Exhibit
10.1


 


CERTAIN
INFORMATION IDENTIFIED BY BRACKETED ASTERISKS ([***]) HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS BOTH (1) NOT MATERIAL AND (2)
WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.


 


EXCLUSIVE
DISTRIBUTION AGREEMENT


 


THIS
EXCLUSIVE DISTRIBUTION AGREEMENT (this “Agreement”) is made on May 13, 2022, (the “Commencement Date”)
between INVO Bioscience Inc., a Nevada Corporation with a registered office at 5582 Broadcast Court, Sarasota, FL 34240 (“INVO”),
Onesky Holdings Limited (“Onesky”), a Hong Kong company with its address of Room 2214, 22nd Floor, Mira
Place Tower A, 132 Nathan Road, Tsim Sha Tsui, Kowloon, Hong Kong, and Guangzhou Kang Cheng Medical Devices Co., Limited (Chinese name:
广州康珵医疗器械有限公司) (“KangCheng”), an
incorporation of the People’s Republic of China (“China”) with its registered office at Room 2701A R&F To-Win Building,
30 Hua Xia Road, Tianhe District, Guangzhou City, China 510623 (Onesky and KangCheng collectively as “DISTRIBUTOR”).
INVO and DISTRIBUTOR may be referred to herein individually as a “Party” and collectively as the “Parties.”


 


WHEREAS,
DISTRIBUTOR are distribution companies with the resources and expertise necessary to distribute medical devices such as the products
manufactured by INVO, and KangCheng is the wholly-owned subsidiary of Onesky;


 


WHEREAS,
INVO is the global manufacturer of the patented medical device (the “INVOcell”) and of affiliated medical devices
and accessories that together enable a unique in vivo method of vaginal incubation (the “INVO Procedure”);


 


WHEREAS,
DISTRIBUTOR desires to obtain from INVO and INVO desires to grant to DISTRIBUTOR, on the terms and conditions set forth below, the exclusive
right to distribute the Products to Customers (including but not limiting qualified physicians and fertility clinics) within the Territory
(“Products”, “Territory” and “Customers” are defined below); and


 


WHEREAS,
INVO is entering into this Agreement based on assurances that DISTRIBUTOR will devote its best efforts to market and distribute certain
Products in the Territory and will otherwise adhere to all the terms and conditions of this Agreement.


 




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NOW,
THEREFORE, for and in consideration of the premises and the mutual covenants and agreements set forth herein, and other good and valuable
consideration, the receipt and adequacy of which are now and forever acknowledged and confessed, the Parties hereto agree as follows:


 


 1. GRANT OF DISTRIBUTION RIGHTS




 


		1.1.	Subject
                                            to all of the terms and conditions of this Agreement (including the attached Exhibits), INVO
                                            hereby grants the DISTRIBUTOR the exclusive right to distribute the INVO products (the “Products”)
                                            set forth on Exhibit A in the territory described in Exhibit B (the “Territory”)
                                            to customers in the Territory (the “Customers”). INVO further acknowledges
                                            that DISTRIBUTOR shall authorize KangCheng as the sole sub-distributor to propagate, sell
                                            and distribute the Product in the Territory, and to become listed as agent of the Products
                                            on NMPA (as defined in Section 4.3) approval. KangCheng shall have the right to establish
                                            second-tier sub-distributors (the “Sub-distributors”) to support distribution
                                            of the Products in the Territory. The appointment by DISTRIBUTOR of any Sub-distributors
                                            shall not relieve DITRIBUTOR from any of its undertakings herein. DISTRIBUTOR shall be responsible
                                            for ensuring that its Sub-distributors (including but not limiting KangCheng being the sole
                                            Sub-distributor of Onesky) fulfill all of the same obligations hereunder as DISTRIBUTOR,
                                            including without limitation all regulatory requirements, and DISTRIBUTOR will remain liable
                                            for any breach of the provisions hereof by any of its Sub-distributors. For the purpose of
                                            this Agreement, “Customers” refers to medical doctors, medical institutions,
                                            hospitals and/or clinics (including but not limiting INVO Centers operated directly or indirectly
                                            by INVO as provided in Section 4.7), person(s) or entity(s) that is domiciled inside
                                            the Territory, and person(s) or entity(s) outside the Territories who DISTRIBUTOR know or
                                            have reason to know intends to use or resell the Products inside the Territories.



 


		1.2.	DISTRIBUTOR
                                            will not, and DISTRIBUTOR shall ensure that each of KangCheng and the Sub-distributors will
                                            not, utilize, re-sell or deliver any Products to any Parties located outside the Territory.
                                            DISTRIBUTOR will not, and DISTRIBUTOR shall ensure that each of KangCheng and the Sub-distributors
                                            will not, distribute or re-sell Products in the Territory to any person or entity, which
                                            DISTRIBUTOR knows or should know, will use, utilize, distribute, sell or deliver Products
                                            outside the Territory. DISTRIBUTOR will promptly notify INVO in writing of all sales requests
                                            received from potential customers inside or outside the Territory for Products, which are
                                            to be utilized, sold or delivered outside the Territory. INVO reserves the right to distribute,
                                            whether directly or indirectly, any and all Products worldwide without restriction outside
                                            of the DISTRIBUTOR’s defined Territory.



 


		1.3.	INVO
                                            is entitled to apply for any license or set up one or more fertility clinics focused on the
                                            INVO Procedure (each, an “INVO Center”) inside or outside the Territory
                                            and enter into any partnership or joint venture agreement or license agreement directly or
                                            indirectly with other China partners for such purpose.



 


		1.4.	INVO
                                            will promptly notify DISTRIBUTOR in writing of all requests received from potential customers
                                            inside the Territory looking to utilize the Products inside the Territory.



 


		1.5.	Any
                                            other products to be purchased by DISTRIBUTOR from INVO during the term hereof and not included
                                            in Exhibit A, may be added to this Agreement by written amendment signed by the Parties.



 




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 2. TERM OF AGREEMENT AND EARLY TERMINATION




 


		2.1.	This
                                            Agreement shall become effective on the Commencement Date and will remain in full force and
                                            effect for a period of five (5) years after the date of NMPA approval (the “Initial
                                            Term”), unless otherwise terminated in writing in accordance with the provisions
                                            of this Agreement. This Agreement shall automatically renew for successive two (2) year periods
                                            (the “Renewed Term”) unless written notice is given by either Party ninety
                                            (90) days prior to the expiry of the Initial Term or each Renewed Term (the Initial Term
                                            and Renewal Term collectively are referred to herein as the “Term”).



 


		2.2.	Early
                                            Termination. Notwithstanding anything to the contrary contained herein, this Agreement
                                            may be terminated before its normal expiration date under the following circumstances:



 


		2.2.1.	If
                                            either Party defaults in the performance of any of its obligations under this Agreement (including
                                            but not limiting the DISTRIBUTOR’s obligation to purchase minimum quantities as set
                                            forth in Exhibit D hereto), the other Party may give written notice to the defaulting
                                            Party specifying the nature and the extent of the default and demanding a cure to the default.
                                            The defaulting Party will then have thirty (30) days to cure each default. If the default
                                            is not cured within thirty (30) days of the date of notice, then the aggrieved Party may
                                            by written notice terminate this Agreement effective immediately upon the defaulting Party’s
                                            receipt of the notice.



 


		2.2.2.	If
                                            either Party becomes bankrupt or insolvent or makes an assignment for the benefit of its
                                            creditors, or has a receiver appointed for it or for any of its properties, the other Party
                                            will have the right to terminate this Agreement effective immediately upon the date of written
                                            notice to the other Party. All outstanding debts will be required to be paid to the other
                                            Party within thirty (30) days of such notice.



 


		2.2.3.	Immediately
                                            upon written notice to the other Party in the event that any other agreement existing between
                                            INVO (or its affiliates) and DISTRIBUTOR (or its affiliates) terminates for cause during
                                            the term of this Agreement.



 


		2.2.4.	In
                                            the event there shall be a change in applicable country statutes, local statutes, case law,
                                            administrative interpretations, regulations or general instructions, the adoption of new
                                            federal or local legislation, or a change in any third-party reimbursement system, any of
                                            which are reasonably likely to materially and adversely affect the manner in which either
                                            Party may perform or be compensated under this Agreement or which shall make this Agreement
                                            or any related agreements unlawful or unenforceable, or which would be reasonably likely
                                            to subject either Party to this Agreement, or any member, manager, officer, director, employee,
                                            agent or affiliated organization to any civil or criminal penalties or administrative sanctions,
                                            the Parties shall as soon as practicable use their best efforts to enter into a new distribution
                                            arrangement or basis for compensation for the distributorship furnished pursuant to this
                                            Agreement that complies with the applicable new laws, regulations, or policies, or which
                                            eliminates the possibility of any penalties, sanctions or unenforceability, and that approximates
                                            as closely as possible the economic position of the Parties prior to the change.



 




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		2.2.5.	Immediately
                                            without notice, in the event any Products sold to DISTRIBUTOR are subsequently and intentionally
                                            sold, or distributed, delivered to any group, person or persons domiciled outside the Territory.



 


		2.2.6.	INVO
                                            is entitled to terminate this Agreement with immediate effect upon receipt of any written
                                            notice (with reasonable evidence) of non-compliance of any law, administrative interpretations
                                            or regulations of the Territory and other Applicable Law (as defined below) by DISTRIBUTOR
                                            relating to the use, sales and distribution of the Products, PROVIDED HOWEVER THAT, INVO
                                            is obliged to conduct investigation against DISTRIBUTOR before delivering termination notice
                                            by disclosing to DISTRIBUTOR in writing such evidence of non-compliance, and DISTRIBUTOR
                                            shall be entitled to defense against such allegation, or otherwise cured such non-compliance
                                            within reasonable period of time..



