As filed with the United States Securities and Exchange Commission on November 5, 2024

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 N.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 N.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
 

M. Ali Panjwani, Esq.

Pryor Cashman LLP

7 Times Square, New York

New York 10036-6569
Telephone: (212) 421-4100

 

 

 

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. ☐

 

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. ☐

 

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. ☐

 

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. ☐

 

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 United States Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

 

 

 

The information in this preliminary prospectus is not complete and may be changed. The securities may not be sold until the registration statement filed with the United States Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell, nor does it seek an offer to buy, the securities in any jurisdiction where such offer or sale is not permitted.

 

PRELIMINARY PROSPECTUS   SUBJECT TO COMPLETION   DATED NOVEMBER 5, 2024

 

Up to 30,769,231 Ordinary Shares

Up to 30,769,231 Pre-Funded Warrants

Up to 30,769,231 Ordinary Shares Underlying the Pre-Funded Warrants

 

 

 

Mainz Biomed N.V.

 

 

 

We are offering on a “best efforts” basis up to 30,769,231 ordinary shares of Mainz Biomed N.V. Our ordinary shares are traded on the Nasdaq Capital Market under the symbol “MYNZ.” The last reported sale price of our ordinary shares on October 30, 2024 as reported on Nasdaq, was $0.26 per share rounded to the nearest whole cent, which is the per share offering price we have assumed for purposes of this preliminary prospectus.

 

We are also offering to each purchaser of ordinary shares that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% of our outstanding ordinary shares immediately following the consummation of this offering the opportunity to purchase pre-funded warrants in lieu of ordinary shares. A holder of pre-funded warrants will not have the right to exercise any portion of its pre-funded warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of the holder, such limit may be increased to up to 9.99%) of the number of ordinary shares outstanding immediately after giving effect to such exercise. Each pre-funded warrant will be exercisable for one ordinary share. The purchase price of each pre-funded warrant will be equal to the price per ordinary share, minus $0.0001, and the remaining exercise price of each pre-funded warrant will equal $0.0001 per ordinary share. The pre-funded warrants will be immediately exercisable (subject to the beneficial ownership cap) and may be exercised at any time until all of the pre-funded warrants are exercised in full. For each pre-funded warrant we sell (without regard to any limitation on exercise set forth therein), the number of ordinary shares we are offering will be decreased on a one-for-one basis. We do not intend to apply for any listing of the pre-funded warrants on any securities exchange or nationally recognized trading system, and we do not expect a market to develop for pre-funded warrants. We are also registering the ordinary shares issuable from time to time upon the exercise of the pre-funded warrants offered hereby. We refer to the ordinary shares and pre-funded warrants offered hereby as the offered securities.

 

The public offering price for the offered securities will be determined at the time of pricing and may be at a discount to the current market price at the time. Therefore, the assumed public offering price used throughout this prospectus may not be indicative of the final offering price. The final public offering price will be determined through negotiation between us, the placement agent and the investors based upon a number of factors, including our history and our prospects, the industry in which we operate, our past and present operating results, the previous experience of our executive officers and the general condition of the securities markets at the time of this offering.

 

This is a best-efforts offering and the placement agent does not have an obligation to purchase any securities. We expect that the offering will end one trading day after we first enter into a securities purchase agreement relating to the offering and the offering will settle delivery versus payment (“DVP”)/receipt versus payment (“RVP”). Accordingly, we and the placement agent have not made any arrangements to place investor funds in an escrow account or trust account since the placement agent will not receive investor funds in connection with the sale of the securities offered hereunder.

 

We are both an “emerging growth company” and a “foreign private issuer” under applicable U.S. Securities and Exchange Commission rules and will be eligible for reduced public company disclosure requirements. See section titled “Prospectus Summary – Implications of Being an Emerging Growth Company” and “Prospectus Summary – Implications of being a Foreign Private Issuer” for additional information.

 

 

 

 

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 U.S. 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
   Per
Pre-Funded
Warrant
   Total 
Public offering price  $          $             $        
Placement Agent Fees(1)  $   $   $ 
Proceeds to us, before expenses(2)  $   $   $ 

 

 

(1)The placement agent, Maxim Group LLC, will receive compensation in addition to the placement agent fees. See “Plan of Distribution” for a description of compensation payable to the placement agent.
(2)The total estimated expenses related to this offering are set forth in the section entitled “Expenses Relating to this Offering.”

 

If we complete this offering, net proceeds will be delivered to us on the closing date.

 

The placement agent expects to deliver the ordinary shares on or about            , 2024.

 

Maxim Group LLC

 

The date of this prospectus is            , 2024

 

 

 

 

TABLE OF CONTENTS

 

    Page
PROSPECTUS SUMMARY   1
RISK FACTORS   13
SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS   17
IMPLICATIONS OF BEING A FOREIGN PRIVATE ISSUER   7 
IMPLICATIONS OF BEING AN EMERGING GROWTH COMPANY   7
USE OF PROCEEDS   18
DIVIDEND POLICY   18
CAPITALIZATION AND INDEBTEDNESS   19
DILUTION   20
MARKET FOR OUR SECURITIES   21
SECURITIES ELIGIBLE FOR FUTURE SALE   22
ARTICLES OF ASSOCIATION OF OUR COMPANY   23
MATERIAL INCOME TAX INFORMATION   31
PLAN OF DISTRIBUTION   40
EXPENSES RELATING TO THIS OFFERING   46
LEGAL MATTERS   46
EXPERTS   46
INTERESTS OF EXPERTS AND COUNSEL   46
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES   46
ENFORCEABILITY OF CIVIL LIABILITIES   47
WHERE YOU CAN FIND MORE INFORMATION   48

 

This prospectus is part of a registration statement on Form F-1 that we filed with the U.S. Securities and Exchange Commission (the “SEC”). You should read this prospectus and the information and documents incorporated herein by reference carefully. Such documents contain important information you should consider when making your investment decision. See “Where You Can Find Additional Information” and “Incorporation of Documents by Reference” in this prospectus.

 

You should rely only on the information contained in this prospectus (inclusive of the documents incorporated by reference herein), any amendment or supplement to this prospectus or any free writing prospectus prepared by or on our behalf. Neither we nor the placement agent have authorized any other person to provide you with different or additional information. Neither we nor the placement agent take responsibility for, nor can we provide assurance as to the reliability of, any other information that others may provide. The placement agent 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 or incorporated by reference 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 placement agent 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 N.V.

 

i

 

 

PROSPECTUS SUMMARY

 

The following summary highlights, and should be read in conjunction with, the more detailed information contained elsewhere in this prospectus or incorporated by reference into this prospectus. You should read carefully the entire document or documents incorporated by reference in this prospectus, including our historical financial statements and related notes incorporated by reference herein, to understand our business, the offered securities 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 as well as the risk factors described under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2023, filed on April 9, 2024.

 

We are a public company under Dutch law. We were incorporated on March 8, 2021 as a private limited liability company (besloten vennootschap met beperkte aansprakelijkheid) under Dutch law. We were formed to acquire PharmGenomics GmbH (“PharmGenomics”), a German company with limited liability, and we acquired PharmGenomics on September 20, 2021. On November 9, 2021, we converted into a Dutch public company with limited liability (naamloze vennootschap). The address for our principal place of business is Robert Koch Strasse 50, 55129 Mainz, Germany, and the telephone number is +49 6131 5542860.

 

We have registered our ordinary shares under the Exchange Act, and we intend to make our current and periodic reports and other information (including interactive data files) 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, and all of our reports and other information filed or submitted publicly with the SEC may also be found there.

 

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

  

General

 

We develop and market in-vitro diagnostic (“IVD”) tests for early cancer detection, initially focusing on colorectal cancer (“CRC”) and advanced precancerous lesions. Our flagship product, ColoAlert, is currently available in European markets. Additionally, we are developing a next-generation mRNA-based colorectal cancer screening test, with plans for future launch in both the United States and Europe. While we operated a clinical diagnostic laboratory through 2023 and early 2024, our primary business model focuses on distributing IVD kits to third-party laboratories across Europe and the United States.

 

Our research and development efforts are aimed at expanding and diversifying our product portfolio. In 2023 and early 2024, we managed a government-funded R&D project for early pancreatic cancer detection, which provided non-refundable grant income to cover a portion of related project costs. Although this funding has concluded, we have continued our R&D activities in 2024, albeit at a reduced level.

  

Products and Product Candidates

 

Our mission is to enhance disease diagnosis by applying cutting-edge genetic diagnostic technologies, enabling earlier and more accurate detection for timely and improved treatment. Alongside our current ColoAlert CRC screening test, we are developing an advanced mRNA-based CRC screening test, as well as PancAlert, a product candidate for pancreatic cancer detection. Our approach integrates proprietary, validated biomarkers with reliable diagnostic tools, further strengthened by machine learning and artificial intelligence to optimize accuracy and applicability. 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 our product candidate PancAlert for the detection of pancreatic cancer. We aim to use proprietary, known and existing biomarkers in applicable and reliable diagnostic tools.

 

1

 

 

ColoAlert and Our Next Generation Colorectal Cancer Screening Test

 

We currently offer ColoAlert, a CE-IVD certified diagnostic test for CRC to laboratories across Europe. Its simple, at-home collection process makes it easier for individuals to participate in CRC screening, promoting early detection and increasing the likelihood of effective treatment.

 

According the World Health Organization, as of July 2023 CRC is the third most commonly diagnosed cancer in the world. 1 Due to its ability to move into large, adjacent areas leading to other cancers, including pancreatic cancer and other gasto-intestinal cancers, the World Health Organization suggests as of February 2022, CRC is the second leading cause of cancer death globally.2 Further, Global Market Insights anticipates that the annual market for CRC diagnostics will surpass $30 billion by 20323.

 

In the intestines, epithelial cells are continuously shed into the stool. This includes not only healthy cells but also cells from polyps and colon cancer. Using advanced genetic diagnostic techniques like PCR analysis—which amplifies DNA from a small sample into millions of copies—these shed cells can be isolated and examined for genetic mutations, enhancing the early detection of CRC.

 

ColoAlert is a multitarget test that analyzes stool samples for both genetic abnormalities and hidden (occult) blood. The genetic analysis includes quantifying human DNA and detecting specific somatic point mutations in the KRAS (codon 12/13) and BRAF (codon 600) genes. An independent clinical study led by Professor Matthias Dollinger and conducted with 566 patients at the University Hospitals of Leipzig and Halle-Wittenberg, Germany, demonstrated ColoAlert’s high sensitivity (85%) and specificity (92%), with a patient satisfaction rate of 98%. The selected genetic markers enhance the diagnostic precision of the occult blood test, increasing the clinical value of the test. Since this study, we have upgraded the occult blood test component of ColoAlert to a fully automated version, further improving the test’s overall sensitivity.

 

Early screening for CRC has the potential to dramatically impact its treatment and prevention and, ultimately, save lives. For example, the Journal of the National Cancer Institute has reported in 2022 that diagnostic tests with a sensitivity of 10% for advanced adenomas (“AA”), a type of pre-cancerous polyp often attributed to CRC, could reduce mortality rates for adults over 45 by 47% and that diagnostic tests with a sensitivity of 76% for AA could reduce mortality rates for adults over 45 by 67%.4 Most CRC screening programs currently recommend beginning screening at age 50. However, there is a growing trend to lower this starting age. For example, the FDA recently recommended starting CRC screening at age 45. In 2023, the American Cancer Society highlighted the rapid progression of CRC among younger individuals, noting that CRC diagnoses in people under 55 increased from 11% in 1995 to 20% in 2019. Given the rising prevalence of CRC in younger populations, we anticipate that screening guidelines will continue to lower the starting age, particularly for methods like ColoAlert that can detect cancer in its early stages. Additional factors supporting CRC screening include a family history of CRC, risk factors such as obesity, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), high consumption of red meat, alcohol, and nicotine, as well as pre-existing conditions like breast cancer or type 2 diabetes.

 

Until February 2023, we licensed the ColoAlert test from the Norwegian research and development firm ColoAlert AS. In February 2023, we acquired the test and its related intellectual property from ColoAlert AS under an agreement that includes: (i) a $2 million cash payment, to be made over the next four years, (ii) the issuance of 300,000 ordinary restricted shares, and (iii) a revenue share capped at $1 per test sold over a 10-year period.

 

In the European Union, the ColoAlert PCR kit (“ColoAlert Lab Kit Core II”) is CE-IVD certified under the current In-Vitro Diagnostics Directive 98/79/EC (IVD-D). As of May 26, 2022, IVD products in the EU are regulated by the In-Vitro Diagnostics Regulation, EU 2017/746 (IVD-R), which supersedes the IVD-D. The ColoAlert sample collection kit has already been successfully registered under the IVD-R, and we are currently assessing the requirements to certify our ColoAlert PCR kit under these new regulations. ColoAlert is validated for use on the Roche LightCycler 480 II, and Mainz BioMed plans to validate it for additional real-time PCR instruments used in laboratories worldwide, which may accelerate market adoption. The ColoAlert PCR kits are manufactured at our facility in Mainz, Germany.

 

 

1https://www.who.int/news-room/fact-sheets/detail/colorectal-cancer
2https://www.who.int/news-room/fact-sheets/detail/cancer
3https://www.gminsights.com/industry-analysis/colorectal-cancer-diagnostics-market
4https://academic.oup.com/view-large/365872704

 

2

 

 

In January 2022, we entered into a Technology Rights Agreement concerning a portfolio of novel mRNA biomarkers developed at the Université de Sherbrooke (“UdeS Biomarkers”). mRNA testing can detect molecular changes in cells even before visible abnormalities or symptoms manifest. mRNA biomarkers often reflect the dynamic changes in gene expression that occur during the progression of adenomas to advanced stages. As adenomas evolve, certain genes may be upregulated or downregulated, and RNA biomarkers can capture these changes, providing insights into the stage of adenoma development. mRNA biomarkers are highly specific to particular stages or types of adenomas. By targeting RNA molecules associated with the advanced stage of adenomas, we believe that these biomarkers can distinguish between advanced adenomas and less advanced forms or benign conditions.

 

Through our agreement with the Université de Sherbrooke, we obtained an exclusive, unilateral option to acquire a license for the UdeS Biomarkers. We exercised this option on February 15, 2023, by entering into an Assignment Agreement to acquire the intellectual property rights for these biomarkers. In exchange, we agreed to (i) pay €25,000 in cash and (ii) provide a 2% profit share of net sales from any products incorporating the UdeS biomarkers.

 

The UdeS Biomarkers consist of five gene expression markers shown to be highly effective in detecting colorectal cancer (CRC) lesions, including advanced precancerous lesions, AAs, a type of precancerous polyp often associated with CRC. In a UdeS-sponsored study evaluating these biomarkers, results demonstrated sensitivities of 75% for detecting AA and 95% for CRC, with a specificity of 96%.

 

In relation to the UdeS Biomarkers, we initiated two feasibility studies to assess our next-generation mRNA CRC screening test, combining UdeS Biomarkers with FIT tests. The first study, ColoFuture, is an international, multicenter clinical study across Europe designed to validate the effectiveness of the UdeS biomarkers, specifically their capability to identify advanced precancerous lesions or AA while enhancing sensitivity and specificity for CRC detection. ColoFuture includes 662 participants, covering individuals with average CRC risk and those at increased risk or known to have CRC or AA. Enrollment in ColoFuture concluded in late 2023.

 

Additionally, we conducted a U.S.-based multicenter study called “eAArly DETECT,” which evaluates feasibility and stability in 450 participants, including those with average CRC risk and individuals at elevated risk or known to have CRC or AA. eAArly DETECT was completed by the end of 2023. These studies aim to identify the optimal combination of biomarkers, potentially including mRNA and housekeeping biomarkers alongside a FIT test, for our next-generation product. This product will undergo further testing in the eAArly DETECT v2 study and in the evaluation in our pivotal FDA PMA study, labeled “reconAAsense.” Both ColoFuture and eAArly DETECT studies utilized an advanced machine learning and AI-driven algorithm, developed in partnership with Liquid Biosciences, based in California.

 

In October 2023, we announced the results of the ColoFuture study, which demonstrated a sensitivity of 94% for colorectal cancer (CRC) and 97% specificity, along with an 80% sensitivity for AAs. In December 2023, we released topline results from our eAArly DETECT clinical study in the U.S., which reported a sensitivity of 97% for CRC, 97% specificity, and an 82% sensitivity for advanced adenomas. These topline results reaffirm the positive findings from ColoFuture, our European counterpart, which were reported in October 2023.

 

The eAArly DETECT study enrolled 254 evaluable subjects across 21 sites in the United States, featuring a design similar to that of ColoFuture. Patients aged 45 and older were invited to participate when referred for a colonoscopy, whether for CRC screening (average risk), follow-up on a positive non-invasive test, imaging, or symptoms. Additionally, individuals already diagnosed with CRC were included prior to receiving treatment. Participants who agreed to provide a stool sample before the colonoscopy (or treatment for identified CRC patients) were eligible. Subjects were classified following a central pathology review: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject’s outcome was then compared to the results of the next-generation mRNA-based CRC screening test.

 

In June 2024, the Company presented pivotal data from its largest cohort to date during a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois. This data combined results from the ColoFuture and eAArly DETECT studies, along with additional patients collected since the initial study results were reported, underscoring the significance of our innovative screening approach.

 

The combined analysis included 690 clinical subjects from 30 specialized gastroenterology centers across Europe and the United States, incorporating previously unexamined and unreported samples. This highlighted the exceptional efficacy of Mainz Biomed’s multimodal screening test, which integrates the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, supported by an advanced AI and machine learning algorithm. This comprehensive approach allows for precise differentiation between colorectal cancer (CRC), AAs, non-advanced adenomas, and samples with no pathological findings.

