UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of February 2023
Commission File No. 001-41010
MAINZ BIOMED N.V.
(Translation of registrant’s name into English)
Robert Koch Strasse 50
55129 Mainz
Germany
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1) ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7) ☐
Acquisition of Intellectual Property
ColoAlert Intellectual Property
Our principal product is ColoAlert, a colorectal cancer (“CRC”) screening stool DNA (“deoxyribonucleic acid”) test. On January 1, 2019, we entered into an exclusive licensing agreement (the “Licensing Agreement”) with ColoAlert AS to license the ColoAlert test. On February 11, 2021, we obtained an option exercisable for three years to acquire the intellectual property for the ColoAlert test for (i) either a one-time cash payment of €2,000,000 or a €4,000,000 payment in ordinary shares at the valuation of our most recent financing plus (ii) a lifetime royalty payment of €5 per ColoAlert test sold (the “Option”). If we opt to make the one-time payment in cash, ColoAlert AS has the right to require us to pay the €2,000,000 in ordinary shares at the valuation of our most recent financing. Subsequent to February 11, 2021, ColoAlert AS assigned their interest in ColoAlert and in the Licensing Agreement and the Option to Uni Targeting Research AS.
On February 15, 2023, we entered into an Intellectual Property Asset Purchase Agreement (“IPA), which supercedes the Licensing and Options Agreements. Pursuant to the IPA we acquired the intellectual property for the ColoAlert test. Pursuant to the IPA, we were able to reduce the price paid for the intellectual property to (i) $2 million cash, to be paid out over the next four years, (ii) 300,000 ordinary restricted shares and (iii) a revenue share limited to $1 per test sold for a period of 10 years.
MRNA Biomarkers
In January 2022, we entered into a Technology Rights Agreement related to a portfolio of novel mRNA biomarkers developed at the Université de Sherbrooke (the “UdeS Biomarkers”) and owned by the University’s technology transfer entity SOCPRA Sciences Santé et Humaines S.E.C (TTS). Pursuant to the agreement, we acquired an exclusive unilateral option to acquire the intellectual property rights associated with the UdeS Biomarkers in exchange for a payment of €10,000 and an agreement to pay for the prosecution and maintenance of certain intellectual property relating to the UdeS Biomarkers. We executed on the option on February 15, 2023 when we entered into an Assignment Agreement to acquire the intellectual property rights associated with the UdeS Biomarkers. In exchange for the UdeS Biomarkers, we are to (i) pay 25,000€ in cash and (ii) a profit share of 2% of the net sales of any products that we sell using the UdeS biomarkers.
Other Events
On February 21, 2023, we issued a press release announcing our acquisition of (i) the intellectual property rights incorporated into our current ColoAlert product and (ii) the intellectual property rights associates with the mRNA biomarkers that we purchased from SOCPRA Sciences Santé et Humaines S.E.C.
This current report on Form 6-K and Exhibit 10.1 and 10.2 hereto (but not Exhibit 99.1 hereto) are hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (File No. 333-269091).
Exhibits
1
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: February 21, 2023 | By: | /s/ William J. Caragol |
| William J. Caragol | ||
| Chief Financial Officer |
2
Exhibit 10.1
Intellectual Property Asset Purchase Agreement
This agreement (the “Agreement”) is effective as of February 15, 2023,
| BETWEEN: | MAINZ BIOMED N.V., a corporate body incorporated in Amsterdam, with its principal place of business located at Sirius Gutenberg Park Robert-Koch-Straße 50, 55129, Mainz, Germany; |
hereinafter referred to as “MAINZ”,
| AND: | Uni Targeting Research AS, a Norwegian limited liability company with company identification number 983 422 748 (“UTR”). |
hereinafter referred to as “UTR”,
| AND: | NORDA SA, c/o Andenaesgruppen, Stortingsgata 28, 0161 Oslo, Norway; |
hereinafter referred to as “NORDA”.
| AND: | MAINZ BIOMED GERMANY GMBH, a German limited liability company with company registration number HRB 41529. |
hereinafter referred to as “MYNZ”.
MAINZ, MYNZ, UTR, and NORDA shall each individually be referred to as “Party” and collectively as “Parties”.
| WHEREAS | UTR is the assignee of all of the intellectual property assets of COLOALERT AS, Storgata 61, Postbox 6504, 4307 Sandnes, Norway (“CAAS”) pursuant to the Agreement Regarding Assignment of IPR between UTR and CAAS effective May 31, 2022, wherein UTR assumed all of the rights, interest and obligations of CAAS in and to (i) the ColoAlert Test Agreements and (ii) CA’s Intellectual Property Rights to the ColoAlert Test as defined the May 31, 2022 agreement. |
| WHEREAS | MYNZ is a wholly owned subsidiary of MAINZ and is the successor, in all respects relevant to this Agreement, to the business of PharmGenomics GmbH, Robert-Koch-Strasse 50, 55129 Mainz, Germany (hereinafter “PGx”), including the Option to Purchase Intellectual Property Assets effective February 2021 (the “Option Agreement”) by and between PGx, UTR, and NORDA. |
| WHEREAS | The Option Agreement reflects a culmination of several previous agreements between PGx, CAAS, UTR and NORDA related to certain Intellectual Property Assets as defined in the Option Agreement and previous agreements. |
| WHEREAS | MAINZ, as owner of MYNZ’s rights in the Option Agreement, wishes to exercise the option provided in the Option Agreement. |
| WHEREAS | The Parties have negotiated new terms for MAINZ’s exercise of the option and and MAINZ’s purchase of the Intellectual Property Assets. |
| WHEREAS | The Parties intend for this Agreement to supersede and replace all Prior Agreements between PGx, MYNZ, NORDA and UTR with respect to the Intellectual Property Assets. |
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NOW THEREFORE IN CONSIDERATION of the premises and of the mutual covenants herein set forth, the Parties have covenanted and agreed as follows:
| 1. | Definitions |
| 1.1 | ColoAlert Technology means all all inventions, know how, technology, patent applications, methods, SOP’s, clinical studies and samples and results thereof, trade secrets, trade names, samples, and all historic work by UTR, NORDA, and PGx work related to CRC diagnostics, related to the ColoAlert Test, including the “Genefec Technology”, in any form, including and all documents protocols, samples and results from the Quantitative and qualitative DNA tests 2009 and data, samples and results from the Leipzig study 2008. |
| 1.2 | ColoAlert Test means the ColoAlert Test as further as described in Appendix A, including the Stool Collection Kit and the Laboratory Kit that has been developed by CAAS, NORDA, PGx or any contractors of subcontractors thereof. |
| 1.2 | “Effective Date” means: as of January 1, 2023. |
| 1.3 | Laboratory Kit: means: each ColoAlert Test sold to a third party or any commercially performed single test/analysis in MAINZ’s laboratory. Any laboratory kits used in the context of clinical trials are excluded. |
| 1.4. | Intellectual Property the ColoAlert Technology, the Patent Rights, and the Trademarks, including any and all intellectual Property as defined by the Agreement for the Assignment of IPR effective May 31 2022 between CAAS and UTR. |
| 1.5 | Patent Rights means all applications and all patents which may be granted thereon related to the ColoAlert Technology, and all divisions, renewals and continuations thereof, and all patents which may be granted thereon and all reissues and extensions thereof; which may hereafter be filed in any country or countries, together with the right to file such applications and the right to claim for the same the priority rights derived from the patent under the patent laws of the United States, Europe, the International Convention for the Protection of Industrial Property, or any other international agreement or the domestic laws of the country in which any such application is filed, as may be applicable. |