 


		2.3.	Obligations
                                            Upon Termination or Expiration.



 


		2.3.1.	Immediately
                                            upon the termination or expiration of this Agreement, DISTRIBUTOR’s distributorship
                                            will terminate and all of DISTRIBUTOR’s rights under this Agreement will terminate,
                                            excluding the right to any overdue payments or fees. Following any expiration or termination
                                            of this Agreement, DISTRIBUTOR will, within thirty (30) days of such date of expiration or
                                            early termination, return to INVO all unused Products in its inventory (“Current
                                            Stock”). DISTRIBUTOR shall also provide a list of the Current Stock within fifteen
                                            (15) days of such date of expiration or early termination. INVO will refund DISTRIBUTOR within
                                            thirty (30) days of receipt of such returned Current Stock the purchase price paid by DISTRIBUTOR
                                            for any Current Stock that are unpacked regardless of remaining Shelf Life. INVO shall refund
                                            an amount that is in excess of any and all amounts due to INVO under this Agreement or otherwise.
                                            Such refund commitment shall be subject to DISTRIBUTOR returning the Current Stock in the
                                            same condition as shipped by INVO to DISTRIBUTOR. For the purpose of clarity, DISTRIBUTOR
                                            shall be also responsible for the export tax and all reasonable freight costs associated
                                            with shipping such Current Stock back to INVO. For the purpose of this Agreement, “Shelf
                                            Life” refers to expiry date of the Product, which is 6 years.



 


		2.3.2.	Promptly
                                            upon termination or expiration of this Agreement, DISTRIBUTOR will provide INVO with a complete
                                            and detailed customer list, including contact information, to whom DISTRIBUTOR sold Products
                                            to.



 




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		2.3.3.	The
                                            termination or expiration of this Agreement will operate as a cancellation, as of the date
                                            of the termination or expiration, of all orders which have not been shipped by INVO to DISTRIBUTOR
                                            and, thereafter, INVO will not be obligated to fill such orders. DISTRIBUTOR will not be
                                            obligated to take any orders that have not been shipped by INVO, and orders that have not
                                            arrived at Port Of Destination (defined below in Section 3.7) upon termination date.
                                            Within thirty (30) days after the date of termination or expiration of this Agreement, DISTRIBUTOR
                                            will pay all outstanding invoices deducting such invoiced amount relating to orders that
                                            have not arrived at Port Of Destination upon termination date, and deliver to INVO any and
                                            all other sums due to INVO from DISTRIBUTOR under this Agreement, and will return to INVO
                                            all trade secret and Confidential Information belonging to INVO, along with any and all sales
                                            aids which INVO may have supplied to DISTRIBUTOR under this Agreement.



 


		2.3.4.	In
                                            the event of the termination of this Agreement by INVO pursuant to Sections 2.2.1
                                            or 2.2.3, INVO will have the right to withhold payment of any amounts owed by INVO
                                            under this Agreement as a set-off against any damages, including fines and attorneys’
                                            fees, which INVO incurs as a result of DISTRIBUTOR’s default.



 


		2.4.	Upon
                                            the expiration or effective date of termination of this Agreement, DISTRIBUTOR will immediately
                                            remove from its premises, website and elsewhere all signs, promotion and advertising relating
                                            to being the exclusive distributor of INVO and the Products, and will stop all use of any
                                            trademark, trade name, branding and logos used by INVO in promoting its products and services
                                            or associated with the Products, including, but not limited to, those listed in Exhibit
                                            F hereto (the “INVO Trademarks”). DISTRIBUTOR will also ensure that
                                            any and all use by any affiliate (including KangCheng) or subsidiary of DISTRIBUTOR or others
                                            claiming rights from DISTRIBUTOR (the “Affiliates”) will immediately cease.
                                            Without INVO’s written consent, any name, title or expression in connection with any
                                            business in which DISTRIBUTOR or any Affiliate is engaged in, which, in the judgment of INVO,
                                            resembles any trademark or trade name, or part thereof, owned by INVO, including the INVO
                                            Trademarks, and likely to lead to confusion or uncertainty on the part of the public, will
                                            no longer be used by DISTRIBUTOR and any Affiliate.



 


		2.4.1.	Upon
                                            the expiration or effective date of termination of this Agreement, INVO will immediately
                                            remove from its premises, website and elsewhere all signs and advertising relating to DISTRIBUTOR
                                            and its affiliated businesses.



 




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		2.4.2.	It
                                            is understood by the Parties hereto that in the event of termination or expiration of this
                                            Agreement, INVO shall have no obligation whatsoever to reimburse or otherwise compensate
                                            DISTRIBUTOR, in whole or in part, for the capital or labor investment undertaken in connection
                                            with the storage or utilization of the Products, including without limitation its investment
                                            in personal or real property or any improvements thereto, any personnel employed by DISTRIBUTOR
                                            engaged in the use, handling, storage or utilization of the Products, for advertising, promotion
                                            or marketing efforts undertaken in connection with the Products, or to compensate or indemnify
                                            DISTRIBUTOR in any other way whatsoever, including without limitation on account of the loss
                                            of prospective profits on sales or commitments in connection with the business or goodwill
                                            of DISTRIBUTOR. DISTRIBUTOR acknowledges that (i) DISTRIBUTOR has no expectation and has
                                            received no assurances that its business relationship with INVO will continue beyond the
                                            stated term of this Agreement or it’s termination in accordance with the terms of this
                                            Agreement, or that any investment by DISTRIBUTOR in the promotion of Products will be recovered
                                            or recouped by virtue of this Agreement, and (ii) DISTRIBUTOR will not have or acquire any
                                            vested, proprietary or other right in the promotion of the Products or in any goodwill created
                                            by its efforts under this Agreement. THE PARTIES ACKNOWLEDGE THAT THIS SECTION HAS BEEN INCLUDED
                                            AS A MATERIAL INDUCEMENT FOR INVO TO ENTER INTO THIS AGREEMENT AND THAT INVO WOULD NOT HAVE
                                            ENTERED INTO THIS AGREEMENT BUT FOR THE LIMITATIONS OF LIABILITY OUTLINED IN THIS SECTION.



 


		2.4.3.	The
                                            expiration or termination of this Agreement will not affect any existing obligation of either
                                            Party with respect to any already incurred and due payments or fees or to Confidential Information
                                            (as defined below).



 


 3. TERMS AND CONDITIONS OF SALE TO DISTRIBUTOR




 


		3.1.	Purchase
                                            Orders. DISTRIBUTOR will order Products from INVO, and INVO will sell Products to DISTRIBUTOR
                                            pursuant to the terms and conditions in this Agreement. In the event of a conflict between
                                            the terms of purchase order and the terms of this Agreement, the terms of this Agreement
                                            will control. Each confirmed purchase order will be an agreement between DISTRIBUTOR and
                                            INVO for the delivery of Products in accordance with this Agreement. The purchase order shall
                                            be deemed to have been accepted by INVO when INVO issues written confirmation to accept the
                                            purchase order or, in the absence of written acceptance of the purchase order, on the date
                                            that INVO commences delivery of the Products.



 


		3.2.	Price.
                                            The price payable by DISTRIBUTOR for Products purchased from INVO will be the distributor
                                            prices outlined in Exhibit A to this Agreement (the “Prices”).
                                            All Prices are in United States Dollars, and are shipped EX Works (Incoterms 2010) INVO’s
                                            facilities. Prices do not include handling, shipping and insurance charges, nor any taxes,
                                            such as property, sales, use, or similar taxes. The payment of the full amount of all such
                                            fees, charges and/or taxes will be the responsibility of DISTRIBUTOR. If INVO is required
                                            to collect or pay any such fees, charges or taxes, the amounts so paid or collected will
                                            be billed to and reimbursed by DISTRIBUTOR. DISTRIBUTOR will provide INVO with appropriate
                                            sales tax exemption certificate numbers and forms along with other documentation satisfactory
                                            to the applicable taxing authorities to substantiate any claim of exemption from any such
                                            fees, charges or taxes. Nothing contained herein shall be deemed to limit in any way the
                                            right of DISTRIBUTOR to determine the prices at which or the terms on which the Products
                                            purchased by DISTRIBUTOR may be resold to its sub-distributor(s) and/or Customer(s) in the
                                            Territory.



 




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		3.3.	Payment.
                                            Payments to INVO for all orders will be paid by DISTRIBUTOR thirty (30 days) after the invoice
                                            date. Terms of payment are outlined in Exhibit A. All payments will be made in United
                                            States Dollars. Failure to make any payment when due will be deemed a material breach of
                                            this Agreement by DISTRIBUTOR and will entitle INVO to penalty interest on overdue and outstanding
                                            payments at the rate of one and one half percent (1.5%) per month until paid, beginning with
                                            the due date of the overdue and outstanding payment.



 


		3.4.	INVO
                                            Remedies. In addition to any other legal or equitable remedies INVO may have, INVO reserves
                                            the right to refuse to accept or to cancel any orders placed by DISTRIBUTOR and accepted
                                            by INVO, or to refuse or delay shipment, if DISTRIBUTOR (i) fails to make any payment as
                                            provided for in this Agreement or an INVO invoice, (ii) fails to meet reasonable credit or
                                            financial requirements established by INVO, including any limitations on allowable credit,
                                            and/or (iii) otherwise fails to comply with the terms and conditions of this Agreement.