 

   ColoFuture   eAArly DETECT   Pooled study 
CRC Sensitivity   94%   97%   92%
CRC Specificity   97%   97%   90%
AA Sensitivity   80%   82%   82%
AA Specificity   95%   97%   90%
Location   EU    US    EU & US 
# of Participants   220    254    690 

 

3

 

 

The following tables set out the CRC and AA sensitivity and specificity results of test of our ColoAlert product as compared to some competing products.  

 

 

 

 

5Chung D, et al. N Engl J Med 2024;390:973-983

6Imperiale T, et al. N Engl J Med 2024;390:984-93

7Barnell E, JAMA, 2023;330(18):1760-1768

 

4

 

 

 

 

 

 

 

8Barnell E, et al. JAMA, 2023;330(18):1760-1768

9Imperiale T, et al. N Engl J Med 2024;390:984-93

10Barnell E, JAMA, 2023;330(18):1760-1768

11Chung D, et al. N Engl J Med 2024;390:973-983

 

5

 

 

PancAlert

 

We are in the early stages of developing PancAlert, a stool-based screening test aimed at detecting pancreatic cancer. According to the Global Cancer Observatory, over 460,000 cases of pancreatic cancer were diagnosed worldwide in 2018. Due to its asymptomatic early stages, this disease is often detected too late, making pancreatic cancer one of the most lethal malignancies, with over 430,000 annual deaths reported by the Global Cancer Observatory. In the United States, the SEER program estimated 62,210 new cases and 49,830 deaths from pancreatic cancer in the same year. Between 2012 and 2018, SEER reported that the 5-year survival rate was approximately 44% for localized cases, 15% for regional cases, and only 3% for distant-stage disease. Studies have indicated that asymptomatic patients diagnosed incidentally during other medical examinations have significantly better prognoses than those presenting with characteristic symptoms, such as rapid weight loss or back pain.

 

The average age of onset for pancreatic cancer is 71 years for men and 75 years for women, with age being a significant risk factor similar to other cancers. Most patients are over 50, with the majority of diagnoses occurring between the ages of 60 and 80. Despite being the seventh most common cancer, pancreatic cancer ranks as the third leading cause of cancer-related death in the European Union, underscoring the dire prognosis for patients. Although survival rates for pancreatic cancer have improved in recent decades, there remains an urgent need for enhanced early diagnostic methods.

 

A definitive diagnosis of pancreatic cancer is currently made through a series of investigations, including imaging scans, blood tests, and biopsies, which are typically conducted only in symptomatic patients. However, recent research indicates that the disease can persist for an extended period without presenting symptoms, highlighting a crucial opportunity for early detection. Since pancreatic cancer initiates at the molecular level, genetic diagnostic methods show promise for early identification. Biomarkers associated with pancreatic cancer can be found in the stool, primarily via pancreatic juice, facilitating user-friendly sample collection.

 

Our development strategy involves selecting and validating a specific panel of biomarkers, establishing an appropriate method for sample preparation, and validating the detection and measurement technology using purchased or clinically defined samples (biopsies, pancreatic juice, stool, and others). The next steps include transitioning to routine diagnostics using stool samples, optimizing the process, and conducting clinical evaluations to assess its potential as a screening tool for the early detection of pancreatic cancer.

 

Our goal is to establish PancAlert as the world’s first pancreatic cancer screening test utilizing Real-Time PCR-based multiplex detection of molecular-genetic biomarkers in stool samples. We have recently partnered with Liquid Biosciences, an artificial intelligence and machine learning company, to further evaluate the most promising candidates for disease-specific biomarkers. The platform technology we are using will also allow for the easy integration of additional biomarkers as needed.

 

A specialized artificial intelligence solution will facilitate the analysis of the results. Based on the progress of our research in this project, we plan to initiate an initial pilot study at one or more selected clinical sites, although we do not anticipate completing these studies before 2024. If the clinical pilot studies yield promising results, we aim to develop a product that meets IVD-R and FDA approval for the European and U.S. markets.

 

Strategy Realignment

 

Between July 2024 and October 2024, we restructured our operations to concentrate on: (1) our ColoAlert business in Europe, (2) the development of its next-generation product, and (3) planning and conducting the eAArly Detect 2 clinical study in the U.S. in 2025, aimed at validating the strong clinical performance of our next-generation mRNA-based CRC screening test in an average-risk population.

 

In line with this focus, we implemented cost reduction measures, including a 65% reduction in personnel, decreased external consulting expenses, and the sale or closure of its European Oncology Lab (EOL) business in St. Ingbert, Germany. We believe that these cost reductions will position the business for success in 2025 and beyond.

 

Legal Proceedings

 

In connection with a right of first refusal granted to an investment bank in connection with our initial public offering in 2021, Mainz filed a lawsuit against such investment bank in 2024 in the New York State Supreme Court in New York County, asking the court to determine our and the investment banks rights and obligations under the relevant contracts by and between us and the investment bank. Shortly after our filing of such lawsuit, the investment bank initiated arbitration proceedings against us with the Financial Industry Regulatory Authority (“FINRA”). Thereafter, we requested the arbitration panel stay its proceeding in light of the existing lawsuit.  The arbitration panel agreed with us and on September 13, 2024, issued an order formally staying the arbitration proceeding.

 

Except as set out above, 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 supplement, 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.

 

6

 

 

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.

 

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 ordinary shares 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.

 

7

 

 

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.

 

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.

 

Terms of subsequent financings may adversely impact your investment.

 

Our inability to manage growth could harm our business.

 

We substantially depend upon our management.

 

Our financial statements for the fiscal year ended December 31, 2023 include an explanatory paragraph from our auditor indicating that there is substantial doubt about our ability to continue as a going concern.

 

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 substantial portion of our directors and executive officers reside outside the United States.

 

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.

 

Our success depends heavily on our ColoAlert screening tests.

 

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 our products, which would materially and adversely affect acceptance of our diagnostic tests, and our business, revenues and prospects.

 

We might decide not to incorporate the UdeS Biomarkers after we conclude additional studies on such biomarkers.

 

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

 

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.

 

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.

  

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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.

 

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.

 

Risks Related to Our Ordinary Shares and this Offering

 

This is a best-efforts offering, no minimum amount of securities is required to be sold and we may not raise the amount of capital we believe is required for our business plans.

 

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

 

You will experience immediate and substantial dilution as a result of this offering.

 

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

 

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

 

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

 

We have been notified by Nasdaq that we are not in compliance with certain standards which Nasdaq requires listed companies meet for their respective securities to continue to be listed and traded on its exchange. If we are unable to regain compliance with such continued listing requirements, Nasdaq may choose to delist our securities from its exchange or may subject us to additional restrictions, which may adversely affect the liquidity and trading price of our securities.

 

In an effort to regain compliance with the Minimum Bid Price Requirement, we intend to enact a reverse stock split, and the public market may react negatively to such reverse stock split.

 

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

 

There is no public market for the pre-funded warrants being offered in this offering.

 

Holders of the pre-funded warrants purchased in this offering will have no rights as ordinary shareholders until such holders exercise their pre-funded warrants and acquire our ordinary shares, except as otherwise provided in the pre-funded warrants.

 

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Offering Summary

 

Ordinary Shares Offered:

 

  30,769,231 ordinary shares at an assumed offering price of $0.26 per ordinary share, the closing price of our ordinary shares on the Nasdaq Capital Market on October 30, 2024, rounded to the nearest whole cent
     

Pre-Funded Warrants Offered:

 

 

Up to 30,769,231 pre-funded warrants at an assumed offering price of $0.26 per ordinary share, the closing price of our ordinary shares on the Nasdaq Capital Market on October 30, 2024, rounded to the nearest whole cent minus $0.0001. We are offering to each purchaser of ordinary shares that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% of our outstanding ordinary shares immediately following the consummation of this offering the opportunity to purchase pre-funded warrants in lieu of ordinary shares. A holder of pre-funded warrants will not have the right to exercise any portion of its pre-funded warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of the holder, such limit may be increased to up to 9.99%) of the number of ordinary shares outstanding immediately after giving effect to such exercise. Each pre-funded warrant will be exercisable for one ordinary share. The remaining exercise price of each pre-funded warrant will equal $0.0001 per ordinary share. The pre-funded warrants will be immediately exercisable (subject to the beneficial ownership cap) and may be exercised at any time until all of the pre-funded warrants are exercised in full.

 

For each pre-funded warrant we sell (without regard to any limitation on exercise set forth therein), the number of ordinary shares we are offering will be decreased on a one-for-one basis.

 

Shares Outstanding After the Offering*:   94,810,231.
Use of Proceeds:  


We estimate that we will receive net proceeds of approximately $7,135,000 from this offering, after deducting the placement agent fees and estimated offering expenses of approximately $865,000 payable by us. However, because this is a best-efforts offering and there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, the placement agent’s fees and net proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth on the cover page of this prospectus.

 

We intend to use the net proceeds from this offering for the eAArly Detect 2 study, the development of our next generation screening product, the commercial expansion of our ColoAlert product, repayment of convertible debt and for general corporate purposes.

 

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Market for the Offered Securities:  

Our ordinary shares are currently listed on the Nasdaq Capital Market under the symbol “MYNZ”. The closing price of our ordinary shares rounded to the nearest whole cent on the Nasdaq Capital Market on October 30, 2024 was $0.26.

 

There is no market for our pre-funded warrants, and we do not anticipate that one will develop. We do not intend to apply for our pre-funded warrants to be traded on any public market or quotation system.

 

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


We have agreed to offer and sell the securities offered hereby to the purchasers through the placement agent. The placement agent is not required to buy or sell any specific number or dollar amount of the securities offered hereby, but it will use its reasonable best efforts to solicit offers to purchase the securities offered by this prospectus. See “Plan of Distribution” on page 38 of this prospectus.

 

  * Shares outstanding after the offering (i) is based on 64,041,000 ordinary shares that are outstanding as of the date of this prospectus, (ii) assumes an offering price of $0.26 per share, the closing price  of our ordinary shares rounded to the nearest whole cent on the Nasdaq Capital Market on October 30, 2024, (iii) assumes that any pre-funded warrants sold hereunder are immediately exercised and (iv) excludes:

 

up to 6,597,500 ordinary shares underlying warrants that are outstanding as of the date hereof;

 

up to 2,787,150 ordinary shares underlying options that we have granted as of the date hereof; and

 

up to 30,475,765 ordinary shares underlying principal as of the date hereof under outstanding convertible notes (assuming their conversion at the floor price contained in such notes).

 

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Summary Financial Data

 

The following tables summarize our financial data. We derived the summary financial statement data for the years ended December 31, 2023 and 2022 set forth below from our audited financial statements included in our Annual Report on Form 20-F filed on April 9, 2024 (each of which are incorporated by reference into this prospectus), and for the six months ended June 30, 2024 and 2023 from our unaudited financial statements for the six months ended June 30, 2024 included in our report on Form 6-K filed on October 18, 2024 (which are incorporated by reference into this prospectus). 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 and Analysis of Financial Condition and Results of Operations,” our financial statements, the notes to those statements and the other financial information incorporated by reference into this prospectus.

 

Summary of Operations in U.S. Dollars

 

   Six Months Ended
June 30,
   Years Ended
December 31,
 
   2024   2023   2023   2022 
Revenues  $520,773   $499,049   $895,479   $529,877 
Cost of Revenues   201,735    211,310    385,820    347,726 
GROSS PROFIT   319,038    14,416    509,659    182,151 
                     
OPERATING EXPENSES                    
Research and Development   3,242,622    5,481,229    9,590,393    5,019,366 
Sales and marketing   2,361,105    3,992,975    6,158,477    6,396,906 
General and administrative   4,522,639    5,227,181    11,405,471    15,209,919 
Total operating expenses   10,126,366    14,701,385    27,154,341    26,626,191 
Operating loss   (9,807,328)   (14,413,646)   (26,644,682)   (26,444,040)
                     
OTHER INCOME/(EXPENSE)   (1,216,434)   (398,997)   348,955    56,094 
                     
NET LOSS  $(11,023,762)  $(14,812,643)   (26,295,727)   (26,387,336)
                     
TOTAL COMPREHENSIVE LOSS  $(11,086,128)  $(14,963,239)  $(26,800,221)  $(26,337,633)

 

Balance Sheet in U.S. Dollars

 

   As of
June 30,
2024

 (unaudited)

   As of December 31, 2023

(audited)

 
Cash  $977,764   $7,070,925 
Total Current Assets   2,389,703    8,979,896 
Total Assets   8,545,030    15,409,028 
Total Current Liabilities   10,013,944    9,236,936 
Total Liabilities   12,592,730    12,159,802 

Working Deficit

  $(7,624,241)  $(257,040)
Total Stockholders’ Equity (Deficit)   (4,138,700)   3,249,226 

 

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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 (or incorporated by reference herein), including risk factors in the documents incorporated herein by reference and our historical financial statements and related notes incorporated by reference herein, before you decide to purchase the offered securities. 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 the offered securities. 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 Ordinary Shares and this Offering

 

This is a best-efforts offering, no minimum amount of securities is required to be sold and we may not raise the amount of capital we believe is required for our business plans.

 

The placement agent has agreed to use its reasonable best efforts to solicit offers to purchase the securities being offered in this offering. The placement agent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. There is no required minimum number of securities or amount of proceeds that must be sold as a condition to completion of this offering. Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, placement agent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth above. We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to fund for our operations as described in the “Use of Proceeds” section herein. Thus, we may not raise the amount of capital we believe is required for our operations in the short-term and even if we raise the maximum offering amount in this public offering, we will need to raise additional funds in the future, which may not be available or available on terms acceptable to us.

 

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

 

The public market for our ordinary shares has a limited history. Our ordinary shares began trading on the Nasdaq Capital Market on November 5, 2021, and since that date they have had a high closing price of $27.76 per share and a low closing price of $0.20 per share. The daily trading volume and our per ordinary share market price may decrease significantly after the date of this annual report. The value of our ordinary shares 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 will experience immediate and substantial dilution as a result of this offering.

 

You will incur immediate and substantial dilution as a result of this offering. After giving effect to the sale by us of 30,769,231 ordinary shares (assuming no pre-funded warrants are sold in this offering) at an assumed public offering price of $0.26 per ordinary share and after deducting the placement agent fees and estimated offering expenses payable by us, investors in this offering can expect an immediate dilution of $0.15 per ordinary share on a pro forma as adjusted basis (see Dilution).

 

In addition, you may experience further dilution) upon the exercise of outstanding warrants, options and the conversion of outstanding convertible debt.

 

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. Any such issuances could dilute your voting and economic interest. For example, as of November 5, 2024, we had approximately $3,047,577 in principal and interest outstanding under convertible promissory notes. If all of such amounts were to be converted at the floor price contained in such notes, we would issue approximately 30,475,765 ordinary shares, an amount that is equal to 35% of the outstanding shares on the date hereof and 27% of the outstanding shares after this offering, assuming a per share price of $0.26 and that any pre-funded warrants issued hereunder are immediately exercised.

 

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, including those underlying the warrants and options we have issued and granted, would dilute the voting power of our current shareholders, 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 will be 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.

 

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 will be 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.

 

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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 been notified by Nasdaq that we are not in compliance with certain standards which Nasdaq requires listed companies meet for their respective securities to continue to be listed and traded on its exchange. If we are unable to regain compliance with such continued listing requirements, Nasdaq may choose to delist our securities from its exchange or may subject us to additional restrictions, which may adversely affect the liquidity and trading price of our securities.

 

Our securities are currently listed on Nasdaq. In May 2024, we received written notice (the “Notice”) from the Listing Qualifications Department of Nasdaq notifying us that, based on the closing bid price of our ordinary shares for the last 30 consecutive trading days, we no longer complied with the minimum bid price requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”), and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the Minimum Bid Price Requirement exists if the deficiency continues for a period of 30 consecutive trading days. Pursuant to the Nasdaq Listing Rules, we were provided an initial compliance period of 180 calendar days to regain compliance with the Minimum Bid Price Requirement. To regain compliance, the closing bid price of the ordinary shares has to be at least $1.00 per share for a minimum of 10 consecutive trading days prior to November 25, 2024, and we must otherwise satisfy The Nasdaq Capital Market’s requirements for listing.

 

We are taking steps to regain compliance with the 180-day period provided by Nasdaq, including holding an annual general meeting scheduled for November 13, 2024 at which our shareholders will vote upon a measure to enact a reverse stock split with a 1:2 to 1:100 ratio, such ration to be determined by our board of directors. If we are not successful with regaining compliance prior to November 25, 2024, Nasdaq might not grant us a discretionary extension of up to an additional 180 days. Even if it does, we might be able to regain compliance with that additional extension, and Nasdaq may move to delist our ordinary shares.

 

If Nasdaq delists our ordinary shares from trading on its exchange and we are not able to list our ordinary shares on another national securities exchange, our ordinary shares may be quoted on an over-the-counter market. However, if this were to occur, we could face significant material adverse consequences, including:

 

a limited availability of market quotations for our securities;

 

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reduced liquidity for our securities;

 

a determination that our ordinary shares are a “penny stock”, which will require brokers trading in such ordinary shares to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our ordinary shares;

 

a limited amount of news and analyst coverage; and

 

a decreased ability to issue additional securities or obtain additional financing in the future.

 

As a result, an investor would likely find it more difficult to trade, or to obtain accurate price quotations for, our securities if our securities are de-listed from Nasdaq. Delisting would likely also reduce the visibility, liquidity and value of our securities, including as a result of reduced institutional investor interest in our company, and may increase the volatility of our securities.

 

In an effort to regain compliance with the Minimum Bid Price Requirement, we intend to enact a reverse stock split, and the public market may react negatively to such reverse stock split.

