DISTRIBUTION AGREEMENT This Distribution Agreement (the "Agreement"), is entered into by and between Regenr8, a Delaware Limited Liability Corporation having its principal place of business at 20801 Biscayne Blvd, Suite 403, Aventura, FL 33180 ("Supplier"), and the licensed healthcare provider ("Provider") who has indicated concurrence to these Terms and Conditions:
Supplier and Provider may be collectively referred to as the "Parties", or may be each singularly referred to as a "Party".
Whereas, Supplier is in the business of manufacturing and selling the epigenetic bioresonance mapping, regenerative fast, epigenetic custom superfood, and other products (collectively, the "Products");
Whereas, Provider is a licensed health care provider providing traditional healthcare and wellness therapies to patients or clients (“Clients”) who could benefit from the Products;
Whereas, Provider wishes to purchase the Products from Supplier and resell these Products to Clients (as defined below), subject to the terms and conditions of this Agreement; and
Whereas, Supplier wishes to sell the Products to Provider and appoint Provider as a non-exclusive Provider under the terms and conditions of this Agreement.
NOW THEREFORE, in consideration of the mutual covenants, terms and conditions set out herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
"Effective Date" means the date of concurrence to the Terms and Conditions of this Agreement by Provider.
"Client" means the final purchaser (consumer or patient) that (a) has acquired a Product from Provider for its own internal use and not for resale, remarketing or distribution.
"Intellectual Property Rights" means all industrial and other intellectual property rights comprising or relating to: (a) Patents; (b) Trademarks; (c) internet domain names, whether or not Trademarks, registered by any authorized private registrar or Governmental Authority, web addresses, web pages, website and URLs; (d) works of authorship, expressions, designs and design registrations, whether or not copyrightable, including copyrights and copyrightable works, data, data files, and databases and other specifications and documentation; (e) Trade Secrets; and (f) all rights, interests and protections that are associated with, equivalent or similar to, or
required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, these rights or forms of protection under the Laws of any jurisdiction throughout in any part of the world.
"Products" means those items produced by Supplier and selected for purchase by Provider.
"Representatives" means a Party's affiliates, employees, officers, directors, partners, shareholders, Providers, attorneys, third-party advisors, successors and permitted assigns.
"Supplier's Intellectual Property Rights" means all Intellectual Property Rights owned by or licensed to Supplier.
"Term" has the meaning set out in Section 7 of this Agreement.
"Trademarks" means all rights in and to US and foreign trademarks, service marks, trade names, brand names, logos, trade dress, corporate names and domain names and other similar designations of source, sponsorship, association or origin, together with the goodwill symbolized by any of the foregoing, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, these rights and all similar or equivalent rights or forms of protection in any part of the world.
"Trade Secrets" means all inventions, discoveries, trade secrets, business and technical information and know-how, databases, data collections, patent disclosures and other confidential and proprietary information and all rights therein.
2. Appointment as a Provider
2.1 Non-Exclusive Appointment. Supplier hereby appoints Provider, and Provider accepts the appointment, to act as a non-exclusive Provider of Products to Clients during the Term of this Agreement, solely in accordance with the terms and conditions of this Agreement. Supplier may, in its sole discretion, sell the Products to any other person or entity.
2.2 Status as an Independent Contractor. The relationship between Supplier and Provider is solely that of vendor and vendee. Nothing in this Agreement creates any agency, joint venture, partnership, or other form of joint enterprise, employment or fiduciary relationship between the Parties or an employee/employer relationship. Provider is an independent contractor under this Agreement. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any third party.
2.3 Right to Sell Competitive Products. This Agreement does not preclude either Party from entering into an agreement with any other third party (a “Competitive Transaction”) related to the sale or distribution of other goods or products that are similar to or competitive with the Products.
3. No Franchise or Business Opportunity Agreement or Multi-Level Marketing
3.1 No Franchise or Business Opportunity or Multi-Level Marketing Agreement. The Parties acknowledge and agree that this Agreement is not a franchise, business opportunity or multi-level marketing agreement and does not create a franchise, business opportunity or multi-
level marketing relationship between the Parties. If any provision of this Agreement is deemed to create a franchise, business opportunity or multi-level marketing relationship between the Parties, then Supplier shall have the sole discretion to immediately terminate this Agreement or negotiation with Provider in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in a mutually acceptable manner in order that the transactions contemplated hereby be consummated as a Provider agreement and not a franchise, business opportunity or multi-level marketing agreement.
4. General Provider Performance Obligations
4.1 Marketing and Reselling Products. Provider shall, in good faith and at its own expense:
4.1.1 Observe all directions and instructions given to it by Supplier in relation to the marketing, advertisement and promotion of the Products, including Supplier’s sales, marketing, and merchandising policies as they currently exist or as they may hereafter be changed by Supplier, to the extent that these marketing materials, advertisements, or promotions refer to the Products or otherwise use Supplier’s Trademarks.
4.1.2 Market, advertise, promote, and resell Products and conduct business in a matter that reflects favorably at all times on Products and the good name, goodwill, and reputation of Supplier. Provider agrees to use marketing materials provided by Supplier; if Provider desires to develop and utilize their own marketing materials, they must be pre-approved by Supplier.
4.1.3 Promptly notify Supplier of (and address and investigate, if appropriate) any complaint or adverse claim about any Product or its use of which Provider becomes aware; provided that nothing in this Agreement requires Provider to reveal proprietary pricing information.
5.5 Prohibited Acts. Notwithstanding anything to the contrary in this Agreement, neither Provider nor Provider’s Representatives shall:
5.5.1 Make any representations, warranties, guarantees, indemnities, similar claims, or other commitments actually, apparently, or ostensibly on behalf of Supplier, or to any Client regarding the Products, which representations, warranties, guarantees, indemnities, similar claims or other commitments are addition to or inconsistent with any then-existing representations, warranties, guarantees, indemnities, similar claims, or other commitments in this Agreement or any written documentation provided by Supplier to Provider.
5.5.2 Engage in any unfair, competitive, misleading, or deceptive practices regarding Supplier, Supplier’s Trademarks, or the Products, including any product disparagement or “bait-and-switch” practices.
5.5.3 Sell Products via any third-party-facilitated online retail or online auction website (including, but not limited to: eBay, amazon.com, online shopping price comparison sites, or any other online retail or online auction websites which sell products similar in character to Products). Supplier and Provider acknowledge and agree that this prohibition is necessary to ensure patient and consumer safety and the integrity of the Products. Notwithstanding the
foregoing, Provider shall be permitted to sell individual unit-volumes of the Products on its own direct website.
5.5.4 Make any reference or inference to discounts, price reductions, special call-in-pricing, coupons, price-matching policies, or any other special promotions of Supplier when engaging in any marketing activity regarding or sale of Products.
5.5.5 Make any claims regarding the use of Products which do not appear on the label of Products or Supplier’s online Product listing; i.e., Provider shall not make claims that Products treat specific diseases or conditions (“Disease Claims”) and shall use only supportive statements that appear on the label of Products or in Supplier’s online Product listing. At any time, Supplier may require the Provider to make changes to Provider’s direct website or printed information about the Products if the Provider advertises or markets the Products in any way which Supplier reasonably believes violates applicable regulations promulgated by the Food and Drug Administration (FDA) or the Federal Trade Commission (FTC).
5.6 Supplier’s Right to Discontinue Sales. Supplier reserves the right to discontinue sales of the Product to Provider in the event Provider engages in any Prohibited Acts enumerated at Section 5.5.
6. Minimum Advertised Price
6.1 Provider Agreement / Minimum Advertised Price. Provider agrees to abide by Supplier’s “Minimum Advertised Price Policy,” which applies to all authorized Providers of Products. Accordingly, Provider agrees not to advertise through any medium of mass communication that any Product will be sold at less than the suggested retail price for each respective Product as listed on Supplier’s then-current Product Price List. Provider further agrees not to sell any Product at a volume discount or through any sales promotion that would cause the per sale unit price to drop below the suggested retail price for any respective Product as listed on Supplier’s then-current Product Price List. This Agreement does not establish an actual retail price for the Products; Provider is in no way prohibited from selling Products at higher prices than the prices listed on Supplier’s then-current Product Price List.