 


		3.5.	Risk
                                            of Loss and Title to Products. Risk of loss or damage and Title to the Products will
                                            pass to DISTRIBUTOR when Products are loaded for shipment at the INVO facility, and INVO
                                            will have no further responsibility for any damages or losses to the Products, except when
                                            a defect is discovered upon opening a Product for immediate use. In such an event, INVO will
                                            be responsible to replace any Product in non-conformity, or deemed defective or contaminated;
                                            provided, however, that such Product is deemed defective during its recommended shelf
                                            life. INVO and DISTRIBUTOR will work together to obtain insurance policy(ies) from an insurance
                                            company satisfactory to INVO covering the Products in the amount equal to the order price,
                                            as far as such insurance company are commercially available in the Territory. Unaccounted
                                            for units, not returned for any reason, will be charged the full order price per this Agreement
                                            or any purchase order.



 


		3.6.	Changes
                                            to Products. It is understood that the basic specifications of any Product may be modified
                                            by INVO. INVO will notify DISTRIBUTOR of significant changes in specifications that will
                                            alter the use or handling of the Product upon at least three (3) months prior written notice
                                            to DISTRIBUTOR.



 


		3.7.	Shipment.
                                            INVO must deliver to DISTRIBUTOR the Products free from any right or claim of a third person,
                                            and deliver the Products to Guangzhou Baiyun International Airport, or any other port of
                                            destination in the Territory designated by KangCheng in any relevant purchase order (“Port
                                            Of Destination”). Each order shall be shipped within one (1) week after order confirmation
                                            by INVO in writing, and such written confirmation shall not be unreasonably withheld. All
                                            shipment and delivery of the Products shall be EXW, as that term is defined in Incoterms
                                            2010.



 




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		3.8.	NON-CONFORMITY.
                                            DISTRIBUTOR shall examine the Products, or cause them to be examined within as short period
                                            as is practicable after their arrival at the Port Of Destination. In the event that DISTRIBUTOR
                                            discovers any lack of conformity of the Products with the relevant Purchase Order(s) of the
                                            DISTRIBUTOR or the specification of the Products, whether with respect to the quantity or
                                            quality of the Products delivered, or otherwise, DISTRIBUTOR shall notify INVO in writing,
                                            specifying the nature of the lack of conformity, within seven (7) days after DISTRIBUTOR
                                            has discovered or ought to have discovered the lack of conformity. Where DISTRIBUTOR has
                                            given due written notice of non-conformity to INVO, INVO may at its option, and provided
                                            it can do so without unreasonable delay and without causing DISTRIBUTOR unreasonable inconvenience:
                                            (i) deliver any missing quantity of Products, without any additional expense to DISTRIBUTOR;
                                            or (ii) replace Products with conforming goods, without any additional expense to DISTRIBUTOR;
                                            or (iii) reduce the Contract Price according to the degree of inferiority, extent of damage
                                            and amount of losses suffered by DISTRIBUTOR.



 


		3.9.	Audit
                                            Rights. INVO or its representatives may, not more than twice per calendar year during
                                            normal business hours and upon thirty (30) days prior written notice, inspect the books and
                                            records of DISTRIBUTOR related to the performance of its obligations under this Agreement.
                                            All information received by INVO or its representatives shall be subject to the confidentiality
                                            provisions of this Agreement. The cost of the audit or inspection shall be paid by INVO unless
                                            such audit reveals that DISTRIBUTOR has made significant violations to the terms and conditions
                                            of this Agreement, in which case the cost shall be paid by DISTRIBUTOR.



 


4.
GENERAL CONDITIONS


 


		4.1.	Sales
                                            Promotion. DISTRIBUTOR shall use its best efforts to promote, market and sell the Products
                                            to the Customers in the Territory, to meet the market demand for the Products for use in
                                            the Territory. DISTRIBUTOR shall refrain from misrepresenting the origin of the Products
                                            in such a way that would cause one to believe that the Products are manufactured or developed
                                            by anyone other than INVO. DISTRIBUTOR shall distribute the Products in the Territory so
                                            as to include all warnings and instructions necessary for the proper use of the Products
                                            and shall not make any warranty, express or implied, relating to the Products other than
                                            the warranty set forth in Section 4.17. DISTRIBUTOR shall only promote and market
                                            the Products for the approved indications as stated in the Product labeling.



 


		4.2.	Promotional
                                            Materials. DISTRIBUTOR shall ensure that all advertising, promotional literature and
                                            packaging for the Products complies with all Applicable Law and regulations. DISTRIBUTOR
                                            shall not use any advertising or promotional materials to promote the Products or any packaging
                                            that have not been approved in writing by INVO in advance.



 




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		4.3.	Registrations.
                                            DISTRIBUTOR will notify INVO promptly upon becoming aware of any governmental approval requirements
                                            with respect to the Products in the Territory. If governmental registrations, licenses, permits
                                            or approvals (collectively, the “Registrations”) are required in the Territory,
                                            then DISTRIBUTOR shall, at its own expense, obtain the Registrations that are necessary to
                                            allow for the purchase, distribution and resale by DISTRIBUTOR or any of its sub-distributor
                                            of the Products in the Territory. DISTRIBUTOR shall cover all the cost, fees and/or charges
                                            relating to the Registration with the National Medical Products Administration (“NMPA”),
                                            including but not limited to clinical evaluation and/or clinical trial (if necessary). INVO
                                            shall supply, free of charge, Product samples and/or free loans of any required hardware,
                                            solely for the purpose of product testing at NPMA approved laboratories; and provide, at
                                            its own expenses, all technical documentation (including notarization and apostille of such
                                            documentation) to the satisfaction of NMPA and/or its approved laboratories. INVO shall reasonably
                                            cooperate with the DISTRIBUTOR in connection with obtaining the Registrations. All Registrations
                                            shall be owned by and made in the name of INVO to the fullest extent permitted by Applicable
                                            Laws and regulations of the Territory. DISTRIBUTOR shall provide INVO with all tangible documents,
                                            records, and other property relating to the Registrations. DISTRIBUTOR shall have the right
                                            to maintain copies of all Registrations, as necessary for DISTRIBUTOR’s activities
                                            authorized hereunder subject to the confidentiality obligations hereof. Unless otherwise
                                            stated in this Section 4.3, DISTRIBUTOR shall, at no cost to INVO, execute such documents
                                            and instruments and take such further actions as necessary or appropriate to evidence INVO’s
                                            ownership of the Registrations.



 


		4.4.	Conduct
                                            of Business. DISTRIBUTOR shall conduct, and shall ensure that each of KangCheng and the
                                            Sub-distributors conduct, its business in a manner that reflects favorably at all times on
                                            the Products and the good name, goodwill and reputation of INVO. Without limiting the generality
                                            of the foregoing, DISTRIBUTOR shall (a) avoid deceptive, misleading or unethical practices
                                            that are or might be detrimental to INVO or the public, including but not limited to disparagement
                                            of INVO or the Products, (b) not publish or employ, or cooperate in the publication or employment
                                            of any misleading or deceptive advertising material, (c) make no representations, warranties
                                            or guarantees to third parties with respect to the specifications, features or capabilities
                                            of the Products that are inconsistent with any representations, warranties or guaranties
                                            regarding the Products that are expressly authorized by INVO, (d) use marketing and advertising
                                            efforts of high quality and good taste, and preserve the professional image and reputation
                                            of INVO and the Products, and (e) use professional and properly trained, as per INVO’s
                                            requirements, sales force to promote, market and sell the Products.



 


		4.5.	Inventory.
                                            DISTRIBUTOR will maintain an adequate inventory of Products (and accessories) at all times.
                                            An “adequate inventory” is defined as an inventory that will allow DISTRIBUTOR
                                            to promptly and efficiently meet the demand for INVOcell in the Territory. DISTRIBUTOR shall
                                            ensure that, while Products are under its sub-distributor’s responsibility, storage
                                            and/or transport conditions shall comply with the conditions set by INVO.



 




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		4.6.	Other
                                            Regulations. DISTRIBUTOR will keep INVO currently informed, in writing, of all governmental
                                            and/or technical regulations that may apply to the Products in the Territory. INVO will determine
                                            whether any of the Products will be modified in order to conform to any such regulations,
                                            but INVO will not be required to modify any of the Products.



 


		4.7.	INVO
                                            Centers. INVO shall be entitled, in its sole discretion and at its sole cost, to establish
                                            INVO Centers, whether as new or within existing medical practices, that will promote use
                                            of the Products in the Territory through a contractual relationship with or an ownership
                                            interest by INVO. INVO shall provide written notice to DISTRIBUTOR not less than ninety (90)
                                            days prior to the expected opening of each INVO Center. Distributor will allow INVO to purchase
                                            product for these entities for a $[***] premium per unit above the current transfer
                                            price provided in Exhibit A.



 


		4.8.	Regulatory
                                            Approvals; Compliance with Law.



 


		4.8.1.	INVO
                                            represents and warrants that (a) the INVOcell can be marketed having been approved by several
                                            regulatory agencies, including clearance from the United States Food and Drug Administration
                                            (the “FDA”) (as a class II medical device), the European Union (CE Mark)
                                            in compliance with Medical Device Regulation requirements and various other countries in
                                            Asia and the Americas, and (b) INVO is ISO 13485 registered. INVO agrees to maintain ongoing
                                            quality assurance and testing procedures sufficient to satisfy applicable regulatory requirements
                                            of the NMPA.



 


		4.8.2.	DISTRIBUTOR
                                            represents and warrants that, at its own expense, it shall have in effect at all times during
                                            the Term all licenses, permits, certifications and authorizations from all federal, state,
                                            and local authorities necessary to the performance of its obligations under this Agreement,
                                            and DISTRIBUTOR is responsible for complying with Applicable Law regarding the sales, distribution
                                            and use of the Products within the Territory.



