Exhibit 10.3 Licensing and Distribution Agreement dated April 27, 2020 by and between the Registrant and Somahlution, LLC


 

LICENSING and DISTRIBUTION AGREEMENT

 

This Agreement is made and entered into effective as April 27, 2020 (the “Effective Date”), by and between Somahlution, LLC, with offices located at 225 Chimney Corner Lane, Suite 2001, Jupiter, Florida 33458, a company organized and existing under the laws of Delaware (“Somahlution”), and Marizyme, Inc., a Nevada corporation, with offices located in Davenport, Fla., (“Marizyme”).

 

BACKGROUND

 

WHEREAS, Marizyme is a biotechnology company and is engaged in the marketing, sale and distribution of various medical device products, including the support thereof, in the Territory (as defined below);

 

WHEREAS, Somahlution owns or has certain rights relating to regulated medical Products (as defined below);

 

WHEREAS, Somahlution desires to appoint Marizyme as an exclusive distributor of the Products in certain Territory in accordance with the terms and conditions set forth in this Agreement;

 

WHEREAS, Somahlution desires to license Marizyme as an exclusive licensee of the Products in certain Territory for distribution in the Territory in accordance with the terms and conditions set forth in this Agreement;

 

WHEREAS, Marizyme will seek regulatory approval and registration in the distribution and licensed Territories granted to Marizyme. Somahlution will provide all necessary documents in its possession to assist Marizyme in obtaining registrations in countries in the granted Territories;

 

WHEREAS, Marizyme desires Somahlution to supply Marizyme with the Product for distribution and sale in the Territory in accordance with the terms and conditions set forth in this Agreement and Somahlution may provide the rights to manufacture the product in the Territory for supply to Marizyme Territories;

 

WHEREAS, Somahlution wishes to grant to Marizyme exclusive, perpetual, sub-licensable license to Somahlution’s Intellectual Property for the exclusively licensed Territories, Trade Marks (TM), and all technical knowhow in the Fields of Use including Coronary Artery Bypass Grafting, Peripheral Vascular Bypass grafting and other Vascular Surgeries, to enable it to file for regulatory approvals, ISO 13485 certification, preclinical and clinical studies, manufacture, distribute, market and commercialize the product in the Territory; 

 

WHEREAS, Somahlution wishes to transfer technologies to manufacture for the currently marketed liquid and the solid dosage form (powder formulation) that requires final development and scale up, of DuraGraft formulations to enable Marizyme to manufacture the products at their manufacturing facilities for supply in the licensed Territory; 

 

WHEREAS, Marizyme wishes to pay a royalty on gross income to Somahlution when Marizyme is the manufacturer in the licensed Territories;

 

WHEREAS, Marizyme and Somahlution agree that this Agreement shall supersede and be controlling over any and all prior agreements, written or oral, between the parties.

 

NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties, intending to be legally bound, agree as follows:

 

TERMS

 

ARTICLE 1 

 

DEFINITIONS. IN ADDITION TO THE TERMS DEFINED IN THIS AGREEMENT, THE FOLLOWING TERMS SHALL HAVE THE MEANINGS ASCRIBED TO THEM IN THIS SECTION 1:

 

1.1“Actively Promote Sales” means to actively engage a third party, orally or in writing, to obtain a sale of the Product. 

 

1.2“Customer” or “Customers” shall refer to the end user or end users of the Products. 

 

1.3“Field of Use” shall refer to use of the Product to preserve vascular conduits used in bypasses in cardiovascular surgery, peripheral bypass surgery and other vascular surgeries.  

 

1.4“Products” shall refer to the products (DuraGraft) listed on Appendix 2. 


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1.5“Regulatory Approvals” shall refer to governmental and regulatory agency permits, licenses, authorizations, registrations and/or approvals necessary for the marketing, distribution and sale of the Product into and within the Territory. 

 

1.6“Terms and Conditions” shall refer to Somahlution’s Terms and Conditions of Sale that are attached to the Marizyme credit application, which are part of the Marizyme qualification process. 

 

1.7“Territory” shall refer to the geographical area listed on Appendix 3.  

 

1.8“Trademarks” shall refer to any trademark used by Somahlution in connection with the Product, whether derived from common law use, from registration or from statutory protection against unfair competition, including without limitation those rights to Somahlution’s corporate name, other trade names, model names and trademarks.  

 

ARTICLE 2 

 

LICENSE GRANT, APPOINTMENT, AND SCOPE OF AUTHORITY.

 

2.1Subject to the terms and conditions of this Agreement, Somahlution hereby appoints Marizyme as an exclusive Distributor of the Product for the Territory in the Field of Use. As such, Marizyme shall have the authority to purchase from Somahlution, market and sell the Product in the Territory in the Field of Use. Marizyme may not Actively Promote Sales (e.g. through promotion, advertising, or by establishing branches or distribution depots) outside of the Territory. Furthermore, Marizyme may only Actively Promote Product for the Field of Use. Marizyme hereby accepts such appointment and agrees to use its best efforts to maximize sales of the Product in the Territory in the Field of Use. Marizyme acknowledges that Marizyme’s right to distribute is for the Territory in the Field of Use only.  

 

2.2Somahlution herby grants to Marizyme the following exclusive, perpetual licenses and rights for certain Territories: 

 

(a)Somahlution hereby grants to Marizyme an exclusive, perpetual, sub-licensable license to Somahlution’s Intellectual Property, Trade Marks (TM), and all technical knowhow in the Fields of Use including Coronary Artery Bypass Grafting, Peripheral Vascular Bypass grafting and other Vascular Surgeries, to enable it to file for regulatory approvals, ISO 13485 certification, preclinical and clinical studies, manufacture, distribute, market and commercialize the product in the specified Territory. Through this license Somahlution also extends its CE certificate to include Marizyme’s manufacturing facility. Furthermore, in the event Somahlution ceases to exist or is not able to cite Marizyme’s manufacturing facility on its CE certificate, Somahlution will enable transfer of intellectual property for the product to Marizyme to enable Marizyme to be an independent legal manufacturer of the product. Somahlution’s exclusive license to Marizyme will include Registered TM DURAGRAFT in the Licensed Territory and wherever the patents and trademarks have been filed in the Licensed Territory, and related technical knowhow for manufacture of DuraGraft and marketing and other technical documents. 

 

(b)Somahlution grants to Marizyme exclusive, perpetual, sub-licensable rights to Somahlution’s IP, TradeMark (TM), and all technical knowhow to manufacture, distribute, market and commercialize the product in all Licensed Territories. Territories are those that Somahlution grants to Marizyme and Marizyme pays for any or all patent related costs or files for registration or files for regulatory approvals, CE certification, preclinical and clinical studies. 

 

(c)Somahlution’s agrees that if Marizyme makes changes to the initial Intellectual Property and technical knowhow then Marizyme will own the new Intellectual Property for all changes and enhancements Marizyme makes, however shall license the new intellectual property to Somahlution at no cost to Somahlution for use in its Territories. 

 

2.3As a Distributor Marizyme may appoint sub-distributors, sub-agents or other persons (collectively, “Sub-Distributors”) to perform its obligations under this Agreement, in whole or in part. However, Marizyme must communicate to Somahlution the name and address of the Sub-Distributor. Marizyme agrees that it will obligate all of its Sub-Distributors to be bound by all of the terms, conditions and restrictions to which Marizyme is bound under this Agreement, and Marizyme agrees to cause all such Sub-Distributors to comply with such terms, conditions and restrictions. Sub-Distributors may not market or sell the Products outside of the Distribution Territory or outside of the Field of Use. Neither a Sub-distributor nor Marizyme may sell to a country or party, wherein the sale to said country or party is in violation of a law, regulation or executive order of the United States of America. 


