006 of a government in the Gaza Strip by representatives of the Hamas militant group has created heightened unrest and uncertainty in the region. In mid-2006, Israel engaged in an armed conflict with Hezbollah, a Shiite Islamist militia group based in Lebanon, and in June 2007, there was an escalation in violence in the Gaza Strip. From December 2008 through January 2009 and again in November and December 2012, Israel engaged in an armed conflict with Hamas, which involved missile strikes against civilian targets in various parts of Israel and negatively affected business conditions in Israel. In July 2014, Israel launched an additional operation against Hamas operatives in the Gaza strip in response to Palestinian groups launching rockets at Israel. Recent political uprisings and social unrest in Syria are affecting its political stability, which has led to the deterioration of the political relationship between Syria and Israel and have raised new concerns regarding security in the region and the potential for armed conflict. Similar civil unrest and political turbulence is currently ongoing in many countries in the region. The continued political instability and hostilities between Israel and its neighbors and any future armed conflict, terrorist activity or political instability in the region could adversely affect our operations in Israel and adversely affect the market price of our shares of Common Stock. In addition, several countries restrict doing business with Israel and Israeli companies have been and are today subjected to economic boycotts. The interruption or curtailment of trade between Israel and its present trading partners could adversely affect our business, financial condition and results of operations.

 

Risks Related to Our Common Stock

 

There can be no assurance of a liquid public trading market for our Common Stock or whether investors will be able to readily be able to sell their shares of Common Stock.

 

At present, our Common Stock is subject to quotation on the OTCQB market under the symbol “OWCP”. There is only a limited, liquid public trading market for our Common Stock and there can be no assurance that a more liquid market will ever develop or be sustained. Market liquidity will depend on the perception of our business and any steps that our management might take to bring public awareness of our business to the investing public within the parameters of the federal securities laws. There can be given no assurance that there will be any awareness generated or sustained. Consequently, investors may not be able to liquidate their investment or liquidate it at a price paid by investors equal to or greater than their initial investment in our Common Stock. As a result, holders of our Common Stock may not find purchasers for their shares should they to decide to sell the Common Stock held by them at any particular time if ever. Consequently, our Common Stock should be purchased only by investors who have no immediate need for liquidity in their investment and who can hold our Common Stock, possibly for a prolonged period of time.

 

Our shares of Common Stock are thinly traded, so stockholders may be unable to sell at or near ask prices or at all if they need to sell shares to raise money or otherwise desire to liquidate their shares.

 

Our Common Stock is “thinly-traded,” meaning that the number of persons interested in purchasing our Common Stock at or near ask prices at any given time may be relatively small or non-existent. This situation is attributable to a number of factors, including the fact that we are a small company that is relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we become more seasoned and viable. As a consequence, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot give stockholders any assurance that a broader or more active public trading market for our common shares will develop or be sustained, or that current trading levels will be sustained.

 

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In the event an active trading market develops for our Common Stock, the market price may, from time-to-time, be volatile.

 

In the event an active trading market develops for our Common Stock, the market price of our Common Stock may be highly volatile, as is the market for securities subject to quotation on OTC Markets in particular. Some of the factors that may materially affect the market price of our Common Stock are beyond our control, such as changes in conditions or trends in the industry in which we operate, general market and economic conditions in the United States and world-wide as well as the number of our shares of Common Stock being purchased and sold at any particular time. These factors may materially adversely affect the market price of our Common Stock, regardless of our historic business performance or future prospects. In addition, the public stock markets have experienced and may be expected to experience extreme price and trading volume volatility. This volatility has significantly affected the market prices of securities of many companies for reasons frequently unrelated to their operating performance. These market fluctuations may adversely affect the market price of our Common Stock.

 

A large number of additional shares will be available for resale into the public market pursuant to Rule 144, which may cause the market price of our Common Stock to decline significantly.

 

Sales of a substantial number of shares of our Common Stock in the public market will become available pursuant to Rule 144 promulgated by the SEC under the Securities Act, could adversely affect the market price of our Common Stock. As of December 31, 2017, we had 147,758,908 shares of Common Stock outstanding, of which 15,744,246 shares of Common Stock are restricted and are subject to the resale provisions of Rule 144 and Regulations D and S under the united States federal securities laws and the rules and regulations promulgated by the SEC thereunder. As restrictions on resale of other shares of Common Stock expire, pursuant to the provisions of Rule 144 or otherwise, the market price could drop significantly if the holders of these restricted shares sell them or are perceived by the market as intending to sell them at any given date or over any particular period of time. When restrictions on resale lapse, and if holders of previously restricted securities sell a large number of shares pursuant to Rule 144 under the Securities Act, they could adversely affect the market price for our Common Stock, which such adverse affect could be sustained and over which we have no control.

 

You will experience dilution of your ownership interest because of the future issuance of additional shares of our Common Stock or our preferred stock.

 

In the future, we may issue our authorized but previously unissued equity securities, including shares of our Common Stock, resulting in the dilution of the ownership interests of our present shareholders. We are authorized to issue an aggregate of 500,000,000 shares of Common Stock, par value $0.00001 per share and 20,000,000 shares of preferred stock, par value $0.00001 (the “Preferred Stock”), of which 147,758,908 shares are outstanding at April 16, 2018. In addition, current holders of our Common Stock will experience dilution in their equity ownership from the exercise of outstanding Common Stock purchase warrants and stock options granted under our 2016 Employees Stock Option Plan (the “2016 ESOP”).

 

We may also issue additional shares of our Common Stock, warrants or other securities that are convertible into or exercisable for the purchase of shares of our Common Stock in connection with hiring and/or retaining employees or consultants, future acquisitions, future sales of our securities for capital raising purposes, or for other business purposes. The future issuance of any such additional shares of our Common Stock or other securities, for any reason including those stated above, may have a negative impact on the market price of our Common Stock. There can be no assurance that the issuance of any additional shares of Common Stock, warrants or other convertible securities may not be at a price (or exercise prices) below the then prevailing price at which shares of our Common Stock will be quoted on the OTCQB Market.

 

We may never pay any dividends to our shareholders and capital appreciation, if any, of our Common Stock may be your sole source of gain on your investment.

 

We currently intend to retain any future earnings for use in the operation and expansion of our business. Accordingly, we do not expect to pay any dividends in the foreseeable future, but will review this policy as circumstances dictate. The declaration and payment of all future dividends, if any, will be at the sole discretion of our board of directors, which retains the right to change our dividend policy at any time. Consequently, capital appreciation, if any, of our Common Stock may be your sole source of gain on your investment for the foreseeable future.

 

Insiders own a significant percentage of the shares of our Common Stock, which may limit your ability to influence corporate matters.

 

Our directors and executive officers and present shareholders holding more than 5% of our Common Stock beneficially own a signficiant percentage of our Common Stock on a fully diluted basis. Accordingly, if these shareholders were to choose to act together, they could have a significant influence over all matters requiring shareholder approval, including the election of directors and approval of significant corporate transactions, such as a merger or other sale of our Company or all or a significant percentage of our assets. This concentration of ownership could limit your ability to influence corporate matters and may have the effect of delaying or preventing a third party from acquiring control over us.

 

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Security Ownership of Certain Beneficial Owners and Management.

 

We cannot assure you that the interests of our management and affiliated persons will coincide with the interests of the investors. So long as our management and affiliated persons collectively controls a significant portion of our Common Stock, these individuals and/or entities controlled by them, will continue to collectively be able to strongly influence or effectively control our decisions.

 

We have broad discretion in how we use our cash, cash equivalents and marketable securities, including the net proceeds from our collaborations, public and private securities offerings, and may not use these financial resources effectively, which could affect our results of operations and cause our stock price to decline.

 

Our management has considerable discretion in the application of our cash, cash equivalents and marketable securities, including the fees and milestone payments from our collaborations and the net proceeds of our securities offerings. We intend to use the cash, cash equivalents and marketable securities to advance our product prospects and for working capital and other general corporate purposes, which may include the hiring of additional personnel and capital expenditures. As a result, investors will be relying upon management’s judgment with only limited information about our specific intentions for the use of the cash, cash equivalents and marketable securities. We may use the cash, cash equivalents and marketable securities for purposes that do not yield a significant return or any return at all for our stockholders. In addition, pending their use, we may invest the financial resources from our collaborations and securities offerings in a manner that does not produce income or that loses value.

 

Anti-takeover provisions of the Delaware General Corporation Law may discourage or prevent a change of control, even if an acquisition would be beneficial to our shareholders, which could reduce our stock price.

 

We are subject to the provisions of Section 203 of the Delaware General Corporation Law, which may prohibit certain business combinations with shareholders owning 15% or more of our outstanding voting stock. These and other provisions in our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law could make it more difficult for shareholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by our then-current board of directors, including a merger, tender offer or proxy contest involving our Company. Any delay or prevention of a change of control transaction or changes in our board of directors could cause the market price of our Common Stock to decline.

 

State Blue Sky registration and potential limitations on resale of our Common Stock.

 

The holders of our shares of Common Stock and those persons who desire to purchase our Common Stock in any trading market that might develop, should be aware that there may be state blue-sky law restrictions upon the ability of investors to resell our securities. Accordingly, investors should consider the secondary market for our securities to be a limited one.

 

It is the present intention of management after the active commencement of operations of our clinical cannabis research and development to seek coverage and publication of information regarding the Company in an accepted publication manual, which permits a manual exemption. The manual exemption permits a security to be distributed in a particular state without being registered if the company issuing the security has a listing for that security in a securities manual recognized by the state.

 

However, it is not enough for the security to be listed in a recognized manual. The listing entry must contain (1) the names of issuer’s officers, and directors, (2) an issuer’s balance sheet, and (3) a profit and loss statement for either the fiscal year preceding the balance sheet or for the most recent fiscal year of operations. Furthermore, the manual exemption is a non-issuer exemption restricted to secondary trading transactions, making it unavailable for issuers selling newly issued securities.

 

Most of the accepted manuals are those published in Standard and Poor’s, Moody’s Investor Service, Fitch’s Investment Service, and Best’s Insurance Reports, and many states expressly recognize these manuals. A smaller number of states declare that they “recognize securities manuals” but do not specify the recognized manuals. The following states do not have any provisions and therefore do not expressly recognize the manual exemption: Alabama, Georgia, Illinois, Kentucky, Louisiana, Montana, South Dakota, Tennessee, Vermont and Wisconsin.

 

Despite our efforts and intentions, we may not be successful in obtaining coverage and publication of information regarding the Company in an accepted publication manual, thereby failing to obtain a manual exemption for our Common Stock.

 

Our Common Stock is considered a Penny Stock, which may be subject to restrictions on marketability, so you may not be able to sell your shares.

 

We may be subject now and in the future to the penny stock rules if our shares of Common Stock sell below $5.00 per share. Penny stocks generally are equity securities with a price of less than $5.00. The penny stock rules require broker-dealers to deliver a standardized risk disclosure document prepared by the SEC which provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer must also provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson, and monthly account statements showing the market value of each penny stock held in the customer’s account. The bid and offer quotations, and the broker-dealer and salesperson compensation information must be given to the customer orally or in writing prior to completing the transaction and must be given to the customer in writing before or with the customer’s confirmation.

 

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In addition, the penny stock rules require that prior to a transaction, the broker dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. The penny stock rules are burdensome and may reduce purchases of any Offerings and reduce the trading activity for shares of our Common Stock. As long as our shares of Common Stock are subject to the penny stock rules, the holders of such shares of Common Stock may find it more difficult to sell their securities.

 

Reporting requirements under the Exchange Act and compliance with the Sarbanes-Oxley Act of 2002, including establishing and maintaining acceptable internal controls over financial reporting, are costly and may increase substantially.

 

The rules and regulations of the SEC require a public company to prepare and file periodic reports under the Exchange Act, which will require that the company engage legal, accounting, auditing and other professional service providers. The engagement of such services is costly and continuing. Additionally, the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) requires, among other things, that we design, implement and maintain adequate internal controls and procedures over financial reporting. The costs of complying with the Sarbanes-Oxley Act and the limited technically qualified personnel we have may make it difficult for us to design, implement and maintain adequate internal controls over financial reporting. We expect these costs to be increased as our operations increase in scope and magnitude. In the event that we fail to maintain an effective system of internal controls or discover material weaknesses in our internal controls, we may not be able to produce reliable financial reports and/or discover and report fraud, which may harm our overall financial condition and result in loss of investor confidence and a decline in our share price.

 

As a public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Act of 2010 and other applicable securities rules and regulations. Our legal and financial compliance costs related to these rules and regulations may increase, make some activities more difficult, time-consuming or costly and increase demand on our systems and resources. The Exchange Act requires, among other things, that we file annual and quarterly, and, from time-to-time, current reports with respect to our business and operating results.

 

We are working with our legal, independent accounting and financial advisors to identify those areas in which changes should or could be made to improve our financial and management control systems in order to manage our growth and our legal obligations as a public company. These areas include corporate governance, corporate control, disclosure controls and procedures and financial reporting and accounting systems. We have made, and will continue to make, changes in these and other areas, if and when any perceived deficiencies are discovered. However, we anticipate that the expenses associated with being a reporting public company are expected to be both material and continuing. We estimate that the aggregate cost of legal services; accounting and audit functions; personnel, such as a chief financial officer familiar with the obligations of public company reporting; and consultants to design and implement internal controls could be material. In addition, if and when we retain independent directors and/or additional members of senior management, we may incur additional expenses related to director compensation and/or premiums for directors’ and officers’ liability insurance (“D&O Insurance”), the costs of which we cannot estimate at this time. We may also incur additional expenses associated with investor relations and similar functions, the cost of which we also cannot estimate at this time. However, these additional expenses individually, or in the aggregate, may also be expected to be material. In addition, being a public company could make it more difficult or more costly for us to obtain certain types of insurance, including D&O Insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.

 

The increased costs associated with operating as a public company may decrease our net income or increase our net loss, and may cause us to reduce costs in other areas of our business or increase the prices of our product to offset the effect of such increased costs. Additionally, if these requirements divert our management’s attention from other business concerns, they could have a material adverse effect on our business, financial condition and results of operations.

 

The material weaknesses in our internal control over financial reporting may until remedied cause errors in our financial statements or cause our filings with the SEC to not be timely.

 

We have identified material weaknesses in our internal control over financial reporting as of the evaluation done by management as of December 31, 2017. A material weakness is a deficiency, or a combination of deficiencies, in internal controls over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim consolidated financial statements would not be prevented or detected on a timely basis. If our internal control over financial reporting or disclosure controls and procedures are not effective, there may be errors in our financial statements that could require a restatement or our filings may not be timely made with the SEC. Based on the work undertaken and performed by us, however, we believe the financial statements contained in our reports filed with the SEC are fairly stated in all material respects in accordance with the generally accepted accounting principles of the United States for each of the periods presented. We intend to implement additional corporate governance and control measures to strengthen our control environment as we are able, but we may not achieve our desired objectives. We may identify other material weaknesses and control deficiencies in our internal control over financial reporting in the future that may require remediation and could result in investors losing confidence in our reported financial information, which could lead to a decline in our stock price.

 

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Having availed ourselves of scaled disclosure available to smaller reporting companies, we cannot be certain if such reduced disclosure will make our Common Stock less attractive to investors.

 

Under Section 12b-2 of the Exchange Act, a “smaller reporting company” is a company that is not an investment company, an asset backed issuer, or a majority-owned subsidiary of a parent company that is not a smaller reporting company, and has a public float of less than $75 million and annual revenues of less than $50 million during the most recently completed fiscal year. Similar to emerging growth companies, smaller reporting companies are permitted to provide simplified executive compensation disclosure in their filings; they are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal controls over financial reporting; and they have certain other decreased disclosure obligations in their SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual reports. We are a smaller reporting and are permitted to avail ourselves of the scaled disclosure requirements available to smaller reporting companies. Decreased disclosure in our SEC filings as a result of our having availed ourselves of scaled disclosure may make it harder for investors to analyze our results of operations and financial prospects, which could result in loss of investor confidence and a decline in our share price.

 

Our by-laws provide for indemnification of our directors and the purchase of D&O insurance at our expense and limit their potential or actual liability which may result in a significant cost to us and damage the interests of our shareholders.

 

Our By-Laws include provisions that eliminate the personal liability of the directors of the Company for monetary damages to the fullest extent possible under the laws of the State of Delaware as well as other applicable laws. These provisions eliminate the liability of directors to the Company and its shareholders for monetary damages arising out of any violation of a director of his fiduciary duty of due care. Under Delaware law, however, such provisions do not eliminate the personal liability of a director for: (i) breach of the director’s duty of loyalty; (ii) acts or omissions not in good faith or involving intentional misconduct or knowing violation of law; (iii) payment of dividends or repurchases of stock other than from lawfully available funds; or (iv) any transaction from which the director derived an improper benefit. These provisions do not affect a director’s liabilities under the federal securities laws or the recovery of damages by third parties.

 

Upon dissolution of the Company, our stockholders may not recoup all or any portion of their investment.

 

In the event of a liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary, the proceeds and/or assets of the Company remaining after giving effect to such transaction, and the payment of all of our debts and liabilities will be distributed to the holders of our Common Stock on a pro rata basis. There can be no assurance that we will have available assets to pay to the holders of our Common Stock, or any amounts, upon such a liquidation, dissolution or winding-up of the Company. In this event, our stockholders could lose some or all of their investment.

 

Our former advisor and consultant is alleged to have engaged in a securities fraud scheme. Publicity related to this alleged securities fraud scheme could harm our business, result in loss of investor confidence and a decline in price of our Common Stock.

 

In March 2018, the SEC filed a complaint against Jeffrey O. Friedland, a former advisor and stockholder of the Company, alleging that Mr. Friedland engaged in a securities fraud scheme involving our Common Stock that included a “pump and dump” strategy; misleading interviews, presentations and emails; and violation of numerous SEC rules and federal securities laws (the “Friedland Matter”). A copy of that complaint may be found at https://www.sec.gov/litigation/complaints/2018/comp-pr2018-34.pdf. Neither the Company nor its executive officers and directors were named as defendants in the case. We are unaware of and unable to predict the length, scope, outcome or impact of the SEC’s investigation. Such conditions create volatility and risk for holders of our Common Stock and should be considered by investors. Publicity related to the Friedland Matter and any negative findings or outcomes of the investigation could harm our business and result in loss of investor confidence and a decline in price of our Common Stock.

 

We may expend a substantial amount of time and resources in connection with SEC or stockholder-related inquiries or legal actions related to an ongoing investigation by the SEC.

 

In March 2018, we received a non-public subpoena dated February 16, 2018 issued by the SEC ordering the provision of documents and related information concerning certain of the issues involved in the Friedland Matter. We are in a process of responding to the subpoena and intend to fully cooperate with the SEC. We are unaware of and unable to predict the length, scope, outcome or impact of the SEC’s investigation. As a result, we do not know how the SEC investigation is proceeding, when the investigation will be concluded, or if we will become involved to a greater extent than merely responding to the subpoena we received. This may become a material cost to us, distract the time and attention of our officers and directors or divert our resources away from ongoing research and development programs and result in loss of investor confidence and a decline in price of our Common Stock.

 

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ITEM 1B. UNRESOLVED STAFF COMMENTS

 

None.

 

ITEM 2. PROPERTIES

 

In November 2017 we signed a two-year rental agreement with a landlord for our principle office located in 2 Ben Gurion St. Ramat Gan, Israel 5257334, our telephone number is +972 (72)-260-8004. The rental agreement includes an option for one additional year. The monthly rental fees are approximately $4,200 for 200 square meters of office space and four parking slots. During the option period the monthly rental fees shall increase by approximately 7%

 

We believe that this space is adequate for our current and immediately foreseeable operating needs.

 

ITEM 3. LEGAL PROCEEDINGS

 

On November 22, 2017, Mr. Ziv Turner, the former General Manager of our subsidiary (the “Plaintiff”) filed a claim (the “Claim”) with the Tel Aviv Regional Court of Labor against us, our subsidiary and our CEO. The Plaintiff’s alleged right to receive Company’s 4,125,000 shares in connection options granted to him in 2016 and a cash compensation of approximately $180,000 for breach of rights and damages. On January 23, 2018, we filed a statement of defense rejecting all of the Plaintiffs claims. At this stage we are unable to assess the Claim’s probability.

 

From time to time, we may become involved in various lawsuits and legal proceedings, which arise, in the ordinary course of business. We are currently not aware of any legal proceedings or claims that we believe will have a material adverse effect on our business, financial condition or operating results.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not Applicable.

 

PART II

 

ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF SECURITIES

 

Market Information

 

Our Common Stock is quoted on the OTCQB under the symbol “OWCP.” The following table sets forth for the periods indicated, the high and low sales prices per share of our Common Stock as reported by the OTCQB.

 

    Price Range  
Period   High     Low  
Year Ended December 31, 2016:                
First Quarter   $ 0.15     $ 0.01  
Second Quarter   $ 0.10     $ 0.02  
Third Quarter   $ 0.06     $ 0.01  
Fourth Quarter   $ 0.22     $ 0.01  
Year Ended December 31, 2017:                
First Quarter   $ 3.23     $ 0.17  
Second Quarter   $ 1.37     $ 0.52  
Third Quarter   $ 0.63     $ 0.20  
Fourth Quarter   $ 0.58     $ 0.28  
Year Ending December 31, 2018:                
First Quarter   $ 0.67     $ 0.20  

 

Holders of Common Stock

 

As of April 16, 2018, there were 101 holders of record of our Common Stock. As of such date, 147,758,908 shares of our Common Stock were issued and outstanding.

 

Securities Authorized for Issuance under Equity Compensation Plans

 

We have 36,000,000 shares of Common Stock authorized under our 2016 ESOP, of which options to purchase 27,300,000 shares of Common Stock are outstanding as of December 31, 2017. Reference is made to the disclosure in Note 7c to the notes to consolidated financial statements.

 

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Dividends

 

We have never declared nor paid any cash dividends to stockholders. We currently intend to retain any future earnings for use in the operation and expansion of our business and do not expect to pay any dividends in the foreseeable future. The declaration and payment of all future dividends, if any, will be at the sole discretion of our board of directors, which retains the right to change our dividend policy at any time.

 

Recent Sales of Unregistered Securities

 

Unregistered Common Stock Issued in 2016:

 

2,500,000 Shares of Common Stock Issued for Cash

 

On November 3, 2016, we entered into a Regulation S Unit Subscription Agreement with Michepro Holding Ltd (“Michepro”), pursuant to which the Investor subscribed for 2,307,692 Units consisting of shares and warrants for a cash consideration of $300,000. In connection with the Unit Subscription Agreement, Michepro was issued Class G Warrants exercisable for a period of twenty-four (24) months to purchase 761,538 Shares at an exercise price $0.25; and Class H Warrants exercisable for a period of thirty-six (36) months to purchase 761,538 Shares at an exercise price $0.40.

 

On December 29, 2016, we entered into a Regulation S Unit Subscription Agreement with Jeff Smurlick (the “Smurlick”), pursuant to which the Investor subscribed for 192,308 shares for a cash consideration of $25,000. In connection with the Unit Subscription Agreement, the Compan issued Class G Warrants exercisable for a period of twenty-four (24) months to purchase 192,308 Shares at an exercise price $0.25; and Class H Warrants exercisable for a period of thirty-six (36) months to purchase 192,308 Shares at an exercise price $0.40 to Smurlick.

 

53,844,599 Shares of Common Stock Issued for Note Conversion

 

In August and September 2016, the Company issued 20,142,568 shares underlying a $78,500 convertible note previously issued to Vis Vires. The note was issued to an investor pursuant to Rule 506 of Regulation D of the Securities Act of 1933, as amended.

 

In September and October 2016, the Company issued 33,702,031 shares underlying a $37,500 convertible note previously issued to Kodiak Capital LLC. The note was issued to an investor pursuant to Rule 506 of Regulation D of the Securities Act of 1933, as amended. Reference is made to the Registrant’s Form 8-K filed with the SEC on November 30, 2016 with respect to the issuance of these shares.

 

6,776,683 Shares of Common Stock Issued for Services

 

On January 21, 2016, the Company entered into a consulting agreement with Global Corporation Strategies (“GCS”). In consideration for investor and public relations services to be provided by GCS, the Company issued to GCS 5,134,375 restricted shares of Common Stock.

 

On November 22, 2016, the Company entered into a corporate management services agreement with Sorelenco Limited (“Sorelenco”). In consideration for services, the Company issued to Sorelenco: (i) 1,442,308 shares of the common stock; (ii) Class M Warrants exercisable for a period of twelve (12) months to purchase 1,250,000 Shares at an exercise price $0.08; (iii) Class G Warrants exercisable for a period of twenty-four (24) months to purchase 448,462 Shares at an exercise price $0.25; and (iv) Class H Warrants exercisable for a period of thirty-six (36) months to purchase 448,462 Shares at an exercise price $0.40.

 

On November 28, 2016, the Company entered into a consulting agreement with Bear Creek Capital (“Bear Creek”). In consideration for the services, the Company issued to Bear Creek 100,000 shares of Common Stock.

 

On December 16, 2016, the Company entered into a consulting agreement with Smurlick, pursuant to which Smurlick will provide the Company with services in the areas of investor relations and business development. In consideration for the services, the Company issued to the Smurlick 200,000 Class G Warrants and 200,000 Class H Warrants identical to the Class G and Class H Warrants described above with a cashless exercise feature. During the year ended December 31, 2017 the warrants were exercised on a cashless basis.

 

On December 14, 2016, the Company issued 50,000 shares of Common Stock to Securities Compliance Services for certain compliance services related to our securities. On December 14, 2016, the Company issued to Ivo Heiden 50,000 shares of Common Stock for securities compliance services.

 

Unregistered Common Stock Issued in 2017:

 

6,154,100 Shares of Common Stock Issued for Cash

 

During the first fiscal quarter of 2017, we issued 4,403,638 shares of Common Stock to investors for cash as follows:

 

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We received $117,640 through a placement of 904,924 Common Stock units to four investors for the offering price of $0.13 per unit. Each unit consisted of one share of Common Stock, one Class G Warrant to purchase one share of Common Stock and one Class H Warrant to purchase one share of Common Stock. The 904,924 Class G Warrants are exercisable at $0.25 and expire two years from the issuance date. The 904,924 Class H Warrants are exercisable at $0.40 and expire 3 years from the issuance date.

 

We received $100,000 through a placement of 588,237 Common Stock units to three investors for the offering price of $0.17 per unit. Each unit consisted of one share of Common Stock and one Class H Warrant to purchase one share of Common Stock. The 588,237 Class H Warrants are exercisable at $0.40 and expire 3 years from the issuance date.

 

We received $130,000 through a placement of 520,000 Common Stock units to five investors for the offering price of $0.25 per unit. Each unit consisted of one share of Common Stock and one Class I Warrant to purchase one share of Common Stock. The 520,000 Class I Warrants are exercisable at $0.50 and expire 2 years from the issuance date.

 

We received $883,625 through a placement of 1,767,250 Common Stock units to twenty investors for the offering price of $0.50 per unit. Each unit consisted of one share of Common Stock and one Class K Warrant to purchase one share of Common Stock. The 1,767,250 K warrants are exercisable at $1.00 and expire 18 months from the issuance date.

 

We received $436,260 through a placement of 623,227 Common Stock units to eleven investors for the offering price of $0.70 per unit. Each unit consisted of one share of Common Stock and one Class L Warrant to purchase one share of Common Stock. The 623,227 Class L Warrants are exercisable at $1.40 and expire 18 months from the issuance date.

 

During the year ended December 31, 2017, we received $225,160 upon the exercise of 1,750,462 previously outstanding stock warrants into shares of Common Stock from existing investors at exercise prices ranging from $0.08 to $0.25.

 

1,266,127 Shares of Common Stock Issued for Services

 

In January 2017, we entered a consulting agreement with Lyons Capital LLC (“Lyons”) for the 2017 Wall Street Conference and sponsorship in the conference pursuant to which we issued to Lyons 300,000 fully vested shares of Common Stock and 200,000 Class G Warrants with exercise price of $0.25 and 200,000 Class H Warrants with exercise price of $0.40 and a cashless feature for the purchase of one share each of Common Stock to a consultant as payment for services.

 

Under the consulting agreement with Bear Creek, we became obligated to issue 100,000 additional shares to Bear Creek as of February 28, 2017. The shares were issued in April 2017.

 

On May 9, 2017, we entered a consulting agreement with Lyons for business and corporate developments. Pursuant to the agreement, we issued 450,000 fully vested shares of Common Stock to Lyons as payment for services.

 

On April 19, 2017, we entered another consulting agreement with Smurlick for business development and introduction to commercial partners. Pursuant to the agreement, we issued to Smurlick 416,127 fully vested shares of Common Stock as payment for services.

 

2,347,455 Shares of Common Stock Issued upon exercise of warrants

 

In March 2017, Lyons exercised 200,000 Class G Warrants and 200,000 Class H Warrants on a cashless basis for 334,450 shares of Common Stock.

 

In May 2017, Smurlick exercised 200,000 Class G Warrants and 200,000 Class H Warrants on a cashless basis for 262,363 shares of Common Stock

 

In 2017, we received $225,160 in cash from the exercise of 1,750,642 warrants for 1,750,642 shares of Common Stock at exercise prices ranging from $0.08 to $0.40.

 

All of the securities issued by the Company during fiscal years 2017 and 2016 were issued solely to “accredited investors” in reliance on the exemption from registration afforded by Section 4(a)(2) of the Securities Act, as amended

 

Penny Stock Regulation

 

Our shares must comply with the Penny Stock Reform Act of 1990, which may potentially decrease our shareholders’ ability to easily transfer their shares. Broker-dealer practices in connection with transactions in “penny stocks” are regulated. Penny stocks generally are equity securities with a price of less than $5.00. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides information about penny stocks and the risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, and monthly account statements showing the market value of each penny stock held in the customer’s account. In addition, the penny stock rules generally require that prior to a transaction in a penny stock, the broker-dealer make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for a stock that must comply with the penny stock rules. Since our shares must comply with such penny stock rules, our shareholders will in all likelihood find it more difficult to sell their securities.

 

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ITEM 6. SELECTED FINANCIAL DATA

 

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

 

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATION

 

The following discussion and analysis provides information that we believe is relevant to an assessment and understanding of our results of operations and financial condition. You should read this analysis in conjunction with our audited consolidated financial statements and related notes. This discussion and analysis contains statements of a forward-looking nature relating to future events or our future financial performance. These statements are only predictions, and actual events or results may differ materially. In evaluating such statements, you should carefully consider the various factors identified in this annual report, which could cause actual results to differ materially from those expressed in, or implied by, any forward-looking statements, including those set forth in “Risk Factors” in this annual report. See “Cautionary Note Regarding Forward-Looking Statements.”

 

Plan of Operations

 

We are engaged in research and development of cannabis-based medical products for the treatment of a variety of medical conditions such as multiple myeloma, psoriasis, chronic pain, fibromyalgia and PTSD, and (ii) consulting services to companies and governmental agencies with respect to complex international medical cannabis protocols and regulations.

 

We have not yet commenced any significant activities related to our third-party consulting services.

 

Going Concern

 

The development and commercialization of our product is expected to require substantial expenditures. We have not yet generated material revenues from operations and therefore are dependent upon external sources for financing our operations. In addition, in each year since our inception we reported losses and negative cash flows from operating activities. This means that there is substantial doubt that we can continue as an on-going business for the next twelve months unless we obtain additional capital to pay our bills and meet our other financial obligations. Accordingly, we must raise capital from sources other than the actual sale of the product. We must raise capital to implement our projects and stay in business. Even if we raise additional funds, we do not know how long these funds will last.

 

Our lack of operating history may make it difficult to raise capital. Our inability to borrow funds or raise equity capital to facilitate our business plan may have a material adverse effect on our financial condition and future prospects.

 

Results of Operations during the year ended December 31, 2017 as compared to the year ended December 31, 2016

 

We have not generated significant revenue during the years ended December 31, 2017 and 2016. We have operating expenses related to general and administrative expenses and research and development expenses. During the year ended December 31, 2017, we incurred a net loss of $4,558,447 consisting of general and administrative expenses of $ 4,112,519 and research and development expenses of $441,203 and financing costs of $4,725, compared to a net loss of $2,287,329 consisting of general and administrative expenses of $2,006,216, research and development expenses of $141,858, and financing expenses adjusted for convertible loans of $180,340, exchange differences on principal of long-term loan of $16,972, other finance income of $8,057 in the prior year.

 

Our general and administrative expenses increased $2,106,303 during the year ended December 31, 2017 as compared to the year ended December 31, 2016. The increase was due to a significant increase in non-cash compensation expense of $1,835,197. During the year ended December 31, 2017, our research and development expenses increased by $299,345 or 211% over to the prior year.

 

Liquidity and Capital Resources

 

On December 31, 2017, we had current assets of $1,044,840 consisting of $970,542 in cash and other current assets of $74,298. We had property and equipment, net of accumulated depreciation of $29,890 carried at $16,243 as of December 31, 2017. We had total assets of $1,061,083 as of December 31, 2017. On December 31, 2016, we had current assets of $481,695 consisting of $472,282 in cash and other current assets of $9,413. We had property and equipment, net of accumulated depreciation of $21,549, carried at $15,073 as of December 31, 2016. We had total assets of $496,768 as of December 31, 2016.

 

- 44 -

 

 

On December 31, 2017, we had $270,485 in current liabilities consisting of $64,813 in accounts payable, $105,671 in other current liabilities and deferred revenues of $100,000. On December 31, 2016, we had $145,780 in current liabilities consisting of $7,694 in accounts payable, $38,086 in other current liabilities and deferred revenues of $100,000.

 

In addition, at December 31, 2016 and 2017, we had long-term liabilities of $250,000 and $0, respectively. The $250,000 in long-term liabilities at December 31, 2016, was payable to Medmar under a $300,000 non-recourse, non-interest bearing and non-convertible loan due 36 months from the date of the loan agreement of September 2016. This loan is only repayable from royalties payable by Medmar to us under a license agreement and, to the extent that royalties, if any, are insufficient to repay the loan, we have no obligation to pay any deficiency. The note was paid in full during 2017.

 

We had positive working capital of $774,355 at December 31, 2017 and $335,915 at December 31, 2016. Our accumulated deficits as of December 31, 2017 and December 31, 2016 were $14,516,912 and $9,958,465, respectively.

 

We used $1,185,919 in our operating activities during the year ended December 31, 2017, which was due to a net loss of $4,558,447 offset by depreciation expense of $8,341, stock-based compensation and amortization of services receivable of $3,304,056, an increase in other assets of $64,883, an increase in accounts payable of $59,672, and an increase in other liabilities of $65,031

 

We used $529,269 in our operating activities during the year ended December 31, 2016, which was due to a net loss of $2,287,329 offset by exchange differences on principal of long-term loan of $16,972, adjustments of convertible loans of $180,340, depreciation expense of $9,686, stock-based compensation and amortization of services receivable of $1,468,859, a decrease in other assets of $40,976, a decrease in accounts payable of $20,431, an increase in deferred revenues of $50,000 and an increase in other liabilities of $11,658.

 

We used $9,511 during the year ended December 31, 2017 and $1,860 in the prior year to purchase property and equipment.

 

We financed our negative cash flow from operations during the year ended December 31, 2017 through the issuance of 4,403,638 shares of Common Stock that resulted in net proceeds of $1,667,525. We also received $225,160 in proceeds from the exercise of 1,750,642 warrants and options and an additional $51,005 from the payment of stock subscriptions. Cash inflows from financing activities were offset by the payment of $300,000 which paid off a non-recourse loan.

 

We financed our negative cash flow from operations during the year ended December 31, 2016 through proceeds from issuance of Common Stock of $325,000 from the issuance of 2,500,000 shares of Common Stock, and net proceeds of debt borrowings of $321,250.

 

Based upon our cash position of $970,542 at December 31, 2017, we believe that we will need to raise additional capital, either equity or debt during the second half of fiscal year 2018 to fund our plan of operations including our research and development initiatives for the next eighteen months. There can be no assurance, however, that additional capital will be sufficient to fund our currently anticipated expenditure requirements for the next twelve-month period nor can there be any assurance that financing will be available at satisfactory terms and conditions or at all, for that matter.