 

We intend to enact a 1-for-2 to 1-for-100 reverse stock split (any final ratio in that range to be determined by our board of directors) of our ordinary shares on in an effort to regain compliance with Nasdaq’s Minimum Bid Price Requirement. To regain compliance, the closing bid price of the ordinary shares has to be at least $1.00 per share for a minimum of 10 consecutive trading days and, at Nasdaq’s discretion, up to 20 consecutive trading days. The proposed reverse stock split, if enacted, might not be sufficient to regain compliance with the Minimum Bid Price Requirement.

 

Regardless of whether the reverse stock split achieves its goal of obtaining compliance with the Minimum Bid Price Requirement, the market price per ordinary share could drop as a result of such reverse stock split. Historically, the market price of small-cap companies that enact reverse stock splits often decrease significantly following such split due to fears of dilution irrespective of the performance, prospects, management or results of operation of the company that enacted such reverse stock split. Our market price may drop significantly if we enact a reverse stock split.

 

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.

 

There is no public market for the pre-funded warrants being offered in this offering.

 

There is no established public trading market for the pre-funded warrants being offered in this offering, and we do not expect a market to develop. In addition, we do not intend to apply to list the pre-funded warrants on any securities exchange or nationally recognized trading system, including Nasdaq. Without an active market, the liquidity of the pre-funded warrants will be limited.

 

Holders of the pre-funded warrants purchased in this offering will have no rights as ordinary shareholders until such holders exercise their pre-funded warrants and acquire our ordinary shares, except as otherwise provided in the pre-funded warrants.

 

Until holders of the pre-funded warrants acquire shares of our ordinary shares upon exercise of such warrants, they will have no rights with respect to our ordinary shares underlying such pre-funded warrants. Upon exercise of the pre-funded warrants, the holders will be entitled to exercise the rights of an ordinary shareholder only as to matters for which the record date occurs after the exercise date.

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This prospectus and the documents incorporated by reference herein contain 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 the documents incorporated by reference herein 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 and the documents incorporated by reference herein 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 and the documents incorporated by reference herein, 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, the documents incorporated by reference herein and other documents that we may file from time to time with the securities regulators.

 

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USE OF PROCEEDS

 

Based upon an assumed offering price of $0.26 per ordinary share (the last reported sale price rounded to the nearest whole cent of our ordinary shares as reported on the Nasdaq Capital Market on October 30, 2024), we estimate that we will receive gross proceeds from this offering of approximately $8,000,000, and net proceeds of approximately $7,135,000, after deducting placement agent fees and estimated offering expenses of approximately $865,000 payable by us. However, because this is a best-efforts offering and there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, the placement agent’s fees and net proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth on the cover page of this prospectus.

 

We intend to use the net proceeds from this offering for the eAArly Detect 2 study, the development of our next generation screening product, the commercial expansion of our ColoAlert product, repayment of convertible debt and for general corporate purposes

 

A $0.10 increase or decrease in the assumed public offering price of $0.26 per share would increase or decrease the net proceeds from this offering by approximately $2,861,538 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 placement agent fees 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 $24,180, assuming the assumed public offering price remains the same, and after deducting estimated placement agent fees 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. As of the date of this prospectus, we do not intend to use the proceeds from this offering to make principal payments, scheduled or early, on any of our outstanding debt, however we may reassess this intention not to make additional payments on our outstanding debt immediately after the completion of this offering.

 

DIVIDEND POLICY

 

We have not paid any dividends on our ordinary shares since incorporation. Our management anticipates that we will retain all future earnings and other cash resources for the future operation and development of our business. We do not intend to declare or pay any cash dividends in the foreseeable future. Payment of any future dividends will be at the Board’s discretion, subject to applicable law, after taking into account many factors including our operating results, financial condition and current and anticipated cash needs.

 

Under Dutch law, we may only pay dividends 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. As of June 30, 2024, our shareholders’ equity did not exceed this amount, and we do not anticipate it to do so in the near future.

 

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.

 

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CAPITALIZATION AND INDEBTEDNESS

 

The following table sets forth the capitalization of Mainz Biomed N.V. on:

 

an actual basis;

 

 

a pro forma basis, giving effect since July 1, 2024 to (i) the issuance of a convertible note for net proceeds of $1,340,000, and (ii) the conversion of $5,827,341 in principal and interest on convertible notes and the receipt of net proceeds of $4,780,572, through the issuance of 37,254,425 ordinary shares; and

 

  a pro forma, as adjusted basis, additionally giving effect to the sale by us of 30,769,231 ordinary shares, at an assumed public offering price of $0.26 per ordinary share, after deducting placement agent fees 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 the documents incorporated by reference herein and our unaudited consolidated pro forma information appearing elsewhere in this prospectus and the documents incorporated by reference herein.

 

   As of June 30, 2024 
   Actual   Pro Forma   Pro Forma,
as adjusted
 
Cash  $977,764   $7,098,336   $14,233,336 
                
Debt:               
Convertible debt - related party  $32,140   $32,140   $32,140 
Convertible promissory note at fair value   5,842,003    1,589,159    1,589,159 
Silent partnership   762,892    762,892    762,892 
Silent partnership - related party   267,206    267,206    267,206 
Total Debt  $6,904,241   $2,651,397   $2,651,397 
                
Stockholders’ Equity:               
Share capital   276,378    686,177    1,024,638 
Share premium   54,136,785    64,334,899    71,996,438 
Reserve   22,314,598    22,314,598    22,314,598 
Accumulated deficit   (80,351,783)   (80,586,279)   (80,586,279)
Accumulated other comprehensive income (loss)   (514,678)   (514,678)   (514,678)
Total Stockholders’ Equity   (4,138,700)   6,234,716    14,234,716 
Total Capitalization  $2,765,541   $8,886,113   $16,886,113 

 

The pro forma as adjusted information above assumes the sale of all of the ordinary shares offered hereby. Because this is a best-efforts offering and there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, the placement agent’s fees and net proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth on the cover page of this prospectus. As a result, the pro forma as adjusted information provided herein may be substantially different.

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DILUTION

 

If you invest in our ordinary shares or pre-funded warrants, your interest in our ordinary shares will be diluted to the extent of the difference between the offering price per ordinary share or pre-funded warrant 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, 2024 was $(7,344,754), or approximately $(0.29) per ordinary share. Net tangible book value per ordinary share as of June 30, 2024 represents the amount of total assets less intangible assets and total liabilities, divided by the number of ordinary shares outstanding.

 

After giving effect since July 1, 2024 to (i) the issuance of a convertible note for net proceeds of $1,340,000, and (ii) the conversion of $5,827,341 in principal and interest on convertible notes and the receipt of net proceeds of $4,780,572, through the issuance of 37,254,425 ordinary shares (the “Post-June 30, 2024 Issuances”), our pro forma net tangible book value as of June 30, 2024 would have been approximately $3,028,662, or approximately $0.05 per ordinary share, based on 62,841,000 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, 2024 gives further effect to the assumed sale of 30,769,231 ordinary shares at the assumed public offering price of $0.26 per ordinary share, after deducting the placement agent fees and estimated offering expenses. Our pro forma as adjusted net tangible book value as of June 30, 2024, 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, 2024, will be approximately $10,163,662, or $0.11 per ordinary share. This would result in dilution to investors in this offering of approximately $0.15, or approximately 58% from the assumed offering price of $0.26 per ordinary share. Pro forma as adjusted net tangible book value per ordinary share would increase to the benefit of present shareholders by $0.40 per share attributable to the purchase of the ordinary shares by investors in this offering.

 

The following table sets forth the estimated net tangible book value per ordinary share after the offering and the dilution to persons purchasing ordinary shares.

 

Assumed offering price per ordinary share  $   $0.26 
Pro forma net tangible book value per ordinary share before the offering  $0.04    
Increase per ordinary share attributable to this offering  0.06     
Pro forma as adjusted net tangible book value after the offering  $    $0.11
Pro forma as adjusted dilution per ordinary share to new investors in this offering  $    $0.15

 

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

 

The following table summarizes, as of October 30, 2024, 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 shareholders and by our new investors purchasing shares in our public offering at the assumed public offering price of $0.26 per ordinary share, as disclosed on the cover page of this prospectus, before deducting estimated placement agent fees and estimated offering expenses payable by us:

 

   Shares Purchased   Total Consideration   Average 
   Number   Percent   Amount   Percent   Price Per
Share
 
Existing shareholders   64,041,000    68%   65,021,076    89%  $1.02 
New investors   30,769,231    32%   8,000,000    11%  $0.26 
Total   94,810,231    100%  $73,021,076    100%     

 

The pro forma as adjusted information above assumes the sale of all of the ordinary shares offered hereby and the immediate exercise of any pre-funded warrants sold hereby. Because this is a best-efforts offering and there is no minimum offering amount required as a condition to the closing of this offering, the actual amount of securities sold hereby and net proceeds to us are not presently determinable and may be substantially less than the amounts used to calculate the dilution information herein. As a result, the pro forma as adjusted information provided herein may be substantially different.

 

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MARKET FOR OUR SECURITIES

 

Our ordinary shares began trading on the Nasdaq Capital Market on November 4, 2021 under the symbol “MYNZ”. The following table sets out the high and low bid price for our securities in each completed fiscal quarter since January 1, 2022 as quoted on the Nasdaq Stock Market:

 

   Common Stock 
   High   Low 
2022        
Quarter Ended March 31  $27.76   $10.30 
Quarter Ended June 30  $15.50   $8.91 
Quarter Ended September 30  $11.56   $6.11 
Quarter Ended December 31  $9.39   $6.18 
           
2023          
Quarter Ended March 31  $7.35   $6.08 
Quarter Ended June 30  $6.50   $3.20 
Quarter Ended September 30  $4.90   $2.89 
Quarter Ended December 31  $3.19   $1.02 
           
2024          
Quarter Ended March 31  $1.20   $0.88 
Quarter Ended June 30  $1.13   $0.38 
Quarter Ended September 30  $0.53   $0.20 

 

There is no market for our pre-funded warrants, and we do not expect one to develop.

 

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SECURITIES ELIGIBLE FOR FUTURE SALE

 

Ordinary shares

 

As of the date hereof, we have 64,041,000 ordinary shares outstanding, and upon completion of this offering, we will have 94,810,231 ordinary shares outstanding assuming (i) the offering price per share is $0.26, which is the last reported sale price of our ordinary shares rounded to the nearest whole cent on October 30, 2024 and (ii) that any pre-funded warrants sold hereby are immediately exercised. As of the date hereof, there are 6,597,500 ordinary shares underlying warrants that are outstanding as of the date hereof, 2,787,150 ordinary shares underlying options that we have granted as of the date hereof and 30,475,765 ordinary shares underlying principal under outstanding convertible notes (assuming their conversion at the floor price contained in such notes).

 

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 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.

 

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.

 

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 948,102 shares immediately after this 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

 

The following description of our Articles of Association, as amended by our Deed of Amendment on July 19, 2024 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.

 

Overview

 

We were incorporated on March 8, 2021 as a private limited liability company (besloten vennootschap met beperkte aansprakelijkheid) under Dutch law, and on November 9, 2021 we converted 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. 

 

Our ordinary shares are subject to, and have been created under, Dutch law. Set forth below is a summary of relevant information concerning the material provisions of our articles of association and applicable Dutch law.

 

Board of Directors

 

We have a one-tier board structure. Our board of directors (the “Board of Directors”) consists of one executive director 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 is charged with our management. In fulfilling their duties, our directors will serve our interest and the business connected by us. The executive directors and the executive committee are charged with our day-to-day management. Supervision of the fulfilment of duties by the executive directors and of the general course of our affairs and the business connected with us 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. 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.

 

The following summary of the material terms of our securities is not intended to be a complete summary of the rights and preferences of such securities and is qualified by reference to the Deed of Incorporation, the Articles of Association and the warrant-related documents described herein, which are exhibits to the registration statement of which this prospectus is a part. We urge you to read each of the Deed of Incorporation, the Articles of Association and the warrant-related documents described herein in their entirety for a complete description of the rights and preferences of our securities.

 

Our authorized share capital consists of 225,000,000 ordinary shares with a nominal value of EUR 0.01 per share and 25,000,000 preferred shares with a nominal value of EUR 0.01 per share. The preferred shares are divided into five series, each consisting of 5,000,000 preferred shares. Currently there are no preferred shares outstanding.

 

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.

 

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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.

 

A resolution of the general meeting has authorized our Board of Directors until November 9, 2026, to issue ordinary shares and preferred shares up to the amount of the authorized share capital (from time to time).

 

Pre-emptive Rights

 

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

 

Under our articles of association, the pre-emptive 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 pre-emptive 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.

 

A resolution of the general meeting has authorized our Board of Directors until November 9, 2026 to limit or exclude pre-emptive rights on ordinary shares.

 

Pre-emptive 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 pre-emptive 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 we are a party to the deed of transfer, and acknowledgement by or proper service upon us to be effective.

 

Our articles of association provide that, if one or more ordinary shares or preferred shares are admitted to trading on Nasdaq or any other regulated foreign stock exchange located in the United States the laws of the State of New York will apply to the property law aspects of the ordinary shares and preferred shares included in the part of the register of shareholders kept by the relevant transfer agent.

 

Form of Ordinary Shares

 

Pursuant to our articles of association, the ordinary shares and preferred shares are in registered form.

 

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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.

 

A resolution of the general meeting, dated May 31, 2024, has authorized our Board of Directors until November 29, 2025 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 last closing price for ordinary shares on the Nasdaq Stock Market prior to the transaction, (ii) for self-tender offers, the market price will be the volume weighted average price for the ordinary shares on the Nasdaq Capital 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, 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 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 May 31, 2024, our Board of Directors is furthermore authorized until November 29, 2025 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 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. 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.

 

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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 (iii) 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. 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 with 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 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 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.

 

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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 an absolute 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 an absolute 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 an absolute majority of the votes cast resolve that we will be dissolved. In the event of our dissolution, 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

 

We may only make distributions to its shareholders if our 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. We 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 us (verjaring).

 

Transfer Agent

 

We have appointed 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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DESCRIPTION OF PRE-FUNDED WARRANTS

 

The pre-funded warrants will be issued in physical form directly by the Company to purchasers in this offering.

 

The following summary of certain terms and provisions of the pre-funded warrants offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of the form of pre-funded warrant, which is filed as an exhibit to the registration statement of which this prospectus is a part. Prospective investors should carefully review the terms and provisions set forth in the form of pre-funded warrant.

 

Duration and Exercise Price

 

Each pre-funded warrant offered hereby will have an initial exercise price per share equal to $0.001, will be immediately exercisable and can be exercised until all such pre-funded warrants are exercised in full.

 

The exercise price and number of ordinary shares issuable upon exercise of such pre-funded warrants are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our ordinary shares and the exercise price.

 

Exercisability

 

Each of the pre-funded warrants will be exercisable, at the option of each holder of such pre-funded warrant, in whole or in part, by delivering a duly executed exercise notice accompanied by payment in full for the number of our ordinary shares purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder of such pre-funded warrant (together with its affiliates) may not exercise any portion of the pre-funded warrant to the extent that the holder would own more than 4.99% (or at the election of the holder, 9.99%) of the outstanding ordinary shares immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s pre-funded warrants. No fractional ordinary shares will be issued in connection with the exercise of a pre-funded warrant. In lieu of fractional shares, the number of shares will be rounded down to the nearest whole share.

 

Cashless Exercise

 

If, at the time a holder exercises its pre-funded warrants, in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder thereof may elect instead to receive upon such exercise (either in whole or in part) the net number of pre-funded warrant shares determined according to a formula set forth in such pre-funded warrant.

 

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Fundamental Transaction

 

In the event of a fundamental transaction, as described in the pre-funded warrants and generally including any reorganization, recapitalization or reclassification of our ordinary shares, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding ordinary shares, or any person or group becoming the beneficial owner of 50% of the voting power represented by our outstanding ordinary shares, the holders of the pre-funded warrants will be entitled to receive upon exercise of such pre-funded warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised such pre-funded warrants immediately prior to such fundamental transaction. Notwithstanding the foregoing, in the event of such a fundamental transaction, the holders will have the option, which may be exercised within 30 days after the consummation of the fundamental transaction, to require the company or the successor entity purchase such pre-funded warrant from the holder by paying to the holder an amount of cash equal to the Black Scholes Value (as defined in such pre-funded warrant) of the remaining unexercised portion of such pre-funded warrant on the date of the consummation of such transaction. However, if such fundamental transaction is not within the Company’s control, including not approved by the Board, the holder will only be entitled to receive from the Company or any successor entity, as of the date of consummation of such fundamental transaction, the same type or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion of such pre-funded warrant that is being offered and paid to the holders of our ordinary shares in connection with the fundamental transaction, whether that consideration be in the form of cash, stock or any combination thereof, or whether the holders of our ordinary shares are given the choice to receive from among alternative forms of consideration in connection with the fundamental transaction.

 

Transferability

 

Subject to applicable laws, a pre-funded warrant may be transferred at the option of the holder upon surrender of such pre-funded warrant together with the appropriate instruments of transfer.

 

Exchange Listing

 

There is no established public trading market for the pre-funded warrants, and we do not expect a market to develop. We do not intend to list the pre-funded warrants on any securities exchange or nationally recognized trading system. Without an active trading market, the liquidity of the pre-funded warrants will be limited.

 

Right as a Shareholder

 

Except as otherwise provided in the pre-funded warrants or by virtue of such holder’s ownership of our ordinary shares, the holders of the pre-funded warrants do not have the rights or privileges of holders of our ordinary shares, including any voting rights, until they exercise their pre-funded warrants.

 

Amendment and Waiver

 

The pre-funded warrants may be modified or amended or the provisions thereof waived with the written consent of the Company, and the holder of each such warrant.

 

Governing Law

 

The pre-funded warrants are governed by New York law.

 

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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. 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.

 

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 may 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.

 

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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 may credit the Dutch dividend withholding tax against their income tax or corporate income tax liability (maximized to the amount of corporate income tax due in that financial year) 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.