 


		4.8.3.	DISTRIBUTOR
                                            shall comply with all governmental laws, regulations, and orders in the Territory that may
                                            be applicable to DISTRIBUTOR by reason of its execution of this Agreement, including, without
                                            limitation, any requirement to be registered as INVO’s independent distributor with
                                            any governmental authority, and including any and all laws, regulations, or orders that govern
                                            or affect the ordering, export, shipment, import, sale (including government procurement),
                                            delivery, or redelivery of the Products in the Territory as well as data privacy. DISTRIBUTOR
                                            shall not engage in any course of conduct that, in INVO’s reasonable belief, would
                                            cause INVO to be in violation of the laws of any jurisdiction.



 




    	Page 10 of 34



     


    

 


		4.8.4.	DISTRIBUTOR
                                            represents and warrants that in the performance of its obligations under this Agreement,
                                            DISTRIBUTOR shall not act in any fashion or take any action which will render INVO liable
                                            for a violation of the U.S. Foreign Corrupt Practices Act (“FCPA”), which
                                            prohibits the offering, giving or promising to offer or give, directly or indirectly, money
                                            or anything of value to any official of a government, political party or instrumentality
                                            thereof in order to assist DISTRIBUTOR or INVO in obtaining or retaining business. INVO shall
                                            have the right to terminate this Agreement immediately if DISTRIBUTOR takes any action in
                                            violation of the FCPA. DISTRIBUTOR shall indemnify and hold INVO harmless from and against
                                            all losses, liabilities, damages and expenses (including reasonable attorneys’ fees
                                            and costs) relating to DISTRIBUTOR’s breach of this Section 4.8.4 and the FCPA.



 


		4.8.5.	DISTRIBUTOR
                                            shall, at its sole cost and expense, be responsible for the translation of all required labeling
                                            and instructions for use (“IFUs”) for the Product(s) into simplified Chinese
                                            characters in accordance with then prevailing laws, rules and regulations in force in the
                                            Territory. It is expressly understood and agreed that INVO shall have the right to review
                                            and approve the labeling of the Products and IFUs for the Products. No changes are allowed
                                            to approved labeling and IFUs except accredited translations that have been reviewed and
                                            approved by INVO. Furthermore, INVO hereby represents and warrants that it shall be responsible
                                            for printing such labeling and IFUs, and insert them into the packing of Product before it
                                            is shipped to DISTRIBUTOR.



 


		4.9.	Accurate
                                            Records; Reports of Operation. DISTRIBUTOR agrees to maintain accurate and complete books,
                                            records and accounts of transactions under this Agreement. DISTRIBUTOR will provide INVO
                                            with its actual and forecast usage, market trends for the utilization of Products, and such
                                            other information as INVO reasonably requests. DISTRIBUTOR agrees to follow the medical device
                                            reporting procedures listed in Exhibit G, as well as any related procedures required
                                            under Applicable Law, NMPA rules or other regulatory authorities.



 


		4.9.1.	The
                                            INVOcell is classified as a class II medical device by the FDA and as such proper record
                                            keeping and traceability information must be maintained by DISTRIBUTOR. DISTRIBUTOR will
                                            keep detailed traceable records maintained by lot number of every Product it receives for
                                            distribution to Customers in the Territory. Discarded Products must also be kept tracked
                                            of and logged with their disposition.



 


		4.9.2.	DISTRIBUTOR
                                            is required to report in writing knowledge of any complaints, adverse effect or event that
                                            occurs with the use of any Product as soon as practicable to INVO. INVO will have sole responsibility
                                            for reporting any adverse event associated with any Product to the applicable governmental
                                            authority.



 




    	Page 11 of 34



     


    

 


		4.10.	No
                                            Repackaging or Relabeling. All shipments of the products purchased by DISTRIBUTOR will
                                            be used by DISTRIBUTOR in their original configuration including the original labels provided
                                            by INVO.



 


		4.11.	Advertising.



 


		4.11.1.	Subject
                                            to Sections 4.9.2 and 10, all advertising by DISTRIBUTOR, its agents and employees,
                                            and Affiliates will follow general advertising statements and specific instruction as to
                                            the use of INVO Trademarks provided by INVO (see Exhibit F).



 


		4.11.2.	The
                                            INVO name and branding, and the INVO Trademarks will be featured in advertising and promotion
                                            material used by DISTRIBUTOR and targeted to the Territory with respect to the Products,
                                            unless otherwise previously agreed upon in writing by INVO. DISTRIBUTOR is required to submit
                                            all INVO branded marketing materials of any type to INVO for approval. INVO may request DISTRIBUTOR
                                            to alter its advertising, and DISTRIBUTOR will comply with all such requests at its sole
                                            expense. INVO will provide approved copies of recommended materials bearing the INVO brand
                                            for use by the DISTRIBUTOR while this Agreement is in effect.



 


		4.11.3.	All
                                            marketing, promotional materials and advertising will be in compliance with local market
                                            regulations of the Territory and approved by INVO.



 


		4.11.4.	DISTRIBUTOR
                                            agrees, upon request, to promptly discontinue any promotional activities, advertising or
                                            practice which INVO reasonably determines might mislead or deceive the public or which might
                                            be detrimental to the good name, trademarks, trade names, goodwill or reputation of INVO
                                            or the Products. DISTRIBUTOR may not advertise the Products outside the Territory. Any Product
                                            which DISTRIBUTOR advertises or otherwise represents to customers as being made by or obtained
                                            from INVO must in fact be so made or obtained.



 


		4.11.5.	Social
                                            Media Advertising: DISTRIBUTOR will ensure that any social media accounts used to promote
                                            the Products shall contain only promotional information and product labeling that is in compliance
                                            with local market regulations in the Territory.



 


		4.12.	Trademark
                                            License.



 


		4.12.1.	License.
                                            INVO hereby grants to DISTRIBUTOR an exclusive, revocable and royalty-free license to use
                                            the INVO Trademarks in the Territory in connection with the promotion, distribution, and
                                            sale of the Products during the Term as contemplated by this Agreement. DISTRIBUTOR will
                                            conduct its business under its own trade name, but may refer to itself as an authorized distributor
                                            of INVO and the Products in the Territory.



 




    	Page 12 of 34



     


    

 


		4.12.2.	Quality
                                            Control. In order to protect the goodwill associated with the INVO Trademarks, DISTRIBUTOR
                                            shall use the INVO Trademarks only in connection with the Products sold by DISTRIBUTOR in
                                            the Territory in accordance with such written (including via email) guidance and directions
                                            furnished by INVO from time to time to ensure that the quality of the goods shall always
                                            be satisfactory to INVO. INVO shall be the sole judge of whether or not DISTRIBUTOR has met
                                            or is meeting the standards of quality so established. DISTRIBUTOR will permit duly authorized
                                            representatives of INVO to inspect the premises of and all forms of use of the INVO Trademarks
                                            by DISTRIBUTOR at all reasonable times, for the purpose of ascertaining or determining compliance
                                            with these quality control measures.



 


		4.12.3.	No
                                            Grant of License. Except for the limited rights granted to DISTRIBUTOR in Section
                                            4.12.1 above, nothing contained in this Agreement shall give DISTRIBUTOR or any other
                                            person or entity any rights or interest in any INVO Trademark, and DISTRIBUTOR agrees that
                                            it will not at any time during or after termination of this Agreement assert or claim any
                                            interest in, or do anything which may adversely affect the validity or enforceability of
                                            any INVO Trademark or the rights of INVO therein.



 


		4.12.4.	Ownership.
                                            DISTRIBUTOR acknowledges and agrees that, as between INVO and DISTRIBUTOR, INVO owns and
                                            shall continue to own all right, title and interest in and to the INVO Trademarks throughout
                                            the world, and to any registrations that have issued or may issue thereon. The Parties acknowledge
                                            that any and all goodwill arising from DISTRIBUTOR’s use of the INVO Trademarks shall
                                            inure to the benefit of INVO. DISTRIBUTOR agrees to cooperate and assist INVO in preserving
                                            INVO’s interest in the INVO Trademarks. DISTRIBUTOR agrees not to challenge INVO’s
                                            ownership or validity of the INVO Trademarks or any derivation thereof worldwide. Upon termination
                                            or expiration of this Agreement, DISTRIBUTOR shall cease all display, advertising and use
                                            of the INVO Trademarks and shall not thereafter use, advertise or display any trade name,
                                            trademark, logo or other trade designation which is, or any part of which is, the same as
                                            or confusingly similar to the INVO Trademarks or any such trade name, trademark or other
                                            designation associated with INVO or the Products. DISTRIBUTOR shall not at any time use or
                                            register the INVO Trademarks or any other trademark or trade name used by INVO, whether alone
                                            or in combination with other words or symbols, or any mark, name or logo which is, or any
                                            part of which is, confusingly similar to any designation associated with INVO or the Products.
                                            The provisions of this Section shall survive termination of this Agreement.



 


		4.12.5.	Enforcement.
                                            If DISTRIBUTOR believes that a third party has violated or infringed, or threatens to violate
                                            or infringe the INVO Trademarks, DISTRIBUTOR shall promptly notify INVO thereof and confer
                                            with INVO as to appropriate steps necessary to police such infringement.



 




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		4.13.	Commercial
                                            Practices. DISTRIBUTOR will at all times respect the laws and rules of commerce and fair
                                            competition in the Territory. DISTRIBUTOR attests that it will not enter into exclusive agreements
                                            with Customers to enforce the sale and use of only DISTRIBUTOR owned INVO Products
                                            in the Territory.



 


		4.14.	Inspection.
                                            In the event of a breach and upon request with fourteen (14) days reasonable notice and subject
                                            to the prior consent of the DISTRIBUTOR, INVO and its representatives will have reasonable
                                            access, during normal working hours, to DISTRIBUTOR’s place(s) of business to review
                                            DISTRIBUTOR’s compliance with this Agreement.