 

Funding of Our Research Programs

 

On October 22, 2014, we entered into a collaboration agreement with the Sheba’s hospital relating to the use of cannabis to treat myeloma. Within the framework of this collaboration agreement, we conducted pre-clinical studies on multiple myeloma, which have commenced in April 2015. Pursuant to this collaboration agreement, we are obligated to pay Sheba $170,000. As of December 31, 2017, we have paid Sheba $65,669 as per Sheba’s payment requests. Pursuant to a collaboration agreement, we are obliged to pay Sheba $170,000 throughout 2017 and 2018 for conducting the Study for the cream for treatment of psoriasis. As of December 31, 2017, we have paid Sheba $13,903 as per Sheba’s payment requests and in January 2018, we paid an additional sum of $29,163.

 

At present, we use our available working capital to fund these studies. However, we expect that we will need to raise additional funding prior to or when our clinical studies are commenced.

 

Off-Balance Sheet Arrangements

 

As of December 31, 2017, and 2016, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K promulgated under the Securities Act of 1934.

 

Contractual Obligations and Commitments

 

As of December 31, 2017 and 2016, we did not have any contractual obligations.

 

Critical Accounting Policies

 

Our significant accounting policies are described in the note 2 to our financial statements for the years ended December 31, 2017 and 2016, and are included elsewhere in this annual report.

 

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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We have not entered into, and do not expect to enter into, financial instruments for trading or hedging purposes.

 

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

Report of Independent Registered Public Accounting Firm - Fahn Kanne & Co. Grant Thornton Israel 47
Financial Statements:  
Consolidated Balance Sheets as of December 31, 2017 and December 31, 2016 48
Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2017 and 2016 49
Consolidated Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2017 and 2016 50
Consolidated Statements of Cash Flows for the Years Ended December 31, 2017 and 2016 51
Notes to Consolidated Financial Statements 52

 

- 46 -

 

 

 

 

 

Fahn Kanne & Co.

Report of Independent Registered Public Accounting Firm

Head Office

 

32 Hamasger Street

Tel-Aviv 6721118, ISRAEL

PO Box 36172, 6136101

Board of Directors and Stockholders

 
OWC PHARMACEUTICAL RESEARCH CORP

T +972 3 7106666

 

F +972 3 7106660

 

www.gtfk.co.il

 

Opinion on the financial statements

 

We have audited the accompanying consolidated balance sheets of OWC Pharmaceutical Research Corp (a Delaware corporation) and subsidiary (the “Company”) as of December 31, 2017 and 2016, the related consolidated statements of comprehensive loss, changes in stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2017, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2017 and 2016, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2017, in conformity with accounting principles generally accepted in the United States of America.

 

Going Concern

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1b to the financial statements, the Company has incurred net losses since its inception, and has not yet generated any revenues. As of December 31, 2017, there is an accumulated deficit of $14,516,912. These conditions, along with other matters as set forth in Note 1b, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regards to these matters are also described in Note 1b. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Basis for opinion

 

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting 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.

 

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

/s/ FAHN KANNE & CO. GRANT THORNTON ISRAEL

 

We have served as the Company’s auditor since 2017.

 

Tel-Aviv, Israel

April 16, 2018

 

Certified Public Accountants

Fahn Kanne & Co. is the Israeli member firm of Grant Thornton International Ltd

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

CONSOLIDATED BALANCE SHEETS

 

   

US dollars

(except share data)

 
    December 31,  
    2017     2016  
ASSETS            
Current assets                
Cash and cash equivalents     970,542       472,282  
Other current assets (Note 3)     74,298       9,413  
Total current assets     1,044,840       481,695  
                 
Property and equipment, net (Note 4)     16,243       15,073  
Total Assets     1,061,083       496,768  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable     64,814       7,694  
Other current liabilities     105,671       38,086  
Deferred revenues (Note 6A1)     100,000       100,000  
Total current liabilities     270,485       145,780  
                 
Non-recourse loan (Note 5)     -       250,000  
Total liabilities     270,485       395,780  
Commitments and Contingencies (Note 6)                
                 
Stockholders’ Equity (Note 7):                
Preferred stock, $0.00001 par value; 20,000,000 shares authorized at December 31, 2017 and 2016; no shares issued and outstanding at December 31, 2017 and 2016;     -       -  
Common stock, $0.00001 par value; 500,000,000 shares authorized at December 31, 2017 and 2016; 147,758,908 and 139,447,782 shares issued and outstanding at December 31, 2017 and 2016, respectively     1,478       1,395  
Additional paid-in capital     16,168,469       11,039,102  
Services receivable     (524,792 )     (592,083 )
Common stock subscriptions receivable     (344,006 )     (395,011 )
Accumulated deficit     (14,516,912 )     (9,958,465 )
Accumulated other comprehensive income     6,361       6,050  
Total stockholders’ equity     790,598       100,988  
Total Liabilities and Stockholders’ Equity     1,061,083       496,768  

 

The accompanying notes are an integral part of the consolidated financial statements.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

 

   

US dollars

(except share data)

 
    December 31,  
    2017     2016  
             
Revenue (Note 6A1)     -       50,000  
                 
Operating expenses:                
Research and development     (441,203 )     (141,858 )
General and administrative (Note 8)     (4,112,519 )     (2,006,216 )
Total operating expenses     (4,553,722 )     (2,148,074 )
                 
Operating loss     (4,553,722 )     (2,098,074 )
Financing expenses, net (Note 9)     (4,725 )     (189,255 )
Net loss     (4,558,447 )     (2,287,329 )
                 
Other comprehensive income:                
Foreign currency translation adjustment     311       16,972  
                 
Comprehensive loss     (4,558,136 )     (2,270,357 )
                 
Basic and diluted per share amounts:                
Basic and diluted net loss per share     (0.03 )     (0.02 )
                 
Weighted average number of shares of common stock used in computing basic and diluted net loss per share     145,203,738       96,362,150  

 

The accompanying notes are an integral part of the consolidated financial statements.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

 

    Common Stock                    
    Shares     Common
Stock
    Additional
Paid-in Capital
   

 

 

Services
Receivable

    Common Stock
Subscriptions
Receivable
    Accumulated
Deficit
    Accumulated
Other
Comprehensive
Income (Loss)
    Total
Stockholders’
Equity
 
US dollars (except share data)                                                                
Balance at December 31, 2015     76,326,500       764       8,276,857       -       (395,011 )     (7,548,866 )     (10,922 )     322,822  
                                                                 
Stock-based compensation     100,000       1       1,440,682       -       -       -       -       1,440,683  
Common stock issued upon conversion of debt host and accrued interest     53,844,599       539       123,127       -       -       -       -       123,666  
Reclassification of embedded derivative liability upon conversion of convertible loans host     -       -       130,998       -       -       -       -       130,998  
Financial instruments issued for services to be received     6,676,683       66       742,463       (742,529 )     -       -       -       -  
Amortization of services receivable (see Note 2I)     -       -       -       150,446       -       (122,270 )     -       28,176  
Common stock issued for cash @ $0.13 together with detachable warrants (see Note 7B1)     2,500,000       25       324,975       -       -       -       -       325,000  
Other comprehensive income     -       -       -       -       -       -       16,972       16,972  
Net loss     -       -       -       -       -       (2,287,329 )     -       (2,287,329 )
Balance at December 31, 2016     139,447,782       1,395       11,039,102       (592,083 )     (395,011 )     (9,958,465 )     6,050       100,988  
                                                                 
Stock-based compensation     100,000       1       2,049,738       -       -       -       -       2,049,739  
Financial instruments issued for services to be received     1,166,127       12       1,187,014       (1,187,026 )     -       -       -       -  
Amortization of services receivable ( Note 2I)                             1,254,317       -       -       -       1,254,317  
Common stock issued upon exercise of warrants (Note 7D1)     1,750,642       18       225,142       -       -       -       -       225,160  
Common stock issued upon exercise of options and warrants on cashless basis (Note 7D2-7D3)     890,719       8       (8 )     -       -       -       -       -  
Payments received on subscriptions receivable (Note 3)     -       -       -       -       51,005       -       -       51,005  
Common stock issued for cash @$0.13 together with detachable warrants (see Note 7B2)     904,924       9       117,631       -       -       -       -       117,640  
Common stock issued for cash @$0.17 together with detachable warrants (see Note 7B3)     588,237       6       99,994       -       -       -       -       100,000  
Common stock issued for cash @$0.25 together with detachable warrants (see Note 7B4)     520,000       5       129,995       -       -       -       -       130,000  
Common stock issued for cash @$0.50 together with detachable warrants (see Note 7B5)     1,767,250       18       883,607       -       -       -       -       883,625  
Common stock issued for cash @$0.70 together with detachable warrants (see Note 7B6)     623,227       6       436,254       -       -       -       -       436,260  
Other comprehensive income     -       -       -       -       -       -       311       311  
Net loss     -       -       -       -       -       (4,558,447 )     -       (4,558,447 )
Balance at December 31, 2017     147,758,908       1,478       16,168,469       (524,792 )     (344,006 )     (14,516,912 )     6,361       790,598  
                                                                 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

    US dollars  
    Year ended
December 31,
 
    2017     2016  
             
Cash flows from operating activities:                
Net loss     (4,558,447 )     (2,287,329 )
                 
Adjustments to reconcile net loss to net cash used by operating activities:                
Depreciation     8,341       9,686  
Stock-based compensation     2,049,739       1,440,683  
Amortization of services receivable     1,254,317       28,176  
Exchange differences on principal of non-recourse loan     311       16,972  
Adjustments of convertible loans     -       180,340  
                 
Changes in assets and liabilities:                
(Increase) decrease in other current assets     (64,883 )     40,976  
Increase (decrease) in accounts payable     59,672       (20,431 )
Increase in deferred revenues     -       50,000  
Increase in other current liabilities     65,031       11,658  
Cash used by operating activities     (1,185,919 )     (529,269 )
                 
Cash flows from investing activities:                
Purchase of property and equipment     (9,511 )     (1,860 )
Cash used in investing activities     (9,511 )     (1,860 )
                 
Cash flows from financing activities:                
Proceeds from issuance of common stock and warrants (see Note 7B2-7B6)     1,667,525       325,000  
Proceeds from exercise of warrants into common stock (see Note 7D1)     225,160       -  
Proceeds from the payment received on stock subscriptions     51,005       -  
Proceeds from debt borrowings, net of issuance expenses (Note 5)     50,000       321,250  
Payment of non-recourse loan (Note 5)     (300,000 )     -  
Cash provided by financing activities     1,693,690       646,250  
                 
Change in cash and cash equivalents     498,260       115,121  
Balance of cash and cash equivalents at beginning of year     472,282       357,161  
Balance of cash and cash equivalents at end of year     970,542       472,282  
                 
Supplementary information on financing activities not involving cash flows:                
Reclassification of embedded derivative liability upon conversion of convertible debt     -       130,998  
Conversion of convertible debt and accrued interest into common stock     -       123,666  

 

The accompanying notes are an integral part of the consolidated financial statements.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1 GENERAL

 

  A. Organizational Background

 

OWC Pharmaceutical Research Corp. (“OWCP” or the “Company”) is a Delaware corporation and was incorporated under the laws of the State of Delaware on March 7, 2008. The Company is a medical cannabis-based research and development company that applies conventional pharmaceutical research protocols and disciplines to the field of medical cannabis with the objective of establishing a leadership position in the research and development of medical cannabis therapies, products and delivery technologies. The Company is currently engaged in the research and development of cannabis-based medical products (the “Product Prospects”) for the treatment of multiple myeloma, psoriasis, chronic pain syndromes, fibromyalgia PTSD and utilize unique delivery systems. These include a cannabis-based topical cream, cannabis sublingual disintegrating tablet and advanced Nasal delivery.

 

The accompanying consolidated financial statements of OWCP and its wholly owned subsidiary One World Cannabis, Ltd. (“OWC” or the “Israeli subsidiary”) were prepared from the accounts of the Company under the accrual basis of accounting.

 

  B. Liquidity and Going Concern Uncertainty

 

The development and commercialization of the Company’s product is expected to require substantial expenditures. The Company has not yet generated material revenues from operations and therefore is dependent upon external sources for financing its operations. As of December 31, 2017, the Company has an accumulated deficit of $14,516,912. In addition, in each year since its inception the Company reported losses and negative cash flows from operating activities. Management considered the significance of such conditions in relation to the Company’s ability to meet its current and future obligations and determined that such conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern. Until such time as the Company generates sufficient revenue to fund its operations (if ever), the Company plans to finance its operations through the sale of equity or equity-linked securities and/or debt securities and, to the extent available, short-term and long-term loans. There can be no assurance that the Company will succeed in obtaining the necessary financing to continue its operations as a going concern.

 

During the year ended December 31, 2017, the Company raised a total net amount of $1,667,525 from issuance of units that included Common Stock and detachable warrants (see also Note 7B2-7B6). In addition, during 2017 the Company received $225,160 through the exercise of warrants (see also Note 7D1) and $51,005 through payment of stock subscription. The Company also received $50,000 in proceeds from a non-recourse loan that resulted in a balance of $300,000, all of which was repaid in 2017 (see also Note 5).

 

  C. Risk Factors

 

As described in the above paragraph, the Company has a limited operating history and faces a number of risks and uncertainties, including risks and uncertainties regarding continuation of the development process, demand and market acceptance of the Company’s products, the effects of technological changes, competition and the development of products by competitors. Additionally, other risk factors also exist, such as the ability to manage growth and the effect of planned expansion of operations on the Company’s future results and the availability of necessary financing. In addition, the Company expects to continue incurring significant operating costs and losses in connection with the development and marketing of its products.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

  C. Basis of Presentation

 

The consolidated financial statements were prepared in accordance with accounting principles generally accepted in the United States of America (US GAAP).

 

  B. Principles of Consolidation

 

The financial statements include the accounts of OWCP and its wholly owned subsidiary, OWC. All significant inter-company balances and transactions have been eliminated.

 

  C. Use of Estimates

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from the estimates. As applicable to these consolidated financial statements, the most significant estimates and assumptions relate to (i) stock-based compensation related to employees and non-employees awards, and (ii) the going concern assumptions.

 

  D. Functional Currency

 

The functional currency of the Company is the US dollar, which is the currency of the primary economic environment in which it operates. In accordance with ASC 830, “Foreign Currency Matters”, balances denominated in or linked to foreign currency are stated on the basis of the exchange rates prevailing at the applicable balance sheet date. For foreign currency transactions included in the statement of comprehensive loss, the exchange rates applicable on the relevant transaction dates are used. Gains or losses arising from changes in the exchange rates used in the translation of such transactions are presented within financing income or expenses.

 

The operation of Non-U.S. entity (the Israeli entity) are conducted in New Israeli Shekels (NIS), its local currency. Accordingly, NIS is its functional currency. Results of operations for non-U.S. dollar functional currency entities are translated into U.S. dollars using the actual action date currency rate. Assets and liabilities are translated using currency rates at period end. Foreign currency translation adjustments are recorded as a component of accumulated other comprehensive income within stockholders’ equity.

 

  E. Cash and Cash Equivalents

 

For financial statement presentation purposes, the Company considers those short-term, highly liquid investments with original maturities of three months or less to be cash or cash equivalents.

 

  F. Property and Equipment

 

Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets.

 

  G. Impairment of Long-Lived Assets

 

The Company reviews the recoverability of our long-lived assets including property and equipment, when events or changes in circumstances occur that indicate that the carrying value of the asset may not be recoverable. The assessment of possible impairment is based on our ability to recover the carrying value of the asset from the expected future pre-tax cash flows (undiscounted and without interest charges) of the related operations. If these cash flows are less than the carrying value of such asset, an impairment loss is recognized for the difference between estimated fair value and carrying value. Our primary measure of fair value is based on discounted cash flows. The measurement of impairment requires management to make estimates of these cash flows related to long-lived assets, as well as other fair value determinations. During the years ended December 31, 2017 and 2016, loss from impairment has not been recognized.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

 

  H. Warrants

 

Warrants that were issued are classified as a component of permanent equity if they are freestanding financial instruments that are legally detachable and separately exercisable, contingently exercisable, do not embody an obligation for the Company to repurchase its own shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the warrants must require physical settlement and may not provide any guarantee of value or return. Fully vested and nonforfeitable warrants that meet these criteria are initially recorded at their grant date fair value and are not subsequently re-measured. Warrants that do not meet this criteria represent a derivative liability and are measured upon initial recognition and re-measured at subsequent reporting periods at their fair value. Changes in the fair value are recorded in the consolidated statement of comprehensive loss within financing income or expenses.

 

  I. Stock-Based Compensation

 

The Company accounts for stock-based compensation to employees in accordance with ASC 718, Compensation - Stock Compensation . Accordingly, stock-based compensation to employees is recognized in the statement of comprehensive loss as an operating expense, based on the fair value of the award that is ultimately expected to vest. The fair value of stock-based compensation is estimated using the Black Scholes option-pricing model. The inputs for the valuation analysis of the options include a number of assumptions, of which the most significant are the expected stock price volatility and the expected option term. Expected volatility was calculated based upon historical volatilities of the Company on a daily basis. The expected option term represents the period that the Company’s stock options are expected to be outstanding and is determined based on the simplified method until sufficient historical exercise data will support using expected life assumptions. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The expected dividend yield assumption is based on the Company’s historical experience and expectation of no future dividend payouts. The Company has historically not paid cash dividends and has no foreseeable plans to pay cash dividends in the future. The Company has expensed compensation costs, net of estimated forfeitures, on a straight-line basis, over the requisite service period of the award.

 

Stock based payments awarded to non-employees are accounted for in accordance with ASC 505-50, “ Equity-Based Payments to Non-Employees ”. However, when the Company grants to non-employees a fully vested, non-forfeitable equity instrument, such grants are measured based on the fair value of the award at the date of grant and are not subsequently re-measured. When the fully vested, non-forfeitable equity instruments are granted for services to be received in future periods, the measured cost is recognized as an increase to stockholders’ equity at the measurement date with an offsetting amount as a deduction from stockholders’ equity within the caption “Services receivable”. Such amount is subsequently amortized to the statement of comprehensive loss over the term of the services as an operating expense, as if the Company has paid periodic payments of cash for the services received from such service provider.

 

  J. Fair Value of Financial Instruments

 

ASC 825, “Financial Instruments” (ASC 825), requires entities to disclose the fair value of financial instruments, both assets and liabilities recognized and unrecognized on the balance sheet, for which it is practicable to estimate fair value. ASC 825 defines fair value of a financial instrument as the amount at which the instrument could be exchanged in a current transaction between market participants. At December 31, 2017 and 2016, the carrying value of cash and cash equivalents, other current assets, accounts payable and other current liabilities approximates fair value due to the short-term nature of the instruments or interest rates, which are comparable with current rates.

 

- 54 -

 

 

OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

 

  K. Fair Value Measurements

 

The Company measures fair value under a framework that utilizes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3 measurements). The three levels of inputs which prioritize the inputs used in measuring fair value are:

 

Level 1: Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access.

 

Level 2 : Inputs to the valuation methodology include:

 

  - Quoted prices for similar assets or liabilities in active markets;
     
  - Quoted prices for identical or similar assets or liabilities in inactive markets;
     
  - Inputs other than quoted prices that are observable for the asset or liability;
     
  - Inputs that are derived principally from or corroborated by observable market data by correlation or other means.

 

If the asset or liability has a specified (contractual) term, the level 2 input must be observable for substantially the full term of the asset or liability.

 

Level 3 : Inputs to the valuation methodology are unobservable and significant to the fair value measurement.

 

The assets or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs.

 

When the Company changes its valuation inputs for measuring financial assets and liabilities at fair value, either due to changes in current market conditions or other factors, it may need to transfer those assets or liabilities to another level in the hierarchy based on the new inputs used. The Company recognizes these transfers at the end of the reporting period that the transfers occur. For the fiscal periods ended December 31, 2017 and 2016, there were no transfers of financial assets or financial liabilities between the hierarchy levels.

 

As of December 31, 2017 and 2016, no assets or liabilities were required to be measured at fair value on a recurring basis.

 

  L. Convertible Loans

 

The Company considers the provisions of ASC 815 - 40, “Derivatives and Hedging - Contracts in Entity’s Own Equity” with respect to convertible loans. When the Company determines that the embedded conversion feature is not considered indexed to the Company’s own stock, the embedded conversion feature is bifurcated from the host instrument and is accounted for at fair value as a derivative liability. Accordingly, upon initial recognition, the embedded conversion feature is measured at fair value and the remaining proceeds are allocated to the loan component (Host). In subsequent periods the derivative liability is measured at fair value through profit or loss (with changes presented within financing income or expense, as applicable) and the loan component is measured at amortized cost. The amount that was allocated to the embedded conversion feature upon initial recognition, created a discount on the loan component. Such discount is amortized as interest expense to profit or loss over the term of the loan until its stated maturity.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

 

  L. Convertible Loans (cont.)

 

When the Company determine that the embedded conversion feature should not be separated from the host instrument because it qualified for equity classification, the Company applies ASC 470 - 20, “Debt - Debt with Conversion and Other Options ” which clarifies the accounting for instruments with beneficial conversion features or contingency adjustable conversion ratios. The beneficial conversion feature is calculated by allocating the proceeds received in a financing transactions to the convertible loan and to any detachable warrants included in the transaction, if any, and by measuring the intrinsic value of the convertible loan, based on the effective conversion price as a result of the allocated proceeds. The amount of the beneficial conversion feature is recorded as a discount on the convertible loan with a corresponding amount credited directly to equity as additional paid-in capital. After the initial recognition, the discount on the convertible loan is amortized as interest expense over the term of the loans.

 

  M. Loss per Common Share

 

The Company computes net loss per share in accordance with ASC 260, “Earning per Share” , which requires presentation of both basic and diluted loss per share on the face of the statement of comprehensive loss. Basic loss per share is computed by dividing net loss available to common shareholders (numerator) by the weighted average number of shares outstanding (denominator) during the year. Diluted loss per share gives effect to all potentially dilutive common shares outstanding during the year using the treasury stock method with respect to preferred stock, stock options and stock warrants and convertible loans using the if-converted method. In computing Diluted loss per share, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. Diluted loss per share excludes all potentially dilutive shares if their effect is anti-dilutive. Potentially dilutive shares consist of unexercised stock warrants and stock options that totaled 30,342,308 and 29,723,283 during the years ended December 31, 2017 and 2016, respectively.

 

  N. Liability for Employee Rights upon Retirement

 

OWC’s liability for severance pay is pursuant to Section 14 of the Israeli Severance Compensation Act, 1963 (“Section 14”), pursuant to which all OWC’s employees are included under Section 14, and are entitled only to monthly deposits, at a rate of 8.33% of their monthly salary, made in the employee’s name with insurance companies. Under Israeli employment law, payments in accordance with Section 14 release OWC from any future severance payments in respect of those employees. The fund is made available to the employee at the time the employer-employee relationship is terminated, regardless of cause of termination. The severance pay liabilities and deposits under Section 14 are not reflected in the consolidated balance sheets as the severance pay risks have been irrevocably transferred to the severance funds.

 

Severance expenses for the year ended December 31, 2017, and 2016 amounted to $8,500 and $30,000, respectively.

 

  O. Income Taxes

 

The Company accounts for income taxes in accordance with ASC 740, “Income Taxes”. Accordingly, deferred income taxes are determined utilizing the asset and liability method based on the estimated future tax effects of differences between the financial accounting and the tax bases of assets and liabilities under the applicable tax law. Deferred tax balances are computed using the enacted tax rates expected to be in effect when these differences reverse. Valuation allowances in respect of deferred tax assets are provided for, if necessary, to reduce deferred tax assets to amounts more likely than not to be realized.

 

- 56 -

 

 

OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

 

  O. Income Taxes (cont.)

 

The Company accounts for uncertain tax positions in accordance with ASC 740-10, which prescribes detailed guidance for the financial statement recognition, measurement and disclosure of uncertain tax positions recognized in an enterprise’s financial statements. According to ASC 740-10, tax positions must meet a more-likely-than-not recognition threshold. The Company’s accounting policy is to classify interest and penalties relating to uncertain tax positions under income taxes, however the Company did not recognize such items during the years ended December 31, 2017 and 2016 and did not recognize any liability with respect to unrecognized tax position in its balance sheets.

 

  P. Revenue Recognition

 

Revenues from consulting services are recognized when the services are rendered or when applicable, if the consideration is non-refundable, upon expiration of the Company’s performance obligation.

 

Deferred revenue includes amounts received with respect to consultation services not yet recognized as revenues. Such revenues are deferred and recognized on a straight-line basis over the service period or when service is provided, as applicable to the contract.

 

  Q. Research and Development Expenses

 

Research and development expenses are charged to the statement of comprehensive loss as incurred.

 

  R. Concentrations of Credit Risk

 

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. Cash and cash equivalents are deposited with major banks in Israel and the United States of America. Management believes that such financial institutions are financially sound and, accordingly, minimal credit risk exists with respect to these financial instruments. As of December 31, 2017 and 2016 the balances of accounts receivable were not material and accordingly such balances do not represent substantial concentration of credit risk. The Company does not have any significant off-balance-sheet concentration of credit risk, such as foreign exchange contracts, option contracts or other foreign hedging arrangements.

 

  S. Legal and other Contingencies

 

The Company accounts for its contingent liabilities in accordance with ASC 450 “Contingencies“. A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. As of December 31, 2017, the Company is not a party to any litigation that could have a material adverse effect on the Company’s business, financial position, results of operations or cash flows.

 

Legal costs incurred in connection with loss contingencies are expensed as incurred.

 

  T. Recent Accounting Pronouncements adopted

 

On March 30, 2016, the FASB issued ASU 2016-09, “Compensation-Stock Compensation”, which effects all entities that issue share-based payment awards to their employees. The amendments in this update cover such areas as the recognition of excess tax benefits and deficiencies, the classification of those excess tax benefits on the statement of cash flows, an accounting policy election for forfeitures, the amount an employer can withhold to cover income taxes and still qualify for equity classification and the classification of those taxes paid on the statement of cash flows. This update is effective for annual and interim periods beginning after December 15, 2016. This guidance can be applied either prospectively, retrospectively or using a modified retrospective transition method. The Company adopted the new guidance prospectively in 2017. This new guidance does not have a material impact on the Company’s consolidated financial statements.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

 

  U. Recent Accounting Pronouncements not adopted yet

 

  1. In February 2016, the FASB issued ASU No. 2016-02, Leases. This guidance will require that lease arrangements longer than 12 months result in an entity recognizing an asset and liability equal to the present value of the lease payments in the statement of financial position. This guidance is effective for annual periods beginning after December 15, 2018, and interim periods therein. This standard requires a modified retrospective transition approach for all leases existing at, or entered into after, the date of initial application, with an option to use certain transition relief. Early adoption is permitted. The Company is currently evaluating the impact that the adoption of ASU 2016-02 will have on its financial statements and related disclosures.
     
  2. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): “Restricted Cash” (ASU 2016-18), which requires companies to include amounts generally described as restricted cash and restricted cash equivalents in cash and cash equivalents when reconciling beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. This new guidance does not have a material impact on the Company’s consolidated financial statements.
     
  3. In May 2017, the FASB issued ASU 2017-09, “Compensation-Stock Compensation” guidance on changes to terms and conditions of share-based payment awards. The amendment provides guidance about which changes to terms or conditions of a share-based payment award require an entity to apply modification accounting. The guidance will be effective for the fiscal year beginning on January 1, 2018, including interim periods within that year (early adoption is permitted). The Company is currently evaluating the potential effect of the guidance on its consolidated financial statements.
     
  4. In July 2017, the FASB issued ASU 2017-11, “Earnings per share”, which allows companies to exclude a down round feature when determining whether a financial instrument is considered indexed to the entity’s own stock. As a result, financial instruments with down round features may no longer be required to be accounted classified as liabilities. A company will recognize the value of a down round feature only when it is triggered and the strike price has been adjusted downward. For equity-classified freestanding financial instruments, such as warrants, an entity will treat the value of the effect of the down round, when triggered, as a dividend and a reduction of income available to common shareholders in computing basic earnings per share. The guidance in ASU 2017-11 is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted, and the guidance is to be applied using a full or modified retrospective approach. The Company is currently evaluating the potential effect of the guidance on its consolidated financial statements.

 

NOTE 3 OTHER CURRENT ASSETS

 

    US dollars  
    December 31,  
    2017     2016  
             
Prepaid expenses     74,298       1,536  
Others     -       7,877  
      74,298       9,413  

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 4 PROPERTY AND EQUIPMENT, NET

 

    US dollars  
    December 31,  
    2017     2016  
             
Furniture and office equipment     5,927       2,407  
Computers     31,108       24,641  
Photography     7,238       7,714  
Machinery     1,860       1,860  
      46,133       36,622  
Less - accumulated depreciation     (29,890 )     (21,549 )
      16,243       15,073  

 

During the years ended December 31, 2017 and 2016, depreciation expenses amounted to $8,341 and $9,686, respectively.

 

NOTE 5 - NON-RECOURSE LOAN

 

On September 28, 2016 (the “Effective Date”), OWC entered into a Non-Recourse Loan Agreement (the “Loan Agreement”) with Medmar LLC (“Medmar”), pursuant to which Medmar had agreed to loan OWC a total of $300,000 (the “Loan”) on a non-interest bearing basis, with no conversion rights. The Loan was due in 36 months from the Effective Date, and repayment was to made only by the set off of royalties payable by Medmar to OWC as follows: (i) prior to the full repayment of the Loan, which OWC may prepay at any time, if and to the extent Medmar was required to pay any royalties to OWC under a License Agreement dated March 17, 2016 (see also Note 6A1), Medmar shall set off such royalties from the outstanding principal balance of the Loan; (ii) OWC shall not be required to pay the Loan other than through the set off from the royalties; and (iii) the Loan was a non-recourse loan, meaning that if and to the extent that the royalties are insufficient for any reason in order to fully repay the Loan, Medmar waived any right and/or claim to any deficiency.

 

In addition, the Loan Agreement also provided that: (i) subject to Medmar funding the entire Loan, Medmar shall receive the exclusive right to manufacture, produce, publicize, promote and market OWC’s Licensed Products (as defined in the above-referenced License Agreement) in any state in the U.S., subject to a new license agreement to be negotiated and signed between the parties with respect to each and every state; (ii) the rights to be granted to Medmar under (i) above shall expire within 3 years subject to certain conditions and limitations; and (iii) the right of first refusal agreement between the parties that was executed on February 8, 2016 providing Medmar certain rights in connection with the commercialization of Licensed Products in the States of Hawaii and Pennsylvania be terminated (see also Note 6A1).

 

Through December 31, 2016 the Company had received $250,000 from Medmer under the Loan Agreement and it received an additional amount of $50,000 during the year ended December 31, 2017.

 

On April 21, 2017, OWC sent written notice to Medmar of OWC’s determination to prepay the non-recourse loan by Medmar to OWC in the principal amount of $300,000. OWC exercised what it believes is its absolute right to terminate certain distribution rights granted to Medmar under the Loan Agreement and has repaid the entire Loan, during the year ended December 31, 2017 .

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 6 - COMMITMENTS AND CONTINGENCIES

 

  A. Commitments

 

  1. On October 11, 2015, OWC entered into a memorandum of understanding with Medmar (see also Note 5) for the purpose of granting an exclusive, non-transferable, royalty-bearing license, to manufacture, produce, publicize, promote and market the licensed products described therein in the State of Hawaii and the State of Pennsylvania, pursuant to which Medmar has paid OWC $100,000 ($50,000 during each year ended December 31, 2016 and 2015). On February 8, 2016, OWC and Medmar II, an affiliate of Medmar, executed a right of first refusal agreement providing Medmar certain rights in connection with the commercialization of OWC’s Cannabis-Based Medical Products in other states in the USA, pursuant to which Medmar has paid $50,000 to the Company.
     
    On March 17, 2016, Medmar and OWC executed a consulting and License Agreement (the “Agreement”), pursuant to which OWC granted to Medmar an exclusive, non-transferable, royalty-bearing license, to manufacture, produce, publicize, promote and market certain of OWC’s products (as defined in the Agreement) in the State of Maryland, against payment by Medmar to OWC of a royalty. As part of the Agreement, the Company received from Medmar an amount of $50,000 as a non-refundable advance.
     
    In 2016, and as OWC does not have any performance obligation in connection with the agreement, OWC recorded revenues in an amount of $50,000.
     
  2. In April 2015 OWC engaged G.C. Group Ltd., an Israeli corporation specializing in pharmaceutical R&D to provide formulation development services for OWC’s new delivery system in the form of a cannabis soluble tablet. G.C. Group Ltd. successfully completed the first phase of development, a proof of concept of the desired end-product (the soluble tablet) to test the fabric, durability, solidification and other features of the cannabis soluble tablet.
     
    The agreement was terminated on December 31, 2015.
     
  3. In August 2017 OWC engaged PharmItBe Ltd, a company specializing in pharmaceutical R&D to develop a second generation of its cannabis soluble tablet. This development is expected to be completed during the second quarter of 2018.
     
  4. On November 3, 2016, OWC entered into a Joint Venture Memorandum of Understanding with Michepro Holding Ltd. (“EU Partner”), (“JV” or “MOU”). The EU Partner and OWC have agreed as follows: (i) to establish a strategic marketing and distribution alliance (the “JV”) to promote the sale of OWC’s Products in the European Union (the “EU”); (ii) the interest of the parties in the JV shall be held by the parties such that the EU Partner shall hold 25% of such interest and OWC shall hold the remaining 75% of such interest; (iii) OWC shall provide the JV with OWC’s Products for sale and distribution solely in the EU, at prices to be agreed between the parties from time to time; and (iv) EU Partner shall be responsible for the day-to-day management of the JV, at its own costs, and for this purpose shall make available to the JV its knowledge, business connection and personnel, all in order to maximize the sales of OWC’s Products in the EU through the JV. The JV had not commenced operations and did not have any assets or liabilities as of December 31, 2017.
     
  5. On August 6, 2015, OWC signed a Memorandum of Understanding with Emilia Cosmetics Ltd. (“Emilia”), a large Israeli private label manufacturer which operates in the field of development, production, manufacturing and packaging of health and beauty products including for treatment of human skin disease, for the development, manufacture and marketing of a cannabinoid-based topical cream to treat psoriasis.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 6 - COMMITMENTS AND CONTINGENCIES

 

  A. Commitments

 

  5 . (cont.)

 

On November 27, 2016, the Company and OWC (the “Group”) entered into a license agreement with Emilia (the “License Agreement”). During the fourth quarter of 2016, the Group completed the development process and then initiated a phase I study at Chaim Sheba Medical Center (“Sheba”) to explore the safety of the topical cream on psoriasis. Prior to entering into the License Agreement, the Group and Emilia conducted a development and evaluation program (as defined in the License Agreement) for the development of a specific product comprising Emilia’s formulation with certain medical cannabis extract provided by the Group for topical treatment of psoriasis.

 

Pursuant to the License Agreement, Emilia granted a limited license to the Group with respect to Emilia’s licensed intellectual property to be developed and commercialized worldwide in the topical treatment of psoriasis in humans with OWC’s Product, as defined in the License Agreement. If such trial proves successful, Emilia will grant the Group an exclusive, worldwide, transferable, royalty-bearing license, with the right to grant sublicenses, to use, sell and commercially exploit the Emilia intellectual property, in consideration for which, from and after the first commercial sales of the licensed product, the Group shall pay to Emilia a royalty at the rate of ten percent of net sales during the period beginning upon the first commercial sale and ending ten years thereafter. In the event the sale of the licensed product during the royalty term reaches the minimum sales targets set forth in the License Agreement, the royalty term will be extended for an additional five-year term.

 

  6 .

On December 29, 2016, OWC entered into a Research Agreement with Medical Research Infrastructure Development and Health Services Fund (“fund”) by Chaim Sheba Medical Center. Pursuant to the Research Agreement, the Fund shall perform a Phase I, double blind, randomized, placebo-controlled, maximal dose study (the “Study”) to determine the safety and tolerability of topical cream containing MGC (“Medical Grade Cannabis” or the “Study Drug”) in healthy volunteers, employing the services of Professor. Aviv Barzilay, Director of the Department of Dermatology- Chaim Sheba Medical Center, Tel Hashomer, Israel, to lead the Study (the “Investigator”). The Study shall be conducted in compliance with the following, as defined in the Research Agreement: (1) the Protocol; (2) the Ministry Guidelines; (3) the instructions and terms specified in the Helsinki Committee’s approval; (4) the ICH-GCP; (5) the Helsinki Declarations; (6) the applicable laws, rules and regulations regulating such studies which are applicable in Israel (the “Applicable Laws”); and (7) written instructions and prescriptions issued by OWC and governing the administration of the Study Drug. Pursuant to the collaboration agreements and the related amendments, OWC is obliged to pay Sheba $170,000 throughout 2017 and 2018 for conducting the safety study for the cream. As of December 31, 2017, OWC has paid Sheba $13,903 as per Sheba’s payment requests and in January 2018 an additional sum of $29,163 was paid to Sheba. The Company has recorded $49,035 and $0 as Research and Development expenses related to the Study in 2017 and 2016, respectively.

