As filed with the Securities and Exchange Commission on October 8, 2021

Registration No. 333-_________

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549 

____________________

FORM F-1
REGISTRATION STATEMENT 
UNDER THE SECURITIES ACT OF 1933 

____________________

MAINZ BIOMED B.V.
(Exact name of registrant as specified in its charter)

____________________

The Netherlands

 

8731

 

Not Applicable

(State or other jurisdiction of
incorporation or organization)

 

(Primary Standard Industrial
Classification Code Number)

 

(I.R.S. Employer
Identification Number)

____________________

Mainz Biomed B.V.
Robert Koch Strasse 50
55129 Mainz
Germany
Telephone: 0049 6131 5542860

(Address of principal executive offices, including zip code, and telephone number, including area code)

____________________

Vcorp Services, LLC
25 Robert Pitt Drive, Suite 204
Monsey, NY 10952
Telephone:

(Name, address, including zip code, and telephone number, including area code, of agent of service)

____________________

Copies to:

William Rosenstadt, Esq.
Mengyi “Jason” Ye, Esq.
Tim Dockery, Esq.
Ortoli Rosenstadt LLP
366 Madison Avenue
New York, New York 10022
Telephone: (212) 588
-0022

 

Benjamin Tan, Esq.
Sichenzia Ross Ference LLP
1185 Avenue of the Americas, 31
st Floor
New York, NY 10036
Telephone: (212) 930 9700

____________________

Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act of 1933, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act of 1933, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act of 1933, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.

Emerging growth company

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, 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 7(a)(2)(B) of the Securities Act. o

 

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CALCULATION OF REGISTRATION FEE

Title of each class of securities to be registered(1)

 

Proposed
maximum
aggregate
offering
price
(2)

 

Amount of registration
fee

Ordinary shares(3)

 

$

16,500,000

 

$

1,530

 

Warrants to be issued to the underwriter

 

 

 (4)

 

 

(4)

Ordinary shares underlying warrants to be issued to the underwriter(5)

 

$

805,000

 

$

75

 

   

$

17,305,000

 

$

1,605

 

____________

(1)      Pursuant to Rule 416 under the Securities Act, there are also being registered such indeterminate number of additional securities as may be issued to prevent dilution resulting from share splits, share dividends or similar transactions.

(2)      Estimated solely for the purpose of calculating the amount of the registration fee in accordance with Rule 457(o) under the Securities Act.

(3)      Consists of (i) ordinary shares with an estimated value of $11,500,000 that the registrant is offering in its initial public offering (assuming that the underwriter exercises its over-allotment option) and (ii) ordinary shares with an estimated value of $5,000,000 that the selling shareholders are offering simultaneously.

(4)      No registration fee required pursuant to Rule 457(g).

(5)      We have agreed to issue to the underwriter warrants to purchase ordinary shares representing up to 7% of the ordinary shares issued in the offering. The underwriter warrants are exercisable at a per share exercise price equal to 100% of the public offering price per ordinary share offered hereby. As estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act, the proposed maximum aggregate offering price of the underwriter warrants is $805,000, which is equal to 7% of $11,500,000 (assuming that the underwriter exercises its over-allotment option).

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine

 

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EXPLANATORY NOTE

This Registration Statement contains two forms of prospectuses: one to be used in connection with the public offering of 2,000,000 ordinary shares through the underwriter named on the cover page of this prospectus (the “Prospectus”) and one to be used in connection with the potential resale by the selling shareholders of up to 1,000,000 ordinary shares held by the selling shareholders identified therein (the “Selling Shareholder Prospectus”). The Prospectus and the Selling Shareholder Prospectus will be identical in all respects except for the alternate pages for the Selling Shareholder Prospectus included herein which are labeled “Alternate Pages for Selling Shareholder Prospectus.”

The Selling Shareholder Prospectus is substantively identical to the Prospectus, except for the following principal points:

•        they contain different outside and inside front covers;

•        they contain different Offering sections in the Prospectus Summary section;

•        they contain different Use of Proceeds sections;

•        the Capitalization section is deleted from the Selling Shareholder Prospectus;

•        the Dilution section is deleted from the Selling Shareholder Prospectus;

•        a Selling Shareholder section is included in the Selling Shareholder Prospectus;

•        the Underwriting section from the Prospectus is deleted from the Selling Shareholder Prospectus and a Plan of Distribution is inserted in its place; and

•        the Legal Matters section in the Selling Shareholder Prospectus deletes the reference to counsel for the underwriter.

We have included in this Registration Statement, after the financial statements, a set of alternate pages to reflect the foregoing differences of the Selling Shareholder Prospectus as compared to the Prospectus.

While the selling shareholders have expressed an intent not to sell the shares of ordinary shares offered pursuant to the Selling Shareholder Prospectus prior to the closing of or concurrently with the public offering, the sales of our securities registered in the Prospectus and the Selling Shareholder Prospectus may result in two offerings taking place sequentially or concurrently, which could affect the price and liquidity of, and demand for, our securities. This risk and other risks are included in “Risk Factors” beginning on page 13 of the Prospectus.

 

Table of Contents

The information contained in this preliminary prospectus is not complete and may be changed. Neither we nor the underwriter can sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS

 

SUBJECT TO COMPLETION

 

DATED OCTOBER 8, 2021

2,000,000 Ordinary Shares

Mainz Biomed B.V.

____________________

This is a firm commitment initial public offering of 2,000,000 ordinary shares of Mainz Biomed B.V.. Prior to this offering, there has been no public market for our ordinary shares. We anticipate that the initial public offering price of our shares will be between $4.00 and $6.00.

We have applied to have our ordinary shares listed on the Nasdaq Capital Market under the symbol “MYNZ”.

In addition, we have registered 1,000,000 ordinary shares for resale by certain shareholders by means of a separate prospectus (the “Selling Shareholder Prospectus”). While the selling shareholders have expressed an intent not to sell their ordinary shares registered pursuant to the Selling Shareholder Prospectus prior to the closing of or concurrently with the public offering, the sales of our securities registered in the Prospectus and the Selling Shareholder Prospectus may result in two offerings taking place sequentially or concurrently, which could affect the price and liquidity of, and demand for, our securities.

We are an “emerging growth company” under the federal securities laws and have elected to comply with certain reduced public company reporting requirements.

Investing in our ordinary shares involves a high degree of risk. You should carefully consider the matters described under the caption “Risk Factors” beginning on page 13.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

Per
Common
Share

 

Total

Public offering price

 

$

   

$

 

Underwriter discounts and commissions(1)

 

$

   

$

 

Proceeds to us, before expenses(2)

 

$

   

$

 

____________

(1)      The underwriter, Boustead Securities, LLC , will receive compensation in addition to the discounts and commissions. The registration statement, of which this prospectus is a part, also registers for sale warrants to purchase ordinary shares to be issued to the underwriter (based on the assumed offering price of $5.00 per share, the midpoint of the range set forth on the cover page of this prospectus). We have agreed to issue the warrants to the underwriter as a portion of the underwriting compensation payable to the underwriter in connection with this offering. See “Underwriting” for a description of compensation payable to the underwriter.

(2)      The total estimated expenses related to this offering are set forth in the section entitled “Expenses Relating to this Offering.”

We have granted a 45-day option to the underwriter to purchase up to additional 300,000 ordinary shares to cover over-allotments, if any.

The underwriter expects to deliver the ordinary shares on or about               , 2021.

Boustead Securities, LLC

The date of this prospectus is               , 2021

 

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TABLE OF CONTENTS

 

Page

PROSPECTUS SUMMARY

 

1

RISK FACTORS

 

13

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS

 

26

IMPLICATIONS OF BEING A FOREIGN PRIVATE ISSUER

 

27

IMPLICATIONS OF BEING AN EMERGING GROWTH COMPANY

 

28

USE OF PROCEEDS

 

29

DIVIDEND POLICY

 

30

CAPITALIZATION AND INDEBTEDNESS

 

31

DILUTION

 

32

CURRENCY AND EXCHANGE RATES

 

34

COMPANY INFORMATION

 

35

BUSINESS OVERVIEW

 

36

KEY INFORMATION

 

50

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS

 

51

DIRECTORS AND EXECUTIVE OFFICERS

 

59

EXECUTIVE COMPENSATION

 

65

PRINCIPAL SHAREHOLDERS

 

70

RELATED-PARTY TRANSACTIONS

 

71

MATERIAL AGREEMENTS

 

71

MARKET FOR OUR SECURITIES

 

73

SECURITIES ELIGIBLE FOR FUTURE SALE

 

73

ARTICLES OF ASSOCIATION OF OUR COMPANY

 

75

MATERIAL INCOME TAX INFORMATION

 

81

UNDERWRITING

 

89

EXPENSES RELATING TO THIS OFFERING

 

93

LEGAL MATTERS

 

94

EXPERTS

 

94

INTERESTS OF EXPERTS AND COUNSEL

 

94

DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES

 

94

ENFORCEABILITY OF CIVIL LIABILITIES

 

95

WHERE YOU CAN FIND MORE INFORMATION

 

96

INDEX TO FINANCIAL STATEMENTS

 

F-1

You should rely only on the information contained in this prospectus, any amendment or supplement to this prospectus or any free writing prospectus prepared by or on our behalf. Neither we, nor the selling shareholders, nor the underwriter, have authorized any other person to provide you with different or additional information. Neither we, nor the selling shareholders, nor the underwriter, take responsibility for, nor can we provide assurance as to the reliability of, any other information that others may provide. The underwriter is not making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. The information contained in this prospectus is accurate only as of the date of this prospectus or such other date stated in this prospectus, and our business, financial condition, results of operations and/or prospects may have changed since those dates.

Except as otherwise set forth in this prospectus, neither we nor the selling shareholders, nor the underwriter have taken any action to permit a public offering of these securities outside the United States or to permit the possession or distribution of this prospectus outside the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about and observe any restrictions relating to the offering of these securities and the distribution of this prospectus outside the United States.

Unless the context otherwise requires, in this prospectus, the term(s) “we”, “us”, “our”, “Company”, “our company”, “our business” and “Mainz Biomed” refer to Mainz Biomed B.V.

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PROSPECTUS SUMMARY

The following summary highlights, and should be read in conjunction with, the more detailed information contained elsewhere in this prospectus. You should read carefully the entire document, including our historical financial statements and related notes, to understand our business, the ordinary shares and the other considerations that are important to your investment decision. You should pay special attention to the “Risk Factors” section beginning on page 13.

Our Company

We are a molecular genetics cancer diagnostic company formed in 2021 to acquire PharmGenomics GmbH (“PharmGenomics“) with the purpose of commercializing their product portfolio in Europe and the United States. PharmGenomics, a German DIN EN ISO 13485-certified manufacturer of in-vitro diagnostic (“IVD”) tests with its own molecular genetic laboratory, has developed several IVD tests for the European market since it was founded in 2008.

Our portfolio consists of the following products and product candidates:

•        ColoAlert, a colorectal cancer (“CRC”) screening stool DNA (“deoxyribonucleic acid”) test licensed from ColoAlert AS and sold in Europe,

•        PancAlert, a product candidate in an early stage of research for a pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction (“PCR”)-based multiplex detection of molecular-genetic biomarkers in stool samples,

•        GenoStrip, a proposed platform technology in an early stage of research to detect pathogens in environments on a molecular genetic basis where a qualitative evaluation must be made in a short-time period and

•        Legacy Research-Use-Only (“RUO”) and IVD tests, such as the GenoChips and the HumaSense product line, that we intend to license to third parties, sell or discontinue within the coming 18 months as well as third-party laboratory testing that we plan to discontinue.

About the Industry

The cancer industry can be divided into a diagnostics segment focused on detecting cancers, and a therapeutic segment focused on treating them. We are focused on the diagnostic aspect of the cancer industry.

For most cancer, early detection is lifesaving and for CRC, in particular, the symptoms are unclear and removal of cancer by surgery in the early stage is easy compared to treatment at a late stage. Screening of CRC is both lifesaving and cost saving. We compete with other entities developing and offering diagnostic tests to detect the presence of cancers. Our core product is a CRC screening stool DNA test, and we are in the early stages of researching a similar test for pancreatic cancer.

CRC refers to malignant tumors in the colon or rectum. These tumors usually develop from benign polyps which, over time degenerate and become cancerous. Because of the high survival rates in case of early detection, regular and accurate screening is essential.

According to the American Cancer Society, CRC is the third most-commonly diagnosed cancer but the second leading cause of cancer death in the world.1 According to an article in BMJ Journals, global cases of CRC are expected to increase by 60% to more than 2.2 million new cases and 1.1 million deaths by 2030.2

Industry Arc forecasts that the CRC diagnostic and therapeutic markets will be $31.2 billion in 2025, up from $26.2 billion in 2019, representing a compound annual growth rate (“CAGR”) of 3.0%.3 Factors that add to the rising prevalence of tumors that lead to CRC include unhealthy eating habits, both in the choice of foods and the timing of meals, and an increasing geriatric population in many nations.

____________

1          American Cancer Society, CA — A cancer journal for clinicians, Volume 71, issue3

2          BMJ Journals, Global patterns and trends in colorectal cancer incidents and mortality, Volume 66, Issue 4

3          https://www.industryarc.com/Report/15559/colorectal-cancer-market.html

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A recent report by Fact.MR projects the global CRC diagnostics market to register an expansion at a CAGR of 8.5% from 2017 to 2022. Revenues from the global CRC diagnostics market are expected to surpass $2 billion by the end of 2022.4

Products and Product Candidates

We strive to make the diagnosis of various diseases more effective by using the latest genetic diagnostic technologies. Enabling earlier detection of these diseases allows for earlier and better therapy for affected individuals. In addition to offering the CRC screening test, ColoAlert, we are currently developing two product candidates, PancAlert and GenoStrip. We aim to use known and existing biomarkers (concepts) in applicable and reliable diagnostic tools.

ColoAlert

We offer a CRC screening test, ColoAlert. We believe that molecular genetic stool tests like ColoAlert increase the low participation rate in CRC screening and shift the detection of CRC to an earlier point of time which, in turn, increases the likelihood of successful treatment of the cancer. ColoAlert is currently offered primarily in German-speaking countries due to the geographical location of our offices and facilities. In Germany alone, more than 31 million people are older than the suggested screening age of 50, resulting in a total available market of over 10 million tests per year, based on a screening interval of three years. Over 5 million of them are privately insured and eligible for complete reimbursement.

ColoAlert is a multitarget test in which the stool sample is analyzed for genetic anomalies as well as for the presence of hidden blood, which is often called occult blood. The genetic markers were chosen to complement the diagnostic accuracy of the occult blood test and lead to an increased clinical added value.

We target individuals covered by national CRC screening programs. Most screening programs recommend CRC screening starting at age 50. However, a trend exists to further lower the screening age. For example, the FDA recently recommended CRC screening starting at age 45.

We license the ColoAlert test from a Norwegian research and development company, ColoAlert AS, pursuant to an exclusive licensing agreement dated January 1, 2019. Pursuant to the terms of our license, we pay ColoAlert AS 50% of the net profit that we generate from the ColoAlert test, in addition to a protection fee of €5 per test sold. The licensing agreement has no fixed term but will be terminated if the quarterly fee paid to ColoAlert AS is less than €25,000 for each of the quarters ending on or prior to December 31, 2022 and €250,000 per quarter thereafter. On February 11, 2021, we obtained an option exercisable for three years to acquire the intellectual property for  the ColoAlert test for (i) either a one-time cash payment of €2,000,000 or a €4,000,000 payment in ordinary shares at the valuation of our most recent financing plus (ii) a lifetime royalty payment of €3 per ColoAlert test sold. If we opt to make the one-time payment in cash, ColoAlert AS has the right to require us to pay the €4,000,000 in ordinary shares at the valuation of our most recent financing.

In the European Union, ColoAlert is a CE-IVD registered product under the current In-Vitro Diagnostics Directive 98/79 /EC (“IVD-D”). Starting on May 26, 2022, IVD products in the European Union will be regulated by the In-Vitro Diagnostics Regulation, EU 2017/746 (“IVD-R”), which replaces the IVD-D. We are currently evaluating the necessary steps to meet the upcoming regulations for our ColoAlert product. ColoAlert is currently validated on the Roche LightCycler 480 II and Roche Lightcycler 2.0. Mainz BioMed is planning to validate the test on additional real time PCR instruments used in many laboratories worldwide to allow a potential faster market penetration.

We offer ColoAlert Basic, which consists of the above-described biomarker panel with results obtained in 9 workdays, and ColoAlert Plus, which also includes the detection of the hemoglobin-haptoglobin while delivering results within five workdays.

____________

4          https://www.factmr.com/report/70/colorectal-cancer-diagnostics-market

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We manufacture the ColoAlert IVD test kits at our facility in Mainz, Germany.

Below is a typical process flow for the use of ColoAlert for Germany.

Typical process flow:

1.      The patient is informed about the risk of CRC.

2.      The physician discusses with the patient about the need for a CRC test.

3.      The physician provides a kit to the patient or the patient receives the kit shipped from the laboratory partner.

4.      The patient collects the sample and ships the collected sample to the testing clinical laboratory.

5.      The clinical laboratory tests the sample and provides the result to the ordering physician.

6.      The ordering physician informs the patient about the results and decides on next steps.

PancAlert

We are in the early stages of developing PancAlert, a stool-based screening test for the detection of pancreatic cancer. According to the Global Cancer Observatory, pancreatic cancer was diagnosed in over 460,000 patients worldwide in 2018.5 Due to the asymptomatic early stages, in most cases this disease is detected too late, making pancreatic cancer one of the most lethal malignant neoplasms with over 430,000 annual deaths in 2018 according to the Global Cancer Observatory.6

Our goal is to make PancAlert the world’s first pancreatic cancer screening test based on Real-Time PCR-based multiplex detection of molecular-genetic biomarkers in stool samples. The most promising candidates for disease-specific biomarkers to date are KRAS, mBMP3, NDRG4, and GNAS codon 201. In addition, the platform technology used will enable simple integration of further biomarkers if indicated. The analysis of the results will be additionally facilitated by a specialized IT solution. Although we have conducted some in house clinical trials, we do not expect this to become a commercially available product in the near future, if at all. If further clinical studies show promising results, we intend to start developing an IVD-R and FDA approvable product for the European and U.S. market.

As we are in the early stages of development and have only commenced preclinical trials, we cannot be sure that at this time that PancAlert will ever receive the necessary governmental approvals for us to offer an actual product or that it will be commercially viable if we do. If we do create a commercially viable product, it may not be in the near-term, and our revenues may be wholly reliant on ColoAlert until we do.

_________

5          Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, in press. The online GLOBOCAN 2018 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.

6          https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21492 — Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, in press. The online GLOBOCAN 2018 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.

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GenoStrip

We are in the early stage of developing a rapid and easy to use molecular lateral-flow test that we call GenoStrip. We intend to develop the GenoStrip technology as a platform technology which combines the advantages of highly precise molecular genetics and the easy-to-handle usage of a customized lateral-flow-dipstick to provide molecular results in as little as 20 minutes, depending on the sample preparation method amplification system used. The target sequences (DNA or RNA( Ribonucleic acid)) are amplified either way in single or multiplex amplification reactions.

If successful, the GenoStrip technology could be modified for various applications where qualitative evaluations have to be made within a short time frame, as for instance in the case of COVID-19 diagnosis, and other respiratory viruses, as well as pathogens causing sexually transmitted diseases or the detection of mutated or deleted genes.

As we are in the early stages of development and have only commenced preclinical trials, we cannot be sure that at this time that GenoStrip will ever receive the necessary governmental approvals for us to offer an actual product or that it will be commercially viable if we do. If we do create a commercially viable product, it may not be in the near-term, and our revenues may be wholly reliant on ColoAlert until we do.

Legacy Diagnostic Products and Services

We currently sell several genetic diagnostic products, which we manufacture, to clinical laboratories, mostly in Germany. Some of these products were CE-IVD registered while others are RUO products. Due to the high cost of meeting the new IVD-R regulatory requirements starting in May 2022, we have decided to license out, sell off or discontinue those products. Additionally, we have provided third-party laboratory testing services that we also intend to discontinue.

Competitive Advantages & Operational Strengths

We face competition from providers of more traditional CRC screening diagnostics, such as colonoscopies, as well as other manufacturers of non-invasive stool- or blood-based tests. We believe the primary competitive factors for ColoAlert include but are not limited to:

•        Accuracy:    End-users want as accurate a result as possible without worrying about costs, hassle and time associated with false-negative and false-positive results. A report by Professor Dollinger found ColoAlert to have a specificity of 92%, above the 90% specificity requirement set by the European CRC screening guidelines, and has a sensitivity of 85%. Sensitivity defines how often a test correctly generates a positive result for the condition being tested. Specificity is the ability of the test to correctly identify those without the disease (true negative rate). Since that report, we have updated the occult blood test component of ColoAlert in a way that we believe will increase sensitivity and specificity.

•        Time-to-result:    The faster the results of a diagnostic test are known; the sooner treatment may begin or the end user can gain ease of mind. Due to ColoAlert’s simplicity of the testing procedure, the result turn-around time between the patient’s decision and delivery of the test report can be as low as three days in Germany, which we believe is significantly shorter than most other tests.

•        Ease of use:    As many people will delay or avoid getting an invasive diagnostic test, such as a colonoscopy, the easier it is to take such a test the higher the participation rates will be, which could mean more detection of cancer at earlier stages and higher rates of survival. ColoAlert is less invasive than traditional colonoscopies, requiring neither the drinking of barium (oral or suppository) the night prior to the test, nor prior fasting, and does not require a trip to a clinic or the administration of anaesthesia. Compared to blood-based tests, stool tests can be performed at home and do not require the patient to visit their physician.

•        Executive team:    Our leadership team and advisors have extensive experience developing and commercializing innovative diagnostic products globally. We have strong relationships with government organizations and universities in Europe.

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•        Research and Development:    We are confident that we have organized a strong team to front our research and development. Our research and development efforts have been supported by a grant of up to approximately €440,000 from the German Federal Ministry of Research and Education for the development of PancAlert, a non invasive product candidate to detect pancreatic cancers, and a grant of up to approximately €205,000 from the European Fund for Economic and Regional Development for the development of GenoStrip, a product candidate for a rapid and easy to use molecular lateral-flow test.

Strategy

We intend to make ColoAlert the global CRC screening market leader by providing the best performance of an early detection, less invasive test at an affordable cost. To fulfil this goal efficiently, our sales strategy is primarily based on collaborations with large laboratory chains. This distribution strategy, which we plan to replicate with PancAlert and GenoStrip if they ever become commercial products, is chosen because laboratories typically have a large customer base of physicians as well as a strong sales team. This can increase awareness of ColoAlert within the physician community in a cost-effective manner. At the same time, it offers the opportunity for accelerated product rollouts in foreign markets, as large laboratory chains operate across Europe or worldwide and successful products are often distributed within the laboratory chain. Laboratory partners benefit from the introduction and distribution of ColoAlert especially from the increased medical added value, the positioning as innovation leaders and from, we believe, significantly higher margins compared to conventional stool tests such as FIT. We believe that this distribution approach also provides a strong business differentiation in the United States from the Cologuard, a test offered by Exact Sciences Corporation. Cologuard is performed exclusively in Exact Sciences’ in-house laboratories and therefore other laboratories currently do not have access to a multitarget stool test. By providing the ColoAlert test kits, other laboratories can also offer highly sensitive, non-invasive CRC screening to their affiliated physicians and their patients.

To introduce ColoAlert into the United States and potentially other markets like China, extensive regulatory studies are required. We are actively exploring the required regulatory path for the United States.

Therefore, we intend to use the proceeds from this offering to:

•        Expand the commercial opportunity of our ColoAlert product in Europe by expanding our commercial team and partnerships;

•        Prepare and execute a comprehensive clinical and regulatory strategy to achieve market authorization from the FDA to use ColoAlert as a screening test for CRC in the United States; and

•        Continue research and development of PancAlert and GenoStrip.

Expansion of ColoAlert in Europe

There are currently circa 440 medical care centers with a laboratory focus in Germany, of which one-fifth has a molecular genetic laboratory in house and are therefore in the core target group.7 Approximately 50% of the market share is held by five laboratory chains (Sonic, Limbach, Synlab, Amedes and LADR). We plan on securing additional partner laboratories to market and sell our ColoAlert product through sales representatives. Partner laboratories, once part of our distribution network, will receive support from us for the proper administration of the product in the client’s clinical laboratory. This validation process for new IVD products is being performed daily by other diagnostic companies in Germany (e.g. Roche, Abbott, Siemens). If needed, we will also provide co-branded marketing materials.

We primarily sell the ColoAlert IVD test kits to German clinical reference laboratories. The reference laboratories provide the patient kits and accompanying marketing materials to their affiliated physicians and educate them about the clinical advantages of ColoAlert. The laboratories perform the diagnostic analysis and report the results to the physicians.

We initiated a pilot program to allow patients to use the ColoAlert website to order a patient kit online directly from us. The collected samples are sent by the patient directly to our own clinical laboratory. We plan to conduct joint marketing activities with the reference labs to connect patients and physicians supported by the newly established online portal www.gemeinsam-gegen-darmkrebs.de (currently in beta status).

____________

7          https://www.g-f-v.org/node/1233 or Schöneberg, K., Wilke, P., Klotz, S., Venzke, O. & Wulff, M. (2017). Branchenanalyse Laboranalytik. Hans Huber.

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Our primary market is currently Germany, and we intend to expand to other German-speaking countries. After the rollout in the German-speaking region, we intend to launch ColoAlert in other Western European markets, particularly in the United Kingdom, with its innovation-friendly National Health Service (“NHS”), followed by countries such as Spain or in Scandinavia.

In the coming year, we seek to expand the current European sales team with strong diagnostic sales experience. The sales team will focus on sales of our ColoAlert test to clinical laboratories that perform diagnostics tests ordered by physicians. To ensure that the clinical laboratory sales teams approach the primary care physician with the highest possible efficiency and effectiveness inside their respective laboratory network, we are planning to conduct training for sales representatives, seminars for physicians and joint marketing campaigns to expand our product awareness. We will also look into partnering with third parties or outsourcing parts of the sales organization that directly visit with physicians.

Entry into the U.S. Market

We plan to employ a product and marketing strategy in the United States that is substantially similar to what we use in Europe. Prior to employing these strategies, we will seek to sell the ColoAlert test as a test kit to clinical laboratories that are certified by the Secretary of the Department of Health and Human Services under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA labs”) requiring FDA market authorization, or as a laboratory developed test offered by the Mainz BioMed clinical laboratory governed under US Centers for Medicare and Medicaid Services (“CMS”). We plan to explore the required clinical and regulatory path to submit ColoAlert to the FDA to achieve a CRC screening claim for asymptomatic patients who are at average risk for CRC, aged 45 to 80.

We expect to conduct extensive clinical trials considering the desired CRC screening claims. The duration of the study will be defined by the required number of patients to be enrolled. Cologuard, the main competitor in the United States, has performed multiple large studies which took several years to execute followed by a PMA submission. In addition, we will evaluate achieving claims for early identification of cancerous polyps and advanced adenomas.

During this market preparation period, market conditions may change, existing competitors may improve their products or new competitors may become commercially active which may force us to adjust our future commercial strategy if the FDA eventually authorizes the product. We may consider manufacturing our ColoAlert test kits as private label products to be sold to labs. In this case, we likely would not undertake any marketing efforts in the United States to promote it to physicians and patients but expect our business partner to take on this obligation.

Competition

Our principal product, ColoAlert, competes with other methods of CRC screening, such as the colonoscopy or the FIT test. The current standard for a CRC screening test is the colonoscopy, although we also compete with non-invasive CRC screening tests. In addition to these widespread, traditional screening tests, we also compete with companies that provide or are developing novel CRC screening tests.

Colonoscopy

The colonoscopy was established over 50 years ago and is used by countless physicians worldwide. The colonoscopy is an invasive procedure in which the inner wall of the intestine is examined by a physician using an endoscope. Preparation requires patients to undergo bowel cleansing at least the day prior to the procedure. Colonoscopy is a painful process and associated with risk of punctuating the colon. An experienced scopeist will perform the process with less pain and higher detection rate. The average detection rate of colonoscopy is approximately 95%.

Due to the cumbersome process, the compliance rate for colonoscopy in Germany even after a consultation with a physician is a mere 16%.8

Occult blood tests

With Fecal Immunochemical Tests (“FITs”), a patient’s stool sample can be examined for hidden, or occult, blood in a laboratory which can be a symptom of CRC. Unfortunately, occult blood is often only present in the later stages of the disease. There is no need for patients to prepare prior to sample collection, which leads to a high patient acceptance.

____________

8          Riens B et al (2011) Versorgungsatlas/Krebsfrüherkennung

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According to IKK Südwest, when coordinated by a centralized invitation to screening, participation rates can get as high as 73%.9 Since this method can only provide an indirect indication of CRC via fecal blood, the sensitivity normally hovers around 65% with a false-positive rate around 5% per an article published by the American Gastroenterological Association.10 Since this method depends on the presence of a blood signal and many tumors do not bleed in the early stages, many affected individuals are only diagnosed in later stages of the disease which leads to lower than 5-year survival rates and higher treatment costs.

Entities Providing Screening Tests

We compete with other entities that offer other non-invasive screening tests. Most of our current and potential competitors in Europe and the United States have significantly greater financial, technical, manufacturing, marketing, and other resources than we have and consequently may have better and more competitive products, services, marketing or distribution. Most of our competitors have more extensive customer bases and broader customer and industry relationships than we do. In addition, many of these companies have longer operating histories and greater name recognition than we do. Our competitors may be in a stronger position to respond quickly to new technologies and may be able to design, develop, market and sell their products more effectively.

Entities producing or developing CRC screening tests with which we compete include:

•        Exact Sciences: The most established of the entities that we compete with is Exact Sciences, a publicly-traded molecular diagnostic company focusing on the early detection of various cancers, which manufactures Cologuard and conducts the analysis of the tests. Cologuard is also a stool-based CRC screening test, and it achieves a sensitivity of 92% and a specificity of 87% per a study published in the New England Journal of Medicine.11 The average reimbursement is about $500,12 which is equivalent to approximately $166 annually when used in the recommended three-year screening interval. Exact Sciences is currently pursuing the goal of further expanding the market share it has gained in the United States, broadening its relationships with relevant health care provider and building a diversified product portfolio in the oncology screening space through targeted acquisitions.

•        Epigenomics AG, which focuses on the development of blood tests for cancer detection. The CRC test “Epi proColon”, one of its two approved products approved in the United States and the European Union, is a blood-based test that achieves a sensitivity of 68% with a specificity of 80%.13

•        Novigenix SA, a Swiss company specializing in the development of immuno-transcriptomics solutions. Novigenix’s LITOseek Platform is designed to provide information for early cancer detection, disease progression and therapy selection. For CRC screening, Novigenix has developed the Colox blood test, which is currently available on the Swiss market. it achieved a sensitivity of 78% and a specificity of 92% in a clinical study.14

•        Agena Biosciences Inc., a U.S. company active in the field of genetic diagnostics. The company’s core product is its proprietary MassArray platform. This offers laboratory customers the possibility to provide rapid and broad genetic analysis. From the large number of panels, the UltraSeek Colon Panel initially shows competitive potential. This is used for the investigation of disease progression and resistance of CRC. As this product is not suitable for CRC screening, it is not yet a direct competitor to ColoAlert, but could be relevant through a future product variation.

____________

9         IKK Südwest. IKK Südwest in Zahlen: https://www.ikk-suedwest.de/ueber-uns/daten-und-fakten/ikk-suedwest-in-zahlen/

10        Giess et al. Gastroenterology 154/2018

11        (Imperiale et al (2014) N Engl J Med 2014; 370)

12        https://investor.exactsciences.com/investor-relations/press-releases/press-release-details/2015/ Exact-Sciences-Additional-Update-on-CMS-Reimbursement-for-Cologuard/default.aspx or https://www.businesswire.com/news/home/20151202005242/en/CMS-Corrects-2016-Reimbursement-Rate-for-Cologuard%C2%AE#:~:text=(Nasdaq%3A%20EXAS)%20announced%20that,NLA)%20for%20Cologuard%20at%20%24493.21.

13        https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130001B.pdf

14        https://novigenix.com/wp-content/uploads/2018/02/Tableau-comparatif-novigenix-colox-ENGLISH.pdf

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•        Schebo AG, a German company, has developed a Tumor M2-PK, (Pyruvatekinase M2) based test, a biomarker that is only expressed in tumor tissue in adult humans. M2-PK can be detected in stool as well as in EDTA blood plasma and thus serves as an indicator of cancer. In a clinical study, in the regular combination with an occult blood test, it showed a high sensitivity of over 90%, while its specificity was below 70%.

•        CellMaxLife, a liquid biopsy company focused on blood sample-based cancer screening. The company has no available products on the market yet, but is currently working on the development of the CRC screening test “FirstSight”, which screens patients’ blood sample for circulating gastrointestinal epithelial cells (CECs) and somatic mutations of cell-free tumor DNA (ctDNA).

•        GRAIL, Inc., which develops products based on next-generation sequencing (NGS) for the early detection of cancer. The blood-based screening test “Galleri” is the company’s current core product. According to the company, this test can detect over 50 types of cancer. The list price for screening with Galleri is $959. GRAIL recommends using Galleri only in combination with conventional screening methods.

•        Guardant Health, Inc., a California-based company that aims to improve early cancer detection based on liquid biopsy. The product “Guardant Reveal” is a blood test used to control residual disease and recurrence after CRC. Guardant Reveal was launched in the U.S. market in the start of 2021. Alongside the other products Guardant360, Guardant360 CDx and GuardantOMNI, Guardant Reveal contributes to the development of the LUNAR screening program, which will be used in the future for cancer screening of asymptomatic patients.

•        Thrive, a subsidiary of Exact Sciences Corp., is researching a holistic cancer screening based on a liquid biopsy. The test is currently under development and has not yet received marketing approval.

We might not be able to compete successfully in our market, particularly as we seek to enter the United States and commercialize ColoAlert. We expect that some of the screening tests currently being developed will be commercially available in the United States by the time we obtain FDA approval for ColoAlert, if at all. If our competitors introduce new diagnostic tests that compete with or surpass the accuracy, price or ease of use of our products, we may be unable to satisfy existing customers or attract new customers at the prices and levels that would allow us to generate attractive rates of return on our investment. Increased competition could result in price reductions and revenue shortfalls, loss of customers and loss of market share, which could harm our business, prospects, financial condition and operating results.

Customers

Our current customers are primarily laboratories in Germany, including some of the largest chains in Germany, that offer our ColoAlert test to physicians for use with their patients. Although no customer accounted for more than 10% of our revenues in our prior fiscal year, our revenues are substantially derived from our relationships with those laboratories that use our products. To increase revenues and because a deterioration of our relationship with those or a portion of those laboratories that currently use our products would adversely affect our results of operations and financial condition, we are actively seeking to expand our customer base in Europe, and intend to do so in the United States depending upon the progress of an application with the FDA for approval of ColoAlert.

Implications of Being an Emerging Growth Company

We qualify as and elect to be an “emerging growth company” as defined in the Jumpstart our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include, but not limited to:

•        reduced disclosure about the emerging growth company’s executive compensation arrangements in our periodic reports, proxy statements and registration statements; and

•        an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002.

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We may take advantage of these provisions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company if we have more than $1.07 billion in annual gross revenue, have more than $700 million in market value of our shares of common stock held by non-affiliates or issue more than $1.0 billion of non-convertible debt over a three-year period.

Implications of Being a Foreign Private Issuer

We are a foreign private issuer within the meaning of the rules under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As such, we are exempt from certain provisions applicable to United States domestic public companies. For example:

•        we are not required to provide as many Exchange Act reports or provide periodic and current reports as frequently, as a domestic public company;

•        for interim reporting, we are permitted to comply solely with our home country requirements, which are less rigorous than the rules that apply to domestic public companies;

•        we are not required to provide the same level of disclosure on certain issues, such as executive compensation;

•        we are exempt from provisions of Regulation FD aimed at preventing issuers from making selective disclosures of material information;

•        we are not required to comply with the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; and

•        we are not required to comply with Section 16 of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and establishing insider liability for profits realized from any “short-swing” trading transaction.

Summary Risk Factors

An investment in our ordinary shares involves a high degree of risk. If any of the factors below or in the section entitled “Risk Factors” occurs, our business, financial condition, liquidity, results of operations and prospects could be materially and adversely affected.

•        We are an early revenue stage company and have incurred operating losses since inception, and we do not know when we will attain profitability. An investment in our securities is highly risky and could result in a complete loss of your investment if we are unsuccessful in our business plans.

•        Terms of subsequent financings may adversely impact your investment.

•        Our inability to manage growth could harm our business.

•        We substantially depend upon our management.

•        In September 2021, we acquired all of the equity interests of PharmGenomics, and the combined company may not perform as we expect.

•        Failure of our internal controls over financial reporting could harm our business and financial results.

•        You may face difficulties protecting your interests, and your ability to protect your rights through the U.S. federal courts may be limited because we are incorporated under the laws of the Netherlands, a substantial portion of our assets are in the European Union and a majority of our directors and executive officers reside outside the United States.

•        Changes to trade policy, tariffs, and import/export regulations may have a material adverse effect on our business, financial condition, and results of operations.

•        We may fail to generate sufficient revenue from our relationships with our clients or laboratory partners to achieve and maintain profitability.

•        Our success depends heavily on our ColoAlert screening tests.

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•        Sales of our diagnostic tests could be adversely impacted by the reluctance of physicians to adopt the use of our tests and by the availability of competing diagnostic tests.

•        We may not succeed in establishing, maintaining and strengthening ColoAlert and other brands associated with Mainz Biomed’s products, which would materially and adversely affect acceptance of our diagnostic tests, and our business, revenues and prospects.

•        We may face technology transfer challenges and expenses in adding new tests to our portfolio and in expanding our reach into new geographical areas.

•        If third party payors do not provide reimbursement, breach, rescind or modify their contracts or reimbursement policies or delay payments for our tests, or we are unable to successfully renegotiate reimbursement contracts, our commercial success could be compromised.

•        We may depend on possible future collaborations to develop and commercialize many of our diagnostic test candidates and to provide the manufacturing, regulatory compliance, sales, marketing and distribution capabilities required for the success of our business.

•        If we are unable to obtain and enforce patents and to protect our trade secrets, others could use our technology to compete with us, which could create undue competition and pricing pressures. There is no certainty that any future patent applications will result in the issuance of patents or that issued patents, if we receive any, will be deemed enforceable.

•        Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information.

•        Results of FDA required studies may not create desired clinical performance resulting in follow-on studies delaying the launch of the product in the US.

•        Our business is subject to various complex laws and regulations. We could be subject to significant fines and penalties if we or our partners fail to comply with these laws and regulations.

•        We will have to maintain facilities, or maintain relationships with third party laboratories, for the manufacture and use of diagnostic tests. Our ability to provide services and pursue our research and development and commercialization efforts may be jeopardized if these facilities were to be harmed or rendered inoperable.

•        We anticipate being required to obtain regulatory approval of our diagnostic test products to enter new markets.

•        We are required to comply with national, regional and local laws governing the privacy of health information, and any failure to comply with these laws could result in material criminal and civil penalties.

•        The market price of our ordinary shares may be volatile and may fluctuate in a way that is disproportionate to our operating performance.

•        You may experience dilution of your ownership interests if we issue additional ordinary shares or preferred shares.

•        Volatility in our ordinary shares price may subject us to securities litigation.

•        We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.

•        If we are, or were to become, a passive foreign investment company (a “PFIC”) for U.S. federal income tax purposes, U.S. investors in our ordinary shares would be subject to certain adverse U.S. federal income tax consequences.

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Offering Summary

Ordinary Shares Offered:

 

2,000,000 (excluding the underwriter’s over-allotment option)

     

Assumed Public Offering Price:

 

$5.00 per ordinary share, the midpoint of the price range on the cover page of this prospectus.

     

Over-Allotment:

 

We have granted the underwriter a 45-day option (commencing from the date of this prospectus) to purchase up to an additional 300,000 ordinary shares at the public offering price to cover over-allotments, if any.

     

Shares Outstanding After the Offering:

 

11,710,000 (or 12,010,000 if the underwriter exercises its over-allotment option in full)

     

Use of Proceeds:

 

We intend to use the net proceeds from this offering for research and development (primarily for the further development of ColoAlert, PancAlert and Genostrip), clinical studies for FDA approval of ColoAlert, marketing and sales and for general corporate purposes. We will not receive any proceeds from the sale of ordinary shares by the selling shareholders pursuant to the Selling Shareholder Prospectus.

     

Underwriter:

 

Boustead Securities, LLC

     

Underwriter Warrants:

 

We have agreed to sell to Boustead Securities, LLC, warrants (the “Underwriter’s Warrants”) to purchase up to a total of 140,000 ordinary shares (equal to 7% of the aggregate number of ordinary shares sold in the offering) at a price equal to the price of our ordinary shares offered hereby.

     

Selling Shareholder Offering:

 

Before or simultaneous with this offering, the selling shareholders are offering ordinary shares. The sale of such ordinary shares by the selling shareholders could adversely affect the price and liquidity of, and demand for, our ordinary shares. We will not receive any proceeds from the resale of such ordinary shares.

     

Market for our Ordinary Shares:

 

There is currently no market for our ordinary shares. We intend to apply to have our ordinary shares listed on the Nasdaq Capital Market under the symbol “MYNZ”. The offering that we are conducting with the prospectus will not close unless the Nasdaq Capital Market has approved our ordinary shares for listing.

     

Risk Factors:

 

See “Risk Factors” for a discussion of the factors you should consider before deciding to invest in our securities.

Shares outstanding after the offering is based on 9,710,001 ordinary shares that are outstanding as of the date of this prospectus and excludes up to 3,745,000 ordinary shares underlying warrants that are outstanding as of the date hereof, up to 1,456,650 ordinary shares underlying options that we intend to grant prior to the closing of this offering under the 2021 Omnibus Incentive Plan and 140,000 shares issuable upon exercise of the warrants issued to the underwriter (or 161,000 common share issuable upon exercise of the warrants issued to the underwriter if the over-allotment option is exercised in full), assuming a per share price in the offering of $5.00.

Summary Financial Data

The following tables summarize our financial data. We derived the summary financial statement data for the years ended December 31, 2020 and 2019 set forth below from the audited financial statements of PharmGenomics GmbH, which is considered for accounting purposes to be our predecessor entity, and from the unaudited financial statements of PharmGenomics GmbH for the three and six months ended June 30, 2021 and 2020 contained in this prospectus. Mainz Biomed B.V. was not formed as of December 31, 2020 and to date has had no operations. Our financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. Our historical results are not necessarily indicative of the results that may be expected in the future. You should read the information presented below together with “Management’s Discussion

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and Analysis of Financial Condition and Results of Operations,” our financial statements, the notes to those statements and the other financial information contained in this prospectus and the unaudited consolidated pro forma information appearing elsewhere in this prospectus.

Summary of Operations in U.S. Dollars (audited)

 

Six Months Ended
June 30,

 

Years Ended
December 31,

   

2021

 

2020

 

2020

 

2019

Revenues

 

$

417,311

 

 

$

166,701

 

 

$

493,565

 

 

$

281,393

 

Cost of Revenues

 

 

240,954

 

 

 

152,285

 

 

 

370,480

 

 

 

342,664

 

GROSS PROFIT (LOSS)

 

 

176,357

 

 

 

14,416

 

 

 

123,085

 

 

 

(61,271

)

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and Development

 

 

160,531

 

 

 

144,434

 

 

 

311,851

 

 

 

250,316

 

Sales and marketing

 

 

70,979

 

 

 

51,575

 

 

 

110,380

 

 

 

181,460

 

General and administrative

 

 

199,481

 

 

 

179,438

 

 

 

374,569

 

 

 

428,862

 

Total operating expenses

 

 

430,991

 

 

 

375,343

 

 

 

796,800

 

 

 

860,638

 

Operating loss

 

 

(254,634

)

 

 

(360,927

)

 

 

(673,715

)

 

 

(921,909

)

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OTHER INCOME/(EXPENSE)

 

 

(7,087

)

 

 

20,866

 

 

 

86,820

 

 

 

(35,146

)

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS

 

$

(261,721

)

 

$

(340,061

)

 

 

(586,895

)

 

 

(957,055

)

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign Currency Translation

 

 

82,963

 

 

 

(29,550

)

 

 

(224,656

)

 

 

22,166

 

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TOTAL COMPREHENSIVE LOSS

 

$

(178,758

)

 

$

(369,611

)

 

$

(811,551

)

 

$

(934,889

)

Balance Sheet in U.S. Dollars (audited)

 

As of
June 30,
2021

 

As of
December 31,
2020

Cash

 

$

195,165

 

 

$

122,568

 

Total Current Assets

 

 

281,607

 

 

 

186,398

 

Total Assets

 

 

734,472

 

 

 

673,270

 

Total Current Liabilities

 

 

672,051

 

 

 

701,954

 

Long Term Debt

 

 

2,058,839

 

 

 

2,265,431

 

Total Liabilities

 

 

3,146,548

 

 

 

3,414,825

 

Working Capital (Deficit)

 

$

(390,444

)

 

$

(515,556

)

Total Stockholders’ Deficit

 

 

(2,412,076

)

 

 

(2,741,550

)

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RISK FACTORS

An investment in our ordinary shares carries a significant degree of risk. You should carefully consider the following risks, as well as the other information contained in this prospectus, including our historical financial statements and related notes included elsewhere in this prospectus, before you decide to purchase the ordinary shares. Any one of these risks and uncertainties has the potential to cause material adverse effects on our business, prospects, financial condition and operating results which could cause actual results to differ materially from any forward-looking statements expressed by us and a significant decrease in the value of our ordinary shares. Refer to “Special Note Regarding Forward-Looking Statements”.

We may not be successful in preventing the material adverse effects that any of the following risks and uncertainties may cause. These potential risks and uncertainties may not be a complete list of the risks and uncertainties facing us. There may be additional risks and uncertainties that we are presently unaware of, or presently consider immaterial, that may become material in the future and have a material adverse effect on us. You could lose all or a significant portion of your investment due to any of these risks and uncertainties.

Risks Related to Our Business Generally

We are an early revenue stage company and have incurred operating losses since inception, and we do not know when we will attain profitability. An investment in our securities is highly risky and could result in a complete loss of your investment if we are unsuccessful in our business plans.

We are an early-stage company. Since inception, we have incurred operating losses and negative cash flow, and we expect to continue to incur losses and negative cash flow in the future. Our net losses for the years ended December 31, 2020 and December 31, 2019 were approximately $586,895 and $957,055, respectively, and our net losses for the six months ended June 30, 2021 were $263,618. Ultimately, our ability to generate sufficient operating revenue to earn a profit depends upon our success in developing and marketing or licensing our diagnostic tests and technology. Any failure to do so could result in the possible closure of our business or force us to seek additional capital through loans or additional sales of our equity securities to continue business operations, which could dilute the value of any securities you hold or could result in the loss of your entire investment.

Terms of subsequent financings may adversely impact your investment.

We intend to engage in common equity, debt, or preferred stock financing in the future. Your rights and the value of your investment in our securities could be reduced as a result of any such financing. Interest on debt securities could increase costs and negatively impacts operating results. Preferred shares could be issued in series from time to time with such designation, rights, preferences, and limitations as needed to raise capital. The terms of preferred shares could be more advantageous to those investors than to the holders of ordinary shares. In addition, if we need to raise more equity capital from the sale of ordinary shares, institutional or other investors may negotiate terms at least as, and possibly more, favorable than the terms of your investment. Ordinary shares which we sell could be sold into any public market that develops for our ordinary shares, if any ever develops, which could adversely affect the market price of our ordinary shares.

Our inability to manage growth could harm our business.

We have added, and expect to continue to add, additional personnel in the areas of sales and marketing, research & development, laboratory operations, finance, quality assurance and compliance. As we build our commercialization efforts and expand research and development activities, our operating expenses and capital requirements have also increased, and we expect that they will continue to increase, significantly. Our ability to manage our growth effectively requires us to forecast expenses accurately, and to properly forecast and expand operational and testing facilities, if necessary, to expend funds to improve our operational, financial and management controls, reporting systems and procedures. As we move forward in commercializing our tests and developing our test portfolio, we will also need to effectively manage our growing manufacturing, laboratory operations and sales and marketing needs. If we are unable to manage our anticipated growth effectively, our business could be harmed.

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Risks that we face in undertaking this expansion include:

•        training new personnel;

•        forecasting production and revenue;

•        expanding our marketing efforts;

•        controlling expenses and investments in anticipation of expanded operations;

•        establishing and maintaining relationships with new customers and partners

•        implementing and enhancing administrative infrastructure, systems and processes;

•        Unforeseen delays in the development of new products;

•        Unforeseen delays in regulatory approvals;

•        Unforeseen test performance that we may experience performing FDA studies; and

•        addressing new markets.

We intend to continue to hire additional personnel. Competition for individuals with relevant experience can be intense, and we may not be able to attract, assimilate, train or retain additional highly qualified personnel in the future. The failure to attract, integrate, train, motivate and retain these additional employees could seriously harm our business and prospects.

We substantially depend upon our management.

Our success depends largely on the skills, experience and performance of key members of our management who are critical to directing and managing our growth and development in the future. Our success substantially depends upon our senior management’s ability to lead our company, implement successful corporate strategies and initiatives, develop key relationships, including relationships with collaborators and business partners, and successfully commercialize products and services. While our management has significant experience developing diagnostic products, we have considerably less experience in commercializing these products or services. The efforts of our management will be critical as we develop our technologies and seek to commercialize our tests and other products and services.

In September 2021, we acquired all of the equity interests of PharmGenomics, and the combined company may not perform as we expect.

On September 20, 2021, we acquired all of the equity interests of PharmGenomics, the entity that licenses ColoAlert. The combined company may not perform as we expect. Risks associated with the combined company include:

•        integrating businesses is a difficult, expensive, and time-consuming process. Although we have not had historically substantial operations, the Chief Science Officer and the Chief Operating Officer of the combined company come from the legacy Mainz Biomed side of the acquisition whereas the non-executive employees of the combined company come from the legacy PharmGenomics side of the transaction. Failure to integrate successfully our businesses with the business and operations of PharmGenomics could lead to inefficiencies, the loss of staff, decreased revenue and ineffective marketing campaigns or research and development; and

•        the success of the combined company also depends upon relationships with third parties and any deterioration of the relationship with PharmGenomics’ pre-existing reference laboratories platform could adversely affect the combined company’s business, financial condition, and results of operations.

Failure of our internal controls over financial reporting could harm our business and financial results.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting for external purposes in accordance with accounting principles generally accepted in the

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United States. Internal control over financial reporting includes maintaining records that in reasonable detail accurately and fairly reflect our transactions; providing reasonable assurance that transactions are recorded as necessary for preparation of our financial statements; providing reasonable assurance that receipts and expenditures of our assets are made in accordance with management authorization; and providing reasonable assurance that unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements would be prevented or detected on a timely basis. Because of its inherent limitations, internal control over financial reporting is not intended to provide absolute assurance that a misstatement of our financial statements would be prevented or detected. Our growth and entry into new diagnostic tests, technologies and markets will place significant additional pressure on our system of internal control over financial reporting. Any failure to maintain an effective system of internal control over financial reporting could limit our ability to report our financial results accurately and timely or to detect and prevent fraud.

You may face difficulties protecting your interests, and your ability to protect your rights through the U.S. federal courts may be limited because we are incorporated under the laws of the Netherlands, a substantial portion of our assets are in the European Union and a majority of our directors and executive officers reside outside the United States.

We are constituted under the laws of the Netherlands. A majority of our officers, and directors, reside outside the United States. In addition, a substantial portion of their assets and our assets are located outside of the United States. As a result, you may have difficulty serving legal process within the United States upon us or any of these persons. You may also have difficulty enforcing, both in and outside of the United States, judgments you may obtain in U.S. courts against us or these persons in any action, including actions based upon the civil liability provisions of U.S. Federal or state securities laws. Furthermore, there is substantial doubt as to the enforceability in the Netherlands against us or against any of our directors, officers and the expert named in this prospectus who are not residents of the United States, in original actions or in actions for enforcement of judgments of U.S. courts, of liabilities based solely upon the civil liability provisions of the U.S. federal securities laws. In addition, shareholders in Dutch corporations may not have standing to initiate a shareholder derivative action in U.S. federal courts.

As a result, our public shareholders may have more difficulty in protecting their interests through actions against us, our management, our directors or our major shareholders than would shareholders of a corporation incorporated in a jurisdiction in the United States.

Global economic conditions could materially adversely impact demand for our products and services.

Our operations and performance depend significantly on economic conditions. Global financial conditions continue to be subject to volatility arising from international geopolitical developments and global economic phenomenon, as well as general financial market turbulence and natural phenomena such as the COVID-19 pandemic. Uncertainty about global economic conditions could result in

•        customers postponing purchases of our products and services in response to tighter credit, unemployment, negative financial news and/or declines in income or asset values and other macroeconomic factors, which could have a material negative effect on demand for our products and services; and

•        third-party suppliers being unable to produce components for our products in the same quantity or on the same timeline or being unable to deliver such parts and components as quickly as before or subject to price fluctuations, which could have a material adverse effect on our production or the cost of such production; and accordingly, on our business, results of operations or financial condition.

Access to public financing and credit can be negatively affected by the effect of these events on German, Dutch, European, U.S. and global credit markets. The health of the global financing and credit markets may affect our ability to obtain equity or debt financing in the future and the terms at which financing or credit is available to us. These instances of volatility and market turmoil could adversely affect our operations and the trading price of our ordinary shares.

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Changes to trade policy, tariffs, and import/export regulations may have a material adverse effect on our business, financial condition, and results of operations.

Changes in laws and policies governing foreign trade could adversely affect our business. As a result of recent and future policy changes, there may be greater restrictions and economic disincentives on international trade. Such changes have the potential to adversely impact the global and local economies, our industry and global demand for our products and, as a result, could have a material adverse effect on our business, financial condition and results of operations.

Fluctuations in currency exchange rates may significantly impact our results of operations.

A substantial percentage of our operations are conducted in Europe. As a result, we are exposed to an exchange rate risk between the U.S. and the Euro. The exchange rates between these currencies in recent years have fluctuated significantly and may continue to do so in the future. An appreciation of the Euro against the U.S. dollar could increase the relative cost of our products outside of Europe, which could lead to decreased sales. Conversely, to the extent that we are required to pay for goods or services in U.S. dollars, the depreciation of the Euro dollar against the U.S. dollar would increase the cost of such goods and services.

We do not hedge our currency exposure and, therefore, we incur currency transaction risk whenever we enter into either a purchase or sale transaction using a currency other than the Euro. Given the volatility of exchange rates, we might not be able to effectively manage our currency transaction risks, and volatility in currency exchange rates might have a material adverse effect on our business, financial condition or results of operations.

Risks Related to Our Technology and Business Strategy

We may fail to generate sufficient revenue from our relationships with our clients or laboratory partners to achieve and maintain profitability.

We believe our commercial success depends upon our ability to successfully market and sell our products and solutions, to continue to expand our current relationships and to develop new relationships with customers, physicians, and laboratories. The demand for our existing and future services may decrease for a number of reasons, including, but is not limited to, the development by competitors of new products, and increased competition from companies that offer similar products and solutions. In addition to reducing our revenue, if our laboratory partners or clients decide to decrease or discontinue their partnerships or relationships with us, and their use of our knowledge and interpretation-based solutions, this may reduce our access to research and patient data that facilitates the incorporation of newly developed information about rare diseases into our data repository.

Our success depends heavily on our ColoAlert screening tests.

For the foreseeable future, our ability to generate revenues will depend almost entirely on the commercial success of our colon cancer screening test. The commercial success and our ability to generate revenues will depend on a variety of factors, including the following:

•        patient acceptance of and demand for our tests;

•        acceptance of our test in the medical community;

•        successful sales, marketing, and educational programs;

•        the amount and nature of competition from other colon cancer screening products and procedures;

•        the ease of use of our ordering process for physicians;

•        maintaining and defending intellectual property and trade secrets, and our ability to establish and maintain adequate commercial manufacturing, distribution, sales and laboratory testing capabilities; and

•        The potential of being sued by competitors to avoid or delay market entry in certain geographic markets.

If we are unable to develop and maintain substantial sales of our tests or if we are significantly delayed or limited in doing so, our business prospects, financial condition and results of operation would be adversely affected.

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Sales of our diagnostic tests could be adversely impacted by the reluctance of physicians to adopt the use of our tests and by the availability of competing diagnostic tests.

Physicians and hospitals may be reluctant to try a new diagnostic test due to the high degree of risk associated with the application of new technologies and diagnostic test in the field of human medicine, especially if the new test differs from the current standard of care for detecting cancer in patients. For example, CRC prevention strategies, such as FIT and colonoscopies, are well known in the patient group aged over 50 years, while ColoAlert and similar diagnostic tests are not vastly known by physicians or patients. We will need to expend significant sums of money to market our products to increase the public’s awareness. If our products do not achieve an adequate level of acceptance, we may not generate enough revenues to become profitable or the profitability may occur much later.

Competing tests for the initial diagnosis, reoccurrence diagnosis and optimal treatment of cancer are being manufactured and marketed by other companies. To compete with other diagnostic tests, particularly any that sell at lower prices, our tests will have to provide medically significant advantages or be more cost effective. Even if we can overcome physician reluctance and compete with products that are currently on the market, our competitors may succeed in developing new, safer, more accurate or more cost-effective diagnostic tests that could render our diagnostic tests and technologies obsolete or non-competitive.

We may not succeed in establishing, maintaining and strengthening ColoAlert and other brands associated with Mainz Biomed’s products, which would materially and adversely affect acceptance of our diagnostic tests, and our business, revenues and prospects.

Our business and prospects heavily depend on our ability to develop, maintain and strengthen the ColoAlert brand and the brands of our future products. Any failure to develop, maintain and strengthen these brands may materially and adversely affect our ability to sell our products. Most of our sales are to clinical reference laboratories or routine diagnostic laboratories. Those laboratories are generally more focused on taking orders than on marketing the products that they sell. We need to educate these reference laboratories and the general public as to why we believe our products are superior. If we are not able to establish, maintain and strengthen our brands, we may lose the opportunity to build our customer base.

We expect that our ability to develop, maintain and strengthen our brands will depend heavily on the success of our marketing efforts. We intend to use proceeds from this offering for marketing of our products, but we might not be successful in such expanded marketing. Due to the specifics of the market in which we operate, the investment in customer acquisition will be high and the uptake is likely slow until a critical mass is reached. To further promote our brand, we may be required to change our marketing practices, which could result in substantially increased advertising expenses, including the need to use traditional media such as television, radio and print. If we do not develop and maintain strong brands, our business, prospects, financial condition and operating results will be materially and adversely impacted.

Product liability, warranty, personal injury, property damage and recall claims may materially affect our financial condition and damage our reputation.

We are engaged in a business that exposes us to claims for product liability and warranty claims in the event our products actually or allegedly fail to perform as expected or the use of our products results, or is alleged to result, in property damage, personal injury or death. Any judgment or settlement for personal injury or wrongful death claims could be more than our assets and, even if not justified, could prove expensive to contest.

Although we maintain product and general liability insurance of the types and in the amounts that we believe are customary for the industry, we are not fully insured against all such potential claims. We may experience legal claims in excess of our insurance coverage or claims that are not covered by insurance, either of which could adversely affect our business, financial condition and results of operations. Adverse determination of material product liability and warranty claims made against us could have a material adverse effect on our financial condition and harm our reputation. In addition, if any of our products or components in our products are, or are alleged to be, defective, we may be required to participate in a recall of that product or component. Any such recall and other claims could be costly to us and require substantial management attention.

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We may face technology transfer challenges and expenses in adding new tests to our portfolio and in expanding our reach into new geographical areas.

Our plan for expanding our business includes developing and acquiring additional tests or additional biomarkers that can be transferred into our current and future diagnostic product portfolio and distributed in our target markets. Due to differences in the hardware and software platforms available at different laboratories for running molecular tests, we may need to adjust the configuration of the reagents and there may be changes to the related software in order for the tests to be performed on particular hardware platforms. Making any such adjustments could take a considerable amount of time and expense, and there will be no assurance that we will succeed in running our tests on the hardware and software that we may encounter in different laboratories. To manage this issue, we may license or acquire our own instrument system and software from another company that has a platform that will be compatible with our tests. This may include additional licenses and license fees needed for reagents or components required hereto as well.

If third party payors do not provide reimbursement, breach, rescind or modify their contracts or reimbursement policies or delay payments for our tests, or we are unable to successfully renegotiate reimbursement contracts, our commercial success could be compromised.

Physicians and patients might not order our tests unless third party payors, such as managed care organizations as well as government payors, pay a substantial portion of the test price. Reimbursement by a payor may depend on a number of factors, including a payor’s determination that tests using our technologies are not experimental or investigational, and that they are medically necessary, cost-effective, supported by peer-reviewed publications and included in clinical practice guidelines. There is uncertainty concerning third-party payor reimbursement of any test incorporating new technology.

Reimbursement is based in most countries on reimbursement codes, which differ from country to country. Currently, ColoAlert is reimbursed as a polymerase chain reaction (“PCR”) test in Germany for privately insured patients if an authorized medical care center is performing the analysis. For statutory and/or privately insured patients in Germany and in other countries, we may need to apply for a specific reimbursement code, which may call for a new clinical study and additional CE-IVD approvals.

We believe that it may take several years to achieve reimbursement with a majority of third-party payors for our tests. If we fail to establish and maintain broad adoption of and reimbursement for all of our current tests and any future tests that we may develop, our reputation could be harmed and our future prospects, revenue and our business could suffer. Additionally, we have in the past experienced, and anticipate further experiencing, delays and temporary interruptions in the receipt of payments from third-party payors due to modifications in existing contracts or arrangements, contract implementation matters, documentation requirements and other issues, which could cause our revenues to fluctuate from period to period.

We will need to make significant inroads with general practitioners in Europe. In most European countries, health care is considered a public responsibility, and the main payer is public health insurance. This implies that the private pay market is limited, and that general practitioners are the main gate keepers to market penetration. If we cannot convince general practitioners in Europe that our products are the superior choice, we cannot grow there as quickly as we need, if at all.

We may depend on possible future collaborations to develop and commercialize many of our diagnostic test candidates and to provide the manufacturing, regulatory compliance, sales, marketing and distribution capabilities required for the success of our business.

We may enter into various collaborative research and development, manufacturing, and diagnostic test marketing agreements to develop and commercialize our diagnostic tests. Any future milestone payments and cost reimbursements from collaboration agreements could provide an important source of financing for our research and development programs, thereby facilitating the application of our technology to the development and commercialization of our diagnostic tests, but there are risks associated with entering into collaboration arrangements.

There is a risk that we could become dependent upon one or more collaborative arrangements for diagnostic test development or manufacturing or as a source of revenues from the sale of any diagnostic tests that may be developed by us alone or through one of the collaborative arrangements. A collaborative arrangement upon which we might depend

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might be terminated by our collaboration partner or they might determine not to actively pursue the development or commercialization of our diagnostic tests. A collaboration partner also may not be precluded from independently pursuing competing diagnostic tests or technologies.

There is a risk that a collaboration partner might fail to perform its obligations under the collaborative arrangements or may be slow in performing its obligations. In addition, a collaboration partner may experience financial difficulties at any time that could prevent it from having available funds to contribute to the collaboration. If a collaboration partner fails to conduct its diagnostic test development, manufacturing, commercialization, regulatory compliance, sales and marketing or distribution activities successfully and in a timely manner, or if it terminates or materially modifies its agreements with us, the development and commercialization of one or more diagnostic test candidates could be delayed, curtailed or terminated because we may not have sufficient financial resources or capabilities to continue diagnostic test development, manufacturing, and commercialization on our own.

If we are unable to obtain and enforce patents and to protect our trade secrets, others could use our technology to compete with us, which could create undue competition and pricing pressures. There is no certainty that any future patent applications will result in the issuance of patents or that issued patents, if we receive any, will be deemed enforceable.

The success of our business depends significantly on our ability to operate without infringing patents and other proprietary rights of others. If the technology that we use infringes a patent held by others, we could be sued for monetary damages by the patent holder or its licensee, or we could be prevented from continuing research, development, and commercialization of diagnostic tests that rely on that technology, unless we are able to obtain a license to use the patent. The cost and availability of a license to a patent cannot be predicted, and the likelihood of obtaining a license at an acceptable cost would be lower if the patent holder or any of its licensees is using the patent to develop or market a diagnostic test with which our diagnostic test would compete. If we cannot obtain a necessary license, we would need to develop or obtain rights to alternative technologies, which could prove costly and could cause delays in diagnostic test development, or we could be forced to discontinue the development or marketing of any diagnostic tests that were developed using the technology covered by the patent.

Our success will depend in part on our ability to obtain and enforce intellectual property protection. We currently rely on trade secrets, know how and technology to protect our intellectual property and do not have any patents or any pending patent applications. If we are unsuccessful in obtaining such protection and our trade secrets and know are revealed to our competitors, they could use our intellectual property and create diagnostic tests that compete with our diagnostic tests, without paying license fees or royalties to us.

Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information.

We rely on trade secrets, know-how and technology, which are not protected by patents and do not have any patent applications pending, to protect the intellectual property behind our diagnostic tests. We do not yet use confidentiality agreements with our collaborators, employees, consultants, outside scientific collaborators and sponsored researchers and other advisors to protect our proprietary technology and processes. We intend to use such agreements in the future, but 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, others may independently discover trade secrets and proprietary information, and in such cases, we cannot assert any trade secret rights against such party. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

Results of FDA required studies may not create desired clinical performance resulting in follow-on studies delaying the launch of the product in the US.

We will be required to undertake a clinical study to achieve FDA market authorization that will be significantly larger than the study used to receive CE-IVD certification under the IVD-D. The clinical performance of the ColoAlert test for the FDA study might not meet the current product performance. As a result, we may need to undertake additional studies or abandon the study altogether. Additional studies would be costly and delay or prevent our rollout of ColoAlert in the United States.

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Risks Related to Regulations

Our global operations expose us to numerous and sometimes conflicting legal and regulatory requirements, and violations of these requirements could harm our business.

We are subject to numerous, and sometimes conflicting, legal regimes in the countries in which we operate, including on matters as diverse as health and safety standards, marketing and promotional activities, anticorruption, import/export controls, content requirements, trade restrictions, tariffs, taxation, sanctions, immigration, internal and disclosure control obligations, securities regulation, anti-competition, data privacy and labor relations. This includes in emerging markets where legal systems may be less developed or familiar to us. We strive to abide by and maintain compliance with these laws and regulations. Compliance with diverse legal requirements is costly and time-consuming. Violations of one or more of these regulations in the conduct of our business could result in significant fines, criminal sanctions against us or our board of directors or officers, prohibitions on doing business and damage to our reputation. Violations of these regulations in connection with the performance of our obligations to our clients or partners also could result in liability for significant monetary damages, fines and/or criminal prosecution, unfavorable publicity and other reputational damage, restrictions on our ability to process information and allegations by our clients or partners that we have not performed our contractual obligations. Due to the varying degrees of development of the legal systems of the countries in which we operate, local laws might be insufficient to protect our rights.

Our international operations could be affected by changes in laws, trade regulations, labor and employment regulations, and procedures and actions affecting approval, products and solutions, pricing, reimbursement and marketing of our products and solutions, as well as by inter-governmental disputes. Any of these changes could adversely affect our business. The imposition of new laws or regulations, including potential trade barriers, may increase our operating costs, impose restrictions on our operations or require us to spend additional funds to gain compliance with the new rules, if possible, which could have an adverse impact on our financial condition.

Our business is subject to various complex laws and regulations. We could be subject to significant fines and penalties if we or our partners fail to comply with these laws and regulations.

As a manufacturer of clinical diagnostic products and clinical diagnostic services, we and our partners are subject to extensive and frequently changing federal, state and local laws and regulations governing various aspects of our business. In particular, the clinical laboratory industry is subject to significant governmental certification and licensing regulations, as well as federal and state laws regarding:

•        test ordering and billing practices;

•        marketing, sales and pricing practices;

•        health information privacy and security, including the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and comparable state and local laws;

•        anti-markup legislation; and

•        consumer protection.

We expect to be required to comply with U.S. Food and Drug Administration, or FDA, regulations, including with respect to our labeling and promotion activities. In addition, advertising of our tests is subject to regulation by the Federal Trade Commission, or FTC. Violation of any FDA requirement could result in enforcement actions, such as seizures, injunctions, civil penalties and criminal prosecutions, and violation of any FTC requirement could result in injunctions and other associated remedies, all of which could have a material adverse effect on our business. Most states also have similar regulatory and enforcement authority for devices. Additionally, most foreign countries have authorities comparable to the FDA and processes for obtaining marketing approvals. Obtaining and maintaining these approvals, and complying with all laws and regulations, may subject us to similar risks and delays as those we could experience under FDA and FTC regulation. We incur various costs in complying and overseeing compliance with these laws and regulations.

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Healthcare policy has been a subject of extensive discussion in many national, regional and local governments, and healthcare laws and regulations are subject to change. Development of the existing commercialization strategy for our tests have been based on existing healthcare policies. We cannot predict what additional changes, if any, will be proposed or adopted or the effect that such proposals or adoption may have on our business, financial condition, and results of operations. If we or our partners, including independent sales representatives, fail to comply with these laws and regulations, we could incur significant fines and penalties and our reputation and prospects could suffer. Additionally, our partners could be forced to cease offering our products and services in certain jurisdictions, which could materially disrupt our business.

We will have to maintain facilities, or maintain relationships with third party laboratories, for the manufacture and use of diagnostic tests. Our ability to provide services and pursue our research and development and commercialization efforts may be jeopardized if these facilities were to be harmed or rendered inoperable.

Our facilities and equipment could be harmed or rendered inoperable by natural or man-made disasters, including fire, flooding and power outages, which may render it difficult or impossible for us to perform our tests or provide laboratory services for some period of time. The inability to perform our tests or the backlog of tests that could develop if any of our facilities is inoperable for even a short period of time may result in the loss of customers or harm to our reputation or relationships with key researchers, collaborators, and customers, and we may be unable to regain those customers or repair our reputation in the future. Furthermore, our facilities and the equipment we use to perform our research and development work could be costly and time-consuming to repair or replace.

Additionally, a key component of our research and development process involves using biological samples and the resulting data sets and medical histories, as the basis for our diagnostic test development. In some cases, these samples are difficult to obtain. If the parts of our laboratory facilities where we store these biological samples are damaged or compromised, our ability to pursue our research and development projects, commercialization of our diagnostic tests, as well as our reputation, could be jeopardized. We carry insurance for damage to our property and the disruption of our business, but this insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, if at all.

We anticipate being required to obtain regulatory approval of our diagnostic test products to enter new markets.

If our products enter new markets, they will need to satisfy the regulatory rules in that market. Given the nature of our products and product candidates, we believe that our entry into the U.S. market will require FDA market authorization through pre-market review. This may also be the case for corresponding foreign regulatory authorities. Our products and product candidates may not be cleared or approved on a timely basis, if at all. The regulatory approval process may involve, among other things, successfully completing additional clinical trials and filing a pre-market approval application (PMA) with the FDA. Similar review and approval processes may be applicable for corresponding foreign regulatory authorities.

We are required to comply with national, regional and local laws governing the privacy of health information, and any failure to comply with these laws could result in material criminal and civil penalties.

National, regional and local laws set forth security regulations that establish administrative, physical and technical standards for maintaining the confidentiality, integrity and availability of protected health information in electronic form. If protected health information is breached, additional laws, require us to provide certain health information security breach notifications to those individuals whose protected health information is breached.

We may incur significant compliance costs related to varying national and state privacy regulations and varying national and state privacy and security laws. Given the complexity of such laws and their overlap with national and state privacy and security laws, and the fact that these laws are rapidly evolving and are subject to changing and potentially conflicting interpretation, our ability to comply with such laws and requirements is uncertain and the costs of compliance are significant. The costs of complying with any changes to the national and state privacy restrictions may have a negative impact on our operations. Noncompliance could subject us to criminal penalties, civil sanctions and significant monetary penalties as well as reputational damage.

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We are subject to national and regional healthcare fraud and abuse laws and regulations and could face substantial penalties if we are unable to fully comply with such laws.

We are subject to healthcare fraud and abuse regulation and enforcement by both national governments and the regions in which we conduct our business. In the United States, where we intend to seek approval to rollout our ColoAlert product, these health care laws and regulations include the following:

•        The federal Anti-Kickback Statute;

•        The federal physician self-referral prohibition, commonly known as the Stark Law;

•        The federal false claims and civil monetary penalties laws;

•        The federal Physician Payment Sunshine Act requirements under the Affordable Care Act; and

•        State law equivalents of each of the federal laws enumerated above.

Any action brought against us for violation of these laws or regulations, even if we are in compliance and successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of these laws and regulations, we may be subject to applicable penalties associated with the violation, including, among others, administrative, civil and criminal penalties, damages and fines, and/or exclusion from participation in Medicare, Medicaid programs, including the California Medical Assistance Program (Medi-Cal — the California version of the Medicaid program) or other state or federal health care programs. Additionally, we could be required to refund payments received by us, and we could be required to curtail or cease our operations.

Risks Related to Our Ordinary Shares and this Offering

The market price of our ordinary shares may be volatile and may fluctuate in a way that is disproportionate to our operating performance.

Currently, there is no public market for our ordinary shares. Although we will not close this offering unless our application to list our ordinary shares on the Nasdaq Capital Market is approved, such listing might not result in significant volume, a per ordinary share market price in excess of the per ordinary share price in this offering or per ordinary share price stability. The value of your investment could decline due to the impact of any of the following factors upon the market price of our ordinary shares:

•        sales or potential sales of substantial amounts of our ordinary shares;

•        announcements about us or about our competitors;

•        litigation and other developments relating to our intellectual property or other proprietary rights or those of our competitors;

•        conditions in the diagnostic test industry;

•        governmental regulation and legislation;

•        variations in our anticipated or actual operating results;

•        change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations;

•        change in general economic trends; and

•        investor perception of our industry or our prospects.

Many of these factors are beyond our control. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies. 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. A broad or active public trading market for our ordinary shares may not develop or be sustained.

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You may experience dilution of your ownership interests if we issue additional ordinary shares or preferred shares.

In the future, we may issue our authorized but previously unissued equity securities, resulting in the dilution of the ownership interests of our present shareholders. Upon the proposed filing of our Deed of Conversion, we will be authorized to issue an aggregate of 48,550,000 ordinary shares. Assuming an offering price of $5.00 per ordinary share, the midpoint of the range set forth on the cover page of this prospectus, upon the closing of this offering, we will have approximately 11,710,000 ordinary share outstanding.

We may issue additional ordinary shares or other securities that are convertible into or exercisable for ordinary shares in order to raise additional capital, or in connection with hiring or retaining employees, directors, or consultants, or in connection with future acquisitions of licenses to technology or diagnostic tests in connection with future business acquisitions, or for other business purposes. The future issuance of any such additional ordinary shares or other securities would dilute the voting power of our stockholders who purchase shares in this offering, could dilute the net tangible book value per share at the time of such future issuance and may create downward pressure on the trading price of our ordinary shares.

We may also issue preferred shares having rights, preferences, and privileges senior to the rights of our ordinary shares with respect to dividends, rights to share in distributions of our assets if we liquidate our company, or voting rights. Any preferred shares may also be convertible into ordinary shares on terms that would be dilutive to holders of ordinary shares.

We do not intend to pay dividends, and there will thus be fewer ways in which you are able to make a gain on your investment.

We have never paid any cash or stock dividends, and we do not intend to pay any dividends for the foreseeable future. To the extent that we require additional funding currently not provided for in our financing plan, our funding sources may prohibit the payment of any dividends. Because we do not intend to declare dividends, any gain on your investment will need to result from an appreciation in the price of our ordinary shares. There will therefore be fewer ways in which you are able to make a gain on your investment. Our articles of association prescribe that any profits in any financial year will be distributed first to holders of preferred shares, if outstanding.

FINRA sales practice requirements may limit your ability to buy and sell our ordinary shares, which could depress the price of our shares.

FINRA rules require broker-dealers to have reasonable grounds for believing that an investment is suitable for a customer before recommending that investment to the customer. Prior to recommending speculative low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status and investment objectives, among other things. Under interpretations of these rules, FINRA believes that there is a high probability such speculative low-priced securities will not be suitable for at least some customers. Thus, FINRA requirements may make it more difficult for broker-dealers to recommend that their customers buy our ordinary shares, which may limit your ability to buy and sell our shares, have an adverse effect on the market for our shares and, thereby, depress their market prices.

Volatility in our ordinary shares price may subject us to securities litigation.

The market for our ordinary shares may have, when compared to seasoned issuers, significant price volatility, and we expect that our share price may continue to be more volatile than that of a seasoned issuer for the indefinite future. In the past, plaintiffs have often initiated securities class action litigation against a company following periods of volatility in the market price of its securities. We may, in the future, be the target of similar litigation. Securities litigation could result in substantial costs and liabilities and could divert management’s attention and resources.

We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.

Our management will have broad discretion in the application of the net proceeds from this offering, including for any of the purposes described in the section entitled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. The failure by our management to apply these funds effectively could harm our business.

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We are a foreign private issuer within the meaning of the rules under the Exchange Act, and as such we are exempt from certain provisions applicable to U.S. domestic public companies.

We are a foreign private issuer within the meaning of the rules under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As such, we are exempt from certain provisions applicable to U.S. domestic public companies. For example:

•        we are not required to provide as many Exchange Act reports, or as frequently, as a domestic public company;

•        for interim reporting, we are permitted to comply solely with our home country requirements, which are less rigorous than the rules that apply to domestic public companies;

•        we are not required to provide the same level of disclosure on certain issues, such as executive compensation;

•        we are exempt from provisions of Regulation FD aimed at preventing issuers from making selective disclosures of material information;

•        we are not required to comply with the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; and

•        we are not required to comply with Section 16 of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and establishing insider liability for profits realized from any “short-swing” trading transaction.

Our shareholders may not have access to certain information they may deem important and are accustomed to receiving from U.S. reporting companies.

As an “emerging growth company” under applicable law, we will be subject to lessened disclosure requirements. Such reduced disclosure may make our ordinary shares less attractive to investors.

For as long as we remain an “emerging growth company”, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), we will elect to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies”, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.  Because of these lessened regulatory requirements, our shareholders would be left without information or rights available to shareholders of more mature companies. If some investors find our ordinary shares less attractive as a result, there may be a less active trading market for such securities and their market prices may be more volatile.

We incur significant costs as a result of being a public company, which costs will grow after we cease to qualify as an “emerging growth company.”

We incur significant legal, accounting and other expenses as a public company that we did not incur as a private company. The Sarbanes-Oxley Act, as well as rules subsequently implemented by the SEC and the Nasdaq Capital Market, impose various requirements on the corporate governance practices of public companies. We are an “emerging growth company,” as defined in the JOBS Act and will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the end of the fiscal year in which the fifth anniversary of this offering occurs, (b) in which we have total annual gross revenue of at least $1.07 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our ordinary shares that is held by non-affiliates exceeds $700 million as of the prior February 28th, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.  An emerging growth company may take advantage of specified reduced reporting and other requirements that are otherwise applicable generally to public companies. These provisions include exemption from the auditor attestation requirement under Section 404 in the assessment of the emerging growth company’s internal control over financial reporting and permission to delay adopting new or revised accounting standards until such time as those standards apply to private companies.

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Compliance with these rules and regulations increases our legal and financial compliance costs and makes some corporate activities more time-consuming and costly. After we are no longer an emerging growth company, we expect to incur significant expenses and devote substantial management effort toward ensuring compliance with the requirements of Section 404 and the other rules and regulations of the SEC. For example, as a public company, we have been required to increase the number of independent directors and adopt policies regarding internal controls and disclosure controls and procedures. We have incurred additional costs in obtaining director and officer liability insurance. In addition, we incur additional costs associated with our public company reporting requirements. It may also be more difficult for us to find qualified persons to serve on our board of directors or as executive officers. We are currently evaluating and monitoring developments with respect to these rules and regulations, and we cannot predict or estimate with any degree of certainty the amount of additional costs we may incur or the timing of such costs.

If we are, or were to become, a passive foreign investment company (a “PFIC”) for U.S. federal income tax purposes, U.S. investors in our ordinary shares would be subject to certain adverse U.S. federal income tax consequences.

In general, a non-U.S. corporation will be a PFIC for any taxable year if (i) 75% or more of its gross income consists of passive income or (ii) 50% or more of the average quarterly value of its assets consists of assets that produce, or are held for the production of, passive income. We do not expect to be a PFIC for our current taxable year or in the foreseeable future. However, there can be no assurance that we will not be considered a PFIC for any taxable year. If we were a PFIC for any taxable year during which a U.S. investor held ordinary shares, such investor would be subject to certain adverse U.S. federal income tax consequences, such as ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, an additional interest charge on certain taxes treated as deferred, and additional reporting requirements under U.S. federal income tax laws and regulations. If we are characterized as a PFIC, a U.S. investor may be able to make a “mark-to-market” election with respect to our ordinary shares that would alleviate some of the adverse consequences of PFIC status. Although U.S. tax rules also permit a U.S. investor to make a “qualified electing fund” election with respect to the shares of a non-U.S. corporation that is a PFIC if the non-U.S. corporation provides certain information to its investors, we do not currently intend to provide the information that would be necessary for a U.S. investor to make a valid “qualified electing fund” election with respect to our ordinary shares.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains statements that constitute “forward-looking statements”. Any statements that are not statements of historical facts may be deemed to be forward-looking statements. These statements appear in a number of different places in this prospectus and, in some cases, can be identified by words such as “anticipates”, “estimates”, “projects”, “expects”, “contemplates”, “intends”, “believes”, “plans”, “may”, “will”, or their negatives or other comparable words, although not all forward-looking statements contain these identifying words. Forward-looking statements in this prospectus may include, but are not limited to, statements and/or information related to: strategy, future operations, projected production capacity, projected sales or rentals, projected costs, expectations regarding demand and acceptance of our products, availability of material components, trends in the market in which we operate, plans and objectives of management.

We believe that we have based our forward-looking statements on reasonable assumptions, estimates, analysis and opinions made in light of our experience and our perception of trends, current conditions and expected developments, as well as other factors that we believe to be relevant and reasonable in the circumstances at the date that such statements are made, but which may prove to be incorrect. Although management believes that the assumption and expectations reflected in such forward-looking statements are reasonable, we may have made misjudgments in preparing such forward-looking statements. Assumptions have been made regarding, among other things: our expected production capacity; labor costs and material costs, no material variations in the current regulatory environment and our ability to obtain financing as and when required and on reasonable terms. Readers are cautioned that the foregoing list is not exhaustive of all factors and assumptions which may have been used.

The forward-looking statements, including the statements contained in the sections entitled Risk Factors, Description of Business and Management’s Discussion and Analysis of Financial Conditions and Results of Operations and elsewhere in this prospectus, are subject to known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed or implied by such forward-looking statements.

Although management has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. Forward-looking statements might not prove to be accurate, as actual results and future events could differ materially from those anticipated in such forward-looking statements or we may have mad misjudgments in the course of preparing the forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. We wish to advise you that these cautionary remarks expressly qualify, in their entirety, all forward-looking statements attributable to our company or persons acting on our company’s behalf. We do not undertake to update any forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting such statements, except as, and to the extent required by, applicable securities laws. You should carefully review the cautionary statements and risk factors contained in this prospectus and other documents that we may file from time to time with the securities regulators.

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IMPLICATIONS OF BEING A FOREIGN PRIVATE ISSUER

We are considered a foreign private issuer. In our capacity as a foreign private issuer, we are exempt from certain rules under the Exchange Act that impose certain disclosure obligations and procedural requirements for proxy solicitations under Section 14 of the Exchange Act. In addition, our officers, directors and principal shareholders are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and the rules under the Exchange Act with respect to their purchases and sales of our securities. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. In addition, we are not required to comply with Regulation FD, which restricts the selective disclosure of material information.

We may take advantage of these exemptions until such time as we are no longer a foreign private issuer. We would cease to be a foreign private issuer at such time as more than 50% of our outstanding voting securities are held by U.S. residents and any of the following three circumstances applies: (1) the majority of our executive officers or directors are U.S. citizens or residents, (2) more than 50% of our assets are located in the United States or (3) our business is administered principally in the United States.

We have taken advantage of certain reduced reporting and other requirements in this prospectus. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold equity securities.

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IMPLICATIONS OF BEING AN EMERGING GROWTH COMPANY

The U.S. Congress passed the JOBS Act, which provides for certain exemptions from various reporting requirements applicable to reporting companies under the Exchange Act, that qualify as “emerging growth companies.” We are an “emerging growth company” and we will continue to qualify as an “emerging growth company” until the earliest to occur of: (a) the last day of the fiscal year during which we have total annual gross revenues of $1.07 billion (as such amount is indexed for inflation every five years by the SEC) or more; (b) the last day of our fiscal year following the fifth anniversary of the date of the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act; (c) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt; or (d) the date on which we are deemed to be a “large accelerated filer”, as defined in Exchange Act Rule 12b–2. Therefore, we expect to continue to be an emerging growth company for the foreseeable future.

An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include:

•        the ability to include only two years of audited financial statements and only two years of related management’s discussion and analysis of financial condition and results of operations disclosure in this prospectus;

•        an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002; and

•        Exemption from mandatory audit firm rotation or a supplement to the auditor’s report in which the auditor would be required to provide additional information about the audit and the financial statements of the registrant (auditor discussion and analysis).

We may take advantage of these provisions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company if we have more than $1.07 billion in annual revenue, have more than $700 million in market value of our ordinary shares held by non-affiliates or issue more than $1 billion of non-convertible debt over a three-year period.

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USE OF PROCEEDS

Assuming the sale of 2,000,000 in this offering at a price of $5.00 per share, the midpoint of the range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and offering expenses payable by us, we expect to receive net proceeds of approximately $8,400,000 from this offering. If the underwriter exercises its over-allotment option in full, our aggregate net proceeds will be approximately $10,030,000.

We currently expect to use the net proceeds from this offering (assuming no exercise of the underwriter’s over-allotment option) as follows:

Description of Use

 

Estimated
Amount of
Net Proceeds

Research & Development (further development of ColoAlert, PancAlert and Genostrip)

 

$

3,200,000

Clinical studies for FDA approval of ColoAlert

 

$

2,100,000

Marketing and Sales

 

$

2,400,000

Capital Expenditures

 

$

500,000

General Corporate Purposes

 

$

200,000

Total:

 

$

8,400,000

A $1.00 increase or decrease in the assumed public offering price of $5.00 per share would increase or decrease the net proceeds from this offering by approximately $1,840,000 assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and offering expenses payable by us. Similarly, each increase or decrease of 100,000 shares offered would increase or decrease our net proceeds by approximately $460,000, assuming the assumed public offering price remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

Pending our use of the net proceeds from this offering, we may invest the net proceeds in a variety of capital preservation investments, including short-term, investment grade, interest bearing instruments and U.S. government securities. We do not intend to use the proceeds from this offering to make principal payments, scheduled or early, on any of our outstanding debt.

We will not receive any proceeds from the resale offering of ordinary shares by our selling shareholders.

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DIVIDEND POLICY

Under Dutch law, we may only pay dividends following the closing of the offering to the extent our shareholders’ equity (eigen vermogen) exceeds the sum of the paid-up and called-up share capital plus the reserves required to be maintained by Dutch law or by our articles of association. Subject to such restrictions, the amount of any distributions will depend on many factors, such as our results of operations, financial condition, cash requirements, prospects and other factors deemed relevant by our board of directors.

Our articles of association prescribe that profits in any financial year will be distributed first to holders of our preferred shares, if any are outstanding. Any remaining profits may be reserved by our Board of Directors.

We have not adopted a formal dividend policy with respect to future dividends. We may adopt such a policy in the future.

CORPORATE REORGANIZATION

We are currently a private company with limited liability under Dutch law. We intend to convert our company into a public company under Dutch law and will not complete this offering unless we have done so.

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CAPITALIZATION AND INDEBTEDNESS

The following table sets forth the capitalization of PharmGenomics GmbH, which is considered for accounting purposes to be our predecessor entity. Mainz Biomed B.V. was not formed as of December 31, 2020 and to date has had no operations. Such information is set forth on the following basis:

•        on an actual basis for PharmGenomics GmbH;

•        on a pro forma basis, giving effect to the Contribution Agreement reflecting (i) our merger with PharmGenomics GmbH, (ii) our sale of 1,000,000 units (consisting of an ordinary share and a warrant to purchase an ordinary share at an exercise price of $3.00) in August 2021 at a per unit price of $0.60 and the related issuance of 70,000 broker warrants, (iii) our issuance of 200,000 shares to our Chief Executive Officer and (iv) our sale of 500,000 units (consisting of an ordinary share and a warrant to purchase an ordinary share at an exercise price of $3.00) in September 2021 at a per unit price of $2.00 and the related issuance of 25,000 broker warrants; and

•        on a pro forma, as adjusted basis, giving effect to the sale by us of 1,000,000 Shares (excluding any sale of Shares pursuant to the underwriter’s over-allotment option), at an assumed public offering price of $5.00 per Share, after deducting underwriting discounts and commissions and estimated offering expenses.

The pro forma and pro forma as adjusted information below is illustrative only and our capitalization following the completion of this offering will be adjusted based on the actual public offering price and other terms of this offering determined at pricing. You should read this table together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our audited financial statements and the related notes appearing elsewhere in this prospectus and our and unaudited consolidated pro forma information appearing elsewhere in this prospectus.

 

As of June 30, 2021

   

Actual

 

Pro Forma

 

Pro Forma
as Adjusted

Cash

 

$

195,165

 

 

$

2,069,397

 

 

$

10,469,397

 

Total liabilities

 

 

3,146,548

 

 

 

3,210,987

 

 

 

3,210,987

 

   

 

 

 

 

 

 

 

 

 

 

 

Debt:

 

 

 

 

 

 

 

 

 

 

 

 

Convertible Debt

 

$

 

 

$

 

 

$

 

Convertible Debt – Related Parties

 

 

79,856

 

 

 

79,856

 

 

 

79,856

 

Loans Payable

 

 

23,702

 

 

 

23,702

 

 

 

23,702

 

Loans Payable – Related Parties

 

 

105,414

 

 

 

105,414

 

 

 

105,414

 

Silent Partnerships

 

 

1,537,826

 

 

 

1,537,826

 

 

 

1,537,826

 

Silent Partnerships – Related Parties

 

 

488,726

 

 

 

488,726

 

 

 

488,726

 

Total Debt

 

$

2,235,524

 

 

$

2,235,524

 

 

$

2,235,524

 

   

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ Equity (Deficit):

 

 

 

 

 

 

 

 

 

 

 

 

Common Shares, €1.00 par value, 99,069 shares issued and outstanding of PharmGenomics GmbH; on a Pro Forma basis 9,710,001 common shares of Mainz Biomed B.V., €0.01 par value

 

 

114,010

 

 

 

115,768

 

 

 

139,568

 

Reserves

 

 

2,810,022

 

 

 

4,658,520

 

 

 

13,034,720

 

Accumulated Deficit

 

 

(5,216,581

)

 

 

(5,244,581

)

 

 

(5,244,581

)

Accumulated Other Comprehensive Loss

 

 

(119,527

)

 

 

(119,527

)

 

 

(119,527

)

Total Stockholders’ Equity (Deficit)

 

$

(2,412,076

)

 

$

(589,820

)

 

$

7,810,180

 

Total Capitalization

 

$

(176,552

)

 

$

1,645,704

 

 

$

10,045,704

 

A $1.00 increase or decrease in the assumed public offering price per share would increase or decrease our pro forma as adjusted cash, additional paid-in capital, total stockholders’ equity (deficit) and total capitalization by approximately $1,840,000 assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discount and estimated offering expenses payable by us.

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DILUTION

If you invest in our ordinary shares, your interest in our ordinary shares will be diluted to the extent of the difference between the offering price per ordinary share and the as adjusted net tangible book value per ordinary share after the offering. Dilution results from the fact that the per ordinary share offering price is substantially in excess of the book value per ordinary share attributable to the existing shareholders for our presently outstanding ordinary shares. Our net tangible book value attributable to shareholders at June 30, 2021 was $222,256, or approximately $0.11 per ordinary share. Net tangible book value per ordinary share as of June 30, 2021 represents the amount of total assets less intangible assets and total liabilities, divided by the number of ordinary shares outstanding.

After giving effect to the issuance of 7,700,000 ordinary shares since July 1, 2021, the receipt of $1,600,000 in connection with such issuances (the “Post-June 30, 2021 Issuances”) and our September 2021 merger with PharmGenomics, our pro forma net tangible book value as of June 30, 2021 would have been approximately $1,012,025, or approximately $(0.10) per ordinary share, based on 9,710,000 ordinary shares outstanding on a pro forma basis.

Our pro forma as adjusted net tangible book value of our ordinary shares as of June 30, 2021 gives further effect to the sale of ordinary shares at the assumed public offering price of $5.00 per ordinary share, after deducting the underwriting discounts and commissions and estimated offering expenses and assuming the underwriter does not exercise its over-allotment option. We will issue 2,000,000 ordinary shares upon completion of the offering. Our pro forma as adjusted net tangible book value as of June 30, 2021, which gives effect to the net proceeds from the offering and the issuance of additional shares in the offering, but does not take into consideration any other changes in our net tangible book value after June 30, 2021, will be approximately $7,387,975, or $0.63 per ordinary share. This would result in dilution to investors in this offering of approximately $4.37, or approximately 87% from the assumed offering price of $5.00 per ordinary share. Pro forma as adjusted net tangible book value per ordinary share would increase to the benefit of present shareholders by $0.73 per share attributable to the purchase of the ordinary shares by investors in this offering.

If the underwriter exercises its option to purchase additional shares to cover over-allotments in full, the pro forma as adjusted net tangible book value per share after giving effect to our initial public offering would be approximately $0.73 per share, and the dilution in pro forma net tangible book value per share to investors in our initial public offering would be approximately $4.27 per share.

The following table sets forth the estimated net tangible book value per ordinary share after the offering (assuming no exercise of the over-allotment option) and the dilution to persons purchasing ordinary shares.

Assumed offering price per ordinary share

 

$

 

 

 

$

5.00

Pro forma net tangible book value per ordinary share before the offering

 

$

(0.10

)

 

$

 

Increase per ordinary share attributable to this offering

 

 

0.73 

 

 

 

 

Pro forma as adjusted net tangible book value after the offering

 

$

 

 

 

$

0.63

Pro forma as adjusted dilution per ordinary share to new investors in this offering

 

$

 

 

 

$

4.37

If any ordinary shares are issued upon exercise of outstanding warrants or options, you may experience further dilution.

The following table summarizes, as of September 30, 2021, the differences between the number of ordinary shares purchased from us, the total cash consideration paid, and the average price per share paid by our existing stockholders and by our new investors purchasing shares in our initial public offering at the assumed initial public offering price of $5.00 per ordinary share, the midpoint of the price range on the cover page of this prospectus, before deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us:

 

Shares Purchased

 

Total Consideration

 

Average
Price Per
Share

Number

 

Percent

 

Amount

 

Percent

 

Existing stockholders

 

9,710,001

 

83

%

 

 

5,124,332

 

34

%

 

$

0.53

New investors

 

2,000,000 

 

17

 

 

10,000,000 

 

66

 

 

5.00

Total

 

11,710,001 

 

100%

 

 

$

15,124,332

 

100%

 

 

 

1.29

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A $1.00 increase (decrease) in the assumed initial public offering price of $5.00 per share would increase (decrease) total consideration paid by new investors by $2,000,000 million (and net proceeds by approximately $1,840,000), assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissions payable by us.

If the underwriter exercises its option to purchase additional shares to cover over-allotments in full, our existing stockholders would own 81% and our new investors would own 19% of the total number of shares of our common stock outstanding after our initial public offering.

Sales of ordinary by the selling shareholders in our initial public offering will reduce the number of ordinary shares held by existing stockholders to 8,710,000, or approximately 74.4% of the total ordinary shares outstanding after our initial public offering and will increase the number of shares held by new investors to 3,000,000, or approximately 25.6% of the total ordinary shares outstanding after our initial public offering.

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CURRENCY AND EXCHANGE RATES

The following table sets forth, for each period indicated, the high and low exchange rate for Euros expressed in U.S. dollars, and the average exchange rate for the periods indicated as rounded to the nearest whole cent. These rates are based on the noon-buying rate certified for custom purposes by the U.S. Federal Reserve Bank of New York set forth in the H.10 statistical release of the Federal Reserve Board. These rates are provided solely for your convenience and are not necessarily the exchange rates that we used in preparation of our financial statements or elsewhere in this prospectus or will use in the preparation of our periodic reports or any other information to be provided to you. We make no representation that any Euro or U.S. dollar amounts referred to in this prospectus could have been or could be converted into U.S. dollars or Euros, as the case may be, at any particular rate or at all.

 

Period End

 

High Rate

 

Low Rate

Year Ended

 

 

   

 

   

 

 

December 31, 2020

 

$

1.22

 

$

1.23

 

$

1.07

December 31, 2019

 

$

1.12

 

$

1.15

 

$

1.09

Month Ended

 

 

   

 

   

 

 

January 31, 2021

 

$

1.21

 

$

1.23

 

$

1.21

February 28, 2021

 

$

1.21

 

$

1.22

 

$

1.20

March 31, 2021

 

$

1.17

 

$

1.21

 

$

1.17

April 30, 2021

 

$

1.20

 

$

1.21

 

$

1.18

May 31, 2021

 

$

1.22

 

$

1.22

 

$

1.20

June 30, 2021

 

$

1.18

 

$

1.22

 

$

1.18

July 31, 2021

 

$

1.19

 

$

1.19

 

$

1.18

August 30, 2021

 

$

1.18

 

$

1.19

 

$

1.17

Except in our financial statements or where otherwise noted in this prospectus, we have translated Euro amounts into dollars using the noon-buying rate certified for custom purposes by the U.S. Federal Reserve Bank of New York set forth in the H.10 statistical release of the Federal Reserve Board on December 31, 2020 of €1.00:$1.22.

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COMPANY INFORMATION

History and Development of the Company

We are currently a private company with limited liability under Dutch law, but we will not complete this offering unless we have converted into a public company under Dutch law. We were incorporated in the Netherlands on March 8, 2021. We were formed to acquire PharmGenomics GmbH (“PharmGenomics“), a German company with limited liability, and intend to do so shortly after the confidential submission of the registration statement of which this preliminary prospectus forms a part.

Prior to the completion of this offering we will register our ordinary shares under the Exchange Act, and we intend to make our periodic reports and other information filed with or furnished to the SEC, pursuant to Section 13(a) or 15(d) of the Exchange Act, available free of charge through our website as soon as reasonably practicable after those reports and other information are electronically filed with or furnished to the SEC. The SEC maintains a website at http://www.sec.gov that contains reports and other information regarding issuers that file electronically with the SEC.

Information on our website or any other website is not incorporated by reference into this prospectus and does not constitute a part of this prospectus. We have included our website address as an inactive textual reference only.

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BUSINESS

General

We are a molecular genetics cancer diagnostic company formed in 2021 to acquire PharmGenomics GmbH (“PharmGenomics“) for the purpose of commercializing their product portfolio in Europe and the United States. PharmGenomics, a German DIN EN ISO 13485-certified manufacturer of in-vitro diagnostic (“IVD”) tests with its own molecular genetic laboratory, has developed several IVD tests for the European market since it was founded in 2008.

Our portfolio consists of the following products and product candidates:

•        ColoAlert, a colorectal cancer (“CRC”) screening stool-based DNA (deoxyribonucleic acid) test licensed from ColoAlert AS and sold in Europe,

•        PancAlert, a product candidate in an early stage of research for a pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction (“PCR”)-based multiplex detection of molecular-genetic biomarkers in stool samples,

•        GenoStrip, a proposed platform technology in an early stage of research to detect pathogens or genetic aberrations in environments on a molecular genetic basis where a qualitative evaluation must be made in a short-time period and

•        Legacy Research-Use-Only (“RUO”) and IVD tests, such as the GenoChips and the HumaSense product line, that we intend to license to third parties or sell the products to third parties or discontinue within the coming 18 months as well as third-party laboratory testing that we plan to discontinue.

About the Industry

The cancer industry can be divided into a diagnostics segment focused on detecting cancers, and a therapeutic segment focused on treating them. We are focused on the diagnostic aspect of the cancer industry.

For most cancer, early detection is lifesaving and for CRC, in particular, the symptoms are unclear and removal of cancer by surgery in the early stage is easy compared to treatment at a late stage. Screening of CRC is both lifesaving and cost saving. We compete with other entities developing and offering diagnostic tests to detect the presence of cancers. Our core product is a CRC screening stool DNA test, and we are in the early stages of researching a similar test for pancreatic cancer.

CRC are malignant tumors in the colon or rectum. These tumors usually develop from benign polyps, which over time degenerate and become cancerous. Between 5 and 15 years may elapse between the development of CRC and the formation of metastases. One method for the categorization of cancer stages of CRC is referred to as Dukes’ Stages which range from A, the least threatening, to D, the most severe. In Dukes’ Stage A, the tumor is limited to the superficial cell layers of the intestinal mucosa. According to a 2018 report from the American Cancer Society, if patients are diagnosed at this stage, the 5-year survival rate is usually over 90%. In the course of the further stages, the tumor continuously grows into other tissue layers and spreads to the nearest lymph nodes. In the final Dukes’ Stage D, the tumor metastasizes and affects other organs and thus minimize the 5-year survival rate to 8%. Because of the high survival rates in case of early detection, regular and accurate screening is essential. According to the Robert Koch Institute, relative 5-years survival rates in Germany are 63% for women and 62% for men.16

According to the American Cancer Society, CRC is the third most-commonly diagnosed cancer and the second leading cause of cancer death in the world.17 According to the International Agency for Research on Cancer, the distribution of CRC cases varies widely, with more than two-thirds of all cases and about 60% of all deaths occurring in countries with a high or very-high human development index.18 According to an article in BMJ Journals, global cases of CRC are expected to increase by 60% to more than 2.2 million new cases and 1.1 million deaths by 2030.19 Across Europe,

____________

16              https://www.krebsdaten.de/Krebs/EN/Content/Cancer_sites/Colorectal_cancer/colorectal_cancer_node.html

17              American Cancer Society, CA - A cancer journal for clinicians, Volume 71, issue3

18              Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 11. Lyon, France: International Agency for Research on Cancer, 2013

19              BMJ Journals, Global patterns and trends in colorectal cancer incidents and mortality, Volume 66, Issue 4. Arnold M, Sierra MS, Laversanne M, et alGlobal patterns and trends in colorectal cancer incidence and mortality. Gut 2017;66:683-691.

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378,445 new CRC cases were diagnosed in 2018, with more than 170,000 deaths.20 Therefore, in 2020 CRC was the second most common gender-unspecific cancer in Europe according to the European Commission.21 In the United States 141,074 new cases of CRC were reported in 2018, and 52,163 people died of this cancer according to the U.S. Cancer Statistics Working Group. For every 100,000 people, 37 new CRC cases were reported, with 13 deaths,22 and CRC is expected to cause about 52,980 deaths during 2021 in the United States.23

A recent report by Fact.MR projects the global CRC diagnostics market to register an expansion at a CAGR of 8.5% from 2017 to 2022. Revenues from the global CRC diagnostics market are expected to surpass $2 billion by the end of 2022.24

In Europe, there are more than 194 million people over the age of 50 years. A Global Market Insights Inc. report from 2018 forecasts a European market volume of 50 million screening tests annually by 2023.

Approximately 19 million colonoscopies were performed in 2017 in the United States, according to iData Research.25 With nearly 40% of the US population aged between 50 and 75 years having undergone no CRC screening at all, there is still plenty of potential for highly sensitive, non-invasive tests. With the core target group aged over 50 years growing from 112 million to 157 million26 individuals within the next 10 years, we believe that our addressable market in the United States alone will increase from $3.7 billion to over $5.2 billion annually.

Products and Product Candidates

We strive to make the diagnosis of various diseases more effective by using the latest genetic diagnostic technologies. Enabling earlier detection of these diseases allows for earlier and better therapy for affected individuals. In addition to offering the CRC screening test, ColoAlert, we are currently developing two product candidates, PancAlert and GenoStrip. We aim to use known and existing biomarkers (concepts) in applicable and reliable diagnostic tools.

ColoAlert

We offer a CE-IVD certified CRC diagnostic test, ColoAlert. We believe that molecular genetic stool tests like ColoAlert increase the participation rate in CRC screening and shift the detection of CRC to an earlier point of time which increases the likelihood of successful treatment of the cancer.

In the human intestines, epithelial skin cells are continuously shed into the stool. In addition to healthy cells, cells from polyps and colon cancer are also released. Using state-of-the-art genetic diagnostic methods, such as PCR analysis (a proceed used to rapidly make millions to billions of copies of a specific DNA sample, allowing for the amplification of a small sample of DNA to a large enough amount to study in detail), these shed cells can be isolated and examined for genetic changes.

ColoAlert is a multitarget test in which the stool sample is analyzed for genetic anomalies as well as for the presence of hidden blood, often called occult blood. The genetic analysis consists of the quantification of human DNA, the analysis of somatic point mutations in the KRAS (codon 12/13) and BRAF (codon 600) genes. An independent clinical test lead by Professor Matthias Dollinger and conducted with 566 patients by the University Hospitals in Leipzig and Halle-Wittenberg, Germany showed ColoAlert to have a sensitivity of 85% and a specificity of 92%27 while being as non-invasive as other stool tests and showing a very high patient satisfaction of 98%.28 Compared to the FITs reimbursed in Germany, this meant up to 60% less overseen CRCs.29 The genetic markers were chosen to complement the diagnostic accuracy of the occult blood test and lead to an increased clinical added value. Since the independent clinical study, we have updated the occult blood test component of ColoAlert to what we believe is a more accurate occult blood test in terms of sensitivity and specificity.

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20              UEG Research, Healthcare in Europe: Scenarios and implications for digestive and liver diseases, 2019

21              European Commission. Colorectal cancer burden in EU-27, 2021

22              U.S. Cancer Statistics Working Group. U.S. Cancer Statistics Data Visualizations Tool, based on 2020 submission data (1999-2018): U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; www.cdc.gov/cancer/dataviz, released in June 2021.

23              American Cancer Society, “Key Statistics for ColoRectal Cancer”, https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html

24              https://www.factmr.com/report/70/colorectal-cancer-diagnostics-market

25              https://idataresearch.com/an-astounding-19-million-colonoscopies-are-performed-annually-in-the-united-states/

26              https://www.prb.org/resources/u-s-population-is-growing-older/

27              Dollinger MM et al. (2018) ClinLab 64(10)

28              Internal customer survey with n = 131 (2019)

29              Giess et al. Gastroenterology 154/2018

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We target individuals covered by national CRC screening programs. Most screening programs recommend CRC screening starting at age 50. However, a trend exists to further lower the screening age. For example, the FDA recently recommended CRC screening starting at age 45. Due to the increasing prevalence of the disease in the younger population, we anticipate a further decrease in the screening age, especially for test methods such as ColoAlert that are, in principle, capable of detecting cancer at early stages. In addition to age, other personal characteristics in favor of CRC screening include a family predisposition to CRC, risk factors such as obesity, irritable bowel syndrome (“IBS”), inflammatory bowel disease (“IBD”), excessive meat, alcohol and nicotine consumption, and pre-existing conditions such as breast cancer or type 2 diabetes mellitus.

We license the ColoAlert test from a Norwegian research and development company, ColoAlert AS, pursuant to an exclusive licensing agreement dated January 1, 2019. Pursuant to the terms of our license, we pay ColoAlert AS 50% of the net profit that we generate from the ColoAlert test, in addition to a protection fee of €5 per test sold. The license has no fixed term but will be terminated if the quarterly fee paid to ColoAlert AS is less than €25,000 for each of the quarters ending on or prior to December 31, 2022 and €250,000 per quarter thereafter. On February 11, 2021, we obtained an option exercisable for three years to acquire the intellectual property for the ColoAlert test for (i) either a one-time cash payment of €2,000,000 or a €4,000,000 payment in ordinary shares at the valuation of our most recent financing plus (ii) a lifetime royalty payment of €3 per ColoAlert test sold. If we opt to make the one-time payment in cash, ColoAlert AS has the right to require us to pay the €4,000,000 in ordinary shares at the valuation of our most recent financing.

In the European Union, ColoAlert is a CE-IVD registered product under the current In-Vitro Diagnostics Directive 98/79 /EC (“IVD-D”). Starting on May 26, 2022, IVD products in the European Union will be regulated by the In-Vitro Diagnostics Regulation, EU 2017/746 (“IVD-R”), which replaces the IVD-D. We are currently evaluating the necessary steps to meet the upcoming regulations for our ColoAlert product. ColoAlert is currently validated on the Roche LightCycler 480 II and Lightcycler v2.0. Mainz BioMed is planning to validate the test on additional real time PCR instruments used in many laboratories worldwide to allow a potential faster market penetration.

In Europe, we offer ColoAlert Basic, which consists of the above-described biomarker panel with results obtained in 9 workdays and ColoAlert Plus, which also includes the detection of the hemoglobin-haptoglobin-test while delivering results within five workdays

We manufacture the ColoAlert IVD test kits at our facility in Mainz, Germany.

Below is a typical process flow for the use of ColoAlert for Germany.

Typical process flow:

1.      The patient is informed about the risk of CRC.

2.      The physician discusses with the patient the need for a CRC test.

3.      The physician provides the kit to the patient or the patient receives the kit shipped from the laboratory partner.

4.      The patient collects the sample and ships the collected sample to the testing clinical laboratory.

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5.      The clinical laboratory tests the sample and provides the result to the ordering physician.

6.      The ordering physician informs patient about the results and decides on next steps.

PancAlert

We are in the early stages of developing PancAlert, a stool-based screening test for the detection of pancreatic cancer. According to the Global Cancer Observatory, pancreatic cancer was diagnosed in over 460,000 patients worldwide in 2018.30 Due to the asymptomatic early stages, in most cases this disease is detected too late, making pancreatic cancer one of the most lethal malignant neoplasms with over 430,000 annual deaths according to the Global Cancer Observatory.31 The overall 5-year survival rate is approximately 8%, which is the lowest survival rate of all cancer types. On the other hand, the 5-year survival rate is around 56% if the pancreatic cancer is still in the early stages at the time of diagnosis.32 Studies have shown that the prognosis in asymptomatic patients, when who were diagnosed by chance during other examinations, is significantly better than in patients with characteristic symptoms such as rapid weight loss or back pain.33

The mean age of onset is 71 years for men and 75 years for women .34 Similar to other cancers, age is an essential risk factor. Most patients are over 50, with most diagnoses occurring between the ages of 60 and 80. The fact that pancreatic cancer is the European Union’s third biggest cancer killer, despite being the seventh most common cancer, highlights the extremely poor outlook for patients. Although, the survival rate of pancreatic cancer patients has improved in the last few decades, there is still the urgent need for early diagnostic optimization.

A definitive diagnosis is currently made through a series of investigations, including imaging scans, blood tests and biopsy, which are usually only performed in symptomatic patients. However, recent research suggests that the disease can persist for a longer period of time without patients becoming symptomatic; providing an important opportunity for early detection. Because the initiation of pancreatic cancer occurs on a molecular level, genetic diagnostic methods can be a promising approach for early detection. The biomarkers associated with pancreatic cancer reach the stool, amongst other ways by the pancreatic juice, which enables a user-friendly sample collection. The development approach includes the selection and verification of a specific biomarker panel with the establishment of a suitable method for sample preparation, the establishment and validation of the detection and measurement technology with purchased or clinically defined samples (biopsies, pancreatic juice, stool and others), the transfer to routine diagnostics (stool) and the optimization and clinical evaluation as a potential screening tool for the early detection of pancreatic cancer.

Our goal is to make PancAlert the world’s first pancreatic cancer screening test based on Real-Time PCR-based multiplex detection of molecular-genetic biomarkers in stool samples. The most promising candidates for disease-specific biomarkers to date are KRAS, mBMP3, NDRG4, and GNAS codon 201. In addition, the platform technology used will enable simple integration of further biomarkers if indicated. The analysis of the results will be additionally facilitated by a specialized IT solution. Based on the research progress in this project, we plan to initiate an initial pilot study with one or more selected clinical sites. We do not expect to conclude such studies prior to 2024 at the earliest. If the clinical pilot studies show promising results, we intend to start developing an IVD-R and FDA approvable product for the European market.

GenoStrip

We are in the early stages of developing a rapid and easy to use molecular lateral-flow test that we call GenoStrip. We intend to develop the GenoStrip technology as a platform technology which combines the advantages of highly precise molecular genetics and the easy-to-handle usage of a customized lateral-flow-dipstick to provide molecular results in as little as 20 minutes, depending on the sample preparation method amplification system used. The target sequences (DNA or RNA) are amplified either way in single or multiplex amplification reactions.

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30              Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, in press. The online GLOBOCAN 2018 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.

31              Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, in press. The online GLOBOCAN 2018 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.

32              Egawa S, Takeda K, Fukuyama S et al. Clinicopathological aspects of small pancreatic cancer. Pancrdeas 2004;28:235-40. And http://www.aboutcancer.com/pancreas3.htm

33              Egawa S, Takeda K, Fukuyama S et al. Clinicopathological aspects of small pancreatic cancer. Pancrdeas 2004;28:235-40.

34              Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016, CA Cancer J Clin 2016;66:7-30

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If successful, the GenoStrip technology could be modified for various applications where qualitative evaluations have to be made within a short time frame, as for instance in the case of COVID-19 diagnosis, and other respiratory viruses, as well as pathogens causing sexually transmitted diseases or the detection of mutated or deleted genes.

One prototypic example is our Abacavir Hypersensitivity reaction test (HLA*57:01).

Abacavir is used as an antiretroviral drug to treat HIV-1 infection. A hypersensitive reaction (“HSR”) occurs in 5% to 8% of patients when administered, which manifests itself in symptoms such as fever, rash, malaise, gastrointestinal complaints or shortness of breath and in some cases can even be fatal. These side effects have been shown to be related to the HLA-B * 57:01 allele. For this reason, appropriate screening has been prescribed by the BfArM and FDA since 2008 before the start of therapy.

For this application, the DNA extracted from a simple cheek swab is replicated using allele-specific, labeled primers for the HLA-B * 57: 01 allele in an isothermal approach in a conventional heating block. The detection is then carried out on the lateral flow test strip. If the allele is not present, an internal control confirms that the test has been carried out successfully.

In this particular example, the steps and time requirements are:

•        Extract the DNA from a cheek swab

•        RPA isothermal allele-specific amplification in a heating block

•        Incubation of the lateral flow stripe readout

As we are in the early stages of development, we cannot be sure that at this time that GenoStrip will ever become a commercially viable product.

Legacy Diagnostic Products and Services

We currently sell several genetic diagnostic products that we manufacture to clinical laboratories, mostly in Germany. Some of these products are CE-IVD registered while others are RUO products. Due to the high cost of meeting the new IVD-R regulatory requirements starting in May 2022, we have decided to license out, sell off or discontinue those products. Additionally, we have provided third-party laboratory testing services that we also intend to discontinue.

Competitive Advantages & Operational Strengths

We face competition from providers of more traditional CRC screening diagnostics, such as colonoscopies, as well as other manufacturers of non-invasive stool- or blood-based tests. We believe the primary competitive factors for ColoAlert include but are not limited to:

•        Accuracy:    End-users want as accurate a result as possible without worrying about costs, hassle and time associated with false-negative and false-positive results. A report by Professor Dollinger found ColoAlert to have a specificity of 92%, above the 90% specificity requirement set by the European CRC screening guidelines, and has a sensitivity of 85%. Sensitivity defines how often a test correctly generates a positive result for the condition being tested. Specificity is the ability of the test to correctly identify those without the disease (true negative rate). Since that report, we have updated the occult blood test component of ColoAlert in a way that we believe will increase sensitivity and specificity.

•        Time-to-result:    The faster the results of a diagnostic test are known; the sooner treatment may begin or the end user can gain ease of mind. Due to ColoAlert’s simplicity of the testing procedure, the resultant turn-around time between the patient’s decision and delivery of the test report can be as low as three days in Germany, which we believe is significantly shorter than most other tests.

•        Ease of use:    As many people will delay or avoid getting an invasive diagnostic test, such as a colonoscopy, the easier it is to take such a test, the higher the participation rates will be, which could mean more detection of cancer at earlier stages and higher rates of survival. ColoAlert is less invasive than traditional colonoscopies, requiring neither the drinking of barium (oral or suppository) the night prior to the test, nor prior fasting, and does not require a trip to a clinic or the administration of anaesthesia. Compared to blood-based tests, stool tests can be performed at home and do not require the patient to visit their physician.

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•        Executive team:    Our leadership team and advisors have extensive experience developing and commercializing innovative diagnostic products globally. We have strong relationships with government organizations and universities in Europe.

•        Research and Development:    We are confident that we have organized a strong team to front our research and development. Our research and development efforts have been supported by a grant of up to approximately €440,000 from the German Federal Ministry of Research and Education for the development of PancAlert, a non invasive product candidate to detect pancreatic cancers, and a grant of up to approximately €205,000 from the European Fund for Economic and Regional Development for the development of GenoStrip, a product candidate for a rapid and easy to use molecular lateral-flow test.

Strategy

We intend to make ColoAlert the global CRC screening market leader by providing the best performance at an affordable cost. To fulfil this goal efficiently, our sales strategy is primarily based on collaborations with large laboratory chains. This distribution strategy is chosen because laboratories typically have a large customer base of physicians as well as a strong sales team. This can increase awareness of ColoAlert within the physician community in a cost-effective manner. At the same time, it offers the opportunity for accelerated product rollouts in foreign markets, as large laboratory chains operate across Europe or worldwide and successful products are often distributed within the laboratory chain. Laboratory partners benefit from the introduction and distribution of ColoAlert especially from the increased medical added value, the positioning as innovation leaders and from, we believe, significantly higher margins compared to conventional stool tests such as FIT. We believe that this distribution approach also provides a strong business differentiation in the United States from the Cologuard, a test offered by Exact Sciences Corporation. Cologuard is performed exclusively in Exact Sciences’ in-house laboratories and therefore other laboratories currently do not have access to a multitarget stool test. By providing the ColoAlert test kits, other laboratories can also offer highly sensitive, non-invasive CRC screening to their affiliated physicians and their patients.

To introduce ColoAlert into the United States and potentially other markets like China, extensive regulatory studies are required. We are actively exploring the required regulatory path for the United States.

Therefore, we intend to use the proceeds from this offering to:

•        Expand the commercial opportunity of our ColoAlert product in Europe by expanding our commercial team and partnerships.;

•        Prepare and execute a comprehensive clinical and regulatory strategy to achieve market authorization from the FDA to use ColoAlert as a screening test for CRC in the United States; and

•        Continue research and development of PancAlert and GenoStrip.

Expansion of ColoAlert in Europe

There are currently nearly 400 medical care centers with a laboratory focus in Germany, of which over 60 have a molecular genetic laboratory in house. Approximately 50% of the market share is held by five laboratory chains (Sonic, Limbach, Synlab, Amedes and LADR), rendering activities towards those and their large networks of physicians especially attractive. Two of these five laboratory chains are currently our customers. We plan on securing additional partner laboratories to market and sell our ColoAlert product through the use of sales representatives. Partner laboratories will, once part of our distribution network, receive support from us for the proper administration of the product in the client’s clinical laboratory. This validation process for new IVD products is being performed every day by all other diagnostic companies in Germany (e.g. Roche, Abbott, Siemens). If needed, we will also provide co-branded marketing materials.

We primarily sell the ColoAlert IVD test kits to German clinical reference laboratories. The reference laboratories provide the patient kit and accompanying marketing materials, to their affiliated physicians and educate them about the clinical advantages of ColoAlert. The laboratories perform the diagnostic analysis and report the results to the physicians.

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We also initiated a pilot program to allow patients to use the ColoAlert website for ordering a patient kit online. The collected samples are sent by the patient directly to our own clinical laboratory. We plan to conduct joint marketing activities with the reference labs to connect patients and physicians supported by the newly established online portal www.gemeinsam-gegen-darmkrebs.de (currently in beta status).

Our primary market is currently Germany, and we intend to expand to other German-speaking countries. After the rollout in the German-speaking region, we intend to launch ColoAlert in other western European markets, particularly in the United Kingdom, with its innovation-friendly National Health Service, followed by countries such as Spain or in Scandinavia.

In the coming year, we seek to expand the current European sales team with strong diagnostic sales experience. The sales team will focus on sales of our ColoAlert test to clinical laboratories that perform diagnostics tests ordered by physicians. To ensure that the clinical laboratory sales teams approach the primary care physician with the highest possible efficiency and effectiveness inside their respective laboratory network, we are planning to conduct training for sales representatives, seminars for physicians and joint marketing campaigns to expand our product awareness. We will also look into partnering with third parties or outsourcing parts of the sales organization that directly visit with physicians.