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2.4During the term of this Agreement Somahlution shall be Marizyme’s sole source of the Product, and Marizyme agrees to purchase all of its requirements for the Products from Somahlution, until Marizyme has established capability to manufacture Product and Marizyme’s product is CE certified. During the term of this Agreement and for a period of one year after termination of this Agreement, Marizyme and its officers, principals, employees, affiliates and any Sub-Distributors shall not, directly or indirectly, design, develop, manufacture, assemble, import, sell, distribute or otherwise deal in any product which: (i) is used to preserve, store or flush vascular conduits such as blood vessels, arteries and veins or (ii) which is similar to the Product (whether similar as a technical matter, similar in application or otherwise similar), or (iii) that may compete with any sales of the Product in the Territory, without Somahlution’s express prior written consent. If Marizyme breaches this Section 2.3 during the term of this Agreement, then, at the option of Somahlution and at any time thereafter, in addition to any other rights Somahlution may have pursuant to this Agreement, Somahlution may terminate this Agreement effective immediately upon written notice to Marizyme. Any failure of Somahlution to act does not constitute a waiver of Somahlution’s rights under this section for future action. 

 

(a)The product DuraGraft is a two-component system. Somahlution will produce product component A and B either as bulk product or in separate containers ready for packaging to Marizyme. 

 

(b)For Distribution Territories, Somahlution will be the sole supplier of Product to Marizyme. 

 

(c)In licensed Territories, when possible and up on in-country regulatory approval, Somahlution will supply finished product to Marizyme for distribution or assist Marizyme at Marizyme’s cost, with technology transfer to allow Marizyme to complete the manufacturing of the DuraGraft product at its ISO13485 certified site in the Territory or and release the product with Somahlution participation for commercial use in Marizyme territories.  

 

(d)Somahlution will transfer all Intellectual Property and technologies to manufacture for the currently marketed liquid and the solid dosage form (powder formulation) that requires final development and scale up, of DuraGraft formulations to enable Marizyme to manufacture the products at their manufacturing facilities for supply in the licensed Territory. 

 

(e)Until Marizyme’s ISO-13485 certified manufacturing facility is certified by a Notified Body and included in Somahlution’s CE certificate, Somahlution will supply and Marizyme will purchase DuraGraft from Somahlution final product in all licensed Territories. 

 

(f)In licensed Territories, when Marizyme’s Product manufacturing facility is ready and is certified as indicated above, Marizyme will either purchase components of DuraGraft of the components in bulk for final manufacturing and packaging of the final product DuraGraft or purchase the two manufacturing completed components of DuraGraft which will be assembled in final DuraGraft packaging at Marizyme’s manufacturing facilities. The purchase price for the separate components and/or for bulk package of the components will be agreed to at a later date. 

 

(g)In the event that Marizyme, related companies, licensee or strategic partner or any third party does not begin commercialization of DuraGraft in the licensed Territories within 60 months of the signing of the binding agreement, Marizyme related companies, licensee, strategic partner or third party, Marizyme and Somahlution will mutually agree to terminate the license, and return all materials and documents to Somahlution, at no cost to Somahlution. 

 

(h)In the event Somahlution is unable or unwilling to manufacture the Licensed products then it will transfer to Marizyme the CE mark and all Intellectual Property to enable manufacturing and distribution in the licensed Territories. 

 

2.5Subject to the terms and conditions of this Agreement, Marizyme is authorized to sell Product purchased or otherwise acquired from Somahlution in such manner and manufacture the product, at such prices and upon such terms as Marizyme shall determine in consultation with Somahlution, in order to manage global reference pricing. Marizyme is an independent contractor, and not an employee of Somahlution, and this Agreement shall not be deemed to create a partnership, joint venture or principal-agent relationship between the parties. Marizyme is not authorized to assume or create any obligation or responsibility, including, but not limited to, obligations based on warranties or guarantees or other contractual obligations, on behalf or in the name of Somahlution. Marizyme shall not misrepresent its status or authority and shall be solely responsible for all of its own expenses, employees, agents and actions. Marizyme shall take no action that would or might confer “permanent establishment” or any equivalent status (as defined in applicable law or tax treaty) on Somahlution anywhere in the Territory or in any other country or otherwise subject Somahlution to taxation in any country. Nothing in this Agreement shall be construed to create any relationship whatsoever between Somahlution and any Sub-Distributor. Somahlution shall have no obligation to any such Sub-Distributors under this Agreement and all of Somahlution’s obligations under this Agreement shall be only to Marizyme, unless otherwise expressly set forth in this Agreement. 


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2.6During the term of this Agreement, Marizyme agrees to purchase from Somahlution no less than the specified minimum quantities of the Products for the specified periods of time set forth on Appendix 4 (the “Minimum Purchase Requirements”). If Marizyme fails to meet the Minimum Purchase Requirements for a specified period, such failure shall constitute a material breach of this Agreement. Any failure of Somahlution to act does not constitute a waiver of Somahlution’s rights under this section for future action. 

 

2.7If Somahlution desires to market and sell new products in the Marizyme Licensed Territory (“New Products”) during the term of this Agreement, Somahlution shall present the opportunity to market, sell and distribute the New Products to Marizyme prior to presenting such opportunity to a third party. Somahlution and Marizyme shall negotiate in good faith with respect to such product opportunity, but if the parties do not agree on terms and conditions for marketing, sale and distribution of the products in the Territory within ninety (90) days, Somahlution may elect to have a third party market, sell and distribute the New Products in the Territory.  

 

ARTICLE 3 

 

MARIZYME RESPONSIBILITIES.

 

3.1During the term of this Agreement, Marizyme shall (at its expense except as otherwise provided for in this Agreement): 

 

(a)use its best efforts to vigorously develop business in the Territory and to promote the sale of the Product in the Field of Use, which best efforts will include, without limitation, causing technically and personally suitable employees of Marizyme to call regularly and frequently upon Customers and potential Customers located in the Territory; 

 

(b)commencing six (6) months after the Effective Date, on or before the 10th day of each month during the term of this Agreement, supply in good faith to Somahlution with an updated rolling twelve (12) month forecast of its Product purchases, which forecast shall include anticipated requested shipping dates;  

 

(c)provide Somahlution with a written report, in English, on a quarterly basis throughout the term of this Agreement that contains information relating to business development plan, market trends, pricing and a complete Customer list;  

 

(d)establish, train and maintain a qualified and competent sales staff, clinical specialist training staff and service organization adequate to promote, market, and sell the Product throughout the Territory, and to perform Marizyme’s obligations under this Agreement, and Marizyme shall provide a level of Product service that equals or exceeds the best standards in the medical device industry. Furthermore, Marizyme shall conduct training for its sales personnel within a reasonable time after the signing of this Agreement and at reasonable intervals thereafter; 

 

(e)make available one or more qualified employees, as agreed upon by the parties, or such other location as agreed upon by the parties, to be trained in the clinical use of the Product, such training to be provided by Somahlution at its expense with Marizyme paying travel and other related expenses; 

 

(f)maintain a commercially reasonable level and adequate stock of Product; 

 

(g)provide timely field service to Customers in the Territory; 

 

(h)promptly notify Somahlution of any and all inquiries and requests regarding Product from potential or prospective Customers who are located outside of the Territory; and  

 

(i)keep Somahlution fully informed of all governmental, commercial and industry activities and plans that do or could affect the sale of Product in the Territory. 

 

(j)Marizyme shall notify Somahlution of any recalls or modifications of the Products and provide to detailed information to enable Somahlution to provide these to regulatory authorities. The cost of any corrective action or recall initiated by Somahlution shall be borne entirely by Somahlution. 


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ARTICLE 4

 

SALES PROCEDURES.