7.1 Initial Term. The Term of this Agreement commences on the Effective Date and continues indefinitely, unless or until terminated as provided under this Agreement (the “Initial Term”).
7.2 Supplier’s Right to Terminate. Supplier may terminate this Agreement by providing written notice to Provider:
7.2.1 If Provider fails to pay any amount when due under this Agreement ("Payment Failure") and the failure continues for ninety (90) days after Provider's receipt of any invoice which states Provider’s obligation to pay such amount;
7.2.2 If within any period of two (2) months, two (2) or more Payment Failures occur;
7.2.3 If Provider breaches any provision of this Agreement (other than a Payment Failure), and either the breach cannot be cured or, if the breach can be cured, it
is not cured by Provider within ten (10) days after Provider’s receipt of written Notice of the breach;
7.2.4 If Provider is dissolved or liquidated or takes any corporate action for such purpose, becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or under any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors or applies for, or consents to, the appointment of a trustee, receiver or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due;
Any termination under this Section 7.2 shall be effective on Provider’s receipt of Supplier’s written Notice of termination or any later date set out in the Notice.
7.3 Effect of Termination. The termination of the Term does not affect any rights or obligations that were incurred by the Parties prior to the termination. Upon termination, all indebtedness of Provider to Supplier of any kind is immediately due and payable on the effective date of the Term’s termination without further Notice to Provider. Any Notice of termination under this Agreement automatically operates as a cancellation of any deliveries of Products to Provider scheduled to be made after the effective date of termination, whether or not any orders for the Products had been accepted by Supplier. Regarding any Products that are still in transit on termination of this Agreement, Supplier may require, in its sole discretion, that all sales and deliveries of the Products be made on either a cash-only or certified check basis. Upon expiration or earlier termination of the Term, Provider shall cease to represent itself as Supplier’s authorized Provider regarding the Products, and shall otherwise desist from all conduct or representations that might lead the public to believe Provider is authorized by Supplier to sell the Products. Any commissions due to Provider prior to termination shall be fully due and payable by Supplier to Provider.
8.1 Protection of Confidential Information. From time to time during the Term, either Party (as the "Disclosing Party") may disclose or make available to the other Party (as the "Receiving Party") information about its business affairs, goods and services, confidential information and materials comprising or relating to Intellectual Property Rights, trade secrets, third-party confidential information and other sensitive or proprietary information, as well as the terms of this Agreement, whether orally or in written, electronic or other form or media, and whether or not marked, designated or otherwise identified as "confidential" (collectively, "Confidential Information"). Confidential Information does not include information that, at the time of disclosure:
8.1.1 Is or becomes generally available to and known by the public other than resulting from, directly or indirectly, any breach of this Section by the Receiving Party or any of its Representatives;
8.1.2 Is or becomes available to the Receiving Party on a non-confidential basis from a third-party source, provided that the third party is not and was not prohibited from disclosing the Confidential Information;
8.1.3 Was known by or in the possession of the Receiving Party or its Representatives before being disclosed by or on behalf of the Disclosing Party;
8.1.4 Was or is independently developed by the Receiving Party without reference to or use of, in whole or in part, any of the Disclosing Party's Confidential Information; or
8.1.5 Must be disclosed under applicable Law.
8.2 Obligations of Receiving Party. The Receiving Party shall:
8.2.1 Protect and safeguard the confidentiality of the Disclosing Party's Confidential Information with at least the same degree of care as the Receiving Party would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care
8.2.2 Not use the Disclosing Party's Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and
8.2.3 Not disclose any Confidential Information to any Person, except to the Receiving Party's Representatives who must know the Confidential Information to assist the Receiving Party, or act on its behalf, to exercise its rights or perform its obligations under this Agreement.
8.2.4 Bear responsibility for any breach of this Section 8 caused by any of its Representatives.
8.2.5 Promptly return or destroy all Confidential Information (including copies) and all documents and tangible materials that contain, reflect, incorporate or are based on Confidential Information received under this Agreement, upon request of the Disclosing Party.
9. Intellectual Property Rights
9.1 Ownership. Subject to the express rights granted by Supplier in this Agreement, Provider acknowledges and agrees that:
9.1.1 Supplier's Intellectual Property Rights are the sole and exclusive property of Supplier or its licensors;
9.1.2 Provider shall not acquire any ownership interest in any of Supplier's Intellectual Property Rights under this Agreement;
9.1.3 If Provider acquires any Intellectual Property Rights in or relating to any product (including any Product) purchased under this Agreement (including any rights in any Trademarks, derivative works or patent improvements relating thereto), by operation of law, or otherwise, these rights are deemed and are hereby irrevocably assigned to Supplier or its licensors, as the case may be, without further action by either Party; and
9.1.4 Provider shall use Supplier's Intellectual Property Rights solely for the purposes of performing its obligations under this Agreement and only in accordance with this Agreement and the instructions of Supplier.
9.2 Supplier's Trademark License Grant. This Agreement does not grant either Party the right to use the other Party's or their affiliates' Trademarks except as set out under this Section. Subject to Supplier's trademark policies, Supplier hereby grants to Provider a non-exclusive, non-transferable and non-sublicensable license to use Supplier's Trademarks during the Term solely on or in connection with the promotion, advertising and resale of the Products in accordance with the terms and conditions of this Agreement. Provider will promptly discontinue the display or use of any Trademark to change the manner in which a Trademark is displayed or used with regard to the Products when requested by Supplier. Other than the express licenses granted by this Agreement, Supplier grants no right or license to Provider, by implication, estoppel or otherwise, to the Products or any Intellectual Property Rights of Supplier. Provider agrees to use the symbols TM and ©, as appropriate, when displaying Supplier’s Trademarks, to indicate Supplier’s ownership of the Trademarks; use of such symbols shall not be construed as claims to ownership by the Provider. Provider’s use of Supplier’s Trademarks must be accompanied by a statement substantially as follows: “[INSERT NAMES OF TRADEMARKS] are trademarks of Regenr8, LLC, and are used with permission.” Provider’s website must also include, on all pages that reflect Products, a statement substantially as follows: “This site is not owned or operated by Regenr8, LLC”.
9.3 Prohibited Acts. Provider shall not:
9.3.1 Take any action that interferes with any of Supplier's rights in or to Supplier's Intellectual Property Rights, including Supplier's ownership or exercise thereof;
9.3.2 Challenge any right, title or interest of Supplier in or to Supplier's Intellectual Property Rights;
9.3.3 Make any claim or take any action adverse to Supplier's ownership of Supplier's Intellectual Property Rights;
9.3.4 Register or apply for registrations, anywhere in the world, for Supplier's Trademarks or any other Trademark that is similar to any of Supplier's Trademarks or that incorporates Supplier's Trademarks in whole or in confusingly similar part;
9.3.5 Use any mark, anywhere, that is confusingly similar to Supplier's Trademarks;
9.3.6 Engage in any action that tends to disparage, dilute the value of, or reflect negatively on the products purchased under this Agreement (including Products) or any Supplier Trademark;
9.3.7 Misappropriate any of Supplier's Trademarks for use as a domain name without prior written consent from Supplier; and
9.3.8 Alter, obscure or remove any of Supplier's Trademarks or trademark or copyright notices or any other proprietary rights notices placed on Products or any marketing materials or other materials that Supplier may provide to Provider.
9.4 Supplier's Trademark Notices. Provider shall ensure that all Products sold by Provider and all related quotations, specifications and descriptive literature, and all other materials carrying
Supplier's Trademark, are marked with the appropriate trademark notices in accordance with Supplier's instructions.
9.5 No Continuing Rights. On expiration or earlier termination of this Agreement:
9.5.1 Provider's rights under Section 9.2 cease immediately; and
9.5.2 Provider shall immediately cease all display, advertising, promotion and use of all of Supplier's Trademarks and shall not thereafter use, advertise, promote or display any trademark, trade name or product designation or any part thereof that is similar to or confusing with Supplier's Trademarks or with any trademark, trade name or product designation associated with Supplier or any Product.
10. Price and Payment
10.1 Price. Provider shall purchase the Products from Supplier at the prices set out in Supplier's Provider price list in effect when the Supplier accepts the related Purchase Order ("Prices").