Entry into the U.S. Market

We plan to employ a product and marketing strategy in the United States that is substantially similar to what we use in Europe. Prior to employing these strategies, we will seek to sell the ColoAlert test as a test kit to clinical laboratories that are certified by the Secretary of the Department of Health and Human Services under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA labs”) requiring FDA market authorization. This might be a comparably fast entry option, as the top five laboratory chains in the United States had revenues of nearly USD 38 billion in 2020.35 Alternatively or in addition , we could offer ColoAlert, or as a laboratory developed test offered by the Mainz BioMed clinical laboratory governed under US Centers for Medicare and Medicaid Services (“CMS”). We plan to explore the required clinical and regulatory path to submit ColoAlert to the FDA to achieve a CRC screening claim for asymptomatic patients who are at average risk for CRC, aged 45 to 80.

We expect to conduct extensive clinical trials considering the desired CRC screening claims. The duration of the study will be defined by the required number of patients to be enrolled. Cologuard, the main competitor in the United States, has performed multiple large studies which took several years to execute followed by a PMA submission. In addition, we will evaluate achieving claims for early identification of cancerous polyps and advanced adenomas.

During this market preparation period market conditions may change, existing competitors may improve their products or new competitors may become commercially active which may force us to adjust our future commercial strategy if the FDA eventually authorizes the product. We may consider manufacturing our ColoAlert test kits as private label products to be sold to labs. In this case, we likely would not undertake any marketing efforts in the United States to promote it to physicians and patients but expect our business partner to take on this obligation.

Research and Development

Our research and development strategy is centered on developing our product candidates PancAlert, a proposed stool-based screening test for pancreatic cancer, and GenoStrip, a proposed platform technology to detect pathogens. Both of these product candidates are in the early stages of development and might never become products. Our research and development team is located at our facilities in Mainz, Germany, and consists of 6 employees and independent contractors as of June 30, 2021. We currently do not have any patents or any pending patent applications protecting our intellectual property, but if our research and development efforts are successful for ColoAlert, PancAlert or GenoStrip, we intend to file patent applications to protect the intellectual property derived from such research and development.

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35              marketwatch.com report: Clinical Laboratory Services Market 2020 Global Analysis, Opportunities And Forecast To 2025. LabCorp ($11.5B), Sanofi Genzyme ($8.1B), Quest Diagnostics ($7.75B), Abbott Laboratories ($7.7B) and Charles River ($2.6B)

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We have received government grants as part of our research and development programs, including approximately $200,000 in our fiscal year ended December 31, 2020 and $170,000 in our fiscal year ended December 31, 2019. Since January 1, 2021, we have received additional funding in the aggregate amount of approximately $100,000.

Government Regulation

In-vitro diagnostic devices are regulated by the governments in the areas where such products are sold. Consequently, there is no uniform set of regulations governing our products and product candidates. We summarize below, the material governmental regulations in Europe, our principal market, and the United States, the next market that we seek to enter.

Europe

Currently in Europe, medical devices such as ColoAlert are regulated by the IVD-D requiring CE-Mark through self-certification. Under this system, developers and manufacturers must operate a Quality System and validate medical devices in a limited clinical trial to demonstrate the manufacturer has met analytical and clinical performance criteria. We have implemented an International Organization for Standardization standard — ISO 13485 — quality management system for the design and manufacture of medical devices. ISO 13485 addresses managerial awareness of regulatory requirements, control systems, inspection and traceability, device design, risk and performance criteria as well as verification for corrective and preventative measures for device failure. Medical device companies such as ours are subject to pre-market compliance assessments from Notified Bodies, a certification organization which the national authority (the competent authority) of a European Union member state designates to carry out one or more of the conformity assessment procedures. ISO 13485 certification establishes conformity to specific European Union directives related to medical devices and allows CE Marking and sale of the device.

The new European In Vitro Diagnostic Regulation (EU 2017/746), or the IVD-R, became effective as of May 25, 2017, marking the start of a transition period for manufacturers selling IVD devices into Europe. The IVD-R, which replaces IVD Directive (98/79/EC), or the IVD-D, has a transition period of five years, after which the IVD-R will apply in full, and no new applications pursuant to the IVD-D will be accepted. Manufacturers have the duration of the five-year transition period to update their technical documentation and processes to meet the new, more stringent EU regulatory requirements. We believe that the most challenging areas under the IVD-R will be regarding the classification of products, which will bring almost all IVDs under the direct control of Notified Bodies, and the performance evaluation of IVDs, which will not only include the classic clinical performance and analytical performance but also scientific validity, the role and responsibilities of the economic actors of the supply chain, the traceability and the transparency of the devices with, in particular, the introduction of the UDI-system and an expanded EUDAMED database.

Notified Bodies can begin auditing to the IVD-R once they have been designated as a Notified Body under the IVD-R by their Competent Authority. For now, we expect the first Notified Bodies to be notified according the IVD-R by the end of 2019, and as of this filing TÜV SÜD has been designated as a Notified Body under the IVDR. In practice, it will not be possible to CE mark a product according to the IVDR beforehand. For Class C devices (such as ColoAlert), the conformity assessment procedure will be a combination of the Quality Management System audits and Technical Documentation assessments. The assumed assessment time needed for a Technical Documentation assessment of a Class C device currently is expected to last from about nine months. We have already begun discussions with the TÜV SÜD in order to ensure compliance with the IVD-R as soon as possible.

We believe that we have structured our business operations to comply with applicable legal requirements. However, it is possible that governmental entities or other third parties could interpret these laws differently and assert otherwise, which could have a material adverse impact on our business.

United States

U.S. Food and Drug Administration

Obtaining FDA market authorization for our ColoAlert test is critical to our strategy. We intend to shortly start the process of seeking a premarket approval (PMA) for our ColoAlert test.

Under the FDA’s regulatory framework, in vitro diagnostic devices (IVDs), including tests that can be used in the diagnosis or detection of cancer such as ColoAlert, are a type of medical device. The FDA categorizes medical devices

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into one of three classes — class I, II, or III — based on the risks presented by the device and the regulatory controls necessary to provide a reasonable assurance of the device’s safety and effectiveness. Devices deemed by FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a PMA. We believe that ColoAlert would be a Class III IVD, as this is consistent with the prior FDA approval of similar devices, such as Cologuard. Some pre-amendment devices are unclassified, but are subject to FDA’s premarket notification and clearance process in order to be commercially distributed.

Class III devices generally require PMA approval before they can be marketed. Obtaining PMA approval requires the submission of “valid scientific evidence” to FDA to support a finding of a reasonable assurance of the safety and effectiveness of the device. A PMA must provide complete analytical and clinical performance data and also information about the device and its components regarding, among other things, device design, manufacturing, and labeling. Following receipt of a PMA, FDA determines whether the application is sufficiently complete to permit a substantive review. If FDA accepts the application for review, it has 180 days under the FDC Act to complete its review of a PMA, although in practice, FDA’s review often takes significantly longer, and can take up to several years. An advisory panel of experts from outside FDA may be convened to review and evaluate the application and provide recommendations to FDA as to the approvability of the device. FDA may or may not accept the panel’s recommendation. As part of FDA’s review of a PMA, FDA will typically inspect the manufacturer’s facilities for compliance with Quality System Regulation (QSR) requirements, which impose requirements related to design controls, manufacturing controls, documentation, and other quality assurance procedures.

FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s). FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or requirements to conduct additional clinical studies post-approval. FDA may condition PMA approval on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use. In such cases, the manufacturer might be required to follow certain patient groups for a number of years and to make periodic reports to FDA on the clinical status of those patients. Failure to comply with the conditions of approval can result in material adverse enforcement action, including withdrawal of the approval.

Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications, which affect the safety or effectiveness of the device, require submission of a PMA supplement. PMA supplements often require submission of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel. Certain other changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness.

The studies required in connection with our seeking FDA approval of our technologies will be costly and time-intensive. FDA might not ultimately approve any PMA submitted by us in a timely manner or at all.

Clinical Trials

Clinical trials are usually required to support a premarket approval application. If the device presents a “significant risk,” as defined by the FDA, to human health, the FDA requires the device sponsor to file an IDE application with the FDA and obtain IDE approval prior to commencing the human clinical trials. The investigational device exemption application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The investigational device exemption application must be approved in advance by the FDA for a specified number of patients, unless the product is deemed a “non-significant risk” device and eligible for more abbreviated investigational device exemption requirements. Clinical trials for a significant risk device may begin once the investigational device exemption application is approved by the

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FDA and the appropriate institutional review boards at the clinical trial sites. Our clinical trials must be conducted in accordance with FDA regulations and federal and state regulations concerning human subject protection, including informed consent and healthcare privacy. A clinical trial may be suspended by the FDA or the investigational review board at any time for various reasons, including a belief that the risks to the study participants outweigh the benefits of participation in the study. Even if a study is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device, or may be equivocal or otherwise not be sufficient to obtain approval of our product.

Laboratory Certification, Accreditation and Licensing

If we operate clinical laboratories in the United States, we will also be subject to U.S. and state laws and regulations regarding the operation of clinical laboratories. Federal Clinical Laboratory Improvement Amendments (CLIA) requirements and laws of certain other states impose certification requirements for clinical laboratories, and establish standards for quality assurance and quality control, among other things. Clinical laboratories are subject to inspection by regulators, and to sanctions for failing to comply with applicable requirements. Sanctions available under CLIA include prohibiting a laboratory from running tests, requiring a laboratory to implement a corrective plan, and imposing civil monetary penalties. If we fail to meet any applicable requirements of CLIA or state law, that failure could adversely affect any future CMS consideration of our technologies, prevent their approval entirely, and/or interrupt the commercial sale of any products and otherwise cause us to incur significant expense.

HIPAA and Other Privacy Laws

The Health Insurance Portability and Accountability Act of 1996, or HIPAA, established for the first time comprehensive protection for the privacy and security of health information. The HIPAA standards apply to three types of organizations, or “Covered Entities”: health plans, healthcare clearinghouses, and healthcare providers that conduct certain healthcare transactions electronically. Covered Entities and their business associates must have in place administrative, physical, and technical standards to guard against the misuse of individually identifiable health information. If we are able to commercialize our ColoAlert test, we might perform activities that may implicate HIPAA, such as providing clinical laboratory testing services or entering into specific kinds of relationships with a Covered Entity or a business associate of a Covered Entity.

Federal and State Billing and Fraud and Abuse Laws

Antifraud Laws/Overpayments.    If our ColoAlert test is successfully accepted by federal and state healthcare programs, we will be subject to numerous federal and state antifraud and abuse laws. Many of these antifraud laws are broad in scope, and neither the courts nor government agencies have extensively interpreted these laws. Prohibitions under some of these laws include:

•        the submission of false claims or false information to government programs;

•        deceptive or fraudulent conduct;

•        excessive or unnecessary services or services at excessive prices; and

•        prohibitions in defrauding private sector health insurers.

We could be subject to substantial penalties for violations of these laws, including denial of payment and refunds, suspension of payments from Medicare, Medicaid or other federal healthcare programs and exclusion from participation in the federal healthcare programs, as well as civil monetary and criminal penalties and imprisonment. Numerous federal and state agencies enforce the antifraud and abuse laws. In addition, private insurers may also bring private actions. In some circumstances, private whistleblowers are authorized to bring fraud suits on behalf of the government against providers and are entitled to receive a portion of any final recovery.

Federal and State “Self-Referral” and “Anti-kickback” Restrictions

If we or our operations are found to be in violation of applicable laws and regulations prohibiting improper referrals for healthcare services or products, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in U.S. federal or state health care programs, and the curtailment or restructuring of our operations.

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Anti-Kickback Statute.    The federal Anti-Kickback Statute prohibits persons from knowingly and wilfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be made under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” is not defined in the federal Anti-Kickback Statute and has been broadly interpreted to include anything of value, including for example, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payment, ownership interests and providing anything at less than its fair market value. Sanctions for violations of the federal Anti-Kickback Statute may include imprisonment and other criminal penalties, civil monetary penalties and exclusion from participation in federal healthcare programs. Many states have also adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaid programs, and do not contain identical safe harbors.

Self-Referral law.    The federal “self-referral” law, commonly referred to as the “Stark” law, provides that physicians who, personally or through a family member, have ownership interests in or compensation arrangements with a laboratory are prohibited from making a referral to that laboratory for laboratory tests reimbursable by Medicare, and also prohibits laboratories from submitting a claim for Medicare payments for laboratory tests referred by physicians who, personally or through a family member, have ownership interests in or compensation arrangements with the testing laboratory. The Stark law contains a number of specific exceptions which, if met, permit physicians who have ownership or compensation arrangements with a testing laboratory to make referrals to that laboratory and permit the laboratory to submit claims for Medicare payments for laboratory tests performed pursuant to such referrals. We are subject to comparable state laws, some of which apply to all payors regardless of source of payment, and do not contain identical exceptions to the Stark law.

Any action against us for violation of these or similar foreign laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.

Sunshine Act

In 2010, Congress enacted a statute commonly known as the Sunshine Act, which aims to promote transparency. The Sunshine Act requires manufacturers of drugs, devices, biologicals and medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program, or CHIP, to report annually to CMS any payments or other transfers of value made to physicians and teaching hospitals, with limited exceptions. Manufacturers must also disclose to CMS any physician ownership or investment interests.

Competition

Our principal product, ColoAlert, competes with other methods of CRC screening, such as the colonoscopy or the FIT test. The current standard for CRC screening test is the colonoscopy, although we also compete with non-invasive CRC screening tests. In addition to these widespread, traditional screening tests, we also compete with companies that provide or are developing novel CRC screening tests.

Colonoscopy

The colonoscopy was established over 50 years ago and is used by countless physicians worldwide. The colonoscopy is an invasive procedure in which the inner wall of the intestine is examined by a physician using an endoscope. Preparation requires patients to undergo bowel cleansing at least the day prior to the procedure. Colonoscopy is a painful process and associated with risk of punctuating the colon. An experienced scopeist will perform the process with less pain and higher detection rate. The average detection rate of colonoscopy is approximately 95%.

The compliance rate for colonoscopy in Germany even after a consultation with a physician is a mere 16%.36 The occurrence of false-positive results is not possible due to the nature of the method. Usually, national screening programs suggest a screening interval of 10 years for this method. Because of the invasive procedure and the prior bowel cleansing, this method has a patient acceptance rate of less than 20%. The cost of colonoscopy can vary depending on the region. In Germany, average total costs amount to approximately €220, which corresponds to €22 annually.

____________

36              Riens B et al (2011) Versorgungsatlas / Krebsfrüherkennung

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Any developments that result in the reduction of the cost of colonoscopies, the accuracy of their results or the ease of use may not be transferable to IVD tests.

Occult blood tests

With Fecal Immunochemical Tests (“FITs”), a patient’s stool sample can be examined for hidden, or occult, blood in a laboratory which can be a symptom of CRC. Unfortunately, occult blood is often only present in the later stages of the disease. There is no need for patients to prepare prior to sample collection, which leads to a high patient acceptance. According to IKK Südwest, when coordinated by a centralized invitation to screening, participation rates can get as high as 73%.37 Since this method can only provide an indirect indication of CRC via fecal blood, the sensitivity normally hovers around 65% with a false-positive rate around 5% per an article published by the American Gastroenterological Association.38 Since this method depends on the presence of a blood signal and many tumors do not bleed in the early stages, many affected individuals are diagnosed in later stages of the disease which leads to lower than 5-year survival rates and higher treatment costs. This current state of international screening programs suggests a need for more sensitive non-invasive screening tools. The recommended screening interval for FITs is normally yearly. The average reimbursement for occult blood tests is €14 in Germany39 and $19.92 based on the Current Procedural Terminology (CPT) code 82274 in the United States.40

Entities Providing Screening Tests

We compete with other entities that offer other non-invasive screening tests. Most of our current and potential competitors in Europe and the United States have significantly greater financial, technical, manufacturing, marketing, and other resources than we have and consequently may have better and more competitive products, services, marketing or distribution. Most of our competitors have more extensive customer bases and broader customer and industry relationships than we do. In addition, many of these companies have longer operating histories and greater name recognition than we do. Our competitors may be in a stronger position to respond quickly to new technologies and may be able to design, develop, market and sell their products more effectively.

Entities producing or developing CRC screening tests with which we compete include:

•        Exact Sciences: The most established of the entities that we compete with is Exact Sciences, a publicly traded molecular diagnostic company focusing on the early detection of various cancers, which manufactures Cologuard and conducts the analysis of the tests. Cologuard is also a stool-based CRC screening test, and it achieves a sensitivity of 92% and a specificity of 87% per a study published in the New England Journal of Medicine.41 The average reimbursement is about $500,42 which is equivalent to approximately $166 annually when used in the recommended three-year screening interval. Exact Sciences is currently pursuing the goal of further expanding the market share it has gained in the United States, broadening its relationships with relevant health care provider and building a diversified product portfolio in the oncology screening space through targeted acquisitions. Our ColoAlert product uses three of the four biomarkers used in ColoGuard. We ask for a significantly smaller stool sample for ColoAlert.

•        Epigenomics AG, which focuses on the development of blood tests for cancer detection. The CRC test “Epi proColon”, one of its two approved products approved in the United States and the European Union, is a blood-based test that achieves a sensitivity of 68% with a specificity of 80%.43

____________

37              (IKK Südwest. IKK Südwest in Zahlen: https://www.ikk-suedwest.de/ueber-uns/daten-und-fakten/ikk-suedwest-in-zahlen/)

38              (Giess et al. Gastroenterology 154/2018)

39              (https://www.kbv.de/html/praevention_darmkrebsfrueherkennung.php)

40              https://www.upmc.com/-/media/upmc/healthcare-professionals/physicians/documents/lab-fee-schedule.pdf

41              (Imperiale et al (2014) N Engl J Med 2014; 370)

42             https://investor.exactsciences.com/investor-relations/press-releases/press-release-details/2015/Exact-Sciences-Additional-Update-on-CMS-Reimbursement-for-Cologuard/default.aspx or https://www.businesswire.com/news/home/
20151202005242/en/CMS
-Corrects-2016-Reimbursement-Rate-for-Cologuard%C2%AE#:~:text=(Nasdaq%3A%20EXAS)%20announced%20that,NLA)%20for%20Cologuard%20at%20%24493.21.

43              https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130001B.pdf

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•        Novigenix SA, a Swiss company specializing in the development of immuno-transcriptomics solutions. Novigenix’s LITOseek Platform is designed to provide information for early cancer detection, disease progression and therapy selection. For CRC screening, Novigenix has developed the Colox blood test, which is currently available on the Swiss market. It achieved a sensitivity of 78% and a specificity of 92% in a clinical study.44

•        Agena Biosciences Inc., a U.S. company active in the field of genetic diagnostics. The company’s core product is its proprietary MassArray platform. This offers laboratory customers the possibility to provide rapid and broad genetic analysis. From the large number of panels, the UltraSeek Colon Panel initially shows competitive potential. This is used for the investigation of disease progression and resistance of CRC. As this product is not suitable for CRC screening, it is not yet a direct competitor to ColoAlert, but could be relevant through a future product variation.

•        Schebo AG, a German company, has developed a Tumor M2-PK (Pyruvatekinase M2) based test, a biomarker that is only expressed in tumor tissue in adult humans. M2-PK can be detected in stool as well as in EDTA blood plasma and thus serves as an indicator of cancer. In a clinical study, in the regular combination with an occult blood test, it showed a high sensitivity of over 90%, while its specificity was below 70%.45

•        CellMaxLife, a liquid biopsy company focused on blood sample-based cancer screening. The company has no available products on the market yet, but is currently working on the development of the CRC screening test “FirstSight”, which screens patients’ blood sample for circulating gastrointestinal epithelial cells (CECs) and somatic mutations of cell-free tumor DNA (ctDNA).

•        GRAIL, Inc., which develops products based on next-generation sequencing (NGS) for the early detection of cancer. The blood-based screening test “Galleri” is the company’s current core product. According to the company, this test can detect over 50 types of cancer. The list price for screening with Galleri is $959. GRAIL recommends using Galleri only in combination with conventional screening methods.

•        Guardant Health, Inc., a California-based company that aims to improve early cancer detection based on liquid biopsy. The product “Guardant Reveal” is a blood test used to control residual disease and recurrence after CRC. Guardant Reveal was launched in the U.S. market in the start of 2021. Alongside the other products Guardant360, Guardant360 CDx and GuardantOMNI, Guardant Reveal contributes to the development of the LUNAR screening program, which will be used in the future for cancer screening of asymptomatic patients.

•        Thrive, a subsidiary of Exact Sciences Corp., is researching a holistic cancer screening based on a liquid biopsy. The test is currently under development and has not yet received marketing approval.

We might not be able to compete successfully in our market, particularly as we seek to enter the United States and commercialize ColoAlert. We expect that some of the screening tests currently being developed will be commercially available in the United States by the time we obtain FDA approval for ColoAlert, if at all. If our competitors introduce new diagnostic tests that compete with or surpass the accuracy, price or ease of use of our products, we may be unable to satisfy existing customers or attract new customers at the prices and levels that would allow us to generate attractive rates of return on our investment. Increased competition could result in price reductions and revenue shortfalls, loss of customers and loss of market share, which could harm our business, prospects, financial condition and operating results.

Customers

Our current customers are primarily laboratories in Germany, including some of the largest chains in Germany, that offer our ColoAlert test to physicians for use with their patients. No customer accounted for more than 10% of our revenues in our prior fiscal year. We are actively seeking to expand our customer base in Europe, and intend to do so in the United States depending upon the progress of an application with the FDA for approval of ColoAlert.

____________

44              https://novigenix.com/wp-content/uploads/2018/02/Tableau-comparatif-novigenix-colox-ENGLISH.pdf

45              Dollinger MM et al. (2018) ClinLab 64(10)

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Suppliers and Raw Material

We purchase most of our supplies “off-the-shelf” and at market rates and have normally second source suppliers available in case we experience supply issues with the primary supplier. We are planning to establish a safety stock from the primary suppliers to allow enough time for the necessary valuation to be performed if a secondary supplier is required.

Employees

As of September 30, 2021, the breakdown of employees by main category of activity is as follows:

Activity

 

Number of
Full-Time
Employees

 

Number of
Part-Time
Employees

Manufacturing and Clinical Laboratory

 

2

 

3

Research & Development

 

3

 

0

Sales & Marketing

 

1

 

1

General & Administration

 

2

 

6

Executives

 

4

 

0

Total:

 

12

 

10

None of our employees are covered by a collective bargaining agreement.

Property, Plant and Equipment

Our principal premises are located at Robert Koch Strasse 50, Mainz, Germany. In 2013, we entered into a fifteen year lease agreement for these premises with a monthly minimum rent of approximately €5,730 plus ancillary rental costs of approximately €1,250 per month. The leased premises is approximately 7,300 sq. ft. in size. We use these facilities for administrative purposes, research and development, manufacturing of our products and analysis by our laboratory s. We believe that these facilities will satisfy our manufacturing and research and development needs in the next 12 months.

Some members of our management work outside of these premises in office space that we do not rent.

Legal Proceedings

We are not involved in, or aware of, any legal or administrative proceedings contemplated or threatened by any governmental authority or any other party. As of the date of this prospectus, no director, officer or affiliate is a party adverse to us in any legal proceeding or has an adverse interest to us in any legal proceeding.

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KEY INFORMATION

The following tables summarize our financial data. We derived the summary financial statement data for the years ended December 31, 2020 and 2019 set forth below from the audited financial statements of PharmGenomics GmbH, which is considered for accounting purposes to be our predecessor entity, and from the unaudited financial statements of PharmGenomics GmbH for the three and six months ended June 30, 2021 and 2020 contained in this prospectus. Mainz Biomed B.V. was not formed as of December 31, 2020 and to date has had no operations. Our historical results are not necessarily indicative of the results that may be expected in the future. Our financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. You should read the information presented below together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” our financial statements, the notes to those statements and the other financial information contained in this prospectus and the unaudited consolidated pro forma information appearing elsewhere in this prospectus.

Summary of Operations in U.S. Dollars (audited)

 

Six Months Ended
June 30,

 

Years Ended
December 31,

   

2021

 

2020

 

2020

 

2019

Revenues

 

$

417,311

 

 

$

166,701

 

 

$

493,565

 

 

$

281,393

 

Cost of Revenues

 

 

240,954

 

 

 

152,285

 

 

 

370,480

 

 

 

342,664

 

GROSS PROFIT (LOSS)

 

 

176,357

 

 

 

14,416

 

 

 

123,085

 

 

 

(61,271

)

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and Development

 

 

160,531

 

 

 

144,330

 

 

 

311,851

 

 

 

250,316

 

Sales and Marketing

 

 

70,979

 

 

 

51,575

 

 

 

110,380

 

 

 

181,460

 

General and administrative

 

 

199,481

 

 

 

179,438

 

 

 

374,569

 

 

 

428,862

 

Operating loss

 

 

(254,634

)

 

 

(360,927

)

 

 

(673,715

)

 

 

(921,909

)

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OTHER INCOME/(EXPENSE)

 

 

(7,087

)

 

 

20,866

 

 

 

86,820

 

 

 

(35,146

)

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS

 

 

(261,721

)

 

 

(340,061

)

 

 

(586,895

)

 

 

(957,055

)

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign Currency Translation

 

 

82,963

 

 

 

(29,550

)

 

 

(224,656

)

 

 

22,166

 

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TOTAL COMPREHENSIVE LOSS

 

$

(178,758

)

 

$

(369,611

)

 

$

(811,551

)

 

$

(934,889

)

Balance Sheet in U.S. Dollars (audited)

 

As of
June 30,
2021

 

As of
December 31,
2020

Cash

 

$

195,165

 

 

$

122,568

 

Total Current Assets

 

 

281,607

 

 

 

186,398

 

Total Assets

 

 

734,472

 

 

 

673,270

 

   

 

 

 

 

 

 

 

Total Current Liabilities

 

 

672,051

 

 

 

701,954

 

   

 

 

 

 

 

 

 

Long Term Debt

 

 

2,058,839

 

 

 

2,265,431

 

   

 

 

 

 

 

 

 

Total Liabilities

 

 

3,146,548

 

 

 

3,414,825

 

   

 

 

 

 

 

 

 

Working Capital (Deficit)

 

 

(390,444

)

 

 

(515,556

)

   

 

 

 

 

 

 

 

Total Stockholders’ Equity (Deficit)

 

 

(2,412,076

)

 

 

(2,741,555

)

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes to those statements included elsewhere in this prospectus. This discussion and analysis and other parts of this prospectus contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives, expectations, forecasts and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under the section titled “Risk Factors” and elsewhere in this prospectus. You should carefully read the “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”

Organization and Overview of Operations

On August 3, 2021, Mainz Biomed B.V (“Mainz”) entered into a contribution agreement (the “Contribution Agreement”) with PharmGenomics GmbH. Mainz is a private company with limited liability under Dutch law incorporated for the purpose of acquiring PharmGenomics GmbH. We will not complete this offering unless we have converted into a public company under Dutch law. Under the Contribution Agreement, 100% of the shares of the PharmGenomics GmbH were acquired in exchange for 6,000,000 shares of Mainz. Upon the closing of the Contribution Agreement on September 20, 2021, PharmGenomics GmbH became a wholly owned subsidiary of Mainz, and the former shareholders of the PharmGenomics GmbH hold approximately 62% of the outstanding shares of Mainz.

Pursuant to the accounting guidance provided by IFRS 10 and IFRS 3.7 and B13, we have determined that for accounting purposes the merger of Mainz BioMed B.V. and PharmGenomics GmbH should be treated as a reverse acquisition by PharmGenomics GmbH, with PharmGenomics being the accounting acquirer, and Mainz BioMed B.V. as the acquired company. As such, the assets and liabilities of PharmGenomics have been presented at their historical carrying values. The information below includes financial data and discussion derived from the audited financial statements of PharmGenomics GmbH. Mainz Biomed B.V. was not formed as of December 31, 2020 and to date has had no operations.

We develop in-vitro diagnostic and research use only tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine. We additionally operate a clinical diagnostic laboratory. We develop and distribute our IVD Kits to third party laboratories for their own diagnostic purposes. The majority of our revenues comes from the sale of our IVD Kits.

In addition, we conduct research and development in order to increase and diversify our product portfolio. Currently, we are managing two government funded research and development projects, which provide us non-refundable grant income that cover a percentage of the individual project related costs.

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Results of Operations

Comparison of the Six Months Ended June 30, 2021 and 2020

The following table provides certain selected financial information for the periods presented:

 

Six Months Ended
June 30,

       
   

2021

 

2020

 

Change

 

% Change

Revenue

 

$

417,311

 

 

$

166,701

 

 

$

250,610

 

 

150

%

Cost of revenue

 

$

240,954

 

 

$

152,285

 

 

$

88,669

 

 

58

%

Gross profit

 

$

176,357

 

 

$

14,416

 

 

$

161,941

 

 

1123

%

Gross profit percentage

 

 

42

%

 

 

9

%

 

 

 

 

   

 

Research and Development

 

$

160,531

 

 

$

144,330

 

 

$

16,201

 

 

11

%

Sales and Marketing

 

$

70,979

 

 

$

51,575

 

 

$

19,404

 

 

38

%

General and Administrative

 

$

199,481

 

 

$

179,438

 

 

$

20,043

 

 

11

%

Total operating expenses

 

$

430,991

 

 

$

375,343

 

 

$

55,648

 

 

15

%

Loss from operations

 

$

254,634

 

 

$

360,927

 

 

$

(106,293

)

 

(29

)%

Other income (expense)

 

$

(7,087

)

 

$

20,866

 

 

$

(27,953

)

 

(134

)%

Net loss

 

$

261,721

 

 

$

340,061

 

 

$

(78,340

)

 

(23

)%

Total Comprehensive Loss

 

$

178,758

 

 

$

369,611

 

 

$

(190,853

)

 

(52

)%

Basic and dilutive loss per common share

 

$

2.51

 

 

$

3.67

 

 

$

(1.16

)

 

(32

)%

Weighted average number of common shares outstanding – basic and diluted

 

 

104,869

 

 

 

92,584

 

 

 

 

 

   

 

Revenue

Revenue for the six months ended June 30, 2021 was $417,311 as compared to $166,701 for the six months ended June 30, 2020, an increase of $250,610. This increase was the result of a 100% increase in the sale of ColoAlert Lab-kits and an increase of approximately $245,000 from statutory healthcare system reimbursements related to third-party laboratory testing and lab support, mitigated by a decrease of approximated $46,000 from sales of legacy research use only products and other revenue. Our third-party laboratory testing and related statutory healthcare system reimbursements was related to our support of COVID-19 diagnostic testing during the pandemic, which may or may not continue in the future. We expect our research use only and other legacy products will decrease over time as we focus our marketing and sales efforts on our ColoAlert product.

Our revenue by product and service category is as follows:

 

Six Months Ended
June 30,

   

2021

 

2020

ColoAlert

 

$

104,851

 

$

52,427

Third-party lab testing and support

 

 

261,019

 

 

16,365

Research use only product sales

 

 

37,812

 

 

59,297

Other revenue

 

 

13,630

 

 

38,613

Total Revenue

 

$

417,311

 

$

166,701

Cost of Revenue

Cost of Revenue for the six months ended June 30, 2021 was $240,954 as compared to $152,285 for the six months ended June 30, 2020, a 58% increase. This increase was the result increased revenue and was primarily driven by a $27,978 increase in salary and benefits costs and an increase of $39,793 in royalty payments, resulting from increased sales in the 2021 period.

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Gross profit

Gross profit increased to $176,357 from $14,416, for the six months ended June 30, 2021, as compared to the six months ended June 30, 2020. This gross profit increase was due to increased revenue from our ColoAlert product and statutory healthcare system reimbursements related to third-party laboratory testing and lab support, which have higher gross margins.

Research and Development Expenses

Research and development expenses for the six months ended June 30, 2021 were $160,531 compared to $144,330 for the six months ended June 30, 2020, an increase of $16,201. This increase was driven by an increase of approximately $15,000 in salary related expenses resulting from increased headcount in research and development to support our PancAlert and GenoStrip product candidates.

Sales and Marketing Expenses

Sales and marketing expenses for the six months ended June 30, 2021, were $70,979 compared to $51,575 for the six months ended June 30, 2020, an increase of $19,369. This increase was primarily the result of an approximately $14,000 increase in advertising expenses to support the sale of our ColoAlert product.

General and Administrative Expenses

General and administrative expenses for the six months ended June 30, 2021 were $199,481 compared to $179,438 for the six months ended June 30, 2020, an increase of $20,043. The increased expenses were primarily the result of increased salary related expenses of approximately $18,000, to support our increased volume of business.

Other income (expense)

Other income (expense) for the six months ended June 30, 2021 was $(7,0874) compared to $20,866 for the six months ended June 30, 2020, resulting in increased other expenses (net) of $27,953. The increased expenses were primarily the result of increased accretion expense of $61,315, mitigated by an increase of $47,476 from government R&D grant income.

Liquidity and Capital Resources

Our principal liquidity requirements are for working capital and operating losses. We fund our liquidity requirements primarily through cash on hand, cash flows from operations, and debt financing, including officers, shareholders. As of June 30, 2021, we had $195,165 of cash and cash equivalents, with $122,568 as of December 31, 2020.

The following table summarizes our cash flows from operating, investing and financing activities:

 

Six Months Ended
June 30,

   
   

2021

 

2020

 

Change

Cash used in operating activities

 

$

(132,530

)

 

$

(187,746

)

 

$

55,216

Cash used in investing activities

 

$

(4,580

)

 

$

(5,251

)

 

$

671

Cash provided by financing activities

 

$

217,029

 

 

$

48,448

 

 

$

168,581

Cash Flow from Operating Activities

For the six months ended June 30, 2021, net cash flows used in operating activities was $132,530 compared to $187,746 used during the year ended six months ended June 30, 2020. The improvement in operating cash flows is primarily due improved gross profits in 2021, net of timing differences for the settlement of assets and liabilities.

Cash Flows from Investing Activities

During the six months ended June 30, 2021, we used $4,580 in investing activities compared to $5,251 used during the year ended six months ended June 30, 2020. Cash used for investing activities in both periods was for the purchase of fixed assets.

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Cash Flows from Financing Activities

During the six months ended June 30, 2021, we had cash flow provided by financing activities of $217,029 compared to cash flow provided by financing activities of $48,448 for the six months ended June 30, 2020, an increase of $168,581. This increase was primarily the result of decreased new borrowings. Our financing activities are primarily debt financing, including silent partnerships and convertible debt from officers and shareholders.

Comparison of the Year Ended December 31, 2020 and 2019

The following table provides certain selected financial information for the periods presented:

 

Year Ended
December 31,

       
   

2020

 

2019

 

Change

 

% Change

Revenue

 

$

493,565

 

 

$

281,393

 

 

$

212,172

 

 

75

%

Cost of revenue

 

$

370,480

 

 

$

342,664

 

 

$

27,816

 

 

8

%

Gross profit

 

$

123,085

 

 

$

(61,271

)

 

$

184,356

 

 

NM

 

Gross profit percentage

 

 

25

%

 

 

(22

)%

 

 

 

 

   

 

Research and Development

 

$

311,851

 

 

$

250,316

 

 

$

61,535

 

 

25

%

Sales and Marketing

 

$

110,380

 

 

$

181,460

 

 

$

(71,080

)

 

(39

)%

General and Administrative

 

$

374,569

 

 

$

428,862

 

 

$

(54,293

)

 

(13

)%

Total operating expenses

 

$

796,800

 

 

$

860,638

 

 

$

(63,838

)

 

(7

)%

Loss from operations

 

$

673,715

 

 

$

921,909

 

 

$

(248,194

)

 

(26

)%

Other income (expense)

 

$

86,820

 

 

$

(35,146

)

 

$

121,966

 

 

NM

 

Net loss

 

$

586,985

 

 

$

957,055

 

 

$

(370,070

)

 

(39

)%

Total Comprehensive Loss

 

$

811,551

 

 

$

934,889

 

 

$

(123,338

)

 

(13

)%

Basic and dilutive loss per common share

 

$

6.34

 

 

$

10.34

 

 

$

(4.00

)

 

(39

)%

Weighted average number of common shares outstanding – basic and diluted

 

 

92,584

 

 

 

92,584

 

 

 

 

 

   

 

Revenue

Revenue for the year ended December 31, 2020 was $493,565 as compared to $281,393 for the year ended December 31, 2019, an increase of $212,172. This increase was the result of statutory healthcare system reimbursements related to third party laboratory testing and lab support conducted during 2020, which increased by approximately $111,000, and increased sales volume of ColoAlert Lab-kits, which increased by approximately $30,000, and sales of legacy research use only products which increased by approximately $52,000 in 2020, when compared to 2019.

Our revenue by product and service category is as follows:

 

Year Ended December 31,

   

2020

 

2019

ColoAlert

 

$

167,074

 

$

136,678

Third party lab testing and support

 

 

176,692

 

 

65,987

Research use only product sales

 

 

93,894

 

 

42,084

Other revenue

 

 

55,905

 

 

36,563

Total Revenue

 

$

493,565

 

$

281,313

Cost of Revenue

Cost of Revenue for the year ended December 31, 2020 was $370,480 as compared to $342,684 for the year ended December 31, 2019, an 8% increase. This increase was the result an increase in raw material costs and in tandem with our increase in revenue, off-set in part from license fee payment of approximately $112,000, which was an increase from 2019 to 2020 of $66,000. This decrease is the result of a license payment made in 2019 to record, and pay, an amount we agreed to with ColoAlert AS for 2019 and periods prior to 2019.

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Gross profit

Gross profit increased to $123,085 from $(61,271), for the year ended December 31, 2020, as compared to the year ended December 31, 2019. This increase was due to increased testing volume during 2020, which has higher margin profile, and the one-time license fee for our ColoAlert product in 2019, which decreased our 2019 gross profit. Absent the one-time license fee payment in 2019, gross profit in 2019 would have been positive.

Research and Development Expenses

Research and development expenses for the year ended December 31, 2020, were $311,851 compared to $250,316 for the year ended December 31, 2019, an increase of $61,535. This increase was driven by an increase of approximately $46,000 in salary related expenses resulting from increased headcount in research and development to support our PancAlert and GenoStrip product candidates.

Sales and Marketing Expenses

Sales and marketing expenses for the year ended December 31, 2020, were $110,380 compared to $181,460 for the year ended December 31, 2019, a decrease of $71,080. This decrease was the result of an approximately $47,000 decrease in salary related expenses due our decreased headcount in our sales group. Additionally, we had decreased advertising and office expenses.

General and Administrative Expenses

General and administrative expenses for the year ended December 31, 2020 were $374,569 compared to $428,862 for the year ended December 31, 2019, a decrease of $54,293. From 2019 to 2020 salary costs increased by approximately $45,000 while consulting expenses decreased by approximately $66,000, for a net decrease of $21,000, resulting from the Company’s focus on the use of internal resources. The remainder of the decrease in operating expenses in 2020 was primarily due to a decrease in professional fees, bad debt expense and travel expenses, driven by continued focus on cost savings efforts.

Other income (expense)

Other income (expense) for the year ended December 31, 2020 was $86,820 compared to $(35,146) for the year ended December 31, 2019. This increase was related to government sponsored research and development grants related to PancAlert and GenoStrip and the benefit recorded due to a below market financing benefit related to a government loan.

Liquidity and Capital Resources

Our principal liquidity requirements are for working capital and capital expenditures. We fund our liquidity requirements primarily through cash on hand, cash flows from operations, and debt financing, including officers, shareholders. As of December 31, 2020 we had $122,568 of cash and cash equivalents, with $203,588 as of December 31, 2019.

The following table summarizes our cash flows from operating, investing and financing activities:

 

Year Ended
December 31,

   
   

2020

 

2019

 

Change

Cash used in operating activities

 

$

(468,737

)

 

$

(416,495

)

 

$

(52,242

)

Cash used in investing activities

 

$

(9,685

)

 

$

 

 

$

(9,685

)

Cash provided by financing activities

 

$

396,681

 

 

$

423,996

 

 

$

27,316

 

Cash Flow from Operating Activities

For the year ended December 31, 2020, net cash flows used in operating activities was $468,737 compared to $416,495 used during the year ended December 31, 2019, respectively, primarily due to net loss and timing of settlement of assets and liabilities.

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Cash Flows from Investing Activities

During the year ended December 31, 2020, we used $9,685 in investing activities for the purchase of fixed assets. During the year ended December 31, 2019, we did not have any investing activities.

Cash Flows from Financing Activities

During the year ended December 31, 2020 we had cash flow provided by financing activities of $396,680 compared to cash flow provided by financing activities of $423,996 in 2019, a decrease of $27,316. This decrease was primarily the result of decreased new borrowings. Our financing activities are primarily debt financing, including silent partnerships and convertible debt from officers and shareholders.

Critical Accounting Policies and Significant Judgments and Estimates

This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in the notes to our financial statements included elsewhere in this prospectus, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

We believe our most critical accounting policies and estimates relate to the following:

•        Revenue Recognition

•        Foreign Currency Translation

•        Lease Accounting

•        Financial Instruments

Revenue Recognition

Our revenue is primarily derived through providing genetic diagnostic tests to customers. We recognize revenue in accordance with International Financial Reporting Standards (“IFRS”) 15 “Revenue from Contracts with Customers”.

In accordance with IFRS 15, revenue is recognized upon the satisfaction of performance obligations. Performance obligations are satisfied at the point at which control of the promised goods or services are transferred to customers, in an amount that reflects the consideration we expect to be entitled to receive for those goods and services.

We provide a genetic diagnostic testing service and testing kits which are not considered separately identifiable from each other as we use the testing kits to collect samples in order to deliver the diagnostic test results to the customer. Accordingly, we have one performance obligation which is fulfilled upon the delivery of the test results to the customer and revenue is recognized at that point in time.

We also receive income from government sponsored R&D grants. Income is recognized on these programs when funds are received and all performance obligations, as defined in the grant, are completed. This income is included in the Statements of Comprehensive Loss as Other Income.

Foreign Currency Translation

The functional currency is determined using the currency of the primary economic environment in which that entity operates. The functional, as determined by our management, is the European dollar (EUR).

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Foreign currency transactions are translated into functional currency using the exchange rates prevailing at the date of the transaction. Foreign currency monetary items are translated at the period-end exchange rate. Non-monetary items measured at historical cost continue to be carried at the exchange rate at the date of the transaction. Non-monetary items measured at fair value are reported at the exchange rate at the date when fair values were determined.

Exchange differences arising on the translation of monetary items or on settlement of monetary items are recognized in the statement of comprehensive loss in the period in which they arise, except where deferred in equity as a qualifying cash flow or net investment hedge.

Exchange differences arising on the translation of non-monetary items are recognized in other comprehensive income to the extent that gains and losses arising on those non-monetary items are also recognized in other comprehensive income. Where the non-monetary gain or loss is recognized in profit or loss, the exchange component is also recognized in profit or loss.

Our presentation currency is the US dollar. For presentation purposes, all amounts are translated from the Euro functional currency to the US dollar presentation currency for each period using the exchange rate at the end of each reporting period for the statement of financial position. Revenues and expenses are translated on the basis of average exchange rates during the year.

Exchange gains and losses arising from translation to our presentation currency are recorded as exchange differences on translation to reporting currency, which is included in other comprehensive income (loss).

Lease Accounting

We assess at contract inception whether a contract is, or contains, a lease. That is, if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. We apply a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets. We recognize lease liabilities to make lease payments and right-of-use assets representing the right to use the underlying assets.

At the commencement date of the lease, we recognize lease liabilities measured at the present value of lease payments to be made over the lease term. Lease payments include fixed payments (including in-substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. Lease payments also include the exercise price of a purchase option reasonably certain to be exercised by us and payments of penalties for terminating the lease, if the lease term reflects us exercising the option to terminate. Variable lease payments that do not depend on an index or a rate are recognized as expenses in the period in which the event or condition that triggers the payment occurs. In calculating the present value of lease payments, we use our incremental borrowing rate at the lease commencement date because the interest rate implicit in the lease is not readily determinable. After the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the lease payments (e.g., changes to future payments resulting from a change in an index or rate used to determine such lease payments) or a change in the assessment of an option to purchase the underlying asset.

We recognize right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Right-of-use assets are depreciated on a straight-line basis over the shorter of the lease term and the estimated useful lives of the assets.

Financial Instruments

(a)     Classification

The Company classifies its financial instruments in the following categories: at fair value through profit and loss (“FVTPL”), at fair value through other comprehensive income (loss) (“FVTOCI”) or at amortized cost. The Company determines the classification of financial assets at initial recognition. The classification of debt instruments is driven by the Company’s business model for managing the financial assets and their contractual cash flow characteristics. Equity instruments that are held for trading are classified as FVTPL.

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For other equity instruments, on the day of acquisition the Company can make an irrevocable election (on an instrument-by-instrument basis) to designate them as at FVTOCI. Financial liabilities are measured at amortized cost, unless they are required to be measured at FVTPL (such as instruments held for trading or derivatives) or if the Company has opted to measure them at FVTPL.

(b)    Measurement

Financial assets and liabilities at amortized cost

Financial assets and liabilities at amortized cost are initially recognized at fair value plus or minus transaction costs, respectively, and subsequently carried at amortized cost less any impairment.

Financial assets and liabilities at FVTPL

Financial assets and liabilities carried at FVTPL are initially recorded at fair value and transaction costs are expensed in the statements of loss and comprehensive loss. Realized and unrealized gains and losses arising from changes in the fair value of the financial assets and liabilities held at FVTPL are included in the statements of loss and comprehensive loss in the period in which they arise.

Debt investments at FVTOCI

These assets are subsequently measured at fair value. Interest income calculated using the effective interest method, foreign exchange gains and losses and impairment are recognized in profit or loss. Other net gains and losses are recognized in OCI. On derecognition, gains and losses accumulated in OCI are reclassified to profit or loss.

Equity investments at FVTOCI

These assets are subsequently measured at fair value. Dividends are recognized as income in profit or loss unless the dividend clearly represents a recovery of part of the cost of the investment. Other net gains and losses are recognized in OCI and are never reclassified to profit or loss.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditure or capital resources that is material to investors.

Disclosure of Contractual Arrangements

On December 31, 2020, the Company was committed to minimum lease payments as follows:

Contractual Obligation

 

Less than
One Year

 

1 – 3 Years

 

3 – 5 Years

 

Over 5 Years

Office Rent

 

$

84,312

 

$

168,625

 

$

168,626

 

$

238,886

Laboratory Equipment

 

$

3,417

 

$

6,833

 

$

569

 

$

Office Equipment

 

$

7,064

 

$

14,128

 

$

11,457

 

$

4,378

TOTAL

 

$

94,793

 

$

189,586

 

$

180,652

 

$

243,264

The amounts above are undiscounted and include the total amounts due, including the interest component.

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DIRECTORS AND EXECUTIVE OFFICERS

Board of Directors

We intend to have five directors at the time of the closing of the initial public offering, three of whom will satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act. Our directors are elected annually at each annual meeting of our company’s shareholders. Currently, our board of directors assesses potential director candidates for required skills, expertise, independence and other factors, but after the offering, we intend for out Nominating Committee to take responsibility for this action.

Our Board of Directors is responsible for appointing our company’s officers.

Board Committees

We intend to establish three committees under the board of directors immediately upon the closing of this offering: an Audit Committee, a Compensation Committee and a Nominating Committee. Each committee is to be governed by a charter approved by our Board of Directors.

Audit Committee

We intend to appoint to our Audit Committee three directors that will satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act. One of our directors on the Audit Committee will be an “audit committee financial expert” within the meaning of the SEC rules and possesses financial sophistication within the meaning of the Listing Rules of the Nasdaq Stock Market. The Audit Committee will oversee our accounting and financial reporting processes and the audits of the financial statements of our company. The Audit Committee will be responsible for, among other things:

•        selecting our independent registered public accounting firm and pre-approving all auditing and non-auditing services permitted to be performed by our independent registered public accounting firm;

•        reviewing with our independent registered public accounting firm any audit problems or difficulties and management’s response and approving all proposed related-party transactions, as defined in Item 404 of Regulation S-K;

•        discussing the annual audited financial statements with management and our independent registered public accounting firm;

•        annually reviewing and reassessing the adequacy of our Audit Committee charter;

•        meeting separately and periodically with the management and our independent registered public accounting firm;

•        reporting regularly to the full board of directors;

•        reviewing the adequacy and effectiveness of our accounting and internal control policies and procedures and any steps taken to monitor and control major financial risk exposure; and

•        such other matters that are specifically delegated to our Audit Committee by our board of directors from time to time.

Compensation Committee

We intend to appoint to our Compensation Committee three directors that will satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act. Our Compensation Committee will assist the board in reviewing and approving

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the compensation structure, including all forms of compensation, relating to our directors and executive officers. No officer may be present at any committee meeting during which such officer’s compensation is deliberated upon. The Compensation Committee will be responsible for, among other things:

•        reviewing and approving to the board with respect to the total compensation package for our most senior executive officers;

•        approving and overseeing the total compensation package for our executives other than the most senior executive officers;

•        reviewing and recommending to the board with respect to the compensation of our directors;

•        reviewing periodically and approving any long-term incentive compensation or equity plans;

•        selecting compensation consultants, legal counsel or other advisors after taking into consideration all factors relevant to that person’s independence from management; and

•        programs or similar arrangements, annual bonuses, employee pension and welfare benefit plans.

Nominating Committee

We intend to appoint to our Nominating Committee three directors that will satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act. The Nominating Committee is responsible for overseeing the selection of persons to be nominated to serve on our board of directors. The Nominating Committee considers persons identified by its members, management, shareholders, investment bankers and others.

Directors and Executive Officers 

The following table sets forth the names and ages of all of our directors and executive officers.

Name, Region/State and Country of Residence

 

Age

 

Position

 

Director/Officer Since

Guido Baechler
Berkeley, California

 

56

 

Chief Executive Officer, Director(1)

 

July 2021

William Caragol
Florida, USA

 

54

 

Chief Financial Officer

 

July 2021

Dr. Moritz Eidens
Ingelheim, Germany

 

38

 

Chief Science Officer, Director(2)

 

June 2008

Alberto Libanori
Los Angeles, California

 

32

 

Director(3)

   

Hans Hekland
Bergen, Norway

 

63

 

Director(3)

   

Philipp Freese
Grevenbroich, Germany

 

39

 

Chief Operating Officer(2)

 

February 2015

Nicole Holden
Virginia, USA

 

48

 

Director(3)

   

Marco Messina
Bremen, Germany

 

45

 

Director(4)

 

March 2021

____________

(1)      Mr. Baechler became our Chief Executive Officer in July 1, 2021. We intend for this person to become a director of our company prior to the closing of the initial public offering.

(2)      A current director of PharmGenomics. We intend for this person to become a director of our company prior to the closing of the initial public offering.

(3)      We intend for this person to become a director of our company prior to the closing of the initial public offering.

(4)      Mr. Messina is a current director of Mainz Biomed B.V. and intends to resign upon the closing of the initial public offering.

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Business Experience

The following summarizes the occupation and business experience during the past five years or more for our directors, and executive officers as of the date of this prospectus:

Guido Baechler, our Chief Executive Officer and a director, has global experience in private and public companies specializing in the life science and medical diagnostics fields. Mr. Baechler founded Berkeley Life Science Advisors, a diagnostic and life science start-up consulting business, in 2019. He was the Chief Executive Officer of SummerBio, a leading COVID testing CLIA laboratory in California, from July 2020 to February 2021 and Chief Executive Officer and Chief Operating Officer of Singulex, Inc. from November 2008 to June 2019.

Mr. Baechler previously held several leadership positions at Roche Molecular Systems, including serving as a member of its executive team. He held various leadership positions at Roche Diagnostics within Research, Development, and Marketing in Switzerland and California during his almost twenty years with the company.

Since 2020, Mr. Baechler has been a board member of SummerBio and Chip Diagnostics and the chairman of the board of Telo Genomics, a publicly traded Canadian biotech company.

Mr. Baechler holds a Bachelor’s Degree in Electrical Engineering and completed a series of executive finance and management classes at the London School of Business and at the Haas Business School at the University of California, Berkeley.

William Caragol, our Chief Financial Officer, has over thirty years of experience working with growth stage technology companies. In 2018, he founded and is the Managing Director of Quidem LLC, a corporate strategic and financial advisory firm. Since 2015, Mr. Caragol has been Chairman of the Board of Thermomedics, Inc., a privately held medical diagnostic equipment company. Since February 2021, Mr. Caragol is also on the Board of Directors and is Chairman of the Audit Committee of Greenbox POS (NASDAQ: GBOX) a financial technology company leveraging proprietary blockchain security to build customized payment solutions, and since July 2021 is on the Board of Directors of Worksport Ltd. (Nasdaq: WKSP), an emerging electric vehicle company. From 2012 to 2018, Mr. Caragol was Chairman and CEO of PositiveID, a holding company that was publicly traded that had a portfolio of products in the fields of bio detection systems and molecular diagnostics. Also, since April 2020, Mr. Caragol has served as a director and the Executive Vice President, Chief Operating and Chief Financial Officer of Hawaiian Springs LLC, a natural spring artesian bottled water company. Mr. Caragol earned a B.S. in business administration and accounting from Washington & Lee University and is a member of the American Institute of Certified Public Accountants.

Dr. Moritz Eidens, our Chief Science Officer and a director, received his Masters Degree at the international oriented University of Applied Sciences in Rheinbach near Bonn, Germany in 2006 with a focal point on human genetics and genetic diseases. In 2019, Mr. Eidens graduated from the University-Medicine Hospital of the Johannes Gutenberg University in Mainz, Germany, and was awarded with a Ph.D. from the medical faculty.

In 2008, Mr. Eidens founded PharmGenomics and has served since then as an executive of the organization. Mr. Eidens has been involved in PharmGenomics’ development and distribution of several innovative products, managed and coordinated several national and international grant projects with large industrial or academic partners process development, technology transfer, supply chain management as well as internal and external audits.

Philipp Freese, our Chief Operating Officer, received his Diploma in Business Administration with focus on marketing, business law and production technology at Excellence University RWTH in Aachen/Germany in 2008. Until 2015 he worked in project, product, process, quality and key account management as well as business development for the Cologne Institute for Economic Research. In 2014, he successfully finished his postgraduate studies in the IT-related management of companies.

Mr. Freese served as the Interim Head of Marketing at PharmGenomics from 2013 to 2015, and in 2015 he became its Commercial Managing Director responsible for marketing, sales, operations, legal affairs and Finance/IR. He was the major driver for ColoAlert’s product-market-fit, brand, processes and marketing strategies, established relationships with reference laboratories and assisted in our capital raises.

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Hans Hekland, a director, graduated Siviløkonom (MBA) from Norwegian School of Economics and Business Administration in Bergen, Norway in 1983. He has had several executive positions in international Banking and Industry until 2001 when he established Sarsia Innovation as the tech-transfer-office for University of Bergen. He has during his career developed Sarsia into a venture fund management company, established three venture funds and managed two IPOs. He holds board positions in several healthcare and biotech companies.

Hans Hekland is a certified business coach within the EIT Health program.

In 2013 he established ColoAlert AS together with Dr. Dagfinn Øgreid and Dr Roger Løvlie and engaged PharmGenomics to develop the ColoAlert test, which led to the current license agreement. Since 2017, he has been a business advisor to PharmGenomics GmbH.

Alberto Libanori, a director, is a Research Scientist at the University of California, Los Angeles (“UCLA”) and serves as Senior Advisor to Boustead Securities, LLC. Alberto has 10 years’ work experience at the science-business interface in venture capital, BD&L, M&A and IPOs, focusing in life-sciences, med-tech and cosmeceuticals, having worked with L’Oréal Research and Innovation, M-Ventures, and Novartis Venture Funds (NVF). Previously Alberto founded and helped with the strategic exits of a number of technology start-ups including Atelier Mnemist SAS and Cutech (acquired by Symrise). A prolific scientist, Alberto has published more than 20 peer-reviewed articles in journals including Advanced Materials, ACS Nano, Materials Today and Biosensors and Bioelectronics, and is the holder of two patents. Alberto Libanori holds an MS in Bioengineering from UCLA, with focus on wearable and implantable bioelectronics and biomaterials for regenerative medicine, an MPhil in Bioscience Enterprise from Cambridge University, and a Bachelor’s in Bimolecular Sciences (Hons) from St Andrews University. Raised internationally, Alberto is fluent in English, French, Spanish, Mandarin Chinese and Portuguese, alongside his native Italian.

Nicole Holden, CPA, a director, has more than 20 years of advisory experience including mergers and acquisitions, divestitures, initial public offerings and transaction support services for large publicly traded and privately held clients. Ms. Holden advises clients in matters involving SEC reporting, complex financial transactions, initial public offerings, acquisitions and divestiture accounting, restructuring, discontinued operations, and various technical accounting matters. Currently, Ms. Holden is the Audit Committee Chair for Nerds On Site, Inc. (CSE: NERD), a position she has held since 2018, shortly prior to its Initial Public Offering. Prior to joining our Board, Ms. Holden had a broad professional career. She was a Senior Director in the Advisory Service practice for Alliance. Ms. Holden was also an Assistant Controller for Enviva LP (NYSE: EVA). She was a Director in the Professional practice for the Center for Audit Quality (The CAQ). She also served as a Senior Manager in the Office of Research and Analysis and Assistant Chief Auditor in the Office of the Chief Auditor for the Public Company Accounting Oversight Board (PCAOB). Ms. Holden was involved in the rule-making process impacting auditor independence, audit firm rotation and identification of higher risk audits for closer consideration by the PCAOB Division of Inspections and the PCAOB Division of Enforcement. She was a Director in the Transaction Services practice at KPMG LLP. She also served as a Senior Manager in the Assurance practice at Stonefield Josephson, Inc. She was a Staff Accountant in the Corporate Finance division of the U.S. Securities and Exchange Commission (SEC). Her regulatory experience at the SEC and the PCAOB contributed to her deep understanding of current rules and regulations affecting public companies, audit firms, and Boards of Directors. She also worked on the Internal Audit team for Computer Sciences Corp (NYSE: DXC). She began her career first as an Assurance associate for Arthur Andersen, then as an Assurance associate for Ernst & Young, LLP. Ms. Holden is a licensed Certified Public Accountant in Washington, DC (Active). She received a Master of Accounting from the American University, Kogod School of Business.

Family Relationships

There are no family relationships among any of our directors and executive officers.

Arrangements

We are not aware of any arrangement among shareholders regarding the nomination or approval of directors or senior management.

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Term of Office

Each director is to serve until his successor is elected and qualified or until his death, resignation or removal. Our Board of Directors appoints our officers and each officer is to serve until his successor is appointed and qualified or until his or her death, resignation or removal.

Involvement in Certain Legal Proceedings

During the past ten years, none of our directors or executive officers have been the subject of the following events:

1.      a petition under the Federal bankruptcy laws or any state insolvency law was filed by or against, or a receiver, fiscal agent or similar officer was appointed by a court for the business or property of such person, or any partnership in which he was a general partner at or within two years before the time of such filing, or any corporation or business association of which he was an executive officer at or within two years before the time of such filing;

2.      convicted in a criminal proceeding or is a named subject of a pending criminal proceeding (excluding traffic violations and other minor offenses);

3.      the subject of any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining him from, or otherwise limiting, the following activities;

i)       acting as a futures commission merchant, introducing broker, commodity trading advisor, commodity pool operator, floor broker, leverage transaction merchant, any other person regulated by the Commodity Futures Trading Commission, or an associated person of any of the foregoing, or as an investment adviser, underwriter, broker or dealer in securities, or as an affiliated person, director or employee of any investment company, bank, savings and loan association or insurance company, or engaging in or continuing any conduct or practice in connection with such activity;

ii)      engaging in any type of business practice; or

iii)    engaging in any activity in connection with the purchase or sale of any security or commodity or in connection with any violation of Federal or State securities laws or Federal commodities laws;

4.      the subject of any order, judgment or decree, not subsequently reversed, suspended or vacated, of any Federal or State authority barring, suspending or otherwise limiting for more than 60 days the right of such person to engage in any activity described in paragraph 3.i in the preceding paragraph or to be associated with persons engaged in any such activity;

5.      was found by a court of competent jurisdiction in a civil action or by the SEC to have violated any Federal or State securities law, and the judgment in such civil action or finding by the SEC has not been subsequently reversed, suspended, or vacated;

6.      was found by a court of competent jurisdiction in a civil action or by the Commodity Futures Trading Commission to have violated any Federal commodities law, and the judgment in such civil action or finding by the Commodity Futures Trading Commission has not been subsequently reversed, suspended or vacated;

7.      was the subject of, or a party to, any Federal or State judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged violation of:

i)       any Federal or State securities or commodities law or regulation; or

ii)      any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or

iii)     any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or

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8.was the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act (15 U.S.C. 78c(a)(26))), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.

Director Independence

We intend to have three directors at the time of the offering who qualify as “independent” according to the rules of the Nasdaq Stock Market, LLC. Our Board has determined that the following director is “independent” as such director do not have a direct or indirect material relationship with our company: Alberto Libanori, Nicole Holden and Hans Hekland.

A material relationship is a relationship which could, in the view of our Board of Directors, be reasonably expected to interfere with the exercise of a director’s independent judgment.

Code of Business Conduct and Ethics

We will adopt a Code of Conduct and Ethics that applies to our directors, officers and other employees prior to the consummation of the offering.

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EXECUTIVE COMPENSATION

Compensation Discussion and Analysis

This section sets out the objectives of our company’s executive compensation arrangements, our company’s executive compensation philosophy and the application of this philosophy to our company’s executive compensation arrangements. It also provides an analysis of the compensation design, and the decisions that the Board intends to make starting at the time of this offering with respect to our Named Executive Officers (as defined below). When determining the compensation arrangements for the Named Executive Officers, our Board of Directors acting as the Compensation Committee considers the objectives of: (i) retaining an executive critical to our success and the enhancement of shareholder value; (ii) providing fair and competitive compensation; (iii) balancing the interests of management and our shareholders; and (iv) rewarding performance, both on an individual basis and with respect to the business in general.

Benchmarking

Our Board of Directors handles matters relating to compensation, including benchmarking, but upon the closing of this offering, we will form a Compensation Committee for matters of management’s compensation. The Compensation Committee will consider a variety of factors when designing and establishing, reviewing and making recommendations for executive compensation arrangements for all our executive officers. The Compensation Committee does not intend to position executive pay to reflect a single percentile within the industry for each executive. Rather, in determining the compensation level for each executive, the Compensation Committee will look at factors such as the relative complexity of the executive’s role within the organization, the executive’s performance and potential for future advancement and pay equity considerations.

Elements of Compensation

The compensation paid to Named Executive Officers in any year consists of two primary components:

(a)     base salary; and

(b)    long-term incentives in the form of stock options.

The key features of these two primary components of compensation are discussed below:

Base Salary

Base salary recognizes the value of an individual to our company based on his or her role, skill, performance, contributions, leadership and potential. It is critical in attracting and retaining executive talent in the markets in which we compete for talent. Base salaries for the Named Executive Officers are intended to be reviewed annually. Any change in base salary of a Named Executive Officer is generally determined by an assessment of such executive’s performance, a consideration of competitive compensation levels in companies similar to our company and a review of our performance as a whole and the role such executive officer played in such corporate performance.

Stock Option Awards

We intend to provide long-term incentives to Named Executive Officers in the form of stock options as part of our overall executive compensation strategy. Our Board of Directors acting as the Compensation Committee believes that stock option grants serve our executive compensation philosophy in several ways: firstly, it helps attract, retain, and motivate talent; secondly, it aligns the interests of the Named Executive Officers with those of the shareholders by linking a specific portion of the officer’s total pay opportunity to the share price; and finally, it provides long-term accountability for Named Executive Officers.

Risks Associated with Compensation Policies and Practices

The oversight and administration of our executive compensation program requires the Board of Directors acting as the Compensation Committee to consider risks associated with our compensation policies and practices. Potential risks associated with compensation policies and compensation awards are considered at annual reviews and also whenever it is deemed necessary by the Board of Directors acting as the Compensation Committee or, when established upon the closing of the offering, the Compensation Committee.

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Our executive compensation policies and practices are intended to align management incentives with the long-term interests of the Corporation and its shareholders. In each case, the Corporation seeks an appropriate balance of risk and reward. Practices that are designed to avoid inappropriate or excessive risks include (i) financial controls that provide limits and authorities in areas such as capital and operating expenditures to mitigate risk taking that could affect compensation, (ii) balancing base salary and variable compensation elements and (iii) spreading compensation across short and long-term programs.

Compensation Governance

The Compensation Committee intends to conduct a yearly review of directors’ compensation having regard to various reports on current trends in directors’ compensation and compensation data for directors of reporting issuers of comparative our size. Director compensation is currently limited to the grant of stock options pursuant to the Stock Option Plan. It is anticipated that the Chief Executive Officer will review the compensation of our executive officers for the prior year and in comparison to industry standards via information disclosed publicly and obtained through copies of surveys. The Board expects that the Chief Executive Officer will make recommendations on compensation to the Compensation Committee. The Compensation Committee will review and make suggestions with respect to compensation proposals, and then make a recommendation to the Board.

The Compensation Committee will be comprised of independent directors.

The Compensation Committee’s responsibility is to formulate and make recommendations to our directors in respect of compensation issues relating to our directors and executive officers. Its responsibilities are more fully described under the section of this prospectus entitled “Directors and Executive Officers — Board Committees — Compensation Committee”.

Summary Compensation Table

We set out below certain disclosure on compensation paid to our executives on an aggregate basis for the year ended December 31, 2020, as disclosure of compensation on an individual basis is not required in our home country and is not otherwise publicly disclosed by us.

(U.S. dollars in thousands)

 

All executive officers

Base compensation

 

117,216

Bonuses

 

0

Additional benefit payments

 

15,873

Total cash compensation

 

133,089

Executive Compensation Agreements

Guido Baechler, Chief Executive Officer

On July 1, 2021, we entered into a management services agreement with Guido Baechler (the “Baechler Agreement”). Pursuant to the Baechler Agreement: (a) Mr. Baechler is appointed as our Chief Executive Officer and will undertake and perform the duties and responsibilities normally and reasonably associated with such office; (b) we shall pay to Mr. Baechler annual base remuneration of $240,000 that will increase to $350,000 upon the filing of a Form F-1 for an initial public offering, and to $450,000 in the year after the initial public offering provided we make satisfactory progress in Board-approved goals (the “Base Remuneration”); (c) we shall reimburse Mr. Baechler for one U.S. health plan and one U.S. dental plan (if not included in the health plan) amounting up to $3,500 per month; (d) we shall provide to Mr. Baechler any benefits plan, if and when we have adopted such benefits; (e) our Board of Directors shall, in good faith, consider the payment of an annual bonus equal to 50% of that year’s Base Remuneration based upon our performance and upon the achievement of mutually agreed-upon milestones (the “Annual Bonus”); and (e) Mr. Baechler will be entitled to twenty days paid annual vacation per calendar year as well as the reimbursement of reasonable and necessary business expenses. Furthermore, our Board of Directors will grant Mr. Baechler stock options exercisable into ordinary shares subject to a Stock Option Plan that the Board of Directors and the shareholders of the Company has approved.

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We or Mr. Baechler, under the Baechler Agreement, may terminate the engagement at any time for any reason by providing not less than ten calendar days’ notice in writing, provided that (a) Company shall have the option to provide a lump sum payment equal to ten (10) days’ Base Remuneration in lieu of such notice if terminating without cause; and (b) the Company may waive all or any part of the notice period for no consideration by giving written notice to Mr. Baechler if terminating with cause.

In the event of the Company’s termination of the Baechler Agreement for cause or if Mr. Baechler’s terminates the Baechler Agreement without good reason, Mr. Baechler is entitled to (i) any accrued but unpaid Base Remuneration and payment for any accrued but unused vacation; (ii) reimbursement for unreimbursed business expenses properly incurred by Mr. Baechler; and (iii) such benefits (including equity compensation), if any, to which Mr. Baechler may be entitled under the Company’s benefit plans as of termination; provided that, in no event shall Mr. Baechler be entitled to any payments in the nature of severance or termination payments except as specifically provided in the Baechler Agreement (collectively the “Accrued Amounts”).

If we elect to terminate the Baechler Agreement without good cause or Mr. Baechler resigns with good reason in compliance with the relevant terms and conditions of the Baechler Agreement, we shall be obligated to provide a severance package to Mr. Baechler that includes: (i) the Accrued Amounts (ii) equal installment payments payable under the Company’s normal payroll practices, but no less frequently than monthly, which are in the aggregate equal to the Mr. Baechler’s Base Remuneration for the year in which termination occurs; (iii) an amount equal to the Annual Bonus for the year in which the termination takes place; (iv) Vesting of an additional 12 months (removing any cliff) under all time-based vesting schedules for equity-based incentives held by Mr. Baechler; and (v) Reimbursement for up to $3,500 of the monthly U.S. health insurance premium paid by Mr. Baechler for himself and his dependent until the earliest date set forth by the Baechler Agreement.

The Baechler Agreement will terminate upon the death of Mr. Baechler. The Company may terminate Mr. Bachelor upon disability as defined by the Baechler Agreement. If Mr. Baechler is terminated on account of death or disability, we will provide Mr. Baechler, his estate, or, if applicable, Mr. Baechler’s beneficiaries with the Accrued Amounts.

William Caragol, Chief Financial Officer

On July 16, 2021, we entered into a consulting agreement with William Caragol (the “Caragol Agreement”). Pursuant to the Caragol Agreement: (a) Mr. Caragol will act as our Chief Financial Officer and will undertake and perform the duties and responsibilities normally and reasonably associated with such office; (b) we shall pay to Mr. Caragol a monthly salary of $15,000; and (c) Mr. Caragol will be entitled to receive options to purchase our ordinary shares equal to 1% of our outstanding Ordinary shares upon completion of an initial public offering subject to a Stock Option Plan that the Board of Directors and the shareholders of the Company has approved. Such options shall vest over a four year period on a monthly basis, provided that the Company and Mr. Caragol have agreed to use their best efforts to agree to milestones pursuant to which half of such options may vest.

If we elect to terminate the Caragol Agreement without good cause or Mr. Caragol resigns with good reason in compliance with the relevant terms and conditions of the Caragol Agreement, we shall be obligated to provide a severance package to Mr. Caragol that includes: (i) any amounts due to him under the Caragol Agreement that have not yet been paid, (ii) the amounts due to Mr. Caragol for the year in which termination occurs; and (iii) the vesting of an additional six months under all time-based vesting schedules for equity-based incentives held by Mr. Caragol.

Dr. Moritz Eidens, Chief Science Officer

On January 1, 2019, we entered into a Management Services Agreement with Dr. Moritz Eidens with a term of three years (the “Eidens Agreement”). The Eidens Agreement is subject to automatic renewal on a three-year term basis unless either party provides written notice not to renew the Eidens Agreement with six months’ notice before the end of the current or renewal term.

Pursuant to the terms and provisions of the Eidens Agreement: Dr. Eidens shall remain an executive of PharmGenomics GmbH and will be appointed as a Director of Mainz Biomed B.V. Upon the conversion of the company to a stock corporation under Dutch law, Dr. Eidens will be appointed as a member of the resulting company’s executive board.

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As a Director, Dr. Eidens is expected to undertake and perform the duties and responsibilities normally and reasonably associated with such office. For his services, Dr. Eidens will (a) receive a fixed gross annual salary of €164,000, payable monthly; (b) he will be entitled to participate in our equity incentive plan and receive at least one-eighth of the shares issued under the plan; and (c) be granted, up to the amount of the statutory income threshold applicable at the time, an amount equal to the employer’s share of the contributions to his private health and nursing care insurance (collectively the “Eidens Remuneration”).

Furthermore, we will provide Dr. Eidens with (a) paid annual vacation time of 30 working days; (b) a company car for business and private use upon request; (c) a monthly budget of €400 a month alongside a one-time €2,000 budget for work equipment; (d) an annual budget of €5,000 for health care not covered by insurance; (e) an annual training budget; and (f) a company credit card.

If we terminate the Eidens Agreement, Dr. Eidens is entitled upon request to be released from his duties until the end of the relationship. He will also receive a severance payment equal to three months of Remuneration for each year of service under the Eidens Agreement.

If Dr. Eidens is unable to work due to reasons beyond his control, he is entitled to the Remuneration minus any benefits granted by the statutory health insurance fund institutions or a private health insurance fund for the lesser of six months or the end of the current three-year term. In addition, in the event of Dr. Eidens’ death, his spouse and dependents will be entitled to receive Remuneration for the month of death and the lesser of twelve months or the end of the current three-year term after the month of death.

In the event of a change of control, Dr. Eidens may resign and terminate the Eidens Agreement with written notice until the last day of the sixth month after the change of control has occurred.

Philipp Freese, Chief Operating Officer

On January 1, 2019, we entered into a Management Services Agreement with Mr. Phillip Freese with a three-year term (the “Freese Agreement”). The Freese Agreement is subject to automatic renewal on a three-year term basis unless either party provides written notice not to renew the Freese Agreement with six months’ notice before the end of the current or renewal term.

Pursuant to the terms and provisions of the Freese Agreement: Mr. Freese shall remain an executive of PharmGenomics GmbH and serve as a Director of Mainz Biomed B.V. Upon the conversion of Mainz BioMed B.V. to a stock corporation under Dutch law, Mr. Freese will be appointed as the Chief Operations Officer of the resulting company.

As a Director, Mr. Freese is expected to undertake and perform the duties and responsibilities normally and reasonably associated with such office. For his services, Mr. Freese will (a) receive a fixed gross annual salary of €164,000, payable monthly; (b) he will be entitled to participate in our equity incentive plan and receive at least one-eighth of the shares issued under the plan. (Collectively the “Freese Remuneration”).

Furthermore, we will provide Mr. Freese with (a) paid annual vacation time of 30 working days; (b) a company car for business and private use upon request; (c) a monthly budget of €400 a month alongside a one-time €2,000 budget for work equipment; (d) an annual budget of €5,000 for health care not covered by insurance; (e) an annual training budget; and (f) a company credit card.

If we terminate the Freese Agreement, Mr. Freese is entitled upon request to be released from his duties until the end of the relationship. He will also receive a severance payment equal to three months of the Freese Remuneration for each year of service under the Freese Agreement.

If Mr. Freese is unable to work due to reasons beyond his control, he is entitled to the Freese Remuneration minus any benefits granted by the statutory health insurance fund institutions or a private health insurance fund for the lesser of six months or the end of the current three-year term. In addition, in the event of Mr. Freese’s death his spouse and dependents will be entitled to receive Freese Remuneration for the month of death and the lesser of twelve months or the end of the current three-year term after the month of death.

In the event of a change of control, Mr. Freese may resign and terminate the Freese Agreement with written notice until the last day of the sixth month after the change of control has occurred.

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Stock Option Plans and Stock Options

Prior to the closing of this offering, we intend to adopt our 2021 Omnibus Incentive Plan (the (“Plan”). Under the Plan, we would be authorized to issue equity incentives in the form of incentive stock options, non-statutory stock options, restricted shares, restricted share units, share appreciation rights, performance units or performance shares under separate award agreements. Under the Plan, the aggregate number of shares underlying awards that we could issue could not exceed, 2,300,000 ordinary shares.

Subsequent to the adoption of the Plan and prior to the closing of the offering, we intend to award 1,456,650 stock options under the Plan. Such stock options would be exercisable (i) for any person who owns more than 10% of our outstanding ordinary shares, at a per share price equal to 110% of the per share price in this offering and (ii) for all other persons, at the per share price in this offering. Such stock options for non-senior management team will begin vesting in equal instalments starting one-year after this offering and ending four years after this offering. Such stock options for senior management team will begin vesting in portions equal to 25% of such options granted if prior to the four-year anniversary of the offering:

•        the volume-weighted average price of the ordinary shares on the principal market is at least 50% higher than the per share price in this offering for a period of ten consecutive trading days (with at least 100,000 shares traded per trading day);

•        the volume-weighted average price of the ordinary shares on the principal market is at least 100% higher than the per share price in this offering for a period of ten consecutive trading days (with at least 100,000 shares traded per trading day);

•        since this offering the volume-weighted average price of the ordinary shares on the principal market has at been least 150% higher than the per share price in this offering for a period of ten consecutive trading days (with at least 100,000 shares traded per trading day), provided that such options cannot vest until the twelve-month anniversary of this offering at the earliest; and

•        since this offering the volume-weighted average price of the ordinary shares on the principal market has at been least 200% higher than the per share price in this offering for a period of ten consecutive trading days (with at least 100,000 shares traded per trading day), provided that such options cannot vest until the twelve-month anniversary of this offering at the earliest.

Of the 1,456,650 stock options that we intend to grant prior to this offering, we intend to grant 1,166,650 to our directors and executive officers as follows (i) 467,850 to Guido Baechler, (ii) 233,925 to Dr. Moritz Eidens, (iii) 233,925 to Philipp Freese, (iv) 155,950 to William Caragol, (v) 25,000 to Hans Hekland, (vi) 25,000 to Alberto Libanori and (vii) 25,000 to Nicole Holden.

Director Compensation for Fiscal 2020

We did not pay our directors for their services as directors in our fiscal 2020, although we did compensate some of our directors in that fiscal year for services that they provided as officers.

Pension Benefits

We do not have any defined benefit pension plans or any other plans requiring us to make retirement payments or pay comparable benefits.

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PRINCIPAL SHAREHOLDERS

Security Ownership of Certain Beneficial Owners and Management

The following table sets forth certain information regarding the beneficial ownership of our ordinary shares as of September 30, 2021 by (a) each shareholder who is known to us to own beneficially 5% or more of our outstanding ordinary shares; (b) all directors; (c) our executive officers and (d) all executive officers and directors as a group. Except as otherwise indicated, all persons listed below have (i) sole voting power and investment power with respect to their ordinary shares, except to the extent that authority is shared by spouses under applicable law, and (ii) record and beneficial ownership with respect to their ordinary shares.

Name

 

Ordinary
Shares
Beneficially
Owned
(1)

 

Percentage of
Ordinary
Shares
Beneficially
Owned
(1)

 

Percentage of
Ordinary
Shares
Beneficially Owned After
Offering
(6)

Directors and Executive Officers:

       

 

   

 

Guido Baechler, Chief Executive Officer, Director(5)

 

254,507

 

2.6

%

 

2.2

%

William Caragol, Chief Financial Officer

 

 

 

 

 

Dr. Moritz Eidens, Chief Science Officer, Director(5)

 

890,652

 

9.2

%

 

7.6

%

Alberto Libanori, Director(2)(6)

 

 

 

 

 

Hans Hekland, Director(6)

 

821,427

 

8.5

%

 

7.0

%

Philipp Freese, Chief Operating Officer

 

126,276

 

1.3

%

 

1.1

%

Nicole Holden, Director(6)

 

 

 

 

 

Directors and Executive Officers as a Group (Seven Persons)

 

2,092,862

 

21.6

%

 

17.9

%

         

 

   

 

Other 5% or more Shareholders:

       

 

   

 

S-Innovations-Beteiligungsfinanzierungsgesellschaft Rheinland-Pfalz mbH(3)

 

502,559

 

5.2

%

 

4.3

%

Kreditanstalt für Wiederaufbau(4)

 

1,237,501

 

12.7

%

 

10.6

%

Coloalert AS(2)

 

821,427

 

8.5

%

 

7.0

%

Martin Heyen

 

502,317

 

5.2

%

 

4.3

%

Jelena Jakovljevic

 

550,000

 

5.7

%

 

4.7

%

Andre Doerk

 

546,667

 

5.6

%

 

4.7

%

____________

(1)      Based on 9,710,001 ordinary shares outstanding.

(2)      Hans Hekland has dispositive and voting control over the shares held by ColoAlert AS.

(3)      S-Innovations-Beteiligungsfinanzierungsgesellschaft Rheinland-Pfalz mbH is a fund belonging to Investitions und Strukturbank Rheinland Pfalz, an entity based in Mainz that is part of the State of Rhineland-Palatinate in Germany founded for economic and housing developments.

(4)      Kreditanstalt für Wiederaufbau (known as KfW) is a public law institution (Anstalt des öffentlichen Rechts) serving domestic and international public policy objectives of the Federal Government of the Federal Republic of Germany.

(5)      To become a director upon the closing of the initial public offering.

(6)      Excludes any ordinary shares that may be issued if the underwriter exercises its options to cover over allotments.

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RELATED-PARTY TRANSACTIONS

Apart from the employment and consulting agreements described elsewhere in this prospectus and the agreements with ColoAlert AS (one of our directors is a director and controlling shareholder of ColoAlert AS) described below under “Material Agreements”, we have not entered into any material transactions with our directors, officers, promoters and shareholders or who beneficially own more than 10% of our ordinary shares (or their immediate family members). We have the following arrangements with immediate family members of related parties that we consider to be arms’-length and immaterial: (i) we have a services arrangement with the wife of our Chief Operating Officer whereby we pay her approximately €5,400 per year, (ii) we have an employment agreement with the wife of our Chief Science Officer whereby we pay her approximately €42,000 per year and (iii) we have entered into a loan agreement with the father of our Chief Science Officer whereby a €50,000 loan bearing 6% annual interest is due on January 31, 2023.

MATERIAL AGREEMENTS

We set out below, other than those agreements discussed in the sections of this prospectus entitled “Related-Party Agreements,” “Executive Compensation — Executive Compensation Agreements” and “Business — Property, Plant and Equipment”, those material agreements that we have entered into outside of our ordinary course of business in the past three years.

Contribution Agreement

On September 20, 2021, we acquired PharmGenomics GmbH (“PharmGenomics”) pursuant to the terms of a Contribution Agreement. Under the Contribution Agreement, we acquired all of the outstanding shares of PharmGenomics in exchange for 6,000,000 of our ordinary shares at a deemed valuation of $2.00 per share. The ordinary shares issued to the shareholders of PharmGenomics equaled approximately 62% of our outstanding shares on the date of issuance. Under the Contribution Agreement, we are to establish prior to the closing of this offering an equity incentive plan for a number of shares not to exceed 12% of our issued and outstanding stock. Additionally, under the Contribution Agreement we agreed not to terminate or relocate the business without the consent of each subsidiary of S-Innovations-Beteiligungsfinanzierungsgesellschaft Rheinland-Pfalz mbH, a company with limited liability under German law, that is a currently a shareholder or creditor of PharmGenomics for so long as such subsidiary remains a shareholder or creditor.

ColoAlert License and Development Agreement

On January 1, 2019, we entered into a License and Development Agreement (as amended, the “License Agreement”) with ColoAlert AS whereby we were granted an exclusive, global sub-license to manufacture, market, and sublicense the ColoAlert CRC screening test. In 2017, ColoAlert AS obtained an exclusive license for the ColoAlert CRC screening test from Norda ASA. Under the License Agreement, ColoAlert AS has also engaged us to co-operate and further develop ColoAlert AS’s technology.

In consideration of the exclusive license, we will pay ColoAlert AS (i) a fee of €5 per sample analyzed, payable at the end of each quarter and (ii) a quarterly profit split in which ColoAlert AS receives 50% of the profit from ColoAlert tests (the “Profit Split”).

Either party has the right to terminate the Agreement in the event (i) a material breach is not cured within 30 days of notice; (ii) the other party enters into liquidation (other than for an amalgamation or reconstruction) or if a petition of bankruptcy is filed against either party and not dismissed within 60 days; and (iii) the other party is adjudicated bankrupt or insolvent. Furthermore, ColoAlert shall have the right to terminate the Agreement if the Profit Split is less than for each quarter (i) from January 1, 2020, to December 31, 2022, €25,000 Euros and (ii) thereafter €250,000.

Option to Purchase Intellectual Property Assets

In February 2021, we entered into an Option to Purchase Intellectual Property Assets (the “Option Agreement”) with ColoAlert and Norda ASA (together the “Optionors”), whereby we were granted the option to acquire the intellectual property related to ColoAlert (the “ColoAlert IP”) within a three-year term. The intellectual property that we may acquire pursuant to the Option Agreement are trade secrets and no patents or patents pending currently exist in connection with such intellectual property. The Company believes that its future research and development activities related to ColoAlert, PancAlert and GenoStrip may lead to patent filings in the future.

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Pursuant to the Option Agreement, we may purchase the ColoAlert IP in exchange for (i) €2,000,000 Euro in cash or (ii) €4,000,000 Euro to be paid in our ordinary shares. In the event that we exercise the option for cash, ColoAlert AS has the option to have us instead pay this amount in our ordinary shares.

Silent Partnership Agreements

We have entered into various silent partnership agreements with different investors as described below:

•        In 2020, we entered into a Silent Partnership Agreement to borrow €499,400. Prior to December 31, 2020, we borrowed €299,400 and during the six months ended June 30, 2021, we borrowed the remaining €200,000 that we are to repay by December 31, 2025. We are required to a minimum of 3% interest per annum on the loans, and in addition, until maturity the lenders are entitled to 3% of our net income in each fiscal year that we are profitable. Upon the amounts coming due, the lenders have the option to demand an additional payment equal to 15% of the contribution as a final remuneration;

•        In 2020, we borrowed €50,000 under silent partnership agreements that we are to repay by June 30, 2025. We are required to pay a minimum of 3.5% interest per annum on the loans, and in addition until maturity the lenders are entitled to 0.5% of our net income in each year that we are profitable;

•        Between the years of 2013 to 2016, we entered into silent partnership agreements for loans totaling €798,694 (of which $398,634 matures by June 30, 2023 and $400,000 that matures on December 31, 2025). We must pay a minimum of 8.5% interest per annum on the loans, and in addition until maturity the lenders are entitled to 1.66% of our net income in each year that are profitable. At maturity, the lenders have the option to demand an additional payment equal to 30% of the principal of the loans;

•        In 2010, we entered into a silent partnership agreement to borrow €300,000 that we are to repay January 31, 2023. We must pay a minimum of 8% interest per annum on the loan, and in addition until maturity the lender is entitled to 1.95% of our net income in each that we are profitable. At maturity, the lender has the option to demand an additional payment of up to 30% of the principal of the loan.

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MARKET FOR OUR SECURITIES

There is currently no market for our ordinary shares. We intend to apply to have our ordinary shares listed on the Nasdaq Capital Market under the symbol “MYNZ”. The offering that we are conducting with the prospectus will not close unless the Nasdaq Capital Market has approved our ordinary shares for listing.

SECURITIES ELIGIBLE FOR FUTURE SALE

Ordinary shares

Upon completion of this offering at an assumed offering price of $5.00 per ordinary share, we will have 11,710,000 ordinary shares outstanding. Additionally, as at September 30, 2021, we had granted no options (although we intend to grant up to 1,456,650 options prior to the closing of this offering under the 2021 Omnibus Incentive Plan) and had outstanding warrants exercisable into 3,745,000 ordinary shares. Prior to the closing of the offering, we intend to award 1,456,650 stock options for the purchase of ordinary shares, which options will vest between one and four years from the closing of this offering.

All of the ordinary shares sold in this offering will be freely transferable by persons other than by our “affiliates” without restriction or further registration under the Securities Act. All of the ordinary shares sold in by the selling shareholders will be freely transferable without restriction or further registration under the Securities Act. Sales of substantial amounts of our ordinary share in the public market could adversely affect prevailing market prices of our ordinary share. Prior to this offering, there has been no public market for our ordinary shares. We have applied to list the ordinary shares on the Nasdaq Capital Market under the symbol “MYNZ”.

Underwriter’s Warrants

In addition to cash compensation, we have agreed to issue to the underwriter warrants to purchase up to a total of 140,000 ordinary shares (equal to 7% of the ordinary shares sold in this offering, or 161,000 ordinary shares if the underwriter exercises its option in full), at an exercise price equal to $5.00 per ordinary share assuming an offering price of $5.00 per ordinary share. The warrants will be exercisable from time to time, in whole or in part, from six months after the effective date of the registration statement of which this prospectus forms a part until five years from the effective date of the registration statement. The warrants are exercisable at a per share price equal to the per share offering price. The warrants are also exercisable on a cashless basis. The warrants have been deemed compensation by FINRA and are therefore subject to a 180-day lock-up pursuant to Rule 5110(g)(1) of FINRA. The underwriter (or permitted assignees under FINRA Rule 5110(g)(1)) will not sell, transfer, assign, pledge, or hypothecate these warrants or the securities underlying these warrants, nor will it engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the warrants or the underlying securities for a period of 180 days from the effective date of the offering, except as provided for in FINRA Conduct Rule 5110(g)(2). The exercise price and number of shares issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend, subdivisions, combinations, reclassification, merger or consolidation.

Rule 144

In general, under Rule 144 as currently in effect, once we have been subject to public company reporting requirements for at least 90 days, a person who is not deemed to have been one of our affiliates for purposes of the Securities Act at any time during the 90 days preceding a sale and who has beneficially owned the shares proposed to be sold for at least six months, including the holding period of any prior owner other than our affiliates, is entitled to sell those shares without complying with the manner of sale, volume limitation or notice provisions of Rule 144, subject to compliance with the public information requirements of Rule 144. If such a person has beneficially owned the shares proposed to be sold for at least one year, including the holding period of any prior owner other than our affiliates, then that person is entitled to sell those shares without complying with any of the requirements of Rule 144.

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In general, under Rule 144, as currently in effect, our affiliates or persons selling shares on behalf of our affiliates are entitled to sell within any three-month period beginning 90 days after the date of this prospectus, a number of shares that does not exceed the greater of:

•        1% of the number of ordinary shares then outstanding, which will equal 117,100 shares immediately after our initial public offering, or

•        the average weekly trading volume of the ordinary shares during the four calendar weeks preceding the filing of a notice on Form 144 with respect to such sale.

Sales under Rule 144 by our affiliates or persons selling shares on behalf of our affiliates are also subject to certain manner of sale provisions and notice requirements and to the availability of current public information about us.

Rule 701

In general, under Rule 701 as currently in effect, any of our employees, consultants or advisors who purchase shares from us in connection with a compensatory stock or option plan or other written agreement in a transaction before the effective date of our initial public offering that was completed in reliance on Rule 701 and complied with the requirements of Rule 701 will be eligible to resell such shares 90 days after the date of this prospectus in reliance on Rule 144, but without compliance with certain restrictions, including the holding period, contained in Rule 144.

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ARTICLES OF ASSOCIATION OF OUR COMPANY

Prior to this offering, we intend to convert into a Dutch public company with limited liability (naamloze vennootschap). To effect such conversion we will amend our articles of association. This section includes a description of the material terms of the articles of association that will apply after conversion and of applicable Dutch law. The following description is intended as a summary only and does not constitute legal advice regarding those matters and should not be regarded as such. The description is qualified in its entirety by reference to the complete text of the articles of association that will be effective after conversion and that we will file as an exhibit to the registration statement to which this prospectus relates.

Overview

We were incorporated on March 8, 2021 as a private limited liability company (besloten vennootschap met beperkte aansprakelijkheid) under Dutch law, and prior to the completion of this offering we will convert into a Dutch public company with limited liability (naamloze vennootschap).

We are registered in the Commercial Register of the Chamber of Commerce (Kamer van Koophandel) in the Netherlands under number 82122571. We have our corporate seat is in Amsterdam, the Netherlands and our registered office is at Robert-Koch Strasse 50, 55129 Mainz, Federal Republic of Germany.

The ordinary shares to be sold in this offering will be subject to, and will have been created under, Dutch law. Set forth below is a summary of relevant information concerning the material provisions of our articles of association that we intend to file in connection with our conversion to a Dutch public limited liability company and applicable Dutch law. The following description of our articles of association is presented as if the articles of association have already been amended. If the terms of the amended articles of association that will apply after conversion will differ from the currently proposed terms, we will correspondingly revise this summary prior to the commencement of the offering.

Board of Directors

We have a one-tier board structure. Upon the closing of the offering, the board of directors of the Company (the “Board of Directors”) will consist of two executive directors and three non-executive directors. The Board of Directors shall consist of such number of executive Directors as the Board of Directors may determine.

The Board of Directors will be charged with the management of the company. In fulfilling their duties, our directors will serve the interest of the company and the business connected with it. The executive directors and the executive committee are charged with the day-to-day management of the company. Supervision of the fulfilment of duties by the executive directors and of the general course of the company’s affairs and the business connected with it will primarily be carried out by the non-executive directors. The executive directors must in due time provide the non-executive directors with the information they need to carry out their duties.

Our directors will be elected by the general meeting upon a binding nomination. The Board of Directors will be authorized to nominate one or more director candidates for appointment at the general meeting. Shareholders who individually or jointly represent at least 20% of the issued share capital will have the same right to nominate one or more director candidates for appointment at the general meeting. The general meeting may at all times overrule the binding nature of each nomination by a resolution adopted by a majority of at least two thirds of the votes cast, representing more than half of the issued share capital.

The general meeting may at any time suspend and dismiss a non-executive director or executive director. The general meeting may only adopt a resolution to suspend or dismiss a non-executive director or executive director by a majority of at least two thirds of the votes cast, representing more than half of the issued share capital, unless the resolution is adopted on the basis of a proposal of the Board of Directors; in that case, the resolution may be adopted by an absolute majority of the votes cast, representing more than half of the issued share capital.

Authorized Share Capital

Our authorized share capital consists of 45,000,000 ordinary shares with a nominal value of EUR 0.01 per share and 5,000,000 preferred shares with a nominal value of EUR 0.01 per share. The preferred shares are divided into five series, each consisting of 1,000,000 preferred shares. Currently there are no preferred shares outstanding.

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The number of ordinary shares included in the authorized share capital may be decreased and the number of preferred shares included in the authorized share capital may be increased pursuant to a resolution of the Board of Directors by a number not exceeding the number of ordinary shares included in the authorized share capital which have not been issued and which are not subject to any rights to subscribe for ordinary shares.

The preferred shares may, at the request of the holder, be converted into ordinary shares. The conditions for conversion and the further terms and conditions related to the preferred shares will be determined by our Board of Directors, subject to the prior approval of our general meeting and the meeting of holders of the series of preferred shares concerned, if such series of preferred shares has been issued and are held by persons other than us. The preceding sentence applies by analogy to any adjustment to the conditions.

Issuance of shares

Under Dutch law, shares are issued and rights to subscribe for shares are granted pursuant to a resolution of our general meeting. Our articles of association provide that the general meeting may only resolve to issue shares upon the proposal of our Board of Directors. The general meeting may authorize the Board of Directors to issue new ordinary shares or grant rights to subscribe for ordinary shares. The authorization can be granted and extended, in each case for a period not exceeding five years. For as long as, and to the extent, that such authorization is effective, our general meeting will not have the power to issue ordinary shares.

Prior to this offering, a resolution of the general meeting will irrevocably authorize our Board of Directors, for a period of five years from           , to issue ordinary shares and preferred shares up to the amount of the authorized share capital (from time to time).

Preemptive Rights

Subject to restrictions in our articles of association, holders of ordinary shares have preemptive rights in relation to newly issued ordinary shares under Dutch law.

Under our articles of association, the preemptive rights in respect of newly issued ordinary shares may be restricted or excluded by a resolution of our general meeting, which resolution requires a two-thirds majority of the votes cast if less than half of the issued share capital is present or represented at the meeting. The general meeting may authorize our Board of Directors to limit or exclude the preemptive rights in respect of newly issued ordinary shares. Such authorization for our Board of Directors can be granted and extended, in each case for a period not exceeding five years.

Prior to this offering, a resolution of the general meeting will irrevocably authorize our Board of Directors for a period of five years from            to limit or exclude preemptive rights on ordinary shares.

Preemptive rights do not exist with respect (a) to the issue of ordinary shares or grant of rights to subscribe for ordinary shares to our employees or a “group” company of ours, (b) the issue of ordinary shares against a contribution other than cash, and (c) preferred shares to be issued. A holder of preferred shares has no preemptive right to acquire newly issued ordinary shares.

Transfer of Ordinary Shares

Under Dutch law, transfers of ordinary shares (other than in book-entry form) require a written deed of transfer and, unless the company is a party to the deed of transfer, and acknowledgement by or proper service upon the company to be effective.

Under our articles of association, if one or more ordinary shares are admitted to trading on Nasdaq or any other regulated foreign stock exchange located in the United States, we may, by resolution of our Board of Directors, determine that the laws of the State of New York will apply to the property law aspects of the ordinary shares included in the part of the register of shareholders kept by the relevant transfer agent. Such resolution, as well as the revocation thereof, will be made public as required by law and will be made available for inspection at our office and the Dutch trade register. Our Board of Directors will adopt such resolution prior to the closing of the initial public offering.

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Form of Ordinary Shares

Pursuant to our articles of association, the ordinary shares are registered shares.

Purchase and Repurchase of Ordinary Shares

Under Dutch law, we may not subscribe for newly issued ordinary shares. We may acquire ordinary shares, subject to applicable provisions and restrictions of Dutch law and our articles of association, to the extent that:

•        such ordinary shares are fully paid-up;

•        such repurchase would not cause our shareholders’ equity to fall below an amount equal to the sum of the paid-up and called-up part of the issued share capital and the reserves we are required to maintain pursuant to Dutch law or our articles of association; and

•        immediately after the acquisition of such ordinary shares, we and our subsidiaries would not hold, or would not hold as pledgees, shares having an aggregate nominal value that exceeds 50% of our issued share capital.

Other than ordinary shares acquired for no valuable consideration or under universal title of succession (onder algemene titel) (e.g., through a merger or spin off) under statutory Dutch or other law, we may acquire ordinary shares only if our general meeting has authorized our Board of Directors to do so. An authorization by our general meeting for the acquisition of ordinary shares can be granted for a maximum period of 18 months. Such authorization must specify the number of ordinary shares that may be acquired, the manner in which these shares may be acquired and the price range within which the shares may be acquired. No authorization of our general meeting is required if ordinary shares are acquired by us on Nasdaq with the intention of transferring such ordinary shares to our employees or employees of a group company pursuant to an arrangement applicable to them. For each annual general meeting, we expect that our Board of Directors, will place on the agenda a proposal to re-authorize our Board of Directors to repurchase shares for a period of 18 months from the date of the resolution. We cannot derive any right to any distribution from ordinary shares, or voting rights attached to ordinary shares acquired by it.

Prior to this offering, a resolution of the general meeting will irrevocably authorize our Board of Directors for a period of 18 months to resolve for us to acquire fully paid-up ordinary shares up to the maximum number of ordinary shares permitted pursuant to the law and our articles of association from time to time, through privately negotiated repurchases, in self-tender offers, or through accelerated repurchase arrangements, at prices ranging from the nominal value of the ordinary shares up to one hundred and ten percent (110%) of the market price of ordinary shares, provided that (i) for open market or privately negotiated repurchases, the market price will be the price for ordinary shares Nasdaq at the time of the transaction, (ii) for self-tender offers, the market price will be the volume weighted average price for the ordinary shares on Nasdaq during a period, determined by the Board of Directors, of no less than one and no more than five consecutive trading days immediately prior to the expiration of the tender offer, and (iii) for accelerated repurchase arrangements, the market price will be the volume weighted average price of the ordinary shares on the Nasdaq Capital Market (or other similar exchange on which the ordinary shares are listed) over the term of the arrangement. The volume weighted average price for any number of trading days will be calculated as the arithmetic average of the daily volume weighted average price on those trading days.

Pursuant to a resolution of the general meeting dated , our Board of Directors is furthermore irrevocably authorized for a period of 18 months to resolve for us to acquire fully paid up preferred shares up to the maximum number of preferred shares permitted pursuant to the law and our articles of association from time to time and that preferred shares may be acquired through privately negotiated repurchases, in self-tender offers, or through accelerated repurchase arrangements, at prices ranging from the nominal value of the preferred shares up to the higher of (i) the amount that would be paid by us upon cancellation of such preferred shares in accordance with the relevant provisions of our articles of association and (ii) one hundred and ten percent (110%) of the market price of the ordinary shares into which the preferred shares may be converted in accordance with the applicable provisions of our articles of association, whereby the market price shall be determined in the manner as set out in our articles of association.

Capital Reduction

At a general meeting, our shareholders may resolve on the proposal of our Board of Directors to reduce our issued share capital by (i) cancelling ordinary shares and preferred shares or (ii) reducing the nominal value of the ordinary shares and preferred shares by amending our articles of association. In either case, this reduction would be subject

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to applicable statutory provisions. A resolution to cancel shares may only relate to (i) shares held by us or in respect of which we hold the depository receipts, or (ii) all preferred shares of a particular series if approved by the holders of all shares of that class. In order to be approved by our general meeting, a resolution to reduce the capital requires approval of a majority of the votes cast at a general meeting if at least half of the issued share capital is represented at such meeting or at least two thirds of the votes cast, if less than half of the issued share capital is represented at such meeting.

Reduction of the nominal value of shares without repayment shall be effected proportionally to all ordinary shares and preferred shares. The requirement of proportionality may be waived by agreement of all shareholders concerned.

A resolution that would result in a reduction of capital requires approval by a majority of the votes cast of each group of shareholders of the same class whose rights are prejudiced by the reduction. In addition, a reduction of capital involves a two-month waiting period during which creditors have the right to object to a reduction of capital under specified circumstances.

General Meeting

General meetings are held in Amsterdam, Rotterdam, The Hague, Arnhem, Utrecht, or in the municipality of Haarlemmermeer (Schiphol Airport), the Netherlands. All of our shareholders and others entitled to attend our general meetings are authorized to address the meeting and, in so far as they have such right, to vote, either in person or by proxy.

We will hold at least one general meeting each year, to be held within six months after the end of its financial year. A general meeting will also be held within three months after our Board of Directors has determined it to be likely that our equity has decreased to an amount equal to or lower than half of its paid up and called up capital, in order to discuss the measures to be taken if so required. If our Board of Directors fails to hold such general meeting in a timely manner, each shareholder and other person entitled to attend our general meeting may be authorized by the Dutch court to convene our general meeting.

Our Board of Directors may convene additional extraordinary general meetings at its discretion, subject to the notice requirements described below. Pursuant to Dutch law, one or more shareholders and/or others entitled to attend general meetings of shareholders, alone or jointly representing at least 10% of our issued share capital, may on their application be authorized by the Dutch court to convene a general meeting. The Dutch court will disallow the application if (i) the applicants have not previously requested in writing that our Board of Directors convenes a shareholders’ meeting or (ii) our Board of Directors convenes a shareholders’ meeting or (ii) our Board of Directors has not taken the necessary steps so that the shareholders’ meeting could be held within six weeks after such request.

The general meeting is convened by a notice, which includes an agenda stating the items to be discussed and the location and time of our general meeting. For the annual general meeting the agenda will include, among other things, the adoption of our annual accounts, the appropriation of its profits or losses and proposals relating to the composition of and filling of any vacancies on Board of Directors. In addition, the agenda for a general meeting includes such additional items as determined by our Board of Directors. Pursuant to Dutch law, one or more shareholders and/or others entitled to attend general meetings of shareholders, alone or jointly representing at least 3% of the issued share capital, have the right to request the inclusion of additional items on the agenda of shareholders’ meetings. Such requests must be made in writing, and may include a proposal for a shareholder resolution, and must be received by us no later than on the 60th day before the day the relevant shareholders’ meeting is held. No resolutions will be adopted on items other than those which have been included in the agenda. Under our articles of association, certain items can only be put on the agenda as a voting item by our Board of Directors. Shareholders meeting the relevant requirements may still request the inclusion of such items on the agenda as a discussion item.

We will give notice of each general meeting by publication on its website and, to the extent required by applicable law, in a Dutch daily newspaper with national distribution, and in any other manner that we may be required to follow in order to comply with Dutch law and applicable stock exchange and SEC requirements. We will observe the statutory minimum convening notice period for a general meeting. Holders of registered shares may further be provided notice of the meeting in writing at their addresses as stated in its shareholders’ register.

Pursuant to our articles of association and Dutch law, our Board of Directors may determine a record date (registratiedatum) of 28 calendar days prior to a general meeting to establish which shareholders and others with meeting rights are entitled to attend and, if applicable, vote at our general meeting. The record date, if any, and the

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manner in which shareholders can register and exercise their rights will be set out in the notice of our general meeting. Our articles of association provide that a shareholder must notify us in writing of his or her identity and his or her intention to attend (or be represented at) our general meeting, such notice to be received by us on the date set by our Board of Directors in accordance with our articles of association and as set forth in the convening notice. If this requirement is not complied with or if upon request no proper identification is provided by any person wishing to enter our general meeting, the chairman of our general meeting may, in his or her sole discretion, refuse entry to the shareholder or his or her proxy holder.

Our general meeting will be presided over by the chairman of our Board of Directors, who, nevertheless, may charge another person to preside over the meeting in his place even if he or she is present at the meeting. If the chairman of our Board of Directors is absent and he or she has not charged another person to preside over the meeting in his or her place, the directors present at the meeting will appoint one of them to be chairman. In the absence of all directors, our general meeting will appoint its chairman.

Voting Rights and Quorum

In accordance with Dutch law and our articles of association, each ordinary share, irrespective of which class it concerns, confers the right on the holder thereof to cast one vote at our general meeting. The voting rights attached to any ordinary shares held by us or our direct or indirect subsidiaries are suspended, unless the ordinary shares were encumbered with a right of usufruct or a pledge in favor of a party other than us or a direct or indirect subsidiary before such ordinary shares were acquired by us or such a subsidiary, in which case, the other party may be entitled to exercise the voting rights on the ordinary shares. We may not exercise voting rights for ordinary shares in respect of which its or a direct or indirect subsidiary has a right of usufruct or a pledge.

Voting rights may be exercised by shareholders or by a duly appointed proxy holder (the written proxy being acceptable to the chairman of our general meeting) of a shareholder, which proxy holder need not be a shareholder. The holder of a usufruct or pledge on shares will have the voting rights attached thereto if so provided for when the usufruct or pledge was created.

Under our articles of association, blank votes (votes where no choice has been made), abstentions and invalid votes will not be counted as votes cast. However, shares in respect of which a blank vote or invalid vote has been cast and shares in respect of which the person with meeting rights who is present or represented at the meeting has abstained from voting are counted when determining the part of the issued share capital that is present or represented at a general meeting. The chairman of our general meeting will determine the manner of voting and whether voting may take place by acclamation.

Resolutions of the shareholders are adopted at a general meeting by a majority of votes cast, except where Dutch law or our articles of association provide for a special majority in relation to specified resolutions. Our articles of association do not provide for a quorum requirement, subject to any provision of mandatory Dutch law.

Subject to certain restrictions in our articles of association, the determination during our general meeting made by the chairman of that general meeting with regard to the results of a vote will be decisive. Our Board of Directors will keep a record of the resolutions passed at each general meeting.

Amendment of Articles of Association

At a general meeting, at the proposal of our Board of Directors, our general meeting may resolve to amend the articles of association. A resolution by the shareholders to amend the articles of association requires a majority of the votes cast.

Dissolution and liquidation

Our shareholders may at a general meeting, based on a proposal by our Board of Directors, by means of a resolution passed by a majority of the votes cast resolve that the Company will be dissolved. In the event of dissolution of the company, the liquidation will be effected by our executive directors, under the supervision of our non-executive directors, unless our general meeting decides otherwise.

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Certain Other Major Transactions

Our articles of association and Dutch law provide that resolutions of our Board of Directors concerning a material change in our identity, character or business are subject to the approval of our general meeting. Such changes include:

•        a transfer of all or materially all of its business to a third party;

•        the entry into or termination of a long-lasting alliance of the company or of a subsidiary either with another entity or company, or as a fully liable partner of a limited partnership or partnership, if this alliance or termination is of significant importance to the company; and

•        the acquisition or disposition of an interest in the capital of a company by the company or by its subsidiary with a value of at least one third of the value of our assets, according to the balance sheet with explanatory notes or, if the company prepares a consolidated balance sheet, according to the consolidated balance sheet with explanatory notes in our most recently adopted annual accounts.

Dividends and Other Distributions

The company may only make distributions to its shareholders if its equity exceeds the aggregate amount of the issued share capital and the reserves which must be maintained pursuant to Dutch law.

Under our articles of association, any profits or distributable reserves must first be applied to pay a dividend on the preferred shares, if outstanding. Any amount remaining out of distributable profits is added to our reserves as our Board of Directors determines. After reservation by our Board of Directors of any distributable profits, our general meeting will be authorized to declare distributions on the proposal of our Board of Directors. Our Board of Directors is permitted, to declare interim dividends without the approval of the shareholders. Interim dividends may be declared as provided in our articles of association and may be distributed to the extent that the shareholders’ equity, based on interim financial statements, exceeds the paid-up and called-up share capital and the reserves that must be maintained under Dutch law or our articles of association. We may reclaim any distributions, whether interim or not interim, made in contravention of certain restrictions of Dutch law from shareholders that knew or should have known that such distribution was not permissible. In addition, on the basis of Dutch case law, if after a distribution we are not able to pay its due and collectable debts, then our shareholders or directors who at the time of the distribution knew or reasonably should have foreseen that result may be liable to its creditors.

The general meeting may determine that distributions will be made in whole or in part in the form of shares or a currency other than the Euro, provided on the proposal of the Board of Directors. The Company shall announce any proposal for a distribution and the date when and the place where the distribution will be payable to all shareholders by electronic means of communication with due observance of the applicable law and stock exchange rules. Claims for payment of dividends and other distributions not made within five years from the date that such dividends or distributions became payable will lapse, and any such amounts will be considered to have been forfeited to the company (verjaring).

Transfer Agent

Prior to the closing of the offering, we will appoint Transhare Corporation as the transfer agent for our ordinary shares. Transhare Corporation’s telephone number and address is (303) 662-1112 and 17755 US Hwy 19 N, Clearwater, FL 33764.

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MATERIAL INCOME TAX INFORMATION

Material Dutch Tax Income Tax Considerations

The following are the material Dutch tax consequences of the acquisition, ownership and disposal of our ordinary shares, and, to the extent it relates to legal conclusions under current Dutch tax law. This does not purport to set forth all possible tax considerations or consequences that may be relevant to all categories of investors, some of which may be subject to special treatment under applicable law (such as trusts or other similar arrangements), and in view of its general nature, it should be treated with corresponding caution. Holders or prospective holders of ordinary shares should consult with their tax advisors with regard to the tax consequences of investing in the ordinary shares in their particular circumstances.

Please note that this section does not set forth the tax considerations for:

•        Holders of ordinary shares if such holders, and in the case of individuals, his/her partner or certain relatives by blood or marriage in the direct line (including foster children), have a substantial interest (aanmerkelijk belang) or a deemed substantial interest (fictief aanmerkelijk belang) in us under the Dutch Income Tax Act 2001 (Wet inkomstenbelasting 2001). A holder of ordinary shares in a company is considered to hold a substantial interest in such company if such holder alone or, in the case of individuals, together with his/her partner (as defined in the Dutch Income Tax Act 2001), directly or indirectly holds (i) an interest of 5% or more of the total issued and outstanding capital of that company or of 5% or more of the issued and outstanding capital of a certain class of shares of that company; or (ii) rights to acquire, directly or indirectly, such interest; or (iii) certain profit sharing rights in that company that relate to 5% or more of the company’s annual profits and/or to 5% or more of the company’s liquidation proceeds. A deemed substantial interest may arise if a substantial interest (or part thereof) in a company has been disposed of, or is deemed to have been disposed of, on a non-recognition basis;

•        A holder of ordinary shares that is not an individual for which its shareholdings qualify or qualified as a participation (deelneming) for purposes of the Dutch Corporate Income Tax Act 1969 (Wet op de vennootschapsbelasting 1969). A taxpayer’s shareholding of 5% or more in a company’s nominal paid-up share capital (or, in certain cases, in voting rights) qualifies as a participation. A holder may also have a participation if such holder does not have a shareholding of 5% or more but a related entity (verbonden lichaam) has a participation or if the company in which the shares are held is a related entity (verbonden lichaam);

•        Holders of ordinary shares who are individuals for whom the ordinary shares or any benefit derived from the ordinary shares are a remuneration or deemed to be a remuneration for (employment) activities performed by such holders or certain individuals related to such holders (as defined in the Dutch Income Tax Act 2001); and

•        Pension funds, investment institutions (fiscale beleggingsinstellingen), exempt investment institutions (vrijgestelde beleggingsinstellingen) and other entities that are, in whole or in part, not subject to or exempt from corporate income tax in the Netherlands, as well as entities that are exempt from corporate income tax in their country of residence, such country of residence being another state of the European Union, Norway, Liechtenstein, Iceland or any other state with which the Netherlands have agreed to exchange information in line with international standards.

Except as otherwise indicated, this section only addresses Dutch national tax legislation and published regulations, whereby the Netherlands and Dutch law means the part of the Kingdom of the Netherlands located in Europe and its law, respectively, as in effect on the date hereof and as interpreted in published case law until this date, without prejudice to any amendment introduced (or to become effective) at a later date and/or implemented with or without retroactive effect. The applicable tax laws or interpretations thereof may change, or the relevant facts and circumstances may change, and such changes may affect the contents of this section, which will not be updated to reflect any such changes.

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Dividend Withholding Tax

Holders of ordinary shares are generally subject to Dutch dividend withholding tax at a rate of 15% on dividends distributed by us. We are required to withhold such Dutch dividend withholding tax at source (which dividend withholding tax will not be borne by us but will be withheld by us from the gross dividends paid on the ordinary shares). However, as long as we continue to have our place of effective management in Germany, and not in the Netherlands, we will be considered to be solely tax resident in Germany for purposes of the Convention between the Federal Republic of Germany and the Netherlands for the avoidance of double taxation and prevention of fiscal evasion with respect to taxes on income (the “German-Dutch tax treaty”), and we will in principle not be required to withhold Dutch dividend withholding tax. This exemption from withholding Dutch dividend withholding tax does not apply to dividends distributed by us to a holder who is resident or deemed to be resident in the Netherlands for Dutch income tax purposes or Dutch corporate income tax purposes or to holders of ordinary shares that are neither resident nor deemed to be resident of the Netherlands if the ordinary shares are attributable to a Dutch permanent establishment of such non-resident holder, in which case the following paragraph applies.

Dividends distributed by us to individuals and corporate legal entities who are resident or deemed to be resident in the Netherlands for Dutch (corporate) income tax purposes (“Dutch Resident Individuals” and “Dutch Resident Entities,” as the case may be) or to holders of ordinary shares that are neither resident nor deemed to be resident of the Netherlands if the ordinary shares are attributable to a Dutch permanent establishment of such non-resident holder are generally subject to Dutch dividend withholding tax at a rate of 15%. The expression “dividends distributed” include, but are not limited to:

•        Distributions in cash or in kind, deemed and constructive distributions and repayments of paid-in capital not recognized for Dutch dividend withholding tax purposes;

•        Liquidation proceeds, proceeds of redemption of shares, or proceeds of the repurchase of shares by us or one of our subsidiaries or other affiliated entities to the extent such proceeds exceed the average paid-in capital of those shares as recognized for purposes of Dutch dividend withholding tax, unless, in case of a repurchase, a particular statutory exemption applies;

•        An amount equal to the par value of shares issued or an increase of the par value of shares, to the extent that it does not appear that a contribution, recognized for purposes of Dutch dividend withholding tax, has been made or will be made; and

•        Partial repayment of the paid-in capital, recognized for purposes of Dutch dividend withholding tax, if and to the extent that we have net profits (zuivere winst), unless the holders of shares have resolved in advance at a general meeting to make such repayment and the par value of the shares concerned has been reduced by an equal amount by way of an amendment of our articles of association. The term “net profits” includes anticipated profits that have yet to be realized.

Dutch Resident Individuals and Dutch Resident Entities can generally credit the Dutch dividend withholding tax against their income tax or corporate income tax liability or may under certain circumstances be entitled to an exemption. The same applies to holders of ordinary shares that are neither resident nor deemed to be resident of the Netherlands if the shares are attributable to a Dutch permanent establishment of such non-resident holder. Depending on their specific circumstances, holders of ordinary shares that are resident in a country other than the Netherlands, may be entitled to exemptions from, reduction of, or full or partial refund of, Dutch dividend withholding tax pursuant to Dutch law, EU law or treaties for avoidance of double taxation.

Pursuant to legislation to counteract “dividend stripping,” a reduction, exemption, credit or refund of Dutch dividend withholding tax is not granted if the recipient of the dividend is not the beneficial owner (uiteindelijk gerechtigde) as described in the Dutch Dividend Withholding Tax Act 1965 (Wet op de dividendbelasting 1965) of such dividends. This legislation targets situations in which a shareholder retains its economic interest in shares but reduces the withholding tax costs on dividends by a transaction with another party. It is not required for these rules to apply that the recipient of the dividends is aware that a dividend stripping transaction took place. The Dutch State Secretary of Finance takes the position that the definition of beneficial ownership introduced by this legislation will also apply in the context of a double taxation convention.

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Taxes on Income and Capital Gains

Dutch Resident Individuals

If a holder of ordinary shares is a Dutch Resident Individual, any benefit derived or deemed to be derived from the shares is taxable at the progressive income tax rates, if:

(i)     the ordinary shares are attributable to an enterprise from which the Dutch Resident Individual derives a share of the profit, whether as an entrepreneur (ondernemer) or as a person who has a co-entitlement to the net worth (medegerechtigd tot het vermogen) of such enterprise, without being an entrepreneur or a shareholder in such enterprise, as defined in the Dutch Income Tax Act 2001; or

(ii)    the holder of the shares is considered to derive benefits from the shares that are taxable as benefits from other activities (resultaat uit overige werkzaamheden), such as activities with respect to the shares that go beyond ordinary asset management (normaal actief vermogensbeheer).

If the above-mentioned conditions (i) and (ii) do not apply to the individual holder of ordinary shares, such Dutch Resident Individual holder will be subject to an annual income tax imposed on a deemed return on the net value of the ordinary shares under the regime for savings and investments (inkomen uit sparen en beleggen). Irrespective of the actual income and capital gains realized, the deemed annual return of the Dutch Resident Individual’s net investment assets that are taxed under this regime, including the ordinary shares, is set at a variable percentage of the net value of the investment assets (with a maximum of 5.69% in 2021). Such fictitious annual return deemed to be derived from the ordinary shares will be taxed at a flat rate of 31% in 2021.

The net value of the investment assets for the year are the fair market value of the investment assets less the allowable liabilities on January 1 of the relevant calendar year. The ordinary shares are included as investment assets. A tax-free allowance of €50,000 is available (2021). For the avoidance of doubt, actual income, capital gains or losses in respect of the ordinary shares are as such not subject to Dutch income tax under the regime for savings and investments (inkomen uit sparen en beleggen). The deemed, variable return will be adjusted annually on the basis of historic market yields.

Dutch Resident Entities

Any benefit derived or deemed to be derived from the shares held by Dutch Resident Entities, including any capital gains realized on the disposal thereof, will be subject to Dutch corporate income tax at a rate of 15% with respect to taxable profits up to €245,000 and 25% with respect to taxable profits in excess of that amount (rates and brackets for 2021)

Non-residents of the Netherlands

A holder of ordinary shares that is neither a Dutch Resident Individual nor a Dutch Resident Entity will not be subject to Dutch taxes on income or on capital gains in respect of any payment under shares or any gain realized on the disposal or deemed disposal of the shares, provided that:

•        such holder does not have an interest in an enterprise which, in whole or in part, is either effectively managed in the Netherlands or is carried out through a permanent establishment, or a permanent representative in the Netherlands and to which enterprise or part of an enterprise the shares are attributable; and

•        in the event such holder is an individual, such holder does not derive benefits from the shares that are taxable as benefits from other activities in the Netherlands, such as activities in the Netherlands with respect to the shares that go beyond ordinary asset management.

Under certain specific circumstances, Dutch taxation rights may be restricted for a holder of ordinary shares that is neither a Dutch Resident Individual nor a Dutch Resident Entity pursuant to treaties for the avoidance of double taxation.

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Gift and Inheritance Taxes

Residents of the Netherlands

Gift or inheritance taxes will arise in the Netherlands with respect to a transfer of the ordinary shares by way of a gift by, or on the death of, a holder of ordinary shares who is resident or deemed to be resident in the Netherlands at the time of the gift or the holder’s death.

Non-residents of the Netherlands

No Dutch gift or inheritance taxes will arise on the transfer of the ordinary shares by way of gift by, or on the death of, a holder of ordinary shares who is neither resident nor deemed to be resident in the Netherlands, unless:

•        in the case of a gift of ordinary shares by an individual who at the date of the gift was neither resident nor deemed to be resident in the Netherlands, such individual dies within 180 days after the date of the gift, while being resident or deemed to be resident in the Netherlands; or

•        the transfer is otherwise construed as a gift, such as a gift that is made under a condition precedent, or inheritance made by, or on behalf of, a person who, at the time of the gift or death, is or is deemed to be resident in the Netherlands.