     
  7 . On October 22, 2014, OWC entered into a collaboration agreement with Sheba Academic Medical Center, a hospital in Tel-Aviv, Israel, relating to the use of cannabis to treat Myeloma. Within the framework of this collaboration agreement, OWC conducted pre-clinical studies on multiple myeloma, which commenced in April 2015.

 

Pursuant to the collaboration agreements, OWC was required to pay Sheba $170,000 for conducting the multiple myeloma trial between the 3rd quarter of 2015 and the second quarter of 2016. As of December 31, 2017, the Company has paid Sheba $65,669 as per Sheba’s payment requests. In 2017 and 2016 the Company has not recorded any Research and Development expenses related to this agreement.

 

At present, OWC uses its available working capital to fund these studies. However, the Company expect that it will need to raise additional funding prior to or when its clinical studies are commenced.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 6 - COMMITMENTS AND CONTINGENCIES

 

  B. Contingencies

 

  1. In February 28, 2017, the Company has filed an action for alleged legal malpractice against the NYC law firm of Sichenzia Ross FerenceKesner LLP and Marc J. Ross, Esq. a partner at Sichenzia Ross in New York State Supreme Court in New York County. The Company’s claims arise out of legal services allegedly negligently performed by Ross and Sichenzia Ross. The Company brought the action seeking recovery of monetary damages noted above due to the defendants’ alleged failure to exercise a professional standard of care in their representation of OWCP.
     
    The action is currently pending in the Supreme Court of the State of New York, County of New York and is in the discovery phase.
     
  2.

The Company has also sued certain individuals in the Supreme Court of the State of New York regarding defaulted loan obligations related to 2,354,480 shares granted to them. The matter has been settled as against certain individuals, while the Company is still pursuing its claims against one individual for an outstanding sum of approximately $15,000. The Company is currently monitoring the payment of the settlement funds amounting to $120,500 which are included in Common Stock Subscriptions Receivable.

     
  3.

On November 22, 2017, Mr. Ziv Turner, the Company’s subsidiary’s former General Manager (the “Plaintiff”) filed a claim (the “Claim”) with the Tel Aviv Regional Court of Labor against the Company, its subsidiary and the Company’s CEO. The Plaintiff’s alleged right to receive Company’s 4,125,000 shares of the Company’s Common Stock in connection with options granted to him in 2016 and a cash compensation of approximately $180,000 for breach of rights and damages. On January 23, 2018, the Company filed a statement of defense rejecting all of the Plaintiffs claims. At this stage the Company is unable to assess the Claim’s probability.

     
  4. In November 2017, the Company signed a two-year rental agreement with a landlord for its principle office located in Ramat Gan, Israel. The rental agreement includes an option for one additional year. The monthly rental fees are approximately $4,200 and the remaining minimum payments total approximately $96,600 as of December 31, 2017. During the option period the monthly rental fees shall increase by approximately 7%. During the year ended December 31, 2017, the Company recorded $19,118 as rental expenses.

 

NOTE 7 - STOCKHOLDERS’ EQUITY

 

  A. Common Stock

 

Holders of shares of our common stock are entitled to one vote for each share held of record on all matters submitted to a vote of stockholders. The holders of common stock do not have cumulative voting rights in the election of directors. Holders of shares of our common stock are entitled to receive dividends when and if declared by our Board out of funds legally available therefor, subject to any statutory or contractual restrictions on the payment of dividends and to any restrictions on the payment of dividends imposed by the terms of any outstanding preferred stock. Upon our dissolution or liquidation or the sale of all or substantially all of our assets, after payment in full of all amounts required to be paid to creditors and to the holders of preferred stock having liquidation preferences, if any, the holders of shares of our common stock will be entitled to receive pro rata our remaining assets available for distribution. Holders of shares of our common stock do not have preemptive, subscription, redemption or conversion rights and there are no redemption or sinking fund provisions applicable to tour common stock.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 7 - STOCKHOLDERS’ EQUITY (cont.)

 

  B. Common Stock and Stock Warrants Issued for Cash

 

  1. During the year ended December 31, 2016, the Company received $325,000 through a placement of 2,500,000 common stock units. Those units were sold at $0.13 per unit. Each unit consisted of two shares of common stock and warrants to purchase common stock. 953,846 class “G” warrants exercisable at $0.25 expire on December 2, 2018 and 953,846 class “H” warrants exercisable at $0.40 expire on December 2, 2019. Such warrants were classified within stockholders’ equity.
     
  2. During the year ended December 31, 2017, the Company received $117,640 through a placement of 904,924 common stock units to four investors for the offering price of $0.13 per unit. Each unit consisted of one share of common stock and two (one “G” and one “H”) warrants to purchase one share of common stock. The 904,924 “G” warrants are exercisable at $0.25 and expire two years from the issuance date. The 904,924 “H” warrants are exercisable at $0.40 and expire 3 years from the issuance date. Such warrants were classified within stockholders’ equity.
     
  3. During the year ended December 31, 2017, the Company received $100,000 through a placement of 588,237 common stock units to three investors for the offering price of $0.17 per unit. Each unit consisted of one share of common stock and one “H” warrant to purchase one share of common stock. The 588,237 “H” warrants are exercisable at $0.40 and expire 3 years from the issuance date. Such warrants were classified within stockholders’ equity.
     
  4. During the year ended December 31, 2017, the Company received $130,000 through a placement of 520,000 common stock units to five investors for the offering price of $0.25 per unit. Each unit consisted of one share of common stock and one “I” warrant to purchase one share of common stock. The 520,000 “I” warrants are exercisable at $0.50 and expire 2 years from the issuance date. Such warrants were classified within stockholders’ equity.
     
  5. During the year ended December 31, 2017, the Company received $883,625 through a placement of 1,767,250 common stock units to twenty investors for the offering price of $0.50 per unit. Each unit consisted of one share of common stock and one “K” warrant to purchase one share of common stock. The 1,767,250 “K” warrants are exercisable at $1.00 and expire 18 months from the issuance date. Such warrants were classified within stockholders’ equity.
     
  6. During the year ended December 31, 2017, the Company received $436,260 through a placement of 623,227 common stock units to eleven investors for the offering price of $0.70 per unit. Each unit consisted of one share of common stock and one “L” warrant to purchase one share of common stock. The 623,227 “L” warrants are exercisable at $1.40 and expire 18 months from the issuance date. Such warrants were classified within stockholders’ equity.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 7 - STOCKHOLDERS’ EQUITY (cont.)

 

  C. Stock-Based Compensation

 

  1. Grants to non-employees

 

  A. On November 22, 2016, the Company entered into a Corporate Management Services Agreement with Sorelenco Limited (“Sorelenco”). In consideration for business and European market development services, the Company agreed to issue to the Sorelenco: (i) 1,442,308 restricted shares of the common stock, par value $0.0001 (the “Shares”); (ii) Class M Warrants exercisable for a period of 12 months to purchase 1,250,000 Shares at an exercise price $0.08; (iii) Class G Warrants exercisable for a period of 24 months to purchase 448,462 Shares at an exercise price $0.25; and (iv) Class H Warrants exercisable for a period of 36 months to purchase 448,462 Shares at an exercise price $0.40. The aggregate fair value of the restricted shares and warrants was $432,200. This transaction represents an initiation of business relations between the parties. As the equity instruments issued are fully vested and non-forfeitable, the fair value of the grant was recognized as an increase to stockholders’ equity at the measurement date with an offsetting amount as a deduction from stockholders’ equity within the caption “Services receivable” (see also Note 2I). Such amount will be recognized as consulting expense over the term of the agreement. During the years ended December 31, 2017 and 2016, the Company recognized $144,067 and $22,893, respectively, as consulting expenses. As of December 31, 2017, the related services receivable amounted to $265,240.
     
    The exercise period of the Class M Warrants has been extended by two weeks in which Sorelenco exercised such warrants into 1,250,000 shares of common stock. Such extension has been accounted as a modification under ASC 718 pursuant to which the incremental fair value of $402,588 was recognized immediately as business development service expenses in the statements of comprehensive loss for the year ended December 31, 2017.
     
  B. On November 28, 2016, the Company entered into a Consulting Agreement with Bear Creek Capital. In consideration for the services, the Company issued to Bear Creek 100,000 restricted shares of Common Stock. The aggregate fair value of the restricted shares was $10,000. This transaction represents initiation of business relations between the parties. As the equity instruments issued are fully vested and non-forfeitable, the fair value of the grant was recognized as an increase to stockholders’ equity at the measurement date with an offsetting amount as a deduction from stockholders’ equity within the caption “Services receivable” (see also Note 2I). Such amount will be recognized as consulting expense over the term of the agreement. During the years ended December 31, 2017 and 2016, the Company recognized $6,413 and $3,587, respectively, as investor and public relations service expenses. As of December 31, 2017, there is no services receivable.
     
  C. On December 16, 2016, the Company entered into a Consulting Agreement with Jeff Smurlick, pursuant to which the Consultant shall provide the Company with services in the areas of investor relations and business development. In consideration for the services, the Company issued to the Consultant 200,000 Class G Warrants and 200,000 Class H Warrants identical to the Class G and Class H Warrants described above with a cashless exercise feature. The aggregate fair value of the warrants was $41,259. This transaction represents initiation of business relations between the parties. As the equity instruments issued are fully vested and non-forfeitable, the fair value of the grant was recognized as an increase to stockholders’ equity at the measurement date with an offsetting amount as a deduction from stockholders’ equity within the caption “Services receivable” (see also Note 2I). Such amount will be recognized as investor and public relations services expense over the term of the agreement. During the years ended December 31, 2017 and 2016, the Company recognized $39,563 and $1,696, respectively, as consulting expenses. As of December 31, 2017, there is no services receivable
     
    During the year ended December 31, 2017, the aforesaid warrants were exercised on a cashless basis (see also Note 7D3).

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 7 - STOCKHOLDERS’ EQUITY (cont.)

 

  C. Stock-Based Compensation (cont.)

 

  1. Grants to non-employees (cont.)

 

  D. In January 2017, the Company issued 300,000 fully vested shares of common stock and 400,000 warrants to Lyons Capital LLC. 200,000 “G” warrants with exercise price of $0.25 and 200,000 “H” warrants with exercise price of $0.40 and a cashless feature for the purchase of one share each of common stock to a consultant as payment for services. As the equity instruments issued are fully vested and non-forfeitable, the fair value of the grant was recognized as an increase to stockholders’ equity at the measurement date with an offsetting amount as a deduction from stockholders’ equity within the caption “Services receivable” (see also Note 2I). The shares were measured at the closing price as of the date of the agreement and the related expenses will be recognized as consulting expense over the terms of the agreement. During the year ended December 31, 2017, an amount of $185,030 was recognized as conferences and business development expenses resulting from the issuance of the shares. As of December 31, 2017, the related services receivable amounted to $15,970.
     
    The warrants were measured by using the Black-Scholes-Merton pricing model to estimate total fair value amounting to $153,963. The Black-Sholes-Merton pricing model assumptions that were used are as follows: expected dividend yield of 0%; risk-free interest rate of 0.10%-0.11%; expected volatility of 282%, and warrant exercise period based upon the stated terms (see also Note 7C1). The total amount will be recognized as consulting expense over the terms of the agreement. During the year ended December 31, 2017 amount of $148,901 was recognized as consulting expenses resulting from the issuance of these warrants. As of December 31, 2017, the related services receivable amounted to $5,062.
     
    During the year ended December 31, 2017, the aforesaid warrants were exercised on a cashless exercise (see also Note 7D2).
     
  E. Under the Bear Creek Corporate Advisory Consulting agreement executed in November of 2016, the Company became obligated to issue 100,000 additional shares to Bear Creek as of February 28, 2017. The shares were measured at $262,000 according to the closing price of the underlying shares at February 28, 2017. The shares were issued in April 2017.
     
  F. On January 21, 2016, the Company entered into a two-year Consulting Agreement with Global Corporation Strategies (“GCS”). In consideration for investor and public relations services to be provided by GCS, the Company issued to GCS 5,134,375 restricted shares of Common Stock. The aggregate fair value of the restricted shares was $259,070. This transaction represents initiation of business relations between the parties. As the equity instruments issued are fully vested and non-forfeitable, the fair value of the grant was recognized as an increase to stockholders’ equity at the measurement date with an offsetting amount as a deduction from stockholders’ equity within the caption “Services receivable” (see also Note 2I). Such amount will be recognized as investor and public relations services expense over the term of the agreement. During the years ended December 31, 2017 and 2016, the Company recognized $129,358 and $122,270, respectively, as consulting expenses. As of December 31, 2017, the related services receivable amounted to $7,442.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 7 - STOCKHOLDERS’ EQUITY (cont.)

 

  C. Stock-Based Compensation (cont.)

 

  1. Grants to non-employees (cont.)

 

  G. In 2017, the Company issued 350,000 “E” warrants that are exercisable at $0.25 and expire two years from the date of issuance to purchase one share each of the Company’s common stock to two former employees parties as payment for services. The aggregate fair value of the warrants was $133,210. As the equity instruments issued are fully vested and non-forfeitable, the fair value of the grant was recognized as an increase to stockholders’ equity at the measurement date with an offsetting amount as a deduction from stockholders’ equity within the caption “Services receivable” (see also Note 2I). This amount will be recognized as consulting expense over the terms of the agreements. During the year ended December 31, 2017, the Company recognized $128,830 as consulting expenses. As of December 31, 2017, the related services receivable amounted to $4,380.
     
    The Company used the Black-Scholes-Merton pricing model to estimate the fair value of these warrants. The Black-Sholes-Merton pricing model assumptions used are as follows: expected dividend yield of 0%; risk-free interest rate of 0.10%-0.11%; expected volatility of 282%, and warrant exercise period based upon the stated terms. Shares issued for services are measured at the closing price as of the agreement date.
     
  H. In 2017, the Company issued 450,000 fully vested shares of common stock to Lyons Capital as payment for services. The fair value of these shares was measured at the closing price as of the date of the agreement and the related expenses will be recognized as consulting expense over the terms of the agreement. The aggregate fair value of the shares was $328,500. As the equity instruments issued are fully vested and non-forfeitable, the fair value of the grant was recognized as an increase to stockholders’ equity at the measurement date with an offsetting amount as a deduction from stockholders’ equity within the caption “Services receivable” (see also Note 2I). During the year ended December 31, 2017, an amount of $212,400 was recognized as business development expenses. As of December 31, 2017, the related services receivable amounted to $116,100.
     
  I. In 2017, the Company issued 416,127 fully vested shares of common stock to Jeff Smurlick as payment for services. As the equity instruments issued are fully vested and non-forfeitable, the fair value of the grant was recognized as an increase to stockholders’ equity at the measurement date with an offsetting amount as a deduction from stockholders’ equity within the caption “Services receivable” (see also Note 2I). The shares were measured at the closing price as of the date of the agreement and the related expenses will be recognized as consulting expense over the terms of the agreement. During the year ended December 31, 2017, an amount of $259,754 was recognized as business development and investor relations consulting expenses. As of December 31, 2017, the related services receivable amounted to $110,599.
     
  J. On December 14, 2016, the Company issued 50,000 fully vested restricted shares of Common Stock to Securities Compliance Services for securities compliance services. The aggregate fair value of the restricted shares amounted to $19,000 and was fully recognized as legal expense in 2016.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 7 - STOCKHOLDERS’ EQUITY (cont.)

 

  C. Stock-Based Compensation (cont.)

 

  2. Grants to employees

 

In 2016, the Company approved the 2016 Employee Incentive Plan (the “2016 Plan”) which provides for the issuance of common stock, stock options and other stock-based awards to employees, officers, directors, consultants, and advisors. The number of shares reserved for issuance under the 2016 Plan is 36,000,000 shares of common stock.

 

  A. In January 2016, the Company granted to certain employees 200,000 stock options which are exercisable into 200,000 shares of common stock at $0.05 per share. The fair value of these stock options was measured at $6,342.
     
  B. In December 2016, the Company granted 34,850,000 stock options which are exercisable into 34,850,000 shares of common stock under the 2016 plan at an exercise price of $0.05 per share. The granted stock options become vested over a 2 year period from its date of grant. The stock options vested 1/3 on the grant date and the remaining 2/3 will vest on a quarterly basis (8.33% per quarter).
     
  C. During the second quarter of 2017, the engagement of OWC’s CEO was terminated and the CFO resigned. These combined actions triggered the forfeiture of 10,456,094 options previously granted under the 2016 Plan. The forfeiture resulted in a reversal of $645,434 of previously recognized compensation expense in 2017 ($407,746 out of which was previously recognized as expense in 2016).
     
    As such award was subject to a clawback feature for certain contingent events, such as termination for cause, the Company accounted for the cancellation of the award in accordance with the provisions of ASC 718-10-55. Thus, the Company recognized the original compensation cost related to that grant (which was determined to be less than the current fair value of such award) as a credit to the consolidated statement of comprehensive loss within the line item “General and administrative”.
     
  D. On August 1, 2017, the Company granted options exercisable into 3,000,000 shares to two officers under the plan at an exercise price of $0.05 per share. 1,500,000 options become vested over a 2 year period from its date of grant. The options shall vest 1/3 on the grant date and the remaining 2/3 on a quarterly basis (8.33% per quarter). The remaining 1,500,000 options become vested over a 3 year period from its date of grant. The options shall vest 1/3 on the first anniversary and the remaining 2/3 on a quarterly basis (8.33% per quarter). The Company used the Black-Scholes-Merton pricing model to estimate the fair value. The Black-Sholes-Merton pricing model assumptions used are as follows: expected dividend yield of 0%; risk-free interest rate of 1.8%-2.07%; expected volatility of 255%, and expected term of 5-6.5 years. The fair value of the options at the grant date was $1,019,139.
     
    During the year ended December 31, 2017, the Company recognized stock-based compensation expense related to all employee awards amounting to $438,118.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 7 - STOCKHOLDERS’ EQUITY (cont.)

 

  C. Stock-Based Compensation (cont.)

 

  2. Grants to employees (cont.)

 

  E. The following table presents a summary of the status of the grants of stock options to employees, officers and directors under the 2016 Plan as of December 31, 2017.

 

    Amount     Weighted
average
exercise
price
    Weighted
average
remaining
contractual
term
(years)
    Aggregate
intrinsic value
 
                         
Options outstanding at December 31, 2015     -       -                  
Granted     35,050,000     $ 0.05                  
Exercised     -     $ 0.00                  
Lapsed     -     $ 0.00                  
Options outstanding at December 31, 2016     35,050,000     $ 0.05       5.0     $ 4,398,700  
Granted     3,000,000     $ 0.05                  
Exercise     (293,906 )   $ 0.05                  
Lapsed     (10,456,094 )   $ 0.05                  
Options outstanding at December 31, 2017     27,300,000     $ 0.05       4.6     $ 11,015,580  
Options exercisable at December 31, 2017     16,766,668     $ 0.05       4.1     $ 6,753,794  

 

The aggregate intrinsic value represents the total intrinsic value (the difference between the deemed fair value of the Company’s Common Stock on the last day of fiscal 2017 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on December 31, 2017. This amount is impacted by the changes in the fair value of the Company’s shares.

 

The exercise of 312,500 vested stock options by the former CFO resulted in a net share settlement of 293,906 shares of common stock and the forfeiture of 456,094 remaining vested and unvested stock options. In accordance with the original terms of the option agreement, the exercise was made on a cashless exercise basis based on the average market value of the common shares for the 10 days period preceding the date of exercise.

 

As of December 31, 2017, all options granted are expected to vest and the weighted-average remaining contractual life of all options is 4.6 years. The weighted-average fair value of all stock options granted during the years ended December 31, 2017 and 2016 was $0.34 and $0.13, respectively.

 

The following table presents the assumptions used to estimate the fair values of the options granted in the period presented:

 

    2017     2016  
             
Risk-free interest rate     1.8 %     1.1 %
Dividend yield     -       -  
Expected volatility     255 %     269 %
Expected term (in years)     5.5 - 6.5       5.0  

 

As of December 31, 2017, there was $872,951 of total unrecognized compensation cost related to non-vested stock options granted under the 2016 Plan. This cost is expected to be recognized over a weighted-average period of 1.06 years.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 7 - STOCKHOLDERS’ EQUITY (cont.)

 

  C. Stock-Based Compensation (cont.)

 

  2. Grants to employees (cont.)

 

The following table summarizes information about stock options outstanding at December 31, 2017:

 

Exercise
price
    Outstanding at
December 31,
2017
    Weighted
average
remaining
contractual
life (months)
    Exercise
price
    Exercisable at
December 31,
2017
    Weighted
average
remaining
contractual
life (months)
 
                                 
$ 0.05       27,100,000       55.0     $ 0.05       16,566,668       49.5  
  $0.10-$0.30       200,000       45.6     $ 0.20       200,000       45.6  
          27,300,000                       16,766,668          

 

  D. Stock Warrants

 

  1. In 2017, the Company received $225,160 in cash from exercise of 1,750,642 stock warrants into 1,750,642 shares of common stock at exercise prices ranging from $0.08 to $0.40.
     
  2. In 2017, the consultant mentioned in Note (C.1.D), exercised 400,000 stock warrants into 334,450 shares of common stock. In accordance with the original terms of the warrant agreement, the exercise was made on a cashless exercise basis through a net share settlement based on the average market value of the common shares for the 10 days period preceding the date of such exercise.
     
  3. In 2017, the consultant mentioned in Note (C.1.C) , exercised 400,000 stock warrants into 262,363 shares of common stock. In accordance with the original terms of the warrant agreement, the exercise was made on a cashless exercise basis through a net share settlement based on the average market value of the common shares for the 10 days period preceding the exercise date.
     
  4. The following table presents a summary of the status of the grants of stock warrants as of December 31, 2017:

 

    Amount     Weighted
average
exercise price
    Weighted
average
remaining
contractual
term
(months)
    Aggregate
intrinsic
value
 
                         
Warrants outstanding at December 31, 2015     15,631,602     $ 0.14                  
Granted     4,534,616     $ 0.26                  
Exercised     -     $ 0.00                  
Lapsed     (15,489,935 )   $ 0.14                  
Warrants outstanding at December 31, 2016     4,676,283     $ 0.26       30.0     $ 127,600  
Granted     6,225,228     $ 0.64                  
Exercised     (2,347,455 )   $ 0.18                  
Lapsed     (203,187 )   $ 0.34                  
Warrants outstanding at December 31, 2017     8,350,869     $ 0.56       14.1     $ 701,630  
Warrants exercisable at December 31, 2017     8,350,869     $ 0.56       14.1     $ 701,630  

 

The aggregate intrinsic value represents the total intrinsic value (the difference between the deemed fair value of the Company’s Common Stock on the last day of fiscal 2017 and the exercise price, multiplied by the number of in-the-money warrants) that would have been received by the warrant holders had all warrant holders exercised their warrants on December 31, 2017. This amount is impacted by the changes in the fair value of the Company’s shares.

 

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OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 7 - STOCKHOLDERS’ EQUITY (cont.)

 

D. Stock Warrants

 

The following table summarizes information about stock warrants outstanding at December 31, 2017:

 

    Warrants Outstanding           Warrants Exercisable  
Range of exercise prices   Amount     weighted
average
exercise
price
    Weighted
average
remaining
life in
months
    Amount     weighted
average
exercise
price
 
                               
$ 0.01-$ 0.75     5,960,393     $ 0.34       16.8       5,960,393     $ 0.34  
$ 0.76-$1 .40     2,390,476     $ 1.10       7.3       2,390,476     $ 1.10  
Total Warrants     8,350,869                       8,350,869          

 

  E. Unsecured Notes Payable with Conversion Rights

 

On February 2, 2016, a convertible loan amounting to $78,500 was issued, bears interest at a rate of 8% per annum until paid or converted and had an original maturity date of November 2, 2016. Any or all of the outstanding balance of the note may be converted at the option of the holder at any time into common stock of the Company at a variable conversion price of 65% of market price. Upon the issuance of the convertible note, the Company bifurcated the embedded conversion feature and recorded an initial derivative liability of $41,974 (the estimated fair value at the date of grant based on the Binomial option pricing model) all of which was allocated as debt discount.

 

In 2015, the Company agreed to provide unsecured promissory note with an unrelated party for $37,500. The note was non-interest bearing and was due on September 16, 2016. The note had not been paid and was in default at September 30, 2016. The note had a future conversion right that allowed the holder to convert the principal balance into the Company’s common stock at the lender’s sole discretion at 50% of the then market price per share. In accordance with ASC 470, the Company has analyzed the beneficial nature of the conversion terms and determined that a Beneficial Conversion Feature (“BCF”) existed because the effective conversion price was less than the quoted market price at the time of the issuance. The Company calculated the value of the BCF by using the intrinsic method as stipulated in ASC 470. The BCF of $37,500 had been recorded as a discount to the notes payable and to Additional Paid-in Capital in fiscal 2015 upon initial recognition of such note.

 

For the year ended December 31, 2016, the Company amortized $83,650 of the discount arising from the embedded derivative and BCF of the above described notes. The amortization has been reported as a component of Financing Expenses in the 2016 Consolidated Statement of Comprehensive Loss. As a result of the conversion described below, both notes were derecognized prior to December 31, 2016

 

During August and September 2016, in accordance with the original terms of the note, at the option of the note holders, the entire combined principal balance of $116,000 and accrued interest of $3,140 were converted into 53,844,599 shares of common stock. At the conversion date, the entire derivative liability associated with the bifurcated conversion feature was marked-to-market, resulting in an increase to the total derivative liability of $55,998 which was reclassified into additional paid-in capital on the conversion date. The change in derivative fair value was recorded as a derivative valuation charge within financing expenses in the 2016 consolidated statement of comprehensive loss (see also F below).

 

However, as the $37,500 note was in default, the Company was required to amend the conversion price to 25% of the market price, in accordance with the original terms of such note.

 

- 70 -

 

 

OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 7 - STOCKHOLDERS’ EQUITY (cont.)

 

  F. Embedded Conversion Feature

 

To properly account for the $78,500 convertible note issued in February 2016, as discussed in Note 7E, the Company performed a detailed analysis to obtain a thorough understanding of the transaction. The Company reviewed ASC 815, to identify whether any equity-linked features in the notes are freestanding or embedded. The note was then analyzed in accordance with ASC 815 to determine if the anti-dilution feature should be bifurcated and accounted for at fair value and re-measured at fair value in income. The Company determined that the anti-dilution feature met the requirements for bifurcation, pursuant to ASC 815, due to the variable conversion price and therefore accounted for the anti-dilution features of the notes as a derivative liability. Changes in fair value of the derivative financial instruments were recognized in the Company’s statement of comprehensive loss as a derivative valuation gain or loss within financing expenses in the 2016 consolidated statement of comprehensive loss.

 

The adjustment to market of $55,998 resulted a charge of $14,024 during the year ended December 31, 2016.

 

The Company measured the conversion option derivatives using the lattice model. Assumptions used include:

 

  life through the note maturity date
  expected volatility-152%,
  expected dividends-none
  exercise prices as set forth in the agreements,
  common stock price of the underlying share on the valuation date, and
  number of shares to be issued if the instrument is converted

 

NOTE 8 GENERAL AND ADMINISTRATIVE EXPENSES

 

    US dollars  
    Year ended
December 31,
 
    2017     2016  
Salaries and related expenses(*)     1,568,209       91,962  
Professional fees (*)     2,205,335       1,725,065  
Travel and expenses     57,748       25,685  
Depreciation     8,341       9,686  
Insurance     34,197       20,600  
Other     238,689       133,218  
      4,112,519       2,006,216  
(*) Including stock-based compensation expenses and amortization of services receivable     3,304,056       1,468,859  

 

 

NOTE 9 FINANCING EXPENSES, NET

 

    US dollars  
    Year ended
December 31,
 
    2017     2016  
Adjustments of convertible loans     -       180,340  
Exchange differences on principal of non-current loan     -       16,972  
Others, net     4,725       (8,057 )
      4,725       189,255  

 

- 71 -

 

 

OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 10 - INCOME TAXES

 

The Company and OWC are subject to taxation in the United States and Israel, respectively. In general, the U.S. federal and state income tax returns remain open to examination by taxing authorities for tax years beginning in June 30, 2014 to present. The Israeli income tax returns remain open to examination beginning in 2013 to present. However, if and when the Company claims Net Operating Loss (“NOL”) carryforwards from any prior years against future taxable income, those losses may be examined by the taxing authorities.

 

  1. Tax rates applicable to the Company:

 

On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act of 2017 (the “Tax Act”), which makes broad and complex changes to the U.S. tax code that affected the year ended December 31, 2017, including, but not limited to (1) reducing the U.S. federal corporate tax rate from 34% to 21%, (2) changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017, (3) bonus depreciation that will allow for full expensing of qualified property, (4) generally eliminating U.S. federal income taxes on dividends from foreign subsidiaries, and (5) a one-time transition tax on the mandatory deemed repatriation of cumulative foreign earnings accumulated post 1986 through 2017 that were previously deferred from U.S. income taxes.

 

After the enactment of the Tax Act, the SEC issued Staff Accounting Bulletin No. 118 (“SAB 118”) to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Act. The Company has calculated an estimate of the impact of the Tax Act in our year-end income tax provision in accordance with our understanding of the Tax Act and guidance available as of the date of this filing. The provisional amount related to the re-measurement of our net U.S. deferred tax asset, based on the rate at which we now expect to reverse in the future, was deferred tax expense of $131,653, but which was fully and equally offset by a corresponding reduction in the Company’s valuation allowance. The effect of the change in federal corporate tax rate from 34% to 21% is subject to change based on resolution of estimates used in determining the amounts of deferred tax assets and liabilities that were re-measured. The Company will reflect any adjustments to the provisional amounts in the period the accounting is completed and expects to complete this analysis within the one-year measurement period provided by SAB 118.

 

  2. Tax rates applicable to the subsidiary OWC:

 

  a. Taxable income of the Subsidiary is subject to the Israeli Corporate tax rate which was 25% in 2016 and 24% in 2017.
     
  b. On January 5, 2016, the Israeli Parliament officially published the Law for the Amendment of the Israeli Tax Ordinance (Amendment 216), that reduces the standard corporate income tax rate from 26.5% to 25%.
     
  c. In December 2016, the Israeli Parliament approved the Economic Efficiency Law (Legislative Amendments for Applying the Economic Policy for the 2017 and 2018 Budget Years), a reduction of the corporate tax rate in 2017 from 25% to 24%, and in 2018 and thereafter from 24% to 23%.

 

The change in the tax rate has no impact on the consolidated financial statements.

 

- 72 -

 

 

OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 10 - INCOME TAXES (cont.)

 

  3. Net operating losses carry forward:

 

As of December 31, 2017, the Company has U.S. federal and state NOL carryforwards for United States tax purposes of approximately $1,012,712 which expire in years 2036-2039, if not utilized. These NOL carryforwards could expire unused and be unavailable to offset future income tax liabilities. Under the newly enacted Tax Act, federal net operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal net operating losses is limited. It is uncertain if and to what extent various states will conform to the newly enacted federal tax law.

 

Utilization of the U.S. net operating losses may be subject to substantial annual limitation due to the “change in ownership” provisions provided by the Internal Revenue Code of 1986 (I.R.C. Section 382(a)) and the continuity of business limitation of I.R.C. Section 382(c). The annual limitation may result in the expiration of net operating losses before utilization.

 

As of December 31, 2017, OWC has accumulated losses for tax purposes in the amount of approximately $2,556,097, which may be carried forward and offset against taxable income in the future for an indefinite period.

 

  4. As of December 31, 2017, the Company is not under examination by any jurisdiction for any tax year. The Company’s United States and Israeli income tax returns are open for fiscal years ending on or after December 31, 2014. OWC’s 2013 tax assessment are considered to be final.
     
  5. The components of pretax loss are as follows:

 

    In US Dollars  
    December 31  
    2017     2016  
United States     (3,628,530 )     (1,888,489 )
Israel     (929,917 )     (398,840 )
      (4,558,447 )     (2,287,329 )

 

  6. Deferred income taxes:

 

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows:

 

    In US Dollars  
    December 31  
    2017     2016  
Deferred tax assets:                
Net operating loss carryforward     826,100       610,100  
Research and development credits     367,200       53,700  
Net deferred tax asset before valuation allowance     1,193,300       663,800  
Valuation allowance     (1,193,300 )     (663,800 )
Net deferred tax assets     -       -  

 

In assessing the realization of deferred tax assets, management considers whether it is more likely than not that all or some portion of the deferred tax assets will not be realized. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income during the periods in which temporary differences are deductible and net operating losses are utilized. Based on consideration of these factors, the Company recorded a full valuation allowance at December 31, 2017 and 2016.

 

  7. The main reconciling item between the statutory tax rate of the Company and the effective tax rate is the recognition of valuation allowances in respect to deferred taxes relating to accumulated net operating losses carried forward and temporary differences due to the uncertainty of the realization of such deferred taxes.

 

- 73 -

 

 

OWC PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONT.)

 

NOTE 11 - RELATED PARTY TRANSACTIONS

 

  1. In 2017, Chief Executive Officer of OWCP and OWC received an annual cash compensation of approximately $63,000 and in 2016 received 10,000,000 stock options through the 2016 ESOP which are vested over a period of 2 years with an exercise price of $0.05 and were measured at the grant date in total value of $1,088,081.
     
  2. In 2017, Chairman of OWCP and OWC received an annual cash compensation of approximately $42,000 and 1,500,000 stock options through the 2016 ESOP which are vested over a period of 2 years with an exercise price of $0.05 and were measured at the grant date in total value of $509,475.
     
  3. In 2017, Chief Financial Officer of OWCP and OWC received an annual cash compensation of approximately $49,500 and 1,500,000 stock options through the 2016 ESOP which are vested over a period of 3 years with an exercise price of $0.05 and were measured at the grant date in total value of $509,664.
     
  4. In 2017, Chief Science Officer and Director of Research and Regulatory Affairs received an annual cash compensation of approximately $63,000 and in 2016 received 7,000,000 stock options through the 2016 ESOP which are vested over a period of 2 years with an exercise price of $0.05 and were measured at the grant date in total value of $761,657.
     
  5. In 2017, Chief Operating Officer of OWC received an annual cash compensation of approximately $63,000 and in 2016 received 7,000,000 stock options through the 2016 ESOP which are vested over a period of 2 years with an exercise price of $0.05 and were measured at the grant date in total value of $761,657.

 

The Chief Executive Officer, Chief Science Officer and Director of Research and Regulatory Affairs and the Chief Operating Officer are serving in the Company since 2014 and they are entitled to receive 60 days early notification of ending working relation and employee rights according to Israeli law, including severance pay (see also Note 2n). The Chairman and the Chief Financial Officer are serving in the Company since July 2017. The Chief Financial Officer is entitled to 90 days early notification of ending working relation and employee rights according to Israeli law, including severance pay.

 

NOTE 12 - SUBSEQUENT EVENTS

 

  1. On December 12, 2017, the Company entered into a new agreement with Lyons Capital LLC. In consideration for services in February 2018 relating to the 2018 Wall Street Conference at the Deerfield Beach Florida Hilton and sponsorship in the conference the Company issued 150,000 fully vested restricted shares of Common Stock. The fair value of the grant of approximately $72,000 will be recognized as an increase to the stockholders’ equity within the caption “Additional paid-in capital” and parallel offsetting amount as a deduction from stockholders’ equity within the caption “Services receivable”, which will be amortized to expense over the related service period.
     
  2. In January 2018, the Company received a payment of $105,282 for common stock subscriptions receivable.
     
  3. On February 12, 2018, the Company granted 150,000 stock options which are exercisable into 150,000 shares of common stock to Ms. Hannah Feuer, the Company’s Chairman of the Audit Committee. The options shall become vested over a 3-year period from its date of grant at an exercise price of $0.05.