 

4.1Orders for Products placed by Marizyme from time to time hereunder must be in writing and shall specify the quantities, shipping instructions and shipping schedule requested by Marizyme, and the delivery term, price and payment terms as previously agreed by the parties. Orders are not binding unless accepted by Somahlution and such acceptance by Somahlution shall not be unreasonably withheld. All shipping dates are estimates, and in any event shall be no more than sixty (60) days from order acceptance with respect to the Products. Somahlution shall not be responsible for shipping delays or failure of delivery attributable to circumstances beyond its reasonable control. In the case of a Product shortage, Somahlution reserves the right to allocate its production among its customers (including its distributors) on such basis as Somahlution may reasonably determine, in its sole discretion, provided Somahlution promptly notifies Marizyme of its inability to deliver Product and provides an estimated future delivery date. Marizyme may, in its sole and reasonable discretion, either accept the future delivery date proposed by Somahlution or cancel the applicable purchase order(s). The parties shall revise and reduce any Minimum Purchase Requirement that Marizyme is unable to meet as a result of Somahlution’s inability to supply Products. Somahlution may make delivery of the Products in installments, subject to Marizyme’s agreement in writing; all such installments to be separately invoiced and paid for when due per invoice, without regard to subsequent deliveries. Any delay in delivery of any installment beyond Somahlution’s reasonable control shall not relieve Marizyme of its obligations to accept remaining deliveries provided Marizyme is promptly notified of such delay.  

 

4.2All orders from Marizyme shall be subject to the terms of this Agreement, together with the Terms and Conditions that are not inconsistent with the terms of this Agreement, as supplemented by the specific quantities, shipping instructions and shipping schedule agreed upon in each case. The terms of this Agreement, as so supplemented, shall constitute the entire agreement between the parties with respect to sales of Product by Somahlution to Marizyme, and no additional or different terms set forth in the purchase order, acknowledgment or other forms or correspondence of Marizyme shall govern any such sales.  

 

4.3Unless otherwise specifically notified by Somahlution in writing, Product will be delivered to Marizyme FOB (EXW) Somahlution’s applicable logistics location. Title to the Product purchased hereunder, and all risk of loss or damage to such Product shall pass to Marizyme upon delivery by Somahlution to Marizyme at Somahlution’s logistics location. 

 

4.4Unless otherwise specified in the purchase order accepted by Somahlution, Somahlution shall package the Product in accordance with its standard practices. At Marizyme’s request, expense, and sole risk of loss, Somahlution may arrange for shipment of Marizyme’s Product from the place of manufacture or storage to the port or other point of destination set forth by Marizyme in the order. Somahlution may arrange for freight and insurance coverage on the Products, at Marizyme’s request and expense, in amounts specified by Marizyme, or, if unspecified, that which in Somahlution’s judgment may be proper, provided that Marizyme shall cover and repay Somahlution’s actual cost for such coverage. 

 

4.5Marizyme shall, prior to Somahlution’s scheduled shipment date for Product to be delivered to Marizyme, take all actions and provide all certificates, undertakings and other papers required of Marizyme to allow for proper importation of the Product into the Territory, and Marizyme shall pay all duties, taxes, fees, charges, freight, insurance and other costs necessary to effect such importation. 

 

4.6Marizyme shall take any and all necessary steps to legally import Product, including but not limited to the use of policies and procedures to ensure that the quality and specifications of the Products are maintained during storage, warehousing and shipping to end users. 

 

ARTICLE 5

 

PRICE AND PAYMENT.

 

5.1The initial price for the Products shall be as set forth on the Somahlution Price List set forth on Appendix 4 (the “Price List”). All prices, costs, expenses, and amounts hereunder are quoted and payable in U.S. Dollars. Twelve months after the execution of this Agreement and annually thereafter, Somahlution may increase the price of the Product (typically 2-3% and at most 5% based on the increased cost of business due to cost increases manufacture, transportation, storage or additional regulatory and quality requirements) upon six (6) months’ written notice to Marizyme; provided, however, that any such price increase shall not apply to (i) any order already accepted by Somahlution prior to the date the aforementioned notice is provided to Marizyme. If Marizyme requests a reduction in the applicable price for the Products for a good business reason, Somahlution will consider such request in good faith and the parties will discuss the requested price reduction. If the parties agree in writing on a price reduction for the Products, then the reduced price will apply with prospective effect for the agreed period or, if there is no such agreed period, then until the price for the Products is increased pursuant to the terms of this Agreement.  


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5.2Somahlution may issue its invoice to Marizyme at any time after each shipment. Payment shall be due on or before the 90th day after the date of Somahlution’s invoice for the Product. If Somahlution determines, in its reasonable discretion, that any factor or combination of factors poses, creates or heightens an unacceptable (to Somahlution) credit risk, or if Marizyme places an order for Product that would cause Marizyme to exceed the open credit limit that Somahlution deems to be reasonable under the circumstances, then Somahlution may require a Letter of Credit in advance of shipment of Product hereunder and/or may otherwise modify the applicable payment terms upon written notice to Marizyme. Unless another method of payment is required by Somahlution, Marizyme shall make all payments by wire transfer to the account designated by Somahlution in writing. Any amount not paid as and when due shall bear interest at the rate of LIBOR plus two percent (2%) per annum or at the highest rate permitted by applicable law, whichever is less. Somahlution’s failure at any time to demand payment in advance or to otherwise modify the applicable payment terms shall not be deemed a waiver of Somahlution’s right to do so thereafter. 

 

5.3Any manufacturer’s tax, occupation tax, use tax, sales tax, excise tax, VAT, export tax, import tax, duty, custom, inspection or testing fee, or any other tax, fee, interest or charge of any nature whatsoever imposed by any governmental authority on or measured by the transaction between Somahlution and Marizyme (specifically excluding any income tax, corporate tax or similar tax payable by Somahlution) shall be paid by Marizyme in addition to the prices quoted or invoiced. In the event Somahlution is required to pay any such tax, fee, interest or charge, Marizyme shall reimburse Somahlution therefor upon demand and upon proof thereof. Marizyme shall also pay any and all reasonable collection fees and reasonable attorneys’ fees incurred by Somahlution in collecting payment of the purchase price and any other amounts for which Marizyme is liable under this Agreement. 

 

5.4If Marizyme is performing all manufacturing activities and not purchasing partially made products from Somahlutions for assembly, Marizyme will pay 3% royalty on the first $100 Million of gross income to Somahlution or until patents expire. and shall have no further obligation to pay royalties to Somahlution.  

 

ARTICLE 6

 

COMPLIANCE WITH LAWS

 

6.1Somahlutions shall obtain and maintain all licenses, permits and other governmental approvals necessary to permit the purchase of and payment for Products by Marizyme hereunder and to otherwise permit Marizyme’s performance hereunder. Marizyme shall comply with any and all governmental laws and regulations which may be applicable to Marizyme by reason of its execution of this Agreement or its agreement to act as a Marizyme of Product in the Territory, including but not limited to any law applicable to the marketing of medical devices within the Territory. By placing each order hereunder, Marizyme represents and warrants that it has obtained all requisite licenses, permits and governmental approvals to enable Marizyme to comply with all of the provisions of this Agreement and that such licenses, permits and governmental approvals remain in full force and effect. 

 

6.2Marizyme acknowledges that the Product and associated documentation may be subject to United States export control laws and regulations. Marizyme further acknowledges that technical data contained in any of the foregoing may be subject to export and re-export restrictions imposed by applicable law. Marizyme confirms and agrees that the Product will only be exported to the Territory. Marizyme will not export or re-export Product, directly or indirectly, in violation of applicable laws of the Territory, of the United States or any other applicable law. Marizyme represents and warrants that no governmental agency has suspended, revoked or denied Marizyme’s import, distribution or export privileges. Marizyme shall conduct all due diligence necessary or appropriate to assure that it will not resell to any person or entity in violation of applicable law of the Territory, of the United States or other applicable law. However, such due diligence shall not waive, discharge, limit, restrict or otherwise modify Marizyme’s obligation to comply with the terms of this Agreement. 