For purposes of Dutch gift and inheritance taxes, a person that holds the Dutch nationality will be deemed to be resident in the Netherlands if such person has been resident in the Netherlands at any time during the 10 years preceding the date of the gift or his/her death. Additionally, for purposes of Dutch gift tax, any person, irrespective of his nationality will be deemed to be resident in the Netherlands if such person has been resident in the Netherlands at any time during the 12 months preceding the date of the gift.

Other Taxes and Duties

No Dutch value-added tax (omzetbelasting) and no Dutch registration tax, stamp duty or any other similar documentary tax or duty will be payable by a holder of shares on any payment in consideration for the acquisition, ownership or disposal of the shares.

Material U.S. Federal Income Tax Considerations

The following is a general summary of material U.S. federal income tax considerations applicable to a U.S. Holder (as defined below) arising from the acquisition, ownership and disposition of our securities. This summary applies only to U.S. Holders that acquire securities pursuant to this prospectus, hold our ordinary shares as capital assets within the meaning of Section 1221 of the Code (as defined below) and have the U.S. dollar as their functional currency.

This summary is for general information purposes only and does not purport to be a complete analysis or listing of all potential U.S. federal income tax considerations that may apply to a U.S. Holder as a result of the acquisition, ownership and disposition of our ordinary shares. In addition, this summary does not take into account the individual facts and circumstances of any particular U.S. Holder that may affect the U.S. federal income tax consequences to such U.S. Holder, including specific tax consequences to a U.S. Holder under an applicable tax treaty. Accordingly, this summary is not intended to be, and should not be construed as, legal or U.S. federal income tax advice with respect to any particular U.S. Holder. In addition, this summary does not address the U.S. federal alternative minimum, net investment income, U.S. federal estate and gift, U.S. Medicare contribution, U.S. state and local, or non-U.S. tax consequences of the acquisition, ownership or disposition of our ordinary shares. Except as specifically set forth below, this summary does not discuss applicable tax reporting requirements. Each U.S. Holder should consult its own tax advisor regarding all U.S. federal, U.S. state and local and non-U.S. tax consequences of the acquisition, ownership and disposition of our ordinary shares.

No opinion from U.S. legal counsel or ruling from the Internal Revenue Service (the “IRS”) has been requested, or will be obtained, regarding the U.S. federal income tax consequences of the acquisition, ownership or disposition of our ordinary shares. This summary is not binding on the IRS, and the IRS is not precluded from taking a position that is different from, or contrary to, any position taken in this summary. In addition, because the authorities upon which this summary is based are subject to various interpretations, the IRS and the U.S. courts could disagree with one or more of the positions taken in this summary.

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The following discussion does not describe all the tax consequences that may be relevant to any particular U.S. Holders, including those subject to special tax situations such as:

•        banks and certain other financial institutions;

•        regulated investment companies;

•        real estate investment trusts;

•        insurance companies;

•        broker-dealers;

•        traders that elect to mark-to-market;

•        tax-exempt entities or governmental organizations;

•        individual retirement accounts or other tax deferred accounts;

•        persons deemed to sell our ordinary shares under the constructive sale provisions of the Code;

•        persons liable for alternative minimum tax or the Medicare contribution tax on net investment income;

•        U.S. expatriates;

•        persons holding our ordinary shares as part of a straddle, hedging, constructive sale, conversion or integrated transaction;

•        persons that directly, indirectly, or constructively own 10% or more of the total combined voting power or total value of our ordinary shares;

•        persons that are resident or ordinarily resident in or have a permanent establishment in a jurisdiction outside the United States;

•        persons who acquired our ordinary shares pursuant to the exercise of any employee share option or otherwise as compensation;

•        persons subject to special tax accounting rules as a result of any item of gross income with respect to our ordinary shares being taken into account in an applicable financial statement; or

•        persons holding our ordinary shares through partnerships or other entities or arrangements treated as partnerships for U.S. federal income tax purposes.

PROSPECTIVE PURCHASERS ARE URGED TO CONSULT THEIR TAX ADVISORS ABOUT THE APPLICATION OF THE U.S. FEDERAL TAX RULES TO THEIR PARTICULAR CIRCUMSTANCES AS WELL AS THE STATE, LOCAL AND NON-U.S. TAX CONSEQUENCES TO THEM OF THE PURCHASE, OWNERSHIP, AND DISPOSITION OF OUR ORDINARY SHARES.

As used herein, the term “U.S. Holder” means a beneficial owner of our ordinary shares that, for U.S. federal income tax purposes, is or is treated as:

•        an individual who is a citizen or resident of the United States;

•        a corporation created or organized in or under the laws of the United States, any state thereof or the District of Columbia;

•        an estate whose income is subject to U.S. federal income taxation regardless of its source; or

•        a trust that (1) is subject to the supervision of a court within the United States and the control of one or more U.S. persons or (2) has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.

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The tax treatment of a partner (or other owner) in an entity or arrangement treated as a partnership for U.S. federal income tax purposes that holds our ordinary shares, and such entity or arrangement, generally will depend on such partner’s (or other owner’s) status and the activities of such entity or arrangement. A U.S. Holder that is a partner (or other owner) in such an entity or arrangement should consult its tax advisor.

Dividends and Other Distributions on Our Ordinary shares

Subject to the passive foreign investment company rules discussed below, the gross amount of distributions made by us with respect to our ordinary shares (including the amount of non-U.S. taxes withheld therefrom, if any) generally will be includible as dividend income in a U.S. Holder’s gross income in the year received, to the extent such distributions are paid out of our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Because we do not maintain calculations of our earnings and profits under U.S. federal income tax principles, a U.S. Holder should expect all cash distributions will be reported as dividends for U.S. federal income tax purposes. Such dividends will not be eligible for the dividends-received deduction allowed to U.S. corporations with respect to dividends received from other U.S. corporations.

Dividends received by certain non-corporate U.S. Holders (including individuals) may be “qualified dividend income,” which is taxed at the lower applicable capital gains rate, provided that (1) our ordinary shares are readily tradable on an established securities market in the United States, (2) we are neither a passive foreign investment company (as discussed below) nor treated as such with respect to the U.S. Holder for our taxable year in which the dividend is paid or the preceding taxable year, (3) the U.S. Holder satisfies certain holding period requirements, and (4) the U.S. Holder is not under an obligation to make related payments with respect to positions in substantially similar or related property. Under IRS authority, ordinary shares generally are considered for purposes of clause (1) above to be readily tradable on an established securities market in the United States if they are listed on the Nasdaq Capital Market, as our ordinary shares are expected to be. U.S. Holders should consult their own tax advisors regarding the availability of the lower rate for dividends paid with respect to our ordinary shares.

The amount of any distribution paid in foreign currency will be equal to the U.S. dollar value of such currency, translated at the spot rate of exchange on the date such distribution is actually or constructively received by the U.S. Holder, regardless of whether the payment is in fact converted into U.S. dollars at that time. A U.S. Holder generally should not recognize any foreign currency gain or loss in respect of such distribution if such foreign currency is converted into U.S. dollars on the date received by the U.S. Holder. Any further gain or loss on a subsequent conversion or other disposition of the currency for a different U.S. dollar amount will be U.S. source ordinary income or loss.

Dividends on our ordinary shares generally will constitute foreign source income for foreign tax credit limitation purposes. Subject to certain complex conditions and limitations, non-U.S. taxes withheld, if any, on any distributions on our ordinary shares may be eligible for credit against a U.S. Holder’s U.S. federal income tax liability. The limitation on foreign taxes eligible for credit is calculated separately with respect to specific classes of income. For this purpose, dividends distributed by us with respect to our ordinary shares will generally constitute “passive category income.” The U.S. federal income tax rules relating to foreign tax credits are complex, and U.S. Holders should consult their tax advisors regarding the availability of a foreign tax credit in their particular circumstances and the possibility of claiming an itemized deduction (in lieu of the foreign tax credit) for any foreign taxes paid or withheld.

Sale or Other Taxable Disposition of Our Ordinary shares

Subject to the passive foreign investment company rules discussed below, upon a sale or other taxable disposition of our ordinary shares, a U.S. Holder will recognize capital gain or loss for U.S. federal income tax purposes in an amount equal to the difference between the amount realized and the U.S. Holder’s adjusted tax basis in such ordinary shares. Any such gain or loss generally will be treated as long-term capital gain or loss if the U.S. Holder’s holding period in ordinary shares exceeds one year. Non-corporate U.S. Holders (including individuals) generally will be subject to U.S. federal income tax on long-term capital gain at preferential rates. The deductibility of capital losses is subject to significant limitations. Gain or loss, if any, recognized by a U.S. Holder on the sale or other taxable disposition of our ordinary shares generally will be treated as U.S. source gain or loss for U.S. foreign tax credit limitation purposes.

If the consideration received upon the sale or other disposition of our ordinary shares is paid in foreign currency, the amount realized will be the U.S. dollar value of the payment received, translated at the spot rate of exchange on the date of the sale or other taxable disposition. If our ordinary shares are treated as traded on an established

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securities market, a cash basis U.S. Holder or an accrual basis U.S. Holder who has made a special election (which must be applied consistently from year to year and cannot be changed without the consent of the IRS) will determine the U.S. dollar value of the amount realized in foreign currency by translating the amount received at the spot rate of exchange on the settlement date of the sale. If our ordinary shares are not treated as traded on an established securities market, or the relevant U.S. Holder is an accrual basis taxpayer that does not make the special election, such U.S. Holder will recognize foreign currency gain or loss to the extent attributable to any difference between the U.S. dollar amount realized on the date of sale or disposition (as determined above) and the U.S. dollar value of the currency received translated at the spot rate on the settlement date.

A U.S. Holder’s initial U.S. federal income tax basis in our ordinary shares generally will equal the cost of such ordinary shares. If a U.S. Holder used foreign currency to purchase the ordinary shares, the cost of the ordinary shares will be the U.S. dollar value of the foreign currency purchase price on the date of purchase, translated at the spot rate of exchange on that date. If our ordinary shares are treated as traded on an established securities market and the relevant U.S. Holder is either a cash basis taxpayer or an accrual basis taxpayer who has made the special election described above, the U.S. Holder will determine the U.S. dollar value of the cost of such ordinary shares by translating the amount paid at the spot rate of exchange on the settlement date of the purchase.

Passive Foreign Investment Company Considerations

We will be classified as a passive foreign investment company (a “PFIC”) for any taxable year if either: (1) at least 75% of our gross income is “passive income” for purposes of the PFIC rules or (2) at least 50% of the value of our assets (determined on the basis of a quarterly average) is attributable to assets that produce or are held for the production of passive income. For this purpose, we will be treated as owning our proportionate share of the assets and earning our proportionate share of the income of any other corporation in which we own, directly or indirectly, 25% or more (by value) of the stock.

Under the PFIC rules, if we were considered a PFIC at any time that a U.S. Holder holds our ordinary shares, we would continue to be treated as a PFIC with respect to such U.S. Holder unless (1) we cease to qualify as a PFIC under the income and asset tests discussed in the prior paragraph and (2) the U.S. Holder has made a “deemed sale” election under the PFIC rules.

Based on the anticipated market price of our ordinary shares in the offering and the current and anticipated composition of our income, assets and operations, we do not expect to be treated as a PFIC for the current taxable year or in the foreseeable future. This is a factual determination, however, that depends on, among other things, the composition of our income and assets and the market value of our shares and assets from time to time, and thus the determination can only be made annually after the close of each taxable year. Therefore, there can be no assurance that we will not be classified as a PFIC for the current taxable year or for any future taxable year.

If we are considered a PFIC at any time that a U.S. Holder holds our ordinary shares, any gain recognized by a U.S. Holder on a sale or other disposition of our ordinary shares, as well as the amount of any “excess distribution” (defined below) received by the U.S. Holder, would be allocated ratably over the U.S. Holder’s holding period for our ordinary shares. The amounts allocated to the taxable year of the sale or other disposition (or the taxable year of receipt, in the case of an excess distribution) and to any year prior to the year in which we became a PFIC would be taxed as ordinary income. The amount allocated to each other taxable year would be subject to tax at the highest rate in effect for individuals or corporations, as appropriate, for that taxable year, and an interest charge would be imposed. For the purposes of these rules, an excess distribution is the amount by which any distribution received by a U.S. Holder on its ordinary shares exceeds 125% of the average of the annual distributions on our ordinary shares received during the preceding three years or the U.S. Holder’s holding period, whichever is shorter.

Certain elections may be available that would result in alternative treatments (such as qualified electing fund treatment or mark-to-market treatment) of our ordinary shares if we are considered a PFIC. We do not intend to provide the information necessary for U.S. Holders of our ordinary shares to make qualified electing fund elections, which, if available, would result in tax treatment different from the general tax treatment for an investment in a PFIC described above. If we are treated as a PFIC with respect to a U.S. Holder for any taxable year, the U.S. Holder will be deemed to own shares in any of our subsidiaries that are also PFICs. However, an election for mark-to-market treatment would likely not be available with respect to any such subsidiaries.

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If we are considered a PFIC, a U.S. Holder will also be subject to annual information reporting requirements. U.S. Holders should consult their tax advisors about the potential application of the PFIC rules to an investment in our ordinary shares.

U.S. Information Reporting and Backup Withholding

Dividend payments with respect to our ordinary shares and proceeds from the sale, exchange or redemption of our ordinary shares may be subject to information reporting to the IRS and possible U.S. backup withholding. A U.S. Holder may be eligible for an exemption from backup withholding if the U.S. Holder furnishes a correct taxpayer identification number and makes any other required certification or is otherwise exempt from backup withholding. U.S. Holders who are required to establish their exempt status may be required to provide such certification on IRS Form W-9. U.S. Holders should consult their tax advisors regarding the application of the U.S. information reporting and backup withholding rules.

Backup withholding is not an additional tax. Amounts withheld as backup withholding may be credited against a U.S. Holder’s U.S. federal income tax liability, and such U.S. Holder may obtain a refund of any excess amounts withheld under the backup withholding rules by timely filing an appropriate claim for refund with the IRS and furnishing any required information.

Additional Information Reporting Requirements

A U.S. Holder that acquires ordinary shares generally will be required to file Form 926 with the IRS if (1) immediately after the acquisition such U.S. Holder, directly or indirectly, owns at least 10% of the ordinary shares, or (2) the amount of cash transferred in exchange for ordinary shares during the 12-month period ending on the date of the acquisition exceeds $100,000. Significant penalties may apply for failing to satisfy these filing requirements. U.S. Holders are urged to contact their tax advisors regarding these filing requirements.

Certain U.S. Holders who are individuals (and certain entities) that hold an interest in “specified foreign financial assets” (which may include our ordinary shares) are required to report information relating to such assets, subject to certain exceptions (including an exception for ordinary shares held in accounts maintained by certain financial institutions). Penalties can apply if U.S. Holders fail to satisfy such reporting requirements. U.S. Holders should consult their tax advisors regarding the applicability of these requirements to their acquisition and ownership of our ordinary shares.

THE DISCUSSION ABOVE IS A GENERAL SUMMARY.    IT DOES NOT COVER ALL TAX MATTERS THAT MAY BE IMPORTANT TO YOU. EACH PROSPECTIVE PURCHASER SHOULD CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES OF AN INVESTMENT IN OUR ORDINARY SHARES UNDER THE INVESTOR’S OWN CIRCUMSTANCES.

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UNDERWRITING

In connection with this offering, we entered into an underwriting agreement with Boustead Securities, LLC, as Underwriter in this offering. The Underwriter may retain other brokers or dealers to act as a sub-agents or selected dealers on their behalf in connection with this offering. The Underwriter has agreed to purchase from us, on a firm commitment basis, the number of ordinary shares set forth opposite its name below, at the offering price less the underwriting discounts set forth on the cover page of this prospectus:

Name of Underwriter

 

Number of
Ordinary Shares

Boustead Securities, LLC

 

 

The Underwriter is committed to purchase all the ordinary shares offered by this prospectus if it purchases any ordinary shares. The Underwriter is offering the ordinary shares, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel, and other conditions contained in the underwriting agreement, such as the receipt by the Underwriter of officer’s certificates and legal opinions. The Underwriter reserves the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.

Fees, Commissions and Expense Reimbursement

We will pay the Underwriter a fee/commission equivalent to seven percent (7%) of the gross proceeds of this offering. The Underwriter proposes initially to offer the ordinary shares to the public at the offering price set forth on the cover page of this prospectus and to dealers at those prices less the aforesaid fee (“underwriting discount”) set forth on the cover page of this prospectus. If all of the ordinary shares offered by us are not sold at the offering price, the Underwriter may change the offering price and other selling terms by means of a supplement to this prospectus.

The following table shows the underwriting fees/commission payable to the Underwriting with this offering:

 

Per Ordinary Share

 

Total without over-allotment option

 

Total with full over-allotment option

Public offering price

 

$

 

 

$

 

 

$

 

Underwriting fees and commissions (7%)(1)

 

$

 

 

$

 

 

$

 

Proceeds, before expenses, to us

 

$

 

 

$

 

 

$

 

____________

(1)      The fees do not include the Underwriter’s Warrants or expense reimbursement as described below.

In addition to the cash commission, we will also reimburse the Underwriter for its accountable out-of-pocket expenses not to exceed $250,000. Such accountable out-of-pocket expenses include no more than $100,000 in Underwriter’s legal counsel fees, $75,000 in due diligence and other like expenses and road show, travel, platform on-boarding fees, and other reasonable out-of-pocket accountable expenses not to exceed $75,000. We have paid to Boustead $[    ] in accountable expenses as of the date hereof, which will be refundable to us to the extent actually not incurred by the Underwriter in accordance with FINRA Rule 5110(f)(2)(C).

We estimate that the total expenses payable by us in connection with the offering, other than the underwriting fees and commissions, will be approximately $800,000, which includes the maximum of $250,000 in accountable expenses payable to the Underwriter.

We have granted a 45-day option to the underwriter to purchase up to 300,000 additional ordinary shares at the public offering price from us solely to cover over-allotments, if any, less underwriting discounts and commissions.

We have agreed to issue to the Underwriter and to register herein warrants to purchase up to 140,000 ordinary shares (equal to seven percent (7%) of the ordinary shares sold in this offering) and to also register herein such underlying ordinary shares. The warrants will be exercised at any time, and from time to time, in whole or in part, commencing from the closing of the offering and expiring five (5) years from the effectiveness of the offering. The warrants are exercisable at a per share price of 100% of the offering price of the ordinary shares offered hereby. The Underwriter Warrant shall not be callable or cancellable.

The Underwriter’s Warrant may not be sold, transferred, assigned, pledged or hypothecated, or be the subject of any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the

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securities by any person for a period of 180 days immediately following the commencement of sales of the offering, of which this prospectus forms a part (in accordance with FINRA Rule 5110), except that they may be assigned, in whole or in part, to any successor, officer, manager, member, or partner of the Underwriter, and to members of the syndicate or selling group and their respective officers, managers, members or partners. The Underwriter’s Warrant may be exercised as to all or a lesser number of shares, will provide for cashless exercise and will contain provisions for immediate “piggyback” registration rights at our expense for a period of five years from the date of effectiveness of the offering. We have registered the Underwriter the ordinary shares underlying the Underwriter’s Warrant in this offering.

The Underwriter intends to offer our ordinary shares to their retail customers only in states in which we are permitted to offer our ordinary shares. We have relied on an exemption to the blue sky registration requirements afforded to “covered securities.” Securities listed on a National Securities Exchange are “covered securities.” If we were unable to meet a National Securities Exchange listing standards, then we would be unable to rely on the covered securities exemption to blue sky registration requirements and we would need to register the offering in each state in which we planned to sell shares. Consequently, we will not complete this offering unless we meet a National Securities Exchange’s listing requirements and our application to list on the exchange is approved.

The foregoing does not purport to be a complete statement of the terms and conditions of the underwriting agreement and subscription agreement. A form of the underwriting agreement is included as an exhibit to the registration statement of which this prospectus forms a part.

Right of First Refusal

Until twenty-four (24) months from the closing of this public offering, the Underwriter shall have a right of first refusal to act as lead or managing underwriter, exclusive or joint financial advisor or in any other similar capacity, on the representative’s customary terms and conditions, in the event we pursue a registered, underwritten public offering of securities (in addition to this offering), a public or private offering of securities (debt or equity), a merger, acquisition of another company or business, change of control, sale of substantially all assets, business combination, recapitalization or other similar transaction (regardless of whether we would be considered an acquiring party, a selling party or neither in such transaction). In accordance with FINRA Rule 5110(f)(2)(E)(i), such right of first refusal shall not have a duration of more than three years from the date of commencement of sales of the public offering or the termination date of the engagement between the us and the Underwriter. Notwithstanding the above, we have the right to terminate our obligations as they pertain to the Underwriter’s “right of first refusal” for “cause” pursuant to FINRA Rule 5110(g)(5)(B)(i). For the avoidance of doubt, “for cause” termination shall include termination due to any material failure by the Underwriter to provide the underwriting services contemplated herein.

Lock-Up Agreements

We have agreed that, subject to certain exceptions set forth in the underwriting agreement, we will not, without the prior written consent of the Underwriter, from the date of execution of the underwriting agreement and continuing for a period of 12 months from the date on which the trading of the ordinary shares on a National Securities Exchange commences, (i) offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant or extend any option, right or warrant to purchase or otherwise transfer or dispose of, directly or indirectly, or file with the SEC a registration statement under the Securities Act relating to, any ordinary shares or any securities convertible into or exercisable or exchangeable for ordinary shares, or (ii) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the ordinary shares or any such other securities.

Our officers, directors, and all existing shareholders agree not to offer, issue, sell, contract to sell, encumber, grant any option for the sale of or otherwise dispose of any ordinary shares or other securities convertible into or exercisable or exchangeable for ordinary shares for a period of up to 12 months after the date of the underwriting agreement between the Company and the Underwriter without the prior written consent of the Underwriter; provided that those persons who purchased units in our April 2021 private placement and August 2021 private placement would be able to:

•        sell one-third of the shares contained in the units that are not registered for resale in the selling shareholder offering and one-third of the shares underlying the warrants contained in such units after 180 days from the initial public offering;

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•        sell one-third of the shares contained in the units that are not registered for resale in the selling shareholder offering and one-third of the shares underlying the warrants contained in such units after 270 days from the initial public offering;

•        sell one-third of the shares contained in the units that are not registered for resale in the selling shareholder offering and one-third of the shares underlying the warrants contained in such units after 365 days from the initial public offering; and

•        commencing 90 days after the initial public offering, if our ordinary share price is over $7.50 per share for ten consecutive trading days, with at least 100,000 shares traded per day, the such persons may sell one-third of their shares subject to a maximum sale on any trading day of 3% of the daily volume;

•        commencing 90 days after the initial public offering, if our ordinary share price is over $10.00 per share for ten consecutive trading days, with at least 100,000 shares traded per day, such persons may sell an additional one-third of their shares subject to a maximum sale on any trading day of 3% of the daily volume; and

•        commencing 90 days after the initial public offering, if our ordinary share price is over $15.00 per share for ten consecutive trading days, with at least 100,000 shares traded per day, such persons may sell an additional one-third constituting a maximum total of all of their shares subject to a maximum sale on any trading day of 3% of the daily volume.

The Underwriter may in its sole discretion and at any time without notice release some or all of the ordinary shares subject to lock-up agreements prior to the expiration of the lock-up period. When determining whether or not to release shares from the lock-up agreements, the Underwriter will consider, among other factors, the security holder’s reasons for requesting the release, the number of shares for which the release is being requested and market conditions at the time.

Price Stabilization

The Underwriter will be required to comply with the Securities Act and the Exchange Act, including without limitation, Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of shares of capital stock by the Underwriter acting as principal. Under these rules and regulations, the Underwriter:

•        may not engage in any stabilization activity in connection with our securities; and

•        may not bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange Act, until it has completed its participation in the distribution.

Determination of Offering Price

The public offering price of the ordinary shares we are offering was determined by us in consultation with the Underwriter based on discussions with potential investors in light of the history and prospects of our Company, the stage of development of our business, our business plans for the future and the extent to which they have been implemented, an assessment of our management, the public stock price for similar companies, general conditions of the securities markets at the time of the offering and such other factors as were deemed relevant.

Electronic Offer, Sale and Distribution of Securities

A prospectus in electronic format may be delivered to potential investors by the Underwriter. The prospectus in electronic format will be identical to the paper version of such prospectus. Other than the prospectus in electronic format, the information on the Underwriter’ website and any information contained in any other website maintained by the Underwriter is not part of the prospectus or the registration statement of which this Prospectus forms a part.

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Foreign Regulatory Restrictions on Purchase of our Ordinary Shares

We have not taken any action to permit a public offering of our ordinary shares outside the United States or to permit the possession or distribution of this prospectus outside the United States. People outside the United States who come into possession of this prospectus must inform themselves about and observe any restrictions relating to this offering of our ordinary shares and the distribution of this prospectus outside the United States.

Indemnification

We have agreed to indemnify the Underwriter against liabilities relating to the offering arising under the Securities Act and the Exchange Act and to contribute to payments that the Underwriter may be required to make for these liabilities. We have been advised that, in the opinion of the Securities and Exchange Commission, indemnification of liabilities under the Securities Act is against public policy as expressed in the Securities Act, and is therefore, unenforceable.

Nasdaq Listing

We will not complete this offering unless our ordinary shares have been approved for listing on the Nasdaq Capital Market under the symbol “MYNZ”.

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EXPENSES RELATING TO THIS OFFERING

Set forth below is an itemization of the total expenses, excluding placement discounts and commissions, the underwriter’s non-accountable expenses and the underwriter’s accountable expenses, that we expect to incur in connection with this offering. With the exception of the SEC registration fee, the FINRA filing fee and the Nasdaq Capital Market listing fee, all amounts are estimates.

Securities and Exchange Commission Registration Fee

 

$

1,714

Nasdaq Capital Market Listing Fee

 

$

50,000

FINRA

 

$

2,000

Legal Fees and Expenses

 

$

275,000

Accounting Fees and Expenses

 

$

167,000

Printing and Engraving Expenses

 

$

35,000

Miscellaneous Expenses

 

$

19,286

Total Expenses

 

$

550,000

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LEGAL MATTERS

Ortoli Rosenstadt LLP is acting as counsel to our company regarding U.S. securities law matters. The current address of Ortoli Rosenstadt LLP is 501 Madison Avenue, 14th Floor, New York, NY 10022. CMS Derks Star Busmann N.V. is acting as counsel to our company regarding Dutch securities law matters. The current address of CMS Derks Star Busmann N.V. is Atrium, Parnassusweg 737, 1077 DG Amsterdam, Netherlands.

Sichenzia Ross Ference LLP is acting as counsel to the underwriter.

EXPERTS

The financial statements of Mainz Biomed, B.V. as of March 31, 2021 and for the period from March 8, 2021 (inception) through to March 31, 2021 included in this prospectus and registration statement have been so included in reliance on the report of BF Borgers CPA P.C., an independent registered public accounting firm, given on the authority of said firm as experts in accounting and auditing. BF Borgers CPA P.C. has offices at 5400 W Cedar Ave, Lakewood, CO 80226. Their telephone number is (303) 953-1454.

The financial statements of PharmGenomics GmbH as of December 31, 2020 and 2019 for the years respectively then ended included in this prospectus and registration statement have been so included in reliance on the report of BF Borgers CPA P.C., an independent registered public accounting firm, given on the authority of said firm as experts in accounting and auditing. BF Borgers CPA P.C. has offices at 5400 W Cedar Ave, Lakewood, CO 80226. Their telephone number is (303) 953-1454.

INTERESTS OF EXPERTS AND COUNSEL

None of the named experts or legal counsel was employed on a contingent basis, owns an amount of shares in our company which is material to that person, or has a material, direct or indirect economic interest in our company or that depends on the success of the offering.

DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling the registrant pursuant to the foregoing provisions, the registrant has been informed that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

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ENFORCEABILITY OF CIVIL LIABILITIES

We are a corporation organized under the laws of the Netherlands, and the majority of our directors and officers reside outside of the United States. Service of process upon such persons may be difficult or impossible to effect within the United States. Furthermore, because a substantial portion of our assets, and substantially all the assets of our directors and officers and the experts named herein, are located outside of the United States, any judgment obtained in the United States, including a judgment based upon the civil liability provisions of United States federal securities laws, against us or any of such persons may not be collectible within the United States.

As there is no treaty on the reciprocal recognition and enforcement of judgments other than arbitration awards in civil and commercial matters between the United States and the Netherlands, courts in the Netherlands will not automatically recognize and enforce a final judgment rendered by a U.S. court. In order to obtain a judgment enforceable in the Netherlands, claimants must litigate the relevant claim again before a Dutch court of competent jurisdiction. Under current practice, however, a Dutch court will generally recognize and consider as conclusive evidence a final and conclusive judgment for the payment of money rendered by a U.S. court and not rendered by default, provided that the Dutch court finds that:

•        the jurisdiction of the U.S. court has been based on grounds that are internationally acceptable;

•        the final judgment results from proceedings compatible with Dutch concepts of proper administration of justice including sufficient safeguards (behoorlijke rechtspleging);

•        the final judgment does not contravene public policy (openbare orde) of the Netherlands;

•        the judgment by the U.S. court is not incompatible with a decision rendered between the same parties by a Dutch court, or with a previous decision rendered between the same parties by a foreign court in a dispute that concerns the same subject and is based on the same cause, provided that the previous decision qualifies for acknowledgment in the Netherlands; and

the final judgment has not been rendered in proceedings of a penal, revenue or other public law nature. If a Dutch court upholds and regards as conclusive evidence the final judgment, that court generally will grant the same judgment without litigating again on the merits.

Shareholders may originate actions in the Netherlands based upon applicable Dutch laws.

Under Dutch law, in the event that a third party is liable to us, only we ourselves can bring civil action against that party. The individual shareholders do not have the right to bring an action on our behalf. Only in the event that the cause for the liability of a third party to us also constitutes a tortious act directly against a shareholder does that shareholder have an individual right of action against such third party in its own name. The Dutch Civil Code does provide for the possibility to initiate such actions collectively. A foundation or an association whose objective is to protect the rights of a group of persons having similar interests can institute a collective action. The collective action itself cannot result in an order for payment of monetary damages but may only result in a declaratory judgment (verklaring voor recht). In order to obtain compensation for damages, the foundation or association and the defendant may reach — often on the basis of such declaratory judgment — a settlement. A Dutch court may declare the settlement agreement binding upon all the injured parties with an opt out choice for an individual injured party. An individual injured party may also itself institute a civil claim for damages.

The name and address of our agent for service of process in the United States is Vcorp Services, LLC, 25 Robert Pitt Drive, Suite 204, Monsey, NY 10952.

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WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC a registration statement on Form F-1 under the Securities Act with respect to the ordinary shares offered hereby. This prospectus does not contain all of the information set forth in the registration statement and the exhibits thereto, to which reference is hereby made. With respect to each contract, agreement or other document filed as an exhibit to the registration statement, reference is made to such exhibit for a more complete description of the matter involved. The registration statement and the exhibits thereto filed by us with the SEC may be inspected at the public reference facility of the SEC listed below.

The registration statement, reports and other information filed or to be filed with the SEC by us can be inspected and copied at the public reference facilities maintained by the SEC at 100 F. Street NW, Washington, D.C. 20549. The SEC maintains a website at www.sec.gov that contains reports, proxy and information statements, and other information regarding registrants that make electronic filings with the SEC using its EDGAR system.

We are subject to the information reporting requirements of the Exchange Act that are applicable to foreign private issuers, and under those requirements are filing reports with the SEC. Those other reports or other information may be inspected without charge at the locations described above. As a foreign private issuer, we are exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file annual, quarterly and current reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. However, we will file with the SEC, within 120 days after the end of each fiscal year, or such applicable time as required by the SEC, an annual report on Form 20-F containing financial statements audited by an independent registered public accounting firm, and will submit to the SEC, on Form 6-K, unaudited quarterly financial information.

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INDEX TO FINANCIAL STATEMENTS

 

Page

MAINZ BIOPHARMA B.V.

   

From March 1, 2021 (inception) to March 31, 2021

   

Report of Independent Registered Public Accounting Firm

 

F-2

Financial Statements:

   

Statement of operations from March 1, 2021 (inception) to March 31, 2021

 

F-3

Statement of Financial Position

 

F-4

Statement of Changes in Shareholders’ Deficit

 

F-5

Statement of Cash Flows

 

F-6

Notes to Financial Statements

 

F-7

     

From March 1, 2021 (inception) to June 30, 2021

   

Statement of operations from March 1, 2021 (inception) to June 30, 2021

 

F-12

Statement of Financial Position

 

F-13

Statement of Changes in Shareholders’ Deficit

 

F-14

Statement of Cash Flows

 

F-15

Notes to Financial Statements

 

F-16

     

PHARMGENOMICS GmbH

   

Year Ended December 31, 2020 and 2019

   

Report of Independent Registered Public Accounting Firm

 

F-22

Financial Statements:

   

Statements of Financial Position

 

F-23

Statements of Comprehensive Loss

 

F-24

Statements of Changes in (Deficiency) Equity

 

F-25

Statements of Cash Flows

 

F-26

Notes to Financial Statements

 

F-27

     

Six Months Ended June 30, 2021

   

Statements of Financial Position

 

F-47

Statements of Comprehensive Loss

 

F-48

Statements of Changes in (Deficiency) Equity

 

F-49

Statements of Cash Flows

 

F-50

Notes to Financial Statements

 

F-51

     

UNAUDITED PRO FORMA COMBINED FINANCIAL STATEMENTS

 

F-64

Year Ended December 31, 2020

   

Unaudited Pro Forma Consolidated Balance Sheet as of March 31, 2021

 

F-65

Unaudited Pro Forma Consolidated Statement of Operations for the Year Ended March 31, 2021

 

F-66

     

Period Ended June 30, 2020

   

Unaudited Pro Forma Consolidated Balance Sheet as of June 30, 2021

 

F-70

Unaudited Pro Forma Consolidated Statement of Operations for the six months Ended June 30, 2021

 

F-71

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Report of Independent Registered Public Accounting Firm

To the shareholders and the board of directors of Mainz Biomed B.V.

Opinion on the Financial Statements

We have audited the accompanying statement of financial position of Mainz Biomed B.V. (the “Company”) as of March 31, 2021, the related statement of operations, stockholders’ equity (deficit), and cash flows for the period from March 8, 2021 (inception) thru to March 31, 2021, 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 March 31, 2021, and the results of its operations and its cash flows for the period from March 8, 2021 (inception) thru to March 31, 2021, in conformity with the International Financial Reporting Standards as issued by the International Accounting Standards Board.

Substantial Doubt about the Company’s Ability to Continue as a Going Concern

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company’s significant operating losses raise substantial doubt about its ability to continue as a going concern. The 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 audit. 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 audit 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 audit, 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 audit 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 regarding the amounts and disclosures in the financial statements. Our audit 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 audit provides a reasonable basis for our opinion.

/s/ BF Borgers CPA PC

BF Borgers CPA PC

Served as Auditor since 2021

Lakewood, CO

August 3, 2021

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Mainz Biomed B.V.
Statement of Operations

 

Note

 

March 8, 2021
(Inception) to
March 31,
2021

Net sales

     

$

 

       

 

 

 

Operating expenses:

     

 

 

 

Professional fees

     

 

39,992

 

Total operating expenses

     

 

39,992

 

       

 

 

 

Loss from operations

     

 

(39,992

)

       

 

 

 

Net loss

     

$

(39,992

)

       

 

 

 

Comprehensive loss

     

$

(39,992

)

       

 

 

 

Basic and dilutive loss per ordinary share

     

$

(39,992.00

)

Weighted average number of ordinary shares outstanding

     

 

1

 

The accompanying notes are an integral part of these financial statements.

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Mainz Biomed B.V.
Statement of Financial position

 

Note

 

March 31,
2021

ASSETS

     

 

 

 

Current Assets

     

 

 

 

Cash

     

$

 

Total Current Assets

     

 

 

       

 

 

 

Total assets

     

$

 

       

 

 

 

LIABILITIES AND SHAREHOLDER’S DEFICIT

     

 

 

 

Current Liabilities

     

 

 

 

Accounts payable

     

$

39,992

 

Total current liabilities

     

 

39,992

 

       

 

 

 

Total Liabilities

     

 

39,992

 

       

 

 

 

Shareholder’s equity

     

 

 

 

Capital

     

 

 

Accumulated deficit

 

5

 

 

(39,992

)

Total shareholder’s deficit

     

 

(39,992

)

       

 

 

 

Total liabilities and shareholder’s deficit

     

$

 

The accompanying notes are an integral part of these financial statements.

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Mainz Biomed B.V.
Statement of Changes in Shareholders’ Deficit

 

Note

 

Share
Capital

 

Accumulated
Deficit

 

Total
Shareholders’
Deficit

Inception, March 8, 2021

     

$

 

$

 

 

$

 

Share issuance at inception

 

5

 

 

 

 

 

 

 

 

Net loss

     

 

 

 

(39,992

)

 

 

(39,992

)

Balance, March 31, 2021

     

$

 

$

(39,992

)

 

$

(39,992

)

The accompanying notes are an integral part of these financial statements.

F-5

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Mainz Biomed B.V.
Statement of Cash Flows

 

Note

 

March 8, 2021
(Inception) to
March 31,
2021

CASH FLOWS FROM OPERATING ACTIVITIES

     

 

 

 

Net income

     

$

(39,992

)

Adjustments to reconcile net income to net cash provided by (used in)
operating activities:

     

 

 

 

Changes in operating assets and liabilities:

     

 

 

 

Accounts payable

     

 

39,992

 

Cash generated from operating activities

     

 

 

Net cash provided by (used in) operating activities

     

 

 

       

 

 

 

Net change in cash

     

 

 

Cash at beginning of period

     

 

 

Effect of movements in exchange rates

     

 

 

Cash at end of period

     

$

 

The accompanying notes are an integral part of these financial statements.

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Mainz Biomed B.V.
Notes to the Financials Statements
March 8, 2021 (Inception) to March 31, 2021

NOTE 1. Reporting Entity

Mainz Biomed B.V. (the “Company”) is domiciled in Netherlands. The Company’s registered office is at Sirius Gutenberg Park, Robert-Koch-Str. 50, 55129 Mainz, Germany. The Company was formed to acquire the business of PharmGenomics GmbH (“PharmaGenomics”), is a limited liability company based in Mainz, Germany. PharmGenomics develops in-vitro diagnostic and research use only tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine.  The Company plans to complete a Contribution Agreement to affect such acquisition (see Note 7).

NOTE 2. Basis of preparation and going concern

These financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and interpretations of the International Financial Reporting Issues Committee (“IFRIC”). The principal accounting policies applied in the preparation of these financial statements are set out below. They were authorized for issue by the Company’s board of directors on August 3, 2021.

These financial statements are presented in United States dollars. The fiscal year end is December 31.

Going concern

These financial statements have been prepared on a going concern basis which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The continuing operations of the Company are dependent upon its ability to evaluate and complete a business combination. At March 31, 2021, the Company has an accumulated deficit of $39,992 including a loss for the year ended March 31, 2021 of $39,992.

These uncertainties may cast significant doubt upon the Company’s ability to continue as a going concern. These financial statements do not include any adjustments relating to the recoverability and classification of assets and liabilities which might be necessary should the Company be unable to continue in existence.

NOTE 3. Use of judgements and estimates

In preparing these financial statements, management has made judgements and estimates that affect the application of the Company’s accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates.

Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to estimates are recognized prospectively. Areas requiring a significant degree of estimation and judgment include fair value measurements for financial instruments, the recoverability and measurement of deferred tax assets and liabilities and assessment of the Company’s ability to continue as a going concern.

NOTE 4. Significant accounting policies

General

The accounting policies described in these financial statements have been applied consistently to all periods presented in these financial statements.

Foreign currency

Transactions in foreign currencies are translated to the respective functional currencies of the Company using the exchange rates at transaction date. Receivables, payables and other monetary assets and liabilities denominated in foreign currencies are re-translated to the functional currency using the exchange rates at the balance sheet date. Resulting foreign currency differences are recognized in the income statement, except for foreign currency differences arising on re-translation of Fair Value through Other Comprehensive Income (FVOCI) investments and financial liabilities designated as a hedge of a net investment, which are recognized in other comprehensive income.

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Mainz Biomed B.V.
Notes to the Financials Statements
March 8, 2021 (Inception) to March 31, 2021

NOTE 4. Significant accounting policies (cont.)

Non-monetary assets and liabilities denominated in foreign currencies that are measured at fair value are re-translated to the functional currency at the exchange rate at the date that the fair value was determined. Non-monetary items in a foreign currency that are measured at cost are translated into the functional currency at the exchange rate at transaction date.

Cash and cash equivalents

Cash and cash equivalents include cash on hand and other short-term highly liquid investments with original maturities of three months or less.

Revenue

Revenue is measured based on the consideration specified in a contract with a customer. The Company recognizes revenue when it transfers control over a good or service to a customer.

Earnings (loss) per share

The calculation of earnings per share (EPS) for the period ended March 31, 2021 is based on the loss attributable to the shareholder of the Company (net profit (loss)) and the weighted average number of shares outstanding (basic and diluted) during the period ended March 31, 2021. The Company has no potentially dilutive securities, such as options or warrants, currently issued and outstanding.

Income tax

Income tax expense comprises current and deferred tax. It is recognized in profit or loss except to the extent that it relates to a business combination, or items recognized directly in equity or in OCI.

Current tax comprises the expected tax payable or receivable on the taxable income or loss for the year and any adjustment to the tax payable or receivable in respect of previous years. The amount of current tax payable or receivable is the best estimate of the tax amount expected to be paid or received that reflects uncertainty related to income taxes, if any. It is measured using tax rates enacted or substantively enacted at the reporting date. Current tax also includes any tax arising from dividends. Current tax assets and liabilities are offset only if certain criteria are met.

Deferred tax is recognized in respect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred tax is not recognized for:

•        temporary differences on the initial recognition of assets or liabilities in a transaction that is not a business combination and that affects neither accounting nor taxable profit or loss;

•        temporary differences related to investments in subsidiaries, associates and joint arrangements to the extent that the Company is able to control the timing of the reversal of the temporary differences and it is probable that they will not reverse in the foreseeable future; and

•        taxable temporary differences arising on the initial recognition of goodwill.

The amount of deferred tax provided is based on the expected manner of recovery or settlement of the carrying amount of assets and liabilities, using tax rates (substantively) enacted, at year-end.  Deferred tax assets are recognized to the extent that it is probable that future taxable profits will be available against which they can be utilized. Deferred tax assets and liabilities are offset if there is a legally enforceable right to offset current tax liabilities and assets, and they relate to income taxes levied by the same tax authority on the same taxable entity, or on different taxable entities which intend either to settle current tax liabilities and assets on a net basis or to realize the assets and settle the liabilities simultaneously.  Current and deferred tax are recognized in the income statement, except when it relates to a business combination or for items directly recognized in equity or other comprehensive income.

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Mainz Biomed B.V.
Notes to the Financials Statements
March 8, 2021 (Inception) to March 31, 2021

NOTE 4. Significant accounting policies (cont.)

Foreign Currency Translation

The functional and reporting currency of the Company is the United States dollar. Transactions denominated in foreign currencies are translated using the exchange rate in effect on the transaction date or at an average rate. Monetary assets and liabilities denominated in foreign currencies are translated at the rate of exchange in effect at the statement of financial position date. Non-monetary items are translated using the historical rate on the date of the transaction. Foreign exchange gains and losses are included in profit and loss

Share capital

Incremental costs directly attributable to the issue of ordinary shares are recognized as a deduction from equity. Income tax relating to transaction costs of an equity transaction is accounted for in accordance with IAS 12.

Fair value measurement

Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date in the principal or, in its absence, the most advantageous market to which the Company has access at that date. The fair value of a liability reflects its non-performance risk.

When one is available, the Company measures the fair value of an instrument using the quoted price in an active market for that instrument. A market is regarded as ‘active’ if transactions for the asset or liability take place with sufficient frequency and volume to provide pricing information on an ongoing basis. If there is no quoted price in an active market, then the Company uses valuation techniques that maximize the use of relevant observable inputs and minimize the use of unobservable inputs. The chosen valuation technique incorporates all of the factors that market participants would take into account in pricing a transaction. If an asset or a liability measured at fair value has a bid price and an ask price, then the Company measures assets and long positions at a bid price and liabilities and short positions at an ask price

Accounting standard issued but not yet effective

Certain accounting standards or amendments to existing accounting standards that have been issued but have future effective dates are either not applicable or are not expected to have a significant impact on the Company’s financial statements

NOTE 5. Capital

 

Ordinary shares
2021

Inception at March 8, 2021

   

Share issuance at inception

 

1

Issued and outstanding at March 31, 2021

 

1

Ordinary shares

Holders of these shares are entitled to dividends as declared from time to time and are entitled to one vote per share at general meetings of the Company. All rights attached to the Company’s shares held by the Company are suspended until those shares are reissued.

On March 8, 2021, the Company issued share capital of EUR0.01 consisting of one share with a nominal value of EUR0.01.

F-9

Table of Contents

Mainz Biomed B.V.
Notes to the Financials Statements
March 8, 2021 (Inception) to March 31, 2021

NOTE 6. Financial instruments and risk management

Financial instruments

Trade receivables and debt securities issued are initially recognized when they are originated. All other financial assets and financial liabilities are initially recognized when the Company becomes a party to the contractual provisions of the instrument.

A financial asset (unless it is a trade receivable without a significant financing component) or financial liability is initially measured at fair value plus or minus, for an item not at Fair value through profit or loss (FVTPL), transaction costs that are directly attributable to its acquisition or issue. A trade receivable without a significant financing component is initially measured at the transaction price.

The Company derecognizes a financial asset when:

•        the contractual rights to the cash flows from the financial asset expire; or

•        it transfers the rights to receive the contractual cash flows in a transaction in which either:

•        substantially all of the risks and rewards of ownership of the financial asset are transferred; or

•        the Company neither transfers nor retains substantially all of the risks and rewards of ownership and it does not retain control of the financial asset

Financial liabilities are classified as measured at amortized cost or fair value through profit or loss (FVTPL). A financial liability is classified as at FVTPL if it is classified as held-for-trading, it is a derivative or it is designated as such on initial recognition. Financial liabilities at FVTPL are measured at fair value and net gains and losses, including any interest expense, are recognized in profit or loss. Other financial liabilities are subsequently measured at amortized cost using the effective interest method. Interest expense and foreign exchange gains and losses are recognized in profit or loss. Any gain or loss on derecognition is also recognized in profit or loss.

The Company derecognizes a financial liability when its contractual obligations are discharged or cancelled, or expire. The Company also derecognizes a financial liability when its terms are modified and the cash flows of the modified liability are substantially different, in which case a new financial liability based on the modified terms is recognized at fair value. On derecognition of a financial liability, the difference between the carrying amount extinguished and the consideration paid (including any non-cash assets transferred or liabilities assumed) is recognized in profit or loss.

At March 31, 2021, the Company’s financial instrument is trade payables.

Financial risk management

The Company’s board of directors has overall responsibility for the establishment and oversight of the Company’s risk management framework. The board of directors has established the risk management committee, which is responsible for developing and monitoring the Company’s risk management policies. The committee reports regularly to the board of directors on its activities.

The Company’s risk management policies are established to identify and analyze the risks faced by the Company, to set appropriate risk limits and controls and to monitor risks and adherence to limits. Risk management policies and systems are reviewed regularly to reflect changes in market conditions and the Company’s activities. The Company, through its training and management standards and procedures, aims to maintain a disciplined and constructive control environment in which all employees understand their roles and obligations.

F-10

Table of Contents

Mainz Biomed B.V.
Notes to the Financials Statements
March 8, 2021 (Inception) to March 31, 2021

NOTE 6. Financial instruments and risk management (cont.)

The Company has exposure to the following risks arising from financial instruments:

•        Credit risk is the risk of financial loss to the Company if a customer or counterparty to a financial instrument fails to meet its contractual obligations and arises principally from the Company’s receivables from customers and investments in debt securities.

•        Liquidity risk is the risk that the Company will encounter difficulty in meeting the obligations associated with its financial liabilities that are settled by delivering cash or another financial asset. The Company’s objective when managing liquidity is to ensure, as far as possible, that it will have sufficient liquidity to meet its liabilities when they are due, under both normal and stressed conditions, without incurring unacceptable losses or risking damage to the Company’s reputation.

•        Market risk is the risk that changes in market prices — e.g. foreign exchange rates, interest rates and equity prices — will affect the Company’s income or the value of its holdings of financial instruments. The objective of market risk management is to manage and control market risk exposures within acceptable parameters, while optimizing the return.

Currency risk

The Company is exposed to transactional foreign currency risk to the extent that there is a mismatch between the currencies in which sales, purchases, receivables and payables are denominated and the respective functional currency of the Company. The functional currency of the Company is the United States dollar. The currencies in which these transactions are primarily denominated are Euro, United States dollar, British pound sterling and Canadian dollar.

NOTE 7. Subsequent events

Management evaluated all additional events subsequent to the balance sheet date through to August 3, 2021, the date the financial statements were available to be issued, and determined the following items:

On April 22, 2021, the Company entered into securities purchase agreement. The Company shall issue and sell to the buyers in the respective amounts of units set forth against the relevant buyer’s name on the buyers’ signature page(s) (the “Subscription Amounts”) an aggregate of up to 2,010,000 Units (which amount may be increased upon approval of the Company’s Board of Directors). Each unit shall consist of (i) one (1) ordinary share in the capital of the Company (an “Ordinary Share”) and (ii) one (1) warrant to purchase an Ordinary Share at an exercise price of $3.00 and expire five years from issuance (the “Warrant Share”). The purchase price for each Unit shall be $0.30. On April 26, 2021, the Company sold 2,010,000 of these units and an additional 140,000 warrants at an excise price of $3.00, for total proceeds of $603,000.

On August 3, 2021, the Company entered into a contribution agreement (the “Contribution Agreement”) to acquire PharmGenomics GmbH, a company with limited liability under German law. Under the Contribution Agreement, 100% of the shares of the PharmGenomics will be acquired in exchange for 6,000,000 shares of the Company. Upon the closing of the Contribution Agreement, PharmGenomics will become a wholly owned subsidiary of the Company and the former shareholders of PharmGenomics will hold approximately 62% of the outstanding shares of the Company.

F-11

Table of Contents

Mainz Biomed B.V.
Condensed Interim Statements of Operations
(Unaudited)

 

Note

 

March 8,
2021
(Inception) to
June 30,
2021

Net sales

     

$

 

       

 

 

 

Operating expenses:

     

 

 

 

General and administrative

     

 

38,385

 

Professional fees

     

 

242,359

 

Total operating expenses

     

 

280,744

 

       

 

 

 

Loss from operations

     

 

(280,744

)

       

 

 

 

Net loss

     

$

(280,744

)

       

 

 

 

Comprehensive loss

     

$

(280,744

)

       

 

 

 

Basic and dilutive loss per ordinary share

     

$

(0.23

)

Weighted average number of ordinary shares outstanding

     

 

1,211,801

 

The accompanying notes are an integral part of these unaudited financial statements.

F-12

Table of Contents

Mainz Biomed B.V.
Condensed Interim Statements of Financial position
(Unaudited)

 

Note

 

June 30,
2021

ASSETS

     

 

 

 

Current Assets

     

 

 

 

Cash

     

$

274,232

 

VAT receivable

     

 

12,463

 

Total Current Assets

     

 

286,695

 

Total assets

     

$

286,695

 

       

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

     

 

 

 

Current Liabilities

     

 

 

 

Accounts payable

     

$

64,439

 

Total current liabilities

     

 

64,439

 

Total Liabilities

     

 

64,439

 

       

 

 

 

Shareholders’ equity

     

 

 

 

Share capital

     

 

24,138

 

Share premium

     

 

442,312

 

Reserve

     

 

36,550

 

Accumulated deficit

 

4

 

 

(280,744

)

Total shareholders’ equity

     

 

222,256

 

Total liabilities and shareholders’ equity

     

$

286,695

 

The accompanying notes are an integral part of these unaudited financial statements.

F-13

Table of Contents

Mainz Biomed B.V.
Condensed Interim Statement of Changes in Shareholders’ Equity
(Unaudited)

 

Note

 

Share
Capital

 

Share
Premium

 

Reserve

 

Accumulated
Deficit

 

Total
Shareholders’
Equity

Inception, March 8, 2021

     

$

 

$

 

$

 

$

 

 

$

 

Share issuance at inception

 

4

 

 

 

 

 

 

 

 

 

 

 

 

Issue of ordinary shares and warrants

 

4

 

 

24,138

 

 

442,312

 

 

36,550

 

 

 

 

 

503,000

 

Net loss

     

 

 

 

 

 

 

 

(280,744

)

 

 

(280,744

)

Balance, June 30, 2021

     

$

24,138

 

$

442,312

 

$

36,550

 

$

(280,744

)

 

$

222,256

 

The accompanying notes are an integral part of these unaudited financial statements.

F-14

Table of Contents

Mainz Biomed B.V.
Condensed Interim Statements of Cash Flows
(Unaudited)

 

Note

 

March 8,
2021
(Inception) to
June 30,
2021

Cash Flows From Operating Activities

     

 

 

 

Net loss

     

$

(280,744

)

Adjustments to reconcile net loss to net cash used in operating activities:

     

 

 

 

Changes in operating assets and liabilities:

     

 

 

 

VAT receivable

     

 

(12,463

)

Accounts payable

     

 

64,439

 

Net cash used in operating activities

     

 

(228,768

)

       

 

 

 

Cash Flows From Financing Activities

     

 

 

 

Proceeds from issuance of ordinary shares and warrants, net of offering fees

     

 

503,000

 

Net cash provided by financing activities

     

 

503,000

 

       

 

 

 

Net change in cash

     

 

274,232

 

Cash at beginning of period

     

 

 

Effect of movements in exchange rates

     

 

 

Cash at end of period

     

$

274,232

 

The accompanying notes are an integral part of these unaudited financial statements.

F-15

Table of Contents

Mainz Biomed B.V.
Notes to the Condensed Interim Financial Statements
For the period from March 8, 2021 to June 30, 2021
(Unaudited)

NOTE 1. Reporting Entity

Mainz Biomed B.V. (the “Company”) is domiciled in Netherlands. The Company’s registered office is at Keizersgracht 391A, EJ Amsterdam. The Company was formed to acquire the business of PharmGenomics GmbH (“PharmaGenomics”), and is a limited liability company based in Mainz, Germany. PharmGenomics develops in-vitro diagnostic and research use only tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine. Subsequent to June 30, 2021, the Company completed a Contribution Agreement to effect such acquisition (see Note 7).

NOTE 2. Basis of preparation and going concern

Statement of compliance with International Financial Reporting Standards (“IFRS”)

These condensed interim financial statements, including comparatives, have been prepared in accordance with International Accounting Standards (“IAS”) 34, “Interim Financial Reporting” using accounting policies consistent with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and International Financial Reporting Interpretations Committee (“IFRIC”). This interim financial report does not include all of the information required of a full annual financial report and is intended to provide users with an update in relation to events and transactions that are significant to an understanding of the changes in financial position and performance of the Company since its March 31, 2021 audited financial statements. It is therefore recommended that this financial report be read in conjunction with the audited financial statements of the Company for the period from March 8, 2021 (inception) to March 31, 2021 and notes thereto contained in the Company’s registration statement on Form F-1.

The condensed interim financial statements were authorized for issuance by the Board of Directors on October 1, 2021.

Basis of measurement

These condensed interim financial statements are presented in United States dollars. The Company’s fiscal year end is December 31.

Going concern

These financial statements have been prepared on a going concern basis which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The continuing operations of the Company are dependent upon its ability to evaluate and complete a business combination. At June 30, 2021, the Company has an accumulated deficit of $280,744 including a loss for the three months ended June 30, 2021 of $240,752.

These uncertainties may cast significant doubt upon the Company’s ability to continue as a going concern. These financial statements do not include any adjustments relating to the recoverability and classification of assets and liabilities which might be necessary should the Company be unable to continue in existence.

NOTE 3. Use of judgements and estimates

In preparing these financial statements, management has made judgements and estimates that affect the application of the Company’s accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates.

Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to estimates are recognized prospectively. Areas requiring a significant degree of estimation and judgment include fair value measurements for financial instruments, the recoverability and measurement of deferred tax assets and liabilities and assessment of the Company’s ability to continue as a going concern.

F-16

Table of Contents

Mainz Biomed B.V.
Notes to the Condensed Interim Financial Statements
For the period from March 8, 2021 to June 30, 2021
(Unaudited)

NOTE 4. Capital

 

Ordinary
shares

March 31, 2021

 

1

Share issuance on April 22, 2021

 

2,010,000

Shares issued at June 30, 2021

 

2,010,001

Ordinary shares

Holders of these shares are entitled to dividends as declared from time to time and are entitled to one vote per share at general meetings of the Company. All rights attached to the Company’s shares held by the Company are suspended until those shares are reissued.

On March 8, 2021, the Company issued share capital of EUR0.01 consisting of one share with a nominal value of EUR0.01.

On April 22, 2021, the Company entered into securities purchase agreement (“SPA”). Pursuant to the SPA, the Company sold 2,010,000 Units. Each unit consisted of (i) one (1) ordinary share of the Company (an “Ordinary Share”) and (ii) one (1) warrant to purchase an Ordinary Share at an exercise price of $3.00, with an expiration date that is two years from the date of the Company’s planned initial public offering. The purchase price for each Unit was $0.30.

On April 26, 2021, the Company closed the SPA, selling 2,010,000 units and issuing an additional 140,000 warrants to a broker, with identical terms to the investor warrants, for gross proceeds of $603,000. Fees and expenses from the financing were $100,000.

Warrants

During the period ended June 30, 2021, the Company granted 2,150,000 warrants valued at $36,550. The warrants were valued using the Black-Scholes pricing model. The Black-Scholes model requires six basic data inputs: the exercise or strike price, time to expiration, the risk free interest rate, the current stock price, the estimated volatility of the stock price in the future, and the dividend rate. Changes to these inputs could produce a significantly higher or lower fair value measurement.

For the period ended June 30, 2021, the estimated fair values of the warrants measured are as follows:

 

June 30,
2021

Stock price

 

$

0.28

 

Expected term

 

 

2 years

 

Expected average volatility

 

 

95

%

Expected dividend yield

 

 

0

 

Risk-free interest rate

 

 

0.16

%

A summary of activity during the period ended June 30, 2021 follows:

 

Warrant
Outstanding

 

Weighted-Average
Exercise Price

Balance as of March 8, 2021

 

 

$

Grants

 

2,150,000

 

 

3.00

Exercised

 

 

 

Expiry

 

 

 

Balance as of June 30, 2021

 

2,150,000

 

$

3.00

F-17

Table of Contents

Mainz Biomed B.V.
Notes to the Condensed Interim Financial Statements
For the period from March 8, 2021 to June 30, 2021
(Unaudited)

NOTE 5. Financial instruments and risk management

Financial instruments

Trade receivables and debt securities issued are initially recognized when they are originated. All other financial assets and financial liabilities are initially recognized when the Company becomes a party to the contractual provisions of the instrument.

A financial asset (unless it is a trade receivable without a significant financing component) or financial liability is initially measured at fair value plus or minus, for an item not at Fair value through profit or loss (FVTPL), transaction costs that are directly attributable to its acquisition or issue. A trade receivable without a significant financing component is initially measured at the transaction price.

The Company derecognizes a financial asset when:

•        the contractual rights to the cash flows from the financial asset expire; or

•        it transfers the rights to receive the contractual cash flows in a transaction in which either:

•        substantially all of the risks and rewards of ownership of the financial asset are transferred; or

•        the Company neither transfers nor retains substantially all of the risks and rewards of ownership and it does not retain control of the financial asset

Financial liabilities are classified as measured at amortized cost or fair value through profit or loss (FVTPL). A financial liability is classified as at FVTPL if it is classified as held-for-trading, it is a derivative or it is designated as such on initial recognition. Financial liabilities at FVTPL are measured at fair value and net gains and losses, including any interest expense, are recognized in profit or loss. Other financial liabilities are subsequently measured at amortized cost using the effective interest method. Interest expense and foreign exchange gains and losses are recognized in profit or loss. Any gain or loss on derecognition is also recognized in profit or loss.

The Company derecognizes a financial liability when its contractual obligations are discharged or cancelled, or expire. The Company also derecognizes a financial liability when its terms are modified and the cash flows of the modified liability are substantially different, in which case a new financial liability based on the modified terms is recognized at fair value. On derecognition of a financial liability, the difference between the carrying amount extinguished and the consideration paid (including any non-cash assets transferred or liabilities assumed) is recognized in profit or loss.

At June 30, 2021, the Company’s financial instrument is cash, VAT receivable and trade payables.

Financial risk management

The Company’s board of directors has overall responsibility for the establishment and oversight of the Company’s risk management framework. The board of directors has established the risk management committee, which is responsible for developing and monitoring the Company’s risk management policies. The committee reports regularly to the board of directors on its activities.

The Company’s risk management policies are established to identify and analyze the risks faced by the Company, to set appropriate risk limits and controls and to monitor risks and adherence to limits. Risk management policies and systems are reviewed regularly to reflect changes in market conditions and the Company’s activities. The Company, through its training and management standards and procedures, aims to maintain a disciplined and constructive control environment in which all employees understand their roles and obligations.

F-18

Table of Contents

Mainz Biomed B.V.
Notes to the Condensed Interim Financial Statements
For the period from March 8, 2021 to June 30, 2021
(Unaudited)

NOTE 5. Financial instruments and risk management (cont.)

The Company has exposure to the following risks arising from financial instruments:

•        Credit risk is the risk of financial loss to the Company if a customer or counterparty to a financial instrument fails to meet its contractual obligations, and arises principally from the Company’s receivables from customers and investments in debt securities.

•        Liquidity risk is the risk that the Company will encounter difficulty in meeting the obligations associated with its financial liabilities that are settled by delivering cash or another financial asset. The Company’s objective when managing liquidity is to ensure, as far as possible, that it will have sufficient liquidity to meet its liabilities when they are due, under both normal and stressed conditions, without incurring unacceptable losses or risking damage to the Company’s reputation.

•        Market risk is the risk that changes in market prices — e.g. foreign exchange rates, interest rates and equity prices — will affect the Company’s income or the value of its holdings of financial instruments. The objective of market risk management is to manage and control market risk exposures within acceptable parameters, while optimizing the return.

Currency risk

The Company is exposed to transactional foreign currency risk to the extent that there is a mismatch between the currencies in which sales, purchases, receivables and payables are denominated and the respective functional currency of the Company. The functional currency of the Company is the United States dollar. The currencies in which these transactions are primarily denominated are Euro, United States dollar, British pound sterling and Canadian dollar.

NOTE 6. Subsequent events

Management evaluated all additional events subsequent to the balance sheet date through to September 30, 2021, the date the condensed interim financial statements were available to be issued, and determined the following items:

On July 1, 2021, the Company recruited a Chief Executive Officer and entered into an employment agreement. Pursuant to the employment agreement the CEO was issued 200,000 shares of restricted stock. These shares vest 50% immediately, 25% vest after one year and 25% vest after two years following a successful initial public offering by the Company. The shares were valued at $56,600, based on the value of shares that were sold to third party investors, in an arm’s length transaction on April 26, 2021. The Company plans to record the compensation expense based on the vesting schedule of the restricted shares.

On August 3, 2021, the Company entered into a contribution agreement (the “Contribution Agreement”) to acquire PharmGenomics GmbH, a company with limited liability under German law. Under the Contribution Agreement, 100% of the shares of the PharmGenomics will be acquired in exchange for 6,000,000 shares of the Company. On September 20, 2021 the Company and PharmGenomics closed the Contribution Agreement. Upon the closing of the Contribution Agreement, PharmGenomics became a wholly owned subsidiary of the Company with the former shareholders of PharmGenomics holding approximately 62% of the outstanding shares of the Company.

On August 20, 2021, the Company entered into securities purchase agreement (the “August SPA”). Pursuant to the August SPA, the Company sold 1,000,000 Units. Each unit consisted of (i) one (1) ordinary share in the capital of the Company (an “Ordinary Share”) and (ii) one (1) warrant to purchase an Ordinary Share at an exercise price of $3.00 and an expiration date two years from the date of the Company’s initial public offering of ordinary shares. The purchase price for each Unit was $0.60, and the Company issued 70,000 broker warrants in conjunction with the offering, with identical terms to the investor warrants.

F-19

Table of Contents

Mainz Biomed B.V.
Notes to the Condensed Interim Financial Statements
For the period from March 8, 2021 to June 30, 2021
(Unaudited)

NOTE 6. Subsequent events (cont.)

On September 20, 2021, the Company entered into securities purchase agreement (the “September SPA”). Pursuant to the September SPA, the Company sold 500,000 units. Each unit consisted of (i) one (1) ordinary share in the capital of the Company (an “Ordinary Share”) and (ii) one (1) warrant to purchase an Ordinary Share at an exercise price of $3.00 and an expiration date two years from the date of the Company’s initial public offering of ordinary shares. The purchase price for each Unit was $2.00, and the Company issued 25,000 broker warrants in conjunction with the offering, with identical terms to the investor warrants.

F-20

Table of Contents

PharmGenomics GmbH

Mainz

FINANCIAL STATEMENTS

DECEMBER 31, 2020 and 2019

(Expressed in US Dollars)

 

Table of Contents

Report of Independent Registered Public Accounting Firm

To the shareholders and the board of directors of PharmGenomics GmbH

Opinion on the Financial Statements

We have audited the accompanying statements of financial position of PharmGenomics GmbH (the “Company”), as of December 31, 2020 and 2019, the related statements of comprehensive loss, changes in shareholders’ equity (deficit) and cash flows for the years then ended, and 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, 2020 and 2019, and the results of its operations and its cash flows for the years ended December 31, 2020 and 2019, in conformity with the International Financial Reporting Standards as issued by the International Accounting Standards Board.

Substantial Doubt about the Company’s Ability to Continue as a Going Concern

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company’s significant operating losses raise substantial doubt about its ability to continue as a going concern. The 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 audit 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 audit, 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 audit 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 regarding the amounts and disclosures in the financial statements. Our audit 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 audit provides a reasonable basis for our opinion.

/s/ BF Borgers CPA PC

Served as Auditor since 2021
Lakewood, CO
August 3, 2021

F-22

Table of Contents

PharmGenomics GmbH

STATEMENTS OF FINANCIAL POSITION

(Expressed in US Dollars)

As at

 

Note

 

December 31, 2020

 

December 31, 2019

ASSETS

     

 

 

 

 

 

 

 

Current

     

 

 

 

 

 

 

 

Cash

     

$

122,568

 

 

$

203,588

 

Trade and other receivables

 

4

 

 

44,241

 

 

 

40,800

 

Prepaid and other current assets

     

 

19,589

 

 

 

15,618

 

       

 

186,398

 

 

 

260,006

 

Non-current

     

 

 

 

 

 

 

 

Property and equipment

 

5

 

$

30,337

 

 

$

22,815

 

Right-of-use assets

 

6

 

 

456,535

 

 

 

433,138

 

Total assets

     

$

673,270

 

 

$

715,959

 

       

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ DEFICIENCY

     

 

 

 

 

 

 

 

Current

     

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

7

 

$

433,813

 

 

$

249,953

 

Deferred revenue

     

 

1,508

 

 

 

2,500

 

Convertible debt – related party

 

8,14

 

 

86,189

 

 

 

78,815

 

Loans payable

 

9

 

 

24,527

 

 

 

 

Loans payable – related party

 

9,14

 

 

108,306

 

 

 

94,843

 

Lease liabilities

 

6

 

 

47,611

 

 

 

33,603

 

       

 

701,954

 

 

 

459,714

 

Non-current

     

 

 

 

 

 

 

 

Convertible debt

 

8

 

 

409,660

 

 

 

337,714

 

Convertible debt – related party

 

8,14

 

 

37,521

 

 

 

31,763

 

Silent partnerships

 

10

 

 

1,319,769

 

 

 

976,257

 

Silent partnerships – related party

 

10,14

 

 

498,481

 

 

 

442,668

 

Lease liabilities

 

6

 

 

447,440

 

 

 

418,139

 

Total liabilities

     

 

3,414,825

 

 

 

2,666,255

 

       

 

 

 

 

 

 

 

Deficiency

     

 

 

 

 

 

 

 

Share capital

     

$

106,111

 

 

$

106,111

 

Reserves

     

 

2,309,684

 

 

 

2,289,392

 

Accumulated deficit

     

 

(4,954,860

)

 

 

(4,367,965

)

Accumulated other comprehensive income

     

 

(202,490

)

 

 

22,166

 

Total stockholders’ deficiency

     

 

(2,741,55

)

 

 

(1,950,296

)

Total liabilities and stockholders’ deficiency

     

$

673,270

 

 

$

715,959

 

Nature of operations and going concern (Note 1)

Subsequent events (Note 18)

The accompanying notes are an integral part of these financial statements.

F-23

Table of Contents

PharmGenomics GmbH

STATEMENTS OF COMPREHENSIVE LOSS

(Expressed in US Dollars)

For the years ended December 31,

 

Note

 

2020

 

2019

Revenue

 

16

 

$

493,565

 

 

$

281,393

 

Cost of Revenues

 

13

 

 

(370,480

)

 

 

(342,664

)

Gross Profit

     

 

123,085

 

 

 

(61,271

)

       

 

 

 

 

 

 

 

Operating Expenses

     

 

 

 

 

 

 

 

Research and development

 

19

 

 

311,851

 

 

 

250,316

 

Sales and marketing

 

19

 

 

110,380

 

 

 

181,460

 

General and administrative

 

19

 

 

374,569

 

 

 

428,862

 

       

 

(796,800

)

 

 

(860,638

)

       

 

 

 

 

 

 

 

Other Income (Expense)

     

 

 

 

 

 

 

 

Accretion expense

 

8,9,10

 

 

(92,375

)

 

 

(45,069

)

Gain on debt extinguishment

 

9

 

 

8,214

 

 

 

 

Government grant – research and development

 

15

 

 

224,134

 

 

 

151,015

 

Government grant – below market financing

 

10,15

 

 

92,774

 

 

 

 

Interest expense

     

 

(176,417

)

 

 

(156,867

)

Other income

     

 

30,490

 

 

 

15,775

 

       

 

86,820

 

 

 

(35,146

)

       

 

 

 

 

 

 

 

Net loss

     

$

(586,895

)

 

$

(957,055

)

       

 

 

 

 

 

 

 

Foreign currency translation

     

$

(224,656

)

 

$

22,166

 

       

 

 

 

 

 

 

 

Total comprehensive loss

     

$

(811,551

)

 

$

(934,889

)

       

 

 

 

 

 

 

 

Income (Loss) per share – Basic and diluted

     

$

(6.34

)

 

$

(10.34

)

       

 

 

 

 

 

 

 

Weighted average number of common shares outstanding – basic and diluted

     

 

92,584

 

 

 

92,584

 

The accompanying notes are an integral part of these financial statements.

F-24

Table of Contents

PharmGenomics GmbH

STATEMENT OF CHANGES IN (DEFICIENCY) EQUITY

(Expressed in US Dollars)

 

Common Stock

 

Reserves

 

Accumulated Deficit

 

Accumulated Other Comprehensive Income

 

Total Equity

Number of shares

 

Amount

 

Balance, January 1, 2019

 

92,584

 

106,111

 

2,198,084

 

(3,410,910

)

 

 

 

(1,106,715

)

Debt conversion feature (Note 8)

 

 

 

91,308

 

 

 

 

 

91,308

 

Net loss

 

 

 

 

(957,055

)

 

 

 

(957,055

)

Currency translation adjustment

 

 

 

 

 

 

22,166

 

 

22,166

 

Balance, December 31, 2019

 

92,584

 

106,111

 

2,289,392

 

(4,367,965

)

 

22,166

 

 

(1,950,296

)

Debt conversion feature (Note 8)

 

 

 

20,292

 

 

 

 

 

20,292

 

Net loss

 

 

 

 

(586,895

)

 

 

 

(586,895

)

Currency translation adjustment

 

 

 

 

 

 

(224,656

)

 

(224,656

)

Balance, December 31, 2020

 

92,584

 

106,111

 

2,309,684

 

(4,937,881

)

 

(202,490

)

 

(2,741,555

)

The accompanying notes are an integral part of these financial statements.

F-25

Table of Contents

PharmGenomics GmbH

STATEMENTS OF CASH FLOWS

(Expressed in US Dollars)

For the years ended December 31,

 

2020

 

2019

Cash flows from operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(586,895

)

 

$

(957,055

)

Items not affecting cash:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

60,462

 

 

 

53,042

 

Bad debt expense

 

 

506

 

 

 

19,411

 

Accretion expense

 

 

92,375

 

 

 

45,069

 

Government grant

 

 

(92,774

)

 

 

 

   

 

 

 

 

 

 

 

Changes in non-cash working capital

 

 

 

 

 

 

 

 

Trade and other receivables

 

 

(99,152

)

 

 

339,624

 

Prepaid expenses and other assets

 

 

(2,510

)

 

 

111

 

Accounts payable and accrued liabilities

 

 

160,476

 

 

 

87,419

 

Deferred revenue

 

 

(1,225

)

 

 

(4,116

)

   

 

 

 

 

 

 

 

Net cash flows used in operating activities

 

 

(468,737

)

 

 

(416,495

)

   

 

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

 

 

 

Purchases of fixed assets

 

 

(9,685

)

 

 

 

   

 

 

 

 

 

 

 

Net cash flows used in investing activities

 

 

(9,685

)

 

 

 

   

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

 

 

 

Proceeds received from convertible debt

 

 

11,414

 

 

 

450,143

 

Proceeds received from loans payable

 

 

25,334

 

 

 

4,265

 

Proceeds received from silent partnerships

 

 

398,811

 

 

 

 

Repayment of principal portion of lease obligations

 

 

(38,878

)

 

 

(30,413

)

   

 

 

 

 

 

 

 

Net cash flows provided by financing activities

 

 

396,681

 

 

 

423,995

 

   

 

 

 

 

 

 

 

Change in cash

 

$

(81,741

)

 

$

7,500

 

   

 

 

 

 

 

 

 

Effects of currency translation on cash

 

 

721

 

 

 

(33,442

)

   

 

 

 

 

 

 

 

Cash

 

 

 

 

 

 

 

 

Beginning of year

 

$

203,588

 

 

$

229,530

 

End of year

 

$

122,568

 

 

$

203,588

 

   

 

 

 

 

 

 

 

Supplemental cash flow disclosure

 

 

 

 

 

 

 

 

Interest paid

 

$

159,438

 

 

$

156,867

 

Right of use asset additions

 

$

39,850

 

 

$

 

The accompanying notes are an integral part of these financial statements.

F-26

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

1.       NATURE OF OPERATIONS AND GOING CONCERN

PharmGenomics GmbH, is a limited liability company based in Mainz, Germany and was incorporated in Germany under the laws of Mainz, Germany. The Company develops in-vitro diagnostic and research use only tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine. The Company offers genotyping services. The registered office of the Company is located at Sirius Gutenberg Park, Robert-Koch-Str.50, 55129 Mainz, Germany.

The Company has recurring losses, a working capital deficiency of $515,556, accumulated deficit totaling $4,954,860 and negative cash flows used in operating activities of $468,737 as of and for the year ended December 31, 2020. The Company has the ability to reduce discretionary spending and may also receive additional financial support from the current investor group and certain executives that have the financial ability and interest to fund any financial shortfalls. Other strategic options may be available to the Company under certain circumstances. As a result of the actions noted above, management believes that it will have sufficient working capital to meet its planned operating cash flow requirements.

On March 11, 2020, the outbreak of the novel strain of coronavirus specifically identified as “COVID-19” was declared a pandemic by the World Health Organization. The outbreak has resulted in governments worldwide enacting emergency measures to combat the spread of the virus which in turn have caused material disruption to business globally. Global equity markets have experienced significant volatility and weakness. Governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The duration and impact of the COVID-19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions. It is not possible to reliably estimate the length and severity of these developments and the impact on the financial results and condition of the Company in future periods.

These financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. These financial statements do not reflect the adjustments to the carrying values of assets and liabilities, the reported revenues and expenses, and the statement of financial position classifications used, that would be necessary if the Company were unable to realize its assets and settle its liabilities as a going concern in the normal course of operations. Such adjustments could be material.

2.      BASIS OF PRESENTATION

Basis of Presentation and Statement of Compliance

These financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and interpretations of the International Financial Reporting Issues Committee (“IFRIC”). The principal accounting policies applied in the preparation of these financial statements are set out below. These policies have been consistently applied to all years presented, unless otherwise stated.

These financial statements have been prepared on a historical cost basis, modified where applicable. In addition, these financial statements have been prepared using the accrual basis of accounting except for cash flow information. They were authorized for issue by the Company’s board of directors on August 3, 2021.

F-27

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

3.     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS

Property and Equipment

Property and equipment are recorded at cost less accumulated depreciation. Expenditures that extend the life of the asset are capitalized and depreciated. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the assets. Maintenance and repairs are charged to expense as incurred; cost of major additions and betterments are capitalized. Leasehold improvements are depreciated on a straight-line basis over the lesser of the length of the lease and the estimated useful life of the assets. Upon sale or other disposition of a depreciable asset, cost and accumulated depreciation are removed from property and equipment and any gain or loss is reflected as a gain or loss from operations.

The estimated useful lives are:

 

Laboratory equipment

 

5 – 10 years

Office equipment

 

3 – 10 years

Right-of-use assets

 

Lease terms

Impairment of Assets

The Company performs impairment tests on its long-lived assets, including property and equipment when new events or circumstances occur, or when new information becomes available relating to their recoverability. When the recoverable amount of each separately identifiable asset or cash generating unit (“CGU”) is less than its carrying value, the asset or CGU’s assets are written down to their recoverable amount with the impairment loss charged against profit or loss. A reversal of the impairment loss in a subsequent period will be charged against profit or loss if there is a significant reversal of the circumstances that caused the original impairment. The impairment will be reversed up to the amount of depreciated carrying value that would have otherwise occurred if the impairment loss had not occurred.

The CGU’s recoverable amount is evaluated using fair value less costs to sell calculations. In calculating the recoverable amount, the Company utilizes discounted cash flow techniques to determine fair value when it is not possible to determine fair value from active markets or a written offer to purchase. Management calculates the discounted cash flows based upon its best estimate of a number of economic, operating, engineering, environmental, political and social assumptions. Any changes in the assumptions due to changing circumstances may affect the calculation of the recoverable amount.

Leases

The Company assesses at contract inception whether a contract is, or contains, a lease. That is, if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. The Company applies a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets. The Company recognizes lease liabilities to make lease payments and right-of-use assets representing the right to use the underlying assets.

At the commencement date of the lease, the Company recognizes lease liabilities measured at the present value of lease payments to be made over the lease term. Lease payments include fixed payments (including in-substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. Lease payments also include the exercise price of a purchase option reasonably certain to be exercised by the Company and payments of penalties for terminating the lease, if the lease term reflects the Company exercising the option to terminate. Variable lease payments that do not depend on an index or a rate are recognized as expenses in the period in which the event or condition that triggers the payment occurs. In calculating the present value of lease payments, the Company

F-28

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

3.     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)

uses its incremental borrowing rate at the lease commencement date because the interest rate implicit in the lease is not readily determinable. After the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the lease payments (e.g., changes to future payments resulting from a change in an index or rate used to determine such lease payments) or a change in the assessment of an option to purchase the underlying asset.

The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Right-of-use assets are depreciated on a straight-line basis over the shorter of the lease term and the estimated useful lives of the assets.

Revenue Recognition

The Company’s revenue is primarily derived through providing genetic diagnostic tests to customers. The Company recognizes revenue in accordance with International Financial Reporting Standards (“IFRS”) 15 “Revenue from Contracts with Customers”.

In accordance with IFRS 15, revenue is recognized upon the satisfaction of performance obligations. Performance obligations are satisfied at the point at which control of the promised goods or services are transferred to customers, in an amount that reflects the consideration the Company expects to be entitled to receive for those goods and services.

The Company provides a genetic diagnostic testing service and testing kits which are not considered separately identifiable from each other as the Company uses the testing kits to collect samples in order to deliver the diagnostic test results to the customer. Accordingly, the Company has one performance obligation which is fulfilled upon the delivery of the test results to the customer and revenue is recognized at that point in time.

Research and Development

Expenditure on research activities, undertaken with the prospect of gaining new technical knowledge and understanding, is recognized in profit or loss as incurred.

Development activities involve a plan or design for the production of new or substantially improved products and processes. Development expenditure is capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and the Company intends to and has sufficient resources to complete development and to use or sell the asset. The expenditure capitalized includes the cost of materials, direct labour, overhead costs that are directly attributable to preparing the asset for its intended use, and borrowing costs on qualifying assets. Other development expenditures are recognized in profit or loss as incurred.

Research and development costs incurred subsequent to the acquisition of externally acquired intangible assets and on internally generated intangible assets are accounted for as research and development costs.

F-29

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

3.     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)

Government Grants

The Company receives government grants related to research and development programs. Government grants are recognized only when there is reasonable assurance that (a) the Company has complied with any conditions attached to the grant and (b) the grant will be received. Government grant income is recognized in the statement of operations as Other Income.

Financial Instruments

(a)     Classification

The Company classifies its financial instruments in the following categories: at fair value through profit and loss (“FVTPL”), at fair value through other comprehensive income (loss) (“FVTOCI”) or at amortized cost. The Company determines the classification of financial assets at initial recognition. The classification of debt instruments is driven by the Company’s business model for managing the financial assets and their contractual cash flow characteristics. Equity instruments that are held for trading are classified as FVTPL. For other equity instruments, on the day of acquisition the Company can make an irrevocable election (on an instrument-by-instrument basis) to designate them as at FVTOCI. Financial liabilities are measured at amortized cost, unless they are required to be measured at FVTPL (such as instruments held for trading or derivatives) or if the Company has opted to measure them at FVTPL.

(b)    Measurement

Financial assets and liabilities at amortized cost

Financial assets and liabilities at amortized cost are initially recognized at fair value plus or minus transaction costs, respectively, and subsequently carried at amortized cost less any impairment.

Financial assets and liabilities at FVTPL

Financial assets and liabilities carried at FVTPL are initially recorded at fair value and transaction costs are expensed in the statements of loss and comprehensive loss. Realized and unrealized gains and losses arising from changes in the fair value of the financial assets and liabilities held at FVTPL are included in the statements of loss and comprehensive loss in the period in which they arise.

Debt investments at FVTOCI

These assets are subsequently measured at fair value. Interest income calculated using the effective interest method, foreign exchange gains and losses and impairment are recognized in profit or loss. Other net gains and losses are recognized in OCI. On derecognition, gains and losses accumulated in OCI are reclassified to profit or loss.

Equity investments at FVTOCI

These assets are subsequently measured at fair value. Dividends are recognized as income in profit or loss unless the dividend clearly represents a recovery of part of the cost of the investment. Other net gains and losses are recognized in OCI and are never reclassified to profit or loss.

(c)     Impairment of financial assets at amortized cost

The Company recognizes a loss allowance for expected credit losses on financial assets that are measured at amortized cost. At each reporting date, the Company measures the loss allowance for the financial asset at an amount equal to the lifetime expected credit losses if the credit risk on the financial asset has increased

F-30

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

3.     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)

significantly since initial recognition. If at the reporting date, the financial asset has not increased significantly since initial recognition, the Company measures the loss allowance for the financial asset at an amount equal to the twelve month expected credit losses. The Company shall recognize in the statements of loss and comprehensive loss, as an impairment gain or loss, the amount of expected credit losses (or reversal) that is required to adjust the loss allowance at the reporting date to the amount that is required to be recognized.

(d)    Derecognition

Financial assets

The Company derecognizes financial assets only when the contractual rights to cash flows from the financial assets expire, or when it transfers the financial assets and substantially all of the associated risks and rewards of ownership to another entity.

Financial liabilities

The Company derecognizes a financial liability when its contractual obligations are discharged or cancelled, or expire. The Company also derecognizes a financial liability when the terms of the liability are modified such that the terms and/or cash flows of the modified instrument are substantially different, in which case a new financial liability based on the modified terms is recognized at fair value.

Gains and losses on derecognition are generally recognized in profit or loss.

Foreign Currency Translation

The functional currency is determined using the currency of the primary economic environment in which that entity operates. The functional, as determined by management, of the Company is the Euro (EUR).

Foreign currency transactions are translated into functional currency using the exchange rates prevailing at the date of the transaction. Foreign currency monetary items are translated at the period-end exchange rate. Non-monetary items measured at historical cost continue to be carried at the exchange rate at the date of the transaction. Non-monetary items measured at fair value are reported at the exchange rate at the date when fair values were determined.

Exchange differences arising on the translation of monetary items or on settlement of monetary items are recognized in the statement of comprehensive loss in the period in which they arise, except where deferred in equity as a qualifying cash flow or net investment hedge.

Exchange differences arising on the translation of non-monetary items are recognized in other comprehensive income to the extent that gains and losses arising on those non-monetary items are also recognized in other comprehensive income. Where the non-monetary gain or loss is recognized in profit or loss, the exchange component is also recognized in profit or loss.

The Company’s presentation currency is the US dollar. For presentation purposes, all amounts are translated from the Euro functional currency to the US dollar presentation currency for each period using the exchange rate at the end of each reporting period for the statement of financial position. Revenues and expenses are translated on the basis of average exchange rates during the year.

Exchange gains and losses arising from translation to the Company’s presentation currency are recorded as exchange differences on translation to reporting currency, which is included in other comprehensive income (loss).

F-31

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

3.     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)

Income Taxes

Current income tax:

Current income tax assets and liabilities for the current period are measured at the amount expected to be recovered from or paid to taxation authorities. The tax rates and tax laws used to compute the amount are those that are enacted or substantively enacted, at the reporting date, in the countries where the Company operates and generates taxable income.

Current income tax relating to items recognized directly in other comprehensive income or equity is recognized in other comprehensive income or equity and not in profit or loss. Management periodically evaluates positions taken in the tax returns with respect to situations in which applicable tax regulations are subject to interpretation and establishes provisions where appropriate.

Deferred tax:

Deferred tax is recognized on temporary differences at the reporting date arising between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes.

The carrying amount of deferred tax assets is reviewed at the end of each reporting period and recognized only to the extent that it is probable that future taxable income will be available to allow all or part of the temporary differences to be utilized.

Deferred tax assets and liabilities are measured at the tax rates that are expected to apply to the year when the asset is realized or the liability is settled, based on tax rates (and tax laws) that have been enacted or substantively enacted and are expected to apply by the end of the reporting period. Deferred tax assets and deferred income tax liabilities are offset if a legally enforceable right exists to set off current tax assets against current income tax liabilities and the deferred taxes relate to the same taxable entity and the same taxation authority.

Government Grants

Government grants are recognized when there is reasonable assurance that the grant will be received and that the Company will comply with the conditions attached to them. When the grant relates to an expense item, it is recognized as income on a systematic basis over the periods that the related costs, for which it is intended to compensate, are expensed. When the grant relates to an asset, it is recognized as income in equal amounts over the expected useful life of the related asset.

Loans received from government grants are recognized initially at fair value, with the difference between the fair value of the loan based on prevailing market interest rates and the amount received recorded as a government grant gain in the statements of loss and comprehensive loss.

Loss per Share

Basic loss per share is calculated by dividing the loss attributable to common shareholders by the weighted average number of common shares outstanding in the period. For all periods presented, the loss attributable to common shareholders equals the reported loss attributable to owners of the Company.

F-32

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

3.     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)

Critical Accounting Estimates and Significant Management Judgments

The preparation of financial statements in accordance with IFRS requires the Company to use judgment in applying its accounting policies and make estimates and assumptions about reported amounts at the date of the financial statements and in the future. The Company’s management reviews these estimates and underlying assumptions on an ongoing basis, based on experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. Revisions to estimates are adjusted for prospectively in the period in which the estimates are revised.

Useful lives of property and equipment

Estimates of the useful lives of property and equipment are based on the period over which the assets are expected to be available for use. The estimated useful lives are reviewed annually and are updated if expectations differ from previous estimates due to physical wear and tear, technical or commercial obsolescence, not electing to exercise renewal options on Leases, and legal or other limits on the use of the relevant assets. In addition, the estimation of the useful lives of the relevant assets may be based on internal technical evaluation and experience with similar assets. It is possible, however, that future results of operations could be materially affected by changes in the estimates brought about by changes in the factors mentioned above. The amounts and timing of recorded expenses for any period would be affected by changes in these factors and circumstances. A reduction in the estimated useful lives of the property and equipment would increase the recorded expenses and decrease the non-current assets.

Provision for expected credit losses on trade receivables

The provision for expected credit losses on trade receivables are estimated based on historical information, customer concentrations, customer solvency, current economic and geographical trends, and changes in customer payment terms and practices. The Company will calibrate its provision matrix to adjust the historical credit loss experience with forward-looking information. The assessment of the correlation between historical observed default rates, forecast economic conditions and expected credit losses is a significant estimate. The amount of expected credit losses is sensitive to changes in circumstances and of forecast economic conditions. The Company’s historical credit loss experience and forecast of economic conditions may also not be representative of customer’s actual default in the future.

Estimating the incremental borrowing rate on leases

The Company cannot readily determine the interest rate implicit in leases where it is the lessee. As such, it uses its incremental borrowing rate (“IBR”) to measure lease liabilities. The IBR is the rate of interest that the Company would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of comparable value to the right-of-use asset in a similar economic environment. IBR therefore reflects what the Company “would have to pay”, which requires estimation when no observable rates are available or where the applicable rates need to be adjusted to reflect the terms and conditions of the lease. The Company estimates the IBR using observable inputs (such as market interest rates) when available and is required to make certain entity-specific estimates.

F-33

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

3.     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)

Other significant judgments

The preparation of these financial statements in accordance with IFRS requires the Company to make judgments, apart from those involving estimates, in applying accounting policies. The most significant judgments in applying the Company’s financial statements include:

 

 

The assessment of the Company’s ability to continue as a going concern and whether there are events or conditions that may give rise to significant uncertainty;

   

 

The determination of the lease term of contracts with renewal and termination options;

   

 

Determination of the extent to which it is probable that future taxable income will be available to allow all or part of the temporary differences to be utilized; and

   

 

Whether there are indicators of impairment of the Company’s long-lived assets.

4.      TRADE AND OTHER RECEIVABLES

     

December 31, 2020

 

December 31, 2019

Accounts receivable

 

$

47,149

 

 

$

81,661

 

Less: allowance for doubtful accounts

 

 

(3,066

)

 

 

(41,450

)

Accounts receivable, net

 

 

44,083

 

 

 

40,211

 

Other

 

 

158

 

 

 

589

 

   

$

44,241

 

 

$

40,800

 

5.      PROPERTY AND EQUIPMENT

Property and equipment consisted of the following as of December 31, 2020, December 31, 2019 and January 1, 2019:

     

Laboratory Equipment

 

Office Equipment

 

Total

Cost

 

 

 

 

 

 

 

 

 

 

 

 

Balance at January 1, 2019

 

$

55,110

 

 

$

10,243

 

 

$

65,353

 

Effects of currency translation

 

 

(1,184

)

 

 

(221

)

 

 

(1,405

)

Balance at December 31, 2019

 

$

53,926

 

 

$

10,022

 

 

$

63,948

 

Additions

 

 

7,949

 

 

 

1,739

 

 

 

9,685

 

Effects of currency translation

 

 

5,637

 

 

 

1,067

 

 

 

6,704

 

Balance at December 31, 2020

 

$

67,512

 

 

$

12,825

 

 

$

80,337

 

   

 

 

 

 

 

 

 

 

 

 

 

Accumulated depreciation

 

 

 

 

 

 

 

 

 

 

 

 

Balance at January 1, 2019

 

$

33,003

 

 

$

4,836

 

 

$

37,839

 

Depreciation

 

 

3,312

 

 

 

787

 

 

 

4,099

 

Effects of currency translation

 

 

(703

)

 

 

(102

)

 

 

(805

)

Balance at December 31, 2019

 

$

35,612

 

 

$

5,521

 

 

$

41,133

 

Depreciation

 

 

3,818

 

 

 

852

 

 

 

4,670

 

Effects of currency translation

 

 

3,616

 

 

 

581

 

 

 

4,197

 

Balance at December 31, 2020

 

$

43,046

 

 

$

6,954

 

 

$

50,000

 

   

 

 

 

 

 

 

 

 

 

 

 

Net book value

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2019

 

$

18,314

 

 

$

4,501

 

 

$

22,815

 

December 31, 2020

 

$

24,466

 

 

$

5,871

 

 

$

30,337

 

F-34

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

5.      PROPERTY AND EQUIPMENT (cont.)

As of December 31, 2020, December 31, 2019 and January 1, 2019, management assessed that there were no events or changes in circumstances that would require impairment testing.

6.      LEASES

Right-of-Use Assets

The Company’s leases certain assets under lease agreements.

     

Office Equipment

 

Laboratory Equipment

 

Office

 

Total

Cost

 

 

   

 

   

 

 

 

 

 

 

 

Balance at January 1, 2019

 

$

 

$

 

$

492,760

 

 

$

492,760

 

Additions

 

 

 

 

 

 

 

 

 

 

Effects of currency translation

 

 

 

 

 

 

(10,589

)

 

 

(10,589

)

Balance at December 31, 2019

 

$

 

$

 

$

 

 

 

$

 

Additions

 

 

29,395

 

 

10,455

 

 

 

 

 

39,850

 

Effects of currency translation

 

 

2,189

 

 

779

 

 

45,114

 

 

 

48,082

 

Balance at December 31, 2020

 

$

31,584

 

$

11,234

 

$

527,285

 

 

$

570,103

 

   

 

   

 

   

 

 

 

 

 

 

 

Accumulated depreciation

 

 

   

 

   

 

 

 

 

 

 

 

Balance at January 1, 2019

 

$

 

$

 

$

 

 

$

 

Depreciation

 

 

 

 

 

 

48,943

 

 

 

48,943

 

Effects of currency translation

 

 

 

 

 

 

90

 

 

 

90

 

Balance at December 31, 2019

 

$

 

$

 

$

49,033

 

 

$

49,033

 

Depreciation

 

 

3,707

 

 

2,178

 

 

49,907

 

 

 

55,792

 

Effects of currency translation

 

 

276

 

 

162

 

 

8,305

 

 

 

8,743

 

Balance at December 31, 2020

 

$

3,983

 

$

2,340

 

$

107,245

 

 

$

113,568

 

   

 

   

 

   

 

 

 

 

 

 

 

Net book value

 

 

   

 

   

 

 

 

 

 

 

 

December 31, 2019

 

$

 

$

 

$

433,138

 

 

$

433,138

 

December 31, 2020

 

$

27,601

 

$

8,894

 

$

420,040

 

 

$

456,535

 

As of December 31, 2020, December 31, 2019 and January 1, 2019, management assessed that there were no events or changes in circumstances that would require impairment testing.

The carrying amount of the right-of-use assets is depreciated on a straight-line basis over the life of the leases, which at December 31, 2020, had an average expected life of 8 years.

F-35

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

6.      LEASES (cont.)

Lease Liabilities

The Company’s lease liabilities consists of office and laboratory equipment and office space The present value of future lease payments were measured using an incremental borrowing rate of 10% per annum as of January 1, 2019.

     

Total

Balance as at January 1, 2019

 

$

492,760

 

Additions

 

 

 

Interest expenses

 

 

46,543

 

Lease payments

 

 

(76,956

)

Effects of currency translation

 

 

(10,605

)

As at December 31, 2019

 

$

451,742

 

Additions

 

 

39,850

 

Interest expenses

 

 

47,173

 

Lease payments

 

 

(86,051

)

Effects of currency translation

 

 

42,337

 

As at December 31, 2020

 

$

495,051

 

 

Lease liabilities

 

December 31, 2020

 

December 31, 2019

Current portion

 

$

47,611

 

$

33,603

Long-term portion

 

 

447,440

 

 

418,139

Total lease liabilities

 

$

495,051

 

$

451,742

At December 31, 2020, the Company is committed to minimum lease payments as follows:

 

Maturity analysis

 

December 31, 2020

Less than one year

 

$

94,973

 

One year to three years

 

 

189,586

 

Three to five years

 

 

180,652

 

Greater than five years

 

 

243,264

 

Total undiscounted lease liabilities

 

$

708,295

 

Amount representing implicit interest

 

 

(213,244

)

Lease obligations

 

$

495,051

 

7.      ACCOUNTS PAYABLE AND ACCRUED EXPENSES

     

December 31, 2020

 

December 31, 2019

Accounts payable

 

$

248,576

 

$

200,061

Accrued liabilities

 

 

78,345

 

 

36,208

Payroll liabilities

 

 

87,075

 

 

8,192

Value added taxes payable

 

 

19,817

 

 

5,492

   

$

433,813

 

$

249,953

F-36

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

8.      CONVERTIBLE DEBT

During the years ended December 31, 2019 and 2020, the Company entered into loan agreements totalling EUR$417,133 (approximately $467,154) (the “2019 and 2020 Convertible Loans”). The 2019 and 2020 Convertible Loans bear interest at 3.5% and have a maturity date of September 30, 2022. While the 2019 and 2020 Convertible Loans are outstanding, the lenders are entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. At maturity, the 2019 and 2020 Convertible Loans are convertible common shares of the Company at EUR$1 per share.

The 2019 and 2020 Convertible Loans were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 2019 and 2020 Convertible Loans between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature.

In November 2017, the Company entered into loan agreements with two shareholders of the Company for loans totalling EUR$80,278 (approximately $92,007) (the “2017 Convertible Loans”). The loans are convertible at the option of the lender to shares totalling 4.25% of the Company’s common shares outstanding at the time of conversion. The loans are non-interest bearing, are unsecured and are due on demand. During the year ended December 31, 2019, principal in the amount of EUR$5,000 ($5,597) was exchanged for the 2019 and 2020 Convertible Loans and EUR$5,000 ($5,597) was extinguished as the lender elected to offset the debt amount against amounts in trade receivables due to the Company.

A continuity of the Company’s convertible debt is as follows:

     

2019 and 2020 Convertible Loans

 

2017 Convertible Loans

 

Total

Balance, December 31, 2018

 

$

 

 

$

92,007

 

 

$

92,007

 

Issued during the year

 

 

450,143

 

 

 

 

 

 

450,143

 

Conversion feature

 

 

(91,307

)

 

 

 

 

 

(91,307

)

Accretion

 

 

4,358

 

 

 

 

 

 

4,358

 

Extinguished

 

 

 

 

 

(5,597

)

 

 

(5,597

)

Exchanged

 

 

5,597

 

 

 

(5,597

)

 

 

 

Effects of currency translation

 

 

686

 

 

 

(1,998

)

 

 

(1,312

)

Balance, December 31, 2019

 

 

369,477

 

 

 

78,815

 

 

 

448,292

 

Issued during the year

 

 

11,414

 

 

 

 

 

 

11,414

 

Conversion feature

 

 

(2,055

)

 

 

 

 

 

(2,055

)

Accretion

 

 

30,786

 

 

 

 

 

 

30,786

 

Effects of currency translation

 

 

37,559

 

 

 

7,374

 

 

 

44,933

 

Balance, December 31, 2020

 

$

447,181

 

 

$

86,189

 

 

$

533,370

 

9.      LOANS PAYABLE

During the year ended December 31, 2020, the Company entered into a loan agreement for the principal amount of EUR20,000 (approximately $22,828) (the “0.1% Loan). The 0.1% Loan bears interest at 0.1% per month and is due on demand. And is secured against the Company’s trade receivables.

Between the years of 2011 to 2013, the Company received loans from related parties totalling EUR$35,000 (approximately $40,144) (the “6% Loans”). The Loans have a stated interest rate of at 6.0%. EUR$10,000 (approximately $11,461) of the loans matures on July 31, 2020 and EUR$25,000 (approximately $28,653) of the

F-37

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

9.      LOANS PAYABLE (cont.)

loan matures on December 31, 2021. As the 6% Loans were received at below market interest rates, the initial fair value of the 3% Loan was determined to be EUR$21,936 (approximately $25,140), determined using an estimated effective interest rate of 11.5%.

In 2017, the Company was obtained a line of credit of up to EUR$200,000 (approximately $458,440) (the “LOC”). The LOC accrues interest of 4% on amounts drawn, and a 0.5% fee if no amounts are drawn. The LOC is available until September 30, 2020.

A continuity of the Company’s loans payable is as follows:

     

0.1%
Loan

 

6%
Loans

 

LOC

 

Total

Balance, December 31, 2018

 

$

 

$

34,927

 

 

$

55,712

 

 

$

90,639

 

Issued during the year

 

 

 

 

 

 

 

4,265

 

 

 

4,265

 

Accretion

 

 

 

 

1,876

 

 

 

 

 

 

1,876

 

Effects of currency translation

 

 

 

 

(747

)

 

 

(1,190

)

 

 

(1,937

)

Balance, December 31, 2019

 

 

 

 

36,056

 

 

 

58,787

 

 

 

94,843

 

Issued during the year

 

 

22,828

 

 

 

 

 

2,506

 

 

 

25,334

 

Accretion

 

 

 

 

1,765

 

 

 

 

 

 

1,765

 

Effects of currency translation

 

 

1,700

 

 

3,505

 

 

 

5,686

 

 

 

10,891

 

Balance, December 31, 2020

 

$

24,528

 

$

41,326

 

 

$

66,979

 

 

$

132,833

 

10.    SILENT PARTNERSHIPS

During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lender agreed to lend a total of EUR$299,400 (approximately $341,740) (the “3% SPAs”). The Company is to repay the amount by December 31, 2025. The Company must pay a minimum of 3% interest per annum on the loans. The lender is entitled to 3% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt ; the lender does not partake in the Company’s losses. Upon the amounts coming due, the lender of the 3% SPAs have the option to demand an additional payment equal to 15% of the contribution as a final remuneration (the “Final Renumeration”). The Final Remuneration is considered to be the cost of issuing debt. The 3% SPAs were received at below market interest rates as part of a government program for COVID-19 relief. The initial fair value of the 3% SPAs was determined to be EUR$218,120 (approximately $248,966), which was determined using an estimated effective interest rate of 11.5%. The difference between the face value and the fair value of the 3% SPAs of EUR$81,280 ($92,774) has been recognized as government grant income during the period.

During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lender agreed to lend a total of EUR$50,000 (approximately $57,071) (the “3.5% SPAs”). The Company is to repay the amount by June 30, 2025. The Company must pay a minimum of 3.5% interest per annum on the loans. The lender is entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the ender does not partake in the Company’s losses. The 3.5% SPAs are convertible to common shares of the Company at EUR$1 per share in the event that the Company is involved in any of the following transactions: capital increases, a share or asset deal or a public offering. Pursuant to the silent partnership agreement, the Company notified the holder, at which point the holder declined the opportunity to convert their loan into common shares. The 3.5% SPAs were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 3.5% SPAs between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature.

F-38

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

10.     SILENT PARTNERSHIPS (cont.)

Between the years of 2013 to 2016, the Company entered into silent partnership agreements for loans totalling EUR$798,694 (approximately $915,383) (the “8.5% SPAs”). Under the 8.5% SPAs, the Company is to repay EUR$398,634 (approximately $408,496) of the loans by June 30, 2023 and EUR$400,000 (approximately $409,859) of the loans matures on December 31, 2025. The Company must pay a minimum of 8.5% interest per annum on the loans. The lenders are entitled to 1.66% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. At maturity, the lenders of the 8.5% SPAs have the option to demand an additional payment equal to 30% of the principal of the loans as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8.5% SPAs was determined to be EUR$772,568 (approximately $85,440), determined using an estimated effective interest rate of 11.5%. Under the agreements, the lenders also agreed to invest in the Company and contributed EUR676,366 (approximately $775,183) to acquire 27,752 shares of the Company between the years of 2013 and 2016. During the year ended December 31, 2020, EUR80,000 (approximately $99,527) of the 8.5% SPAs was extinguished as the lender, who is a also a customer of the Company, elected to offset the debt amount against amounts in trade receivables due to the Company. The debtor did not demand the Final Remuneration and the Company recognized a gain on the extinguishment of $8,214.

In 2010, the Company entered into a silent partnership agreement whereby the lender agreed to lend the Company EUR$300,000 (approximately $343,830) (the “8% SPA”). The Company must repay the loan by January 31, 2023. The Company must pay a minimum of 8% interest per annum on the loan. The lender is entitled to 1.95% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lender does not partake in the Company’s losses. At maturity, the lender of the 8% SPA has the option to demand an additional payment of up to 30% of the principal of the loan as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8% SPA was determined to be EUR$289,900 (approximately $332,254), determined using an estimated effective interest rate of 11.5%. Under the agreements, the lender also agreed to invest in the Company and contributed EUR100,000 to acquire 2,800 shares of the Company.

A continuity of the Company’s silent partnerships is as follows:

     

3%
SPAs

 

3.5%
SPAs

 

8.5%
SPAs

 

8%
SPAs

 

Total

Balance, December 31, 2018

 

$

 

 

$

 

 

$

1,002,907

 

 

$

407,415

 

 

$

1,410,322

 

Accretion

 

 

 

 

 

 

 

 

29,710

 

 

 

9,125

 

 

 

38,835

 

Effects of currency translation

 

 

 

 

 

 

 

 

(21,494

)

 

 

(8,738

)

 

 

(30,232

)

Balance, December 31, 2019

 

 

 

 

 

 

 

 

 

1,011,123

 

 

 

407,802

 

 

 

1,418,925

 

Issued during the year

 

 

341,740

 

 

 

57,071

 

 

 

 

 

 

 

 

 

398,811

 

Extinguished

 

 

 

 

 

 

 

 

(99,527

)

 

 

 

 

 

(99,527

)

Discount

 

 

(92,774

)

 

 

(18,238

)

 

 

 

 

 

 

 

 

(111,012

)

Accretion

 

 

19,596

 

 

 

1,478

 

 

 

29,204

 

 

 

9,544

 

 

 

59,822

 

Effects of currency translation

 

 

19,996

 

 

 

3,002

 

 

 

89,367

 

 

 

38,866

 

 

 

151,231

 

Balance, December 31, 2020

 

$

288,558

 

 

$

43,313

 

 

$

1,030,167

 

 

$

456,212

 

 

$

1,818,250

 

F-39

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

11.    EQUITY

Authorized share capital

Unlimited number of common shares with a par value of EUR$1 per share. German corporate law dictates that the registered nominal amount of a GmbH entity must be at least EUR$1 per share.

Shares outstanding

As at December 31, 2020: 92,584 common shares issued and outstanding (2019 – 92,584).

There were no share capital transactions during the years ended December 31, 2020 and 2019.

12.     SEGMENTED INFORMATION

The Company has one operating segment, being the provider of genetic diagnostic testing services.

13.    COST OF REVENUE

     

December 31, 2020

 

December 31, 2019

Test kit materials

 

$

149,612

 

$

79,179

Selling expenses

 

 

26,696

 

 

54,101

Maintenance of laboratory equipment

 

 

56,151

 

 

39,761

Salaries and benefits

 

 

88,665

 

 

55,006

Royalties

 

 

46,017

 

 

111,940

Depreciation of laboratory equipment

 

 

3,339

 

 

2,677

Total costs of revenue

 

$

370,480

 

$

342,664

The royalty expense includes an approximate $66,000 decrease from 2019 to 2020. This decrease is the result of a license payment made in 2019 to record, and pay, an amount agreed to between the Company and ColoAlert A.S. for 2019 and periods prior to 2019.

14.    RELATED PARTY TRANSACTIONS

Related Party Transactions

Key management personnel include those persons having authority and responsibility for planning, directing and controlling the activities of the Company as a whole. The Company has determined that key management personnel consist of members of the Company’s Board of Directors and corporate officers. The remuneration of directors and key management personnel during the year ended December 31, 2020 and 2019 was as follows:

     

December 31, 2020

 

December 31, 2019

Salaries and benefits

 

$

202,442

 

$

192,423

Remuneration paid to related parties other than key personnel during the year ended December 31, 2020 and 2019 was as follows:

     

December 31, 2020

 

December 31, 2019

Salaries and benefits

 

$

33,078

 

$

3,500

During the year ended December 31, 2020, the Company incurred interest expense of $5,658 (2019 – $4,920) on balances owing to related parties.

F-40

Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

14.     RELATED PARTY TRANSACTIONS (cont.)

During the year ended December 31, 2020, the Company incurred accretion expense of $2,135 (2019 – $1,916) on balances owing to related parties.

Related Party Balances

As at December 31, 2020, $1,148 (2019 - $Nil) is included in accounts payable and accrued liabilities and loans payable in relation to transactions with related parties, which are non-interest bearing, unsecured and due on demand.

As at December 31, 2020 and 2019, the entire balance of the 6% Loans of $41,326 (2019 – $36,056) were owing to shareholders of the Company (Note 8).

As at December 31, 2020, EUR$30,130 (approximately $36,951) (2019 – EUR$30,130, $33,790) and EUR40,139 (approximately $49,226) (2019 – EUR$40,139, $44,931) of the 2017 Convertible Loans were owing to the Chief Executive Officer (the “CEO”) of the Company and a major shareholder of the Company, respectively. The amounts are due on demand (Note 8).

As at December 31, 2020, EUR$5,000 (approximately $6,132) (2019 – EUR$5,000, $5,607) with a carrying value of $5,360 (2019 – 4,537) and EUR$30,000 (approximately $36,792) (2019 – EUR$30,000, $33,581) with a carrying value of $32,161 (2019 – $27,225) of the 2019 and 2020 Convertible Loans were owing to the CEO of the Company and a major shareholder of the Company, respectively. The amounts are due on September 30, 2022.

As at December 31, 2020, EUR$350,000 (approximately $429,240) (2019 – EUR$350,000, $392,516) with a carrying value of $498,481 (2019 – $442,668) of the 8.5% SPAs were owing to major shareholders of the Company. EUR$150,000 of the loan is due on June 30, 2023 and EUR$200,000 of the loan is due on December 31, 2025.

As at December 31, 2020 and 2019, the entire balance of the LOC of $66,979 (2019 – $58,787) is due to a family member of the CEO of the Company (Note 9).

15.    GOVERNMENT GRANTS

The Company receives government grants related to its research and development activities. The amount of government grants received during the years ended December 31, 2020 and 2019 and recognized as research grant revenue were as follows:

 

Research and Development Projects

 

December 31, 2020

 

December 31, 2019

Rapid detection of antibody-based pathogens

 

$

91,461

 

$

Multi-marker test for the early detection of pancreatic cancer

 

 

100,591

 

 

Microarray based on nucleic acid detection for respiratory pathogens

 

 

5,995

 

 

51,511

Genetically based rapid detection of respiratory tract infections

 

 

26,087

 

 

99,503

   

$

224,134

 

$

151,015

As of December 31, 2020, the grants for rapid detection of antibody-based pathogens and a multi-marker test for the early detection of pancreatic cancer had remaining grant balances of approximately $148,000 and $456,000, respectively.

During the year ended December 31, 2020, the Company recognized government grant income in the amount of $92,774 related to the 3% SPAs which were received at below market interest rates as part of a government program for COVID-19 relief (Note 10).

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PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

16.    FINANCIAL INSTRUMENT RISK MANAGEMENT

Basis of Fair Value

Financial instruments measured at fair value are classified into one of three levels in the fair value hierarchy according to the relative reliability of the inputs used to estimate the fair values. The three levels of the fair value hierarchy are:

•        Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities;

•        Level 2 — Inputs other than quoted prices that are observable for the asset or liability either directly or indirectly; and

•        Level 3 — Inputs that are not based on observable market data.

The Company’s financial instruments consist of cash, trade and other receivables, accounts payable and accrued liabilities, lease liabilities, convertible debentures, and loans payable. With the exception of convertible debentures and loans payable, the carrying value of the Company’s financial instruments approximate their fair values due to their short-term maturities. The fair value of convertible debentures and notes payable approximate their carrying value, excluding discounts, due to minimal changes in interest rates and the Company’s credit risk since issuance of the instruments.

The Company is exposed in varying degrees to a variety of financial instrument related risks. The Board of Directors approves and monitors the risk management processes, inclusive of documented investment policies, counterparty limits, and controlling and reporting structures.

Credit Risk

The Company’s principal financial assets are cash and trade receivables. The Company’s credit risk is primarily concentrated in its cash which is held with institutions with a high credit worthiness. Management believes that the Company is not exposed to any significant credit risk with respect to its cash.

The Company mitigates its credit risk on receivables by actively managing and monitoring its receivables. The Company has been determined that no credit loss provision is required, as all amounts outstanding are considered collectible. During the year ended December 31, 2020, the Company incurred $19,411 in bad debt expense (2019 - $506). The Company mitigates credit risk by evaluating the creditworthiness of customers prior to conducting business with them and monitoring its exposure for credit losses with existing customers.

Liquidity Risk

Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they fall due. The Company has a planning and budgeting process in place to help determine the funds required to support the Company’s normal operating requirements on an ongoing basis. As at December 31, 2020, the Company had an unrestricted cash balance of $122,568 to settle current liabilities of $814,491.

Historically, the Company’s primary source of funding has been the issuance of equity securities for cash, primarily through the issuance of preferred shares and credit facility borrowings. The Company’s access to financing is always uncertain. There can be no assurance of continued access to significant equity funding.

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PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

16.     FINANCIAL INSTRUMENT RISK MANAGEMENT (cont.)

The following is an analysis of the contractual maturities of the Company’s financial liabilities as at December 31, 2020:

     

Within
one year

 

Between one and
five years

 

More than
five years

Accounts payable and accrued liabilities

 

$

415,570

 

$

 

$

Convertible debt

 

 

86,189

 

 

511,571

 

 

Loans payable

 

 

312,732

 

 

 

 

Silent partnerships

 

 

 

 

1,775,869

 

 

Lease liabilities

 

 

94,793

 

 

370,238

 

 

243,264

   

$

814,491

 

$

2,287,440

 

$

243,264

Foreign Exchange Risk

Foreign currency risk is the risk that the fair values of future cash flows of a financial instrument will fluctuate because they are denominated in currencies that differ from the respective functional currency. The Company is not exposed to currency risk as it does not hold any financial assets or liabilities in foreign denominated currencies.

Interest Rate Risk

Interest rate risk is the risk that the fair value of future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The Company is not exposed to interest rate risk as its financial liabilities carry interest at fixed rates.

Capital Management

In the management of capital, the Company includes components of stockholders’ equity. The Company aims to manage its capital resources to ensure financial strength and to maximize its financial flexibility by maintaining strong liquidity and by utilizing alternative sources of capital including equity, debt and bank loans or lines of credit to fund continued growth. The Company sets the amount of capital in proportion to risk and based on the availability of funding sources. The Company manages the capital structure and makes adjustments to it in light of changes in economic conditions and the risk characteristics of the underlying assets. As a young growth company, issuance of equity has been the primary source of capital to date. Additional debt and/or equity financing may be pursued in future as deemed appropriate to balance debt and equity. To maintain or adjust the capital structure, the Company may issue new shares, take on additional debt or sell assets to reduce debt.

17.    CONCENTRATIONS

Major customers are defined as customers that each individually account for greater than 10% of the Company’s annual revenues. For the year ended December 31, 2020, the Company had revenue from three major customers (2019 — four major customers) that accounted for approximately 46% (2019 – $59%) of revenue.

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PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

18.    INCOME TAXES

The provision for income taxes differs from the amount that would have resulted in applying the combined federal statutory tax rate as follows:

     

December 31, 2020

 

December 31, 2019

Net loss for the period

 

$

(569,619

)

 

$

(957,055

)

Statutory income tax rate

 

 

31.2

%

 

 

31.2

%

Expected in tax recovery at statutory income tax rates

 

$

(177,814

)

 

$

(298,889

)

Permanent differences

 

 

14,390

 

 

 

3,498

 

Difference in tax rates, foreign exchange, and other

 

 

(112,435

)

 

 

16,485

 

Change in deferred tax assets not recognized

 

 

275,859

 

 

 

278,906

 

Income tax recovery

 

$

 

 

$

 

Temporary differences that give rise to the following deferred tax assets and liabilities at are:

     

December 31, 2020

 

December 31, 2019

Deferred tax assets

 

 

 

 

 

 

 

 

Net operating loss carryforwards

 

$

1,347,532

 

 

$

1,071,673

 

Deferred tax assets not recognized

 

 

(1,347,532

)

 

 

(1,071,673

)

Net deferred tax asset

 

$

 

 

$

 

As at December 31, 2020, the Company has approximately $4,314,863 (2019 – $3,752,610) of non-capital losses in Germany that may be used to offset future taxable income. These losses may be carried forward on an indefinite basis and do not expire. The Company has not recognized the deferred tax assets due to the uncertainty around utilizing all of the losses carry-forwards.

Tax attributes are subject to review, and potential adjustment, by tax authorities.

19.     OPERATING EXPENSES

For the years ended December 31, 2020 and 2019, operating expenses consisted of the follows,

 

General and administrative

 

2020

 

2019

Bad Debt

 

$

506

 

$

19,411

Consulting

 

 

2,179

 

 

68,424

Depreciation

 

 

26,069

 

 

20,666

Office

 

 

55,497

 

 

45,363

Professional Fees

 

 

20,020

 

 

36,997

Salaries and Benefits

 

 

268,545

 

 

223,495

Travel and entertainment

 

 

1,753

 

 

14,506

   

$

374,569

 

$

428,862

 

Research and development

 

2020

 

2019

Depreciation

 

$

23,220

 

$

17,867

Office

 

 

49,432

 

 

39,221

Salaries and Benefits

 

 

239,199

 

 

193,228

   

$

311,851

 

$

250,316

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Table of Contents

PharmGenomics GmbH

NOTES TO THE FINANCIAL STATEMENTS

(Expressed in US dollars)

December 31, 2020 and 2019

19.     OPERATING EXPENSES (cont.)

 

Sales and marketing

 

2020

 

2019

Advertising

 

$

5,187

 

$

15,690

Depreciation

 

 

7,833

 

 

11,833

Office

 

 

16,674

 

 

25,973

Salaries and Benefits

 

 

80,686

 

 

127,964

   

$

110,380

 

$

181,460

20.    SUBSEQUENT EVENTS

Management evaluated all additional events subsequent to the balance sheet date through to August 3, 2021, the date the consolidated financial statements were available to be issued, and determined the following items:

•        Subsequent to the year ended December 31, 2020, EUR$387,133 (approximately $474,780) of the 2019 and 2020 Convertible Loans and EUR$30,139 (approximately $36,962) of the 2017 Convertible Loans were converted to 13,985 shares of the Company. 7,500 of the shares issued for the settlement of the Convertible Loans were held by the Company as at December 31, 2020 and transferred to the debtholders. The Company issued 6,485 new shares to satisfy the remainder of the obligation.

•        On August 3, 2021, the Company entered into a contribution agreement (the “Contribution Agreement”) with Mainz Biomed B.V. (“Mainz”), which is a private company with limited liability under Dutch law incorporated for the purpose of acquiring the Company. Mainz intends to apply to list its shares on the Nasdaq along with a concurrent financing of a minimum $7 million and a maximum of $10 million at a price of $5 per share. Under the Contribution Agreement, 100% of the shares of the Company will be acquired in exchange for 6,000,000 shares of Mainz. Upon the closing of the Contribution Agreement, the Company will become a wholly owned subsidiary of Mainz and the former shareholders of the Company will hold approximately 62% of the outstanding shares of Mainz.

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PharmGenomics GmbH

UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
JUNE 30, 2021
(Expressed in US Dollars)

 

Table of Contents

PharmGenomics GmbH

UNAUDITED CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION

(Expressed in US Dollars)

 

Note

 

June 30,
2021

 

December 31, 2020

ASSETS

     

 

 

 

 

 

 

 

Current

     

 

 

 

 

 

 

 

Cash

     

$

195,165

 

 

$

122,568

 

Trade and other receivables

 

4

 

 

74,536

 

 

 

44,241

 

Prepaid expenses

     

 

11,906

 

 

 

19,589

 

       

 

281,607

 

 

 

186,398

 

Non-current

     

 

 

 

 

 

 

 

Property and equipment

 

5

 

 

30,660

 

 

 

30,337

 

Right-of-use asset

 

6

 

 

422,205

 

 

 

456,535

 

Total assets

     

$

734,472

 

 

$

673,270

 

       

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ DEFICIENCY

     

 

 

 

 

 

 

 

Current

     

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

7

 

$

442,657

 

 

$

433,813

 

Deferred revenue

     

 

1,458

 

 

 

1,508

 

Convertible debt – related party

 

8

 

 

47,569

 

 

 

86,189

 

Loans payable

 

9

 

 

23,702

 

 

 

24,527

 

Loans payable – related party

 

9

 

 

105,414

 

 

 

108,306

 

Lease liabilities

     

 

51,251

 

 

 

47,611

 

       

 

672,051

 

 

 

701,954

 

Non-current

     

 

 

 

 

 

 

 

Convertible debt

 

8

 

 

 

 

 

409,660

 

Convertible debt – related party

 

8

 

 

32,287

 

 

 

37,521

 

Silent partnerships

 

10

 

 

1,537,826

 

 

 

1,319,769

 

Silent partnerships – related party

 

10

 

 

488,726

 

 

 

498,481

 

Lease liabilities

 

6

 

 

415,658

 

 

 

447,440

 

Total liabilities

     

 

3,146,548

 

 

 

3,414,825

 

       

 

 

 

 

 

 

 

Deficiency

     

 

 

 

 

 

 

 

Share capital

     

 

114,010

 

 

 

106,111

 

Reserves

     

 

2,810,022

 

 

 

2,309,684

 

Accumulated deficit

     

 

(5,216,581

)

 

 

(4,954,860

)

Accumulated other comprehensive income

     

 

(119,527

)

 

 

(202,490

)

Total stockholders’ deficiency

     

 

(2,412,076

)

 

 

(2,741,555

)

Total liabilities and stockholders’ deficiency

     

$

734,472

 

 

$

673,270

 

Nature of operations and going concern (Note 1)

Subsequent events (Note 18)

The accompanying notes are an integral part of these unaudited condensed financial statements.