| 1.6 | Prior Agreements means those agreements by and between UTR, CAAS, NORDA MYNZ, and/or MAINZ related to the Intellectual Property as listed in Exhibit B. |
| 1.7 | Trademarks means the ColoAlert trademark in any form and in any country, including but not limited to Registration No. DE302014052515and any other trademark registration or application for registration owned by UTR and/or NORDA directed to any aspect of the ColoAlert Test. |
| 2. | Assignment of Intellectual Property |
| 2.1 | UTR and NORDA, individually and collectively, hereby sell, assign, transfer and convey to MAINZ, its successors and assigns, their entire right, title and interest in and to the Intellectual Property. |
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| 3. | Consideration |
| 3.1 | MAINZ will pay UTR an assignment fee of US$2,000,000 (two million U.S. dollars) (the “Assignment Fee”) according to the following schedule |
| (a) | within five days after date this Agreement is executed, MAINZ will pay UTR US$500,000. |
| (b) | within 10 days of each calendar quarter end (March 31, June 30, September 30, and December 31), beginning with the second calendar quarter of 2023, MAINZ will pay UTR US$100,000 (one hundred thousand United States dollars) for fifteen calendar quarters. |
| (c) | notwithstanding the above, if MAINZ should raise equity capital, either in a single transaction or in a series of transactions, of US$50,000,000 (fifty million United States dollars) or more, then the Assignment Fee shall be paid in full. MAINZ shall inform UTR and NORDA about any such transactions and pay the remaining Assignment Fee without undue delay after said transactions are completed. |
| 3.2 | Upon the Effective Date, MAINZ shall deliver to 300,000 shares of restricted stock in MAINZ (200,000 of such shares will be issued to UTR and 100,000 of such shares will be delivered to NORDA) subject to one year lock up and leak out with 12.5% per quarter free each quarter after the first anniversary of the Effective Date. |
| 3.3 | MAINZ shall pay UTR a “Revenue Share” of US$1.00 (one US dollar) for each Laboratory Kit sold until December 31, 2032, beginning 1 January 2023 (the “Revenue Share”). No further Revenue Share obligations or any or other obligation are due after December 31, 2032. |
| 4. | Payment Terms |
| 4.1 | Payment Obligations. The Revenue Share according to Section 3.3 will accrue and will be payable to UTR when Laboratory Kits are invoiced, or if not invoiced, when delivered or otherwise exploited by MAINZ in a manner constituting a sale. |
| 4.2 | Schedule. MAINZ will pay the accrued Revenue Share to UTR quarterly on or before February 28 (for the calendar quarter ending December 31), May 31 (for the calendar quarter ending March 31), August 31 (for the calendar quarter ending June 30) and November 30 (for the calendar quarter ending September 30) of each calendar year. Each payment will be for Revenue Share which has accrued for the most recently completed calendar quarter. |
| 4.3 | As long as any amount of the Assignment Fee is outstanding, MAINZ shall not incur, or enter into any agreement to incur, any loan, debt or credit whatsoever, or grant or allow to be maintained any security over any of its assets, without the prior written consent of UTR, except for a Permitted Loan. A Permitted Loan is a a debt instrument that is approved by the Company’s Board of Directors. In case of breach of this clause by MAINZ, UTR shall have the right to demand payment of the entire outstanding Assignment Fee by five (5) calendar days notice, whereupon the entire outstanding Assignment Fee shall become immediately due and payable. |
| 4.4 | Currency. All consideration due UTR will be payable and will be made in US dollars to UTR by wire transfer to an account designated by UTR. UTR is responsible for all bank or other transfer charges. |
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| 4.5 | Late Payments. In the event that any monies owed to UTR are not received by UTR when due, MAINZ will pay to UTR interest at a rate of eight percent (8%) simple interest per annum. Such interest will be calculated from the date payment was due until actually received by UTR. |
| 4.6 | Remedy for Non-Performance. If MAINZ fails to pay any consideration according to Sections 3.1-3.3 within three (3) months of receiving notice of default from UTR, Mainz agrees to provide UTR a world-side, full paid up, royalty free, non-exclusive license to the Intellectual Property, which shall include improvements to said Intellectual Property. Mainz may terminate the non-exclusive license if Mainz cures such default within six (6) months of notice from UTR. |
| 4.7 | MAINZ’s sole obligations for payment under Sections 3.1-3.3 are to UTR only. NORDA agrees that it will seek an appropriate share of any consideration soley from UTR, such share to be determined and memorialized in a separate agreement by and between NORDA and UTR. NORDA agrees that MAINZ has no obligation for payment of any consideration to NORDA. |
| 5. | Patent Rights; UTR and NORDA Cooperation |
| 5.1 | Upon execution of this Agreement, and following due payment of the consideration under Section 3.1(a), MAINZ will have the sole right and obligation regarding patent prosecution, maintenance and enforcement of the Patent Rights. |
| 5.2 | UTR and NORDA hereby agree, upon the request and at the expense of MAINZ, its successors and assigns, |
| (a) | to perform all commercially reasonable acts deemed necessary or desirable by the MAINZ to permit and assist the MAINZ, at the MAINZ’s expense, in obtaining and enforcing the full benefits, enjoyment, rights and title throughout the world in the Intellectual Property. |
| (b) | to execute any and all original patent applications, divisional, continuation and substitute applications arising from the Intellectual Property, and any necessary oath, affidavit or declaration relating thereto, and any application for the reissue or extension of any Letters Patent that may be granted upon said application and any and all applications and other documents for Letters Patent in foreign countries on said invention, that MAINZ, its successors or assigns may deem necessary or expedient, and UTR and NORDA authorize MAINZ to apply for patents for said invention in its own name in such countries where such procedure is proper, and |
| (c) | upon the request of MAINZ, its successors and assigns to cooperate to the best of the ability of the UTR and NORDA and to a reasonable extent with MAINZ, its successors and assigns, in any proceedings or transactions involving such applications or patents, including the preparation and execution of preliminary statements, giving and producing evidence, and performing any and all other acts necessary to obtain, maintain and enforce the Patent Rights, worldwide, and vest all rights therein hereby conveyed in MAINZ, its successors and assigns, whereby said Patent Rights will be held and enjoyed by MAINZ, its successors and assigns, to the full end of the term for which said Patent Rights will be granted, as fully and entirely as the same would have been held and enjoyed by UTR and/or NORDA if this assignment had not been made. |
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| 5.3 | If, during any proceeding before any tribunal regarding the Patent Rights, UTR and/or NORDA are required by law to be joined as a party to such proceeding, UTR and/or NORDA will join and cooperate at the expense of MAINZ. |
| 5.4 | If UTR and/or NORDA require counsel in view of the obligations of Sections 5.2 or 5.3, MAINZ will be entitled to select counsel with the consent of UTR and/or NORDA which consent shall not be unreasonably withheld, provided that UTR and/or NORDA shall be able to select counsel to clarify its obligations towards MAINZ under the Agreement. MAINZ will pay all fees for counsel and other fees necessary for UTR’s and/or NORDA’s cooperation with or participation in any proceeding. |
| 6. | Relationship to Prior Agreements |