 

As of January 1, 2024, in addition to the (regular) Dutch dividend withholding tax, a conditional dividend withholding tax (the “Conditional Dividend Withholding Tax”) is imposed on dividends paid to related entities in designated low-tax jurisdictions and in certain abusive situations. If due, the Conditional Dividend Withholding Tax may be imposed at the highest Dutch corporate income tax rate in effect at the time of the distribution (currently 25.8%), if the shareholder entitled to those dividend payments has such an interest in us, possibly as part of a cooperating group, that such party can exert such influence on our decisions as to determine our activities, while that shareholder is established in a jurisdiction that is included in the Regulation of low-taxing countries and non-cooperative jurisdictions for tax purposes (Regeling laagbelastende staten en niet-coöperatieve rechtsgebieden voor belastingdoeleinden), or has a relevant connection therewith. Any (regular) Dutch dividend withholding tax due in respect of the same dividend distribution may be credited against the Conditional Dividend Withholding Tax.

 

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 German-Dutch tax treaty, and we will in principle not be required to withhold the Conditional Dividend Withholding Tax.

 

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.

 

Pursuant to additional measures introduced with effect from January 1, 2024, the burden of proof as regards the absence of dividend stripping has been shifted to the taxpayer.

 

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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 variable percentages of the value of the investment assets and liabilities. For 2024, the variable percentages are set at 1.03% for savings, at 6.04% for other investments (such as ordinary shares) and at 2.47% for liabilities. Such fictitious annual return deemed to be derived from the ordinary shares will be taxed at a flat rate of 36% in 2024.

 

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 €57,000 is available (2024). 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.

 

The Dutch Government issued a draft legislative proposal for internet consultation on September 8, 2023 to introduce a new system regarding the taxation of income from savings and investments as of the tax year 2027. Such new system will be based on actual returns realized (such as dividends) and the value development of assets (such as a capital gain on shares or capital loss on shares). The Dutch cabinet forwarded an amended legislative proposal to the Council of State for advice on June 14, 2024. At this stage, it remains uncertain whether the authorities will be able to implement the new system by 2027.

 

On June 6, 2024, the Dutch Supreme Court confirmed in several rulings that taxation under the current regime for savings and investments violates Section 1 of the First Protocol to the European Convention on Human Rights in conjunction with Section 14 of the European Convention on Human Rights, to the extent that the fictitious annual return to be recognized is higher than the actual return realized, calculated in accordance with the rules set out in the recent decisions of the Dutch Supreme Court.

 

Dutch resident individual holders of ordinary shares are advised to consult their own tax advisor to ensure that the tax in respect of their ordinary shares is levied in accordance with the applicable Dutch tax rules at the relevant time.

 

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 19% with respect to taxable profits up to €200,000 and 25.8% with respect to taxable profits in excess of that amount (rates and brackets for 2024).

 

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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.

 

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.

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Material United States Tax Income Tax Considerations

  

Subject to the limitations and qualifications stated herein, this discussion sets forth the material U.S. federal income tax considerations relating to the acquisition, ownership and disposition by U.S. Holders (as defined below) of ordinary shares acquired pursuant to this offering, the ownership, exercise and disposition of pre-funded warrants acquired pursuant to this offering, and the ordinary shares received upon the exercise of such pre-funded warrants (the “Pre-Funded Warrant Shares”). The term “securities” as used in this discussion includes the ordinary shares, pre-funded warrants and Pre-Funded Warrant Shares, as applicable.

 

The discussion is based on the U.S. Internal Revenue Code of 1986, as amended (the “Code”), its legislative history, existing and proposed regulations thereunder, published rulings and court decisions, all as currently in effect and all subject to change at any time, possibly with retroactive effect. This summary applies only to U.S. Holders and does not address tax consequences to a non-U.S. Holder (as defined below) investing in securities.

 

This discussion of a U.S. Holder’s tax consequences addresses only those persons that hold securities as capital assets and does not address the tax consequences to any special class of holders, including without limitation, holders (directly, indirectly or constructively) of 10% or more of our equity (based on value or voting power), dealers in securities or currencies, banks, tax-exempt organizations, insurance companies, financial institutions, broker-dealers, regulated investment companies, real estate investment trusts, traders in securities that elect the mark-to-market method of accounting for their securities holdings, persons that hold securities that are a hedge or that are hedged against currency or interest rate risks or that are part of a straddle, conversion or “integrated” transaction, persons required to accelerate the recognition of any item of gross income with respect to the ordinary shares as a result of such income being recognized on an applicable financial statement, U.S. expatriates or former long-term residents of the United States, partnerships or other pass-through entities for U.S. federal income tax purposes, U.S. Holders that acquire securities in connection with the exercise of employee stock options or otherwise as compensation for services and U.S. Holders whose functional currency for U.S. federal income tax purposes is not the U.S. dollar. This discussion does not address the effect of the U.S. federal alternative minimum tax, U.S. federal estate and gift tax, alternative minimum tax, the 3.8% Medicare contribution tax on net investment income or any state, local or non-U.S. tax laws applicable to a holder of securities. This discussion 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. Each U.S. Holder should consult its own tax advisor regarding the U.S. federal, U.S. state and local, U.S. federal estate and gift, alternative minimum, and non-U.S. tax consequences of the acquisition, ownership and disposition of the securities.

 

For purposes of this discussion, a “U.S. Holder” is a beneficial owner of securities acquired pursuant to this offering that is for U.S. federal income tax purposes: (a) an individual who is a citizen or resident of the United States; (b) a corporation (or other entity taxable as a corporation for U.S. federal income tax purposes) created or organized in or under the laws of the United States, any state thereof or the District of Columbia; (c) an estate the income of which is subject to U.S. federal income taxation regardless of its source; or (d) a trust (i) if a court within the United States can exercise primary supervision over its administration, and one or more U.S. persons have the authority to control all of the substantial decisions of that trust, or (ii) that has a valid election in effect under applicable Treasury regulations to be treated as a U.S. person. The term “non-U.S. Holder” means any beneficial owner of securities acquired pursuant to this offering that is not a U.S. Holder, a partnership (or an entity or arrangement that is treated as a partnership or other pass-through entity for U.S. federal income tax purposes) or a person holding securities through such an entity or arrangement.

 

If a partnership or an entity or arrangement that is treated as a partnership for U.S. federal income tax purposes holds securities, the tax treatment of a partner generally will depend upon the status of the partner and the activities of the partnership. Partners in partnerships that hold securities should consult their own tax advisors. You are urged to consult your own independent tax advisor regarding the specific U.S. federal, state, local and non-U.S. income and other tax considerations relating to the acquisition, ownership and disposition of securities.

 

U.S. Federal Income Tax Consequences of the Acquisition, Ownership, and Disposition of Ordinary Shares, Pre-Funded Warrants and Pre-Funded Warrant Shares

 

The following discussion is subject in its entirety to the rules described below under the heading “Passive Foreign Investment Company Considerations.”

 

Cash Dividends and Other Distributions

 

As described in the section entitled “Dividend Policy” above, we currently intend to retain any future earnings to fund business development and growth, and we do not expect to pay any dividends in the foreseeable future. However, to the extent there are any distributions (including constructive distributions) made with respect to an ordinary share, pre-funded warrant or Pre-Funded Warrant Share, a U.S. Holder generally will be required to include the amount of such distribution in gross income (including the amount of Dutch taxes withheld, if any) as dividend income to the extent of our current and accumulated earnings and profits (computed using U.S. federal income tax principles). A dividend generally will be taxed to a U.S. Holder at ordinary income tax rates if the Company is a PFIC for the tax year of such distribution or the preceding tax year. To the extent that a distribution exceeds our current and accumulated “earnings and profits,” such distribution will be treated first as a non-taxable return of capital to the extent of the holder’s adjusted tax basis in such securities and, thereafter, as gain from the sale or exchange of such securities (see “Sale or Disposition” below). There can be no assurance that we will maintain calculations of our earnings and profits in accordance with U.S. federal income tax accounting principles. U.S. Holders should therefore assume that any distribution with respect to the securities will constitute ordinary dividend income. Dividends paid on such securities generally will not be eligible for the dividends received deduction generally allowed to U.S. corporations.

 

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Dividends paid to a non-corporate U.S. Holder by a “qualified foreign corporation” may be subject to reduced rates of taxation if certain holding period and other requirements are met. A qualified foreign corporation generally includes a foreign corporation (other than a foreign corporation that is a PFIC in the taxable year in which the dividend is paid or the preceding taxable year) if (i) its securities are readily tradable on an established securities market in the United States or (ii) it is eligible for benefits under a comprehensive U.S. income tax treaty that includes an exchange of information program and which the U.S. Treasury Department has determined is satisfactory for these purposes. Our ordinary shares (which would include Pre-Funded Warrant Shares) are readily tradable on an established securities market in the United States, the Nasdaq. However, the pre-funded warrants are not readily tradable on an established securities market.

 

Non-corporate U.S. Holders will not be eligible for reduced rates of taxation on any dividends received from us if we are a PFIC in the taxable year in which such dividends are paid or in the preceding taxable year.

 

A U.S. Holder who pays (whether directly or through withholding) Dutch taxes with respect to dividends paid on our securities (or with respect to any constructive dividend on the pre-funded warrants) may be entitled to receive, at the election of such U.S. Holder, either a deduction or a foreign tax credit for such taxes paid. Complex limitations apply to the foreign tax credit, including the general limitation that the credit cannot exceed the proportionate share of a U.S. Holder’s U.S. federal income tax liability that such U.S. Holder’s “foreign source” taxable income bears to such U.S. Holder’s worldwide taxable income. In applying this limitation, a U.S. Holder’s various items of income and deduction must be classified, under complex rules, as either “foreign source” or “U.S. source.” In addition, this limitation is calculated separately with respect to specific categories of income. Dividends paid by us generally will constitute “foreign source” income and generally will be categorized as “passive category income.” However, if 50% or more of our equity (based on voting power or value) is treated as held by U.S. persons, we will be treated as a “United States-owned foreign corporation,” in which case dividends may be treated for foreign tax credit limitation purposes as “foreign source” income to the extent attributable to our non-U.S. source earnings and profits and as “U.S. source” income to the extent attributable to our U.S. source earnings and profits. Because the foreign tax credit rules are complex, each U.S. Holder should consult its own tax advisor regarding the foreign tax credit rules.

 

Sale or Disposition

 

Subject to the PFIC rules discussed below, a U.S. Holder generally will recognize gain or loss on the taxable sale or exchange of its ordinary shares, pre-funded warrants or Pre-Funded Warrant Shares in an amount equal to the difference between the U.S. dollar amount realized on such sale or exchange (determined in the case of securities sold or exchanged for currencies other than U.S. dollars by reference to the spot exchange rate in effect on the date of the sale or exchange or, if the securities sold or exchanged are traded on an established securities market and the U.S. Holder is a cash basis taxpayer or an electing accrual basis taxpayer, the spot exchange rate in effect on the settlement date) and the U.S. Holder’s adjusted tax basis in the securities sold or otherwise disposed of determined in U.S. dollars.

 

Assuming we are not a PFIC and have not been treated as a PFIC during your holding period for our securities, such gain or loss will be capital gain or loss and will be long-term gain or loss if the applicable securities have been held for more than one year. Under current law, long-term capital gains of non-corporate U.S. Holders generally are eligible for reduced rates of taxation. The deductibility of capital losses is subject to limitations. Capital gain or loss, if any, recognized by a U.S. Holder generally will be treated as U.S. source income or loss for U.S. foreign tax credit purposes. Consequently, a U.S. Holder may not be able to use the foreign tax credit arising from any Dutch tax imposed on the disposition of a security unless such credit can be applied (subject to applicable limitations) against tax due on other income treated as derived from foreign sources. U.S. Holders are encouraged to consult their own tax advisors regarding the availability of the U.S. foreign tax credit in their particular circumstances.

 

Passive Foreign Investment Company Considerations

 

Status as a PFIC

 

The rules governing PFICs can have adverse tax effects on U.S. Holders. We generally will be classified as a PFIC for U.S. federal income tax purposes if, for any taxable year, either: (1) 75% or more of our gross income consists of certain types of passive income, or (2) the average value (determined on a quarterly basis), of our assets that produce, or are held for the production of, passive income is 50% or more of the value of all of our assets.

 

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For purposes of the PFIC provisions, “gross income” generally means sales revenues less cost of goods sold, plus income from investments and from incidental or outside operations or sources. Passive income generally includes dividends, interest, rents and royalties (other than certain rents and royalties derived in the active conduct of a trade or business), annuities and gains from assets that produce passive income. If a non-U.S. corporation owns at least 25% by value of the stock of another corporation, the non-U.S. corporation is treated for purposes of the PFIC tests as owning its proportionate share of the assets of the other corporation and as receiving directly its proportionate share of the other corporation’s income.

 

Additionally, if we are classified as a PFIC in any taxable year with respect to which a U.S. Holder owns securities, we generally will continue to be treated as a PFIC with respect to such U.S. Holder in all succeeding taxable years, regardless of whether we continue to meet the tests described above, unless the U.S. Holder makes the “deemed sale election” described below.

 

We do not believe that we are currently a PFIC, and we do not anticipate becoming a PFIC in the foreseeable future. Notwithstanding the foregoing, the determination of whether we are a PFIC is made annually and depends on the particular facts and circumstances (such as the valuation of our assets, including goodwill and other intangible assets) and also may be affected by the application of the PFIC rules, which are subject to differing interpretations. The fair market value of our assets is expected to depend, in part, upon (a) the market price of our ordinary shares, which is likely to fluctuate, and (b) the composition of our income and assets, which will be affected by how, and how quickly, we spend any cash that is raised in any financing transaction, including this offering. In light of the foregoing, no assurance can be provided that we are not currently a PFIC or that we will not become a PFIC in any future taxable year. Prospective investors should consult their own tax advisors regarding our potential PFIC status.

 

U.S. Federal Income Tax Treatment of a Shareholder of a PFIC

 

If we are classified as a PFIC for any taxable year during which a U.S. Holder owns securities, the U.S. Holder, absent certain elections (including the mark-to-market and QEF elections described below), generally will be subject to adverse rules (regardless of whether we continue to be classified as a PFIC) with respect to (i) any “excess distributions” (generally, any distributions received by the U.S. Holder on its securities in a taxable year that are greater than 125% of the average annual distributions received by the U.S. Holder in the three preceding taxable years or, if shorter, the U.S. Holder’s holding period for its securities) and (ii) any gain realized on the sale or other disposition, including a pledge, of its securities.

 

Under these adverse rules (a) the excess distribution or gain will be allocated ratably over the U.S. Holder’s holding period, (b) the amount allocated to the current taxable year and any taxable year prior to the first taxable year in which we are classified as a PFIC will be taxed as ordinary income, (c) the amount allocated to each other taxable year during the U.S. Holder’s holding period in which we were classified as a PFIC (i) will be subject to tax at the highest rate of tax in effect for the applicable category of taxpayer for that year and (ii) will be subject to an interest charge at a statutory rate with respect to the resulting tax attributable to each such other taxable year, and (d) loss recognized on the disposition of the securities will not be deductible.

 

If we are classified as a PFIC, a U.S. Holder generally will be treated as owning a proportionate amount (by value) of stock or shares owned by us in any direct or indirect subsidiaries that are also PFICs and will be subject to similar adverse rules with respect to any distributions we receive from, and dispositions we make of, the stock or shares of such subsidiaries. You are urged to consult your tax advisors about the application of the PFIC rules to any of our subsidiaries.

 

If we are classified as a PFIC and then cease to be so classified, a U.S. Holder may make an election (a “deemed sale election”) to be treated for U.S. federal income tax purposes as having sold such U.S. Holder’s ordinary shares, pre-funded warrants or Pre-Funded Warrant Shares on the last day our taxable year during which we were a PFIC. A U.S. Holder that makes a deemed sale election with respect to such securities would then cease to be treated as owning stock in a PFIC by reason of ownership of our ordinary shares, pre-funded warrants or Pre-Funded Warrant Shares. However, gain recognized as a result of making the deemed sale election would be subject to the adverse rules described above and loss would not be recognized.

 

PFIC “Mark-to-Market” Election

 

In certain circumstances, a U.S. Holder can avoid certain of the adverse rules described above by making a mark-to-market election with respect to its ordinary shares and Pre-Funded Warrant Shares, provided that such shares are “marketable.” The ordinary shares and Pre-Funded Warrant Shares generally will be marketable if they are “regularly traded” on certain U.S. stock exchanges or on a foreign stock exchange that meets certain conditions. For these purposes, the ordinary shares and Pre-Funded Warrant Shares will be considered regularly traded during any calendar year during which they are traded, other than in de minimis quantities, on at least 15 days during each calendar quarter. Any trades that have as their principal purpose meeting this requirement will be disregarded. Our ordinary shares (which include Pre-Funded Warrant Shares) are listed on the Nasdaq, which is a qualified exchange for these purposes. Consequently, if our ordinary shares and Pre-Funded Warrant Shares remain listed on the Nasdaq and are regularly traded, and you are a holder of ordinary shares or Pre-Funded Warrant Shares, we expect the mark-to-market election would be available to you if we are a PFIC. There can be no assurance that the shares will be “regularly traded” in subsequent calendar quarters. You should consult your own tax advisor as to the whether a mark-to-market election is available or advisable with respect to the ordinary shares and the Pre-Funded Warrant Shares. A mark-to-market election may not be available with respect to the pre-funded warrants.