F-47

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PharmGenomics GmbH

UNAUDITED CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(Expressed in US Dollars)

 

Note

 

2021

 

Six months ended
June 30,
2020

       

 

 

 

 

 

 

 

Revenue

 

16

 

$

417,311

 

 

$

166,701

 

Cost of revenue

 

13

 

 

(240,954

)

 

 

(152,285

)

Gross profit

     

 

176,357

 

 

 

14,416

 

       

 

 

 

 

 

 

 

Operating expenses

     

 

 

 

 

 

 

 

General and administrative

 

20

 

 

199,481

 

 

 

179,438

 

Research and development

 

20

 

 

160,531

 

 

 

144,330

 

Sales and marketing

 

17,20

 

 

70,979

 

 

 

51,575

 

       

 

430,991

 

 

 

375,343

 

       

 

 

 

 

 

 

 

Other income (expense)

     

 

 

 

 

 

 

 

Accretion expense

 

8,9,10

 

 

(95,687

)

 

 

(34,372

)

Government grant – research and development

 

9

 

 

143,712

 

 

 

96,236

 

Government grant – below market financing

 

10

 

 

1,897

 

 

 

 

Interest expense

 

15

 

 

(73,364

)

 

 

(64,291

)

Gain on debt extinguishment

     

 

 

 

 

7,932

 

Other income

     

 

16,355

 

 

 

15,361

 

       

 

(7,087

)

 

 

20,866

 

       

 

 

 

 

 

 

 

Net loss

     

$

(261,721

)

 

$

(340,061

)

       

 

 

 

 

 

 

 

Foreign currency translation

     

 

82,963

 

 

 

(29,550

)

Total comprehensive loss

     

 

(178,758

)

 

 

(369,611

)

       

 

 

 

 

 

 

 

Loss per share – Basic and diluted

     

$

(2.51

)

 

$

(3.67

)

Weighted average number of common shares outstanding – basic and diluted

     

 

98,281

 

 

 

92,584

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

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PharmGenomics GmbH

UNAUDITED CONDENSED INTERIM STATEMENTS OF CHANGES IN (DEFICIENCY) EQUITY

(Expressed in US Dollars)

For the six months ended June 30, 2021

 


Share Capital

 

Reserves

 

Accumulated deficit

 

Accumulated
Other
comprehensive
loss

 

Total

   

Number of
shares

 

Amount

 

Balance, December 31, 2020

 

92,584

 

$

106,111

 

$

2,309,684

 

$

(4,954,860

)

 

$

(202,490

)

 

$

(2,741,555

)

Shares issued for conversion of debt (Note 8, 11)

 

6,485

 

 

7,899

 

 

500,338

 

 

 

 

 

 

 

 

508,237

 

Net loss

 

 

 

 

 

 

 

(261,721

)

 

 

 

 

 

(261,721

)

Currency translation

 

 

 

 

 

 

 

 

 

 

82,963

 

 

 

82,963

 

Balance, June 30, 2021

 

99,069

 

$

114,010

 

$

2,811,919

 

$

(5,216,581

)

 

$

(119,527

)

 

$

(2,412,076

)

For the six months ended June 30, 2020

 


Share Capital

 

Reserves

 

Accumulated deficit

 

Accumulated
Other
comprehensive
Income
(loss)

 

Total

   

Number of
shares

 

Amount

 

Balance, December 31, 2019

 

92,584

 

$

106,111

 

$

2,289,392

 

$

(4,367,965

)

 

$

22,166

 

 

$

(1,950,296

)

Debt conversion feature (Note 8)

 

 

 

 

 

20,292

 

 

 

 

 

 

 

 

20,292

 

Net loss

 

 

 

 

 

 

 

(340,061

)

 

 

 

 

 

(340,061

)

Currency translation

 

 

 

 

 

 

 

 

 

 

(29,550

)

 

 

(29,550

)

Balance, June 30, 2020

 

92,584

 

$

106,111

 

$

2,309,684

 

$

(4,708,026

)

 

$

(7,384

)

 

$

(2,299,615

)

The accompanying notes are an integral part of these unaudited condensed financial statements.

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PharmGenomics GmbH

UNAUDITED CONDENSED INTERIM STATEMENTS OF CASH FLOWS

(Expressed in US Dollars)

For the six months ended June 30, 2021 and 2020

 

Six months ended
June 30,

   

2021

 

2020

Cash flows from operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(261,721

)

 

$

(340,061

)

Items not affecting cash:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

34,835

 

 

 

28,073

 

Accretion expense

 

 

95,687

 

 

 

34,372

 

   

 

 

 

 

 

 

 

Changes in non-cash working capital

 

 

 

 

 

 

 

 

Trade and other receivables

 

 

(32,325

)

 

 

(62,138

)

Prepaid expenses and other assets

 

 

7,143

 

 

 

7,716

 

Accounts payable and accrued liabilities

 

 

23,851

 

 

 

145,393

 

Deferred revenue

 

 

 

 

 

(1,101

)

   

 

 

 

 

 

 

 

Net cash flows used in operating activities

 

 

(132,530

)

 

 

(187,746

)

   

 

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(4,580

)

 

 

(5,251

)

   

 

 

 

 

 

 

 

Net cash flows used in investing activities

 

 

(4,580

)

 

 

(5,251

)

   

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

 

 

 

Proceeds received from convertible debt

 

 

 

 

 

11,023

 

Proceeds received from silent partnerships

 

 

241,040

 

 

 

55,115

 

Repayment of principal portion of lease obligations

 

 

(24,011

)

 

 

(17,690

)

   

 

 

 

 

 

 

 

Net cash flows provided by financing activities

 

 

217,029

 

 

 

48,448

 

   

 

 

 

 

 

 

 

Change in cash

 

$

79,919

 

 

$

(144,549

)

   

 

 

 

 

 

 

 

Effects of currency translation on cash

 

 

(7,322

)

 

 

9,419

 

   

 

 

 

 

 

 

 

Cash

 

 

 

 

 

 

 

 

Beginning of period

 

$

122,568

 

 

$

203,588

 

End of period

 

$

195,165

 

 

$

68,458

 

   

 

 

 

 

 

 

 

Supplemental cash flow disclosure

 

 

 

 

 

 

 

 

Interest paid

 

$

23,959

 

 

$

21,914

 

Right of use asset additions

 

$

12,346

 

 

$

38,485

 

Capital shares issued for conversion debt

 

$

508,237

 

 

$

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

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PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

1.       NATURE OF OPERATIONS AND GOING CONCERN

PharmGenomics GmbH (the “Company”), is a limited liability company based in Mainz, Germany and was incorporated in Germany under the laws of Germany. The Company develops in-vitro diagnostic and research use only tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine. The Company also offers genotyping services. The registered office of the Company is located at Sirius Gutenberg Park, Robert-Koch-Str.50, 55129 Mainz, Germany.

The Company has recurring losses, a working capital deficiency of $390,444, accumulated deficit totalling $5,219,966 and negative cash flows used in operating activities of $134,427 as of and for the six months ended June 30, 2021. The Company has the ability to reduce discretionary spending and may also receive additional financial support from the current investor group and certain executives that have the financial ability and interest to fund any financial shortfalls. Other strategic options may be available to the Company under certain circumstances. As a result of the actions noted above, management believes that it will have sufficient working capital to meet its planned operating cash flow requirements.

On March 11, 2020, the outbreak of the novel strain of coronavirus specifically identified as “COVID-19” was declared a pandemic by the World Health Organization. The outbreak has resulted in governments worldwide enacting emergency measures to combat the spread of the virus which in turn have caused material disruption to business globally. Global equity markets have experienced significant volatility and weakness. Governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The duration and impact of the COVID-19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions. It is not possible to reliably estimate the length and severity of these developments and the impact on the financial results and condition of the Company in future periods.

These condensed interim financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. These condensed interim financial statements do not reflect the adjustments to the carrying values of assets and liabilities, the reported revenues and expenses, and the condensed interim statement of financial position classifications used, that would be necessary if the Company were unable to realize its assets and settle its liabilities as a going concern in the normal course of operations. Such adjustments could be material.

2.       BASIS OF PRESENTATION

Basis of Presentation and Statement of Compliance

These condensed interim financial statements, including comparatives, have been prepared in accordance with International Accounting Standards (“IAS”) 34, “Interim Financial Reporting” using accounting policies consistent with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and International Financial Reporting Interpretations Committee (“IFRIC”). These condensed interim financial statements do not include all of the information required of a full set of annual financial statements and is intended to provide users with an update in relation to events and transactions that are significant to an understanding of the changes in financial position and performance of the Company since the end of the last annual reporting period. It is therefore recommended that these condensed interim financial statements be read in conjunction with the annual financial statements of the Company for the year ended December 31, 2020 and notes thereto contained in the Company’s Form F-1.

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PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

2.       BASIS OF PRESENTATION (cont.)

These condensed interim financial statements have been prepared on a historical cost basis, modified where applicable. In addition, these condensed interim financial statements have been prepared using the accrual basis of accounting except for cash flow information.

The condensed interim financial statements were authorized for issuance by the Managing Directors on September 30, 2021.

3.       CRITICAL ACCOUNTING ESTIMATES AND SIGNIFICANT MANAGEMENT JUDGMENTS

The preparation of financial statements in accordance with IFRS requires the Company to use judgment in applying its accounting policies and make estimates and assumptions about reported amounts at the date of the financial statements and in the future. The Company’s management reviews these estimates and underlying assumptions on an ongoing basis, based on experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. Revisions to estimates are adjusted for prospectively in the period in which the estimates are revised.

Useful lives of property and equipment

Estimates of the useful lives of property and equipment are based on the period over which the assets are expected to be available for use. The estimated useful lives are reviewed annually and are updated if expectations differ from previous estimates due to physical wear and tear, technical or commercial obsolescence, not electing to exercise renewal options on Leases, and legal or other limits on the use of the relevant assets. In addition, the estimation of the useful lives of the relevant assets may be based on internal technical evaluation and experience with similar assets. It is possible, however, that future results of operations could be materially affected by changes in the estimates brought about by changes in the factors mentioned above. The amounts and timing of recorded expenses for any period would be affected by changes in these factors and circumstances. A reduction in the estimated useful lives of the property and equipment would increase the recorded expenses and decrease the non-current assets.

Provision for expected credit losses on trade receivables

The provision for expected credit losses on trade receivables are estimated based on historical information, customer concentrations, customer solvency, current economic and geographical trends, and changes in customer payment terms and practices. The Company will calibrate its provision matrix to adjust the historical credit loss experience with forward-looking information. The assessment of the correlation between historical observed default rates, forecast economic conditions and expected credit losses is a significant estimate. The amount of expected credit losses is sensitive to changes in circumstances and of forecast economic conditions. The Company’s historical credit loss experience and forecast of economic conditions may also not be representative of customer’s actual default in the future.

Estimating the incremental borrowing rate on leases

The Company cannot readily determine the interest rate implicit in leases where it is the lessee. As such, it uses its incremental borrowing rate (“IBR”) to measure lease liabilities. The IBR is the rate of interest that the Company would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of comparable value to the right-of-use asset in a similar economic environment. IBR therefore reflects what the Company “would have to pay”, which requires estimation when no observable rates are available or where the applicable rates need to be adjusted to reflect the terms and conditions of the lease. The Company estimates the IBR using observable inputs (such as market interest rates) when available and is required to make certain entity-specific estimates.

F-52

Table of Contents

PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

3.       CRITICAL ACCOUNTING ESTIMATES AND SIGNIFICANT MANAGEMENT JUDGMENTS (cont.)

Other significant judgments

The preparation of these financial statements in accordance with IFRS requires the Company to make judgments, apart from those involving estimates, in applying accounting policies. The most significant judgments in applying the Company’s financial statements include:

 

 

The assessment of the Company’s ability to continue as a going concern and whether there are events or conditions that may give rise to significant uncertainty;

 

The determination of the lease term of contracts with renewal and termination options;

 

Determination of the extent to which it is probable that future taxable income will be available to allow all or part of the temporary differences to be utilized; and

 

Whether there are indicators of impairment of the Company’s long-lived assets.

4.       TRADE AND OTHER RECEIVABLES

Trade and other receivables consisted of the following as of June 30, 2021 and December 31, 2020:

     

June 30,
2021

 

December 31, 2020

Accounts receivable

 

$

77,346

 

 

$

47,149

 

Less: allowance for doubtful accounts

 

 

(2,963

)

 

 

(3,066

)

Accounts receivable, net

 

 

74,383

 

 

 

44,083

 

Other

 

 

153

 

 

 

158

 

   

$

74,536

 

 

$

44,241

 

5.       PROPERTY AND EQUIPMENT

Property and equipment consisted of the following as of June 30, 2021 and December 31, 2020:

     

Laboratory equipment

 

Office equipment

 

Total

Cost

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2020

 

$

67,512

 

 

$

12,825

 

 

$

80,337

 

Additions

 

 

4,580

 

 

 

 

 

 

4,580

 

Disposal

 

 

 

 

 

(213

)

 

 

(213

)

Effects of currency translation

 

 

(2,351

)

 

 

(427

)

 

 

(2,778

)

Balance at June 30, 2021

 

$

69,741

 

 

$

12,185

 

 

$

81,926

 

   

 

 

 

 

 

 

 

 

 

 

 

Accumulated depreciation

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2020

 

$

43,046

 

 

$

6,954

 

 

$

50,000

 

Depreciation

 

 

2,308

 

 

 

692

 

 

 

3,000

 

Effects of currency translation

 

 

(1,488

)

 

 

(246

)

 

 

(1,734

)

Balance at June 30, 2021

 

$

43,866

 

 

$

7,400

 

 

$

51,266

 

   

 

 

 

 

 

 

 

 

Net book value

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2020

 

$

24,466

 

 

$

5,871

 

 

$

30,337

 

June 30, 2021

 

$

25,875

 

 

$

4,785

 

 

$

30,660

 

F-53

Table of Contents

PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

5.       PROPERTY AND EQUIPMENT (cont.)

As of June 30, 2021 and December 31, 2020, management assessed that there were no events or changes in circumstances that would require impairment testing.

6.       LEASES

Right-of-Use Assets

The Company’s leases certain assets under lease agreements.

     

Office Equipment

 

Laboratory Equipment

 

Office

 

Total

Cost

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2020

 

$

31,584

 

 

$

11,234

 

 

$

527,285

 

 

$

570,103

 

Additions

 

 

 

 

 

12,346

 

 

 

 

 

 

12,346

 

Effects of currency translation

 

 

(1,064

)

 

 

(585

)

 

 

(17,756

)

 

 

(19,405

)

Balance at June 30, 2021

 

$

30,520

 

 

$

22,995

 

 

$

509,529

 

 

$

563,044

 

Check:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated depreciation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2020

 

$

3,983

 

 

$

2,340

 

 

$

107,245

 

 

$

113,568

 

Depreciation

 

 

2,610

 

 

 

2,666

 

 

 

26,349

 

 

 

31,625

 

Effects of currency translation

 

 

(178

)

 

 

(123

)

 

 

(4,053

)

 

 

(4,354

)

Balance at June 30, 2021

 

$

6,415

 

 

$

4,883

 

 

$

129,541

 

 

$

140,839

 

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net book value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2020

 

$

27,601

 

 

$

8,894

 

 

$

420,040

 

 

$

456,535

 

June 30, 2021

 

$

24,105

 

 

$

18,112

 

 

$

379,988

 

 

$

422,205

 

As of June 30, 2021 and December 31, 2020, management assessed that there were no events or changes in circumstances that would require impairment testing.

The carrying amount of the right-of-use assets is depreciated on a straight-line basis over the life of the leases, which at June 30, 2021, had an average expected life of 7.5 years.

Lease Liabilities

The Company’s lease liabilities consist of office and laboratory equipment and office space The present value of future lease payments were measured using an incremental borrowing rate of 10% per annum.

     

Total

Balance as at December 31, 2020

 

$

495,051

 

Additions

 

 

12,346

 

Interest expenses

 

 

23,959

 

Lease payments

 

 

(47,970

)

Effects of currency translation

 

 

(16,477

)

As at June 30, 2021

 

$

466,909

 

F-54

Table of Contents

PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

6.       LEASES (cont.)

Lease payments and interest expenses during the six months ended June 30, 2020, were $37,890 and $21,786

 

Lease liabilities

 

June 30,
2021

 

December 31,
2020

Current portion

 

$

51,251

 

$

47,611

Long-term portion

 

 

415,658

 

 

447,440

Total lease liabilities

 

$

466,909

 

$

495,051

At June 30, 2021, the Company is committed to minimum lease payments as follows:

 

Maturity analysis

 

June 30,
2021

Less than one year

 

$

47,718

 

One to two years

 

 

94,888

 

Two to three years

 

 

94,888

 

Three to four years

 

 

92,136

 

Four to five years

 

 

85,705

 

More than five years

 

 

235,072

 

Total undiscounted lease liabilities

 

$

650,407

 

Amount representing implicit interest

 

 

(183,498

)

Lease liabilities

 

$

466,909

 

7.       ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consisted of the following as of June 30, 2021 and December 31, 2020:

     

June 30,
2021

 

December 31, 2020

Accounts payable

 

$

234,671

 

$

248,576

Accrued liabilities

 

 

98,216

 

 

78,345

Payroll liabilities

 

 

71,883

 

 

87,075

Value added taxes payable

 

 

37,887

 

 

19,817

   

$

442,657

 

$

433,813

8.       CONVERTIBLE DEBT

During the years ended December 31, 2019 and 2020, the Company entered into loan agreements totalling EUR417,133 (approximately $467,154) (the “2019 and 2020 Convertible Loans”). The 2019 and 2020 Convertible Loans bear interest at 3.5% and have a maturity date of September 30, 2022. While the 2019 and 2020 Convertible Loans are outstanding, the lenders are entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. At maturity, the 2019 and 2020 Convertible Loans are convertible common shares of the Company at EUR1 per share.

The 2019 and 2020 Convertible Loans were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 2019 and 2020 Convertible Loans between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature.

F-55

Table of Contents

PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

8.       CONVERTIBLE DEBT (cont.)

In November 2017, the Company entered into loan agreements with two shareholders of the Company for loans totalling EUR80,278 (approximately $92,007) (the “2017 Convertible Loans”). The loans are convertible at the option of the lender to shares totalling 4.25% of the Company’s common shares outstanding at the time of conversion. The loans are non-interest bearing, are unsecured and are due on demand.

During the six months ended June 30, 2021, the loan amount of EUR417,272 ($508,237) were converted into 6,485 shares of share capital. To satisfy these conversions, the Company also issued 7,500 shares that the Company held for a total of 13,985 ordinary shares issued for the conversions. The conversion rights for all loans not converted have been waived.

A continuity of the Company’s convertible debt is as follows:

     

2019 and 2020
Convertible
Loans

 

2017
Convertible
Loans

 

Total

Balance, December 31, 2020

 

$

447,181

 

 

$

86,189

 

 

$

533,370

 

Accretion

 

 

59,956

 

 

 

 

 

 

59,956

 

Conversion

 

 

(471,528

)

 

 

(36,709

)

 

 

(508,237

)

Effects of currency translation

 

 

(3,322

)

 

 

(1,911

)

 

 

(5,233

)

Balance, June 30, 2021

 

$

32,287

 

 

$

47,569

 

 

$

79,856

 

9.       LOANS PAYABLE

During the year ended December 31, 2020, the Company entered into a loan agreement for the principal amount of EUR20,000 (approximately $22,828) (the “0.1% Loan). The 0.1% Loan bears interest at 0.1% per month and is due on demand. And is secured against the Company’s trade receivables.

Between the years of 2011 to 2013, the Company received loans from related parties totalling EUR35,000 (approximately $40,144) (the “6% Loans”). The Loans have a stated interest rate of at 6.0%. EUR10,000 (approximately $11,461) of the loans matures on July 31, 2020 and EUR25,000 (approximately $28,653) of the loan matures on December 31, 2021. As the 6% Loans were received at below market interest rates, the initial fair value of the 6% Loan was determined to be EUR21,936 (approximately $25,140), determined using an estimated effective interest rate of 11.5%.

In 2017, the Company was obtained a line of credit of up to EUR200,000 (approximately $458,440) (the “LOC”). The LOC accrues interest of 4% on amounts drawn, and a 0.5% fee if no amounts are drawn. The LOC is available until September 30, 2020.

A continuity of the Company’s loans payable is as follows:

     

0.1%
Loan

 

6%
Loans

 

LOC

 

Total

Balance, December 31, 2020

 

$

24,528

 

 

$

41,326

 

 

$

66,979

 

 

$

132,833

 

Accretion

 

 

 

 

 

768

 

 

 

 

 

 

768

 

Interest expense

 

 

 

 

 

 

 

 

 

 

 

 

Effects of currency translation

 

 

(826

)

 

 

(1,404

)

 

 

(2,255

)

 

 

(4,485

)

Balance, June 30, 2021

 

$

23,702

 

 

$

40,690

 

 

$

64,724

 

 

$

129,116

 

F-56

Table of Contents

PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

10.     SILENT PARTNERSHIPS

During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lenders agreed to lend a total of EUR499,400, of which EUR299,400 was received by the Company by December 31, 2020 (approximately $341,740) (the “3% SPAs”). The Company is to repay the amount by December 31, 2025. The Company must pay a minimum of 3% interest per annum on the loans. The lender is entitled to 3% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt ; the lender does not partake in the Company’s losses. Upon the amounts coming due, the lender of the 3% SPAs have the option to demand an additional payment equal to 15% of the contribution as a final remuneration (the “Final Renumeration”). The Final Remuneration is considered to be the cost of issuing debt. The 3% SPAs were received at below market interest rates as part of a government program for COVID-19 relief. The initial fair value of the 3% SPAs received in 2020 was determined to be EUR218,120 (approximately $248,966), which was determined using an estimated effective interest rate of 11.5%. The difference between the face value and the fair value of the 3% SPAs received in 2020 of EUR81,280 ($92,774) has been recognized as government grant income during the period. During the six months ended June 30, 2021 the Company received the remaining EUR200,000 ($241,040). The initial fair value of the 3.0% SPAs received during the six months ended June 30, 2021, was determined to be EUR230,000 (approximately $272,573), determined using an estimated effective interest rate of 6.1%. The initial fair value of the 3.0% SPAs received during June 30, 2021 was determined to be EUR198,426 (approximately $239,143), which was determined using an estimated effective interest rate of 3.1% – 3.3%. The difference between the face value and the fair value of the 3.0% SPAs received in 2021 of EUR1,574 (approximately $1,897) has been recognized as government grant income during the period.

During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lender agreed to lend a total of EUR50,000 (approximately $57,071) (the “3.5% SPAs”). The Company is to repay the amount by June 30, 2025. The Company must pay a minimum of 3.5% interest per annum on the loans. The lender is entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the ender does not partake in the Company’s losses. The 3.5% SPAs are convertible to common shares of the Company at EUR1 per share in the event that the Company is involved in any of the following transactions: capital increases, a share or asset deal or a public offering. The 3.5% SPAs were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 3.5% SPAs between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature.

Between the years of 2013 to 2016, the Company entered into silent partnership agreements for loans totalling EUR798,694 (approximately $915,383) (the “8.5% SPAs”). Under the 8.5% SPAs, the Company is to repay EUR398,634 (approximately $408,496) of the loans by June 30, 2023 and EUR400,000 (approximately $409,859) of the loans matures on December 31, 2025. The Company must pay a minimum of 8.5% interest per annum on the loans. The lenders are entitled to 1.66% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. At maturity, the lenders of the 8.5% SPAs have the option to demand an additional payment equal to 30% of the principal of the loans as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8.5% SPAs was determined to be EUR772,568 (approximately $85,440), determined using an estimated effective interest rate of 11.5%. Under the agreements, the lenders also agreed to invest in the Company and contributed EUR676,366

F-57

Table of Contents

PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

10.     SILENT PARTNERSHIPS (cont.)

(approximately $775,183) to acquire 27,752 shares of the Company between the years of 2013 and 2016. During the year ended December 31, 2020, EUR80,000 (approximately $99,527) of the 8.5% SPAs was extinguished as the lender, who is a also a customer of the Company, elected to offset the debt amount against amounts in trade receivables due to the Company. The debtor did not demand the Final Remuneration and the Company recognized a gain on the extinguishment of $8,214.

In 2010, the Company entered into a silent partnership agreement whereby the lender agreed to lend the Company EUR300,000 (approximately $343,830) (the “8% SPA”). The Company must repay the loan by January 31, 2023. The Company must pay a minimum of 8% interest per annum on the loan. The lender is entitled to 1.95% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lender does not partake in the Company’s losses. At maturity, the lender of the 8% SPA has the option to demand an additional payment of up to 30% of the principal of the loan as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8% SPA was determined to be EUR289,900 (approximately $332,254), determined using an estimated effective interest rate of 11.5%. Under the agreements, the lender also agreed to invest in the Company and contributed EUR100,000 to acquire 2,800 shares of the Company.

A continuity of the Company’s silent partnerships is as follows:

     

3%
SPAs

 

3.5%
SPAs

 

8.5%
SPAs

 

8%
SPAs

 

Total

Balance, December 31,
2020

 

$

288,558

 

 

$

43,313

 

 

$

1,030,167

 

 

$

456,212

 

 

$

1,818,250

 

Issued during the year

 

 

241,040

 

 

 

 

 

 

 

 

 

 

 

 

241,040

 

Discount

 

 

 

 

 

 

 

 

(1,897

)

 

 

 

 

 

(1,897

)

Accretion

 

 

13,249

 

 

 

1,593

 

 

 

15,049

 

 

 

5,069

 

 

 

34,960

 

Effects of currency translation

 

 

(13,958

)

 

 

(1,485

)

 

 

(34,911

)

 

 

(15,447

)

 

 

(65,801

)

Balance, June 30, 2021

 

$

528,889

 

 

$

43,421

 

 

$

1,008,408

 

 

$

445,834

 

 

$

2,026,552

 

11.     EQUITY

Authorized share capital

Unlimited number of common shares with a par value of EUR1 per share. German corporate law dictates that the registered nominal amount of a GmbH entity must be at least EUR1 per share.

Shares outstanding

As at June 30, 2021: 99,069 common shares issued and outstanding (December 31, 2020: 92,584).

During the six months ended June 30, 2021, 6,485 shares were issued for conversion of debt of $508,237.

F-58

Table of Contents

PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

12.     COST OF REVENUE

Cost of revenue consisted of the following for the six months ended June 30, 2021 and 2020:

     

Six months ended
June 30,

   

2021

 

2020

Test kit materials

 

$

64,776

 

$

53,919

Selling expenses

 

 

8,967

 

 

7,159

Maintenance of laboratory equipment

 

 

54,997

 

 

46,764

Salaries and benefits

 

 

67,562

 

 

39,584

Royalties

 

 

44,652

 

 

4,859

Total costs of revenue

 

$

240,954

 

$

152,285

13.     RELATED PARTY TRANSACTIONS

Related Party Transactions

Key management personnel include those persons having authority and responsibility for planning, directing and controlling the activities of the Company as a whole. The Company has determined that key management personnel consist of members of the Company’s Board of Directors and corporate officers. The remuneration of directors and key management personnel during the six months ended June 30, 2021 and 2020 was as follows:

     

June 30,
2021

 

June 30,
2020

Salaries and benefits

 

$

109,733

 

$

114,044

Remuneration paid to related parties other than key personnel during the six months ended June 30, 2021 and 2020 was as follows:

     

June 30,
2021

 

June 30,
2020

Salaries and benefits

 

$

943

 

$

15,972

During the six months ended June 30, 2021, the Company incurred interest expense of $24,983 (2020 – $22,831) on balances owing to related parties.

During the six months ended June 30, 2021, the Company incurred accretion expense of $9,908 (2020 – $8,567) on balances owing to related parties.

Related Party Balances

As at June 30, 2021, $1,001 (December 31, 2020, $1,148) is included in accounts payable and accrued liabilities and loans payable in relation to transactions with related parties, which are non-interest bearing, unsecured and due on demand.

As at June 30, 2021, the entire balance of the 6% Loans of $41,326 (December 31, 2020 - $41,326) were owing to shareholders of the Company (Note 8).

As at June 30, 2021, EUR40,139 (approximately $47,569) of the 2017 Convertible Loans was owed to a major shareholder of the Company (December 31, 2020 — EUR70,278, $86,189); the right of conversion has been waived. The amounts are due on demand (Note 8).

F-59

Table of Contents

PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

13.     RELATED PARTY TRANSACTIONS (cont.)

As at June 30, 2021, EUR30,000 (approximately $35,553) (December 31, 2020 — EUR30,000, $36,792) with a carrying value of $32,787 (December 31, 2020 — $32,161) of the 2019 and 2020 Convertible Loans were owing to a major shareholder of the Company, respectively; the rights of conversion have been waived. The amounts are due on September 30, 2022.

As at June 30, 2021, EUR350,000 (approximately $414,785) (December 31, 2020 — EUR350,000, $429,240) with a carrying value of $488,726 (December 31, 2020 — $498,481) of the 8.5% SPAs were owing to major shareholders of the Company. EUR150,000 of the loan is due on June 30, 2023 and EUR200,000 of the loan is due on December 31, 2025.

As at June 30, 2021, the entire balance of the LOC of $64,724 (December 31, 2020 — $66,979) is due to a family member of the CEO of the Company (Note 9).

14.     GOVERNMENT GRANTS

The Company receives government grants related to its research and development activities. The amount of government grants received during the six months ended June 30, 2021 and 2020 and recognized in other income were as follows:

 

Research and Development Projects

 

June 30,
2021

 

June 30,
2020

Rapid detection of antibody-based pathogens

 

$

64,596

 

$

40,200

Multi-marker test for the early detection of pancreatic cancer

 

 

79,116

 

 

25,053

Microarray based on nucleic acid detection for respiratory pathogens

 

 

 

 

5,790

Genetically based rapid detection of respiratory tract infections

 

 

 

 

25,193

   

$

143,712

 

$

96,236

15.     FINANCIAL INSTRUMENT RISK MANAGEMENT

Basis of Fair Value

Financial instruments measured at fair value are classified into one of three levels in the fair value hierarchy according to the relative reliability of the inputs used to estimate the fair values. The three levels of the fair value hierarchy are:

•        Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities;

•        Level 2 — Inputs other than quoted prices that are observable for the asset or liability either directly or indirectly; and

•        Level 3 — Inputs that are not based on observable market data.

The Company’s financial instruments consist of cash, trade and other receivables, accounts payable and accrued liabilities, lease liabilities, convertible debentures, and loans payable. With the exception of convertible debentures and loans payable, the carrying value of the Company’s financial instruments approximate their fair values due to their short-term maturities. The fair value of convertible debentures and notes payable approximate their carrying value, excluding discounts, due to minimal changes in interest rates and the Company’s credit risk since issuance of the instruments.

The Company is exposed in varying degrees to a variety of financial instrument related risks. The Board of Directors approves and monitors the risk management processes, inclusive of documented investment policies, counterparty limits, and controlling and reporting structures.

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PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

15.     FINANCIAL INSTRUMENT RISK MANAGEMENT (cont.)

Credit Risk

The Company’s principal financial assets are cash and trade receivables. The Company’s credit risk is primarily concentrated in its cash which is held with institutions with a high credit worthiness. Management believes that the Company is not exposed to any significant credit risk with respect to its cash.

The Company mitigates its credit risk on receivables by actively managing and monitoring its receivables. The Company has been determined that no credit loss provision is required, as all amounts outstanding are considered collectible. During the six months ended June 30, 2021, the Company incurred $0 in bad debt expense (2020 — $0). The Company mitigates credit risk by evaluating the creditworthiness of customers prior to conducting business with them and monitoring its exposure for credit losses with existing customers.

Liquidity Risk

Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they fall due. The Company has a planning and budgeting process in place to help determine the funds required to support the Company’s normal operating requirements on an ongoing basis. As at June 30, 2021, the Company had an unrestricted cash balance of $195,165 to settle current liabilities of $672,051.

Historically, the Company’s primary source of funding has been the issuance of equity securities for cash, primarily through the issuance of preferred shares and credit facility borrowings. The Company’s access to financing is always uncertain. There can be no assurance of continued access to significant equity funding.

The following is an analysis of the contractual maturities of the Company’s financial liabilities as at June 30, 2021:

     

Within
one year

 

Between one and
five years

 

More than
five years

Accounts payable and accrued liabilities

 

$

442,657

 

$

 

$

Convertible debt

 

 

47,569

 

 

32,287

 

 

Loans payable

 

 

129,116

 

 

 

 

Silent partnerships

 

 

 

 

2,026,552

 

 

Lease liabilities

 

 

47,718

 

 

367,617

 

 

235,072

   

$

667,060

 

$

2,426,456

 

$

235,072

Foreign Exchange Risk

Foreign currency risk is the risk that the fair values of future cash flows of a financial instrument will fluctuate because they are denominated in currencies that differ from the respective functional currency. The Company is not exposed to currency risk as it does not hold any financial assets or liabilities in foreign denominated currencies.

Interest Rate Risk

Interest rate risk is the risk that the fair value of future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The Company is not exposed to interest rate risk as its financial liabilities carry interest at fixed rates.

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PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

15.     FINANCIAL INSTRUMENT RISK MANAGEMENT (cont.)

Capital Management

In the management of capital, the Company includes components of stockholders’ equity. The Company aims to manage its capital resources to ensure financial strength and to maximize its financial flexibility by maintaining strong liquidity and by utilizing alternative sources of capital including equity, debt and bank loans or lines of credit to fund continued growth. The Company sets the amount of capital in proportion to risk and based on the availability of funding sources. The Company manages the capital structure and makes adjustments to it in light of changes in economic conditions and the risk characteristics of the underlying assets. As a young growth company, issuance of equity has been the primary source of capital to date. Additional debt and/or equity financing may be pursued in future as deemed appropriate to balance debt and equity. To maintain or adjust the capital structure, the Company may issue new shares, take on additional debt or sell assets to reduce debt.

16.     CONCENTRATIONS

Major customers are defined as customers that each individually account for greater than 10% of the Company’s annual revenues. For the six months ended June 30, 2021, the Company had revenue from two major customers (2020 — four major customers) that accounted for approximately 51.32% (2020 — 58.55%) of revenue.

17.     OPERATING EXPENSES

For the periods ended June 30, 2021 and 2020, operating expenses consisted of the following:

 

General and administrative

 

2021

 

2020

Depreciation

 

$

15,801

 

$

12,811

Office

 

 

26,823

 

 

30,607

Professional Fees

 

 

14,521

 

 

11,072

Salaries and Benefits

 

 

141,359

 

 

123,842

Travel and entertainment

 

 

977

 

 

1,106

   

$

199,481

 

$

179,438

 

Research and development

 

2021

 

2020

Depreciation

 

$

14,074

 

$

11,411

Office

 

 

20,546

 

 

22,610

Salaries and Benefits

 

 

125,911

 

 

110,309

   

$

160,531

 

$

144,330

 

Sales and marketing

 

2021

 

2020

   

Advertising

 

$

16,829

 

$

2,891

   

Depreciation

 

 

4,748

 

 

3,849

   

Office

 

 

6,930

 

 

7,626

   

Salaries and Benefits

 

 

42,472

 

 

37,209

       

$

70,979

 

$

51,575

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PharmGenomics GmbH

NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS

(Expressed in US dollars)

Six months ended June 30, 2021 and 2020

18.     SUBSEQUENT EVENTS

Management evaluated all additional events subsequent to the balance sheet date through to September 30, 2021, the date the consolidated financial statements were available to be issued, and determined the following items:

•        On August 3, 2021, the Company entered into a contribution agreement (the “Contribution Agreement”) with Mainz Biomed B.V. (“Mainz”), which is a private company with limited liability under Dutch law incorporated for the purpose of acquiring the Company. Mainz intends to apply to list its shares on the Nasdaq along with a concurrent initial public offering of its ordinary shares. Under the Contribution Agreement, 100% of the shares of the Company will be acquired in exchange for 6,000,000 shares of Mainz. Upon the closing of the Contribution Agreement, the Company will become a wholly owned subsidiary of Mainz and the former shareholders of the Company will hold approximately 62% of the outstanding shares of Mainz. On September 20, 2021 the Company and Mainz closed the Contribution Agreement.

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MAINZ BIOMED B.V.
UNAUDITED PRO FORMA COMBINED FINANCIAL STATEMENTS

The following unaudited pro forma combined financial statements give effect to the acquisition of PharmGenomics GmbH (“PharmGenomics”) by Mainz Biomed B.V. (the “Company”) pursuant to a Contribution Agreement, dated August 3, 2021. Pursuant to the Contribution Agreement the Company will acquire all of the outstanding shares of capital stock of PharmGenomics from its shareholders in exchange for 6,000,000 shares of the Company issued pro rata to the PharmGenomics’ shareholders. These financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board.

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MAINZ BIOMED B.V.
Unaudited Pro Forma Condensed Combined Balance Sheet
As of March 31, 2021

 

Mainz
Biomed B.V.
March 31,
2021

 

PharmGenomics
GmbH
December 31,
2020

 

Proforma
Adjustments

 

Notes

 

Proforma
As Adjusted

Assets

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Current Assets

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Cash

 

$

 

 

$

122,568

 

 

$

1,203,000

 

 

4(c)

 

$

1,325,568

 

Trade and other receivables

 

 

 

 

 

44,241

 

 

 

 

     

 

44,241

 

Prepaid expenses

 

 

 

 

 

19,589

 

 

 

 

     

 

19,589

 

Total Current assets

 

 

 

 

 

186,398

 

 

 

 

     

 

1,389,398

 

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Property and equipment

 

 

 

 

 

30,337

 

 

 

 

     

 

30,337

 

Right-of-use asset

 

 

 

 

 

456,535

 

 

 

 

     

 

456,535

 

Total Assets

 

$

 

 

$

673,270

 

 

$

 

     

$

1,876,270

 

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Liabilities and Shareholders’ Deficit

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Accounts payable and accrued liabilities

 

$

39,992

 

 

$

433,813

 

 

$

 

     

$

473,805

 

Deferred revenue

 

 

 

 

 

1,508

 

 

 

 

     

 

1,508

 

Convertible debt – related party

 

 

 

 

 

86,189

 

 

 

(36,963

)

 

4(a)

 

 

49,226

 

Loans payable

 

 

 

 

 

24,527

 

 

 

 

     

 

24,527

 

Loans payable – related party

 

 

 

 

 

108,306

 

 

 

 

     

 

108,306

 

Lease liabilities

 

 

 

 

 

47,611

 

 

 

 

     

 

47,611

 

Total Current Liabilities

 

 

39,992

 

 

 

701,954

 

 

 

(36,963

)

     

 

704,983

 

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Convertible debt

 

 

 

 

 

409,660

 

 

 

(398,940

)

 

4(a)

 

 

10,720

 

Convertible debt – related party

 

 

 

 

 

37,521

 

 

 

(16,081

)

 

4(a)

 

 

21,440

 

Silent partnerships

 

 

 

 

 

1,319,769

 

 

 

 

     

 

1,319,769

 

Silent partnerships – related party

 

 

 

 

 

498,481

 

 

 

 

     

 

498,481

 

Lease liabilities

 

 

 

 

 

447,440

 

 

 

 

     

 

447,440

 

Total Liabilities

 

 

39,992

 

 

 

3,414,825

 

 

 

(451,984

)

     

 

3,002,833

 

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Shareholders’ Deficit

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Capital: 1 common share issued and outstanding and 6,000,001 common shares outstanding as adjusted

 

 

 

 

 

106,111

 

 

 

482,084

 

 

4(a), (b) and (c)

 

 

588,195

 

Reserves

 

 

 

 

 

2,309,684

 

 

 

1,172,900

 

 

4(c)

 

 

3,482,584

 

Accumulated deficit

 

 

(39,992

)

 

 

(4,954,860

)

 

 

 

     

 

(4,994,852

)

Accumulated other comprehensive loss

 

 

 

 

 

(202,490

)

 

 

 

     

 

(202,490

)

Total Shareholder’s Deficit

 

 

(39,992

)

 

 

(2,741,555

)

 

 

1,654,984

 

     

 

(1,126,563

)

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Total Liabilities and Shareholders’ Deficit

 

$

 

 

$

673,270

 

 

$

 

     

$

1,876,270

 

See accompanying notes to the Unaudited Pro Forma Condensed Combined Financial Statements.

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MAINZ BIOMED B.V.
Unaudited Pro Forma Condensed Combined Statement of Operations
Year Ended March 31, 2021

 

Mainz
Biomed B.V.
Year ended
March 31,
2021

 

PharmGenomics
GmbH
Year ended
December 31,
2020

 

Proforma
Adjustments

 

Notes

 

Proforma
As Adjusted

Revenue

 

$

 

 

$

493,565

 

 

$

     

$

493,565

 

Cost of revenue

 

 

 

 

 

370,480

 

 

 

     

 

370,480

 

Gross profit

 

 

 

 

 

123,085

 

 

 

     

 

123,085

 

   

 

 

 

 

 

 

 

 

 

       

 

 

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

       

 

 

 

Research and Development

 

 

 

 

 

311,851

 

 

 

     

 

311,851

 

Sales and Marketing

 

 

 

 

 

110,380

 

 

 

     

 

110,380

 

General and Administrative

 

 

39,992

 

 

 

374,569

 

 

 

     

 

414,561

 

Total operating expenses

 

 

39,992

 

 

 

796,800

 

 

 

     

 

836,792

 

Operating loss

 

 

(39,992

)

 

 

(673,715

)

 

 

     

 

(713,707

)

Other Income (Expense)

 

 

 

 

 

 

 

 

 

 

       

 

 

 

Accretion expense

 

 

 

 

 

(92,375

)

 

 

28,563

 

4(a)

 

 

(63,812

)

Gain on debt extinguishment

 

 

 

 

 

8,214

 

 

 

     

 

8,214

 

Government grant – research and development

 

 

 

 

 

 

224,134

 

 

 

       

 

224,134

 

Government grant – below market financing

 

 

 

 

 

92,774

 

 

 

     

 

92,774

 

Interest expense

 

 

 

 

 

(176,417

)

 

 

15,339

 

4(a)

 

 

(161,078

)

Other income

 

 

 

 

 

30,490

 

 

 

     

 

30,490

 

Total other expense

 

 

 

 

 

86,820

 

 

 

43,902

     

 

130,722

 

   

 

 

 

 

 

 

 

 

 

       

 

 

 

Net loss before provision for income taxes

 

 

(39,992

)

 

 

(586,895

)

 

 

43,902

     

 

(582,985

)

Income taxes

 

 

 

 

 

 

 

 

     

 

 

Net loss

 

$

(39,992

)

 

$

(586,895

)

 

$

43,902

     

$

(582,985

)

   

 

 

 

 

 

 

 

 

 

       

 

 

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

       

 

 

 

Foreign currency translation adjustment

 

 

 

 

 

(224,656

)

 

 

     

 

(224,656

)

Total comprehensive loss

 

$

(39,992

)

 

$

(811,551

)

 

$

43,902

     

$

(807,641

)

   

 

 

 

 

 

 

 

 

 

       

 

 

 

Basic and dilutive loss per common share

 

$

(39,992.00

)

 

 

 

 

 

 

       

$

(0.10

)

Weighted average number of common shares outstanding

 

 

1

 

 

 

 

 

 

 

6,000,000

 

4(b)

 

 

6,000,001

 

See accompanying notes to the Unaudited Pro Forma Condensed Combined Financial Statements.

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MAINZ BIOMED B.V.
Notes to the Unaudited Pro Forma Condensed Combined Financial Statements

On August 3, 2021, Mainz Biomed B.V. (the “Company”) entered into a Contribution Agreement (the “Agreement”) with PharmGenomics GmbH, a company registered in Mainz, Germany (“PharmGenomics”), pursuant to which the Company will acquire all of the outstanding shares of capital stock of PharmGenomics from its shareholders in exchange for 6,000,000 shares of the Company issued pro rata to the PharmGenomics’ shareholders.

NOTE 1. BASIS OF PRO FORMA PRESENTATION

The unaudited pro forma condensed combined financial statements are based on the Company’s and PharmGenomics’ historical consolidated financial statements as adjusted to give effect to the acquisition of PharmGenomics and the shares issued as part of the acquisition. The unaudited pro forma combined statements of operations for the year ended March 31, 2021 give effect to the PharmGenomics’ acquisition as if it had occurred on April 1, 2020. The unaudited proforma combined balance sheet as of March 31, 2021 gives effect to the PharmGenomics acquisition as if it had occurred on March 31, 2021.

For accounting purposes, the Company has considered the accounting guidance provided by IFRS 10 and IFRS 3.7 and B13 and determined that the merger of Mainz BioMed B.V. and PharmGenomics GmbH should be treated as a reverse acquisition by PharmGenomics GmbH, with PharmGenomics being the accounting acquirer, and Mainz BioMed B.V. as the acquired company. As such, the assets and liabilities of PharmaGenomics have been presented at their historical carrying values.

Historical financial information has been adjusted in the pro forma balance sheet to pro forma events that are: (1) directly attributable to the acquisition; (2) factually supportable; and (3) expected to have a continuing impact on the Company’s results of operations. The pro forma adjustments presented in the pro forma combined balance sheet and statement of operations are described in Note 4 — Pro Forma Adjustments.

The unaudited pro forma condensed combined financial information is for illustrative purposes only. These companies may have performed differently had they actually been combined for the periods presented. You should not rely on the pro forma combined financial information as being indicative of the historical results that would have been achieved had the companies always been combined or the future results that the combined companies will experience after the acquisition.

NOTE 2. ACCOUNTING PERIODS PRESENTED

Certain pro forma adjustments were made to conform PharmGenomics accounting policies to the Company’s accounting policies as noted below.

The unaudited pro forma condensed combined balance sheet as of March 31, 2021 is presented as if the acquisition had occurred on March 31, 2021 and combines the historical balance sheet of the Company at March 31, 2021 and the historical balance sheet of the PharmGenomics at December 31, 2020.

The unaudited pro forma condensed combined statement of operations for the year ended March 31, 2021 has been prepared by combining the Company’s historical consolidated statement of operations for the period ended March 31, 2021, with the historical statement of operations of PharmGenomics for the year ended December 31, 2020.

NOTE 3. PRO FORMA ADJUSTMENTS

The pro forma adjustments are based on our preliminary estimates and assumptions that are subject to change. The following adjustments have been reflected in the unaudited pro forma condensed combined financial information:

a)      In connection with the Agreement, a portion of convertible debt of PharmGenomics is being converted to commons shares of PharmGenomics prior to the share exchange. This represents the adjustment to reduce interest and accretion expenses, to give effect to the cost savings from the reduced debt and to record the conversion of €368,544 ($451,984) in debt to 6,485 common shares of PharmGenomics. Such converted common shares of PharmGenomics were in turn exchanged for common shares of the Company pursuant to the Contribution Agreement.

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MAINZ BIOMED B.V.
Notes to the Unaudited Pro Forma Condensed Combined Financial Statements

NOTE 3. PRO FORMA ADJUSTMENTS (cont.)

b)      Represents an adjustment to increase common shares of the Mainz by the par value of the 6,000,000 shares issued in connection with the transaction and to eliminate the carrying value of the common shares of PharmGenomics, as well as increase the capital for the net difference.

c)      Represents the adjustments to reflect two sales of units by Mainz BioMed B.V. The first offering in April 2021 was for the sale of 2,010,000 units, which included 2,010,000 ordinary shares and warrants to purchase 2,010,000 ordinary shares at a strike price of $3.00. The second offering, which closed in August 2021 was for the sale of 1,000,000 units, each unit including a common share and a warrant to acquire a common share at a strike price of $3.00. The first offering raised $603,000 and the second offering raised $600,000 of gross proceeds. The offerings included broker warrants of 140,000 and 70,000 warrants, with the same terms as investor warrants, respectively.

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MAINZ BIOMED B.V.
UNAUDITED PRO FORMA COMBINED FINANCIAL STATEMENTS

The following unaudited pro forma combined financial statements give effect to the acquisition of PharmGenomics GmbH (“PharmGenomics”) by Mainz Biomed B.V. (the “Company”) pursuant to a Contribution Agreement, dated August 3, 2021, which closed on September 20, 2021. Pursuant to the Contribution Agreement the Company acquired all of the outstanding shares of capital stock of PharmGenomics from its shareholders in exchange for 6,000,000 shares of the Company issued pro rata to the PharmGenomics’ shareholders. These financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board.

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MAINZ BIOMED B.V.
Unaudited Pro Forma Condensed Combined Balance Sheet
As of June 30, 2021

 

Mainz
Biomed B.V.
June 30,
2021

 

PharmGenomics
GmbH
June 30,
2021

 

Proforma
Adjustments

 

Notes

 

Proforma
As Adjusted

Assets

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Current Assets

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Cash

 

$

274,232

 

 

$

195,165

 

 

$

1,600,000

 

 

3 (b)

 

$

2,069,397

 

Trade and other receivables

 

 

12,463

 

 

 

74,536

 

 

 

 

     

 

86,999

 

Prepaid expenses

 

 

 

 

 

11,906

 

 

 

 

     

 

11,906

 

Total Current assets

 

 

286,695

 

 

 

281,607

 

 

 

1,600,000

 

     

 

2,168,302

 

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Property and equipment

 

 

 

 

 

30,660

 

 

 

 

     

 

30,660

 

Right-of-use asset

 

 

 

 

 

422,205

 

 

 

 

     

 

422,205

 

Total Assets

 

$

286,695

 

 

$

734,472

 

 

$

1,600,000

 

     

$

2,621,167

 

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Liabilities and Shareholders’ Deficit

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Accounts payable and accrued liabilities

 

$

64,439

 

 

$

442,657

 

 

$

 

     

$

507,096

 

Deferred revenue

 

 

 

 

 

1,458

 

 

 

 

     

 

1,458

 

Convertible debt – related party

 

 

 

 

 

47,569

 

 

 

 

     

 

47,569

 

Loans payable

 

 

 

 

 

23,702

 

 

 

 

     

 

23,702

 

Loans payable – related party

 

 

 

 

 

105,414

 

 

 

 

     

 

105,414

 

Lease liabilities

 

 

 

 

 

51,251

 

 

 

 

     

 

51,251

 

Total Current Liabilities

 

 

64,439

 

 

 

672,051

 

 

 

 

     

 

736,490

 

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Convertible debt – related party

 

 

 

 

 

32,287

 

 

 

 

     

 

32,287

 

Silent partnerships

 

 

 

 

 

1,537,826

 

 

 

 

     

 

1,537,826

 

Silent partnerships – related party

 

 

 

 

 

488,726

 

 

 

 

     

 

488,726

 

Lease liabilities

 

 

 

 

 

415,658

 

 

 

 

     

 

415,658

 

Total Liabilities

 

 

64,439

 

 

 

3,146,548

 

 

 

 

     

 

3,210,987

 

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Shareholders’ Deficit

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Capital: 2,010,001 common shares issued and outstanding and 9,710,001 common shares outstanding as adjusted

 

 

24,138

 

 

 

114,010

 

 

 

(22,380

)

 

3(a, b, c)

 

 

115,768

 

Share premium

 

 

442,312

 

 

 

 

 

 

1,397,636

 

 

3(a, b, c)

 

 

1,839,948

 

Reserves

 

 

36,550

 

 

 

2,810,022

 

 

 

(28,000

)

 

3(c)

 

 

2,818,572

 

Accumulated deficit

 

 

(280,744

)

 

 

(5,216,581

)

 

 

252,744

 

     

 

(5,244,581

)

Accumulated other comprehensive loss

 

 

 

 

 

(119,527

)

 

 

 

     

 

(119,527

)

Total Shareholder’s Deficit

 

 

222,256

 

 

 

(2,412,076

)

 

 

1,600,000

 

     

 

(589,820

)

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Total Liabilities and Shareholders’ Deficit

 

$

286,695

 

 

$

734,472

 

 

$

1,600,000

 

     

$

2,621,167

 

See accompanying notes to the Unaudited Pro Forma Condensed Combined Financial Statements.

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MAINZ BIOMED B.V.
Unaudited Pro Forma Condensed Combined Statement of Operations
Period Ended June 30, 2021

 

Mainz
Biomed B.V.
Period ended
June 30,
2021

 

PharmGenomics
GmbH
Period ended
June 30,
2021

 

Proforma
Adjustments

 

Notes

 

Proforma
As Adjusted

Revenue

 

$

 

 

$

417,311

 

 

$

 

     

$

417,311

 

Cost of revenue

 

 

 

 

 

240,954

 

 

 

 

     

 

240,954

 

Gross profit

 

 

 

 

 

176,357

 

 

 

 

     

 

176,357

 

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

General and administrative

 

 

280,744

 

 

 

199,481

 

 

 

28,000

 

 

4(c)

 

 

508,225

 

Research and development

 

 

 

 

 

160,531

 

 

 

 

     

 

160,531

 

Sales and marketing

 

 

 

 

 

70,979

 

 

 

 

     

 

70,979

 

Total operating expenses

 

 

280,744

 

 

 

430,991

 

 

 

28,000

 

     

 

739,735

 

Operating loss

 

 

(280,744

)

 

 

(254,634

)

 

 

(28,000

)

     

 

(563,378

)

Other Income (Expense)

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Accretion expense

 

 

 

 

 

(95,687

)

 

 

 

     

 

(95,687

)

Government grant – research and development

 

 

 

 

 

143,712

 

 

 

 

     

 

143,712

 

Government grant – below market financing

 

 

 

 

 

1,897

 

 

 

 

     

 

1,897

 

Interest expense

 

 

 

 

 

(73,364

)

 

 

 

     

 

(73,364

)

Other income

 

 

 

 

 

16,355

 

 

 

 

     

 

16,355

 

Total other expense

 

 

 

 

 

(7,087

)

 

 

 

     

 

(7,087

)

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Net loss before provision for income taxes

 

 

(280,744

)

 

 

(261,721

)

 

 

(28,000

)

     

 

(570,465

)

Income taxes

 

 

 

 

 

 

 

 

 

     

 

 

Net loss

 

$

(280,744

)

 

$

(261,721

)

 

$

(28,000

)

     

$

(570,465

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Foreign currency translation adjustment

 

 

 

 

 

82,963

 

 

 

 

     

 

82,963

 

Total comprehensive loss

 

$

(280,744

)

 

$

(178,758

)

 

$

(28,000

)

     

$

(487,502

)

   

 

 

 

 

 

 

 

 

 

 

 

     

 

 

 

Basic and dilutive loss per common share

 

$

(0.18

)

 

 

 

 

 

 

 

 

     

$

(0.06

)

Weighted average number of common shares outstanding

 

 

1,531,316

 

 

 

 

 

 

 

7,700,000

 

 

3(a)

 

 

9,231,316

 

See accompanying notes to the Unaudited Pro Forma Condensed Combined Financial Statements.

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MAINZ BIOMED B.V.
Notes to the Unaudited Pro Forma Condensed Combined Financial Statements

NOTE 1. BASIS OF PRO FORMA PRESENTATION

On August 3, 2021, Mainz Biomed B.V. (the “Company”) entered into a Contribution Agreement (the “Agreement”) with PharmGenomics GmbH, a company registered in Mainz, Germany (“PharmGenomics”), pursuant to which the Company acquired all of the outstanding shares of capital stock of PharmGenomics from its shareholders in exchange for 6,000,000 shares of the Company issued pro rata to the PharmGenomics’ shareholders. On September 20, 2021, the Company and PharmGenomics closed the Contribution Agreement.

The unaudited pro forma condensed combined financial statements are based on the Company’s and PharmGenomics’ historical consolidated financial statements as adjusted to give effect to the acquisition of PharmGenomics and the shares issued as part of the acquisition. The unaudited pro forma combined statements of operations for the period ended June 30, 2021, give effect to the PharmGenomics’ acquisition as if it had occurred on January 1, 2021. The unaudited proforma combined balance sheet as of June 30, 2021 gives effect to the PharmGenomics acquisition as if it had occurred on June 30, 2021.

For accounting purposes, the Company has considered the accounting guidance provided by IFRS 10 and IFRS 3.7 and B13 and determined that the merger of Mainz BioMed B.V. and PharmGenomics GmbH should be treated as a reverse acquisition by PharmGenomics GmbH, with PharmGenomics being the accounting acquirer, and Mainz BioMed B.V. as the acquired company. As such, the assets and liabilities of PharmGenomics have been presented at their historical carrying values.

Historical financial information has been adjusted in the pro forma balance sheet to pro forma events that are: (1) directly attributable to the acquisition; (2) factually supportable; and (3) expected to have a continuing impact on the Company’s results of operations. The pro forma adjustments presented in the pro forma combined balance sheet and statement of operations are described in Note 4 — Pro Forma Adjustments.

The unaudited pro forma condensed combined financial information is for illustrative purposes only. These companies may have performed differently had they actually been combined for the periods presented. You should not rely on the pro forma combined financial information as being indicative of the historical results that would have been achieved had the companies always been combined or the future results that the combined companies will experience after the acquisition.

NOTE 2. ACCOUNTING PERIODS PRESENTED

Certain pro forma adjustments were made to conform PharmGenomics accounting policies to the Company’s accounting policies as noted below.

The unaudited pro forma condensed combined balance sheet as of June 30, 2021 is presented as if the acquisition had occurred on June 30, 2021 and combines the historical balance sheet of the Company at June 30, 2021 and the historical balance sheet of the PharmGenomics at June 30, 2021.

The unaudited pro forma condensed combined statement of operations for the period ended June 30, 2021 has been prepared by combining the Company’s historical consolidated statement of operations from inception (March 8, 2021) to June 30, 2021, with the historical statement of operations of PharmGenomics for the six months ended June 30, 2021.

NOTE 3. PRELIMINARY PURCHASE PRICE ALLOCATION

On September 20, 2021, the Company acquired PharmGenomics for total consideration of 6,000,000 shares of Company’s common stock. The unaudited pro forma condensed combined financial statements include various assumptions, including those related to the preliminary purchase price allocation of the assets acquired and liabilities assumed of PharmGenomics based on carrying values. For accounting purposes, the Company has determined that the merger of Mainz BioMed B.V. and PharmGenomics GmbH should be treated as a reverse acquisition by PharmGenomics GmbH, with PharmGenomics being the accounting acquirer, and Mainz BioMed B.V. as the acquired company. As such, the assets and liabilities of PharmGenomics have been presented at their historical carrying values. Accordingly, pro forma adjustments are preliminary and have been made solely for illustrative purposes.

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MAINZ BIOMED B.V.
Notes to the Unaudited Pro Forma Condensed Combined Financial Statements

NOTE 4. PRO FORMA ADJUSTMENTS

The pro forma adjustments are based on our preliminary estimates and assumptions that are subject to change. The following adjustments have been reflected in the unaudited pro forma condensed combined financial information:

a)      Represents an adjustment to increase common shares of Mainz BioMed B.V. by the par value of the 6,000,000 shares issued in connection with the acquisition of PharmGenomics, including the elimination of the historical balance of the PharmGenomics Capital account. This entry also eliminates the historical balance of the Company’s accumulated deficit to create a combined cumulative deficit that reflects the historical balance of PharmGenomics, the acquiror for accounting purposes.

b)      Represents the adjustments to reflect two sales of units by Mainz BioMed B.V. The first offering, which closed in August 2021 was for the sale of 1,000,000 units, each unit including a common share and a warrant to acquire a common share at a strike price of $3.00. The second offering, which closed in September 2021 was for the sale of 500,000 units, each unit including a common share and a warrant to acquire a common share at a strike price of $3.00. The first offering raised $600,000 and the second offering raised $1,000,000 of gross proceeds, respectively. The offerings included broker warrants of 70,000 and 25,000 warrants, with the same terms as investor warrants, respectively.

c)      Represents the adjustment to reflect the July 1, 2021 issuance of 200,000 ordinary shares issued to our Chief Executive Officer, pursuant to an employment contract.

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2,000,000 Shares

MAINZ BIOMED, B.V.

____________________________

PROSPECTUS

____________________________

Boustead Securities, LLC

, 2021

Through and including              (the 25th day after the date of this offering), all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to a dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.

 

 

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The information in this selling shareholder prospectus is not complete and may be changed. The selling shareholders named in this selling shareholder prospectus may not sell these securities until the registration statement filed with the Securities and Exchange Commission is declared effective. This selling shareholder prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS

 

SUBJECT TO COMPLETION

 

DATED OCTOBER 8, 2021

ALTERNATE PAGES FOR SELLING SHAREHOLDER PROSPECTUS

1,000,000 Ordinary Shares

Mainz Biomed B.V.

________________

PROSPECTUS

_______________ ordinary shares

The selling shareholders plan to sell an aggregate of 1,000,000 ordinary shares (the “Resale Shares”).

The ordinary shares offered by this selling shareholder prospectus may be sold by the selling shareholders from time-to-time in the open market, through privately negotiated transactions or a combination of these methods, at market prices prevailing at the time of sale or at negotiated prices. By a separate prospectus (the “Prospectus”), we have registered 2,000,000 ordinary shares, which we are offering for sale to the public through our underwriter. The selling shareholders have expressed an intent not to sell shares prior to the closing of or concurrently with the public offering.

We have applied to have our ordinary shares listed on the Nasdaq Capital Market under the symbol “MYNZ”.

The distribution of the shares by the selling shareholders is not subject to any underwriting agreement. We will not receive any proceeds from the sale of the Resale Shares by the selling shareholders. We will bear all expenses of registration incurred in connection with this offering, but all selling and other expenses incurred by a selling shareholder will be borne by such selling shareholder.

An investment in our securities may be considered speculative and involves a high degree of risk, including the risk of a substantial loss of your investment. See “Risk Factors” beginning on page 13 to read about the risks you should consider before buying our securities. An investment in our securities is not suitable for all investors.

Sales of our ordinary shares registered in this selling shareholder prospectus and the Prospectus will result in two offerings taking place concurrently.

You should rely only on the information contained in this selling shareholder prospectus and any prospectus supplement or amendment. We have not authorized anyone to provide you with different information. This selling shareholder prospectus may only be used where it is legal to sell these securities. The information in this selling shareholder prospectus is only accurate on the date of this selling shareholder prospectus, regardless of the time of any sale of securities.

NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR PASSED UPON THE ADEQUACY OR ACCURACY OF THIS SELLING SHAREHOLDER PROSPECTUS.    ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

The date of this selling shareholder prospectus is             , 2021

 

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EXPLANATORY NOTE

Concurrent with this offering, the Company is registering 2,000,000 ordinary shares.  We anticipate that the public offering price of our ordinary shares will be between $4.00 and $6.00. Sales by selling shareholders may reduce the price of our ordinary shares, demand for our ordinary shares and, as a result, the liquidity of your investment.

SELLING SHAREHOLDERS

This selling shareholder prospectus relates to the resale from time to time by the selling shareholders identified herein of up to an aggregate of 1,000,000 Resale Shares.

The Resale Shares are being registered to permit public sales of the Resale Shares, and the selling shareholders may offer the Resale Shares for resale from time to time pursuant to this selling shareholder prospectus. The selling shareholders may also sell, transfer or otherwise dispose of all or a portion of their respective Resale Shares in transactions exempt from the registration requirements of the Securities Act or pursuant to another effective registration statement covering those Resale Shares.

The table below sets forth certain information regarding the selling shareholders and the Resale Shares offered in this selling shareholder prospectus. Except for the entry into agreements for the purchase of the Resale Shares and one of the selling shareholders, Marco Messina, serving as our director, none of the selling shareholders have had a material relationship with us within the past three years.

Beneficial ownership is determined in accordance with the rules of the SEC. The selling shareholders’ percentage of ownership of our outstanding shares in the table below is based, as applicable, upon 9,710,000 ordinary shares issued and outstanding as of September 30, 2021 and upon our issuance of an estimated 2,000,000 shares in our initial public offering to occur concurrent with the start of the offering by the selling shareholders. Under the terms of Warrants held by the selling shareholders, the selling shareholders, may not exercise such warrants to the extent (but only to the extent) it or any of its affiliates would beneficially own a number of ordinary shares which would exceed 4.99% of the total ordinary shares issued and outstanding upon such exercise. The number of shares and the percentages in this table do not reflect these limitations. Except as otherwise set out in the section entitled “Principal Shareholders”, these limitations would prevent any selling shareholder from owning 5% or more of our securities after the offering.

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Name of Selling Shareholders

 

Number of Ordinary Shares Owned Prior to Offering

 

Maximum Number of Ordinary Shares to be Sold Pursuant to this Prospectus

 

Number of Ordinary Shares Owned After Offering

 

Number of Ordinary Shares that May Be Sold in This Offering As A Percentage of Currently Outstanding Shares(8)

 

Percentage of Ordinary Shares Owned After the Offering(8)

Jelena Jakovljevic

 

1,100,000

 

133,057

 

966,943

 

1.4

%

 

7.9

%

Andre Doerk

 

1,093,334

 

132,503

 

960,831

 

1.4

%

 

7.8

%

Camino Capital GmbH(1)

 

666,666

 

55,371

 

611,295

 

0.6

%

 

5.1

%

Laura Jensen

 

600,000

 

49,834

 

550,166

 

0.5

%

 

4.6

%

Prodigious Wealth Limited(2)

 

200,000

 

16,611

 

183,389

 

0.2

%

 

1.6

%

Jeremy Poirier

 

200,000

 

16,611

 

183,389

 

0.2

%

 

1.6

%

Rai Wu

 

666,666

 

55,371

 

611,295

 

0.6

%

 

5.1

%

Accent Capital GmbH(3)

 

210,000

 

54,967

 

155,033

 

0.6

%

 

1.3

%

Alexander Schornstein(6)

 

866,000

 

16,611

 

794,684

 

0.2

%

 

8.8

%

Andreas Lambrou

 

20,000

 

1,661

 

18,339

 

0.0

%

 

0.2

%

Marco Messina

 

40,000

 

11,661

 

28,339

 

0.1

%

 

0.2

%

Lidia Glinskaya

 

15,000

 

7,500

 

7,500

 

0.1

%

 

0.1

%

Gerion Weber

 

5,000

 

2,500

 

2,500

 

0.0

%

 

0.0

%

Markus Bussler

 

20,000

 

10,000

 

10,000

 

0.1

%

 

0.1

%

Jochen Kauper

 

15,000

 

7,500

 

7,500

 

0.1

%

 

0.1

%

Aaron Keay

 

160,000

 

80,000

 

80,000

 

0.8

%

 

0.7

%

Oleta Investments(4)

 

580,000

 

123,333

 

456,778

 

1.3

%

 

3.8

%

Wai Kai Lam

 

453,334

 

79,346

 

373,988

 

0.5

%

 

0.4

%

CDM Capital Partners Inc.(5)

 

20,000

 

10,000

 

10,000

 

0.1

%

 

0.1

%

Marion Schlegel

 

15,000

 

7,500

 

7,500

 

0.1

%

 

0.1

%

Robert Oliver

 

80,000

 

40,000

 

40,000

 

0.4

%

 

0.3

%

Noah Boeken

 

80,000

 

40,000

 

40,000

 

0.4

%

 

0.3

%

Eternal Horizon International Company Limited(8)

 

580,000

 

48,174

 

531,826

 

0.5

%

 

4.4

%

____________

(1)      Alexander Schornstein has voting and dispositive power of over such shares.

(2)      Ha Wing Kuen has voting and dispositive power of over such shares.

(3)      Joerg Schweizer has voting and dispositive power of over such shares.

(4)      Chris Etherington has voting and dispositive power of over such shares.

(5)      Darren Devine and Darryl Cardey each have voting and dispositive power of over such shares.

(6)      Includes shares and shares underlying warrants that are held by Camino Capital GmbH over which he has voting and dispositive control.

(7)      Excludes any ordinary shares that may be issued if the underwriter exercises its options to cover over allotments.

(8)      Jie Xu has voting and dispositive power of over such shares.

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PLAN OF DISTRIBUTION

The selling shareholders may, from time to time, sell any or all of their Resale Shares on any stock exchange, market or trading facility on which the shares are traded or in private transactions. If the Resale Shares are sold through underwriters, the selling shareholders will be responsible for underwriting discounts or commissions or agent’s commissions. The Resale Shares may be sold at prevailing market prices or privately negotiated prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale or at negotiated prices. The selling shareholders may use any one or more of the following methods when selling shares:

•        ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

•        block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction;

•        purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

•        an exchange distribution in accordance with the rules of the applicable exchange;

•        privately negotiated transactions;

•        settlement of short sales entered into after the effective date of the registration statement of which this selling shareholder prospectus is a part;

•        in transactions through broker-dealers that agree with the selling shareholder to sell a specified number of such securities at a stipulated price per security;

•        through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

•        a combination of any such methods of sale; or

•        any other method permitted pursuant to applicable law.

The selling shareholders may also sell shares under Rule 144 under the Securities Act, if available, rather than under this selling shareholder prospectus. In general, a person who has beneficially owned restricted ordinary shares for at least six months, in the event we have been a reporting company under the Exchange Act for at least 90 days, would be entitled to sell such securities, provided that such person is not deemed to be an affiliate of ours at the time of sale or to have been an affiliate of ours at any time during the three months preceding the sale.

The selling shareholders may also engage in short sales against the box, puts and calls and other transactions in our securities or derivatives of our securities and may sell or deliver shares in connection with these trades.

Broker-dealers engaged by the selling shareholders may arrange for other broker-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the selling shareholders (or, if any broker-dealer acts as agent for the purchaser of shares, from the purchaser) in amounts to be negotiated. The selling shareholders do not expect these commissions and discounts to exceed what is customary in the types of transactions involved. Any profits on the Resale Shares by a broker-dealer acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act. Discounts, concessions, commissions and similar selling expenses, if any, attributable to the sale of the Resale Shares will be borne by a selling shareholder. The selling shareholders may agree to indemnify any agent, dealer or broker-dealer that participates in transactions involving sales of the Resale Shares if liabilities are imposed on that person under the Securities Act.

In connection with the sale of the Resale Shares, the selling shareholders may enter into hedging transactions with broker-dealers, which may in turn engage in short sales of our ordinary shares in the course of hedging in positions they assume. The selling shareholders may also sell Resale Shares short and deliver our ordinary shares covered by this selling shareholder prospectus to close out short positions and to return borrowed shares in connection with such short sales. The selling shareholders may also loan or pledge the Resale Shares to broker-dealers that in turn may sell such shares.

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The selling shareholders may from time to time pledge or grant a security interest in some or all of their Resale Shares and, if a selling shareholder defaults in the performance of its secured obligations, the pledgees or secured parties may offer and sell the Resale Shares from time to time under this selling shareholder prospectus after we have filed an amendment to this selling shareholder prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling shareholders to include the pledgee, transferee or other successors in interest as a selling shareholder under this selling shareholder prospectus.

The selling shareholders also may transfer the Resale Shares in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this selling shareholder prospectus and may sell the Resale Shares from time to time under this selling shareholder prospectus after we have filed an amendment to this selling shareholder prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling shareholders to include the pledgees, transferees or other successors in interest as a selling shareholder under this selling shareholder prospectus. The selling shareholders also may transfer and donate the Resale Shares in other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this selling shareholder prospectus.

The selling shareholders and any broker-dealers or agents that are involved in selling the Resale Shares may be deemed to be an “Underwriter” within the meaning of the Securities Act in connection with such sales. In such event, any commissions paid, or any discounts or concessions allowed to, such broker-dealers or agents and any profit realized on the Resale Shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. At the time a particular offering of the Resale Shares is made, a prospectus supplement, if required, will be distributed which will set forth the aggregate amount of Resale Shares being offered and the terms of the offering, including the name or names of any broker-dealers or agents, any discounts, commissions and other terms constituting compensation from the selling shareholders and any discounts, commissions or concessions allowed or re-allowed or paid to broker-dealers. Under the securities laws of some states, the Resale Shares may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states the Resale Shares may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with. There can be no assurance that the selling shareholders will sell any or all of the Resale Shares registered pursuant to the registration statement, of which this selling shareholder prospectus forms a part.

The selling shareholders have informed us that they do not have any agreement or understanding, directly or indirectly, with any person to distribute the Resale Shares. At the time of the purchase of the Resale Shares, they had no agreements, plans or understandings, directly or indirectly, with any person to distribute the securities.

We are required to pay all fees and expenses incident to the registration of the Resale Shares. We are not obligated to pay any of the expenses of any attorney or other advisor engaged by the selling shareholders.

If we are notified by a selling shareholder that any material arrangement has been entered into with a broker-dealer for the sale of their Resale Shares, we will file a post-effective amendment to the registration statement. If a selling shareholder uses this selling shareholder prospectus for any sale of its Resale Shares, it will be subject to the prospectus delivery requirements of the Securities Act.

The anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of the Resale Shares and activities of the selling shareholders, which may limit the timing of purchases and sales of any of the Resale Shares by the selling shareholders and any other participating person. Regulation M may also restrict the ability of any person engaged in the distribution of the Resale Shares to engage in passive market-making activities with respect to the Resale Shares. Passive market making involves transactions in which a market maker acts as both our underwriter and as a purchaser of our ordinary shares in the secondary market. All of the foregoing may affect the marketability of the Resale Shares and the ability of any person or entity to engage in market-making activities with respect to the Resale Shares.

Once sold under the registration statement, of which this selling shareholder prospectus forms a part, the Resale Shares will be freely tradable in the hands of persons other than our affiliates.

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USE OF PROCEEDS

We will not receive proceeds from sales of the Resale Shares made under this selling shareholder prospectus.

DETERMINATION OF OFFERING PRICE

The selling shareholders will offer the Resale Shares at the prevailing market prices or privately negotiated price. The offering price of our ordinary shares does not necessarily bear any relationship to our book value, assets, past operating results, financial condition or any other established criteria of value. Our ordinary shares might not trade at market prices in excess of the offering price as prices for ordinary shares in any public market will be determined in the marketplace and may be influenced by many factors, including the depth and liquidity. See “Plan of Distribution” above for more information.

LEGAL MATTERS

Ortoli Rosenstadt LLP is acting as counsel to our company regarding U.S. securities law matters. The current address of Ortoli Rosenstadt LLP is 501 Madison Avenue, 14th Floor, New York, NY 10022. CMS Derks Star Busmann N.V. is acting as counsel to our company regarding matters of Dutch law. The current address of CMS Derks Star Busmann N.V. is Atrium — Parnassusweg 737, 1077 DG Amsterdam, PO Box 94700, 1090 GS Amsterdam, Netherlands.

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PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

ITEM 6: INDEMNIFICATION OF DIRECTORS AND OFFICERS

Under Dutch law, members of the board of directors may be liable to the registrant for damages in the event of improper or negligent performance of their duties. They may be jointly and severally liable for damages to the registrant and third parties for infringement of our Articles of Association or certain provisions of the Dutch Civil Code. In certain circumstances, they may also incur additional specific civil and criminal liabilities.

Pursuant to the registrant’s articles of association, to the fullest extent permitted by Dutch law, the following shall be reimbursed to the indemnified officers:

(a)     the costs of conducting a defence against claims, also including claims by the Company and its group companies, as a consequence of any acts or omissions in the fulfilment of their duties or any other duties currently or previously performed by them at the company’s request;

(b)    any damages or financial penalties payable by them as a result of any such acts or omissions;

(c)     any amounts payable by them under settlement agreements entered into by them in connection with any such acts or omissions;

(d)    the costs of appearing in other legal proceedings in which they are involved as directors or former directors, with the exception of proceedings primarily aimed at pursuing a claim on their own behalf;

(e)     any taxes payable by them as a result of any reimbursements in accordance with the articles of association.

An indemnitee shall not be entitled to reimbursement if and to the extent that:

(a)     it has been adjudicated by a Dutch court or, in the case of arbitration, an arbitrator, in a final and conclusive decision that the act or omission of the Indemnitee may be characterised as intentional, deliberately reckless or grossly negligent conduct, unless Dutch law provides otherwise or this would, in view of the circumstances of the case, be unacceptable according to standards of reasonableness and fairness; or

(b)    the costs or financial loss of the Indemnitee are covered by an insurance and the insurer has paid out the costs or financial loss.

The description of indemnity herein is merely a summary of the provisions in the registrant’s articles of association described above, and such description shall not limit or alter the mentioned provisions in the articles of association or other indemnification agreements.

Prior to the public offering of the securities being registered by this registration statement, we intend to enter into a directors’ and officers’ liability insurance policy to cover the liability of members of the board of directors and members.

The underwriting agreement the registrant will enter into in connection with the offering being registered hereby provides that the underwriter will indemnify, under certain conditions, the registrant’s board of directors and its officers against certain liabilities arising in connection with this offering.

ITEM 7. RECENT SALES OF UNREGISTERED SECURITIES

In the past three years, we have issued and sold the securities described below without registering the securities under the Securities Act. None of these transactions involved the underwriter’s underwriting discounts or commissions or any public offering. We believe that each of the following issuances was exempt from registration under the Securities Act in reliance on Regulation S promulgated under the Securities Act regarding sales by an issuer in offshore transactions, Regulation D under the Securities Act, Rule 701 under the Securities Act or pursuant to Section 4(a)(2) of the Securities Act regarding transactions not involving a public offering.

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Since our founding, we have issued:

•        2,010,000 units in April 2021, each consisting of one ordinary share and a warrant to purchase an ordinary share at an exercise price of $3.00, for a per unit offering price of $0.30;

•        140,000 broker warrants in connection with such April 2021 unit offering, which warrants were on the same terms as the warrants in the unit offering;

•        200,000 ordinary shares in July 2021 to our Chief Executive Officer in connection with his being appointed as our executive officer, of which 100,000 have been issued immediately, 50,000 will be issued one year after the successful completion of an initial public offering and 50,000 will be issued two years after the successful completion of an initial public offering;

•        1,000,000 units in August 2021, each consisting of one ordinary share and a warrant to purchase an ordinary share at an exercise price of $3.00, for a per unit offering price of $0.60;

•        70,000 broker warrants in connection with such August 2021 unit offering, which warrants were on the same terms as the warrants in the unit offering.

•        6,000,000 ordinary shares in connection with our Contribution Agreement with PharmGenomics GmbH in September 2021

•        1,000,000 units in September 2021, each consisting of one ordinary share and a warrant to purchase an ordinary share at an exercise price of $3.00, for a per unit offering price of $2.00; and

•        25,000 broker warrants in connection with such September 2021 unit offering, which warrants were on the same terms as the warrants in the unit offering.

ITEM 8. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

The following exhibits are filed with this registration statement:

1.1

 

Form of Underwriting Agreement

3.1

 

Form of Deed of Conversion

4.1

 

Share Certificate — Ordinary Shares*

4.2

 

Form of Underwriter’s Warrant (included in Exhibit 1.1)

5.1

 

Form of Opinion of CMS Derks Star Busmann N.V.

10.1

 

License and Development Agreement, dated January 1, 2019, between the Company and ColoAlert AS

10.2

 

Amendment to License and Development Agreement, dated November 2, 2020, between the Company and ColoAlert AS

10.3

 

Option to Purchase Intellectual Property Assets, dated February 2021, among the Company, ColoAlert AS and Norda ASA

10.4

 

Management Services Agreement, dated July 1, 2020, between the Company and Guido Baechler

10.5

 

Consulting Agreement, dated July 16, 2021, between the Company and William Caragol

10.6

 

Management Services Agreement, dated January 1, 2019, between the Company and Dr. Moritz Eidens

10.7

 

Management Services Agreement, dated January 1, 2019, between the Company and Philipp Freese

10.8

 

Contribution Agreement between the Company and PharmGenomics GmbH

10.9

 

Form of Silent Partnership Agreements

10.10

 

Form of Mainz Biomed N.V. 2021 Omnibus Incentive Plan

14.1

 

Code of Conduct and Ethics*

23.1

 

Consent of BF Borgers CPA PC for use of report for Mainz Biomed B.V.

23.2

 

Consent of BF Borgers CPA PC for use of report of PharmGenomics GmbH (included in exhibit 23.1)

23.3

 

Consent of CMS Derks Star Busmann N.V. (contained in exhibit 5.1)*

____________

*        To be filed by amendment

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ITEM 9. UNDERTAKINGS

The undersigned Registrant hereby undertakes:

(1)    To file, during any period in which offers or sales of securities are being made, a post-effective amendment to this registration statement to:

(i)     Include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;

(ii)    Reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and

(iii)   Include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement.

(2)    That, for the purpose of determining any liability under the Securities Act of 1933, each such post- effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(3)    To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

(4)     To file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A. of Form 20-F at the start of any delayed offering or throughout a continuous offering. Financial statements and information otherwise required by Section 10(a)(3) of the Act need not be furnished, provided that the Registrant includes in the prospectus, by means of a post- effective amendment, financial statements required pursuant to this paragraph (4) and other information necessary to ensure that all other information in the prospectus is at least as current as the date of those financial statements. Notwithstanding the foregoing, with respect to registration statements on Form F-3, a post-effective amendment need not be filed to include financial statements and information required by Section 10(a)(3) of the Act or Rule 3-19 of Regulation S- X if such financial statements and information are contained in periodic reports filed with or furnished to the Commission by the Registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the Form F-3.

(5)    Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the provisions described herein, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.

(6)    Each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the Registrant certifies that it has reasonable grounds to believe it meets all of the requirements for filing on Form F-1 and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized on October 8, 2021.

 

MAINZ BIOMED, B.V

   

(Registrant)

   

By:

 

/s/ Guido Baechler

       

Guido Baechler, Chief Executive Officer

       

(Principal Executive Officer)

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.

Signature

 

Title

 

Date

/s/ Guido Baechler

 

Chief Executive Officer (Principal Executive Officer)

 

October 8, 2021

Guido Baechler

       

/s/ William Caragol

 

Chief Financial Officer (Principal Financial Officer and

 

October 8, 2021

William Caragol

 

Principal Accounting Officer)

   

/s/ Marco Messina

 

Director

 

October 8, 2021

Marco Messina

       

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SIGNATURE OF AUTHORIZED REPRESENTATIVE IN THE UNITED STATES

Pursuant to the Securities Act of 1933, the undersigned, the duly authorized representative in the United States of Mainz Biomed B.V., has signed this registration statement or amendment thereto in New York, New York, on October 8, 2021.

 

Ortoli Rosenstadt LLP

   

By:

 

/s/ William S. Rosenstadt

   

Name:

 

William S. Rosenstadt

   

Title:

 

Managing Partner

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Exhibit 1.1

 

Mainz Biomed B.V.

 

UNDERWRITING AGREEMENT

 

[    ], 2021

 

Boustead Securities, LLC

6 Venture, Suite 395

Irvine, CA 92618

Attn: Keith Moore, Chief Executive Officer

Attn: Daniel J. McClory, Managing Director

 

Ladies and Gentlemen:

 

This underwriting agreement (this “Agreement”) constitutes the agreement between Mainz Biomed B.V., a Dutch company limited by shares (collectively with its subsidiaries and affiliates, including, without limitation, all entities disclosed or described in the Registration Statement (as hereafter defined) as being subsidiaries or affiliates of the Company, the “Company”) on the one hand, and Boustead Securities, LLC (the “Underwriter”), on the other hand, pursuant to which the Underwriter shall serve as the underwriter for the Company in connection with the proposed offering (the “Offering”) by the Company of their Securities (as defined below) on a “Firm Commitment” basis.

 

The Company proposes, subject to the terms and conditions stated herein, to issue and sell to the Underwriter an aggregate of [     ] authorized but unissued ordinary shares (the “Firm Shares”), €0.01 par value (the “Ordinary Shares”), of the Company.

 

The Firm Shares together with the Option Shares (as defined herein) may also be referred to as the “Securities.”

 

The Company hereby confirms its agreement with the Underwriter as follows:

 

Section 1. Agreement to Act as Underwriter.

 

(a) Underwriting Discount; Expenses.

 

(i) Underwriting Discount. An underwriting discount equal to seven percent (7%) of the aggregate public sales price of the Securities sold on a Closing Date, which will be paid to and allocated by the Underwriter among the selling syndicate and soliciting dealers in their sole discretion, if applicable.

 

(ii) Underwriter’s Warrant. The Company hereby agrees to issue to the Underwriter (and/or its designees) on a Closing Date, as defined in Section 3(c) herein, a warrant to purchase a number of Ordinary Shares equal to seven percent (7%) of the Ordinary Shares sold on such Closing Date (“Underwriter’s Warrant”). The Underwriter’s Warrant, in the form attached hereto as Exhibit A, shall be exercisable, in whole or in part, commencing on the date of issuance and expiring on the five-year anniversary from the date that the Commission (as defined herein) declared the Registration Statement (as defined herein) effective (the “Effective Date”) at an initial exercise price equal to the Per Share Price (as defined below) of the Securities. The Underwriter’s Warrant shall include a “cashless” exercise feature. The Underwriter understands and agrees that there are significant restrictions pursuant to FINRA Rule 5110 against transferring the Underwriter’s Warrant and the underlying Ordinary Shares during the one hundred eighty (180) days after the Effective Date and by its acceptance thereof shall agree that it will not sell, transfer, assign, pledge or hypothecate the Underwriter’s Warrant, or any portion thereof, or be the subject of any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of such securities for a period of one hundred eighty (180) days following the Effective Date to anyone other than the circumstances listed under FINRA Rule 5110(g)(2).

 

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Delivery of the Underwriter’s Warrant shall be made on a Closing Date and shall be issued in the name or names and in such authorized denominations as the Underwriter may request.

 

(iii) Non-Accountable Expenses. The Company agrees that, in addition to the expenses payable pursuant to Section 1(iv) below, on each Closing Date it shall pay to the Underwriter, by deduction from the net proceeds of the Offering contemplated herein, a non-accountable expense allowance equal to one percent (1%) of the gross proceeds received by the Company from the sale of the Securities on such Closing Date.

 

(iv) Expenses. Whether or not the transactions contemplated by this Agreement and the Registration Statement are consummated or this Agreement is terminated, the Company hereby agrees to pay all costs and expenses incident to the Offering, including the following:

 

  A. all expenses in connection with the preparation, printing, formatting for EDGAR and filing of the Registration Statement, and any and all amendments and supplements thereto and the mailing and delivering of copies thereof to the Underwriter and dealers;
     
  B. all fees and expenses in connection with filings with FINRA’s Public Offering System;
     
  C. all fees, disbursements and expenses of the Company’s counsel and accountants in connection with the registration of the Securities under the Securities Act of 1933, as amended (the “Securities Act”) and the Offering;
     
  D. all reasonable expenses in connection with the qualifications of the Securities for offering and sale under state or blue-sky laws, when applicable;
     
  E. all fees and expenses in connection with listing the Securities on the Nasdaq (a “Senior Exchange”);
     
  F. any stock transfer taxes incurred in connection with this Agreement or the Offering;
     
  G. the cost and charges of any transfer agent or registrar for the Securities;
     
  H.

all of the Underwriter’s reasonable out-of-pocket expenses in connection with the performance of its services hereunder, with the aggregate amount not to exceed $250,000, including but not limited to:

 

(i) Underwriter’s counsel’s fees and expenses up to $100,000,

 

(ii) due diligence and other expenses incurred prior to completion of the Offering, which shall not exceed $75,000; and

 

(iii) road show, travel, platform on-boarding fees, and other reasonable out-of-pocket accountable expenses which shall not exceed $75,000 (the “Road Show and Travel Expenses”).

 

Prior to the date of this Agreement, the Company has paid to the Underwriter $[ ]. Any advances made by the Company have been (and shall be) made for reasonably anticipated out-of-pocket accountable expenses in connection with the Offering, and any unused portion will be returned to the Company to the extent not actually incurred.

 

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In the event that this Agreement is terminated pursuant to Section 9 hereof, or subsequent to a Material Adverse Change, the Company will pay all documented out-of-pocket and unreimbursed expenses of the Underwriter (including but not limited to fees and disbursements of Underwriter’s counsel, expenses associated with a due diligence report and reasonable travel specified in Sections 1(a)(iv)(H) incurred in connection herewith which shall be limited to expenses which are actually incurred as allowed under FINRA Rule 5110 and in any event, the aggregate amount of such expenses to be paid or reimbursed by the Company directly or indirectly to or on behalf of the Underwriter shall not exceed $[ ].

 

(b) Exclusivity. The term of the Underwriter’s exclusive engagement (the “Exclusive Term”) will be until the termination of the engagement agreement by and between the Company and the Underwriter dated April 13, 2021 (the “Engagement Letter”). Notwithstanding anything to the contrary contained herein, the provisions concerning confidentiality, indemnification and contribution contained herein will survive any expiration or termination of this Agreement, and the Company’s obligation to pay fees actually earned and payable and to reimburse expenses actually incurred and reimbursable pursuant to Section 1 hereof and which are permitted to be reimbursed under FINRA Rule 5110(g)(4)(A), will survive any expiration or termination of this Agreement. Nothing in this Agreement shall be construed to limit the ability of the Underwriter or its Affiliates to pursue, investigate, analyze, invest in, or engage in investment banking, financial advisory or any other business relationship with Persons (as defined below) other than the Company. As used herein (i) “Persons” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind and (ii) “Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person as such terms are used in and construed under Rule 405 under the Securities Act. If during the Exclusive Term, or within twelve (12) months after the date of termination or expiration of the Engagement Letter, no Closing has occurred, the Company sells securities to investors introduced to the Company by the Underwriter or its Affiliates prior to such termination or expiration, then the Company shall pay to the Underwriter, at the time of each such sale, the compensation, set forth in Section 1(a) above, with respect to any such sale.

 

Section 2. Representations, Warranties and Covenants of the Company. The Company hereby represents, warrants and covenants to the Underwriter, as of the date hereof, and as of each Closing Date, except as set out in the Registration Statement, as follows:

 

(a) Securities Law Filings. The Company has filed with the Securities and Exchange Commission (the “Commission”) a registration statement on Form F-1 (Registration File No. [ ]) under the Securities Act and the rules and regulations (the “Rules and Regulations”) of the Commission promulgated thereunder. At the time of the effective date of the Registration Statement, the Registration Statement and amendments will materially meet the requirements of Form F-1 under the Securities Act. The Company will file with the Commission pursuant to Rules 430A and 424(b) under the Securities Act, a final prospectus included in such registration statement relating to the Offering and the underwriting thereof (the “Final Prospectus”) and has advised the Underwriter of all further information (financial and other) with respect to the Company required to be set forth therein. Such registration statement, including the exhibits thereto, as amended at the date of this Agreement, is hereinafter called the “Registration Statement”; such prospectus in the form in which it appears in the Registration Statement as amended at the date of this Agreement is hereinafter called the “Prospectus.” All references in this Agreement to financial statements and schedules and other information that is “contained,” “included,” “described,” “referenced,” “set forth” or “stated” in the Registration Statement or the Prospectus (and all other references of like import) shall be deemed to mean and include all such financial statements and schedules and other information that is or is deemed to be incorporated by reference in the Registration Statement or the Prospectus, as the case may be. The Registration Statement has been declared effective on the date hereof. The Company shall, prior to the Closing Date for the Firm Shares, file with the Commission a Form 8-A providing for the registration under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), of the Ordinary Shares.

 

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(b) Assurances. The Registration Statement (and any further documents to be filed with the Commission) contains all exhibits and schedules as required by the Securities Act. Each of (i) the Registration Statement at the time it became effective, (ii) the Prospectus at the time the Registration Statement became effective, (iii) any post-effective amendment to the Registration Statement at the time it becomes effective and (iv) and the Final Prospectus filed with the Commission pursuant to Rule 424(b) at the time of such filing, and at all other subsequent times at each Closing Date, complied in all material respects with the Securities Act and the applicable Rules and Regulations, as amended or supplemented, if applicable, and did not and will not, contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not materially misleading (provided, however, that the preceding representations and warranties contained in this sentence shall not apply to any statements or omissions made in reliance upon and in conformity with information furnished in writing to the Company by the Underwriter expressly for use therein (the “Underwriter Information”). The Prospectus, as of its date, complies in all material respects with the Securities Act and the applicable Rules and Regulations, and the Final Prospectus, as of its date, will comply in all material respects with the Securities Act and the applicable Rules and Regulations. As of its date, the Prospectus did not and will and the Final Prospectus will not contain as of the date thereof any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading (provided, however, that the preceding representations and warranties contained in this sentence shall not apply to any Underwriter Information). All post-effective amendments to the Registration Statement reflecting facts or events arising after the date thereof which represent, individually or in the aggregate, a fundamental change in the information set forth therein have been so filed with the Commission. There are no documents required to be filed with the Commission in connection with the transaction contemplated hereby that (x) have not been filed as required pursuant to the Securities Act or (y) will not be filed within the requisite time period. There are no material contracts or other documents required to be described in the Prospectus (or the Final Prospectus) or filed as exhibits or schedules to the Registration Statement that have not been (or will not be) described or filed as required. The Company is eligible to use free writing prospectuses in connection with the Offering pursuant to Rules 164 and 433 under the Securities Act. Any free writing prospectus that the Company is required to file pursuant to Rule 433(d) under the Securities Act has been, or will be, filed with the Commission in accordance with the requirements of the Securities Act and the applicable Rules and Regulations. Each free writing prospectus that the Company has filed, or is required to file, pursuant to Rule 433(d) under the Securities Act or that was prepared by or behalf of or used by the Company complies or will comply in all material respects with the requirements of the Securities Act and the applicable Rules and Regulations. The Company will not, without the prior consent of the Underwriter, prepare, use or refer to, any free writing prospectus. Except as set out on Schedule 2(b), there are no free-writing prospectuses in connection with this offering.

 

(c) Offering Materials. The Company has delivered, or will as promptly as practicable deliver, to the Underwriter complete conformed copies of the Registration Statement and of each consent and certificate of experts, as applicable, filed as a part thereof, and conformed copies of the Registration Statement (without exhibits) and the Prospectus, as amended or supplemented (including the Final Prospectus), in such quantities and at such places as the Underwriter reasonably requests. Neither the Company nor any of its directors and officers has distributed and none of them will distribute, prior to any Closing Date, any offering material in connection with the offering and sale of the Securities other than the Prospectus, the Final Prospectus, the Registration Statement, and any other materials permitted by the Securities Act (collectively, the “Offering Materials”).

 

(d) Subsidiaries. All of the direct and indirect subsidiaries of the Company (the “Subsidiaries”) are described in the Registration Statement to the extent necessary. The Company owns, directly or indirectly, all of its capital stock or other equity interests of each Subsidiary free and clear of any liens, charges, security interests, encumbrances, rights of first refusal, preemptive rights or other restrictions (collectively, “Liens”), and all of the issued and outstanding shares of capital stock of each Subsidiary are validly issued and are fully paid, non-assessable and free of preemptive and similar rights to subscribe for or purchase securities.

 

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(e) Organization and Qualification. The Company and each of the Subsidiaries is an entity duly incorporated or otherwise organized, validly existing and in good standing (where applicable) under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted. Neither the Company nor any Subsidiary is in violation or default of any of the provisions of its respective certificate or articles of incorporation, bylaws or other organizational or charter documents. Each of the Company and the Subsidiaries is duly qualified to conduct business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, could not reasonably be expected to result in: (i) a material adverse effect on the legality, validity or enforceability of this Agreement or any other agreement entered into between the Company and the Underwriter (“Transaction Documents”), (ii) a material adverse effect on the results of operations, assets, business, prospects (as such prospects are described in the Prospectus) or condition (financial or otherwise) of the Company and the Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under this Agreement or the Offering (any of (i), (ii) or (iii), a “Material Adverse Effect”) and to the best knowledge of the Company, no action, claim, suit, investigation or proceeding (including, without limitation, an informal investigation or partial proceeding, such as a deposition), whether commenced or threatened (“Proceeding”) has been instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.

 

(f) Authorization; Enforcement. The Company has the requisite corporate power and authority to enter into and to consummate the transactions contemplated by this Agreement and each of the other Transaction Documents and the Offering and otherwise to carry out its obligations hereunder and thereunder. The execution and delivery of this Agreement by the Company and each of the other Transaction Documents and the consummation by it of the transactions contemplated hereby have been duly authorized by all necessary action on the part of the Company and no further action is required by the Company, the Company’s Board of Directors (the “Board of Directors”) or the Company’s shareholders in connection therewith other than in connection with the Required Approvals (as defined below). This Agreement and each other Transaction Document to which it is a party has been duly executed by the Company and, when delivered in accordance with the terms hereof, will constitute the valid and binding obligation of the Company enforceable against the Company in accordance with its terms, except (i) as limited by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies and (iii) insofar as indemnification and contribution provisions may be limited by applicable law.

 

(g) No Conflicts. The execution, delivery and performance by the Company of this Agreement, the other Transaction Documents to which it is a party and the transactions contemplated hereby do not and will not (i) conflict with or violate any provision of the Company’s or any Subsidiary’s certificate or articles of incorporation, bylaws or other organizational or charter documents, or (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any Lien upon any of the properties or assets of the Company or any Subsidiary, or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other instrument (evidencing a Company or Subsidiary debt or otherwise) or other understanding to which the Company or any Subsidiary is a party or by which any property or asset of the Company or any Subsidiary is bound or affected, or (iii) subject to the Required Approvals, conflict with or result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which the Company or a Subsidiary is subject (including federal and state securities laws and regulations), or by which any property or asset of the Company or a Subsidiary is bound or affected; except in the case of each of clauses (i), (ii) and (iii), such conflict, default or violation could not reasonably be expected to result in a Material Adverse Effect.

 

(h) Filings, Consents and Approvals. The Company is not required to obtain any consent, waiver, authorization or order of, give any notice to, or make any filing or registration with, any court or other federal, state, local or other governmental authority or other Person in connection with the execution, delivery and performance by the Company of this Agreement, the other Transaction Documents to which it is a party and the transactions contemplated hereby, other than: (i) the filing with the Commission of the Final Prospectus as required by Rule 424 under the Securities Act, (ii) application to a Senior Exchange (the “Trading Market”), for the listing of the Securities for trading thereon in the time and manner required thereby and (iii) if applicable, such filings as are required to be made under applicable state securities laws (collectively, the “Required Approvals”).

 

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(i) Issuance of the Securities; Registration. The Securities are duly authorized and, when issued and paid for in accordance with this Agreement, the other Transaction Documents to which it is a party, and the terms of the Offering as described in the Prospectus, will be duly and validly issued, fully paid and non-assessable, free and clear of all Liens imposed by the Company. The Company has sufficient Ordinary Shares for the issuance of the maximum number of Securities issuable pursuant to the Offering as described in the Prospectus.

 

(j) Capitalization. The capitalization of the Company as of the date hereof is as set forth in the Registration Statement, and the Prospectus. The Company has not issued any Ordinary Shares since the date of this Agreement, other than pursuant to the Company’s equity incentive plans, the issuance of Ordinary Shares to employees, directors or consultants pursuant to the Company’s equity incentive plans and pursuant to the conversion and/or exercise of any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire Ordinary Shares at any time, including, without limitation, any debt, preferred shares, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive (“Ordinary Shares Equivalents”). No Person has any right of first refusal, preemptive right, right of participation, or any similar right to participate in the transactions contemplated by the Offering Materials. Except as a result of the purchase and sale of the Securities or as disclosed in the Registration Statement, and the Prospectus, there are no outstanding options, warrants, scrip rights to subscribe to, calls or commitments of any character whatsoever relating to, or securities, rights or obligations convertible into or exercisable or exchangeable for, or giving any Person any right to subscribe for or acquire, any Ordinary Shares or the capital stock of any Subsidiary, or contracts, commitments, understandings or arrangements by which the Company or any Subsidiary is or may become bound to issue additional Ordinary Shares or Ordinary Shares Equivalents or capital stock of any Subsidiary. The issuance and sale of the Securities will not obligate the Company or any Subsidiary to issue Ordinary Shares or other securities to any Person (other than the Underwriter) and will not result in a right of any holder of Company securities to adjust the exercise, conversion, exchange or reset price under any of such securities. There are no securities of the Company or any Subsidiary that have any anti-dilution or similar adjustment rights (other than adjustments for stock splits, recapitalizations, and the like) to the exercise or conversion price, have any exchange rights, or reset rights. Except as set forth in the Registration Statement, and the Prospectus, there are no outstanding securities or instruments of the Company or any Subsidiary that contain any redemption or similar provisions, and there are no contracts, commitments, understandings or arrangements by which the Company or any Subsidiary is or may become bound to redeem a security of the Company or such Subsidiary. The Company does not have any share appreciation rights or “phantom stock” plans or agreements or any similar plan or agreement. All of the outstanding Ordinary Shares of the Company are duly authorized, validly issued, fully paid and non-assessable, have been issued in compliance in all material respects with all federal and state securities laws, and none of such outstanding Ordinary Shares was issued in violation of any preemptive rights or similar rights to subscribe for or purchase securities. No further approval or authorization of any shareholder, the Board of Directors or others is required for the issuance and sale of the Securities. Except for the operating agreement of the Company, there are no shareholders agreements, voting agreements or other similar agreements with respect to the Company’s Ordinary Shares to which the Company is a party or, to the knowledge of the Company, between or among any of the Company’s shareholders.

 

(k) Material Changes; Undisclosed Events, Liabilities or Developments. Since the date of the latest audited financial statements included within the Registration Statement, except as specifically disclosed in the Registration Statement, the Prospectus and the Final Prospectus, (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to United States generally accepted accounting principles (“GAAP”) or disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution of cash or other property to its shareholders or purchased, redeemed or made any agreements to purchase or redeem any Ordinary Shares of the Company and (v) the Company has not issued any equity securities to any officer, director or Affiliate, except pursuant to existing Company stock option plans, if any. The Company does not have pending before the Commission any request for confidential treatment of information. Except for the issuance of the Securities contemplated by the Prospectus or disclosed in the Registration Statement or the Prospectus, no event, liability, fact, circumstance, occurrence or development has occurred or exists or is reasonably expected to occur or exist with respect to the Company or its Subsidiaries or their respective business, prospects (as such prospects are described in the Prospectus), properties, operations, assets or financial condition that would be required to be disclosed by the Company under applicable securities laws at the time this representation is made or deemed made that has not been publicly disclosed at least one trading day prior to the date that this representation is made.

 

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(l) Litigation. Except for such matter disclosed in the Offering Materials, there is no action, suit, inquiry, notice of violation, proceeding or investigation pending or, to the knowledge of the Company, threatened against or affecting the Company, any Subsidiary or any of their respective properties before or by any court, arbitrator, governmental or administrative agency or regulatory authority (federal, state, county, local or foreign) (an “Action”) which (i) adversely affects or challenges the legality, validity or enforceability of this Agreement, any of the Transaction Documents, the Offering or the Securities or (ii) could, if there were an unfavorable decision, reasonably be expected to result in a Material Adverse Effect. Neither the Company nor any Subsidiary, nor any director or officer thereof, is or has within the last 10 years been the subject of any Action involving a claim of violation of or liability under federal or state securities laws or a claim of breach of fiduciary duty. There has not been, and to the knowledge of the Company, there is not pending or contemplated, any investigation by the Commission involving the Company or any current or former director or officer of the Company.

 

(m) Labor Relations. No material labor dispute exists or, to the knowledge of the Company, is imminent with respect to any of the employees of the Company, which could reasonably be expected to result in a Material Adverse Effect. None of the Company’s or its Subsidiaries’ employees is a member of a union that relates to such employee’s relationship with the Company or such Subsidiary, and neither the Company nor any of its Subsidiaries is a party to a collective bargaining agreement, and the Company and its Subsidiaries believe that their relationships with their employees are good. No executive officer, to the knowledge of the Company, is, or is now expected to be, in violation of any material term of any employment contract, confidentiality, disclosure or proprietary information agreement or non-competition agreement, or any other contract or agreement or any restrictive covenant in favor of any third party, and the continued employment of each such executive officer does not subject the Company or any of its Subsidiaries to any liability with respect to any of the foregoing matters. To the Company’s actual knowledge, the Company and its Subsidiaries are in compliance with all applicable laws and regulations relating to employment and employment practices, terms and conditions of employment and wages and hours, except where the failure to be in compliance could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

 

(n) Compliance. Except as set forth in the Offering Materials, neither the Company nor any Subsidiary: (i) is in default under or in violation of (and no event has occurred that has not been waived that, with notice or lapse of time or both, would result in a default by the Company or any Subsidiary under), nor has the Company or any Subsidiary received notice of a claim that it is in default under or that it is in violation of, any indenture, loan or credit agreement or any other agreement or instrument to which it is a party or by which it or any of its properties is bound (whether or not such default or violation has been waived), (ii) is in violation of any judgment, decree or order of any court, arbitrator or governmental body or (iii) is or has been in violation of any statute, rule, ordinance or regulation of any governmental authority, including without limitation all foreign, federal, state and local laws relating to taxes, environmental protection, occupational health and safety, product quality and safety and employment and labor matters, except in each case as could not reasonably be expected to result in a Material Adverse Effect.

 

(o) Regulatory Permits. The Company and the Subsidiaries possess all certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct their respective businesses as described in the Prospectus, except where the failure to possess such permits could not reasonably be expected to result in a Material Adverse Effect (“Material Permits”), and neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation or modification of any Material Permit.

 

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(p) Title to Assets. The Company and the Subsidiaries have good and marketable title in fee simple to all real property owned by them and good and marketable title in all personal property owned by them that is material to the business of the Company and the Subsidiaries, in each case free and clear of all Liens, except for Liens disclosed in the Prospectus, Liens as do not materially affect the value of such property and do not materially interfere with the use made and proposed to be made of such property by the Company and the Subsidiaries and Liens for the payment of federal, state or other taxes, the payment of which is neither delinquent nor subject to penalties. Except as disclosed in the Offering Materials, any real property and facilities held under lease by the Company and the Subsidiaries are held by them under valid, subsisting and enforceable leases with which the Company and the Subsidiaries are in compliance.

 

(q) Patents and Trademarks. Except as disclosed in the Offering Materials and to the best of the Company’s actual knowledge, the Company and the Subsidiaries have, or have rights to use, all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights necessary or required for use in connection with their respective businesses as described in the Offering Materials and which the failure to so have could have a Material Adverse Effect (collectively, the “Intellectual Property Rights”). None of, and neither the Company nor any Subsidiary has received a notice (written or otherwise) that any of, the Intellectual Property Rights has expired, terminated or been abandoned, or is expected to expire or be abandoned, within two (2) years from the date of this Agreement, except where such action would not reasonably be expected to have a Material Adverse Effect. Except as disclosed in the Offering Materials, neither the Company nor any Subsidiary has received, since the date of the latest audited financial statements included within the Offering Materials, a written notice of a claim or otherwise has any knowledge that the Intellectual Property Rights violate or infringe upon the rights of any Person, except as would not have or reasonably be expected to not have a Material Adverse Effect. To the knowledge of the Company, all such Intellectual Property Rights are enforceable and there is no existing infringement by another Person of any of the Intellectual Property Rights. The Company and its Subsidiaries have taken reasonable security measures to protect the secrecy, confidentiality and value of all of their intellectual properties, except where failure to do so would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. The Company has no knowledge that it lacks or will be unable to obtain any rights or licenses to use all Intellectual Property Rights that are necessary to conduct its business.

 

(r) Transactions with Affiliates and Employees. Except as set forth in the Registration Statement and the Prospectus, none of the officers or directors of the Company and, to the knowledge of the Company, none of the employees of the Company is presently a party to any transaction with the Company or any Subsidiary (other than for services as employees, officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, or otherwise requiring payments to or from any officer, director or such employee or, to the knowledge of the Company, any entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee or partner, in each case in excess of $120,000 other than for (i) payment of salary or consulting fees for services rendered, (ii) reimbursement for expenses incurred on behalf of the Company and (iii) other employee benefits, including stock option agreements under any stock option plan of the Company.

 

(s) Sarbanes-Oxley; Internal Accounting Controls. Except as disclosed in the Registration Statement and in the Prospectus, the Company is in compliance with any and all applicable requirements of the Sarbanes-Oxley Act of 2002 that are effective and applicable to the Company as of the date hereof, and any and all applicable rules and regulations promulgated by the Commission thereunder that are effective as of the date hereof and as of each Closing Date. Except as set forth in the Offering Materials, the Company and the Subsidiaries maintains a system of internal accounting controls sufficient to provide reasonable assurance that: (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization, and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company and the Subsidiaries have established disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Company and the Subsidiaries and designed such disclosure controls and procedures to ensure that information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms.

  

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(t) Certain Fees, FINRA Affiliation. Except as set forth herein and in the Prospectus, contemplated by this Agreement, or a separate agreement regarding the Offering with a soliciting dealer in the sole discretion of the Underwriter, no brokerage or finder’s fees or commissions are or will be payable by the Company or any Subsidiary to any broker, financial advisor or consultant, finder, placement agent, investment banker, bank or other Person with respect to the transactions contemplated by the Transaction Documents. Except as set forth in the Registration Statement, and the Prospectus, to the Company’s knowledge, there are no other arrangements, agreements or understandings of the Company or, to the Company’s knowledge, any of its stockholders that may affect the Underwriter’s compensation, as determined by FINRA. Except for payments to the Underwriter, the Company has not made any direct or indirect payments (in cash, securities or otherwise) to (i) any person, as a finder’s fee, investing fee or otherwise, in consideration of such person raising capital for the Company or introducing to the Company persons who provided capital to the Company, (ii) any FINRA member, or (iii) any person or entity that has any direct or indirect affiliation or association with any FINRA member within the 12-month period prior to the date on which the Registration Statement was filed with the Commission (the “Filing Date”) or thereafter. To the Company’s knowledge, no (i) officer or director of the Company or its subsidiaries, (ii) except for the Underwriter, owner of 5% or more of the Company’s unregistered securities or that of its subsidiaries or (iii) except for the Underwriter, owner of any amount of the Company’s unregistered securities acquired within the 180-day period prior to the Filing Date, has any direct or indirect affiliation or association with any FINRA member. The Company will advise the Underwriter if it becomes aware that any officer, director or stockholder of the Company or its Subsidiaries is or becomes an Affiliate or associated person of a FINRA member participating in the Offering.

 

(u) Investment Company. The Company is not, and is not an Affiliate of, and immediately after receipt of payment for the Securities, will not be or be an Affiliate of, an “investment company” within the meaning of the Investment Company Act of 1940, as amended. The Company shall conduct its business in a manner so that it will not become an “investment company” subject to registration under the Investment Company Act of 1940, as amended.

 

(v) Registration Rights. Except as set forth in the Registration Statement or the Prospectus, no Person has any right to cause the Company to effect the registration under the Securities Act of any securities of the Company.

 

(w) Registration. The Company shall use its commercially reasonable efforts to maintain the effectiveness of the Registration Statement and a current Prospectus relating thereto for as long as the Securities remain outstanding.

 

(x) Solvency. Based on the consolidated financial condition of the Company, as of each Closing Date, after giving effect to the receipt by the Company of the proceeds from the sale of the Securities hereunder, the current cash flow of the Company, together with the proceeds the Company would receive, were it to liquidate all of its assets, after taking into account all anticipated uses of the cash, are sufficient to pay all amounts on or in respect of its liabilities when such amounts are required to be paid. The Company does not intend to incur debts beyond its ability to pay such debts as they mature (taking into account the timing and amounts of cash to be payable on or in respect of its debt). Except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any facts or circumstances which lead it to believe that it will file for reorganization or liquidation under the bankruptcy or reorganization laws of any jurisdiction within one year from each Closing Date. The Registration Statement and the Prospectus sets forth as of the date hereof all outstanding secured and unsecured Indebtedness of the Company or any Subsidiary, or for which the Company or any Subsidiary has commitments. For the purposes of this Agreement, “Indebtedness” means (x) any liabilities for borrowed money or amounts owed in excess of $50,000 (other than trade accounts payable incurred in the ordinary course of business), (y) all guaranties, endorsements and other contingent obligations in respect of indebtedness of others, whether or not the same are or should be reflected in the Company’s consolidated balance sheet (or the notes thereto), except guaranties by endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business; and (z) the present value of any lease payments in excess of $50,000 due under leases required to be capitalized in accordance with GAAP. Except as set forth in the Registration Statement and the Prospectus, neither the Company nor any Subsidiary is in default with respect to any Indebtedness.

 

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(y) Tax Status. Except for matters that would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company and each Subsidiary (i) has made or filed all income and franchise tax returns, reports and declarations required by any jurisdiction to which it is subject, (ii) has paid all taxes and other governmental assessments and charges that are material in amount, shown or determined to be due on such returns, reports and declarations and (iii) has set aside on its books provision reasonably adequate for the payment of all material taxes for periods subsequent to the periods to which such returns, reports or declarations apply. There are no unpaid taxes in any material amount claimed to be due by the taxing authority of any jurisdiction, and the officers of the Company or of any Subsidiary know of no basis for any such claim.

 

(z) Accountants. BF Borgers CPA PC (“BFB”) is the Company’s independent registered public accounting firm. To the knowledge and belief of the Company, such accounting firm (i) is a registered public accounting firm as required by the Exchange Act and (ii) has expressed its opinion with respect to the financial statements of the Company for the period from March 8, 2021 (inception) thru to March 31, 2021.

 

(aa) Office of Foreign Assets Control. Neither the Company nor, to the Company’s knowledge, any director, officer, agent, employee or affiliate of the Company is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Treasury Department (“OFAC”).

 

(bb) Company Not Ineligible Issuer. (i) At the time of filing the Registration Statement relating to the Securities and (ii) as of the date of the execution and delivery of this Agreement (with such date being used as the determination date for purposes of this clause (ii)), the Company met all the requirements set forth in General Instruction I of Form F-1.

 

(cc) Emerging Growth Company. From the time of the initial confidential submission of the Registration Statement to the Commission (or, if earlier, the first date on which the Company engaged directly or through any person authorized to act on its behalf in any Testing-the-Waters Communications) through the date hereof, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of the Securities Act (an “Emerging Growth Company”). “Testing-the-Waters Communication” means any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the Securities Act.

 

(dd) Certificates. Any certificate signed by an officer of the Company and delivered to the Underwriter or to counsel for the Underwriter shall be deemed to be a representation and warranty by the Company to the Underwriter as to the matters set forth therein.

 

(ee) Reliance. The Company acknowledges that the Underwriter will rely upon the accuracy and truthfulness of the foregoing representations and warranties and hereby consents to such reliance.

 

(ff) Forward-Looking Statements. No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act) contained in either the Registration Statement or the Prospectus has been made or reaffirmed without a reasonable basis or has been disclosed other than in good faith.

 

(gg) Statistical or Market-Related Data. Any statistical, industry-related and market-related data included or incorporated by reference in the Registration Statement or the Prospectus, are based on or derived from sources that the Company reasonably and in good faith believes to be reliable and accurate, and such data agree with the sources from which they are derived.

 

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(hh) Listing and Maintenance Requirements. The Ordinary Shares are registered pursuant to Section 12(b) or 12(g) of the Exchange Act, and the Company has taken no action designed to, or which to its knowledge is likely to have the effect of, terminating the registration of the Securities under the Exchange Act nor has the Company received any notification that the Commission is contemplating terminating such registration. Except as disclosed in the Offering Materials, the Company is, and has no reason to believe that it will not in the foreseeable future continue to be, in compliance with all such listing and maintenance requirements. The Ordinary Shares are currently eligible for electronic transfer through the Depository Trust Company or another established clearing corporation and the Company is current in payment of the fees to the Depository Trust Company (or such other established clearing corporation) in connection with such electronic transfer. The issuance and sale of the Securities hereunder does not contravene the rules and regulations of a Senior Exchange.

 

(ii) Foreign Corrupt Practices. Neither the Company, nor to the knowledge of the Company, any agent or other person acting on behalf of the Company, has (i) directly or indirectly, used any funds for unlawful contributions, gifts, entertainment or other unlawful expenses related to foreign or domestic political activity, (ii) made any unlawful payment to foreign or domestic government officials or employees or to any foreign or domestic political parties or campaigns from corporate funds, (iii) failed to disclose fully any contribution made by the Company (or made by any person acting on its behalf of which the Company is aware) which is in violation of law, or (iv) violated in any material respect any provision of the Foreign Corrupt Practices Act of 1977, as amended.

 

(jj) Regulation M Compliance. The Company has not, and to its knowledge no one acting on its behalf has, (i) taken, directly or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of any of the Securities, (ii) sold, bid for, purchased, or, paid any compensation for soliciting purchases of, any of the Securities, or (iii) paid or agreed to pay to any Person any compensation for soliciting another to purchase any other securities of the Company, other than, in the case of clauses (ii) and (iii), compensation paid to the Underwriter in connection with the Offering.

 

(kk) Testing the Waters Communications. The Company (a) has not alone engaged in any Testing-the-Waters Communication other than Testing-the-Waters Communications with the consent of the Underwriter with entities that are qualified institutional buyers within the meaning of Rule 144A under the Securities Act or institutions that are accredited investors within the meaning of Rule 501 under the Securities Act and (b) has not authorized anyone other than the Underwriter to engage in Testing-the-Waters Communications. The Company reconfirms that the Underwriter has been authorized to act on its behalf in undertaking Testing-the-Waters Communications. The Company has not distributed any Written Testing-the-Waters Communications.

 

(ll) Money Laundering. The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance with applicable financial record-keeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, applicable money laundering statutes and applicable rules and regulations thereunder (collectively, the “Money Laundering Laws”), and no Action or Proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any Subsidiary with respect to the Money Laundering Laws is pending or, to the knowledge of the Company or any Subsidiary, threatened.

 

(mm) Insurance. The Company and the Subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as the Company believes are prudent and customary in the businesses in which the Company and the Subsidiaries are engaged. Neither the Company nor any Subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business without a significant increase in cost.

 

(nn) Bank Holding Company Act. Neither the Company nor any of its Subsidiaries is subject to the Bank Holding Company Act of 1956, as amended (the “BHCA”) and to regulation by the Board of Governors of the Federal Reserve System (the “Federal Reserve”). Neither the Company nor any of its Subsidiaries owns or controls, directly or indirectly, five percent or more of the outstanding shares of any class of voting securities or 25 percent or more of the total equity of a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve. Neither the Company nor any of its Subsidiaries exercises a controlling influence over the management or policies of a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve.

 

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(oo) U.S. Real Property Holding Corporation. The Company is not and has never been a U.S. real property holding corporation within the meaning of Section 897 of the Internal Revenue Code of 1986, as amended, and the Company shall so certify upon the Underwriter’s request.

 

(pp) Senior Exchange Listing. The Ordinary Shares has been approved for listing on a Senior Exchange, subject to official notice of issuance, and the Company has taken no action designed to, or likely to have the effect of, delisting the Ordinary Shares from the Senor Exchange, nor has the Company received any notification that the Senor Exchange is contemplating terminating such listing.

 

(qq) D&O Questionnaires. To the Company’s knowledge, all information contained in the questionnaires (the “Questionnaires”) completed by each of the Company’s directors, officers and 5% shareholders immediately prior to the Offering (the “Insiders”) as supplemented by all information concerning the Company’s directors, officers and principal shareholders as described in the Offering Materials, provided to the Underwriter, is true and correct in all material respects and the Company has not become aware of any information which would cause the information disclosed in the Questionnaires to become materially inaccurate and incorrect.

 

(rr) Electronic Road Show. The Company has made available a “bona fide electronic road show” in compliance with Rule 433(d)(8)(ii) of the Securities Act Regulations such that no filing of any “road show” (as defined in Rule 433(h) of the Securities Act Regulations) is required in connection with the Offering.

 

(ss) Margin Securities. The Company owns no “margin securities” as that term is defined in Regulation U of the Board of Governors of the Federal Reserve System (the “Federal Reserve Board”), and none of the proceeds of Offering will be used, directly or indirectly, for the purpose of purchasing or carrying any margin security, for the purpose of reducing or retiring any indebtedness which was originally incurred to purchase or carry any margin security or for any other purpose which might cause any of the Securities to be considered a “purpose credit” within the meanings of Regulation T, U or X of the Federal Reserve Board.