10.2 Shipping Charges, Insurance and Taxes. Provider shall pay for shipping charges and shipping insurance costs for the Products. All Prices are exclusive of all sales, use and excise taxes, and any other similar taxes, duties and charges of any kind imposed by any Governmental Authority on any amounts payable by Provider under this Agreement. Provider is responsible for all charges, costs and taxes; provided, however, that, Provider is not responsible for any taxes imposed on, or regarding, Supplier's income, revenues, gross receipts, Personnel or real or personal property or other assets.
10.3 Payment Terms. Supplier shall issue invoices to Provider for all Products ordered. Provider shall pay all invoiced amounts due to Supplier on receipt, as indicated on each invoice.
Specific Payment Terms are as Follows:
- Analyze™. No payment required except for shipping at time of sample submission. This will be netted against Provider’s Services Fee for managing the sample collection, submission, and report interpretation, so no cash payment required by Provider.
- The Regenr8-ive Fast™(“TRF”). For all TRF products purchased in the current month, payment shall be due by the 15th of the following month via Provider Credit Card on file with Supplier.
- Optim8™ Epigenetic Custom Superfood. No payment required; Supplier handles all billing, collection, shipping, logistics, and commission to Provider.
10.4 Late Payments. Except for invoiced payments that Provider has successfully disputed, Provider shall pay interest on all late payments, calculated daily and compounded monthly, at the lesser of the rate of 1.5% per month or the highest rate permissible under applicable Law. Provider shall also reimburse Supplier for all costs reasonably incurred in collecting any late payments, including, without limitation, attorneys' fees. In addition to all other remedies available under this Agreement or at Law (which Supplier does not waive by the exercise of any rights under this Agreement), Supplier may suspend the delivery of any Products if Provider fails to pay any undisputed amounts when due under this Agreement and may thereafter terminate this Agreement under the terms of Section 7.2.1.
11.1 Provider Indemnification. Provider shall indemnify, hold harmless, and defend Supplier and its parent, officers, directors, partners, members, shareholders, employees, Providers, affiliates, successors and permitted assigns (collectively, "Indemnified Party") against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including attorneys' fees, fees or fines, and the costs of enforcing any right to indemnification under this Agreement and the cost of pursuing any insurance providers (collectively, "Losses"), incurred by Indemnified Party and arising out of or relating to any Claim of a third party:
11.1.1 Relating to a breach or non-fulfillment of any obligation under this Agreement by Provider or Provider's Personnel;
11.1.2 Alleging or relating to any grossly negligent or more culpable act or omission of Provider or its Personnel (including any recklessness or willful misconduct) in connection with the performance of its obligations under this Agreement;
11.1.3 Alleging or relating to any bodily injury, death of any Person or damage to real or tangible personal property caused by the willful or negligent acts or omissions of Provider or its Personnel;
11.1.4 Relating to a purchase of a Product by any person or entity purchasing directly or indirectly through Provider; or
11.1.5 Relating to any failure by Provider or its Personnel to comply with any applicable Laws.
12.1 Entire Agreement. This Agreement, including and together with any Purchase Order Transaction Terms and any related exhibits, schedules, attachments and appendices, constitutes the Parties' sole and entire agreement regarding the subject matter of this Agreement and therein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, regarding this subject matter.
12.2 Notices. Each Party shall deliver all notices, requests, consents, claims, demands, waivers and other communications under this Agreement (each, a "Notice") in writing and addressed to the other Party at its address set forth above. Each Party shall deliver all Notices by personal delivery, nationally recognized overnight courier or certified or registered mail (in each case, return receipt requested, postage prepaid). Notice given by facsimile or e-mail (with confirmation of transmission) satisfies the requirements of this Section.
12.3 Severability. If any term or provision of this Agreement is invalid, illegal or unenforceable in any jurisdiction, the invalidity, illegality or unenforceability does not affect any other term or provision of this Agreement or invalidate or render unenforceable the term or provision in any other jurisdiction; provided, however, that if any fundamental term or provision of this Agreement is invalid, illegal or unenforceable, the remainder of this Agreement is unenforceable. On a determination that any term or provision is invalid, illegal or unenforceable, the Parties shall
negotiate in good faith to modify this Agreement to effectuate the Parties' original intent as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
12.4 Amendment and Modification. No amendment to this Agreement is effective unless it is in writing, identified as an amendment to this Agreement, and signed by an authorized representative of each Party.
12.5 Equitable Remedies. Provider acknowledges and agrees that (a) a breach or threatened breach by Provider of any of its obligations under this Agreement would give rise to irreparable harm to the Supplier for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Provider of any of these obligations, Supplier shall, in addition to any and all other rights and remedies that may be available to Supplier at law, at equity or otherwise in respect of this breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages do not afford an adequate remedy. Provider agrees that it will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this Section.
12.6 Assignment. Provider may not assign any of its rights or delegate any of its obligations under this Agreement without the prior written consent of Supplier. Any purported assignment or delegation in violation of this Section is null and void. No assignment or delegation relieves the assigning or delegating Party of any of its obligations under this Agreement. Supplier may assign any of its rights or delegate any of its obligations to any Affiliate or to any Person acquiring all or substantially all of Supplier's assets without the consent of Provider.
12.7 Choice of Law. This Agreement, including all exhibits, schedules, attachments and appendices attached hereto and thereto, are governed by, and construed in accordance with, the Laws of the State of Florida, without regard to the conflict of laws provisions thereof to the extent these principles or rules would require or permit the application of the Laws of any jurisdiction other than those of the State of Florida.
12.14 Force Majeure. No Party shall be liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement (except for any obligations to make payments to the other Party under this Agreement), when and to the extent the failure or delay is caused by or results from acts beyond the impacted Party's ("Impacted Party") reasonable control, including the following force majeure events ("Force Majeure Events": (a) acts of God; (b) flood, fire, earthquake or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot or other civil unrest; (d) requirements of Law; (e) actions, embargoes or blockades in effect on or after the date of this Agreement; (f) action by any Governmental Authority; (g) national or regional emergency; (h) strikes, labor stoppages or slowdowns or other industrial disturbances; and (i) shortage of adequate power or transportation facilities. The Impacted Party shall give Notice within fifteen (15) days of the Force Majeure Event to the other Party, stating the period of time the occurrence is expected to continue. The Impacted Party shall use diligent efforts to end the failure or delay and ensure the effects of the Force Majeure Event are minimized. The Impacted Party shall resume the performance of its obligations as soon as reasonably practicable after the removal of the cause. In the event that the Impacted Party's failure or delay remains uncured for a period of thirty (30) days following written Notice
given by it under this Section, either Party may thereafter terminate this Agreement on fifteen (15) days' written Notice.
END OF TERMS AND CONDITIONS
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This addendum (“Addendum”) will take effect on the date prescribed by the first paragraph of the REGENR8 SERVICES AGREEMENT dated as of the Enrollment Date (the “Agreement”) by and between Regenr8, LLC (“Company”), and the Enrolled Provider (“Provider”) to support requirements of the Health Insurance Portability & Accountability Act of 1996 (“HIPAA”) and its implementing regulations (45 CFR 160-164 as amended from time to time, the “Privacy Rules”).
Section I. APA Responsibilities
1.1 Permitted Uses and Disclosures. Company agrees not to use or further disclose “protected health information,” as defined by the Privacy Rules (“PHI”), received from or created on behalf of Provider other than as permitted or required by this Addendum or as required by law. Except as otherwise limited in this Addendum, Company may use or disclose PHI to perform functions, activities and services for or on behalf of Provider as specified in the Agreement, as well as for the proper management and administration of Company, provided that such use or disclosure would not violate the Privacy Rules. Company agrees to abide by the Privacy Rules with respect to Protected Health Information it receives from or creates for the Provider as if the Company were considered a health care provider under the Privacy Rules.
1.2 Safeguarding the Privacy of PHI. Company agrees that it shall utilize appropriate safeguards to prevent the use or disclosure of PHI other than as provided in this Addendum.
1.3 Privacy Breaches. Company agrees to report to Provider any use or disclosure of PHI, which is inconsistent with the terms of this Addendum and of which Company, becomes aware, including, but not limited to, any discovery of an inconsistent use or disclosure by an agent or subcontractor of Company. Company agrees to mitigate, to the extent practicable, any harmful effect that is known to Company of a use or disclosure of PHI by Company in violation of this Agreement.