 

- 74 -

 

 

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

 

Effective December 23, 2016, we determined not to re-engage our independent auditor, M&K CPAS, PLLC for our audit for the year ending December 31, 2016. The decision to change accountants was recommended and approved by our board of directors.

 

Effective December 23, 2016, we engaged Fahn Kanne & Co. Grant Thornton Israel, with offices located at 32 Hamasger Street, Tel-Aviv 6721118, Israel as our independent registered public accounting firm for the fiscal year ending December 31, 2016, effective immediately.

 

Reference is made to our Form 8-K Item 4.01 Changes in Registrant’s Certifying Accountant as filed with the SEC on December 28, 2016.

 

ITEM 9A. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures.

 

As of December 31, 2017, the Company’s chief executive officer and chief financial officer conducted an evaluation regarding the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act. Based upon the evaluation of these controls and procedures, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were ineffective as of the end of the fiscal year 2017 under the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013).

 

Management’s Annual Report on Internal Control over Financial Reporting

 

The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rule 13a-15. Internal control over financial reporting is defined in Rule 13a-15(f) and 15(d)-15(f) under the Exchange Act as a process designed to provide reasonable assurance to the Company’s management and Board of Directors regarding the preparation and fair presentation of published financial statements. Management conducted an assessment of the Company’s internal control over financial reporting as of December 31, 2017 based on the framework and criteria established by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013). Management is not permitted to conclude that the Company’s internal control over financial reporting is effective if there are one or more material weaknesses in the Company’s internal control over financing reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal controls over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim consolidated financial statements would not be prevented or detected on a timely basis. Based on our assessment and those criteria, we have concluded that our internal controls over financial reporting were ineffective because of the identification of material weaknesses including lack of sufficient internal accounting personnel in order to ensure complete documentation of complex and non-routine transactions and adequate financial reporting during the year ended December 31, 2017. Management has identified corrective actions for the weaknesses and intends to implement procedures to address before mentioned material weaknesses during the fiscal year 2018.

 

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, 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.

 

This annual report does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the Company to provide only Management’s report in this annual report.

 

- 75 -

 

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting or in other factors identified in connection with the evaluation required by paragraph (d) of Exchange Act Rules 13a-15 or 15d-15 that occurred during the fourth fiscal quarter ended December 31, 2017 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

ITEM 9B. OTHER INFORMATION

 

None.

 

PART III

 

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

 

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Management and Corporate Governance Matters,” “Section 16(a) Beneficial Ownership Reporting Compliance,” and “Code of Conduct and Ethics” in the Company’s Proxy Statement for the 2018 Annual Meeting of Stockholders.

 

ITEM 11. EXECUTIVE COMPENSATION

 

The response to this item is incorporated by reference from the discussion responsive thereto under the caption “Executive Officer and Director Compensation” in the Company’s Proxy Statement for the 2018 Annual Meeting of Stockholders.

 

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

 

The response to this item is incorporated by reference from the discussion responsive thereto under the caption “Security Ownership of Certain Beneficial Owners and Management” in the Company’s Proxy Statement for the 2018 Annual Meeting of Stockholders.

 

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTORS INDEPENDENCE

 

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Certain Relationships and Related Person Transactions” and “Management and Corporate Governance” in the Company’s Proxy Statement for the 2018 Annual Meeting of Stockholders.

 

ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES

 

The response to this item is incorporated by reference from the discussion responsive thereto under the caption “Independent Registered Public Accounting Firm” in the Company’s Proxy Statement for the 2018 Annual Meeting of Stockholders.

 

PART IV

 

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

 

Item 15(a) The following documents are filed as part of this Annual Report on Form 10-K:

 

Item 15(a)(1) and (2) See “Consolidated Financial Statements and Supplementary Data” at Item 8 to this Annual Report on Form 10-K. Other financial statement schedules have not been included because they are not applicable, or the information is included in the financial statements or notes thereto.

 

- 76 -

 

 

Item 15(a)(3) The following exhibits are filed as part of, or incorporated by reference into, this Annual Report on Form 10-K.

 

Exhibit   Description
3.1*   Articles of Incorporation, as amended.
3.2   Bylaws (incorporated by reference to Exhibit 3.2 to the Company’s Form 10 filed on November 21, 2012).
10.1   Patent Transfer and Sale Agreement with Appelfeld Zer Fisher (incorporated by reference to Exhibit 10.1 to the Company’s Form 10-12G/A on April 10, 2014).
10.2.1   Convertible Note, as amended, between the Company and Sheer Trust (incorporated by reference to Exhibit10.2(a) to the Company’s Form 10-12G filed on February 28, 2013).
10.2.2   Convertible Note, as amended, between the Company and Mediouni, (incorporated by reference to Exhibit 10.2(b)(a)1 to the Company’s Form 10 filed on May 13, 2013).
10.2.3   Convertible Note, as amended, between the Company and Shonfeld (incorporated by reference to Exhibit 10.2(c)(a) to the Company’s Form 10 filed on May 13, 2013).
10.2.4   Convertible Note, as amended, between the Company and Silverman (incorporated by reference to Exhibit 10.2(d)(a)1 to the Company’s Form 10 filed on May 13, 2013).
10.2.5   Convertible Note, as amended, between the Company and Oofliam LLC (incorporated by reference to Exhibit 10.2(e)(a) to the Company’s Form 10 filed on May 13, 2013)
10.2.6   Convertible Note, as amended, between the Company and Mediouni (incorporated by reference to Exhibit 10.2(f)(a)2 to the Company’s Form 10 filed on May 13, 2013)
10.2.7   Convertible Note, as amended, between the Company and Silverman (incorporated by reference to Exhibit 10.2(g)(a)2 to the Company’s Form 10 filed on May 13, 2013)
10.3   Agreement between the Company and Nickelshpur and CV (incorporated by reference to Exhibit 10.3 to the Company’s Form 10-12G filed on February 28, 2013).
10.4   Agreement between the Company and Sensoil Ltd, dated April 17, 2013 (incorporated by reference to Exhibit 10.4 to the Company’s Form 10-12G/A filed on April 10, 2014).
10.5   Services Agreement between the Company and Mr. Bignitz, dated October 2, 2014 (incorporated by reference to Exhibit 10.5 to the Company’s Form S-1 filed on April 23, 2015).
10.6   Services Agreement between the Company and Mr. De-Saban, dated October 2, 2014 (incorporated by reference to Exhibit 10.6 to the Company’s Form S-1 as filed on April 23, 2015).
10.7   Service Agreement between the Company and Sheba Academic Medical Center, dated October 22, 2014 (incorporated by reference to Exhibit 10.7 to the Company’s S-1/A filed on June 9, 2015).
10.8   Service Agreement between the Company and Sheba Academic Medical Center, dated October 22, 2014, (incorporated by reference to Exhibit 10.8 to the Company’s S-1/A filed on August 13, 2015).
10.9   Loan Agreement between the Company and Medmar LLC, dated September 28, 2016 (incorporated by reference to Exhibit 10.9 to the Company’s Form 8-K filed on September 30, 2016).
10.10   Termination Agreement and Mutual General Release between the Company and GUMI Tel Aviv Ltd dated February 3, 2016 (incorporated by reference to Exhibit 10.12 to the Company’s S-1 filed on June 16, 2016).
10.11   Services Agreement between the Company and Shmuel De-Saban dated January 31, 2016, (incorporated by reference to Exhibit 10.14 to the Company’s S-1 filed on June 16, 2016).
10.12   Securities Purchase Agreement between the Company and Vis Vires Group, Inc. dated February 2, 2016, (incorporated by reference to Exhibit 10.15 to the Company’s S-1 filed on June 16, 2016).
10.13   Convertible Promissory Note issuable to Vis Vires Group, Inc. dated February 2, 2016 (incorporated by reference to Exhibit 10.16 to the Company’s S-1 filed on June 16, 2016).
10.14   Unit Subscription Agreement dated November 3, 2016 (incorporated by reference to Exhibit 10.17 to the Company’s Form 8-K filed on November 4, 2016).
10.15   Memorandum of Understanding between the Company and Michepro Holding Ltd. dated November 3, 2016 (incorporated by reference to Exhibit 10.18 to the Company’s Form 8-K filed on November 4, 2016).
10.16   License Agreement between the Company and Emilia Cosmetics Ltd dated November 27, 2016 (incorporated by reference to Exhibit 10.19 to the Company’s Form 8-K filed on November 28, 2016).
10.17   Research Agreement between One World Cannabis Ltd and Medical Research Infrastructure Development and Health Services Fund by Chaim Sheba Medical Center dated December 29, 2016 (incorporated by reference to Exhibit 10.21 to the Company’s Current Report on Form 8-K filed on January 12, 2017).
10.18*+   Executive Employment Agreement by and between the Company and Alon Sinai, dated February 1, 2018
10.19+   Letter of Resignation of Mr. Shmuel De-Saban dated June 12, 2017 (incorporated by reference to Exhibit 17.5 to the Company’s Current Report on Form 8-K filed on June 15, 2017).
10.20*+   Executive Employment Agreement by and between the Company and Yossi Dagan, dated June 4, 2017
10.21*+   Executive Employment Agreement by and between the Company and Dr. Oron Yacoby Zeevi, dated February 18, 2018
10.22*+   Executive Consulting Agreement by and between the Company and Dr. Stanley Hirsch, dated July 24, 2017
10.23*   Audit Committee Charter.
10.24*+   2016 Employees Stock Option Plan
10.25*+   Employee’s Option Grant Form
21.1*   Subsidiaries of the Company.
31.1*   Certification of Principal Executive Officer Pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act of 1934, as amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*   Certification of Principal Financial Officer Pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act of 1934, as amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32**   Certification of Principal Executive Officer and Principal Accounting Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS   XBRL Instance Document.
101.SCH   XBRL Taxonomy Extension Schema Document.
101.CAL   XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF   XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB   XBRL Taxonomy Extension Labels Linkbase Document.
101.PRE   XBRL Taxonomy Extension Presentation Linkbase Document.

 

 

* Filed herewith
** Furnished herewith. This certification is not deemed filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, and is not deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act.
+ Indicates a management contract or compensatory plan or arrangement

 

Item 16. 10-K Summary

 

None

 

- 77 -

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized .

 

  OWC PHARMACEUTICAL RESEARCH CORP.
                              
Date: April 16, 2018 By: /s/ Mordechi Bignitz
    Mordechi Bignitz
    Chief Executive Officer and Director
    (Principal 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 in the capacities indicated below and on the dates indicated.

 

Name   Title   Date
         
/s/ Mordechi Bignitz   Chief Executive Officer and Director   April 16, 2018
Mordechi Bignitz   (Principal Executive Officer)    
         
/s/ Yossi Dagan   Chief Financial Officer   April 16, 2018
Yossi Dagan   (Principal Financial Officer and Principal Accounting Officer)    
         
/s/ Stanley Hirsch   Chairman of the Board    
Stanley Hirsch     April 16, 2018
         

 

- 78 -

 

 

     
     

 

PERSONAL EMPLOYMENT AGREEMENT

 

THIS PERSONAL EMPLOYMENT AGREEMENT (the “ Agreement ”) is made and entered into as of February 1, 2018 by and between One World Cannabis Ltd. (the “ Company ”), and Alon Sinai (the “ Employee ”).

 

WHEREAS , the Company and the Employee have entered into a consulting agreement, dated July 1, 2014 as amended on November 8, 2015 and on July 30, 2017 (the “ Consulting Agreement ”) pursuant to which the Employee has provided consulting services to the Company; and

 

WHEREAS , the Company and the Employee wish to replace the Consulting Agreement as of the Start Date (as such term is defined hereunder) in its entirety with this Agreement, such that as of the Start Date the Employee shall only serve the Company in the capacity of an employee under this agreement; and

 

WHEREAS , the Company wishes to employ the Employee, and the Employee wishes to be employed by the Company, as of the Start Date; and

 

WHEREAS , the parties desire to state the terms and conditions of the Employee’s employment by the Company, as set forth below.

 

NOW, THEREFORE , in consideration of the mutual premises, covenants and other agreements contained herein, the parties hereby agree as follows:

 

General

 

  1. Position . The Employee will serve in the position described in Exhibit A and shall be under the direction of the person stated in Exhibit A , or such other person as shall be decided by the Company from time to time. The Employee undertakes to perform his duties diligently, conscientiously and in furtherance of the Company’s best interests
     
  2. Scope of Employment . The Employee is employed on a part time basis in a scope of 60% of a full time position. The Employee may engage in other paid or unpaid employment, occupation or other business activities which are not in the field of medical and pharmaceutical formulations derived from and or utilizing cannabis and its CBD and or THC components, either natural or synthetic, and delivery systems specifically developed for the administration of the above. For the avoidance of doubt, this also incorporates formulations or carries developed in the course of the work of the Company, which have medical effect, even if such formulations or carriers do not contain the above-mentioned cannabis components (the “ Field of Business ”), all subject to and without derogating from Employee’s undertakings hereunder, including (without limitation) pursuant to Section 6 and Exhibit B hereunder. Any engagement in the Field of Business shall be subject to the Company’s prior written approval which shall be in its sole discretion.
     
  3. Employee’s Representations and Undertakings . The Employee represents that the execution and delivery of this Agreement and the fulfillment of its terms: (i) will not constitute a default under or conflict with any agreement or other instrument to which the Employee is a party or by which the Employee is bound, including, without limitation, any confidentiality or non-competition agreement; and (ii) will not require the consent of any person or entity. The Employee undertakes to inform the Company immediately after becoming aware of any matter that may in any way raise a conflict of interest between the Employee and the Company. The Employee shall not receive any payment, compensation or benefit from any third party in connection, directly or indirectly, with the Employee’s position in the Company. The Employee further acknowledges and agrees (i) to the transfer of any information concerning the Employee and held by the Company to a database (including a database located abroad) and to third parties in general, as is reasonable for business purposes or in pursuit of the Company’s business interests; (ii) to travel abroad from time to time if and as may be required pursuant to his position; (iii) to adhere to any applicable law or provision, pertaining to his employment; (iv) to protect the good name of the Company and not to perform any act that may bring the Company into disrepute; (v) to use any equipment (such as laptop) and access to systems (such as email system) provided to the Employee by the Company for purposes related to the Employee’s employment.

 

 
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  4. The Employee further acknowledges and agress that all information, content and data on the Company’s computers and telephones, including electronic mail transmissions, Internet usage, messages and data whether sent from, received by, or stored in or upon the Company’s computers or communications systems are the property of the Company, regardless of the form and/or content of these messages and data, and the Company shall have the right to conduct inspections of such property. The Employee should not consider messages and data sent from, received by, or stored in or upon the Company’s computer, telephones and communications systems to be private and should not send, receive, or store sensitive personal or private information using these systems. The Employee is deemed to have consented to any reasonable use, transfer and disclosure of all messages and data contained or sent via the Company’s computer, telephones and communications systems, including electronic mail.
     
  5. Term and Termination . The Employee’s employment with the Company began, or will begin, on the date set forth in Exhibit A (the “ Start Date ”). Either party may terminate this Agreement and the employment relationship hereunder at any time by giving the other party prior written notice of termination of such number of days as set forth in Exhibit A (the “ Notice Period ”). Notwithstanding the aforesaid, the Company is entitled to terminate this Agreement and the employment relationship with immediate effect or at any time during the Notice Period upon a written notice to the Employee and payment to the Employee of a one-time amount equal to the Salary the Employee would have been entitled to receive in respect of the portion of the Notice Period which was forfeited, in lieu of such prior notice period.
     
    Notwithstanding the aforesaid, in the event of a Cause (as defined below), the Company will be entitled to terminate this Agreement immediately and this Agreement and the employment relationship will be deemed effectively terminated as of the time of delivery of such notice (subject to any minimal mandatory notice requirement under applicable law) and the Company shall have no obligation to pay any compensation during or in lieu of the notice period. The term “ Cause ” means: (i) the Employee engages in any act of dishonesty, fraud, misrepresentation, or intentional illegal conduct; (ii) the Employee’s violation of any law or regulation applicable to the Company’s business; (iii) any unauthorized use or disclosure by the Employee of the Company’s confidential information or trade secrets or any other breach of the Proprietary Information, Assignment of Inventions and Non-Competition Agreement attached as Exhibit B hereto; (iv) a material breach by the Employee of any agreement between the Employee and the Company; (v) a failure by the Employee to comply with the Company’s written policies or rules; or (vi) any circumstances which allow for termination without severance payment under applicable law.

 

 
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    During the Notice Period, this Agreement will remain in full force and effect and there will be no change in Employee’s position with the Company or any obligations hereunder, unless otherwise determined by the Company in a written notice to Employee, and the Employee will cooperate with the Company and use the Employee’s best efforts to assist the integration into the Company’s organization of the person or persons who will assume the Employee’s responsibilities. Upon termination of the employment for any reason or cause what-so-ever, Employee shall immediately surrender to the Company all property, equipment, documents and information in his possession or disposal, as such may have been delivered to him during or due to his employment with the Company, and Employee shall have no rights of lien or possession in respect thereof.
     
  6. Proprietary Information; Confidentiality and Non-Competition . The Employee shall, simultaneously herewith, execute and deliver, and hereby agrees to be bound by the provisions of, the Proprietary Information, Assignment of Inventions and Non-Competition Agreement attached in Exhibit B hereto, the terms of which will survive termination of this Agreement.
     
  7. Salary . The Company will pay the Employee a gross monthly salary in the amount set forth in Exhibit A (the “ Salary ”). Except as specifically set forth herein, the Salary includes any and all payments to which Employee is entitled hereunder and under any applicable laws, regulations or agreements. Payment of the Salary will be made no later than the 9 th day of each calendar month after the month for which the Salary is paid, after deduction of applicable taxes and any amounts deductible under this Agreement.
     
  8. Social Benefits . The Company shall, on a monthly basis, pay to a pension scheme for the benefit of the Employee and shall deduct from the Employee’s Salary a respective payment towards such pension scheme (the “ Pension Scheme ”). The contributions to the Pension Scheme will be as follows:

 

  (i) The Company will pay an amount equal to 8 1/3% (eight percent and one third of a percent) of the Salary as a severance pay component;
     
  (ii) In case of a Pension Scheme of a managers insurance type (and not a pension fund), the Company shall pay for a disability insurance in an amount of 2.5% of the Salary or a lower amount as required to insure 75% of the Salary (the “ Disability Insurance Component ”);
     
  (iii) The Company will pay towards a savings component (A) an amount equal to 6.5% of the Salary in case the Pension Scheme is through a pension fund or (B) an amount equal to 6.5% of the Salary less the Disability Insurance Component, but in no event less than 5%, in case of a managers insurance type Pension Scheme; and
     
  (iv) The Company shall deduct from the net Salary an amount equal to 6% of the Salary which amount shall be allocated to a savings component.

 

  All payments to the Pension Scheme will be made in compliance with Section 14 of the Severance Compensation Law, 1963 (“ Section 14 ”), and in accordance with the general approval of the Labor Minister dated June 9, 1998, promulgated under said Section 14, a copy of which is attached hereby as Exhibit C , and the terms of Section 14 and said general approval will apply to the relationship hereunder. Therefore, the ownership of the Pension Scheme will be transferred to the Employee following termination of employment and the Company will not be entitled to retrieve any of the funds it transferred to the Pension Scheme, other than in accordance with Section 14 and said general approval, and the transfer of the Pension Scheme to the ownership of the Employee will be the full and only compensation to be paid by the Company to the Employee in such circumstances in respect of severance pay.

 

 
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  9. Vacation . The Employee will be entitled to that number of vacation days per year set forth in Exhibit A . The Company will be entitled to direct the use of the vacation days, at its discretion. Right to accumulate unused vacation days shall be as decided by the Company from time to time and the Company shall be entitled to change its policy in that respect without any liability to the Employee. It is the Company’s current policy to allow the Employee to accumulate any unused vacation days up to the number of vacation days specified in Exhibit A and once the Employee has reached such accumulation no additional vacation days will be accumulated, but rather be forfeited. The Employee will not be entitled to redemption of accumulated and unused vacation days, except in the event of termination of employment and then only in accordance with applicable law.
     
  10. Recreation Pay . The Employee will be entitled to recreation pay (Dmei Havra’a) in accordance with applicable law.
     
  11. Additional Benefits . The Employee may be entitled to additional benefits if and only to the extent set forth in Exhibit A .
     
  12. Policies and Guidelines . The Employee undertakes to abide by and at all times be in compliance with the policies, guidelines and regulations which are and shall be established by the Company.
     
  13. General . Headings in this Agreement are included for reference purposes only and are not to be used in interpreting this Agreement. The exhibits to this Agreement constitute an integral part thereof. Subject to applicable law, no collective bargaining agreement will apply to the relationship between the parties, whether such agreement was signed among the government, the General Federation of Labor and Employers organizations, or any of such parties, or whether signed by others, in relation to the field or fields of the business of the Company or in relation to the position held by or the profession of the Employee. No failure, delay of forbearance of either party in exercising any power or right hereunder will in any way restrict or diminish such party’s rights and powers under this Agreement, or operate as a waiver of any breach or nonperformance by either party of any terms or conditions hereof. In the event it is determined under any applicable law that a certain provision set forth in this Agreement is invalid or unenforceable, such determination will not affect the remaining provisions of this Agreement unless the business purpose of this Agreement is substantially frustrated thereby.
     
    This Agreement constitutes the entire understanding and agreement between the parties, supersedes any and all prior discussions, agreements and correspondence with regard to the subject matter hereof, including without limitation the termination of the Consulting Agreement (provided that Sections 4-6, together with Exhibit C of the Consulting Agreement shall survive in full force and effect), and may not be amended, modified or supplemented in any respect, except by a subsequent writing executed by both parties. .
     
    The Employee acknowledges and confirms that all terms of Employee’s employment are personal and confidential, and undertakes to keep such terms in confidence and refrain from disclosing such terms to any third party.

 

 
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IN WITNESS WHEREOF the parties have signed this Agreement as of the date first hereinabove set forth.

 

One World Cannabis  
     
  Alon Sinai /s/  
By: Mordechai Bignitz /s/  
Title: CEO  

 

 
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Exhibit A

To the Personal Employment Agreement by and between

One World Cannabis Ltd. and the Employee whose name is set forth herein

 

1. Name of Employee: Alon Sinai
   
2. ID No. of Employee: 022996797
   
3. Address of Employee: 69 Bait Nehemia, Israel
   
4. Position in the Company: COO - Chief Operating Officer
   
5. Under the Direction CEO
   
6. Start Date: February 1, 2018
   
7. Work Week and Hours of Work; Rest Day As shall be coordinated between the Company and the Employee from time to time, based on the scope of engagement.
   
8. Notice Period: 30 days
   
9. Salary:

a) As of February 1, 2018 and until March 31, 2018 - the Employee shall be entitled to a gross monthly salary of NIS 17,500 (the “ Base Salary ”). In addition, in consideration for overtime hours that the Employee may work during the month the Employee shall receive a global payment of NIS 7,500 per month (the “ Global Overtime Compensation ”, and together with the Base Salary, the “ Salary ”).

 

b) As of April 1, 2018 - the Employee shall be entitled to a Base Salary of NIS 3,710. In addition, the Employee shall receive a Global Overtime Compensation of NIS 1,590, such that the total Salary shall be NIS 5,300.

 

The Global Overtime Compensation has been determined based on Company’s estimation of the average of overtime hours per month that the Employee’s position may require.

   
10. Vacation Days Per Year: 12 annual vacation days for a full time position, as shall be adjusted for the actual scope of employment. Employee may accumulate at any time unused vacation days in the aggregate number equal to no more than twice the number of the annual vacation days he is entitled to receive.
   
11. Transportation The employee will be entitled to payment for transportation from and to work, pursuant to applicable law.

 

 
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Exhibit B to Personal Employment Agreement

Proprietary Information, Confidentiality and Non-Competition Agreement

between the Employee and One World Cannabis Ltd.

 

  Employee’s Name Alon Sinai

 

1. Capitalized terms herein will have the meanings given to them in the Personal Employment Agreement to which this Exhibit is attached (the “ Agreement ”). The term Company will include also all subsidiaries and affiliates of the Company, as applicable, including its parent company, OWC Pharmaceutical Research Corp. (the “ Parent Company ”), which are deemed third party beneficiaries of this Agreement. The Employee’s obligations and the Company’s rights under this Exhibit will apply as of the beginning of the engagement between the Company and the Employee, regardless of the Start Date or the date of execution of the Agreement or this Exhibit.

 

Confidentiality; Proprietary Information

 

2. The Employee acknowledges and agrees that Employee may have access to confidential and proprietary information concerning the business and financial activities of the Company, including without limitation information relating to the Company’s research and development activities, investments, properties, employees, marketing plans, customers, suppliers, trade secrets, test results, processes, data, know-how, improvements, inventions, techniques, intellectual property and products (actual or planned). Such information, whether documentary, written, oral or computer generated, will be referred to as “ Proprietary Information ”. However, Proprietary Information will exclude information that Employee can demonstrate (i) was known to Employee prior to Employee’s association with the Company (except if related in any way to the Company, including without limitation to the Company’s current and/or contemplated business, services, products and/or activities); or (ii) is or will become part of the public knowledge except as a result of the breach of the Agreement or this Exhibit by the Employee.
   
3. The Employee recognizes that the Company may receive confidential or proprietary information from third parties, subject to a duty on the Company’s part to maintain the confidentiality of such information and to use it only for certain limited purposes. In connection with such duties, such information will be deemed Proprietary Information hereunder, mutatis mutandis . The Employee will not, during his employment with the Company, improperly use or disclose any proprietary information or trade secrets of any former or concurrent employer or other person or entity and will not bring onto the premises of the Company any unpublished document or proprietary information belonging to any such employer, person or entity unless consented to in writing by such employer, person or entity.
   
4. The Employee agrees that all Proprietary Information and any patents, trademarks, copyrights and other intellectual property and ownership rights in connection therewith are and will be the sole property of the Company and its assigns. At all times, during Employee’s engagement by the Company and thereafter, the Employee will keep in confidence and trust all Proprietary Information and will not use or disclose Proprietary Information or anything relating to it without the written consent of the Company, except as may be necessary in the ordinary course of performing Employee’s duties under the Agreement.

 

 
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5. Upon termination of the Employee’s employment with the Company, the Employee will promptly deliver to the Company all documents and materials of any nature pertaining to Employee’s work with the Company, and will not retain any documents or materials or copies thereof containing any Proprietary Information.
   
  For the avoidance of doubt, Employee’s undertakings set forth in Sections 2-5 shall remain in full force and effect after termination of the Agreement (for any reason whatsoever) or any renewal thereof.

 

Disclosure and Assignment of Inventions

 

6. From and after the date the Employee first became employed by the Company, the Employee undertakes and covenants that the Employee will promptly disclose in confidence to the Company all inventions, improvements, developments, original works of authorship, designs, concepts, techniques, methods, systems, processes, know how, computer software programs, databases, mask works, trade secrets, discoveries and any other intellectual creations of any nature whatsoever (“ Inventions ”), whether or not patentable, copyrightable or protectable as trade secrets, that are made or conceived or first reduced to practice or created by Employee, either alone or jointly with others during the course of or in connection with Employee’s employment with the Company. The Employee undertakes not to disclose to the Company any confidential information of any third party and not to make any use of any intellectual property rights of any third party in the framework of the Employee’s employment by the Company.
   
7. Without derogating from applicable law, the Employee agrees that all Inventions, whether or not patentable, copyrightable or protectable as trade secrets, that are made or conceived or first reduced to practice or created by Employee, either alone or jointly with others, during the course of or in connection with Employee’s employment with the Company that (a) are developed in whole or in part on Company’s time or using equipment, supplies, facilities, resources or Proprietary Information of the Company, (b) result from or are suggested by any task assigned to Employee or any work performed by the Employee for or on behalf of the Company or by the scope of Employee’s duties and responsibilities with Company, or (c) relate to the Company’s business, activities, services, products or research and development (whether current or anticipated) will be the sole and exclusive property of the Company and the Employee will have no rights in or thereto (“ Company Inventions ”).
   
8. The Employee has listed below in this Section 8 a complete list of all inventions to which he claims ownerships (the “ Prior Inventions ”) and that the Employee desires to remove from the operation of this Exhibit, and acknowledges and agrees that such list is complete. If no such list is attached to this Exhibit, the Employee represents that he has no such Inventions at the time of signing this Agreement. The Prior Inventions, if any, patented or unpatented, are excluded from the scope of this Exhibit. If, in the course of employment with the Company, the Employee incorporates a Prior Invention into a Company product, process or machine, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, worldwide license (with rights to sublicense through multiple tiers of sublicensees) to make, have made, modify, use and sell such Prior Invention. Notwithstanding the foregoing, the Employee agrees that the Employee will not incorporate, or permit to be incorporated, Prior Inventions in any Company Inventions without the Company’s prior written consent. The Employee hereby represents and undertakes that none of his previous employers or any entity with whom the Employee was engaged, has any rights in the Inventions or Prior Inventions and such employment with the Company will not grant any of them any right in the results of the Employee’s work.

 

Prior Inventions : [fill-in, if any.]

 

None.

 

 
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9. The Employee hereby irrevocably transfers and assigns to the Company, without further compensation, all worldwide patents, patent applications, copyrights, mask works, trade secrets and other intellectual property rights in any Company Invention, and waives any and all moral rights that Employee may have in or with respect to any Company Invention. The Employee hereby irrevocably, unconditionally and expressly waives any right and/or claim to any consideration or compensation whatsoever with regard to the Company Inventions and the assignment, use or commercialization thereof, including without limitation any royalty payment and other payment with respect thereto (and including without limitation under Section 134 of the Israeli Patent Law, 1967). The Employee agrees and understands that the Salary (set forth in Exhibit A) includes adequate compensation for any transfer or assignment made by the Employee, if any, pursuant to this Section 9.
   
  The Employee agrees to assist the Company, at the Company’s expense, in every proper way to obtain for the Company and enforce patents, copyrights, mask work rights, and other legal protections for the Company’s Inventions in any and all countries. The Employee will execute any documents that the Company may reasonably request for use in obtaining or enforcing such patents, copyrights, mask work rights, trade secrets and other legal protections. Such obligation will continue beyond the termination of the Employee’s employment with the Company. The Employee hereby irrevocably designates and appoints the Company and its officers and agents as the Employee’s agent and attorney in fact, coupled with an interest to act for and on Employee’s behalf and in Employee’s stead to execute and file any document needed to apply for or prosecute any patent, copyright, trademark, trade secret, any applications regarding same or any other right or protection relating to any Proprietary Information (including Company Inventions), and to do all other lawfully permitted acts to further the prosecution and issuance of patents, copyrights, trademarks, trade secrets or any other right or protection relating to any Proprietary Information (including Company Inventions), with the same legal force and effect as if executed by the Employee.
   
  Non-Competition; Non-Solicitation
   
10. Employee agrees and understands that the Employee’s Salary (set forth in Exhibit A) includes adequate compensation for his undertakings under this Section 10. Therefore, in order to enable the Company to effectively protect its Proprietary Information, the Employee undertakes that, so long as Employee is employed by the Company and for a period of twelve (12) months thereafter, the Employee will not, directly or indirectly, as owner, employee, agent, or in any capacity whatsoever engage in, become financially interested in, be employed by, render services or assists to, or have any connection with, any person, corporation, business or venture that is engaged in any activities involving services, products, information, processes, technology or equipment that are competitive to those of the Company; provided, however, that Employee may own securities of any publicly traded corporation in an amount not to exceed three percent of any class of stock or securities of such company, and so long as Employee has no active role in such corporation in any capacity.
   
11. The Employee agrees and undertakes that during the period of Employee’s employment and for a period of twelve (12) months thereafter, the Employee will not, directly or indirectly, including personally or in any business in which Employee is an officer, director or shareholder, for any purpose or in any place solicit (i) for employment any person employed by the Company (or retained by the Company as a consultant, if such consultant is prevented thereby from continuing to render its services to the Company in the manner provided immediately before) on the date of such termination or during the preceding twelve (12) months, and (ii) the business of any customer of the Company for the purpose of offering services or products which compete with the services or products supplied to such customer by the Company.

 

 
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Reasonableness of Protective Covenants; Remedies for Breach

 

12. Insofar as the protective covenants set forth in this Exhibit are concerned, the Employee specifically acknowledges, stipulates and agrees as follows: (i) the protective covenants are reasonable and necessary to protect the goodwill, property and Proprietary Information of the Company, and the operations and business of the Company; and (ii) the time duration of the protective covenants is reasonable and necessary to protect the goodwill and the operations and business of Company, and does not impose a greater restrain than is necessary to protect the goodwill or other business interests of the Company. Nevertheless, if any term contained in this Exhibit B will for any reason be held to be excessively broad with regard to time, geographic scope or activity, such term will be construed in a manner to enable it to be enforced to the extent compatible with applicable law.
   
13. The Employee acknowledges that the legal remedies for breach of the provisions of this Exhibit may be found inadequate and therefore agrees that, in addition to all of the remedies available to the Company in the event of a breach or a threatened breach of any of such provisions, the Company may also, in addition to any other remedies which may be available under applicable law, obtain temporary, preliminary and permanent injunctions against any and all such actions.
   
14. The Employee recognizes and agrees: (i) that this Exhibit is necessary and essential to protect the business of the Company and to realize and derive all the benefits, rights and expectations of conducting the Company’s business; (ii) that the area and duration of the protective covenants contained herein are in all things reasonable; and (iii) that good and valuable consideration exists under the Agreement, for the Employee’s agreement to be bound by the provisions of this Exhibit.
   
15. The Employee acknowledges that the Parent Company is a publicly traded company. As such, it agrees not to use any Proprietary Information in connection with the purchase or sale of the securities of the Parent Company in violation of the U.S. Securities and Exchange Commission regulation or any other applicable securities laws.

 

IN WITNESS WHEREOF the Employee has signed this Proprietary Information, Confidentiality and Non-Competition Agreement as of the date first hereinabove set forth.

 

 
Alon Sinai /s/  

 

 
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Schedule C

 

Order and Confirmation Regarding Payments of Employers to Pension Funds and Insurance Funds instead of Severance Pay

 

 

 
 

 

Personal Employment Agreement

 

This Personal Employment Agreement (“ Agreement ”) is entered into as of June 4, 2017, by and between One World Cannabis Ltd. (the “ Company ”) and Yossi Dagan (the “ Employee ”).

 

1. Position . The Employee will serve in the position described in Exhibit A and shall be under the direction of the person stated in Exhibit A , or such other person as shall be decided by the Company from time to time. The Employee undertakes to perform his/her duties diligently, conscientiously and in furtherance of the Company’s best interests.
   
2. Fulltime Employment . The Employee is employed on a full time basis and as such, the Employee undertakes to devote his/her business time and attention to the business and affairs of the Company and to the performance of his/her duties to the Company. The Employee may engage in other paid or unpaid employment, occupation or other business activities which are not competitive and/or in conflict with his position in the Company and/or Company’s business, provided that the Company has granted its prior written consent to such other activities.
   
3. Employee’s Representations and Undertakings . The Employee represents that the execution and delivery of this Agreement and the fulfillment of its terms: (i) will not constitute a default under or conflict with any agreement or other instrument to which the Employee is a party or by which the Employee is bound, including, without limitation, any confidentiality or non-competition agreement; and (ii) will not require the consent of any person or entity. The Employee undertakes to inform the Company immediately after becoming aware of any matter that may in any way raise a conflict of interest between the Employee and the Company. The Employee shall not receive any payment, compensation or benefit from any third party in connection, directly or indirectly, with the Employee’s position in the Company. The Employee further acknowledges and agrees (i) to the transfer of any information concerning the Employee and held by the Company to a database (including a database located abroad) and to third parties in general, as is reasonable for business purposes or in pursuit of the Company’s business interests; (ii) to travel abroad from time to time if and as may be required pursuant to his/her position; (iii) to adhere to any applicable law or provision, pertaining to his/her employment; (iv) to protect the good name of the Company and not to perform any act that may bring the Company into disrepute; (v) to use any equipment (such as lap top) and access to systems (such as email system) provided to the Employee by the Company for purposes related to the Employee’s employment (and the Employee acknowledges and agrees that such equipment and systems may be reasonably monitored by the Company for business purposes and the Employee should not expect a right of privacy therein).
   