 

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A U.S. Holder that makes a mark-to-market election must include in gross income, as ordinary income, for each taxable year that we are a PFIC an amount equal to the excess, if any, of the fair market value of the U.S. Holder’s ordinary shares, pre-funded warrants, and any Pre-Funded Warrant Shares at the close of the taxable year over the U.S. Holder’s adjusted tax basis in such securities. An electing U.S. Holder may also claim an ordinary loss deduction for the excess, if any, of the U.S. Holder’s adjusted tax basis in its ordinary shares, pre-funded warrants and any Pre-Funded Warrant Shares over the fair market value of such securities at the close of the taxable year, but this deduction is allowable only to the extent of any net mark-to-market gains previously included in income. A U.S. Holder that makes a mark-to-market election generally will adjust such U.S. Holder’s tax basis in its ordinary shares, pre-funded warrants and Pre-Funded Warrant Shares to reflect the amount included in gross income or allowed as a deduction because of such mark-to-market election. Gains from an actual sale or other disposition of such securities in a year in which we are a PFIC will be treated as ordinary income, and any losses incurred on a sale or other disposition of such securities will be treated as ordinary losses to the extent of any net mark-to-market gains previously included in income.

 

If we are classified as a PFIC for any taxable year in which a U.S. Holder owns securities but before a mark-to-market election is made, the adverse PFIC rules described above will apply to any mark-to-market gain recognized in the year the election is made. Otherwise, a mark-to-market election will be effective for the taxable year for which the election is made and all subsequent taxable years. The election cannot be revoked without the consent of the IRS, unless the securities cease to be marketable, in which case the election is automatically terminated.

 

A U.S. Holder makes a mark-to-market election by attaching a completed IRS Form 8621 to a timely filed U.S. federal income tax return. Each U.S. Holder should consult its own tax advisor regarding the availability of, and procedure for making, a mark-to-market election.

 

A mark-to-market election is not permitted for the shares of any of our subsidiaries that are also classified as PFICs. Prospective investors should consult their own tax advisors regarding the availability of, and the procedure for making, a mark-to-market election.

 

PFIC “QEF” Election

 

In some cases, a shareholder of a PFIC can avoid the interest charge and the other adverse PFIC consequences described above by obtaining certain information from such PFIC and by making a QEF election to be taxed currently on its share of the PFIC’s undistributed income. We do not, however, expect to provide the information regarding our income that would be necessary in order for a U.S. Holder to make a QEF election with respect to securities if we are classified as a PFIC.

 

PFIC Information Reporting Requirements

 

If we are a PFIC in any year, a U.S. Holder of securities in such year will be required to file an annual information return on IRS Form 8621 regarding distributions received on such securities and any gain realized on disposition of such securities. In addition, if we are a PFIC, a U.S. Holder generally will be required to file an annual information return with the IRS (also on IRS Form 8621, which PFIC shareholders are required to file with their U.S. federal income tax or information return) relating to their ownership of securities. This new filing requirement is in addition to the pre-existing reporting requirements described above that apply to a U.S. Holder’s interest in a PFIC (which this requirement does not affect).

 

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NO ASSURANCE CAN BE GIVEN THAT WE ARE NOT CURRENTLY A PFIC OR THAT WE WILL NOT BECOME A PFIC IN THE FUTURE. U.S. HOLDERS SHOULD CONSULT THEIR OWN TAX ADVISORS WITH RESPECT TO THE OPERATION OF THE PFIC RULES AND RELATED REPORTING REQUIREMENTS IN LIGHT OF THEIR PARTICULAR CIRCUMSTANCES, INCLUDING THE ADVISABILITY OF MAKING ANY ELECTION THAT MAY BE AVAILABLE.

 

Reporting Requirements and Backup Withholding

 

Under U.S. federal income tax law and applicable Treasury Regulations, certain categories of U.S. Holders must file information returns with respect to their investment in, or involvement in, a non-U.S. corporation. For example, U.S. return disclosure obligations (and related penalties) are imposed on U.S. Holders that hold certain specified foreign financial assets in excess of certain threshold amounts. The definition of specified foreign financial assets includes not only financial accounts maintained in foreign financial institutions, but also, unless held in accounts maintained by a financial institution, any stock or security issued by a non-U.S. person, any financial instrument or contract held for investment that has an issuer or counterparty other than a U.S. person, and any interest in a non-U.S. entity. U.S. Holders may be subject to these reporting requirements unless such U.S. Holder’s securities are held in an account at certain financial institutions. Penalties for failure to file certain of these information returns are substantial.

 

Payments made within the United States or by a U.S. payor or U.S. middleman of (a) distributions on the securities, and (b) proceeds arising from the sale or other taxable disposition of securities generally may be subject to information reporting and backup withholding, currently at the rate of 24%, if a U.S. Holder (a) fails to furnish such U.S. Holder’s correct U.S. taxpayer identification number (generally on IRS Form W-9), (b) furnishes an incorrect U.S. taxpayer identification number, (c) is notified by the IRS that such U.S. Holder has previously failed to properly report items subject to backup withholding, or (d) fails to certify, under penalty of perjury, that such U.S. Holder has furnished its correct U.S. taxpayer identification number and that the IRS has not notified such U.S. Holder that it is subject to backup withholding. However, certain exempt persons generally are excluded from these information reporting and backup withholding rules. Any amounts withheld under the U.S. backup withholding rules will be allowed as a credit against a U.S. Holder’s U.S. federal income tax liability, if any, or will be refunded, if such U.S. Holder furnishes required information to the IRS in a timely manner.

 

THE ABOVE DISCUSSION DOES NOT COVER ALL TAX MATTERS THAT MAY BE OF IMPORTANCE TO A PARTICULAR INVESTOR. YOU ARE STRONGLY URGED TO CONSULT YOUR OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES TO YOU OF AN INVESTMENT IN THE SECURITIES.

 

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PLAN OF DISTRIBUTION

 

We are offering on a “best efforts” basis up to [-----------] of our ordinary shares.

 

We are also offering to each purchaser of ordinary shares that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% of our outstanding ordinary shares immediately following the consummation of this offering the opportunity to purchase pre-funded warrants in lieu of ordinary shares. A holder of pre-funded warrants will not have the right to exercise any portion of its pre-funded warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of the holder, such limit may be increased to up to 9.99%) of the number of ordinary shares outstanding immediately after giving effect to such exercise. Each pre-funded warrant will be exercisable for one ordinary share. The purchase price of each pre-funded warrant will be equal to the price per ordinary share, minus $0.0001, and the remaining exercise price of each pre-funded warrant will equal $0.0001 per ordinary share. The pre-funded warrants will be immediately exercisable (subject to the beneficial ownership cap) and may be exercised at any time until all of the pre-funded warrants are exercised in full. For each pre-funded warrant we sell (without regard to any limitation on exercise set forth therein), the number of ordinary shares we are offering will be decreased on a one-for-one basis.

 

The following table shows the public offering price, placement agent fees and proceeds, before expenses, to us.

 

   Per
Common
Share
   Per
Pre-
Funded Warrant
 
Public offering price  $           $          
Placement agent fees  $    $   
Proceeds to us, before expenses  $    $   

 

We estimate that the total expenses of the offering, including registration, filing and listing fees, printing fees, legal and accounting expenses, expenses for background ground checks, travel and lodging expenses associated with road show trips, but excluding the placement agent fees, will be approximately $[----------], all of which are payable by us.

 

There is no minimum amount of proceeds that is a condition to closing of this offering. The actual amount of gross proceeds, if any, in this offering could vary substantially from the gross proceeds from the sale of the maximum amount of securities being offered in this prospectus.

 

Because this is a best-efforts offering, the placement agent does not have an obligation to purchase any securities. We expect that the offering will end one trading day after we first enter into a securities purchase agreement relating to the offering and the offering will settle delivery versus payment (“DVP”)/receipt versus payment (“RVP”). Accordingly, we and the placement agent have not made any arrangements to place investor funds in an escrow account or trust account since the placement agent will not receive investor funds in connection with the sale of the securities offered hereunder.

 

Pursuant to a placement agency agreement, dated as of                       , 2024, we have engaged Maxim Group LLC to act as our exclusive placement agent to solicit offers to purchase the securities offered by this prospectus. The placement agent is not purchasing or selling any securities, nor is it required to arrange for the purchase and sale of any specific number or dollar amount of securities, other than to use its “reasonable best efforts” to arrange for the sale of the securities by us. Therefore, we may not sell the entire amount of securities being offered. There is no minimum amount of proceeds that is a condition to closing of this offering. We will enter into a securities purchase agreement directly with the investors, at the investor’s option, who purchase our securities in this offering. Investors who do not enter into a securities purchase agreement shall rely solely on this prospectus in connection with the purchase of our securities in this offering. The placement agent may engage one or more subagents or selected dealers in connection with this offering.

 

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Placement Agent Fees, Commissions and Expenses

 

Upon the closing of this offering, we will pay the placement agent a cash fee equal to seven percent (7%) of the aggregate gross cash proceeds to us from the sale of the securities in the offering. Under the placement agency agreement, we will agree to reimburse the placement agent for its legal fees, costs and expenses in connection with the offering, irrespective of whether the offering is consummated, (i) up to US$100,000 (inclusive of any advance paid by us to the placement agent) in the event the offering is completed and (ii) up to US$50,000 if an offering is not consummated.

 

The placement agency agreement provides that the placement agent’s obligations are subject to conditions contained in the placement agency agreement.

 

We will deliver the securities being issued to the investors upon receipt of investor funds for the purchase of the securities offered pursuant to this prospectus. We expect to deliver the securities being offered pursuant to this prospectus on or about                , 2024.

 

Indemnification

 

We have agreed to indemnify the placement agent against certain liabilities, including liabilities under the Securities Act and liabilities arising from breaches of representations and warranties contained in the placement agency agreement, or to contribute to payments that the placement agent may be required to make in respect of those liabilities.

 

Lock-Up Agreements

 

We, and each of our Directors, executive officers and certain holders of our outstanding ordinary shares as of the effective date of the registration statement related to this offering have agreed to a six-month “lock-up” period from the closing of this offering with respect to the ordinary shares that they beneficially own. This means that, for a period of six (6) months following the closing of the offering, such persons may not offer, issuer, sell, contract to sell, encumber, grant any option for the sale of or otherwise dispose of any of our securities without the prior written consent of the placement agent, including the issuance of shares upon the exercise of currently outstanding options approved by the placement agent. We have also agreed to similar restrictions on the issuance, sale, disposal and registration (subject to certain exceptions) of our securities for six (6) months following the closing of this offering, subject to certain customary exceptions, without the prior written consent of the placement agent.

 

The placement agent has no present intention to waive or shorten the lock-up period; however, the terms of the lock-up agreements may be waived at its discretion. In determining whether to waive the terms of the lock-up agreements, the placement agent may base its decision on its assessment of the relative strengths of the securities markets and companies similar to ours in general, and the trading pattern of, and demand for, our securities in general.

 

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Other Compensation

 

Upon the closing of this offering, or if the engagement period as provided in the engagement letter between us and the placement agent ends prior to a closing of an offering (other than a termination for cause), then if within six (6) months following such time, we complete any financing of equity, equity-linked, convertible or debt or other capital-raising activity with, or receive any proceeds from, any investors that were contacted, introduced or participated in this offering, then the Company shall pay to the placement agent a commission as described in this section, in each case only with respect to the portion of such financing received from such investors.

 

Regulation M

 

The placement agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissions received by it and any profit realized on the resale of the securities sold by it while acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act. As an underwriter, the placement agent would be required to comply with the requirements of 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 our securities by the placement agent acting as principal. Under these rules and regulations, the placement agent (i) may not engage in any stabilization activity in connection with our securities and (ii) 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.

 

Certain Relationships

 

The placement agent and its affiliates have and may in the future provide, from time to time, investment banking and financial advisory services to us in the ordinary course of business, for which they may receive customary fees and commissions.

 

Listing

 

Our ordinary shares are currently listed on the Nasdaq Capital Market under the symbol “MYNZ”. We do not intend to list the pre-funded warrants on any securities exchange or other trading market.

 

Affiliations

 

The placement agent and its respective affiliates are full service financial institutions engaged in various activities, which may include securities trading, commercial and investment banking, financial advisory, investment management, investment research, principal investment, hedging, financing and brokerage activities. The placement agent and its affiliates may from time to time in the future engage with us and perform services for us or in the ordinary course of their business for which they will receive customary fees and expenses. In the ordinary course of their various business activities, the placement agent and its respective affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own account and for the accounts of their customers, and such investment and securities activities may involve securities and/or instruments of us. The placement agent and its respective affiliates may also make investment recommendations and/or publish or express independent research views in respect of these securities or instruments and may at any time hold, or recommend to clients that they acquire, long and/or short positions in these securities and instruments.

 

Electronic Distribution

 

A prospectus in electronic format may be made available on websites or through other online services maintained by the placement agent of this offering, or by its affiliates. Other than the prospectus in electronic format, the information on the placement agent’s website and any information contained in any other website maintained by the placement agent is not part of this prospectus or the registration statement of which this prospectus forms a part, has not been approved and/or endorsed by us or the placement agent in its capacity as the placement agent, and should not be relied upon by investors.

 

In connection with this offering, the placement agent or certain securities dealers may distribute prospectuses by electronic means, such as e-mail.

 

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Selling Restrictions Outside the United States

 

No action may be taken in any jurisdiction other than the United States that would permit a public offering of our securities or the possession, circulation, or distribution of this prospectus in any jurisdiction where action for that purpose is required. Accordingly, our securities may not be offered or sold, directly or indirectly, and neither the prospectus nor any other offering material or advertisements in connection with our securities may be distributed or published in or from any country or jurisdiction except under circumstances that will result in compliance with any applicable laws, rules and regulations of any such country or jurisdiction. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any of our securities offered by this prospectus in any jurisdiction in which such an offer or a solicitation is unlawful.

 

Notice to Prospective Investors in Canada

 

Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particulars of these rights or consult with a legal advisor.

 

Pursuant to section 3A.3 (or, in the case of securities issued or guaranteed by the government of a non-Canadian jurisdiction, section 3A.4) of National Instrument 33-105 Underwriting Conflicts (NI 33-105), the underwriters are not required to comply with the disclosure requirements of NI 33-105 regarding underwriter conflicts of interest in connection with this offering. Our securities may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of our securities must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.

 

Notice to Prospective Investors in the United Kingdom

 

In relation to each Member State of the European Economic Area which has implemented the Prospectus Directive (each, a "Relevant Member State") an offer to the public of any securities which are the subject of the offering contemplated by this prospectus may not be made in that Relevant Member State except that an offer to the public in that Relevant Member State of any such securities may be made at any time under the following exemptions under the Prospectus Directive, if they have been implemented in that Relevant Member State:

 

  (a) to legal entities which are authorized or regulated to operate in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;
  (b) to any legal entity which has two or more of (1) an average of at least 250 employees during the last financial year; (2) a total balance sheet of more than €43,000,000 and (3) an annual net turnover of more than €50,000,000, as shown in its last annual or consolidated accounts;
  (c) by the underwriters to fewer than 100 natural or legal persons (other than qualified investors as defined in the Prospectus Directive); or
  (d) in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of these securities shall result in a requirement for the publication by the issuer or the underwriters of a prospectus pursuant to Article 3 of the Prospectus Directive.

 

For the purposes of this provision, the expression an "offer to the public" in relation to any of the securities in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any such securities to be offered so as to enable an investor to decide to purchase any such securities, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State and the expression "Prospectus Directive" means Directive 2003/71/EC and includes any relevant implementing measure in each Relevant Member State.

 

The representative has represented, warranted and agreed that:

 

 

 

(a) it has only communicated or caused to be communicated and will only communicate or cause to be communicated any invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000 (the FSMA)) received by it in connection with the issue or sale of any of the securities in circumstances in which section 21(1) of the FSMA does not apply to the issuer; and
  (b) it has complied with and will comply with all applicable provisions of the FSMA with respect to anything done by it in relation to the securities in, from or otherwise involving the United Kingdom.

 

Notice to Prospective Investors in Singapore

 

This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectus and any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of our securities may not be circulated or distributed, nor may our securities be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to any person in Singapore other than (i) to an institutional investor (as defined in Section 4A of the Securities and Futures Act 2001 (the “SFA”)) pursuant to Section 274 of the SFA, (ii) to a relevant person (as defined in Section 275(2) of the SFA) pursuant to Section 275(1) of the SFA, or any person pursuant to Section 275(1A) of the SFA (where applicable) and Regulation 3 of the Securities and Futures (Classes of Investors) Regulations 2018 of Singapore, and in accordance with the conditions specified in Section 275 of the SFA, or (iii) otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA.

 

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Where the shares are subscribed or purchased under Section 275 of the SFA by a relevant person which is:

 

  (a) a corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor; or
     
  (b) a trust (where the trustee is not an accredited investor) whose sole purpose is to hold investments and each beneficiary of the trust is an individual who is an accredited investor, securities or securities-based derivatives contracts (each term as defined in Section 2(1) of the SFA) of that corporation or the beneficiaries’ rights and interest (howsoever described) in that trust shall not be transferred within six months after that corporation or that trust has acquired the shares pursuant to an offer made under Section 275 of the SFA except:

 

(1)to an institutional investor or to a relevant person, or to any person arising from an offer referred to in Section 275(1A) or Section 276(4)(i)(B) of the SFA;

 

(2)where no consideration is or will be given for the transfer;

 

(3)where the transfer is by operation of law;

 

(4)as specified in Section 276(7) of the SFA; or

 

(5)as specified in Regulation 37A of the Securities and Futures (Offers of Investments) (Securities and Securities-based Derivatives Contracts) Regulations 2018 of Singapore.

 

In connection with Section 309B of the SFA and the Securities and Futures (Capital Markets Products) Regulations 2018 (the “CMP Regulations 2018”), unless otherwise specified before an offer of the shares, the Company has determined, and hereby notifies all relevant persons (as defined in Section 309A(1) of the SFA) (where applicable), that the shares are “prescribed capital markets products” (as defined in the CMP Regulations 2018) and Excluded Investment Products (as defined in MAS Notice SFA 04-N12: Notice on the Sale of Investment Products and MAS Notice FAA-N16: Notice on Recommendations on Investment Products).