 

6.3Marizyme shall not, and shall ensure that none of its officers, directors, employees or agents, offer, pay, promise to pay, or authorize the payment of any money, or offer, gift, promise to give, or authorize the giving of anything of value to (i) any official from government, hospital or other, political party or official thereof or any candidate for political office or (ii) any person, while knowing that all or a portion of such money or thing of value will be offered, given, or promised, directly or indirectly, to any official, to any political party or official thereof, or to any candidate for political office, for purposes of (1) influencing any act or decision of such official, political party, party official or candidate in its or his official capacity, as the case may be; (2) inducing such official, political party, party official, or candidate to do or omit to do any act in violation of the lawful duty of such official, party, official or candidate; or securing any improper advantage for Marizyme or any other party; or (3) inducing such official, party, official, or candidate to use its or his influence with a government or instrumentality thereof to affect or influence any act or decision of such government or instrumentality, in order to assist Marizyme in obtaining or retaining business for or with, or directing business to, any person.  


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6.4Marizyme acknowledges that the Product is not designed to meet the labeling requirements of the Territory. Marizyme shall be responsible for ensuring that all Products sold by it within the Territory comply with all labeling requirements. Marizyme shall also ensure that all Products sold by it bear all instructions and labels that have been applied or provided by Somahlution and that are applicable to the Product that are necessary under laws, regulations or practices in the Territory, and shall, at Marizyme’s sole expense, translate into an appropriate language of the Territory, and reproduce in such translation, all instructional materials provided in English by Somahlution. Such labeling and identification must be acceptable to Somahlution and shall not be altered or added to by Marizyme unless prior written approval in obtained from Somahlution. 

 

6.7Marizyme shall notify Somahlution of the existence and content of any provision of law in the Territory or any other applicable law which conflicts with any provision of this Agreement at the time of its execution or anytime thereafter. Without limiting any of the foregoing, Marizyme warrants, covenants and agrees that it will comply with all applicable laws of the Territory and of the U.S., including but not limited to the U.S. Foreign Corrupt Practices Act [(15 U.S.C. §§ 78dd-1, et seq.) ("FCPA")]. 

 

ARTICLE 7

 

SOMAHLUTION RESPONSIBILITIES.

 

7.1Somahlution shall provide Marizyme with sales, marketing and technical information applicable to the Products, in English and Spanish as requested by Marizyme, all in reasonable quantities as determined by Somahlution and at Marizyme costs. 

 

7.2Somahlution shall make available and provide training to Marizyme’s field service and clinical support personnel, which such training shall occur at Somahlution’s facilities in Jupiter, Florida, USA, or such other location as the parties agree in good faith. The content of such training shall include, but is not limited to, the proper use of the Products, as well as training to enable Marizyme’s clinical support personnel to provide clinical consultation and support to its Customers for the use of such Product. Marizyme shall be solely responsible for any and all travel, living or other expenses related to such trainings. Somahlution shall provide Marizyme with training updates at Marizyme’s request and expense.  

 

7.3Somahlution shall provide Customer support Monday through Friday 9:00 AM to 5:00 PM Eastern Time through Somahlution’s Customer-Care Unit, except on legal holidays.  

 

7.4Somahlution shall notify Marizyme of any recalls or modifications of the Products and provide to Marizyme instructions as required, for their rectification. The cost of any corrective action or recall initiated by Somahlution shall be borne entirely by Somahlution. 

 

7.5Somahlution shall use commercially reasonable efforts to deliver all orders within the requested delivery schedule.  

 

7.6Somahlution will provide Marizyme with a reasonable quantity of Somahlution’s current advertising and promotional materials at no cost to Marizyme. In the event Marizyme chooses to produce local advertising and promotional materials, which shall include any translations of existing Somahlution materials, Marizyme shall provide Somahlution, free of charge, with copies of such materials, including audio visual aids, and English translations thereof, and such materials shall be subject to Somahlution’s approval prior to their distribution to the market. 

 

7.7Somahlution will provide the assistance and participation of Satish Chandran, CEO and Catherine Pachuk, CSO of Somahlution to provide technical support for technology transfer process, pre-clinical trial research, clinical trials, regulatory, quality and commercialization. Marizyme will reimburse relevant expenses to Somahlution personnel involved in supporting Marizyme’s product development and commercial activities.  

 

7.8Somahlution has received an OPS (procedural) code for the product for tracking purposes in German hospitals and will provide all information required to Marizyme for successful commercialization. 


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7.9In any Territory that Marizyme or its agent previously paid for and prospectively pays for any patent application, extension or any invoice related to any Somahlution intellectual property in any field of use, then Marizyme shall own all right, title, and interest in all of the intellectual property underlying the payment made for that Territory in perpetuity and Somahlution shall assign the ownership of the intellectual property to Marizyme upon request from Marizyme. Somahlution agrees that Appendix 6 describes the Territories where Marizyme has already paid invoices and Somahlution further agrees that Marizyme currently owns all right, title and interest to the intellectual property and patents listed in perpetuity. Somahlution will use its best efforts to formally assign, upon request from Marizyme, those patents and intellectual property listed in Appendix 6 to Marizyme using a form of assignment in Appendix 7 or a similar document as agreed by the parties at the time of the assignment, and as required by the country PTO. Until the assignment is complete, Somahlution agrees that it has received good and valuable consideration from Marizyme or its agent and that Marizyme currently is the rightful owner of the intellectual property and patents as described in Appendix 6.  

 

ARTICLE 8 

 

REGUALTORY LISTINGS AND QUALITY ASSURANCE ACTIVITIES.

 

8.1Marizyme will list the Products with Local Health Authorities for the Field of Use, if required by law, prior to import and sale of the Products in the Territory. 

 

8.2Marizyme will be responsible, after taking possession of Product, to maintain Product in environmental conditions that will not affect the safety, efficacy or performance of Product.  

 

8.3Marizyme will choose appropriate shipping and logistics firms that can provide evidence of temperature control and monitoring. 

 

8.4Marizyme will ship the Products to end-users while maintaining proper temperature conditions and will store the Products in a temperature-controlled facility or storage areas that meets the storage and handling specifications of the Products listed in Appendix 5 attached hereto. 

 

ARTICLE 9 

 

TRADEMARKS AND PROPRIETARY RIGHTS.

 

9.1Marizyme acknowledges the commercial and proprietary value to Somahlution of the Trademarks, as well as the validity thereof. Somahlution shall retain sole and exclusive ownership of all goodwill associated with the Products, as represented and symbolized by the Trademarks, and Marizyme shall not register any of the Trademarks in its name. Marizyme shall not remove or alter any copyright notices or any Trademarks from the packaging for the Products or add any notices, marks or labels of any kind, except as expressly permitted hereunder or authorized by Somahlution in writing. Marizyme shall not grant or attempt to grant to any third party any right or license to use the Trademarks. 

 

9.2The Trademarks are and shall remain the sole and exclusive property of Somahlution, which has and shall continue to have the exclusive right to register the Trademarks, including, but not limited to, within the Territory and, as applicable, to apply for entry or removal of Marizyme as a registered user thereof; and Marizyme agrees to be so entered or removed, and shall execute all documents required to accomplish such entry or removal. Marizyme shall not acquire any ownership rights in or to the Trademarks; and all use of the Trademarks by Marizyme shall inure to the benefit of Somahlution. In the event Marizyme shall be deemed to have acquired any such rights in the Trademarks, Marizyme agrees to execute all documents reasonably requested by Somahlution to assign all such rights in the Trademarks to Somahlution. Marizyme is permitted to use the Trademarks only insofar as the Product and/or materials supplied or approved by Somahlution may bear the Trademarks. Marizyme agrees to display the Trademarks solely in connection with identifying Somahlution in the sale and marketing of Product hereunder. Without limiting the foregoing, Marizyme shall not use Somahlution’s corporate name or any of Somahlution’s trade names without the express, written permission of Somahlution. Unless otherwise provided for in this Agreement, upon expiration or termination of this Agreement, Marizyme shall forthwith remove from its property and immediately cease to use, directly or indirectly, the Trademarks and any word, title, expression, trademark, design or marking which, in the opinion of Somahlution, is confusingly similar thereto, and (if required) Marizyme shall join with Somahlution in executing all documents and doing all acts and things as shall be necessary or convenient for canceling any entry in any register of trademarks relating to the right of Marizyme to use any of the Trademarks. 