 

(tt) Export and Import Laws. The Company and, to the Company’s knowledge, each of its Affiliates, and any director, officer, agent or employee of, or other person associated with or acting on behalf of the Company, has acted at all times in compliance with applicable Export and Import Laws (as defined below) and there are no claims, complaints, charges, investigations or Proceedings pending or expected or, to the knowledge of the Company, threatened between the Company or any of its subsidiaries and any governmental authority under any Export or Import Laws. The term “Export and Import Laws” means the Arms Export Control Act, the International Traffic in Arms Regulations, the Export Administration Act of 1979, as amended, the Export Administration Regulations, and all other laws and regulations of the United States government regulating the provision of services to non-U.S. parties or the export and import of articles or information from and to the United States of America, and all similar laws and regulations of any foreign government regulating the provision of services to parties not of the foreign country or the export and import of articles and information from and to the foreign country to parties not of the foreign country.

 

(uu) Integration. Neither the Company, nor any of its affiliates, nor any person acting on its or their behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security, under circumstances that would cause the Offering to be integrated with prior offerings by the Company for purposes of the Securities Act that would require the registration of any such securities under the Securities Act.

 

(vv) No Fiduciary Duties. The Company acknowledges and agrees that the Underwriter’s responsibility to the Company is solely contractual in nature and that none of the Underwriter or its Affiliates or any selling agent shall be deemed to be acting in a fiduciary capacity, or otherwise owes any fiduciary duty to the Company or any of its Affiliates in connection with the Offering and the other transactions contemplated by this Agreement. Notwithstanding anything in this Agreement to the contrary, the Company acknowledges that the Underwriter may have financial interests in the success of the Offering that are not limited to the difference between the Per Share Price to the public and the purchase price paid to the Company by the Underwriter for the Offering Securities and the Underwriter has no obligation to disclose, or account to the Company for, any of such additional financial interests. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriter with respect to any breach or alleged breach of fiduciary duty.

 

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Section 3. Delivery and Payment.

 

3.1 Firm Shares

 

(a) On the basis of the representations, warranties and agreements herein contained, but subject to the terms and conditions herein set forth, the Company agrees to issue and sell the Securities to the Underwriter, and the Underwriter agrees to purchase the Securities. The purchase price for each Share shall be $[   ] (the “Per Share Price”).

 

(b) [Intentionally omitted].

 

(c) The Firm Shares will be delivered by the Company to the Underwriter against payment of the purchase price therefor by wire transfer of same day funds payable to the order of the Company’s offices, or such other location as may be mutually acceptable, at 6:00 a.m. Pacific Time, on the second (or if the Firm Shares are priced, as contemplated by Rule 15c6-1(c) under the Exchange Act, after 4:30 p.m. Eastern Time, the third) full business day following the date hereof, or at such other time and date as the Underwriter and the Company determine pursuant to Rule 15c6-1(a) under the Exchange Act. The time and date of delivery of the Firm Shares and Option Shares, as applicable, is referred to herein as a “Closing Date”. If the Underwriter so elects, delivery of the Firm Shares may be made by credit through full fast transfer to the account at The Depository Trust Company designated by the Underwriter.

 

3.2 Option Shares

 

(a) For the purposes of covering any over-allotments in connection with the distribution and sale of the Firm Shares, the Company hereby grants to the Underwriters an option (the “Over-allotment Option”) to purchase, in the aggregate, up to three hundred thousand (300,000) additional shares of the Common Stock (the “Option Shares”), representing fifteen percent (15%) of the Firm Shares sold in the offering, from the Company. The purchase price to be paid per Option Share shall be equal to the Per Share Price. The Option Shares shall be issued directly by the Company and shall have the rights and privileges described in the Registration Statement, the Pricing Disclosure Package and the Prospectus referred to below.

 

(b) The Over-allotment Option granted pursuant to Section 3.2(a) hereof may be exercised by the Underwriter as to all (at any time) or any part (from time to time) of the Option Shares within forty-five (45) days after the Closing Date for the Firm Shares. The Underwriter shall not be under any obligation to purchase any of the Option Shares prior to the exercise of the Over-allotment Option. The Over-allotment Option granted hereby may be exercised by the giving of written notice to the Company from the Underwriter, setting forth the number of the Option Shares to be purchased and the date and time for delivery of and payment for the Option Shares (the “Option Closing Date”), which shall not be later than five (5) full Business Days after the date of the notice or such other time as shall be agreed upon by the Company and the Underwriter, at the offices of the Underwriter’s Counsel or at such other place (including remotely by facsimile or other electronic transmission) as shall be agreed upon by the Company and the Underwriter. If such delivery and payment for the Option Shares does not occur on the Closing Date for the Firm Shares, the Option Closing Date will be as set forth in the notice. Upon exercise of the Over-allotment Option with respect to all or any portion of the Option Shares subject to the terms and conditions set forth herein, (i) the Company shall become obligated to sell to the Underwriter the number of the Option Shares specified in such notice and (ii) the Underwriter shall purchase that portion of the total number of the Option Shares then being purchased.

 

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(c) The Firm Shares will be delivered by the Company to the Underwriter against payment of the purchase price therefor by wire transfer of same day funds payable to the order of the Company’s offices, or such other location as may be mutually acceptable, at 6:00 a.m. Pacific Time, on the second (or if the Firm Shares are priced, as contemplated by Rule 15c6-1(c) under the Exchange Act, after 4:30 p.m. Eastern Time, the third) full business day following the date hereof, or at such other time and date as the Underwriter and the Company determine pursuant to Rule 15c6-1(a) under the Exchange Act. If the Underwriter so elects, delivery of the Option Shares may be made by credit through full fast transfer to the account at The Depository Trust Company designated by the Underwriter. For Dutch law purposes, the payment of the purchase price for the Underwritten Shares will be deemed to be a payment on the Underwritten Shares.

 

Section 4. Covenants and Agreements of the Company. The Company further covenants and agrees with the Underwriter as follows:

 

(a) Registration Statement Matters. The Registration Statement and any amendments thereto have been declared effective, and if Rule 430A is used or the filing of the Prospectus is otherwise required under Rule 424(b), the Company will file the Prospectus (properly completed if Rule 430A has been used) pursuant to Rule 424(b) within the prescribed time period and will provide evidence satisfactory to the of such timely filing. The Company will advise the Underwriter promptly after they receive notice thereof Underwriter of the time when any amendment to the Registration Statement has been filed or becomes effective or any supplement or amendment to the Prospectus has been filed and will furnish the Underwriter with copies thereof. The Company will file promptly all reports and any definitive proxy or information statements required to be filed by the Company with the Commission pursuant to Section 13(a), 14 or 15(d) of the Exchange Act subsequent to the date of the Prospectus and for so long as the delivery of a prospectus is required in connection with the Offering. The Company will advise the Underwriter, promptly after it receives notice thereof (i) of any request by the Commission to amend the Registration Statement or to amend or supplement the Prospectus or for additional information, and (ii) of the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto or any order preventing or suspending the use of the Prospectus or any amendment or supplement thereto or any post-effective amendment to the Registration Statement, of the suspension of the qualification of the Securities for offering or sale in any jurisdiction, of the institution or threatened institution of any proceeding for any such purpose, or of any request by the Commission for the amending or supplementing of the Registration Statement or the Prospectus or for additional information. The Company shall use its commercially reasonable efforts to prevent the issuance of any such stop order or prevention or suspension of such use. If the Commission shall enter any such stop order or order or notice of prevention or suspension at any time, the Company will use its commercially reasonable efforts to obtain the lifting of such order at the earliest possible moment, or will file a new registration statement and use its commercially reasonable efforts to have such new registration statement declared effective as soon as practicable. Additionally, the Company agrees that it shall comply with the provisions of Rules 424(b), 430A, 430B and 430C, as applicable, under the Securities Act, including with respect to the timely filing of documents thereunder, and will use its commercially reasonable efforts to confirm that any filings made by the Company under such Rule 424(b) are received in a timely manner by the Commission.

 

(b) Blue Sky Compliance. The Company will cooperate with the in endeavoring to qualify the Securities for sale under the securities laws of such jurisdictions (United States Underwriter and foreign) as the Underwriter may reasonably request and will make such applications, file such documents, and furnish such information as may be reasonably required for that purpose, provided the Company shall not be required to qualify as a foreign corporation or to file a general consent to service of process in any jurisdiction where it is not now so qualified or required to file such a consent, and provided further that the Company shall not be required to produce any new disclosure document other than the Prospectus. The Company will, from time to time, prepare and file such statements, reports and other documents as are or may be required to continue such qualifications in effect for so long a period as the Underwriter may reasonably request for distribution of the Securities. The Company will advise the Underwriter promptly of the suspension of the qualification or registration of (or any such exemption relating to) the Securities for offering, sale or trading in any jurisdiction or any initiation or threat of any proceeding for any such purpose, and in the event of the issuance of any order suspending such qualification, registration or exemption, the Company shall use its commercially reasonable efforts to obtain the withdrawal thereof at the earliest possible moment.

 

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(c) Amendments and Supplements to the Prospectus and Other Matters. The Company will comply with the Rules and Regulations so as to permit the completion of the distribution of the Securities as contemplated in this Agreement and the Prospectus. If during the period in which a prospectus is required by law to be delivered in connection with the distribution of Securities contemplated by the Prospectus (the “Prospectus Delivery Period”), any event shall occur as a result of which, in the judgment of the Company or in the opinion of the Underwriter or counsel for the Underwriter, it becomes necessary to amend or supplement the Prospectus in order to make the statements therein, in the light of the circumstances under which they were made, as the case may be, not misleading, or if it is necessary at any time to amend or supplement the Prospectus to comply with any law, the Company will promptly prepare and file with the Commission, and furnish at its own expense to the Underwriter and to dealers, an appropriate amendment to the Registration Statement or supplement to the Registration Statement or the Prospectus that is necessary in order to make the statements in the Prospectus as so amended or supplemented, in the light of the circumstances under which they were made, as the case may be, not misleading, or so that the Registration Statement or the Prospectus, as so amended or supplemented, will comply with law. Before amending the Registration Statement or supplementing the Prospectus in connection with the Offering, the Company will furnish the Underwriter with a copy of such proposed amendment or supplement and will not file any such amendment or supplement to which the Underwriter reasonably objects; the Underwriter, and its counsel shall have at least three (3) business days to review and return any comments to the Company.

 

(d) Copies of any Amendments and Supplements to the Prospectus. The Company will furnish the Underwriter, without charge, during the period beginning on the date hereof and ending on the final Closing Date of the Offering, as many copies of the Prospectus and any amendments and supplements thereto as the Underwriter may reasonably request.

 

(e) Free Writing Prospectus. The Company covenants that it will not, unless it obtains the prior consent of the Underwriter, make any offer relating to the Securities that would constitute a Company Free Writing Prospectus (as defined below) or that would otherwise constitute a “free writing prospectus” (as defined in Rule 405 of the Securities Act) required to be filed by the Company with the Commission or retained by the Company under Rule 433 of the Securities Act. In the event that the Underwriter expressly consent in writing to any such free writing prospectus (a “Permitted Free Writing Prospectus”), the Company covenants that it shall (i) treat each Permitted Free Writing Prospectus as a Company Free Writing Prospectus, and (ii) comply with the requirements of Rule 164 and 433 of the Securities Act applicable to such Permitted Free Writing Prospectus, including in respect of timely filing with the Commission, legending and record keeping. “Company Free Writing Prospectus” means any “issuer free writing prospectus,” as defined in Rule 433 of the Securities Act Regulations (“Rule 433”), including without limitation any “free writing prospectus” (as defined in Rule 405 of the Securities Act Regulations) relating to the public securities that is (i) required to be filed with the Commission by the Company, (ii) a “road show that is a written communication” within the meaning of Rule 433(d)(8)(i), whether or not required to be filed with the Commission, or (iii) exempt from filing with the Commission pursuant to Rule 433(d)(5)(i) because it contains a description of the public securities or of the Offering that does not reflect the final terms, in each case in the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company’s records pursuant to Rule 433(g).

 

(f) Transfer Agent. The Company will maintain, at its expense, a registrar and transfer agent for its Ordinary Shares for so long as the Ordinary Shares are publicly traded.

 

(g) Earnings Statement. As soon as practicable and in accordance with applicable requirements under the Securities Act, but in any event not later than 18 months after the last Closing Date, the Company will make generally available to its security holders and to the Underwriter an earnings statement, covering a period of at least 12 consecutive months beginning after the last Closing Date, that satisfies the provisions of Section 11(a) and Rule 158 under the Securities Act.

 

(h) Periodic Reporting Obligations. During the Prospectus Delivery Period, the Company will duly file, on a timely basis, with the Commission all reports and documents required to be filed under the Exchange Act within the time periods and in the manner required by the Exchange Act.

 

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(i) Additional Documents. The Company will enter into any subscription, purchase or other customary agreements as the Underwriter deems necessary or appropriate to consummate the Offering, all of which will be in form and substance reasonably acceptable to the Company and the Underwriter.

 

(j) No Manipulation of Price. The Company will not take, directly or indirectly, any action designed to cause or result in, or that has constituted or might reasonably be expected to constitute, the stabilization or manipulation of the price of any securities of the Company.

 

(k) Company Lock-Up.

 

(i) The Company will not, without the prior written consent of the Underwriter, from the date of execution of this Agreement and continuing for a period of 12 months from the date on which the trading of the Ordinary Shares on a Senior Exchange commences (the “Lock-Up Period”), (i) offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, change the terms of or grant any option, right or warrant to purchase or otherwise transfer or dispose of, directly or indirectly, or file with the Commission a registration statement under the Securities Act relating to, any Ordinary Shares or any securities convertible into or exercisable or exchangeable for Ordinary Shares, or (ii) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the Ordinary Shares or any such other securities, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Ordinary Shares or such other securities, in cash or otherwise, except to the Underwriter pursuant to this Agreement. The Company agrees not to accelerate the vesting of any option or warrant or the lapse of any repurchase right prior to the expiration of the Lock-Up Period.

 

(ii) The restrictions contained in Section 4(k)(i) hereof shall not apply to: (A) the Securities, (B) any security issued or proposed to be issued under an employee stock purchase plan, (which issuances under such plan shall be no more than 10% of the Company’s current issued and outstanding shares) in each case, as described in the Offering Materials, and (C) capital stock issued or registered pursuant to acquisitions or strategic transactions, not primarily for the purposes of raising capital, and approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a person or company or an owner of an asset in a business synergistic with the business of the Company and (D) Ordinary Shares or other securities issued in connection with a transaction with an unaffiliated third party that includes a bona fide commercial relationship (including joint ventures, marketing or distribution arrangements, collaboration agreements or intellectual property license agreements) or any acquisition of assets or acquisition of not less than a majority or controlling portion of the equity of another entity; provided that (x) the aggregate number of Ordinary Shares issued pursuant to clause (C) shall not exceed five percent (5%) of the total number of outstanding Ordinary Shares immediately following the issuance and sale of the Securities and (y) the recipient of any such Ordinary Shares or other securities issued or granted pursuant to clauses (B), (C) and (D) during the Lock-Up Period shall enter into an agreement substantially in the form of Exhibit B hereto.

 

(l) Acknowledgment. The Company acknowledges that any advice given by the Underwriter to the Company is solely for the benefit and use of the Board of Directors of the Company and may not be used, reproduced, disseminated, quoted or referred to, without such Underwriter’s prior written consent.

 

(m) Listing. The Company shall use its commercially reasonable efforts to maintain the listing of the Securities on a Senior Exchange for five (5) years after the date of this Agreement.

 

(n) Application of Net Proceeds. The Company shall apply the net proceeds from the Offering of the Securities received by it in a manner consistent with the application thereof described under the caption “Use of Proceeds” in the Registration Statement, the Prospectus and the Final Prospectus.

 

(o) Rule 158. The Company will timely file such reports pursuant to the Exchange Act as are necessary in order to make generally available to its security holders as soon as practicable an earnings statement for the purposes of, and to provide to the Underwriter the benefits contemplated by Rule 158(a) under Section 11(a) of the Securities Act.

 

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(p) Stabilization. Neither the Company nor, to its knowledge, any of its employees, directors or shareholders (without the consent of the Underwriter) has taken or shall take, directly or indirectly, any action designed to or that has constituted or that might reasonably be expected to cause or result in, under Regulation M of the Exchange Act, or otherwise, stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Securities.

 

(q) Internal Controls. The Company shall maintain a system of internal accounting controls sufficient to provide reasonable assurances that: (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions are recorded as necessary in order to permit preparation of financial statements in accordance with GAAP and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

 

(r) Accountants. The Company shall retain an independent registered public accounting firm reasonably acceptable to the Underwriter (it being understood that BF Borgers CPA PC is an independent registered public accounting firm that is reasonably acceptable to the Underwriter), and the Company shall continue to retain a nationally recognized independent registered public accounting firm for a period of at least five (5) years after the date of this Agreement.

 

(s) FINRA. The Company shall advise the Underwriter (who shall make an appropriate filing with FINRA) if it is or becomes aware that (i) any officer or director of the Company, (ii) any beneficial owner of 5% or more of any class of the Company’s securities or (iii) any beneficial owner of the Company’s unregistered equity securities which were acquired during the 180 days immediately preceding the original filing of the Registration Statement is or becomes an affiliate or associated person of a FINRA member participating in the Offering (as determined in accordance with the rules and regulations of FINRA).

 

(t) Board Composition and Board Designations. The Company shall ensure that: (i) the qualifications of the persons serving as Board members and the overall composition of the Board comply with the Sarbanes-Oxley Act and the rules promulgated thereunder and with the listing requirements of the Senior Exchange and (ii) if applicable, at least one member of the Board qualifies as a “financial expert” as such term is defined under the Sarbanes-Oxley Act and the rules promulgated thereunder.

 

Section 5. Conditions of the Obligations of the Underwriter. The obligations of the Underwriter hereunder shall be subject to the accuracy of the representations and warranties on the part of the Company set forth in Section 2 hereof, in each case as of the date hereof and as of each Closing Date as though then made, to the timely performance by each of the Company of its covenants and other obligations hereunder on and as of such dates, and to each of the following additional conditions:

 

(a) Accountants’ Comfort Letter. On the date hereof, the Underwriter shall have received, and the Company shall have caused to be delivered to the Underwriter, a letter from BF Borgers CPA PC addressed to the Underwriter, dated as of the date hereof, in form and substance satisfactory to the Underwriter. The letter shall not disclose any change in the condition (financial or other), earnings, operations, business or prospects of the Company from that set forth in the Prospectus, which, in the Underwriter’s sole judgment, is material and adverse and that makes it, in the Underwriter’s sole judgment, impracticable or inadvisable to proceed with the Offering of the Securities as contemplated by the Prospectus.

 

(b) Compliance with Registration Requirements; No Stop Order; No Objection from the FINRA. The Registration Statement shall have become effective and all necessary regulatory and listing approvals shall have been received not later than 5:30 P.M., New York City time, on the date of this Agreement, or at such later time and date as shall have been consented to in writing by the Underwriter. The Prospectus (in accordance with Rule 424(b)) and “free writing prospectus” (as defined in Rule 405 of the Securities Act), if any, shall have been duly filed with the Commission in a timely fashion in accordance with the terms thereof. At or prior to each Closing Date and the actual time of the Closing, no stop order suspending the effectiveness of the Registration Statement or any part thereof shall have been issued and no proceeding for that purpose shall have been initiated or threatened by the Commission; no order preventing or suspending the use of the Prospectus shall have been issued and no proceeding for that purpose shall have been initiated or threatened by the Commission; no order having the effect of ceasing or suspending the distribution of the Securities or any other securities of the Company shall have been issued by any securities commission, securities regulatory authority or stock exchange and no proceedings for that purpose shall have been instituted or shall be pending or, to the knowledge of the Company, contemplated by any securities commission, securities regulatory authority or stock exchange; all requests for additional information on the part of the Commission shall have been complied with; and the FINRA shall have raised no objections to the fairness and reasonableness of the placement terms and arrangements. On each Closing Date, the Company’s Ordinary Shares shall have been approved for listing on the Senior Exchange.

 

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(c) Corporate Proceedings. All corporate proceedings and other legal matters in connection with this Agreement, the Registration Statement and the Prospectus, and the registration, sale and delivery of the Securities, shall have been completed or resolved in a manner reasonably satisfactory to the Underwriter’s counsel.

 

(d) No Material Adverse Effect. Subsequent to the execution and delivery of this Agreement and prior to each Closing Date, in the Underwriter’s sole judgment after consultation with the Company, there shall not have occurred any Material Adverse Effect.

 

(e) Opinions of Counsel for the Company. The Underwriter shall have received on each Closing Date

 

(i) the favorable opinion of Ortoli Rosenstadt LLP, Company securities counsel, dated as of such Closing Date, including, without limitation, a customary negative assurance letter, addressed to the Underwriter in customary form reasonably satisfactory to the Underwriter; and

 

(ii) the favorable opinion of CMS Derks Star Busmann N.V., Company Dutch counsel, dated as of such Closing Date, including, without limitation, a customary negative assurance letter for applicable sections, addressed to the Underwriter in customary form reasonably satisfactory to the Underwriter 

(iii) the favorable opinion of German counsel, dated as of such Closing Date, including, without limitation, a customary negative assurance letter for applicable sections, addressed to the Underwriter in customary form reasonably satisfactory to the Underwriter.

 

The Underwriter shall rely on the opinions of (i) the Company’s Dutch counsel, CMS Derks Star Busmann N.V. , filed as Exhibit 5.1 to the Registration Statement, as to the due incorporation, validity of the Securities and due authorization, execution and delivery of the Agreement and (ii) the Company’s German counsel, [    ], filed as Exhibit 8.1 to the Registration Statement.

 

(f) Officers’ Certificate. The Underwriter shall have received on each Closing Date a certificate of the Company, dated as of such Closing Date, signed by the Chief Executive Officer and Chief Financial Officer of the Company, to the effect that, and the Underwriter shall be satisfied that, the signers of such certificate have reviewed the Registration Statement and the Prospectus, and this Agreement and to the further effect that:

 

(i) The representations and warranties of the Company in this Agreement are true and correct, as if made on and as of such Closing Date, and the Company has complied with all the agreements and satisfied all the conditions on its part to be performed or satisfied at or prior to such Closing Date;

 

(ii) No stop order suspending the effectiveness of the Registration Statement or the use of the Prospectus has been issued and no proceedings for that purpose have been instituted or are pending or, to the Company’s knowledge, threatened under the Securities Act; no order having the effect of ceasing or suspending the distribution of the Securities or any other securities of the Company has been issued by any securities commission, securities regulatory authority or stock exchange in the United States and no proceedings for that purpose have been instituted or are pending or, to the knowledge of the Company, contemplated by any securities commission, securities regulatory authority or stock exchange in the United States;

 

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(iii) When the Registration Statement became effective, at the time of sale, and at all times subsequent thereto up to the delivery of such certificate, the Registration Statement, when it became effective, contained all material information required to be included therein by the Securities Act and the applicable rules and regulations of the Commission thereunder, as the case may be, and in all material respects conformed to the requirements of the Securities Act and the applicable rules and regulations of the Commission thereunder, as the case may be, and the Registration Statement, did not and does not include any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading (provided, however, that the preceding representations and warranties contained in this paragraph (iii) shall not apply to any statements or omissions made in reliance upon and in conformity with the Underwriter Information) and, since the effective date of the Registration Statement, there has occurred no event required by the Securities Act and the rules and regulations of the Commission thereunder to be set forth in the Registration Statement which has not been so set forth; and

 

(iv) Subsequent to the respective dates as of which information is given in the Registration Statement and the Prospectus, there has not been: (a) any Material Adverse Effect; (b) any transaction that is material to the Company and the Subsidiaries taken as a whole, except transactions entered into in the ordinary course of business; (c) any obligation, direct or contingent, that is material to the Company and the Subsidiaries taken as a whole, incurred by the Company or any Subsidiary, except obligations incurred in the ordinary course of business; (d) any material change in the capital stock (except changes thereto resulting from the exercise of outstanding options or warrants or conversion of outstanding indebtedness into Ordinary Shares of the Company) or outstanding indebtedness of the Company or any Subsidiary (except for the conversion of such indebtedness into Ordinary Shares of the Company); (e) any dividend or distribution of any kind declared, paid or made on Ordinary Shares of the Company; or (f) any loss or damage (whether or not insured) to the property of the Company or any Subsidiary which has been sustained or will have been sustained which has a Material Adverse Effect.

 

(g) Secretary’s Certificate. As of each Closing Date the Underwriter shall have received a certificate of the Company signed by the Secretary of the Company (or if no Secretary exists on such date, an executive officer of the Company), dated such Closing Date, certifying: (i) that each of the Company’s Articles of Association and Memorandum of Association attached to such certificate is true and complete, has not been modified and is in full force and effect; (ii) that each of the Subsidiaries’ Articles of Association, Memorandum of Association or charter documents attached to such certificate is true and complete, has not been modified and is in full force and effect; (iii) that the resolutions of the Company’s Board of Directors relating to the Offering attached to such certificate are in full force and effect and have not been modified; and (iv) the good standing of the Company and each of the Subsidiaries. The documents referred to in such certificate shall be attached to such certificate.

 

(h) Bring-down Comfort Letter. On each Closing Date, the Underwriter shall have received from BF Borgers CPA PC, or such other independent registered public accounting firm engaged by the Company at such time, a letter dated as of such Closing Date, in form and substance satisfactory to the Underwriter, to the effect that they reaffirm the statements made in the letter furnished pursuant to subsection (a) of this Section 5, except that the specified date referred to therein for the carrying out of procedures shall be no more than three business days prior to such Closing Date.

 

(i) Additional Documents. On or before each Closing Date, the Underwriter and counsel for the Underwriter shall have received such customary information and documents as they may reasonably require for the purposes of enabling them to pass upon the issuance and sale of the Securities as contemplated herein, or in order to evidence the accuracy of any of the representations and warranties, or the satisfaction of any of the conditions or agreements, herein contained. If any condition specified in this Section 5 is not satisfied when and as required to be satisfied, this Agreement may be terminated by the Underwriter by notice to the Company at any time on or prior to such Closing Date, which termination shall be without liability on the part of any party to any other party, except that Section 6 (Payment of Expenses), Section 7 (Indemnification and Contribution) and Section 8 (Representations and Indemnities to Survive Delivery) shall at all times be effective and shall survive such termination.

 

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(j) Subsequent to the execution and delivery of this Agreement or, if earlier, the dates as of which information is given in the Registration Statement (exclusive of any amendment thereof) and the Prospectus (exclusive of any supplement thereto), there shall not have been any change in the capital stock or long-term debt of the Company (other than as described in the Registration Statement or the Prospectus) or any change or development involving a change, whether or not arising from transactions in the ordinary course of business, in the business, condition (financial or otherwise), results of operations, shareholders’ equity, properties or prospects of the Company, taken as a whole, including but not limited to the occurrence of any fire, flood, storm, explosion, accident, act of war or terrorism or other calamity, the effect of which, in any such case described above, is, in the sole judgment of the Underwriter, so material and adverse as to make it impracticable or inadvisable to proceed with the sale of Securities or Offering as contemplated hereby.

 

(k) Subsequent to the execution and delivery of this Agreement and up to each Closing Date, there shall not have occurred any of the following: (i) trading in securities generally on a Senior Exchange or any Trading Market shall not have commenced, (ii) a banking moratorium shall have been declared by federal or state authorities or a material disruption has occurred in commercial banking or securities settlement or clearance services in the United States, (iii) the United States shall have become engaged in hostilities in which it is not currently engaged, the subject of an act of terrorism, there shall have been an escalation in hostilities involving the United States, or there shall have been a declaration of a national emergency or war by the United States, or (iv) there shall have occurred any other calamity or crisis or any change in general economic, political or financial conditions in the United States or elsewhere, if the effect of any such event in clause (ii) or (iv) makes it, in the sole judgment of the Underwriter, impracticable or inadvisable to proceed with the sale or delivery of the Securities on the terms and in the manner contemplated by the Prospectus.

 

(l) The Underwriter shall have received a lock-up agreement from each Lock-Up Party set forth on Schedule A, duly executed by the applicable Lock-Up Party, in each case substantially in the form attached as Exhibit B.

 

(m) No action shall have been taken and no statute, rule, regulation or order shall have been enacted, adopted or issued by any federal, state or foreign governmental or regulatory authority that would, as of any Closing Date, prevent the issuance or sale of the Securities; and no injunction or order of any federal, state or foreign court shall have been issued that would, as of such Closing Date, prevent the issuance or sale of the Securities or materially and adversely affect or potentially materially and adversely affect the business or operations of the Company.

 

If any of the conditions specified in this Section 5 shall not have been fulfilled when and as required by this Agreement, or if any of the certificates, opinions, written statements or letters furnished to the Underwriter or to Underwriter’s counsel pursuant to this Section 5 shall not be reasonably satisfactory in form and substance to the Underwriter and to Underwriter’s counsel, all obligations of the Underwriter hereunder may be cancelled by the Underwriter at, or at any time prior to, the consummation of the Offering. Notice of such cancellation shall be given to the Company in writing or orally. Any such oral notice shall be confirmed promptly thereafter in writing.

 

Section 6. Payment of Company Expenses. The Company agrees to pay all costs, fees and expenses incurred by the Company in connection with the performance of its obligations hereunder and in connection with the transactions contemplated hereby, including, without limitation: (i) all expenses incident to the issuance, delivery and qualification of the Securities (including all printing and engraving costs); (ii) all fees and expenses of the registrar and transfer agent of the Securities; (iii) all necessary issue, transfer and other stamp taxes in connection with the issuance and sale of the Securities; (iv) all fees and expenses of the Company’s counsel, independent public or certified public accountants and other advisors; (v) all costs and expenses incurred in connection with the preparation, printing, filing, shipping and distribution of the Registration Statement (including financial statements, exhibits, schedules, consents and certificates of experts), the Prospectus, and all amendments and supplements thereto, and this Agreement; (vi) all filing fees, reasonable attorneys’ fees and expenses incurred by the Company or the Underwriter in connection with qualifying or registering (or obtaining exemptions from the qualification or registration of) all or any part of the Securities for offer and sale under the state securities or blue sky laws or the securities laws of any other country, and, if reasonably requested by the Underwriter, preparing and printing a “Blue Sky Survey,” an “International Blue Sky Survey” or other memorandum, and any supplements thereto, advising any of the Underwriter of such qualifications, registrations and exemptions; (vii) if applicable, the filing fees incident to the review and approval by the FINRA of the Underwriter’s participation in the offering and distribution of the Securities; (viii) the fees and expenses associated with including the Ordinary Shares on the Trading Market; and (ix) all costs and expenses incident to the travel and accommodation of the Company’s employees on the “roadshow,” as described in Section 1(a)(iii) of this Agreement.

 

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Section 7. Indemnification and Contribution.

 

(a) The Company agrees to indemnify, defend and hold harmless the Underwriter, its Affiliates, directors and officers and employees, and each person, if any, who controls the Underwriter within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act (each an “Underwriter Indemnified Party”), from and against any losses, claims, damages or liabilities (including in settlement of any litigation if such settlement is effected with the prior written consent of the Company) arising out of (i) an untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, including the information deemed to be a part of the Registration Statement at the time of effectiveness and at any subsequent time pursuant to Rules 430A and 430B of the Securities Act Regulations, or arise out of or are based upon the omission from the Registration Statement, or alleged omission to state therein, a material fact required to be stated therein or necessary to make the statements therein not misleading; or (ii) an untrue statement or alleged untrue statement of a material fact contained in the Prospectus, or any amendment or supplement thereto, or in any other materials used in connection with the Offering, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, and will reimburse such Underwriter Indemnified Party for any legal or other expenses reasonably incurred by it in connection with evaluating, investigating or defending against such loss, claim, damage, liability or action; provided, however, that the Company shall not be liable in any such case to the extent that any such loss, claim, damage, liability or action arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission made in the Registration Statement, the Prospectus, or any amendment or supplement thereto, or, in reliance upon and in conformity with the Underwriter Information. The indemnification obligations under this Section 7(a) are not exclusive and will be in addition to any liability which the Company might otherwise have and shall not limit any rights or remedies which may otherwise be available at law or in equity to each Underwriter Indemnified Party.

 

(b) The Underwriter will indemnify, defend and hold harmless the Company, its Affiliates, directors, officers and employees, and each person, if any, who controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act (each a “Company Indemnified Party”), from and against any losses, claims, damages or liabilities to which such Company Indemnified Party may become subject, under the Securities Act or otherwise (including in settlement of any litigation, if such settlement is effected with the written consent of the Representative), insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon an untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, the Prospectus, or any amendment or supplement thereto, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, in each case to the extent, but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made in the Registration Statement, the Prospectus, or any amendment or supplement thereto, in reliance upon and in conformity with the Underwriter Information, and will reimburse such Company Indemnified Party for any legal or other expenses reasonably incurred by it in connection with defending against any such loss, claim, damage, liability or action; provided, however, that the Underwriter shall not be liable in any such case to the extent that any such loss, claim, damage, liability or action arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission made in the Registration Statement, the Prospectus, or any amendment or supplement thereto, or, in reliance upon and in conformity with information furnished in writing to the Underwriter by the Company. The indemnification obligations under this Section 7(b) are not exclusive and will be in addition to any liability which the Underwriter might otherwise have and shall not limit any rights or remedies which may otherwise be available at law or in equity to each Company Indemnified Party.

 

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(c) Promptly after receipt by an indemnified party under subsection (a) or (b) above of notice of the commencement of any action, such indemnified party shall, if a claim in respect thereof is to be made against the indemnifying party under such subsection, notify the indemnifying party in writing of the commencement thereof, but the failure to notify the indemnifying party shall not relieve the indemnifying party from any liability that it may have to any indemnified party except to the extent such indemnifying party has been materially prejudiced by such failure. In case any such action shall be brought against any indemnified party, and it shall notify the indemnifying party of the commencement thereof, the indemnifying party shall be entitled to participate in, and, to the extent that it shall wish, jointly with any other indemnifying party similarly notified, to assume the defense thereof, with counsel reasonably satisfactory to such indemnified party, and after notice from the indemnifying party to such indemnified party of the indemnifying party’s election so to assume the defense thereof, the indemnifying party shall not be liable to such indemnified party under such subsection for any legal or other expenses subsequently incurred by such indemnified party in connection with the defense thereof; provided, however, that if (i) the indemnified party has reasonably concluded (based on advice of counsel) that there may be legal defenses available to it or other indemnified parties that are different from or in addition to those available to the indemnifying party, (ii) a conflict or potential conflict exists (based on advice of counsel to the indemnified party) between the indemnified party and the indemnifying party (in which case the indemnifying party will not have the right to direct the defense of such action on behalf of the indemnified party), or (iii) the indemnifying party has not in fact employed counsel reasonably satisfactory to the indemnified party to assume the defense of such action within a reasonable time after receiving notice of the commencement of the action, the indemnified party shall have the right to employ a single counsel to represent it in any claim in respect of which indemnity may be sought under subsection (a) or (b) of this Section 7, in which event the reasonable fees and expenses of such separate counsel shall be borne by the indemnifying party or parties and reimbursed to the indemnified party as incurred.

 

(d) The indemnifying party under this Section 7 shall not be liable for any settlement of any proceeding effected without its written consent, but if settled with such consent or if there be a final judgment for the plaintiff, the indemnifying party agrees to indemnify the indemnified party against any loss, claim, damage, liability or expense by reason of such settlement or judgment. No indemnifying party shall, without the prior written consent of the indemnified party, effect any settlement, compromise or consent to the entry of judgment in any pending or threatened action, suit or proceeding in respect of which any indemnified party is a party or could be named and indemnity was or would be sought hereunder by such indemnified party, unless such settlement, compromise or consent (i) includes an unconditional release of such indemnified party from all liability for claims that are the subject matter of such action, suit or proceeding and (ii) does not include a statement as to or an admission of fault, culpability or a failure to act by or on behalf of any indemnified party. Notwithstanding the foregoing, if at any time an indemnified party shall have requested an indemnifying party to reimburse the indemnified party for fees and expenses of counsel pursuant to Section 7(c), such indemnifying party agrees that it shall be liable for any settlement effected without its written consent if (i) such settlement is entered into more than 45 days after receipt by such indemnifying party of the aforesaid request and (ii) such indemnifying party shall not have reimbursed such indemnified party in accordance with such request prior to the date of such settlement.

 

(e) If the indemnification provided for in this Section 7 is unavailable or insufficient to hold harmless an indemnified party under subsection (a) or (b) above, then the indemnifying party shall contribute to the amount paid or payable by such indemnified party as a result of the losses, claims, damages or liabilities referred to in subsection (a) or (b) above, (i) in such proportion as is appropriate to reflect the relative benefits received by the Company on the one hand and the Underwriter on the other hand from the offering and sale of the Securities or (ii) if the allocation provided by clause (i) above is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause (i) above but also the relative fault of the Company on the one hand and the Underwriter on the other hand in connection with the statements or omissions that resulted in such losses, claims, damages or liabilities, as well as any other relevant equitable considerations. The relative benefits received by the Company on the one hand and the Underwriter on the other hand shall be deemed to be in the same proportion as the total net proceeds from the Offering (before deducting expenses) received by the Company bear to the total cash compensation received by the Underwriter. The relative fault shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Company or the Underwriter and the parties’ relevant intent, knowledge, access to information and opportunity to correct or prevent such untrue statement or omission. The Company and the Underwriter agrees that it would not be just and equitable if contributions pursuant to this subsection (e) were to be determined by pro rata allocation (even if the Underwriter were treated as one entity for such purpose) or by any other method of allocation that does not take account of the equitable considerations referred to in the first sentence of this subsection (e). The amount paid by an indemnified party as a result of the losses, claims, damages or liabilities referred to in the first sentence of this subsection (e) shall be deemed to include any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending against any action or claim that is the subject of this subsection (e). No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation.

 

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(f) For purposes of this Agreement, the Underwriter confirms, and the Company acknowledges, that there is no information concerning the Underwriter furnished in writing to the Company by the Underwriter specifically for preparation of or inclusion in the Registration Statement or the Prospectus other than the Underwriter Information.

 

Section 8. Representations and Indemnities to Survive Delivery. The respective indemnities, agreements, representations, warranties and other statements of the Company or any person controlling the Company, of its officers, and of the Underwriter set forth in or made pursuant to this Agreement will remain in full force and effect, regardless of any investigation made by or on behalf of the Underwriter, the Company, or any of its or their partners, officers or directors or any controlling person, as the case may be, and will survive delivery of and payment for the Securities sold hereunder and any termination of this Agreement. A successor to the Underwriter, or to the Company, its directors or officers or any person controlling the Company, shall be entitled to the benefits of the indemnity, contribution and reimbursement agreements contained in this Agreement.

 

Section 9. Termination.

 

(a) This Agreement shall become effective upon the later of: (i) receipt by the Underwriter and the Company of notification of the effectiveness of the Registration Statement or (ii) the execution of this Agreement. The Underwriter shall have the right to terminate this Agreement at any time upon 15 days written notice to the Company, or as practical as possible prior to any Closing Date if: (i) any domestic or international event or act or occurrence has materially disrupted, or in the reasonable opinion of the Underwriter will in the immediate future materially disrupt, the market for the Company’s securities or securities in general; or (ii) trading on a Senior Exchange has been rejected by such Senior Exchange or made subject to material limitations, or minimum or maximum prices for trading have been fixed, or maximum ranges for prices for securities have been required, on the Senior Exchange or by order of the Commission, FINRA or any other governmental authority having jurisdiction; or (iii) a banking moratorium has been declared by any state or federal authority or any material disruption in commercial banking or securities settlement or clearance services has occurred; or (iv) (A) there has occurred any outbreak or escalation of hostilities or acts of terrorism involving the United States or China or there is a declaration of a national emergency or war by the United States or China or (B) there has been any other calamity or crisis or any change in political, financial or economic conditions, if the effect of any such event in (A) or (B), in the reasonable judgment of the Underwriter, is so material and adverse that such event makes it impracticable or inadvisable to proceed with the Offering, sale and delivery of the Securities on the terms and in the manner contemplated by the Prospectus.

 

(b) Any notice of termination pursuant to this Section 9 shall be in writing.

 

(c) If this Agreement shall be terminated pursuant to any of the provisions hereof, or if the sale of the Securities provided for herein is not consummated because any condition to the obligations of the Underwriter set forth herein is not satisfied or because of any refusal, inability or failure on the part of the Company to perform any agreement herein or comply with any provision hereof, the Company will, subject to demand by the Underwriter, reimburse the Underwriter for only those out-of-pocket expenses (including the reasonable fees and expenses of their counsel, and expenses associated with a due diligence report), actually incurred by the Underwriter in connection herewith as allowed under FINRA Rule 5110, less any amounts previously paid by the Company, subject to the cap on expenses set forth in Section 1(a)(iii) hereof. To the extent that the Underwriter’s out-of-pocket expenses are less than the sums already advanced by the Company to the Underwriter (“Advances”), the Underwriter will return to the Company that portion of the Advances not offset by actual expenses.

 

Section 10. Right of First Refusal The Company agrees that it shall provide the Underwriter the right of first refusal (“Right of First Refusal”) for the longer of two (2) years from the termination or expiration of the Engagement Letter (other than termination for Cause, as defined below) to act as financial advisor or to act as joint financial advisor on at least equal economic terms on any public or private financing (debt or equity), merger, business combination, recapitalization or sale of some or all of the equity or assets of the Company (collectively, “Future Services”). In the event the Company notifies the Underwriter of its intention to pursue an activity that would enable the Underwriter to exercise its Right of First Refusal to provide Future Services, the Underwriter shall notify the Company of its election to provide such Future Services, including notification of the compensation and other terms to which the Underwriter claim to be entitled, within thirty (30) days of written notice by the Company. In the event the Company engages the Underwriter to provide such Future Services, the Underwriter will be compensated consistent with Section 2 of the Engagement Letter, unless mutually agreed otherwise by the Company and the Underwriter. The Right of First Refusal granted hereunder may be terminated by the Company for “Cause,” which shall mean a material breach by the Underwriter of this Agreement or a material failure by the Underwriter to provide the services as contemplated by this Agreement.

 

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Section 11. Notices. All communications hereunder shall be in writing and shall be mailed, hand delivered, delivered by reputable overnight courier (i.e., Federal Express) or delivered by facsimile or e-mail transmission to the parties hereto as follows:

 

If to the Underwriter, then to:

 

Boustead Securities, LLC

6 Venture, Suite 395

Irvine, CA 92618

  Attn: Keith Moore
  Attn: Daniel J. McClory
  Email: Keith@boustead1828.com
    Dan@boustead1828.com

 

With a copy (which shall not constitute notice) to:

 

Sichenzia Ross Ference LLP

1185 Avenue of the Americas, 37th Floor

New York, NY 10036

Attn: Benjamin Tan, Esq.
Email: btan@SRF.LAW

 

If to the Company:

Mainz Biomed B.V.

Robert Koch Strasse 50

55129 Mainz

Germany

Attn:

Email:

 

 

With a copy (which shall not constitute notice) to:

 

Ortoli Rosenstadt LLP

366 Madison Avenue

New York, NY 10017

Attn: William Rosenstadt, Esq.

Tim Dockery, Esq.

Email: wsr@orllp.legal

tld@orllp.legal

 

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Any party hereto may change the address for receipt of communications by giving written notice to the others.

 

Section 12. Successors. This Agreement will inure to the benefit of and be binding upon the parties hereto, and to the benefit of the employees, officers and directors and controlling persons referred to in Section 7 hereof, and to their respective successors, and no other person will have any right or obligation hereunder.

 

Section 13. Partial Unenforceability. The invalidity or unenforceability of any section, paragraph or provision of this Agreement shall not affect the validity or enforceability of any other section, paragraph or provision hereof. If any Section, paragraph or provision of this Agreement is for any reason determined to be invalid or unenforceable, there shall be deemed to be made such minor changes (and only such minor changes) as are necessary to make it valid and enforceable.

 

Section 14. Governing Law Provisions. This Agreement shall be deemed to have been made and delivered in New York and both this Agreement and the transactions contemplated hereby shall be governed as to validity, interpretation, construction, effect and in all other respects by the internal laws of the State of New York, without regard to the conflict of laws principles thereof. Each of the Underwriter and the Company: (i) agrees that any legal suit, action or proceeding arising out of or relating to this Agreement and/or the transactions contemplated hereby shall be instituted exclusively in New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York, (ii) waives any objection which it may now or hereafter have to the venue of any such suit, action or proceeding, and (iii) irrevocably consents to the jurisdiction of the New York Supreme Court, County of New York, and the United States District Court for the Southern District of New York in any such suit, action or proceeding. Each of the Underwriter and the Company further agrees to accept and acknowledge service of any and all process which may be served in any such suit, action or proceeding in the New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York and agrees that service of process upon the Company mailed by certified mail to the Company’s address shall be deemed in every respect effective service of process upon the Company, in any such suit, action or proceeding, and service of process upon the Underwriter mailed by certified mail to the Underwriter’s address(es) shall be deemed in every respect effective service process upon the Underwriter, in any such suit, action or proceeding.

 

Section 15. General Provisions.

 

(a) This Agreement constitutes the entire agreement of the parties to this Agreement and supersedes all prior written or oral and all contemporaneous oral agreements, understandings and negotiations solely with respect to the subject matters hereof. Notwithstanding anything to the contrary set forth herein, it is understood and agreed by the parties hereto that all other terms and conditions of the Engagement Letter shall remain in full force and effect. This Agreement may be executed in two or more counterparts, each one of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement may not be amended or modified unless in writing and signed by all of the parties hereto, and no condition herein (express or implied) may be waived unless waived in writing by each party whom the condition is meant to benefit. Section headings herein are for the convenience of the parties only and shall not affect the construction or interpretation of this Agreement.

 

(b) The Company acknowledges that in connection with the Offering of the Securities: (i) the Underwriter has acted at arm’s length, is not an agent of, and owes no fiduciary duties to the Company or any other person, (ii) the Underwriter owes the Company only those duties and obligations set forth in this Agreement and (iii) the Underwriter may have interests that differ from those of the Company. The Company waives to the full extent permitted by applicable law any claims it may have against the Underwriter arising from an alleged breach of fiduciary duty in connection with the offering of the Securities.

 

[The remainder of this page has been intentionally left blank.]

 

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If the foregoing is in accordance with your understanding of our agreement, please sign below whereupon this instrument, along with all counterparts hereof, shall become a binding agreement in accordance with its terms.

 

  Very truly yours,
   
  Mainz Biomed B.V.
     
  By:  
  Name:  
  Title:  

 

The foregoing Underwriting Agreement is hereby confirmed and agreed to of the date first above written.

 

  BOUSTEAD SECURITIES, LLC
     
  By:  
  Name: Keith Moore
  Title: Chief Executive Officer

 

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Schedule A

 

Lock-up Party

 

Locked-up Parties   Ordinary Shares
Beneficially Owned
  Lock Up Period
         
         
         
         
         

 

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Exhibit A

Form of Underwriter’s Warrant

 

THE REGISTERED HOLDER OF THIS PURCHASE WARRANT BY ITS ACCEPTANCE HEREOF, AGREES THAT IT WILL NOT SELL, TRANSFER OR ASSIGN THIS PURCHASE WARRANT EXCEPT AS HEREIN PROVIDED AND THE REGISTERED HOLDER OF THIS PURCHASE WARRANT AGREES THAT IT WILL NOT SELL, TRANSFER, ASSIGN, PLEDGE OR HYPOTHECATE THIS PURCHASE WARRANT FOR A PERIOD OF ONE HUNDRED EIGHTY (180) DAYS FOLLOWING THE EFFECTIVE DATE OF THE REGISTRATION STATEMENT TO ANYONE OTHER THAN (I) BOUSTEAD SECURITIES, LLC, OR A REPRESENTATIVE OR A SELECTED DEALER IN CONNECTION WITH THE OFFERING, OR (II) A BONA FIDE OFFICER OR PARTNER OF BOUSTEAD SECURITIES, LLC, OR OF ANY SUCH UNDERWRITERS OR SELECTED DEALER.

 

THIS PURCHASE WARRANT IS NOT EXERCISABLE PRIOR TO [●], 20[__]. VOID AFTER 5:00 P.M., EASTERN TIME, [●], 20[__].

 

UNDERWRITER’S WARRANT

 

FOR THE PURCHASE OF [●] ORDINARY SHARES

 

OF

 

Mainz Biomed N.V.

 

1. Purchase Warrant. THIS CERTIFIES THAT, pursuant to that certain Underwriting Agreement by and between MAINZ BIOMED N.V., a Dutch company (the “Company”), on one hand, and Boustead Securities, LLC (the “Holder”), on the other hand, dated [●], 2021 (the “Underwriting Agreement”), the Holder, as registered owner of this Purchase Warrant, is entitled, at any time or from time to time from [●], 20[__] (the “Exercise Date”), and at or before 5:00 p.m., Eastern time, on [●], 20[__] (the “Expiration Date”)1, but not thereafter, to subscribe for, purchase and receive, in whole or in part, up to ______________2 ordinary shares (the “Shares”) of the Company, par value €0.01 per ordinary share (the “Ordinary Shares”), subject to adjustment as provided in Section 6 hereof. If the Expiration Date is a day on which banking institutions are authorized by law or executive order to close, then this Purchase Warrant may be exercised on the next succeeding day which is not such a day in accordance with the terms herein. During the period ending on the Expiration Date, the Company agrees not to take any action that would terminate this Purchase Warrant. This Purchase Warrant is initially exercisable at $ per Ordinary Share3provided, however, that upon the occurrence of any of the events specified in Section 6 hereof, the rights granted by this Purchase Warrant, including the exercise price per Ordinary Share and the number of Ordinary Shares to be received upon such exercise, shall be adjusted as therein specified. The term “Exercise Price” shall mean the initial exercise price as set forth above or the adjusted exercise price as a result of the events set forth in Section 6 below, depending on the context. Capitalized terms not defined herein shall have the meaning ascribed to them in the Underwriting Agreement. 

 

2. Exercise.

 

2.1 Exercise Form. In order to exercise this Purchase Warrant, the exercise form attached hereto as Exhibit A must be duly executed and completed and delivered to the Company, together with this Purchase Warrant and payment of the Exercise Price for the Ordinary Shares being purchased payable in cash by wire transfer of immediately available funds to an account designated by the Company or by certified check. If the subscription rights represented hereby shall not be exercised at or before 5:00 p.m., Eastern time, on the Expiration Date, this Purchase Warrant shall become and be void without further force or effect, and all rights represented hereby shall cease and expire.

 

 

 

1 Which shall be the five-year anniversary of the Effective Date .
2 Such number of Ordinary Shares of the Company as equates to seven percent (7%) of the Ordinary Shares in the Offering.
3 100% of the price of the Ordinary Shares sold in the Offering.

 

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2.2 Cashless Exercise. If at the time of exercise hereof there is no effective registration statement registering, or the prospectus contained therein is not available for the issuance of the Shares to the Holder, then this Warrant may also be exercised, in whole or in part, at such time by means of a “cashless exercise” in which the Holder shall be entitled to receive a number of Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where:

 

(A) = as applicable: (i) the VWAP on the trading day immediately preceding the date of the applicable exercise form if such exercise form is (1) both executed and delivered pursuant to Section 2.1 hereof on a day that is not a trading day or (2) both executed and delivered pursuant to Section 2.1 hereof on a trading day prior to the opening of “regular trading hours” (as defined in Rule 600(b)(68) of Regulation NMS promulgated under the federal securities laws) on such trading day, (ii) at the option of the Holder, either (y) the VWAP on the trading day immediately preceding the date of the applicable exercise form or (z) the Bid Price of the Ordinary Shares on the principal Trading Market as reported by Bloomberg as of the time of the Holder’s execution of the applicable exercise form if such exercise form is executed during “regular trading hours” on a Trading Day and is delivered within two (2) hours thereafter (including until two (2) hours after the close of “regular trading hours” on a Trading Day) pursuant to Section 2.1 hereof or (iii) the VWAP on the date of the applicable exercise form if the date of such exercise form is a Trading Day and such exercise form is both executed and delivered pursuant to Section 2.1 hereof after the close of “regular trading hours” on such Trading Day;

 

(B) = the Exercise Price of this Warrant, as adjusted hereunder; and

 

(X) = the number of Ordinary Shares underlying the Warrant that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise.

 

If Shares are issued in such a cashless exercise, the parties acknowledge and agree that in accordance with Section 3(a)(9) of the Securities Act, the Shares shall take on the registered characteristics of the Warrants being exercised. The Company agrees not to take any position contrary to this Section 2.2..

 

Notwithstanding anything herein to the contrary, on the Expiration Date, this Warrant shall be automatically exercised via cashless exercise pursuant to this Section 2.2.

 

“Bid Price” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Ordinary Shares are then listed or quoted on a Trading Market, the bid price of the Ordinary Shares for the time in question (or the nearest preceding date) on the Trading Market on which the Ordinary Shares are then listed or quoted as reported by Bloomberg L.P. (“Bloomberg”) (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average price of the Ordinary Shares for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Ordinary Shares are not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Ordinary Shares are then reported on the Pink Open Market (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Ordinary Shares so reported, or (d) in all other cases, the fair market value of an Ordinary Share as determined by an independent appraiser selected in good faith by the Holders of a majority in interest of the Warrants then outstanding and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company.

 

“Trading Market” means the NASDAQ Stock Market LLC, or any of the following other markets or exchanges on which the Ordinary Shares are listed or quoted for trading on the date in question: the NYSE American, the Nasdaq Global Market, the Nasdaq Global Select Market or the New York Stock Exchange (or any successors to any of the foregoing).

 

“VWAP” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Ordinary Shares are then listed or quoted on a Trading Market, the value shall be deemed to be the highest intra-day or closing price on any trading day on such Trading Market on which the Ordinary Shares are then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)) during the five trading days preceding the exercise, (b) if OTCQB or OTCQX is not an Trading Market, the value shall be deemed to be the highest intra-day or closing price on any trading day on the OTCQB or OTCQX on which the Ordinary Shares are then quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)) during the five trading days preceding the exercise, as applicable, (c) if the Ordinary Shares are not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Ordinary Shares are then reported in the Pink Open Market (or a similar organization or agency succeeding to its functions of reporting prices), the value shall be deemed to be the highest intra-day or closing price on any trading day on the Pink Open Market on which the Ordinary Shares are then quoted as reported by OTC Markets Group (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)) during the five trading days preceding the exercise, or (d) in all other cases, the fair market value of an Ordinary Share as determined by an independent appraiser selected in good faith by the holders of a majority in interest of the Warrants then outstanding and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company.

 

Upon a cashless exercise of this Purchase Warrant pursuant to this Section 2.2 the Ordinary Shares to be issued to Holder shall be paid up out of any of the Company's freely distributable reserves, other than share premium reserves maintained by the Company for the benefit of holders of preferred shares, or out of any of the Company's statutory reserves which may be converted into share capital, to be determined by the Company's board of directors in its sole discretion. A cashless exercise of this Purchase Warrant pursuant to this Section 2.2 shall only be permitted to the extent the Company has sufficient freely distributable reserves, other than share premium reserves maintained by the Company for the benefit of holders of preferred shares, or reserves which may be converted into share capital. 

 

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2.3 Legend. Each certificate for the securities purchased under this Purchase Warrant shall bear the following legends unless such securities have been registered under the Securities Act of 1933, as amended (the “Act”), or are exempt from registration under the Act:

 

(i) “THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR APPLICABLE STATE LAW. NEITHER THE SECURITIES NOR ANY INTEREST THEREIN MAY BE OFFERED FOR SALE, SOLD OR OTHERWISE TRANSFERRED EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT, OR PURSUANT TO AN EXEMPTION FROM REGISTRATION UNDER THE ACT AND APPLICABLE STATE LAW WHICH, IN THE OPINION OF COUNSEL TO THE COMPANY, IS AVAILABLE.”

 

(ii) Any legend required by the securities laws of any state to the extent such laws are applicable to the Shares represented by a certificate, instrument, or book entry so legended.

  

3. Transfer.

 

3.1 General Restrictions. The registered Holder of this Purchase Warrant agrees by his, her or its acceptance hereof, that such Holder will not: (a) sell, transfer, assign, pledge or hypothecate this Purchase Warrant (or any Shares issuable upon the exercise of this Purchase Warrant) for a period of one hundred eighty (180) days following the effective date of the Registration Statement (the “Effective Date”) to anyone other than: (i) the Underwriter or a selected dealer participating in the Offering, or (ii) a bona fide officer or partner of the Underwriter or of any such selected dealer, in each case in accordance with FINRA Conduct Rule 5110(e)(1), or (b) cause this Purchase Warrant or the securities issuable hereunder to be the subject of any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of this Purchase Warrant or the securities hereunder, except as provided for in FINRA Rule 5110(e)(2). On and after that date that is one hundred eighty (180) days after the Effective Date, transfers to others may be made subject to compliance with or exemptions from applicable securities laws. In order to make any permitted assignment, the Holder must deliver to the Company the assignment form attached hereto as Exhibit B duly executed and completed, together with this Purchase Warrant and payment of all transfer taxes, if any, payable in connection therewith. The Company shall within five (5) Business Days transfer this Purchase Warrant on the books of the Company and shall execute and deliver a new Purchase Warrant or Purchase Warrants of like tenor to the appropriate assignee(s) expressly evidencing the right to purchase the aggregate number of Ordinary Shares purchasable hereunder or such portion of such number as shall be contemplated by any such assignment.

 

3.2 Restrictions Imposed by the Act. The securities evidenced by this Purchase Warrant shall not be transferred unless and until: (i) the Company has received the opinion of counsel for the Company that the securities may be transferred pursuant to an exemption from registration under the Act and applicable state securities laws, the availability of which is established to the reasonable satisfaction of the Company, (ii) a registration statement or a post-effective amendment to the Registration Statement relating to the offer and sale of such securities that has been declared effective by the U.S. Securities and Exchange Commission (the “Commission”) and includes a current prospectus or (iii) a registration statement, pursuant to which the Holder has exercised its registration rights pursuant to Section 4.1 herein, relating to the offer and sale of such securities has been filed and declared effective by the Commission and compliance with applicable state securities law has been established.

 

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4. Registration Rights.

 

4.1 “Piggy-Back” Registration. At any time after 180 days from the date hereof that all of the Shares may not be resold by the Holder pursuant to an exemption from registration under the Securities Act upon exercise on a cashless basis and unless all of the Ordinary Shares underlying the Purchase Warrant (collectively, the “Registrable Securities”) are included in an effective registration statement with a current prospectus, the Holder shall have the right, until the Expiration Date, to include the remaining Registrable Securities as part of any other registration of securities filed by the Company (other than in connection with a transaction contemplated by Rule 145 promulgated under the Act or pursuant to Forms S-8, F-3, F-4 or any equivalent forms); provided, however, that if, solely in connection with any primary underwritten public offering for the account of the Company, the managing underwriter(s) thereof shall, in its reasonable discretion, impose a limitation on the number of Registrable Securities which may be included in the registration statement because, in such underwriter(s)’ judgment, marketing or other factors dictate such limitation is necessary to facilitate public distribution, then the Company shall be obligated to include in such registration statement only such limited portion of the Registrable Securities with respect to which the Holder requested inclusion hereunder as the underwriter shall reasonably permit; and further provided that ) no such piggy-back rights shall exist for so long as the Registrable Securities (which term shall include those paid as consideration pursuant to the cashless exercise provisions of this Warrant) may be sold pursuant to Rule 144 of the Act without restriction. Any exclusion of Registrable Securities shall be made pro rata among the Holders seeking to include Registrable Securities in proportion to the number of Registrable Securities sought to be included by such Holders; provided, however, that the Company shall not exclude any Registrable Securities unless the Company has first excluded all outstanding securities, the holders of which are not entitled to inclusion of such securities in such Registration Statement or are not entitled to pro rata inclusion with the Registrable Securities. In the event of such a proposed registration, the Company shall furnish the then Holders of outstanding Registrable Securities with not less than fifteen (15) days written notice prior to the proposed date of filing of such registration statement. Such notice to the Holders shall continue to be given for each registration statement filed by the Company until such time as all of the Registrable Securities have been sold by the Holder. The Holders of the Registrable Securities shall exercise the “piggy-back” rights provided for herein by giving written notice, within seven (7) days of the receipt of the Company’s notice of its intention to file a registration statement. Except as otherwise provided in this Purchase Warrant, there shall be no limit on the number of times the Holder may request registration under this Section 4.1.

 

4.2 General Terms.

 

4.2.1 Expenses of Registration. The Company shall bear all fees and expenses attendant to registering the Registrable Securities pursuant to Section 4 hereof, but the Holders shall pay any and all underwriting commissions and the expenses of any legal counsel selected by the Holders to represent them in connection with the sale of the Registrable Securities.

 

4.2.2 Indemnification. The Company shall indemnify the Holder(s) of the Registrable Securities to be sold pursuant to any registration statement hereunder and each person, if any, who controls such Holders within the meaning of Section 15 of the Act or Section 20 (a) of the Securities Exchange Act of 1934, as amended (“Exchange Act”), against all loss, claim, damage, expense or liability (including all reasonable attorneys’ fees and other expenses reasonably incurred in investigating, preparing or defending against any claim whatsoever) to which any of them may become subject under the Act, the Exchange Act or otherwise, arising from such registration statement but only to the same extent and with the same effect as the provisions pursuant to which the Company has agreed to indemnify the Underwriter contained in Section 7 of the Underwriting Agreement.

 

4.2.3 Exercise of Purchase Warrant. Nothing contained in this Purchase Warrant shall be construed as requiring the Holder(s) to exercise their Purchase Warrant prior to or after the initial filing of any registration statement or the effectiveness thereof.

  

4.2.4 Documents to be Delivered by Holder(s). Each of the Holder(s) participating in any of the registration statement filed by the Company shall furnish to the Company a completed and executed questionnaire provided by the Company requesting information customarily sought of selling security holders.

 

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4.2.5 Damages. Should the registration or the effectiveness thereof required by Section 4 hereof be delayed by the Company or the Company otherwise fails to comply with such provisions, the Holder(s) shall, in addition to any other legal or other relief available to the Holder(s), be entitled to obtain specific performance or other equitable (including injunctive) relief against the threatened breach of such provisions or the continuation of any such breach, without the necessity of proving actual damages and without the necessity of posting bond or other security.

 

5. New Purchase Warrants to be Issued.

 

5.1 Partial Exercise or Transfer. Subject to the restrictions in Section 3 hereof, this Purchase Warrant may be exercised or assigned in whole or in part. In the event of the exercise or assignment hereof in part only, upon surrender of this Purchase Warrant for cancellation, together with the duly executed exercise or assignment form and funds sufficient to pay any Exercise Price and/or transfer tax if exercised pursuant to Section 2.1 hereof, the Company shall cause to be delivered to the Holder without charge a new Purchase Warrant of like tenor to this Purchase Warrant in the name of the Holder evidencing the right of the Holder to purchase the number of Ordinary Shares purchasable hereunder as to which this Purchase Warrant has not been exercised or assigned.

 

5.2 Lost Certificate. Upon receipt by the Company of evidence satisfactory to it of the loss, theft, destruction or mutilation of this Purchase Warrant and of reasonably satisfactory indemnification or the posting of a bond, the Company shall execute and deliver a new Purchase Warrant of like tenor and date. Any such new Purchase Warrant executed and delivered as a result of such loss, theft, mutilation or destruction shall constitute a substitute contractual obligation on the part of the Company.

 

6. Adjustments.

 

6.1 Adjustments to Exercise Price and Number of Ordinary Shares. The Exercise Price and the number of Ordinary Shares underlying this Purchase Warrant shall be subject to adjustment from time to time as hereinafter set forth:

 

6.1.1 Share Dividends; Split Ups. If, after the date hereof, and subject to the provisions of Section 6.3 below, the number of outstanding Ordinary Shares is increased by a stock dividend payable in Ordinary Shares or by a split up of Ordinary Shares or other similar event, then, on the effective day thereof, the number of Ordinary Shares purchasable hereunder shall be increased in proportion to such increase in outstanding Ordinary Shares, and the Exercise Price shall be proportionately decreased.

 

6.1.2 Aggregation of Ordinary Shares. If, after the date hereof, and subject to the provisions of Section 6.3 below, the number of outstanding Ordinary Shares is decreased by a consolidation, combination or reclassification of Ordinary Shares or other similar event, then, on the effective date thereof, the number of Ordinary Shares purchasable hereunder shall be decreased in proportion to such decrease in outstanding shares, and the Exercise Price shall be proportionately increased.

  

6.1.3 Replacement of Ordinary Shares upon Reorganization, etc. In case of any reclassification or reorganization of the outstanding Ordinary Shares other than a change covered by Section 6.1.1 or Section 6.1.2 hereof or that solely affects the par value of such Ordinary Shares, or in the case of any share reconstruction or amalgamation or consolidation of the Company with or into another corporation (other than a consolidation or share reconstruction or amalgamation in which the Company is the continuing corporation and that does not result in any reclassification or reorganization of the outstanding Ordinary Shares), or in the case of any sale or conveyance to another corporation or entity of the property of the Company as an entirety or substantially as an entirety in connection with which the Company is dissolved, the Holder of this Purchase Warrant shall have the right thereafter (until the expiration of the right of exercise of this Purchase Warrant) to receive upon the exercise hereof, for the same aggregate Exercise Price payable hereunder immediately prior to such event, the kind and amount of ordinary shares or other securities or property (including cash) receivable upon such reclassification, reorganization, share reconstruction or amalgamation, or consolidation, or upon a dissolution following any such sale or transfer, by a Holder of the number of Ordinary Shares of the Company obtainable upon exercise of this Purchase Warrant immediately prior to such event; and if any reclassification also results in a change in Ordinary Shares covered by Section 6.1.1 or Section 6.1.2, then such adjustment shall be made pursuant to Section 6.1.1Section 6.1.2 and this Section 6.1.3. The provisions of this Section 6.1.3 shall similarly apply to successive reclassifications, reorganizations, share reconstructions or amalgamations, or consolidations, sales or other transfers.

 

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6.1.4        Fundamental Transaction. If, at any time while this Purchase Warrant is outstanding, (i) the Company, directly or indirectly, in one or more related transactions effects any merger or consolidation of the Company with or into another Person, (ii) the Company, directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of its assets in one or a series of related transactions, (iii) any direct or indirect purchase offer, tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Ordinary Shares are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the outstanding Ordinary Shares, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Ordinary Shares or any compulsory share exchange pursuant to which the Ordinary Shares is effectively converted into or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spinoff or scheme of arrangement) with another Person or group of Persons whereby such other Person or group acquires more than 50% of the outstanding Ordinary Shares (not including any Ordinary Shares held by the other Person or other Persons making or party to, or associated or affiliated with, the other Persons making or party to such stock or share purchase agreement or other business combination) (each a "Fundamental Transaction"), then, upon any subsequent exercise of this Purchase Warrant, the Holder shall have the right to receive, for each Purchase Warrant Ordinary Share that would have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, the number Ordinary Shares of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional or alternative consideration (the "Alternative Consideration") receivable as a result of such Fundamental Transaction by a holder of the number of Ordinary Shares for which this Purchase Warrant is exercisable immediately prior to such Fundamental Transaction. For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternative Consideration based on the amount of Alternative Consideration issuable in respect of one Ordinary Share in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternative Consideration in a reasonable manner reflecting the relative value of any different components of the Alternative Consideration. If holders of Ordinary Shares are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternative Consideration it receives upon any exercise of this Purchase Warrant following such Fundamental Transaction. The Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the "Successor Entity") to assume in writing all of the obligations of the Company under this Purchase Warrant, and to deliver to the Holder in exchange for this Purchase Warrant a security of the Successor Entity evidenced by a written instrument substantially similar in form and substance to this Purchase Warrant which is exercisable for a corresponding number of shares of capital stock of such Successor Entity (or its parent entity) equivalent to the Ordinary Shares acquirable and receivable upon exercise of this Purchase Warrant prior to such Fundamental Transaction, and with an exercise price which applies the Exercise Price hereunder to such shares of capital stock (but taking into account the relative value of the Ordinary Shares pursuant to such Fundamental Transaction and the value of such shares of capital stock, such number of shares of capital stock and such exercise price being for the purpose of protecting the economic value of this Purchase Warrant immediately prior to the consummation of such Fundamental Transaction). Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for (so that from and after the date of such Fundamental Transaction, the provisions of this Purchase Warrant and the other Transaction Documents referring to the "Company" shall refer instead to the Successor Entity), and may exercise every right and power of, the Company and shall assume all of the obligations of the Company, under this Purchase Warrant and the other Transaction Documents with the same effect as if such Successor Entity had been named as the Company herein.

 

6.1.5   Changes in Form of Purchase Warrant. This form of Purchase Warrant need not be changed because of any change pursuant to this Section 6.1, and Purchase Warrants issued after such change may state the same Exercise Price and the same number of Ordinary Shares as are stated in the Purchase Warrant initially issued pursuant to the Underwriting Agreement. The acceptance by any Holder of the issuance of new Purchase Warrants reflecting a required or permissive change shall not be deemed to waive any rights to an adjustment occurring after the date hereof or the computation thereof.

 

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6.2 Substitute Purchase Warrant. In case of any consolidation of the Company with, or share reconstruction or amalgamation of the Company with or into, another corporation (other than a consolidation or share reconstruction or amalgamation which does not result in any reclassification or change of the outstanding Ordinary Shares), the corporation formed by such consolidation or share reconstruction or amalgamation shall execute and deliver to the Holder a supplemental Purchase Warrant providing that the Holder of each Purchase Warrant then outstanding or to be outstanding shall have the right thereafter (until the stated expiration of such Purchase Warrant) to receive, upon exercise of such Purchase Warrant, the kind and amount of Ordinary Shares and other securities and property receivable upon such consolidation or share reconstruction or amalgamation, by a holder of the number of Ordinary Shares of the Company for which such Purchase Warrant might have been exercised immediately prior to such consolidation, share reconstruction or amalgamation, sale or transfer. Such supplemental Purchase Warrant shall provide for adjustments which shall be identical to the adjustments provided for in this Section 6. The above provision of this Section 6 shall similarly apply to successive consolidations or share reconstructions or amalgamations. 

 

6.3 Elimination of Fractional Interests. The Company shall not be required to issue certificates representing fractions of Ordinary Shares upon the exercise of the Purchase Warrant, nor shall it be required to issue scrip or pay cash in lieu of any fractional interests, it being the intent of the parties that all fractional interests shall be eliminated by rounding any fraction up or down, as the case may be, to the nearest whole number of Ordinary Shares or other securities, properties or rights.

 

7. Reservation and Listing. The Company shall at all times reserve and keep available out of its authorized Ordinary Shares, solely for the purpose of issuance upon exercise of this Purchase Warrant, such number of Ordinary Shares or other securities, properties or rights as shall be issuable upon the exercise thereof. The Company covenants and agrees that, upon exercise of this Purchase Warrant and payment of the Exercise Price therefor, in accordance with the terms hereby, all Ordinary Shares and other securities issuable upon such exercise shall be duly and validly issued, fully paid and non-assessable and not subject to preemptive rights of any shareholder. The Company further covenants and agrees that upon exercise of this Purchase Warrant and payment of the exercise price therefor, all Ordinary Shares and other securities issuable upon such exercise shall be duly and validly issued, fully paid and non-assessable and not subject to preemptive rights of any shareholder. As long as this Purchase Warrant shall be outstanding, the Company shall use its commercially reasonable efforts to cause all Ordinary Shares issuable upon exercise of this Purchase Warrant to be listed (subject to official notice of issuance) on all national securities exchanges (or, if applicable, on the OTCQB Market or any successor quotation system) on which the Ordinary Shares issued to the public in the Offering may then be listed and/or quoted (if at all).

 

8. Certain Notice Requirements.

 

8.1 Holder’s Right to Receive Notice. Nothing herein shall be construed as conferring upon the Holders the right to vote or consent or to receive notice as a shareholder for the election of directors or any other matter, or as having any rights whatsoever as a shareholder of the Company. If, however, at any time prior to the expiration of this Purchase Warrant and its exercise, any of the events described in Section 8.2 shall occur, then, in one or more of said events, the Company shall give written notice of such event at least fifteen days prior to the date fixed as a record date or the date of closing the transfer books (the “Notice Date”) for the determination of the shareholders entitled to such dividend, distribution, conversion or exchange of securities or subscription rights, or entitled to vote on such proposed dissolution, liquidation, winding up or sale. Such notice shall specify such record date or the date of the closing of the transfer books, as the case may be. Notwithstanding the foregoing, the Company shall deliver to each Holder a copy of each notice given to the other shareholders of the Company at the same time and in the same manner that such notice is given to the shareholders.

 

8.2 Events Requiring Notice. The Company shall be required to give the notice described in this Section 8 upon one or more of the following events: (i) if the Company shall take a record of the holders of its Ordinary Shares for the purpose of entitling them to receive a dividend or distribution payable otherwise than in cash, or a cash dividend or distribution payable otherwise than out of retained earnings, as indicated by the accounting treatment of such dividend or distribution on the books of the Company, (ii) the Company shall offer to all the holders of its Ordinary Shares any additional shares of capital stock of the Company or securities convertible into or exchangeable for shares of capital stock of the Company, or any option, right or warrant to subscribe therefor, or (iii) a dissolution, liquidation or winding up of the Company (other than in connection with a consolidation or share reconstruction or amalgamation) or a sale of all or substantially all of its property, assets and business shall be proposed. 

 

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8.3 Notice of Change in Exercise Price. The Company shall, promptly after an event requiring a change in the Exercise Price pursuant to Section 6 hereof, send notice to the Holders of such event and change (“Price Notice”). The Price Notice shall describe the event causing the change and the method of calculating same and shall be certified as being true and accurate by the Company’s Chief Financial Officer.

 

8.4 Transmittal of Notices. All notices, requests, consents and other communications under this Purchase Warrant shall be in writing and shall be deemed to have been duly made if made in accordance with the notice provisions of the Underwriting Agreement to the addresses and contact information for the Holder appearing on the books and records of the Company.

 

If to the Holder, then to:

 

Boustead Securities, LLC

6 Venture, Suite 265

Irvine, CA 92618

Attn: Keith Moore

Attn: Daniel J. McClory

Email: keith@boustead1828.com

dan@boustead1828.com

 

With a copy to:

 

Sichenzia Ross Ference LLP

1185 Avenue of the Americas, 37th Floor

New York, NY 10036

Attn: Benjamin Tan, Esq.
Email: btan@srf.law

 

If to the Company:

 

Mainz Biomed N.V.

Robert Koch Strasse 50

55129 Mainz

Germany

Attn:

Email:

 

 

With a copy (which shall not constitute notice) to:

 

Ortoli Rosenstadt LLP

366 Madison Avenue

New York, NY 10017

Attn: William Rosenstadt, Esq.

Tim Dockery, Esq.

Email: wsr@orllp.legal

tld@orllp.legal

 

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9. Miscellaneous.

 

9.1 Amendments. The Company and the Underwriter may from time to time supplement or amend this Purchase Warrant without the approval of any of the Holders in order to cure any ambiguity, to correct or supplement any provision contained herein that may be defective or inconsistent with any other provisions herein, or to make any other provisions in regard to matters or questions arising hereunder that the Company and the Underwriter may deem necessary or desirable and that the Company and the Underwriter deem shall not adversely affect the interest of the Holders, in their sole and absolute discretion. All other modifications or amendments shall require the written consent of and be signed by the party against whom enforcement of the modification or amendment is sought.

 

9.2 Headings. The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning or interpretation of any of the terms or provisions of this Purchase Warrant.

 

9.3. Entire Agreement. This Purchase Warrant (together with the other agreements and documents being delivered pursuant to or in connection with this Purchase Warrant) constitutes the entire agreement of the parties hereto with respect to the subject matter hereof, and supersedes all prior agreements and understandings of the parties, oral and written, with respect to the subject matter hereof.

 

9.4 Binding Effect. This Purchase Warrant shall inure solely to the benefit of and shall be binding upon, the Holder and the Company and their permitted assignees, respective successors, legal representative and assigns, and no other person shall have or be construed to have any legal or equitable right, remedy or claim under or in respect of or by virtue of this Purchase Warrant or any provisions herein contained.

 

9.5 Governing Law; Submission to Jurisdiction; Trial by Jury. This Purchase Warrant shall be governed by and construed and enforced in accordance with the laws of the State of New York, without giving effect to conflict of laws principles thereof. The Company hereby agrees that any action, proceeding or claim against it arising out of, or relating in any way to this Purchase Warrant shall be brought and enforced in the New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York, and irrevocably submits to such jurisdiction, which jurisdiction shall be exclusive. The Company hereby waives any objection to such exclusive jurisdiction and that such courts represent an inconvenient forum. Any process or summons to be served upon the Company may be served by transmitting a copy thereof by registered or certified mail, return receipt requested, postage prepaid, addressed to it at the address set forth in Section 8 hereof. Such mailing shall be deemed personal service and shall be legal and binding upon the Company in any action, proceeding or claim. The Company and the Holder agree that the prevailing party(ies) in any such action shall be entitled to recover from the other party(ies) all of its reasonable attorneys’ fees and expenses relating to such action or proceeding and/or incurred in connection with the preparation therefor. The Company (on its behalf and, to the extent permitted by applicable law, on behalf of its stockholders and affiliates) and the Holder hereby irrevocably waive, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Agreement or the transactions contemplated hereby.

 

9.6 Waiver, etc. The failure of the Company or the Holder to at any time enforce any of the provisions of this Purchase Warrant shall not be deemed or construed to be a waiver of any such provision, nor to in any way affect the validity of this Purchase Warrant or any provision hereof or the right of the Company or any Holder to thereafter enforce each and every provision of this Purchase Warrant. No waiver of any breach, non-compliance or non-fulfillment of any of the provisions of this Purchase Warrant shall be effective unless set forth in a written instrument executed by the party or parties against whom or which enforcement of such waiver is sought; and no waiver of any such breach, non-compliance or non-fulfillment shall be construed or deemed to be a waiver of any other or subsequent breach, non-compliance or non-fulfillment.

 

9.7 Exchange Agreement. As a condition of the Holder’s receipt and acceptance of this Purchase Warrant, Holder agrees that, at any time prior to the complete exercise of this Purchase Warrant by Holder, if the Company and the Underwriter enter into an agreement (“Exchange Agreement”) pursuant to which they agree that all outstanding Purchase Warrants will be exchanged for securities or cash or a combination of both, then Holder shall agree to such exchange and become a party to the Exchange Agreement.

 

9.8       Execution in Counterparts. This Purchase Warrant may be executed in one or more counterparts, and by the different parties hereto in separate counterparts, each of which shall be deemed to be an original, but all of which taken together shall constitute one and the same agreement, and shall become effective when one or more counterparts has been signed by each of the parties hereto and delivered to each of the other parties hereto. Such counterparts may be delivered by facsimile transmission or other electronic transmission.

 

9.9 Holder Not Deemed a Shareholder. Except as otherwise specifically provided herein, the Holder, solely in its capacity as a holder of this Purchase Warrant, shall not be entitled to vote or receive dividends or be deemed the holder of share capital of the Company for any purpose, nor shall anything contained in this Purchase Warrant be construed to confer upon the Holder, solely in its capacity as the Holder of this Purchase Warrant, any of the rights of a shareholder of the Company or any right to vote, give or withhold consent to any corporate action (whether any reorganization, issue of share, reclassification of share, consolidation, merger, conveyance or otherwise), receive notice of meetings, receive dividends or subscription rights, or otherwise, prior to the issuance to the Holder of the Ordinary Shares which it is then entitled to receive upon the due exercise of this Purchase Warrant. In addition, nothing contained in this Purchase Warrant shall be construed as imposing any liabilities on the Holder to purchase any securities (upon exercise of this Purchase Warrant or otherwise) or as a shareholder of the Company, whether such liabilities are asserted by the Company or by creditors of the Company.

 

[Signature Page to Follow]

 

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IN WITNESS WHEREOF, the Company has caused this Purchase Warrant to be signed by its duly authorized officer as of the ____ day of _______, 2021.

 

  MAINZ BIOMED N.V.
     
  By:   
    Name: Guido Baechler
    Title: Chief Executive Officer

 

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EXHIBIT A

Exercise Notice

 

Form to be used to exercise Purchase Warrant:

 

Date: __________, 20___

 

The undersigned hereby elects irrevocably to exercise the Purchase Warrant for ______ Ordinary Shares of MAINZ BIOMED B.V., a Dutch company (the “Company”) and hereby makes payment of $____ (at the rate of $____ per Ordinary Share) in payment of the Exercise Price pursuant thereto. Please issue the Ordinary Shares as to which this Purchase Warrant is exercised in accordance with the instructions given below and, if applicable, a new Purchase Warrant representing the number of Ordinary Shares for which this Purchase Warrant has not been exercised.

 

or

 

The undersigned hereby elects irrevocably to convert its right to purchase ___ Ordinary Shares under the Purchase Warrant for ______ Ordinary Shares, as determined in accordance with the following formula:

 

dividing [(A-B) (X)] by (A), where:

 

(A) = as applicable: (i) the VWAP on the trading day immediately preceding the date of the applicable exercise form if such exercise form is (1) both executed and delivered pursuant to Section 2.1 hereof on a day that is not a trading day or (2) both executed and delivered pursuant to Section 2.1 hereof on a trading day prior to the opening of “regular trading hours” (as defined in Rule 600(b)(68) of Regulation NMS promulgated under the federal securities laws) on such trading day, (ii) at the option of the Holder, either (y) the VWAP on the trading day immediately preceding the date of the applicable exercise form or (z) the Bid Price of the Ordinary Shares on the principal Trading Market as reported by Bloomberg as of the time of the Holder’s execution of the applicable exercise form if such exercise form is executed during “regular trading hours” on a Trading Day and is delivered within two (2) hours thereafter (including until two (2) hours after the close of “regular trading hours” on a Trading Day) pursuant to Section 2.1 hereof or (iii) the VWAP on the date of the applicable exercise form if the date of such exercise form is a Trading Day and such exercise form is both executed and delivered pursuant to Section 2.1 hereof after the close of “regular trading hours” on such Trading Day;

 

(B) = the Exercise Price of this Warrant, as adjusted hereunder; and

 

(X) = the number of Ordinary Shares underlying the Warrant that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise.

 

 

The undersigned agrees and acknowledges that the calculation set forth above is subject to confirmation by the Company and any disagreement with respect to the calculation shall be resolved by the Company in its sole discretion.

 

Please issue the Ordinary Shares as to which this Purchase Warrant is exercised in accordance with the instructions given below and, if applicable, a new Purchase Warrant representing the number of Ordinary Shares for which this Purchase Warrant has not been converted.

 

Signature

 

Signature Guaranteed

 

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EXHIBIT B

 

Form to be used to assign Purchase Warrant: ASSIGNMENT

 

(To be executed by the registered Holder to effect a transfer of the within Purchase Warrant):

 

FOR VALUE RECEIVED,           does hereby sell, assign and transfer unto the right to purchase [●] ordinary shares of MAINZ BIOMED B.V. , a Dutch company (the “Company”), evidenced by the Purchase Warrant and does hereby authorize the Company to transfer such right on the books of the Company.

 

Dated: , 20__

 

Signature

 

Signature Guaranteed

 

NOTICE: The signature to this form must correspond with the name as written upon the face of the within Purchase Warrant without alteration or enlargement or any change whatsoever, and must be guaranteed by a bank, other than a savings bank, or by a trust company or by a firm having membership on a registered national securities exchange.

 

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INSTRUCTIONS FOR REGISTRATION OF SECURITIES

 

Name:

(Print in Block Letters)

Address:

 

NOTICE: The signature to this form must correspond with the name as written upon the face of the Purchase Warrant without alteration or enlargement or any change whatsoever, and must be guaranteed by a bank, other than a savings bank, or by a trust company or by a firm having membership on a registered national securities exchange.

  

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Exhibit B

Form of Lock-up Agreement

 

[_____________], 2021

 

Boustead Securities, LLC

6 Venture, Suite 395

Irvine, CA 92618

 

Re: Proposed Public Offering by Mainz Biomed B.V.

 

Ladies and Gentlemen:

 

The undersigned, a stockholder, director or officer of Mainz Biomed B.V., a Dutch company limited by shares (the “Company”), understands that Boustead Securities, LLC (the “Underwriter”) will act as an underwriter to carry out an offering (the “Offering”) of the Company’s ordinary shares, €0.01 par value (the “Ordinary Shares”). In recognition of the benefit that the Offering will confer upon the undersigned, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the undersigned agrees with the Underwriter that, without the prior written consent of the Underwriter, during a period of up to 12  months from the date on which the trading of the Ordinary Shares on the Senior Exchange commences (the “Lock-Up Period”), the undersigned will not, without the prior written consent of the Underwriter, directly or indirectly (i) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase or otherwise transfer or dispose of any securities of the Company (including the issuance of Ordinary Shares upon the exercise of options, but excluding any securities registered under the Securities Act of 1933, as amended, in connection with the Company’s initial public offering) (collectively, the “Lock-Up Securities”), whether now owned or hereafter acquired by the undersigned or with respect to which the undersigned has or hereafter acquires the power of disposition, or file, or cause to be filed, any registration statement under the Securities Act of 1933, as amended, with respect to any of the foregoing or (ii) enter into any swap or any other agreement or any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of the Lock-Up Securities, whether any such swap or transaction described in clause (i) or (ii) above is to be settled by delivery of the Lock-Up Securities or such other securities, in cash or otherwise.

 

Notwithstanding the foregoing, and subject to the conditions below, the undersigned may transfer the Lock-Up Securities without the prior written consent of the Underwriter:

 

(I) in an amount equal to 33% of the Lock-Up Securities held by the undersigned on the date hereof starting on the date that is 180 days from the date hereof;

 

(II) in an amount equal to 66% of the Lock-Up Securities held by the undersigned on the date hereof (which amount shall include any Lock-Up Securities sold under (I) above) starting on the date that is 270 days from the date hereof;

 

(III) commencing 90 days after the date hereof,

 

(a) if the high bid per Ordinary Shares exceeds $7.50 for ten consecutive trading days, with at least 100,000 Ordinary Shares traded per day, the investors may sell 33% of the Lock-Up Securities held by the undersigned on the date hereof subject to a maximum sale on any trading day of 3% of the daily volume;

 

(b) if the high bid per Ordinary Shares exceeds $10.00 for ten consecutive trading days, with at least 100,000 Ordinary Shares traded per day, the investors may sell 66% of the Lock-Up Securities held by the undersigned on the date hereof (which amount shall include any Lock-Up Securities sold under (III(a)) above) subject to a maximum sale on any trading day of 3% of the daily volume; and

 

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(c) if the high bid per Ordinary Shares exceeds $15.00 for ten consecutive trading days, with at least 100,000 Ordinary Shares traded per day, the investors may all of the Lock-Up Securities subject to a maximum sale on any trading day of 3% of the daily volume.

 

(IV) as follows, provided that (1) the Underwriter receives a signed lock-up agreement for the balance of the Lock-Up Period from each donee, trustee or transferee, as the case may be, (2) any such transfer shall not involve a disposition for value, (3) such transfers are not required to be reported in any public report or filing with the Securities and Exchange Commission, or otherwise and (4) the undersigned does not otherwise voluntarily effect any public filing or report regarding such transfers:

 

(1) as a bona fide gift or gifts; or

 

(2) to any trust or other entity for the direct or indirect benefit of, or wholly-owned by, the undersigned or the immediate family of the undersigned (for purposes of this lock-up agreement, “immediate family” shall mean any relationship by blood, marriage or adoption, not more remote than first cousin); or

 

(3) if the undersigned is a corporation, partnership, limited liability company, trust or other business entity (1) transfers to another corporation, partnership, limited liability company, trust or other business entity that is a direct or indirect affiliate (as defined in Rule 405 promulgated under the Securities Act of 1933, as amended) of the undersigned or (2) distributions of Ordinary Shares or any security convertible into or exercisable for Ordinary Shares to limited partners, limited liability company members or stockholders of the undersigned; or

 

(4) if the undersigned is a trust, transfers to the beneficiary of such trust; or

 

(5) by will, other testamentary document or intestate succession; or

 

(6) by operation of law pursuant to a qualified domestic order or in connection with a divorce settlement.; or

 

(7) pursuant to a trading plan established prior to the date of this Agreement, 2020 pursuant to Rule 10b5-1 of the Exchange Act.

 

The undersigned further agrees that, prior to engaging in any transaction or taking any other action that is subject to the terms of this lock-up agreement during the Lock-Up Period, it will give notice thereof to the Company and will not consummate such transaction or take any such action unless it has received written confirmation from the Company that the Lock-Up Period has expired.

 

The undersigned understands that, if the Offering shall terminate or be terminated prior to payment for and delivery of the Securities, the undersigned shall be released from all obligations set forth herein.

 

The undersigned also agrees and consents to the entry of stop transfer instructions with the Company’s transfer agent and registrar against the transfer of the Lock-Up Securities except in compliance with the foregoing restrictions.

 

The undersigned, whether or not participating in the Offering, understands that the Underwriter is proceeding with the Offering in reliance upon this lock-up agreement.

 

This lock-up agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to the conflict of laws principles thereof.

 

[Signature page follows]

 

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  Very truly yours,
   
   
  (Name - Please Print)
   
   
  (Signature)

 

 

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Exhibit 3.1

 

Draft of 4 October 2021

 

This document is an unofficial English translation of a document prepared in Dutch. In preparing this document, an attempt has been made to translate as literally as possible without jeopardising the overall continuity of the text, except that, for convenience, the definitions set out in article 1.1 of the articles of association contained in this document have been placed in the English alphabetical order. Inevitably, however, differences may occur in translation and if they do, the Dutch text will govern by law. In this translation, Dutch legal concepts are expressed in English terms and not in their original Dutch terms. The concepts concerned may not be identical to concepts described by the English terms as such terms may be understood under the laws of other jurisdictions.

 

FORM OF

DEED OF CONVERSION

MAINZ BIOMED B.V.

(new name: Mainz Biomed N.V.)

 

On the [●] day of [●] two thousand and twenty-one appears before me, [●], civil law notary in Amsterdam, the Netherlands:

 

[●].

 

The person appearing declares:

 

(A) On the [●] day of [●] two thousand and twenty-one the general meeting of Mainz Biomed B.V., a private company with limited liability under Dutch law, having its seat in Amsterdam, the Netherlands, and its address at Robert-Koch-Straβe 50, 55129 Mainz, Germany, registered with the Dutch trade register under number 82122571 (the “Company”), resolved to convert the Company into a public company, to amend the articles of association of the Company and to authorise the person appearing to execute the deed of conversion. The resolutions to convert the Company, amend the articles of association and authorise the person appearing are evidenced by a document, which is attached to this deed (annex).

 

(B) The Company was incorporated by deed, executed on the eighth day of March two thousand and twenty-one before M.M. van der Bie, civil law notary in Amsterdam, the Netherlands. The articles of association of the Company have never been amended.

 

In order to implement the aforementioned resolutions to convert the Company and to amend the articles of association, the person appearing declares that the Company is hereby converted into a public company and that the articles of association of the Company are hereby amended such that these shall read in full as follows:

 

ARTICLES OF ASSOCIATION

 

1. Definitions and interpretation

 

1.1 In these Articles of Association the following definitions apply:

 

Annual Accounts” means the annual accounts referred to in section 2:361 of the Dutch Civil Code;

 

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Draft of 4 October 2021

 

Articles of Association” means these articles of association;

 

Auditor” means an auditor as referred to in section 2:393 subsection 1 of the Dutch Civil Code or an organisation within which such auditors cooperate, in each case, as the context may require;

 

Board of Directors” means the board of directors of the Company;

 

Chief Executive Officer” means the Executive Director who has been granted the title of Chief Executive Officer in accordance with these Articles of Association;

 

Company” means the public company under Dutch law which is governed by these Articles of Association;

 

Director” means a director of the Company, including each Executive Director and each Non-Executive Director, unless the context otherwise requires;

 

Convertible Reserve” means a reserve referred to in sections 2:389 or 2:390 of the Dutch Civil Code;

 

Distributable Reserve” means a distributable reserve other than a share premium reserve maintained by the Company for the benefit of the holders of a series of Preferred Shares pursuant to these Articles of Association;

 

Executive Director” means an executive director of the Company;

 

General Meeting” means the body of the Company consisting of the Persons with Meeting Rights or a meeting of Persons with Meeting Rights, in each case, as the context may require;

 

Group” means a group as referred to in section 2:24b of the Dutch Civil Code;

 

Group Company” means a legal person or partnership affiliated with the Company in a group as referred to in section 2:24b of the Dutch Civil Code;

 

Indemnified Person” means a current or former Director;

 

Management Report” means the management report referred to in section 2:391 of the Dutch Civil Code;

 

Meeting Rights” means the right to attend the General Meeting and to address the General Meeting;

 

Non-Executive Director” means a non-executive director of the Company;

 

Ordinary Share” means an ordinary share in the share capital of the Company;

 

Person with Meeting Rights” means a person to whom the Meeting Rights accrue;

 

Pledgee” means a holder of a right of pledge on one or more Shares;

 

Preferred Share” means a preferred share in the share capital of the Company;

 

Share” means a share in the share capital of the Company, including each Ordinary Share and each Preferred Share, unless the context otherwise requires;

 

Shareholder” means a holder of one or more Shares;

 

Subsidiary” means a subsidiary as referred to in section 2:24a of the Dutch Civil Code;

 

Usufructuary” means a holder of a right of usufruct on one or more Shares.

 

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Draft of 4 October 2021

 

1.2 In these Articles of Association references to Articles are to articles of these Articles of Association, unless otherwise specified.

 

2. Name, seat and structure

 

2.1 The name of the Company is: Mainz Biomed N.V.

 

2.2 The Company has its seat in Amsterdam, the Netherlands.

 

2.3 The Company applies section 2:129a of the Dutch Civil Code.

 

3. Objects

 

The objects of the Company are:

 

(a) to research, develop, manufacture and commercialise tests for clinical diagnostics in the area of human diagnostics and to render advice and services in connection therewith;

 

(b) to participate in, to take an interest in any other way in, to conduct the management of and to finance other businesses, of whatever nature;

 

(c) to provide security, to give guarantees and to bind itself in any other way for its own debts and obligations and for those of other persons;

 

(d) to borrow, to lend and to raise funds, including the issue of bonds, debt instruments and other securities, as well as to enter into agreements in connection therewith;

 

(e) to acquire, manage, exploit and dispose of immovable property and other registered property;

 

(f) to trade in currencies and securities, as well as in items of property in general;

 

(g) to develop, exploit and trade in patents, trademarks, licenses, know-how, copyrights, database rights and other intellectual property rights;

 

(h) to perform all activities of an industrial, financial or commercial nature,

 

as well as all activities which are incidental to or which may be conducive to any of the foregoing in the broadest sense.

 

4. Share capital and Shares

 

4.1 The authorised share capital of the Company amounts to five hundred thousand euros (EUR 500,000.00) and is divided into:

 

(a) forty-five million (45,000,000) Ordinary Shares with a nominal value of one eurocent (EUR 0.01) each; and

 

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Draft of 4 October 2021

 

(b) five million (5,000,000) Preferred Shares with a nominal value of one eurocent (EUR 0.01) each, divided into:

 

(i) a series A consisting of one million (1,000,000) Preferred Shares;

 

(ii) a series B consisting of one million (1,000,000) Preferred Shares;

 

(iii) a series C consisting of one million (1,000,000) Preferred Shares;

 

(iv) a series D consisting of one million (1,000,000) Preferred Shares; and

 

(v) a series E consisting of one million (1,000,000) Preferred Shares.

 

4.2 The number of Ordinary Shares included in the authorised share capital may be decreased and the number of Preferred Shares included in the authorised share capital may be increased pursuant to a resolution of the Board of Directors by a number not exceeding the number of Ordinary Shares included in the authorised share capital which have not been issued and which are not subject to any rights to subscribe for Ordinary Shares. The Company shall deposit a resolution to decrease the number of Ordinary Shares included in the authorised share capital and increase the number of Preferred Shares included in the authorised share capital at the offices of the Dutch trade register.

 

4.3 Each series of Preferred Shares shall constitute a separate class.

 

4.4 The Shares shall be in registered form and shall be numbered consecutively, the Ordinary Shares from 1 onwards, the series A Preferred Shares from PA 1 onwards, the series B Preferred Shares from PB 1 onwards, the series C Preferred Shares from PC 1 onwards, the series D Preferred Shares from PD 1 onwards and the series E Preferred Shares from PE 1 onwards, or in such other manner as the Board of Directors may determine.

 

5. Conversion of Preferred Shares into Ordinary Shares

 

5.1 Each Preferred Share shall be convertible, at the request of the holder, into Ordinary Shares, if permitted pursuant to the applicable conditions for conversion.

 

5.2 The conditions for conversion and the further terms applicable to the Preferred Shares shall be determined by the Board of Directors, subject to the prior approval of the General Meeting and the meeting of holders of the series of Preferred Shares concerned, if Preferred Shares of such series have been issued and are held by any persons other than the Company, provided that in no event may any Preferred Share be converted into more than ten Ordinary Shares.

 

5.3 Article 5.2 shall apply by analogy to any amendments of or supplementations to the terms applicable to the Preferred Shares.

 

5.4 The Board of Directors shall implement the conversion of Preferred Shares into Ordinary Shares in accordance with the applicable conditions for conversion by a resolution to that effect. The resolution converting the Preferred Shares into Ordinary Shares may determine that, upon the conversion, the number of Ordinary Shares included in the authorised share capital be decreased by a number equal to the number of Preferred Shares that are converted into Ordinary Shares and the number of Preferred Shares included in the authorised share capital be increased by a number equal to the number of Ordinary Shares into which the Preferred Shares are converted. The Company shall deposit a resolution to convert Preferred Shares into Ordinary Shares at the offices of the Dutch trade register.

 

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Draft of 4 October 2021

 

5.5 Any obligation to pay up Ordinary Shares arising from a conversion of Preferred Shares into Ordinary Shares shall be charged to the share premium reserve maintained by the Company for the benefit of the holders of the series of Preferred Shares concerned; if this reserve is insufficient, the difference shall be charged to the Distributable Reserves or the Convertible Reserves determined by the Board of Directors; if these reserves are insufficient, the difference shall be satisfied by the holder of the Ordinary Shares concerned by payment in cash.

 

5.6 If Preferred Shares of a particular series are converted into Ordinary Shares, an amount equal to the amount of the proportional entitlement of the holder of the Preferred Shares concerned to the balance of the share premium reserve maintained by the Company for the benefit of the holders of the Preferred Shares concerned, minus the amount charged to such share premium reserve by way of application of Article 5.5, shall be charged to the share premium reserve concerned and added to the Distributable Reserves determined by the Board of Directors.

 

6. Issue of Shares

 

6.1 Shares may be issued pursuant to a resolution of the Board of Directors, if the Board of Directors has been authorised to resolve to issue Shares by a resolution of the General Meeting for a specified period not exceeding five years. The resolution granting the authorisation shall specify the number of Shares that may be issued. The authorisation may from time to time be extended, in each case, for a period not exceeding five years. Unless otherwise specified in the resolution granting the authorisation, the authorisation may not be revoked.

 

6.2 For so long as and to the extent the Board of Directors is not authorised to resolve to issue Shares, the General Meeting shall have the authority to resolve to issue Shares on the proposal of the Board of Directors.

 

6.3 Articles 6.1 and 6.2 shall apply by analogy to a grant of rights to subscribe for Shares, but shall not apply to the issue of Shares to a person who exercises a previously acquired right to subscribe for Shares.

 

7. Pre-emption rights upon issue of Shares

 

7.1 Upon the issue of Ordinary Shares, each holder of Ordinary Shares shall have a pre-emption right in proportion to the aggregate amount of his Ordinary Shares, subject to Article 7.2.

 

7.2 A holder of Ordinary Shares shall have no pre-emption right in respect of:

 

(a) Ordinary Shares which are issued against payment in a form of consideration other than cash;

 

(b) Ordinary Shares which are issued to employees of the Company or of a Group Company; and

 

(c) Preferred Shares to be issued.

 

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Draft of 4 October 2021

 

7.3 Holders of Preferred Shares shall have no pre-emption right in respect of Shares to be issued.

 

7.4 Pre-emption rights may be limited or excluded by a resolution of the Board of Directors, if the Board of Directors has been authorised to limit or exclude pre-emption rights by a resolution of the General Meeting for a specified period not exceeding five years. The authorisation may from time to time be extended, in each case, for a period not exceeding five years. Unless otherwise specified in the resolution granting the authorisation, the authorisation may not be revoked.

 

7.5 A resolution of the General Meeting to limit or exclude pre-emption rights or to authorise the Board of Directors to limit or exclude pre-emption rights shall require a majority of at least two thirds of the votes cast, if less than half the issued share capital is represented at the meeting.

 

7.6 For so long as and to the extent the Board of Directors is not authorised to limit or exclude pre-emption rights, the General Meeting shall have the authority to limit or exclude pre-emption rights on the proposal of the Board of Directors.

 

7.7 The Company shall announce an issue of Shares where pre-emption rights apply and the period within which such rights may be exercised in accordance with applicable law and stock exchange rules.

 

7.8 Articles 7.1 up to and including 7.7 shall apply by analogy to a grant of rights to subscribe for Shares, but shall not apply to the issue of Shares to a person who exercises a previously acquired right to subscribe for Shares.

 

8. Payment on Shares

 

8.1 Without prejudice to section 2:80 subsection 2 of the Dutch Civil Code, upon any subscription for Shares, the nominal value must be paid up on such Shares and, if such Shares are subscribed for a higher price than the nominal value, the difference between the higher price and the nominal value. However, upon any subscription for Preferred Shares, it may be stipulated that a part, not exceeding three fourths, of the nominal value may remain unpaid until a period of one month has lapsed after it shall have been called by the Company.

 

8.2 Payment on a Share must be made in cash, insofar as no alternative contribution has been agreed.

 

8.3 Payment in a currency other than the euro may only be made with the consent of the Company and with due observance of section 2:80a subsection 3 of the Dutch Civil Code.

 

8.4 Payment in a form of consideration other than cash shall be made with due observance of sections 2:80b and 2:94b of the Dutch Civil Code.

 

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Draft of 4 October 2021

 

8.5 Ordinary Shares which are issued under any incentive plan or similar arrangement may be paid up out of the Distributable Reserves or the Convertible Reserves determined by the Board of Directors.

 

8.6 The Board of Directors shall be authorised to perform the legal acts referred to in section 2:94 subsection 1 of the Dutch Civil Code without the prior approval of the General Meeting.

 

9. Acquisition of Shares by the Company

 

9.1 Without prejudice to Article 9.2, the Company may only acquire fully paid up Shares for consideration if and to the extent the General Meeting has authorised the Board of Directors to acquire Shares. Such authorisation shall be valid for a period not exceeding eighteen months. The resolution of the General Meeting granting the authorisation shall specify the number of Shares that may be acquired, the manner in which such Shares may be acquired and the limits within which the price must be set. The authorisation may from time to time be extended, in each case, for a period not exceeding eighteen months. Unless otherwise specified in the resolution granting the authorisation, the authorisation may not be revoked.

 

9.2 The authorisation of the General Meeting shall not be required if the Company acquires Ordinary Shares for the purpose of transferring such Ordinary Shares to employees of the Company or of a Group Company pursuant to any incentive plan or similar arrangement applicable to such employees, provided that such Ordinary Shares are listed on any stock exchange.

 

9.3 Any acquisition of Shares by the Company shall be effected with due observance of section 2:98 of the Dutch Civil Code.

 

9.4 If depositary receipts for Shares have been issued, such depositary receipts for Shares shall be put on par with Shares for the purpose of Articles 9.1 up to and including 9.3.

 

10. Financial assistance

 

10.1 In respect of the subscription for or acquisition of Shares or depositary receipts thereof by other persons, the Company may not provide security, give a guarantee as to the price of the Shares, give guarantees in any other manner and may not bind itself either jointly or severally in addition to or for other persons. This prohibition shall also apply to its Subsidiaries.

 

10.2 In respect of the subscription for or acquisition of Shares or depositary receipts thereof by other persons, the Company and its Subsidiaries may only grant loans with due observance of section 2:98c subsections 2 up to and including 7 of the Dutch Civil Code.

 

10.3 Articles 10.1 and 10.2 shall not apply if Shares are subscribed for or acquired by or for the account of employees of the Company or of a Group Company.

 

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Draft of 4 October 2021

 

11. Reduction of share capital

 

11.1 The General Meeting may resolve to reduce the issued share capital by cancelling Shares or by reducing the nominal value of Shares by an amendment of the Articles of Association. The resolution shall specify the Shares to which the resolution applies and shall describe how such a resolution shall be implemented. The amount of the issued share capital may not fall below the minimum share capital as required by law in effect at the time of the resolution.

 

11.2 The General Meeting may only resolve to reduce the issued share capital on the proposal of the Board of Directors.

 

11.3 A resolution to cancel Shares may only apply to Shares which are held by the Company itself or to Shares for which the Company holds depositary receipts or to all Preferred Shares of a particular series.

 

11.4 Reduction of the nominal value of Shares without repayment shall be effected proportionally to all Shares. The requirement of proportionality may be waived by agreement of all Shareholders concerned.

 

11.5 Cancellation of Preferred Shares which are held by any person other than the Company shall be effected against:

 

(a) repayment of the amount paid up on the Preferred Shares concerned;

 

(b) if applicable, simultaneous release from the obligation to pay in respect of the Preferred Shares concerned; and

 

(c) simultaneous distribution of an amount equal to:

 

(i) the balance of the share premium reserve maintained by the Company for the benefit of the holders of the series of Preferred Shares concerned;

 

(ii) any deficit, referred to in Article ‎‎37.2; and

 

(iii) the amount, referred to in Article 37.2 under (a), calculated up to the date on which the Preferred Shares concerned are cancelled,

 

all with due observance of Article 38.5.

 

11.6 Partial repayment on Shares may only be effected in implementation of a resolution to reduce the nominal value of the Shares. Such repayment shall be effected proportionally on all Shares or exclusively on all Shares of a same class. The requirement of proportionality may be waived by agreement of all Shareholders concerned.

 

11.7 The validity of a resolution of the General Meeting to reduce the issued share capital shall require a prior or simultaneous approving resolution of each group of holders of Shares of a same class whose rights are prejudiced by such share capital reduction.

 

11.8 A resolution of the General Meeting to reduce the issued share capital shall require a majority of at least two thirds of the votes cast, if less than half of the issued share capital is represented at the meeting.

 

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Draft of 4 October 2021

 

11.9 Reduction of the issued share capital shall be effected with due observance of sections 2:99 and 2:100 of the Dutch Civil Code.

 

12. Right of usufruct and right of pledge on Shares

 

12.1 A right of usufruct may be created on Shares. The voting rights on the Shares encumbered with a right of usufruct shall accrue to the Shareholder. In derogation of the preceding sentence, the voting rights shall accrue to the Usufructuary if so provided at the time of the creation of the right of usufruct.

 

12.2 A right of pledge may be created on Shares. The voting rights on the Shares encumbered with a right of pledge shall accrue to the Shareholder. In derogation of the preceding sentence, the voting rights shall accrue to the Pledgee if so provided at the time of the creation of the right of pledge.

 

13. Depositary receipts for Shares

 

The Company shall be authorised to cooperate in the issue of depositary receipts for Shares.

 

14. Shareholders register

 

14.1 A register shall be kept by or on behalf of the Company in which the names and addresses of all Shareholders, Usufructuaries and Pledgees shall be recorded, stating the information that must be recorded pursuant to section 2:85 of the Dutch Civil Code and such further information as the Board of Directors may consider appropriate. Part of the register may be kept outside the Netherlands to comply with applicable law and stock exchange rules.

 

14.2 The register shall be updated regularly.

 

15. Joint holding

 

15.1 If one or more Shares or depositary receipts for Shares issued with the Company’s cooperation are jointly held by two or more persons or if a right of usufruct or a right of pledge on one or more Shares is jointly held by two or more persons, the joint holders may only be represented vis-à-vis the Company by a person who has been designated by them in writing for that purpose.

 

15.2 The Board of Directors may, whether or not subject to certain conditions, grant an exemption from Article 15.1.

 

16. Form of transfer of Shares

 

16.1 Except as otherwise provided or permitted by applicable law, the transfer of Shares or of a right of usufruct on Shares, or the creation or release of a right of usufruct or a right of pledge on Shares, shall require an instrument intended for that purpose and, unless the Company is a party to the legal act, the written acknowledgement by the Company of such transfer. The acknowledgement shall be made in the instrument or by a dated statement of acknowledgement on the instrument or on a copy or extract thereof signed as a true copy by the transferor. Service of such instrument, true copy or extract upon the Company shall be deemed to have the same effect as an acknowledgement.

 

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Draft of 4 October 2021

 

16.2 A right of pledge may also be created without acknowledgement by or service upon the Company. In such case section 3:239 of the Dutch Civil Code shall apply by analogy, whereby acknowledgement by or service upon the Company shall substitute the notice referred to in section 3:239 subsection 3 of the Dutch Civil Code.

 

16.3 For so long as one or more Shares are listed on the Nasdaq Stock Market or any other regulated stock exchange operating in the United States of America, the laws of the State of New York, United States of America, shall apply to the property law aspects of the Shares included in the part of the register of shareholders kept by the relevant transfer agent, without prejudice to sections 10:140 and 10:141 of the Dutch Civil Code. Articles 16.1 and 16.2 shall not apply to such Shares.

 

17. Board of Directors

 

17.1 The Board of Directors shall consist of such number of Executive Directors and such number of Non-Executive Directors as the Board of Directors may determine.

 

17.2 Directors must be natural persons.

 

18. Appointment, suspension and dismissal of Directors

 

18.1 Directors shall be appointed by the General Meeting on the basis of one or more binding nominations of the Board of Directors or one or more Shareholders who individually or jointly represent at least twenty percent (20%) of the issued share capital of the Company.

 

18.2 The Board of Directors shall announce in due time when, for what reasons and according to which profile a vacancy is to be filled.

 

18.3 A nomination shall specify the vacancy for which the nomination is made, the candidate’s age and profession, the number of Shares held by him or her and the positions he or she holds or held insofar as relevant to the fulfilment of the duties as a Director. Furthermore, mention shall be made of the legal persons for which he or she serves as a director whereby, provided that if legal persons are included which belong to the same Group, it shall be sufficient to mention such Group. The nomination for appointment or reappointment shall include the reasons. In case of reappointment, account shall be taken of the manner in which the candidate has fulfilled his or her duties as a Director. A nomination shall comprise only one candidate.

 

18.4 A nomination made by one or more Shareholders who individually or jointly represent at least twenty percent (20%) of the issued share capital of the Company shall only be binding if such Shareholder or Shareholders has or have given notice thereof to the Company in writing no later than on the sixtieth day prior to the date of the General Meeting at which the appointment is to be discussed.

 

18.5 The General Meeting may at all times overrule the binding nature of a nomination by a resolution adopted by a majority of at least two thirds of the votes cast, representing more than half of the issued share capital.

 

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Draft of 4 October 2021

 

18.6 If there is only one nomination, a resolution on the nomination will result in the candidate having been appointed, unless the binding nature of the nomination is overruled.

 

18.7 If there is more than one nomination, the candidate who obtained the highest number of votes shall be appointed, unless the binding nature of all nominations is overruled.

 

18.8 If none of the candidates has been appointed, the Board of Directors or one or more Shareholders who individually or jointly represent at least twenty percent (20%) of the issued share capital of the Company may make a new binding nomination for the next General Meeting, unless the Board of Directors resolves to reduce the number of Directors as a result of which the vacancy ceases to exist.

 

18.9 The notice for a General Meeting at which the appointment is to be discussed shall include the nomination.

 

18.10 The General Meeting may at any time suspend or dismiss a Director. The General Meeting may only adopt a resolution to suspend or dismiss a Director by a majority of at least two thirds of the votes cast, representing more than half of the issued share capital, unless the resolution is adopted on the proposal of the Board of Directors. The Board of Directors shall be authorised to suspend an Executive Director at any time.

 

18.11 If the General Meeting has suspended a Director or the Board of Directors has suspended an Executive Director, the General Meeting shall within three months after the suspension has taken effect resolve either to dismiss such Director or to terminate the suspension, failing which the suspension will lapse.

 

19. Remuneration of Directors

 

19.1 The Company shall have a policy regarding remuneration of the Board of Directors. The policy shall be adopted by the General Meeting on the proposal of the Board of Directors. The remuneration policy shall at least include the matters described in sections 2:383c up to and including 2:383e of the Dutch Civil Code, to the extent they apply to the Board of Directors.

 

19.2 The remuneration of Directors shall be determined by the Board of Directors with due observance of the policy referred to in Article 19.1.

 

19.3 The Board of Directors shall submit proposals concerning arrangements for issuing Shares or granting rights to subscribe for Shares in accordance with the policy referred to in Article 19.1 to the General Meeting for approval. The proposal shall at least include the information required pursuant to section 2:135 subsection 5 of the Dutch Civil Code.

 

20. Duties, division of duties and decision-making by the Board of Directors

 

20.1 Subject to the limitations provided in these Articles of Association, the Board of Directors shall be charged with the management of the Company. The management of the Company includes in any event determining the policy and the strategy of the Company. In fulfilling their duties the Directors shall serve the interest of the Company and the business connected with it.

 

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20.2 Without prejudice to the duties and powers of the Board of Directors, the Executive Directors shall be charged with the day-to-day management of the Company.

 

20.3 Supervision of the fulfilment of duties by the Executive Directors and of the general course of the Company’s affairs and the business connected with it shall be primarily carried out by the Non-Executive Directors. The Executive Directors shall in due time provide the Non-Executive Directors with the information needed to carry out their duties.

 

20.4 The Board of Directors may adopt rules with respect to the matters concerning the Board of Directors.

 

20.5 The Board of Directors may, whether or not by rule, determine the duties with which each Director will be particularly charged.

 

20.6 The Non-Executive Directors shall appoint from among their number a chairman.

 

20.7 The Board of Directors shall grant to an Executive Director the title of Chief Executive Officer.

 

20.8 The Board of Directors shall meet whenever a Director considers appropriate.

 

20.9 An Executive Director may only be represented at a meeting by another Director authorised in writing and a Non-Executive Director may only be represented at a meeting by another Non-Executive Director authorised in writing. The requirement of written form for the authorisation shall be met if the authorisation has been recorded electronically.

 

20.10 Each Director may participate in a meeting by electronic means of communication, provided that all Directors participating in the meeting can hear each other simultaneously.

 

20.11 Each Director shall have one vote. All resolutions of the Board of Directors shall be adopted by an absolute majority of votes cast at a meeting at which more than half of the Non-Executive Directors entitled to vote are present or represented. In the event of a tie vote, the proposal shall have been rejected.

 

20.12 A Director shall not participate in the discussion and the decision-making process of the Board of Directors with regard to a matter in which he has a direct or indirect personal interest that conflicts with the interest of the Company and the business connected with it. Where, as a consequence, the Board of Directors could not adopt a resolution, the Director shall, however, continue to be authorised to participate in the discussion and decision-making process and the resolution shall be adopted by the Board of Directors as if none of the Directors has a direct or indirect personal interest that conflicts with the interest of the Company and the business connected with it.

 

20.13 The Executive Directors shall not participate in the discussion and the decision-making process with regard to the determination of the remuneration of Executive Directors, or the giving of an assignment to an Auditor to audit the Annual Accounts, if the General Meeting has failed to give the assignment.

 

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20.14 A written statement of the chairman of the meeting of the Board of Directors that the Board of Directors has adopted a resolution shall constitute proof of such resolution vis-à-vis third parties.

 

20.15 The Board of Directors may adopt resolutions without holding a meeting, provided that all Directors entitled to vote have consented to this manner of adopting resolutions and the votes are cast in writing or by electronic means. Articles 20.11 up to and including 20.13 shall apply by analogy to the adoption of resolutions by the Board of Directors without holding a meeting.

 

20.16 The Executive Directors may validly adopt resolutions with regard to matters falling within the scope of the day-to-day management of the Company. Articles 20.8 up to and including 20.12, 20.14 and 20.15 shall apply by analogy to the adoption of resolutions by the Executive Directors. The Executive Directors shall as soon as possible notify the Non-Executive Directors of the adopted resolutions.

 

20.17 The Non-Executive Directors may validly adopt resolutions with regard to matters falling within the scope of their duties and powers. Articles 20.8 up to and including 20.12, 20.14 and 20.15 shall apply by analogy apply by analogy to the adoption of resolutions by the Non-Executive Directors. The Non-Executive Directors shall as soon as possible notify the Executive Directors of the adopted resolutions.

 

20.18 The Board of Directors may appoint, whether or not from among its number, such committees as it may reasonably deem necessary to the fulfilment of its duties. The Board of Directors shall determine the composition, duties, powers and working procedures of the committees.

 

21. Approval of resolutions of the Board of Directors

 

21.1 Resolutions of the Board of Directors with regard to an important change in the identity or character of the Company or the business connected with it are subject to the approval of the General Meeting, including in any case:

 

(a) transfer of the business or almost the entire business to a third party;

 

(b) entry into or termination of a long-term cooperation by the Company or any of its Subsidiaries with another legal person or partnership or as a fully liable partner in a limited or general partnership, if such cooperation or termination thereof is of far-reaching significance to the Company;

 

(c) acquisition or disposal by the Company or any of its Subsidiaries of a participating interest in the capital of a company with a value of at least one-third of the amount of the assets as shown in the balance sheet with explanatory notes or, if the Company prepares a consolidated balance sheet, as shown in the consolidated balance sheet with explanatory notes, according to the most recently adopted Annual Accounts of the Company.

 

21.2 The absence of the approval of the General Meeting of a resolution as referred to in Article 21.1 shall not affect the power of the Board of Directors or Directors to represent the Company.

 

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22. Representation

 

22.1 The Board of Directors shall have the power to represent the Company. The power to represent the Company shall, in addition to the power of the Board of Directors, only be vested in:

 

(a) the Chief Executive Officer individually; and

 

(b) two Executive Directors jointly.

 

22.2 The Board of Directors may grant to one or more persons general or restricted power to represent the Company on a continuing basis. The Board of Directors may also grant a title to such persons.

 

23. Failing or prevention from acting of Directors

 

23.1 In the event that an Executive Director is failing or prevented from acting, the duties and powers of that Executive Director shall temporarily be exercised by the remaining Executive Directors or the only remaining Executive Director, unless the Non-Executive Directors designate or have designated one or more persons for that purpose. In the event that all Executive Directors are or the only Executive Director is failing or prevented from acting, the duties and powers of the Executive Directors, or the only Executive Director, shall temporarily be exercised by one or more persons to be designated or designated for that purpose by the General Meeting.

 

23.2 In the event that a Non-Executive Director is failing or prevented from acting, the duties and powers of that Non-Executive Director shall temporarily be exercised by the remaining Non-Executive Directors or the only remaining Non-Executive Director, unless the General Meeting designates or has designated one or more persons for that purpose. In the event that all Non-Executive Directors are failing or prevented from acting, the duties and powers of the Non-Executive Directors shall temporarily be exercised by one or more persons to be designated or designated for that purpose by the General Meeting.

 

23.3 In the event that all Directors are failing or prevented from acting, the duties and powers of the Directors shall temporarily be exercised by one or more persons to be designated or designated for that purpose by the General Meeting.

 

23.4 A Director shall be deemed to be prevented from acting if he has been suspended, if he is temporarily unable to exercise his duties and powers as a consequence of illness, leave or any other cause or if he is inaccessible during at least five consecutive days, or such other period as the General Meeting may determine. Furthermore, a Director shall be deemed to be prevented from acting if he has notified the Company in writing that he is prevented from acting for a specified period, stating the reason. The requirement of written form for the notification shall be met if the notification has been recorded electronically.

 

24. Indemnification

 

24.1 To the fullest extent permitted by Dutch law, the following shall be reimbursed to the Indemnified Persons:

 

(a) the costs of conducting a defence against claims, also including claims by the Company and its Group Companies, as a consequence of any acts or omissions in the fulfilment of their duties or any other duties currently or previously performed by them at the Company’s request;

 

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(b) any damages or financial penalties payable by them as a result of any such acts or omissions;

 

(c) any amounts payable by them under settlement agreements entered into by them in connection with any such acts or omissions;

 

(d) the costs of appearing in other legal proceedings in which they are involved as Directors or former Directors, with the exception of proceedings primarily aimed at pursuing a claim on their own behalf;

 

(e) any taxes payable by them as a result of any reimbursements in accordance with this Article 24.1.

 

24.2 An Indemnified Person shall not be entitled to reimbursement as referred to in Article 24.1 if and to the extent that:

 

(a) it has been adjudicated by a Dutch court or, in the case of arbitration, an arbitrator, in a final and conclusive decision that the act or omission of the Indemnified Person may be characterised as intentional, deliberately reckless or grossly negligent conduct, unless Dutch law provides otherwise or this would, in view of the circumstances of the case, be unacceptable according to standards of reasonableness and fairness; or

 

(b) the costs or financial loss of the Indemnified Person are covered by an insurance and the insurer has paid out the costs or financial loss.