 

Notice to Prospective Investors in the People’s Republic of China

 

This prospectus may not be circulated or distributed in China and our securities may not be offered or sold, and will not offer or sell to any person for re-offering or resale directly or indirectly to any resident of China except pursuant to applicable laws, rules and regulations of China. For the purpose of this paragraph only, China does not include Taiwan and the special administrative regions of Hong Kong and Macau.

 

Notice to Prospective Investors in Hong Kong

 

Our securities may not be offered or sold in Hong Kong by means of any document other than (i) in circumstances which do not constitute an offer to the public within the meaning of the Companies Ordinance (Cap. 32, Laws of Hong Kong), (ii) to “professional investors” within the meaning of the Securities and Futures Ordinance (Cap. 571, Laws of Hong Kong) and any rules made thereunder, or (iii) in other circumstances which do not result in the document being a “prospectus” within the meaning of the Companies Ordinance (Cap. 32, Laws of Hong Kong) and no advertisement, invitation or document relating to our securities be issued or may be in the possession of any person for the purpose of issue (in each case whether in Hong Kong or elsewhere), which is directed at, or the contents of which are likely to be accessed or read by, the public in Hong Kong (except if permitted to do so under the laws of Hong Kong) other than with respect to our securities which are or are intended to be disposed of only to persons outside Hong Kong or only to “professional investors” within the meaning of the Securities and Futures Ordinance (Cap. 571, Laws of Hong Kong) and any rules made thereunder.

 

Notice to Prospective Investors in Israel

 

This document does not constitute a prospectus under the Israeli Securities Law, 5728-1968, or the Securities Law, and has not been filed with or approved by the Israel Securities Authority. In the State of Israel, this document is being distributed only to, and is directed only at, and any offer of the shares is directed only at, investors listed in the first addendum, or the Addendum, to the Israeli Securities Law, consisting primarily of joint investment in trust funds, provident funds, insurance companies, banks, portfolio managers, investment advisors, members of the Tel Aviv Stock Exchange, underwriters, venture capital funds, entities with equity in excess of NIS 50 million and "qualified individuals", each as defined in the Addendum (as it may be amended from time to time), collectively referred to as qualified investors (in each case purchasing for their own account or, where permitted under the Addendum, for the accounts of their clients who are investors listed in the Addendum). Qualified investors will be required to submit written confirmation that they fall within the scope of the Addendum, are aware of the meaning of same and agree to it.

 

44

 

 

Notice to Prospective Investors in Taiwan

 

Our securities have not been and will not be registered with the Financial Supervisory Commission of Taiwan, pursuant to relevant securities laws and regulations and may not be offered or sold in Taiwan through a public offering or in any manner which would constitute an offer within the meaning of the Securities and Exchange Act of Taiwan or would otherwise require registration with or the approval of the Financial Supervisory Commission of Taiwan.

 

Notice to Prospective Investors in the Cayman Islands

 

No invitation, whether directly or indirectly may be made to the public in the Cayman Islands to subscribe for our securities. This prospectus does not constitute a public offer of our securities, whether by way of sale or subscription, in the Cayman Islands. Our securities have not been offered or sold, and will not be offered or sold, directly or indirectly, in the Cayman Islands.

 

Notice to Prospective Investors in the European Economic Area

 

In relation to each Member State of the European Economic Area (each a “Member State”), none of our securities have been offered or will be offered pursuant to the offering to the public in that Member State prior to the publication of a prospectus in relation to our securities which has been approved by the competent authority in that Member State or, where appropriate, approved in another Member State and notified to the competent authority in that Member State, all in accordance with the Prospectus Regulation, except that offers of our securities may be made to the public in that Member State at any time under the following exemptions under the Prospectus Regulation:

 

to any legal entity which is a qualified investor as defined under the Prospectus Regulation;

 

 

to fewer than 150 natural or legal persons (other than qualified investors as defined under the Prospectus Regulation), subject to obtaining the prior consent of the underwriter for any such offer; or

 

  in any other circumstances falling within Article 1(4) of the Prospectus Regulation.

 

provided that no such offer of our securities shall require us or any of our representatives to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation and each person who initially acquires any of our securities or to whom any offer is made will be deemed to have represented, acknowledged and agreed to and with each of the representatives and us that it is a “qualified investor” as defined in the Prospectus Regulation.

 

In the case of any of our securities being offered to a financial intermediary as that term is used in Article 5 of the Prospectus Regulation, each such financial intermediary will be deemed to have represented, acknowledged and agreed that our securities acquired by it in the offer have not been acquired on a nondiscretionary basis on behalf of, nor have they been acquired with a view to their offer or resale to, persons in circumstances which may give rise to an offer of any of our securities to the public other than their offer or resale in a Member State to qualified investors as so defined or in circumstances in which the prior consent of the representatives has been obtained to each such proposed offer or resale.

 

For the purposes of this provision, the expression an “offer to the public” in relation to any of our securities in any Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any of our securities to be offered so as to enable an investor to decide to purchase or subscribe for any of our securities, and the expression “Prospectus Regulation” means Regulation (EU) 2017/1129 (as amended).

 

Stamp Taxes

 

If you purchase our securities offered by this prospectus, you may be required to pay stamp taxes and other charges under the laws and practices of the country of purchase, in addition to the public offering price listed on the cover page of this prospectus.

 

45

 

 

EXPENSES RELATING TO THIS OFFERING

 

Set forth below is an itemization of the total expenses, excluding placement discounts and commissions, the placement agent’s non-accountable expenses and the placement agent fees, that we expect to incur in connection with this offering. With the exception of the SEC registration fee and the FINRA filing fee listing fee, all amounts are estimates.

 

Securities and Exchange Commission Registration Fee  $1,409 
FINRA  $1,880 
Legal Fees and Expenses  $150,000 
Accounting Fees and Expenses  $15,000 
Printing and Engraving Expenses  $3,000 
Miscellaneous Expenses  $2,000 
Total Expenses  $173,289 

 

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.

 

Pryor Cashman LLP, New York, NY, is acting as counsel to the placement agent.

 

EXPERTS

 

The financial statements of Mainz Biomed, N.V. as of December 31, 2023 and 2022 for the years respectively then ended incorporated by reference into this prospectus and the registration statement have been so included in reliance on the report of Reliant CPA PC, an independent registered public accounting firm, given on the authority of said firm as experts in accounting and auditing. Reliant CPA PC has offices at 895 Dove Street, Suite 300, #300180, Newport Beach, CA 92660. Their telephone number is (949)558-7781.

 

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.

 

46

 

 

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.

 

47

 

 

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 and the documents incorporated by reference herein do 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.

 

INCORPORATION OF DOCUMENTS BY REFERENCE

 

The SEC allows us to incorporate by reference the information we file with them. This means that we can disclose important information to you by referring you to those documents. Each document incorporated by reference is current only as of the date of such document, and the incorporation by reference of such documents should not create any implication that there has been no change in our affairs since such date. The information incorporated by reference is considered to be a part of this prospectus and should be read with the same care. When we update the information contained in documents that have been incorporated by reference by making future filings with the SEC, the information incorporated by reference in this prospectus is considered to be automatically updated and superseded. In other words, in the case of a conflict or inconsistency between information contained in this prospectus and information incorporated by reference into this prospectus, you should rely on the information contained in the document that was filed later.

 

We incorporate by reference the documents listed below:

 

Form 6-K filed with the SEC on October 21, 2024;

 

Form 6-K filed with the SEC on October 18, 2024;

 

Form 6-K filed with the SEC on October 9, 2024;

 

Form 6-K filed with the SEC on October 3, 2024;

 

Form 6-K filed with the SEC on May 31, 2024;

 

Form 6-K filed with the SEC on April 24, 2024;

 

Form 6-K filed with the SEC on April 19, 2024; and

 

Our Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC on April 9, 2024.

 

Any statement contained herein or in a document, all or a portion of which is incorporated or deemed to be incorporated by reference herein, shall be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained herein or in any other subsequently filed document which also is or is deemed to be incorporated by reference herein modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or amended, to constitute a part of this prospectus.

 

Our filings with the SEC, and exhibits incorporated in and amendments to those reports, are available free of charge on our website (http://www.mainzbiomed.com) as soon as reasonably practicable after they are filed with, or furnished to, the SEC. Our website and the information contained on that site, or connected to that site, are not incorporated into and are not a part of this prospectus.

 

Upon written or oral request, we will provide to each person to whom this prospectus is delivered, a copy of any or all of the reports or documents that have been incorporated by reference into this prospectus at no cost. If you would like a copy of any of these documents, at no cost, please write or call us at:

 

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

 

48

 

 

Up to 30,769,231 Ordinary Shares

Up to 30,769,231 Pre-Funded Warrants

Up to 30,769,231 Ordinary Shares Underlying the Pre-Funded Warrants

 

 

MAINZ BIOMED, N.V.

 

 

 

 

 

 

 

 

 

PROSPECTUS

 

 

 

 

 

 

 

 

 

 

Maxim Group LLC

 

            , 2024

 

 

 

 

 

 

 

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.

 

 

 

 

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 defense 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 characterized 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 placement agency agreement the registrant will enter into in connection with the offering being registered hereby provides that the placement agent 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 placement agent fees 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.

 

From March 8, 2021 to September 2021, 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;

 

II-1

 

 

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. Our management determined the fair value of our ordinary shares in such grant to be $0.283 per share;

 

500,000 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.

 

During calendar 2022, 821,456 ordinary shares were issued upon the exercise of warrants issued that were issued in 2021.

 

During calendar 2022 73,000 ordinary shares were issued to consultants for services rendered, valued at an average price of $12.42 per share.

 

During calendar 2023 305,771 ordinary shares were issued on the exercise of warrants issued that were issued in 2021.

 

On June 28, 2023 54,428 ordinary shares were issued as a commitment fee related to a pre-paid advance Agreement entered into as of the same date, valued at $4.59 per share.

 

On February 15, 2023 300,000 ordinary shares were issued under an intellectual property asset purchase agreement, valued at $6.85 per share.

 

During calendar 2023 142,775 ordinary shares were issued to consultants for services rendered, valued at an average price of $3.84 per share.

 

On September 3, 2023 1,200,000 ordinary shares issued to a consultant for services rendered, valued at an average price of $0.35 per share 

 

In October 2024 7,640,486 ordinary shares were issued for the conversion of debt valued at $1,734,345 for an average price of $0.23 per share.

 

II-2

 

 

ITEM 8. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

 

The following exhibits are filed with this registration statement:

 

1.1 Form of Placement Agency Agreement between the Company and Maxim Group LLC***
2.1 Description of Securities registered under Section 12 of the Exchange Act**
3.1 Unofficial English translation of Deed of Conversion**
3.2

Unofficial English translation of Deed of Amendment, dated July 19, 2024*

4.1 Share Certificate—Ordinary Shares**
4.2 Form of Pre-Funded Warrant***
5.1 Opinion of CMS Derks Star Busmann N.V.*
5.2 Opinion of Ortoli Rosenstadt LLP***
10.1 Management Services Agreement, dated July 1, 2020, between the Company and Guido Baechler**
10.2 Amendment to Management Services Agreement, dated October 2021, between Guido Baechler and the Company**
10.3 Amendment to Management Services Agreement, dated October 2024, between Guido Baechler and the Company*
10.4 Consulting Agreement, dated July 16, 2021, between the Company and William Caragol**
10.5 Amendment to Consultant Agreement, dated October 2021, between William Caragol and the Company**
10.6 Amendment to Consultant Agreement, dated October 2024, between William Caragol and the Company*
10.7 Form of Silent Partnership Agreements**
10.8 Mainz Biomed N.V. 2021 Omnibus Incentive Plan**
10.9 Mainz Biomed N.V. Amended and Restated 2022 Omnibus Incentive Plan**
10.10 Technology Rights Agreement, dated January 4, 2022, between the Company and Socpra Sciences Santé Et Humaines S.E.C. **
10.11 Employment Contract with William Caragol, dated April 29, 2022**
10.12 Intellectual Property Asset Purchase Agreement, dated February 15, 2023, with Uni Targeting Research AS**
10.13 Assignment Agreement, dated February 15, 2023, with SOCPRA Sciences Santé et Humaines S.E.C. **
10.14 Mainz Biomed USA, Inc. Carve-Out Plan**
10.15 Pre-Paid Advance Agreement (the “PPA”), dated June 28, 2023, between the Company and YA II PN, Ltd.**
10.16 Form of Promissory Note to be issued under the PPA**
10.17 Supplemental Agreement to PPA, dated April 18, 2024**
10.18 Second Supplemental Agreement to PPA, dated October 8, 2024**
11.1 Insider Trading Policy**
11.2 Code of Ethics and Business Conduct**
23.1 Consent of Reliant CPA PC*
23.2 Consent of CMS Derks Star Busmann N.V. (contained in Exhibit 5.1)*
23.3 Consent of Ortoli Rosenstadt LLP (contained in Exhibit 5.2)***
97.1 Executive Compensation Clawback Policy**
107 Filing Fee Table*

  

*Filed herewith.
**Previously filed

*** To be filed by amendment

 

II-3

 

 

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.

 

II-4

 

 

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 November 5, 2024.

 

  MAINZ BIOMED N.V.
  (Registrant)
   
  By: /s/ Guido Baechler
    Guido Baechler, Chief Executive Officer
(Principal Executive Officer)

 

We, the undersigned directors and officers of the Registrant, hereby severally constitute and appoint Guido Baechler and William Caragol, and each of them singly, our true and lawful attorneys, with full power to them, and to each of them singly, to sign for us and in our names in the capacities indicated below, the registration statement on Form F-1 filed herewith, and any and all pre-effective and post-effective amendments to said registration statement, and any registration statement filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, in connection with the registration under the Securities Act of 1933, as amended, of equity securities of the Registrant, and to file or cause to be filed the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as each of us might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes, shall do or cause to be done by virtue of this Power of Attorney.

 

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),   November 5, 2024
Guido Baechler   Executive Director    
         
/s/ William Caragol   Chief Financial Officer (Principal Financial Officer and   November 5, 2024
William Caragol   Principal Accounting Officer)    
         
/s/ Dr. Heiner Dreismann   Director   November 5, 2024
Dr. Heiner Dreismann        
         
/s/  Gregory Tibbits   Director   November 5, 2024
Gregory Tibbits        
         
/s/ Hans Hekland   Director   November 5, 2024
Hans Hekland        

 

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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 N.V., has signed this registration statement or amendment thereto in New York, New York, on November 5, 2024.

 

  Ortoli Rosenstadt LLP
   
  By: /s/ William S. Rosenstadt
  Name: William S. Rosenstadt
  Title: Managing Partner

 

 

II-6

 

Exhibit 3.2

 

 

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.

 

ARTICLES OF ASSOCIATION

Mainz Biomed N.V.

dated 19 July 2024

 

ARTICLES OF ASSOCIATION

 

1.Definitions and interpretation

 

1.1In 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;

 

“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;

 

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“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.

 

1.2In these Articles of Association references to Articles are to articles of these Articles of Association, unless otherwise specified.

 

2.Name, seat and structure

 

2.1The name of the Company is: Mainz Biomed N.V.

 

2.2The Company has its seat in Amsterdam, the Netherlands.

 

2.3The 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;

 

(t)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.

 

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4.Share capital and Shares

 

4.1The authorised share capital of the Company amounts to one million euros (EUR 1,000,000.00) and is divided into:

 

(a)ninety million (90,000,000) Ordinary Shares with a nominal value of one eurocent (EUR 0.01) each; and

 

(b)ten million (10,000,000) Preferred Shares with a nominal value of one eurocent (EUR 0.01) each, subdivided into:

 

(i)a series A consisting of two million (2,000,000) Preferred Shares;

 

(ii)a series B consisting of two million (2,000,000) Preferred Shares;

 

(iii)a series C consisting of two million (2,000,000) Preferred Shares;

 

(iv)a series D consisting of two million (2,000,000) Preferred Shares; and

 

(v)a series E consisting of two million (2,000,000) Preferred Shares.

 

4.2The 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.

 

4.3Each series of Preferred Shares shall constitute a separate class.

 

4.4The 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

 

5.1Each Preferred Share shall be convertible, at the request of the holder, into Ordinary Shares, if permitted pursuant to the applicable conditions for conversion.

 

5.2The 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.

 

5.3Article 5.2 shall apply by analogy to any amendments of or supplementations to the terms applicable to the Preferred Shares.

 

5.4The Board of Directors shall effect 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 increased 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 decreased 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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5.5Any 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.

 

5.6If 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

 

6.1Shares 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.

 

6.2For 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.

 

6.3The validity of a resolution of the General Meeting to issue Shares or to authorise the Board of Directors to issue Shares 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 issue.

 

6.4Articles 6.1 up to and including 6.3 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

 

7.1Upon 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.

 

7.2A 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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7.3Holders of Preferred Shares shall have no pre-emption right in respect of Shares to be issued.

 

7.4Pre-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.

 

7.5A 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.

 

7.6For 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.

 

7.7The 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.

 

7.8Articles 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

 

8.1Without 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.

 

8.2Payment on a Share must be made in cash, insofar as no alternative contribution has been agreed.

 

8.3Payment 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.

 

8.4Payment 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.

 

8.5Ordinary 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.

 

8.6The 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.

 

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9.Acquisition of Shares by the Company

 

9.1Without 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.

 

9.2The 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.

 

9.3Any acquisition of Shares by the Company shall be effected with due observance of section 2:98 of the Dutch Civil Code.

 

9.4If 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

 

10.1In 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.

 

10.2In 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.

 

10.3Articles 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.

 

11.Reduction of share capital

 

11.1The 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.

 

11.2The General Meeting may only resolve to reduce the issued share capital on the proposal of the Board of Directors.

 

11.3A 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.