1.4 Sub-business Associates. Company agrees to enter into written contracts with any of its agents or independent contractors who receive PHI related to Provider patients from Company or create PHI on behalf of the Provider and such contracts shall obligate Company’s agents or independent contractors to abide by the conditions and terms of this Addendum.
1.5 Individual’s Right to Access. Company agrees to provide the subjects of PHI access to the subject’s PHI in accordance with the rights of access to PHI set forth in 42 CFR 164.524 and in accordance with any process mutually agreed upon by the parties. Company reserves to itself the rights set forth for covered entities in 42 CFR 164.524 with respect to the subject’s right to access to PHI.
1.6 Individual’s Right to REGENR8-IVE PROTOCOL Testing. Company agrees to make available PHI to the subject of PHI for REGENR8 PROTOCOL testing and shall incorporate any REGENR8 PROTOCOL testing to PHI in accordance with the subject’s right to request REGENR8 PROTOCOL testing to PHI as set forth in 42 CFR 164.526 and in accordance with any process mutually agreed upon by the parties. Company reserves to itself the rights set forth for Covered Entities in 42 CFR 164.526.
1.7 Individual’s Right to an Accounting of Disclosures. Company agrees to document such disclosures of PHI and information related to such disclosures as would be required for Provider to respond to individual requests for an accounting of disclosures of their PHI in accordance with 45 CFR 164.528. Company agrees to make available to the subject of PHI an accounting of Company disclosures of the subject’s PHI in accordance with the subject’s right to request an accounting of disclosures as set forth in 42 CFR 164.528 and in accordance with any process mutually agreed upon by the parties. Company reserves to itself the rights set forth for Covered Entities in 42 CFR 164.528.
1.8 Access by Secretary of Health & Human Services. Company agrees to allow the Secretary of Health & Human Services access to its books, records and internal Providers with respect to the use and disclosure of PHI received from or created or received by Company on behalf of Provider for the purposes of determining the Provider’s compliance with the Privacy Rules.
Section II. Provider Responsibilities.
2.1 Notifications Due to Company. With respect to the use and disclosure of the PHI by Company, Provider agrees to: (1) provide Company with a copy of its privacy notice(s) (“Notice(s)”), as well as of any changes in the Notice(s) and to provide Company with a copy of the current Notice(s); (2) inform Company of any change in or revocation of any consent or authorization provided to Provider by individuals pursuant to applicable law, including, but not limited to, the Privacy Rules and which is applicable to Company; and (3) to timely notify Company, in writing, of any arrangement permitted or required of Provider under applicable law, including, but not limited to, the Privacy Rules, that may impact in any manner the use or disclosure of the PHI by Company under this Agreement, including, but not limited to, any agreement by Provider to restrict use or disclosure of any PHI as permitted by the Privacy Rules. Unless otherwise specifically provided in this Agreement, the parties agree that Company shall only be responsible for complying with limitations conveyed by Provider in accordance with this Section 2.1.
2.2 No Improper Requests. Provider shall not request Company to use or disclose PHI in any manner that would not be permissible under the Privacy Rules if done by Provider.
Section III. Termination
3.1 Termination for Breach. Upon Provider’s knowledge of a material breach of this Addendum by Company, Provider shall provide an opportunity for Company to cure the breach or end the violation and terminate the Agreement if Company does not cure the breach or end the violation within thirty (30) calendar days, or immediately terminate the Agreement if Company has breached a material term of this Addendum and cure is not possible.
3.2 Effect of Termination.
(a) Except as provided in this section, upon termination of the Agreement, for any reason, Company shall return or destroy all PHI received from Provider, or created or received by Company on behalf of Provider. This provision shall apply to PHI that is in the possession of subcontractors or agents of Company. Company shall retain no copies of PHI.
In the event that Company determines that returning or destroying the PHI is infeasible, Company shall provide to Provider notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Parties that return or destruction of PHI is infeasible; Company shall extend the protections of this Agreement to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as Company maintains such PHI.
Section IV. Miscellaneous
4.1 Applicable Law. The parties acknowledge and agree that the existing Privacy Rules may be amended and additional guidance and/or regulations implementing HIPAA may be issued after the date of the execution of this Addendum and may affect the parties’ obligations under this Addendum (“Future Directives”). Parties agree to abide by such Future Directives as these Future Directives may affect the obligations of the parties and to take such action as is necessary to amend this Agreement from time in order to comply with Future Directives.
4.2 Conflicts. The terms and conditions of this Addendum will override and control any conflicting term or condition of the Agreement. All non-conflicting terms and conditions of the Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, Company and Provider execute this Addendum.
_Concurrence at Enrollment__
Gregory D. Nakagawa _Enrolled Provider_______________
Regenr8, LLC ______________________________
BUSINESS ASSOCIATE AGREEMENT (BAA)
THIS BUSINESS ASSOCIATE AGREEMENT (“Agreement”) is entered into by and between the Enrolled Provider (“Provider”) and Regenr8, LLC, a Delaware limited liability company (“Business Associate”) on this Enrollment Date (“Date”). This Agreement between Provider and Business Associate outlines the terms of service for the secure and appropriate receipt, processing, disclosure, storage, removal and elimination of data classified as Protected Health Information, and for the implementation of appropriate safeguards to protect the confidentiality, integrity and availability of Electronic Protected Health Information.
A. Provider and Business Associate are entering into this REGENR8 HEALTHCARE PROVIDER SERVICES AGREEMENT.
B. Provider and Business Associate have mutual obligations under that necessitate the Business Associate performing functions or activities that could involve the use or disclosure of Provider’s Protected Health Information as that term is defined by HIPAA, and
C. This Agreement is intended to permit Provider and Business Associate to access, use, disclose and exchange Protected Health Information in a manner which complies with HIPAA, as defined below.
NOW, THEREFORE, in consideration of the foregoing, the agreements contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by the parties, Provider and Business Associate agree as follows:
Section 1 – Definitions
Terms used but not otherwise defined in this Agreement shall have the meanings given to them under HIPAA. To the extent a term is defined in both this Agreement and HIPAA, the definition given such term under HIPAA shall govern.
1.1 Breach. “Breach” means the acquisition, access, use, or disclosure of protected health information in a manner not permitted under subpart E of (45. C.F.R. part 164) which compromises the security or privacy of the Protected Health Information.
1.2 Breach Notification Rule. “Breach Notification Rule” means Notification in the Case of
Breach of Unsecured Protected Health Information at 45 C.F.R. part 164, subpart D.
1.3 Designated Record Set. “Designated Record Set” means (1) A group of records maintained by or for a Provider that is: (i) The medical records and billing records about individuals maintained by or for a covered health care provider; (ii) The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or (iii) Used, in whole or in part, by or for the Provider to make decisions about individuals.” For such purposes, the term “record” means “any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for a Provider.
1.4 Electronic Protected Health Information or EPHI. “Electronic Protected Health Information” or “EPHI” means “individually identifiable health information:... (i) Transmitted by electronic media; [or] (ii) Maintained in electronic media,” limited to the information created, received, maintained or transmitted by Subcontractor from, to or on behalf of Business Associate.
1.5 Enforcement Rule. “Enforcement Rule” means the enforcement standards located at 45
C.F.R. part 160, subparts C, D, and E.
1.6 HIPAA. “HIPAA” means the Health Insurance Portability and Accountability Act of
1996, Public Law 104-191, and all corresponding regulations as may be amended from time, which includes but is not limited to the Privacy Rule, the Security Rule, the Breach Notification Rule and the Enforcement Rule.
1.7 Individual. “Individual” means the person who is the subject of protected health information, and includes a person who qualifies as a personal representative in accordance with
45 C.F.R. 164.502(g).
1.8 Law Enforcement Official. “Law Enforcement Official” means an officer or employee of any agency or authority of the United States, a State, a territory, a political subdivision of a State or territory, or an Indian tribe, who is empowered by law to: (1) Investigate or conduct an official inquiry into a potential violation of law; or (2) Prosecute or otherwise conduct a criminal, civil, or administrative proceeding arising from an alleged violation of law.