 

24.3 If and to the extent that it has been adjudicated by a Dutch court or, in the case of arbitration, an arbitrator, in a final and conclusive decision that the act or omission of the Indemnified Person may be characterised as intentional, deliberately reckless or grossly negligent conduct or that the Indemnified Person is otherwise not entitled to reimbursement as referred to in Article 24.1, he or she shall immediately repay the amount reimbursed by the Company. The Company may request that the Indemnified Person provides appropriate security for his repayment obligation. The Company may take out liability insurance for the benefit of Directors and former Directors.

 

24.4 The Company may, by agreement or otherwise, give further implementation to Articles 24.1 up to and including 24.3.

 

24.5 Where this Article 24 would limit any contractual entitlement of any Indemnified Persons to indemnification or reimbursement, such contractual entitlement shall prevail.

 

24.6 Amendment of this Article 24 may not prejudice the entitlement of any Indemnified Persons to reimbursement as referred to in Article 24.1 as a result of acts or omissions in the period during which that article was in force.

 

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25. General Meetings

 

25.1 Annually, within six months of the end of the financial year, a General Meeting shall be held. The notice for this meeting shall in any case mention the following matters:

 

(a) the consideration of the Annual Accounts, the Management Report and the information, referred to in section 2:392 subsection 1 of the Dutch Civil Code, insofar as that subsection applies to the Company; and

 

(b) the adoption of the Annual Accounts.

 

These items need not be mentioned in the notice of meeting if the period for preparing the Annual Accounts and for presenting the Management Report has been extended by the General Meeting or if the notice of meeting mentions a proposal to that effect.

 

25.2 The Board of Directors shall be authorised to convene a General Meeting.

 

25.3 A General Meeting shall be convened whenever the Board of Directors considers appropriate, without prejudice to sections 2:110 up to including 2:112 of the Dutch Civil Code.

 

26. Venue, notice and agenda of the General Meetings

 

26.1 General Meetings shall be held in the Netherlands, in Amsterdam, Rotterdam, The Hague, Arnhem, Utrecht or Haarlemmermeer (Schiphol Airport).

 

26.2 Notice of a General Meeting shall be given by the Board of Directors or a Director.

 

26.3 Notice of a General Meeting shall be given by means of an announcement made by electronic means of communication which is directly and permanently accessible until the General Meeting and with due observance of applicable law and stock exchange rules.

 

26.4 The notice of a General Meeting shall mention:

 

(a) the matters to be discussed;

 

(b) the place and time of the meeting;

 

(c) the procedure for attending the meeting by a proxy authorised in writing; and

 

(d) the procedure for attending the meeting and the exercise of the voting rights by any means of electronic communication in the event such right can be exercised in accordance with Article 29.3.

 

26.5 Notifications which pursuant to the law or these Articles of Association are to be addressed to the General Meeting may be included in the notice of meeting and, where applicable, in a document that has been made available at the offices of the Company for inspection, provided that this is mentioned in the notice.

 

26.6 A matter of which discussion has been requested in writing by one or more Persons with Meeting Rights who are so entitled pursuant to section 2:114a subsection 2 of the Dutch Civil Code shall be mentioned in the notice of meeting or announced in the same manner if the Company has received the request, including the reasons, or a proposal for a resolution no later than on the date specified in section 2:114a subsection 2 of the Dutch Civil Code. The requirement of written form for the request shall be met if the request has been recorded electronically.

 

26.7 Notice shall be given with due observance of the notice period prescribed by applicable law.

 

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27. Chairman and secretary of the General Meeting

 

The General Meeting shall be presided over by the chairman of the Board of Directors, who, nevertheless, may charge another person to preside over the meeting in his or her place even if he or she is present at the meeting. If the chairman of the Board of Directors is absent and he or she has not charged another person to preside over the meeting in his or her place, the Directors present at the meeting shall appoint one of them to be chairman. In the absence of all Directors, the General Meeting shall appoint its chairman. The chairman shall designate the secretary of the General Meeting.

 

28. Minutes and recording of resolutions of the General Meeting

 

28.1 The secretary of the General Meeting shall keep minutes of the proceedings at the meeting, unless a notarial record is prepared. Minutes shall be adopted and in evidence of such adoption be signed by the chairman and the secretary of the meeting.

 

28.2 The chairman of the General Meeting and each Director may at any time give instructions that a notarial record of the proceedings at the meeting be prepared at the expense of the Company.

 

28.3 If the Board of Directors was not represented at the meeting, the chairman of the General Meeting shall as soon as possible notify the chairman of the Board of Directors of the adopted resolutions.

 

28.4 The Board of Directors shall keep a record of the adopted resolutions. The records shall be available at the offices of the Company for inspection by the Persons with Meeting Rights. Upon request, each of them shall be provided with a copy or extract of such records at no more than cost.

 

29. Rights at the General Meeting

 

29.1 Only Shareholders, Usufructuaries and Pledgees who are entitled to the voting rights and holders of depositary receipts for Shares issued with the cooperation of the Company have Meeting Rights.

 

29.2 Each Person with Meeting Rights shall be authorised to attend the General Meeting, to address the General Meeting and to exercise the voting rights he or she is entitled to in person or by a proxy authorised in writing.

 

29.3 The Board of Directors may determine that each Person with Meeting Rights will be authorised, in person or by a proxy authorised in writing, to attend the General Meeting, to address the General Meeting and to exercise the voting rights by electronic means of communication. For the purpose of the preceding sentence, the Person with Meeting Rights must be identifiable through the electronic means of communication and be able to directly observe the proceedings at the meeting and to exercise the voting rights. The Board of Directors may set conditions for the use of the electronic means of communication, provided that such conditions are reasonable and necessary for the identification of the Person with Meeting Rights and the reliability and safety of the communication. If such conditions are set, they shall be mentioned in the notice of the meeting.

 

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29.4 For the purpose of Articles 29.1 and 29.3 the requirement of written form for the authorisation shall be met if the authorisation has been recorded electronically.

 

29.5 For the purpose of Articles 29.1 and 29.3 the persons who on a record date to be set by the Board of Directors with due observance of section 2:119 subsection 2 of the Dutch Civil Code have the right to vote or attend the General Meeting and are registered as such in a register designated by the Board of Directors shall be deemed to have such rights and therefore be deemed to be Persons with Meeting Rights, irrespective of whom are entitled to the Shares at the time of the meeting. The notice of meeting shall mention the record date as well as the manner in which the persons entitled to vote and attend the General Meeting can register and the manner in which they can exercise their rights.

 

29.6 A Person with Meeting Rights who on the record date referred to in Article 29.5 has the right to vote or attend the General Meeting, or a proxy authorised in writing, will only be admitted to the meeting if the Person with Meeting Rights has informed the Board of Directors of his or her intention to attend the meeting and, if applicable, of the authorisation prior to the date to be set by the Board of Directors. Such date may not be set earlier than on the eighth day prior to the date of the meeting. The notice of meeting shall mention the date referred to in the preceding sentence. The Company shall offer the Person with Meeting Rights the possibility to inform the Company by electronic means of the authorisation.

 

29.7 Each person present at the General Meeting who is entitled to vote must sign the attendance list, stating his or her name and the number of votes he or she may cast. The chairman of the meeting may determine that the attendance list must also be signed by other persons present at the meeting.

 

29.8 The Board of Directors may determine that votes which are cast prior to the General Meeting by electronic means of communication or by letter shall be put on par with votes which are cast at the time of the meeting. These votes shall not be cast earlier than on the record date set by the Board of Directors with due observance of section 2:117b subsection 3 of the Dutch Civil Code. For the purposes of the two preceding sentences, the persons who have the right to vote or attend the meeting and are registered as such in a register designated by the Board of Directors as of the record date set by the Board of Directors shall be deemed to have such rights for purposes of the General Meeting and therefore be deemed to be Persons with Meeting Rights, irrespective of whoever is entitled to the Shares at the time of the General Meeting. The notice of meeting shall mention the record date as well as the manner in which the persons entitled to vote and attend the General Meeting can register and the manner in which they can exercise their rights.

 

29.9 The Directors shall as such have an advisory vote at the General Meeting.

 

29.10 The chairman of the General Meeting shall decide on the admittance of other persons to the meeting.

 

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30. Order of the General Meeting

 

30.1 The chairman of the General Meeting shall determine the order of the meeting.

 

30.2 The chairman of the General Meeting may limit the time any person present at the meeting may address the meeting and may take any other measures as to ensure orderly proceedings at the meeting.

 

31. Adoption of resolutions at the General Meeting

 

31.1 Each Share confers the right to cast one vote. Blank votes and invalid votes shall be regarded as not having been cast.

 

31.2 Unless the law or these Articles of Association require a larger majority, resolutions of the General Meeting shall be adopted by an absolute majority of votes cast.

 

31.3 The chairman of the General Meeting shall determine the manner of voting.

 

31.4 The chairman’s decision at the General Meeting on the result of a vote shall be conclusive. The same shall apply to the contents of an adopted resolution, to the extent that the vote related to a proposal not made in writing. If immediately after the chairman’s decision its correctness is contested, there shall be a new free vote if the majority of the meeting or, if the original vote was not taken on a poll or by a ballot, any person present who is entitled to vote so requires. Such new vote shall overrule the legal consequences of the original vote.

 

31.5 A written statement of the chairman of the General Meeting that the General Meeting has adopted a resolution shall constitute proof of such resolution vis-à-vis third parties.

 

31.6 In the General Meeting no votes may be cast in respect of a Share held by the Company or a Subsidiary of the Company; no votes may be cast in respect of a Share the depositary receipt for which is held by the Company or a Subsidiary of the Company. However, the holders of a right of usufruct and holders of a right of pledge on Shares held by the Company and its Subsidiaries are not excluded from their right to vote, if the right of usufruct or the right of pledge was created prior to the time such Share was held by the Company or a Subsidiary of the Company. Neither the Company nor a Subsidiary of the Company may cast votes in respect of a Share on which it holds a right of usufruct or a right of pledge.

 

31.7 When determining to what extent the Persons with Meeting Rights entitled to vote cast votes, are present or represented, or to what extent the share capital is represented, no account shall be taken of Shares for which no vote may be cast pursuant the law or these Articles of Association.

 

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32. Meetings of holders of Shares of a particular class

 

32.1 The Board of Directors shall be authorised to convene a meeting of holders of Shares of a particular class.

 

32.2 A meeting of holders of Shares of a particular class shall be convened whenever pursuant to the law or these Articles of Association a resolution of the meeting of holders of Shares of the relevant class is required and furthermore whenever the Board of Directors considers appropriate.

 

32.3 Articles 26 up to and including 31 shall apply by analogy to meetings of holders of Shares of a particular class, provided, however, that:

 

(a) notice shall be given no later than on the sixth day prior to the date of the meeting; and

 

(b) on the proposal of the Board of Directors, holders of Shares of a particular class may adopt resolutions without holding a meeting, provided that they are adopted by unanimous vote of the holders of Shares of the particular class entitled to vote and that the votes are cast in writing or by electronic means; the holders of Shares of the particular class involved shall as soon as possible notify the chairman of the Board of Directors of the adopted resolutions; Article 29.4 shall apply by analogy to these resolutions.

 

33. Financial year

 

The Company’s financial year shall coincide with the calendar year.

 

34. Annual Accounts and Management Report

 

34.1 Annually, within the period prescribed by applicable law and stock exchange rules, the Board of Directors shall prepare Annual Accounts and shall make these available at the offices of the Company for inspection by the Persons with Meeting Rights. The Board of Directors shall also make the Management Report available at the offices of the Company for inspection by the Persons with Meeting Rights within said period. The Board of Directors shall add to the Annual Accounts and the Management Report the information, referred to in section 2:392 subsection 1 of the Dutch Civil Code, insofar as that subsection applies to the Company.

 

34.2 The Annual Accounts shall be signed by all Directors; if the signature of one or more of them is lacking, this shall be disclosed, stating the reasons thereof.

 

34.3 The Company shall ensure that the Annual Accounts as prepared, the Management Report and the additional information to be added pursuant to section 2:392 subsection 1 of the Dutch Civil Code shall be available at the offices of the Company as of the date of the notice of the General Meeting at which they are to be discussed. The Persons with Meeting Rights may inspect the documents at the offices of the Company and obtain a copy thereof at no cost.

 

34.4 The Annual Accounts shall be adopted by the General Meeting. Adoption of the Annual Accounts shall not be deemed to grant a Director a discharge.

 

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35. Auditor

 

35.1 The Company shall give an assignment to an Auditor to audit the Annual Accounts.

 

35.2 The General Meeting shall be authorised to give the assignment. If the General Meeting fails to do so, the Board of Directors shall be so authorised. The assignment may be revoked by the General Meeting and, if the Board of Directors has given the assignment, by the Board of Directors. The assignment may only be revoked on serious grounds with due observance of section 2:393 subsection 2 of the Dutch Civil Code.

 

35.3 The Auditor shall report on his, her or its audit to the Board of Directors and shall issue a certificate containing its results.

 

36. Share premium reserves

 

36.1 The Company shall maintain separate share premium reserves for the benefit of the holders of each series of Preferred Shares. Payments on Preferred Shares of a particular series in excess of the nominal value shall be added to the share premium reserve maintained by the Company for the benefit of the holders of the series of Preferred Shares concerned.

 

36.2 Article 36.1 shall apply by analogy to any disposal by the Company of Preferred Shares, or of depositary receipts thereof, provided that in such case the nominal value of the Preferred Shares of the series concerned, or of the Preferred Shares of the series concerned for which the depositary receipts have been issued, also shall be added to the relevant share premium reserve.

 

37. Profit and loss

 

37.1 The General Meeting shall be authorised to allocate the profits, subject to Articles 37.2 and 37.3.

 

37.2 Out of the profits made in any financial year, first of all, to the extent possible, the following distributions shall be made:

 

(a) to the holders of Preferred Shares, an amount equal to the average during the financial year concerned of the twelve month Euro Interbank Offered Rate (Euribor), as set by the European Central Bank, weighted by the number of days on which such interest rate was applicable, increased by a margin not exceeding five hundred basis points, to be set by the Board of Directors upon the issue of the relevant Preferred Shares, calculated on the weighted average during that financial year of the aggregate amount paid up and called up on their Preferred Shares; therefore, any increases and reductions of the amounts paid up and called up on their Preferred Shares during that financial year shall be taken into account for the purpose of calculating each distribution; the days during which the Preferred Shares were held by the Company shall be disregarded; and

 

(b) if Preferred Shares were cancelled during the preceding financial year, to the last former holders of those Preferred Shares, an amount equal to the amount of the distribution referred to in Article 11.5 under (b), reduced by the amount of the distribution already received by them pursuant to that provision.

 

If in any financial year the profits are insufficient to make such distributions, the deficit shall, to the extent possible, be distributed out of the Distributable Reserves determined by the Board of Directors. If the profits made in any financial year or the Distributable Reserves are insufficient to make such distributions, the deficit shall be distributed out of the profits made and the Distributable Reserves maintained in the following financial years and the preceding sentence of this Article 37.2 and Article 37.3 shall first apply after the deficit has been fully made up. Other than as set out in this Article 37.2, the Preferred Shares shall not participate in the profits and the reserves of the Company, except that the holders of a series of Preferred Shares shall participate in the share premium reserve maintained by the Company for the benefit of the holders of the relevant series of Preferred Shares.

 

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37.3 The Board of Directors shall be authorised to determine that the profits remaining after application of Article 37.3 shall in whole or in part be reserved.

 

37.4 The General Meeting shall be authorised to allocate the profits remaining after application of Article 37.3.

 

37.5 The Board of Directors shall be authorised to determine how a loss will be accounted for.

 

37.6 A deficit may only be applied against reserves maintained pursuant to the law to the extent permitted by law.

 

38. Distributions

 

38.1 The General Meeting shall be authorised to declare distributions, subject to Articles 38.2 up to and including 38.4.

 

38.2 The General Meeting may only resolve to declare distributions on the proposal of the Board of Directors.

 

38.3 The Company may only make distributions to the Shareholders and other persons entitled to distributable profits to the extent that its equity exceeds the aggregate amount of the issued share capital and the reserves which must be maintained pursuant to applicable law.

 

38.4 Any distribution of profits shall be made only following the adoption of the Annual Accounts by the General Meeting that show such distribution is permitted in accordance with Article 38.3.

 

38.5 The Board of Directors may resolve to may make interim distributions, provided that the requirement of Article 38.3 has been met as evidenced by an interim financial statement as referred to in section 2:105 subsection 4 of the Dutch Civil Code.

 

38.6 Shares held by the Company shall not be taken into account for the purpose of calculating each distribution, unless such Shares are encumbered with a right of usufruct or a right of pledge.

 

38.7 Distributions on Shares of a particular class shall be made proportionally on all Shares of the particular class concerned, subject to Article 38.6. Distributions to the last former holders of Preferred Shares that have been cancelled shall be made in proportion to the aggregate amount of the Preferred Shares held by them immediately before the cancellation.

 

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38.8 Distributions shall be due and payable four weeks after they have been declared, unless the General Meeting determines another date on the proposal of the Board of Directors.

 

38.9 Distributions which have not been collected within five years of the start of the day after the day on which they became due and payable shall revert to the Company.

 

38.10 The General Meeting may determine that distributions shall be made in whole or in part in the form of Shares or in a currency other than the euro, provided on the proposal of the Board of Directors.

 

38.11 The Company shall announce any proposal for a distribution and the date when and the place where the distribution will be payable to all Shareholders by electronic means of communication with due observance of the applicable law and stock exchange rules.

 

39. Amendment of these Articles of Association

 

39.1 The General Meeting shall be authorised to amend these Articles of Association.

 

39.2 The General Meeting may only resolve to amend these Articles of Association on the proposal of the Board of Directors.

 

39.3 If a proposal to amend these Articles of Association is to be made to the General Meeting, such shall always be mentioned in the notice of the General Meeting.

 

40. Dissolution and liquidation

 

40.1 The General Meeting shall be authorised to dissolve the Company.

 

40.2 The General Meeting may only resolve to dissolve the Company on the proposal of the Board of Directors.

 

40.3 Article 39.3 shall apply by analogy to a proposal to dissolve the Company.

 

40.4 If the Company is dissolved pursuant to a resolution of the General Meeting, its assets shall be liquidated by the Executive Directors, under the supervision of the Non-Executive Directors, if and to the extent that the General Meeting shall not resolve otherwise.

 

40.5 The General Meeting shall determine the remuneration of the liquidators and of the persons charged with the supervision of the liquidation.

 

40.6 The liquidation shall take place with due observance of the relevant provisions of Book 2 title 1 of the Dutch Civil Code. During the liquidation period these Articles of Association shall, to the extent possible, remain in full force.

 

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40.7 Out of the balance of the assets of the Company remaining after the creditors have been paid first of all, to the extent possible, the following distributions shall be made:

 

(a) to the holders of Preferred Shares, in proportion to the aggregate amount of their Preferred Shares:

 

(i) the amount paid up on their Preferred Shares;

 

(ii) any deficit, referred to in Article 37.2; and

 

(iii) an amount equal to the amount referred to in Article 37.2 under (a) calculated up to the date on which the Company was dissolved;

 

(b) to the holders of each series of Preferred Shares, in proportion to the aggregate amount of their Preferred Shares, the balance of the share premium reserve maintained by the Company for the benefit of the holders of the relevant series of Preferred Shares;

 

(c) to the last former holders of the Preferred Shares that have been cancelled, in proportion to the aggregate amount of the Preferred Shares held by them immediately before the cancellation:

 

(i) any deficit, referred to in Article 37.2; and

 

(ii) if their Preferred Shares were cancelled in the financial year in which the Company was dissolved, an amount equal to the amount of the distribution referred to in Article 11.5 under (b), reduced by the amount of the distribution already received by them pursuant to that provision.

 

If the surplus is insufficient to make such distributions in full, the surplus shall be distributed to the holders of Preferred Shares and the last former holders of Preferred Shares that have been cancelled in proportion to the aggregate amount to which they would be entitled if the surplus would be sufficient.

 

40.8 The balance remaining after application of Article 40.7 shall be distributed to the holders of Ordinary Shares in proportion to the aggregate amount of their Ordinary Shares.

 

40.9 After the Company has ceased to exist, its books, records and other data carriers shall remain in the custody of the person designated for that purpose by the liquidators for a period of seven years.

 

41. Transitional provision I

The Company’s first financial year ends on the thirty-first day of December two thousand and twenty-one. This Article 41 shall lapse after expiry of the first financial year.

 

24

Draft of 4 October 2021

 

42. Transitional provision II

 

In derogation of Article 4.1, the authorised share capital of the Company amounts to four hundred and eighty-five thousand euros (EUR 485,000.00) and is divided into:

 

(a) forty-three million six hundred and fifty thousand (43,650,000) Ordinary Shares with a nominal value of one eurocent (EUR 0.01) each; and

 

(b) four million eight hundred and fifty (4,850,000) Preferred Shares with a nominal value of one eurocent (EUR 0.01) each, divided into:

 

(i) a series A consisting of nine hundred and seventy thousand (970,000) Preferred Shares;

 

(ii) a series B consisting of nine hundred and seventy thousand (970,000) Preferred Shares;

 

(iii) a series C consisting of nine hundred and seventy thousand (970,000) Preferred Shares;

 

(iv) a series D consisting of nine hundred and seventy thousand (970,000) Preferred Shares; and

 

(v) a series E consisting of nine hundred and seventy thousand (970,000) Preferred Shares.

 

Article 4.1 shall apply as of the date on which the number of issued Ordinary Shares first amounts to or exceeds ten million (10,000,000). As soon as Article 4.1 applies, the Company shall deposit a statement at the offices of the Dutch trade register evidencing that Article 4.1 applies, stating the date as of which that Article applies. This Article 41 shall lapse once Article 4.1 applies.

 

FINAL DECLARATIONS

 

Finally, the person appearing declares:

 

(a) pursuant to the present amendment of articles of association becoming effective each issued share in the share capital of the Company is converted into an ordinary share;

 

(b) by a resolution, adopted on the [●] day of [●] two thousand and twenty-one, the general meeting of the Company authorised the board of directors for a period of five years, commencing on the date on which this deed is executed and consequently ending on the [●] day of [●] two thousand and twenty-six, to resolve to issue shares and to grant rights to subscribe for shares. The resolution of the general meeting granting the authorisation specifies that the authority to resolve to issue shares and to grant rights to subscribe for shares concerns all unissued shares of the authorised share capital as applicable on the date on which this deed is executed or at any time in the future minus any shares that will be issued after that date pursuant to a resolution of the general meeting adopted prior to that date;

 

(c) by a resolution, adopted on the [●] day of [●] two thousand and twenty-one, the general meeting of the Company authorised the board of directors for a period of five years, commencing on the date on which this deed is executed and consequently ending on the [●] day of [●] two thousand and twenty-six, to limit or exclude pre-emption rights in respect of ordinary shares;

 

25

Draft of 4 October 2021

 

(d) by a resolution, adopted on the [●] day of [●] two thousand and twenty-one, the general meeting of the Company authorised the board of directors for a period of eighteen months, commencing on the date on which this deed is executed and consequently ending on the [●] day of [●] two thousand and twenty-two, to acquire ordinary shares in the share capital of the Company or depositary receipts thereof for consideration. The resolution of the general meeting granting the authorisation specifies that the maximum number of ordinary shares permitted pursuant to applicable law and the articles of association from time to time may be acquired and that ordinary shares may be acquired through repurchases negotiated in the open market or privately, in self-tender offers, or through accelerated repurchase arrangements, at prices ranging from the nominal value of the ordinary shares up to one hundred and ten percent (110%) of the market price of the ordinary shares, provided that:

 

(i) for open market or privately negotiated repurchases, the market price shall be the price of the ordinary shares on the Nasdaq Stock Market at the time of the transaction;

 

(ii) for self-tender offers, the market price shall be the volume weighted average price of the ordinary shares on the Nasdaq Stock Market during a period, determined by the board of directors, of no less than one and no more than five consecutive trading days immediately prior to the expiration of the tender offer;

 

(iii) for accelerated repurchase arrangements, the market price shall be the volume weighted average price of the ordinary shares on the Nasdaq Stock Market over the term of the arrangement.

 

The volume weighted average price for any number of trading days shall be calculated as the arithmetic average of the daily volume weighted average price on those trading days;

 

(e) by a resolution, adopted on the [●] day of [●] two thousand and twenty-one, the general meeting of the Company authorised the board of directors for a period of eighteen months, commencing on the date on which this deed is executed and consequently ending on the [●] day of [●] two thousand and twenty-two, to acquire Preferred shares in the share capital of the Company or depositary receipts thereof for consideration. The resolution of the general meeting granting the authorisation specifies that the maximum number of Preferred shares permitted pursuant to applicable law and the articles of association from time to time may be acquired and that Preferred shares may be acquired through repurchases negotiated in the open market or privately, in self-tender offers, or through accelerated repurchase arrangements, at prices ranging from the nominal value of the Preferred shares up to the higher of:

 

(i) the amount that would be paid by the Company upon cancellation of such Preferred shares in accordance with the applicable provisions of the articles of association of the Company; and

 

(ii) one hundred and ten percent (110%) of the market price of the ordinary shares into which the Preferred shares may be converted in accordance with the applicable provisions of the articles of association of the Company, whereby the market price shall be determined in the manner as set out above under ‎(d); and

 

(f) at the time of the present amendment of articles of association becoming effective the issued share capital of the Company amounts to ninety seven thousand one hundred euros (EUR 97,100.00).

 

The certificate of which section 2:72 subsection 1 of the Dutch Civil Code prescribes that it shall be attached to this deed is attached to this deed (annex).

 

The person appearing is known to me, civil law notary.

 

In witness whereof this deed is executed in Amsterdam, the Netherlands, on the date first mentioned in the head of this deed.

 

After having conveyed the contents of this deed and having given an explanation thereto to the person appearing, she declared that she has taken note of the contents of this deed and agrees with the same. Thereupon, immediately after limited reading of this deed, it is signed by the person appearing and by me, civil law notary, at ten hours and forty-five minutes Central European Time.

 

 

26

 

Exhibit 5.1

 

FORM OF LEGAL OPINION
     

PRIVILEGED AND STRICTLY CONFIDENTIAL

Mainz Biomed N.V.

 

 

 

 

Subject to opinion committee approval

 

 

 

CMS Derks Star Busmann N.V.

Atrium | Parnassusweg 737

NL-1077 DG Amsterdam

P.O. Box 94700

NL-1090 GS Amsterdam

 

Bank account (Stichting Derdengelden)

Iban: NL31 RABO 0103 3545 49

Swift/bic: RABONL2U

 

T +31 20 301 63 01

F +31 20 301 63 05

I  cms.law

 

Our ref. /CW/CW

Subject: Mainz Biomed / Legal opinion [●] 2021
       
Dear Sirs,

We have acted as Dutch legal counsel to Mainz Biomed N.V., a public company (naamloze vennootschap) of Amsterdam, the Netherlands (the “Company”) in respect of certain matters of Dutch law in connection with the filing of a registration statement on Form F-1 (the “Registration Statement”) with the United States Securities and Exchange Commission. The Registration Statement covers [●] ordinary shares in the capital of the Company (the “Registration Shares”).

 

For the purpose of this legal opinion, we have examined and relied solely upon the following documents:

 

(a) an electronically received copy of an extract relative to the Company, dated [●] (the “Extract”) from the trade register (handelsregister) of the Dutch Chamber of Commerce (Kamer van Koophandel) (the “Trade Register”);

 

(b) an official copy of the notarial deed of incorporation (akte van oprichting) of Mainz Biomed B.V., dated 8 March 2021 (the “Deed of Incorporation”), containing the articles of association of the Company before the execution of the Deed of Conversion (the “B.V. Articles of Association”)

 

 

All services are rendered under an agreement of instruction with CMS Derks Star Busmann N.V., with registered office in Amsterdam, the Netherlands. This agreement is subject to the General Conditions of CMS Derks Star Busmann N.V., which have been filed with the registrar of the District Court Amsterdam, the Netherlands, under no. 84/2020 and which contain a limitation of liability. These terms have been published on the website cms.law and will be provided upon request. CMS Derks Star Busmann N.V. is a company with limited liability under the laws of the Netherlands and is registered in the Netherlands with the trade register under no. 30201194 and in Belgium with the RPR Brussels under no. 0877.478.727. The VAT number of CMS Derks Star Busmann N.V. for the Netherlands is NL8140.16.479.B01 and for Belgium BE 0877.478.727.
 
CMS Derks Star Busmann is a member of CMS, the organisation of European law firms. In certain circumstances, CMS is used as a brand or business name of, or to refer to, some or all of the member firms or their offices. Further information can be found at www.cms.law.
 
CMS offices and associated offices: Aberdeen, Algiers, Amsterdam, Antwerp, Barcelona, Beijing, Belgrade, Berlin, Bogotá, Bratislava, Bristol, Brussels, Bucharest, Budapest, Casablanca, Cologne, Dubai, Duesseldorf, Edinburgh, Frankfurt, Funchal, Geneva, Glasgow, Hamburg, Hong Kong, Istanbul, Johannesburg, Kyiv, Leipzig, Lima, Lisbon, Ljubljana, London, Luanda, Luxembourg, Lyon, Madrid, Manchester, Mexico City, Milan, Mombasa, Monaco, Moscow, Munich, Muscat, Nairobi, Paris, Podgorica, Poznan, Prague, Reading, Rio de Janeiro, Riyadh, Rome, Santiago de Chile, Sarajevo, Seville, Shanghai, Sheffield, Singapore, Skopje, Sofia, Strasbourg, Stuttgart, Tirana, Utrecht, Vienna, Warsaw, Zagreb and Zurich.

 

 

 

 

(c) an official copy of the notarial deed of conversion, dated [●] (the “Deed of Conversion”), containing the current articles of association of the Company (the “N.V. Articles of Association”);

 

(d) an electronically received copy of an underwriting agreement dated [●] 2021 between the Company and the underwriters named in it (the “Underwriting Agreement”);]  

 

(e) [an official copy of the notarial deed of issue of [●] [Registration Shares] to [●], dated [●] (the “Deed of Issue”)]  ;

 

(f) an electronically received copy of a written resolution of the management board (het bestuur) of the Company, dated [●] 2021 (the “Board Resolution”); and

 

(g) an electronically received copy of a written resolution of the general meeting (algemene vergadering) of the Company, dated [●] 2021 (the “Shareholder Resolution”) (the Board Resolution and the Shareholder Resolution shall collectively be referred to as the “Resolutions”).

 

We do not express any opinion in respect of the Underwriting Agreement.

 

In connection with such examination and for the purpose of the legal opinion expressed herein, we have assumed:

 

(i) at the time of the issuances of the Registration Shares, the Company’s authorized capital will be sufficient;

 

(ii) the Registration Shares will be subscribed for, issued and accepted by their subscribers in accordance with all applicable laws (including for the avoidance of doubt, Dutch law);

 

(iii) [the Registration Shares will be validly paid up at the time of the issuances [in accordance with the Underwriting Agreement;]  

 

(iv) [each party other than the Company has validly entered into the Deed of Issue;]

 

(v) [the Registration Shares issued pursuant to the Deed of Issue have been accepted by their subscribers in accordance with all applicable laws (including for the avoidance of doubt, Dutch law); ]

 

(vi) the genuineness of all signatures on all original documents of the persons purported to have signed the same;

 

(vii) the conformity to their originals of all documents submitted or transmitted to us in the form of photocopies, electronically or otherwise, and the authenticity and completeness of such originals;

 

(viii) that the Resolutions and the resolutions reflected therein have been validly signed and will be in full force and effect at the time of the issuance of the Registration Shares and that none of these resolutions have been or will be withdrawn or restated and that no resolutions have been or will be adopted to amend the contents of these resolutions;

 

(ix) that the Deed of Incorporation and the Deed of Conversion are valid notarial deeds (notariële aktes), that the contents thereof are correct and complete, it being hereby confirmed that on the face of the Deed of Incorporation and the Deed of Conversion it does not appear that the Deed of Incorporation and the Deed of Conversion are not valid notarial deeds;

 

Page 2

 

 

(x) that the B.V. Articles of Association were in full force and effect before the execution of the Deed of Conversion and that the N.V. Articles of Association are in full force and effect as at the date hereof, it being hereby confirmed that on the face of the N.V. Articles of Association and the Extract it does not appear that the N.V. Articles of Association are not in full force and effect as at the date hereof;

 

(xi) any and all authorisations and consents of, or other filings with or notifications to, any public authority or other relevant body or person in or of any jurisdiction which may be required (other than under Dutch law) in respect of the issuance of the Registration Shares have been or will be duly obtained or made, as the case may be;

 

(xii) that no petition has been presented to nor order made by a court for the bankruptcy (faillissement) of the Company and that no resolution has been adopted concerning a statutory merger (juridische fusie) or division (splitsing) involving the Company as disappearing entity, or a voluntary liquidation (ontbinding) of the Company;

 

(xiii) that, at the date hereof, the information contained in the Extract truly and correctly reflects the position of the Company as mentioned therein;

 

(xiv) that, at the time of the issuances of the Registration Shares, the Company is not included on the consolidated list of persons, groups and entities subject to EU financial sanctions (the “Sanctions List”);

 

(xv) that, at the date hereof, the directors of the Company are not included on the list of natural persons subject to a director’s disqualification (civielrechtelijk bestuursverbod) under the laws of the Netherlands (the “Disqualification List”); and

 

(xvi) that the Company has not been dissolved (ontbonden), merged (gefuseerd) involving the Company as disappearing entity, demerged (gesplitst), converted (omgezet), granted a suspension of payments (surséance verleend), subjected to emergency regulations (noodregeling) as provided for in the Financial Supervision Act (Wet op het Financieel Toezicht), declared bankrupt (failliet verklaard), subjected to any other insolvency proceedings listed in Annex A or winding up proceedings listed in Annex B of Council Regulation (EC) No 1346/2000 on insolvency proceedings of 29 May 2000, listed on the list referred to in article 2 (3) of Council Regulation (EC) No 2580/2001 of 27 December 2001, listed in Annex I to Council Regulation (EC) No 881/2002 of 27 May 2002 or listed and marked with an asterisk in the Annex to Council Common Position 2001/931 of 27 December 2001 relating to measures to combat terrorism, as amended from time to time, and no trustee (curator), administrator (bewindvoerder) or similar officer has been appointed in respect of the Company or any of its respective assets.

 

In support of the assumptions under (xii), ‎(xiii)‎ and (xiv), we have carried out the following investigations. The office of the bankruptcy registrar of the District Court of Amsterdam has confirmed to us by telephone today at [●] that the Company has not been declared bankrupt (in staat van faillissement) and has not been granted a suspension of payment (surséance van betaling). Furthermore, we have obtained a confirmation through http://www.rechtspraak.nl, derived from the segment for EU registrations of the Central Insolvency Register, that the Company is not registered as being subject to insolvency proceedings. The Trade Register has confirmed to us by telephone today at [●] that the Company has not been dissolved at the initiative of the Dutch Chamber of Commerce and that no resolution to dissolve, merge (juridisch fuseren) or demerge (splitsen) the Company was filed. In the same telephone call, the official of the Trade Register confirmed to us that no amendments in the registration of the Company occurred in the period from the provision of the Extract to us through the date and time hereof. Moreover, in support of the assumption under (xiv), we have carried out an online search today at [●] on https://webgate.ec.europa.eu/europeaid/fsd/fsf showing that the Company is not included on the Sanctions List. We have not investigated any matter that is the subject of an assumption made in this legal opinion other than as set forth herein.

 

Page 3

 

 

We express no opinion as to any law other than the laws of the Netherlands in force at the date hereof as applied and interpreted according to present duly published case law of the Dutch courts. No opinion is rendered with respect to any matters of fact, anti-trust law, market abuse, equal treatment of shareholders, financial assistance, tax law or the laws of the European Communities, to the extent not or not fully implemented in the laws of the Netherlands.

 

In this legal opinion, Dutch legal concepts are expressed in English terms and not in their original Dutch terms. Where indicated in italics, Dutch equivalents of these English terms have been given for the purpose of clarification. The Dutch concepts may not be identical to the concepts described by the same English terms as they exist under the laws of other jurisdictions. Terms and expressions of law and of legal concepts as used in this legal opinion have the meaning attributed to them under the laws of the Netherlands and this legal opinion should be read and understood accordingly.

 

This legal opinion is strictly limited to the matters stated herein and may not be read as extending by implication to any matter not specifically referred to. Nothing in this legal opinion should be taken as expressing an opinion in respect of the factual accuracy of any representations or warranties, or other information, contained in any document, referred to herein or examined in connection with this legal opinion, except as expressly stated otherwise. For the purpose hereof, we have assumed such accuracy.

 

Based upon the foregoing (including, without limitation, the documents and the assumptions set out above) and subject to the qualifications set out below and any facts, circumstances, events or documents not disclosed to us in the course of our examination referred to above, we are, at the date hereof, of the opinion that:

 

[When issued,] the Registration Shares [will] have been validly issued, fully paid and will be non-assessable .

 

The opinion expressed above is subject to the following qualifications:

 

(A) The opinion expressed above may be affected or limited by any applicable bankruptcy, insolvency, fraudulent conveyance (actio pauliana), reorganization, suspension of payment and other or similar laws now or hereafter in effect, relating to or affecting the enforcement or protection of creditors’ rights.

 

(B) A power of attorney (volmacht) or mandate (lastgeving) granted or issued by the Company will terminate by force of law and without any notice being required upon bankruptcy of the Company and will become ineffective upon a suspension of payments (surséance van betaling) being granted to the Company.

 

Page 4

 

 

(C) A court applying the laws of the Netherlands may: (i) at the request of any party to an agreement change the effect of an arrangement or dissolve it in whole or in part in the event of unforeseen circumstances (onvoorziene omstandigheden) of such nature that do not, according the standards of reasonableness and fairness, justify the other party to expect the agreement to be maintained unchanged; (ii) limit any claim for damages or penalties on the basis that such claim is deemed excessive by the court; and (iii) refuse to give effect to any provisions for the payment of expenses in respect of the costs of enforcement (actual or attempted) or unsuccessful litigation brought before such court or tribunal or where such court or tribunal has itself made an order for costs.

 

(D) If a party is controlled by or otherwise connected with a person, organization or country that is currently the subject of sanctions by the United Nations, the European Community or the Netherlands, implemented, effective or sanctioned in the Netherlands under the Sanctions Act 1977 (Sanctiewet 1977), the Economic Offences Act (Wet op de economische delicten) or the Financial Supervision Act (Wet op het Financieel Toezicht) or is otherwise the target of any such sanctions, the obligations of the Company to that party may be unenforceable, void or otherwise affected.

 

(E) The term “non-assessable” has no equivalent legal term under Dutch law and for the purpose of this opinion, “non-assessable” means that a holder of a Registration Share will not by reason of merely being such a holder, be subject to assessment or calls by the Company or its creditors for further payment on such Registration Share.

 

This opinion is rendered to you for the sole purpose of the filing of this opinion as an exhibit to the Registration Statement to be submitted by the Company on the date hereof, to which filing we consent under the express condition that:

 

(i) we do not admit that we are within the category of persons whose consent is required within Section 7 of the Securities Act of 1933;

 

(ii) any issues of interpretation of liability arising under this legal opinion will be governed exclusively by the laws of the Netherlands and be brought exclusively before a Dutch court;

 

(iii) this legal opinion is subject to acceptance of the limitation of liability as mentioned on the first page of this letter;

 

(iv) we do not assume any obligation to notify or to inform you of any developments subsequent to the date hereof that might render its contents untrue or inaccurate in whole or in part at such time; and

 

(v) this legal opinion is strictly limited to the matters set forth herein and no opinion may be inferred or implied beyond our opinion expressly stated herein.

 

Yours faithfully,

     
CMS Derks Star Busmann N.V.    

 

 

Page 5

 

 

Exhibit 10.1 

 

 

 

 

 

 

 

 

LICENSE and DEVELOPMENT AGREEMENT

 

between

 

ColoAlert AS

 

and

 

PharmGenomics GmbH

 

 

 

 

 

 

 

 

License AND DEVELOPMENT agreement

 

This license and development agreement (the ”Agreement”) is entered into the 1st of January, 2019 between:

 

(1) ColoAlert AS, Trimtowers, Postboks 1063 Sandnes, Norway, company registration number 913 028 570 ("CA"), and

 

(2) PharmGenomics GmbH, Robert Koch Strasse 50, 55129 Mainz, Germany, company registration number HRB 41529 ("PGx")

 

in the following referred to individually as "Party" and jointly the "Parties".

 

***

 

1 BACKGROUND

 

CA is a diagnostic company established with the main objective to commercialize a technology related to colorectal cancer detection ("CRC"), as further specified below.

 

CA has obtained an exclusive license for a non-invasive screening test for CRC based detection of blood and genetic markers in stool samples (the "Genefec Test") from the Norwegian company Norda ASA ("Norda"), pursuant to an exclusive license agreement signed 4 December 2017 by Norda and 6 December 2017 by CA respectively (the "Norda Agreement"). The technology and knowhow related to the Genefec Test covered by the Norda Agreement is for the purposes of this Agreement referred to as the "Genefec Technology".

 

PGx is an innovative company specializing in the development and distribution of pharmacogenetic and human genetic diagnostic test for clinical applications. PGx has relevant the governmental accreditation for providing diagnostic service in Germany.

 

Pursuant to the Contract Development Agreement GenoChip Genefec dated 29 August 2013 (now terminated), CA engaged PGx to assist CA in further developing the Genefec Test under the trademark and brand name "ColoAlert Test", and further to get the ColoAlert Test validated.

 

The further development of the ColoAlert Test belonging to CA shall for the purposes of this Agreement be referred to as the "ColoAlert Technology".

 

The ColoAlert Test consists of two kits: (a) "Stool Collection Kit" (for patient use), and (b) a "Laboratory Kit" (for laboratory use).

 

The Parties entered into a Binding Term Sheet for Collaboration and License Agreement dated 2 June 2015 which opened for a launch of the ColoAlert Test as a lab-service provided by PGx.

 

The Parties entered into a Head of Terms dated 6 May 2016 which redefined the agreement to manufacturing and distribution of the Laboratory Kit in Europe and Gulf Cooperation Council states (the "HOT I-agreement").

 

The HOT I-agreement was replaced by the Heads of Terms of Development and a License for Manufacturing and Distribution of the ColoAlert Test Kits dated 31 May 2017 (the "HOT II-agreement").

 

Page 2 of 12

 

PGx wishes to sub-license the ColoAlert Test and the underlying intellectual property and knowhow to third parties on the world market. PGx has, inter alia, been contacted by a Chinese Company that wishes to manufacture, market and sell the ColoAlert Test in China.

 

CA is willing to grant PGx an exclusive license to the ColoAlert Test and the underlying intellectual property and knowhow, including the right to sub-license, on the terms and conditions of this Agreement.

 

The Parties also wishes to continue to co-operate in developing and improving the ColoAlert Technology.

 

The Parties therefore agree as follows:

 

2 definitions

 

Unless otherwise specified in this Agreement, the terms set forth below shall have the following meaning:

 

a) ColoAlertTestpanel: Panel of samples to ensure the uniform operative laboratory performance of the test, to be supplied by PharmGenomics.

 

b) Diagnostic Laboratories: Laboratories authorized to perform genetic analysis.

 

c) Field of Use: Development and manufacturing of diagnostic tests, here under but not limited to cancer screening tests.

 

d) Licensed Kits: The ColoAlert Test as further specified in Appendix A, including the Stool Collection Kit and the Laboratory Kit, developed by CA or its subcontractors.

 

e) Licensed Technology: All intellectual property and knowhow related to the ColoAlert Test, including the ColoAlert Technology and the Genefec Technology, hereunder all historic and future work by CA and PGx work related to CRC diagnostic- and screening- test using a combination of tumour markers and blood detected in stool by use of regular PCR and/or the use of CA and PGx technologies.

 

f) PGx Profit from Licensed Kits: The total revenue from Licensed Kits to Diagnostic Laboratories, Third Parties and Sub-Licensees, including but not limited to revenue from sale, license fees, royalty fees or other contingent payment received thereunder (the "Total Revenue").

 

The Total Revenue shall include revenue from sale of Licensed Kits to PGx' internal use as Diagnostic Laboratory. The internal purchase price for PGx shall be the equal to the ex-works price offered to Diagnostic Laboratories in Germany or in case of no such, the average of the ex-works obtained from Third Parties in Europe.

 

The following costs shall be subtracted from the Total Revenue, provided that the costs are duly documented by PGx, and directly related to Licensed Kits :

 

The Protection Fee (as specified in Clause 6 below).

 

Costs of sales (commission, packaging, travel & transport costs, share of personnel cost directly associated with the sale and sublicensing ColoAlert kits).

 

Page 3 of 12

 

Costs of goods (reagents, consumables, potential licence costs to suppliers etc).

 

Cost of direct production (personnel, manufacturing cost, but not administrative- and overhead- cost).

 

No margins shall be added to cost of goods and cost of direct production. Neither shall PGx' revenue and production cost from the clinical genetic analysis be included. Neither shall there be any deduction in the royalties, license fees or other contingent payment made by Sub-Licensees to PGx with the exception of the Protection Fee, unless otherwise expressly agreed between the Parties in writing.

 

g) Sub-Licensee: Any Diagnostic Laboratories, Third Parties or other companies which have entered into a license agreement with PGx for the manufacturing, marketing and/or sale of the Licensed Kits and/or the Licensed Technology.

 

h) Territory: The world.

 

i) Third Parties: Entities active in distribution and sale of diagnostic/screening tests to private individuals, such as providers of Health Insurance Hospitals, Health Clinics, Pharmacies and General Practitioners.

 

3 subject matter and scope of the license

 

CA hereby grants to PGx an exclusive license to the Licensed Technology in the Field of Use to manufacture and sell Licensed Kits to Diagnostic Laboratories and Third Parties in the Territory and to further develop the Licensed Technology in co-operation with CA.

 

The license shall include the right for PGx to sub-license its rights hereunder to the Licensed Kits to Sub-Licensees on the terms and conditions set forth in this Agreement. In the event of a sub-license PGx shall remain fully liable for all of its obligations under this Agreement.

 

PGx shall actively keep CA informed about negotiations and potential agreements with any Sub-Licensee. Each potential agreement with any Sub-Licensee shall be subject to CA's prior acceptance in writing, which may not be unreasonable withheld.

 

CA will neither itself nor enable other parties to be active in the Territory for the duration of this Agreement.

 

4 further obligations for pgx

 

PGx agrees to use its best efforts to engage in and promote the production and sale of the Licensed Kits in the Territory.

 

PGx acknowledges and agrees that the Licensed Technology and the Licensed Kits contains valuable intellectual property and knowhow which shall be considered CA's trade secrets and protected information, see also Clause 13 below, and that certain information pertaining to the Licensed Technology and Licensed Kits as specified below in Clause 5 shall not be communicated and/or forwarded to Sub-Licensees or any other Third Parties under any circumstances.

 

Page 4 of 12

 

5 agreements with suB-licensees

 

PGx shall have the right to enter into agreements with Sub-Licensees regarding the manufacturing, marketing and sale of the Licensed Kits. PGx shall not grant any Sub-Licensees more extensive or wider rights than conferred to PGx pursuant to this Agreement.

 

Sub-Licensees may be granted the right to manufacture the Licensed Kits subject to CA's written approval, provided that the following procedures shall be complied with:

 

1. All changes test of reagents, consumables, analytical setup (machines) and standard operating procedures ("SOPs") shall be qualified, using the ColoAlert Testpanels. A test report shall be approved in writing by PGx – after consultation with CA – before any changes are used for real patient samples.

 

2. The ColoAlert confidential reagents (the "ColoAlert Mix") shall consist of :

 

a. K-1 (K-ras primer set and probes) and K-2 (Blocker)

 

b. B-1 (B-ras primer set and probes) and B- 2 (Blocker)

 

c. H (Human DNA primer set and probes)

 

 

not be supplied from any other source than PGx:

 

The ColoAlert Mixes and the ColoAlert Testpanel shall be manufactured exclusively by PGx and be sold under the brand name ColoAlert.

 

Sub-Licensees shall be subject to a non-compete clause obligating the Sub-Licensee, any affiliates, legal representatives, directors and employees to refrain from developing, manufacturing and selling tests within the field of CRC-stool for a period of 3 years after the termination of the agreement with PGx.

 

Sub-Licensees shall be subject to confidentiality obligations at least as strict as those imposed on PGx pursuant to this Agreement, including the obligations set forth in Clause 13 below. Sub-Licensees shall ensure that its affiliates, legal representatives, directors and employees are adequately restricted from disclosure of confidential information.

 

PGx and CA shall have the right to inspect the Sub-Licensees facilities related to the production, marketing and sale of the Licensed Kits. PGx and CA shall also have to right to instruct the Sub-Licensees to get the Sub-Licensees production of Licensed Kits in accordance with quality requirements and procedures set forth by PGx and CA. Sub-Licensees shall be obliged to comply with PGx' and CA's instructions. Any Agreements between PGx and Sub-Licensees shall include the obligations put on PGx and the Sub-Licensees pursuant to this Agreement.

 

6 financial terms

 

PGx shall pay to CA (i) the following, as further specified in this Clause:

 

(i) A protection fee (the "Protection Fee"); and

 

(ii) A performance based "Profit split to CA" on a quarterly basis, 15 days after every ended quarter (the "Profit Split")

 

Protection fee: The Protection Fee shall be EUR 3 per sample analysed. The Protection fee shall be calculated from Laboratory Kits sold, meaning EUR 3 multiplied with the number of analysis which can be performed from one Laboratory Kit sold.

 

Page 5 of 12

 

The Profit Split: The Profit Split shall be 50% of PGx Profit from the Licensed Kits.

 

PGx shall at the end of each calendar quarter present a report to CA stating and documenting the amount of Laboratory Kits sold and the PGx Profit from the Licensed Kits.

 

Payment shall be made within 30 days from receipt of invoice, if not otherwise specified in the invoice.

 

Payment shall be made in EUR at the official rate of exchange as of the date of payment.

 

7 books and records

 

PGx shall keep complete and accurate books and records in accordance with established accounting principles in sufficient detail to permit ready computation of the Protection Fee and the Profit Split payments required under this Agreement.

 

The said records shall be open to inspection following a reasonable notice at any time during regular business hours at the office of PGx by an independent chartered accountant of CA’s choice and reasonably acceptable to PGx with written authority of CA, all at the expense of CA.

 

In the event that the agent or representative reports that PGx has underpaid the amounts due to CA by more than 10 (ten) percent, PGx shall bear the cost of such audit.

 

8 infringements

 

8.1 Infringement challenges by third parties

 

PGx shall, at its own discretion, take reasonable steps to prevent and prosecute third party infringement of the ColoAlert Test, and shall be responsible for all costs and expenses related hereto.

 

If either Party have knowledge of or suspect an infringement of any of the ColoAlert Test, that Party shall promptly notify the other Party in writing thereof. CA shall have the right to request information whether and how PGx plans to prosecute the infringing party.

 

In the event PGx fails, or decides not to commence enforcement proceedings against the infringement, CA shall have the right, but not the obligation, to commence enforcement proceedings at its own expense.

 

8.2 Infringement of Third Party Rights

 

PGx shall at its own cost diligently defend any claim of infringement asserted by a third party to flow from PGx' practice of its licensed rights under this Agreement. Without limiting the foregoing, PGx shall retain qualified litigation counsel and shall instruct said counsel to diligently defend. PGx shall keep CA fully informed of all developments of the case.

 

CA shall at all times have the right, at its sole discretion and at its own cost, to participate in the defence, including, but not limited to, participation in all defence strategy discussions, access to all defence documents and materials and all technical evaluation.

 

Page 6 of 12

 

In no event shall PGx be entitled to enter into a settlement with a third party without prior consultation with and approval of CA. CA may only withhold its consent if, in the opinion of CA, the proposed settlement is not based on a bona fide and arms length basis or otherwise is detrimental to the interest of CA.

 

9 warranty

 

CA warrants that it has entered into an exclusive license agreement with Norda related to the Genefec Technology on the terms and conditions set forth in the Norda Agreement as attached in Appendix B.

 

To the best of CA's knowledge the development, manufacture and use of Licensed Technology and Licenced Kits does not infringe intellectual property rights or misappropriate trade secrets of any third party.

 

Each Party warrants and represents that it has the full power, authority and legal right to enter into this Agreement.

 

Each Party warrants and represents that it has valid and sufficient agreements with its employees and any third parties performing work or services on behalf of that Party pursuant to the Agreement to ensure the said employees and third parties are bound by confidentiality requirements at least as restrictive as those in the Agreement.

 

Each Party warrants and represents that it is not, and will not be as long as this Agreement is effective, a party to any other agreement which would prevent the Party from entering into the Agreement.

 

10 indemnities

 

CA undertakes no responsibility for the risks of industrial realisation and commercial exploitation of the Licensed Kits which are or may be manufactured or sold by PGx or its Sub-Licensees, if any.

 

CA shall in no event be liable for any infringement of any patent rights or other intellectual property rights of a third party due to the activities of PGx or its Sub-Licensees. If CA during the term of the Agreement shall be held liable by a court of competent jurisdiction for infringement of any patent rights or other intellectual property rights of a third party following from such activities, or if CA settles allegations of such infringement, PGx shall indemnify CA for any and all costs incurred in the defence against such allegations, damages and other monies payable by reason thereof.

 

PGx shall assume full responsibility for its use of the Licensed Kits and shall defend, indemnify and hold CA harmless from and against all liability, costs, demands, damages, expenses (including attorney's and expert witness fees and expenses) and losses by reason of death, personal injury, illness or property damage, or any other injury or damage arising out of the use by PGx or its Sub-Licensees of the Licensed Kits, including but not limited to, the use or reliance upon such Products by third party customers. CA shall have no product liability.

 

PGx shall indemnify and hold CA harmless for any and all losses incurred by CA due to breach of the confidentiality or non-compete clauses in this Agreement, including breach by its affiliates, legal representatives, directors or employees.

 

In no event shall CA be liable to the other for any special, indirect, exemplary or consequential damages arising out of this Agreement or use of the Licensed Kits.

 

Page 7 of 12

 

11 insurance

 

Each Party shall carry and maintain such minimum insurance coverage as required by local law, and shall each maintain insurance at its own cost necessary to cover liabilities assumed under this Agreement.

 

12 development of the coloaltert technology, intellectual property

 

12.1 Further development – roles and responsibilities

 

Technology Development: The Parties wish to continue co-operating to further develop CA's proprietary owned ColoAlert Technology and the Licensed Kits. The work is to be based on an "open book" were new ideas for improvements of methods, instruments, reagents, analytical protocols, suppliers and test results shall be shared between the Parties. CA and PGx shall use their best efforts to finalize the development of the Licensed Kits, including choice of scientific methods, procedures, chemicals, reagents, sample collection materials, markers, tubes, instruments and analytical markers. CA shall approve final SOPs for external use.

 

CE-IVD approval: PGx shall be responsible for the validation and approval of the Licensed Kits and SOPs used in PGx' lab and for external use. CA shall be listed as holder and owner of any validations and approvals related to the Licensed Kits.

 

Sale and Distribution: CA and PGx shall jointly be responsible for the sale and distribution of the Licensed Kits from PGx to Diagnostic Laboratories and Third Parties in the Territory. The Licensed Kits shall be marketed and sold under the "ColoAlert" trademark and brand name if not otherwise agreed between the Parties in writing.

 

12.2 Costs of development and approvals

 

Each Party shall be responsible for its own cost related to the further development of the ColoAlert Technology and CE-IVD approval (when needed) and cost of sales of the Licensed Kits, unless otherwise agreed in writing between the PartiesCollaboration committee

 

The Parties shall form a collaboration committee with a responsibility to monitor the development of the ColoAlert Technology and the commercialization of said technology on a monthly basis.

 

12.3 Outsourcing

 

In the event that alternative production of the ColoAlert Test with a lower cost base than PGx can be found and utilized, without compromising the intellectual property of CA and PGx, the Parties shall cooperate in the process of outsourcing the manufacturing to such party. This Clause shall only come into use in the case a higher joint profit to the Parties can documented and otherwise no other Clause in this Agreement are affected. Any agreement regarding outsourcing of manufacturing of the ColoAlert Test shall be subject to written approval from CA, which may be withheld at CA's sole discretion.

 

12.4 Intellectual property

 

Title and ownership to any and all existing and future intellectual property and know how related to the ColoAlert Technology shall belong to CA. This includes all patents, trademarks, trade names, know-how, trade secrets, technology and other intellectual property rights related to the ColoAlert Technology (the "Intellectual Property").

 

The Intellectual Property shall include the right to the ColoAlert trademark and brand name.

 

If any of PGx' background intellectual property – meaning intellectual property which have been developed by PGx prior to the start of the collaboration with CA – has been or will be incorporated in the ColoAlert Technology, then CA shall be granted a perpetual, worldwide, royalty-free, non-exclusive license to use the background intellectual property in the further use, marketing, sale and further development of its products and services; including sublicensing. The license shall include the right to make modifications and changes to said background intellectual property.

 

Page 8 of 12

 

12.5 Patent filing and patent maintenance

 

The Parties shall inform each other about any patentable invention relating to the Licensed Technology, and take the necessary precautions to ensure the patentability of said inventions. CA shall be listed as owner and holder of any patents and/or patent applications related to the Licensed Technology.

 

13 confidentiality

 

All information related to the Licensed Technology and Licensed Kits shall be considered confidential information ("Confidential Information"), unless otherwise explicitly agreed between the Parties in writing. PGx agrees that the Confidential Information (a) shall not be used except in connection with the activities contemplated under and during the term of this Agreement, (b) in accordance with the provisions of this Agreement, and (c) shall be maintained in confidence by PGx.

 

The terms and conditions of this Agreement shall be deemed Confidential Information as well.

 

The following information shall not be regarded as Confidential Information:

 

(i) information which was generally known by the general public or other persons within the relevant industries at the time of disclosure other than as a result of a disclosure made in breach of this Agreement.

 

(ii) information which is publicised by a Party pursuant to a regulatory disclosure obligation;

 

(iii) information which the receiving Party acquires on a non-confidential basis from a third party, provided that such source is not prohibited from transmitting the information to the receiving Party by any contractual or other legal obligation.

 

(iv) information which the relevant Party can show has been developed or compiled independently and without the aid, application or use of the Confidential Information. 

 

PGx shall only permit access to Confidential Information to those of its employees having a need to know and who are bound by obligations of confidentiality the same as or substantially similar to those contained within these terms and conditions.

 

14 non-compete

 

PGx, including its affiliates, legal representatives, directors and employees, shall refrain from developing, manufacturing and selling tests within the field of CRC stool-testing for a period of 3 years after the termination of this Agreement.

 

Page 9 of 12

 

15 term and termination

 

This Agreement shall commence upon the signing of this Agreement by the duly authorized representatives of the Parties and shall continue thereafter unless terminated in accordance with this Clause.

 

Either Party shall have the right to terminate this Agreement with immediate effect by notice in writing to the other Party in any of the following events:

 

a) in the event a Party commits a material breach of the terms and conditions in this Agreement and does not cure said breach within a period of 30 days after been requested to do so by the non-defaulting Party; or

 

b) if the other Party enters into liquidation whether compulsory or voluntarily, other than for the purpose of amalgamation or reconstruction, or a petition in bankruptcy is filed by or against either Party in any competent court and the same is not dismissed within 60 days; or

 

c) either Party is adjudicated bankrupt or insolvent.

 

CA shall have the right to terminate this Agreement in the event that the quarterly Profit Split is less than EUR 25,000. PGx shall for a period of 2 years  have the right to maintain the License by paying the shortfall of minimum Profit Split.

 

In the event CA decides to sell ColoAlert assets (intellectual property and know how related to the ColoAlert Test) to a party who has no interest in a continuation of this Agreement, CA shall have the right to terminate this Agreement by giving PGx a 30 days written notice. In such event CA shall pay PGx a compensation equal to 25 % of the net proceeds from such a transaction. PGx shall in case of a legally binding formal bid, within 60 days have a first right of refusal to the transaction on equal terms, whereby the 25 % compensation shall be deducted from the transaction price.

 

The rights and obligations of the Parties intended by their nature to survive termination of the Agreement are including but not limited to Clause 4 ("Further obligations for PGx"), Clause 5 ("Agreements with Sub-Licensees"), Clause 6 ("Financial Terms"), Clause 7 ("Books and Records", Clause 9 ("Warranties "), Clause 10 ("Indemnities"), Clause 11 ("Insurance"), Clause 12.4 ("Intellectual Property"), Clause 13 ("Confidentiality"), Clause 14 ("Non-compete"), Clause 16 ("Assignment"), Clause 17 ("Miscellaneous") and Clause 18 ("Governing law and dispute resolution").

 

Upon termination of this Agreement by any reason whatsoever, the Parties shall disclose all relevant documentation and information relating to the ColoAlert Technology to the other Party.

 

Upon termination of this Agreement by any reason whatsoever, PGx shall immediately cease any use of the trade mark and brand name "ColoAlert" and transfer to CA all rights and title to any "ColoAlert" trademark. PGx shall assist ColoAlert to get any trademark authorities to change the owner of any "ColoAlert" trademark from PGx to CA.

 

Upon termination of this Agreement by any reason whatsoever, PGx shall immediately cease any use of the Genefec Technology.

 

16 assignment

 

CA shall have the right to assign this Agreement en bloc to a company merging with CA or acquiring a majority of the shares of CA or a substantial part of CA's business operation, hereunder the rights to the Licensed Technology.

 

Page 10 of 12

 

17 miscellanous

 

17.1 Waiver and Modification

 

Failure by either party to enforce any provision of this Agreement shall not be deemed a waiver of future enforcement of that or any other provision. Any waiver, amendment or other modification of any provision of this Agreement shall be effective only if in writing and signed by the parties.

 

17.2 Severability

 

If for any reason a court of competent jurisdiction finds any provision of this Agreement to be unenforceable, that provision of the Agreement shall be enforced to the maximum extent permissible so as to effect the intent of the parties, and the remainder of this Agreement shall continue in full force and effect.

 

17.3 Changes

 

No addition or modification to this Agreement shall be valid unless made in writing and signed by the authorized representatives of the Parties.

 

18 governing law and dispute resolution

 

All disputes, controversies and differences which may arise between the Parties shall be tried to be settled amicably through mutual consultation within 30 days of a written settlement request of either Party.

 

Both Parties will use their best endeavours to settle all matters in the dispute amicably. All disputes and differences of any kind related to this Agreement, which cannot be settled amicably by the Parties, shall be referred to arbitration.

 

The arbitration, including appointment of arbitrators, shall be carried out in accordance with the Norwegian Arbitration Act of 14 May 2004 (as amended) and in accordance with the principles set out herein. The arbitration shall take place in Bergen and be conducted in the English language.

 

* * *

 

This Agreement has been prepared in 2 originals, of which each Party has received one.

 

ColoAlert AS   PharmGenomics GmbH
     
     
Dagfinn Øgreid   Moritz Eidens

 

Attachments:

 

Appendix A: Description of the ColoAlert test for detection of CRC.

 

Appendix B: The exclusive license agreement between Norda ASA and ColoAlert AS signed on 4 and 6 December 2017 respectively.

 

Page 11 of 12

 

Appendix A

 

Description of the ColoAlert method for detection of CRC.

 

ColoAlert is a stool based test used for detection of colorectal cancer. The test will combine the use of genetic markers and detection of blood in stool samples. The test is based on extracting DNA from stool samples, and then analyzing that DNA for human DNA and somatic mutations within genes known to cause colorectal cancer. In addition, the ColoAlert method will combine the genetic testing with established methods for measuring the presence of blood in stool samples.

 

The ColoAlert technology licensed will include two kits:

 

- A stool collection kit
- A laboratory kit for detection of CRC

 

Stool collection kit

 

This first kit will be a stool sample collection kit. It will be a small box with the necessary tools and reagents for a patient to collect a stool sample and then deliver that sample to the ColoAlert analysis laboratory. Each stool collection kit will contain a transport safety tube, a stool collection tube, instructions for use, and if wanted by Third Party a packaging, transports solution and iFOBT or FOBT test may be included. More specifically, the stool collection tube will contain a special stool transport buffer for stabilizing the DNA in the stool sample until it arrives in the laboratory. The tube has a screw cap with a spoon attached – this spoon is used to collect the necessary amount of stool.

 

The content of the stool collection kit may be changed in the future for improving the collection kit (e.g. new stabilizing buffer, new stool collection device etc). These possible changes should be regarded as part of the stool collection kit and be included in the license.

 

Laboratory kit

 

This second “kit” contains the tools and reagents to perform the necessary analysis of the stool samples for detection of colorectal cancer. The kit enables the following steps:

 

Step 1: Automated DNA isolation from stool samples

 

The ColoAlert technology is based on extracting total DNA from stool samples collected with the above described stool collection kit. Currently the Diasorin (NorDiag) Arrow automated nucleic acid extraction platform is used for this purpose. There might be other DNA extraction methods developed in the future.

 

Step 2: DNA mutation analysis

 

Subsequent to the DNA isolation step, the DNA will be amplified (copied) by means of a polymerase chain reaction (PCR) and analyzed for presence of somatic mutations in the Kras and Braf genes down to 1%.

 

Step 3: Total Human DNA analysis

 

Subsequent to the DNA isolation step, the human DNA will be amplified (copied) by means of a polymerase chain reaction (PCR). The analysis measures the presence of total human DNA using a realtime PCR method to score the patient as positive or negative using a predefined threshold value.

 

Step 4: Detection of blood in stool (if this part of the is performed in a lab and not by the physician himself)

 

If wanted by Third Parties also stool samples will be analyzed for the presence of blood using a guaiac based FOBT test called ColoScreen from Helena laboratories. This is the same FOBT test that was used originally in the Leipzig trial. In future versions of the ColoAlert kit this FOBT analysis may be changed with other analysis methods for detection of blood in stool.

 

 

Page 12 of 12

 

 

Exhibit 10.2

 

Amendment to License AND DEVELOPMENT agreement

 

This amendment refers to the License and Development Agreement entered into the 1st of January, 2019 (the ”Agreement”) between the parties:

 

ColoAlert AS, Storgata 61 0504, 4307 Sandnes, Norway, company registration number 913 028 570 ("CA"), and PharmGenomics GmbH, Robert-Koch-Straße 50, 55129 Mainz, Germany, company registration number HRB 41529 ("PGx"), in the following referred to individually as "Party" and jointly the "Parties".

***

WHereas

 

The Agreement shall be amended to support PGx during the ongoing fundraising process and the Covid-19 pandemic, which has caused a significant delay, possibly termination of the dIPO originally planned with the support of Aescuvest GmbH, significantly increasing the risk of an insolvency situation.

 

Now therefore

 

in order to accommodate the needs of new situation, and to support the commercial development of the licensed ColoAlert test, PGx and CA have agreed to enter into this Amendment with the effective date January 1st 2020 (“Effective Date“).

 

The following clauses in the Agreement shall be replaced as of Effective Date:

 

§6 FINANCIAL TERMS

 

(Section “Protection fee”) The protection fee shall be EUR five (5) per sample analysed. PGx agrees to pay outstanding Protection Fees after every ended quarter. The Protection fee shall be calculated from Laboratory Kits sold, meaning EUR 5 multiplied with the number of analysis, which can be performed from one Laboratory Kit sold.

 

§15 TERM AND TERMINATION

 

(section 3) CA shall have the right to terminate this Agreement in the event that the quarterly Profit Split is less than a Minimum Profit Split. The Minimum Profit Split for the period January 1st 2020 to December 31st 2022 shall be € 25,000, and thereafter € 250,000.

 

The Payment of the Minimum Profit Split for the 3 first quarters of 2020 is agreed to be deferred until December 31st 2021.

 

(last section) Upon termination of this Agreement by any reason whatsoever, PGx shall immediately cease any use of the Licensed Technology, and all outstanding and or deferred payments to CA shall immediately fall due, whether or not they are invoiced by CA.

 

MISCELLANIOUS

 

In case a clause in the Amendment and the Agreement is not aligned, the Amendment shall supersede the Agreement.

 

* * *

 

This contract has been prepared in 2 originals, of which each Party has received one.

 

Bergen/ Mainz, 25. October 2020

 

ColoAlert AS     PharmGenomics GmbH
     
     
Hans Hekland     Dr. Moritz Eidens

 

 

Exhibit 10.3

 

Silent Partnership Agreement

 

Between the Company

 

PharmGenomics GmbH, Robert-Koch-Str. 50, 55129 Mainz, Germany

 

- hereinafter also referred to as the “Participant” -

 

and the

 

[______________________]

 

- hereinafter also referred to as the “Participation Provider” -

 

§ 1

 

Overview

 

(1) The Participation Provider agrees to be a silent partner in the commercial enterprise operated by the Participant in accordance with the following provisions set forth in this Silent Partnership Agreement (the “Agreement”).

 

(2) This Agreement shall become effective upon fulfilment of the requirements set forth in § 4 by the Participant, but no earlier than the day following the signing of this Agreement by all Parties.

 

§ 2

 

Contribution

 

(1) The Participation Provider makes a contribution of EUR [________] ([_____________] thousand euros) in cash (the “Contribution”).

 

(2) The Contribution shall be made in accordance with and upon fulfilment of the provisions of this Agreement, including Annexes 1 to 4, by way of a call for corresponding funds by the Participant.

 

(3) The Participant may refuse to pay the Contribution if there are reasons which would entitle it to terminate the agreement in accordance with § 16 (2) of this agreement or if the Participant is insolvent or threatened with insolvency in accordance with §§ 17, 18 of the German Insolvency Statute (the “InsO”) as amended or if the Participant is over-indebted in accordance with § 19 of the InsO as amended, even if no application for the opening of insolvency proceedings has been filed.

 

(4) The Participant is only entitled to dispose of the Contribution as defined in the preceding paragraphs to third parties with the prior consent of the Participation Provider.

 

(5) There is no obligation on the part of the Participation Provider to make additional contributions.

 

§ 3

 

Use of Funds

 

The funds made available by the Participation Provider on the basis of this Agreement may only be used by the Participant to finance the project described in below and in § 3 :

 

Residual development and market launch of further genetic tests in the field of “in vitro diagnostics”.

 

The total amount of the project costs should not exceed EUR [________] ([_____________] euros) or the cost/financing plan for the project set forth in Annex 1 and the implementation of the “ERP Start-up Funding Plan,” attached as Annex 4.

 

 

 

 

§ 4

 

Effect of the contract

 

The effectiveness of the contract is dependent on the fulfilment of the following conditions:

 

(1) Full financing of the project

 

Commitment of [€________] for open participation in the total amount of [€_________];

 

Commitment of the FIB for an open participation in the total amount of [€_______];

 

Commitment for silent participations in the amount of [€_________].

 

(2) Submission of a current certificate in tax matters from the responsible tax office in the original.

 

(3) Before the Contribution, the acquisition of shares must have been carried out in accordance with the standards of the Participation Provider under an open participation agreement and an amendment of the articles of association.

 

(4) Before the Contribution, Participant must demonstrate that it owns the entire right, title and interest in its patents, trademarks, copyrights, trade secrets, know-how and other proprietary material and concepts (“Intellectual Property”), and demonstrate that no claims have been asserted challenging Participant’s inventorship, ownership or right to use the Intellectual Property. Possible future patent applications must be disclosed by Participant.

 

(5) All documents to be submitted must not give rise to any concerns.

 

§ 5

 

Call for funds

 

(1) The Participation Provider shall make available the Contribution in accordance with the following provisions:

 

The payment of the Contribution will be made in two tranches and is subject to the condition that the Participant is satisfying the submitted business plan set forth in Annex 4.

 

The Participant and Participation Provider agree to the following:

 

The conditions set forth in Annex 4 must be fulfilled before a first payment of € [________] is made by [________] .

 

All relevant evidence must be provided in writing by PharmGenomics GmbH.

 

Before a second disbursement in the amount of € [______] is made by [________] at the latest, the requirements set forth in Annex 4 must be met.

 

Revenues are reported using BWAs. Other operating income is evidenced by grant notices, quarterly payment requests and bank statements. EBITDA is evidenced by appropriate supporting documentation from a tax accountant’s office or auditor.

 

If the above requirements are not met, the Participation Provider is not obliged to disburse the Contribution. If the above requirements for the call of funds are met, the Participant may call for the Contribution immediately and in the amount provided.

 

(2) The Participation Provider assumes that the Contribution will be called by the Participant in accordance with the cost/financing plan, but no later than [_____________]. If the first tranche is not called by this date, this agreement shall end without the need for written termination.

 

§ 6

 

Repayment of appropriations in the event of misuse

 

The Participation Provider shall be entitled to repayment of the portion of the Contribution not used immediately or in full for the purpose stipulated in § 3 of this Agreement. The funds may only be called up again once the conditions for their appropriate use have been met. Statutory rights of recovery as well as the other provisions of this Agreement shall remain unaffected by the provision pursuant to § 6 of this Agreement.

 

2

 

 

§ 7

 

Duration of the silent partnership

 

The silent partnership begins with the payment of the Contribution or, in the case of partial payment, with the payment of the first tranche. The silent partnership established by this contract ends regularly with the full repayment of the contribution in accordance with the provisions of this contract, but no later than [________________].

 

§ 8

 

Financial year

 

The fiscal year of the silent partnership corresponds to that of the Participant. The financial year of the Participant ends on December 31.

 

§ 9

 

Remuneration

 

(1) The Participant owes the Participation Provider a minimum remuneration of [___]% of the Contribution or portion of the Contribution made (the “Renumeration “). The Remuneration is due in arrears on 30 June 30 and December 31 of each year.

 

(2) In addition to the Renumeration, the Participation Provider receives a share of the Participant’s annual net income before taxes as determined in accordance with subsection a) below. This amounts to [____]% of the net income before taxes, but not more than [___]%of the amount invested (profit-related remuneration); however, for a period in which the Participation Provider holds more than one silent participation in the Participant, it only receives a total of 50 % of the net income before taxes.

 

a) The profit participation of the Participation Provider shall be determined on the basis of the pre-tax annual net profit determined in the commercial balance sheet of the Participant before taking into account the profit share attributable to the Participation Provider. The annual net income before taxes determined in accordance with this section shall form the basis for the calculation of the profit participation of the provider of the participation after the corrections carried out below have been made:

 

Managing directors’ salaries of the Participant and other payments to managing directors (e.g. bonuses, pension provisions) are to be added to the annual result.

 

Special reserves with an equity portion and tax-exempt reserves are allocated to profit or loss when they are created and deducted when they are released.

 

b) The profit-related remuneration payable is to be paid to the Participation Provider within two weeks of the preparation of the annual financial statements.

 

c) If the annual financial statements of the Participant are amended, the amended amounts shall also be taken into account when determining the Participant’s profit participation. Compensation payments are to be made by the Participant within four weeks after the amendment of the corresponding tax assessment notices has become final.

 

(3) The Participation Provider is entitled to demand a one-off remuneration (final remuneration) at the end of the investment term. The final remuneration amounts to [___] % of the Participation Provider’s contribution.

 

(4) If the annual financial statements are not available within six months of the end of the financial year, an amount of [____]% of the Contribution shall be paid in advance as profit-related remuneration. If, after the annual financial statements are available, it becomes apparent that the advance payment of the profit-related remuneration has not been made or has not been made in full, the participant may demand that the overpaid amount be refunded. The participant is not entitled to interest on the overpaid amount.

 

(5) Any capital gains tax incurred shall be borne by the Participation Provider. The registration and payment of the capital gains tax and the solidarity surcharge - as long as this is levied - is carried out by the participant. The Participant shall promptly issue a tax certificate in accordance with section 45a(2) of the German Income Tax Law (“EStG”) for the amounts remitted and forward it to the Provider.

 

(6) The Participant authorises the Participation Provider to collect all remuneration pursuant to this § 9 by direct debit from the following account:

 

Bank:

 

Account holder:

 

Account no.:

 

Bank code:

 

or

IBAN:

BIC:

 

3

 

 

§ 10

 

Accounts of the Participation Provider; withdrawals

 

The Contribution must be entered by the Participant in a separate account for accounting purposes. Withdrawals by the Participation Provider from this account are excluded during the term of the participation.

 

§ 11

 

Loss participation, subordination

 

(1) The Particidpating Provider does not participate in the loss of the participant with his contribution.

 

(2) Provided that

 

- any other silent partners make a subordination to the extent set out below and maintain it for the duration of their silent participation; and

 

- all other shareholders make subordination declarations with regard to their claims of all kinds against the Participant and maintain them for their contractual term

 

in order to avoid over-indebtedness under section 19 of InsO, as amended), the Participant shall, in any insolvency proceedings relating to the assets of the Participant, subordinate its claim for repayment of the contribution in accordance with sections 19(2) and 39(2) of InsO to the claims specified in section 39(1) of InsO.

 

To the extent and as long as this is necessary to avoid over-indebtedness, the provider of the participation may demand repayment of the contributions, even outside of insolvency proceedings, only to the extent that payment can be made from a balance sheet profit, a liquidation surplus or the assets exceeding the other liabilities of the participant in the participation.

 

Insofar as creditors of the Participant have also submitted a declaration of subordination or comparable declarations, the Participation Provider shall rank pari passu with these creditors if the requirements of sentence 2 are met.

 

However, in relation to creditors who are shareholders of the Participant or close relatives of a shareholder within the meaning of § 15 of the German Fiscal Code (“AO”) or companies affiliated with a shareholder within the meaning of §§ 15 et seq. of the German Stock Corporation Act (“AktG”), the deposit claim of the Participation Provider shall, however, be satisfied with priority if the requirements of sentence 2 of §§ 15 et seq.of the AktG are met.

 

§ 12

 

Management
Transactions requiring approval

 

(1) Management is the sole responsibility of the Participant.

 

(2) The Participant is obliged to obtain the prior consent of the principal in the case of legal transactions and actions that go beyond the scope of normal business operations and may have a not merely insignificant impact on the net assets and results of operations. The prior consent of the principal is required in particular for the following measures:

 

a) Change of the object of the Participant;

 

b) Conversions within the meaning of the German Transformation Act (“UmwG”);

 

c) Changes in the corporate relationships, in particular the admission of further shareholders including the establishment of further silent partnerships as well as their premature termination and/or repayment;

 

d) Appointment and dismissal of managing directors;

 

e) Determination of the level of directors’ salaries;

 

f) Hiring and firing of employees with an annual income of more than EUR 60,000 and their remuneration in any form;

 

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g) Acquisition of or participation in other companies and their disposal;

 

h) Abandonment, sale, lease or relocation of the business or significant parts of the business;

 

i) the not merely insignificant expansion, restriction or other change in the scope of business;

 

j) Establishment of branches;

 

k) Acquisition, sale or encumbrance of real estate or rights equivalent to real estate and sale or encumbrance of other not insignificant assets of the Participant;

 

l) Assumption of guarantees or warranties for third parties, granting of loans, if and to the extent that the assumption or granting goes beyond the ordinary course of business;

 

m) Repayment of loans to shareholders;

 

n) Conclusion, amendment or cancellation of control, profit and loss transfer agreements;

 

o) Conclusion, termination, amendment and extension of consultancy contracts of all kinds with a remuneration of more than EUR 15,000 per annum;

 

p) Assumption of obligations for investments that are not included in the project financing by the equity provider and that exceed the amount of EUR 50,000 or in the case of leasing, rental or lease agreements that exceed the amount of EUR 3,000 per month;

 

q) Disposition of industrial property rights as well as conclusion and termination of patent, license, know-how, distribution and cooperation agreements, if and to the extent that the disposition, conclusion or termination of the agreement goes beyond the ordinary course of business.

 

(3) It must be ensured that there are no transfers of assets of any kind, in particular as a result of changes in the shareholder structure, Participant spin-offs or
splits, conversions, increases in managing directors’ salaries/executive board remuneration, sales of Participant assets to relatives, employment of relatives and/or other (legal) transactions at non-market conditions.

 

(4) Profit distributions to the shareholders may only be made once all due payment obligations to the Participation Provider, including any arrears, have been fulfilled. Statutory regulations on the admissibility of profit distributions in terms of reason and amount remain unaffected by the regulation pursuant to section 12(1).

 

(5) Insofar as legal transactions and actions have been undertaken in breach of the above paragraphs 2 to 4, the Participation Provider shall be placed in the position it would have been in if the legal transaction or action had not been undertaken, in particular when calculating its payment claims in accordance with § 9 of this Agreement. Further rights of the Participation Provider, in particular to termination of this Agreement or any claims for damages, shall remain unaffected by the provision pursuant to section 12(1).

 

§ 13

 

Information obligations of the Participant; proof of use of funds

 

(1) The Participant must provide the Participation Provider with evidence of the proper use of the funds within [ ] months of the end of the project period, but no later than the end of the sixth month following the request for the second tranche of the contribution. Upon request by the Participation Provider, the Participant is additionally obliged to submit proof of interim use of funds within a period of four weeks.

 

(2) The Participant shall prepare its annual financial statements within the first five months after the end of each financial year and shall submit them to the Participation Provider in writing before they are adopted. Objections to the annual financial statements may only be raised by the Participation Provider within three weeks of receipt of the annual financial statements.

 

(3) The Participant is obliged to submit to the Participation Provider within the first six months of the following financial year the audited balance sheet with profit and loss account as well as the audit report. In addition, the annual financial statements of subsidiaries, affiliated companies and, if applicable, existing consolidated financial statements must be submitted to the Participant within the same period. If the completion of annual financial statements is delayed, this must be notified to the provider of the participation, stating the reasons and submitting the necessary documents. In this case, the preliminary figures are to be submitted first with a confirmation from a tax advisor.

 

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(4) The Participant shall, without being requested to do so, fulfil the submission and reporting obligations vis-à-vis the provider of the equity participation set out in Section II.7 of the Principles of Equity Participation within the deadlines specified.

 

(5) Furthermore, the Participant undertakes to inform the Participation Provider without delay of any circumstances that may jeopardise the purpose of the Participation and/or cause considerable delays in the funded project.

 

§ 14

 

Control rights of the Participation Provider

 

(1) The Participation Provider and/or its agents shall be entitled to monitor and inspect the Participant, in particular with regard to the use of funds agreed in this Agreement. The Participant and its agents may demand all necessary information from the Participant, inspect its business documents, including tax files, and visit the Participant’s premises at any time. The Federal Audit Office and the Federal Ministry for Economic Affairs and Energy (BMWi) have corresponding monitoring and inspection rights. An auditor may also be commissioned to carry out the monitoring and review.

 

(2) The Participation Provider reserves the right to demand the involvement of external consultants if deficits are identified in the commercial and/or business management area. This is particularly the case if the reporting system to be provided to the Participation Provider does not meet the required standard.

 

(3) The Participation Provider shall have a claim against the Participant for reimbursement of the costs incurred in the course of the monitoring and review insofar as the Participant is responsible for the reason for the specific monitoring or review measures. This shall be the case in particular if the Participant has not or not sufficiently complied with the information obligations set out in § 13 of this Agreement despite having given notice of defects within 2 weeks.

 

§ 15

 

Release from secrecy

 

The Participant releases the guarantor from the duty of confidentiality vis-à-vis its Participants, including their executive bodies, the bodies authorised to audit in connection with the acquisition of the participation, as well as vis-à-vis the Federal Audit Office and the Federal Ministry of Economics and Technology. Furthermore, the Participant is released from the duty of confidentiality insofar as it is legally obligated to provide information to third parties or provides information to third parties who are themselves legally obligated to maintain confidentiality. In addition, the Participant releases its principal bank from the duty of confidentiality vis-à-vis the Participation Sponsor.

 

§ 16

 

Early termination of the Participant

 

(1) The participant is entitled to terminate the participation prematurely in whole or in part subject to a notice period of 12 months. Notice of termination shall be given to the Participation Provider by registered letter. Ordinary termination by the Participation Provider is excluded during the term of the contract.

 

(2) The provider of the participation may only terminate the Participant prematurely without notice if there is good cause. Good cause shall be deemed to exist in particular if

 

a) the Participant or its shareholders have provided incorrect information about their financial circumstances or the conditions for the acquisition of the participation were not met;

 

b) the Participant does not fulfil its obligations arising from this Agreement, in particular

 

the funds are not used for the intended purpose, or

 

fails to obtain prior consent to legal transactions requiring consent within the meaning of section 12(2) or infringes section 12(3) or (4), or

 

fails to submit tax certificates in accordance with Section 45a (2) of the German Income Tax Act within two months of the due date of the payments for which the certificates are to be issued, or

 

fails to comply with the submission and reporting obligations pursuant to § 13 within 2 weeks despite notification of defects;

 

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c) the repayment of the investment is at risk. Such a risk exists in particular if

 

insolvency proceedings have been opened with respect to the assets of the participant or have been rejected for lack of assets or an out-of-court settlement (deferral, quota or liquidation settlement) has been concluded to which all or a group of comparable creditors have agreed, or

 

the Participant ceases to make payments, or

 

in the opinion of the Participation Provider, the economic situation of the Participant is unlikely to improve in the event of continuing losses;

 

d) the know-how provider(s) who, at the time of conclusion of this Agreement, is (are) no longer a full-time member of the management of the Participant.

 

(3) If the Participant ends prematurely as a result of termination on the part of the participant or as a result of termination on the part of the Participation Provider for good cause for which the participant is responsible, the Participation Provider may demand a premium. This does not apply to a termination pursuant to paragraph 2 c) above. The premium amounts to 2.0 % p.a. of the terminated amount and is calculated for the period by which the agreed participation term is reduced (settlement to the day).

 

(4) If the Participation Provider’s contribution has not yet been made or has not been made in full at the time of termination, the Participation Provider shall be released from his obligation to make a contribution upon the declaration of termination.

 

§ 17

 

Repayment of the contribution; due date

 

(1) In the event of termination of the Participant, in particular due to the passage of time or termination, the contribution shall be due for repayment in the amount of the nominal amount less any partial payments already made on the nominal amount.

 

(2) At the same time, the Renumeration as well as, if applicable, the terminal bonus and the premium are due for payment.

 

§ 18

 

Remuneration surcharges

 

(1) If, during the existence of the silent partnership, payments are not made on the contractually agreed dates, interest is payable on them at the rate of 1% per month for each month or part thereof of non-payment.

 

(2) Upon termination of the silent partnership, interest shall be paid on the total receivables due to the Participation Provider from the due date until receipt of payment at a rate of at least 1% per month for each month or part thereof.

 

(3) The Participation Provider reserve the right to assert further damage caused by delay.

 

§ 19

 

Insurance

 

The Participant shall keep its business operations adequately insured against the usual risks. The equity provider may require the conclusion of term life insurance for individual know-how holders.

 

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§ 20

 

Place of performance and jurisdiction

 

The place of performance and jurisdiction for legal disputes arising from this contractual relationship is the domicile of the Participation Provider.

 

§ 21

 

Supplementary provisions

 

Possible future patent applications must be filed by PharmGenomics GmbH.

 

§ 22

 

“intentionally released”

 

§ 23

 

Subsidiary agreements; severability clause

 

(1) No ancillary agreements outside of this contract have been made.

 

(2) Amendments or supplements to this contract must be made in writing. This also applies to compliance with the written form requirement.

 

(3) Should any provision of this contract be legally invalid, this shall not affect the remaining provisions. In such a case, the contracting parties shall be obliged to replace the legally ineffective provisions with legally effective provisions which economically correspond to the meaning and purpose of the contract.

 

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PharmGenomics GmbH   COMPANY
     
Participant   Participation Provider
                                   
By:     By:  
Name:      Name:                                 
Title:     Title:  
Date:     Date:  

 

 

Attachments:   Annex 1: Cost/Financing Plan
    Annex 2: Personal statement of the management
    Annex 3: Anti-Money Laundering Amendment
    Annex 4: ERP Start-up Funding Plan

 

 

 

 

Annex 1

Cost/Financing Plan

 

Cost plan       Financing plan    
Investments           Silent Partnership        
non-investive expenditures           Private Participation Providers        
Market launch costs           ISB companies        
Total           Total        

 

Project duration:

 

 

 

 

 

 

Annex 2

 

Personal Statement of the Management

 

Pursuant to § 12 of the agreement on the establishment of a typical silent partnership, the Participant is obliged to obtain the prior consent of the Participation Provider for legal transactions and actions that go beyond the scope of normal business operations and may have a not merely insignificant impact on the net assets and results of operations. The prior consent of the principal is required in particular for the following measures:

 

a) Change of the object of the Participant;

 

b) Conversions within the meaning of the UmwG;

 

c) Changes in the corporate relationships, in particular the admission of further shareholders including the establishment of further silent partnerships as well as their premature termination and/or repayment;

 

d) Appointment and dismissal of executive officers;

 

e) Determination of the amount of directors’ salaries/remuneration;

 

f) Hiring and firing of employees with an annual income of more than EUR 60,000 and their remuneration in any form;

 

g) Acquisition of or participation in other companies and their disposal;

 

h) Abandonment, sale, lease or relocation of the business or significant parts of the business;

 

i) the not merely insignificant expansion, restriction or other change in the scope of business;

 

j) Establishment of branches;

 

k) Acquisition, sale or encumbrance of real estate or rights equivalent to real estate and sale or encumbrance of other not insignificant assets of the Participant;

 

l) Assumption of guarantees or warranties for third parties, granting of loans, if and to the extent that the assumption or granting goes beyond the ordinary course of business;

 

m) Repayment of loans to shareholders;

 

n) Conclusion, amendment or cancellation of profit and loss transfer agreements;

 

o) Conclusion, termination, amendment and extension of consultancy contracts of all kinds with a remuneration of more than EUR 15,000 per annum;

 

p) Assumption of obligations for investments that are not included in the project financing by the equity provider and that exceed the amount of EUR 50,000 or, in the case of leasing, rental or lease agreements, that exceed the amount of EUR 3,000 per month;

 

q) Disposition of industrial property rights as well as conclusion and termination of patent, license, know-how, distribution and cooperation agreements, if and to the extent that the disposition, conclusion or termination of the agreement goes beyond the ordinary course of business;

 

Furthermore, it must be ensured that there are no transfers of assets of any kind, in particular as a result of changes in the shareholder structure, spin-offs or splits of businesses, conversions, increases in managing directors’ salaries/executive board remuneration, sales of business assets to relatives, employment of relatives and/or other (legal) transactions at non-market conditions.

 

In addition, profit distributions to the shareholders may only be made once all due payment obligations to the Participation Provider, including any arrears, have been fulfilled. Statutory regulations on the admissibility of profit distributions in terms of reason and amount remain unaffected by the above provision.

 

The undersigned hereby declare that they will not participate in any legal transactions and actions that violate the above provisions and, in the event of a violation of this obligation, that they will be personally liable to the Participation Provider for all damages and losses resulting from such participation.

 

The signatories undertake to place their labour at the disposal of the Participant only, unless the contracting parties decide otherwise.

 

 

 

 

Until their departure, the signatories may neither enter into a participation in another Participant nor found a Participant that competes with the Participant without the consent of the provider of the participation. Excluded are purely capital participations below 2% of the capital of the Participant in which this purely capital participation takes place, provided that the purely capital participation does not exceed EUR 10,000.

 

 

PharmGenomics GmbH  
     
By:    
Name:                         
Title:    
Date:    

 

 

 

 

 

Annex 3

 

Anti-Money Laundering Amendment

 

1) In order to satisfy the identification requirement under the German Anti-Money Laundering Act or Geldwäschegesetz (GwG) , the Participant undertakes to provide the necessary information pursuant to Section 4 of the GwG.

 

2) The Participant shall disclose the extent that it is acting on behalf of a beneficial owner within the meaning of Section 1 (6) of the GwG.

 

3) If the Participant is not a natural person, the Participant is required to disclose its ownership and control structure, including the percentage of capital and voting shares.

 

4. The Participant shall disclose if it is, within the meaning of the GwG, a natural person not residing in Germany who holds or has held an important public office, or an immediate family member of such a person or a person known to be close to such a person. Disclosure is not required if the public office has not been held for more than one year.

 

5 Insofar as the cooperation of the Participant is necessary for the Equity Provider to fulfil its obligations resulting from the GwG (e.g. in the establishment of the business relationship or in the ongoing monitoring of the business relationship), the Participant shall be obliged to cooperate to the extent required, in particular it shall provide the necessary details, make available the necessary information and documents and immediately notify any changes arising in the course of the business relationship.

 

6) If the Participant violates its aforementioned obligations, the Provider of the Participation may refuse to establish a business relationship or may terminate an existing business relationship by giving notice or by other means and shall not be obliged to carry out any Transactions.

 

 

PharmGenomics GmbH  
     
By:    
Name:                      
Title:    
Date:    

 

 

 

 

 

Annex 4

 

ERP Start-Up Funding Plan

 

 

 

 

 

 

 

Exhibit 10.4

 

MANAGEMENT SERVICES AGREEMENT

 

This Management Services Agreement (the “Agreement”) is made and entered into as of July 1, 2021 by and between Guido Bächler (“Baechler”) and Mainz Biomed B.V. (the “Company”).

 

WHEREAS, Baechler has been requested to become a director (bestuurder) of the Company will be appointed director (bestuurder) of the Company on or around the date hereof (the “Effective Date”),

 

WHEREAS, Baechler has been granted the title of Chief Executive Officer;

 

WHEREAS, for the purposes of Dutch law, the legal relationship between the Company and Baechler set forth in this Agreement qualifies as a service agreement (overeenkomst van opdracht) within the meaning of Section 7:400 et seq. of the Dutch Civil Code and the Parties do not envisage creating an employment agreement (arbeidsovereenkomst) within the meaning of Section 7:610 et seq. of the Dutch Civil Code.

 

WHEREAS, This Agreement sets out the terms and conditions of the services to be provided by Baechler.

 

NOW, THEREFORE, in consideration of the mutual covenants, promises, and obligations set forth herein, the parties agree as follows:

 

1. Term.

 

Baechler shall perform services hereunder as of the Effective Date. The period between the Effective Date and the termination of this Agreement for any reason Baechler is hereinafter referred to as the “Services Term”.

 

2. Position and Duties.

 

2.1 Position. During the Services Term, Baechler shall serve as the Chief Executive Officer at the Board of Directors of the Company (the “Board”). In such positions, Baechler shall have such duties, authority, and responsibilities as shall be determined from time to time by the Board and the articles of association (statuten) of the Company, which duties, authority, and responsibilities are consistent with Baechler’s position and those assigned to Chief Executive Officers of companies listed on the Nasdaq Capital Market. The Board of Directors intends to nominate Baechler to become and remain a member of the Company’s Board in accordance with Dutch law and the Company’s articles of association. Baechler shall, if requested, also serve as an officer or director of any affiliate of the Company for no additional compensation. Baechler will be given an indemnification agreement with terms reasonably satisfactory to Baechler. In addition, the Company and any such affiliate shall at all times maintain directors and officers insurance and such other insurance as is customary for similarly situated businesses.

 

2.2 Duties. During the Services Term, Baechler shall devote substantially all of Baechler’s business time and attention to the performance of Baechler’s duties hereunder; provided that you may continue as a director and/or consultant, for SummerBio, Chip Diagnostics, and Telo Genomics, and to other entities that are not directly competitive with the Company to the extent that such activities do not conflict with your obligations hereunder. Baechler will not otherwise engage in any other business, profession, or occupation for compensation or otherwise which would conflict or interfere with the performance of such services either directly or indirectly without the prior written consent of the Board (it being acknowledged by the Company, that all directorships in other entities held by Baechler on the date hereof shall not be deemed to cause such a conflict or interference). Baechler will not be permitted without the written consent of a majority of the Board members, which shall not be unreasonably conditioned or denied, to (a) act or serve as a director, trustee, committee member, or principal of any type of company, entity or business, civic, or charitable organization and (b) purchase or own five percent (5%) or more of the publicly traded securities of any corporation or have any such ownership position in such an entity that does not represent a passive investment or that makes Baechler a controlling person of, or a member of a group that controls, such entity.

 

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3. Place of Performance. Until such time as the Company establishes offices for its operations, Baechler shall be reimbursed up to $500 a month for the reasonable out-of-pocket cost of maintaining his workspace or office and the costs of operating such office.

 

4. Compensation.

 

4.1 Base Remuneration. Baechler’s annual base remuneration (the “Base Remuneration”) will initially be US$240,000 per year. The Company shall pay Baechler an annual Base Remuneration of US$350,000 from and after the filing of a publicly available Form F-1 with respect to any initial public offering, in the United States, of the Company’s equity securities (the “IPO”). It is anticipated that such annual Base Remuneration shall be increased starting in the year after the IPO to US$450,000, provided that the Company has made satisfactory progress towards Board approved strategic goals. The Company shall pay the Base Remuneration due hereunder in periodic installments, subject to applicable withholding, and in accordance with the Company’s customary payroll practices, but no less frequently than monthly. Baechler’s Base Remuneration shall be reviewed at least annually by the Board’s Compensation Committee or, in its absence, the Board (the “Compensation Committee”) and the Compensation Committee may, but shall not be required to, increase the Base Remuneration during the Services Term. However, Baechler’s base remuneration may not be decreased during the Services Term other than as part of an across-the-board remuneration reduction that applies in the same manner and same percentage as all senior employees. Baechler’s annual base remuneration, as in effect from time to time, is hereinafter referred to as “Base Remuneration”.

 

4.2 Annual Bonus. For each year of the Services Term following the IPO, Baechler shall be eligible to receive an annual bonus (the “Annual Bonus”) equal to 50% of the Base Remuneration. Baechler and the Board of Directors or Compensation Committee shall use reasonable efforts to mutually agree upon milestones and associated and commensurate payment amounts for any such Annual Bonus thereafter. The Annual Bonus, if any, will be paid as soon as reasonably practicable within the calendar year following the calendar year to which the Annual Bonus relates, as determined by the Compensation Committee.

 

4.3 Equity Awards.

 

(a) In consideration of Baechler entering into this Agreement and as an inducement to join the Company, on the Effective Date, the Company will grant 200,000 restricted ordinary shares of the Company to Baechler on the Effective Date of which 100,000 restricted ordinary shares (the “Restricted Shares”) shall be subject to a claw-back pursuant to which the Company may repurchase all or some of such Restricted Shares at a per share purchase price equal to 50% of the fair market value of such share when originally issued, which claw-back will lapse as to, and no longer apply to, (i) the first 50,000 shares (x) on the one year anniversary of the IPO (or such later date agreed among Baechler and the Company) subject to the Company and/or Baechler meeting milestones to be determined by the mutual agreement of Baechler and the Company’s Board of Directors and/or Compensation Committee or (y) if the Company does not exercise such clawback within 30 days of such date and (ii) an additional 50,000 shares on the (x) second anniversary of the IPO (or such later date agreed among Baechler and the Company) subject to the Company and/or Baechler meeting milestones to be determined by the mutual agreement of Baechler and the Company’s Board of Directors and/or Compensation Committee or (y) if the Company does not exercise such clawback within 30 days of such date. For applicable tax reporting purposes, the Company shall treat its ordinary shares as having a fair market value of $0.30 per ordinary share, which is the price at which the ordinary shares were most recently issued to cash investors.

 

(b) On the date of the IPO, Baechler shall be granted options (“IPO Options”) to acquire at the exercise price per ordinary share paid in the IPO to acquire a number of ordinary shares (currently anticipated to be 331,000 additional shares) that will equal five percent (5%) of the outstanding ordinary shares immediately prior to the IPO (calculated excluding shares reserved for equity incentives and outstanding warrants), less (x) the 200,000 ordinary shares issued pursuant to Section 4.3(a) and (y) 54,507 ordinary shares previously acquired Baechler (as (x) and (y) may be adjusted for stock splits, dividends, recapitalization and the like). The IPO Options are to be granted pursuant to a Stock Option Plan that has been approved by the Board of Directors and shareholders of the Company and will vest over 4 years from the Effective Date in equal monthly installments, and will accelerate on a change in control or sale of substantially all of the assets of the Company. Baechler’s equity ownership will be reviewed within 12 months of the IPO for increase, if applicable, to be consistent with industry standards for CEOs of similarly situated companies.

 

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4.4 Health Benefit Payment. The Company shall reimburse Baechler for payments to participate in any one U.S. health insurance plan and one U.S. dental plan (if not included in the U.S. Health Insurance Plan) for the benefit of Baechler and any spouse or dependents eligible under such plan in an amount of up to $3,500 per month; provided that if Baechler provides sufficient information for such payments, the Company will make such payments directly on Baechler’s behalf when due. Such amount shall not be cumulative, and if such payments are less than $3,500 per month, the difference shall not be available for future or prior months.

 

4.5 Benefits. During the Services Term, Baechler shall be entitled to participate in all employee benefit plans, practices, and programs maintained by the Company, as in effect from time to time (collectively, “Employee Benefit Plans”) to the extent consistent with applicable law and the terms of the applicable Employee Benefit Plans. The Company reserves the right to amend or terminate any Employee Benefit Plans at any time in its sole discretion, subject to the terms of such Employee Benefit Plan and applicable law.

 

4.6 Vacation; Paid Time-Off. During the Services Term, Baechler shall be entitled to twenty- (20) paid vacation days per calendar year (prorated for partial years) in accordance with the Company’s vacation policies, as in effect from time to time. Unused vacation time will rollover into future years.

 

4.8 Business Expenses. Baechler shall be entitled to reimbursement for all reasonable and necessary out-of-pocket business, entertainment, and travel expenses incurred by Baechler in connection with the performance of Baechler’s duties hereunder in accordance with the Company’s expense reimbursement policies and procedures; provided that in any calendar month where expenses are above an aggregate $10,000 any further expenses above $2,500 individually shall be first approved by at least one independent member of the Board, unless incurred in connection with existing Company policies.

 

4.9 Indemnification. In the event that Baechler is made a party or threatened to be made a party to any action, suit, or proceeding, whether civil, criminal, administrative, or investigative (a “Proceeding”), other than any Proceeding initiated by Baechler or the Company related to any contest or dispute between Baechler and the Company or any of its affiliates with respect to this Agreement or Baechler’s services hereunder, by reason of the fact that Baechler is or was a director or officer of the Company, or any affiliate of the Company, or is or was serving at the request of the Company as a director, officer, member, employee, or agent of another corporation or a partnership, joint venture, trust, or other enterprise, Baechler shall be indemnified and held harmless by the Company to the fullest extent applicable to any other officer or director of the Company from and against any liabilities, costs, claims, and expenses, including all reasonable costs and expenses incurred in defense of any Proceeding (including attorneys’ fees). Moreover, the Company shall advance such reasonable costs such that Baechler will not have to submit such costs for reimbursement. This indemnification obligation shall be further documented pursuant to an indemnification agreement with customary terms and conditions that are acceptable to Baechler and the Company.

 

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5. Termination of Agreement. This Agreement and the Services Term may be terminated by either the Company or Baechler at any time and for any reason; provided that, unless otherwise provided herein, either party shall be required to give the other party at least ten (10) days advance written notice of any termination of this Agreement. Upon termination of this Agreement, Baechler shall be entitled to the compensation and benefits described in this Section 5 and shall have no further rights to any compensation or any other benefits from the Company or any of its affiliates.

 

This Agreement will terminate automatically upon:

 

i. resignation or death of Baechler; or

 

ii. dismissal of Baechler by the general meeting of the Company, in accordance with the articles of association of the Company.

 

The general meeting of the Company may at any time suspend and dismiss Baechler, with due observance of the articles of association. Suspension of Baechler will not terminate this Agreement or the obligations of the parties hereunder. Any termination of this Agreement pursuant to (ii) (dismissal) shall be deemed a termination by the Company for the purposes of this Agreement.

 

5.1 Termination For Cause or Without Good Reason.

 

(a) This Agreement may be terminated by the Company for Cause or by Baechler without Good Reason. If this Agreement is terminated by the Company for Cause or by Baechler without Good Reason, Baechler shall be entitled to receive upon the Termination Date (as defined below):

 

(i) any accrued but unpaid Base Remuneration and accrued but unused vacation which shall be paid;

 

(ii) reimbursement for unreimbursed business expenses properly incurred by Baechler, which shall be subject to and paid in accordance with the Company’s expense reimbursement policy; and

 

(iii) such benefits (including equity compensation), if any, to which Baechler may be entitled under the Company’s employee benefit plans as of the Termination Date; provided that, in no event shall Baechler be entitled to any payments in the nature of severance or termination payments except as specifically provided herein.

 

Items 5.1(a)(i) through 5.1(a)(iii) are referred to herein collectively as the “Accrued Amounts”.

 

(b) For purposes of this Agreement, “Cause” shall mean:

 

(i) the willful, substantial and continuing failure of Baechler, after specific written notice thereof, to render services to the Company in accordance with the terms or requirements of employment, which is not cured within thirty (30) days of such notice;

 

(ii) Baechler’s willful failure to attempt in good faith to implement a clear, reasonable valid and legal directive of the Board;

 

(iii) Baechler’s engagement in material dishonesty, illegal conduct, or other material misconduct, which is, in each case, materially injurious to the Company or its affiliates;

 

(iv) Baechler’s conviction of embezzlement, material misappropriation, or willful fraud (1) related to Baechler’s services to the Company or (2) which would material harm to the business, standing or reputation of the Company

 

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(v) Baechler’s conviction of or plea of guilty or nolo contendere to a crime that constitutes a felony (or state law equivalent) or a crime that constitutes a misdemeanor involving moral turpitude;

 

(vi) Baechler’s deliberate disregard of the written rules or policies of the Company which is, in each case, materially injurious to the Company or its affiliates;

 

(vii) Baechler’s willful unauthorized disclosure of Confidential Information (as defined below) in a manner not reasonably believed to be in furtherance of the interests of the Company, and which is, in each case, materially injurious to the Company or its affiliates; or

 

(viii) Baechler’s willful and material breach of any material obligation under this Agreement or any other written agreement between Baechler and the Company, which breach is not cured in all material respects within 30 days of specific written notice with respect theretofore.

 

(c) For purposes of this Agreement, “Good Reason” shall mean the occurrence of any of the following, in each case during the Services Term without Baechler’s written consent:

 

(i) a material reduction in Baechler’s Base Remuneration (other than a general reduction in Base Remuneration that affects all similarly situated employees in substantially the same proportions);

 

(ii) a material reduction in Baechler’s authority, duties or responsibilities, which shall include, without limitation, any situation other than Baechler’s resignation that results in Baechler no longer serving on the Board of Directors;

 

(iii) a relocation of Baechler’s principal place of service with the Company to a place that increases Baechler’s one-way commute by more than thirty-five (35) miles as compared to Baechler’s then-current principal place of service immediately prior to such relocation (excluding regular travel in the ordinary course of business); or

 

(iv) any material breach by the Company of any material provision of this Agreement or any material provision of any other agreement between Baechler and the Company.

 

Except in the case of dismissal as a director, Baechler cannot resign for Good Reason unless Baechler has provided written notice to the Company of the existence of the circumstances providing grounds for termination for Good Reason within ninety (90) days of learning of the initial existence of such grounds and the Company has thirty (30) days from the date on which such notice is provided to cure such circumstances. If Baechler does not resign for Good Reason within t ninety (90) days after the first occurrence of the applicable grounds, then Baechler will be deemed to have waived Baechler’s right to terminate for Good Reason with respect to such grounds.

 

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5.2 Termination Without Cause or for Good Reason. This Agreement and the Services Term may be terminated by Baechler for Good Reason or by the Company without Cause. In the event of such termination, Baechler shall be entitled to receive the Accrued Amounts and subject to Baechler’s compliance with ii, Section 7, Section 8, and Section 9 of this Agreement and Baechler’s execution of a release of claims in favor of the Company, its affiliates and their respective officers and directors in a form provided by the Company (the “Release”) and such Release becoming effective within 60 days following the Termination Date (such 60-day period, the “Release Execution Period”), Baechler shall be entitled to receive the following:

 

(a) equal installment payments payable in accordance with the Company’s normal payroll practices, but no less frequently than monthly, which are in the aggregate equal to Baechler’s Base Salary for the year in which the Termination Date occurs, which shall begin within ten (10) days following the Termination Date; provided that, the first installment payment shall include all amounts that would otherwise have been paid to Baechler during the period beginning on the Termination Date and ending twelve (12) months thereafter;

 

(b) An amount equal to Baechler’s target Annual Bonus for the year in which the termination takes place, with all criterion for such Annual Bonus deemed to be achieved; and

 

(c) Vesting of an additional 12 months (removing any cliff) under all time-based vesting schedules for equity based incentives held by Baechler;

 

(d) the Company shall reimburse Baechler for up to $3,500 of the monthly U.S. health insurance premium paid by Baechler for himself and his dependents. Such reimbursement shall be paid to Baechler on the tenth of the month immediately following the month in which Baechler timely remits the premium payment. Baechler shall be eligible to receive such reimbursement until the earliest of: (i) the 12-month anniversary of the Termination Date; (ii) the date Baechler is no longer eligible to receive COBRA continuation coverage; and (iii) the date on which Baechler becomes eligible to receive health insurance coverage from another employer or other source. Notwithstanding the foregoing, if the Company’s making payments under this Section 5.2(d) would violate the nondiscrimination rules applicable to non-grandfathered plans under the Affordable Care Act (the “ACA”), or result in the imposition of penalties under the ACA and the related regulations and guidance promulgated thereunder), the parties agree to reform this Section 5.2(d) in a manner as is necessary to comply with the ACA, while providing as much of the intended benefit as possible.]

 

5.3 Death or Disability.

 

(a) Baechler’s employment hereunder shall terminate automatically upon Baechler’s death during the Services Term, and the Company may terminate Baechler’s this Agreement on account of Baechler’s Disability.

 

(b) If this Agreement on account of Baechler’s death or Disability, Baechler (or Baechler’s estate and/or beneficiaries, as the case may be) shall be entitled to receive the Accrued Amounts. Notwithstanding any other provision contained herein, all payments made in connection with Baechler’s Disability shall be provided in a manner which is consistent with federal and state law.

 

(c) For purposes of this Agreement, “Disability” shall mean Baechler’s inability, due to physical or mental incapacity, to perform the essential functions of Baechler’s job, with or without reasonable accommodation, for one hundred eighty (180) days out of any three hundred sixty-five (365) day period or one hundred twenty (120) consecutive days. Any question as to the existence of Baechler’s Disability as to which Baechler and the Company cannot agree shall be determined in writing by a qualified independent physician mutually acceptable to Baechler and the Company. If Baechler and the Company cannot agree as to a qualified independent physician, each shall appoint such a physician and those two physicians shall select a third who shall make such determination in writing. The determination of Disability made in writing to the Company and Baechler shall be final and conclusive for purposes of this Agreement.

 

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5.4 Notice of Termination. Any termination of this Agreement hereunder by the Company or by Baechler during the Services Term (other than termination pursuant to Section 5.3(a) on account of Baechler’s death) shall be communicated by written notice of termination (“Notice of Termination”) to the other party hereto in accordance with Section 27. The Notice of Termination shall specify:

 

(a) The termination provision of this Agreement relied upon;

 

(b) To the extent applicable, the facts and circumstances claimed to provide a basis for termination of Baechler’s services under the provision so indicated; and

 

(c) The applicable Termination Date.

 

5.5 Termination Date. Baechler’s “Termination Date” shall be:

 

(a) If this Agreement is terminated on account of Baechler’s death, the date of Baechler’s death;

 

(b) If this Agreement is terminated on account of Baechler’s Disability, the date that it is determined that Baechler has a Disability;

 

(c) If the Company terminates this Agreement hereunder for Cause, the date the Notice of Termination is delivered to Baechler;

 

(d) If the Company terminates this Agreement without Cause, the date specified in the Notice of Termination, which shall be no less than ten (10) days following the date on which the Notice of Termination is delivered; provided that, the Company shall have the option to provide Baechler with a lump sum payment equal to ten (10) days’ Base Remuneration in lieu of such notice, which shall be paid in a lump sum on Baechler’s Termination Date and for all purposes of this Agreement, Baechler’s Termination Date shall be the date on which such Notice of Termination is delivered;

 

(e) If Baechler terminates this Agreement with or without Good Reason, the date specified in Baechler’s Notice of Termination, which shall be no less than ten (10) days following the date on which the Notice of Termination is delivered; provided that, the Company may waive all or any part of the notice period for no consideration by giving written notice to Baechler and for purposes of this Agreement, Baechler’s Termination Date shall be the date determined by the Company; and

 

Notwithstanding anything contained herein, the Termination Date shall not occur until the date on which Baechler incurs a “separation from service” within the meaning of Section 409A.

 

5.6 Resignation of All Other Positions. Upon termination of this Agreement for any reason, Baechler shall be deemed to have resigned from all positions that Baechler holds as an officer or member of the Board (or a committee thereof) of the Company or any of its affiliates (unless otherwise agreed to by a majority of the Board).

 

5.9 Section 280G.

 

(a) If any of the payments or benefits received or to be received by Baechler (including, without limitation, any payment or benefits received in connection with a Change in Control or Baechler’s termination, whether pursuant to the terms of this Agreement or any other plan, arrangement, or agreement, or otherwise) (all such payments collectively referred to herein as the “280G Payments”) constitute “parachute payments” within the meaning of Section 280G of the Code and would, but for this Section 5.9, be subject to the excise tax imposed under Section 4999 of the Code (the “Excise Tax”), then such 280G Payments shall be reduced in a manner reasonably determined by the Company (by the minimum possible amounts) that is consistent with the requirements of Section 409A solely to the extent that, and only until, the amount to be received by Baechler on an after-tax basis is greater than the amount that would be received by Baechler in the absence of any such reduction.

 

(b) All calculations and determinations under this Section 5.9 shall be made by an independent accounting firm or independent tax counsel appointed by the Company (the “Tax Counsel”) whose determinations shall be conclusive and binding on the Company and Baechler for all purposes. For purposes of making the calculations and determinations required by this Section 5.9, the Tax Counsel may rely on reasonable, good faith assumptions and approximations concerning the application of Section 280G and Section 4999 of the Code. The Company and Baechler shall furnish the Tax Counsel with such information and documents as the Tax Counsel may reasonably request in order to make its determinations under this Section 5.9. The Company shall bear all costs the Tax Counsel may reasonably incur in connection with its services.

 

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6. Cooperation. The parties agree that certain matters in which Baechler will be involved during the Services Term may necessitate Baechler’s cooperation in the future. Accordingly, following the termination of this Agreement for any reason, to the extent reasonably requested by the Board, Baechler shall cooperate with the Company in connection with matters arising out of Baechler’s service to the Company; provided that, the Company shall make reasonable efforts to minimize disruption of Baechler’s other activities. The Company shall reimburse Baechler for reasonable expenses incurred in connection with such cooperation and, to the extent that Baechler is required to spend more than a de minimus amount of time on such matters, the Company shall compensate Baechler at an hourly rate based on Baechler’s Base Remuneration on the Termination Date.

 

7. Confidential Information. Baechler understands and acknowledges that during the Services Term, Baechler will have access to and learn about Confidential Information, as defined below.

 

7.1 Confidential Information Defined.

 

(a) Definition.

 

For purposes of this Agreement, “Confidential Information” includes, but is not limited to, all information not generally known to the public, in spoken, printed, electronic or any other form or medium, including that relating directly or indirectly to: business processes, practices, methods, policies, plans, publications, documents, research, operations, services, strategies, techniques, agreements, contracts, terms of agreements, transactions, potential transactions, negotiations, pending negotiations, know-how, trade secrets, computer programs, computer software, applications, operating systems, software design, web design, work-in-process, databases, manuals, records, articles, systems, material, sources of material, supplier information, vendor information, financial information, results, accounting information, accounting records, legal information, marketing information, advertising information, pricing information, credit information, design information, payroll information, staffing information, personnel information, employee lists, supplier lists, vendor lists, developments, reports, internal controls, security procedures, graphics, drawings, sketches, market studies, sales information, revenue, costs, formulae, notes, communications, algorithms, product plans, designs, styles, models, ideas, audiovisual programs, inventions, unpublished patent applications, original works of authorship, discoveries, experimental processes, experimental results, specifications, customer information, customer lists, client information, client lists, manufacturing information, factory lists, distributor lists, and buyer lists of the Company Group or its businesses or any existing or prospective customer, supplier, investor or other associated third party, or of any other person or entity that has entrusted information to the Company Group in confidence.

 

Baechler understands that the above list is not exhaustive, and that Confidential Information also includes other information that is marked or otherwise identified as confidential or proprietary, or that would otherwise appear to a reasonable person to be confidential or proprietary in the context and circumstances in which the information is known or used.

 

Baechler understands and agrees that Confidential Information includes information developed by Baechler in the course of Baechler’s engagement by the Company as if the Company furnished the same Confidential Information to Baechler in the first instance. Confidential Information shall not include information that is generally available to and known by the public at the time of disclosure to Baechler; provided that, such disclosure is through no direct or indirect fault of Baechler or person(s) acting on Baechler’s behalf.

 

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(b) Company Creation and Use of Confidential Information.

 

Baechler understands and acknowledges that the Company and its affiliates (the “Group”) have invested, and continue to invest, substantial time, money, and specialized knowledge into developing their resources, creating a customer base, generating customer and potential customer lists, training its employees, and improving its offerings and business. Baechler understands and acknowledges that as a result of these efforts, the they have created, and continue to use and create Confidential Information. This Confidential Information provides them with a competitive advantage over others in the marketplace.

 

(c) Disclosure and Use Restrictions.

 

Baechler agrees and covenants: (i) to treat all Confidential Information as strictly confidential; (ii) not to directly or indirectly disclose, publish, communicate, or make available Confidential Information, or allow it to be disclosed, published, communicated, or made available, in whole or part, to any entity or person whatsoever (including other employees of the Group) not having a need to know and authority to know and use the Confidential Information in connection with the business of the Group and, in any event, not to anyone outside of the direct employ of the Group except as required in the performance of Baechler’s duties to the Company or with the prior consent of the Board acting on behalf of the Group in each instance (and then, such disclosure shall be made only within the limits and to the extent of such duties or consent); and (iii) not to access or use any Confidential Information, and not to copy any documents, records, files, media, or other resources containing any Confidential Information, or remove any such documents, records, files, media, or other resources from the premises or control of the Group, except as required in the performance of Baechler’s duties to the Company or with the prior consent of the Board acting on behalf of the Group in each instance (and then, such disclosure shall be made only within the limits and to the extent of such duties or consent). Nothing herein shall be construed to prevent disclosure of Confidential Information as may be required by applicable law or regulation, or pursuant to the valid order of a court of competent jurisdiction or an authorized government agency, provided that the disclosure does not exceed the extent of disclosure required by such law, regulation, or order. Baechler shall promptly provide written notice of any such order to the Board.

 

8. Restrictive Covenants.

 

8.1 Acknowledgement. Baechler understands that the nature of Baechler’s position gives Baechler access to and knowledge of Confidential Information and places Baechler in a position of trust and confidence with the Group. Baechler understands and acknowledges that the intellectual or artistic and other services Baechler provides to the Group are unique, special, or extraordinary because of the unique nature of the automotive and manufacturing industries.

 

Baechler further understands and acknowledges that the Group’s ability to reserve these for the exclusive knowledge and use of the Group is of great competitive importance and commercial value to the Group, and that improper use or disclosure by Baechler is likely to result in unfair or unlawful competitive activity.

 

8.2 Non-Solicitation of Employees. Baechler agrees and covenants not to directly or indirectly solicit, , recruit, or recruit, or induce the termination of employment of any employee of the Group during twelve (12) months, to run consecutively, beginning on Termination Date; provided however that this Section 8.2 does not apply to any such employee that responds to a position opening that is generally advertised and not targeted towards such individual or any employee that contacts Baechler without first being directly or indirectly contacted by Baechler.

 

8.3 Non-Solicitation of Customers. Baechler understands and acknowledges that because of Baechler’s experience with and relationship to the Group, Baechler will have access to and learn about much or all of the Group’s customer information. “Customer Information” includes, but is not limited to, names, phone numbers, addresses, e-mail addresses, order history, order preferences, chain of command, pricing information, and other information identifying facts and circumstances specific to the customer and relevant to sales and/or services.

 

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Baechler understands and acknowledges that loss of this customer relationship and/or goodwill will cause significant and irreparable harm.

 

Baechler agrees and covenants, during eighteen (18) months, to run consecutively, beginning on the last day of Baechler’s engagement with the Company, not to use the Company’s trade secrets to directly or indirectly solicit, contact (including but not limited to e-mail, regular mail, express mail, telephone, fax, and instant message), attempt to contact, or meet with the Company’s current, customers (as of the Termination Date) for purposes of offering or accepting goods or services similar to or competitive with those offered by the Company.

 

9. Non-Disparagement. Baechler and Company each agree and covenants that such party will not at any time make, publish or communicate to any person or entity or in any public forum any defamatory or disparaging remarks, comments, or statements concerning the Group or its businesses, or any of its employees, officers, and investors and other associated third parties or Baechler.

 

This Section 9 does not, in any way, restrict or impede Baechler from exercising protected rights to the extent that such rights cannot be waived by agreement or from complying with any applicable law or regulation or a valid order of a court of competent jurisdiction or an authorized government agency, provided that such compliance does not exceed that required by the law, regulation, or order. Baechler shall promptly provide written notice of any such order to the Board.