 

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11.4Reduction 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.

 

11.5Cancellation 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.

 

11.6Partial 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.

 

11.7The 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.

 

11.8A 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.

 

11.9Reduction 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

 

12.1A right of usufruct may be created on Shares. The voting rights on the Shares encumbered with a right ofusufruct shall accrue to the Shareholder. Notwithstanding the preceding sentence, the voting rights shall accrue to the Usufructuary if so provided at the time of the creation of the right ofusufruct.

 

12.2A 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. Notwithstanding 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.

 

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14.Shareholders register

 

14.1A 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.

 

14.2The register shall be updated regularly.

 

15.Joint holding

 

15.1If 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 ofusufruct 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-a-vis the Company by a person who has been designated by them in writing for that purpose.

 

15.2The Board of Directors may, whether or not subject to certain conditions, grant an exemption from Article 15.1.

 

16.Transfer of Shares

 

16.1Except 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.

 

16.2A 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.

 

16.3For 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

 

17.1The 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.

 

17.2Directors must be natural persons.

 

18.Appointment, suspension and dismissal of Directors

 

18.1Directors shall be appointed by the General Meeting on the basis of one or more binding nominations of the Board of Directors.

 

18.2The Board of Directors shall announce in due time when, for what reasons and according to which profile a vacancy is to be filled.

 

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18.3A 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.

 

18.4The General Meeting may at all times overrule the binding nature ofa 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.

 

18.5If 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.

 

18.6If 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.

 

18.7If none of the candidates has been appointed, the Board of Directors 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.

 

18.8The notice for a General Meeting at which the appointment is to be discussed shall include the nomination.

 

18.9The 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.

 

18.10If 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

 

19.1The 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.

 

19.2The remuneration of Directors shall be determined by the Board of Directors with due observance of the policy referred to in Article 19.1.

 

19.3The 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.

 

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20.Duties, division of duties and decision-making by the Board of Directors

 

20.1Subject 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.

 

20.2Without 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.

 

20.3Supervision 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.

 

20.4The Board of Directors may adopt rules with respect to the matters concerning the Board of Directors.

 

20.5The Board of Directors may, whether or not by rule, determine the duties with which each Director will be particularly charged.

 

20.6The Board of Directors shall appoint from among the Non-Executive Directors a chairman.

 

20.7The Board of Directors shall grant to an Executive Director the title of Chief Executive Officer. The Board of Directors may grant other titles to Executive Directors.

 

20.8The Board of Directors shall meet whenever a Director considers appropriate.

 

20.9An 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.

 

20.10Each Director may participate in a meeting by electronic means of communication, provided that all Directors participating in the meeting can hear each other simultaneously.

 

20.11Each 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.

 

20.12A 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.

 

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20.13The 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.

 

20.14A 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-a-vis third parties.

 

20.15The 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.

 

20.16The 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.

 

20.17The 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.

 

20.18The 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

 

21.1Resolutions 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.

 

21.2The 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

 

22.1The 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 each Executive Director individually.

 

22.2The 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

 

23.1In 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.

 

23.2In 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 Non-Executive Directors designate or have 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.

 

23.3In 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.

 

23.4A 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 ifhe 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 ifhe 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.Indemnity

 

24.1To 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;

 

(b)any damages or financial penalties payable by them as a result of any such acts or omissions;

 

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(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.

 

24.2An 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.

 

24.3If 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.

 

24.4The Company may, by agreement or otherwise, give further implementation to Articles 24.1 up to and including 24.3.

 

24.5Where this Article 24 would limit any contractual entitlement of any Indemnified Persons to indemnification or reimbursement, such contractual entitlement shall prevail.

 

24.6Amendment 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.

 

25.General Meetings

 

25.1Annually, 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.

 

25.2The Board of Directors shall be authorised to convene a General Meeting.

 

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25.3A 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

 

26.1General Meetings shall be held in the Netherlands, in Amsterdam, Rotterdam, The Hague, Arnhem, Utrecht or Haarlemmermeer (Schiphol Airport).

 

26.2Notice of a General Meeting shall be given by the Board of Directors or a Director.

 

26.3Notice 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.

 

26.4The 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.

 

26.5Notifications 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.

 

26.6A 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.

 

26.7Notice shall be given with due observance of the notice period prescribed by applicable law.

 

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

 

28.1The 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.

 

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28.2The 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.

 

28.3If 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.

 

28.4The 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

 

29.1Only 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.

 

29.2Each 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.

 

29.3The 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.

 

29.4For 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.

 

29.5For 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.

 

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29.6A 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.

 

29.7Each 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.

 

29.8The 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 2:1176 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.

 

29.9The Directors shall as such have an advisory vote at the General Meeting.

 

29.10The chairman of the General Meeting shall decide on the admittance of other persons to the meeting.

 

30.Order of the General Meeting

 

30.1The chairman of the General Meeting shall determine the order of the meeting.

 

30.2The 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

 

31.1Each Share confers the right to cast one vote. Blank votes and invalid votes shall be regarded as not having been cast.

 

31.2Unless 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.

 

31.3The chairman of the General Meeting shall determine the manner of voting.

 

31.4The 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.

 

31.5A written statement of the chairman of the General Meeting that the General Meeting has adopted a resolution shall constitute proof of such resolution vis-a-vis third parties.

 

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31.6In 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.

 

31.7When 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.

 

32.Meetings of holders of Shares of a particular class

 

32.1The Board of Directors shall be authorised to convene a meeting of holders of Shares of a particular class.

 

32.2A 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.

 

32.3Articles 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

 

34.1Annually, 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.

 

34.2The 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.

 

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34.3The 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.

 

34.4The Annual Accounts shall be adopted by the General Meeting. Adoption of the Annual Accounts shall not be deemed to grant a Director a discharge.

 

35.Auditor

 

35.1The Company shall give an assignment to an Auditor to audit the Annual Accounts.

 

35.2The 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.

 

35.3The 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

 

36.1The 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.

 

36.2Article 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

 

37.1The General Meeting shall be authorised to allocate the profits, subject to Articles 37.2 and 37.3.

 

37.2Out 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

 

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(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 (c), 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 ofthis Article 37.2 and Article

 

37.3shall 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.

 

37.3The 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.

 

37.4The General Meeting shall be authorised to allocate the profits remaining after application of Article 37.3.

 

37.5The Board of Directors shall be authorised to determine how a loss will be accounted for.

 

37.6A deficit may only be applied against reserves maintained pursuant to the law to the extent permitted by law.

 

38.Distributions

 

38.1The General Meeting shall be authorised to declare distributions, subject to Articles

 

38.2up to and including 38.4.

 

38.2The General Meeting may only resolve to declare distributions on the proposal of the Board of Directors.

 

38.3The 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.

 

38.4Any 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.

 

38.5The 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.

 

38.6Shares 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.

 

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38.7Distributions 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.

 

38.8Distributions 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.

 

38.9Distributions 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.

 

38.10The 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 ofDircctors.

 

38.11The 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

 

39.1The General Meeting shall be authorised to amend these Articles of Association.

 

39.2The General Meeting may only resolve to amend these Articles of Association on the proposal of the Board of Directors.

 

39.3If 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

 

40.1The General Meeting shall be authorised to dissolve the Company.

 

40.2The General Meeting may only resolve to dissolve the Company on the proposal of the Board of Directors.

 

40.3Article 39.3 shall apply by analogy to a proposal to dissolve the Company.

 

40.4If 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.

 

40.5The General Meeting shall determine the remuneration of the liquidators and of the persons charged with the supervision of the liquidation.

 

40.6The 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.

 

40.7Out 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

 

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(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 (c), 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.

 

40.8The 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.

 

40.9After 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

 

Notwithstanding Article 4.1, the authorised share capital of the Company amounts to two million five hundred thousand euros (EUR 2,500,000.00) and is divided into:

 

(a)two hundred and twenty-five million (225,000,000) Ordinary Shares with a nominal value of one eurocent (EUR 0.01) each; and

 

(b)twenty-five million million (25,000,000) Preferred Shares with a nominal value of one eurocent (EUR 0.01) each, divided into:

 

(i)a series A consisting of five million (5,000,000) Preferred Shares;

 

(ii)a series B consisting of five million (5,000,000) Preferred Shares;

 

(iii)a series C consisting of five million (5,000,000) Preferred Shares;

 

(iv)a series D consisting of five million (5,000,000) Preferred Shares; and

 

(v)a series E consisting of five million (5,000,000) Preferred Shares.

 

Article 4.1 shall apply as of the time on which the number of issued Ordinary Shares first amounts to or exceeds fifty million (50,000,000). 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 time as of which that Article applies. This Article 41 shall lapse once Article 4.1 applies.

 

 

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Exhibit 5.1

 

   
     
    CMS Derks Star Busmann N.V.
    Atrium | Parnassusweg 737
    NL-1077 DG Amsterdam
    P.O. Box 94700
Mainz Biomed N.V.   NL-1090 GS Amsterdam
Robert Koch Strasse 50    
55129 Mainz   Bank account (Stichting Derdengelden)
GERMANY   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 5 November 2024

 

Dear Madam/Sir,

 

We have acted as Dutch legal counsel to Mainz Biomed N.V. of Amsterdam, the Netherlands (the “Company”), in respect of certain matters of Dutch law in connection with an offering of (i) up to 30,769,231 ordinary shares in the capital of the Company with a nominal value of EUR 0.01 (the “Ordinary Shares”), and (ii) pre-funded warrants to purchase ordinary shares in the capital of the Company (the “Ordinary Shares Underlying the Pre-Funded Warrants”, the Ordinary Shares and the Ordinary Shares Underlying the Pre-Funded Warrants shall collectively be referred to as the “Registration Shares”). The number of Ordinary Shares will be decreased on a one-for-one basis by Ordinary Shares Underlying the Pre-Funded Warrants and the number of Registration Shares will not exceed 30,769,231.

 

The Registration Shares may be issued to various investors pursuant to the terms of a placement agency agreement between the Company and Maxim Group LLC (the “PAA”). The pre-funded warrants and Registration Shares are being offered pursuant to a registration statement on form F-1 filed by the Company on or around 5 November 2024 (the “Registration Statement”) and a prospectus (the “Prospectus”).

 

 

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.

 

 

 

 

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 4 November 2024 (the “Extract”) from the trade register (handelsregister) of the Dutch Chamber of Commerce (Kamer van Koophandel) (the “Trade Register”);

 

(b)an official copy (afschrift) of the notarial deed of incorporation (akte van oprichting) of the Company, dated 8 March 2021 (the “Deed of Incorporation”), containing the articles of association of the Company before the execution of the Deed of Conversion;

 

(c)an official copy of a notarial deed of conversion dated 9 November 2021 (the Deed of Conversion”);

 

(d)an official copy of the notarial deed of amendment of the articles of association of the Company, dated 19 July 2024 (the Deed of Amendment”), containing the articles of association of the Company as of such date (the “Articles of Association”);

 

(e)a written resolution of the board (bestuur) of the Company, dated 4 November 2024 (the “Board Resolution”);

 

(f)a written resolution of the general meeting (algemene vergadering) of the Company, dated 1 November 2021 (the “Shareholder Resolution”); and

 

(g)an electronically received copy of the Registration Statement and Prospectus forwarded to us on 4 November 2024.

 

We do not express any opinion in respect of the pre-funded warrants, the PAA, the Registration Statement or the Prospectus.

 

In connection with such examination and for the purpose of the legal opinion expressed herein, we have assumed:

 

(i)that at the time of the issuance of the Registration Shares, the Company’s authorized capital will be sufficient to allow for the issuance;

 

(ii)that the Registration Shares will be subscribed for, issued and accepted by the investors in accordance with all applicable laws (including for the avoidance of doubt, Dutch law);

 

(iii)that the PAA constitutes legal, valid and binding obligations of each of the parties thereto (other than the Company), enforceable in accordance with its terms under the laws to which they are subject;

 

(iv)that the Registration Shares will be validly paid up at the time of the issuances;

 

(v)that the Registration Shares will be issued in the form and manner prescribed by the articles of association at the time of the issuances;

 

(vi)that the Company will duly sign a deed of issue to implement each issuance of Registration Shares;

 

(vii)each signature on each document is the original or electronic (as relevant) signature of the relevant stated person;

 

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(viii)the genuineness of all signatures on all original documents of the persons purported to have signed the same;

 

(ix)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;

 

(x)that the Shareholder Resolution and the Board Resolution have been validly signed and that the resolutions reflected therein will be in full force and effect at the time of the issuance of the Registration Shares and that none of these resolutions will be withdrawn or restated and that no resolutions have been or will be adopted to amend the contents of these resolutions;

 

(xi)that the Deed of Incorporation, the Deed of Conversion and the Deed of Amendment are valid notarial deeds (notariële aktes), that the content thereof is correct and complete, it being hereby confirmed that on the face of the Deed of Incorporation, the Deed of Conversion and the Deed of Amendment it does not appear that the deeds are not a valid notarial deed;

 

(xii)that the Articles of Association are in full force and effect at the date hereof, it being hereby confirmed that on the face of the Articles of Association and the Extract it does not appear that the Articles of Association are not in full force and effect as at the date hereof;

 

(xiii)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;

 

(xiv)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;

 

(xv)that the information contained in the Extract truly and correctly reflects the position of the Company as mentioned therein;

 

(xvi)that, at the time of the issuances of the Registration Shares, the Company, the investors and the parties to the PAA are:

 

(a)not included on the consolidated list of persons, groups and entities subject to EU financial sanctions;

 

(b)not subject to the restrictive measures deriving from Council Regulation (EU) 2022/262 and Council Decision (CFSP) 2022/264, issued by the Council of the European Union on 23 February 2022, in view of Russia’s actions destabilising the situation in Ukraine;

 

(c)not subject to the restrictive measures deriving from Council Regulation (EU) 2022/334 and Council Decision (CFSP) 2022/335, issued by the Council of the European Union on 28 February 2022, in view of Russia’s actions destabilising the situation in Ukraine;

 

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(d)not subject to the restrictive measures deriving from Council Regulation (EU) 2022/428 and Council Decision (CFSP) 2022/430, issued by the Council of the European Union on 15 March 2022, in view of Russia’s actions destabilising the situation in Ukraine; and

 

(e)not subject to any other restrictive measures issued by the Council of the European Union, in view of Russia’s actions destabilising the situation in Ukraine;

 

(xvii)that, at the date hereof, the directors of the Company are not subject to a director’s disqualification (civielrechtelijk bestuursverbod) under Dutch law, which assumption is supported by the confirmation of the directors in the Board Resolution; and

 

(xviii)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 of Regulation (EU) 2015/848 of the European Parliament and of the Council of 20 May 2015 on insolvency proceedings (recast), 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;

 

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.

 

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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.

 

(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)The opinion expressed above may be limited or affected by:

 

(i)claims based on tort (onrechtmatige daad);

 

(ii)in relation to the issuance of the Registration Shares, including but not limited to an issuance below market value, the rules of force majeure (niet toerekenbare tekortkoming), reasonableness and fairness (redelijkheid en billijkheid), suspension (opschorting), dissolution (ontbinding), unforeseen circumstances (onvoorziene omstandigheden) and vitiated consent (i.e., duress (bedreiging), fraud (bedrog), abuse of circumstances (misbruik van omstandigheden) and error (dwaling)) or a difference of intention (wil) and declaration (verklaring).

 

(E)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.

 

(F)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.

 

(G)The envisaged reverse stock split within a range between 2:1 and 100:1 could affect the rights and obligations of the Company and the rights attached to the Registration Shares.

 

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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 or liability arising under this legal opinion will be governed exclusively by the laws of the Netherlands and be brought exclusively before a Dutch court;

 

(i)this legal opinion is subject to acceptance of the limitation of liability as mentioned on the first page of this letter. Subject to its terms, our insurance policy provides for a maximum insured amount of EUR 100,000,000;

 

(iii)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

 

(iv)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,
 
/s/ CMS Derks Star Busmann N.V.  
   
CMS Derks Star Busmann N.V.  

 

 

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Exhibit 10.3

 

FIRST AMENDMENT
TO

MANAGEMENT SERVICES AGREEMENT

 

This first amendment dated as of October 17, 2024, to that management services agreement (this “First Amendment”), is entered between Mainz Biomed N.V., a Dutch public company (“Company”), and Guido Baechler (“Baechler” and, together with the Company, each, a “Party” and collectively, the “Parties”).

 

PRELIMINARY STATEMENTS

 

A. Reference is hereby made to that management services agreement, dated as of July 1, 2021 (the “Agreement” as may be amended, amended and restated, extended, supplemented or otherwise modified in writing from time to time and in effect immediately prior to the effectiveness of this First Amendment (the “Existing Agreement” and the Existing Agreement, as amended by this First Amendment the “Amended Agreement”), between the Company and the Baechler.

 

B. The Parties desire to amend certain of the terms and provisions of the Existing Agreement as specifically set forth in this First Amendment.

 

C. The Parties are prepared to amend the Existing Agreement subject to the conditions and in reliance on the representations set forth in this First Amendment.

 

Accordingly, in consideration of the premises and the mutual covenants contained herein, and other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereto agree as follows:

 

SECTION 1. Defined Terms. Unless otherwise defined herein, all capitalized terms used herein, including in preamble and the preliminary statements hereto, shall have the meanings assigned to such terms in the Existing Agreement.

 

SECTION 2. Amendment to Existing Agreement. In reliance upon the representations and warranties set forth in Article 4 herein, the Existing Agreement is hereby amended as follows:

 

(a)Article 2.2 of the Existing Agreement shall be deleted in its entirety and replaced with the following:

 

Duties. During the Services Term, Baechler shall devote sixty percent (60%) 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 Vail Scientific, 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.”

 

(b)Article 4.1 of the Existing Agreement shall be deleted in its entirety and replaced with the following:

 

Base Remuneration. Baechler’s annual base remuneration (the “Base Remuneration”) will be US$270,000 per year. 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.”