4. Term and Termination . The Employee’s employment with the Company began, or will begin, on the date set forth in Exhibit A (the “ Start Date ”). Either party may terminate this Agreement and the employment relationship hereunder at any time by giving the other party prior written notice of termination of such number of days as set forth in Exhibit A (the “ Notice Period ”). Notwithstanding the aforesaid, the Company is entitled to terminate this Agreement and the employment relationship with immediate effect or at any time during the Notice Period upon a written notice to the Employee and payment to the Employee of a one time amount equal to the Salary the Employee would have been entitled to receive in respect of the portion of the Notice Period which was forefeited, in lieu of such prior notice period.

 

Notwithstanding the aforesaid, in the event of a Cause (as defined below), the Company will be entitled to terminate this Agreement immediately and this Agreement and the employment relationship will be deemed effectively terminated as of the time of delivery of such notice (subject to any minimal mandatory notice requirement under applicable law) and the Company shall have no obligation to pay any compensation during or in lieu of the notice period. The term “ Cause ” means: (i) the Employee engages in any act of dishonesty, fraud, misrepresentation, or intentional illegal conduct; (ii) the Employee’s violation of any law or regulation applicable to the Company’s business; (iii) any unauthorized use or disclosure by the Employee of the Company’s confidential information or trade secrets or any other breach of the Proprietary Information, Assignment of Inventions and Non-Competition Agreement attached as Exhibit B hereto; (iv) a material breach by the Employee of any agreement between the Employee and the Company; (v) a failure by the Employee to comply with the Company’s written policies or rules; or (vi) any circumstances which allow for termination without severance payment under applicable law.

 

     
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During the Notice Period, this Agreement will remain in full force and effect and there will be no change in Employee’s position with the Company or any obligations hereunder, unless otherwise determined by the Company in a written notice to Employee, and the Employee will cooperate with the Company and use the Employee’s best efforts to assist the integration into the Company’s organization of the person or persons who will assume the Employee’s responsibilities. Upon termination of the employment for any reason or cause whatsoever, Employee shall immediately surrender to the Company all property, equipment, documents and information in his/her possession or disposal, as such may have been delivered to him/her during or due to his/her employment with the Company, and Employee shall have no rights of lien or possession in respect thereof.

 

5. Proprietary Information; Confidentiality and Non-Competition . The Employee shall, simultaneously herewith, execute and deliver, and hereby agrees to be bound by the provisions of, the Proprietary Information, Assignment of Inventions and Non-Competition Agreement attached in Exhibit B hereto, the terms of which will survive termination of this Agreement.
   
6. Salary . The Company will pay the Employee a gross monthly salary in the amount set forth in Exhibit A (the “ Salary ”). Except as specifically set forth herein, the Salary includes any and all payments to which Employee is entitled hereunder and under any applicable laws, regulations or agreements. Payment of the Salary will be made no later than the 9 th day of each calendar month after the month for which the Salary is paid, after deduction of applicable taxes and any amounts deductible under this Agreement.
   
7. Social Benefits . The Company shall, on a monthly basis, pay to a pension scheme for the benefit of the Employee and shall deduct from the Employee’s Salary a respective payment towards such pension scheme (the “ Pension Scheme ”). The contributions to the Pension Scheme will be as follows:

 

  (i) The Company will pay an amount equal to 8 1/3% (eight percent and one third of a percent) of the Salary as a severance pay component;
     
  (ii) In case of a Pension Scheme of a managers insurance type (and not a pension fund), the Company shall pay for a disability insurance in an amount of 2.5% of the Salary or a lower amount as required to insure 75% of the Salary (the “ Disability Insurance Component ”);
     
  (iii) The Company will pay towards a savings component (A) an amount equal to 6.5% of the Salary in case the Pension Scheme is through a pension fund or (B) an amount equal to 6.5% of the Salary less the Disability Insurance Component, but in no event less than 5%, in case of a managers insurance type Pension Scheme; and
     
  (iv) The Company shall deduct from the net Salary an amount equal to 6% of the Salary which amount shall be allocated to a savings component.

 

All payments to the Pension Scheme will be made in compliance with Section 14 of the Severance Compensation Law, 1963 (“ Section 14 ”), and in accordance with the general approval of the Labor Minister dated June 9, 1998, promulgated under said Section 14, a copy of which is attached hereby as Exhibit C , and the terms of Section 14 and said general approval will apply to the relationship hereunder. Therefore, the ownership of the Pension Scheme will be transferred to the Employee following termination of employment and the Company will not be entitled to retrieve any of the funds it transferred to the Pension Scheme, other than in accordance with Section 14 and said general approval, and the transfer of the Pension Scheme to the ownership of the Employee will be the full and only compensation to be paid by the Company to the Employee in such circumstances in respect of severance pay.

 

     
  3 -  

 

8. Vacation . The Employee will be entitled to that number of vacation days per year set forth in Exhibit A . The Company will be entitled to direct the use of the vacation days, at its discretion. Right to accumulate unused vacation days shall be as decided by the Company from time to time and the Company shall be entitled to change its policy in that respect without any liability to the Employee. It is the Company’s current policy to allow the Employee to accumulate any unused vacation days up to the number of vacation days specified in Exhibit A and once the Employee has reached such accumulation no additional vacation days will be accumulated, but rather be forfeited. The Employee will not be entitled to redemption of accumulated and unused vacation days, except in the event of termination or resignation of employment and then only in accordance with applicable law.
   
9. Recreation Pay . The Employee will be entitled to recreation pay (Dmei Havra’a) in accordance with applicable law.
   
10. Additional Benefits . The Employee may be entitled to additional benefits if and only to the extent set forth in Exhibit A .
   
11. Policies and Guidelines . The Employee undertakes to abide by and at all times be in compliance with the policies, guidelines and regulations which are and shall be established by the Company.
   
12. General . Headings in this Agreement are included for reference purposes only and are not to be used in interpreting this Agreement. The exhibits to this Agreement constitute an integral part thereof. Subject to applicable law, no collective bargaining agreement will apply to the relationship between the parties, whether such agreement was signed among the government, the General Federation of Labor and Employers organizations, or any of such parties, or whether signed by others, in relation to the field or fields of the business of the Company or in relation to the position held by or the profession of the Employee. No failure, delay of forbearance of either party in exercising any power or right hereunder will in any way restrict or diminish such party’s rights and powers under this Agreement, or operate as a waiver of any breach or nonperformance by either party of any terms or conditions hereof. In the event it is determined under any applicable law that a certain provision set forth in this Agreement is invalid or unenforceable, such determination will not affect the remaining provisions of this Agreement unless the business purpose of this Agreement is substantially frustrated thereby. This Agreement constitutes the entire understanding and agreement between the parties, supersedes any and all prior discussions, agreements and correspondence with regard to the subject matter hereof, and may not be amended, modified or supplemented in any respect, except by a subsequent writing executed by both parties. The Employee acknowledges and confirms that all terms of Employee’s employment are personal and confidential, and undertakes to keep such terms in confidence and refrain from disclosing such terms to any third party.

 

     
  4 -  

 

The Employee acknowledges that this Agreement, together with the Exhibits thereto, constitutes a due notice to the Employee of the terms of employment, as required under law.

 

 

IN WITNESS WHEREOF , the parties have executed this Agreement as of the date first above written.

 

One World Cannabis Ltd.   Yossi Dagan
     
     
By:   Signature
Title:    

 

     
  5 -  

 

Exhibit A to Personal Employment Agreement

 

Employee Name   Yossi Dagan, ID# 032243115
     
Address   [__________]
     
Position   Chief Financial Officer
     
Under the Direction   CEO
     
Start Date   July 1, 2017
     
Work Week and Hours of Work; Rest Day   The scope of employment shall be 5 days a week, with regular work hours in accordance with the Company’s policy (currently, 9:00-18:00), subject to overtime requests by the Company. The rest day is Saturday.
     
Prior Notice   Three (3) months. However, during the first three months of employment the notice period shall be one month.
     
Salary (NIS)   The Employee shall be entitled to a gross monthly salary of NIS 18,750 (the “ Base Salary ”). In addition, in consideration for overtime hours that the Employee may work during the month the Employee shall receive a global payment of NIS 6,250 per month (the “ Global Overtime Compensation ”, and together with the Base Salary, the “ Salary ”). The Global Overtime Compensation has been determined based on Company’s estimation of the average of overtime hours per month that the Employee’s position may require.
     
Annual Vacation Days   24 annual vacation days. Employee may accumulate at any time unused vacation days in the aggregate number equal to no more than twice the number of the annual vacation days he is entitled to receive.
     
Education Fund  

The Company and the Employee will maintain an advanced study fund (Keren Hishtalmut). The Company will contribute to such fund an amount equal to 7.5% of the Salary, and will deduct from the Salary and transfer to such fund an amount equal to 2.5% of the Salary.

 

For the avoidance of doubt, no amount remitted by the Company in respect of this paragraph will be considered as part of the Salary for purposes of any deduction therefrom or calculations of severance pay.

     
Cellular Phone   Company shall reimburse Employee for expenses related to use of cellular phone in accordance with a company policy in that respect, as may be changed from time to time, subject to the submission by the Employee of applicable invoices.
     
Transportation   The employee will be entitled to payment for transportation from and to work in the amount of NIS 300 per month.
     
Options  

The Company shall recommend its Board of Directors of its parent company, OWC Pharmaceutical Research Corp. (the “ Board ” and “ Parent ”, respectively) to grant the Employee options (the “ Options ”) to purchase up to 1,500,000 shares of Common Stock of the Parent (as may be adjusted due to stock split, reverse stock split and the like), under the Parent’s stock incentive plan (the “ Plan ”). The grant of the Options shall be subject to the approval of the Board, at its sole discretion. The Options shall vest over a 3-year period from the vesting start date determined by the Board (which shall not be earlier than the Start Date), such that 500,000 Options shall vest upon the one year anniversary of the Start Date and the remaining Options shall vest in eight equal installments at the end of each 3-month period thereafter, in each case, provided that the Employee continues to be employed by the Company at the applicable date of vesting. Additional conditions for exercise may apply. The exercise price per share of the Options shall be determined by the Board. The Options shall be subject to the terms of the Plan and their grant shall further be subject to the signing by the Employee of an applicable option agreement and such other grant documents in the forms provided by the Company. Upon cessation of Employee’s employment, any unvested portion of the Option shall immediately expire and any vested portion may be exercisable in the manner and for the period as shall be specified in the grant documents to be provided by the Company.

 

All tax consequences arising from the grant, exercise of the Options or the payment of the exercise price of the Options shall be borne solely by the Employee and the Company and/or Parent shall withhold taxes according to the requirements under the applicable laws, rules, and regulations, including withholding taxes at source, all as shall be detailed in the Plan and/or an option grant agreement to be executed between the parties.

 

     
  6 -  

 

Exhibit B to Personal Employment Agreement

Proprietary Information, Confidentiality and Non-Competition Agreement

between the Employee and One World Cannabis Ltd.

 

  Employee’s Name Yossi Dagan

 

1. Capitalized terms herein will have the meanings given to them in the Personal Employment Agreement to which this Exhibit is attached (the “ Agreement ”). The term Company will include also all subsidiaries and affiliates of the Company, as applicable, which are deemed third party beneficiaries of this Agreement. The Employee’s obligations and the Company’s rights under this Exhibit will apply as of the beginning of the engagement between the Company and the Employee, regardless of the Start Date or the date of execution of the Agreement or this Exhibit.

 

Confidentiality; Proprietary Information

 

2. The Employee acknowledges and agrees that Employee may have access to confidential and proprietary information concerning the business and financial activities of the Company, including without limitation information relating to the Company’s research and development activities, investments, properties, employees, marketing plans, customers, suppliers, trade secrets, test results, processes, data, know-how, improvements, inventions, techniques, intellectual property and products (actual or planned). Such information, whether documentary, written, oral or computer generated, will be referred to as “ Proprietary Information ”. However, Proprietary Information will exclude information that Employee can demonstrate (i) was known to Employee prior to Employee’s association with the Company (except if related in any way to the Company, including without limitation to the Company’s current and/or contemplated business, services, products and/or activities); or (ii) is or will become part of the public knowledge except as a result of the breach of the Agreement or this Exhibit by the Employee.
   
3. The Employee recognizes that the Company may receive confidential or proprietary information from third parties, subject to a duty on the Company’s part to maintain the confidentiality of such information and to use it only for certain limited purposes. In connection with such duties, such information will be deemed Proprietary Information hereunder, mutatis mutandis . The Employee will not, during his/her employment with the Company, improperly use or disclose any proprietary information or trade secrets of any former or concurrent employer or other person or entity and will not bring onto the premises of the Company any unpublished document or proprietary information belonging to any such employer, person or entity unless consented to in writing by such employer, person or entity.
   
4. The Employee agrees that all Proprietary Information and any patents, trademarks, copyrights and other intellectual property and ownership rights in connection therewith are and will be the sole property of the Company and its assigns. At all times, during Employee’s engagement by the Company and thereafter, the Employee will keep in confidence and trust all Proprietary Information and will not use or disclose Proprietary Information or anything relating to it without the written consent of the Company, except as may be necessary in the ordinary course of performing Employee’s duties under the Agreement.
   
5. Upon termination of the Employee’s employment with the Company, the Employee will promptly deliver to the Company all documents and materials of any nature pertaining to Employee’s work with the Company, and will not retain any documents or materials or copies thereof containing any Proprietary Information.

 

     
  7 -  

 

For the avoidance of doubt, Employee’s undertakings set forth in Sections 2-5 shall remain in full force and effect after termination of the Agreement (for any reason whatsoever) or any renewal thereof.

 

Disclosure and Assignment of Inventions

 

6. From and after the date the Employee first became employed by the Company, the Employee undertakes and covenants that the Employee will promptly disclose in confidence to the Company all inventions, improvements, developments, original works of authorship, designs, concepts, techniques, methods, systems, processes, know how, computer software programs, databases, mask works, trade secrets, discoveries and any other intellectual creations of any nature whatsoever (“ Inventions ”), whether or not patentable, copyrightable or protectable as trade secrets, that are made or conceived or first reduced to practice or created by Employee, either alone or jointly with others during the course of or in connection with Employee’s employment with the Company. The Employee undertakes not to disclose to the Company any confidential information of any third party and not to make any use of any intellectual property rights of any third party in the framework of the Employee’s employment by the Company.
   
7. Without derogating from applicable law, the Employee agrees that all Inventions, whether or not patentable, copyrightable or protectable as trade secrets, that are made or conceived or first reduced to practice or created by Employee, either alone or jointly with others, during the course of or in connection with Employee’s employment with the Company that (a) are developed in whole or in part on Company’s time or using equipment, supplies, facilities, resources or Proprietary Information of the Company, (b) result from or are suggested by any task assigned to Employee or any work performed by the Employee for or on behalf of the Company or by the scope of Employee’s duties and responsibilities with Company, or (c) relate to the Company’s business, activities, services, products or research and development (whether current or anticipated) will be the sole and exclusive property of the Company and the Employee will have no rights in or thereto (“ Company Inventions ”).
   
8. The Employee has listed below in this Section 8 a complete list of all inventions to which he claims ownerships (the “ Prior Inventions ”) and that the Employee desires to remove from the operation of this Exhibit, and acknowledges and agrees that such list is complete. If no such list is attached to this Exhibit, the Employee represents that he has no such Inventions at the time of signing this Agreement. The Prior Inventions, if any, patented or unpatented, are excluded from the scope of this Exhibit. If, in the course of employment with the Company, the Employee incorporates a Prior Invention into a Company product, process or machine, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, worldwide license (with rights to sublicense through multiple tiers of sublicensees) to make, have made, modify, use and sell such Prior Invention. Notwithstanding the foregoing, the Employee agrees that the Employee will not incorporate, or permit to be incorporated, Prior Inventions in any Company Inventions without the Company’s prior written consent. The Employee hereby represents and undertakes that none of his/her previous employers or any entity with whom the Employee was engaged, has any rights in the Inventions or Prior Inventions and such employment with the Company will not grant any of them any right in the results of the Employee’s work.

 

Prior Inventions : [fill-in, if any.]

 

None.

 

     
  8 -  

 

9. The Employee hereby irrevocably transfers and assigns to the Company, without further compensation, all worldwide patents, patent applications, copyrights, mask works, trade secrets and other intellectual property rights in any Company Invention, and waives any and all moral rights that Employee may have in or with respect to any Company Invention. The Employee hereby irrevocably, unconditionally and expressly waives any right and/or claim to any consideration or compensation whatsoever with regard to the Company Inventions and the assignment, use or commercialization thereof, including without limitation any royalty payment and other payment with respect thereto (and including without limitation under Section 134 of the Israeli Patent Law, 1967). The Employee agrees and understands that the Salary (set forth in Exhibit A) includes adequate compensation for any transfer or assignment made by the Employee, if any, pursuant to this Section 9.

 

The Employee agrees to assist the Company, at the Company’s expense, in every proper way to obtain for the Company and enforce patents, copyrights, mask work rights, and other legal protections for the Company’s Inventions in any and all countries. The Employee will execute any documents that the Company may reasonably request for use in obtaining or enforcing such patents, copyrights, mask work rights, trade secrets and other legal protections. Such obligation will continue beyond the termination of the Employee’s employment with the Company. The Employee hereby irrevocably designates and appoints the Company and its officers and agents as the Employee’s agent and attorney in fact, coupled with an interest to act for and on Employee’s behalf and in Employee’s stead to execute and file any document needed to apply for or prosecute any patent, copyright, trademark, trade secret, any applications regarding same or any other right or protection relating to any Proprietary Information (including Company Inventions), and to do all other lawfully permitted acts to further the prosecution and issuance of patents, copyrights, trademarks, trade secrets or any other right or protection relating to any Proprietary Information (including Company Inventions), with the same legal force and effect as if executed by the Employee.

 

Non-Competition; Non-Solicitation

 

10. Employee agrees and understands that the Employee’s Salary (set forth in Exhibit A) includes adequate compensation for his/her undertakings under this Section 10. Therefore, in order to enable the Company to effectively protect its Proprietary Information, the Employee undertakes that, so long as Employee is employed by the Company and for a period of twelve (12) months thereafter, the Employee will not, directly or indirectly, as owner, employee, agent, or in any capacity whatsoever engage in, become financially interested in, be employed by, render services or assists to, or have any connection with, any person, corporation, business or venture that is engaged in any activities involving services, products, information, processes, technology or equipment that are competitive to those of the Company; provided, however, that Employee may own securities of any publicly traded corporation in an amount not to exceed three percent of any class of stock or securities of such company, and so long as Employee has no active role in such corporation in any capacity.
   
11. The Employee agrees and undertakes that during the period of Employee’s employment and for a period of twelve (12) months thereafter, the Employee will not, directly or indirectly, including personally or in any business in which Employee is an officer, director or shareholder, for any purpose or in any place solicit (i) for employment any person employed by the Company (or retained by the Company as a consultant, if such consultant is prevented thereby from continuing to render its services to the Company in the manner provided immediately before) on the date of such termination or during the preceding twelve (12) months, and (ii) the business of any customer of the Company for the purpose of offering services or products which compete with the services or products supplied to such customer by the Company.

 

     
  9 -  

 

Reasonableness of Protective Covenants; Remedies for Breach

 

12. Insofar as the protective covenants set forth in this Exhibit are concerned, the Employee specifically acknowledges, stipulates and agrees as follows: (i) the protective covenants are reasonable and necessary to protect the goodwill, property and Proprietary Information of the Company, and the operations and business of the Company; and (ii) the time duration of the protective covenants is reasonable and necessary to protect the goodwill and the operations and business of Company, and does not impose a greater restrain than is necessary to protect the goodwill or other business interests of the Company. Nevertheless, if any term contained in this Exhibit B will for any reason be held to be excessively broad with regard to time, geographic scope or activity, such term will be construed in a manner to enable it to be enforced to the extent compatible with applicable law.
   
13. The Employee acknowledges that the legal remedies for breach of the provisions of this Exhibit may be found inadequate and therefore agrees that, in addition to all of the remedies available to the Company in the event of a breach or a threatened breach of any of such provisions, the Company may also, in addition to any other remedies which may be available under applicable law, obtain temporary, preliminary and permanent injunctions against any and all such actions.
   
14. The Employee recognizes and agrees: (i) that this Exhibit is necessary and essential to protect the business of the Company and to realize and derive all the benefits, rights and expectations of conducting the Company’s business; (ii) that the area and duration of the protective covenants contained herein are in all things reasonable; and (iii) that good and valuable consideration exists under the Agreement, for the Employee’s agreement to be bound by the provisions of this Exhibit.

 

IN WITNESS WHEREOF the Employee has signed this Proprietary Information, Confidentiality and Non-Competition Agreement as of the date first hereinabove set forth.

 

   
Yossi Dagan /s/  

 

     
  10 -  

 

Exhibit C

 

 

     
 

 

 

Personal Employment Agreement

 

This Personal Employment Agreement (“ Agreement ”) is entered into as of February 18, 2018, by and between One World Cannabis Ltd. (the “ Company ”) and Oron Yacoby Zeevi (the “ Employee ”).

 

1. Position . The Employee will serve in the position described in Exhibit A and shall be under the direction of the person stated in Exhibit A , or such other person as shall be decided by the Company from time to time. The Employee undertakes to perform his/her duties diligently, conscientiously and in furtherance of the Company’s best interests.

 

2. Full Time Employment . The Employee is employed on a part time basis in a scope of 40% of a full-time position. The Employee may engage in other paid or unpaid employment, occupation or other business activities which are not in the field of medical and pharmaceutical formulations derived from and or utilizing cannabis and its CBD and or THC components, either natural or synthetic, and delivery systems specifically developed for the administration of the above. For the avoidance of doubt, this also incorporates formulations or carriers developed in the course of the work of the company, which have medical effect, even if such formulations or carriers do not contain the above-mentioned cannabis components (the “ Field of Business ”). If the Employee has or develops ideas or inventions, not in the Field of Business, which Employee believes may be of interest to the Company, Employee may offer these to the Company (the “ Offer ”), at Employee’s sole discretion. The company may choose to negotiate the terms of such Offer with the Employee for a period of 6 months from the time of the Offer. If the Company declines the Offer, it shall issue a formal release to the Employee declaring that such Offer is the sole property of the Employee. Any engagement in the Field of Business shall be subject to the Company’s prior written approval which shall be in its sole discretion.

 

3. Employee’s Representations and Undertakings . The Employee represents that the execution and delivery of this Agreement and the fulfillment of its terms: (i) will not constitute a default under or conflict with any agreement or other instrument to which the Employee is a party or by which the Employee is bound, including, without limitation, any confidentiality or non-competition agreement; and (ii) will not require the consent of any person or entity. The Employee undertakes to inform the Company immediately after becoming aware of any matter that may in any way raise a conflict of interest between the Employee and the Company. The Employee shall not receive any payment, compensation or benefit from any third party in connection, directly or indirectly, with the Employee’s position in the Company. The Employee further acknowledges and agrees (i) to the transfer of any information concerning the Employee and held by the Company to a database (including a database located abroad) and to third parties in general, as is reasonable for business purposes or in pursuit of the Company’s business interests; (ii) to travel abroad from time to time if and as may be required pursuant to his/her position; (iii) to adhere to any applicable law or provision, pertaining to his/her employment; (iv) to protect the good name of the Company and not to perform any act that may bring the Company into disrepute; (v) to use any equipment (such as lap top) and access to systems (such as email system) provided to the Employee by the Company for purposes related to the Employee’s employment (and the Employee acknowledges and agrees that such equipment and systems may be reasonably monitored by the Company for business purposes and the Employee should not expect a right of privacy therein).

 

 
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4. Term and Termination . The Employee’s employment with the Company began, or will begin, on the date set forth in Exhibit A (the “ Start Date "). Either party may terminate this Agreement and the employment relationship hereunder at any time by giving the other party prior written notice of termination of such number of days as set forth in Exhibit A (the “ Notice Period ”). Notwithstanding the aforesaid, the Company is entitled to terminate this Agreement and the employment relationship with immediate effect or at any time during the Notice Period upon a written notice to the Employee and payment to the Employee of a one time amount equal to the Salary the Employee would have been entitled to receive in respect of the portion of the Notice Period which was forfeited, in lieu of such prior notice period.

 

Notwithstanding the aforesaid, in the event of a Cause (as defined below), the Company will be entitled to terminate this Agreement immediately and this Agreement and the employment relationship will be deemed effectively terminated as of the time of delivery of such notice (subject to any minimal mandatory notice requirement under applicable law) and the Company shall have no obligation to pay any compensation during or in lieu of the notice period. The term “ Cause ” means: (i) the Employee engages in any act of dishonesty, fraud, misrepresentation, or intentional illegal conduct; (ii) the Employee’s violation of any law or regulation applicable to the Company’s business; (iii) any unauthorized use or disclosure by the Employee of the Company’s confidential information or trade secrets or any other breach of the Proprietary Information, Assignment of Inventions and Non-Competition Agreement attached as Exhibit B hereto; (iv) a material breach by the Employee of any agreement between the Employee and the Company; (v) a failure by the Employee to comply with the Company’s written policies or rules; or (vi) any circumstances which allow for termination without severance payment under applicable law.

 

During the Notice Period, this Agreement will remain in full force and effect and there will be no change in Employee’s position with the Company or any obligations hereunder, unless otherwise determined by the Company in a written notice to Employee, and the Employee will cooperate with the Company and use the Employee’s best efforts to assist the integration into the Company’s organization of the person or persons who will assume the Employee’s responsibilities. Upon termination of the employment for any reason or cause whatsoever, Employee shall immediately surrender to the Company all property, equipment, documents and information in his/her possession or disposal, as such may have been delivered to him/her during or due to his/her employment with the Company, and Employee shall have no rights of lien or possession in respect thereof.

 

5. Proprietary Information; Confidentiality and Non-Competition . The Employee shall, simultaneously herewith, execute and deliver, and hereby agrees to be bound by the provisions of, the Proprietary Information, Assignment of Inventions and Non-Competition Agreement attached in Exhibit B hereto, the terms of which will survive termination of this Agreement.

 

6. Salary . The Company will pay the Employee a gross monthly salary in the amount set forth in Exhibit A (the “ Salary ”). Except as specifically set forth herein, the Salary includes any and all payments to which Employee is entitled hereunder and under any applicable laws, regulations or agreements. Payment of the Salary will be made no later than the 9 th day of each calendar month after the month for which the Salary is paid, after deduction of applicable taxes and any amounts deductible under this Agreement.

 

7. Social Benefits . The Company shall, on a monthly basis, pay to a pension scheme for the benefit of the Employee and shall deduct from the Employee’s Salary a respective payment towards such pension scheme (the “ Pension Scheme ”). The contributions to the Pension Scheme will be as follows:

 

(i) The Company will pay an amount equal to 8 1/3% (eight percent and one third of a percent) of the Salary as a severance pay component;

 

 
- 3  -

 

(ii) In case of a Pension Scheme of a managers insurance type (and not a pension fund), the Company shall pay for a disability insurance in an amount of 2.5% of the Salary or a lower amount as required to insure 75% of the Salary (the “ Disability Insurance Component ”);

 

(iii) The Company will pay towards a savings component (A) an amount equal to 6.5% of the Salary in case the Pension Scheme is through a pension fund or (B) an amount equal to 6.5% of the Salary less the Disability Insurance Component, but in no event less than 5%, in case of a managers insurance type Pension Scheme; and

 

(iv) The Company shall deduct from the net Salary an amount equal to 6% of the Salary which amount shall be allocated to a savings component.

 

All payments to the Pension Scheme will be made in compliance with Section 14 of the Severance Compensation Law, 1963 (“ Section 14 ”), and in accordance with the general approval of the Labor Minister dated June 9, 1998, promulgated under said Section 14, a copy of which is attached hereby as Exhibit C , and the terms of Section 14 and said general approval will apply to the relationship hereunder. Therefore, the ownership of the Pension Scheme will be transferred to the Employee following termination of employment and the Company will not be entitled to retrieve any of the funds it transferred to the Pension Scheme, other than in accordance with Section 14 and said general approval, and the transfer of the Pension Scheme to the ownership of the Employee will be the full and only compensation to be paid by the Company to the Employee in such circumstances in respect of severance pay.

 

8. Vacation . The Employee will be entitled to that number of vacation days per year set forth in Exhibit A . The Company will be entitled to direct the use of the vacation days, at its discretion. Right to accumulate unused vacation days shall be as decided by the Company from time to time and the Company shall be entitled to change its policy in that respect without any liability to the Employee. It is the Company’s current policy to allow the Employee to accumulate any unused vacation days up to the number of vacation days specified in Exhibit A and once the Employee has reached such accumulation no additional vacation days will be accumulated, but rather be forfeited. The Employee will not be entitled to redemption of accumulated and unused vacation days, except in the event of termination of employment and then only in accordance with applicable law.

 

9. Recreation Pay . The Employee will be entitled to recreation pay (Dmei Havra’a) in accordance with applicable law.

 

10. Additional Benefits . The Employee may be entitled to additional benefits if and only to the extent set forth in Exhibit A .

 

11. Policies and Guidelines . The Employee undertakes to abide by and at all times be in compliance with the policies, guidelines and regulations which are and shall be established by the Company.

 

12. General . Headings in this Agreement are included for reference purposes only and are not to be used in interpreting this Agreement. The exhibits to this Agreement constitute an integral part thereof. Subject to applicable law, no collective bargaining agreement will apply to the relationship between the parties, whether such agreement was signed among the government, the General Federation of Labor and Employers organizations, or any of such parties, or whether signed by others, in relation to the field or fields of the business of the Company or in relation to the position held by or the profession of the Employee. No failure, delay of forbearance of either party in exercising any power or right hereunder will in any way restrict or diminish such party’s rights and powers under this Agreement, or operate as a waiver of any breach or nonperformance by either party of any terms or conditions hereof. In the event it is determined under any applicable law that a certain provision set forth in this Agreement is invalid or unenforceable, such determination will not affect the remaining provisions of this Agreement unless the business purpose of this Agreement is substantially frustrated thereby. This Agreement constitutes the entire understanding and agreement between the parties, supersedes any and all prior discussions, agreements and correspondence with regard to the subject matter hereof, and may not be amended, modified or supplemented in any respect, except by a subsequent writing executed by both parties. The Employee acknowledges and confirms that all terms of Employee’s employment are personal and confidential, and undertakes to keep such terms in confidence and refrain from disclosing such terms to any third party.

 

 
- 4  -

 

The Employee acknowledges that this Agreement, together with the Exhibits thereto, constitutes a due notice to the Employee of the terms of employment, as required under law.

 

העובדת מצהירה בזאת, כי השפה האנגלית מוכרת לה ואינה זקוק לתרגום לשפה אחרת וכי קראה והבינה את כל האמור בהסכם זה על נספחיו.

 

 

IN WITNESS WHEREOF , the parties have executed this Agreement as of the date first above written.

 

One World Cannabis Ltd.   Oron Yacoby Zeevi /s/
       
By:

Mordechai Bignitz /s/

  Signature
Title: CEO    

 

 

 
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Exhibit A to Personal Employment Agreement

 

Employee Name Oron Yacoby Zeevi, ID# 056738511
   
Address 204 Hanarkisim, Bitsaron, Israel
   
Position Chief Scientific Officer
   
Under the Direction CEO
   
Start Date February 18, 2018
   
Scope of Employment The scope of employment shall be 2 days a week, on such days and times as shall be coordinated between the Company and the Employee from time to time.
   
Prior Notice One month. However, during the first three months of employment the notice period shall be the minimum notice period under applicable law.
   
Salary (NIS) The Employee shall be entitled to a gross monthly salary of NIS 18,750 (the “ Base Salary ”). In addition, in consideration for overtime hours that the Employee may work during the month the Employee shall receive a global payment of NIS 6,250 per month (the “ Global Overtime Compensation ”, and together with the Base Salary, the “ Salary ”). The Global Overtime Compensation has been determined based on Company’s estimation of the average of overtime hours per month that the Employee’s position may require.
   
Annual Vacation Days 24 annual vacation days for a full time position, as shall be adjusted for the actual scope of employment. Employee may accumulate at any time unused vacation days in the aggregate number equal to no more than twice the number of the annual vacation days he is entitled to receive.
   
Cellular Phone Company shall reimburse Employee for expenses related to use of cellular phone in accordance with a company policy in that respect, as may be changed from time to time, subject to the submission by the Employee of applicable invoices.
   
Transportation The employee will be entitled to payment for transportation from and to work in the amount of NIS 300 per month.
   
Options

The Company shall recommend the Board of Directors of its parent company, OWC Pharmaceutical Research Corp. (the “ Board ” and “ Parent ”, respectively) to grant the Employee options (the “ Options ”) to purchase up to 1,500,000 shares of Common Stock of the Parent (as may be adjusted due to stock split, reverse stock split and the like), under the Parent’s stock incentive plan (the “ Plan ”). The grant of the Options shall be subject to the approval of the Board, at its sole discretion. The Options shall vest over a 3-year period from the vesting start date determined by the Board (which shall not be earlier than the Start Date), such that 500,000 Options shall vest upon the one year anniversary of the Start Date and the remaining Options shall vest in eight equal installments at the end of each 3-month period thereafter, in each case, provided that the Employee continues to be employed by the Company at the applicable date of vesting. Additional conditions for exercise may apply. The exercise price per share of the Options shall be determined by the Board. The Options shall be subject to the terms of the Plan and their grant shall further be subject to the signing by the Employee of an applicable option agreement and such other grant documents in the forms provided by the Company. Upon cessation of Employee’s employment, any unvested portion of the Option shall immediately expire and any vested portion may be exercisable in the manner and for the period as shall be specified in the grant documents to be provided by the Company.

 

All tax consequences arising from the grant, exercise of the Options or the payment of the exercise price of the Options shall be borne solely by the Employee and the Company and/or Parent shall withhold taxes according to the requirements under the applicable laws, rules, and regulations, including withholding taxes at source, all as shall be detailed in the Plan and/or an option grant agreement to be executed between the parties.

 

 
- 6  -

 

Exhibit B to Personal Employment Agreement

 

Proprietary Information, Confidentiality and Non-Competition Agreement

 

between the Employee and One World Cannabis Ltd.

 

 

  Employee’s Name Oron Yacoby Zeevi

 

 

1. Capitalized terms herein will have the meanings given to them in the Personal Employment Agreement to which this Exhibit is attached (the “ Agreement ”). The term Company will include also all subsidiaries and affiliates of the Company, as applicable, which are deemed third party beneficiaries of this Agreement. The Employee’s obligations and the Company’s rights under this Exhibit will apply as of the beginning of the engagement between the Company and the Employee, regardless of the Start Date or the date of execution of the Agreement or this Exhibit.

 

Confidentiality; Proprietary Information

 

2. The Employee acknowledges and agrees that Employee may have access to confidential and proprietary information concerning the business and financial activities of the Company, including without limitation information relating to the Company’s research and development activities, investments, properties, employees, marketing plans, customers, suppliers, trade secrets, test results, processes, data, know-how, improvements, inventions, techniques, intellectual property and products (actual or planned). Such information, whether documentary, written, oral or computer generated, will be referred to as “ Proprietary Information ”. However, Proprietary Information will exclude information that Employee can demonstrate (i) was known to Employee prior to Employee’s association with the Company (except if related in any way to the Company, including without limitation to the Company’s current and/or contemplated business, services, products and/or activities); or (ii) is or will become part of the public knowledge except as a result of the breach of the Agreement or this Exhibit by the Employee.

 

3. The Employee recognizes that the Company may receive confidential or proprietary information from third parties, subject to a duty on the Company’s part to maintain the confidentiality of such information and to use it only for certain limited purposes. In connection with such duties, such information will be deemed Proprietary Information hereunder, mutatis mutandis . The Employee will not, during his/her employment with the Company, improperly use or disclose any proprietary information or trade secrets of any former or concurrent employer or other person or entity and will not bring onto the premises of the Company any unpublished document or proprietary information belonging to any such employer, person or entity unless consented to in writing by such employer, person or entity.

 

4. The Employee agrees that all Proprietary Information and any patents, trademarks, copyrights and other intellectual property and ownership rights in connection therewith are and will be the sole property of the Company and its assigns. At all times, during Employee’s engagement by the Company and thereafter, the Employee will keep in confidence and trust all Proprietary Information and will not use or disclose Proprietary Information or anything relating to it without the written consent of the Company, except as may be necessary in the ordinary course of performing Employee’s duties under the Agreement.