 

10. Acknowledgement. Baechler acknowledges and agrees that the services to be rendered by Baechler to the Company are of a special and unique character; that Baechler will obtain knowledge and skill relevant to the Company’s industry, methods of doing business and marketing strategies by virtue of Baechler’s relationship with the Company; and that the restrictive covenants and other terms and conditions of this Agreement are reasonable and reasonably necessary to protect the legitimate business interest of the Group.

 

Baechler further acknowledges that the amount of Baechler’s compensation reflects, in part, Baechler’s obligations and the Company’s rights under Section 7, Section 8, and Section 9 of this Agreement; that Baechler has no expectation of any additional compensation, royalties or other payment of any kind not otherwise referenced herein in connection herewith; and that Baechler will not be subject to undue hardship by reason of Baechler’s full compliance with the terms and conditions of Section 7, Section 8, and Section 9 of this Agreement or the Company’s enforcement thereof.

 

11. Remedies. In the event of a breach or threatened breach by Baechler of Section 7, Section 8, or Section 9 of this Agreement, Baechler hereby consents and agrees that the Company shall be entitled to seek, in addition to other available remedies, a temporary or permanent injunction or other equitable relief against such breach or threatened breach from any court of competent jurisdiction, without the necessity of showing any actual damages or that money damages would not afford an adequate remedy, and without the necessity of posting any bond or other security. The aforementioned equitable relief shall be in addition to, not in lieu of, legal remedies, monetary damages, or other available forms of relief

 

12. Arbitration. Any dispute, controversy, or claim arising out of or related to this Agreement or any breach of this Agreement shall be submitted to and decided by binding arbitration. Arbitration shall be administered exclusively by the American Arbitration Association under its Employment Arbitration Rules and Mediation Procedures and judgment upon the award rendered by the arbitrator(s) may be entered in any court having jurisdiction thereof.. Any arbitral award determination shall be final and binding upon the parties.

 

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13. Proprietary Rights.

 

13.1 Work Product. Baechler acknowledges and agrees that all right, title, and interest in and to all writings, works of authorship, technology, inventions, discoveries, processes, techniques, methods, ideas, concepts, research, proposals, materials, and all other work product of any nature whatsoever, that are created, prepared, produced, authored, edited, amended, conceived, or reduced to practice by Baechler individually or jointly with others during the Services Term and relate in any way to the business or contemplated business, products, activities, research, or development of the Company or result from any work performed by Baechler for the Company (in each case, regardless of when or where prepared or whose equipment or other resources is used in preparing the same), all rights and claims related to the foregoing, and all printed, physical and electronic copies, and other tangible embodiments thereof (collectively, “Work Product”), as well as any and all rights in and to US and foreign (a) patents, patent disclosures and inventions (whether patentable or not), (b) trademarks, service marks, trade dress, trade names, logos, corporate names, and domain names, and other similar designations of source or origin, together with the goodwill symbolized by any of the foregoing, (c) copyrights and copyrightable works (including computer programs), mask works, and rights in data and databases, (d) trade secrets, know-how, and other confidential information, and (e) all other intellectual property rights, in each case whether registered or unregistered and including all registrations and applications for, and renewals and extensions of, such rights, all improvements thereto and all similar or equivalent rights or forms of protection in any part of the world (collectively, “Intellectual Property Rights”), shall be the sole and exclusive property of the Company.

 

For purposes of this Agreement, Work Product includes, but is not limited to, Group information, including plans, publications, research, strategies, techniques, agreements, documents, contracts, terms of agreements, negotiations, know-how, computer programs, computer applications, software design, web design, work in process, databases, manuals, results, developments, reports, graphics, drawings, sketches, market studies, formulae, notes, communications, algorithms, product plans, product designs, styles, models, audiovisual programs, inventions, unpublished patent applications, original works of authorship, discoveries, experimental processes, experimental results, specifications, customer information, client information, customer lists, client lists, manufacturing information, marketing information, advertising information, and sales information.

 

13.2 Work Made for Hire; Assignment. Baechler acknowledges that, by reason of being employed by the Company at the relevant times, to the extent permitted by law, all of the Work Product consisting of copyrightable subject matter is “work made for hire” as defined in 17 U.S.C. § 101 and such copyrights are therefore owned by the Company. To the extent that the foregoing does not apply, Baechler hereby irrevocably assigns to the Company, for no additional consideration, Baechler’s entire right, title, and interest in and to all Work Product and Intellectual Property Rights therein, including the right to sue, counterclaim, and recover for all past, present, and future infringement, misappropriation, or dilution thereof, and all rights corresponding thereto throughout the world. Nothing contained in this Agreement shall be construed to reduce or limit the Company’s rights, title, or interest in any Work Product or Intellectual Property Rights so as to be less in any respect than that the Company would have had in the absence of this Agreement.

 

13.3 Further Assurances; Power of Attorney. During and after the Services Term, Baechler agrees to reasonably cooperate with the Company to (a) apply for, obtain, perfect, and transfer to the Company the Work Product as well as any and all Intellectual Property Rights in the Work Product in any jurisdiction in the world; and (b) maintain, protect and enforce the same, including, without limitation, giving testimony and executing and delivering to the Company any and all applications, oaths, declarations, affidavits, waivers, assignments, and other documents and instruments as shall be requested by the Company. Baechler hereby irrevocably grants the Company power of attorney to execute and deliver any such documents on Baechler’s behalf in Baechler’s name and to do all other lawfully permitted acts to transfer the Work Product to the Company and further the transfer, prosecution, issuance, and maintenance of all Intellectual Property Rights therein, to the full extent permitted by law, if Baechler in physically unable to cooperate with the Company’s request (without limiting the rights the Company shall have in such circumstances by operation of law). The power of attorney is coupled with an interest and shall not be affected by Baechler’s subsequent incapacity.

 

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13.4 No License. Baechler understands that this Agreement does not, and shall not be construed to, grant Baechler any license or right of any nature with respect to any Work Product or Intellectual Property Rights or any Confidential Information, materials, software, or other tools made available to Baechler by the Company.

 

14. Security.

 

14.1 Security and Access. Baechler agrees and covenants (a) to comply with all Group security policies and procedures as in force from time to time including without limitation those regarding computer equipment, telephone systems, voicemail systems, facilities access, monitoring, key cards, access codes, Group intranet, internet, social media and instant messaging systems, computer systems, e-mail systems, computer networks, document storage systems, software, data security, encryption, firewalls, passwords and any and all other Group facilities, IT resources and communication technologies (“Facilities and Information Technology Resources”); (b) not to access or use any Facilities and Information Technology Resources except as authorized by the Company; and (iii) not to access or use any Facilities and Information Technology Resources in any manner after the termination of Baechler’s engagement by the Company, whether termination is voluntary or involuntary. Baechler agrees to notify the Company promptly in the event Baechler learns of any violation of the foregoing by others, or of any other misappropriation or unauthorized access, use, reproduction, or reverse engineering of, or tampering with any Facilities and Information Technology Resources or other Group property or materials by others.

 

14.2 Exit Obligations. Upon (a) voluntary or involuntary termination of this Agreement or (b) the Company’s request at any time during Baechler’s engagement, Baechler shall (i) provide or return to the Company any and all Group property, including keys, key cards, access cards, identification cards, security devices, employer credit cards, network access devices, computers, cell phones, smartphones, PDAs, pagers, fax machines, equipment, speakers, webcams, manuals, reports, files, books, compilations, work product, e-mail messages, recordings, tapes, disks, thumb drives or other removable information storage devices, hard drives, negatives, and data and all Group documents and materials belonging to the Company and stored in any fashion, including but not limited to those that constitute or contain any Confidential Information or Work Product, that are in the possession or control of Baechler, whether they were provided to Baechler by the Group or any of its business associates or created by Baechler in connection with Baechler’s employment by the Company; and (ii) delete or destroy all copies of any such documents and materials not returned to the Company that remain in Baechler’s possession or control, including those stored on any non- Group devices, networks, storage locations, and media in Baechler’s possession or control.

 

15. Publicity. Baechler hereby irrevocably consents to any and all good faith, reasonable uses and displays, by the Group and its agents, representatives and licensees, of Baechler’s name, voice, likeness, image, appearance, and biographical information in, on or in connection with any pictures, photographs, audio and video recordings, digital images, websites, television programs and advertising, other advertising and publicity, sales and marketing brochures, books, magazines, other publications, CDs, DVDs, tapes, and all other printed and electronic forms and media throughout the world, at any time during or after the period of Baechler’s engagement by the Company, for all legitimate commercial and business purposes of the Group (“Permitted Uses”) without further consent from or royalty, payment, or other compensation to Baechler. Baechler hereby forever waives and releases the Group and its directors, officers, employees, and agents from any and all claims, actions, damages, losses, costs, expenses, and liability of any kind, arising under any legal or equitable theory whatsoever at any time during or after the period of Baechler’s engagement by the Company, arising directly or indirectly from the Group’s and its agents’, representatives’, and licensees’ exercise of their rights in connection with any Permitted Uses.

 

16. Governing Law: Jurisdiction and Venue. This Agreement, for all purposes, shall be construed in accordance with the laws of California without regard to conflicts of law principles. To the extent that any action or proceeding by either of the parties to enforce this Agreement is not brought in accordance the arbitration provisions of Section 12 hereof, they shall be brought exclusively in a state or federal court located in Santa Clara County, CA. The parties hereby irrevocably submit to the exclusive jurisdiction of such courts and waive the defense of inconvenient forum to the maintenance of any such action or proceeding in such venue. Nothing contained herein is intended to affect or modify the characterization of Baechler’s relationship with the Company as such relationship may be provided for under California law.

 

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17. Entire Agreement. Unless specifically provided herein, this Agreement contains all of the understandings and representations between Baechler and the Company pertaining to the subject matter hereof and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter. The parties mutually agree that the Agreement can be specifically enforced in court and can be cited as evidence in legal proceedings alleging breach of the Agreement.

 

19. Modification and Waiver. No provision of this Agreement may be amended or modified unless such amendment or modification is agreed to in writing and signed by Baechler and by the Chairman of the Company’s Board of Directors as directed by the Board and/or the Compensation Committee. No waiver by either of the parties of any breach by the other party hereto of any condition or provision of this Agreement to be performed by the other party hereto shall be deemed a waiver of any similar or dissimilar provision or condition at the same or any prior or subsequent time, nor shall the failure of or delay by either of the parties in exercising any right, power, or privilege hereunder operate as a waiver thereof to preclude any other or further exercise thereof or the exercise of any other such right, power, or privilege.

 

20. Severability. Should any provision of this Agreement be held by a court of competent jurisdiction (or pursuant to arbitration under Section 12) to be enforceable only if modified, or if any portion of this Agreement shall be held as unenforceable and thus stricken, such holding shall not affect the validity of the remainder of this Agreement, the balance of which shall continue to be binding upon the parties with any such modification to become a part hereof and treated as though originally set forth in this Agreement.

 

The parties further agree that any such court is expressly authorized to modify any such unenforceable provision of this Agreement in lieu of severing such unenforceable provision from this Agreement in its entirety, whether by rewriting the offending provision, deleting any or all of the offending provision, adding additional language to this Agreement, or by making such other modifications as it deems warranted to carry out the intent and agreement of the parties as embodied herein to the maximum extent permitted by law.

 

The parties expressly agree that this Agreement as so modified shall be binding upon and enforceable against each of them. In any event, should one or more of the provisions of this Agreement be held to be invalid, illegal, or unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect any other provisions hereof, and if such provision or provisions are not modified as provided above, this Agreement shall be construed as if such invalid, illegal, or unenforceable provisions had not been set forth herein.

 

21. Captions. Captions and headings of the sections and paragraphs of this Agreement are intended solely for convenience and no provision of this Agreement is to be construed by reference to the caption or heading of any section or paragraph.

 

22. Counterparts. This Agreement may be executed in separate counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument.

 

23. Tolling. Should Baechler violate any of the terms of the restrictive covenant obligations articulated herein, the obligation at issue will run from the first date on which Baechler ceases to be in violation of such obligation.

 

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24. Section 409A.

 

24.1 General Compliance. This Agreement is intended to comply with Section 409A or an exemption thereunder and shall be construed and administered in accordance with Section 409A. Notwithstanding any other provision of this Agreement, payments provided under this Agreement may only be made upon an event and in a manner that complies with Section 409A or an applicable exemption. Any payments under this Agreement that may be excluded from Section 409A either as separation pay due to an involuntary separation from service or as a short-term deferral shall be excluded from Section 409A to the maximum extent possible. For purposes of Section 409A, each installment payment provided under this Agreement shall be treated as a separate payment. Any payments to be made under this Agreement upon a termination of this Agreement shall only be made upon a “separation from service” under Section 409A. Notwithstanding the foregoing, the Company makes no representations that the payments and benefits provided under this Agreement comply with Section 409A, and in no event shall the Company be liable for all or any portion of any taxes, penalties, interest, or other expenses that may be incurred by Baechler on account of non-compliance with Section 409A.

 

24.2 Specified Employees. Notwithstanding any other provision of this Agreement, if any payment or benefit provided to Baechler in connection with termination of this Agreement is determined to constitute “nonqualified deferred compensation” within the meaning of Section 409A and Baechler is determined to be a “specified employee” as defined in Section 409A(a)(2)(b)(i), then such payment or benefit shall not be paid until the first payroll date to occur following the six-month anniversary of the Termination Date or, if earlier, on Baechler’s death (the “Specified Payment Date”). The aggregate of any payments that would otherwise have been paid before the Specified Payment Date and interest on such amounts calculated based on the applicable federal rate published by the Internal Revenue Service for the month in which Baechler’s separation from service occurs shall be paid to Baechler in a lump sum on the Specified Payment Date and thereafter, any remaining payments shall be paid without delay in accordance with their original schedule. Each payment hereunder shall be treated as a separate payment for purposes of applying Section 409A.

 

24.3 Reimbursements. To the extent required by Section 409A, each reimbursement or in-kind benefit provided under this Agreement shall be provided in accordance with the following:

 

(a) the amount of expenses eligible for reimbursement, or in-kind benefits provided, during each calendar year cannot affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other calendar year;

 

(b) any reimbursement of an eligible expense shall be paid to Baechler on or before the last day of the calendar year following the calendar year in which the expense was incurred; and

 

(c) any right to reimbursements or in-kind benefits under this Agreement shall not be subject to liquidation or exchange for another benefit.

 

24.4 Tax Gross-ups. Any tax gross-up payments provided under this Agreement shall be paid to Baechler on or before December 31 of the calendar year immediately following the calendar year in which Baechler remits the related taxes.

 

24.5 Payments During Release Execution Period. In that the Release Execution Period begins in one calendar year and ends in a subsequent calendar year, any payments that would become payable to Baechler during the Release Execution Period shall be paid on the first regularly scheduled payroll date in such subsequent calendar year.

 

25. Notification to Subsequent Employer. When this Agreement terminates the Company terminates, Baechler agrees to notify any subsequent employer of the restrictive covenants sections contained in this Agreement. Baechler will also deliver a copy of such notice to the Company before Baechler commences employment with any subsequent employer. In addition, Baechler authorizes the Company to provide a copy of the restrictive covenants sections of this Agreement to third parties, including but not limited to, Baechler’s subsequent, anticipated, or possible future employer.

 

26. Successors and Assigns. This Agreement is personal to Baechler and shall not be assigned by Baechler. Any purported assignment by Baechler shall be null and void from the initial date of the purported assignment. The Company may assign this Agreement to any successor or assign (whether direct or indirect, by purchase, merger, consolidation, or otherwise) to all or substantially all of the business or assets of the Company. This Agreement shall inure to the benefit of the Company and permitted successors and assigns.

 

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27. Notice. Notices and all other communications provided for in this Agreement shall be in writing and shall be delivered personally or sent by registered or certified mail, return receipt requested, or by overnight carrier to the parties at the addresses set forth below (or such other addresses as specified by the parties by like notice):

 

If to the Company:

 

Robert-Koch-Strasse 50

55129 Mainz, Germany

Attention: Marco Messina
E-Mail: marco@messina.consulting

 

If to Baechler:

 

Guido Baechler

3150 Porter Drive

Palo Alto CA 94306

Guido.baechler@mainz-biomed.com

 

With a copy (which shall not constitute notice) to:

Adrian M. Rich

Perkins Coie LLP

arich@perkinscoie.com

 

28. Representations of Baechler. Baechler represents and warrants to the Company that:

 

Baechler’s execution of this Agreement and the performance of Baechler’s duties hereunder will not conflict with or result in a violation of, a breach of, or a default under any contract, agreement, or understanding to which Baechler is a party or is otherwise bound. Baechler’s execution of this Agreement with the Company and the performance of Baechler’s duties hereunder will not violate any non-solicitation, non-competition, or other similar covenant or agreement of a prior employer.

 

29. Withholding. The Company shall have the right to withhold from any amount payable hereunder any Federal, state, and local taxes in order for the Company to satisfy any withholding tax obligation it may have under any applicable law or regulation.

 

30. Survival. Upon the expiration or other termination of this Agreement, the respective rights and obligations of the parties hereto shall survive such expiration or other termination to the extent necessary to carry out the intentions of the parties under this Agreement.

 

31. Acknowledgement of Full Understanding. Baechler ACKNOWLEDGES AND AGREES THAT Baechler HAS FULLY READ, UNDERSTANDS AND VOLUNTARILY ENTERS INTO THIS AGREEMENT. Baechler ACKNOWLEDGES AND AGREES THAT Baechler HAS HAD AN OPPORTUNITY TO ASK QUESTIONS AND CONSULT WITH AN ATTORNEY OF Baechler’S CHOICE BEFORE SIGNING THIS AGREEMENT.

 

32. Expenses. Company will reimburse Baechler for legal fees in the amount of up to $7,500 incurred in connection with the review and negotiation of this Agreement. Should Baechler determine in the future that any request by the Company makes it desirable for Baechler to obtain individual counsel, Company shall reimburse the reasonable fees and expenses incurred by Baechler for any such advice.

 

[Signature Page Follows]

 

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

 

 

Mainz Biomed B.V.

     
  By  
  Name:  
  Title:  

 

BAECHLER

 
     
Signature:    
Print Name: Guido Bächler  

 

 

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Exhibit 10.5

 

CONSULTANT AGREEMENT

 

This Consultant Agreement (the “Agreement”) is made and entered into as of July 16, 2021, by and between William Caragol (the “Consultant”) and Mainz Biomed B.V. (the “Company”).

 

WHEREAS, the Company desires to for the Consultant to provide services on the terms and conditions set forth herein; and

 

WHEREAS, the Consultant desires to be employed by the Company on such terms and conditions.

 

NOW, THEREFORE, in consideration of the mutual covenants, promises, and obligations set forth herein, the parties agree as follows:

 

1. Term. The Consultant shall serve as the Chief Financial Officer of the Company and to assist the Company, among other things, in (i) the preparation and review of financial statements and forecasts, and (ii) the preparation and review of the Company’s proposed registration statement on Form F-1, and (iii) all other service typically performed by a Chief Financial Officer (the “Services”) . This Agreement shall be effective as of the date hereof, 2021 (the “Effective Date”). The period during which the Consultant is employed by the Company hereunder is hereinafter referred to as the “Consulting Term.

 

2. Position and Duties.

 

2.1 Position. During the Consulting Term, the Consultant shall report to the Company’s Chief Executive Officer and the Chairperson of the Board of Directors. In providing the Services, the Consultant shall have such duties, authority, and responsibilities as shall be determined from time to time by the CEO and the Board of Directors.

 

2.2 Duties. During the Consulting Term, the Consultant will not engage in any other business, profession, or occupation for compensation or otherwise which would conflict or interfere with the performance of the Services either directly or indirectly without the prior written consent of the Board. The Consultant has disclosed to the Company all of his other business interests and it was mutually agreed that these interests do not conflict with the performance of the Services.

 

3. Place of Performance. The principal place of Consultant’s service shall be mutually agreed by the Consultant and the CEO, provided that, the Consultant will be required to make frequent visits to the Company’s various facilities and may be required to travel on Company business during the Consulting Term. The Consultant shall be responsible for the cost of maintaining his workspace or office at and the costs of operating such office.

 

4. Compensation.

 

4.1 Base Compensation. For the Services, the Company shall pay to the Consultant $15,000 per month (the “Base Compensation”) due hereunder in periodic installments in accordance with the Company’s customary practices and applicable laws, but no less frequently than monthly.

 

4.2 Equity Compensation. On the date of the IPO, the Employee shall be granted options to acquire at the price per ordinary share in the IPO, options (“IPO Options”) to acquire a number of ordinary shares that will equal one percent (1%) of the outstanding ordinary shares immediately following the IPO. The IPO Options are to be granted pursuant to a Stock Option Plan that has been approved by the Board of Directors and shareholders of the Company and will vest over 4 years from the Effective Date in equal monthly installments, provided that the Company’s Board of Directors and the Consultant shall use their best efforts to agree to milestones pursuant to which the number of IPO Options equal to 50% of (i) the all IPO Options less (ii) those IPO Options that vested as of the date such milestones are met shall immediately vest (and shall equally reduce the amount of IPO options to vest each month pursuant to this section).

 

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4.3 Business Expenses. The Consultant shall be entitled to reimbursement for all reasonable and necessary out-of-pocket business, entertainment, and travel expenses incurred by the Consultant in connection with the performance of the Consultant’s duties hereunder in accordance with the Company’s expense reimbursement policies and procedures; provided that any expense above $1,500 shall be first approved by the CEO.

 

4.4 Indemnification. In the event that the Consultant is made a party or threatened to be made a party to any action, suit, or proceeding, whether civil, criminal, administrative, or investigative (a “Proceeding”), other than any Proceeding initiated by the Consultant or the Company related to any contest or dispute between the Consultant and the Company or any of its affiliates with respect to this Agreement or the Consultant’s service hereunder, by reason of the fact that the Consultant is or was a director or officer of the Company, or any affiliate of the Company, or is or was serving at the request of the Company as a director, officer, member, Consultant, or agent of another corporation or a partnership, joint venture, trust, or other enterprise, the Consultant shall be indemnified and held harmless by the Company to the fullest extent applicable to any other officer or director of the Company from and against any liabilities, costs, claims, and expenses, including all costs and expenses incurred in defense of any Proceeding (including attorneys’ fees).

 

4.5 Clawback Provisions. Any amounts payable under this Agreement are subject to any applicable law, government regulation, or stock exchange listing requirement providing for clawback or recovery of amounts that were paid to the Consultant.

 

5. Termination of Consultant. The Consulting Term and the Consultant’s service hereunder may be terminated by either the Company or the Consultant at any time and for any reason; provided that, unless otherwise provided herein, either party shall be required to give the other party at least 10 (ten) days advance written notice of any termination of the Consultant’s service. Upon termination of the Consultant’s service during the Consulting Term, the Consultant shall be entitled to the compensation and benefits described in this Section 5 and shall have no further rights to any compensation or any other benefits from the Company or any of its affiliates.

 

5.1 Expiration of the Term, For Cause or Without Good Reason.

 

(a) The Consultant’s service hereunder may be terminated by the expiration of the Consulting Term, by Company for Cause or by the Consultant without Good Reason. If the Consultant’s service is terminated upon the expiration of the Consulting Term, by the Company for Cause or by the Consultant without Good Reason, the Consultant shall be entitled to receive within two (2) weeks following the Termination Date (as defined below):

 

(i) any accrued but unpaid Base Compensation;

 

(ii) reimbursement for unreimbursed business expenses properly incurred by the Consultant, which shall be subject to and paid in accordance with the Company’s expense reimbursement policy; and

 

Items 5.1(a)(i) through 5.1(a)(ii) are referred to herein collectively as the “Accrued Amounts”.

 

(b) For purposes of this Agreement, “Cause” shall mean:

 

(i) the Consultant’s failure to perform Consultant’s duties (other than any such failure resulting from incapacity due to physical or mental illness);

 

(ii) the Consultant’s failure to comply with any valid and legal directive of the Board;

 

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(iii) the Consultant’s engagement in dishonesty, illegal conduct, or misconduct, which is, in each case, injurious to the Company or its affiliates;

 

(iv) the Consultant’s embezzlement, misappropriation, or fraud, whether or not related to the Consultant’s service with the Company and whether or not occurring during the Consulting Term;

 

(v) the Consultant’s conviction of or plea of guilty or nolo contendere to a crime that constitutes a felony (or state law equivalent) or a crime that constitutes a misdemeanor involving moral turpitude;

 

(vi) the Consultant’s violation of a material policy of the Company;

 

(vii) the Consultant’s unauthorized disclosure of Confidential Information (as defined below);

 

(viii) the Consultant’s material breach of any material obligation under this Agreement or any other written agreement between the Consultant and the Company; or

 

(ix) any material failure by the Consultant to comply with the Company’s written policies or rules, as they may be in effect from time to time during the Consulting Term.

 

(c) For purposes of this Agreement, “Good Reason” shall mean the occurrence of any of the following, in each case during the Consulting Term without the Consultant’s written consent:

 

(i) a material reduction in the Consultant’s Base Compensation (other than a general reduction in Base Compensation that affects all similarly situated consultants in substantially the same proportions);

 

(ii) any material breach by the Company of any material provision of this Agreement or any material provision of any other agreement between the Consultant and the Company;

 

The Consultant cannot terminate Consultant’s service for Good Reason unless Consultant has provided written notice to the Company of the existence of the circumstances providing grounds for termination for Good Reason within 10 (ten) days of the initial existence of such grounds and the Company has had at least 10 (ten) days from the date on which such notice is provided to cure such circumstances. If the Consultant does not terminate Consultant’s service for Good Reason within 10 (ten) days after the first occurrence of the applicable grounds, then the Consultant will be deemed to have waived Consultant’s right to terminate for Good Reason with respect to such grounds.

 

5.2 Termination Without Cause or for Good Reason. The Consulting Term and the Consultant’s service hereunder may be terminated by the Consultant for Good Reason or by the Company without Cause. In the event of such termination, the Consultant shall be entitled to receive the Accrued Amounts and subject to the Consultant’s compliance with Section 6Section 7Section 8, and Section 9 of this Agreement and the Consultant’s execution of a release of claims in favor of the Company, its affiliates and their respective officers and directors in a form provided by the Company (the “Release”) and such Release becoming effective within 60 days following the Termination Date (such 60-day period, the “Release Execution Period”), the Consultant shall be entitled to receive the following:

 

(a) equal installment payments payable in accordance with the Company’s normal payroll practices, but no less frequently than monthly, which are in the aggregate equal to 1 (one) times the sum of the Consultant’s Base Compensation for the year in which the Termination Date occurs, which shall begin within 30 (thirty) days following the Termination Date; provided that, the first installment payment shall include all amounts that would otherwise have been paid to the Consultant during the period beginning on the Termination Date and ending on the first payment date if no delay had been imposed;

 

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(b) Accelerated vesting for any stock options outstanding at the time of the Termination Date that would have vested in the six months following the Termination Date.

 

5.3 Death or Disability.

 

(a) The Consultant’s service hereunder shall terminate automatically upon the Consultant’s death during the Consulting Term, and the Company may terminate the Consultant’s service on account of the Consultant’s Disability.

 

(b) If the Consultant’s service is terminated during the Consulting Term on account of the Consultant’s death or Disability, the Consultant (or the Consultant’s estate and/or beneficiaries, as the case may be) shall be entitled to receive the Accrued Amounts. Notwithstanding any other provision contained herein, all payments made in connection with the Consultant’s Disability shall be provided in a manner which is consistent with federal and state law.

 

(c) For purposes of this Agreement, “Disability” shall mean the Consultant’s inability, due to physical or mental incapacity, to perform the essential functions of Consultant’s job, with or without reasonable accommodation, for one hundred eighty (180) days out of any three hundred sixty-five (365) day period or one hundred twenty (120) consecutive days. Any question as to the existence of the Consultant’s Disability as to which the Consultant and the Company cannot agree shall be determined in writing by a qualified independent physician mutually acceptable to the Consultant and the Company. If the Consultant and the Company cannot agree as to a qualified independent physician, each shall appoint such a physician and those two physicians shall select a third who shall make such determination in writing. The determination of Disability made in writing to the Company and the Consultant shall be final and conclusive for all purposes of this Agreement.

 

5.4 Notice of Termination. Any termination of the Consultant’s service hereunder by the Company or by the Consultant during the Consulting Term (other than termination pursuant to Section 5.3(a) on account of the Consultant’s death) shall be communicated by written notice of termination (“Notice of Termination”) to the other party hereto in accordance with Section 27. The Notice of Termination shall specify:

 

(a) The termination provision of this Agreement relied upon;

 

(b) To the extent applicable, the facts and circumstances claimed to provide a basis for termination of the Consultant’s service under the provision so indicated; and

 

(c) The applicable Termination Date.

 

5.5 Termination Date. The Consultant’s “Termination Date” shall be:

 

(a) If the Consultant’s service hereunder terminates on account of the Consultant’s death, the date of the Consultant’s death;

 

(b) If the Consultant’s service hereunder is terminated on account of the Consultant’s Disability, the date that it is determined that the Consultant has a Disability;

 

(c) If the Company terminates the Consultant’s service hereunder for Cause, the date the Notice of Termination is delivered to the Consultant;

 

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(d) If the Company terminates the Consultant’s service hereunder without Cause, the date specified in the Notice of Termination, which shall be no less than 10 (ten) days following the date on which the Notice of Termination is delivered; provided that, the Company shall have the option to provide the Consultant with a lump sum payment equal to 10 (ten) days’ Base Compensation in lieu of such notice, which shall be paid in a lump sum on the Consultant’s Termination Date and for all purposes of this Agreement, the Consultant’s Termination Date shall be the date on which such Notice of Termination is delivered;

 

(e) If the Consultant terminates Consultant’s service hereunder with or without Good Reason, the date specified in the Consultant’s Notice of Termination, which shall be no less than 10 (ten) days following the date on which the Notice of Termination is delivered; provided that, the Company may waive all or any part of the 10 (ten) day notice period for no consideration by giving written notice to the Consultant and for all purposes of this Agreement, the Consultant’s Termination Date shall be the date determined by the Company; and

 

Notwithstanding anything contained herein, the Termination Date shall not occur until the date on which the Consultant incurs a “separation from service” within the meaning of Section 409A.

 

5.6 Resignation of All Other Positions. Upon termination of the Consultant’s service hereunder for any reason, the Consultant shall be deemed to have resigned from all positions that the Consultant holds as an officer or member of the Board (or a committee thereof) of the Company or any of its affiliates (unless otherwise agreed to by a majority of the Board).

 

6. Cooperation. The parties agree that certain matters in which the Consultant will be involved during the Consulting Term may necessitate the Consultant’s cooperation in the future. Accordingly, following the termination of the Consultant’s service for any reason, to the extent reasonably requested by the Board, the Consultant shall cooperate with the Company in connection with matters arising out of the Consultant’s service to the Company; provided that, the Company shall make reasonable efforts to minimize disruption of the Consultant’s other activities. The Company shall reimburse the Consultant for reasonable expenses incurred in connection with such cooperation and, to the extent that the Consultant is required to spend substantial time on such matters, the Company shall compensate the Consultant at a rate based on the Consultant’s Base Compensation on the Termination Date.

 

7.  Confidential Information. The Consultant understands and acknowledges that during the Consulting Term, Consultant will have access to and learn about Confidential Information, as defined below.

 

7.1 Confidential Information Defined.

 

(a) Definition.

 

For purposes of this Agreement, “Confidential Information” includes, but is not limited to, all information not generally known to the public, in spoken, printed, electronic or any other form or medium, including that relating directly or indirectly to: business processes, practices, methods, policies, plans, publications, documents, research, operations, service, strategies, techniques, agreements, contracts, terms of agreements, transactions, potential transactions, negotiations, pending negotiations, know-how, trade secrets, computer programs, computer software, applications, operating systems, software design, web design, work-in-process, databases, manuals, records, articles, systems, material, sources of material, supplier information, vendor information, financial information, results, accounting information, accounting records, legal information, marketing information, advertising information, pricing information, credit information, design information, payroll information, staffing information, personnel information, Consultant lists, supplier lists, vendor lists, developments, reports, internal controls, security procedures, graphics, drawings, sketches, market studies, sales information, revenue, costs, formulae, notes, communications, algorithms, product plans, designs, styles, models, ideas, audiovisual programs, inventions, unpublished patent applications, original works of authorship, discoveries, experimental processes, experimental results, specifications, customer information, customer lists, client information, client lists, manufacturing information, factory lists, distributor lists, and buyer lists of the Company Group or its businesses or any existing or prospective customer, supplier, investor or other associated third party, or of any other person or entity that has entrusted information to the Company Group in confidence.

 

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The Consultant understands that the above list is not exhaustive, and that Confidential Information also includes other information that is marked or otherwise identified as confidential or proprietary, or that would otherwise appear to a reasonable person to be confidential or proprietary in the context and circumstances in which the information is known or used.

 

The Consultant understands and agrees that Confidential Information includes information developed by Consultant in the course of Consultant’s service to the Company as if the Company furnished the same Confidential Information to the Consultant in the first instance. Confidential Information shall not include information that is generally available to and known by the public at the time of disclosure to the Consultant; provided that, such disclosure is through no direct or indirect fault of the Consultant or person(s) acting on the Consultant’s behalf.

 

(b) Company Creation and Use of Confidential Information.

 

The Consultant understands and acknowledges that the Company and its affiliates (the “Group”) have invested, and continue to invest, substantial time, money, and specialized knowledge into researching, developing and commercializing its property and assets. The Consultant understands and acknowledges that as a result of these efforts, the Company has created, and continues to use and create Confidential Information. This Confidential Information provides them with a competitive advantage over others in the marketplace.

 

(c) Disclosure and Use Restrictions.

 

The Consultant agrees and covenants: (i) to treat all Confidential Information as strictly confidential; (ii) not to directly or indirectly disclose, publish, communicate, or make available Confidential Information, or allow it to be disclosed, published, communicated, or made available, in whole or part, to any entity or person whatsoever (including other Consultants of the Group) not having a need to know and authority to know and use the Confidential Information in connection with the business of the Group and, in any event, not to anyone outside of the direct employ of the Group except as required in the performance of the Consultant’s authorized Consulting duties to the Company or with the prior consent of the Board acting on behalf of the Group in each instance (and then, such disclosure shall be made only within the limits and to the extent of such duties or consent); and (iii) not to access or use any Confidential Information, and not to copy any documents, records, files, media, or other resources containing any Confidential Information, or remove any such documents, records, files, media, or other resources from the premises or control of the Group, except as required in the performance of the Consultant’s authorized Consulting duties to the Company or with the prior consent of the Board acting on behalf of the Group in each instance (and then, such disclosure shall be made only within the limits and to the extent of such duties or consent). Nothing herein shall be construed to prevent disclosure of Confidential Information as may be required by applicable law or regulation, or pursuant to the valid order of a court of competent jurisdiction or an authorized government agency, provided that the disclosure does not exceed the extent of disclosure required by such law, regulation, or order. The Consultant shall promptly provide written notice of any such order to the Board.

 

8. Restrictive Covenants.

 

8.1 Acknowledgement. The Consultant understands that the nature of the Consultant’s position gives Consultant access to and knowledge of Confidential Information and places Consultant in a position of trust and confidence with the Group. The Consultant understands and acknowledges that the intellectual or artistic and other service Consultant provides to the Group are unique, special, or extraordinary because of the unique nature of the automotive and manufacturing industries.

 

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The Consultant further understands and acknowledges that the Group’s ability to reserve these for the exclusive knowledge and use of the Group is of great competitive importance and commercial value to the Group, and that improper use or disclosure by the Consultant is likely to result in unfair or unlawful competitive activity.

 

8.2 Non-Competition. Because of the Group’s legitimate business interest as described herein and the good and valuable consideration offered to the Consultant, during the Consulting Term and for the six months, to run consecutively, beginning on the last day of the Consultant’s service with the Company, for any reason or no reason and whether Consulting is terminated at the option of the Consultant or the Group, the Consultant agrees and covenants not to engage in Prohibited Activity.

 

For purposes of this Section 8, “Prohibited Activity” is activity in which the Consultant contributes Consultant’s knowledge, directly or indirectly, in whole or in part, as an Consultant, employer, owner, operator, manager, advisor, consultant, agent, Consultant, partner, director, stockholder, officer, volunteer, intern, or any other similar capacity to an entity engaged in the same or similar business as the Group, including those engaged in the pharmaceutical industry or the material businesses of the Company as set out in its filings with the U.S. Securities and Exchange Commission. Prohibited Activity also includes activity that may require or inevitably requires disclosure of trade secrets, proprietary information, or Confidential Information.

 

Nothing herein shall prohibit the Consultant from purchasing or owning less than five percent (5%) of the publicly traded securities of any corporation, provided that such ownership represents a passive investment and that the Consultant is not a controlling person of, or a member of a group that controls, such corporation.

 

This Section 8 does not, in any way, restrict or impede the Consultant from exercising protected rights to the extent that such rights cannot be waived by agreement or from complying with any applicable law or regulation or a valid order of a court of competent jurisdiction or an authorized government agency, provided that such compliance does not exceed that required by the law, regulation, or order. The Consultant shall promptly provide written notice of any such order to the Board.

 

8.3 Non-Solicitation of Consultants. The Consultant agrees and covenants not to directly or indirectly solicit, hire, recruit, attempt to hire or recruit, or induce the termination of Consulting of any Consultant of the Group during eighteen (18) months, to run consecutively, beginning on the last day of the Consultant’s service with the Company.

 

8.4 Non-Solicitation of Customers. The Consultant understands and acknowledges that because of the Consultant’s experience with and relationship to the Group, Consultant will have access to and learn about much or all of the Group’s customer information. “Customer Information” includes, but is not limited to, names, phone numbers, addresses, e-mail addresses, order history, order preferences, chain of command, pricing information, and other information identifying facts and circumstances specific to the customer and relevant to sales and/or service.

 

The Consultant understands and acknowledges that loss of this customer relationship and/or goodwill will cause significant and irreparable harm.

 

The Consultant agrees and covenants, during twenty-four (24) months, to run consecutively, beginning on the last day of the Consultant’s service with the Company, not to directly or indirectly solicit, contact (including but not limited to e-mail, regular mail, express mail, telephone, fax, and instant message), attempt to contact, or meet with the Company’s current, former or prospective customers for purposes of offering or accepting goods or service similar to or competitive with those offered by the Company.

 

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9. Non-Disparagement. The Consultant and Company mutually agree and covenants that they will not at any time make, publish or communicate to any person or entity or in any public forum any defamatory or disparaging remarks, comments, or statements concerning the Group or its businesses, or any of its Consultants, officers, and existing and prospective customers, suppliers, investors and other associated third parties.

 

This Section 9 does not, in any way, restrict or impede the Consultant from exercising protected rights to the extent that such rights cannot be waived by agreement or from complying with any applicable law or regulation or a valid order of a court of competent jurisdiction or an authorized government agency, provided that such compliance does not exceed that required by the law, regulation, or order. The Consultant shall promptly provide written notice of any such order to the Board.

 

10. Acknowledgement. The Consultant acknowledges and agrees that the service to be rendered by Consultant to the Company are of a special and unique character; that the Consultant will obtain knowledge and skill relevant to the Company’s industry, methods of doing business and marketing strategies by virtue of the Consultant’s service; and that the restrictive covenants and other terms and conditions of this Agreement are reasonable and reasonably necessary to protect the legitimate business interest of the Group.

 

The Consultant further acknowledges that the amount of Consultant’s compensation reflects, in part, Consultant’s obligations and the Company’s rights under Section 7, Section 8, and Section 9 of this Agreement; that Consultant has no expectation of any additional compensation, royalties or other payment of any kind not otherwise referenced herein in connection herewith; and that Consultant will not be subject to undue hardship by reason of Consultant’s full compliance with the terms and conditions of Section 7, Section 8, and Section 9 of this Agreement or the Company’s enforcement thereof.

 

11. Remedies. In the event of a breach or threatened breach by the Consultant of Section 7, Section 8, or Section 9 of this Agreement, the Consultant hereby consents and agrees that the Company shall be entitled to seek, in addition to other available remedies, a temporary or permanent injunction or other equitable relief against such breach or threatened breach from any court of competent jurisdiction, without the necessity of showing any actual damages or that money damages would not afford an adequate remedy, and without the necessity of posting any bond or other security. The aforementioned equitable relief shall be in addition to, not in lieu of, legal remedies, monetary damages, or other available forms of relief.

 

12. [Reserved].

 

13. Proprietary Rights.

 

13.1 Work Product. The Consultant acknowledges and agrees that all right, title, and interest in and to all writings, works of authorship, technology, inventions, discoveries, processes, techniques, methods, ideas, concepts, research, proposals, materials, and all other work product of any nature whatsoever, that are created, prepared, produced, authored, edited, amended, conceived, or reduced to practice by the Consultant individually or jointly with others during the provision of Consultant’s service to the Company and relate in any way to the business or contemplated business, products, activities, research, or development of the Company or result from any work performed by the Consultant for the Company (in each case, regardless of when or where prepared or whose equipment or other resources is used in preparing the same), all rights and claims related to the foregoing, and all printed, physical and electronic copies, and other tangible embodiments thereof (collectively, “Work Product”), as well as any and all rights in and to US and foreign (a) patents, patent disclosures and inventions (whether patentable or not), (b) trademarks, service marks, trade dress, trade names, logos, corporate names, and domain names, and other similar designations of source or origin, together with the goodwill symbolized by any of the foregoing, (c) copyrights and copyrightable works (including computer programs), mask works, and rights in data and databases, (d) trade secrets, know-how, and other confidential information, and (e) all other intellectual property rights, in each case whether registered or unregistered and including all registrations and applications for, and renewals and extensions of, such rights, all improvements thereto and all similar or equivalent rights or forms of protection in any part of the world (collectively, “Intellectual Property Rights”), shall be the sole and exclusive property of the Company.

 

8

 

 

For purposes of this Agreement, Work Product includes, but is not limited to, Group information, including plans, publications, research, strategies, techniques, agreements, documents, contracts, terms of agreements, negotiations, know-how, computer programs, computer applications, software design, web design, work in process, databases, manuals, results, developments, reports, graphics, drawings, sketches, market studies, formulae, notes, communications, algorithms, product plans, product designs, styles, models, audiovisual programs, inventions, unpublished patent applications, original works of authorship, discoveries, experimental processes, experimental results, specifications, customer information, client information, customer lists, client lists, manufacturing information, marketing information, advertising information, and sales information.

 

13.2 Work Made for Hire; Assignment. The Consultant acknowledges that, by reason of being employed by the Company at the relevant times, to the extent permitted by law, all of the Work Product consisting of copyrightable subject matter is “work made for hire” as defined in 17 U.S.C. § 101 and such copyrights are therefore owned by the Company. To the extent that the foregoing does not apply, the Consultant hereby irrevocably assigns to the Company, for no additional consideration, the Consultant’s entire right, title, and interest in and to all Work Product and Intellectual Property Rights therein, including the right to sue, counterclaim, and recover for all past, present, and future infringement, misappropriation, or dilution thereof, and all rights corresponding thereto throughout the world. Nothing contained in this Agreement shall be construed to reduce or limit the Company’s rights, title, or interest in any Work Product or Intellectual Property Rights so as to be less in any respect than that the Company would have had in the absence of this Agreement.

 

13.3 Further Assurances; Power of Attorney. During and after Consultant’s service, the Consultant agrees to reasonably cooperate with the Company to (a) apply for, obtain, perfect, and transfer to the Company the Work Product as well as any and all Intellectual Property Rights in the Work Product in any jurisdiction in the world; and (b) maintain, protect and enforce the same, including, without limitation, giving testimony and executing and delivering to the Company any and all applications, oaths, declarations, affidavits, waivers, assignments, and other documents and instruments as shall be requested by the Company. The Consultant hereby irrevocably grants the Company power of attorney to execute and deliver any such documents on the Consultant’s behalf in Consultant’s name and to do all other lawfully permitted acts to transfer the Work Product to the Company and further the transfer, prosecution, issuance, and maintenance of all Intellectual Property Rights therein, to the full extent permitted by law, if the Consultant does not promptly cooperate with the Company’s request (without limiting the rights the Company shall have in such circumstances by operation of law). The power of attorney is coupled with an interest and shall not be affected by the Consultant’s subsequent incapacity.

 

13.4 No License. The Consultant understands that this Agreement does not, and shall not be construed to, grant the Consultant any license or right of any nature with respect to any Work Product or Intellectual Property Rights or any Confidential Information, materials, software, or other tools made available to Consultant by the Company.

 

14. Security.

 

14.1 Security and Access. The Consultant agrees and covenants (a) to comply with all Group security policies and procedures as in force from time to time including without limitation those regarding computer equipment, telephone systems, voicemail systems, facilities access, monitoring, key cards, access codes, Group intranet, internet, social media and instant messaging systems, computer systems, e-mail systems, computer networks, document storage systems, software, data security, encryption, firewalls, passwords and any and all other Group facilities, IT resources and communication technologies (“Facilities and Information Technology Resources”); (b) not to access or use any Facilities and Information Technology Resources except as authorized by the Company; and (iii) not to access or use any Facilities and Information Technology Resources in any manner after the termination of the Consultant’s service by the Company, whether termination is voluntary or involuntary. The Consultant agrees to notify the Company promptly in the event Consultant learns of any violation of the foregoing by others, or of any other misappropriation or unauthorized access, use, reproduction, or reverse engineering of, or tampering with any Facilities and Information Technology Resources or other Group property or materials by others.

 

9

 

 

14.2 Exit Obligations. Upon (a) voluntary or involuntary termination of the Consultant’s service or (b) the Company’s request at any time during the Consultant’s service, the Consultant shall (i) provide or return to the Company any and all Group property, including keys, key cards, access cards, identification cards, security devices, employer credit cards, network access devices, computers, cell phones, smartphones, PDAs, pagers, fax machines, equipment, speakers, webcams, manuals, reports, files, books, compilations, work product, e-mail messages, recordings, tapes, disks, thumb drives or other removable information storage devices, hard drives, negatives, and data and all Group documents and materials belonging to the Company and stored in any fashion, including but not limited to those that constitute or contain any Confidential Information or Work Product, that are in the possession or control of the Consultant, whether they were provided to the Consultant by the Group or any of its business associates or created by the Consultant in connection with Consultant’s service to the Company; and (ii) delete or destroy all copies of any such documents and materials not returned to the Company that remain in the Consultant’s possession or control, including those stored on any non- Group devices, networks, storage locations, and media in the Consultant’s possession or control.

 

15. Publicity. The Consultant hereby irrevocably consents to any and all uses and displays, by the Group and its agents, representatives and licensees, of the Consultant’s name, voice, likeness, image, appearance, and biographical information in, on or in connection with any pictures, photographs, audio and video recordings, digital images, websites, television programs and advertising, other advertising and publicity, sales and marketing brochures, books, magazines, other publications, CDs, DVDs, tapes, and all other printed and electronic forms and media throughout the world, at any time during or after the period of Consultant’s service to the Company, for all legitimate commercial and business purposes of the Group (“Permitted Uses”) without further consent from or royalty, payment, or other compensation to the Consultant. The Consultant hereby forever waives and releases the Group and its directors, officers, Consultants, and agents from any and all claims, actions, damages, losses, costs, expenses, and liability of any kind, arising under any legal or equitable theory whatsoever at any time during or after the period of Consultant’s service to the Company, arising directly or indirectly from the Group’s and its agents’, representatives’, and licensees’ exercise of their rights in connection with any Permitted Uses.

 

16. Governing Law: Jurisdiction and Venue. This Agreement, for all purposes, shall be construed in accordance with the laws of Delaware without regard to conflicts of law principles. Any action or proceeding by either of the parties to enforce this Agreement shall be brought exclusively in a state or federal court located in New York County, New York. The parties hereby irrevocably submit to the exclusive jurisdiction of such courts for purposes of this Agreement and waive the defense of inconvenient forum to the maintenance of any such action or proceeding in such venue.

 

17. Entire Agreement. Unless specifically provided herein, this Agreement contains all of the understandings and representations between the Consultant and the Company pertaining to the subject matter hereof and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter. The parties mutually agree that the Agreement can be specifically enforced in court and can be cited as evidence in legal proceedings alleging breach of the Agreement.

 

19. Modification and Waiver. No provision of this Agreement may be amended or modified unless such amendment or modification is agreed to in writing and signed by the Consultant and by the Chairman of the Company’s Board of Directors as directed by the Board and the Compensation Committee. No waiver by either of the parties of any breach by the other party hereto of any condition or provision of this Agreement to be performed by the other party hereto shall be deemed a waiver of any similar or dissimilar provision or condition at the same or any prior or subsequent time, nor shall the failure of or delay by either of the parties in exercising any right, power, or privilege hereunder operate as a waiver thereof to preclude any other or further exercise thereof or the exercise of any other such right, power, or privilege.

 

20. Severability. Should any provision of this Agreement be held by a court of competent jurisdiction (or pursuant to arbitration under Section 12) to be enforceable only if modified, or if any portion of this Agreement shall be held as unenforceable and thus stricken, such holding shall not affect the validity of the remainder of this Agreement, the balance of which shall continue to be binding upon the parties with any such modification to become a part hereof and treated as though originally set forth in this Agreement.

 

The parties further agree that any such court is expressly authorized to modify any such unenforceable provision of this Agreement in lieu of severing such unenforceable provision from this Agreement in its entirety, whether by rewriting the offending provision, deleting any or all of the offending provision, adding additional language to this Agreement, or by making such other modifications as it deems warranted to carry out the intent and agreement of the parties as embodied herein to the maximum extent permitted by law.

 

10

 

 

The parties expressly agree that this Agreement as so modified shall be binding upon and enforceable against each of them. In any event, should one or more of the provisions of this Agreement be held to be invalid, illegal, or unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect any other provisions hereof, and if such provision or provisions are not modified as provided above, this Agreement shall be construed as if such invalid, illegal, or unenforceable provisions had not been set forth herein.

 

21. Captions. Captions and headings of the sections and paragraphs of this Agreement are intended solely for convenience and no provision of this Agreement is to be construed by reference to the caption or heading of any section or paragraph.

 

22. Counterparts. This Agreement may be executed in separate counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument.

 

23. Tolling. Should the Consultant violate any of the terms of the restrictive covenant obligations articulated herein, the obligation at issue will run from the first date on which the Consultant ceases to be in violation of such obligation.

24. Notification to Subsequent Employer. When the Consultant’s service with the Company terminates, the Consultant agrees to notify any subsequent employer of the restrictive covenants sections contained in this Agreement. The Consultant will also deliver a copy of such notice to the Company before the Consultant commences Consulting with any subsequent employer. In addition, the Consultant authorizes the Company to provide a copy of the restrictive covenants sections of this Agreement to third parties, including but not limited to, the Consultant’s subsequent, anticipated, or possible future employer.

 

25. Successors and Assigns. This Agreement is personal to the Consultant and shall not be assigned by the Consultant. Any purported assignment by the Consultant shall be null and void from the initial date of the purported assignment. The Company may assign this Agreement to any successor or assign (whether direct or indirect, by purchase, merger, consolidation, or otherwise) to all or substantially all of the business or assets of the Company. This Agreement shall inure to the benefit of the Company and permitted successors and assigns.

 

26. Notice. Notices and all other communications provided for in this Agreement shall be in writing and shall be delivered personally or sent by registered or certified mail, return receipt requested, or by overnight carrier to the parties at the addresses set forth below (or such other addresses as specified by the parties by like notice):

 

If to the Company:

 

Mainz Biomed B.V.

Robert Koch Strasse 50

55129 Mainz, Germany

Attn: Guido Baechler

 

If to the Consultant:

 

William Caragol

[address]

Email: bill@quidemllc.com 

 

27. Representations of the Consultant. The Consultant represents and warrants to the Company that:

 

The Consultant’s acceptance of Consulting with the Company and the performance of Consultant’s duties hereunder will not conflict with or result in a violation of, a breach of, or a default under any contract, agreement, or understanding to which Consultant is a party or is otherwise bound. The Consultant’s acceptance of Consulting with the Company and the performance of Consultant’s duties hereunder will not violate any non-solicitation, non-competition, or other similar covenant or agreement of a prior employer.

 

28. Withholding. The Company shall have the right to withhold from any amount payable hereunder any Federal, state, and local taxes in order for the Company to satisfy any withholding tax obligation it may have under any applicable law or regulation.

 

29. Survival. Upon the expiration or other termination of this Agreement, the respective rights and obligations of the parties hereto shall survive such expiration or other termination to the extent necessary to carry out the intentions of the parties under this Agreement.

 

30. Acknowledgement of Full Understanding. THE CONSULTANT ACKNOWLEDGES AND AGREES THAT CONSULTANT HAS FULLY READ, UNDERSTANDS AND VOLUNTARILY ENTERS INTO THIS AGREEMENT. THE CONSULTANT ACKNOWLEDGES AND AGREES THAT CONSULTANT HAS HAD AN OPPORTUNITY TO ASK QUESTIONS AND CONSULT WITH AN ATTORNEY OF CONSULTANT’S CHOICE BEFORE SIGNING THIS AGREEMENT.

 

[SIGNATURE PAGE TO FOLLOW]

 

11

 

 

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

 

  Mainz Biomed B.V.
   
  By  
  Name:  
  Title:  

 

CONSULTANT  
   
Signature:    
Print Name:    

 

 

12

 

 

Exhibit 10.6

 

Geschäftsführer-Dienstvertrag

 

zwischen

 

der Mainz Biomed B.V. mit Sitz in Amsterdam, Geschäftsanschrift: Robert-Koch-Str. 50, 55129 Mainz, vertreten durch die Gesellschafterversammlung, diese wiederum vertreten durch Herrn Marco Messina,

 

– nachfolgend auch: „Gesellschaft“ –

 

und

 

Herrn Dr. Moritz Eidens, Am Emmerling Park 22, 55218 Ingelheim,

 

– nachfolgend auch: „Geschäftsführer“ –

 

– nachfolgend beide gemeinsam: „die Parteien“ – 

Management Services Agreement

 

between

 

Mainz Biomed B.V. based in Amsterdam, company address: Robert-Koch-Str. 50, 55129 Mainz, Germany, represented by the shareholders’ meeting, which is in turn represented by Mr Marco Messina,

 

hereinafter also referred to as ’Company’ –

 

and

 

Dr Moritz Eidens, Am Emmerling Park 22, 55218 Ingelheim, Germany,

 

– hereinafter also referred to as ’Director‘ –

 

– hereinafter both together referred to as ‘the Parties’ –

Präambel

 

Herr Dr. Eidens ist Geschäftsführer der PharmGenomics GmbH mit Sitz in Mainz, eingetragen im Handelsregister des Amtsgerichts Mainz unter HRB 41529. Er hat dieses Unternehmen im Jahr 2008 als Gesellschafter mitgegründet und hält derzeit noch ca. 11,5% der Geschäftsanteile.

 

Die Mainz Biomed B.V. ist eine Gesellschaft mit beschränkter Haftung nach niederländischem Recht (besloten vennootschap met beperkte aansprakelijkheid – B.V.) und hat ihren Sitz in Amsterdam. Sie ist im Handelsregister der Niederlande unter der Nummer 82116296 eingetragen.

Preamble

 

Dr Eidens is Managing Director of PharmGenomics GmbH, which is based in Mainz and registered in the Commercial Register of the Local Court of Mainz under HRB 41529. He co-founded this company in 2008 as a shareholder and currently still holds approximately 11.5% of the shares.

 

Mainz Biomed B.V. is a limited liability company under Dutch law (besloten vennootschap met beperkte aansprakelijkheid – B.V.) and has its registered office in Amsterdam. It is registered in the commercial register of the Netherlands under number 82116296.

 

page 1 of 13

 

 

Die Gesellschafter der PharmGenomics GmbH werden auf der Grundlage des „Contribution Agreements“ vom [Datum] ihre Geschäftsanteile gegen Geschäftsanteile der Mainz Biomed B.V. tauschen und so zu Gesellschaftern der Mainz Biomed B.V. werden. Die PharmGenomics GmbH wird hierdurch eine 100%ige Tochtergesellschaft der Mainz Biomed B.V.

 

Herr Dr. Eidens bleibt Geschäftsführer der PharmGenomics GmbH. Zudem ist beabsichtigt, dass die Gesellschafterversammlung Herrn Dr. Eidens gem. Ziff. 4.2 (b) (iv) des Contribution Agreements vom [Datum] zum Geschäftsführer der Mainz Biomed B.V. bestellt.

 

Die Gesellschafter der Mainz Biomed B.V. beabsichtigen, die Gesellschaft in naher Zukunft in eine Aktiengesellschaft nach niederländischem Recht (naamloze vennootschap – N.V.) umzuwandeln und die Zulassung der Aktien der N.V. zur Notierung an der Nasdaq in New York zu beantragen. Zwischen den Parteien besteht Einigkeit, dass Herr Dr. Eidens mit dem Wirksamwerden der Umwandlung zum Vorstandsmitglied der N.V. bestellt werden wird (Wissenschaftlicher Vorstand / Chief Scientific Officer – CSO). Dieser Dienstvertrag wird – soweit rechtlich möglich – für das Dienstverhältnis mit der N.V. fortgelten. Die Parteien werden zeitnah die erforderlichen Anpassungen vornehmen, wobei Herrn Dr. Eidens mindestens die Konditionen gewährt werden, die dieser Dienstvertrag vorsieht.

 

Die Parteien beabsichtigen allein, einen Dienstvertrag zu den in diesem Vertrag festgelegten Bedingungen abzuschließen. Es ist der ausdrückliche Wille der Parteien, keinen Arbeitsvertrag i.S.d. § 611a Abs. 1 BGB abzuschließen.

The shareholders of PharmGenomics GmbH will exchange their shares for shares in Mainz Biomed B.V. on the basis of the "Contribution Agreement" of August 3, 2021 and thus become shareholders of Mainz Biomed B.V. PharmGenomics GmbH will thereby become a wholly-owned subsidiary of Mainz Biomed B.V.

 

Dr Eidens will remain Managing Director of PharmGenomics GmbH. In addition, it is intended that the shareholders' meeting will appoint Dr Eidens as Director of Mainz Biomed B.V. pursuant to Section 4.2 (b) (iv) of the Contribution Agreement of August 3, 2021.

 

The shareholders of Mainz Biomed B.V. intend to convert the Company into a stock corporation under Dutch law (naamloze vennootschap – N.V.) in the near future and to apply for admission of the shares of the N.V. to listing on Nasdaq in New York. The Parties agree that Dr Eidens will be appointed as a member of the Executive Board of N.V. (Chief Scientific Officer – CSO) upon the conversion becoming effective. This service agreement will – as far as legally possible – continue to apply to the service relationship with N.V. The Parties will make the necessary adjustments in a timely manner, whereby Dr Eidens will be granted at least the conditions provided for in this service agreement.

 

The Parties only wish to enter into a service agreement under the terms and conditions as set out in this service agreement. It is the express intention of the Parties not to enter into an employment contract as defined in Section 611a Para. 1 of the German Civil Code (BGB).

 

page 2 of 13

 

 

Dies vorausgeschickt vereinbaren die Parteien was folgt:

 

§ 1 Geschäftsführung / Vertretung

 

(1)    Der Geschäftsführer führt die Gesellschaft nach Maßgabe der Gesetze, dieses Vertrags, des Gesellschaftsvertrags sowie der Bestimmungen der Gesellschafter.

 

(2)    Inhalt und Umfang der Vertretungsbefugnis und Zeichnungsberechtigung des Geschäftsführers richten sich nach Maßgabe der Vorschriften des Gesellschaftsvertrags.

Having said this, the Parties agree as follows:

 

Sec. 1 Management / Representation

 

(1)    The Director shall run the Company in accordance with the statutes, this contract, the articles of association as well as the stipulations of the shareholders.

 

(2)    The content and extent of the Director's powers of representation and signature are governed by the provisions of the articles of association.

§ 2 Dienstzeit und -sitz

 

(1)    Der Geschäftsführer stellt seine gesamte Arbeitskraft, fachlichen Kenntnisse und Erfahrungen der Gesellschaft und der PharmGenomics GmbH zur Verfügung. In seiner Zeiteinteilung ist der Geschäftsführer frei.

 

(2)    Der Dienstsitz des Geschäftsführers ist dessen jeweiliger Wohnsitz. Eine Versetzung des Geschäftsführers an einen anderen Ort ist ohne seine Zustimmung nicht zulässig. Der Geschäftsführer ist in der Wahl seines Aufenthaltsorts während der Dienstausübung frei.

Sec. 2 Working time / Place of work

 

(1)    The Director shall place his entire working capacity, professional knowledge and experience at the disposal of the Company and PharmGenomics GmbH. The Director shall be free in the allocation of his time.

 

(2)    The place of business of the Director shall be his respective place of residence. A relocation of the Director to another place is not permissible without his consent. The Director shall be free to choose his place of work during the performance of his duties.

§ 3 Vertragsdauer

 

(1)    Dieser Dienstvertrag beginnt mit der Bestellung zum Geschäftsführer durch die Gesellschafterversammlung gem. Ziff. 4.2 (b) (iv) des Contribution Agreements vom [Datum] und wird auf drei Jahre geschlossen. Er verlängert sich jeweils um drei weitere Jahre, wenn er nicht von einer der Vertragsparteien mit einer Frist von sechs Monaten vor Ablauf des jeweiligen Verlängerungszeitraums gekündigt wird. 

Sec. 3 Term of contract

 

(1)    This service agreement commences upon appointment as Director by the shareholders’ meeting pursuant to Section 4.2 (b) (iv) of the Contribution Agreement of [date] and is concluded for a term of three years. It shall extend by three years at a time if it is not terminated by one of the Parties with a notice period of six months prior to the respective extension period.

 

page 3 of 13

 

 

(2)    Während der Vertragsdauer gem. Abs. 1 ist eine ordentliche Kündigung dieses Dienstvertrags beiderseits ausgeschlossen. Das Recht zur außerordentlichen Kündigung aus wichtigem Grund (§ 626 BGB) bleibt unberührt.

 

(3)    Jede Kündigung bedarf der Schriftform.

 

(4)    Eine Kündigung des Geschäftsführers ist gegenüber einem weiteren Geschäftsführer oder dem Vorsitzenden der Gesellschafterversammlung zu erklären.

 

(5)    Im Fall einer Kündigung der Gesellschaft gem. Abs. 1 ist der Geschäftsführer auf sein Verlangen bis zur Beendigung des Dienstverhältnisses unter Fortzahlung der Vergütung gem. § 4 dieses Dienstvertrags von der Erbringung der Dienstleistung freizustellen.

 

(6)    Die Parteien sind sich einig, dass ein Beschluss der Gesellschafter, die gesellschaftsrechtliche Beziehung des Geschäftsführers zur Gesellschaft zu beenden, nicht das Ende des Dienstverhältnisses des Geschäftsführers mit der Gesellschaft zur Folge hat. In diesem Fall besteht dieser Dienstvertrag in vollem Umfang fort.

(2)    During the term of the contract pursuant to Para. 1, termination of this service agreement shall be excluded by both parties. The right to termination for good cause (Section 626 of the German Civil Code – BGB) shall remain unaffected.

 

(3)    Any notice of termination must be in writing.

 

(4)    Notice of termination by the Director shall be given to another Director or to the Chairman of the shareholders’ meeting.

 

(5)    In the event of termination by the Company pursuant to Para. 1, the Director shall, at his request, be released from his duties until the termination of the service relationship with continued payment of the remuneration pursuant to Section 4 of this service agreement.

 

(6)    The Parties agree that a resolution taken by the shareholders of the Company to terminate the corporate law relationship of the Director with the Company does not imply the end of the service relationship of the Director with the Company. In that case this service agreement will continue to be in full force and effect.

 

page 4 of 13

 

 

§ 4 Vergütung

 

(1)    Als Vergütung für seine Dienste erhält der Geschäftsführer ein Jahresgrundgehalt in Höhe von EUR 164.000,00 brutto. Das Jahresgrundgehalt ist zahlbar in zwölf gleichen Raten, jeweils am Ende eines Kalendermonats sowie unter Abzug von Steuern und Sozialabgaben. Im Jahr des Eintritts und im Jahr des Austritts wird das Jahresgrundgehalt zeitanteilig gezahlt.

 

(2)    Der Geschäftsführer ist zur Teilnahme am Equity Incentive Plan der Gesellschaft berechtigt und wird mindestens ein Achtel der im Rahmen des Equity Incentive Plan ausgegebenen Aktien erhalten.

 

(3)    Für die Dauer dieses Dienstvertrags übernimmt die Gesellschaft bis zur Höhe der jeweils geltenden gesetzlichen Beitragsbemessungsgrundlage einen Betrag in Höhe des auf diesen Teilbetrag fiktiv entfallenden Arbeitgeberanteils an den Beiträgen zur privaten Kranken- und Pflegeversicherung des Geschäftsführers, höchstens jedoch in Höhe der Hälfte des Betrags, den der Geschäftsführer für seine Kranken- und Pflegeversicherung tatsächlich zu zahlen hat.

Sec. 4 Remuneration

 

(1)    As remuneration for his services, the Director shall receive a fixed annual salary of EUR 164,000 gross. The fixed annual salary shall be payable in twelve equal installments at the end of a calendar month, less taxes and social security contributions. In the year of joining and in the year of leaving the Company, the fixed annual salary is paid pro rata temporis.

 

(2)    The Director is entitled to participate in the Company's Equity Incentive Plan and will receive at least one eighth of the shares issued under the Equity Incentive Plan.

 

(3)    For the duration of this service agreement, the Company shall bear, up to the amount of the statutory income threshold applicable at the time, an amount equal to the employer's share of the contributions to the Director's private health and nursing care insurance that is fictitiously attributable to this partial amount, but no more than half of the amount that the Director actually has to pay for his health and nursing care insurance.

§ 5 Fortzahlung der Vergütung

 

(1)    Wird der Geschäftsführer durch Arbeitsunfähigkeit infolge Krankheit oder einem anderen von ihm nicht zu vertretenden Grund an der Erbringung seiner vertraglichen Leistung gehindert, wird ihm die Vergütung nach § 4 sechs Monate, längstens aber bis zur Beendigung des Dienstverhältnisses fortgezahlt. Etwaige aufgrund der Dienstverhinderung von den Trägern der gesetzlichen Krankenkasse oder einer privaten Krankenversicherung gewährte Leistungen werden auf die Vergütung angerechnet. 

 

(2)    Im Fall des Todes des Geschäftsführers während der Dauer dieses Vertrags haben sein Ehepartner und seine unterhaltsberechtigten Kinder als Gesamtgläubiger Anspruch auf Fortzahlung der Vergütung gem. § 4 Abs. 1 für den Sterbemonat und die zwölf folgenden Monate, längstens aber bis zur Beendigung des Dienstverhältnisses.

Sec. 5 Continued payment of remuneration

 

(1)    Should the Director be prevented from rendering services pursuant to this contract due to an inability to work resulting from illness or another reason beyond his control, the remuneration pursuant to Section 4 shall continue to be paid for six months, but at most up to the end of the service relationship. Any benefits granted by the institutions of the statutory health insurance fund or a private health insurance fund due to the Director’s inability to work will be offset against the remuneration. 

 

(2)    In the event of the Directors death during the term of this contract, his spouse and dependent children shall be entitled as joint and several creditors to continued payment of the remuneration pursuant to Section 4 Para. 1 for the month of death and the following twelve months, but at most up to the end of the service relationship.

 

page 5 of 13

 

 

§ 6 Abfindung

 

(1)    Im Fall einer Kündigung der Gesellschaft gem. § 3 Abs. 1 erhält der Geschäftsführer eine Abfindung in Höhe von drei durchschnittlichen Bruttomonatsvergütungen gem. § 4 für jedes zurückgelegte Dienstjahr, wobei auch die bei der PharmGenomics GmbH als Arbeitnehmer und Geschäftsführer zurückgelegten Dienstjahre einzubeziehen sind. Zeiträume von mehr als sechs Monaten werden für die Berechnung auf ein volles Dienstjahr aufgerundet.

 

(2)    Für die Berechnung der durchschnittlichen Bruttomonatsvergütung wird die Vergütung gem. § 4 Abs. 1 und 2 während der letzten 60 Kalendermonate vor Ausspruch der Kündigung zugrunde gelegt. Hat das Dienstverhältnis noch keine 60 Kalendermonate bestanden, ist hinsichtlich der für die Berechnung fehlenden Kalendermonate die zuletzt von der PharmGenomics GmbH erhaltende Vergütung in Höhe von EUR 48.000,00 brutto zugrunde zu legen.

 

(3)    Die Abfindung wird mit der Beendigung des Dienstverhältnisses zur Zahlung fällig.

Sec. 6 Severance payment

 

(1)    In the event of termination by the Company pursuant to Section 3 Para. 1, the Director shall receive a severance payment in the amount of three average gross monthly remunerations pursuant to Section 4 for each year of service completed, including the years of service as Employee and Managing Director of PharmGenomics GmbH. Periods of more than six months shall be rounded up to one full year of service for the purpose of calculation.

 

(2)    The calculation of the average gross monthly remuneration shall be based on the remuneration pursuant to Section 4 Para. 1 and 2 during the last 60 calendar months prior to the notice of termination. If the service relationship has not yet existed for 60 calendar months, the remuneration last received by PharmGenomics GmbH in the amount of EUR 48,000 gross shall be taken as the basis with regard to the calendar months missing for the calculation.

 

(3)    The severance payment shall become due for payment upon termination of the service relationship.

§ 7 Dienstwagen

 

(1)    Die Gesellschaft stellt dem Geschäftsführer auf sein Verlangen ein Dienstfahrzeug (Bruttolistenpreis bis maximal EUR 60.000,00 oder monatliche Brutto-Leasingrate bis maximal EUR 500,00) zur dienstlichen und privaten Nutzung zur Verfügung.

 

(2)   Die Kosten des Dienstwagens einschließlich aller Betriebskosten trägt die Gesellschaft. Die Einkommenssteuer auf den geldwerten Vorteil der Privatnutzung trägt der Geschäftsführer.

Sec. 7 Company Car

 

(1)    At the request of the Director, the Company shall provide him with a company car (gross list price up to a maximum of EUR 60,000.00 or monthly gross leasing rate up to a maximum of EUR 500.00) for business and private use.

 

(2)    The costs of the company car including all operating costs are borne by the Company. Income tax on the imputed income for the private use shall be borne by the Director.

 

page 6 of 13

 

 

 

§ 8 Reisekosten / Spesen / sonstige Aufwendungen

 

(1)    Für die Bewirtung von Geschäftspartnern und Geschäftsreisen hat der Geschäftsführer Anspruch auf Ersatz seiner angemessenen Auslagen, soweit sie dem Geschäftsführer im Interesse der Gesellschaft entstehen. Die Einzelheiten wird die Gesellschaft in einer Reisekosten- und Spesenrichtlinie für die Geschäftsführung festlegen.

 

(2)    Die Gesellschaft stellt dem Geschäftsführer monatlich ein Budget in Höhe von EUR 400,00 für Arbeitsmittel (z.B. Dienst-PC, -Notebook, -Tablet, -Smartphone) und sonstige dienstliche Aufwendungen (z.B. Vertrags- und Verbindungskosten eines dienstlich genutzten Telefon-Anschlusses oder Mobilvertrags) zur Verfügung. Zusätzlich zu dem monatlichen Budget stellt die Gesellschaft dem Geschäftsführer zu Beginn des Dienstverhältnisses zur Einrichtung eines Home-Office-Arbeitsplatzes einmalig ein Budget von EUR 2.000,00 zur Verfügung.

 

(3)    Die Gesellschaft stellt dem Geschäftsführer jährlich ein Budget in Höhe von EUR 5.000,00 für Kosten der Gesunderhaltung (z.B. Gesundheitsuntersuchungen, die nicht von der Krankenversicherung getragen werden, oder Physiotherapie/Massage-Anwendungen) zur Verfügung. Das am Ende eines Kalenderjahres nicht verbrauchte Budget verfällt mit Ablauf des jeweiligen Kalenderjahres.

 

(4)    Die Gesellschaft stellt dem Geschäftsführer jährlich ein Fortbildungsbudget zur Verfügung. Einzelheiten wird die Gesellschaft in einer Fortbildungsrichtlinie für die Geschäftsführung festlegen. 

 

(5)    Die Gesellschaft stellt dem Geschäftsführer zur Deckung der Aufwendungen gem. Abs. 1 bis 4 eine Firmenkreditkarte zur Verfügung.

Sec. 8 Travel costs / Expenses / other costs

 

(1)    For entertaining business partners and for business trips, the Director is entitled to reimbursement of his reasonable expenses to the extent these are incurred to the Director in the interests of the Company. The Company will define details in a travel and expense policy for the Board of Directors.

 

(2)    The Company shall provide the Director with a monthly budget of EUR 400.00 for work equipment (e.g. company PC, notebook, tablet, smartphone) and other business expenses (e.g. contract and connection costs for a telephone connection or mobile phone contract used for business purposes). In addition to the monthly budget, the Company shall provide the Director with a one-time budget of EUR 2,000.00 at the beginning of the service relationship to set up a home office.

 

(3)    The Company shall provide the Director with an annual budget of EUR 5,000 for health care costs (e.g. health examinations not covered by health insurance or physiotherapy/massage treatments). The budget not used at the end of a calendar year lapses at the end of the respective calendar year.

 

(4)    The Company shall provide the Director with an annual training budget. The Company will define details in a training policy for the Board of Directors. 

 

(5)    The Company shall provide the Director with a company credit card to cover the expenses pursuant to Paras. 1 to 4.

 

page 7 of 13

 

 

§ 9 Versicherungen

 

(1)    Die Gesellschaft schließt für die Dauer dieses Vertrags zugunsten des Geschäftsführers eine Unfallversicherung für Berufsunfälle und Unfälle des täglichen Lebens mit Deckungssummen von EUR 500.000,00 für den Todesfall und EUR 1.000.000,00 für den Invaliditätsfall ab.

 

Bezugsberechtigt aus der Versicherung sind im Invaliditätsfall der Geschäftsführer, im Todesfall die von ihm benannten Personen, bei Fehlen einer solchen Bestimmung seine Erben.

 

(2)    Die Gesellschaft versichert den Geschäftsführer auf ihre Kosten gegen Ansprüche, insbesondere Schadensersatzansprüche, die der Gesellschaft und/oder Dritten gegen den Geschäftsführer aufgrund oder im Zusammenhang mit seiner Tätigkeit zustehen können mit einer Deckungssumme von EUR 5.000.000,00 pro Schadensfall („D&O-Versicherung“). Der Versicherungsschutz schließt hinsichtlich des Verschuldensgrades lediglich wissentlich begangene Pflichtverletzungen vom Versicherungsschutz aus. Die Rückwärtsversicherung ist unbegrenzt und es wird eine mindestens 5-jährige unverfallbare Nachmeldefrist vereinbart.

 

Die Gesellschaft gewährt dem Geschäftsführer jederzeit auf Verlangen Einsicht in die Versicherungsunterlagen und legt die Belege über die Prämienzahlungen vor. Diese Verpflichtung gilt auch nach Beendigung dieses Dienstvertrags. 

Sec. 9 Insurances

 

(1)    The Company shall take out accident insurance for the Director against work-related accidents and accidents in daily life for the duration of this contract with a coverage of EUR 500,000 for death and EUR 1,000,000 for invalidity.

 

In case of invalidity, the Director is entitled to the benefits ensuing from the insurance coverage, in the case of death, the persons appointed by him, and in the absence of such an appointment, his heirs.

 

(2)    The Company shall insure the Director at its own expense against claims, in particular damages claims, to which the Company and/or third parties could be entitled due to or in connection with the Director’s activities, with a coverage of EUR 5,000,000 per damage event (‘D&O insurance’). The insurance protection shall exclude, with regard to the degree of fault, mere breaches of duty that were knowingly committed from the insurance coverage. The retroactive insurance coverage is unlimited, and a vested extended reporting period of at least five years shall be agreed upon.

 

The Company shall allow the Director, upon his request at any time, to inspect the insurance documents and present the receipts for the premium payments. This obligation shall survive this service agreement.

 

page 8 of 13

 

 

§ 10 Urlaub

 

(1)    Der Geschäftsführer hat Anspruch auf einen bezahlten Jahresurlaub von 30 Arbeitstagen, wobei der Samstag nicht als Arbeitstag zählt. Der Urlaub ist unter Berücksichtigung der Interessen der Gesellschaft im Einvernehmen mit den anderen Geschäftsführern festzulegen.

 

(2)    Soweit Urlaub im Lauf eines Kalenderjahres nicht genommen werden kann, wird er auf das nächste Jahr übertragen. Ein Verfall von Urlaubsansprüchen ist ausgeschlossen.

 

(3)    Für das Jahr, in dem das Dienstverhältnis beginnt, steht dem Geschäftsführer für jeden angefangenen Monat des Bestehens des Dienstverhältnisses 1/12 des Jahresurlaubs gem. Abs. 1 zu. Zusätzlich hat er Anspruch auf den im Zeitpunkt des Beginns dieses Dienstverhältnisses noch bestehenden Resturlaub bei der PharmGenomics GmbH, der damit als abgegolten gilt.

Sec. 10 Vacation

 

(1)    The Director shall have a claim to paid annual vacation of 30 working days, whereby Saturday shall not count as a working day. The vacation periods shall be determined in consultation with the other Directors, taking into account the interests of the Company.

 

(2)    If vacation cannot be taken in the course of a calendar year, it shall be carried over to the next year. There shall be no forfeiture of vacation entitlements.

 

(3)    For the year in which the service relationship commences, the Director shall be entitled to 1/12 of the annual vacation pursuant to Para. 1 for each month or part thereof of the service relationship. In addition, he shall be entitled to the remaining vacation at PharmGenomics GmbH at the time of commencement of this service relationship, which shall be deemed to be compensated hereby.

§ 11 Change of Control

 

(1)    Der Geschäftsführer hat für den Fall, dass es während der Vertragslaufzeit zu einem Change of Control i.S.d. nachfolgenden Abs. 2 kommt, das Recht, sein Amt als Geschäftsführer niederzulegen und das Dienstverhältnis außerordentlich mit einer Frist von sechs Monaten zum Monatsende zu kündigen. 

Sec. 11 Change of Control

 

(1)    In the event of a change of control within the meaning of Para. 2 below during the term of the contract, the Director shall be entitled to resign from office as Director and to terminate the service relationship with extraordinary notice of six months to the end of the month. 

 

page 9 of 13

 

 

(2)    Ein Change of Control im Sinne dieses Vertrags liegt vor, wenn

 

-    ein Dritter oder mehrere gemeinsam handelnde Dritte, die im Zeitpunkt des Vertragsschlusses nicht oder mit weniger als 50 % der Stimmrechte an der Gesellschaft beteiligt ist/sind, mindestens 50 % + 1 der Stimmrechte an der Gesellschaft erwerben bzw. erreichen, sei es durch Anteilsbesitz oder auf andere Weise, oder das Recht oder die Befähigung hat/haben, (a) eine solche Anzahl an Mitgliedern der Geschäftsführung oder eines vergleichbaren Organs der Gesellschaft zu bestellen oder abzuberufen oder (b) die Bestellung oder Abberufung einer solchen Anzahl an Mitgliedern anzuweisen, die erforderlich ist, um die für verbindliche Entscheidungen erforderliche Stimmenmehrheit in diesem Organ zu erreichen;

 

-     eine Spaltung, Verschmelzung oder Übertragung des Vermögens der Gesellschaft auf einen dritten Rechtsträger unter Auflösung der Gesellschaft stattgefunden hat,

 

-     die Gesellschaft Bestandteile ihres Vermögens im Umfang von mehr als 50 % des Wertes des Anlagevermögens veräußert oder überträgt. 

(2)    A change of control within the meaning of this contract shall exist if

 

-    a third party or several third parties acting jointly, which at the time of the conclusion of the agreement do not hold or hold less than 50% of the voting rights in the Company, acquire or reach at least 50% + 1 of the voting rights in the Company, whether through ownership or otherwise, or has the rights or ability to (a) appoint or remove or (b) direct the appointment or removal of, such number of members of the management board or a similar body of the Company with decisive voting power in such body;

 

-     a division, merger or transfer of the assets of the Company to a third legal entity has taken place with the Company as disappearing entity,

 

-     the Company sells or transfers components of its assets amounting to more than 50% of the value of the fixed assets. 

 

page 10 of 13

 

 

 

(3)    Die Kündigung in Ausübung des Kündigungsrechts gem. Abs. 1 ist innerhalb einer Frist von sechs Monaten nach dem Ende des Kalendermonats zu erklären, in dem

 

-     im Fall einer Änderung der Stimmrechtsverhältnisse die Stimmrechtsänderung nach den jeweils einschlägigen rechtlichen Vorschriften veröffentlicht worden ist,

 

-    bei einer Verschmelzung, Vermögensübertragung oder bei Abschluss eines Beherrschungs- bzw. Gewinnabführungsvertrags die Eintragung in das Handelsregister der Gesellschaft erfolgt ist,

 

-    bei einer rechtsgeschäftlichen Übertragung des Vermögens der dingliche Vollzug des Kaufvertrags stattgefunden hat.

 

(4)    Im Fall der berechtigten Ausübung des Sonderkündigungsrechts gem. Abs. 1 zahlt die Gesellschaft dem Geschäftsführer eine einmalige Entschädigung in Höhe des Jahresgrundgehalts gem. § 4 Abs. 1 dieses Dienstvertrags, das ohne Ausübung des Sonderkündigungsrechts in dem Zeitraum nach der Beendigung des Dienstvertrags bis zum regulären Ende des Dienstvertrags gem. § 2 Abs. 1 zu zahlen gewesen wäre. Zudem hat der Geschäftsführer Anspruch auf die Abfindung gem. § 6 dieses Dienstvertrags.

(3)     Notice of termination in exercise of the right of termination pursuant to Para. 1 shall be given within a period of six months after the end of the calendar month in which

 

-    in the case of a change in voting rights, the change in voting rights has been published in accordance with the relevant legal provisions,

 

-    in the case of a merger, transfer of assets or conclusion of a control or profit transfer agreement, the entry has been made in the Commercial Register of the Company,

 

-    in the case of a legal transfer of assets, the in rem execution of the purchase agreement has taken place.

 

(4)    In the event of the justified exercise of the extraordinary right of termination pursuant to Para. 1, the Company shall pay the Director a one-time compensation in the amount of the fixed annual salary pursuant to Section 4 Para. 1 of this service agreement which would have been payable without the exercise of the extraordinary right of termination in the period after the termination of the service agreement until the regular end of the service agreement pursuant to Section 2 Para. 1. In addition, the Director is entitled to the severance payment pursuant to Section 6 of this service agreement.

 

page 11 of 13

 

 

§ 12 Wettbewerbsverbot

 

Dem Geschäftsführer ist es untersagt, während der Dauer dieses Vertrags in selbstständiger, unselbstständiger oder sonstiger Weise für ein Unternehmen tätig zu werden, welches mit der Gesellschaft in direktem oder indirektem Wettbewerb steht oder mit einem Wettbewerbsunternehmen i.S.v. § 15 AktG verbunden ist. In gleicher Weise ist es dem Geschäftsführer untersagt, während der Dauer dieses Verbots ein solches Unternehmen zu errichten, zu erwerben oder sich hieran unmittelbar oder mittelbar zu beteiligen, es sei denn, der Anteilsbesitz ermöglicht keinen Einfluss auf die Organe des betreffenden Unternehmens. Das Wettbewerbsverbot gilt auch zugunsten von mit der Gesellschaft i.S.v. § 15 AktG verbundenen Unternehmen.

Sec. 12 Covenant not to compete

 

The Director shall be prohibited from working for a company during the term of this contract on a freelance, dependent or other basis that is in direct or indirect competition with the Company or is affiliated with a competitive company within the meaning of Section 15 of the German Stock Corporation Act (Aktiengesetz – AktG). In the same way, the Director shall be prohibited from forming, acquiring or directly or indirectly participating in such a company during the term of this contract unless his shareholding does not enable him to exert influence over the governing bodies of the company in question. The covenant not to compete shall also apply to the benefit of affiliates of the Company within the meaning of Section 15 of the German Stock Corporation Act (Aktiengesetz – AktG).

§ 13 Geheimhaltung

 

Der Geschäftsführer ist verpflichtet, gegenüber Dritten über alle vertraulichen Angelegenheiten der Gesellschaft, insbesondere Betriebs- und Geschäftsgeheimnisse, Stillschweigen zu bewahren.

Sec. 13 Confidentiality

 

The Director shall be obligated to maintain secrecy vis-à-vis third parties with respect to all confidential matters of the Company, in particular trade and business secrets.

§ 14 Rückgabe von Unterlagen und Arbeitsmitteln

 

Der Geschäftsführer hat nach Beendigung des Dienstverhältnisses alle die Angelegenheiten der Gesellschaft betreffenden Unterlagen und alle etwaig überlassenen Arbeitsmittel unaufgefordert an die Gesellschaft zurückzugeben.

Sec. 14 Return of documents and working equipment

 

After termination of the service relationship, the Director shall return to the Company, without being asked to do so, all documents relating to the affairs of the Company as well as any work equipment that may have been provided.

 

page 12 of 13

 

 

§ 15 Schlussbestimmungen

 

(1)    Änderungen und Ergänzungen dieses Dienstvertrags bedürfen zu ihrer Wirksamkeit der Schriftform. Gleiches gilt für die Aufhebung dieses Schriftformerfordernisses.

 

(2)    Sollten einzelne Bestimmungen dieses Dienstvertrags ganz oder teilweise unwirksam sein oder werden, soll hierdurch die Wirksamkeit der übrigen Bestimmungen nicht berührt werden. Die Parteien sind im Fall einer unwirksamen Bestimmung verpflichtet, über eine wirksame und zumutbare Ersatzregelung zu verhandeln, die dem von den Parteien mit der unwirksamen Bestimmung verfolgten wirtschaftlichen Zweck möglichst nahekommt.

 

(3)    Dieser Dienstvertrag unterliegt deutschem Recht.

 

(4)    Ausschließlicher Gerichtsstand für alle Streitigkeiten zwischen der Gesellschaft und dem Geschäftsführer ist Mainz, Deutschland.

 

(5)    Dieser Dienstvertrag wird in deutscher und englischer Fassung ausgefertigt. Die Parteien sind sich darüber einig, dass die englische Fassung lediglich der Information dient. Die deutsche Fassung ist rechtlich bindend.

Sec. 15 Final provisions

 

(1)    Changes or amendments to this service agreement must be in writing in order to be valid. The same applies to the cancellation of this written form requirement.

 

(2)    Should any provisions of this service agreement be or become wholly or partially invalid, this shall not affect the validity of the remaining provisions. In the event of an invalid provision, the Parties shall be obliged to negotiate an effective and reasonable replacement provision which comes as close as possible to the economic purpose pursued by the Parties with the invalid provision.

 

(3)    This service agreement shall be governed by German law.

 

(4)    The exclusive place of jurisdiction for all disputes between the Company and the Director shall be Mainz, Germany.

 

(5)    This service agreement shall be executed in German and English. The Parties agree that the English version is for information purposes only. The German version shall be legally binding.

 

Mainz Biomed B.V.   Dr Moritz Eidens
     
     
     
Place, date   Place, date
     
     
     
Marco Messina   Dr Moritz Eidens

 

 

page 13 of 13

 

Exhibit 10.7

 

Dienstvertrag

 

zwischen

 

der Mainz Biomed B.V. mit Sitz in Amsterdam, Geschäftsanschrift: Robert-Koch-Str. 50, 55129 Mainz, vertreten durch die Gesellschafterversammlung, diese wiederum vertreten durch Herrn Marco Messina,

 

– nachfolgend auch: „Gesellschaft” –

 

und

 

Herrn Philipp Freese, Albert-Schweitzer-Weg 3, 41515 Grevenbroich

 

– nachfolgend auch: „Executive” –

 

– nachfolgend beide gemeinsam: „die Parteien” –

 

Management Services Agreement

 

between

 

Mainz Biomed B.V. based in Amsterdam, company address: Robert-Koch-Str. 50, 55129 Mainz, Germany, represented by the shareholders’ meeting, which is in turn represented by Mr Marco Messina,

 

hereinafter also referred to as ‘Company’ –

 

and

 

Mr Philipp Freese, Albert-Schweitzer-Weg 3, 41515 Grevenbroich, Germany

 

– hereinafter also referred to as ‘Executive’ –

 

– hereinafter both together referred to as ‘the Parties’ –

Präambel

 

Herr Freese ist seit dem 01.02.2015 Geschäftsführer der PharmGenomics GmbH mit Sitz in Mainz, eingetragen im Handelsregister des Amtsgerichts Mainz unter HRB 41529. Zuvor war er seit dem 01.09.2013 als Arbeitnehmer für das Unternehmen tätig. Er hält ca. 2,1 % der Geschäftsanteile der PharmGenomics GmbH.

 

Die Mainz Biomed B.V. ist eine Gesellschaft mit beschränkter Haftung nach niederländischem Recht (besloten vennootschap met beperkte aansprakelijkheid – B.V.) und hat ihren Sitz in Amsterdam. Sie ist im Handelsregister der Niederlande unter der Nummer 82116296 eingetragen.

 

Die Gesellschafter der PharmGenomics GmbH werden auf der Grundlage des „Contribution Agreements” vom [Datum] ihre Geschäftsanteile gegen Geschäftsanteile der Mainz Biomed B.V. tauschen und so zu Gesellschaftern der Mainz Biomed B.V. werden. Die PharmGenomics GmbH wird hierdurch eine 100%ige Tochtergesellschaft der Mainz Biomed B.V.

Preamble

 

Mr Freese is Managing Director of PharmGenomics GmbH, which is based in Mainz and registered in the Commercial Register of the Local Court of Mainz under HRB 41529. Previously, he worked for this company as an employee since 1 September 2013. He holds approximately 2.1 % of the shares.

 

Mainz Biomed B.V. is a limited liability company under Dutch law (besloten vennootschap met beperkte aansprakelijkheid – B.V.) and has its seat in Amsterdam. It is registered in the commercial register of the Netherlands under number 82116296.

 

The shareholders of PharmGenomics GmbH will exchange their shares for shares in Mainz Biomed B.V. on the basis of the “Contribution Agreement” of [date] and thus become shareholders of Mainz Biomed B.V. PharmGenomics GmbH will thereby become a wholly-owned subsidiary of Mainz Biomed B.V.

 

page 1 of 12

 

 

Herr Freese bleibt Geschäftsführer der PharmGenomics GmbH. Zudem ist beabsichtigt, dass Herr Freese gem. Ziff. 4.2 (b) (iv) des Contribution Agreements vom [Datum] bis auf Weiteres als Geschäftsführer („Director”) der Mainz Biomed B.V. tätig wird.

 

Die Gesellschafter der Mainz Biomed B.V. beabsichtigen, die Gesellschaft in naher Zukunft in eine Aktiengesellschaft nach niederländischem Recht (naamloze vennootschap – N.V.) umzuwandeln und die Zulassung der Aktien der N.V. zur Notierung an der Nasdaq in New York zu beantragen. Es ist beabsichtigt, dass Herr Freese mit dem Wirksamwerden der Umwandlung nicht mehr als Geschäftsführer („Director”), sondern gem. Ziff. 11.6 des Contribution Agreements vom [Datum] als Executive Officer der Mainz Biomed B.V. tätig werden wird (Chief Operations Officer – COO). Es wird ausdrücklich klargestellt, dass dieser Dienstvertrag auch nach der genannten Umwandlung in vollem Umfang fortbesteht.

 

Vor diesem Hintergrund wählen die Parteien die Bezeichnung von Herrn Freese als „Executive” in diesem Dienstvertrag einheitlich sowohl für dessen Position als Geschäftsführer („Director”) der Mainz Biomed B.V. als auch für dessen Position als Executive Officer der N.V. nach der Umwandlung.

 

Die Parteien beabsichtigen allein, einen Dienstvertrag zu den in diesem Vertrag festgelegten Bedingungen abzuschließen. Es ist der ausdrückliche Wille der Parteien, keinen Arbeitsvertrag i.S.d. § 611a Abs. 1 BGB abzuschließen.

Mr Freese will remain Managing Director of PharmGenomics GmbH. In addition, it is intended that Mr Freese will, for the time being, serve as Director of Mainz Biomed B.V. pursuant to Section 4.2 (b) (iv) of the Contribution Agreement of August 3, 2021.

 

The shareholders of Mainz Biomed B.V. intend to convert the Company into a stock corporation under Dutch law (naamloze vennootschap – N.V.) in the near future and to apply for admission of the shares of the N.V. to listing on Nasdaq in New York. It is intended that Mr Freese will, as of the said conversion, no longer serve as a Director of Mainz Biomed B.V. but as an Executive Officer of Mainz Biomed B.V. (Chief Operations Officer – COO) pursuant to Section 11.6 of the Contribution Agreement of August 3, 2021. For the avoidance of doubt, this service agreement will continue to be in full force and effect also after the said conversion.

 

In this regard, the Parties choose the designation of Mr Freese as ‘Executive’ in this service agreement consistently both for his position as Director of Mainz Biomed B.V. and for his position as Executive Officer of N.V. after the conversion.

 

The Parties only wish to enter into a service agreement under the terms and conditions as set out in this service agreement. It is the express intention of the Parties not to enter into an employment contract as defined in Section 611a Para. 1 of the German Civil Code (BGB).

 

page 2 of 12

 

 

 

Dies vorausgeschickt vereinbaren die Parteien was folgt:

 

Having said this, the Parties agree as follows:

 

§ 1 Geschäftsführung / Vertretung

 

(1)    Der Executive führt die Gesellschaft nach Maßgabe der Gesetze, dieses Vertrags, des Gesellschaftsvertrags sowie der Bestimmungen der Gesellschafter.

 

(2)    Inhalt und Umfang der Vertretungsbefugnis und Zeichnungsberechtigung des Executives richten sich nach Maßgabe der Vorschriften des Gesellschaftsvertrags oder werden vom Board of Directors der Gesellschaft festgelegt.

Sec. 1 Management / Representation

 

(1)    The Executive shall run the Company in accordance with applicable law, this contract, the articles of association as well as the stipulations of the shareholders.

 

(2)    The content and extent of the Executive’s powers of representation and signature are governed by the provisions of the articles of association or determined by the Company’s Board of Directors.

§ 2 Dienstzeit und -sitz

 

(1)    Der Executive stellt seine gesamte Arbeitskraft, fachlichen Kenntnisse und Erfahrungen der Gesellschaft und der PharmGenomics GmbH zur Verfügung. In seiner Zeiteinteilung ist der Executive frei.

 

(2)    Der Dienstsitz des Executives ist dessen jeweiliger Wohnsitz. Eine Versetzung des Executives an einen anderen Ort ist ohne seine Zustimmung nicht zulässig. Der Executive ist in der Wahl seines Aufenthaltsorts während der Dienstausübung frei.

Sec. 2 Working time / Place of work

 

(1)    The Executive shall place his entire working capacity, professional knowledge and experience at the disposal of the Company and PharmGenomics GmbH. The Executive shall be free in the allocation of his time.

 

(2)    The place of business of the Executive shall be his respective place of residence. A relocation of the Executive to another place is not permissible without his consent. The Executive shall be free to choose his place of work during the performance of his duties.

 

page 3 of 12

 

 

§ 3 Vertragsdauer

 

(1)    Dieser Dienstvertrag beginnt mit der Bestellung zum Geschäftsführer („Director”) durch die Gesellschafterversammlung gem. Ziff. 4.2 (b) (iv) des Contribution Agreements vom [Datum] und wird auf drei Jahre geschlossen. Er verlängert sich jeweils um drei weitere Jahre, wenn er nicht von einer der Vertragsparteien mit einer Frist von sechs Monaten vor Ablauf des jeweiligen Verlängerungszeitraums gekündigt wird.

 

(2)    Während der Vertragsdauer gem. Abs. 1 ist eine ordentliche Kündigung dieses Dienstvertrags beiderseits ausgeschlossen. Das Recht zur außerordentlichen Kündigung aus wichtigem Grund (§ 626 BGB) bleibt unberührt.

 

(3)    Jede Kündigung bedarf der Schriftform.

 

(4)    Eine Kündigung des Executives ist gegenüber der Gesellschaft zu erklären.

 

(5)    Im Fall einer Kündigung der Gesellschaft gem. Abs. 1 ist der Executive auf sein Verlangen bis zur Beendigung des Dienstverhältnisses unter Fortzahlung der Vergütung gem. § 4 dieses Dienstvertrags von der Erbringung der Dienstleistung freizustellen.

 

(6)    Die Parteien sind sich einig, dass ein Beschluss der Gesellschafter oder des Board of Directors der Gesellschaft, die gesellschaftsrechtliche Beziehung des Executives zur Gesellschaft zu beenden, nicht das Ende des Dienstverhältnisses des Executives mit der Gesellschaft zur Folge hat. In diesem Fall besteht dieser Dienstvertrag in vollem Umfang fort. 

Sec. 3 Term of contract

 

(1)    This service agreement commences upon appointment as Director by the shareholders’ meeting pursuant to Section 4.2 (b) (iv) of the Contribution Agreement of [date] and is concluded for a term of three years. It shall extend by three years at a time if it is not terminated by one of the Parties with a notice period of six months prior to the respective extension period.

 

(2)    During the term of the contract pursuant to Para. 1, termination of this service agreement shall be excluded by both parties. The right to termination for good cause (Section 626 of the German Civil Code – BGB) shall remain unaffected.

 

(3)    Any notice of termination must be in writing.

 

(4)    Notice of termination by the Executive shall be given to the Company.

 

(5)    In the event of termination by the Company pursuant to Para. 1, the Executive shall, at his request, be released from his duties until the termination of the service relationship with continued payment of the remuneration pursuant to Section 4 of this service agreement.

 

(6)    The Parties agree that a resolution taken by the shareholders or the Company’s Board of Directors to terminate the corporate law relationship of the Executive with the Company does not imply the end of the service relationship of the Executive with the Company. In that case this service agreement will continue to be in full force and effect.

 

page 4 of 12

 

 

§ 4 Vergütung

 

(1)    Als Vergütung für seine Dienste erhält der Executive ein Jahresgrundgehalt in Höhe von EUR 164.000,00 brutto. Das Jahresgrundgehalt ist zahlbar in zwölf gleichen Raten, jeweils am Ende eines Kalendermonats sowie unter Abzug von Steuern und Sozialabgaben. Im Jahr des Eintritts und im Jahr des Austritts wird das Jahresgrundgehalt zeitanteilig gezahlt.

 

(2)    Der Executive ist zur Teilnahme am Equity Incentive Plan der Gesellschaft berechtigt und wird mindestens ein Achtel der im Rahmen des Equity Incentive Plan ausgegebenen Aktien erhalten.

Sec. 4 Remuneration

 

(1)    As remuneration for his services, the Executive shall receive a fixed annual salary of EUR 164,000 gross. The fixed annual salary shall be payable in twelve equal installments at the end of a calendar month, less taxes and social security contributions. In the year of joining and in the year of leaving the Company, the fixed annual salary is paid pro rata temporis.

 

(2)    The Executive is entitled to participate in the Company’s Equity Incentive Plan and will receive at least one eighth of the shares issued under the Equity Incentive Plan.

§ 5 Fortzahlung der Vergütung

 

(1)    Wird der Executive durch Arbeitsunfähigkeit infolge Krankheit oder einem anderen von ihm nicht zu vertretenden Grund an der Erbringung seiner vertraglichen Leistung gehindert, wird ihm die Vergütung nach § 4 sechs Monate, längstens aber bis zur Beendigung des Dienstverhältnisses fortgezahlt. Etwaige aufgrund der Dienstverhinderung von den Trägern der gesetzlichen Krankenkasse oder einer privaten Krankenversicherung gewährte Leistungen werden auf die Vergütung angerechnet.

(2)    Im Fall des Todes des Executives während der Dauer dieses Vertrags haben sein Ehepartner und seine unterhaltsberechtigten Kinder als Gesamtgläubiger Anspruch auf Fortzahlung der Vergütung gem. § 4 Abs. 1 für den Sterbemonat und die zwölf folgenden Monate, längstens aber bis zur Beendigung des Dienstverhältnisses.

Sec. 5 Continued payment of remuneration

 

(1)    Should the Executive be prevented from rendering services pursuant to this contract due to an inability to work resulting from illness or another reason beyond his control, the remuneration pursuant to Section 4 shall continue to be paid for six months, but at most up to the end of the service relationship. Any benefits granted by the institutions of the statutory health insurance fund or a private health insurance fund due to the Executive’s inability to work will be offset against the remuneration.

 

(2)    In the event of the Executive’s death during the term of this contract, his spouse and dependent children shall be entitled as joint and several creditors to continued payment of the remuneration pursuant to Section 4 Para. 1 for the month of death and the following twelve months, but at most up to the end of the service relationship.

 

page 5 of 12

 

 

§ 6 Abfindung

 

(1)    Im Fall einer Kündigung der Gesellschaft gem. § 3 Abs. 1 erhält der Executive eine Abfindung in Höhe von drei durchschnittlichen Bruttomonatsvergütungen gem. § 4 für jedes zurückgelegte Dienstjahr, wobei auch die bei der PharmGenomics GmbH als Arbeitnehmer und Geschäftsführer zurückgelegten Dienstjahre einzubeziehen sind. Zeiträume von mehr als sechs Monaten werden für die Berechnung auf ein volles Dienstjahr aufgerundet.

 

(2)    Für die Berechnung der durchschnittlichen Bruttomonatsvergütung wird die Vergütung gem. § 4 Abs. 1 und 2 während der letzten 60 Kalendermonate vor Ausspruch der Kündigung zugrunde gelegt. Hat das Dienstverhältnis noch keine 60 Kalendermonate bestanden, ist hinsichtlich der für die Berechnung fehlenden Kalendermonate die zuletzt von der PharmGenomics GmbH erhaltende Vergütung in Höhe von EUR 48.000,00 brutto zugrunde zu legen.

 

(3)    Die Abfindung wird mit der Beendigung des Dienstverhältnisses zur Zahlung fällig.

Sec. 6 Severance payment

 

(1)    In the event of termination by the Company pursuant to Section 3 Para. 1, the Executive shall receive a severance payment in the amount of three average gross monthly remunerations pursuant to Section 4 for each year of service completed, including the years of service as Employee and Managing Director of PharmGenomics GmbH. Periods of more than six months shall be rounded up to one full year of service for the purpose of calculation.

 

(2)    The calculation of the average gross monthly remuneration shall be based on the remuneration pursuant to Section 4 Para. 1 and 2 during the last 60 calendar months prior to the notice of termination. If the service relationship has not yet existed for 60 calendar months, the remuneration last received by PharmGenomics GmbH in the amount of EUR 48,000 gross shall be taken as the basis with regard to the calendar months missing for the calculation.

 

(3)    The severance payment shall become due for payment upon termination of the service relationship.

§ 7 Dienstwagen

 

(1)    Die Gesellschaft stellt dem Executive auf sein Verlangen ein Dienstfahrzeug (monatliche Brutto-Leasingrate bis maximal EUR 500,00) zur dienstlichen und privaten Nutzung zur Verfügung.

 

(2)    Die Kosten des Dienstwagens einschließlich aller Betriebskosten trägt die Gesellschaft. Die Einkommenssteuer auf den geldwerten Vorteil der Privatnutzung trägt der Executive.

Sec. 7 Company Car

 

(1)    At the request of the Executive, the Company shall provide him with a company car (monthly gross leasing rate up to a maximum of EUR 500.00) for business and private use.

 

(2)    The costs of the company car including all operating costs are borne by the Company. Income tax on the imputed income for the private use shall be borne by the Executive.

 

page 6 of 12

 

 

§ 8 Reisekosten / Spesen / sonstige Aufwendungen

 

(1)    Für die Bewirtung von Geschäftspartnern und Geschäftsreisen hat der Executive Anspruch auf Ersatz seiner angemessenen Auslagen, soweit sie dem Executive im Interesse der Gesellschaft entstehen. Die Einzelheiten wird die Gesellschaft in einer Reisekosten- und Spesenrichtlinie für die Geschäftsführung festlegen.

 

(2)    Die Gesellschaft stellt dem Executive monatlich ein Budget in Höhe von EUR 400,00 für Arbeitsmittel (z.B. Dienst-PC, -Notebook, -Tablet, -Smartphone) und sonstige dienstliche Aufwendungen (z.B. Vertrags- und Verbindungskosten eines dienstlich genutzten Telefon-Anschlusses oder Mobilvertrags) zur Verfügung. Zusätzlich zu dem monatlichen Budget stellt die Gesellschaft dem Executive zu Beginn des Dienstverhältnisses zur Einrichtung eines Home-Office-Arbeitsplatzes einmalig ein Budget von EUR 2.000,00 zur Verfügung.

 

(3)    Die Gesellschaft stellt dem Executive jährlich ein Budget in Höhe von EUR 5.000,00 für Kosten der Gesunderhaltung (z.B. Gesundheitsuntersuchungen, die nicht von der Krankenversicherung getragen werden, oder Physiotherapie/Massage-Anwendungen) zur Verfügung. Das am Ende eines Kalenderjahres nicht verbrauchte Budget verfällt mit Ablauf des jeweiligen Kalenderjahres.

 

(4)    Die Gesellschaft stellt dem Executive jährlich ein Fortbildungsbudget zur Verfügung. Einzelheiten wird die Gesellschaft in einer Fortbildungsrichtlinie für die Geschäftsführung festlegen.

 

(5)    Die Gesellschaft stellt dem Executive zur Deckung der Aufwendungen gem. Abs. 1 bis 4 eine Firmenkreditkarte zur Verfügung.

Sec. 8 Travel costs / Expenses / other costs

 

(1)    For entertaining business partners and for business trips, the Executive is entitled to reimbursement of his reasonable expenses to the extent these are incurred to the Executive in the interests of the Company. The Company will define details in a travel and expense policy for the Board of Directors.

 

(2)    The Company shall provide the Executive with a monthly budget of EUR 400.00 for work equipment (e.g. company PC, notebook, tablet, smartphone) and other business expenses (e.g. contract and connection costs for a telephone connection or mobile phone contract used for business purposes). In addition to the monthly budget, the Company shall provide the Executive with a one-time budget of EUR 2,000.00 at the beginning of the service relationship to set up a home office.

 

(3)    The Company shall provide the Executive with an annual budget of EUR 5,000 for health care costs (e.g. health examinations not covered by health insurance or physiotherapy/massage treatments). The budget not used at the end of a calendar year lapses at the end of the respective calendar year.

 

(4)    The Company shall provide the Executive with an annual training budget. The Company will define details in a training policy for the Board of Directors.

 

(5)    The Company shall provide the Executive with a company credit card to cover the expenses pursuant to Paras. 1 to 4.

 

page 7 of 12

 

 

§ 9 Versicherungen

 

(1)    Die Gesellschaft schließt für die Dauer dieses Vertrags zugunsten des Executives eine Unfallversicherung für Berufsunfälle und Unfälle des täglichen Lebens mit Deckungssummen von EUR 500.000,00 für den Todesfall und EUR 1.000.000,00 für den Invaliditätsfall ab.

 

Bezugsberechtigt aus der Versicherung sind im Invaliditätsfall der Executive, im Todesfall die von ihm benannten Personen, bei Fehlen einer solchen Bestimmung seine Erben.

 

(2)    Die Gesellschaft versichert den Executive auf ihre Kosten gegen Ansprüche, insbesondere Schadensersatzansprüche, die der Gesellschaft und/oder Dritten gegen den Executive aufgrund oder im Zusammenhang mit seiner Tätigkeit zustehen können mit einer Deckungssumme von EUR 5.000.000,00 pro Schadensfall („D&O-Versicherung”). Der Versicherungsschutz schließt hinsichtlich des Verschuldensgrades lediglich wissentlich begangene Pflichtverletzungen vom Versicherungsschutz aus. Die Rückwärtsversicherung ist unbegrenzt und es wird eine mindestens 5-jährige unverfallbare Nachmeldefrist vereinbart.

 

Die Gesellschaft gewährt dem Executive jederzeit auf Verlangen Einsicht in die Versicherungsunterlagen und legt die Belege über die Prämienzahlungen vor. Diese Verpflichtung gilt auch nach Beendigung dieses Dienstvertrags.

Sec. 9 Insurances

 

(1)    The Company shall take out accident insurance for the Executive against work-related accidents and accidents in daily life for the duration of this contract with a coverage of EUR 500,000 for death and EUR 1,000,000 for invalidity.

 

In case of invalidity, the Executive is entitled to the benefits ensuing from the insurance coverage, in the case of death, the persons appointed by him, and in the absence of such an appointment, his heirs.

 

(2)    The Company shall insure the Executive at its own expense against claims, in particular damages claims, to which the Company and/or third parties could be entitled due to or in connection with the Executive’s activities, with a coverage of EUR 5,000,000 per damage event (‘D&O insurance’). The insurance protection shall exclude, with regard to the degree of fault, mere breaches of duty that were knowingly committed from the insurance coverage. The retroactive insurance coverage is unlimited, and a vested extended reporting period of at least five years shall be agreed upon.

 

The Company shall allow the Executive, upon his request at any time, to inspect the insurance documents and present the receipts for the premium payments. This obligation shall survive this service agreement.

§ 10 Urlaub

 

(1)    Der Executive hat Anspruch auf einen bezahlten Jahresurlaub von 30 Arbeitstagen, wobei der Samstag nicht als Arbeitstag zählt. Der Urlaub ist unter Berücksichtigung der Interessen der Gesellschaft im Einvernehmen mit den anderen Geschäftsführern („Directors”) bzw. mit den anderen Mitgliedern des „Executive Committees” festzulegen.

 

(2)    Soweit Urlaub im Lauf eines Kalenderjahres nicht genommen werden kann, wird er auf das nächste Jahr übertragen. Ein Verfall von Urlaubsansprüchen ist ausgeschlossen.

 

(3)    Für das Jahr, in dem das Dienstverhältnis beginnt, steht dem Executive für jeden angefangenen Monat des Bestehens des Dienstverhältnisses 1/12 des Jahresurlaubs gem. Abs. 1 zu. Zusätzlich hat er Anspruch auf den im Zeitpunkt des Beginns dieses Dienstverhältnisses noch bestehenden Resturlaub bei der PharmGenomics GmbH, der damit als abgegolten gilt.

Sec. 10 Vacation

 

(1)    The Executive shall have a claim to paid annual vacation of 30 working days, whereby Saturday shall not count as a working day. The vacation periods shall be determined in consultation with the other Directors or with the other members of the Executive Committee, taking into account the interests of the Company.

 

(2)    If vacation cannot be taken in the course of a calendar year, it shall be carried over to the next year. There shall be no forfeiture of vacation entitlements.

 

(3)    For the year in which the service relationship commences, the Executive shall be entitled to 1/12 of the annual vacation pursuant to Para. 1 for each month or part thereof of the service relationship. In addition, he shall be entitled to the remaining vacation at PharmGenomics GmbH at the time of commencement of this service relationship, which shall be deemed to be compensated hereby. 

 

page 8 of 12

 

 

§ 11 Change of Control

 

(1)    Der Executive hat für den Fall, dass es während der Vertragslaufzeit zu einem Change of Control i.S.d. nachfolgenden Abs. 2 kommt, das Recht, sein Amt als Geschäftsführer („Director”) bzw. Executive Officer niederzulegen und das Dienstverhältnis außerordentlich mit einer Frist von sechs Monaten zum Monatsende zu kündigen.

 

(2)    Ein Change of Control im Sinne dieses Vertrags liegt vor, wenn

 

-     ein Dritter oder mehrere gemeinsam handelnde Dritte, die im Zeitpunkt des Vertragsschlusses nicht oder mit weniger als 50 % der Stimmrechte an der Gesellschaft beteiligt ist/sind, mindestens 50 % + 1 der Stimmrechte an der Gesellschaft erwerben bzw. erreichen, sei es durch Anteilsbesitz oder auf andere Weise, oder das Recht oder die Befähigung hat/haben, (a) eine solche Anzahl an Mitgliedern der Geschäftsführung oder eines vergleichbaren Organs der Gesellschaft zu bestellen oder abzuberufen oder (b) die Bestellung oder Abberufung einer solchen Anzahl an Mitgliedern anzuweisen, die erforderlich ist, um die für verbindliche Entscheidungen erforderliche Stimmenmehrheit in diesem Organ zu erreichen;

 

-     eine Spaltung, Verschmelzung oder Übertragung des Vermögens der Gesellschaft auf einen dritten Rechtsträger unter Auflösung der Gesellschaft stattgefunden hat,

 

-     die Gesellschaft Bestandteile ihres Vermögens im Umfang von mehr als 50 % des Wertes des Anlagevermögens veräußert oder überträgt.

 

(3)    Die Kündigung in Ausübung des Kündigungsrechts gem. Abs. 1 ist innerhalb einer Frist von sechs Monaten nach dem Ende des Kalendermonats zu erklären, in dem

 

-     im Fall einer Änderung der Stimmrechtsverhältnisse die Stimmrechtsänderung nach den jeweils einschlägigen rechtlichen Vorschriften veröffentlicht worden ist,

 

-     bei einer Verschmelzung, Vermögensübertragung oder bei Abschluss eines Beherrschungs- bzw. Gewinnabführungsvertrags die Eintragung in das Handelsregister der Gesellschaft erfolgt ist,

 

-     bei einer rechtsgeschäftlichen Übertragung des Vermögens der dingliche Vollzug des Kaufvertrags stattgefunden hat.

 

(4)    Im Fall der berechtigten Ausübung des Sonderkündigungsrechts gem. Abs. 1 zahlt die Gesellschaft dem Executive eine einmalige Entschädigung in Höhe des Jahresgrundgehalts gem. § 4 Abs. 1 dieses Dienstvertrags, das ohne Ausübung des Sonderkündigungsrechts in dem Zeitraum nach der Beendigung des Dienstvertrags bis zum regulären Ende des Dienstvertrags gem. § 2 Abs. 1 zu zahlen gewesen wäre. Zudem hat der Executive Anspruch auf die Abfindung gem. § 6 dieses Dienstvertrags.

Sec. 11 Change of Control

 

(1)    In the event of a change of control within the meaning of Para. 2 below during the term of the contract, the Executive shall be entitled to resign from office as Director or Executive Officer and to terminate the service relationship with extraordinary notice of six months to the end of the month.

 

(2)    A change of control within the meaning of this contract shall exist if

 

-     a third party or several third parties acting jointly, which at the time of the conclusion of the agreement do not hold or hold less than 50% of the voting rights in the Company, acquire or reach at least 50% + 1 of the voting rights in the Company, whether through ownership or otherwise, or has the rights or ability to (a) appoint or remove or (b) direct the appointment or removal of, such number of members of the management board or a similar body of the Company with decisive voting power in such body;

 

-     a division, merger or transfer of the assets of the Company to a third legal entity has taken place with the Company as disappearing entity,

 

-     the Company sells or transfers components of its assets amounting to more than 50% of the value of the fixed assets.

 

(3)    Notice of termination in exercise of the right of termination pursuant to Para. 1 shall be given within a period of six months after the end of the calendar month in which

 

-     in the case of a change in voting rights, the change in voting rights has been published in accordance with the relevant legal provisions,

 

-     in the case of a merger, transfer of assets or conclusion of a control or profit transfer agreement, the entry has been made in the Commercial Register of the Company,

 

-     in the case of a legal transfer of assets, the in rem execution of the purchase agreement has taken place.

 

(4)    In the event of the justified exercise of the extraordinary right of termination pursuant to Para. 1, the Company shall pay the Executive a one-time compensation in the amount of the fixed annual salary pursuant to Section 4 Para. 1 of this service agreement which would have been payable without the exercise of the extraordinary right of termination in the period after the termination of the service agreement until the regular end of the service agreement pursuant to Section 2 Para. 1. In addition, the Executive is entitled to the severance payment pursuant to Section 6 of this service agreement.

 

 

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§ 12 Wettbewerbsverbot

 

Dem Executive ist es untersagt, während der Dauer dieses Vertrags in selbstständiger, unselbstständiger oder sonstiger Weise für ein Unternehmen tätig zu werden, welches mit der Gesellschaft in direktem oder indirektem Wettbewerb steht oder mit einem Wettbewerbsunternehmen i.S.v. § 15 AktG verbunden ist. In gleicher Weise ist es dem Executive untersagt, während der Dauer dieses Verbots ein solches Unternehmen zu errichten, zu erwerben oder sich hieran unmittelbar oder mittelbar zu beteiligen, es sei denn, der Anteilsbesitz ermöglicht keinen Einfluss auf die Organe des betreffenden Unternehmens. Das Wettbewerbsverbot gilt auch zugunsten von mit der Gesellschaft i.S.v. § 15 AktG verbundenen Unternehmen.

Sec. 12 Covenant not to compete

 

The Executive shall be prohibited from working for a company during the term of this contract on a freelance, dependent or other basis that is in direct or indirect competition with the Company or is affiliated with a competitive company within the meaning of Section 15 of the German Stock Corporation Act (Aktiengesetz – AktG). In the same way, the Executive shall be prohibited from forming, acquiring or directly or indirectly participating in such a company during the term of this contract unless his shareholding does not enable him to exert influence over the governing bodies of the company in question. The covenant not to compete shall also apply to the benefit of affiliates of the Company within the meaning of Section 15 of the German Stock Corporation Act (Aktiengesetz – AktG).

§ 13 Geheimhaltung

 

Der Executive ist verpflichtet, gegenüber Dritten über alle vertraulichen Angelegenheiten der Gesellschaft, insbesondere Betriebs- und Geschäftsgeheimnisse, Stillschweigen zu bewahren.

Sec. 13 Confidentiality

 

The Executive shall be obligated to maintain secrecy vis-à-vis third parties with respect to all confidential matters of the Company, in particular trade and business secrets.

§ 14 Rückgabe von Unterlagen und Arbeitsmitteln

 

Der Executive hat nach Beendigung des Dienstverhältnisses alle die Angelegenheiten der Gesellschaft betreffenden Unterlagen und alle etwaig überlassenen Arbeitsmittel unaufgefordert an die Gesellschaft zurückzugeben.

Sec. 14 Return of documents and working equipment

 

After termination of the service relationship, the Executive shall return to the Company, without being asked to do so, all documents relating to the affairs of the Company as well as any work equipment that may have been provided.

 

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§ 15 Schlussbestimmungen

 

(1)    Änderungen und Ergänzungen dieses Dienstvertrags bedürfen zu ihrer Wirksamkeit der Schriftform. Gleiches gilt für die Aufhebung dieses Schriftformerfordernisses.

 

(2)    Sollten einzelne Bestimmungen dieses Dienstvertrags ganz oder teilweise unwirksam sein oder werden, soll hierdurch die Wirksamkeit der übrigen Bestimmungen nicht berührt werden. Die Parteien sind im Fall einer unwirksamen Bestimmung verpflichtet, über eine wirksame und zumutbare Ersatzregelung zu verhandeln, die dem von den Parteien mit der unwirksamen Bestimmung verfolgten wirtschaftlichen Zweck möglichst nahekommt.

 

(3)    Dieser Dienstvertrag unterliegt deutschem Recht.

 

(4)    Ausschließlicher Gerichtsstand für alle Streitigkeiten zwischen der Gesellschaft und dem Executive ist Mainz, Deutschland.

 

(5)    Dieser Dienstvertrag wird in deutscher und englischer Fassung ausgefertigt. Die Parteien sind sich darüber einig, dass die englische Fassung lediglich der Information dient. Die deutsche Fassung ist rechtlich bindend.

Sec. 15 Final provisions

 

(1)    Changes or amendments to this service agreement must be in writing in order to be valid. The same applies to the cancellation of this written form requirement.

 

(2)    Should any provisions of this service agreement be or become wholly or partially invalid, this shall not affect the validity of the remaining provisions. In the event of an invalid provision, the Parties shall be obliged to negotiate an effective and reasonable replacement provision which comes as close as possible to the economic purpose pursued by the Parties with the invalid provision.

 

(3)    This service agreement shall be governed by German law.

 

(4)    The exclusive place of jurisdiction for all disputes between the Company and the Executive shall be Mainz, Germany.

 

(5)    This service agreement shall be executed in German and English. The Parties agree that the English version is for information purposes only. The German version shall be legally binding.

 

page 11 of 12

 

 

Mainz Biomed B.V.   Philipp Freese
     
     
Place, date   Place, date
     
     
Marco Messina   Philipp Freese

 

 

page 12 of 12

 

 

 

Exhibit 10.8

 

Final version

 

 

 

DATED 29 JULY 2021

 

 

 

 

CONTRIBUTION AGREEMENT

 

between

 

THE CONTRIBUTORS NAMED HEREIN

 

and

 

MAINZ BIOMED B.V.