| 6.1 | This Agreement supersedes all prior or contemporaneous negotiations, commitments, agreements (written or oral) and writings between the MAINZ, MYNZ, NORDA and UTR with respect to the subject matter hereof, including all of the Prior Agreements, provided that MAINZ shall pay all outstanding Protection Fees and other fees owed to UTR and/or NORDA at the date of execution of this Agreement, which the Parties agree shall be €12.275. All such other negotiations, commitments, agreements and writings will have no further force or effect, and the parties to any such other negotiation, commitment, agreement or writing will have no further rights or obligations thereunder. As certain agreements related to the Intellectual Property have been entered into between MYNZ, UTR and/or NORDA, MYNZ has been included as a party to this Agreement to give effect to this Section 6.1. For clarity, MYNZ shall not have any other rights under this Agreement nor any further obligations to NORDA and/or UTR. |
| 6.2 | In consideration for the payments set forth in Section 3, NORDA and UTR, each on their own behalf, and on behalf of their respective heirs, successors, subsidiaries, affiliates, assigns, agents, officers, directors, employees and related entities, hereby release, remise, acquit, forever discharge and covenant not to sue PGx, MYNZ or MAINZ, and their current and former officers, directors, employees, attorneys, agents, representatives, affiliated entities, subsidiaries, successors and assigns from any and all claims, demands, causes of action, suits, debts, obligations, choses in action, liabilities, damages, interest, fees, costs, expenses and rights whatsoever, in law or equity, known or unknown, suspected or unsuspected, previously existing or existing as of the Effective Date of this Agreement arising out of or relating to any acts, errors, omissions, contracts, torts, federal or state statute, to the extent that such claims arose or could have been asserted prior to the Effective Date. |
| 7. | Warranties |
| 7.1 | NORDA and UTR individually warrant themselves to be the owner of the entire right, title and interest in the Intellectual Property belonging to NORDA and UTR respectively at the Effective Date and to have the right to make this assignment, and further warrants that there are no outstanding prior assignments, licenses, or other liens or encumbrances on the Intelletual Property herein assigned. For clarity, NORDA and UTR respectively warrants on behalf of itself and not on behalf of the other entity, meaning that UTR shall not be liable for any lack of right, title and interest in the Intellectual Property transferred to MAINZ by NORDA, and the same shall hold for NORDA regarding Intellectual Property transferred to Main by UTR. |
| 7.2 | UTR and NORDA represent and warrant that they do not own or control, directly or indirectly, any patents, patent applications, know-how, trade secrets or other intellectual property rights, other than the Intellectual Property assigned herein, that MAINZ may reasonably require or find useful in the manufacture, import, use and/or sale of any Laboratory Test and any component thereof, and any other laboratory test incorporating the Intellectual Property relating to CRC. |
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| 7.3 | Each Party (i) has the corporate power and/or authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (ii) has taken all the necessary corporate or civil action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of each Party and constitutes a legal, valid, binding obligation, enforceable against such party in accordance with its terms. |
| 7.4 | Consents. All necessary consents, approvals and authorizations of all governmental authorities and any third parties required to be obtained by such Party in connection with this Agreement have been obtained. |
| 7.5 | No Conflict. The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (i) do not conflict with or violate applicable laws, and (ii) do not conflict with or constitute a default under any contractual obligation of such Party. |
| 7.6 | UTR and NORDA warrant or represent that the ColoAlert Test is free from claims or allegations of infringement of third party patents, copyrights, trademarks, industrial design or other intellectual property rights, and that to UTR’s and NORDA’s knowledge, they are not aware that the ColoAlert Test conflicts with, infringes upon or violates any patent, copyright, trademark, registration or other intellectual property right of any other person or entity. UTR and NORDA shall in no event be liable for any infringement of any patent rights or other intellectual property rights of a third party related to the use of the Intellectual Property and Labatory Kits. |
| 8. | Books and Record |
| 8.1 | Auditing. MAINZ shall keep complete and accurate books and records in accordance with established accounting principles in sufficient detail to permit ready computation of the Revenue Share payments required under this Agreement. Books and records shall be open to inspection by representatives or agents NORDA and/or UTR at reasonable times and upon reasonable notice to MAINZ. NORDA and UTR shall bear the fees and expenses of such examination but if an error in Revenue Share of more than 2.5 percent (2.5%) of the total Revenue Share due for any year is discovered in any examination then MAINZ shall bear the fees and expenses of that examination and shall remit such underpayment (together with the fees and expenses) to UTR within thirty (30) days of the examination results. Audits are limited to the previous three years of sales of Laboratory Tests. |
| 9. | Liability |
| 9.1 | UTR and NORDA undertake no responsibility for the risks of industrial realisation and commercial exploitation of the Intellectual Property and/or the Labatory Kits. UTR and NORDA do not warrant the validity or scope of the Patent Rights and the Intellectual Property. The invalidation, revocation or limitation of any Patent Rights or Intellectual Property shall not entitle MAINZ to any claims for damages or other remedies. |
| 9.2 | MAINZ shall assume full responsibility for its use of the Laboratory Kits and Intellectual Property and shall defend, indemnify and hold UTR and NORDA harmless from and against all liability, costs, demands, damages, expenses (including attorney’s and expert witness fees and expenses) and losses by reason of death, personal injury, illness or property damage, or any other injury or damage arising out of the use of the Labatory Kits and Intellectual Property, including but not limited to, the use or reliance upon the Labatory Kits and Intellectual Property by third parties. |
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| 9.3 | No compensation shall be payable with respect to any claim unless MAINZ notifies UTR and NORDA in writing without undue delay after MAINZ became aware that a claim could be brought, together with a reasonable specification of the basis for the claim and the estimated amount of the loss to the extent known by MAINZ. |
| 9.4 | The total aggregate and collective liability of UTR and NORDA under this Agreement shall not exceed $2,000,000. |
| 9.5 | Except for claims arising for breach of any warranty according to Section 7.1-7.6, (a) the time limitation for forwarding claims under the Agreement shall be 3 (three) years after the signing of this Agreement, and (b) no compensation shall be payable for any loss to the extent the loss is recoverable under any insurance for the benefit of MAINZ. |
| 10. | Assignment |
| 10.1 | MAINZ may assign this Agreement without consent of UTR or NORDA, provided that (i) the portion of the Assignment Fee due and owing at the time of the assignment is paid in full and (ii) MAINZ informs UTR and NORDA about any such assignment prior to implementation of the assignment. |
Notwithstanding the above, UTR and NORDA shall have the right to refuse consent should the assignee, in UTR and NORDA’s commercially reasonable opinion, not have the financial means to pay the remaining Assignment Fee.
UTR and/or NORDA may not assign this Agreement without written authorization from MAINZ, not to be unreasonably withheld.