1.9 Privacy Rule. “Privacy Rule” means the Standards for Privacy of Individually
Identifiable Health Information at 45 C.F.R. parts 160 and 164, subparts A and E.
1.10 Protected Health Information or PHI. “Protected Health Information” or “PHI” means individually identifiable health information; (i) Transmitted by electronic media; (ii) Maintained in electronic media; or (iii) Transmitted or maintained in any other form or medium,” limited to the information created, received, maintained or transmitted by Subcontractor from, or on behalf of Business Associate.
1.11 Required By Law. “Required By Law” means a mandate contained in law that compels an entity to make a use or disclosure of protected health information and that is enforceable in a court of law. Required by law includes, but is not limited to, court orders and court-ordered warrants; subpoenas or summons issued by a court, grand jury, a governmental or tribal inspector general, or an administrative body authorized to require the production of information; a civil or an authorized investigative demand; Medicare conditions of participation with respect to health care providers participating in the program; and statutes or regulations that require the production of information, including statutes or regulations that require such information if payment is sought under a government program providing public benefits.
1.12 Secretary. “Secretary” means the Secretary of the Department of Health and Human
Services or his designee.
1.13 Security Incident. “Security Incident” means security the attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system.
1.14 Security Rule. “Security Rule” means the Security Standards for the Protection of
Electronic Protected Health Information at 45 C.F.R. parts 160 and 164, subpart C.
Section 2 – Obligations and Activities of Business Associate
With regard to its use and disclosure of PHI, Business Associate agrees:
2.1 to use or disclose PHI only if such use or disclosure is in compliance with each applicable requirement of 45 C.F.R. 164.504(e).
2.2 to not use or disclose PHI other than as permitted or required by this Agreement or as
Required by Law.
2.3 to use appropriate safeguards to prevent use or disclosure of the PHI other than as provided for by this Agreement including the implementation of all requirements of the HIPAA Security Rule with respect to EPHI.
2.4 to implement administrative, physical and technical safeguards in compliance with the Security Rule requirements at 45 C.F.R. sections 164.308, 164.310 and 164.312 that will protect the confidentiality, integrity and availability of the EPHI that Business Associate creates, receives, maintains or transmits on behalf of Provider.
2.5 to mitigate, to the extent practicable, any harmful effect that is known to Business Associate of a use or disclosure of PHI by Business Associate in violation of the requirements of this Agreement.
2.6 to the extent the Business Associate is to carry out the Provider’s obligations under the Privacy Rule, the Business Associate shall comply with the Privacy Rule’s requirements that apply to the Provider in the performance of such obligation.
2.7 to require that any agent of Business Associate, including a subcontractor, to whom Business Associate provides PHI agrees, in writing, to the same restrictions and conditions that apply through this Agreement to Business Associate with respect to such PHI.
2.8 to provide access, at the request of Provider and within fifteen (15) days of such request, to PHI in a Designated Record Set, to Provider or, as directed by Provider, to an Individual in order to meet the requirements under 45 C.F.R. 164.524. If an Individual makes a request for access to PHI directly to Business Associate, Business Associate shall notify Provider of the request within five (5) business days of such request. Business Associate acknowledges that Individuals have the right to obtain access to their PHI in an electronic format, and Business Associate will provide PHI maintained in a Designated Record Set in an electronic format requested, if such format is readily producible, or in another readable electronic format as may be agreed to by the Individual.
2.9 to make any amendment(s) to PHI in a Designated Record Set that Provider directs or agrees to pursuant to 45 C.F.R. 164.526 at the request of Provider, within fifteen (15) days of receiving such request. If an Individual makes a request for an amendment to PHI directly to Business Associate, Business Associate shall notify Provider of the request within five (5) business days of such request.
2.10 to make Business Associate’s internal practices, books, and records relating to the use and disclosure of PHI received from, or created or received by Business Associate on behalf of Provider available to the Secretary, within fifteen (15) days or in a time and manner
designated by the Secretary, for purposes of the Secretary determining Covered Entity compliance with the Privacy Rule.
2.11 to document such disclosures of PHI and information related to such disclosures as would be required to respond to a request by an Individual for an accounting of disclosures of PHI in accordance with 45 C.F.R. 164.528. At a minimum, the following information regarding the disclosure will be documented: (1) the date of the disclosure; (2) the name of the entity or person who received the Protected Health Information, and the address of such entity or person; (3) a brief description of the Protected Health Information disclosed; (4) a brief statement regarding the purpose and an explanation of the basis of such disclosure; and (5) the names of Individuals whose Protected Health Information was disclosed.
2.12 to provide to Provider, within thirty (30) days of receiving a request by the
Provider or an Individual for an accounting of disclosures of PHI in accordance with 45
C.F.R. 164.528, information collected in accordance with Section 2.11 of this Agreement, to permit Provider to respond to such a request; and if such a request is to Business Associate by an Individual to provide notice of the request to Provider within ten (10) days of receiving the request..
2.13 to not directly or indirectly receive remuneration in exchange for any PHI unless one of the following applies:
a. Provider has obtained an authorization from such Individual (and provided a copy of the authorization to the Individual) that meets the requirements of 45 C.F.R. 164.508(c) which is signed and dated by the Individual and contains, at a minimum, a statement that direct or indirect remuneration to Provider or Business Associate from a third party is involved.
b. The purpose of the exchange meets an exception detailed in 45 C.F.R.
Section 3 – Permitted Uses and Disclosures by Business Associate
3.1 General Use and Disclosure Provision. Except as otherwise limited in this Agreement, Business Associate may use or disclose PHI to perform functions, activities, or services for, or on behalf of, Provider as specified in the Master Agreement, provided that such use or disclosure does not violate HIPAA, including its minimum necessary requirements.
3.2 Specific Use and Disclosure Provision.
a. Except as otherwise limited in this Agreement, Business Associate may use PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate.
b. Except as otherwise limited in this Agreement, Business Associate may disclose PHI for the proper management and administration of the Business Associate, provided that disclosures are Required By Law, or Business Associate obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and be
used or further disclosed only as Required By Law or for the purpose for which it was disclosed to the person, and the person notifies the Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.
c. Business Associate may use and disclose PHI as Required by Law.
d. Patient Marketing Program. Provider specifically authorizes Business Associate to access Provider’s Patient Database (contact info only) for the purposes of approved marketing of the Regenr8-ive Protocol to Provider’s Patients, under the auspices of Company’s Patient Marketing Program (“PMP”). Provider reserves the right to withdraw from the PMP at any time upon written request to Company, at which time Company shall return Provider’s Patient Database file to Provider, and Company warrants there shall be no further utilization of this data.
Section 4 – Reporting Obligations of Business Associate
4.1 Business Associate agrees to notify Covered Entity within forty-eight (48) hours following the discovery of any Breach.
4.2 Business Associate agrees to report to Provider any use or disclosure of the PHI
not provided for by this Agreement of which it becomes aware.
4.3 Business Associate agrees to report to Provider any Security Incident of which it becomes aware.
4.4 Business Associate agrees to notify Provider following the discovery of any
Breach of unsecured PHI as required by 45 C.F.R. 164.410.
4.5 Business Associate agrees to fully cooperate with any investigation or risk assessment of a reported Breach performed by Provider.
4.6 A Breach is considered discovered by Business Associate as of the first day on which the unauthorized acquisition, access, use or disclosure of the PHI was known, or by exercising reasonable diligence, would have been known to Business Associate or any employee, officer, or agent, as determined under the Federal common law of agency of Business Associate, other than the individual committing the Breach.
4.7 The notice to Provider shall include, to the extent such information is available at the time of notification;
a. The identification of each Individual whose unsecured PHI has been, or is reasonably believed by Business Associate to have been, accessed, acquired, or disclosed during the Breach;
b. A description of the types of unsecured PHI that have involved in the Breach (such as whether the Individuals’ full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved); and
c. A brief description of what happened, including the date of the Breach, if known, and the date the Breach was discovered.