 

5. Upon termination of the Employee’s employment with the Company, the Employee will promptly deliver to the Company all documents and materials of any nature pertaining to Employee’s work with the Company, and will not retain any documents or materials or copies thereof containing any Proprietary Information.

 

 
- 7  -

 

For the avoidance of doubt, Employee’s undertakings set forth in Sections 2-5 shall remain in full force and effect after termination of the Agreement (for any reason whatsoever) or any renewal thereof.

 

Disclosure and Assignment of Inventions

 

6. From and after the date the Employee first became employed by the Company, the Employee undertakes and covenants that the Employee will promptly disclose in confidence to the Company all inventions, improvements, developments, original works of authorship, designs, concepts, techniques, methods, systems, processes, know how, computer software programs, databases, mask works, trade secrets, discoveries and any other intellectual creations that are related to the Company’s Field of Business (“ Inventions ”), whether or not patentable, copyrightable or protectable as trade secrets, that are made or conceived or first reduced to practice or created by Employee, either alone or jointly with others during the course of or in connection with Employee’s employment with the Company. The Employee undertakes not to disclose to the Company any confidential information of any third party and not to make any use of any intellectual property rights of any third party in the framework of the Employee’s employment by the Company.

 

7. Without derogating from applicable law, the Employee agrees that all Inventions, whether or not patentable, copyrightable or protectable as trade secrets, that are made or conceived or first reduced to practice or created by Employee, either alone or jointly with others, during the course of or in connection with Employee’s employment with the Company that: (a) are developed in whole or in part on Company’s time or using equipment, supplies, facilities, resources or Proprietary Information of the Company, (b) result from or are suggested by any task assigned to Employee or any work performed by the Employee for or on behalf of the Company or by the scope of Employee’s duties and responsibilities with Company, or (c) relate to the Field of Business (as defined in the Agreement), will be the sole and exclusive property of the Company and the Employee will have no rights in or thereto (“ Company Inventions ”).

 

8. The Employee has listed below in this Section 8 a complete list of all inventions to which he claims ownerships (the “ Prior Inventions ”) and that the Employee desires to remove from the operation of this Exhibit, and acknowledges and agrees that such list is complete. If no such list is attached to this Exhibit, the Employee represents that he has no such Inventions at the time of signing this Agreement. The Prior Inventions, if any, patented or unpatented, are excluded from the scope of this Exhibit. If, in the course of employment with the Company, the Employee incorporates a Prior Invention into a Company product, process or machine, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, worldwide license (with rights to sublicense through multiple tiers of sublicensees) to make, have made, modify, use and sell such Prior Invention. Notwithstanding the foregoing, the Employee agrees that the Employee will not incorporate, or permit to be incorporated, Prior Inventions in any Company Inventions without the Company’s prior written consent. The Employee hereby represents and undertakes that none of his/her previous employers or any entity with whom the Employee was engaged, has any rights in the Inventions or Prior Inventions and such employment with the Company will not grant any of them any right in the results of the Employee’s work.

 

Prior Inventions : [fill-in, if any.]

 

_____ Extractions and derivatives thereof from medicinal plants, excluding cannabis, for medical uses;

 

Production of CBG; Formulations of CBG; Medical uses of CBG;

 

Formulations for the sub-cutaneous and transdermal delivery of drugs;

 

 
- 8  -

 

9. The Employee hereby irrevocably transfers and assigns to the Company, without further compensation, all worldwide patents, patent applications, copyrights, mask works, trade secrets and other intellectual property rights in any Company Invention, and waives any and all moral rights that Employee may have in or with respect to any Company Invention related only to the scope of work with the company and its field of business. The Employee hereby irrevocably, unconditionally and expressly waives any right and/or claim to any consideration or compensation whatsoever with regard to the Company Inventions and the assignment, use or commercialization thereof, including without limitation any royalty payment and other payment with respect thereto (and including without limitation under Section 134 of the Israeli Patent Law, 1967). The Employee agrees and understands that the Salary (set forth in Exhibit A) includes adequate compensation for any transfer or assignment made by the Employee, if any, pursuant to this Section 9.

 

The Employee agrees to assist the Company, at the Company’s expense, in every proper way to obtain for the Company and enforce patents, copyrights, mask work rights, and other legal protections for the Company’s Inventions in any and all countries. The Employee will execute any documents that the Company may reasonably request for use in obtaining or enforcing such patents, copyrights, mask work rights, trade secrets and other legal protections. Such obligation will continue beyond the termination of the Employee’s employment with the Company. The Employee hereby irrevocably designates and appoints the Company and its officers and agents as the Employee’s agent and attorney in fact, coupled with an interest to act for and on Employee’s behalf and in Employee’s stead to execute and file any document needed to apply for or prosecute any patent, copyright, trademark, trade secret, any applications regarding same or any other right or protection relating to any Proprietary Information (including Company Inventions), and to do all other lawfully permitted acts to further the prosecution and issuance of patents, copyrights, trademarks, trade secrets or any other right or protection relating to any Proprietary Information (including Company Inventions), with the same legal force and effect as if executed by the Employee.

 

Non-Competition; Non-Solicitation

 

10. Employee agrees and understands that the Employee’s Salary (set forth in Exhibit A) includes adequate compensation for his/her undertakings under this Section 10. Therefore, in order to enable the Company to effectively protect its Proprietary Information, the Employee undertakes that, so long as Employee is employed by the Company and for a period of twelve (12) months thereafter, the Employee will not, directly or indirectly, as owner, employee, agent, or in any capacity whatsoever engage in, become financially interested in, be employed by, render services or assists to, or have any connection with, any person, corporation, business or venture that is engaged in any activities involving services, products, information, processes, technology or equipment that are competitive to those of the Company in the Field of Business; provided, however, that Employee may own securities of any publicly traded corporation in an amount not to exceed three percent of any class of stock or securities of such company, and so long as Employee has no active role in such corporation in any capacity.

 

11. The Employee agrees and undertakes that during the period of Employee’s employment and for a period of twelve (12) months thereafter, the Employee will not, directly or indirectly, including personally or in any business in which Employee is an officer, director or shareholder, for any purpose or in any place solicit (i) for employment any person employed by the Company (or retained by the Company as a consultant, if such consultant is prevented thereby from continuing to render its services to the Company in the manner provided immediately before) on the date of such termination or during the preceding twelve (12) months, and (ii) the business of any customer of the Company for the purpose of offering services or products which compete with the services or products supplied to such customer by the Company.

 

Reasonableness of Protective Covenants; Remedies for Breach

 

12. Insofar as the protective covenants set forth in this Exhibit are concerned, the Employee specifically acknowledges, stipulates and agrees as follows: (i) the protective covenants are reasonable and necessary to protect the goodwill, property and Proprietary Information of the Company, and the operations and business of the Company; and (ii) the time duration of the protective covenants is reasonable and necessary to protect the goodwill and the operations and business of Company, and does not impose a greater restrain than is necessary to protect the goodwill or other business interests of the Company. Nevertheless, if any term contained in this Exhibit B will for any reason be held to be excessively broad with regard to time, geographic scope or activity, such term will be construed in a manner to enable it to be enforced to the extent compatible with applicable law.

 

 
- 9  -

 

13. The Employee acknowledges that the legal remedies for breach of the provisions of this Exhibit may be found inadequate and therefore agrees that, in addition to all of the remedies available to the Company in the event of a breach or a threatened breach of any of such provisions, the Company may also, in addition to any other remedies which may be available under applicable law, obtain temporary, preliminary and permanent injunctions against any and all such actions.

 

14. The Employee recognizes and agrees: (i) that this Exhibit is necessary and essential to protect the business of the Company and to realize and derive all the benefits, rights and expectations of conducting the Company’s business; (ii) that the area and duration of the protective covenants contained herein are in all things reasonable; and (iii) that good and valuable consideration exists under the Agreement, for the Employee’s agreement to be bound by the provisions of this Exhibit.

 

IN WITNESS WHEREOF the Employee has signed this Proprietary Information, Confidentiality and Non-Competition Agreement as of the date first hereinabove set forth.

 

 

Oron Yacoby Zeevi /s/

 

 
- 10  -

 

 
 

 

 

 

Consulting Agreement

 

This consulting agreement (the “ Agreement ”) is entered into as of July 24, 2017, by and between One World Cannabis Ltd, an Israeli company with its principal place of business at 30 Shaham St., Petach-Tikva, Israel (the “ Company ”), and Zeas Technolgoy & Science Management Ltd., an Israeli company with its principal place of business at 34 Harav Friedman, Tel-Aviv, Israel (“ Consultant ”).

 

Whereas Consultant has the requisite professional expertise, know-how, experience and skills to provide expert Services to the Company (as defined below); and

 

Whereas the Company wishes for the Consultant to provide pursuant to the terms and conditions set forth in this Agreement.

 

NOW, THEREFORE, it is hereby agreed as follows:

 

1. Term; Termination .

 

  1.1. The terms of this Agreement are effective as of August 1, 2017 (the “ Effective Date ”), and shall continue until terminated in accordance with Section 1.2 hereunder (such term shall be referred to in this Agreement as the “ Term ”).
     
  1.2. Either party may terminate this Agreement for any reason upon a prior written notice of 60 days, to the other party, at any time. Additionally, either party may by notice in writing immediately terminate this Agreement in the event of a breach by the other party of its obligations under this Agreement, which has not been cured (if curable) within 10 days of receipt of written notice of such breach. In addition, in the event of a Cause (as defined below), the Company will be entitled to terminate this Agreement immediately and this Agreement and the engagement will be deemed effectively terminated as of the time of delivery of such notice and the Company shall have no obligation to pay any compensation during or in lieu of the notice period. The term “ Cause ” means: (i) the Consultant engages in any act of dishonesty, fraud, or misrepresentation, in his capacity as Consultant; (ii) the Consultant engages in any intentional illegal conduct; (iii) the Consultant’s violation of any law or regulation applicable to the Company’s business; or (iv) any unauthorized use or disclosure by the Consultant of the Company’s confidential information or trade secrets or any other breach of the provisions of Sections 4-6 hereto. For the avoidance of doubt, the undertakings in Sections 4-7 shall remain in full force and effect after termination of the Agreement (for any reason whatsoever

 

2. The Services . Services shall be provided by Consultant solely through Dr. Stanley Hirsch, unless otherwise agreed by the Company in writing. Any provision of Section 1 and 4-7 herein shall also apply to Dr. Stanley Hirsch mutatis mutandis . Consultant agrees to provide the services further detailed in Exhibit A attached hereto (the “ Services ”) and in the scope described therein, and shall not deviate from such scope without the Company’s prior written approval. The dates and places for performance of the Services shall be coordinated between Consultant and the Company. Consultant shall utilize the highest professional skill, diligence, ethics and care to ensure that the Services are performed to the satisfaction of the Company and to provide the expertise required in connection with such Services. Consultant shall furnish the Company with such reports concerning his activities as the Company may request from time to time.
   
3. Consideration; Expenses .

 

  3.1. As sole compensation for the Services the Company shall pay Consultant the consideration stated in Exhibit A hereto (the “ Fee ”). The Fee constitutes the full and final consideration for the Services hereunder, and Consultant shall not be entitled to any additional consideration, of any form, for the Services.

 

 
- 2 -

 

  3.2. The Fees due in respect of the Services provided in each calendar month shall be payable by the 9th day of each calendar month with respect to the Services provided during the preceding month. and Consultant will issue a valid invoice and receipt immediately after a payment transfer by the Company.
     
  3.3. Consultant shall be entitled to reimbursement of expenses as specified in Exhibit A .
     
  3.4. Consultant acknowledges and agrees that as a service provider to the Company, Consultant is not entitled to receive from the Company any social benefits (including without limitation, paid vacation days, paid sick leave, severance payments, pension funds, etc.). All tax consequences related to any consideration or benefit provided to the Consultant pursuant to this Agreement shall be borne by the Consultant and shall be subject to any tax withholding required of the Company under applicable law (provided that Company shall not withhold any amount, or reduce the amount withheld by it, as applicable, in the event Consultant submits to the Company an exemption or reduced withholding approval from the requisite tax authorities).

 

4. Confidentiality .

 

  4.1. Consultant agrees to keep confidential all information concerning the Company’s business or its ideas, products, customers or services that could be considered to be confidential or proprietary to the Company including without limitation, all business, technical financial or other information created or exchanged between the parties in the course of the Services being provided, and any information belonging to or in the possession or control of the Company that is of a confidential, proprietary or trade secret nature, and that is furnished or disclosed to Consultant during the course of their dealings pursuant to this Agreement (collectively, the “ Confidential Information ”). For the avoidance of doubt, Confidential Information will remain the property of the Company and Consultant will not acquire any rights to that Confidential Information even after the Agreement expires or is terminated.
     
  4.2. Consultant: (i) may not use any Confidential Information for any purpose other than the performance of its obligations under this agreement; (ii) may not disclose any Confidential Information to any person except with the prior written consent of the Company or in order to perform the obligations of Consultant under this Agreement; and (iii) shall make every reasonable effort to prevent the unauthorized use or disclosure of the Confidential Information.
     
  4.3. Notwithstanding anything in this Agreement to the contrary, the following shall not be considered Confidential Information: (i) information that is in the possession of or is published or is otherwise in the public domain or publicly available prior to its receipt by Consultant; (ii) information that becomes part of the public domain or publicly available through no fault of Consultant; (iii) information that is required to be disclosed by any applicable law or regulation; or (iv) information that is received by Consultant from a third party with right to disclose such Confidential Information and without breach of confidentiality obligations to Company.
     
  4.4. Without prejudice to any other rights or remedies which the Company may have, Consultant acknowledges and agrees that in the event of breach of this Section, the Company shall, without proof of special damage, be entitled to an injunction or other equitable remedy for any threatened or actual breach of the provisions of this Section in addition to any damages or other remedies to which Consultant may be entitled.
     
  4.5. Upon the Company’s demand, Consultant shall return to the Company all documents or materials or copies thereof containing any Confidential Information and shall erase any electronic record thereof.

 

 
- 3 -

 

  4.6. For the purposes this Agreement, Confidential Information shall also include any information as detailed above with respect to the Company’s Parent Company, OWC Pharmaceutical Research Corp. (the “ Parent Company ”). The Consultant hereby acknowledges that the Parent Company is a publicly traded company. As such, it agrees not to use any Confidential Information in connection with the purchase or sale of the securities of the Parent Company in violation of United States or other applicable securities laws.

 

5. Inventions .

 

  5.1. Inventions ” means any and all inventions, improvements, designs, concepts, techniques, methods, systems, processes, know how, computer software programs, databases, mask works and trade secrets, whether or not patentable, copyrightable or protectable as trade secrets; “ Company Inventions ” means any Inventions that are made or conceived or first reduced to practice or created by Consultant, whether alone or jointly with others, during or after the Term, and which: (i) are developed using Confidential Information, trade secrets or equipment of the Company, or (ii) result from work performed by Consultant for the Company.
     
  5.2. The Consultant undertakes to promptly disclose in confidence to the Company all Company Inventions. The Company will be the exclusive owner of all Company Inventions and any patents, trademarks, copyrights and other intellectual property and ownership rights in connection therewith. The Company Inventions will constitute “works made for hire,” and the ownership of such Company Inventions will vest in the Company. Without derogating from the above, Consultant hereby assigns and transfers to the Company all right, title and interest that Consultant may now or hereafter have in the Company Inventions and waives any moral rights with respect thereto. Consultant acknowledges that the Fees include adequate consideration for the above mentioned assignment and that Consultant shall not be due any consideration, royalties or other form of payment aside from the Fees in connection with such assignment (including without limitation under Section 134 of the Israeli Patent Law - 1967, to the extent applicable).
     
  5.3. Consultant will take all necessary action deemed expedient by the Company (including, but not limited to, the execution, acknowledgment, delivery and assistance in preparation of documents or the giving of testimony) as may reasonably be requested by the Company, and provided that the Company duly compensates Consultant therefore, to evidence, transfer, vest or confirm the Company’s right, title and interest in the Company Inventions.
     
  5.4. The Consultant will not, during his engagement with the Company, improperly use or disclose any proprietary information or trade secrets of any third party. The Consultant agrees that the Consultant will not incorporate, or permit to be incorporated, any Inventions which are not Company Inventions in any Company Inventions without the Company’s prior written consent. If however, despite the prohibition in the preceding sentence, the Consultant incorporates an Invention that is not a Company Invention into a Company product, process or machine, then without derogating from any remedies available to the Company in such case, the Company shall be deemed to have been granted by the Consultant a nonexclusive, royalty-free, irrevocable, perpetual, worldwide license (with rights to sublicense through multiple tiers of sublicensees) to make, have made, modify, use and sell such Invention.

 

 
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6. Non-Competition; Non-Solicitation .

 

  6.1. In order to enable the Company to effectively protect its Confidential Information, the Consultant undertakes that, so long as the Consultant is engaged by the Company and for a period of twelve (12) months thereafter, the Consultant will not, directly or indirectly, as owner, employee, agent, or in any capacity whatsoever engage in, become financially interested in, be employed by, render services to, or have any connection with any business or venture that is engaged in cannabis based pharmaceuticals (a “ Barred Entity ”). Notwithstanding the forgoing, (i) Consultant may engage in any manner with or by a Barred Entity which has other activities aside from those related to cannabis based pharmaceuticals in the event it is engaging such Barred Entity with respect to such other activities, and (ii) may hold up to 5% of the issued shares of any Barred Entity, provided Consultant has no active involvement whatsoever, in any capacity, with the cannabis based pharmaceuticals activities of such Barred Entity.
     
  6.2. The Consultant agrees and undertakes that during the period of the Consultant’s engagement with the Company and for a period of twelve (12) months thereafter, the Consultant will not, directly or indirectly, including personally or in any business in which Consultant is an officer, director or shareholder, for any purpose or in any place solicit (i) for employment any person employed by the Company (or retained by the Company as a consultant, advisor or service provider) on the date of such termination or during the preceding twelve months, and (ii) the business of any customer of the Company for the purpose of offering services or products which compete with the services or products supplied to such customer by the Company.

 

7. Independent Contractor . The Consultant acknowledges that Consultant is not an employee of the Company, but rather a service provider, that Consultant was offered the opportunity to serve as an employee of the Company and has expressly insisted not to be so employed, but rather enter into this Agreement with the Company as an independent contractor and the terms of this Agreement, including the Fees, reflect such agreement between the parties. The Consultant hereby undertakes to indemnify and hold harmless the Company for any liability, damage, cost or expense (including, without limitation, legal and other reasonable expenses) caused to the Company, in connection with or as a result of a competent authority’s decision that the Consultant is or was, in fact, in spite of the aforesaid, an employee of the Company. Without derogating from the above, the parties hereby further agree that in the event that any competent court of law and/or other authority shall rule, in spite of the explicit agreement between the parties as aforesaid in the preamble and in this Section 7, that the relations between the parties hereto are employer-employee relations (a “ Ruling ”), then the following terms shall be in effect:

 

  7.1. The Consultant shall not be entitled to the consideration due and/or paid to him under this Agreement, retroactive to the date upon which the Consultant commenced the provision of Services to the Company. The Consultant shall instead be entitled to receive a gross salary equal to 65% of the Fees (the “ Reduced Consideration ”). It is hereby agreed by the parties that the Reduced Consideration shall constitute fair and reasonable wages in the event of a Ruling.
     
  7.2. The parties shall settle their account, and the Consultant shall immediately repay the Company any amounts paid to it beyond the amounts in Section 7.1 above, together with interest and linkage differentials from the date of actual payment to the Consultant to the date of repayment to the Company.
     
  7.3. In the event that the Company shall be required to pay any amount or grant any right to any third party due to a Ruling, the Consultant shall indemnify and hold the Company harmless against any amount that it shall be required to pay to any such third party and/or against any other liability which the Company shall be required to bear due to such Ruling. For the purposes of this Section 7.3, the term “required” shall include without limitation any amounts paid for the settlement of a claim against the Company in this context, whether or not such claim has reached the courts.
     
  7.4. The Company shall be entitled to deduct any amounts due to the Company from the Consultant hereunder from any amount which it is required to pay to the Consultant or any third party, in accordance with or as a result of a Ruling, if any, or to set off such amounts from any debt. Nothing in this Section 7.4 shall be construed as releasing the Consultant from his obligation to repay any debts to the Company, if Company does not so deduct, or if the amounts so deducted shall be insufficient to cover the full amount due to the Company from the Consultant.

 

 
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8. Representations . The parties represent and warrant to each other that the execution and delivery of this Agreement and the fulfillment of the terms hereof by them (i) will not constitute a default under or conflict with any agreement or other instrument to which each is a party or by which each is bound; (ii) will not result in a breach of any confidentiality undertaking to any third party, and (iii) do not require the consent of any person or entity. Consultant further represents and warrants that Consultant is not subject to any agreement or other instrument which gives any rights to a third party in the Company Inventions.
   
9. Miscellaneous . This Agreement constitutes the entire understanding between the parties with respect to the matters referred to herein. This Agreement shall be governed by the laws of the State of Israel, excluding its conflict of law rules, and the courts of Tel-Aviv-Jaffa shall have exclusive jurisdiction over the parties. This Agreement may not be assigned by the Consultant without the Company’s prior written consent. The Company may freely assign this Agreement. This Agreement may not be amended or modified, except by the written consent of both parties hereto. No failure or delay on the part of any party hereto in exercising any right, power or remedy hereunder shall operate as a waiver thereof. Headings to Sections herein are for the convenience of the parties only, and are not intended to be or to affect the meaning or interpretation of this Agreement. In the event that any covenant, condition or other provision contained in this Agreement is held to be invalid, void or illegal by any court of competent jurisdiction, the same shall be deemed severable from the remainder thereof, and shall in no way affect, impair or invalidate any other covenant, condition or other provision therein contained. All notices required to be delivered under this Agreement shall be effective only if in writing and shall be deemed given when received by the party to whom notice is required to be given and shall be delivered personally, by registered mail, by fax or by means of electronic communication.

 

[ Signature page follows ]

 

 
- 6 -

 

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.

 

Consultant acknowledges that:

 

(1) prior to signing this Agreement, the Consultant read and fully understood all the provisions of this Agreement and its Exhibits; (2) the Consultant’s knowledge of the English language allows him/her to understand all of the terms and conditions detailed in this Agreement and its Exhibits, and there is no portion of this Agreement and its Exhibits which the Consultant did not understand.

 

 

 

ONE WORLD CANNABIS LTD.   ZEAS TECHNOLGOY & SCIENCE MANAGEMENT LTD.
     
By: Mordechai Bignitz /s/   By: Stanley Hirsch /s/
Title: CEO   Title: CEO and founder

 

The undersigned agrees to be bound by the terms of Sections 4-7 of the Agreement, as if it were the Consultant.

 

Dr. Stanley Hirsch /s/

 

 
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Exhibit A

 

Services; Fees; Expenses

 

Description of Services: The Consultant shall provide pharmaceutical and operational management consulting services to the Company, and other related services as may be requested by the Company from time to time:
   
  The Consultant may also provide such services to the Parent Company, upon request of the Company (provided that the Company shall be required to pay all Fees).
   
Scope of Services: The Consultant shall provide the Services in an average scope to be agreed from time-to-time between the Consultant and the CEO of the Company. For the avoidance of doubt, it is hereby agreed that the Consultant shall not be entitled to any additional compensation with respect to additional monthly work hours, unless such additional work hours were priorly approved in writing by the Company, at its sole discretion.
   
Fee : The Consultant shall be entitled to consideration, with respect to his Services to the Company within the above specified scope, in the amount of 25,000 NIS per month, plus VAT, at the standard rate, if applicable.
   
Expenses : Consultant shall be entitled to reimbursement of expenses, based on the Company’s reimbursement policy, as shall be amended from time to time, and in addition, to any expenses which have been approved in advance and in writing by the CEO of the Company.

 

 
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Corporate Advisory Consulting Agreement

 

This Services Agreement (this “Agreement”), is made as of this 24 day of July 2017 (the “Effective Date”), between OWC Pharmaceutical Research Corp., a Delaware corporation, having its principal place of business located at 30 Shacham Street, PO Box 8324, Petach Tikva 4918103 Israel (the “Company”) and Mr. Stanley Hirsch, a resident of the State of Israel with an address at 34 HaRav Friedman Street, Tel Aviv 6230334 Israel (“Mr. Hirsch” or the “Chairman”). The Company and the Chairman are sometimes referred to individually, as a “Party” and collectively, as the “Parties.”

 

NOW, THEREFORE, in consideration of the premises and promises, warranties and representations herein contained, it is agreed as follows:

 

1. Services : Mr. Hirsch shall provide services to the Company in the capacity as Chairman of the Company’s Board of Directors (the “Services”), and provide such time the services of the nature and in the scope set forth in Exhibit A hereto.

 

2. Consideration : In consideration for Services, the Company shall cause to be granted to the Chairman options (the “Options”) to purchase a total of one million five hundred thousand (1,500,000) shares of the Company’s common stock, par value $0.0001 (the “Option Shares”), at an exercise price of $0.05 per Option Share, pursuant to the Company’s 2016 ESOP plan as follows:

 

(i) Options exercisable to purchase 500,000 Option Shares, vesting immediately upon the “Effective Date; 

 

(ii) Options exercisable to purchase 500,000 additional Option Shares, vesting twelve (12) months from the Effective Date; and

 

(iii) Options exercisable to purchase 500,000 additional Option Shares, vesting. on a quarterly basis from month 13 after the Effective Date].

 

The Options shall be granted to the Chairman under Section 102 of the Israeli Income Tax Ordinance [New Version] 5721-1961, and the Company shall take all actions necessary to qualify the grant of Options to the Chairman as a 102 grant (including without limitation the engagement of a trustee, and submission of the Company’s ESOP plan to the Israeli Tax Authority).

 

3. Representations and Warranties :

 

3.1. For purposes of this Agreement, Mr. Hirsch represents and warrants as follows:

 

(i) Mr. Hirsch is aware that the Option Shares, when issued, will be fully-paid and nonassessable shares of the Company’s common stock but said Option Shares, when issued, will not have been registered under the Securities Act of 1933, as amended (the “Act”) and, as a result, are not transferable under this Agreement and applicable securities laws unless such shares are registered under the Act or pursuant to an available exemption under Rule 144 or other rule or regulation promulgated by the Securities and Exchange Commission (the “SEC”) under the Act;

 

(ii) Mr. Hirsch is aware that the Company is subject to reporting requirements with the SEC under the Securities Exchange Act of 1934 (the “Exchange Act”), and that in order for Mr. Hirsch to avail himself of the exemption to sell the Option Shares under the Act all applicable legal requirements of the Act pertaining to such sale must be complied with; and

 

(iii) Mr. Hirsch is an “accredited investor” as that term is defined in rule 501 of Regulation D promulgated by the SEC under the Act.

 

3.2. For purposes of this Agreement, the Company represents and warrants that the Option Shares, when issued, will be fully-paid and non-assessable shares of the Company’s common stock, free and clear of any liens, charges or other restrictions aside from those specified in Section 5.1.(i) above and the Company’s certificate of incorporation;

 

4. No Third-Party Rights : The Parties represent and warrant that they are authorized to enter into this Agreement and that no third parties have any interest in any of the Services contemplated hereby. The Company further represents that all necessary approvals for this Agreement and the transactions contemplated herein, including without limitation those of its shareholders and requisite committees, have been attained.

 

 
- 9 -

 

5. Indemnification and Insurance : The Company shall promptly, and no later than 30 days following the Effective Date, enter into an indemnification agreement with the Chairman in the standard form executed with other members of the Company’s Board of Directors (and in the event no such standard form exists, in a form that assures the Chairman the utmost protection allowed under applicable law), and shall assure that the Chairman is covered by the Company’s D&O insurance, such insurance to contain coverage amounts and other protective provisions no less protective than those standard for similar companies in the Company’s field of business. At the Chairman’s request, the Company shall provide the Chairman copies of the applicable D&O insurance policies.

 

6. Governing Law/Arbitration : This Agreement shall be governed by and construed in accordance with the laws of the State of New York. Any dispute arising under or related to this Agreement or the construction or application of this Agreement, any claim arising out of this Agreement or its breach, shall be submitted to arbitration in New York County, State of New York, before one arbitrator in accordance with the Commercial Arbitration Rules of the American Arbitration Association, upon the written request of one Party after service of that request on the other Party. The cost of arbitration shall be borne by the losing Party as shall be determined by the arbitrator. The arbitrator is also authorized to award reasonable attorney’s fees to the prevailing Party.

 

7. Entire Agreement : This Agreement contains the entire understanding of the Parties on the subject matter hereof and cannot be altered or amended except by an amendment duly executed by the Parties hereto. This Agreement shall be binding upon and inure to the benefit of the successors, assigns and personal representatives of the Parties.

 

IN WITNESS WHEREOF, the Parties hereto have executed this Agreement effective as of the date first written above.

 

OWC Pharmaceutical Research Corp.     Stanley Hirsch
       
Name: /s/ Mordechai Bignitz       /s/ Stanley Hirsch
Title: Chief Executive Officer    

 

 
- 10 -

 

EXHIBIT A

 

DESCRIPTION OF ADDITIONAL SERVICES OF CONSULTANT

 

The Consultant agrees, to the extent reasonably required in the conduct of its business with the Company, to place at the disposal of the Company its judgment and experience and to provide business development services to the Company including, but not limited, to, the following:

 

(i) review the Company’s financial requirements;

(ii) analyze and assess alternatives for the Company’s financial requirements;

(iii) provide introductions to professional analysts and money managers;

(iv) assist the Company in financing arrangement to be determined and governed by separate and distinct financing agreements;

(v) assist the Company in developing and maintaining relationships with media, IR and related professionals for the furtherance of the Company’s business.

 

Scope of Services: as to be determined between the CEO and the Chairman from time-to-time.

 

 
 

 

 

 

OWC PHARMACEUTICAL RESEARCH CORP.

 

Audit Committee Charter

 

Purpose

 

The Committee is appointed by the Board of Directors of OWC Pharmaceutical Research Corp. (the “Company”) to (a) assist the Board in its oversight of (i) the integrity of the Company’s consolidated financial statements, (ii) the Company’s compliance with legal and regulatory requirements, (iii) the Company’s system of internal controls, (iv) certain aspects of the Company’s risk management as described herein, (v) the qualifications and independence of the Company’s independent registered public accounting firm (“independent auditor”) and (vi) the performance of the Company’s internal and independent auditors, and (b) prepare a report to be included in the Company’s annual proxy statement.

 

It is the responsibility of the Company’s management to prepare consolidated financial statements that are complete and accurate and in accordance with generally accepted accounting principles in the United States (“GAAP”) and to establish satisfactory internal control over financial reporting. It is the responsibility of the Company’s independent auditor to audit the Company’s financial statements and the effectiveness of the Company’s internal control over financial reporting. The Committee’s responsibility in this regard is one of oversight and review. The Committee does not provide any expert or other special assurance as to such financial statements concerning compliance with laws, regulations or GAAP.

 

Membership

 

  1. The Committee shall be comprised of at least three Board members appointed by the Board after considering the recommendation of the Nominating and Governance Committee, if any. No Board member shall serve simultaneously on the Committee and the audit committee of more than two other public companies, unless the Board shall determine that such simultaneous service would not impair the Board member’s ability to serve effectively on the Committee and such determination is disclosed in the Company’s proxy statement. Committee members shall serve at the pleasure of the Board and for such term as the Board determines. The Board shall designate one Committee member as the Committee’s chair (the “Chair”).
     
  2. Each Committee member shall have no material relationship with the Company and shall satisfy the independence requirements of the Company, the New York Stock Exchange (“NYSE”), the Securities Exchange Act of 1934 (the “Exchange Act”), and the rules and regulations of the Securities and Exchange Commission (“SEC”).
     
  3. Each Committee member shall be financially literate in accordance with NYSE requirements or must become financially literate in accordance with such requirements within a reasonable period of time after his or her appointment to the Committee.
     
  4. At least one Committee member shall have accounting or related financial management expertise in accordance with NYSE requirements, and at least one Committee member shall, in the judgment of the Board, be an “audit committee financial expert” as defined by the SEC.

 

 

 

 

Operations

 

  1. The Committee shall hold regular meetings at least four times per year and report to the Board on a regular basis. Meetings shall include any participants the Committee deems appropriate and shall be of sufficient duration and scheduled at such times as the Committee deems appropriate to discharge properly its responsibilities. The Chairman and Chief Executive Officer, Chief Financial Officer and other Executive Officers, if any, shall generally attend all regularly scheduled in person quarterly meetings of the Committee.
     
  2. The Committee shall meet, as deemed necessary and appropriate, with the independent auditor and with management, including the Chief Financial Officer and other Executive Officers, if any, in separate executive sessions.
     
  3. The Committee shall receive information and participate in informal meetings and briefings with management, including the Chief Financial Officer and other Executive Officers, if any, and representatives of the independent auditor, as necessary and appropriate between formal meetings of the Committee. Such briefings and informal meetings may be through the Committee Chair or individual Committee members, as appropriate.
     
  4. The Committee, or the Chair or other individual committee members, may meet with regulators as requested or when determined appropriate, regarding matters applicable to the mandate of the Committee.
     
  5. The Committee shall evaluate the independent auditor’s qualifications, performance and independence and present its conclusions to the Board of Directors. The Committee shall review with the full Board any issues arising with respect to the quality or integrity of the Company’s financial statements, the Company’s compliance with legal or regulatory requirements, the performance and independence of the Company’s independent auditor, or the performance of the internal audit department.
     
  6. The Committee may form and delegate to one or more subcommittees all or any portion of the Committee’s authority, duties and responsibilities, and may establish such rules as it determines necessary or appropriate to conduct the Committee’s business.

 

 

 

 

  7. The Committee shall have direct access to, and complete and open communication with, the Company’s management and internal and independent auditors and may obtain advice and assistance from internal legal, accounting or other advisors. The Committee may retain independent legal, accounting or other advisors. The Committee shall have authority to perform or supervise investigations, and the Company shall provide for appropriate funding, as determined by the Committee, for the payment of expenses related to any such investigation.
     
  8. The Company shall provide for appropriate funding, as determined by the Committee, for the payment of: (i) compensation to the independent auditor engaged for the purpose of preparing or issuing an audit report or performing other audit, review or attest services or other permitted services for the Company; (ii) ordinary administrative expenses of the Committee that are necessary or appropriate in carrying out its duties and responsibilities; and (iii) compensation to independent legal, accounting or other advisors retained by the Committee.
     
  9. The Committee shall review and assess annually its performance and report the results to the Board.
     
  10. The Committee shall review and assess annually the adequacy of this charter and, if appropriate, recommend changes to the charter to the Board.

 

Authority, Duties and Responsibilities

 

The Committee shall:

 

Oversight of the Company’s Relationship with the Independent Auditor

 

  1. Have the sole authority and responsibility to appoint (which appointment may be presented to shareholders for ratification), compensate, retain, oversee, evaluate and, when appropriate, replace the independent auditor engaged for the purpose of preparing or issuing an audit report or performing other audit, review and attest services. The independent auditor shall report directly to the Committee.
     
  2. Preapprove all audit, review and attest services and permitted non-audit services to be performed for the Company by its independent auditor, subject to the de minimis exception for non-audit services described in Section 10A(i)(1)(B) of the Exchange Act that are approved by the Committee prior to the completion of the audit. The Committee may form and delegate authority to subcommittees consisting of one or more members the authority to grant preapprovals of audit and permitted non-audit services, provided that decisions of such subcommittee to grant preapprovals shall be presented to the full Committee at its next quarterly meeting.
     
  3. Review and evaluate annually the qualifications, performance and independence of the lead partner of the independent auditor and assure regular rotation of the lead audit partner, reviewing partner and other audit engagement team partners of the independent auditor as required by law. Consider, as appropriate, the rotation of the independent auditor. Review and assess annually the qualifications and performance of the independent auditor.

 

 

 

 

  4. Evaluate the independence of the independent auditor by, among other things, ensuring that the independent auditor periodically, and at least annually, submits to the Committee a formal written report delineating all relationships between the independent auditor and the Company, including any non-audit service permitted under the Exchange Act provided to the Company and the matters set forth in Public Company Accounting Oversight Board (“PCAOB”) rules or other applicable laws, regulations or standards. Review and evaluate such report and engage in a dialogue with the independent auditor with respect to any disclosed relationships or services that may impact their objectivity and independence.
     