 


		4.15.	Cooperation
                                            with Recall. If INVO, or one of INVO’s suppliers, institutes a recall or other
                                            field action including but not limiting notification campaign, or similar program, with respect
                                            to any and all of the Products, DISTRIBUTOR will implement such recall or other field actions
                                            (including location and retrieval of the recalled Products) with respect to DISTRIBUTOR’s
                                            customers in accordance with the written instruction of INVO to comply with the terms and
                                            goals of such campaign or program. INVO agrees to refund within a reasonable period of time
                                            the EXW price, freight charges and insurance on shipment, import tax and VAT paid by DISTRIBUTOR
                                            for such recalled Products and any reasonable out of pocket administrative costs and freight
                                            charges and insurance on shipment incurred by the DISTRIBUTOR relating to such recall.



 


		4.16.	Limited
                                            Warranty. INVO’s Warranty is for the entire Shelf Life of the product until it’s
                                            expiration date on the product label. INVO WILL HAVE NO LIABILITY TO DISTRIBUTOR, CUSTOMERS
                                            OR OTHER THIRD PARTIES FOR CLAIMS OR DAMAGES OF ANY KIND, INCLUDING INCIDENTAL OR CONSEQUENTIAL
                                            DAMAGES, OTHER THAN AS EXPRESSLY PROVIDED FOR IN THIS AGREEMENT. No employee, agent or representative
                                            of INVO has the authority to bind INVO to any oral representation or warranty concerning
                                            any Product. Any oral representation or warranty made prior to the purchase of any Product
                                            and not set forth in writing and signed by a duly authorized officer of INVO shall not be
                                            enforceable by DISTRIBUTOR. INVO makes no warranty and shall have no obligation with respect
                                            to expendable or consumable parts and supplies or with respect to damage caused by or resulting
                                            from accident, misuse, neglect or unauthorized installation, alterations or repairs to the
                                            Products.



 


If
used as authorized in accordance with INVO specifications, INVO’s limited warranty provides that the Products will not have significant
defects in materials or workmanship that make the Product unusable. If the Product is deemed unusable or defective by the Parties, such
limited warranty entitles DISTRIBUTOR to the sole remedy of receiving replacement Product from INVO for any Products still under warranty.
INVO makes no warranty or representation that the Products will meet any customer-specific requirements. INVO makes no warranty, implied
or otherwise, regarding the performance or reliability of any third-party products such as culture medium. This limited warranty does
not cover damage of any sort resulting from, but not limited to, accidents, improper storage, improper operation, alterations, tampering,
abuse, neglect, fire, flood, war, or acts of God. Additionally, this limited warranty does not cover unintended use, failure to follow
IFUs, re-use, modification to the Products or INVO Procedure or unauthorized repair/modification of the Products. INVO EXPRESSLY DISCLAIMS
ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING THE WARRANTIES OF MERCHANTABILITY, AND FITNESS FOR A PARTICULAR
PURPOSE.


 




    	Page 14 of 34



     


    

 


		4.17.	Warranty
                                            Return Procedures. DISTRIBUTOR shall be responsible for all communication concerning
                                            warranty claims, maintenance and support requests. DISTRIBUTOR shall comply with INVO’s
                                            Product return procedures. This procedure is called the “return material authorization”
                                            (“RMA”) procedure. At its option, INVO may (a) replace defective Product(s)
                                            that are covered by INVO’s limited warranty and returned in accordance with INVO’s
                                            RMA procedure or (b) provide a refund to the DISTRIBUTOR of the price paid to INVO for such
                                            Product. INVO shall pay freight charges on shipments to DISTRIBUTOR of the replaced Product(s)
                                            under warranty and be responsible for the import tax and duty incurred by replacing the Product(s);
                                            provided, however, that DISTRIBUTOR shall pay all taxes (other than import tax) if
                                            applicable and other charges on such shipments. Products that INVO determines are not defective,
                                            not under warranty or not returned in compliance with INVO’s RMA procedure shall be
                                            returned to DISTRIBUTOR and DISTRIBUTOR shall pay all freight, insurance, taxes and other
                                            charges related to these Products. It is DISTRIBUTOR’s responsibility to manage its
                                            inventory of INVO Products. Any Products that exceed the expiration date (shelf life) may
                                            be used for demonstration purposes and training only.



 


		4.18.	Indemnification.



 


		4.18.1.	DISTRIBUTOR
                                            shall defend, indemnify and hold harmless INVO, its officers, directors, their successors,
                                            representatives and assigns, and INVO affiliated companies against any and all liability,
                                            claims, causes of action, suits, damages and expenses (including reasonable attorneys’
                                            fees and expenses), which they, or any of them are or become liable for, or may incur, or
                                            be compelled to pay by reason of any acts, whether of omission or commission, that may be
                                            committed by DISTRIBUTOR, any of its servants, affiliates or employees or any other persons
                                            who are connected with the distribution and use of the Products in the Territory in connection
                                            with the performance of this Agreement. DISTRIBUTOR releases INVO and its affiliated companies
                                            from any direct, collateral, incidental or consequential damages, whether for personal injury
                                            or property damage, in connection with DISTRIBUTOR’s or such other persons’ use
                                            or other disposal of any Product in the Territory. DISTRIBUTOR shall also be liable for any
                                            and all liability, claims, causes of action, suits, damages and expenses suffered or may
                                            be suffered by INVO due to the breach of this Agreement by DISTRIBUTOR.



 




    	Page 15 of 34



     


    

 


		4.18.2.	INVO
                                            will defend, indemnify and hold harmless DISTRIBUTOR, its officers, directors, their successors,
                                            representatives and assigns, and DISTRIBUTOR affiliated companies against any and all liability,
                                            claims, causes of action, suits, damages and expenses (including reasonable attorneys’
                                            fees and expenses), which they, or any of them are or become liable for, or may incur, or
                                            be compelled to pay by reason of any acts, arising from INVO’s breach of this Agreement.
                                            INVO releases DISTRIBUTOR and its affiliated companies from any direct, collateral, incidental
                                            or consequential damages, whether for personal injury or property damage, in connection with
                                            INVO’s or such other persons’ sale or other disposal of any Product, except for
                                            such damages as are covered by insurance. DISTRIBUTOR will not be liable to INVO for any
                                            claim arising from or based upon the manufacture of the INVOcell. INVO will not be liable
                                            to DISTRIBUTOR for any claim arising from or based upon the combination or use of any Product
                                            with other products not supplied by INVO, or arising from any alteration, modification or
                                            misuse by DISTRIBUTOR or others of Products or by an error committed during an INVO Procedure.



 


		4.18.3.	The
                                            provisions of this Section 4.18 will survive the termination or expiration of this
                                            Agreement.



 


		4.19.	Status
                                            of the Parties. DISTRIBUTOR and DISTRIBUTOR’s employees are in no way the sales
                                            representatives or agents of INVO for any purpose whatsoever and have no right or authority
                                            to represent themselves or act as such or in any way to bind INVO to any obligation to a
                                            third party, and they will not assume or create in writing or otherwise any obligation of
                                            any kind, express or implied, in the name of or on behalf of INVO, unless specifically authorized
                                            to do so in writing by INVO and in accordance with the conditions specified by INVO.



 


		4.20.	Independent
                                            Contractor. DISTRIBUTOR warrants and agrees that it will be at all times an independent
                                            contractor, and that it will do business at its own risk and for its own profit and not as
                                            a joint venture, agent or employee of INVO or of any of its affiliated companies. DISTRIBUTOR
                                            and employees will not be entitled to any benefits, privileges or compensation given or extended
                                            by INVO to INVO’s employees. All personnel of DISTRIBUTOR will be deemed to be DISTRIBUTOR’s
                                            employees exclusively, and their entire management, direction and control will be the responsibility
                                            of DISTRIBUTOR.



 


		4.21.	Limitation
                                            of Actions. Any cause of action for breach of warranty must be brought by DISTRIBUTOR,
                                            if at all, within fifteen (15) days from the date the cause of action occurred.



 




    	Page 16 of 34



     


    

 





5.
REPRESENTATIONS AND WARRANTIES OF DISTRIBUTOR



 


		5.1.	DISTRIBUTOR
                                            specifically represents, warrants and agrees to the following and agrees to indemnify, defend
                                            and hold INVO and its affiliated companies harmless from the results of any failure on its
                                            part to comply with the following:



 


		5.1.1.	Onesky
                                            is a corporation duly incorporated in Hong Kong, and KangCheng is a limited liability company
                                            duly incorporated in China. DISTRIBUTOR each has all requisite corporate power and authority
                                            to own, lease and operate its properties and to carry on its business as contemplated to
                                            be conducted. DISTRIBUTOR is duly qualified to transact business as a corporation in its
                                            jurisdiction, and is in good standing in its jurisdiction in which the failure to do so would
                                            have a material adverse effect on its business, properties, prospects or condition (financial
                                            or otherwise).



 


		5.1.2.	The
                                            DISTRIBUTOR will make available to INVO upon request true, correct, and complete copies of
                                            its business license, certificate of incorporation, its bylaws and any similar documents
                                            all as in effect on the Commencement Date, as well as an officially stamped copy of its certificate
                                            of good standing or similar document.