| 11. | Taxes |
| 11.1 | All tax liability of UTR and/or NORDA associated with this Agremeent or any consideration pursuant to Section 3 shall be the sole responsility of UTR and/or NORDA. |
| 12. | Publicity |
| 12.1 | UTR and Norda agree not to use MAINZ’s name, nor any of their trademarks (registered or not), including those assigned herein, logos, slogans, trade names, domain names or other identifiers, for any means without the prior written consent of MAINZ. However, NORDA and UTR may mention, without MAINZ’s prior authorization the existence of this Agreement and the assignment of rights herein without disclosing the terms and conditions of the assignment. |
| 13. | Applicable Law |
| 13.1 | This Agreement shall be governed by and construed in accordance with the laws of Germany in force therein without regard to its conflict of law rules. For the purposes hereof, the Parties elect domicile in the judicial district of Mainz, Germany. |
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| 14. | Arbitration in Case of Disagreement |
| 14.1 | In the event of any dispute arising between the parties concerning this Agreement, its enforceability or the interpretation thereof, the same shall be finally resolved by a single arbitrator appointed pursuant to Mediation Rules of the European Centre of Arbitration and Mediation. The place of arbitration shall be Frankfurt, Germany. The language to be used in the arbitration proceedings shall be English. |
| 14.2 | Notwithstanding the foregoing, either Party may apply to a court of competent jurisdiction for interim protection such as, by way of example, an interim injunction. |
| 15. | Confidential Information |
| 15.1 | Other than as expressly provided herein, UTR and NORDA may not (i) disclose the Confidential Information or (ii) use the Confidential Information, without the prior written approval of MAINZ; except that UTR and NORDA may disclose the Confidential Information to its or their employees and other persons under its supervision that are operating within its organization, who (A) have a legitimate “need to know” to comply with the terms of this Agreement; (B) are informed of the confidential nature of the Confidential Information; and (C) are obligated to protect such Confidential Information pursuant to terms and conditions not less restrictive than those contained in this Agreement. |
| 15.2 | UTR and NORDA acknowledge that the Confidential Information contains trade secrets that require perpetual non-disclosure to protect Mainz commercial interests in the Intellectual Property. |
| 15.3 | Mainz may disclose any or all Confidential Information without permission from UTR or NORDA. |
| 15.4 | “Confidential Information” means: |
| (a) | the terms and conditions of this Agreement, |
| (b) | any and all confidential or proprietary information shared between or among Parties for the purposes of this Agreement, and |
| (c) | any and all Intellectual Property, expressed in whatever form and may include technical information, procedures, formulae, protocols, software, specifications, flowcharts, instructions, research, financial or marketing data, business plans, patent applications, and other documents and materials, and all modifications, variations, updates, enhancements and improvements thereof. Confidential Information may include unique combinations of separate items, which individually may or may not be confidential. |
The Parties acknowledge that the following information is not considered Confidential Information:
| (b) | information that is published or becomes available to the general public other than through a breach of this Agreement; |
| (c) | information that is obtained from a third party with a valid right to disclose it, provided that said third party is not under a confidentiality obligation to MAINZ; |
| (d) | information that is independently developed by employees, agents or consultants of NORDA and/or UTR have no knowledge of or access to the Confidential Information as evidenced by the business records of UTR and/or NORDA; or |
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| 15.5 | Disclosure Required by Law. If, in the reasonable opinion of Receiving Party’s counsel, any of Disclosing Party’s Confidential Information is required to be disclosed pursuant to law, regulation, court order, or rules of the stock exchange on which the securities of the Receiving Party is traded, Receiving Party shall give Disclosing Party prompt, written notice (of at least five (5) business days’, if reasonably possible) in order to allow Disclosing Party to take whatever action it deems necessary to protect its Confidential Information. In the event that Receiving Party is legally obligated to disclose Confidential Information of the Disclosing Party, Receiving Party shall furnish only that portion of the Confidential Information which Receiving Party is advised by Receiving Party counsel is legally required. |
| 16. | Notices |
| 16.1 | All notices or other documents that either of the Parties hereto are required or may desire to deliver to the other party hereto may be delivered by personal delivery, by courier, by telecopy, or by registered or certified mail, all postage and other charges prepaid, or by electronic mail upon confirmation of the recipient, at the address for such party set forth hereinafter or at such other address as that party may designate in writing to the other. |
If to MAINZ or MYNZ:
MAINZ BIOMED N.V.
Att. To: Bill Caragol
Robert-Koch-Strasse 50
55129 Mainz, Germany
Phone: +49 (0) 6131 / 55428-60
Email: Bill.Caragol@mainzbiomed.com
If to UTR:
Uni Targeting Research AS
Att. To:
Address
Phone:
Email:
If to NORDA:
NORDA SA
Att. To:
c/o Andenaesgruppen, Stortingsgata 28
55129 Mainz, Germany
Phone:
Email:
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| 17. | No Waiver |
| 17.1 | No condoning or overlooking by any Party of any default or breach by any other Party in respect of any terms of this Agreement shall operate as a waiver of such Party’s rights under this Agreement in respect of any continuing or subsequent default or breach, and no waiver shall be inferred from or implied by anything done or omitted by such Party, save only an express waiver in writing. |
| 18. | Force Majeure |
| 18.1 | The Parties to this Agreement shall be excused from any performance required hereunder if such performance is rendered impossible or unfeasible due to any catastrophes or other major events beyond their reasonable control and those which are not a result of the defaulting party’s making or negligence or contribution, including, without limitation, pandemic, war, riots, and insurrection, laws, proclamations, edicts, ordinances, or regulations; strikes, lockouts, or other serious labor disputes; and floods, fires, explosions, or other natural disasters. When such events have abated, the Parties’ respective obligations hereunder will resume. |
| 19. | Independence of Individual Clauses |
| 19.1 | In the event that any part, session, clause, paragraph or subparagraph of this greement shall be held to be indefinite, invalid, illegal or otherwise voidable or unenforceable, the entire Agreement shall not fail on account thereof, and the balance of the Agreement shall continue in full force and effect. |
| 20. | This Agreement Comprises Entire Understanding between Parties |
| 20.1 | This agreement set forth the entire understanding between the Parties and no modifications hereof shall be binding unless executed in writing by the Parties hereto. |
| 21. | Electronic Copy |
| 21.1 | The Parties agree that a copy of the original signature (including an electronic copy) may be used for any and all purposes for which the original signature may have been used. The parties further waive any right to challenge the admissibility or authenticity of this document in a court of law based solely on the absence of an original signature. |
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IN CONSIDERATION WHEREOF the Parties hereto have executed this Agreement on the dates and locations set forth below but effective as of the date first above written by their duly authorized officer.
| Uni Targeting Research AS | |||
| /s/ Hans Hekland | Date: 2/15/2023 | ||
| Name: | Hans Hekland | ||
| Title: | CEO | ||
| MAINZ BIOMED N.V. | |||
| /s/ Guido Baechler | Date: 2/15/2023 | ||
| Name: | Guido Baechler | ||
| Title: | CEO | ||
| NORDA AS | |||
| /s/ Christian Abyholm | Date: 2/15/2023 | ||
| Name: | Christian Abyholm | ||
| Title: | Chairman | ||
| MAINZ BIOMED GERMANY GMBH | |||
| /s/ Moritz Eidens | Date: 2/15/2023 | ||
| Name: | Moritz Eidens | ||
| Title: | CSO | ||
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Exhibit 10.2
Assignment Agreement
This agreement (the “Assignment Agreement”) is effective as of February 15, 2023, (the “Effective Date”).
| BETWEEN: | SOCPRA SCIENCES SANTÉ ET HUMAINES S.E.C., operating under the name TRANSFERTECH SHERBROOKE, a Limited Partnership duly incorporated pursuant to the Civil Code of Québec, having its head office at 35 Radisson Street, Office 200, Sherbrooke, (Quebec), Canada, J1L 1E2, acting and represented by its General Partner, GESTION SOCPRA SCIENCES SANTÉ ET HUMAINES INC., a legal person duly constituted under the Business Corporations Act (Quebec), said General Partner being represented by its agent and mandatory GESTION SOCPRA INC, herein acting and represented by Michel Lambert, its President and CEO, duly authorized for the purposes hereof as he so declares by signing; |
(hereinafter referred to as “TTS”)
| AND: | MAINZ BIOMED N.V., a corporate body incorporated in Amsterdam, with its principal place of business located at Sirius Gutenberg Park Robert-Koch-Straße 50, 55129, Mainz, Germany; |
(hereinafter referred to as “Mainz Biomed” or “Mainz”)
Mainz Biomed and TTS shall each individually be referred to as “Party” and collectively as “Parties”.