8




 

 

9.3Except as agreed in Article 7.9 above, Marizyme acknowledges and agrees that Somahlution owns and will retain all rights, title and interest in and to the intellectual property rights that are embodied in or relate to the Product, including without limitation all patent rights, trademarks, trade names, inventions, discoveries, developments, modifications, copyrights, know-how, trade secrets and the like relating to the design, manufacture, operation, use or sale of the Product. Marizyme hereby specifically acknowledges and agrees that it does not have, nor will it have claim to, any proprietary rights in the Products. The sole right which is granted to Marizyme regarding the Products is to sell the Products under the terms and conditions of this Agreement. In addition, Marizyme shall be entitled to use, subject to the obligations imposed by Article 12 below, Somahlution’s technical data and other know-how relating to the Product supplied by Somahlution, provided that such use by Marizyme shall be for the sole and limited purposes of implementing use of the Product being used by Customers within the Territory in the Field of Use and/or training of Customers in the proper and lawful use of such Product. 

 

9.4Marizyme hereby acknowledges and agrees that in the event of any violation of Section 9.1, Section 9.2 or Section 9.3 Somahlution shall be authorized and entitled to obtain from any court of competent jurisdiction preliminary and permanent injunctive relief, as well as an equitable accounting of all profits and benefits arising out of such violation, which rights and remedies shall be cumulative and in addition to any and all other rights or remedies to which Somahlution shall be entitled at law or in equity under this Agreement. 

 

9.5Marizyme agrees to inform Somahlution within thirty (30) days of discovery of any possible infringement by third parties of Somahlution’s proprietary rights, including without limitation any duplication of the Products, and to participate with Somahlution, at Somahlution’s expense, regarding any legal action against such infringement which, in Somahlution’s judgment, is necessary. 

 

9.6If Marizyme notifies Somahlution of a claim it has received that the Product or any part thereof purchased by Marizyme hereunder infringes a third party’s proprietary rights in the Territory, then Somahlution agrees, at its discretion, either to (a) defend the claim at its expense, with the cooperation of Marizyme, or (b) purchase the right to use such proprietary right. The foregoing states the entire liability of Somahlution with respect to infringement of patents or other proprietary rights by the Products or any part thereof, including without limitation their use or operation. 

 

ARTICLE 10 

 

WARRANTY.

 

10.1Subject to the terms and conditions hereof, Somahlution warrants to the Customer that the Product provided under this Agreement: (i) complies with the specifications for such Product, and (ii) was manufactured consistent with any applicable Good Manufacturing Practice regulations promulgated by the U.S. Food and Drug Administration and/or of ISO:13485.  

 

10.2Marizyme shall extend to each Customer the applicable Warranty for the Product, subject to all of the terms, conditions and limitations of such Warranty, and shall not extend any other warranty to the Products. If Marizyme becomes aware of any warranty claim by any of its Customers with respect to the Products, Marizyme will within 7 days of such claim notify Somahlution thereof in writing and shall provide such detail and information as Somahlution may request. Marizyme shall cooperate with Somahlution, at Somahlution’s expense, to resolve any breach of warranty claims arising from a Warranty and to fulfill the warranty obligations set forth in the applicable Warranty. Marizyme shall be responsible for any and all representations, warranties and statements which were not specifically authorized in writing by Somahlution and shall defend, indemnify and hold harmless Somahlution from and against any and all reasonable costs, damages, expenses, liabilities and obligations arising from or relating in any way to any such representation or statement made or any warranty offered or extended by Marizyme other than the Warranty offered in strict accordance with the terms of this Article 10. 

 

10.3Section 10.1 above sets forth the sole warranty made by Somahlution with respect to the Product and its delivery to Marizyme. The parties to this Agreement acknowledge and agree that other than the foregoing, no other warranty, whether expressed, implied or by applicable law, shall be effective with respect to the Product or their delivery, and Somahlution SPECIFICALLY MAKES NO WARRANTY OF MERCHANTABILITY OR WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCT OR ANY OTHER MATTER CONTEMPLATED BY THIS AGREEMENT. 


9




 

 

ARTICLE 11 

 

INDEMNIFICATION AND INSURANCE.

 

11.1Marizyme shall indemnify and hold Somahlution harmless from and against any and all third party claims, losses, demands, actions, suits, damages, liabilities, costs and expenses, including reasonable attorney’s fees, incurred by Somahlution by reason of (a) the negligence or misconduct and intentional misconduct of Marizyme or its employees or agents, (b) any misrepresentations or omissions by Marizyme or its employees or agents relating to the Product, or (c) a breach by Marizyme of any provision of this Agreement or the failure of Marizyme to perform its obligations under this Agreement. 

 

11.2Somahlution shall indemnify and hold Marizyme harmless from and against any and all third party claims, losses, demands, actions, suits, damages, liabilities, costs and expenses, including reasonable attorney’s fees, incurred by Marizyme by reason of (a) the negligence or misconduct of Somahlution or its employees or agents, (b) any misrepresentations or omissions by Somahlution or its employees or agents relating to the Product, or (c) a breach by Somahlution of any provision of this Agreement or the failure of Somahlution to perform its obligations under this Agreement. 

 

11.3Each party shall, at its own expense, maintain in force policies of insurance with reputable and solvent insurers sufficient in coverage and amounts to secure its obligations and potential liabilities. Such insurance shall be in form and substance reasonably satisfactory to the other party hereto and, in any event, shall include commercial general liability, third party, and product liability insurance with policy limits of at least one million U.S. Dollars (USD $1,000,000.00) each occurrence for bodily injury, one million U.S. Dollars (USD $1,000,000.00) each occurrence for damage to property, or, alternatively, one million U.S. Dollars (USD $1,000,000.00) combined single limit each occurrence for injury and property damage combined. At a party’s request, the other party shall provide documentation satisfactory to the requesting party evidencing such insurance and copies of such insurance policies. Such insurance shall not, however, limit either party’s obligations or potential liability under this Agreement. 

 

ARTICLE 12 

 

CONFIDENTIALITY.

 

12.1The term “Confidential Information” means all inventions, technical information, processes, trade secrets, know-how, designs, formulations, certificates of analysis, specifications, plans, drawings, blueprints, samples, models, prototypes, catalogs, service manuals, data sheets, sales, service and technical bulletins, customer lists, sales and marketing programs, price lists, cost data, sales aids (such as videos and recordings) and all other publications and information, whether or not reduced to writing, relating to the design, manufacture, use, marketing or sale of the Product, as well as any other information relating to the business of Somahlution which may be divulged to or otherwise obtained by Marizyme in the course of its performance of this Agreement and which is generally not known in the trade. “Confidential Information” shall not include any information disclosed by Somahlution hereunder which Marizyme can demonstrate by reasonable documentary evidence (a) is already known to Marizyme and which Marizyme had in its possession in written or physical embodiment prior to the disclosure, unless such Confidential Information was previously disclosed by Somahlution, or (b) is rightfully received by Marizyme in the routine course of business from a third party who is not in breach of any confidentiality obligation by disclosing such information. 

 

12.2Marizyme shall hold the Confidential Information in strict confidence and shall not use or disclose or distribute it except as required to perform its obligations under this Agreement. Marizyme agrees not to reverse engineer any Confidential Information or the Product. Without limiting the foregoing, Marizyme agrees that the Confidential Information shall be disclosed only to such of its employees and sales or service representatives or other persons as have a need to know such Confidential Information for a use expressly contemplated by this Agreement, and only to such employees, sales or service representatives or other persons who have been informed of the obligations contained in this Article 12 and have agreed in writing to be bound by such obligations. Marizyme will be responsible and liable for any breach of these obligations that is committed by any such employee, sales or service representative, sub-Marizyme or other person as if the breach had been committed by Marizyme. 