  5. Obtain, review and evaluate, at least annually, a report by the independent auditor describing the independent auditor’s internal quality-control procedures, any material issues raised by the most recent internal quality-control review, peer review, or PCAOB review, of the independent auditor, or by any inquiry or investigation by governmental or professional authorities, within the preceding five years, respecting one or more independent audits carried out by the independent auditor, and any steps taken in response to any such issues.
     
  6. Set policies for the Company with respect to hiring current and former employees of the independent auditor.

 

Oversight of the Company’s Internal Audit Department and Internal Controls

 

7. Approve the appointment and, when and if appropriate, replacement of the Global Audit Director, who shall functionally report directly to the Committee and administratively to the Chief Executive Officer. Review the qualifications, performance and compensation of the Global Audit Director.

 

8. Review the significant reports to management, or summaries thereof, prepared by the internal audit department, management’s responses and the status of associated remediation plans.

 

9. Discuss, as appropriate, the adequacy of the Company’s internal controls with the internal and independent auditors and management including, without limitation, reports from the Chief Executive Officer and the Chief Financial Officer regarding significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting or any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal controls.

 

10. Review and discuss, as appropriate, any major issues as to the adequacy of the Company’s internal controls and any special audit steps adopted in light of material control deficiencies.

 

 

 

 

11. Review the Chief Executive Officer and Chief Financial Officer certification process and the role of the Company’s Disclosure Committee.

 

12. Review and discuss with management and the internal and independent auditors management’s annual report on, and the independent auditor’s evaluation of the effectiveness of, the Company’s internal control over financial reporting. Receive reports from management regarding management’s quarterly evaluations of changes in internal control over financial reporting and discuss with management and the internal and independent auditors as appropriate.

 

13. Review the annual plan and scope of work and coverage of the internal audit department, including the risk-based approach to development of the plan, and receive updates on significant changes in scope of the plan and coverage during the year, as appropriate. Review the responsibilities, budget, resources and staffing of the internal audit department, including any outsourcing or co-sourcing of services. Review the results of internal and external quality assurance reviews of the internal audit department, and participate in selection of the third parties engaged to conduct external quality assurance reviews. Review and approve the internal audit department charter, as appropriate.

 

Oversight of the Financial Statements, Audit and Disclosure

 

14. Review (i) the results of internal and independent audits and reviews of, and meet to review and discuss with management and the independent auditor, the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q (including the Company’s annual audited consolidated financial statements and condensed consolidated quarterly and year-to-date financial statements) and (ii) the Company’s specific disclosures under “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and other matters required by applicable PCAOB standards or under applicable legal, regulatory or NYSE requirements.

 

15. Regularly review with the independent auditor significant issues regarding accounting principles and financial statement presentations, including (i) any significant changes in the Company’s selection or application of accounting principles; (ii) analyses prepared by management and/or the independent auditor setting forth significant financial reporting issues and judgments made in connection with the preparation of the financial statements, including analyses of the effects of alternative GAAP methods on the financial statements; and (iii) any significant communications between the independent audit team and the independent auditor’s national office respecting auditing or accounting issues presented by the engagement.

 

16. Review and discuss with the independent auditor and, to the extent appropriate, management, in connection with the Company’s Annual Report on Form 10-K, and otherwise, as appropriate, any reports of the independent auditor required by law or professional auditing standards, including reports on: (i) critical accounting policies and practices used in preparing the financial statements; (ii) alternative treatments under GAAP for policies and procedures related to material items discussed with management, ramifications of the use of such alternative disclosures and treatments, and the treatment preferred by the independent auditor; and (iii) other material written communications between the independent auditor and management of the Company, such as any “management” or “internal control” letter issued, or proposed to be issued, by the independent auditor to the Company, and a schedule of unadjusted differences, if any.

 

 

 

 

17. Discuss with the independent auditor the matters required to be discussed relating to the audit, in accordance with applicable audit standards, including the quality and appropriateness of the Company’s accounting principles, difficulties encountered in the course of the audit work, restrictions on the scope of activities or access to requested information, significant disagreements with management, and management’s response.

 

18. Review the annual plan and scope of work and coverage of the independent auditor. Receive updates on significant changes in scope of the plan and coverage and status of the plan during the year.

 

19. Obtain a statement from the independent auditor that the audit was conducted in a manner consistent with PCAOB standards and applicable portions of Section 10A of the Exchange Act.

 

20. After review, recommend to the Board the acceptance and inclusion of the annual audited consolidated financial statements in the Company’s Annual Report on Form 10-K.

 

21. Review or discuss, as and when appropriate: (i) the information to be disclosed and the type of presentation to be made in earnings press releases, including the use of “pro forma” or “adjusted” non-GAAP information and any reconciliation to GAAP information, that have been, or will be, issued by the Company, as well as the financial information and earnings guidance that have been, or will be, provided to analysts and rating agencies; and (ii) the effect of regulatory and accounting initiatives and off-balance sheet structures on the Company’s consolidated financial statements.

 

22. Be responsible for resolution of disagreements between management and the independent auditor regarding financial reporting.

 

Oversight of Compliance with Legal and Regulatory Requirements

 

23. When deemed appropriate, review with the Company’s SEC Counsel or appropriate delegates, legal, disclosure or other matters that may have a material impact on the Company’s consolidated financial statements or on the Company’s compliance policies.

 

24. Review significant regulatory reports and findings of regulators, as applicable to the mandate of the Committee, including management’s associated remediation plans and progress against such plans.

 

 

 

 

25. Obtain, review and evaluate reports from the SEC Counsel or management with respect to the Company’s policies and procedures regarding compliance with applicable legal and regulatory requirements, and the Company’s Code of Ethics and Business Conduct. The Company’s SEC Counsel shall have the authority to communicate personally to the Committee promptly on any matter involving criminal conduct or potential criminal conduct and, at least annually, shall report to the Committee on the implementation and effectiveness of the Company’s compliance and ethics program.

 

26. Obtain, review and evaluate reports from the Company’s SEC Counsel with respect to the Company’s Anti-Money Laundering/Bank Secrecy Act and Office of Foreign Assets Control compliance program.

 

27. Establish procedures for: (i) the receipt, retention and treatment of complaints received by the Company regarding accounting, internal accounting controls, or auditing matters; and (ii) the confidential, anonymous submission by Company employees of concerns regarding questionable accounting or auditing matters.

 

28. Discuss with management and the independent auditor any significant correspondence with regulators or governmental agencies and any external or employee complaints or published reports that raise material issues regarding the Company’s financial statements or accounting policies.

 

29. Review and discuss, as and when appropriate, the Internal Audit department’s review of perquisites, expenses and conflicts of interest, if any, of members of senior management.

 

30. Provide the report of the Committee as required by the SEC for inclusion in the Company’s annual proxy statement.

 

Oversight of the Company’s Risk Management

 

31. Review or discuss, as and when appropriate, with the members of management, the Company’s guidelines and policies that govern the process for risk assessment and risk management.

 

32. Review the major legal and compliance risk exposures of the Company and the steps management has taken to monitor and control such exposures.

 

33. The management shall each have access to communicate with the Committee on any matter relevant to risk and compliance.

 

Coordination with Management and Other Board Committees

 

34. Coordinate with management (which coordination may be through the Committee Chair) to help ensure that the committees have received the information necessary to permit them to fulfill their duties and responsibilities with respect to oversight of risk management and risk assessment guidelines and policies.

 

 

 

 

35. Coordinate with the Chief Executive Officer and the Compensation, Management Development and Succession Committee, if any (which coordination may be through the Committee Chair) in relation to the compensation and performance of the Company’s management.

 

Other Authority

 

36. Make such recommendations with respect to any of the above and other matters as the Committee deems necessary or appropriate.

 

37. Have such other authority, duties and responsibilities as may be delegated to the Committee by the Board.

 

The Committee’s authority, duties and responsibilities are discharged through evaluating reports given to the Committee, presentations made to the Committee and other significant financial reporting decisions reported to the Committee by management, the internal and independent auditors and by other persons or organizations the Committee deems appropriate.

 

Ratified and Approved:

 

Dated: January 1, 2018        
         
/s/ Mordechai Bignitz, Director   /s/ Dr. Stanley Hirsch, Chairman   /s/ Hannah Feuer, Director

 

 

 

 

 

OWC PHARMACEUTICAL RESEARCH CORP.

 

2016 ISRAELI EMPLOYEE SHARE OPTION PLAN

 

1

 

 

PREFACE

 

This plan, as amended from time to time, shall be known as the “OWC Pharmaceutical Research Corp.” -Israeli Employee Share Option Plan” (the “ Plan ”).

 

1. PURPOSE OF THE PLAN

 

The purpose of this Plan is to foster and promote the long-term financial success of OWC and its Affiliates and increase shareholder value by:

 

  (a) Motivating superior performance by means of performance-related incentives;
     
  (b) Encouraging and providing for the acquisition of an ownership interest in the Company by eligible Employees; and
     
  (c) Enabling OWC to attract and retain the services of outstanding management team and other qualified and dedicated Employees upon whose judgment, interest and special effort the successful conduct of its operations is largely dependent.

 

2. DEFINITIONS

 

For purposes of this Plan and related documents, including the Grant Letter, the following definitions shall apply:

 

  2.1 102 Option - means an Option that the Board intends to be a “102 Option” which shall only be granted to Employees, and shall be subject to and construed consistently with the requirements of Section 102 of the Ordinance. Approved 102 Options may either be classified as Capital Gains Track Options ( CGTO ) or Ordinary Income Track Options ( OITO ). 102 Options may either be granted to a Trustee or without a Trustee.
     
  2.2 3(i) Option - means Options granted pursuant to Section 3(i) of the Ordinance.
     
  2.3 Administrator ” - means the Board or the Committee as shall be administering this Plan, in accordance with Section ‎3 מתחת.
     
  2.4 Affiliate ” - means any company eligible to be qualified as an “employing company”, with respect to the Company, within the meaning of Section 102(a) of the Ordinance including any and all rules and regulations promulgated thereunder, as now in effect or as hereafter amended.
     
  2.5 Approved 102 Option ” - means an Option granted pursuant to Section 102(b) of the Ordinance, including any and all rules and regulations promulgated thereunder, as now in effect or as hereafter amended, and held in trust by a Trustee for the benefit of the Optionee, pursuant to Section 102.
     
  2.6 Articles of Association ” - means the Articles of Association of the Company as same are in effect from time to time.
     
  2.7 Board ” - means the Board of Directors of the Company.
     
  2.8 Capital Gains Track Option ” or “ CGTO ” - as defined in Section ‎5.4 מתחת.

 

2

 

 

  2.9 Cashless Exercise ” shall mean a way of paying the Exercise Price not in cash but by getting a number of Shares that reflects only the economic benefit the Optionee has at exercise point of time, so the Company allocates the Optionee a smaller number of Shares comparing the number of Shares the Optionee would receive according to the conversion rate set forth in the Grant Letter.
     
  2.10 Cause ” - means, with respect to an Employee (i) as such term is defined in the individual employment agreement or other engagement agreement between an Employee and OWC or its any of Affiliates, or (ii) if no such agreement is in place, then ‘Cause’ shall mean any one of the following: (a) conviction of any felony involving moral turpitude or affecting OWC; (b) any failure to carry out, as an Employee of OWC or its Affiliates, a reasonable directive of the chief executive officer, OWC’s board or the Optionee’s direct supervisor, which involves the business of OWC or its Affiliates and which was capable of being lawfully performed by Optionee; (c) embezzlement or theft of funds of OWC or its Affiliates; (d) any breach of the Optionee’s fiduciary duties or duties of care of OWC, including, without limitation, self-dealing, prohibited disclosure of confidential information of, or relating to, OWC, engagement in any business competitive to the business of OWC or of its Affiliates or breach of non-solicitation covenants; (e) any conduct (other than conduct in good faith) reasonably determined by the Board to be materially detrimental to OWC, and (f) any other circumstances under which OWC is entitled to terminate Optionee’s employment with OWC without paying Optionee severance pay under applicable law; and with respect to a Non-Employee (i) as such term is defined in the individual engagement agreement between the Optionee and OWC or its Affiliates, or (ii) if no such agreement is in place, then ‘Cause’ shall mean any one of the circumstances set forth in (a) through and including (e) herein, as applicable to such Non-Employee.
     
  2.11 Chairperson - means the chairperson of the Committee.
     
  2.12 Committee - means a share option compensation committee appointed by the Board, which shall consist of no fewer than two members of the Board, and if no such compensation committee is appointed, then the Board.
     
  2.13 Company ” – means OWC Pharmaceutical Research Corp., a company organized and existing under the laws of the state of New York, USA, whose principal office is at Wall Street 40 NY, NY, USA 10005.
     
  2.14 Companies Law - means the Israeli Companies Law, 5759-1999, including any rules and regulations promulgated thereunder and any provisions of the Companies Ordinance [New Version], 1983 still in effect, as amended from time to time.
     
  2.15 Controlling Shareholder ” - shall have the meaning ascribed to it in Section 32(9) of the Ordinance.
     
  2.16 “Cut-Off Date” – as defined in Section ‎11.3‎(b) מתחת.
     
  2.17 Date of Grant ” - means the date of grant of an Option, as determined by the Board and set forth in the Optionee’s Grant Letter, and in any event not earlier than the first date on which the Company is permitted to effect Option grants under this ESOP and the provisions of the Ordinance, including any and all rules and regulations promulgated thereunder, as now in effect or as hereafter amended.
     
  2.18 “Disability” – as defined in Section ‎9.5‎(v) מתחת.
     
  2.19 “Election” – as defined in Section ‎5.6 מתחת.

 

3

 

 

  2.20 Employee ” - means a person who is employed by the Company or its Affiliates including an individual who is serving as a director or an office holder, but excluding Controlling Shareholders.
     
  2.21 “Event” – as defined in Section ‎11.2 מתחת.
     
  2.22 Expiration Date ” - means the date upon which an Option shall expire, as set forth in Section ‎9.2 below.
     
  2.21 “Grant Letter” - means the grant letter given by the Company to the Optionee and signed by the Optionee, and which sets out the terms and conditions of an Option.
     
  2.22 ESOP ” - means as defined in the preface hereto.
     
  2.23 ITA - means the Israeli Tax Authority.
     
  2.24 NIS ” – means, New Israeli Shekels.
     
  2.25 Non-Employee - means a consultant, adviser, service provider, Controlling Shareholder or any other person who is not an Employee.
     
  2.26 Ordinary Income Track Option ” or “ OITO ” - as defined in Section ‎5.5 מתחת.
     
  2.27 Option ” - means an option to purchase one or more Shares of the Company pursuant to this ESOP.
     
  2.28 Optionee ” - means a person who receives or holds an Option under this ESOP.
     
  2.29 Ordinance - means the Israeli Income Tax Ordinance [New Version] 1961.
     
  2.30 Exercise Price ” - means the exercise price for each Share underlying an Option, as determined in Section ‎0 מתחת.
     
  2.31 “Representative” – as defined in Section ‎9.1 מתחת.
     
  2.32 Restricted Period ” – as defined in Section ‎6.1 מתחת.
     
  2.33 Section 102 - means Section 102 of the Ordinance, including any and all rules, regulations, orders and procedures promulgated thereunder, as now in effect or as hereafter amended.
     
  2.34 Share ” - means the Ordinary Shares of the Company, of nominal value NIS 0.1 each.
     
  2.35 Successor Company - means any entity into or with which the Company is merged or by which, the Company is acquired, pursuant to a Transaction in which the Company is not the surviving entity.
     
  2.36 Transaction means (i) a merger, acquisition or reorganization of the Company with one or more other entities in which the Company is not the surviving entity, or (ii) a sale of all or substantially all of the assets or shares of the Company.
     
  2.37 Trustee - means any individual or entity appointed by the Company to serve as a trustee and who has been approved by the ITA, all in accordance with the provisions of Section 102(a) of the Ordinance, including any and all rules and regulations promulgated thereunder, as now in effect or as hereafter amended.
     
  2.38 US$ ” – means United States of America dollars.

 

4

 

 

  2.39 Vested Option ” – means any Option that has already become vested and exercisable according to its Vesting Schedule or otherwise (e.g. acceleration upon certain events).
     
  2.40 Vesting Schedule ” - means, with respect to any Option, the date(s) as of which the Optionee shall be entitled to exercise such Option, as set forth Optionee’s individual Grant Letter, and if no such date(s) are specified in Optionee’s individual Grant Letter, then as set out in Section ‎10.2 מתחת.
     
  2.41 Unapproved 102 Option ” - means an Option granted pursuant to Section 102(c) of the Ordinance, including any and all rules and regulations promulgated thereunder, as now in effect or as hereafter amended, and not held in trust by a Trustee.

 

3. ADMINISTRATION OF THIS ESOP

 

This Plan shall be administered by the Board. The Board shall have the authority in its sole discretion, subject and not inconsistent with the express provisions of this Plan, to administer this Plan and to exercise all the powers and authorities specifically granted to it under this Plan as necessary and advisable in the administration of this Plan.

 

Provided that the Board is entitled by the Articles of Association and by law to delegate all and any of its powers and authority granted to it under this Plan to a Committee, then such powers and authority may be delegated to the Committee. The Committee shall have the responsibility of construing and interpreting this Plan and of establishing and amending such rules and regulations, as it deems necessary or desirable for the proper administration of this Plan.

 

  3.1 The Committee shall select one of its members as its Chairperson and shall hold its meetings at such times and places, as the Chairperson shall determine or as otherwise convened in accordance with the Articles of Association. The Committee shall keep records of its meetings and shall make such rules and regulations for the conduct of its business, as it shall deem advisable.
     
  3.2 The Committee shall have the power to recommend to the Board, and the Board shall have the full power and authority to: (i) designate Optionees; (ii) determine the Date of Grant, terms and provisions of the respective Grant Letters (which need not be identical), including, but not limited to, the number of Options to be granted to each Optionee, the number of Shares to be covered by each Option, provisions concerning the time and extent to which the Options may be exercised, and the nature and duration of restrictions as to the transferability, or restrictions constituting substantial risk of forfeiture upon occurrence of certain events; (iii) designate the type of Options; and (iv) cancel or suspend Options, as necessary.
     
  3.3 Subject to the provisions of this Plan, the Articles of Association, the applicable laws and, the specific duties delegated by the Board to the Committee, and subject to the approval of any relevant authorities, the Committee shall have the authority, in its sole discretion:

 

  (i) To construe and interpret the terms of this Plan and any Options granted pursuant hereto;
     
  (ii) To designate the Employees and Non-Employees to whom Options may from time to time be granted hereunder;
     
  (iii) To determine the number of Shares to be covered by each such Option granted hereunder;
     
  (iv) To prescribe forms of agreements and/or Grant Letters for use under this ESOP;

 

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  (v) To determine the terms of any Option granted hereunder;
     
  (vi) To determine the Exercise Price of any Option granted hereunder;
     
  (vii) To prescribe, amend and rescind rules and regulations relating to this Plan, provided that any such amendment or rescindment that would adversely affect the rights of an Optionee that has received or been granted an Option shall not be made without the Optionee’s written consent.
     
  (viii) To take all other action and make all other determinations necessary for the administration of this Plan.
     
  (ix) To determine the total number of Shares with in the pool allocated for the purpose of this Plan from time to time, and or any additional awards hereafter, subject to this Plan.

 

3.4 Subject to the Articles of Association and applicable law, all decisions and selections made by the Board or the Committee pursuant to the provisions of this Plan shall be made by a majority of its members. Any decision reduced to writing shall be executed in accordance with the provisions of the Articles of Association, as the same may be in effect from time to time.
     
3.5 Any decision or action taken or to be taken by the Committee, arising out of or in connection with the construction, administration, interpretation and effect of this Plan and of its rules and regulations, shall, to the maximum extent permitted by applicable law, be within its absolute discretion (except as otherwise specifically provided herein) and shall be conclusive and binding upon all Optionees and any person claiming under or through any Optionee.
     
3.6 The liability of any member of the Board or the Committee, with respect to this Plan or any Option granted hereunder, shall be in accordance with the Articles of Association and applicable law.
     
3.7 Any member of the Committee shall be eligible to receive Options under this Plan while serving on the Committee, unless otherwise specified herein. No person shall be eligible to be a member of the Committee if that person’s membership would prevent this Plan from complying with exemptions provided under applicable laws.

 

4. DESIGNATION OF OPTIONEES

 

  4.1 The persons eligible for participation in this Plan as Optionees shall include any Employees and/or Non-Employees of the Company or of any Affiliate thereof; provided, however, that (i) Employees may only be granted 102 Options; and (ii) Non-Employees may only be granted 3(i) Options.
     
  4.2 Each Option granted pursuant to this Plan shall be evidenced by a Grant Letter, substantially in such form attached hereto as Exhibits A and B . Each Grant Letter shall state, among other matters, the number of Shares to which the Option relates, the type of Option granted thereunder (whether an CGTO, OITO, Unapproved 102 Option or a 3(i) Option), the Vesting Schedule, the Exercise Price per share, the Expiration Date and such other terms and conditions included in the Grant Letter, including any such other terms that the Committee or the Board in their discretion may prescribe, provided in all cases that they are consistent with this Plan. The Grant Letter shall be delivered to the Optionee and executed by the Optionee and shall incorporate the terms of this Plan by reference and specify the terms and conditions thereof and any rules applicable thereto.

 

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  4.3 Neither this Plan nor any Grant Letter nor any offer of Options to an Optionee shall impose any obligation on the Company to continue to employ or to engage the services of any Optionee, and nothing in this Plan or in any Option granted pursuant thereto shall give any Optionee any right to continued employment, service with or engagement by the Company or restrict the right of the Company to terminate such employment, services or engagement at any time. Further, the Company and each Affiliate expressly reserves the right at any time to dismiss an Optionee free from any liability, or any claim under thisPlan, except as provided herein or in any agreement entered into with respect to an Option.
     
  4.4 The grant of an Option hereunder shall neither entitle the Optionee to participate nor disqualify the Optionee from participating in, any other grant of Options pursuant to this Plan or any other option or share plan of the Company or any of its Affiliates.
     
  4.5 Notwithstanding anything in the Plan to the contrary, all grants of Options to directors and office holders shall be authorized and implemented in accordance with the provisions of the Companies Law.

 

5. DESIGNATION OF OPTIONS PURSUANT TO SECTION 102

 

  5.1 The Company may designate Options granted to Employees pursuant to Section 102 as Unapproved 102 Options or Approved 102 Options.
     
  5.2 The grant of Approved 102 Options under this ESOP shall be made in accordance with the provisions herein, including the provisions of Section ‎6 below, and shall be conditioned upon the approval of this Plan by the ITA.
     
  5.3 An Approved 102 Option may either be classified as either a Capital Gains Track Option (CGTO) or an Ordinary Income Track Option (OITO).
     
  5.4 An Approved 102 Option elected and designated by the Company to qualify under the capital gain tax treatment in accordance with the provisions of Section 102(b)(2) shall be referred to herein as “CGTO” .
     
  5.5 An Approved 102 Option elected and designated by the Company to qualify under the ordinary income tax treatment in accordance with the provisions of Section 102(b)(1) shall be referred to herein as “OITO” .
     
  5.6 The Company’s election of the type of Approved 102 Options as CGTO or OITO granted to Employees (the “Election” ) shall be appropriately filed with the ITA before the first Date of Grant of an Approved 102 Option under such Election. Such Election shall become effective beginning the first Date of Grant of an Approved 102 Option under such Election and shall remain in effect until changed, but in any case not earlier than the end of the year following the year during which the Company first granted Approved 102 Options under such Election. The Election shall obligate the Company to grant only the type of Approved 102 Option it has elected, and shall apply to all Optionees who were granted Approved 102 Options during the period indicated herein, all in accordance with the provisions of Section 102(g) of the Ordinance, including any and all rules and regulations promulgated thereunder, as now in effect or as hereafter amended. For avoidance of doubt, such Election shall not prevent the Company from granting Unapproved 102 Options simultaneously.
     
  5.7 Designation of Approved 102 Options – if an Optionee exercises and sells his Shares within the Restricted Period, the Company shall not bear any tax liability arising due to the exercise and or sale of such Shares resulting from Optionee’s termination of employment, except for the tax liability mentioned in Section ‎21 מתחת.
     
  5.8 All Approved 102 Options must be held in trust by the Trustee, as described in Section ‎6 מתחת.
     
  5.9 For avoidance of doubt, the designation of Unapproved 102 Options and Approved 102 Options shall be subject to the terms and conditions set forth in Section 102.

 

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6. TRUSTEE

 

  6.1 Approved 102 Options which shall be granted under this Plan and/or any Shares allocated or issued upon exercise of such Approved 102 Options and/or other shares received subsequently following any realization of rights, including, without limitation, bonus shares, shall be allocated or issued to the Trustee (and registered in the Trustee’s name in the Company’s shareholders register) and held by the Trustee for the benefit of the Optionees to whom such Approved 102 Options were granted for such period of time as required by Section 102 (the “Restricted Period” ). All certificates representing Shares issued to the Trustee under this ESOP shall be deposited with the Trustee, and shall be held by the Trustee until such time that such Shares are released from the aforesaid trust as herein provided. If the requirements for Approved 102 Options are not met, the Approved 102 Options may be treated as Unapproved 102 Options, all in accordance with the provisions of Section 102.
     
  6.2 Notwithstanding anything to the contrary herein, the Trustee shall not release any Shares allocated or issued upon exercise of Approved 102 Options prior to the full payment of the Optionee’s tax liabilities arising from Approved 102 Options, which were granted to such Optionee and/or any Shares allocated or issued upon exercise of such Options.
     
  6.3 With respect to any Approved 102 Option, subject to the provisions of Section 102, an Optionee shall not sell or release from trust any Share received upon the exercise of an Approved 102 Option and/or any share received subsequently following any realization of rights, including without limitation, bonus shares, until the lapse of the Restricted Period required under Section 102. Notwithstanding the above, if any such sale or release occurs during the Restricted Period, the sanctions under Section 102 shall apply to and shall be borne by such Optionee.
     
  6.4 Upon receipt of Approved 102 Option, the Optionee will sign an undertaking to release the Trustee from any liability in respect of any action or decision duly taken and bona fide executed in relation with this Plan, or any Approved 102 Option or Share granted to him hereunder. Such release may be incorporated into the Grant Letter.
     
  6.5 3(i) Options which shall be granted under the Plan, may, but need not, be issued to the Trustee, and if so issued to the Trustee, shall be held for the benefit of the Optionee. The Trustee shall hold such Options and the shares issued upon the exercise thereof (in the event of an exercise of such Options) pursuant and subject to Section 3(i) of the Ordinance, including any and all rules, regulations, orders and procedures promulgated thereunder, as now in effect or as hereafter amended. Anything to the contrary notwithstanding, the Trustee shall not release any 3(i) Options held by it and which were not already exercised into shares of the Company by the Optionee, nor shall the Trustee release any shares issued upon the exercise of 3(i) Options – in both cases - prior to the full payment of the relevant Optionee’s tax liabilities arising from those 3(i) Options which were granted to him and any shares issued upon the exercise of such 3(i) Options.

 

7. SHARES RESERVED FOR THE PLAN; RESTRICTIONS THEREON

 

  7.1 The Company shall from time to time reserve, out of its authorized but un-issued share capital, such number of Shares as the Board deems appropriate (subject to the Articles of Association) for the purposes of this Plan and/or for the purposes of any other share option plans which have previously been, or may in the future be, adopted by the Company, subject to adjustment as set forth in Section ‎11 below. Any Shares which remain un-issued and which are not subject to then outstanding Options at the termination or expiration of this Plan shall cease to be reserved for the purpose of this Plan, but may continue to be reserved for other share option plans then in effect, and in any event, until termination of this Plan the Company shall at all times reserve sufficient number of Shares to meet the requirements of any then outstanding Options. Should any Option for any reason expire or be canceled prior to its exercise or relinquishment in full, the Shares subject to such Option may again be subjected to a new Option under this Plan or under the Company’s other share option plans, provided, however, that Shares that have actually been issued under this Plan shall not be returned to the pool under this Plan and shall not become available for future distribution under this Plan.

 

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8. EXERCISE PRICE

 

  8.1 The Exercise Price of each Share subject to an Option shall be as determined by the Committee in its sole and absolute discretion in accordance with applicable law, subject to any guidelines as may be determined by the Board from time to time. Each Grant Letter will contain the Exercise Price determined for each Option covered thereby (but in any event, not less than the nominal value of the Share issuable upon exercise thereof). In no event shall the Exercise Price of an Option be less than the par value of the shares for which such Option is exercisable. The Exercise Price shall also be subject to adjustment as provided in Section ‎11.5 hereof.
     
  8.2 The total consideration to be paid for the Shares to be issued upon exercise of an Option, including the method of payment, shall be determined by the Administrator and may consist entirely of (1) cash, (2) check, or (3) any combination of the foregoing methods of payment. In making its determination as to the type of consideration to accept, the Administrator shall consider if acceptance of such consideration may be reasonably expected to benefit the Company. The Committee shall have the authority to postpone the date of payment on such terms as it may determine.
     
  8.3 The Exercise Price shall be denominated in NIS or US$ or otherwise as determined by the Committee.
     
  8.4 The proceeds received by the Company from the issuance of Shares subject to the Options will be added to the general funds of the Company and used for its corporate purposes.

 

9. TERM AND EXERCISE OF OPTIONS

 

  9.1 Options shall be exercised by the Optionee by giving written notice to the Company and/or to any third party designated by the Company (the “Representative” ), in such form and method as may be determined by the Committee and when applicable, by the Trustee in accordance with the requirements of Section 102, which exercise shall be effective upon receipt of such notice by the Company and/or the Representative and the payment of the Exercise Price at the Company’s or the Representative’s principal office. The notice shall specify the number of Shares with respect to which the Option is being exercised.
     
  9.2 Options, to the extent not previously exercised, shall terminate forthwith upon the earlier of: (i) the date set forth in the Grant Letter (and unless otherwise determined in accordance with the provisions of this Plan with respect to any Option(s), such date shall be ten (10) years from the respective Date of Grant); or (ii) the expiration of any extended period in any of the events set forth in Section ‎9.5 מתחת (the “ Expiration Date ”).
     
  9.3 The Options may be exercised by the Optionee in whole at any time or in part from time to time, to the extent that the Options become vested and exercisable, prior to the Expiration Date, and provided that, subject to the provisions of Section ‎9.5 מתחת, the Optionee who is an Employee is employed by or providing services to the Company or any of its Affiliates, at all times during the period beginning with the granting of the Option and ending upon the date of exercise. An Optionee who is a Non-Employee may exercise the Options in whole at any time or in part from time to time, to the extent that the Options have become vested and exercisable, prior to the Expiration Date.

 

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  9.4 Subject to the provisions of Section ‎9.5 מתחת, in the event of termination of Optionee’s employment or services, with the Company or any of its Affiliates, all Options granted to such Optionee that are at the time of termination non-vested will immediately expire. A notice of termination of employment or service shall be deemed to constitute termination of employment or service. For the avoidance of doubt, in case of such termination of employment or service, the unvested portion of the Optionee’s Option shall not vest and shall not become exercisable and any unvested portion of the Optionee’s Option shall revert to the pool of Shares under this Plan or that of other share option plans then in effect.
     
  9.5 Notwithstanding anything to the contrary herein and unless otherwise determined in the Optionee’s Grant Letter, an Option may be exercised after the date of termination of Optionee’s employment or service with the Company or any Affiliates during an additional period of time beyond the date of such termination, but only with respect to the number of Vested Options at the time of such termination according to the Vesting Schedule, as follows:

 

  (i) If termination is without Cause, then any Vested Option still in force and un-expired may be exercised within a period of three (3) months after the date of such termination, provided however, that no Option shall be exercisable prior to the lapse of the first anniversary following the Date of Grant;
     
  (ii) If termination is the result of death, or Disability (defined below) of the Optionee, then any Vested Option still in force and un-expired may be exercised within a period of twelve (12) months after the date of such termination;
     
  (iii) With respect to (i) and (ii) above, prior to the expiration of the periods set out therein (i.e., the 3-month period in (i) above, and the 12-month period in (ii) above), the Committee may authorize an extension of the terms of exercise post-termination of all or part of the Vested Options beyond the date of such termination for a period not to exceed the period during which the Options by their terms would otherwise have been exercisable.
     
  (iv) For avoidance of any doubt, notwithstanding anything herein to the contrary, if termination of employment or service is for Cause any outstanding unexercised Option (whether vested or non-vested), will immediately expire and terminate, and the Optionee shall not have any right in connection to such outstanding Options.
     
  (v) As used herein: the term “ Disability ” shall have the meaning ascribed thereto in the individual employment or engagement agreement between the Optionee and the Company or any of its Affiliates, as applicable and if no such definition exists, then “Disability” shall mean Optionee’s inability to perform his/her duties to the Company or to any of its Affiliates, for a consecutive period of at least 180 days, by reason of any medically determinable physical or mental impairment as determined by a medical doctor satisfactory to the Committee.

 

  9.6 To avoid doubt, the Optionees shall not be deemed owners of the Shares issuable upon the exercise of Options and shall not have any of the rights or privileges of shareholders of the Company in respect of any Shares purchasable upon the exercise of any Option, nor shall they be deemed to be a class of shareholders of the Company for any purpose, including but not limited for the purpose of the operation of Sections 350 and 351 of the Companies Law or any successor to such section, until registration of the Optionee as holder of such Shares in the Company’s register of shareholders upon exercise of the Option in accordance with the provisions of this Plan, but in case of Options and Shares held by the Trustee, subject to the provisions of Section ‎6 מעל. Notwithstanding anything herein to the contrary, in no event shall the Optionees be deemed a class of creditors of the Company for any purpose whatsoever, including but not limited to for the purpose of the operation of Sections 350 and 351 of the Companies Law or any successor to such section.

 

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  9.7 The form of Grant Letter customarily used by the Company in connection with the grant of Options, provided it is consistent with the provisions of this Plan, may contain such other provisions, as the Committee or the Board may, from time to time, deem advisable.
     
  9.8 The inability of the Company to obtain authority from any regulatory body having jurisdiction, which authority is deemed by the Company’s counsel to be necessary for the lawful issuance and sale of any Shares hereunder, shall relieve the Company of any liability in respect of the failure to issue or sell such Shares as to which such requisite authority shall not have been obtained.
     
  9.9 With respect to Unapproved 102 Options, if the Optionee ceases to be employed the Company or any Affiliate, the Optionee shall extend to the Company and/or its Affiliate a security or guarantee for the payment of tax due at the time of sale of Shares, all in accordance with the provisions of Section 102. In respect of any employer’s tax liability for the purpose of employment taxes such as in the case of social taxes, see Section ‎21 מתחת.
     
  9.10 Shares shall not be issued pursuant to the exercise of an Option unless the exercise of such Option, the method of payment and the issuance and delivery of such Shares shall comply with applicable laws.
     
  9.11 Upon their issuance, the Shares shall carry equal voting rights on all matters where such vote is permitted by applicable laws of the jurisdiction of incorporation of the Company.
     
  9.12 It is hereby clarified that the Company shall have no liability to an Optionee, or to any other party, if an Option (or any part thereof), which is intended to be a 102 Option, does not eventually qualify as a 102 Option.
     
  9.13 Voting Proxy . The right to vote any Shares acquired under this Plan pursuant to a Grant Letter shall, unless otherwise determined by the Committee, be given by the Optionee, pursuant to an irrevocable proxy (in a form approved by the Board or the Committee), to the Chairman of the Board of the Company or to any other person or persons designated by such. Such a proxy shall include a provision according to which such Shares shall be voted in the same proportion as the result of the shareholder vote at the shareholders meeting or written consent in respect of which such Shares will be voted. Unless otherwise determined by the Committee, all Options granted hereunder shall be conditioned upon the execution of such irrevocable proxy. So long as any such Shares are held by a Trustee, such Shares shall be voted by the Trustee (or a proxy thereof designated by the Board or the Committee), and such Shares shall be voted in the same proportion as the result of the shareholder vote at the shareholders meeting or written consent in respect of which the Shares held by the Trustee are being voted.

 

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10. VESTING OF OPTIONS

 

  10.1 Subject to the provisions of this Plan, each Option shall vest and become exercisable commencing on the Vesting Date thereof, as determined by the Board or by the Committee, for the number of Shares as shall be provided in the Grant Letter. However, no Option shall be exercisable prior to the lapse of the first anniversary following the Date of Grant and after the Expiration Date.
     