4.8 Business Associate shall also provide Provider with the following information in the notification to Provider, or as it becomes available, but no later than thirty (30) days after the Breach is discovered:
a. Any steps Individuals should take to protect themselves from potential harm that may result from the Breach;
b. A brief description of what Business Associate is doing to investigate the Breach, to mitigate harm to the Individuals, and to protect against any further Breaches; and
c. Contact procedures for Individuals to ask questions or learn additional Information, which shall include a toll-free telephone number, an e-mail address, Web site, or postal address.
4.9 The notification described in this Section 4 shall be provided to Provider’s Privacy
Officer, or such other person as Provider may designate from time to time.
4.10 In the event that a Law Enforcement Official instructs Business Associate to delay notification to Provider, Business Associate shall be permitted to do so; provided, however, that if a Law Enforcement Official’s instructions are oral, Business Associate may not delay notification to Provider more than thirty (30) days from the date of the oral statement unless, during such thirty (30) day period, Business Associate receives a written statement from a Law Enforcement Official which specifies a longer time period to delay notification.
Section 5 – Obligations of Provider
5.1 Provisions for Provider to Inform Business Associate of Privacy Practices and
a. Provider shall notify Business Associate of any limitation(s) in its notice of privacy practices of Provider in accordance with 45 C.F.R.
164.520, to the extent that such limitation may affect Business Associate’s use or disclosure of PHI.
b. Provider shall notify Business Associate of any changes in, or revocation of, permission by an Individual to use or disclose PHI, to the extent that such changes may affect Business Associate’s use or disclosure of Protected Health Information.
c. Provider shall notify Business Associate of any restriction to the use or disclosure of PHI that Provider has agreed to in accordance with
45 C.F.R. 164.522, to the extent that such restriction may affect Business
Associate’s use or disclosure of PHI.
5.2 Permissible Requests by Provider. Provider shall not request Business Associate to use or disclose Protected Health Information in any manner that causes Business Associate to violate the Privacy Rule.
Section 6 – Term and Termination
6.1 Term. This Agreement shall become effective on the date upon the date that both parties have executed the Agreement.
6.2 Continuation of Agreement. This Agreement supersedes any prior Business Associate Agreement between Provider and Business Associate. This Agreement shall continue after any new MSA is entered into between Provider and Business Associate except to the extent that such other agreement includes business associate agreement provisions or specifically states that it supersedes this Agreement.
6.3 Termination for Cause. Upon a party’s knowledge of a material breach by the other party, the non-breaching party shall either:
a. Provide an opportunity for the breaching party to cure the breach or end the violation, and terminate this Agreement if the breaching party does not cure the breach or end the violation within the reasonable time specified by the non-breaching party; or
b. Immediately terminate this Agreement if the breaching party has breached a material term of this Agreement and cure is not possible.
6.4 Effect of Termination.
a. Except as provided in paragraph (b) of this section, upon termination of this Agreement, for any reason, Business Associate shall return or destroy all PHI received from Provider, or created or received by Business Associate on behalf of Provider. This provision shall apply to PHI that is in the possession of subcontractors or agents of Business Associate. Business Associate shall retain no copies of the PHI.
b. In the event that Business Associate determines that returning or destroying the PHI is infeasible, for example, because such information must be retained for compliance with applicable laws, Business Associate shall provide to Provider notification of the conditions that make return or destruction infeasible. Upon notification that return or destruction of PHI is infeasible, Business Associate shall extend the protections of this Agreement to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as Business Associate maintains such PHI.
c. This Section 6.4 shall survive termination of this Agreement and the
Section 7 – Miscellaneous
7.1 Independent Contractor. Provider and Business Associate expressly acknowledge and agree that Business Associate is an “independent contractor” and shall not for any purpose be deemed to be an agent (as determined in accordance with the federal common law of agency), employee, servant, partner or joint venturer of Provider.
7.2 Regulatory References. A reference in this Agreement to a section in the Privacy Rule, the Security Rule, the Breach Notification Rule, the Enforcement Rule or HIPAA means the relevant section as in effect or as amended.
7.3 Amendment. The parties agree to take such action as is necessary to amend this Agreement from time to time as is necessary to comply with the requirements of HIPAA, and any rules and regulations promulgated thereunder. In the event that the parties are unable to agree to such amendment, the parties may terminate this Agreement in accordance with Section 6.
7.4 State Law. Where any provision of applicable state law is more stringent or otherwise constitutes a basis upon which HIPAA is preempted, such state law controls and the parties agree to comply fully therewith.
7.5 Assignment. Neither this Agreement nor any rights or obligations hereunder may be assigned, in whole or in part, without the prior written consent of the other party.
7.6 No Third Party Beneficiaries. This Agreement is effective only in regards to the rights and obligations of Provider and Business Associate. Provider and Business Associate expressly do not intend this Agreement to create any independent rights in any third party or to make any third party a beneficiary of this Agreement.
7.7 Survival. The respective rights and obligations of Business Associate under Section 6.4 of this Agreement shall survive the expiration or termination of this Agreement and the Services Agreement, regardless of the cause of such termination
7.8 Interpretation. Any ambiguity in this Agreement shall be resolved to permit compliance with HIPAA and any rules and regulations thereunder, as they may become available or effective.
[Signature Page to Follow]
IN WITNESS WHEREOF, the parties have caused this Business Associate Agreement to be executed in their respective names or by their respective officers, thereunto duly authorized, as of the respective dates set forth below.
PROVIDER: BUSINESS ASSOCIATE:
___________________________________ Regenr8, LLC
By: Concurrence at Enrollment By:
Name: Enrolled Provider Name: Gregory D. Nakagawa
Title: Provided at Enrollment Title: President
PROVIDER PLUS AGREEMENT
TERMS AND CONDITIONS
THIS MARKETING SERVICES AGREEMENT (the “Agreement”) is made on this date of confirmation of the Terms and Conditions (the “Effective Date”), by and Regenr8 LLC, a Delaware Limited Liability Company with a principal address of 20801 Biscayne Blvd, Suite 403, Aventura, FL 33180 (the “Company”) and the Provider participating in the Regenr8 Peer-to-Peer Referral Program, agreeing to these Term and Conditions (the “Provider Plus”).
WHEREAS, the Provider Plus is the business of providing certain Peer-to-Peer Referral Services (as defined herein); and
WHEREAS, the Company desires to engage the Provider Plus to provide Services to the Company in accordance with the terms set forth herein.
NOW, THEREFORE, in consideration of the foregoing and the mutual agreements hereinafter set forth, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows:
l.1.1. The Company hereby engages the Provider Plus to provide the services identified on Exhibit A attached hereto (the “Services”) to the Company, and the Provider Plus accepts such engagement in accordance with the terms and conditions of this Agreement.
1.1.2. The Provider Plus shall perform the Services only in accordance with the Company’s and affiliates policies and procedures and standard operating procedures as may be in effect from time-to-time (“SOP”), and with the care, skill and diligence consistent with applicable professional standards. If applicable, the Company’s and affiliates SOP in effect as of the Effective Date are attached hereto as Exhibit B.
l.1.3. Provider Plus shall not enter into any contract on behalf of, or otherwise bind, the Company or execute any documents on the Company’s behalf.
1.2. Compensation for Services. In consideration for the Services, the Company shall pay to the Provider Plus per the fee schedule set forth on Exhibit C attached hereto (the “Service Fee”).
2. REPRESENTATIONS, WARRANTIES, AND OTHER COVENANTS
2.1. Authorization. Each party has full power and authority to enter into this Agreement and to carry out the transactions contemplated hereby. Each party, by all requisite action (whether corporate or otherwise), has duly authorized the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby; and no other proceedings, corporate or otherwise, on the part of any party are necessary to authorize this Agreement, which, when executed, will constitute the valid and binding agreement of each party, enforceable in accordance with its terms. Neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated hereby will constitute a violation or breach of (i) the articles or certificate of incorporation, bylaws or other organizational documents of any party, (ii) any provisions of any contract or other instrument to which any party is a party or by which any party, or its businesses, assets or properties may be affected or secured, (iii) any order, writ, injunction or decree applicable to any party, or (iv) any statute, rule or regulation.
2.2. Consents. No consent, approval, order or authorization of, or registration, declaration or filing with, any governmental or other third party, domestic or foreign, is required by or with respect to any party in connection with its execution and delivery of this Agreement, or the consummation of the transactions contemplated hereby.