 

12.3The terms of this Article 12 shall survive expiration or termination of this Agreement for a period of five (5) years immediately following such expiration or termination. Notwithstanding anything in this Agreement to the contrary, each party’s rights, duties and obligations, whether arising under this Agreement or at law, with respect to any Confidential Information that constitutes a ‘trade secret’ shall continue until such Confidential Information is no longer considered a trade secret under applicable law (other than as the result of breach or expiration or termination of this Agreement or any other confidentiality obligation). 

 

12.4Marizyme shall return to Somahlution all Confidential Information, including all copies thereof, upon expiration or termination of this Agreement or upon Somahlution’s request, whichever event shall occur first. 


10




 

 

12.5Marizyme shall bind in writing its employees, officers, sales, technical, maintenance and service representatives, and other third parties (if any) to whom Confidential Information is disclosed as permitted hereunder, to the terms and conditions contained herein. 

 

12.6Unless otherwise specifically stated herein, this Agreement does not grant Marizyme any manufacturing, assembly, production or licensing rights, or any rights in any patents, patent applications, trademarks, trade names, copyrights or know-how of Somahlution. 

 

12.7The Parties agree that this Agreement does not prohibit the disclosure of Confidential Information where applicable law requires, including, but not limited to, disclosure in response to subpoenas and/or orders of a governmental agency or court of competent jurisdiction and any disclosures necessary to comply with applicable securities laws. In the event Somahlution or Marizyme is required to disclose Confidential Information in accordance with the previous sentence, that party shall immediately, and in no event later than five (5) days prior to such required disclosure, notify the other party in writing, and cooperate with in seeking to limit the disclosure of such Confidential Information in accordance with public law.  

 

12.8Marizyme hereby acknowledges and agrees that in the event of any violation of this Article 12, Somahlution shall be authorized and entitled to obtain from any court of competent jurisdiction preliminary and permanent injunctive relief, as well as an equitable accounting of all profits and benefits arising out of such violation, which rights and remedies shall be cumulative and in addition to any and all other rights and remedies to which Somahlution shall be entitled at law or equity under this Agreement. 

 

ARTICLE 13 

 

TERM AND TERMINATION.

 

13.1The term of this Agreement shall commence on the Effective Date and, subject to earlier termination pursuant to its terms, shall remain in full force and effect for an initial term of five (5) years. At the end of the initial five (5) year term, the term of this Agreement shall be extended in perpetuity in all areas where the Marizyme is already operating. This Agreement may be terminated prior to the expiration of the initial or any renewal term by prior written notice from one party to the other party as follows: 

 

(a)By Somahlution, effective immediately upon written notice, in the event that Marizyme breaches any of its obligations under Article 2, Article 3, Article 9 or Article 12; 

 

(b)By Somahlution, effective immediately upon notice, in the event of any submission by Marizyme to Somahlution of any false or fraudulent claim, or statement in support thereof, for payment, for compensation or for any discount, allowance, refund or credit, warranty claim, or any claim made by Marizyme to Somahlution; 

 

(c)By Somahlution, effective immediately upon written notice, in the event that Marizyme defaults under any of its monetary obligations under this Agreement and fails to remedy such monetary default within ten (10) business days after receiving written notice thereof; 

 

(d)By Somahlution, if Marizyme fails to maintain a current account status or to furnish reasonable financial information on request within thirty (30) calendar days after receiving written demand therefor; 

 

(e)By Somahlution, in the event that Marizyme fails to maintain and properly train a staff of sales and service personnel of adequate size for the Product and fails to remedy such failure within forty-five (45) calendar days after receiving written demand therefor; 

 

(f)By either party, in the event the other party is in breach of this Agreement (other than a breach with respect to which the termination rights are otherwise expressly addressed in this Section 0 or elsewhere in this Agreement) and fails to cure such breach within forty five (45) calendar days after receiving written demand therefor; 

 

(g)By Somahlution, effective immediately, if Marizyme attempts to transfer by any means more than fifty percent (50%) of the assets of Marizyme, Somahlution’s consent shall not be unreasonably withheld. 

 

(h)For purposes of this Section 13.1(h) a “change in ownership or control” shall mean any direct or indirect change of control of Marizyme, including, without limitation, any event that results in the person or persons who ultimately own or control Marizyme as of the date first written above (i) ceasing to have the right or ability to direct or cause the direction of the management and/or policies of Marizyme, or (ii) ceasing directly or indirectly to own of record or beneficially more than fifty percent (50%) of the ownership or equity interests of Marizyme;  


11




 

 

(i)By either party effective immediately, if the other party becomes the subject of any voluntary or involuntary bankruptcy, receivership or other insolvency proceedings or makes any assignment or other arrangements for the benefit of creditors;  

 

(j)By Somahlution, effective immediately, if any law or regulation is adopted or in effect in the Territory that would restrict Somahlution’s termination rights or otherwise invalidate any provision of this Agreement, or if any of Marizyme’s assets are seized, expropriated or nationalized; or  

 

(k)By Somahlution, effective immediately upon written notice, in the event that Marizyme does not meet the Minimum Purchase Requirements under this Agreement and fails to remedy such default within thirty (30) business days after receiving written notice thereof.  

 

13.2Upon expiration or termination of this Agreement, any and all balances owed by Marizyme to Somahlution that are then outstanding shall become immediately due and payable without further notice or demand, which is hereby expressly waived, and Somahlution shall be entitled to reimbursement for any reasonable attorneys’ fees that it may incur in collecting or enforcing payment of such obligations. In addition, upon expiration or termination of this Agreement, Marizyme shall return all catalogs, price lists, drawings, instruction sheets, advertising and other promotional materials and all of Somahlution’s supplies of every kind and character, and all other documents relating to the business of Somahlution which may be in the possession or under the control of Marizyme, including without limitation any and all Confidential Information. Furthermore, Marizyme shall provide Somahlution with a list of all of its Customers, as well as potential Customers and Customer prospects, together with relevant contact information and such detail concerning buying history, price and payment history and the like as Somahlution may request and shall assign to and deliver all Regulatory Approvals to Somahlution. 

 

13.3At the time of expiration or termination of this Agreement, Marizyme may sell remaining unsold Product previously purchased and paid for by Marizyme at Somahlution’s sole discretion.  

 

13.4Somahlution acknowledges that Marizyme may have entered into binding contractual obligations with third parties before termination or expiration of this Agreement; accordingly, following termination or expiration of this Agreement, Somahlution shall make available to Marizyme: (a) the Product that is the subject of such contractual obligation, upon proof thereof; and (b) such support, no less favorable than that provided during the term of this Agreement, to permit Marizyme to fulfill service support and maintenance obligations entered into with Customers during the term of this Agreement.  

 

13.5The clauses of this Agreement that are intended to survive its expiration or termination, including without limitation Articles 9, 10, 11, 12 and 14 and any and all obligations including any enforcement actions that arise prior to expiration or termination, shall survive expiration or termination of this Agreement. 

 

ARTICLE 14 

 

MISCELLANEOUS.

 

14.1SOMAHLUTION SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL OR CONTINGENT DAMAGES WHATSOEVER, WHETHER ARISING OUT OF BREACH OF CONTRACT, WARRANTY, TORT (INCLUDING NEGLIGENCE AND STRICT LIABILITY) OR OTHER THEORIES OF LAW, WITH RESPECT TO PRODUCT SOLD HEREUNDER, OR ANY UNDERTAKINGS, ACTS OR OMISSIONS RELATING THERETO, AND SOMAHLUTION HEREBY DISCLAIMS ALL SUCH DAMAGES. Without limiting the foregoing provision, Somahlution specifically disclaims and shall not be liable hereunder for any claims for loss of use or lost profits, lost income or damage to reputation.  