| WHEREAS | Mainz Biomed and TTS have agreed upon and signed a Technology Rights Agreement effective as of January 4, 2022, through which TTS has granted Mainz Biomed the exclusive option to acquire the certain technology and patent rights for which TTS holds all the rights. |
| WHEREAS | Mainz Biomed and the University of Sherbrooke have agreed upon and signed a Research Colloboration and Material Transfer Agreement effective Febaruary 10, 2022 (“RCMTA”) that provided for exchange of material and information between Mainz Biomed and the University of Sherbrooke, as well as the creation of “Intellectual Property of the Project” as defined by the RCMTA. |
| WHEREAS | the University of Sherbrooke has since then transferred to TTS all of its rights under the RCMTA regarding the Intellectual Property of the Project; |
| WHEREAS | Mainz Biomed wishes to exercise the exclusive option in accordance with the Technology Rights Agreement. |
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NOW THEREFORE IN CONSIDERATION of the premises and of the mutual covenants herein set forth, the Parties have covenanted and agreed as follows:
| 1.0 | Definitions |
| 1.1 | “Confidential Information” means the terms and conditions of this Assignment Agreement, any confidential or proprietary information shared between or among Parties for the purposes of this Assignment Agreement, and any and all discoveries, inventions, processes, methods, techniques, know-how, and Intellectual Property and proprietary rights relating to the Technology, expressed in whatever form and may include technical information, procedures, formulae, protocols, software, specifications, flowcharts, instructions, research, financial or marketing data, business plans, patent applications, and other documents and materials, and all modifications, variations, updates, enhancements and improvements thereof, that are disclosed by one Party to another Party during the term of this Assignment Agreement. Confidential Information may include unique combinations of separate items, which individually may or may not be confidential. |
Confidential Information includes “Intellectual Property of the Project” at defined in the RCMTA.
The Parties acknowledge that the following information is not considered Confidential Information:
| (a) | information that is made subject to an order by judicial or administrative process requiring Recipient to disclose any or all of the Information, provided however that Recipient shall promptly notify Provider and allow Provider reasonable time to oppose such process before disclosing any of the Confidential Information; |
| (b) | information that is published or becomes available to the general public other than through a breach of this Assignment Agreement; |
| (c) | information that is obtained by Recipient from a third Party with a valid right to disclose it, provided that said third Party is not under a confidentiality obligation to Provider; |
| (d) | information that is independently developed by employees, agents or consultants of Recipient who have no knowledge of or access to the Provider’s Confidential Information, as evidenced by the Recipient’s business records; or |
| (e) | information that was possessed by the Recipient prior to receipt from Provider or the Provider’s Investigator, other than through prior disclosure by Provider or the Provider’s Investigator, as evidenced by Recipient’s business records. |
| 1.2 | Intellectual Property means all rights related to the inventions, the Patents, the Technology, TTS-owned Improvements, and the “Intellectual Property of the Project” as defined in the RCMTA. |
| 1.3 | Net Sales means all income and consideration earned by MAINZ BIOMED, its Affiliates or subsidiaries from the exploitation of the Technology or any TTS-owned Improvements in the Territory, including, without limitation, income from any consideration of value, the sale or other disposition of Products or Services in accordance with generally accepted accounting principles. From this income, only the following will be deducted: |
| (a) | duly authorized volume discounts or wholesale discounts that are taken according to the usual amounts in the industry; |
| (b) | packaging, shipping, freight, insurance, and transportation charges, including distribution costs paid to distributors and third parties, including third-party logistics providers; |
| (c) | amounts reimbursed or credited because of a refusal, timely return, and rebates, and recall or other corrective action, and |
| (d) | customs duties, brokerage fees, excise taxes, sales taxes, tariffs, and value-added taxes. |
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| 1.4 | Patents means US provisional patent application Serial No: 63,108,510, filed November 2, 2020 and International Application Serial No: PCT/CA2021/051548 filed November 2, 2021, including but not limited to any national-stage applications, amendments, divisions, continuations, continuations-in-part, reissues, renewals, extensions and supplementary protection certificates of any such patents and patent applications. |
| 1.5 | Provider, which may be any Party, shall mean a Party that provides Confidential Information or Materials to a “Recipient.” |
| 1.6 | Products and Services means any article, parts, device, system, method, unit, product or component of a product, service or service contract which results from use of the Technology, incorporates the Technology in whole or in part or is covered by one or more patent applications or patents covering the Invention. This includes any Product or Service intended to improve or change a Product or Service. |
| 1.7 | RCMTA means the Research Colloboration and Material Transfer Agreement effective February 10, 2022 by Mainz Biomed and the University of Sherbrooke. |
| 1.8 | Technology means the drawings, software, technical information, know-how, documents, copyright, patterns, prototypes, models, processes, formulas, products, samples, files, diagrams, plans, specifications, algorithms, methods, research or data owned or controlled by TTS, as they relate a method for stratifying the risk of a subject of having an advanced colorectal adenoma or a colorectal cancer based on determining the presence of overexpressed mRNA transcripts in the subject’s stool. The method can be used to screen for subjects suitable for a colonoscopy. The method can also be used to tailor the stratified subject’s treatment regimen. |
| 1.9 | Territory means the world. |
| 1.10 | TTS-owned Improvements means any addition, modification, extension or perfecting to or of the Technology, which promotes its development, production or marketing and that are developed exclusively by University of Sherbrooke investogators, which may or may not be the subject of intellectual property protection. |
| 1.11 | Valid Claim means a claim of a patent or patent application in any country that (i) has not expired; (ii) has not been disclaimed; (iii) has not been cancelled or superseded, or if cancelled or superseded, has been reinstated; and (iv) has not been revoked, held invalid, or otherwise declared unenforceable or not allowable by a tribunal or patent authority of competent jurisdiction over such claim in such country from which no further appeal has or may be taken. |
| 2.0 | Assignment of Intellectual Property |
| 2.1 | TTS hereby sells, assigns, transfers and conveys to Mainz Biomed, its successors and assigns, the entire right, title and interest in and to the Intellectual Property, including all TTS’ rights, title and interest throughout the world in, to and under the Patents, including, without limitation, all patent applications and all patents which may be granted thereon, and all divisions, renewals and continuations thereof, and all patents which may be granted thereon and all reissues and extensions thereof; which may hereafter be filed in any country or countries, together with the right to file such applications and the right to claim for the same the priority rights derived from the patent under the patent laws of the Canada, the International Convention for the Protection of Industrial Property, or any other international agreement or the domestic laws of the country in which any such application is filed, as may be applicable. |
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| 3.0 | Consideration |
| 3.1 | Within ten (10) days of the Effective Date, Mainz Biomed will pay TTS an assignment fee of €25,000 (twenty-five thousand Euros). |
| 3.2 | Within ten (10) days of the Effective Date, Mainz will pay TTS the costs of drafting, filng, prosecuting and maintaining the Patents in an amount of CA $10,025.58 (ten thousand twenty-five dollars fifty-eight cents). |