2.3. Regulatory Compliance. It is both Company’s and Provider Plus’s responsibility to ensure that it operates in strict compliance with all applicable federal, state and local healthcare laws, rules and regulations including those related to prohibitions against remuneration to physicians and/or other referral sources. Both parties acknowledge that they have not (i) been served with a notice of proposed exclusion, or committed any acts which are cause for exclusion, from participation in, or had any sanctions, or civil or criminal penalties imposed upon it under, any federal or state health care program, including, but not limited to, Medicare or Medicaid, or (ii) been convicted, under federal or state law (including, without limitation, a plea of nolo contendere or participation in a first offender deterred adjudication or other arrangement whereby a judgment of conviction has been withheld), of a criminal offense related to (a) fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct in connection with the delivery of a health care item or service or with respect to any act or omission in any health care program operated by or financed in whole or in part by any federal, state or local government agency. Each party further agrees to notify the other parties immediately after becoming aware that any of the foregoing representations and warranties may be inaccurate or may become incorrect. Provider Plus specifically represents and warrants to Company that it will not offer or pay anything of value to any physicians in return for their or recommending Company or Company’s offerings to their patients.
3, TERM & TERMINATION
3.1. Term. This Agreement will commence on the Effective Date and remain in effect for an initial term of one (1) years (the “Initial Term”) and shall automatically renew for additional one (l) year terms (each, a “Renewal Term” and, together with the Initial Term, the “Term”), unless any party gives notice to the other parties of non-renewal no later than thirty (30) days prior to the end of the Initial Term or Renewal Term, as applicable.
3.2. Termination of Agreement for Breach. In the event that a party commits a material breach of this Agreement, the non-breaching part(ies) may immediately terminate this Agreement if such breach is not cured within ten (10) days after notice of such breach is duly given. Additionally, Company shall have the right to terminate this agreement for any reason or no reason with thirty (30) days written notice.
3.3. Termination for Non-Compliance or Insolvency. Any party may immediately terminate this Agreement upon notice to the other parties if (i) any license, permit or approval required for the operation of any party is at any time suspended or revoked, or (ii) any party shall apply for or consent to the appointment of a receiver, trustee or liquidator of such party or of all or a substantial part of its assets, file a voluntary petition in bankruptcy, make a general assignment for the benefit of creditors, file a petition or an answer seeking reorganization or similar arrangements with creditors or take advantage of any insolvency law, or if an order, judgment or decree shall be entered by any court of competent jurisdiction, on the application of a creditor, adjudicating such party bankrupt or insolvent, and such order, judgment or decree shall continue unstayed and in effect for any period of sixty (60) consecutive days. Additionally, either party may immediately terminate this agreement at its sole discretion if it has reasonable knowledge that the other is not or has not complied with section 2.3 of this agreement.
3.4. Termination for Change in Applicable Laws. In the event of a change in any Applicable Laws (as defined below) that materially affects the performance of this Agreement or the relationship of the parties as described herein, including but not limited to, laws regulating laboratories, the parties will meet in good faith to discuss amending this Agreement to preserve its material terms and maintain compliance with Applicable Laws. If any party, acting in good faith and on the advice of counsel, believes that this Agreement cannot be amended to comply with such laws, such party may terminate this Agreement on thirty (30) days’ written notice to the other parties.
3.5. No Cause Termination. This Agreement may be terminated at any time by either party by providing the other party with at least thirty (30) days written notice of such party’s intention to terminate this Agreement.
3.6. Effect of Termination. Upon expiration or termination of this Agreement, neither party shall have any further obligations hereunder, except for (i) obligations incurred prior to the date of expiration or No Cause Termination, including, without limitation, the payments of the Service Fee earned by the Contractor prior to the termination of this Agreement, and (ii) other obligations set forth in this Agreement that specifically survive the expiration and/or earlier termination hereof. Notwithstanding the foregoing, nothing contained in this Section 3.6 shall relieve any party from liability for any breach of this Agreement. The exercise by any party of any right of termination under this Section 3.6 shall not constitute a waiver of any other rights or remedies available to such party for breach of this Agreement under this Agreement or under applicable law or in equity. Each remedy specifically provided under this Agreement is non-exclusive and shall be taken and construed as cumulative and in addition to any other remedy provided herein or by law.
4. CONFIDENTIAL INFORMATION; RESTRICTIVE COVENANTS; INTELLECTUAL PROPERTY
4.1. Confidential Information. Each party agrees that during and after the Term it will, and will ensure that its officers, directors, managers, partners, members, employees, contractors, and Provider Plus will, hold in confidence and not use or disclose the following confidential information of the other parties (collectively, “Confidential Information”): (i) this Agreement; (ii) any Services provided under this Agreement; and (iii) any information relating to each party’s business, including trade secrets or other information relating to the business, financial condition, operations, techniques and practices, fee schedules, business methods, records, prospects, customers, assets or liabilities of the others party. The following shall not be considered Confidential Information: (i) information that is in the public domain other than by reason of a breach of this Agreement; (ii) information that was in the rightful possession of the recipient party at or prior to the time of disclosure, and which had not previously been obtained under an obligation of confidence; or (iii) information obtained by the recipient party in good faith from a third party entitled to disclose it.
4.2. Uses and Disclosures of Confidential Information. Each party may use and disclose, as applicable, Confidential Information: (i) as reasonably required in fulfillment of this Agreement; (ii) to the employees, professional advisors, consultants, and contractors of such party to the extent that disclosure is necessary to perform such party’s obligations hereunder and such parties agree to be bound by this Agreement; (iii) with the prior consent of the applicable party; and/or (iv) as required by law. If either party receives a subpoena or similar notice or request from any judicial, administrative or other party arising out of, or in connection with, this Services Agreement including, but not limited to use or disclosure of Confidential Information, the receiving party shall promptly forward a copy of such subpoena, notice or request to the other party and afford such other party the opportunity to exercise any rights it may have under law.
4.3. Non-Compete. Because, under this agreement, the both Parties may learn from Company, through its submission of the detailed information to the Company necessary to place Services business, and through generally working with the Company, the names of various companies, business contacts, telephone numbers, addresses, e-mail addresses, and other related data (hereinafter “the Contacts”), both Parties mutually acknowledges, accepts and agrees for the duration of this agreement and for one (1) years thereafter (hereinafter the “Protected Period), not to disclose, reveal or make use of any of the Contacts or any related information provided to the Company for the purpose of placing business competitive to the Offering, specifically Company’s Regenr8-ive Products and Services. However, Provider Plus may continue to provide other offerings to the Contacts that are not competitive to the Offering.
4.4. Non-Circumvention. Neither party will not approach any person business, entity, employee, distributor, sales consultant, supplier or company directly which was introduced by Company to Provider Plus to in any way, directly or indirectly, for the purposes of circumventing or interfering with Company’s relationship with such any person business, entity, employee, distributor, sales consultants or company for twelve (12) months after termination or expiration of this agreement for any reason.
4.5. Non-Solicitation. During the term of this Agreement and for a period of eighteen (18) months following the termination of this Agreement both Parties, both personally and corporately, agree not, directly or indirectly, for themselves or any other individual or entity, to knowingly hire or employ any employee, contractor, of the other Party. Notwithstanding the foregoing, since Provider Plus’s contractors also become a contractor of the Company, nothing shall prohibit Provider Plus from hiring or employing such contractor any time after their tenure with Company. Company and Provider Plus agree, both personally and corporately, that any breach of this non-solicitation provision would cause irreparable harm to the other Party.
4.5. Intellectual Property Ownership. The parties acknowledge and agree that, except with respect to any proprietary information, technology or services licensed by Provider Plus in connection with the provision of the Services hereunder, the Company owns and shall retain all right, title and interest in and to any proprietary information included in the Offering, including, without limitation, all policies and procedures and all work product and deliverables developed or provided by the Company or others under this Agreement or in the provision of any element of the Offering (collectively, “Company Intellectual Property”). To the extent any right, title or interest in any Company Intellectual Property vests in the Provider Plus, the Provider Plus hereby assigns to the Company any and all such right, title and interest.