 

14.2Marizyme represents and warrants that: (i) it is not currently and will not in any way whatsoever during the term of this Agreement be contractually restricted or prohibited from entering into this Agreement and performing its obligations herein contained, and (ii) its execution of this Agreement, and its performance of its obligations herein contained, do not and will not constitute a default or an event that, with or without notice or lapse of time or both, would be a default, breach or violation of any agreement, contract, instrument or arrangement to which it is a party or by which it is bound. 


12




 

 

14.3This Agreement may not be assigned by either party, in whole or in part, whether voluntarily or by operation of law, without the prior written consent of the other party. Any attempted assignment by either party without such consent shall be null and void and without legal effect. Notwithstanding the foregoing, however, Somahlution, may, upon written notice to Marizyme, assign or otherwise transfer this Agreement or the rights and obligations arising hereunder to a third-party to whom Somahlution sells all rights to the Products, any affiliate of Somahlution or to any acquirer of all or substantially all of Somahlution’s assets without Marizyme’s consent. For purposes of this Section 0, the term “affiliate” shall include any person or entity that, directly or indirectly, controls, is controlled by, or is under common control with Somahlution. 

 

14.4This Agreement constitutes the entire agreement between the parties, and it supersedes any and all prior and contemporaneous oral or written agreements, understandings, conditions and warranties, between the parties hereto on the subject matter hereof. Except as otherwise expressly contemplated herein, this Agreement may be modified or amended only by a writing signed by both of the parties hereto. There are no conditions to this Agreement which are not set forth herein. 

 

14.5Notification required or permitted hereby shall be given in writing and shall be deemed given only upon transmission by confirmed facsimile on the first business day after transmission thereof or five (5) business days after being sent postage pre-paid by registered or certified airmail, return receipt requested, or on the date of delivery by private international courier upon proof thereof, and (in each case) addressed to the party to be given notification at the address listed in conjunction with that party’s name as set forth in Appendix 1. 

 

14.6THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF FLORIDA, U.S.A., WITHOUT REFERENCE TO PRINCIPLES OF CONFLICTS OF LAWS. THIS AGREEMENT AND ANY AND ALL SALES OF PRODUCT BY SOMAHLUTION TO MARIZYME SHALL NOT BE GOVERNED BY THE PROVISIONS OF THE 1980 U.N. CONVENTION ON CONTRACTS FOR THE INTERNATIONAL SALE OF PRODUCT.  

 

14.7Any dispute, controversy or claim arising out of or relating to this Agreement, its interpretation or enforcement, or the breach, expiration, termination or invalidity hereof, shall be adjudicated in English in U.S. Federal District Court for the Southern District of Florida in West Palm Beach, Florida. 

 

14.8Except as otherwise expressly provided in this Agreement, the rights and remedies provided each of the parties herein shall be cumulative and in addition to any other rights and remedies provided by law or otherwise. Any failure in the exercise by either party of its right to terminate this Agreement or to enforce any provision of this Agreement for any default or violation by the other party shall not prejudice such party’s right of termination or enforcement for such or any other default or violation. 

 

14.9If, by reason of any cause beyond the reasonable control of either party hereto, including, but not limited to, strikes, failure of major subcontractors, fire, hurricane, flood or other acts of nature or acts of God, accidents, war, acts of terrorism, civil unrest, embargo or other governmental act, regulation or request, or other legal restrictions, such party is delayed in its performance, in whole or in part, of its obligations under this Agreement (other than monetary obligations), then such party shall be excused from such performance and such nonperformance will not make the party liable to the other party. The party delayed shall, as promptly as reasonably possible, notify the other party of the reasons for the delay and its estimated duration. 

 

14.10In the event a court of competent jurisdiction determines any one or more of the provisions contained in this Agreement to be invalid, illegal or unenforceable, this Agreement shall be construed so that the remaining provisions contained herein shall not in any way be affected thereby but shall remain in full force and effect, and any such invalid, illegal or unenforceable provision(s) shall be deemed, without further action by any person or entity, to be modified or limited to the minimum extent necessary to render the same valid and enforceable in such jurisdiction. 

 

14.11This Agreement shall not take effect unless and until both parties have signed it. However, this Agreement may be executed in any number of counterparts, each of which when so executed shall constitute an original, and all of which shall be deemed one and the same instrument, and which counterparts may be exchanged as an attachment to an email or by facsimile transmission. 

 

14.12This Agreement has been expressed in English at the wish of the parties. The parties confirm and agree that the English-language version of this Agreement shall govern and control any translation of this Agreement into any other language.  


13




 

 

IN WITNESS WHEREOF, the parties have caused their duly authorized representatives to execute this Agreement as of the date first above written.

 

	SOMAHLUTION LLC

	 

	 

	Marizyme, Inc.

	 


	(“Somahlution”)

	 

	 

	(“Marizyme”)

	 


	 

	 

	 

	 

	 


	By:

	/s/ Satish Chandran 

	 

	By:

	/s/ Nicholas DeVito


	Title:

	CEO

	 

	Title:

	CEO


	Date:

	April 27, 2020

	 

	Date:

	April 27, 2020





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Appendix 2

 

Products

 

1.DuraGraft – Vascular Conduit Solution- For use in Cardiac and Peripheral Bypass Grafting with Arteries and Veins and For Vascular Surgeries 

 

2.“A CE Marked Product” – Notified Body is BSI, Netherlands 

 

a.SOMVC001 

b.SOMVC002 


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Appendix 3

 

Territory

 

1.Exclusive License for, Manufacture and Distribution of both Somahlution and Marizyme made product 

 

a.Mexico 

 

b.All Countries in South America 

 

c.Canada 

 

d.South Korea 

 

e.China, including Hong Kong 

 

f.Japan 

 

g.Taiwan 

 

h.Australia 

 

i.South Africa 

 

j.Israel 

 

k.New Zealand 

 

l.License for Distribution only using Somahlution made product at transfer pricing and ASPs consistent with EU pricing to prevent parallel import issues in EU and for future manufacturing once Somahlutions transfers the CE mark per Section 2.4.f to Marizyme 

 

m.Germany (upon expiration of existing distribution agreement with HeartCor on January 31, 2020). 

 

n.Czech Republic (upon expiration of existing distribution agreement with Medical Innovation on January 2021) 

 

o.Poland (upon expiration of existing distribution agreement with Medical Innovation on January 2021) 

 

p.Sweden (upon expiration of existing distribution agreement with Wingmed on January 31, 2020). 

 

q.United Kingdom (upon expiration of existing distribution agreement with Cardiac Services on January 31, 2020). 

 

r.Ireland (upon expiration of existing distribution agreement with Sisk Medical on January 31, 2020). 

 

s.All remaining countries in Europe 

 

2.Somahlution will make best efforts to transfer manufacturing responsibility to Marizyme in all Licensed Territories.  


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Appendix 6

Current Intellectual Property and Patent Ownership. 

 

	Country

	Patent or patent application

	Owned by


	Argentina

	Commercial DuraGraft (DG); Pending; Under examination; 

	Marizyme


	Australia

	Commercial DG; Granted. Annuity Payment Issue.

	Marizyme


	Brazil

	Commercial DG; Pending; Under Examination

	Marizyme


	Canada

	Commercial DG; Pending; Under examination

	Marizyme


	China

	Commercial DG; Pending; Under examination

	Marizyme


	Eurasia

	Commercial DG; Pending; Under examination

	Marizyme


	Europe *

	Commercial DG: Granted 

Alternate DG; Granted

Somah solution; Granted

	Somahlution


	India

	Commercial DG; Pending; under examination

Somah; Pending; under examination

	Somahlution


	Indonesia

	Commercial DG; Pending; under examination

	Marizyme


	Israel

	Commercial DG; Pending; Under examination

	Marizyme


	Jordan

	Commercial DG; Pending

	Somahlution


	Malaysia

	Commercial DG; Pending

	Somahlution


	Philippines

	Commercial DG: Granted 

	Somahlution


	Singapore

	Commercial DG; Granted 

	Somahlution


	South Korea

	Commercial DG; Pending.