| 3.3 | Mainz shall pay TTS a “Profit Share” of two percent (2%) of Net Sales of Products and Services covered by a Valid Claim on a country-by-country basis. |
| 3.4 | All applicable sales taxes will be charged in addition to all amounts payable. |
| 4.0 | Payment Terms |
| 4.1 | Payment Obligations. The Profit Share according to section 3.3 will accrue in each country and will be payable to TTS when Products and Services are invoiced, or if not invoiced, when delivered or otherwise exploited by Mainz Biomed in a manner constituting a Net Sale. |
| 4.2 | Schedule. Upon receipt by TTS of a “Detailed Report” of Net Sales and Profit Share calculation for each period and after validation thereof, TTS will invoice Mainz for the validated amounts. Mainz Biomed will provide the Detailed Report to TTS quarterly on or before February 28 (for the calendar quarter ending December 31), May 31 (for the calendar quarter ending March 31), August 31 (for the calendar quarter ending June 30) and November 30 (for the calendar quarter ending September 30) of each calendar year. Mainz will pay each invoice from TTS within thirty (30) days. |
| 4.3 | Currency. All consideration due will be payable and will be made in Canadian dollars to TTS by wire transfer to an account designated by TTS. TTS is responsible for all bank or other transfer charges. When Net Sales are made in monies other than Canadian dollars, the Profit Share will first be determined in the foreign currency of the country in which such Products or Services were sold and then converted into equivalent Canadian dollars. In all cases, the exchange rate will be the average exchange rate quoted in The Wall Street Journal during the last thirty (30) days of the reporting period. |
| 4.4 | Accrual. In the event that any Patent or Valid Claim thereof is held invalid by a court or other tribunal of competent jurisdiction (including, but not limited to, USPTO Patent Trial and Appeal Board and the EPO Opposition Division), Mainz Biomed will be allowed to accrue Profit Share if and until a final decision by a court of last resort from which no appeal has or can be taken. Mainz Biomed will have sole discretion whether to appeal any decision of any court or other tribunal regarding the Patents. If, upon appeal, a Patent or Valid Claim that had been found to be invalid or unforceable is found to be valid and enforceable, Mainz Biomed wil pay TTS the accrued Profit Share within thirty days according to Section 4.3. |
| 4.5 | Late Payments. In the event that any monies owed to TTS are not received by TTS when due, Mainz Biomed will pay to TTS interest at a rate of six percent (6%) simple interest per annum. Such interest will be calculated from the date payment was due until actually received by TTS. |
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| 5.0 | Patent Rights and TTS Cooperation |
| 5.1 | Upon execution of this Assignment Agreement, Mainz Biomed will have the sole right and obligation regarding patent prosecution, maintenance and enforcement of the Intellectual Property. |
| 5.2 | TTS hereby agrees, upon the request and at the expense of Mainz Biomed, its successors and assigns: |
| (a) | to execute any and all divisional, continuation and substitute applications for said inventions, and any necessary oath, affidavit or declaration relating thereto, and any application for the reissue or extension of any Letters Patent that may be granted upon said application and any and all applications and other documents for Letters Patent in foreign countries on said invention, that Mainz Biomed, its successors or assigns may deem necessary or expedient, and the undersigned authorizes Mainz Biomed to apply for patents for said invention in its own name in such countries where such procedure is proper and further agree, upon the request of Mainz Biomed, its successors and assigns, |
| (b) | to cooperate to the best of the ability of the undersigned with Mainz Biomed, its successors and assigns, in any proceedings or transactions involving such applications or patents, including the preparation and execution of preliminary statements, giving and producing evidence, and performing any and all other acts necessary to obtain, maintain and enforce said Letters Patent, worldwide, and vest all rights therein hereby conveyed in Mainz Biomed, its successors and assigns, whereby said Letters Patent will be held and enjoyed by Mainz Biomed, its successors and assigns, to the full end of the term for which said Letters Patent will be granted, as fully and entirely as the same would have been held and enjoyed by TTS if this assignment had not been made. |
| 5.3 | If, during any proceeding before any tribunal regarding the Patents, TTS is required to be joined as a party to such proceeding, TTS will join and cooperate at the expense of Mainz Biomed. |
| 5.4 | If TTS requires counsel in view of the obligations of Sections 5.2 or 5.3, Mainz Biomed will be entitled to select counsel with the consent of TTS which consent shall not be unreasonably withheld. Mainz will pay all fees for counsel and other fees necessary for TTS’ cooperation with or participation in any proceeding. |
| 5.5 | The Parties agree to execute the Patent Assignment Agreement attached as Exhibit A that may be used in updating the records of the International Bureau and recording in national patent offices as required. |
| 6.0 | Commercial Diligence |
| 6.1 | Mainz Biomed, upon execution of this Assignment Agreement, will use reasonable commercial efforts to proceed with the development, manufacture, and sale of Products and Services. Such diligence shall be met by Mainz BioMed upon completing required clinical trials, meeting requirements for regulatory approval, and initiating sales of Products and Services in the United States and Europe by December 31, 2027. |
| 6.2. | “Europe” shall mean at least two countries selected from Germany, France, England, Spain or Italy. |
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| 7.0 | Warranties |
| 7.1 | TTS warrants itself to be the owner of the entire right, title and interest in said Intellectual Property and to have the right to make this assignment, and further warrants that it has not assigned, licensed, or encumbered the Intelletual Property herein assigned prior to the present Assignment Agreement. |
| 7.2 | Each Party (i) has the corporate power and/or authority and the legal right to enter into this Assignment Agreement and to perform its obligations hereunder, and (ii) has taken all the necessary corporate or civil action on its part to authorize the execution and delivery of this Assignment Agreement and the performance of its obligations hereunder. This Assignment Agreement has been duly executed and delivered on behalf of each Party and constitutes a legal, valid, binding obligation, enforceable against such party in accordance with its terms. |
| 7.3 | Consents. All necessary consents, approvals and authorizations of all governmental authorities and any third parties required to be obtained by such Party in connection with this Assignment Agreement have been obtained. |
| 7.4 | No Conflict. The execution and delivery of this Assignment Agreement and the performance of such Party’s obligations hereunder (i) do not conflict with or violate applicable laws, and (ii) do not conflict with or constitute a default under any contractual obligation of such Party. |
| 7.5 | Nothing in this Assignment Agreement: |
| (a) | constitutes a warranty or representation by TTS that anything made, used, sold or otherwise disposed of under this Assignment Agreement is or will be free from claims or allegations of infringement of patents, copyrights, trademarks, industrial design or other intellectual property rights; or |
| (b) | imposes an obligation on TTS to bring or prosecute or defend actions or suits against third parties for infringement of patents, copyrights, trademarks, industrial designs or other intellectual property or contractual rights. |
| 7.6 | TTS does not bind itself and makes no representation or warranty of any kind whatsoever with respect to the Technology, the TTS-Improvements and the Products and Services and, without limiting the generality of the foregoing, TTS makes no representation or warranty of any kind whatsoever with respect to the usefulness, quality or marketability of the Technology, the TTS-Improvements and the Products and Services or the effects which may result from their use, nor that the development of applications relating to the Technology and the TTS-Improvements are complete. Without limiting the generality of the foregoing, TTS does not guarantee the validity of the patent applications or patents protecting the Technology and makes no representation with respect to their scope and validity. TTS shall not be liable for the warranties, representations, undertakings or any other obligations given or assumed by Mainz toward any party whomsoever with respect to the manufacturing, promotion, distribution, use or sale of any such Products and Services or any other activity relating thereto or to the Technology and the TTS-Improvements. Without limiting the generality of the aforementioned and in any and all cases, TTS’ maximum liability, whether in contract, indemnity, warranty, tort, or otherwise, arising out of or in connection with the Products and Services or any activity relating to or from the Technology and TTS-Improvements, shall not exceed the amounts actually received by TTS in accordance with the Assignment at the date at which such claims arise. |