 

 

 

 

(c)Article 5.2 of the Existing Agreement shall be deleted in its entirety and replaced with the following:

 

“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 equal to the maximum salary such Baechler received during the Employment Term (the “Termination Base Salary”), which shall begin within ten (10) days following the Termination Date; provided that, the first installment payment of such Termination Base Salary 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

 

(c) Vesting of (i) 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(b) in a manner as is necessary to comply with the ACA, while providing as much of the intended benefit as possible.”

 

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SECTION 3. Conditions Precedent to Effectiveness of First Amendment. This First Amendment shall become effective as of November 1, 2024 (the “First Amendment Effective Date”) upon satisfaction of each of the following conditions precedent (except to the extent such conditions precedent are subject to Section 4):

 

(a) First Amendment. This First Amendment shall have been duly executed and delivered by each Party.

 

SECTION 4. Representations and Warranties. All representations and warranties contained in the Amended Agreement shall be true and correct in all respects as of the First Amendment Effective Date as though made on and as of the First Amendment Effective Date (or, to the extent such representations or warranties are expressly made solely as of an earlier date, such representations and warranties shall be true and correct as of such earlier date).

 

Each Party represents and warrants that:

 

(a) Authorization; No Contravention. The execution, delivery and performance by such Party of this First Amendment (i) has been duly and validly authorized by all corporate, stockholder, partnership or limited liability company action required to be taken by such Party, and (ii) does not violate or contravene such Party’s governing documents or any applicable law or any material agreement or instrument or any court order which is binding upon such Party or its property.

 

(b) Enforceability. Each of this First Amendment, and the Amended Agreement is a legal, valid and binding obligation of such Party, enforceable against it in accordance with its terms, except as enforceability may be limited by bankruptcy, insolvency or similar laws affecting the enforcement of creditors’ rights generally and by general equitable principles.

 

SECTION 5. Survival of Representations and Warranties. All representations and warranties made in this First Amendment shall survive the execution and delivery of this First Amendment. Such representations and warranties have been or will be relied upon by the parties and shall continue in full force and effect as long as any obligation under the Amended Agreement shall remain unpaid or unsatisfied.

 

SECTION 6. Effect of First Amendment, Other Agreements, Etc.

 

(a) Effect of First Amendment. After giving effect to this First Amendment on the First Amendment Effective Date, the Amended Agreement shall be and remain in full force and effect in accordance with its terms and is hereby ratified and confirmed by the parties in all respects. The execution, delivery, and performance of this First Amendment shall not operate as a waiver of any right, power, or remedy of any Party under the Existing Agreement. Each Party hereby acknowledges and agrees that, after giving effect to this First Amendment, all of its obligations and liabilities under the Existing Agreement to which it is a Party, as such obligations and liabilities have been amended by this First Amendment, are reaffirmed and remain in full force and effect. All references to the Existing Agreement in any document or instrument delivered in connection therewith shall be deemed to refer to the Amended Agreement. Nothing contained herein shall be construed as a novation of the obligations outstanding under the Existing Agreement, which shall remain in full force and effect, except as modified hereby.

 

(b) Limited Effect. This First Amendment relates only to the specific matters expressly covered herein, shall not be considered to be an amendment or waiver of any rights or remedies that any Party may have under the Existing Agreement or under applicable law, and shall not be considered to create a course of dealing or to otherwise obligate in any respect a Party to execute similar or other amendments or waivers or grant any amendments or waivers under the same or similar or other circumstances in the future.

 

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SECTION 7. Miscellaneous.

 

(a) Headings. Section headings in this First Amendment are included herein for convenience and do not affect the meanings of the provisions that they precede.

 

(b) Severability. If any provision of this First Amendment is held invalid or unenforceable, either in its entirety or by virtue of its scope or application to given circumstances, such provision shall thereupon be deemed modified only to the extent necessary to render same valid, or not applicable to given circumstances, or excised from this First Amendment, and this First Amendment shall be construed and enforced as if such provision had been included herein as so modified in scope or application, or had not been included herein or therein, as the case may be.

 

(c) Binding Effect. This First Amendment binds and is for the benefit of the successors of each Party.

 

(d) Governing Law. This First Amendment shall be governed by and interpreted in accordance with the laws of the State of New York without regard to the principles of conflict of laws. The parties further agree that any action between them shall be heard in New York County, New York, and expressly consent to the jurisdiction and venue of the Supreme Court of New York, sitting in New York County, New York and the United States District Court of the Southern District of New York, sitting in New York, New York, for the adjudication of any civil action asserted pursuant to this Agreement.

 

(e) Execution in Counterparts. This First Amendment may be executed in identical counterparts, both which shall be considered one and the same agreement and shall become effective when counterparts have been signed by each Party and delivered to the other Party. Facsimile or other electronically scanned and delivered signatures, including by e-mail attachment, shall be deemed originals for all purposes of this First Amendment.

 

[Remainder of Page Intentionally Left Blank; Signature Pages Follow]

 

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IN WITNESS WHEREOF, the parties hereto have caused this First Amendment to be executed and delivered as of the date first above written.

 

Baechler  
     
By: /s/ Guido Baechler  
Name:  Guido Baechler  
     
Mainz Biomed N.V.  
     
By: /s/ Heiner Dreismann  
Name: Heiner Dreismann  
Title: Board Member  

 

 

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Exhibit 10.6

 

FIRST AMENDMENT
TO

EMPLOYMENT AGREEMENT

 

This first amendment dated as of October 17, 2024, to that employment agreement (this “First Amendment”), is entered between Mainz Biomed N.V., a Dutch public company (“Company”), and William J. Caragol (the “Employee” and, together with the Company, each, a “Party” and collectively, the “Parties”).

 

PRELIMINARY STATEMENTS

 

A. Reference is hereby made to that employment agreement, dated as of April 29, 2022 (the “Agreement” as may be amended, amended and restated, extended, supplemented or otherwise modified in writing from time to time and in effect immediately prior to the effectiveness of this First Amendment (the “Existing Agreement” and the Existing Agreement, as amended by this First Amendment the “Amended Agreement”), between the Company and the Employee.

 

B. The Parties desire to amend certain of the terms and provisions of the Existing Agreement as specifically set forth in this First Amendment.

 

C. The Parties are prepared to amend the Existing Agreement subject to the conditions and in reliance on the representations set forth in this First Amendment.

 

Accordingly, in consideration of the premises and the mutual covenants contained herein, and other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereto agree as follows:

 

SECTION 1. Defined Terms. Unless otherwise defined herein, all capitalized terms used herein, including in preamble and the preliminary statements hereto, shall have the meanings assigned to such terms in the Existing Agreement.

 

SECTION 2. Amendment to Existing Agreement. In reliance upon the representations and warranties set forth in Article 4 herein, the Existing Agreement is hereby amended as follows:

 

(a)Article 2.2 of the Existing Agreement shall be deleted in its entirety and replaced with the following:

 

Duties. During the Employment Term, the Employee shall devote fifty percent (50%) of Employee’s business time and attention to the performance of the Employee’s duties hereunder; provided that you 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. Annex A to the Employment Agreement is deleted in its entirety.”

 

(b)Article 4.1 of the Existing Agreement shall be deleted in its entirety and replaced with the following:

 

Base Salary. The Company shall pay the Employee an annual rate of Base Salary (as defined herein) of US$175,000. The Company shall pay the Base Salary due hereunder in periodic installments in accordance with the Company’s customary payroll practices and applicable wage payment laws, but no less frequently than monthly. The Employee’s Base Salary 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 salary during the Employment Term. However, the Employee’s base salary may not be decreased during the Employment Term other than as part of an across-the-board salary reduction that applies in the same manner to all senior employees. The Employee’s annual base salary, as in effect from time to time, is hereinafter referred to as the “Base Salary.”

 

 

 

 

(c)Article 4.8 of the Existing Agreement shall be deleted in its entirety and replaced with the following:

 

Business Expenses. The Employee shall be entitled to reimbursement for all reasonable and necessary out-of-pocket business, entertainment, and travel expenses incurred by the Employee in connection with the performance of the Employee’s duties hereunder in accordance with the Company’s expense reimbursement policies and procedures, to be approved by the Company’s CEO prior to reimbursement. The Company will reimburse the Employee for maintaining a remote office, up to $750 per month.”

 

(d)Article 5.2 of the Existing Agreement shall be deleted in its entirety and replaced with the following:

 

“5.2 Termination Without Cause or for Good Reason. The Employment Term and the Employee’s employment hereunder may be terminated by the Employee for Good Reason or by the Company without Cause. In the event of such termination, the Employee shall be entitled to receive the Accrued Amounts and subject to the Employee’s compliance with Section 6, Section 7, Section 8, and Section 9 of this Agreement and the Employee’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 Employee 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 the Employee’s base salary equal to the maximum salary such Employee received during the Employment Term (the “Termination Base Salary”), which shall begin within ten (10) days following the Termination Date; provided that, the first installment payment of such Termination Base Salary shall include all amounts that would otherwise have been paid to the Employee during the period beginning on the Termination Date and ending twelve (12) months thereafter;

 

(b) An amount equal to Employee’s target Annual Bonus for the year in which the termination takes place, with all criterion for such Annual Bonus deemed to be achieved

 

(c) Vesting of (i) an additional 12 months (removing any cliff) under all time-based vesting schedules for equity based incentives held by Employee and (III) 25% of any shares underlying equity incentives, the vesting of which is based on meeting specific milestones; (d) the Company shall reimburse the Employee for up to $2,500 of the monthly U.S. health insurance premium paid by the Employee for himself and his dependents. Such reimbursement shall be paid to the Employee on the tenth of the month immediately following the month in which the Employee timely remits the premium payment. the Employee shall be eligible to receive such reimbursement until the earliest of: (i) the 2-month anniversary of the Termination Date; (ii) the date the Employee is no longer eligible to receive COBRA continuation coverage; and (iii) the date on which the Employee 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(b) in a manner as is necessary to comply with the ACA.”

 

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SECTION 3. Conditions Precedent to Effectiveness of First Amendment. This First Amendment shall become effective as of November 1, 2024 (the “First Amendment Effective Date”) upon satisfaction of each of the following conditions precedent (except to the extent such conditions precedent are subject to Section 4):

 

(a) First Amendment. This First Amendment shall have been duly executed and delivered by each Party.

 

SECTION 4. Representations and Warranties. All representations and warranties contained in the Amended Agreement shall be true and correct in all respects as of the First Amendment Effective Date as though made on and as of the First Amendment Effective Date (or, to the extent such representations or warranties are expressly made solely as of an earlier date, such representations and warranties shall be true and correct as of such earlier date).

 

Each Party represents and warrants that:

 

(a) Authorization; No Contravention. The execution, delivery and performance by such Party of this First Amendment (i) has been duly and validly authorized by all corporate, stockholder, partnership or limited liability company action required to be taken by such Party, and (ii) does not violate or contravene such Party’s governing documents or any applicable law or any material agreement or instrument or any court order which is binding upon such Party or its property.

 

(b) Enforceability. Each of this First Amendment, and the Amended Agreement is a legal, valid and binding obligation of such Party, enforceable against it in accordance with its terms, except as enforceability may be limited by bankruptcy, insolvency or similar laws affecting the enforcement of creditors’ rights generally and by general equitable principles.

 

SECTION 5. Survival of Representations and Warranties. All representations and warranties made in this First Amendment shall survive the execution and delivery of this First Amendment. Such representations and warranties have been or will be relied upon by the parties and shall continue in full force and effect as long as any obligation under the Amended Agreement shall remain unpaid or unsatisfied.

 

SECTION 6. Effect of First Amendment, Other Agreements, Etc.

 

(a) Effect of First Amendment. After giving effect to this First Amendment on the First Amendment Effective Date, the Amended Agreement shall be and remain in full force and effect in accordance with its terms and is hereby ratified and confirmed by the parties in all respects. The execution, delivery, and performance of this First Amendment shall not operate as a waiver of any right, power, or remedy of any Party under the Existing Agreement. Each Party hereby acknowledges and agrees that, after giving effect to this First Amendment, all of its obligations and liabilities under the Existing Agreement to which it is a Party, as such obligations and liabilities have been amended by this First Amendment, are reaffirmed and remain in full force and effect. All references to the Existing Agreement in any document or instrument delivered in connection therewith shall be deemed to refer to the Amended Agreement. Nothing contained herein shall be construed as a novation of the obligations outstanding under the Existing Agreement, which shall remain in full force and effect, except as modified hereby.

 

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(b) Limited Effect. This First Amendment relates only to the specific matters expressly covered herein, shall not be considered to be an amendment or waiver of any rights or remedies that any Party may have under the Existing Agreement or under applicable law, and shall not be considered to create a course of dealing or to otherwise obligate in any respect a Party to execute similar or other amendments or waivers or grant any amendments or waivers under the same or similar or other circumstances in the future.

 

SECTION 7. Miscellaneous.

 

(a) Headings. Section headings in this First Amendment are included herein for convenience and do not affect the meanings of the provisions that they precede.

 

(b) Severability. If any provision of this First Amendment is held invalid or unenforceable, either in its entirety or by virtue of its scope or application to given circumstances, such provision shall thereupon be deemed modified only to the extent necessary to render same valid, or not applicable to given circumstances, or excised from this First Amendment, and this First Amendment shall be construed and enforced as if such provision had been included herein as so modified in scope or application, or had not been included herein or therein, as the case may be.

 

(c) Binding Effect. This First Amendment binds and is for the benefit of the successors of each Party.

 

(d) Governing Law. This First Amendment shall be governed by and interpreted in accordance with the laws of the State of New York without regard to the principles of conflict of laws. The parties further agree that any action between them shall be heard in New York County, New York, and expressly consent to the jurisdiction and venue of the Supreme Court of New York, sitting in New York County, New York and the United States District Court of the Southern District of New York, sitting in New York, New York, for the adjudication of any civil action asserted pursuant to this Agreement.

 

(e) Execution in Counterparts. This First Amendment may be executed in identical counterparts, both which shall be considered one and the same agreement and shall become effective when counterparts have been signed by each Party and delivered to the other Party. Facsimile or other electronically scanned and delivered signatures, including by e-mail attachment, shall be deemed originals for all purposes of this First Amendment.

 

[Remainder of Page Intentionally Left Blank; Signature Pages Follow]

 

4

 

 

IN WITNESS WHEREOF, the parties hereto have caused this First Amendment to be executed and delivered as of the date first above written.

 

Employee  
     
By: /s/ William J. Caragol  
Name:  William J. Caragol  
     
Mainz Biomed N.V.  
     
By: /s/ Guido Baechler  
Name:  Guido Baechler  
Title: CEO  

 

 

5

 

 

Exhibit 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors of

 

Mainz Biomed N.V.

 

We consent to the incorporation by reference in the Form F-1 Registration Statement filed with the Securities & Exchange Commission, of Mainz Biomed N.V. (the “Company”) our report dated April 8, 2024 relating to our audit of the consolidated statements of financial position as of December 31, 2023 and 2022 and consolidated statements of loss and comprehensive loss, stockholders’ equity and cash flows for the three years in the period ended December 31, 2023.

 

We also consent to the reference to us under the caption “Experts” in the Registration Statement.

 

/s/ Reliant CPA PC

 

Certified Public Accountants

Newport Beach, California

November 5, 2024

 

 

Exhibit 107

 

Calculation of Filing Fee Tables

 

F-1

(Form Type)

 

Mainz Biomed N.V.

(Exact Name of Registrant as Specified in its Charter)

 

Table 1: Newly Registered Securities

 

                Proposed   Proposed         
         Fee      Maximum   Maximum         
         Calculation      Offering   Aggregate       Amount of 
   Security  Security  or Carry  Amount   Price Per   Offering       Registration 
   Type  Class Title  Forward Rule  Registered   Unit   Price   Fee Rate   Fee 
Fees to Be Paid  Equity  Ordinary Shares, par value $0.001 per share (1)(2)  Rule 457(o)         –           –    9,200,000(3)   0.00015310   $1,409 
   Equity  Pre-funded warrants to purchase Ordinary Shares(3)(2)  Rule 457(g)           (3)   (4)    
   Equity  Ordinary Shares underlying the pre-funded warrants  Rule 457(o)          $       $ 
Fees Previously Paid                        $0 
   Total Offering Amounts            $9,200,000        $1,409 
   Total Fees Previously Paid                      $0 
   Total Fee Offset                      $0 
   Net Fee Due                      $1,409 

 

(1) Pursuant to Rule 416(a) under the Securities Act of 1933, as amended (the “Securities Act”), there is also being registered hereby such indeterminate number of additional  ordinary shares of the Registrant as may be issued or issuable because of stock splits, stock dividends, stock distributions, and similar transactions.
   
(2) The registration fee for securities is based on an estimate of the Proposed Maximum Aggregate Offering Price of the securities, assuming the sale of the ordinary shares at the highest expected offering price, and such estimate is solely for the purpose of calculating the registration fee pursuant to Rule 457(o).

 

(3) The proposed maximum aggregate offering price of the common shares will be reduced on a dollar-for-dollar basis based on the offering price of any pre-funded warrants issued in the offering, and the proposed maximum aggregate offering price of the pre-funded warrants to be issued in the offering will be reduced on a dollar-for-dollar basis based on the offering price of any ordinary shares issued in the offering. Accordingly, the proposed maximum aggregate offering price of the common shares and pre-funded warrants (including the ordinary shares issuable upon exercise of the pre-funded warrants), if any, is $8,000,000 (or $9,200,000 if the underwriter exercises its over-allotment option).

 

(4) In accordance with Rule 457(g) under the Securities Act, because the Registrant’s ordinary shares underlying the pre-funded warrants are registered hereby, no separate registration fee is required with respect to the warrants registered hereby.

 

 


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