	Marizyme


	Kuwait 

	Commercial DG; Pending

	Somahlution


	Mexico

	Somah Patent; Granted

	Marizyme


	Mexico

	Commercial DG; Pending; under examination

	Marizyme


	South Africa

	Commercial DG; Pending; Under examination

	Marizyme


	Sri Lanka 

	Commercial DG; Granted

	Somahlution


	Taiwan

	Somah; Granted

	Marizyme


	Taiwan

	Alternate DG; Granted

	Marizyme


	Thailand

	Commercial DG; Pending

	Marizyme


	United States

	Commercial DG; Pending; under examination

Alternate DG; Pending; under examination

Somah; Pending; under examination

	Somahlution


	Vietnam

	Commercial DG; Pending

	Somahlution




 

*European Granted Patents covering Commercial DuraGraft, Alternate DuraGraft and Somah Preservation Solutions.

 

Solutions for Increasing the Stability and Shelf Life of an Organ Tissue Preservation Solution”

 

European Patent No. 3027016 

 

Anticipated Expiration: 11/18/2034

 

“Organ and Tissue Preservation Formulations with increased stability and shelf life”

 

European Patent No. 2938186

 

Anticipated Expiration: 12/27/2033

 

“Solution For Preserving Vascular Conduits”

 

European Patent No. 2938187

 

Anticipated Expiration: 12/27/2033


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Appendix 7

 

Forms of Intellectual Property Assignment of patents paid for and owned by Marizyme (Appendix 6)

 

ASSIGNMENT OF RIGHTS - PATENT ISSUED

 

Somahlutions, LLC., with an address in Jupiter, FL (the "Assignor") is owner of (INSERT TERRITORY US, EU, etc.) Patent Number: ______, dated ______, titled ____________[insert name of invention], (the "Patent"). Marizyme, Inc. with an address in Davenport, FL (the "Assignee") desires to acquire all right, title and interest in and to the Patent.

 

Therefore, for valuable consideration, the receipt of which is acknowledged, Assignor assigns to Assignee 100% of his or her right, title and interest in the invention and Patent to Assignee for the entire term of the Patent and any reissues or extensions and for the entire terms of any patents, reissues, or extensions that may issue from foreign applications, divisions, continuations in whole or part, or substitute applications filed claiming the benefit of the Patent. The right, title, and interest conveyed in this Assignment is to be held and enjoyed by Assignee and Assignee's successors as fully and exclusively as it would have been held and enjoyed by Assignor had this assignment not been made.

 

Assignor further agrees to: (a) cooperate with Assignee in the protection of the patent rights and prosecution and protection of foreign counterparts; (b) execute, verify, acknowledge and deliver all such further papers, including patent applications and instruments of transfer; and (c) perform such other acts as Assignee lawfully may request to obtain or maintain the Patent and any and all applications and registrations for the invention in any and all countries.

 

	Date:

	 


	 


	Assignor Signature Block


	 


	Assignee Signature Block


	 




 

[to be completed by notary public]

 

On this _____ day of _________, before me, _________________________, the undersigned Notary Public, personally appeared ____________ ASSIGNOR, personally known to me (or proved to me on the basis of satisfactory evidence) to be the person whose name is subscribed to the within instrument, and acknowledged to me that he or she executed the same. WITNESS my hand and official seal in _____________ County of ______________ on the date set forth in this certificate.

 

 

	Notary Public





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ASSIGNMENT OF RIGHTS: PATENT APPLICATION

 

Somahlutions, LLC., with an address in Jupiter, FL (the "Assignor") is owner of _____________ [insert name of invention], as described in the (insert territory, US, EU, etc..) Patent Application signed by Assignor on _____ [insert date you signed your patent application], (insert territory, US, EU, etc..) Patent and Trademark office Serial Number: _____, filed ________ [insert filing date], (the "Patent Application"). ___________ Marizyme, Inc. with an address in Davenport, FL (the "Assignee") desires to acquire all right, title and interest in and to the Patent Application and the patent (and any reissues or extensions) that may be granted.

 

Therefore, for valuable consideration, the receipt of which is acknowledged, Assignor assigns to Assignee 100% of his or her right, title, and interest in the invention and Patent Application (as well as such rights in any divisions, continuations in whole or part, or substitute applications) to Assignee for the entire term of the issued Patent and any reissues or extensions that may be granted and for the entire terms of any and all foreign patents that may issue from foreign applications (as well as divisions, continuations in whole or part, or substitute applications) filed claiming the benefit of the Patent Application.

 

Assignor authorizes the United States Patent and Trademark Office to issue any Patents resulting from the Patent Application to Assignee according to the percentage interest indicated in this assignment. The right, title, and interest is to be held and enjoyed by Assignee and Assignee's successors and assigns as fully and exclusively as it would have been held and enjoyed by Assignor had this assignment not been made.

 

Assignor further agrees to: (a) cooperate with Assignee in the prosecution of the Application and foreign counterparts; (b) execute, verify, acknowledge, and deliver all such further papers, including patent applications and instruments of transfer; and (c) perform such other acts as Assignee lawfully may request to obtain or maintain the Patent for the invention in any and all countries.

 

	Date:

	 


	 


	Assignor Signature Block


	 


	Assignee Signature Block


	 




 

[to be completed by notary public]

 

On this _____ day of _________, before me, _________________________, the undersigned Notary Public, personally appeared ____________ ASSIGNOR, personally known to me (or proved to me on the basis of satisfactory evidence) to be the person whose name is subscribed to the within instrument, and acknowledged to me that he or she executed the same. WITNESS my hand and official seal in _____________ County of ______________ on the date set forth in this certificate.

 

 

	Notary Public





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ASSIGNMENT OF INTELLECTUAL PROPERTY RIGHTS: NO PATENT ISSUED OR APPLICATION FILED

 

Somahlutions, LLC., with an address in Jupiter, FL (the "Assignor") is the owner of all proprietary and intellectual property rights, including copyrights and patents, in the concepts and technologies known as _____________ [insert name of invention] and more specifically described in Attachment A [attach a description of the invention to the Assignment and label it “Attachment A”] to this Assignment (and referred to collectively as the "Invention") and the right to registrations to the Invention. ______________ Marizyme, Inc. with an address in Davenport, FL (the "Assignee") desires to acquire all the ownership of all proprietary rights, including, but not limited to, the copyrights, trade secrets, trademarks and associated good will and patent rights in the Invention and the registrations to the Invention;

 

Therefore, for valuable consideration, the receipt of which is acknowledged, Assignor, hereby assigns to Assignee 100% of all right, title and interest in the Invention, including:

 

(1)all copyrights, trade secrets, trademarks and associated good will and all patents which may be granted on the Invention; 

 

(2)all applications for patents (including divisions, continuations in whole or part or substitute applications) in the United States or any foreign countries whose duty it is to issue such patents; 

 

(3)any reissues and extensions of such patents; and 

 

(4)all priority rights under the International Convention for the Protection of Industrial Property for every member country. 

 

Assignor warrants that: (1) Assignor is the legal owner of all right, title and interest in the Invention; (2) that such rights have not been previously licensed, pledged, assigned, or encumbered; and (3) that this assignment does not infringe on the rights of any person. Assignor agrees to cooperate with Assignee and to execute and deliver all papers, instruments, and assignments as may be necessary to vest all right, title, and interest in and to the intellectual property rights to the Invention in Assignor. Assignor further agrees to testify in any legal proceeding, sign all lawful papers and applications, and make all rightful oaths and generally do everything possible to aid Assignee to obtain and enforce proper protection for the Invention in all countries.

 

	Date:

	 


	 


	Assignor Signature Block


	 


	Assignee Signature Block


	 




 

[to be completed by notary public]

 

On this _____ day of _________, before me, _________________________, the undersigned Notary Public, personally appeared ____________ ASSIGNOR, personally known to me (or proved to me on the basis of satisfactory evidence) to be the person whose name is subscribed to the within instrument, and acknowledged to me that he or she executed the same.


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