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| 7.7 | Mainz agrees to indemnify and hold harmless TTS, its directors, officers, employees and representatives with respect to any claim or legal proceeding taken against them, as well as the judgements resulting therefrom relating to any damage, loss, cost and expense (including reasonable costs incurred by advisers and attorneys) which they may have incurred as a result of, or arising further from or in connection with the use of the Technology, the TTS-Improvements and the Products and Services by Mainz. |
| 8.0 | Relationship to Prior Agreement |
| 8.1 | This Assignment Agreement supercedes the obligations of Mainz Biomed to TTS under the Technology Rights Agreement or the RCMTA with regard to the Intellectual Property and associated Confidential Information assigned in accordance with this Assignment Agreement: |
| (a) | Mainz Biomed, at its sole discretion, may use, publish or otherwise publically disclose, exploit, sell, and commercialize any Confidential Information associated with the Intellectual Property assigned herein without the consent of TTS or the University of Sherbrooke, with the caveat that Mainz will acknowledge TTS and/or the University of Sherbrooke in any publication that substantially incorporates the Intellectual Property, including but not limited to journals, public meetings or symposia, book chapters, abstracts and internet publications. |
| (b) | Except as expressly provided herein, Mainz Biomed has no obligation to work with, negotiate with, or reach agreement with TTS or the University of Sherbrooke regarding the filing of patent applications or commercial exploitation of the Confidential Information or the Intellectual Property. |
| (c) | Except with regards to the Intellectual Property and associated Confidential Information assigned hereunder, the Parties remain obligated towards each other related to the terms of confidentiality and publication rights associated with the Technology Rights Agreement and the RCMTA. |
| 8.2 | Pursuant to Section 10.2.3 of the RCMTA, the University of Sherbrooke retains a non-exclusive license to use its Results (as defined by the RCMTA) and any Intellectual Property of the Project, for internal research, education and training purposes and not for commercialization. This license is free, worldwide, irrevocable, non-assignable, non-transferable and without the right to sublicense and without time limits. |
| 9.0 | Assignment |
| 9.1 | Either Party may assign this Assignment Agreement without consent of the other Party. |
| 10.0 | Publicity |
| 10.1 | Each Party agrees not to use the name of any of the other Parties, nor any of their trademarks (registered or not), logos, slogans, trade names, domain names or other identifiers, for any means without the prior written consent of the concerned other Party. However, each Party agrees that it may mention, without prior authorization of any of the other Parties, the partnership existing between the Parties, without disclosing the terms and conditions of the Assignment Agreement. |
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| 11.0 | Applicable Law |
| 11.1 | This Assignment Agreement shall be governed by and construed in accordance with the laws of the Province of Quebec and the laws of Canada in force therein without regard to its conflict of law rules. For the purposes hereof, the Parties elect domicile in the judicial district of St-François (Quebec). |
| 12.0 | Arbitration in Case of Disagreement |
| 12.1 | The Parties agree that any dispute or disagreement relating to the interpretation or application of this agreement (the “Dispute”) shall be submitted to mediation. To this end, the Parties hereto agree to attend at least one mediation meeting by delegating one person with decision-making authority. The mediator shall be chosen by the Parties. |
| 12.2 | In the event of any unresolved Dispute arising between the Parties concerning this Assignment Agreement, its enforceability or the interpretation thereof, the same shall be finally resolved by a single arbitrator appointed pursuant to the provisions of articles 620 and following of the Quebec Code of Civil Procedure. The place of arbitration shall be Sherbrooke, Quebec. The language to be used in the arbitration proceedings shall be English. |
| 12.3 | Notwithstanding the foregoing, either Party may apply to a court of competent jurisdiction for interim protection such as, by way of example, an interim injunction. |
| 13.0 | Notices |
| 13.1 | All notices or other documents that either of the Parties hereto are required or may desire to deliver to the other party hereto may be delivered by personal delivery, by courier, by telecopy, or by registered or certified mail, all postage and other charges prepaid, or by electronic mail upon confirmation of the recipient, at the address for such party set forth hereinafter or at such other address as that party may designate in writing to the other. |
If to Mainz Biomed:
MAINZ BIOMED N.V.
Att. To: Mr. Guido Baechler
Robert-Koch-Strasse 50
55129 Mainz, Germany
Phone: +49 (0) 6131 / 55428-60
Email: guido.baechler@mainzbiomed.com and bill.caragol@mainzbiomed.com
If to TTS:
SOCPRA SCIENCES SANTÉ ET HUMAINES S.E.C.
a/s Mr. Patrice Leclerc, Project Director
35 Radisson Street, Office 200,
Sherbrooke (Quebec) Canada J1L 1E2
Phone: 819 821-7961
Email: p.leclerc@transfertech.ca AND info@transfertech.ca
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| 14.0 | No Waiver |
| 14.1 | No condoning or overlooking by any Party of any default or breach by any other Party in respect of any terms of this Assignment Agreement shall operate as a waiver of such Party’s rights under this Assignment Agreement in respect of any continuing or subsequent default or breach, and no waiver shall be inferred from or implied by anything done or omitted by such Party, save only an express waiver in writing. |
| 15.0 | Remedies |
| 15.1 | Remedies for breach of this Assignment Agreement shall be limited to monetary damages, and do not include a reversion of rights in any form to TTS. |
| 16.0 | Force Majuere |
| 16.1 | The Parties to this Assignment Agreement shall be excused from any performance required hereunder if such performance is rendered impossible or unfeasible due to any catastrophes or other major events beyond their reasonable control and those which are not a result of the defaulting Party’s making or negligence or contribution, including, without limitation, pandemic, war, riots, and insurrection, laws, proclamations, edicts, ordinances, or regulations; strikes, lockouts, or other serious labor disputes; and floods, fires, explosions, or other natural disasters. When such events have abated, the Parties’ respective obligations hereunder will resume. |
| 17.0 | Independence of Individual Clauses |
| 17.1 | In the event that any part, session, clause, paragraph or subparagraph of this Assignment Agreement shall be held to be indefinite, invalid, illegal or otherwise voidable or unenforceable, the entire Assignment Agreement shall not fail on account thereof, and the balance of the Assignment Agreement shall continue in full force and effect. |
| 18.0 | This Agreement Comprises Entire Understanding between Parties |
| 18.1 | This agreement sets forth the entire understanding between the Parties regarding the assignment at hand, and no modifications hereof shall be binding unless executed in writing by the Parties hereto. |
| 19.0. | Electronic Copy |
| 19.1 | The Parties agree that a copy of the original signature (including an electronic copy) may be used for any and all purposes for which the original signature may have been used. The parties further waive any right to challenge the admissibility or authenticity of this document in a court of law based solely on the absence of an original signature. |
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IN CONSIDERATION WHEREOF the Parties hereto have executed this Assignment Agreement on the dates and locations set forth below but effective as of the Effective Date.