 

and

 

PHARMGENOMICS GMBH

 

 

 

 

 

 

CMS Derks Star Busmann N.V.

cms.law

 

 

 

 

 

table of contents

 

CLAUSE PAGE
1. Definitions and interpretation 1
2. Conditions Precedent 5
3. Contribution 5
4. Completion 6
5. Warranties of the Contributors 7
6. Warranties of the Company 8
7. Warranties of PharmGenomics 9
8. No obligation to contribute to losses or deficit 10
9. No relocation or termination of business 10
10. Guarantee 11
11. Board of Directors 11
12. Equity incentive plan 12
13. Listing on Nasdaq 11
14. Notices 11
15. Miscellaneous 13
16. Governing law and competent court 13
     
SCHEDULE PAGE
Schedule 1 – Particulars of the Contributors 21
Schedule 2 – Particulars of the Investors 24
Schedule 3 – Deed of Issue 25
Schedule 4 – Deed of Transfer 26
Schedule 5 – Credit Facility Agreement 27
Schedule 6 – Lock-up Agreement 28
Schedule 7 – Management Services Agreement Eidens 29
Schedule 8 – Management Services Agreement Freese 30
Schedule 9 – Company Articles of Association 31
Schedule 10 – PharmGenomics Articles of Association 32

 

 

 

  

THE UNDERSIGNED

 

(1) The Persons named in ‎Schedule 1 (the “Contributors”);

 

(2) Mainz Biomed B.V., a private company with limited liability under Dutch law, having its seat in Amsterdam, the Netherlands, and its address at Robert-Koch-Straβe 50, 55129 Mainz, Germany, registered with the Dutch trade register under number 82122571 (the “Company”); and

 

(3) PharmGenomics GmbH, a company with limited liability under German law, having its address at Robert-Koch-Straβe 50, 55129 Mainz, Germany, registered with the trade register B of the local court of Mainz, Germany, under number HRB 41529 (“PharmGenomics”).

 

RECITALS

 

(A) The Company is a private company with limited liability under Dutch law and has been incorporated for the purpose of investing in and effecting a merger by means of a share exchange with PharmGenomics.

 

(B) The Company intends to apply to list the Company Shares on Nasdaq along with a concurrent financing of a minimum of USD 7 million and a maximum of USD 15 million through a public offering of Company Shares at a price of USD 5.00 per Company Share.

 

(C) The Contributors are the holders of the number of Contribution Shares set out opposite their respective names in Schedule 1 comprising in aggregate the whole of the issued share capital of PharmGenomics.

 

(D) The Existing Investors are the holders of the number of Company Shares and the number of Company Warrants set out opposite their respective names in Schedule 2 comprising in aggregate the whole of the issued share capital of the Company and all outstanding Company Warrants on the date hereof.

 

(E) The Company intends to raise further financing from investors prior to the Completion Date through the issue of units comprising one Company Share and one Company Warrant each, until the Company will have received an aggregate amount of USD 2.2 million from the Existing Investors and any investors participating in any further financing as payment for the Company Shares subscribed for by them.

 

(F) In connection with the proposed merger of the Company and PharmGenomics, the Contributors wish to exchange all shares in the share capital of PharmGenomics held by them for the Company Shares.

 

(G) Immediately following the said share exchange, PharmGenomics will be a 100 per cent subsidiary of the Company and the Contributors will together hold, rounded up, 61.79% of the issued share capital of the Company, on a non-diluted basis.

 

IT IS AGREED AS FOLLOWS

 

1. Definitions and interpretation

 

1.1 In this Agreement the following definitions apply:

 

Affiliate” means, in relation to a Person, any other Person who, directly or indirectly, Controls, is Controlled by, or is under common Control with that Person, but excluding the Company;

 

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Agreement” means this contribution agreement, including the Recitals and the Schedules;

 

Beneficiary” means each Contributor who, or whose Affiliate, on the date hereof:

 

(a) is a silent partner of PharmGenomics under any silent partnership agreement (stille Beteiligung Vertrag) under German law; or

 

(b) has a loan receivable from PharmGenomics under any loan agreement;

 

Board of Directors” means the board of directors (bestuur) of the Company, which prior to Conversion shall consist of Directors and as of Conversion of Executive Directors and a majority of independent Non-Executive Directors;

 

Business Day” means a day, other than a Saturday, Sunday or public holiday, on which banks are open for general business in Amsterdam, the Netherlands, and Mainz, Germany;

 

CMS Netherlands” means CMS Derks Star Busmann N.V., a Dutch law firm serving as legal counsel to the Company for European law matters;

 

Company” has the meaning given in the head of this Agreement;

 

Company Articles of Association” means the articles of association of the Company;

 

Company Shares” means ordinary shares in the share capital of the Company with a nominal value of EUR 0.01 each;

 

Company Warrant” means a warrant to subscribe for one Company Share;

 

Completion” means the taking of each of the steps set out in Clause 4.2;

 

Completion Date” means the date on which Completion is to take place, being 30 July 2021, or if the Conditions Precedent have not been satisfied or waived on or before that date:

 

(a) the second Business Day after they are all satisfied or waived; or

 

(b) or such other date as may be agreed by the Parties in writing;

 

Conditions Precedent” means the conditions precedent set out in Clause 2.1;

 

Contribution Shares” means, in respect of each Contributor, such number of shares in the share capital of PharmGenomics with such nominal value and such consecutive number as set out opposite his, her or its name in Schedule 1;

 

Contributors” has the meaning given in the head of this Agreement;

 

Control” means:

 

(a) in relation to a legal person:

 

(i) the ability, directly or indirectly, whether or not pursuant an agreement with other Persons entitled to vote, to exercise more than half of the voting rights at the general meeting of that legal person, or any similar body of that legal person;

 

(ii) the ability, directly or indirectly, whether or not pursuant an agreement with other Persons entitled to vote, to appoint or dismiss more than half of the directors of that legal person, or of any similar officers of that legal person, also if all Persons entitled to vote were to cast their votes; or

 

(iii) the ability, directly or indirectly, to determine the policies of that legal person;

 

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(b) in relation to a partnership:

 

(i) the ability, directly or indirectly, whether or not pursuant an agreement with other Persons entitled to vote, to exercise more than half of the voting rights upon adoption of a resolution to amend the agreement governing that partnership; or

 

(ii) the ability, directly or indirectly, to determine the policies of that partnership; and

 

(c) in respect of any other Person, the ability, directly or indirectly, to determine the policies of that Person,

 

and the terms “Controls” and “Controlled” shall be construed accordingly;

 

Conversion” has the meaning given Clause 13.2;

 

Credit Facility Agreement” means the credit facility agreement between the Company and PharmGenomics, in the form set out in Schedule 5;

 

Cut-off Date” means 31 October 2021, or such other date as may be agreed by the Parties in writing;

 

Deed of Issue” means the deed of issue of shares relating to the Subscription Shares between the Company and the Contributors, in the form set out in Schedule 3;

 

Deed of Transfer” means the deed of transfer of shares governed by German law relating to the Contribution Shares between the Contributors and the Company, in the form set out in Schedule 4;

 

Director” means a director (bestuurder) of the Company, as of Conversion including each Executive Director and each Non-Executive Director, unless the context otherwise requires;

 

Dutch Notary” means M.M. van der Bie, civil law notary in Amsterdam, the Netherlands, working with CMS Netherlands, and each deputy of his office as appointed from time to time in accordance with the applicable provisions of the Dutch Notaries Act;

 

Encumbrance” means any interest or equity of any Person, including any right to acquire, option or right of pre-emption, or any mortgage, charge, pledge, lien, assignment, hypothecation, security, interest, title, retention or any other security agreement or arrangement;

 

Executive Director” means an executive director (uitvoerende bestuurder) of the Company;

 

Executive Committee” means the executive committee of the Company;

 

Executive Officer” means a member of the Executive Committee, including each Executive Director and each other member of the Executive Committee, unless the context otherwise requires;

 

Existing Investors” means the Persons named in Schedule 2;

 

Existing ISB Subsidiary” means any legal person or partnership which, on the date hereof is, and at any relevant time still is, a subsidiary as referred to in section 2:24a of the Dutch Civil Code of Investitions- und Strukturbank Rheinland-Pfalz (ISB), an institution under German law, registered with the trade register A of the local court of Mainz, Germany, under number HRA 41584;

 

German Notary” means Dr. G. Specks, notary in Aachen, Germany;

 

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Lock-up Agreement” means a lock-up agreement between the Company and each of the Contributors substantially in the form attached as Schedule 6;

 

Management Services Agreement Eidens” means the management services agreement between the Company and Dr. Moritz Eidens, in the form attached as Schedule 7;

 

Management Services Agreement Freese” means the management services agreement between the Company and Philipp Freese, in the form attached as Schedule 8;

 

Nasdaq” means the Nasdaq Capital Market of the Nasdaq Stock Exchange in New York, United States of America;

 

Non-Executive Director” means an independent non-executive director (niet uitvoerende bestuurder) of the Company according to Nasdaq and the SEC;

 

Parties” means the Contributors, the Company and PharmGenomics;

 

Person” means a natural person, legal person, partnership, trust, legal arrangement similar to a trust and each other body or cooperation acting as an independent entity or organisation;

 

PharmGenomics” has the meaning given in the head of this Agreement;

 

PharmGenomics Articles of Association” means the articles of association of PharmGenomics;

 

Qualifying Existing ISB Subsidiary” means any Existing ISB Subsidiary which, at any relevant time, holds one or more Shares or is a creditor of the Company;

 

SEC” means the United States Securities and Exchange Commission;

 

Subscription Shares” means, in respect of each Contributor, such number of Company Shares as set out opposite his, her or its name in Schedule 1;

 

Subsidiary” means a subsidiary as referred to in section 2:24a of the Dutch Civil Code; and

 

Transactions” means the transactions described in this Agreement, mainly including the issue of the Subscription Shares against contribution of the Contribution Shares and the listing of the Company Shares on Nasdaq.

 

1.2 In this Agreement the following rules of interpretation apply:

 

(a) the table of contents and headings are for convenience only and shall not affect the interpretation of this Agreement;

 

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(b) words denoting the singular shall include the plural and vice versa, unless the context otherwise requires;

 

(c) references to Recitals, Clauses and Schedules are to respectively recitals and clauses of and schedules to this Agreement, unless otherwise specified;

 

(d) references to any time of day are references to Central European Time.

 

2. Conditions Precedent

 

2.1 Completion shall be subject to and shall not take place prior to the satisfaction or waiver of the Conditions Precedent of:

 

(a) the general meeting of PharmGenomics having granted its approval to this Agreement and the transactions contemplated hereby;

 

(b) the Contributors having received an opinion of counsel, or other evidence, in form and substance reasonably satisfactory to the Contributors to the effect that the transactions contemplated by this Agreement are tax-neutral for the Contributors;

 

(c) the Contributors having received a confirmation from the Company evidencing that the Company has received an aggregate amount of USD 2.2 million in gross proceeds from the Existing Investors and any investors participating in any further financing as payment for the Company Shares subscribed for by them;

 

(d) the Company and PharmGenomics having entered into the Credit Facility Agreement; and

 

(e) the Company and each of the Contributors having entered into the Lock-up Agreement.

 

2.2 The Parties shall use their reasonable efforts to procure that the Conditions Precedent are satisfied as soon as reasonably possible and in any event by no later than the Cut-off Date.

 

2.3 Each Party shall keep the other Parties fully informed of all progress and developments with regard to the satisfaction of the Conditions Precedent and in any event shall notify the other Parties immediately as soon as it becomes aware that the Conditions Precedent have been satisfied or have become incapable of satisfaction and shall produce to the other Parties such documentation as they shall require to evidence any such satisfaction.

 

2.4 The Conditions Precedent may only be waived by written agreement between the Parties.

 

2.5 If the Conditions Precedent are not satisfied or waived on or before the Cut-off Date, each of the Parties may terminate this Agreement by giving notice thereof to the other Parties, in which event this Agreement shall have no further force and effect and no Party shall have any claim or liability in respect of it except as regards any antecedent breach and save that Clause 1, this Clause 2.5, and Clauses 13 up to and including 16 shall continue in full force and effect.

 

3. Contribution

 

3.1 The Company shall issue to each Contributor and each Contributor shall subscribe for and accept from the Company the number of Subscription Shares set out opposite the relevant Contributor’s name in Schedule 1, under the obligation for each Contributor to pay for the respective Subscription Shares in full by payment in kind by way of contribution of the Contribution Share or Contribution Shares set out opposite the relevant Contributor’s name in Schedule 1.

 

3.2 The Contribution Shares shall be transferred free of any Encumbrance and with all rights attaching or accruing to them at or after the Completion Date.

 

3.3 The difference between the aggregate value of the Contribution Shares and the aggregate nominal value of the Subscription Shares will be regarded as non-stipulated share premium.

 

3.4 The Company undertakes vis-à-vis each of the Contributors that it will not sell, transfer or otherwise dispose of any shares in the share capital of PharmGenomics during a period of seven years, commencing on the date hereof and therefore ending on 28 July 2028, other than with the written consent of all Contributors.

 

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4. Completion

 

4.1 Completion shall take place on the Completion Date.

 

4.2 At Completion, the Parties shall take or procure the taking of each of the following steps in the following order:

 

(a) the Parties will submit to the Dutch Notary a copy of this Agreement duly signed by them;

 

(b) the Company will submit to the Dutch Notary in form and substance satisfactory to the Dutch Notary a written resolution of the shareholders of the Company for:

 

(i) the issue of the Subscription Shares to the Contributors;

 

(ii) the exclusion of any pre-emption rights in respect of the issue of the Subscription Shares;

 

(iii) the approval as referred to in section 2:204 subsection 2 of the Dutch Civil Code of the legal acts contained in this Agreement and the Deed of Issue;

 

(iv) the appointment of Guido Bächler, Dr. Moritz Eidens and Philipp Freese as Directors in accordance with Clause 11.2 with effect as of Completion;

 

(v) the entry into between the Company and Dr. Moritz Eidens of the Management Services Agreement Eidens;

 

(vi) the entry into between the Company and Philipp Freese of the Management Services Agreement Freese;

 

(vii) the dismissal of Mr. M. Messina as Director with effect as of Completion; and

 

(viii) the granting of a full and final discharge Mr. M. Messina for his management of the Company;

 

(c) the Company will submit to the Dutch Notary in form and substance satisfactory to each of the Contributors and the Dutch Notary a description of the Contribution Shares as referred to in section 2:204b subsection 1 in conjunction with section 2:204a subsection 1 of the Dutch Civil Code;

 

(d) the Company and the Contributors will submit to the Dutch Notary in form and substance satisfactory to the Dutch Notary powers of attorney for the execution of the Deed of Issue;

 

(e) the Company will submit to the Dutch Notary the Company’s original shareholders register;

 

(f) the Company and Dr. Moritz Eidens will enter into the Management Services Agreement Eidens;

 

(g) the Company and Philipp Freese will enter into the Management Services Agreement Freese;

 

(h) the Parties will procure the execution of the Deed of Issue before the Dutch Notary;

 

(i) the issue of the Subscription Shares will be registered in the shareholders register of the Company and filed with the Dutch trade register; and

 

(j) the Contributors will submit to the German Notary in form and substance satisfactory to the German Notary powers of attorney for the notarisation of the Deed of Transfer;

 

(k) the Parties will procure the notarisation of the Deed of Transfer before the German Notary.

 

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5. Warranties of the Contributors

 

Each of the Contributors warrants to the Company that, on the date hereof and on the Completion Date, the following is correct:

 

(a) the Contributor, if a legal Person, is a legal Person duly incorporated and validly existing under the laws of the jurisdiction of its organisation;

 

(b) the obligations expressed to be assumed by the Contributor in this Agreement are legal, valid, binding and enforceable obligations;

 

(c) save for the steps to be taken in Clause 4.2 above, the Contributor has the authority to enter into and perform this Agreement and the Transactions contemplated hereby;

 

(d) save for the steps to be taken in Clause 4.2 above, the Contributor has taken all necessary action to authorise the signing and performance of this Agreement and the Transactions contemplated hereby;

 

(e) the Contributor, not being S-Innovations-Beteiligungsfinanzierungsgesellschaft Rheinland-Pfalz mbH (S IFG) or Wagnisfinanzierungsgesellschaft für Technologieförderung in Rheinland-Pfalz mbH (WFT), has waived all rights in his, her or its silent partnerships in PharmGenomics other than any rights in respect of any interest or repayment of his, her or its silent partnerships in PharmGenomics;

 

(f) the Contributor, being S-Innovations-Beteiligungsfinanzierungsgesellschaft Rheinland-Pfalz mbH (S-IFG) or Wagnisfinanzierungsgesellschaft für Technologieförderung in Rheinland-Pfalz mbH (WFT), has waived, or caused to waive, all rights in the following silent partnerships in PharmGenomics, provided, however, that:

 

(i) the following provisions of the silent partnership of S-Innovations-Beteiligungsfinanzierungsgesellschaft Rheinland-Pfalz mbH (S-IFG) with project number 3802700311, in the amount of EUR 150,000, will remain unchanged and continue in full force and effect: § 1 section (1) “Establishment of the company”, § 2 “Amount of the participation”, § 7 “Duration of the silent partnership”, § 8 “Fiscal year”, § 9 “Remuneration”, § 11 “Loss participation, subordination”, § 13 section (1) “Information obligations of the participant, proof of use”, § 14 “Control rights of the participation provider”, § 15 “Release from the duty of confidentiality” and § 17 “Repayment of the contribution, maturity”;

 

(ii) the following provisions of the silent partnership of Wagnisfinanzierungsgesellschaft für Technologieförderung in Rheinland-Pfalz mbH (WFT) with project number 3803500022, in the amount of EUR 300,000, as last extended by 2nd supplementary agreement, will remain unchanged and continue in full force and effect: § 1 section (1) “Amount of participation”, § 2 “Duration of the silent partnership”, § 5 “Participation fee/remuneration/commission”, § 6 “Loss participation”, § 9 “Release from confidentiality”, § 11 sections (1) up to and including (4) and (7) “Monitoring and ongoing reporting”, § 12 “Repayment of the contribution”, § 15 “Fiscal year” and § 17 “Supplementary provision”;

 

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(iii) the following provisions of the silent partnership of Wagnisfinanzierungsgesellschaft für Technologieförderung in Rheinland-Pfalz mbH (WFT) with project number 3801400279, in the amount of EUR 50,000.00, will remain unchanged and continue in full force and effect: § 1 section (1) “Establishment of the company”, § 2 “Amount of the participation”, § 7 ” Duration of the silent partnership”, § 8 “Fiscal year”, § 9 “Remuneration”, § 11 “Loss participation, subordination”, § 13 section (1) “Information obligations of the participant, proof of use”, § 14 “Control rights of the participant”, § 15 “Release from the duty of confidentiality” and § 18 “Repayment of the contribution, maturity”; and

 

(iv) the following provisions of the silent partnership of Wagnisfinanzierungsgesellschaft für Technologieförderung in Rheinland-Pfalz mbH (WFT) with project number 3803500117, in the amount of EUR 98,634.00, will remain unchanged and continue in full force and effect: § 1 section (1), “Establishment of the company”, § 2 “Amount of the participation”, § 7 “Duration of the silent partnership”, § 8 “Fiscal year”, § 9 “Remuneration”, § 11 “Loss participation, subordination”, § 13 sections (1) and (6) “Participant’s duty to provide information, proof of use”, § 14 “Participant’s control rights”, § 15 “Release from the duty of confidentiality”, § 17 “Repayment of the contribution, due date” and § 21 section (1) “Supplementary provisions”.

 

The Company accepts these warranties.

 

6. Warranties of the Company

 

6.1 The Company warrants to each of the Contributors that, on the date hereof and on the Completion Date, the following is correct:

 

(a) the Company is a private company with limited liability under Dutch law, duly incorporated and validly existing under Dutch law;

 

(b) the Company Articles of Association read as set out in Schedule 7;

 

(c) the Company is registered with the Dutch trade register under number 82122571. The information regarding the Company registered with the Dutch trade register is correct and complete;

 

(d) the Company has not been dissolved or liquidated and no resolution has been adopted to dissolve or liquidate the Company, nor has any request thereto been filed nor is there any reason to expect the same;

 

(e) the Company is not subject to any insolvency proceedings as defined in article 2 point (4) of Regulation (EU) 2015/848 of the European Parliament and of the Council of 20 May 2015 on insolvency proceedings (recast), or any analogous proceedings in any jurisdiction, nor have any requests to open any such insolvency proceedings been filed, nor is there any reason to expect the same;

 

(f) the Company is not involved in the preparation of a merger or division within the meaning of Book 2 title 7 of the Dutch Civil Code;

 

(g) no resolution to reduce the issued share capital of the Company has been adopted;

 

(h) with respect to the Company no resolution to make a distribution has been adopted;

 

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(i) the shareholders register of the Company is up-to-date and complete;

 

(j) the obligations expressed to be assumed by the Company in this Agreement are legal, valid, binding and enforceable obligations;

 

(k) save for the steps to be taken in Clause 4.2 above, the Company has the authority to enter into and perform this Agreement and the Transactions contemplated hereby;

 

(l) save for the steps to be taken in Clause 4.2 above, the Company has taken all necessary action to authorise the signing and performance of this Agreement and the Transactions contemplated hereby;

 

(m) the Company has not conducted any business;

 

(n) the Company has not acquired any assets or rights of any kind other than the assets and rights reasonably acquired in connection with the Transactions and has not incurred any liabilities or obligations of any kind other than the liabilities and obligations reasonably incurred in connection with the Transactions;

 

(o) the Company has not entered into any agreements other than the agreements reasonably entered into in connection with the Transactions;

 

(p) the Company does not have any employees; and

 

(q) the Company is not engaged or proposing to engage or directly or indirectly involved in any litigation, arbitration or other legal proceedings, including civil, administrative, criminal and tax proceedings, and there are no claims or actions of any kind that are pending, or threatened or expected against the Company or in respect of which the Company is or may be liable vis-à-vis any other person nor are there any circumstances that could give rise to any litigation, arbitration or other proceedings.

 

Each of the Contributors accepts these warranties.

 

6.2 The Company warrants to each of the Contributors that, immediately following Completion, the issued share capital of the Company will amount to EUR 97,100.00 and will be divided into 9,710,000 ordinary shares with a nominal value of EUR 0.01 each. Each of the Contributors accepts this warranty.

 

7. Warranties of PharmGenomics

 

7.1 PharmGenomics warrants to the Company that, on the date hereof and on the Completion Date, the following is correct:

 

(a) PharmGenomics is a company with limited liability under German law, duly incorporated and validly existing under German law;

 

(b) the PharmGenomics Articles of Association read as set out in Schedule 10;

 

(c) PharmGenomics is registered with the trade register B of the local court of Mainz, Germany, under number HRB 41529. The information regarding PharmGenomics registered with the trade register B of the local court of Mainz, Germany, is correct and complete;

 

(d) PharmGenomics has not been dissolved or liquidated and no resolution has been adopted to dissolve or liquidate PharmGenomics, nor has any request thereto been filed nor is there any reason to expect the same;

 

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(e) PharmGenomics is not subject to any insolvency proceedings as defined in article 2 point (4) of Regulation (EU) 2015/848 of the European Parliament and of the Council of 20 May 2015 on insolvency proceedings (recast), or any analogous proceedings in any jurisdiction, nor have any requests to open any such insolvency proceedings been filed, nor is there any reason to expect the same;

 

(f) PharmGenomics is not involved in the preparation of a measure under the German Transformation Act (Umwandlungsgesetz);

 

(g) no resolution to reduce the issued share capital of PharmGenomics has been adopted that has not been implemented yet;

 

(h) with respect to PharmGenomics no resolution to make a distribution has been adopted that has not been implemented yet;

 

(i) the list of shareholders of PharmGenomics is up-to-date and complete;

 

(j) the obligations expressed to be assumed by PharmGenomics in this Agreement are legal, valid, binding and enforceable obligations;

 

(k) PharmGenomics has the authority to enter into and perform this Agreement and the Transactions contemplated hereby;

 

(l) save for the steps to be taken in Clause 4.2 above, PharmGenomics has taken all necessary action to authorise the signing and performance of this Agreement and the Transactions contemplated hereby;

 

(m) PharmGenomics has at all times conducted its business in accordance with its constitutional documents and all applicable laws;

 

(n) PharmGenomics is not engaged or proposing to engage or directly or indirectly involved in any litigation, arbitration or other legal proceedings, including civil, administrative, criminal and tax proceedings, and there are no claims or actions of any kind that are pending, or threatened or expected against PharmGenomics or in respect of which PharmGenomics is or may be liable vis-à-vis any other person nor are there any circumstances that could give rise to any litigation, arbitration or other proceedings; and

 

(o) Dr. Jochem has waived all rights in his silent partnerships in PharmGenomics other than any rights in respect of any interest or repayment of his silent partnerships in PharmGenomics.

 

The Company accepts these warranties.

 

7.2 PharmGenomics shall not be liable for any claim arising out of or in connection with the warranties set out in Clause 7.1 if and to the extent that such claim would result in a situation where the net assets of PharmGenomics fall short of its registered share capital (Unterbilanz).

 

8. No obligation to contribute to losses or deficit

 

No Contributor shall be obliged to contribute to any losses or deficit of the Company.

 

9. No relocation or termination of business

 

9.1 The Company and PharmGenomics undertake vis-à-vis each Qualifying Existing ISB Subsidiary, by way of a stipulation in favour of a third party as referred to in section 6:253 of the Dutch Civil Code, that PharmGenomics will not relocate or terminate its business or any significant part thereof without the prior written approval of each Qualifying Existing ISB Subsidiary.

 

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9.2 Clause 9.1 will cease to apply as of the first date on which no Existing ISB Subsidiary holds any Company Shares or is a creditor of the Company.

 

10. Guarantee

 

10.1 The Company unconditionally and irrevocably guarantees to each Beneficiary, by way of a separate obligation and therefore not as a surety or co-debtor, the performance of all present and future obligations of PharmGenomics vis-à-vis the Beneficiary or any Affiliate of the Beneficiary existing on or before Completion Date to pay a sum of money under or in connection with:

 

(a) any silent partnership agreement (stille Beteiligung Vertrag) under German law between PharmGenomics and the Beneficiary or any Affiliate of the Beneficiary existing on the date hereof, as amended from time to time; and

 

(b) any loan agreement between PharmGenomics and the Beneficiary or any Affiliate of the Beneficiary existing on the date hereof, as amended from time to time.

 

10.2 If PharmGenomics fails to pay to any Beneficiary or any Affiliate of any Beneficiary from time to time on demand any sum of money which PharmGenomics is at any time liable to pay to the Beneficiary or any Affiliate of the Beneficiary under or pursuant to any agreement referred to in Clause 10.1, the Company shall be liable vis-à-vis the Beneficiary for these obligations of PharmGenomics as if it were a primary obligor and not a surety.

 

10.3 The obligations of the Company under Clauses 10.1 and 10.2 shall be continuing obligations and shall not be impaired or affected by any change in the constitution or control of, or the insolvency, liquidation or winding up of or by any analogous proceedings in any jurisdiction relating to PharmGenomics.

 

11. Board of Directors

 

11.1 As of Completion and until Conversion, for the time being, the Board of Directors shall consist of three Directors, who, for the avoidance of doubt, in fact are executive directors.

 

11.2 As of Completion, for the time being, the Board of Directors shall consist of:

 

(a) Guido Bächler, who has been nominated by the Existing Investors;

 

(b) Dr. Moritz Eidens, who has been nominated by PharmGenomics; and

 

(c) Philipp Freese, who has been nominated by PharmGenomics.

 

11.3 As of Conversion, for the time being, the Board of Directors shall consist of five Directors, comprising two Executive Directors and three Non-Executive Directors.

 

11.4 As of Conversion, for the time being, the Board of Directors shall consist of:

 

(a) the following Executive Directors:

 

(i) Guido Bächler, with the title of Chief Executive Officer, who has been nominated by the Existing Investors; and

 

(ii) Dr. Moritz Eidens, with the title of Chief Scientific Officer, who has been nominated by PharmGenomics;

 

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(b) the following Non-Executive Directors:

 

(i) Alberto Libanori, who has been nominated by the Existing Investors; and

 

(ii) Hans Hekland, who has been nominated by PharmGenomics;

 

(iii) one person who has been nominated by the Existing Investors and PharmGenomics jointly, with such nominee meeting the Nasdaq and SEC qualifications required to serve as the Company’s audit committee chairperson.

 

11.5 As of Conversion, the Company shall have an Executive Committee. The Executive Committee shall consist of all Executive Directors and such number of other Executive Officers as the Board of Directors may determine.

 

11.6 As of Conversion, for the time being, the Executive Committee shall consist of:

 

(a) the Executive Directors, with their respective titles;

 

(b) Philipp Freese, with the title of Chief Operations Officer, who has been nominated by PharmGenomics; and

 

(c) such other Executive Officers with such titles as the Board of Directors may determine.

 

11.7 As of Completion and until Conversion, the persons named in Clause 11.4 but not yet appointed as Director will jointly constitute an advisory board to the Board of Directors. For the avoidance of doubt, such advisory board is not a corporate body (orgaan) of the Company and as such has no formal authority.

 

12. Equity incentive plan

 

The Company shall, in consultation with PharmGenomics, adopt an omnibus incentive plan or other similar arrangement with due observance of applicable law and stock exchange rules, as soon as reasonably practicable following completion of the listing of the Company Shares on Nasdaq, reserving a number of Company Shares representing not more than 12% of the issued share capital of the Company for grant thereunder and with vesting conditions that are reasonably satisfactory to the Company and PharmGenomics.

 

13. Listing on Nasdaq

 

13.1 The Parties shall use their reasonable best efforts to cause the Company Shares to be approved for listing on Nasdaq as soon as reasonably practicable after the date of this Agreement and to cause the Company to satisfy any applicable initial and continuing listing requirements of Nasdaq.

 

13.2 The Parties shall use their reasonable best efforts to cause the Company to be converted into a public company under Dutch law after Completion but prior to the listing of the Company Shares on Nasdaq (“Conversion”).

 

13.3 The Contributors shall use their reasonable best efforts to maintain the composition of the Board of Directors as set out in Clause 11 upon Conversion and at least until the listing of the Company Shares on Nasdaq shall have been completed.

 

14. Notices

 

14.1 Any notice or other communication in connection with this Agreement shall be in writing and shall be delivered personally or by courier or sent by registered post or e-mail. Any notice or other communication shall be in the English language.

 

12

 

 

14.2 Any notice or other communication shall only be effective upon receipt. A notice or other communication shall be deemed to have been received, if delivered personally, upon receipt, if delivered by courier or sent by registered post, upon confirmation of receipt, or if sent by e-mail, upon transmission in legible form.

 

15. Miscellaneous

 

15.1 This Agreement constitutes the entire agreement between the Parties in relation to its subject matter and supersedes any previous written or oral agreements between the Parties to the extent they have any bearing on its subject matter.

 

15.2 No rights or obligations under this Agreement shall be transferable by a Party without the prior written consent of the other Parties.

 

15.3 Except as expressly provided, this Agreement does not contain any stipulation in favour of a third party as referred to in section 6:253 of the Dutch Civil Code.

 

15.4 The Parties waive any right they may have at any time to nullify this Agreement in whole or in part under section 6:228 or 6:229 of the Dutch Civil Code or to dissolve this Agreement in whole or in part under section 6:265 of the Dutch Civil Code.

 

15.5 This Agreement may only be amended or supplemented pursuant to a written agreement between the Parties.

 

15.6 This Agreement may be signed in any number of counterparts. All counterparts together shall constitute one agreement.

 

16. Governing law and competent court

 

16.1 This Agreement and any non-contractual obligations arising out of or in connection with it shall be exclusively governed by and construed in accordance with Dutch law.

 

16.2 Any dispute arising out of or in connection with this Agreement, including a dispute relating to the existence, validity or termination thereof or any non-contractual obligation arising out of or in connection with it, shall exclusively be resolved by the Dutch courts. The competent court of Amsterdam, the Netherlands, shall have exclusive jurisdiction to hear any disputes in the first instance.

 

(Signature pages follow)

 

13

 

  

(Signature page to contribution agreement)

 

AGREED AND SIGNED ON 29 JULY 2021 BY  
   
Dr. M. Eidens  
     
     
     
     
Dr. S. Prause  
     
     
     

 

Wagnisfinanzierungsgesellschaft für Technologieförderung in Rheinland-Pfalz mbH (WFT)

 

Represented by:  
     
     
Name:    
Title:    
     
     
Name:    
Title:    

 

14

 

  

(Signature page to contribution agreement)

 

S-Innovations-Beteiligungsfinanzierungsgesellschaft Rheinland-Pfalz mbH (S-IFG)

 

Represented by:  
     
     
Name:    
Title:    
     
     
Name:    
Title:    

 

Kreditanstalt für Wiederaufbau (KfW)

 

Represented by:  
   
     
Name:    
Title:    
     
     
Name:    
Title:    

  

15

 

 

 

 

  

(Signature page to contribution agreement)  
   
Coloalert AS  
Represented by:  
   
   
Name:  
Title:  
   
   
Name:  
Title:  
   
P. Freese  
   

  

16

 

  

(Signature page to contribution agreement)

 

Fonds für Innovation und Beschäftigung Rheinland-Pfalz Unternehmens-Beteiligungsgesellschaft mbH (FIB)

 

Represented by:  
   
   
Name:  
Title:  
   
   
Name:  
Title:  
   
Norda ASA  
Represented by:  
   
   
Name:  
Title:  
   
   
Name:  
Title:  

  

17

 

  

(Signature page to contribution agreement)

 

MedSalus GmbH

  

Represented by:  
   
   
Name:  
Title:  
   
   
Name:  
Title:  
   
Dr. J. Felbel  
   
   
   
Dr. M. Messina  
   

 

18

 

  

(Signature page to contribution agreement)

 

Technos Invest GmbH  
Represented by:  
   
   
Name:  
Title:  
   
   
Name:  
Title:  
   
J. Schweizer  
   
   
G. Bächler  
   
   
Chi Ming Chan  
   

  

19

 

 

(Signature page to contribution agreement)

 

Chun Yu Yip  
   
   
M. Heyen  
   
   
Mainz Biomed B.V.  
Represented by:  
   
   
Name:  
Title:  
   
PharmGenomics GmbH  
Represented by:  
   
   
Name:  
Title:  
   
   
Name:  
Title:  

  

20

 

  

Schedule 1 – Particulars of the Contributors

  

Name and address of Contributor Number of Contribution Shares Number of Subscription Shares

Dr. M. Eidens

 

Am Emmerling-Park 22, 55218 Ingelheim, Germany

 

– one share with a nominal value of EUR 7,500.00 and consecutive number 2;

 

– one share with a nominal value of EUR 2,083.00 and consecutive number 4;

 

– one share with a nominal value of EUR 3,192.00 and consecutive number 18; and

 

– one share with a nominal value of EUR 1,931.00 and consecutive number 38

 

890,652 ordinary shares with a nominal value of EUR 0.01 each

Dr. S. Prause

 

Stubenlohstraße 14b, 91052 Erlangen, Germany

 

one share with a nominal value of EUR 5,832.00 and consecutive number 3 353,208 ordinary shares with a nominal value of EUR 0.01 each

Wagnisfinanzierungsgesellschaft für Technologieförderung in Rheinland-Pfalz mbH (WFT)

 

Holzhofstraße 4, 55116 Mainz, Germany

 

– one share with a nominal value of EUR 2,800.00 and consecutive number 5; and

 

– one share with a nominal value of EUR 1,366.00 and consecutive number 6

 

252,309 ordinary shares with a nominal value of EUR 0.01 each

S-Innovations-Beteiligungsfinanzierungsgesellschaft Rheinland-Pfalz mbH (S-IFG)

 

Vordere Synagogenstraße 2, 55116 Mainz, Germany

 

– one share with a nominal value of EUR 4,166.00 and consecutive number 7;

 

– one share with a nominal value of EUR 1,389.00 and consecutive number 13; and

 

– one share with a nominal value of EUR 2,743.00 and consecutive number 20

 

502.559 ordinary shares with a nominal value of EUR 0.01 each

Kreditanstalt für Wiederaufbau (KfW)

 

Palmengartenstraße 5-9, 60325 Frankfurt, Germany

 

– one share with a nominal value of EUR 4,166.00 and consecutive number 8;

 

– one share with a nominal value of EUR 5,555.00 and consecutive number 14; and

 

– one share with a nominal value of EUR 10,712.00 and consecutive number 19

 

1,237,501 ordinary shares with a nominal value of EUR 0.01 each

Coloalert AS

 

Storgata 61 H0504, 4307 Sandnes, Norway

 

– one share with a nominal value of EUR 723.00 and consecutive number 9;

 

– one share with a nominal value of EUR 2,222.00 and consecutive number 16;

 

– one share with a nominal value of EUR 734.00 and consecutive number 22; 

821,427 ordinary shares with a nominal value of EUR 0.01 each

 

21

 

  

Name and address of Contributor Number of Contribution Shares Number of Subscription Shares
 

– one share with a nominal value of EUR 3,192.00 and consecutive number 24;

 

– one share with a nominal value of EUR 4,030.00 and consecutive number 36; and

 

– one share with a nominal value of EUR 2,662.00 and consecutive number 39

 

 

Mr. P. Freese

 

Albert-Schweitzer-Weg 3, 41515 Grevenbroich, Germany

 

– one share with a nominal value of EUR 1,668.00 and consecutive number 11; and

 

– one share with a nominal value of EUR 417.00 and consecutive number 12

 

126,276 ordinary shares with a nominal value of EUR 0.01 each

Fonds für Innovation und Beschäftigung Rheinland-Pfalz Unternehmens-Beteiligungsgesellschaft mbH (FIB)

 

Holzhofstraße 4, 55116 Mainz, Germany

 

– one share with a nominal value of EUR 1,389.00 and consecutive number 17; and

 

– one share with a nominal value of EUR 959.00 and consecutive number 23

 

142,204 ordinary shares with a nominal value of EUR 0.01 each

Norda ASA

 

c/o Andenæsgruppen AS, Stortingsgata 28, 0161 Oslo, Norway

 

– one share with a nominal value of EUR 1,596.00 and consecutive number 25; and

 

– one share with a nominal value of EUR 315.00 and consecutive number 40

 

115,738 ordinary shares with a nominal value of EUR 0.01 each

MedSalus GmbH

 

Sackgasse 5a, 8077 Gössendorf, Austria

 

– one share with a nominal value of EUR 3,192.00 and consecutive number 26; and

 

– one share with a nominal value of EUR 3,150.00 and consecutive number 35

 

384,399 ordinary shares with a nominal value of EUR 0.01 each

Dr. J. Felbel

 

Tennelbachstraße 53, 65193 Wiesbaden, Germany

 

– one share with a nominal value of EUR 1,360.00 and consecutive number 27; and

 

– one share with a nominal value of EUR 315.00 and consecutive number 37

 

101,444 ordinary shares with a nominal value of EUR 0.01 each

Mr. M. Messina

 

Hermine-Berthold-Straβe 24, 28205 Bremen, Germany

 

one share with a nominal value of EUR 1,486.00 and consecutive number 29 89,998 ordinary shares with a nominal value of EUR 0.01 each

 

22

 

 

Technos Invest GmbH

 

Am Studio 1, 12489 Berlin, Germany

 

one share with a nominal value of EUR 1,577.00 and consecutive number 41 95,509 ordinary shares with a nominal value of EUR 0.01 each

Mr. J. Schweizer

 

Seidlhofstraße 16, 80639 München

 

– one share with a nominal value of EUR 2,083.00 and consecutive number 10; and

 

– one share with a nominal value of EUR 889.00 and consecutive number 28

 

179,996 ordinary shares with a nominal value of EUR 0.01 each

Mr. G. Baechler

 

2021 Del Norte Street, Berkeley, CA 94707, USA

 

one share with a nominal value of EUR 900.00 and consecutive number 30 54,507 ordinary shares with a nominal value of EUR 0.01 each

Mr. Chi Ming Chan

 

Unit B, 12/F Tower 1, Grand Austin, Austin Road West, Kowloon, Hong Kong

 

– one share with a nominal value of EUR 58.00 and consecutive number 31; and

 

– one share with a nominal value of EUR 1,180.00 and consecutive number 32

 

74,978 ordinary shares with a nominal value of EUR 0.01 each

Mr. Chun Yu Yip

 

1st Floor, 16 Dumbarton Road, Hong Kong

 

one share with a nominal value of EUR 1,238.00 and consecutive number 33 74,978 ordinary shares with a nominal value of EUR 0.01 each

Mr. M. Heyen

 

Heyder Feldweg 50, 52072 Aachen, Germany

 

one share with a nominal value of EUR 8,294.00 and consecutive number 34 502,317 ordinary shares with a nominal value of EUR 0.01 each

  

23

 

 

Schedule 2 – Particulars of the Investors

 

Name Company Shares Company Warrants
Boustead & Company Limited 666,667 ordinary shares with a nominal value of EUR 0.01 each 666,667 warrants to subscribe for ordinary shares with a nominal value of EUR 0.01 each
Mrs. J. Jakovljević 366,667 ordinary shares with a nominal value of EUR 0.01 each 366,667 warrants to subscribe for ordinary shares with a nominal value of EUR 0.01 each
Felix Capital GmbH 333,333 ordinary shares with a nominal value of EUR 0.01 each 333,333 warrants to subscribe for ordinary shares with a nominal value of EUR 0.01 each
Camino Capital GmbH 333,333 ordinary shares with a nominal value of EUR 0.01 each 333,333 warrants to subscribe for ordinary shares with a nominal value of EUR 0.01 each
Mr. G.A. Wall 180,000 ordinary shares with a nominal value of EUR 0.01 each 180,000 warrants to subscribe for ordinary shares with a nominal value of EUR 0.01 each
Prodigious Wealth Limited 60,000 ordinary shares with a nominal value of EUR 0.01 each 60,000 warrants to subscribe for ordinary shares with a nominal value of EUR 0.01 each
Mr. J.A.W. Poirier 60,000 ordinary shares with a nominal value of EUR 0.01 each 60,000 warrants to subscribe for ordinary shares with a nominal value of EUR 0.01 each
Mr. M. Messina 10,000 ordinary shares with a nominal value of EUR 0.01 each 10,000 warrants to subscribe for ordinary shares with a nominal value of EUR 0.01 each
Boustead Securities, LLC 280,000 warrants to subscribe for ordinary shares with a nominal value of EUR 0.01 each

 

24

 

  

Schedule 3 – Deed of Issue

 

[Hard copy]

 

25

 

  

Schedule 4 – Deed of Transfer

 

[Hard copy]

  

26

 

 

Schedule 5 – Credit Facility Agreement

 

[Hard copy]

 

27

 

  

Schedule 6 – Lock-up Agreement

 

[Hard copy]

  

28

 

 

Schedule 7 – Management Services Agreement Eidens

 

[Hard copy]

  

29

 

 

Schedule 8 – Management Services Agreement Freese

 

[Hard copy]

 

30

 

  

Schedule 9 – Company Articles of Association

 

[Hard copy]

  

31

 

 

Schedule 10 – PharmGenomics Articles of Association

 

[Hard copy]

 

 

 

32

 

 

Exhibit 10.9

 

Silent Partnership Agreement

 

Between the Company

 

PharmGenomics GmbH, Robert-Koch-Str. 50, 55129 Mainz, Germany

 

- hereinafter also referred to as the “Participant” -

 

and the

 

[______________________]

 

- hereinafter also referred to as the “Participation Provider” -

 

§ 1

 

Overview

 

(1) The Participation Provider agrees to be a silent partner in the commercial enterprise operated by the Participant in accordance with the following provisions set forth in this Silent Partnership Agreement (the “Agreement”).

 

(2) This Agreement shall become effective upon fulfilment of the requirements set forth in § 4 by the Participant, but no earlier than the day following the signing of this Agreement by all Parties.

 

§ 2

 

Contribution

 

(1) The Participation Provider makes a contribution of EUR [________] ([_____________] thousand euros) in cash (the “Contribution”).

 

(2) The Contribution shall be made in accordance with and upon fulfilment of the provisions of this Agreement, including Annexes 1 to 4, by way of a call for corresponding funds by the Participant.

 

(3) The Participant may refuse to pay the Contribution if there are reasons which would entitle it to terminate the agreement in accordance with § 16 (2) of this agreement or if the Participant is insolvent or threatened with insolvency in accordance with §§ 17, 18 of the German Insolvency Statute (the “InsO”) as amended or if the Participant is over-indebted in accordance with § 19 of the InsO as amended, even if no application for the opening of insolvency proceedings has been filed.

 

(4) The Participant is only entitled to dispose of the Contribution as defined in the preceding paragraphs to third parties with the prior consent of the Participation Provider.

 

(5) There is no obligation on the part of the Participation Provider to make additional contributions.

 

§ 3

 

Use of Funds

 

The funds made available by the Participation Provider on the basis of this Agreement may only be used by the Participant to finance the project described in below and in § 3 :

 

Residual development and market launch of further genetic tests in the field of “in vitro diagnostics”.

 

The total amount of the project costs should not exceed EUR [________] ([_____________] euros) or the cost/financing plan for the project set forth in Annex 1 and the implementation of the “ERP Start-up Funding Plan,” attached as Annex 4.

 

 

 

 

§ 4

 

Effect of the contract

 

The effectiveness of the contract is dependent on the fulfilment of the following conditions:

 

(1) Full financing of the project

 

Commitment of [€________] for open participation in the total amount of [€_________];

 

Commitment of the FIB for an open participation in the total amount of [€_______];

 

Commitment for silent participations in the amount of [€_________].

 

(2) Submission of a current certificate in tax matters from the responsible tax office in the original.

 

(3) Before the Contribution, the acquisition of shares must have been carried out in accordance with the standards of the Participation Provider under an open participation agreement and an amendment of the articles of association.

 

(4) Before the Contribution, Participant must demonstrate that it owns the entire right, title and interest in its patents, trademarks, copyrights, trade secrets, know-how and other proprietary material and concepts (“Intellectual Property”), and demonstrate that no claims have been asserted challenging Participant’s inventorship, ownership or right to use the Intellectual Property. Possible future patent applications must be disclosed by Participant.

 

(5) All documents to be submitted must not give rise to any concerns.

 

§ 5

 

Call for funds

 

(1) The Participation Provider shall make available the Contribution in accordance with the following provisions:

 

The payment of the Contribution will be made in two tranches and is subject to the condition that the Participant is satisfying the submitted business plan set forth in Annex 4.

 

The Participant and Participation Provider agree to the following:

 

The conditions set forth in Annex 4 must be fulfilled before a first payment of € [________] is made by [________] .

 

All relevant evidence must be provided in writing by PharmGenomics GmbH.

 

Before a second disbursement in the amount of € [______] is made by [________] at the latest, the requirements set forth in Annex 4 must be met.

 

Revenues are reported using BWAs. Other operating income is evidenced by grant notices, quarterly payment requests and bank statements. EBITDA is evidenced by appropriate supporting documentation from a tax accountant’s office or auditor.

 

If the above requirements are not met, the Participation Provider is not obliged to disburse the Contribution. If the above requirements for the call of funds are met, the Participant may call for the Contribution immediately and in the amount provided.

 

(2) The Participation Provider assumes that the Contribution will be called by the Participant in accordance with the cost/financing plan, but no later than [_____________]. If the first tranche is not called by this date, this agreement shall end without the need for written termination.

 

§ 6

 

Repayment of appropriations in the event of misuse

 

The Participation Provider shall be entitled to repayment of the portion of the Contribution not used immediately or in full for the purpose stipulated in § 3 of this Agreement. The funds may only be called up again once the conditions for their appropriate use have been met. Statutory rights of recovery as well as the other provisions of this Agreement shall remain unaffected by the provision pursuant to § 6 of this Agreement.

 

2

 

 

§ 7

 

Duration of the silent partnership

 

The silent partnership begins with the payment of the Contribution or, in the case of partial payment, with the payment of the first tranche. The silent partnership established by this contract ends regularly with the full repayment of the contribution in accordance with the provisions of this contract, but no later than [________________].

 

§ 8

 

Financial year

 

The fiscal year of the silent partnership corresponds to that of the Participant. The financial year of the Participant ends on December 31.

 

§ 9

 

Remuneration

 

(1) The Participant owes the Participation Provider a minimum remuneration of [___]% of the Contribution or portion of the Contribution made (the “Renumeration “). The Remuneration is due in arrears on 30 June 30 and December 31 of each year.

 

(2) In addition to the Renumeration, the Participation Provider receives a share of the Participant’s annual net income before taxes as determined in accordance with subsection a) below. This amounts to [____]% of the net income before taxes, but not more than [___]%of the amount invested (profit-related remuneration); however, for a period in which the Participation Provider holds more than one silent participation in the Participant, it only receives a total of 50 % of the net income before taxes.

 

a) The profit participation of the Participation Provider shall be determined on the basis of the pre-tax annual net profit determined in the commercial balance sheet of the Participant before taking into account the profit share attributable to the Participation Provider. The annual net income before taxes determined in accordance with this section shall form the basis for the calculation of the profit participation of the provider of the participation after the corrections carried out below have been made:

 

Managing directors’ salaries of the Participant and other payments to managing directors (e.g. bonuses, pension provisions) are to be added to the annual result.

 

Special reserves with an equity portion and tax-exempt reserves are allocated to profit or loss when they are created and deducted when they are released.

 

b) The profit-related remuneration payable is to be paid to the Participation Provider within two weeks of the preparation of the annual financial statements.

 

c) If the annual financial statements of the Participant are amended, the amended amounts shall also be taken into account when determining the Participant’s profit participation. Compensation payments are to be made by the Participant within four weeks after the amendment of the corresponding tax assessment notices has become final.

 

(3) The Participation Provider is entitled to demand a one-off remuneration (final remuneration) at the end of the investment term. The final remuneration amounts to [___] % of the Participation Provider’s contribution.

 

(4) If the annual financial statements are not available within six months of the end of the financial year, an amount of [____]% of the Contribution shall be paid in advance as profit-related remuneration. If, after the annual financial statements are available, it becomes apparent that the advance payment of the profit-related remuneration has not been made or has not been made in full, the participant may demand that the overpaid amount be refunded. The participant is not entitled to interest on the overpaid amount.

 

(5) Any capital gains tax incurred shall be borne by the Participation Provider. The registration and payment of the capital gains tax and the solidarity surcharge - as long as this is levied - is carried out by the participant. The Participant shall promptly issue a tax certificate in accordance with section 45a(2) of the German Income Tax Law (“EStG”) for the amounts remitted and forward it to the Provider.

 

(6) The Participant authorises the Participation Provider to collect all remuneration pursuant to this § 9 by direct debit from the following account:

 

Bank:

Account holder:

Account no.:

Bank code:

 

or

 

IBAN:

BIC:

 

3

 

 

§ 10

 

Accounts of the Participation Provider; withdrawals

 

The Contribution must be entered by the Participant in a separate account for accounting purposes. Withdrawals by the Participation Provider from this account are excluded during the term of the participation.

 

§ 11

 

Loss participation, subordination

 

(1) The Particidpating Provider does not participate in the loss of the participant with his contribution.

 

(2) Provided that

 

- any other silent partners make a subordination to the extent set out below and maintain it for the duration of their silent participation; and

 

- all other shareholders make subordination declarations with regard to their claims of all kinds against the Participant and maintain them for their contractual term

 

in order to avoid over-indebtedness under section 19 of InsO, as amended), the Participant shall, in any insolvency proceedings relating to the assets of the Participant, subordinate its claim for repayment of the contribution in accordance with sections 19(2) and 39(2) of InsO to the claims specified in section 39(1) of InsO.

 

To the extent and as long as this is necessary to avoid over-indebtedness, the provider of the participation may demand repayment of the contributions, even outside of insolvency proceedings, only to the extent that payment can be made from a balance sheet profit, a liquidation surplus or the assets exceeding the other liabilities of the participant in the participation.

 

Insofar as creditors of the Participant have also submitted a declaration of subordination or comparable declarations, the Participation Provider shall rank pari passu with these creditors if the requirements of sentence 2 are met.

 

However, in relation to creditors who are shareholders of the Participant or close relatives of a shareholder within the meaning of § 15 of the German Fiscal Code (“AO”) or companies affiliated with a shareholder within the meaning of §§ 15 et seq. of the German Stock Corporation Act (“AktG”), the deposit claim of the Participation Provider shall, however, be satisfied with priority if the requirements of sentence 2 of §§ 15 et seq.of the AktG are met.

 

§ 12

 

Management
Transactions requiring approval

 

(1) Management is the sole responsibility of the Participant.

 

(2) The Participant is obliged to obtain the prior consent of the principal in the case of legal transactions and actions that go beyond the scope of normal business operations and may have a not merely insignificant impact on the net assets and results of operations. The prior consent of the principal is required in particular for the following measures:

 

a) Change of the object of the Participant;

 

b) Conversions within the meaning of the German Transformation Act (“UmwG”);

 

c) Changes in the corporate relationships, in particular the admission of further shareholders including the establishment of further silent partnerships as well as their premature termination and/or repayment;

 

d) Appointment and dismissal of managing directors;

 

e) Determination of the level of directors’ salaries;

 

f) Hiring and firing of employees with an annual income of more than EUR 60,000 and their remuneration in any form;

 

g) Acquisition of or participation in other companies and their disposal;

 

h) Abandonment, sale, lease or relocation of the business or significant parts of the business;

 

i) the not merely insignificant expansion, restriction or other change in the scope of business;

 

j) Establishment of branches;

 

4

 

 

k) Acquisition, sale or encumbrance of real estate or rights equivalent to real estate and sale or encumbrance of other not insignificant assets of the Participant;

 

l) Assumption of guarantees or warranties for third parties, granting of loans, if and to the extent that the assumption or granting goes beyond the ordinary course of business;

 

m) Repayment of loans to shareholders;

 

n) Conclusion, amendment or cancellation of control, profit and loss transfer agreements;

 

o) Conclusion, termination, amendment and extension of consultancy contracts of all kinds with a remuneration of more than EUR 15,000 per annum;

 

p) Assumption of obligations for investments that are not included in the project financing by the equity provider and that exceed the amount of EUR 50,000 or in the case of leasing, rental or lease agreements that exceed the amount of EUR 3,000 per month;

 

q) Disposition of industrial property rights as well as conclusion and termination of patent, license, know-how, distribution and cooperation agreements, if and to the extent that the disposition, conclusion or termination of the agreement goes beyond the ordinary course of business.

 

(3) It must be ensured that there are no transfers of assets of any kind, in particular as a result of changes in the shareholder structure, Participant spin-offs or
splits, conversions, increases in managing directors’ salaries/executive board remuneration, sales of Participant assets to relatives, employment of relatives and/or other (legal) transactions at non-market conditions.

 

(4) Profit distributions to the shareholders may only be made once all due payment obligations to the Participation Provider, including any arrears, have been fulfilled. Statutory regulations on the admissibility of profit distributions in terms of reason and amount remain unaffected by the regulation pursuant to section 12(1).

 

(5) Insofar as legal transactions and actions have been undertaken in breach of the above paragraphs 2 to 4, the Participation Provider shall be placed in the position it would have been in if the legal transaction or action had not been undertaken, in particular when calculating its payment claims in accordance with § 9 of this Agreement. Further rights of the Participation Provider, in particular to termination of this Agreement or any claims for damages, shall remain unaffected by the provision pursuant to section 12(1).

 

§ 13

 

Information obligations of the Participant; proof of use of funds

 

(1) The Participant must provide the Participation Provider with evidence of the proper use of the funds within [        ] months of the end of the project period, but no later than the end of the sixth month following the request for the second tranche of the contribution. Upon request by the Participation Provider, the Participant is additionally obliged to submit proof of interim use of funds within a period of four weeks.

 

(2) The Participant shall prepare its annual financial statements within the first five months after the end of each financial year and shall submit them to the Participation Provider in writing before they are adopted. Objections to the annual financial statements may only be raised by the Participation Provider within three weeks of receipt of the annual financial statements.

 

(3) The Participant is obliged to submit to the Participation Provider within the first six months of the following financial year the audited balance sheet with profit and loss account as well as the audit report. In addition, the annual financial statements of subsidiaries, affiliated companies and, if applicable, existing consolidated financial statements must be submitted to the Participant within the same period. If the completion of annual financial statements is delayed, this must be notified to the provider of the participation, stating the reasons and submitting the necessary documents. In this case, the preliminary figures are to be submitted first with a confirmation from a tax advisor.

 

(4) The Participant shall, without being requested to do so, fulfil the submission and reporting obligations vis-à-vis the provider of the equity participation set out in Section II.7 of the Principles of Equity Participation within the deadlines specified.

 

(5) Furthermore, the Participant undertakes to inform the Participation Provider without delay of any circumstances that may jeopardise the purpose of the Participation and/or cause considerable delays in the funded project.

 

5

 

 

§ 14

 

Control rights of the Participation Provider

 

(1) The Participation Provider and/or its agents shall be entitled to monitor and inspect the Participant, in particular with regard to the use of funds agreed in this Agreement. The Participant and its agents may demand all necessary information from the Participant, inspect its business documents, including tax files, and visit the Participant’s premises at any time. The Federal Audit Office and the Federal Ministry for Economic Affairs and Energy (BMWi) have corresponding monitoring and inspection rights. An auditor may also be commissioned to carry out the monitoring and review.

 

(2) The Participation Provider reserves the right to demand the involvement of external consultants if deficits are identified in the commercial and/or business management area. This is particularly the case if the reporting system to be provided to the Participation Provider does not meet the required standard.

 

(3) The Participation Provider shall have a claim against the Participant for reimbursement of the costs incurred in the course of the monitoring and review insofar as the Participant is responsible for the reason for the specific monitoring or review measures. This shall be the case in particular if the Participant has not or not sufficiently complied with the information obligations set out in § 13 of this Agreement despite having given notice of defects within 2 weeks.

 

§ 15

 

Release from secrecy

 

The Participant releases the guarantor from the duty of confidentiality vis-à-vis its Participants, including their executive bodies, the bodies authorised to audit in connection with the acquisition of the participation, as well as vis-à-vis the Federal Audit Office and the Federal Ministry of Economics and Technology. Furthermore, the Participant is released from the duty of confidentiality insofar as it is legally obligated to provide information to third parties or provides information to third parties who are themselves legally obligated to maintain confidentiality. In addition, the Participant releases its principal bank from the duty of confidentiality vis-à-vis the Participation Sponsor.

 

§ 16

 

Early termination of the Participant

 

(1) The participant is entitled to terminate the participation prematurely in whole or in part subject to a notice period of 12 months. Notice of termination shall be given to the Participation Provider by registered letter. Ordinary termination by the Participation Provider is excluded during the term of the contract.

 

(2) The provider of the participation may only terminate the Participant prematurely without notice if there is good cause. Good cause shall be deemed to exist in particular if

 

a) the Participant or its shareholders have provided incorrect information about their financial circumstances or the conditions for the acquisition of the participation were not met;

 

b) the Participant does not fulfil its obligations arising from this Agreement, in particular

 

the funds are not used for the intended purpose, or

 

fails to obtain prior consent to legal transactions requiring consent within the meaning of section 12(2) or infringes section 12(3) or (4), or

 

fails to submit tax certificates in accordance with Section 45a (2) of the German Income Tax Act within two months of the due date of the payments for which the certificates are to be issued, or

 

fails to comply with the submission and reporting obligations pursuant to § 13 within 2 weeks despite notification of defects;

 

c) the repayment of the investment is at risk. Such a risk exists in particular if

 

insolvency proceedings have been opened with respect to the assets of the participant or have been rejected for lack of assets or an out-of-court settlement (deferral, quota or liquidation settlement) has been concluded to which all or a group of comparable creditors have agreed, or

 

the Participant ceases to make payments, or

 

in the opinion of the Participation Provider, the economic situation of the Participant is unlikely to improve in the event of continuing losses;

 

d) the know-how provider(s) who, at the time of conclusion of this Agreement, is (are) no longer a full-time member of the management of the Participant.

 

6

 

 

(3) If the Participant ends prematurely as a result of termination on the part of the participant or as a result of termination on the part of the Participation Provider for good cause for which the participant is responsible, the Participation Provider may demand a premium. This does not apply to a termination pursuant to paragraph 2 c) above. The premium amounts to 2.0 % p.a. of the terminated amount and is calculated for the period by which the agreed participation term is reduced (settlement to the day).

 

(4) If the Participation Provider’s contribution has not yet been made or has not been made in full at the time of termination, the Participation Provider shall be released from his obligation to make a contribution upon the declaration of termination.

 

§ 17

 

Repayment of the contribution; due date

 

(1) In the event of termination of the Participant, in particular due to the passage of time or termination, the contribution shall be due for repayment in the amount of the nominal amount less any partial payments already made on the nominal amount.

 

(2) At the same time, the Renumeration as well as, if applicable, the terminal bonus and the premium are due for payment.

 

§ 18

 

Remuneration surcharges

 

(1) If, during the existence of the silent partnership, payments are not made on the contractually agreed dates, interest is payable on them at the rate of 1% per month for each month or part thereof of non-payment.

 

(2) Upon termination of the silent partnership, interest shall be paid on the total receivables due to the Participation Provider from the due date until receipt of payment at a rate of at least 1% per month for each month or part thereof.

 

(3) The Participation Provider reserve the right to assert further damage caused by delay.

 

§ 19

 

Insurance

 

The Participant shall keep its business operations adequately insured against the usual risks. The equity provider may require the conclusion of term life insurance for individual know-how holders.

 

§ 20

 

Place of performance and jurisdiction

 

The place of performance and jurisdiction for legal disputes arising from this contractual relationship is the domicile of the Participation Provider.

 

§ 21

 

Supplementary provisions

 

Possible future patent applications must be filed by PharmGenomics GmbH.

 

§ 22

 

“intentionally released”

 

§ 23

 

Subsidiary agreements; severability clause

 

(1) No ancillary agreements outside of this contract have been made.

 

(2) Amendments or supplements to this contract must be made in writing. This also applies to compliance with the written form requirement.

 

(3) Should any provision of this contract be legally invalid, this shall not affect the remaining provisions. In such a case, the contracting parties shall be obliged to replace the legally ineffective provisions with legally effective provisions which economically correspond to the meaning and purpose of the contract.

 

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PharmGenomics GmbH   COMPANY
     
Participant   Participation Provider
         
By:                    By:                
Name:      Name:   
Title:     Title:  
Date:     Date:  

 

 

Attachments: Annex 1: Cost/Financing Plan
  Annex 2: Personal statement of the management
  Annex 3: Anti-Money Laundering Amendment
  Annex 4: ERP Start-up Funding Plan

 

8

 

 

Annex 1

 

Cost/Financing Plan

 

Cost plan       Financing plan    
Investments           Silent Partnership        
non-investive expenditures           Private Participation Providers        
Market launch costs           ISB companies        
Total           Total        

 

Project duration:

 

 

9

 

 

Annex 2

 

 

Personal Statement of the Management

 

Pursuant to § 12 of the agreement on the establishment of a typical silent partnership, the Participant is obliged to obtain the prior consent of the Participation Provider for legal transactions and actions that go beyond the scope of normal business operations and may have a not merely insignificant impact on the net assets and results of operations. The prior consent of the principal is required in particular for the following measures:

 

a) Change of the object of the Participant;

 

b) Conversions within the meaning of the UmwG;

 

c) Changes in the corporate relationships, in particular the admission of further shareholders including the establishment of further silent partnerships as well as their premature termination and/or repayment;

 

d) Appointment and dismissal of executive officers;

 

e) Determination of the amount of directors’ salaries/remuneration;

 

f) Hiring and firing of employees with an annual income of more than EUR 60,000 and their remuneration in any form;

 

g) Acquisition of or participation in other companies and their disposal;

 

h) Abandonment, sale, lease or relocation of the business or significant parts of the business;

 

i) the not merely insignificant expansion, restriction or other change in the scope of business;

 

j) Establishment of branches;

 

k) Acquisition, sale or encumbrance of real estate or rights equivalent to real estate and sale or encumbrance of other not insignificant assets of the Participant;

 

l) Assumption of guarantees or warranties for third parties, granting of loans, if and to the extent that the assumption or granting goes beyond the ordinary course of business;

 

m) Repayment of loans to shareholders;

 

n) Conclusion, amendment or cancellation of profit and loss transfer agreements;

 

o) Conclusion, termination, amendment and extension of consultancy contracts of all kinds with a remuneration of more than EUR 15,000 per annum;

 

p) Assumption of obligations for investments that are not included in the project financing by the equity provider and that exceed the amount of EUR 50,000 or, in the case of leasing, rental or lease agreements, that exceed the amount of EUR 3,000 per month;

 

q) Disposition of industrial property rights as well as conclusion and termination of patent, license, know-how, distribution and cooperation agreements, if and to the extent that the disposition, conclusion or termination of the agreement goes beyond the ordinary course of business;

 

Furthermore, it must be ensured that there are no transfers of assets of any kind, in particular as a result of changes in the shareholder structure, spin-offs or splits of businesses, conversions, increases in managing directors’ salaries/executive board remuneration, sales of business assets to relatives, employment of relatives and/or other (legal) transactions at non-market conditions.

 

In addition, profit distributions to the shareholders may only be made once all due payment obligations to the Participation Provider, including any arrears, have been fulfilled. Statutory regulations on the admissibility of profit distributions in terms of reason and amount remain unaffected by the above provision.

 

The undersigned hereby declare that they will not participate in any legal transactions and actions that violate the above provisions and, in the event of a violation of this obligation, that they will be personally liable to the Participation Provider for all damages and losses resulting from such participation.

 

The signatories undertake to place their labour at the disposal of the Participant only, unless the contracting parties decide otherwise.

 

10

 

 

Until their departure, the signatories may neither enter into a participation in another Participant nor found a Participant that competes with the Participant without the consent of the provider of the participation. Excluded are purely capital participations below 2% of the capital of the Participant in which this purely capital participation takes place, provided that the purely capital participation does not exceed EUR 10,000.

 

 

PharmGenomics GmbH  
     
By:                    
Name:     
Title:    
Date:    

 

 

11

 

 

Annex 3

 

Anti-Money Laundering Amendment

 

1) In order to satisfy the identification requirement under the German Anti-Money Laundering Act or Geldwäschegesetz (GwG) , the Participant undertakes to provide the necessary information pursuant to Section 4 of the GwG.

 

2) The Participant shall disclose the extent that it is acting on behalf of a beneficial owner within the meaning of Section 1 (6) of the GwG.

 

3) If the Participant is not a natural person, the Participant is required to disclose its ownership and control structure, including the percentage of capital and voting shares.

 

4. The Participant shall disclose if it is, within the meaning of the GwG, a natural person not residing in Germany who holds or has held an important public office, or an immediate family member of such a person or a person known to be close to such a person. Disclosure is not required if the public office has not been held for more than one year.

 

5 Insofar as the cooperation of the Participant is necessary for the Equity Provider to fulfil its obligations resulting from the GwG (e.g. in the establishment of the business relationship or in the ongoing monitoring of the business relationship), the Participant shall be obliged to cooperate to the extent required, in particular it shall provide the necessary details, make available the necessary information and documents and immediately notify any changes arising in the course of the business relationship.

 

6) If the Participant violates its aforementioned obligations, the Provider of the Participation may refuse to establish a business relationship or may terminate an existing business relationship by giving notice or by other means and shall not be obliged to carry out any Transactions.

 

 

PharmGenomics GmbH  
     
By:                  
Name:     
Title:    
Date:    

 

 

12

 

 

Annex 4

 

ERP Start-Up Funding Plan

 

 

 

 

 

13

 

Exhibit 10.10

 

Form of

 

MAINZ BIOMED B.V.

 

(TO BE RENAMED MAINZ BIOMED N.V.)

 

2021 OMNIBUS INCENTIVE PLAN

 

SECTION 1. Establishment and Purpose.

 

(a) Purpose. The purpose of the Plan is to promote the interests of Mainz Biomed B.V., a corporation incorporated in the Netherlands (the “Corporation”), and its shareholders by providing eligible employees, directors and consultants with additional incentives to remain with the Corporation and its affiliated entities and subsidiaries, to increase their efforts to make the Corporation more successful, to reward such persons by providing an opportunity to acquire Ordinary Shares and to attract and retain the best available personnel to participate in the ongoing business operations of the Corporation. The Plan permits the grant of Incentive Stock Options, Nonstatutory Stock Options, Restricted Shares, Restricted Share Units, Share Appreciation Rights, Performance Units and Performance Shares.

 

(b) Adoption and Term. The Plan has been approved by the Board of Directors of the Corporation, and subject to the approval of a majority of the voting power of the shareholders of the Corporation, is effective______, 2021. The Plan will remain in effect until terminated or abandoned by action of the Board of Directors except as otherwise provided in Section 15. The Plan replaces and supersedes any equity incentive plan maintained by the Corporation and its affiliated entities and subsidiaries.

 

SECTION 2. Definitions.

 

(a) “Applicable Laws means the requirements relating to the administration of equity-based awards under U.S. state corporate laws, U.S. federal and state securities laws, the Code, any stock exchange or quotation system on which the Ordinary Shares are listed or quoted and the applicable laws of any foreign country or jurisdiction where Awards are, or will be, granted under the Plan.

 

(b) “Award means the grant of Incentive Stock Options, Nonstatutory Stock Options, Restricted Shares, Restricted Share Units, Share Appreciation Rights, Performance Units or Performance Shares made pursuant to the Plan.

 

(c) “Award Agreement means an agreement entered into by the Corporation and the Participant setting forth the terms applicable to an Award granted to the Participant under the Plan.

 

(d) “Board of Directors means the Board of Directors of the Corporation, as constituted from time to time.

 

(e) “Cause means (i) conviction of, or the entry of a plea of guilty or no contest to, a felony or any other crime that causes the Corporation public disgrace or disrepute, or adversely affects the Corporation’s operations, condition (financial or otherwise), prospects or interests, (ii) gross negligence or willful misconduct with respect to the Corporation, including, without limitation fraud, embezzlement, theft or dishonesty in the course of his or her employment; (iii) alcohol abuse or use of controlled drugs other than in accordance with a physician’s prescription; (iv) refusal, failure or inability to perform any material obligation or fulfill any duty (other than any duty or obligation of the type described in clause (6) below) to the Corporation (other than due to a disability), which failure, refusal or inability is not cured within 10 days after delivery of notice thereof; (v) material breach of any agreement with or duty owed to the Corporation; or (vi) any breach of any obligation or duty to the Corporation (whether arising by statute, common law, contract or otherwise) relating to confidentiality, noncompetition, nonsolicitation or proprietary rights. Notwithstanding the foregoing, if a Participant and the Corporation have entered into an employment agreement, consulting agreement or other similar agreement that specifically defines “Cause,” then with respect to such Participant, “Cause” shall have the meaning defined in that employment agreement, consulting agreement or other agreement.

 

1

 

 

(f) “Change of Control means the occurrence of any of the following, in one transaction or a series of related transactions: (i) any person (as such term is used in Section 13(d) and 14(d) of the Exchange Act) becoming a “beneficial owner” (as defined in Rule 13d-3 of the Exchange Act), directly or indirectly, of securities of the Corporation representing more than 50% of the voting power of the Corporation’s then outstanding capital stock; (ii) a consolidation, share exchange, reorganization or merger of the Corporation resulting in the shareholders of the Corporation immediately prior to such event not owning at least a majority of the voting power of the resulting entity’s securities outstanding immediately following such event or, if the resulting entity is a direct or indirect subsidiary of the entity whose securities are issued in such transaction(s), the voting power of such issuing entity’s securities outstanding immediately following such event; (iii) the sale or other disposition of all or substantially all the assets of the Corporation (other than a transfer of financial assets made in the ordinary course of business for the purpose of securitization or any similar purpose); (iv) a change in the effective control of the Company which occurs on the date that a majority of members of the Board is replaced during any period of 24 consecutive months by Directors whose appointment or election is not endorsed by a vote of at least two-thirds of the members of the Board prior to the date of the appointment or election; (v) a liquidation or dissolution of the Corporation; or (vi) any similar event deemed by the Committee to constitute a Change in Control for purposes of the Plan. For the avoidance of doubt, a transaction or a series of related transactions will not constitute a Change in Control if such transaction(s) result(s) in the Corporation, any successor to the Corporation, or any successor to the Corporation’s business, being controlled, directly or indirectly, by the same person or persons who controlled the Corporation, directly or indirectly, immediately before such transaction(s).

 

(g) “Code means the Internal Revenue Code of 1986, as amended.

 

(h) “Committee means the Compensation Committee of the Board of Directors or such other committee or individuals satisfying Applicable Laws appointed by the Board in accordance with Section 3 hereof.

 

(i) “Consultant means any person other than an Employee, engaged by the Corporation or Subsidiary to render services to such entity.

 

(j) “Corporation means Mainz Biomed B.V. (to be renamed Mainz Biomed N.V.), a corporation incorporated into the Netherlands and, where applicable, its Subsidiaries.

 

(k) “Date of Grant means the date on which the Committee grants an Award pursuant to the Plan.

 

(l) “Disability means total and permanent disability as defined in Section 22(e)(3) of the Code, provided that in the case of Awards other than Incentive Stock Options, the Committee in its discretion may determine whether a permanent and total disability exists in accordance with uniform and non-discriminatory standards adopted by the Committee from time to time.

 

(m) “Effective Date means_______________, 2021.

 

(n) “Employee means any individual who is a common-law employee of the Corporation or a Subsidiary.

 

(o) “Exchange Act means the Securities Exchange Act of 1934, as amended.

 

2

 

 

(p) “Exchange Program means a program established by the Committee under which outstanding Awards are amended to provide for a lower Exercise Price or surrendered or cancelled in exchange for (i) Awards with a lower exercise price, (ii) a different type of Award or awards under a different equity incentive plan, (iii) cash, or (iv) a combination of (i), (ii) and/or (iii). Notwithstanding the preceding, the term Exchange Program does not include any (i) action described in Section 13 or any action taken in connection with a Change in Control transaction or (ii) transfer or other disposition permitted under Section 13. For the purpose of clarity, each of the actions described in the prior sentence, none of which constitute an Exchange Program, may be undertaken (or authorized) by the Committee in its sole discretion without approval by the Corporation’s shareholders.

 

(q) “Exercise Price with respect to an Option, means the price per share at which an Optionee may exercise his Option to acquire all or a portion of the Ordinary Shares that are the subject of such Option, as determined by the Committee on the Date of Grant. Except with respect to Substitute Awards, in no event shall the Exercise Price of any Ordinary Shares made the subject of an Option, be less than (i) the Fair Market Value on the Date of Grant or (ii) for 10% Shareholders, 110% of the Fair Market Value on the Date of Grant.

 

(r) “Fair Market Value means, as of any date, the value of Ordinary Shares determined as follows:

 

(i) If the Ordinary Shares are listed on any established stock exchange or a national market system, including without limitation the New York Stock Exchange, the Nasdaq Global Select Market, the Nasdaq Global Market or the Nasdaq Capital Market of The Nasdaq Stock Market, its Fair Market Value will be the closing sale price for such Ordinary Shares (or the closing bid, if no sales were reported) as quoted on such exchange or system on the day of determination, as reported in The Wall Street Journal or such other source as the Committee deems reliable;

 

(ii) If the Ordinary Shares are regularly quoted by a recognized securities dealer but selling prices are not reported, or if the Ordinary Shares are quoted on the Over-the-Counter (OTC) market, be that the OTCQB, OTCBB or Pink Sheets, the Fair Market Value of a Share will be the mean between the high bid and low asked prices for the Ordinary Shares on the day of determination, as reported in The Wall Street Journal, the OTC, or such other source as the Committee deems reliable;

 

(iii) For purposes of any Awards granted on the Registration Date, the Fair Market Value will be the initial price to the public as set forth in the final prospectus included within the registration statement in Form F-1 filed with the Securities and Exchange Commission for the initial public offering of the Corporation’s Ordinary Shares; or

 

(iv) In the absence of an established market for the Ordinary Shares, the Fair Market Value will be determined in good faith by the Board of Directors after taking into account such factors as the Board shall deem appropriate

 

(s) “Incentive Stock Option” or “ISO means a stock option intended to satisfy the requirements of Section 422(b) of the Code.

 

(t)  “Nonstatutory Option means a stock option not intended to satisfy the requirements of Section 422(b) of the Code.

 

(u) “Officer means a person who is an officer of the Corporation within the meaning of Section 16 of the Exchange Act and the rules and regulations promulgated thereunder.

 

(v) “Option means an ISO or Nonstatutory Option granted under the Plan and entitling the holder to purchase Ordinary Shares.

 

(w) “Ordinary Shares means those ordinary shares, par value [----] per share, of the Corporation as authorized by the Corporation’s Articles of Association, as amended.

 

3

 

 

(x) “Option Shares means those Ordinary Shares made the subject of an Option granted pursuant to the Plan.

 

(y) “Optionee means an individual who is granted an Option.

 

(z) “Other Share-Based Award means an equity-based or equity-related Award, other than an Option, Performance Share, Performance Unit, SAR, Restricted Shares, or Restricted Share Unit, granted in accordance with the terms and conditions set forth under Section 11 (including upon the attainment of any performance goals or otherwise as permitted under the Plan).

 

(aa) “Outside Director means a member of the Board of Directors who is not an Employee.

 

(bb) “Participant means a person who has an outstanding Award under the Plan. The term Participant also refers to an Optionee.

 

(cc) “Performance Goal means a performance goal established by the Committee pursuant to Section 10(c) of the Plan.

 

(dd) “Performance Share means an Award denominated in Shares which may be earned in whole or in part upon attainment of Performance Goals or other vesting criteria as the Committee may determine pursuant to Section 10.

 

(ee) “Performance Unit means an Award which may be earned in whole or in part upon attainment of Performance Goals or other vesting criteria as the Committee may determine and which may be settled for cash, Shares or other securities or a combination of the foregoing pursuant to Section 10.

 

(ff) “Plan means this Mainz Biomed B.V. (to be renamed Mainz Biomed N.V.) 2021 Omnibus Incentive Plan.

 

(gg) “Registration Date means the effective date of the first registration statement that is filed by the Corporation and declared effective pursuant to Section 12(g) of the Exchange Act, with respect to any class of the Corporation’s securities.

 

(hh) Restricted Shares” means those Ordinary Shares made the subject of an Award granted under the Plan.

 

(ii) “Restricted Share Unit means a bookkeeping entry representing an amount equal to the Fair Market Value of one Share, granted pursuant to Section 8. Each Restricted Share Unit represents an unfunded and unsecured obligation of the Corporation.

 

(jj) “Rule 16b-3 means Rule 16b-3 of the Exchange Act or any successor to Rule 16b-3, as in effect when discretion is being exercised with respect to the Plan.

 

(kk) “Section 16(b) means Section 16(b) of the Exchange Act.

 

(ll) “Service means service as an Employee, Consultant or Outside Director.

 

(mm) “Share means an Ordinary Shares, as adjusted in accordance with Section 13 of the Plan.

 

(nn) “Share Appreciation Right” or “SAR means a right awarded to a Participant pursuant to Section 9 of the Plan, which shall entitle the Participant to receive cash, Ordinary Shares, other property or a combination thereof, as determined by the Committee, in an amount equal to or otherwise based on the excess of (a) the Fair Market Value of an Ordinary Share at the time of exercise over (b) the exercise price of the right, as established by the Committee on the date the award is granted.

 

4

 

 

(oo) “Subsidiary means any corporation (other than the Corporation) in an unbroken chain of corporations beginning with the Corporation if each of the corporations other than the last corporation in the unbroken chain owns stock possessing fifty percent (50%) or more of the total combined voting power of all classes of stock in one of the other corporations in such chain. A corporation that attains the status of a Subsidiary on a date after the adoption of the Plan shall be considered a Subsidiary commencing as of such date.

 

(pp) “Substitute Award” means an Award granted under the Plan in assumption of, or in substitution for, outstanding awards previously granted by an entity acquired by the Corporation or with which the Corporation combines.

 

SECTION 3. Administration.

 

(a) Committee of the Board of DirectorsThe Plan may be administered by the Compensation Committee of the Board of Directors or such other Committee or individuals as appointed by the Board to administer the Plan. Each Committee shall have such authority and be responsible for such functions as the Board of Directors has assigned to it. Members of the Committee shall serve for such period of time as the Board of Directors may determine and shall be subject to removal by the Board of Directors at any time. The Board of Directors may also at any time terminate the functions of the Committee and reassume all powers and authorities previously delegated to the Committee. If no Committee has been appointed, the entire Board of Directors shall administer the Plan.

 

To the extent desirable to qualify transactions hereunder as exempt under Rule 16b-3, the transactions contemplated hereunder will be structured to satisfy the requirements for exemption under Rule 16b-3.

 

(b) AuthoritySubject to the terms and conditions of the Plan, the Committee shall have the sole discretionary authority:

 

(i) to authorize the granting of Awards under the Plan;

 

(ii) to select the Employees, Consultants or Outside Directors who are to be granted Awards under the Plan and to determine the conditions subject to such Awards;

 

(iii) to construe and interpret the Plan;

 

(iv) to determine Fair Market Value;

 

(v) to establish and modify administrative rules for the Plan;

 

(vi) to impose such conditions and restrictions with respect to the Awards, not inconsistent with the terms of the Plan, as it determines appropriate;

 

(vii) to execute or cause to be executed Award Agreements; and

 

(viii) generally, to exercise such power and perform such other acts in connection with the Plan and the Awards, and to make all determinations under the Plan as it may deem necessary or advisable or as required, provided or contemplated hereunder.

 

Any person delegated or designated by the Committee shall be subject to the same obligations and requirements imposed on the Committee and its members under the Plan.

 

(c) Exchange Program. Notwithstanding anything in this Section 3, the Committee shall not implement an Exchange Program without the approval of the holders of a majority of the Shares that are present in person or by proxy and entitled to vote at any annual or special meeting of Corporation’s shareholders.

 

5

 

 

(d) Delegation by the Committee. The Committee, in its sole discretion and on such terms and conditions as it may provide, may delegate all or any part of its authority and powers under the Plan to one or more Directors or officers of the Corporation; provided, however, that the Committee may not delegate its authority and powers (a) with respect to an Officer or (b) in any way which would jeopardize the Plan’s qualification under Code Section 162(m), if applicable, or Rule 16b-3.

 

(e) Indemnification. To the maximum extent permitted by law, the Corporation shall indemnify each member of the Committee, the Board, and any Employee with duties under the Plan, against all liabilities and expenses (including any amount paid in settlement or in satisfaction of a judgment) reasonably incurred by the individual in connection with any claims against the individual by reason of the performance of the individual’s duties under the Plan. This indemnity shall not apply, however, if: (i) it is determined in the action, lawsuit, or proceeding that the individual is guilty of gross negligence or intentional misconduct in the performance of those duties; or (ii) the individual fails to assist the Corporation in defending against any such claim. The Corporation shall have the right to select counsel and to control the prosecution or defense of the suit. The Corporation shall not be obligated to indemnify any individual for any amount incurred through any settlement or compromise of any action unless the Corporation consents in writing to the settlement or compromise.

 

SECTION 4. Eligibility and Award Limitations.

 

(a) Award Eligibility. Employees, Consultants and Outside Directors shall be eligible for the grant of Awards under the Plan. Only Employees shall be eligible for the grant of Incentive Share Options.

 

(b) Award Limitations. The Corporation may apply limits on the grant of Awards during any fiscal year or any particular type or amount of Award.

 

SECTION 5. Shares Subject To The Plan.

 

(a) Shares Subject to the Plan. Subject to the provisions of Section 13 of the Plan, the maximum aggregate number of Shares that may be issued under the Plan is 2,300,000 Shares (the “Initial Share Reserve”). The Shares may be authorized, but unissued, or reacquired Ordinary Shares. Notwithstanding the foregoing and, subject to adjustment as provided in Section 13, the maximum number of Shares that may be issued upon the exercise of Incentive Stock Options will equal the aggregate Share number stated in this Section 5(a), plus, to the extent allowable under Section 422 of the Code and the Treasury Regulations promulgated thereunder, any Shares that become available for issuance under the Plan pursuant to Section 5(b).

 

(b) Lapsed Awards. To the extent an Award expires, is surrendered pursuant to an Exchange Program or becomes unexercisable without having been exercised or, with respect to Restricted Shares, Restricted Share Units, Performance Units or Performance Shares, is forfeited to or repurchased by the Corporation due to failure to vest, the unpurchased Shares (or for Awards other than Options or Share Appreciation Rights the forfeited or repurchased Shares), which were subject thereto will become available for future grant or sale under the Plan (unless the Plan has terminated). Notwithstanding the foregoing (and except with respect to Restricted Shares that are forfeited rather than vested), Shares that have actually been issued under the Plan under any Award will not be returned to the Plan and will not become available for future distribution under the Plan; provided, however, that if Shares issued pursuant to Awards of Restricted Shares, Restricted Share Units, Performance Shares or Performance Units are repurchased by the Corporation or are forfeited to the Corporation, such Shares will become available for future grant under the Plan. Shares used to pay the exercise price of an Award or to satisfy the tax withholding obligations related to an Award will become available for future grant under the Plan. To the extent an Award under the Plan is paid out in cash rather than Shares, such cash payment will not result in reducing the number of Shares available for issuance under the Plan.

 

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SECTION 6. Terms And Conditions Of Stock Options.

 

(a) Power to Grant Options. Subject to the maximum per person share limitation in Section 4, the Committee may grant to such Employees or persons as the Committee may select, Options entitling the Optionee to purchase Ordinary Shares from the Corporation in such quantity, and on such terms and subject to such conditions not inconsistent with the terms of the Plan, as may be established by the Committee at the time of grant or pursuant to applicable resolution of the Committee, and as set forth in the Participant’s Option Award Agreement. Options granted under the Plan may be Nonstatutory Stock Options or Incentive Stock Options.

 

(b) Optionee to Have No Rights as a Shareholder. An Optionee, or a transferee of an Optionee, shall have no rights as a shareholder of the Corporation with respect to the Ordinary Shares made subject to an Option unless and until such Optionee exercises such Option and is issued the shares purchased thereby. No adjustments shall be made for distributions, dividends, allocations, or other rights with respect to any Ordinary Shares prior to the exercise of such Option.

 

(c) Award Agreements. The terms of any Option shall be set forth in an Award Agreement in such form as the Committee shall from time to time determine. Each Award Agreement shall comply with and be subject to the terms and conditions of the Plan and such other terms and conditions as the Committee may deem appropriate. In the event that any provision of an Option granted under the Plan shall conflict with any term in the Plan as constituted on the Date of Grant of such Option, the term in the Plan constituted on the Date of Grant of such Option shall control. No person shall have any rights under any Option granted under the Plan unless and until the Corporation and the Optionee have executed an Award Agreement setting forth the grant and the terms and conditions of the Option.

 

(d) Vesting. Unless a different vesting schedule is listed in an individual Award Agreement, the Shares subject to an Option granted under the Plan shall vest and become exercisable in accordance with the following schedule:

 

Completed Years of Employment/Service
From Date of Grant
  Cumulative
Vesting Percentage
1   25%
2   50%
3   75%
4 Years or more   100%

 

(e) Exercise Price and Procedures.

 

(1) Exercise Price. The Exercise Price means the price per share at which an Optionee may exercise his Option to acquire all or a portion of the Ordinary Shares that are the subject of such Option. Notwithstanding the foregoing, except with respect to Substitute Awards, in no event shall the Exercise Price of any Ordinary Shares made the subject of an Option be less than the Fair Market Value of such Ordinary Shares, determined as of the Date of Grant.

 

(2) Exercise Procedures. Each Option granted under the Plan shall be exercised by providing written notice to the Committee, together with payment of the Exercise Price, which notice and payment must be received by the Committee on or before the earlier of (i) the date such Option expires, and (ii) the last date on which such Option may be exercised as provided in paragraph (f) below.

 

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(3) Payment of Exercise Price. The Exercise Price times the number of the shares to be purchased upon exercise of an Option granted under the Plan shall be paid in full at the time of exercise. The Committee will determine the acceptable form of consideration for exercising an Option, including the method of payment. In the case of an Incentive Stock Option, the Committee will determine the acceptable form of consideration at the time of grant. Such consideration for both types of Options may consist entirely of: (i) cash; (ii) check; (iii) promissory note, to the extent permitted by Applicable Laws, (iv) other Shares, provided that such Shares have a Fair Market Value on the date of surrender equal to the aggregate exercise price of the Shares as to which such Option will be exercised and provided that accepting such Shares will not result in any adverse accounting consequences to the Corporation, as the Committee determines in its sole discretion; (v) consideration received by the Corporation under a broker-assisted (or other) cashless exercise program (whether through a broker or otherwise) implemented by the Corporation in connection with the Plan; (vi) by net exercise; (vii) such other consideration and method of payment for the issuance of Shares to the extent permitted by Applicable Laws; or (viii) any combination of the foregoing methods of payment.

 

Unless the Committee determines otherwise at the time of a grant of an Option, all Options shall be exercisable by the Optionee on a “cashless” basis whereby such Optionee may, in lieu of paying the Exercise Price in cash, elect to pay the Exercise Price by surrendering a portion of the Options being exercised in exchange for Shares in accordance with the following formula:

 

X     = (Y(A-B))/A

 

Where,

 

X =           The number of Shares to be issued to Optionee;

 

Y =           The number of Shares for which the Option is being exercised;

 

A =           The Fair Market Value of one Share at the time of exercise; and

 

B = The Exercise Price.(f) Effect of Termination of Service. Subject to paragraph (k) below regarding Special Rules for Incentive Stock Options, the following provisions shall govern the exercise of any Options granted to an Optionee that are vested and outstanding at the time Optionee’s Service ceases:

 

(1) Termination of Employment for Reasons Other than Death, Disability or a Termination for Cause. Should Optionee’s Service with the Corporation cease for any reason other than death, Disability or a termination for Cause (as determined by the Committee), then each Option shall remain exercisable until the close of business on the earlier of (i) 3 months following the date Optionee’s Service ceased or (ii) the expiration date of the Option.

 

(2) Termination of Employment Due to Death or Disability. Should Optionee’s Service cease due to death or Disability, then each Option shall remain exercisable until the close of business on the earlier of (i) the 12 month anniversary of the date Optionee’s Service ceased, or (ii) the expiration date of the Option.

 

(3) Termination for Cause. Should Optionee’s Service be terminated for Cause while his Option remains outstanding, each outstanding Option granted to Optionee (whether vested or unvested) shall terminate immediately and Optionee shall forfeit all rights with respect to such Award.

 

(g) Limited Transferability of Options. An Option shall be exercisable only by the Optionee during his lifetime and shall not be assignable or transferable other than by will or by the laws of inheritance following Optionee’s death.

 

(h) Acceleration of Exercise Vesting. Notwithstanding anything to the contrary in the Plan, the Committee, in its discretion, may allow the exercise in whole or in part, at any time after the Date of Grant, any Option held by an Optionee, which Option has not previously become exercisable. In the event of a Change of Control of the Corporation, any unvested equity award shall become 100% vested and exercisable on the date of the Change of Control. Options shall also become 100% vested in the event Optionee dies or becomes Disabled while employed.

 

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(i) Modification, Extension, Cancellation and Regrant. Within the limitations of the Plan and after taking into account any possible adverse tax or accounting consequences, the Committee may modify, or extend outstanding Options or may accept the cancellation of outstanding Options (whether granted by the Corporation or another issuer) in return for the grant of new Options for the same or a different number of shares and at the same or a different Exercise Price. The foregoing notwithstanding, no modification of an Option shall, without the consent of the Optionee, impair the Optionee’s rights or increase the Optionee’s obligations under such Option or cause a violation of Code Section 409A.

 

(j) Term of Option. No Option shall have a term in excess of ten (10) years measured from the date that the Option is granted.

 

(k) Special Rules For Incentive Stock Options (“ISOs”). In addition to the provisions of this Section 6, the terms specified below shall be applicable to all Incentive Stock Options granted under the Plan. Except as modified by the provisions of this paragraph (k), all of the provisions of the Plan shall be applicable to Incentive Stock Options. Options that are specifically designated as Nonstatutory Options are not subject to the terms of this paragraph (k).

 

(1) Eligibility. Incentive Options may only be granted to Employees.

 

(2) Dollar Limitation. The aggregate Fair Market Value of the Ordinary Shares (determined as of the Date of Grant) for which one or more Incentive Options granted to any Employee pursuant to the Plan may for the first time become exercisable as Incentive Options during any one calendar year shall not exceed $100,000. To the extent that an Optionee’s Options exceed that limit, they will be treated as Nonstatutory Options (but all of the other provisions of the Option shall remain applicable), with the first Options that were awarded to Optionee to be treated as Incentive Stock Options.

 

(3) Restrictions on Sale of Shares. Shares issued pursuant to the exercise of an Incentive Stock Option may not be sold by the Employee until the expiration of 12 months after exercise and 24 months from the Date of Grant. Shares that do not satisfy these restrictions shall be treated as a grant of Nonstatutory Options.

 

(4) Special Rules for Incentive Stock Options Granted to 10% Shareholder.

 

a. Exercise Price. If any Employee to whom an Incentive Stock Option is granted is a 10% Shareholder, the Exercise Price of the Incentive Stock Option must be at least 110% of the Fair Market Value of the Corporation’s Ordinary Shares.

 

b. Term of Option. If any Employee to whom an Incentive Stock Option is granted is a 10% Shareholder, then the Option term shall not exceed five years measured from the date the Incentive Stock Option is granted.

 

c. Definition of 10% Shareholder. For purposes of the Plan, an Employee is deemed to be a “10% Shareholder” if he owns more than 10% of the Corporation or any Subsidiary.

 

(5) Special Rules for Exercise of Incentive Stock Options Following Termination of Employment.

 

a. Death or Disability. In order to preserve tax treatment as an Incentive Stock Option, Options granted to an Optionee who dies or becomes Disabled while employed must be exercised by the Optionee or his executor or beneficiary no later than (i) 12 months following the date of death or Disability, or (ii) the expiration date of the Incentive Stock Option, if earlier.

 

b. Termination For Reason Other Than Death or Disability. In order to preserve tax treatment as an Incentive Stock Option, an Optionee must exercise any vested and outstanding Incentive Stock Options no later than: (i) three (3) months following the date the Optionee terminates employment for any reason other than death or Disability; or (ii) the expiration date of the Incentive Stock Option if earlier.

 

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(6) Miscellaneous. With respect to Incentive Stock Options, if this Plan does not contain any provision required to be included herein under Section 422 of the Code, such provision shall be deemed to be incorporated herein with the same force and effect as if such provision had been set out at length herein. To the extent any Option that is intended to qualify as an Incentive Stock Option cannot so qualify, such Option, to that extent, shall be deemed to be a Nonstatutory Stock Option for all purposes of this Plan.

 

(l) Shareholder Rights. Until the Shares covered by an Option are issued (as evidenced by the appropriate entry on the books of the Corporation or of a duly authorized transfer agent of the Corporation), no right to vote or receive dividends or any other rights as a shareholder will exist with respect to the Shares subject to an Option, notwithstanding the exercise of the Option. The Corporation will issue (or cause to be issued) such Shares promptly after the Option is exercised. No adjustment will be made for a dividend or other right for which the record date is prior to the date the Shares are issued, except as provided in Section 13 of the Plan.

 

SECTION 7. Restricted Shares.

 

(a) Grant of Restricted Shares. The Committee may cause the Corporation to issue shares of Restricted Shares under the Plan, subject to such restrictions, conditions and other terms as the Committee may determine in addition to those set forth herein.

 

(b) Establishment of Performance Criteria and Restrictions. Restricted Share Awards will be subject to time vesting under paragraph (f) of this Section 7. The Committee may, in its sole discretion, at the time a grant is made, prescribe restrictions in addition to or other than time vesting, including the satisfaction of corporate or individual performance objectives, which shall be applicable to all or any portion of the Restricted Shares. Corporate or individual performance criteria include, but are not limited to, designated levels or changes in total shareholder return, net income, total asset return, or such other financial measures or performance criteria as the Committee may select. Such restrictions shall be set forth in the Participant’s Restricted Share Agreement.

 

(c) Share Certificates and Transfer Restrictions. Restricted Shares awarded to a Participant may be held under the Participant’s name in a book entry account maintained by or on behalf of the Corporation. Upon vesting of the Restricted Shares, the Corporation will establish procedures regarding the delivery of share certificates or the transfer of shares in book entry form. None of the Restricted Shares may be sold, transferred, assigned, pledged or otherwise encumbered or disposed of prior to the date on which such Restricted Shares vest in accordance with the Plan.

 

(d) Voting and Dividend Rights. Except as otherwise determined by the Committee either at the time Restricted Shares are awarded or at any time thereafter prior to the lapse of the restrictions, holders of Restricted Shares shall not have the right to vote such shares or the right to receive any dividends with respect to such shares, until such shares are vested. All distributions, if any, received by the Participant with respect to Restricted Shares as a result of any stock split, stock distributions, combination of shares, or other similar transaction shall be subject to the restrictions of the Plan.

 

(e) Award Agreements. The terms of the Restricted Shares granted under the Plan shall be as set forth in an Award Agreement in such form as the Committee shall from time to time determine. Each Award Agreement shall comply with and be subject to the terms and conditions of the Plan and such other terms and conditions as the Committee may deem appropriate. No Person shall have any rights under the Plan unless and until the Corporation and the Participant have executed an Award Agreement setting forth the grant and the terms and conditions of the Restricted Shares. The terms of the Plan shall govern all Restricted Shares granted under the Plan. In the event that any provision of an Award Agreement shall conflict with any term in the Plan as constituted on the Date of Grant, the term in the Plan shall control.

 

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(f) Time Vesting. Except as otherwise provided in a Participant’s Award Agreement, the Restricted Shares granted under the Plan will vest in accordance with the following schedule:

 

Completed Years of Employment/Service
From Date of Grant
  Cumulative
Vesting Percentage
1   25%
2   50%
3   75%
4 Years or more   100%

 

In the event a Participant terminates employment prior to 100% vesting, any Shares of Restricted Shares which are not vested shall be forfeited immediately and permanently. However, a Participant shall be 100% vested in his Restricted Shares in the event he terminates employment by reason of death or Disability. A Participant shall also be 100% vested in his Restricted Shares on the date of a Change of Control. If a Participant’s Service is terminated for Cause as determined in the sole discretion of the Committee, his or her Restricted Share Award (whether vested or unvested) shall be forfeited immediately. The Committee may approve Restricted Share grants that provide alternate vesting schedules. Fractional shares shall be rounded down.

 

(g) Acceleration of VestingNotwithstanding anything to the contrary in the Plan, the Board of Directors, in its discretion, may accelerate, in whole or in part, the vesting schedule applicable to a grant of Restricted Shares.

 

SECTION 8. Restricted Share Units

 

(a) Grant. Restricted Share Units may be granted at any time and from time to time as determined by the Committee. After the Committee determines that it will grant Restricted Share Units under the Plan, it will advise the Participant in an Award Agreement of the terms, conditions, and restrictions (if any) related to the grant, including the number of Restricted Share Units.

 

(b) Vesting Criteria and Other Terms. The Committee will set vesting criteria in its discretion, which, depending on the extent to which the criteria are met, will determine the number of Restricted Share Units that will be paid out to the Participant. The Committee may set vesting criteria based upon the achievement of Corporation-wide, business unit, or individual goals (including, but not limited to, continued employment), or any other basis (including the passage of time) determined by the Committee in its discretion. Unless a different vesting schedule is set forth in the Award Agreement, the following time vesting schedule will apply:

 

Completed Years of Employment/Service
From Date of Grant
  Cumulative
Vesting Percentage
1   25%
2   50%
3   75%
4 Years or more   100%

 

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(c) Earning of Restricted Share Units. Upon meeting the applicable vesting criteria, the Participant will be entitled to receive a payout as determined by the Committee and as set forth in the Award Agreement on the Date of Grant. Notwithstanding the foregoing, at any time after the grant of Restricted Share Units, the Committee, in its sole discretion, may reduce or waive any vesting criteria that must be met to receive a payout as long as such reduction or waiver does not violate Code Section 409A.

 

(d) Dividend Equivalents. The Committee may, in its sole discretion, award dividend equivalents in connection with the grant of Restricted Share Units that may be settled in cash, in Shares of equivalent value, or in some combination thereof.

 

(e) Form and Timing of Payment. Payment of earned Restricted Share Units will be made upon the date(s) determined by the Committee and set forth in the Award Agreement. The Committee, in its sole discretion, may settle earned Restricted Share Units in cash, Shares, or a combination of both. Timing and payment of Restricted Share Units will be subject to and structured to comply with the rules of Code Section 409A and the treasury regulations thereunder.

 

(f) Cancellation. On the date set forth in the Award Agreement, all unearned Restricted Share Units will be forfeited to the Corporation.

 

SECTION 9. Share Appreciation Rights.

 

(a) Grant. A Participant may be granted one or more Share Appreciation Rights under the Plan and such SARs shall be subject to such terms and conditions, consistent with the other provisions of the Plan, as shall be determined by the Committee in its sole discretion. A SAR may relate to a particular Stock Option and may be granted simultaneously with or subsequent to the Stock Option to which it relates. Except to the extent otherwise modified in the grant, (i) SARs not related to a Stock Option shall be granted subject to the same terms and conditions applicable to Stock Options as set forth in Section 6, and (ii) all SARs related to Stock Options granted under the Plan shall be granted subject to the same restrictions and conditions and shall have the same vesting, exercisability, forfeiture and termination provisions as the Stock Options to which they relate. SARs may be subject to additional restrictions and conditions. The per-share base price for exercise or settlement of SARs shall be determined by the Committee, but shall be a price that is equal to or greater than the Fair Market Value of such shares. Other than as adjusted pursuant to Section 13, the base price of SARs may not be reduced without shareholder approval (including canceling previously awarded SARs and regranting them with a lower base price).

 

(b) Exercise and Payment. To the extent a SAR relates to a Stock Option, the SAR may be exercised only when the related Stock Option could be exercised and only when the Fair Market Value of the shares subject to the Stock Option exceed the exercise price of the Stock Option. When a Participant exercises such SARs, the Stock Options related to such SARs shall automatically be cancelled with respect to an equal number of underlying shares. Unless the Committee decides otherwise (in its sole discretion), SARs shall only be paid in cash or in Ordinary Shares. For purposes of determining the number of shares available under the Plan, each Share Appreciation Right shall count as one Ordinary Share, without regard to the number of shares, if any, that are issued upon the exercise of the Share Appreciation Right and upon such payment. Shares issuable in connection with a SAR are subject to the transfer restrictions under the Plan.

 

SECTION 10. Performance Units and Performance Shares.

 

(a) Grant of Performance Units/Shares. Subject to the terms of the Plan, Performance Units and Performance Shares may be granted to eligible Employees, Consultants or Outside Directors at any time and from time to time, as shall be determined by the Committee, in its sole discretion. The Committee shall have complete discretion in determining the number of Performance Units and Performance Shares granted to each Participant.

 

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(b) Value of Performance Units/Shares. Each Performance Unit shall have an initial value that is established by the Committee at the time of the grant. Each Performance Share shall have an initial value equal to the Fair Market Value of a Share on the date of grant. The Committee shall set performance goals in its discretion which, depending on the extent to which they are met, will determine the number and/or value of Performance Units/Shares that will be paid out to the Participants. The time period during which the performance goals must be met shall be called a “Performance Period.”

 

(c) Performance Objectives and Other Terms. The Committee will set Performance Goals or other vesting provisions (including, without limitation, continued status as an Employee, Consultant or Outside Director) in its discretion which, depending on the extent to which they are met, will determine the number or value of Performance Units/Shares that will be paid out to an Employee, Consultant or Outside Director. The time period during which the performance objectives or other vesting provisions must be met will be called the “Performance Period.” Each Award of Performance Units/Shares will be evidenced by an Award Agreement that will specify the Performance Period, and such other terms and conditions as the Committee, in its sole discretion, will determine. The Committee may set performance objectives based upon the achievement of Corporation-wide, divisional, or individual goals, applicable federal or state securities laws, or any other basis determined by the Committee in its discretion.

 

(d) Measurement of Performance Goals. Performance Goals shall be established by the Committee on the basis of targets to be attained (“Performance Targets”) with respect to one or more measures of business or financial performance (each, a “Performance Measure”), subject to the following:

 

(i) Performance Measures. For each Performance Period, the Committee shall establish and set forth in writing the Performance Measures, if any, and any particulars, components and adjustments relating thereto, applicable to each Participant. The Performance Measures, if any, will be objectively measurable and will be based upon the achievement of a specified percentage or level in one or more objectively defined and non-discretionary factors preestablished by the Committee. Performance Measures may be one or more of the following, as determined by the Committee: (i) sales or non-sales revenue; (ii) return on revenues; (iii) operating income; (iv) income or earnings including operating income; (v) net income; (vi) pre-tax income or after-tax income; (vii) net income excluding amortization of intangible assets, depreciation and impairment of goodwill and intangible assets and/or excluding charges attributable to the adoption of new accounting pronouncements; (viii) raising of financing or fundraising; (ix) project financing; (x) revenue backlog; (xi) power purchase agreement backlog; (xii) gross margin; (xiii) operating margin or profit margin; (xiv) capital expenditures, cost targets, reductions and savings and expense management; (xv) return on assets (gross or net), return on investment, return on capital, or return on shareholder equity; (xvi) cash flow, free cash flow, cash flow return on investment (discounted or otherwise), net cash provided by operations, or cash flow in excess of cost of capital; (xvii) performance warranty and/or guarantee claims; (xviii) stock price or total shareholder return; (xix) earnings or book value per share (basic or diluted); (xx) economic value created; (xxi) pre-tax profit or after-tax profit; (xxii) strategic business criteria, consisting of one or more objectives based on meeting specified market penetration or market share, geographic business expansion, objective customer satisfaction or information technology goals; (xxiii) objective goals relating to divestitures, joint ventures, mergers, acquisitions and similar transactions; (xxiv) construction projects consisting of one or more objectives based upon meeting project completion timing milestones, project budget, site acquisition, site development, or site equipment functionality; (xxv) objective goals relating to staff management, results from staff attitude and/or opinion surveys, staff satisfaction scores, staff safety, staff accident and/or injury rates, headcount, performance management, completion of critical staff training initiatives; (xxvi) objective goals relating to projects, including project completion timing milestones, project budget; (xxvii) key regulatory objectives; and (xxviii) enterprise resource planning.

 

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(ii) Committee Discretion on Performance Measures. As determined in the discretion of the Committee, the Performance Measures for any Performance Period may (a) differ from Participant to Participant and from Award to Award, (b) be based on the performance of the Corporation as a whole or the performance of a specific Participant or one or more Subsidiaries, divisions, departments, regions, stores, segments, products, functions or business units of the Corporation, (c) be measured on a per share, per capita, per unit, per square foot, per employee, per branch basis, and/or other objective basis (d) be measured on a pre-tax or after-tax basis, and (e) be measured on an absolute basis or in relative terms (including, but not limited to, the passage of time and/or against other companies, financial metrics and/or an index). Without limiting the foregoing, the Committee shall adjust any performance criteria, Performance Measures or other feature of an Award that relates to or is wholly or partially based on the number of, or the value of, any stock of the Corporation, to reflect any stock dividend or split, repurchase, recapitalization, combination, or exchange of shares or other similar changes in such stock.

 

(e) Earning of Performance Units/Shares. After the applicable Performance Period has ended, the holder of Performance Units/Shares shall be entitled to receive a payout of the number of Performance Unit/Shares earned by the Participant over the Performance Period, to be determined as a function of the extent to which the corresponding Performance Goals have been achieved. Notwithstanding the preceding sentence, after the grant of a Performance Unit/Share, and subject to restrictions under Applicable Laws such as Code Section 409A, the Committee, in its sole discretion, may waive the achievement of any performance goals for such Performance Unit/Share.

 

(f) Form and Timing of Payment of Performance Units/Shares. Payment of earned Performance Units/Shares shall be made in a single lump sum, within 90 calendar days following the close of the applicable Performance Period. The Committee, in its sole discretion, may pay earned Performance Units/Shares in the form of cash, in Shares (which have an aggregate fair market value equal to the value of the earned Performance Units/Shares at the close of the applicable Performance Period) or in combination thereof. Prior to the beginning of each Performance Period, Participants may, if so permitted by the Corporation, elect to defer the receipt of any Performance Unit/Share payout upon such terms as the Committee shall determine.

 

(g) Cancellation of Performance Units/Shares. Subject to the applicable Award Agreement, upon the earlier of (a) the Participant’s termination of employment, or (b) the date set forth in the Award Agreement, all remaining Performance Units/Shares shall be forfeited by the Participant to the Corporation, the Shares subject thereto shall again be available for grant under the Plan.

 

(h) Non-transferability. Performance Units/Shares may not be sold, transferred, pledged, assigned, or otherwise alienated or hypothecated, other than by will or by the laws of descent and distribution. Further a Participant’s rights under the Plan shall be exercisable during the Participant’s lifetime only by the Participant or the Participant’s legal representative.

 

SECTION 11. Other Share-Based Awards.

 

(a) Other Stock-Based AwardsThe Committee may grant types of equity-based or equity-related Awards not otherwise described by the terms of the Plan (including the grant or offer for sale of unrestricted Shares), in amounts and subject to terms and conditions, determined by the Committee (including, if applicable, the attainment of any performance goals, as set forth in the applicable Award Agreement). Other Share-Based Awards may involve the transfer of actual Shares to Participants, or payment in cash or otherwise of amounts based on the value of Shares. The terms and conditions of the Awards shall be consistent with the Plan and set forth in the Award Agreement and need not be uniform among all the Awards or all Participants receiving the Awards.

 

(b) Value of Awards. Each Other Share-Based Award shall be expressed in terms of Ordinary Shares or units based on Ordinary Shares, as determined by the Committee. The Committee may establish performance goals and/or criteria in its discretion, and any such performance goals and/or criteria shall be set forth in the applicable Award Agreement. If the Committee exercises its discretion to establish performance goals and/or criteria, the number and/or value of Other Share-Based Awards that will be paid out to the Participant will depend on the extent to which the performance goals and/or criteria are met.

 

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(c) Payment of Awards. Payment, if any, with respect to an Other Share-Based Award shall be made in accordance with the terms of the Award, as set forth in the Award Agreement, in cash, Common Shares or a combination of cash and Common Shares, as the Committee determines.

 

(d) Vesting. The Committee shall determine the extent to which the Participant shall have the right to receive Other Share-Based Awards following the Participant’s termination of employment or service (including by reason of the Participant’s death, disability (as determined by the Committee), or termination for or without Cause or for or without Good Reason). These provisions shall be determined in the sole discretion of the Committee and these provisions may be included in the applicable Award Agreement, but need not be uniform among all Other Share-Based Awards issued pursuant to the Plan, and may reflect distinctions based on the reasons for the termination of employment or service.

 

SECTION 12. Tax Withholding.

 

(a) Tax Withholding for Options. The Corporation shall be entitled, if the Committee deems it necessary or desirable, to withhold (or secure payment in cash in United States dollars from an Optionee or beneficiary in lieu of withholding) the amount of any withholding or other tax required by law to be withheld or paid by the Corporation with respect to any amount payable and/or Ordinary Shares issuable under such Optionee’s Option, and the Corporation may defer payment or issuance of the Ordinary Shares upon such Optionee’s exercise of an Option unless indemnified to its satisfaction against any liability for such tax. The amount of any such withholding shall be determined by the Corporation.

 

(b) Tax Withholding for Restricted Shares and Other Awards. When a Participant incurs tax liability in connection with the vesting, lapse of a restriction or distribution of Restricted Shares or other Award, and the Participant is obligated to pay an amount required to be withheld under applicable tax laws, the Committee shall establish procedures to satisfy the withholding tax obligation. The Participant also has the option to make payment in cash in United States dollars pursuant to procedures established by the Corporation. The amount of any such withholding shall be determined by the Corporation.

 

SECTION 13. Adjustment of Shares and Representations.

 

(a) General. Should any change be made to the Ordinary Shares by reason of any stock split, reverse stock split, stock dividend, recapitalization, combination of shares, exchange of shares or other change affecting the outstanding Ordinary Shares as a class without the Corporation’s receipt of consideration, the Committee shall make appropriate adjustments to (i) the maximum number and/or class of securities issuable pursuant to the Plan, (ii) the number and/or class of securities and the Exercise Price per share in effect for each outstanding Option in order to prevent the dilution or enlargement of benefits, (iii) the number of shares of Restricted Shares granted; or (iv) the number of Performance Shares awarded, if applicable. As a condition to the exercise of an Award, the Corporation may require the person exercising such Option to make such representations and warranties at the time of any such exercise as the Corporation may at that time determine, including without limitation, representations and warranties that (i) the Shares are being purchased only for investment and without any present intention to sell or distribute such Shares in violation of applicable federal or state securities laws, and (ii) such person is knowledgeable and experienced in financial and business matters and is capable of evaluating the merits and the risks associated with purchasing the Shares.

 

The inability of the Corporation to obtain authority from any regulatory body having jurisdiction, which authority is deemed by the Corporation’s counsel to be necessary to the lawful issuance and sale of any Shares under this Plan, shall relieve the Corporation 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.

 

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(b) Mergers and Consolidations. In the event that the Corporation is a party to a Change of Control, outstanding Awards that are not yet vested shall be subject to the agreement of merger or consolidation or asset sale. Such agreement, without the Participant’s consent, may provide for:

 

(i) The continuation of such outstanding Awards by the Corporation (if the Corporation is the surviving Corporation);

 

(ii) The assumption of the Plan and such outstanding Awards by the surviving Corporation;

 

(iii) The substitution by the surviving Corporation of options with substantially the same terms for such outstanding Awards; [shouldn’t #2 and #3 be acceleration events]

 

(iv) Such other action as the Board of Directors determines.

 

Each Option that is assumed or otherwise continued in effect in connection with a Change of Control shall be appropriately adjusted, immediately after such Change of Control, to apply to the number and class of securities which would have been issuable to the Optionee in connection with the consummation of such Change of Control, had the Option been exercised immediately prior to such Change of Control.

 

(c) Reservation of Rights. Except as provided in this Section 13, a Participant shall have no Shareholder rights by reason of (i) any subdivision or consolidation of shares of stock of any class, or (ii) any other increase or decrease in the number of shares of stock of any class. Any issuance by the Corporation of shares of stock of any class, or securities convertible into shares of stock of any class, shall not affect, and no adjustment by reason thereof shall be made with respect to, the number or Exercise Price of shares subject to an Option. The grant of an Option pursuant to the Plan shall not affect in any way the right or power of the Corporation to make adjustments, reclassifications, reorganizations or changes of its capital or business structure, to merge or consolidate or to dissolve, liquidate, sell or transfer all or any part of its business or assets.

 

SECTION 14. Miscellaneous.

 

(a) Regulatory Approvals. The implementation of the Plan, the granting of any Options, Restricted Shares or Performance Unit/Performance Share Awards under the Plan, and the issuance of any Ordinary Shares upon the exercise of any Option, lapse of restrictions on Restricted Shares, or payout of Performance Share Award shall be subject to the Corporation’s procurement of all approvals and permits required by regulatory authorities, if any, including applicable securities laws having jurisdiction over the Plan, the Options or Restricted Shares granted, and the Ordinary Shares issued pursuant to it.

 

(b) Strict Construction. No rule of strict construction shall be implied against the Committee, the Corporation or Subsidiary or any other person in the interpretation of any of the terms of the Plan, any Award granted under the Plan or any rule or procedure established by the Committee.

 

(c) Choice of Law. All determinations made and actions taken pursuant to the Plan shall be governed by the internal laws of [the State of New York] and construed in accordance therewith.

 

(d) Compliance With Code Section 409A. Awards will be designed and operated in such a manner that they are either exempt from the application of, or comply with, the requirements of Code Section 409A such that the grant, payment, settlement or deferral will not be subject to the additional tax or interest applicable under Code Section 409A. The Plan and each Award Agreement under the Plan is intended to meet the requirements of Code Section 409A (or an exemption therefrom) and will be construed and interpreted in accordance with such intent, except as otherwise determined in the sole discretion of the Committee. To the extent that an Award or payment, or the settlement or deferral thereof, is subject to Code Section 409A, the Award will be granted, paid, settled or deferred in a manner that will meet the requirements of Code Section 409A (or an exemption therefrom), such that the grant, payment, settlement or deferral will not be subject to the additional tax or interest applicable under Code Section 409A. In no event will the Corporation be responsible for or reimburse a Participant for any taxes or other penalties incurred as a result of applicable of Code Section 409A.

 

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(e) Date of Grant. The date of grant of an Award will be, for all purposes, the date on which the Committee makes the determination granting such Award, or such other later date as is determined by the Committee. Notice of the determination will be provided to each Participant within a reasonable time after the date of such grant.

 

(f) Conditions Upon Issuance of Shares.

 

(i) Legal Compliance. Shares will not be issued pursuant to the exercise of an Award unless the exercise of such Award and the issuance and delivery of such Shares will comply with Applicable Laws and will be further subject to the approval of counsel for the Corporation with respect to such compliance.

 

(ii) Investment Representations. As a condition to the exercise of an Award, the Corporation may require the person exercising such Award to represent and warrant at the time of any such exercise that the Shares are being purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Corporation, such a representation is required.

 

(g) Shareholder Approval. The Plan will be subject to approval by the shareholders of the Corporation within twelve (12) months after the date the Plan is adopted by the Board. Such shareholder approval will be obtained in the manner and to the degree required under Applicable Laws.

 

SECTION 15. No Employment or Service Retention Rights.

 

Nothing in the Plan or in any Award granted under the Plan shall confer upon the Participant any right to continue in Service for any period of specific duration or interfere with or otherwise restrict in any way the rights of the Corporation (or any Subsidiary employing or retaining the Participant) or of the Participant, which rights are hereby expressly reserved by each, to terminate his or her Service at any time and for any reason, with or without cause.

 

SECTION 16. Duration and Amendments.

 

(a) Term of the Plan. The Plan, as set forth herein, shall become effective on the date of its adoption by the Board of Directors, subject to the approval of the Corporation’s shareholders. In the event that the shareholders fail to approve the Plan within 12 months after its adoption by the Board of Directors, any grants of Awards that have already occurred for which shareholder approval is a prerequisite for the granting of such Awards, shall be rescinded, and no such additional grants or awards shall be made thereafter under the Plan. The Plan shall terminate automatically ten (10) years after its adoption only with respect to the Corporation’s ability to grant ISOs under the Plan and may be terminated at any date by the Board of Directors pursuant to paragraph (b) below.

 

(b) Right to Amend or Terminate the Plan. The Committee may amend, suspend or terminate the Plan at any time and for any reason; provided, however, that certain amendments, including amendments that increase the number of Ordinary Shares available for issuance under the Plan (except as provided in Section 13) or change the class of persons who are eligible for the grant of ISOs, shall be subject to the approval of the Corporation’s shareholders. The Corporation will obtain shareholder approval of any Plan amendment to the extent necessary and desirable to comply with Applicable Laws. For purposes of clarity, without shareholder approval (i) no amendment or modification may reduce the Exercise Price of any Option or SAR, (ii) the Committee may not cancel any outstanding Option or SAR where the Fair Market Value of the Ordinary Shares underlying such Option or SAR is less than its Exercise Price and replace it with a new Option or SAR, another Award or cash and (iii) the Committee may not take any other action that is considered a “repricing” for purposes of the shareholder approval rules of the applicable securities exchange or inter-dealer quotation system on which the Ordinary Shares are listed or quoted.

 

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(c) Effect of Amendment or Termination. No amendment, alteration, suspension or termination of the Plan will impair the rights of any Participant, unless mutually agreed otherwise between the Participant and the Committee, which agreement must be in writing and signed by the Participant and the Corporation. No Ordinary Shares shall be issued or sold under the Plan after the termination thereof, except upon exercise of an Option granted prior to such termination. The termination of the Plan, or any amendment thereof, shall not affect any shares of Restricted Shares or Performance Shares previously issued or any Option previously granted under the Plan.

 

SECTION 17. Execution.

 

To record the adoption of the Plan by the Board of Directors, the Corporation has caused its authorized officer to execute the same.

 

  MAINZ BIOMED B.V.
   
  By:                    
  Title:  
  Date:  

 

 

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Exhibit 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

 

To the Board of Directors of

 

Mainz Biomed B.V.

Pharmgenomics GmbH

 

We consent to the inclusion in the Form F-1 Registration Statement of Mainz Biomed B.V. (the “Company”) our report dated August 3, 2021 relating to our audit of the balance sheet as of March 31, 2021, and statements of operations, stockholders’ equity and cash flows for the period from March 8, 2021 (inception) thru to March 31, 2021.

 

We consent to the inclusion in the to the Form F-1 Registration Statement of the Company our report of Pharmgenomics GmbH dated August 3, 2021 relating to our audit of the balance sheets as of December 31, 2020 and 2019, and consolidated statements of operations, stockholders’ equity and cash flows for the years ended December 31, 2020 and 2019.

 

We also consent to the reference to us under the caption “Experts” in the Registration Statement.

 

 

 

/s/ BF Borgers CPA PC

 

Certified Public Accountants

Lakewood, Colorado

October 8, 2021