 


		5.1.3.	The
                                            DISTRIBUTOR has all requisite corporate power and authority to execute and deliver this Agreement
                                            and to perform fully its obligations hereunder. The execution and delivery of this Agreement
                                            and any related documents, and the consummation of the transactions contemplated thereby,
                                            have been duly authorized by all necessary corporate action on the part of the DISTRIBUTOR.
                                            This Agreement has been duly executed and delivered by the DISTRIBUTOR and constitutes legal,
                                            valid and binding obligations of the DISTRIBUTOR, enforceable against the DISTRIBUTOR in
                                            accordance with its respective terms, subject to applicable bankruptcy, insolvency, reorganization,
                                            moratorium or other similar laws now or hereafter in effect relating to creditors’
                                            rights and remedies generally and subject, as to enforceability, to general principles of
                                            equity, regardless of whether enforceability is considered in a proceeding at law or in equity.



 


		5.1.4.	The
                                            execution, delivery and performance by the DISTRIBUTOR of this Agreement and any related
                                            document, and the performance of all of the obligations of the DSITRIBUTOR under this Agreement
                                            and any related document have been authorized by the DISTRIBUTOR’s board of directors,
                                            and no other corporate action on the part of the DISTRIBUTOR and no other corporate or other
                                            approval or authorization is required on the part of the DISTRIBUTOR or any other individual,
                                            corporation, limited liability company, partnership, trust, incorporated or unincorporated
                                            organization, joint venture, joint stock company, or a government or any agency or political
                                            subdivision thereof or other entity of any kind (each a “Person”), by
                                            law or otherwise, in order to make this Agreement and any related documents the valid, binding
                                            and enforceable obligations (subject to (i) laws of general application relating to bankruptcy,
                                            insolvency, and the relief of debtors, and (ii) rules of law governing specific performance,
                                            injunctive relief, or other equitable remedies) of the DISTRIBUTOR, as the case may be.



 




    	Page 17 of 34



     


    

 


		5.1.5.	DISTRIBUTOR
                                            is not in violation of or default under any provision of its business license, certificate
                                            of incorporation, its bylaws or any similar document. The execution, delivery, and performance
                                            of, and compliance with this Agreement, and the consummation of the transactions contemplated
                                            hereby, have not and will not:



 


		5.1.5.1.	violate,
                                            conflict with or result in a breach of any provision of or constitute a default (or an event
                                            which, with notice or lapse of time or both, would constitute a default) under, or result
                                            in the termination of, or accelerate the performance required by, any of the terms, conditions
                                            or provisions of the DISTRIBUTOR’s, business license, certificate of incorporation,
                                            its bylaws or similar document, or any Material Contract (as defined below); or



 


		5.1.5.2.	violate
                                            any law of any court or federal, state, county or local government or any other governmental,
                                            regulatory or administrative agency or authority which is applicable to the DISTRIBUTOR,
                                            or any of their assets, properties or businesses.



 


“Material
Contract” shall mean any written and oral contract, agreement, deed, mortgage, lease, sublease, license, instrument, note,
commitment, commission, undertaking, arrangement or understanding (i) which by its terms involves, or would reasonably be expected to
involve, aggregate payments by or to the DISTRIBUTOR during any 12-month period in excess of $50,000, or (ii) the breach of which by
the DISTRIBUTOR or any subsidiary would be material to the DISTRIBUTOR or such subsidiary.


 


		5.1.6.	DISTRIBUTOR
                                            will, and DISTRIBUTOR shall ensure that each of its Sub-distributors will, comply in all
                                            respects with all federal and state laws and laws, regulations and standards in the Territory
                                            and other jurisdictions that are applicable to its activities under this Agreement as such
                                            laws, regulations and standards may be amended from time to time, including without limitation
                                            any applicable export or import laws and regulations of the United States of America, China
                                            and Hong Kong (“Applicable Law”), and will conduct its activities in accordance
                                            with professional business practices of honesty and integrity. In that connection, the DISTRIBUTOR
                                            represents and agrees that: (1) it will from time to time confirm to INVO, upon written request
                                            by INVO, that it is in compliance with Applicable Law, INVO’s code of conduct and any
                                            other INVO policy, protocol and procedure relating to the transaction of business in the
                                            Territory that has been communicated in writing to the DISTRIBUTOR; and (2) none of its partners,
                                            owners, principals, officers or staff members are officials, officers or representatives
                                            of any government or political party or a candidate for political office, and no part of
                                            the revenue it is to receive as a result of this Agreement will be used for any purpose which
                                            would violate Applicable Law.



 




    	Page 18 of 34



     


    


 


		5.1.7.	DISTRIBUTOR
                                            will, and DISTRIBUTOR shall ensure that each of its Sub-distributors will, employ its own
                                            personnel and ensure it is well-trained on regulatory compliance issues to perform DISTRIBUTOR’S
                                            marketing, contract negotiations, and billing and collections activities.



 


		5.1.8.	DISTRIBUTOR
                                            will enter into its own contracts with Customers and vendors, and will maintain, manage and
                                            ship Products from its own inventory.



 


		5.1.9.	DISTRIBUTOR
                                            represents and warrants that it is adequately and appropriately capitalized and insured,
                                            as reasonable and customary for a medical device distributor with significant investment,
                                            and has purchased adequate insurance policies (to the extent such insurance policy is commercially
                                            available in the Territory) for its business operation and performing its obligations under
                                            this Agreement.



 


		5.1.10.	Unless
                                            otherwise stated in this Agreement, DISTRIBUTOR will be responsible for any and all expenses,
                                            charges, fees, and taxes that may be levied or imposed by any authority within the Territory
                                            or elsewhere, upon DISTRIBUTOR by reason of its activities under this Agreement.



 


		5.1.11.	The
                                            DISTRIBUTOR understands and confirms that INVO is relying on the foregoing representations
                                            in transacting business with the DISTRIBUTOR. No representation or warranty by the DISTRIBUTOR
                                            contained in this Agreement contains any untrue statement of a material fact or omits to
                                            state a material fact in order to make the statements made therein, in light of the circumstances
                                            under which they were made, not misleading.



 





6. RESPONSIBILITIES
OF INVO



 


		6.1.	INVO
                                            will furnish to DISTRIBUTOR current information on procedures, protocols, Products, and any
                                            information changes concerning the Products, and will inform DISTRIBUTOR in writing of all
                                            changes to the Price outlined in Exhibit A.



 


		6.2.	INVO
                                            will cooperate with DISTRIBUTOR in promoting the use of the Products and will supply DISTRIBUTOR
                                            with copies of product bulletins, advertising material, published literature and other sales
                                            promotion aides, of a type that INVO believes will allow DISTRIBUTOR to enhance the marketing
                                            and marketability of the Products and INVO Procedure’s adoption. The shipping costs,
                                            taxes, and other applicable expenses of such materials will be paid by DISTRIBUTOR under
                                            Incoterm EXW guidelines as that term is defined in Incoterm 2010, unless otherwise agreed
                                            in writing by the Parties. INVO will furnish to DISTRIBUTOR, upon request, photographs, retouching,
                                            negatives or engravings from INVO available stock, but DISTRIBUTOR will pay for all literature
                                            or advertising in which it uses any such materials.



 






    	Page 19 of 34



     


    

 


		6.3.	INVO
                                            will furnish to the DISTRIBUTOR such reasonable quantity of Product samples free of charge,
                                            technical and clinical advice, assistance and support as INVO believes is reasonable to enable
                                            DISTRIBUTOR to register and sell the Products in the Territory.








 


		6.4.	INVO
                                            shall provide Product training to DISTRIBUTOR’s product manager, sales personnel and
                                            key account Customers on an as-needed basis during the Term of this Agreement to enable DISTRIBUTOR
                                            to promote the sales of Product and to perform post-sales customer training, technical assistance
                                            and support for its Customers. Such Product training shall be conducted, at mutually agreed
                                            upon frequency, times and locations requested by DISTRIBUTOR and agreed upon by INVO, and
                                            will be free of charge provided, however, that DISTRIBUTOR shall be responsible for all out-of-pocket
                                            expenses incurred in connection with such Product training, including travel, airfare and
                                            lodging expenses incurred by DISTRIBUTOR’s personnel while attending such training.



 





7.
MINIMUM PURCHASE AMOUNTS



 


During
the term of this Agreement, DISTRIBUTOR agrees to purchase from INVO a minimum number of Products per year commencing the date of NMPA
approval, as outlined in Exhibit D. DISTRIBUTOR expressly acknowledges that (a) such commitment is a reasonable estimate of the
amount of Products it can distribute within the Territory; and (b) that to maintain the exclusive nature of this Agreement, DISTRIBUTOR
will need to pay INVO the Price associated with such minimum Product amounts.


 





8.
USE OF OTHER PRODUCTS



 


		8.1.	Upon
                                            termination of the Agreement by DISTRIBUTOR or INVO for cause, DISTRIBUTOR will not, and
                                            DISTRIBUTOR will not, without INVO’s prior written consent, during the Term, use, manufacture,
                                            aid in the manufacture, export, sell, distribute or otherwise handle such competing products
                                            or offer competing in-vivo intravaginal fertility services or directly or indirectly facilitate
                                            or promote the use, distribution or sale of any competing products or hold or acquire, directly
                                            or indirectly, any participation in any organization or entity using, selling, distributing
                                            or otherwise handling competing products or manufacture or reproduce, in whole or in part,
                                            any Products, unless otherwise agreed to in writing prior to the execution of this Agreement.
                                            For the purposes hereof, “competing products” means any products similar
                                            to any of the Products manufactured by INVO or which can be put to identical or similar in-vivo
                                            intravaginal fertility procedure uses or which might compete with or hinder the sale of such
                                            Products and INVO Procedures, a specific name list of competing products to be provided by
                                            INVO in writing. Non-compliance by DISTRIBUTOR with the provisions of this Section 8.1
                                            during the Term will constitute an incurable default under this Agreement.