| SOCPRA SCIENCES SANTÉ ET HUMAINES S.E.C (TTS) | |||
| /s/ Michel Lambert | Date: 2/15/2023 | ||
| Name: | Michel Lambert | ||
| Title: | CEO | ||
| As TTS representative | |||
| MAINZ BIOMED N.V.: | |||
| /s/ Guido Baechler | Date: 2/15/2023 | ||
| Name: | Guido Baechler | ||
| Title: | CEO | ||
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Exhibit A
PATENT ASSIGNMENT AGREEMENT
THIS ASSIGNMENT, by SOCPRA SCIENCES SANTÉ ET HUMAINES S.E.C., a Limited Partnership having its principal place of business having its head office at 35 Radisson Street, Office 200, Sherbrooke, (Quebec), Canada, J1L 1E2 (hereinafter referred to as “Assignor”), witnesseth:
WHEREAS, Assignor is the owner of the entire right, title and interest in and to the invention described in the following patent applications:
| Title of Invention: | Stratification methods for assessing the progression and risk of advanced colorectal adenoma and colorectal cancer | ||
| PCT Application No.: | PCT/CA2021/051548, filed November 2, 2021, and |
US provisional patent application No. 63/108,510, filed November 2, 2020
WHEREAS, MAINZ BIOMED N.V., a corporate body incorporated in Amsterdam, with its principal place of business located at Sirius Gutenberg Park Robert-Koch-Straße 50, 55129, Mainz, Germany (hereinafter referred to as “Assignee”), pursuant to the Assignment Agreement effective February 15, 2023 (hereinafter referred to as “the Assignment Agreement”) between Assignor and Assignee, has acquired Assignor’s right, title, and interest in and to the above-mentioned application and invention, the right to file applications on said invention, and the right, title and interest in and to any applications, including provisional applications, on said invention for Letters Patent worldwide, and any applications claiming priority to said applications, and in and to any Letters Patent or Patents of any country, to be obtained therefor and thereon;
NOW, THEREFORE, pursuant to the Assignment Agreement, for good and sufficient consideration, receipt of which is hereby acknowledged by Assignor has assigned, transferred and set over, and by these presents does assign, transfer and set over unto Assignee, and Assignee’s successors, legal representatives, and assigns, all of Assignor’s right, title and interest in and to the above-mentioned invention and application, the right to file applications on said invention, and the right, title and interest in and to any such applications, including provisional applications, and any applications claiming priority from said applications for Letters Patent of the United States or other countries, and any and all Letters Patent or Patents of the United States of America and all foreign countries that have been or may be granted therefor and thereon, and in and to any and all divisions, renewals, substitutions, conversions, continuations, and continuations-in-part of said applications, and reissues, prolongations and extensions of said Letters Patent or Patents, and all rights under the Paris Convention for the Protection of Industrial Property, including the right to claim priority, the same to be held and enjoyed by Assignee, for its own use and behalf and the use and behalf of Assignee’s successors, legal representatives, and assigns, to the full end of the term or terms for which Letters Patent or Patents may be granted as fully and entirely as the same would have been held and enjoyed by Assignors had this Assignment not been made;
AND for the same consideration, Assignor hereby covenants and agrees to and with Assignee, its successors, legal representatives, and assigns, that Assignor shall, whenever counsel of Assignee, or the counsel of its successors, legal representative and assigns, advised that any proceeding in connection with said invention or said applications for Letters Patent or Patents, or any proceeding in connection with Letters Patent or Patents for said invention in any country, including interference proceedings, is lawful and desirable, or that any application claiming priority to said applications, division, continuation, continuation-in-part, substitution or conversion of any applications for Letters Patent or Patents, or any reissue, prolongation or extension of any Letters Patent or Patents to be obtained thereon, is lawful and desirable, sign all papers and documents, take all lawful oaths and do all acts necessary or required to be done for the procurement, maintenance, enforcement and defense of Letters Patent or Patents for said invention, without charge to Assignee, but at the cost and expense of Assignee, it successors, legal representatives, and assigns;
AND Assignor hereby requests the Commissioners of Patents in all countries to issue any and all said Letters Patent or Patents to Assignee as the assignee of said invention and the Letters Patent or Patents issued and to be issued thereon for the sole use and behalf of Assignee, its successors, legal representatives, and assigns.
A-1
IN TESTIMONY WHEREOF, a duly authorized representatives of Assignor and Assignee have signed on the date indicated.
| SOCPRA SCIENCES SANTÉ ET HUMAINES S.E.C. | ||
| Date: 2/15/2023 | By: | /s/ Michel Lambert |
| Printed Name: |
| Title: | ||
| MAINZ BIOMED N.V., | ||
| Date: 2/15/2023 | By: | /s/ Guido Baechler |
| Printed Name: |
| Title: |
Application No. PCT/CA2021/051548
A-2
Exhibit 99.1
Mainz Biomed Acquires
Entire Intellectual Property Portfolio for its Colorectal
Cancer Diagnostic Test Program
Transaction entails executing option agreements
to purchase IP portfolio associated with current
ColoAlert product and the novel gene expression (mRNA) biomarkers being evaluated in
ColoFuture/eAARLY DETECT Studies
BERKELEY, US – MAINZ, Germany – February 21, 2023 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the execution of its option from Uni Targeting Research AS to acquire all of the previously licensed scientific intellectual property (“IP”) for its flagship product ColoAlert, a highly efficacious, and easy-to-use detection test for colorectal cancer (“CRC”) being commercialized across Europe. Simultaneously, the Company also exercised its exclusive option with SOCPRA Sciences Sante et Humaines S.E.C. (“SOCPRA”), to outright purchase IP, including a pending patent, associated with a portfolio of novel gene expression (mRNA) biomarkers that have demonstrated ability to detect CRC lesions, including advanced adenomas (“AA”), a type of pre-cancerous polyp often attributed to this deadly disease.
“This is an important value generation milestone for us as we continue executing our commercial strategy and product development plan to ultimately bring to market the gold-standard CRC self-administered diagnostic test,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Securing complete IP ownership is integral to our growth strategy as it streamlines administration, reduces per-test expenses, and provides us the opportunity to ramp-up corporate development activities, “added Baechler.
Mainz Biomed is commercializing ColoAlert across Europe and in select international markets through a differentiated business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. Under the standard terms of all partnerships, Mainz Biomed is providing ColoAlert to the respective labs, including co-branding with key accounts, whereby each facility purchases Mainz Biomed’s customized polymerase chain reaction (“PCR”) assay kits on an on-demand basis and provides their respective network of physicians and patients with a comprehensive solution for advanced CRC detection.
The Company is in the process of evaluating the mRNA biomarkers it is has acquired from SOCPRA in ColoFuture and eAArly DETECT, an international multi-center clinical study (US and Europe) assessing the potential for the integration of the mRNA biomarkers into ColoAlert. This particular portfolio of mRNA biomarkers selected by Mainz Biomed was based on work in the field by the University of Sherbrooke, where researchers tested multiple novel transcriptional biomarkers using colorectal cancer and precancerous lesion samples. The results from these studies demonstrated that the mRNA targets chosen by the Company provided a dynamic combination of sensitivity and specificity of detection (Herring et al. 2021). The ColoFuture study (extended into the US as eAArly DETECT) is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to expand its capability to identify AA while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.
ColoFuture’s eAArly DETECT study is on track to complete enrollment in the first quarter of 2023, with results reported in the first half of 2023. Based on the study’s outcome, Mainz Biomed will decide on integrating the biomarkers into the ReconAAsense study, which is on track to enroll patients in the summer of 2023, with results reported in 2025.
The ReconAAsense study (ClinicalTrials.gov Identifier: NCT05636085) will form the basis of the data package for review by the US Food and Drug Administration (FDA) to achieve marketing authorization. It is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AA. If successful, the Company’s mRNA and DNA-based CRC screening test will be positioned as the most robust and accurate at-home diagnostic screening test on the market, as it will not only detect cancerous polyps with a high degree of accuracy but has the potential to prevent CRC through early detection of precancerous adenomas.
About ColoAlert
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy (Dollinger MM et al., 2018). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT). It is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVDR marked (complying with EU safety, health and environmental requirements) and commercially available in a selection of countries in the European Union and the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. If approved in the United States, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.
About Colorectal Cancer
According to the Centers for Disease Control and Prevention (“CDC”), CRC is the second most lethal cancer in the United States and Europe, but also the most preventable, with early detection providing survival rates above 90%. The American Cancer Society estimated that in 2021 there were approximately 149,500 new cases of colon and rectal cancer in the US, with 52,980 resulting in death. Recent decisions by the U.S. Food and Drug Administration (FDA) suggest that screening with stool DNA tests such as ColoAlert in the United States should be conducted once every three years starting at age 45. Currently, there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years and a US market opportunity of approximately $3.7 billion per year.
About Mainz Biomed N.V.
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for CRC. ColoAlert is currently marketed across Europe and in select international territories. The Company is currently running a pivotal FDA clinical study for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time PCR multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
For media inquiries, please contact press@mainzbiomed.com
In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu
In the US:
Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
mainz@spectrumscience.com
For investor inquiries, please contact info@mainzbiomed.com
Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on May 5, 2022. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.