  10.2 Unless otherwise determined by the Administrator, all Options granted pursuant to this Plan, shall, subject to the Optionee’s continued employment with or service to the Company or its Affiliate, become vested over a two (2) year period from its Date of Grant, as follows:

 

  10.2.1 Thirty three percent (33%) of the Options shall vest on the Date of Grant;
     
  10.2.2 Eight and a quarter percent (8.25%) of the Options shall vest on a quarterly basis from the Date of Grant and until the end of the first anniversary of the Date of Grant; and
     
  10.2.3 Eight and a half percent (8.5%) of the Options shall vest on a quarterly basis from the first anniversary of the Date of Grant and until the end of the second anniversary from the Date of Grant.
     
  10.2.4  

 

  10.3 An Option may be subject to such other terms and conditions on the time or times when it may be exercised, as the Committee may deem appropriate. The vesting provisions of individual Options may vary.
     
  10.4 To remove any doubt, no Option shall be exercisable prior to the lapse of the first anniversary following the Date of Grant.

 

11. ADJUSTMENTS

 

  11.1 Changes in Capitalization . Subject to any required action by the shareholders of the Company, the number of Shares covered by each outstanding Option, the number of Shares which have been reserved for issuance under this Plan and/or any other share option plan adopted by the Company, but as to which no Options have yet been granted or which have been returned to this Plan or such other share option plans upon cancellation or expiration of an Option, as well as the Exercise Price per share of Shares covered by each such outstanding Option, shall be proportionately adjusted for any increase or decrease resulting from a share split, bonus shares (share dividend), combination or reclassification of the Shares, or any other increase or decrease in the number of issued Shares effected without receipt of consideration by the Company. The adjustments described herein shall be made by the Administrator, whose determination in that respect shall be final, binding and conclusive. Except as expressly provided herein, no issuance by the Company of shares of any class, or securities convertible into shares of any class, shall affect, and no adjustment by reason thereof shall be made with respect to the number or the price of Shares subject to an Option. If the Options or the Shares issued upon the exercise of such Options will be deposited with a Trustee, as determined by the Administrator, all of the Shares formed by these adjustments also will be deposited with the Trustee on the same terms and conditions as the original Options or Shares.

 

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  11.2 Dissolution or Liquidation . In the event of any dissolution or liquidation of the Company, whether voluntary or involuntary (the “ Event” ), the Administrator shall notify each Optionee as soon as practicable prior to the effective date of such Event. The Option holders shall then have fifteen (15) days to exercise any unexercised Vested Options held by them at that time, in accordance with the exercise procedure set forth herein. Upon the expiration of such 15-day period, all remaining unexercised Options and any non-Vested Options will terminate immediately. The Administrator in its sole discretion may allow the exercise of any or all-outstanding Options, whether or not such Options are Vested Options, during a longer period following such notification and prior to the Event, all subject to the provisions of applicable laws. To the extent it has not been previously exercised, an Option and all Optionee’s rights thereto will terminate immediately prior to the Event.
     
  11.3 Transaction .

 

  (a) In the event of a Transaction, and to the extent possible by the terms of the Transaction, each outstanding Option shall be assumed for an equivalent option or right substituted by the successor corporation or a parent or subsidiary of the successor corporation, and appropriate adjustments shall be made in the number of options in order to reflect such an action and to keep the Optionee harmless due to the Transaction.
     
  (b) In the event that as part of the Transaction the successor corporation refuses to assume or substitute outstanding Options, the vesting periods defined in the Grant Letters shall be accelerated so that any unvested Option or any portion thereof shall be immediately vested as of the date which is ten (10) days prior to the effective date of the Transaction, in which event the Company shall notify the Optionee that the Options are fully exercisable for a period of ten (10) days from the date of such notice, and the Options shall terminate upon the expiration of such period. [Odelia: Need to check if this does not cause a taxable event to the Optionee Subject to the following paragraph of this Section ‎11.3‎(b), any Vested Options shall be fully exercisable for such period as determined by the Board, where any un-Vested or Vested but un-exercised Options shall terminate upon the expiration of such period.
     
    In any event, any Vested Option not exercised by the date determined above (the “ Cut-Off Date ”), and any un-Vested Options on such Cut-Off Date, shall immediately terminate and no longer be exercisable by the Optionee as of the Cut-Off Date.
     
  (c) Without derogating from the provisions of paragraph ‎(b) מעל, if as a condition precedent to a Transaction, all Optionees are required to sell or exchange their Vested Options and/or any Shares issued upon exercise thereof as part of the Transaction, then each Optionee shall be obligated to sell or exchange, as the case may be, any Vested Options and/or Shares such Optionee holds or purchased under this Plan, in accordance with the instructions of the Board, at its sole and absolute discretion, in connection with the Transaction, and on the same terms as shall be determined to all the holders of Ordinary Shares in the Company. For avoidance of doubt, on the Cut-Off Date, any Vested Options not sold or exchanged and any non-Vested Options shall terminate and expire as of the Cut-Off Date.
     
  (d) For the purposes of this paragraph, the Option shall be considered assumed if, following a Transaction, the Optionee receives the right to purchase or receive, for each Share subject to the Option immediately prior to the Transaction, the consideration (whether in shares, stocks, cash, other securities or property or any other manner as the Administrator shall determine, which may include procedures for Cashless Exercise) received in the Transaction by holders of Shares for each Share held on the effective date of the Transaction (and if holders were offered a choice of consideration, the type of consideration chosen by the holders of a majority of the outstanding Shares); provided, however, that if such consideration received in the Transaction is not solely shares of the successor corporation or its parent or subsidiary, the Administrator may, with the consent of the successor corporation, provide for each Optionee to receive solely Shares of the successor company or its parent or subsidiary equal to the per share consideration received by holders of Shares in the Transaction.

 

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  11.4 No changes will be made to the terms of the Options upon the consummation of a Transaction, except as the Board determines to be necessary or desired to effect such Transaction.
     
  11.5 Stock Dividend, Bonus Shares, Stock Split .

 

  (a) If the outstanding shares of the Company shall at any time be changed or exchanged by declaration of a share dividend (bonus shares), share split, combination or exchange of shares, recapitalization, or any other like event by or of the Company, and as often as the same shall occur, then the number, class and kind of the Shares subject to this Plan or subject to any Options therefor granted, and the Exercise Prices, shall be appropriately and equitably adjusted so as to maintain the proportionate number of Shares without changing the aggregate Exercise Price, provided, however, that the Exercise Price shall not be less than the nominal value of the Share underlying any such Options, and provided further, that no adjustment shall be made by reason of the distribution of subscription rights (rights offering) on outstanding shares. Upon the occurrence of any of the foregoing, the class and aggregate number of Shares issuable pursuant to this Plan (as set forth in Section 7 hereof), in respect of which Options have not yet been exercised, shall be appropriately adjusted, all as will be determined by the Board whose determination shall be final.
     
  (b) Except as expressly provided herein, no issuance by the Company of shares of any class, or securities convertible into shares of any class, shall affect, and no adjustment by reason thereof shall be made with respect to, the number or price of Shares subject to an Option.

 

12. PURCHASE FOR INVESTMENT; REPRESENTATIONS

 

  12.1 The Company’s obligation to issue or allocate Shares upon exercise of an Option granted under this Plan is expressly conditioned upon: (a) the Company’s completion of any registration or other qualifications of such Shares under all applicable laws, rules and regulations or (b) representations and undertakings by the Optionee (or his legal representative, heir or legatee, in the event of the Optionee’s death) to assure that the sale of the Shares complies with any registration exemption requirements which the Company in its sole discretion shall deem necessary or advisable. Such required representations and undertakings may include representations and agreements that such Optionee (or his legal representative, heir, or legatee): (a) is purchasing such Shares for investment and not with any present intention of selling or otherwise disposing thereof; and (b) agrees to have placed upon the face and reverse of any certificates evidencing such Shares a legend setting forth (i) any representations and undertakings which such Optionee has given to the Company or a reference thereto; and (ii) that, prior to effecting any sale or other disposition of any such Shares, the Optionee must furnish to the Company an opinion of counsel, satisfactory to the Company, that such sale or disposition will not violate the applicable laws, rules, and regulations, whether of the State of Israel or of any other State having jurisdiction over the Company and the Optionee.
     
  12.2 The Optionee acknowledges that in the event that the Company’s shares shall be registered for trading in any public market, Optionee’s rights to sell the Shares may be subject to certain limitations (including a lock-up period), as will be requested by the Company or its underwriters, and the Optionee unconditionally agrees and accepts any such limitations.

 

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  12.3 If any Shares shall be registered under the United States Securities Act of 1933, no public offering otherwise than a national securities exchange (as defined in the United States Securities Exchange Act of 1934, as amended) of any Shares shall be made by the Optionee (or any other person) under such circumstances that he or she (or such other person) may be deemed an underwriter, as defined in the United States Securities Act of 1933.
     
  12.4 Upon the grant of Options to an Optionee or the issuance of Shares upon the exercise thereof, the Company shall obtain from the Optionee the representations and undertakings as follows, and any other representations and warranties that the Committee may deem advisable, and the giving of such representations and warranties by the Optionee shall be a condition precedent to Optionee’s right to receive the Option and/or be issued the Shares upon exercise thereof:

 

  (a) That the Optionee knows that there is no certainty that the exercise of the Options will be financially worthwhile. The Optionee thereby undertakes not to have any claim against the Company or any of its directors, employees, stockholders or advisors if it emerges, at the time of exercising the Options, that the Optionee’s investment in the Company’s Shares was not worthwhile, for any reason whatsoever.
     
  (b) That the Optionee knows and understands that his rights regarding the Options and the Shares are subject for all intents and purposes to the instructions of the Company’s documents of incorporation and to the agreements of the shareholders in the Company.
     
  (c) That the Optionee knows that in addition to the allocations set forth above, the Company has allocated and/or is entitled to allocate Options and Shares to other employees and other people, and the Optionee shall have no claim regarding such allocations, their quantity, the relationship among them and between them and the other shareholders in the Company, exercising of the options or any matter related to or stemming from them.
     
  (d) That the Optionee knows that neither this Plan nor the grant of Option or Shares thereunder shall impose any obligation on OWC to continue the engagement of the Optionee, and nothing in this Plan or in any Option or Shares granted pursuant thereto shall confer upon any Optionee any right to continue being engaged by the Company, or restrict the right of the Company to terminate such engagement at any time.

 

13. DIVIDENDS

 

With respect to all Shares (but excluding, for avoidance of any doubt, any unexercised Options) allocated or issued upon the exercise of Options purchased by the Optionee and held by the Optionee or by the Trustee, as the case may be, the Optionee shall be entitled to receive dividends in accordance with the quantity of such Shares, subject to the provisions of the Articles of Association and subject to any applicable taxation on distribution of dividends, and, when applicable, subject to the provisions of Section 102.

 

14. RESTRICTIONS ON ASSIGNABILITY AND SALE OF OPTIONS

 

  14.1 No Option or any right with respect thereto, purchasable hereunder, whether fully paid or not, shall be assignable, transferable or given as collateral or any right with respect to it given to any third party whatsoever, except as specifically allowed under this Plan, and during the lifetime of the Optionee each and all of such Optionee’s rights to purchase Shares hereunder shall be exercisable only by the Optionee.
     
    Any such action made directly or indirectly, for an immediate validation or for a future one, shall be void.
     
  14.2 So long as Options and/or Shares are held by the Trustee on behalf of the Optionee , all rights of the Optionee over the Shares are personal, can not be transferred, assigned, pledged or mortgaged, other than by will or pursuant to the laws of descent and distribution.

 

15

 

 

15. EFFECTIVE DATE AND DURATION OF THE PLAN

 

This Plan shall be effective as of the day it was adopted by the Board and shall terminate at the end of ten (10) years from such day of adoption, unless terminated earlier in accordance with Section ‎0 מתחת.

 

16. AMENDMENTS OR TERMINATION

 

The Board may at any time, but when applicable, after consultation with the Trustee, amend, alter, suspend or terminate this Plan. No amendment, alteration, suspension or termination of this Plan shall impair the rights of any Optionee, unless mutually agreed otherwise between the Optionee and the Company, which agreement must be in writing and signed by the Optionee and the Company. Termination of this Plan shall not affect the Committee’s ability to exercise the powers granted to it hereunder with respect to Options granted under this Plan prior to the date of such termination.

 

17. GOVERNMENT REGULATIONS

 

This Plan, and the grant and exercise of Options hereunder, and the obligation of the Company to sell and deliver Shares under such Options, shall be subject to all applicable laws, rules, and regulations, whether of the State of Israel any other State having jurisdiction over the Company and the Optionee, including, without limitation, the United States Securities Act of 1933, the Companies Law, the Securities Law, 1968, and the Ordinance (including any and all rules and regulations promulgated thereunder, as now in effect or as hereafter amended), and to such approvals by any governmental agencies or national securities exchanges as may be required. Nothing herein shall be deemed to require the Company to register the Shares under the securities laws of any jurisdiction.

 

18. CONTINUANCE OF EMPLOYMENT OR HIRED SERVICES

 

Neither this Plan nor the Grant Letter with the Optionee shall impose any obligation on the Company or an Affiliate thereof, to continue any Optionee in its employ or service, and nothing in this Plan or in any Option granted pursuant thereto shall confer upon any Optionee any right to continue in the employ or service of the Company or an Affiliate thereof or restrict the right of the Company or an Affiliate thereof to terminate such employment or service at any time.

 

19. GOVERNING LAW & JURISDICTION

 

This Plan shall be governed by and construed and enforced in accordance with the laws of the State of Israel applicable to contracts made and to be performed therein, without giving effect to the principles of conflict of laws. The competent courts of Tel Aviv district, Israel shall have sole and exclusive jurisdiction in any matters pertaining to this Plan and any Grant Letters effected hereunder.

 

20. INTEGRATION OF SECTION 102 AND TAX COMMISSIONER’S PERMIT

 

  20.1 With regards to Approved 102 Options, the provisions of this Plan and the Grant Letter shall be subject to the provisions of Section 102 and the ITA Commissioner’s permit, and the said provisions and permit shall be deemed an integral part of this Plan and of the individual Grant Letters with each Optionee.
     
  20.2 Any provision of Section 102 and/or the said permit which is necessary in order to receive and/or to keep any tax benefit pursuant to Section 102, which is not expressly specified in this Plan or the individual Grant Letter of the Optionees, shall be considered binding upon the Company and the Optionees.

 

16

 

 

21. TAX CONSEQUENCES

 

  21.1 Any tax consequences arising from the grant or exercise of any Option, from the payment for Shares covered thereby or from any other event or act (of the Company and/or its Affiliates, the Trustee or the Optionee), hereunder, shall be borne solely by the Optionee. The Company and/or its Affiliates and/or the Trustee shall withhold taxes according to the requirements of any applicable laws, rules, and regulations, including withholding taxes at source. Furthermore, the Optionee shall agree to indemnify the Company and/or its Affiliates and/or the Trustee and hold them harmless against and from any and all liability for any such tax or interest or penalty thereon, including without limitation, liabilities relating to the necessity to withhold, or to have withheld, any such tax from any payment made to the Optionee.
     
  21.2 The Company and, when applicable, the Trustee shall not be required to release any Share or share certificate representing such Shares to an Optionee until all required payments have been fully made.
     
  21.3 To the extent provided by the terms of any Grant Letter, the Optionee may satisfy any tax withholding obligation relating to the exercise or acquisition of Shares under an Option by any of the following means (in addition to the Company’s right to withhold from any compensation paid to the Optionee by the Company) or by a combination of such means: (i) tendering a cash payment; (ii) subject to the Committee’s approval on or prior to the payment date, authorizing the Company to withhold Shares from the Shares otherwise issuable to the Optionee as a result of the exercise or acquisition of Shares under the Option in an amount not to exceed the minimum amount of tax required to be withheld by law; or (iii) subject to Committee approval on or prior to the payment date, delivering to the Company owned and unencumbered Shares; provided that Shares acquired on exercise of Options have been held for at least 6 months from the date of exercise.
     
  21.4 The Company shall have the right to deduct from all amounts paid to an Optionee in cash (whether under this Plan or otherwise) any taxes required by law to be withheld in respect of Options under this Plan. In the case of any Option satisfied by the issuance of Shares, no Shares shall be issued unless and until arrangements satisfactory to the Committee shall have been made to satisfy any withholding tax obligations applicable with respect to such Option. Without limiting the generality of the foregoing and subject to such terms and conditions as the Committee may impose, the Company shall have the right to retain, or the Committee may, subject to such terms and conditions as it may establish from time to time, permit Optionees to elect to tender, Shares to satisfy, in whole or in part, the amount required to be withheld.
     
  21.5 In respect of any employer’s tax liability arising only for the purpose of employment taxes such as in the case of social taxes resulting from a breach of Section 102, the Company shall not bear any tax due at the time of sale of Shares, all in accordance with the provisions of Section 102.
     
  21.6 Notwithstanding anything herein to the contrary of Section ‎21.5 above, only in the event of termination of employment by the Company, other than termination for Cause, Company should bear the tax liability arising only for the purpose of employment taxes such as in the case of social taxes.
     
  21.7 For avoidance of any doubt, notwithstanding anything herein to the contrary, if termination of employment or service is for Cause, the Company shall not bear any tax liability derived due to the exercise and or sale of the Options as a result of Optionee’s termination.

 

17

 

 

22. NON-EXCLUSIVITY OF THIS ESOP

 

The adoption of this Plan by the Board shall not be construed as amending, modifying or rescinding any previously approved incentive arrangements or as creating any limitations on the power of the Board to adopt such other incentive arrangements as it may deem desirable, including, without limitation, the granting of options to purchase shares of the Company otherwise than under this Plan, and such arrangements may be either applicable generally or only in specific cases.

 

For the avoidance of doubt, prior grant of options to Employees and/or Non-Employees of the Company under their employment agreements or other engagement agreements, and not in the framework of any previous option plan, shall not be deemed an approved incentive arrangement for the purpose of this Section ‎22.

 

23. MULTIPLE AGREEMENTS

 

The terms of each Option may differ from the terms of other Options granted under this Plan at the same time, or at any other time. The Board may also grant more than one Option to a given Optionee during the term of this Plan, either in addition to, or in substitution for, one or more Options previously granted to that Optionee.

 

24. DISPUTES

 

Any dispute or disagreement which may arise under or as a result of or pursuant to this Plan or the individual Grant Letters shall be determined by the Board in its sole discretion and any interpretation made by the Board of the terms of this Plan or the individual Grant Letters shall be final, binding and conclusive.

 

This ESOP was adopted by the Board on May 29, 2016.

 

/s/ Mordechai Bignitz, CEO

OWC Pharmaceutical Research Corp.

 

18

 

 

Exhibit A

 

Form of 102 Options Grant Letter

 

19

 

 

Exhibit B

 

Form of 3(i) Options Grant Letter

 

20

 

 

 

102 Grant letter   July 1, 2017

 

owc pharmaceutical research corp.

The “ Company

 

Grant Letter

 

To the Optionee, ___________, holder of Israeli identity card number _________, from ____________________, Israel.

 

1. You are hereby notified that on ______ the Board of Directors of the Company (the “ Board ”) has resolved to grant you _________ options, each to purchase one (1) Ordinary Share of the Company, nominal value of US$ 0.0001 each (the “ Option ” and/or “ Options ”), at an exercise price per Ordinary Share of US$ _______ (the “ Purchase Price ”).

 

2. The Options, Ordinary Shares of the Company, US$ 0.0001 par value each, resulting from their exercise (the “ Shares ”) shall be allocated on your behalf to the Trustee ESOP-Excellence Trust company (the “ Trustee ”).

 

3. The Options shall be allocated on your behalf to the Trustee under the provisions of the Capital Gains Tax Track and will be held by the Trustee for the period stated in Section 102 of the Income Tax Ordinance, 1961 and the Income Tax Regulations (Tax Relieves in Allocation of Shares to Employees), 2003 promulgated thereunder, as such Section and regulations may be amended from time to time (“ Section 102 ”).

 

4. The Options are granted to you and allocated to the Trustee according to the provisions of Section 102, the 2016 Israeli Employee Share Option Plan adopted by the Company (“ Plan ”) and the Trust Agreement signed between the Company and the Trustee (the “ Trust Agreement ”), all being attached herewith and made an integral part of this Grant Letter. The Options allocated on your behalf to the Trustee shall be subject to all the provisions and limitations of Section 102. A copy of the Plan is attached to this Grant Letter as Exhibit A .

 

5. Any term not specifically defined in this Grant Letter shall have the meaning ascribed thereto in the Plan, Section 102, the Company’s Articles of Association in effect from time to time (the “ Articles of Association ”) and in any other document to which reference may be made in the Plan and the Articles of Association.

 

6. Unless otherwise determined by the Administrator, all Options granted to you on this date, in this Grant Letter, shall, subject to your continued employment with or service to the Company or its Affiliate, become vested and exercisable in accordance with the vesting schedule detailed below. The vesting shall be over a period of three (3) years, and the commencement date of your vesting schedule is ________________ (the “ Commencement Date ”).

 

(A) __________ of the Options shall vest on the first anniversary of the Commencement Date.

 

(B) ___________ of the Options shall vest on a quarterly basis commencing at the end of the first quarter after the first anniversary of Commencement Date and until the end of the third anniversary of the Commencement Date ; and

 

In accordance with the above, all of such Options shall become fully vested by the third anniversary of the Commencement Date.

 

To remove any doubt, no Option shall be exercisable prior to the lapse of the first anniversary following the Commencement Date.

 

 
 

 

7. Method of Exercise . You may exercise all or part of any Options that have, at the time of such exercise, vested in you in accordance with the foregoing vesting schedule, by delivery of an exercise notice in the form attached as Exhibit B to this Grant Letter (the “ Exercise Notice ”), and such other representations and agreements as may be reasonably required by the Company for such purposes. In addition to the foregoing, you hereby agree and undertake to sign any and all documents that may be required by law and/or by the Trustee for the purpose of exercising the Options. In order for the Exercise Notice to become effective, the Exercise Notice must be accompanied by (A) payment of the aggregate Purchase Price for the number of shares to be purchased, and (B) payment of the aggregate withholding taxes due with respect to the exercised shares, if applicable. Options shall be deemed to be exercised upon receipt by the Company of such fully executed Exercise Notice accompanied by the aggregate Purchase Price and withholding taxes due with respect to the exercised shares, if applicable, all as set forth herein.

 

8. No shares shall be issued pursuant to the exercise of an Option unless such issuance and such exercise comply with applicable laws. If any law or regulation requires the Company to take any action with respect to the shares specified in such notice before the issuance thereof, then the date of their issuance shall be extended for the period necessary to take such action.

 

9. Notification to Trustee . The Company will notify the Trustee of any exercise by you of all or part of your Options as set forth in the Exercise Notice(s). If the exercise and such notification are delivered during the Restricted Period, the shares issued upon the exercise of the Option shall be issued directly to the Trustee, and shall be held by the Trustee in trust on your behalf. In the event that such exercise and notification are delivered after the Restricted Period, the shares issued upon the exercise of the Option shall be transferred either to the Trustee or to you directly, at your election, provided however that in the event you elect to receive the shares directly to your possession, the transfer thereof shall be subject to the payment by you of the applicable taxes you may be liable to pay according to applicable law.

 

10. The Options are granted to you on condition that you sign the ‘Approval of the Optionee’ set forth and detailed below.

 

11. By signing this Grant Letter, I hereby give an irrevocable proxy to the Chairman of the Board of Directors of the Company, or to any other representative appointed by the Company’s Board of Directors, in accordance with Section 10.1 of the Plan, including without limitation, to vote any Shares that will be issued to me following the exercise of Options granted to me under the Plan, all as stipulated in the Irrevocable Power of Attorney and Proxy attached hereto as Exhibit C (the “ Proxy ”).
12. In the event of a conflict between the terms and conditions of the Plan and this Grant Letter, other than with respect to the vesting schedule and Purchase Price, the terms and conditions of the Plan shall prevail. In the event of a conflict between the terms and conditions of the Plan and this Grant Letter vis-à-vis the Trust Agreement, then the provisions of the latter shall prevail and take precedence. If there is a conflict between the terms of the Plan and any provision of the Ordinance, then the provisions of the Ordinance shall govern and prevail. A copy of the Trust Agreement is attached hereto as Exhibit D .

   

  owc pharmaceutical research corp.
     
     
     
  Name:  
  Title: Chief Executive Officer

 

2
 

 

APPROVAL OF THE OPTIONEE :

 

I, the undersigned, hereby agree that all the Options granted to me, shall be allocated to the Trustee under provisions of the Capital Gains Tax Track and shall be held by the Trustee for the period stated in Section 102 and in accordance with the provisions of the Trust Agreement and the Plan, or for a shorter period if an approval therefor is received from the tax authorities.

 

I am aware of the fact that upon termination of my employment with the Company, I shall not have a right to the Options, except as specified in the Plan.

 

I hereby confirm that:

 

1. I have read the Plan and I understand and accept its terms and conditions. I am aware of the fact that the Company agrees to grant me the Options based on my confirmations contained herein; I further represent that I understand and undertake to comply with all of the provisions of the Plan.

 

2. I understand the provisions of Section 102 and the applicable tax track of this grant of Options;

 

3. I agree to the terms and conditions of the Trust Agreement;

 

4. Subject to the provisions of Section 102, I confirm that I shall not sell nor transfer the Options from the Trustee until the end of the Restricted Period, as such term is defined in Section 6.1 of the Plan;

 

5. If I sell or withdraw the Options from the Trustee and the trust thereunder before the end of the Restricted Period (a “ Violation ”), either (A) I shall fully reimburse the Company, within three (3) days of its demand, for the employer portion of the payment paid by the Company to the National Insurance Institute plus linkage and interest in accordance with applicable law, as well as any other expense that the Company shall have to bear as a result of the said Violation, or (B) I agree that the Company may, in its sole discretion, deduct the foregoing amounts directly from any monies to be paid to me as a result of my Violation by disposing the Shares;

 

6. I understand that this grant of Options is conditioned upon the receipt of all required approvals from the Israeli tax authorities; and

 

7. I hereby acknowledge and agree that the vesting of the Options pursuant to the vesting schedule contained in this Grant Letter hereof is earned only by my continued employment with the Company, at the will of the Company. I hereby further acknowledge and agree that this Grant Letter, the transactions contemplated hereunder and the vesting schedule set forth herein do not constitute an express or implied promise of continued employment with the Company and shall not interfere in any way with my right or Company’s right to terminate my employment at any time, with or without Cause.

 

8. I hereby acknowledge and agree that the Company may assign any of its rights under this Grant Letter to a single or multiple assignees, and this Grant Letter shall inure to the benefit of the successors and assigns of the Company. Subject to the restrictions on transfer set forth herein and in the Plan, this Grant Letter shall be binding upon me and my heirs, executors, successors and assigns.

 

9. I hereby confirm that I read this letter thoroughly, received all the clarifications and explanations I requested, I understand the contents of this letter and the obligations I undertake in signing it.

 

3
 

 

 

I, THE UNDERSIGNED, ACKNOWLEDGE THAT I AM FAMILIAR WITH THE ENGLISH LANGUAGE AND DO NOT REQUIRE TRANSLATION OF THIS APPROVAL AND ANY ANNEXED DOCUMENTS TO ANY OTHER LANGUAGE. I FURTHER ACKNOWLEDGE THAT I HAVE BEEN ADVISED BY THE COMPANY THAT I MAY CONSULT AN ATTORNEY BEFORE EXECUTING THIS GRANT LETTER APPROVAL AND THAT I HAVE BEEN AFFORDED AN OPPORTUNITY TO DO SO .

 

 

 

 

         
Printed Name of Optionee   Signature   Date

 

Attachments:

 

Exhibit A: Israeli Employee Share Option Plan
Exhibit B: Notice of Exercise
Exhibit C: Trust Agreement

 

4
 

 

Exhibit A

 

Israeli Employee Share Option Plan

 

5
 

 

Exhibit B

 

Notice Of Exercise

 

OWC Pharmaceutical Research Corp.

__________ , _______

Israel

 

Attention: Chief Executive Officer

 

1. Exercise of Option . Effective as of today, I, ____________, the undersigned (the “ Optionee ”) hereby elect to exercise Optionee’s option to purchase_______ Shares under and pursuant to the 2016 Israeli Employee Share Option Plan (the “ Plan ”) and the Grant Letter dated _______________ (the “ Optioned Shares ”).

 

2. Delivery of Payment . Optionee herewith delivers to the Company the amount of US$ [________], constituting the full and aggregate Purchase Price of the Shares being exercised under this Notice of Exercise, as set forth in the Grant Letter.

 

3 Rights as Shareholder . Until the issuance of the Shares (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), no right to receive dividends or any other rights as a shareholder shall exist with respect to the Optioned Shares, notwithstanding the exercise of the Option. The Shares shall be issued to Optionee as soon as practicable after the Option is exercised. No adjustment shall be made for a dividend or other right for which the record date is prior to the date of issuance except as provided in the Plan.

 

4 Tax Consultation . Optionee understands that he/she may suffer adverse tax consequences as a result of Optionee’s purchase or disposition of the Shares. Optionee represents that he/she has had ample opportunity to consult with a tax consultant of Optionee’s choice in connection with the purchase or disposition of the Shares being exercised hereunder and that Optionee is not relying on the Company or any Affiliate of the Company for any tax advice.

 

5 Additional Representations . The Optionee hereby acknowledges that he/she has been informed as follows:

 

5.1 Nothing herein shall obligate the Company to register its shares or any portion of its shares on any stock exchange.

 

5.2 The Optionee hereby agrees that the terms of Section 102 of the Israeli Income Tax Ordinance including all rules and regulations promulgated thereunder (“ Section 102 ”) shall apply regarding to the Optioned Shares.

 

5.3 The Optionee is prohibited from selling or removing from the Trustee the Shares granted to him/her prior to the end of Restricted Period as defined in Section 6.1 of the Plan.

 

5.4 The Optionee is aware of the directives set forth in Section 102, and of the tax track that was chosen under Section 102 and the implications of such tax track on Optionee.

 

6
 

 

Signature Page of Notice of Exercise of Options

 

Optionee   Company
     
Acknowledged, understood and agreed:   OWC Pharmaceutical Research Corp.
     
     
[Signature of Optionee]   [Signature]
     
     
[Printed Name of Optionee]   [Printed Name of Signatory]
     
     
    Chief Executive Officer
[Address of Optionee]   [Title of Signatory]
     
     
[Date Received by Optionee]   [Date signed by Company]

 

7
 

 

EXHIBIT C

 

PROXY

 

The undersigned Yossi Dagan (the “ Holder ”), the registered holder of securities of OWC Pharmaceutical Research Corp., a company incorporated under the laws of New York (respectively, the “ Securities ” and the “ Company ”), does hereby irrevocably appoint the Chairman of the Board of Directors of the Company or to any other person or persons designated by the Chairman of the Board of Directors (the “ Attorney-In-Fact ”), as a true and lawful attorney-in-fact, in the Holder’s place and stead, to act, as Holder’s proxy, including to vote and exercise all voting and other rights, including without limitation, any contractual rights and rights under applicable law (to the full extent that the Holder is entitled to do so), with respect to all matters arising in connection with any action affecting or relating to the Securities or other securities of the Company’s share capital, which the Holder now holds or hereafter in the future may hold, actually or constructively, directly or indirectly, and any and all other shares or securities of the Company issued or issuable to the Holder in respect thereof, on or after the date hereof, including as a result of any change, by subdivision or combination in any manner of the Company’s share capital or by the making of a share dividend (i.e., bonus shares) on or after the date hereof (collectively, the “ Shares ”), including, without limitation, the right, on the Holder’s behalf:

 

(i)       to execute any agreement, waiver, amendment, consent or any other document, including without limitation, any shareholders’ agreements, amendment to shareholders’ agreement, waivers of rights of first refusal, waivers of anti-dilution, waivers of rights to first offer, waivers of rights of co-sale, waivers of pre-emptive rights, waivers of bring-along rights and such other waivers, all in connection with the Shares;

 

(ii)       to attend and to vote in all shareholders’ meetings of the Company (including the right to receive on behalf of the Holder materials/information provided to shareholders), or execute and deliver written consents pursuant to applicable law, with respect to the Shares, in the same manner and with the same effect as if the Holder was personally present at any such meeting or voting such Shares or personally acting on any matters submitted to the Company’s shareholders for approval or consent, giving and granting to said Attorney-In-Fact full power and authority to do and perform each and every act and thing whether necessary or desirable that may be done as its Attorney-In-Fact in relation to the Shares other than to sell or transfer the Shares without the prior written consent of the Holder, provided however, that no such consent shall be required, and the Attorney-In-Fact shall have the right to sell or transfer the Shares without the prior written consent of the Holder, in the event of a sale of Shares effectuated as a result of an exercise of a “bring along” or in the event of a Transaction (as such term is defined in the Company’s 2016 Share Option Plan).

 

(iii)       To sign such other certificates, documents and agreements and take any and all other actions as the Attorney-In-Fact may deem necessary or desirable in connection with the consummation of the transactions contemplated by this Proxy.

 

This Proxy shall be interpreted in the widest possible sense, in reliance upon the goals and intentions thereof and shall apply to any Securities currently held or to be held in the future by the Holder, or any permitted transferee, successor and/or assignee to which the Holder may transfer his Securities in the future, as if such transferee, successor and/or assignee had signed this Proxy.

 

8
 

 

This Proxy is an agency coupled with an interest and all authority conferred hereby shall be irrevocable, and shall not be terminated by any act of the undersigned or by operation of law, or by the occurrence of any other event or events, and it is hereby clarified that the Company shall serve as a third party beneficiary thereof, and no amendment or other modification shall be made to this Proxy or to any of the terms and conditions herein without the prior written consent of the Company.

 

By this Proxy, the Attorney-In-Fact shall vote such Shares on any issue brought before the shareholders of the Company either (i) pro-rata to the vote of the other shareholders of the Company, which are entitled to participate in the vote (such pro-rata vote shall take into account only shareholders participating in the vote, in person, written ballot or proxy, whether voting for, against or abstaining from voting on the issue brought before them); or (ii) in such other manner as shall be prescribed by the Chairman of the Board of Directors.

 

The undersigned hereby ratifies and confirms all that said Attorney-In-Fact shall do or cause to be done by virtue of and in accordance with the terms and conditions of this Proxy. In addition, the Holder hereby confirms and undertakes that he shall not have, and hereby irrevocably waives, any claim or demand against the Company in connection with this Proxy or any action taken or not taken by the Attorney-In-Fact in accordance with the provisions hereof.

 

IN WITNESS WHEREOF , the undersigned has executed this Irrevocable Power of Attorney and Proxy as of the date first set forth below.

 

     
NAME   DATE

 

9
 

 

Exhibit D

 

Trust Agreement

 

10
 

 

Exhibit 21.1

 

Subsidiaries

 

Entity   Jurisdiction of Organization
One World Cannabis Ltd.   Israel

 

     
     

 

Exhibit 31.1

 

CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Mordechi Bignitz, certify that:

 

1. I have reviewed this Annual Report on Form 10-K of OWC Pharmaceutical Research Corp.;
   
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
   
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
   
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
     
  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  (b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
     
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
     
  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: April 16, 2018 By: /s/ Mordechi Bignitz
    Mordechi Bignitz
    Chief Executive Officer

 

     

 

 

 

Exhibit 31.2

 

CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Yossi Dagan, certify that:

 

1. I have reviewed this Annual Report on Form 10-K of OWC Pharmaceutical Research Corp.;
   
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
   
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
   
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
     
  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  (b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
     
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
     
  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: April 16, 2018 By: /s/ Yossi Dagan
    Yossi Dagan
    Chief Financial Officer

 

     

 

 

 

Exhibit 32

 

CERTIFICATIONS UNDER SECTION 906

 

Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of OWC Pharmaceutical Research Corp., a Delaware corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:

 

The Annual Report for the year ended December 31, 2017 (the “Form 10-K”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-K fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Dated: April 16, 2018 /s/ Mordechi Bignitz
  Mordechi Bignitz
  Chief Executive Officer
  (principal executive officer)
   
Dated: April 16, 2018 /s/ Yossi Dagan
  Yossi Dagan
  Chief Financial Officer
  (principal financial officer and principal accounting officer)

 

A signed original of this written statement required by Section 906 has been provided to OWC Pharmaceutical Research Corp. and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.