 






    	Page 20 of 34



     


    

 


		8.2.	If
                                            this Section 8 or any part of it is held by a court or arbitration panel, administrative
                                            body or governmental agency of competent jurisdiction to be invalid, illegal or unenforceable
                                            for any reason, it is agreed that within such jurisdiction the restrictions set forth in
                                            this Section 8 will automatically be considered modified to embrace the greatest possible
                                            time and area of restriction then permitted under Applicable Law, and such invalidity, illegality
                                            or unenforceability will not impair the enforceability of these restrictions as so modified
                                            nor in any manner otherwise affect the remaining provisions of this Agreement.



 





9. TECHNICAL
INFORMATION; CONFIDENTIALITY



 


		9.1.	INVO
                                            will furnish to DISTRIBUTOR technical information to assist DISTRIBUTOR in the sales, distribute
                                            and use of the Products in the Territory. DISTRIBUTOR acknowledges that this Agreement, all
                                            technical and commercial information and know-how furnished by INVO and its affiliated companies
                                            to DISTRIBUTOR and discussions between the Parties (collectively, the “Confidential
                                            Information”) during the term of this Agreement are proprietary and are of a highly
                                            confidential and secret nature. Both Parties further acknowledge that Confidential Information
                                            shall also include, without limitation, information concerning the other Party’s or
                                            its affiliated companies’ distributor network, business development plans, marketing
                                            strategies, budget and/or other financial/accounting information or materials in whatever
                                            form not generally known to the public.



 


		9.2.	Both
                                            Parties agree that all Confidential Information provided by one Party to the other Party
                                            is given and received in strict confidence and is to be used by both Parties solely for the
                                            purpose of carrying out the purpose of this Agreement. Both Parties will keep in strict confidence
                                            the Confidential Information and will not, for any reason whatsoever, reveal, disclose, sell
                                            or transfer any part of such Confidential Information, directly or indirectly, to its own
                                            employees or agents or to any third party except as permitted by the terms of this Agreement.



 


		9.3.	In
                                            the performance of its obligations under this Section 9, both Parties will, at their
                                            own cost, take all precautions and steps which may be reasonably requested in order to protect
                                            Confidential Information (including the bringing of legal action in order to ensure that
                                            others respect this undertaking of confidentiality). Nothing in this Agreement should be
                                            interpreted as prohibiting either Party from bringing such legal actions at its own expense
                                            within or outside the Territory as it may choose.



 


		9.4.	Both
                                            Parties will have the right to disclose Confidential Information to those of its employees,
                                            agents and any subsidiaries who require the information on a need-to-know basis and both
                                            Parties agree to exercise a reasonably high degree of care in the selection of its employees,
                                            subsidiaries and agents to whom Confidential Information will be disclosed, and to bind them
                                            to obligations of confidentiality at least as stringent as those provided for in this Agreement.
                                            Both Parties will indemnify and hold the other Party harmless for the consequences of any
                                            unauthorized disclosure or misuse of such Confidential Information because of the breach
                                            of this Section 9.



 






    	Page 21 of 34



     


    

 


		9.5.	Both
                                            Parties obligations set forth in this Section 9 will survive and remain in effect
                                            even after the expiration or the termination of this Agreement.



 


		9.6.	It
                                            is expressly agreed that the obligations of both Parties to maintain the confidentiality
                                            of Confidential Information under this Section 9 will not apply to any information
                                            which:



 


		9.6.1.	was
                                            in the public domain at the time of disclosure to the other Party;



 


		9.6.2.	was
                                            in the possession of the other Party without binder of secrecy prior to disclosure to it;
                                            or



 


		9.6.3.	though
                                            confidential at the time of disclosure, subsequently becomes part of the public domain through
                                            no fault of the either Party.



 


		9.7.	Each
                                            Party will immediately inform the other if it becomes aware of any violations of Confidential
                                            Information rights within the Territory or otherwise. If either Party, after consultation
                                            with the other Party but in its entire discretion, decides to institute a legal action in
                                            its own name, it may do so at its own expense. The other Party may participate in such legal
                                            action at its own cost. The initiating Party will have the final decision with regard to
                                            the conduct of all such legal actions and will retain all settlements, recoveries and judgments
                                            arising from such actions, after reimbursement to the other Party for out-of-pocket expenses,
                                            if any, incurred by the other Party in connection with legal action taken at the initiating
                                            Party’s specific request. If the other Party decides not to participate in such legal
                                            action, it will cooperate with the initiating Party and assign to the initiating Party any
                                            claims it may have, without compensation.



 


		9.8.	Both
                                            Party’s obligations upon the expiration or termination of the Agreement are to return
                                            all Confidential Information upon written request from the other Party.



 


		9.9.	DISTRUBUTOR
                                            shall be liable for any breach of this Section 9 of its Affiliates or the Sub-distributors
                                            who have received the Confidential Information.



 





10. TRADEMARKS,
BRANDING and PATENT RIGHTS



 


		10.1.	DISTRIBUTOR
                                            acknowledges that the INVO Trademarks are the exclusive property of INVO and/or its affiliated
                                            companies. DISTRIBUTOR undertakes throughout the Term to display the INVO Trademarks in publications,
                                            signs and displays and in other suitable advertising and sales promotion media of all types
                                            in association with the names and/or illustrations of the INVO Procedure and the Products
                                            or on such Products themselves only in a manner that is in compliance with such rules and
                                            regulations regarding their use as INVO provides to DISTRIBUTOR. Neither DISTRIBUTOR nor
                                            any assistant, employee or affiliate/subsidiary of DISTRIBUTOR will acquire any right or
                                            interest whatsoever, as a result of this Agreement, in any patents, the INVO Trademarks or
                                            other trademarks, trade names, branding, logos owned by INVO or its affiliated companies
                                            or other industrial property rights of INVO or its affiliated companies or will use same
                                            in any manner except as explicitly authorized by INVO.



 






    	Page 22 of 34



     


    

 


		10.2.	If
                                            any case of unfair competition or infringement by third parties in the Territory of the INVO
                                            Trademarks or other trade names, trademarks, branding or other industrial property rights
                                            of INVO or its affiliated companies or of the manufacturers of Products which are not INVO
                                            Products comes to the knowledge of DISTRIBUTOR, the latter will inform INVO immediately.
                                            INVO will, at its own discretion, decide whether it will prosecute any such case of which
                                            it is so notified and in what manner it will prosecute. At the request of INVO, DISTRIBUTOR
                                            will assist INVO to the best of its ability.



 


		10.3.	DISTRIBUTOR
                                            may not directly or indirectly, in whole or in part use any of the INVO Trademarks, branding
                                            or any other trademark, branding or trade name that is now or may hereafter be owned by INVO
                                            or its affiliated companies as part of DISTRIBUTOR’s corporate or business name, or
                                            in away in connection with DISTRIBUTOR’s business, unless INVO has specifically consent
                                            to any such use in writing.



 


		10.4.	DISTRIBUTOR
                                            acknowledges that any patent developed by or during the Term for any use of, with or for
                                            the INVOcell or the INVO Procedure will be owned by INVO. DISTRIBUTOR shall not reverse engineering
                                            any Product or patent owned or developed by INVO.



 


		10.5.	DISTRIBUTOR
                                            acknowledges that any breach of its obligations regarding INVO Confidential Information will
                                            cause INVO irreparable injury for which there are no adequate remedies at law, and therefore
                                            INVO will be entitled to equitable relief in addition to all other remedies provided by this
                                            Agreement or available at law.



 





11.
NOTICES



 


Any
notice regarding this Agreement should be in writing and should be sent by registered or certified mail, postage prepaid, to the party
notified, addressed to the Party at its address outlined below, or any updated address that a Party may have submitted in writing to
the other Party:


 


	INVO:	 	INVO Bioscience, Inc.
	 	 	Attn: Chief Financial Officer
	 	 	5582 Broadcast Court
	 	 	Sarasota, FL 34240
	 	 	legal@invobio.com


 






    	Page 23 of 34



     


    

 


	DISTRIBUTOR:	 	Onesky Holdings Limited
	 	 	Attn: Director 
	 	 	Room 2214, 22nd Floor Mira Place Tower A 
	 	 	132 Nathan Road, Kowloon, Hong Kong 
	 	 	cmchan@biomedichk.com 


 


	CC:	 	Guangzhou Kang Cheng Medical Devices Co., Limited
	                            	 	Attn: CEO
	 	 	Room 2701A R&F To-Win Building 
	 	 	30 Hua Xia Road, Tianhe District
	 	 	Guangzhou, China 510623 
	 	 	ralf@biomedichk.com 


 






12.
ENTIRE AGREEMENT; MODIFICATIONS



 


This
Agreement, including exhibits, forms the entire Agreement and understanding between the Parties regarding this license and distributorship
relationship. This Agreement may only be amended in writing signed by duly authorized representatives of both Parties.


 





13.
FORCE MAJEURE



 


Neither
Party will be liable for any claim regarding a failure to perform under this Agreement if the failure to perform is due to any cause
beyond the Party’s reasonable control, including without limitation, acts of God, acts of civil or military authority, labor disputes,
fire, riots, civil commotions, sabotage, war, embargo, blockade, floods, epidemics, power shortages, or governmental restrictions.


 





14.
ENGLISH LANGUAGE TEXT



 


This
Agreement has been executed in the English language, and any interpretation or construction of this Agreement will be based on the English
language text.


 





15.
GOVERNING LAW



 


This
Agreement has been entered into in the State of New York and will be governed by and construed in accordance with the laws of the State
of New York without giving effect to principles of conflicts of law. The Parties also agree that all sales made by INVO to DISTRIBUTOR
during the term of this Agreement will be made, if made, by the acceptance by INVO of orders in any state of the United States of America
in which INVO operates. This Agreement will not be subject to the United Nations Convention for the International Sale of Goods. Non-exclusive
jurisdiction of any disputes under this Agreement will lie in Federal courts of the Southern District of the State of New York, without
prejudice to the right of the parties to commence legal proceedings in any other jurisdiction.


 






    	Page 24 of 34



     


    

 





16.
ASSIGNABILITY ; SUCCESSORS AND ASSIGNS



 


This
Agreement and the rights and obligations of DISTRIBUTOR outlined in this Agreement are not assignable by DISTRIBUTOR, by operation of
law or otherwise, without the prior written consent of INVO. Any attempted assignment in violation of this Section 16 will be
considered void. INVO will have the right, without notice to DISTRIBUTOR, to assign all or any part of its rights and obligations under
this Agreement, but only to one of its affiliated companies. It is expressly agreed that this Agreement will be binding on and will benefit
the successors and permitted assigns of the Parties.


 





17. WAIVER



 


The
failure of either Party at any time to require performance by the other Party of any provision in this Agreement will not affect the
full right to require such performance at a future date, and a waiver of any one breach should not be considered a waiver of any other
breaches.


 





18.
EQUITABLE RELIEF



 


Both
Parties acknowledges that any breach of its obligations regarding Confidential Information for each Party will cause the other Party
irreparable injury for which there are no adequate remedies at law, and therefore the breached Party will be entitled to equitable relief
in addition to all other remedies provided by this Agreement or available at law. DISTRIBUTOR further acknowledges that any breach of
its obligations regarding INVO Trademarks will cause INVO irreparable injury for which there are no adequate remedies at law, and therefore
the INVO will be entitled to equitable relief in addition to all other remedies provided by this Agreement or available at law.


 




    	Page 25 of 34



     


    

 


IN
WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized respective officers as of the Commencement
Date.


 


	DISTRIBUTOR:		Onesky
  Holdings Limited INVO: INVO Bioscience, Inc.	



 


	By:	/s/ Chan Chi Ming	 	By:	/s/ Michael Campbell
	Name:	Chan Chi Ming	 	Name:	 Michael Campbell
	Title:	Director	 	Title:	COO\VP Business Development



 


	 	 
	DISTRIBUTOR:
Guangzhou Kang Cheng
    	 
	Medical
Devices Co., Limited
    	 



 


	By:	/s/
    Xiang Shu Qin	 
	Name: 	 Xiang Shu Qin
    	 
	Title:	 CEO
    	 




 










    	Page 26 of 34



     


    

 


EXHIBIT
A


 


Products,
Pricing and Payment Terms


(US
dollars)


 


		1.	PRODUCTS



 


	PRODUCT	PART #	DISTRIBUTOR
    PRICING (Incoterm 2010: EXW)
	INVOcell	FG-002	[***]
    USD
	The INVOcell is a single use three-part sterile assembly
	INVOcell Retention Device

                                                          
	 	Included
    with INVOcell FG-002
	The
    INVOcell retention device is a specially designed single use retention device that supports the retention of the INVOcell within
    the vaginal cavity.



 


INVO
Bioscience will not increase the price for the first three (3) years after receiving NMPA approval, and such new Distributor Price will
not be effective until ninety (90) days after INVO gives DISTRIBUTOR written notice of such change.


 


INVO
warehouse facility:


NORTHEAST
3PL


20
North Wentworth Avenue


Londonderry,
NH 03053, USA


 


Minimum
volume for each purchase order:


INVOcell
comes in a box of 6 units, minimum order is 12 boxes.


 


		2.	PAYMENTS
                                            TERMS & TAXES



 


At
the time of shipping the Products to DISTRIBUTOR, INVO shall invoice DISTRIBUTOR for the Products included in such shipment. All orders
will be invoiced and billed to Onesky Holdings Limited. DISTRIBUTOR shall pay each such invoice within thirty (30) days after the date
thereof. DISTRIBUTOR shall make all payments in United States Dollars, in immediately available funds, by wire transfer to such account
as INVO designates for such purpose. Any late payment by DISTRIBUTOR shall be a material breach of this Agreement set forth in Section
3.3.


 


DISTRIBUTOR
shall pay all sales, use and transfer taxes and other charges arising out of the purchase and sale of the Products, including any VAT
and personal property taxes and all customs inspection fees and duties, applicable to the sale and transport of the Products by DISTRIBUTOR
in the Territory which are applicable thereto. INVO shall not be responsible for any business, occupation, withholding or similar tax,
or any taxes of any kind, relating to the purchase and sale of the Products.


 


		3.	DISTRIBUTION
                                            FACILTY



 


INVO
will ship to DISTRIBUTOR’s preferred facility to hold inventory for direct distribution in the Territory by DISTRIBUTOR. INVO will
invoice DISTRIBUTOR for the shipment costs.


 




    	Page 27 of 34



     


    

 


EXHIBIT
B


 


Territory


 


People’s
Republic of China, excluding Hong Kong, Macau and Taiwan.


 




    	Page 28 of 34



     


    

 


EXHIBIT
C


 


[deleted]


 




    	Page 29 of 34



     


    

 


EXHIBIT
D


 


Minimums;
Business Plan; Forecast


 


As
a requisite to retain exclusivity in the Territory, the following milestones, based on a review of the Territory and its market potential,
must be adhered too by DISTRIBUTOR.


 


		1.	MINIMUM
                                            PURCHASE AMOUNTS



 


Year
1 after NMPA approval Date: 640,000 USD


Year
2 after NMPA approval Date: 1,280,000 USD


Year
3 after NMPA approval Date: 3,200,000 USD


Year
4 after NMPA approval Date: 4,000,000 USD


Year
5 after NMPA approval Date: 5,000,000 USD


 


For
the avoidance of doubt, Minimum Purchase Amount shall include sales of Products directly purchased by DISTRIBUTOR


 


See
attached as Exhibit E.


 


		2.	FORECAST



 


DISTRIBUTOR
will provide a non-binding, 12-month rolling forecast updated bi-annually to allow INVO to maintain sufficient inventory to meet DISTRIBUTOR’s
requirements.


 




    	Page 30 of 34



     


    

 


EXHIBIT
E


 


Business
Plan


 


See
attached file named “INVO Onesky business plan - Exhibit E.pdf”.


 




    	Page 31 of 34



     


    

 


EXHIBIT
F


 


INVO
Trademarks and Branding


 


		1.	REGISTERED
                                            TRADEMARKS



 


INVOcell®


INVO®


INVO
Bioscience®


INVO
Center®


 


		2.	BRANDING



 


INVOcell,
Life Begins Within


Intravaginal
Culture (IVC)


 


Product
logos:


 







 


		3.	BRANDING



 


DISTRIBUTOR
must use language and messaging approved by INVO when describing the Products. Please see invobio.com and invocell.com for approved content.
Examples:


 


		●	Intravaginal
                                            culture (IVC) is the process where a woman’s body acts as a natural incubator. The
                                            first and only FDA-cleared, CE-marked medical device for IVC, INVOcell holds the eggs and
                                            sperm within the woman’s body during fertilization and early embryo development. A
                                            safe, intimate way for women to be connected right from the very beginning. With INVOcell,
                                            Life Begins Within.



 


		●	INVOcell
                                            allows fertilization and early embryo development to take place within the woman’s
                                            body. It creates efficiencies throughout the whole process, making it easier to treat more
                                            people.



 




    	Page 32 of 34



     


    

 


EXHIBIT
G


 


Medical
Device Reporting


 


		1.	In
                                            the event DISTRIBUTOR considers or has reason to believe that a Product that it has placed
                                            on the market is not in conformity with Applicable Law or regulations, is defective or falsified,
                                            DISTRIBUTOR shall suspend sales and immediately inform INVO, so that INVO may address the
                                            issue and promptly inform any relevant authority.



 


		2.	DISTRIBUTOR
                                            shall cooperate with INVO and the competent authorities to ensure that necessary corrective
                                            action(s) are taken to bring any non-conforming Product into conformity, to withdraw it,
                                            and/or recall it.



 


		3.	DISTRIBUTOR
                                            shall immediately report to INVO all matters of vigilance in writing, including complaints
                                            or reports of suspected incidents related to Products that DISTRIBUTOR has placed on the
                                            market. INVO will inform any relevant authority of such matters. DISTRIBUTOR shall provide
                                            INVO the information required on Form-028, attached hereto as Exhibit H regarding
                                            the alleged product issue.



 


		4.	DISTRIBUTOR
                                            shall keep a register of complaints, of defective Products and of any recalls and withdrawals
                                            for a minimum of ten (10) years after the related Products were shipped by DISTRIBUTOR to
                                            Customers. DISTRIBUTOR shall provide INVO with a copy of such register and information to
                                            allow an investigation to occur. INVO will inform any relevant authority of any such investigation.



 


		5.	DISTRIBUTOR
                                            shall maintain proper traceability records of Products for a minimum of ten (10) years after
                                            shipment by DISTRIBUTOR to Customers, including information regarding:



 


		5.1.	All
                                            details on Products directly received by DISTRIBUTOR; and



 


		5.2.	All
                                            details on recipients to whom DISTRIBUTOR has supplied Products, in particular any health
                                            institution or healthcare professional.



 


		6.	DISTRIBUTOR
                                            shall co-operate with INVO or its authorized representative, if applicable, in matters of
                                            vigilance and compliance to Applicable Law.



 


		7.	DISTRIBUTOR
                                            shall ensure that, while Products are under its responsibility, storage and/or transport
                                            conditions shall comply with the conditions set by INVO.



 




    	Page 33 of 34



     


    

 


EXHIBIT
H


 


 



    	Page 34 of 34