5. COMPLIANCE WITH LAWS AND REGULATIONS
5.1. Compliance with Laws. Each party shall perform its duties and responsibilities hereunder in compliance with all applicable federal, state and local laws and regulations (including the safe harbor regulations and statutory exceptions under the federal Anti-Kickback Statute (42 U.S.C. S 1320a-7b(b)), such as the statutory exceptions and regulatory safe harbors applicable to discount arrangements and to personal services and management contracts and the analogous state laws and regulations of the state in which the Company is located, the federal and state patient and personal information privacy and security laws, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Economic and Clinical Health Act, enacted as Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (HITECH) and regulations promulgated pursuant thereto, and applicable laboratory laws and regulations) (collectively, “Applicable Laws”). Additionally, it is the parties’ intent that this arrangement comply with all Applicable Laws, including, without limitation, applicable laboratory laws, HIPAA, HITECH, and applicable safe harbor regulations and statutory exceptions.
5.2. Commercial Reasonableness. The parties acknowledge and agree that the compensation terms of this Agreement are set at fair market value, are commercially reasonable, have been negotiated in an arms-length transaction. Additionally, the parties represent and warrant that the Services: (i) set forth and include all of the services to be provided during the Term in connection herewith between the parties, (ii) do not involve the counseling or promotion of a business arrangement or other activity that violates any Applicable Laws; and (iii) do not exceed those services which are reasonably necessary to accomplish the commercially reasonable business purpose of the Services.
6. INDEMNIFICATION AND HOLD HARMLESS; LIMITATION OF LIABILITY
6.1. By Provider Plus. Provider Plus agrees to defend, indemnify and hold harmless Company, its respective employees, officers, directors, consultants, affiliates, vendors and shareholders (collectively, “Indemnified Parties”), from and against any and all losses, claims, damages, expenses or liabilities, including reasonable attorneys’ fees (collectively, “Losses”) suffered by Indemnified Parties, resulting from or in any way connected with Provider Plus’s (i) breach of any terms or provisions of this Agreement; or (ii) gross negligence or willful misconduct.
6.2. By Company. Company agrees to defend, indemnify and hold harmless Provider Plus, its respective employees, officers, directors, Provider Pluss, affiliates, vendors and shareholders (collectively, “Indemnified Parties”), from and against any and all losses, claims, damages, expenses or liabilities, including reasonable attorneys’ fees (collectively, “Losses”) suffered by Indemnified Parties, resulting from or in any way connected with Company’s (i) breach of any terms or provisions of this Agreement; or (ii) gross negligence or willful misconduct.
6.3. Release. The Company hereby releases the Provider Plus from any liability or cost relating to the Offering attributable to any false, inaccurate or incomplete information provided by or on behalf of the Company. Neither party may assert against the other any claim in connection with this Agreement unless the asserting party has given the other party written notice of the claim within one hundred eighty (180) days after the asserting party knew or should have known of the facts giving rise to such claim, except that claims for payment of fees may be brought at any time.
7. MISCELLANEOUS PROVISIONS
7.1. Further Assurances. In connection with this Agreement, each party shall execute and deliver any additional documents and instruments and perform any additional acts that may be necessary or appropriate to effectuate and perform the provisions of this Agreement.
7.2. Independent Contractor. The Provider Plus, on one hand, and the Company, on the other hand, are independent contractors. Nothing in this Agreement shall create an employment, partnership, joint venture, or any other relationship between the parties. By entering into this Agreement, no party to this Agreement is, in any way, assuming any liabilities, debts or obligations of any other party, whether now existing or hereafter created.
7.3. No Waiver. A party to this Agreement may decide not to require, or fail to require, full or timely performance of any obligation arising under this Agreement. The decision not to require, or failure of a party to require, full or timely performance of any obligation arising under this Agreement (whether on a single occasion or on multiple occasions) shall not be deemed a waiver of any such obligation. No such decisions or failures shall give rise to any claim of estoppel, laches, course of dealing, amendment of this Agreement by course of dealing, or other defense of any nature to any obligation arising hereunder.
7.5. Notices. Any and all notices or other communications necessary or desirable to be served hereunder shall be in writing and shall be delivered personally, sent by certified mail or overnight delivery service to the intended recipient at the address for such intended recipient set forth below, or sent by facsimile to the fax number for such intended recipient set forth below, or to such other address or facsimile number as the party may designate in writing. Any notice sent by mail as provided above shall be deemed delivered on the second (2nd) business day next following the postmark date which it bears. Any notice sent by facsimile or hand delivery as provided above shall be deemed delivered when sent. Any notice sent by a nationally recognized overnight carrier shall be deemed delivered on the next business day next following the postmarked date which it bears.
To the Provider Plus: To the Name and Address Indicated on the Initial Concurrence to these Terms and Conditions.
To Company: Regner8 LLC
20801 Biscayne Blvd, Suite 403
Aventura, FL 33180
Attn: Gregory D. Nakagawa
7.6. No Special or Consequential Damages. Except as set forth in Section 7.7, no party shall be entitled to recover special, consequential, exemplary or punitive damages from any other party, and each party hereby waives any claim or right to special, consequential, exemplary or punitive damages hereunder, even if caused by the active, passive, sole, joint, concurrent or comparative negligence, strict liability, or other fault of any party.
7.7. Remedies/Damages. The Parties agrees that remedies at law for any violation of Sections 4 of this Agreement are inadequate and that either Party has the right to seek injunctive relief in addition to any other remedies available to it. Therefore, if either Party breaches Sections 4 of this Agreement, the other Party has the right to, and may seek issuance of a court ordered temporary restraining order, preliminary injunction and permanent injunction as well as any and all other remedies and damages, including monetary damages. Breaching Party further agrees to pay any and all legal fees, including without limitation, all attorneys’ fees, court costs, and any other related fees and/or costs incurred by the other Party in enforcing this Agreement.
7.8. Headings. Article and Section headings are for convenience of reference only and shall not be used to construe the meaning of any provision of this Agreement.
7.9. Counterparts. This Agreement may be executed in any number of counterparts, including by facsimile or other electronic transmission signature, each of which shall be an original and all of which shall together constitute one agreement.
7.10. Construction. This Agreement and all the provisions of this Agreement, shall be deemed drafted by each of the parties hereto, and shall not be construed against any party on the basis of that party’s role in drafting this Agreement.
7.11. Successors and Assigns. Except as expressly provided herein, this Agreement may not be assigned by any party hereto without the prior written consent of the other parties and any attempted assignment or delegation without such consent shall be void and of no effect. This Agreement shall be binding upon and shall insure to the benefit of the parties and their respective successors and permitted assigns.
7.12. Third Party Beneficiaries. Nothing in this Agreement shall provide any benefit to any person or entity other than the parties hereto, and their respective successors and permitted assigns, any rights, benefits or remedies under or by reason of this Agreement.
7.13. Unenforceability. Should any part of this Agreement be determined to be legally invalid or unenforceable, such invalidity or unenforceability shall not affect the validity and enforceability of the remaining portions.
7.14. Authorization. Each entity signing this Agreement warrants that such execution has been duly authorized by the party for which he or she is signing. Each party represents and warrants to the other parties that the execution, delivery and performance of this Agreement by such party has been duly authorized by all necessary company action, and this Agreement constitutes the valid and binding obligation of such party, enforceable against such party in accordance with its terms.
7.15. Governing Law and Venue. This Agreement shall be construed in accordance with the internal substantive laws of the State of Florida, without regard to conflict of laws principles. The parties agree that any claim brought by any party against another party or any of its members or their respective affiliates or their respective employees, independent contractors or consultants must be maintained only in the state or federal courts sitting in the State of Florida.
7.16. Amendment: Binding Effect. With the exception of Schedule C which may be modified by Company, this Agreement may not be modified except in writing executed by all parties. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns.
7.17. Entire Agreement. This Agreement together with the Exhibits hereto constitutes the entire agreement of the parties hereto and supersedes all prior agreements and representations with respect to the subject matter hereof.
7.18. Survival. Any covenants intended to be performed subsequent to the termination of this Agreement, along with any representations and warranties made herein, including, without limitation, the provisions of Sections 1, 2, 3.5, 4, 5, 6 and 7 shall survive termination of this Agreement.
END OF TERMS AND CONDITIONS
EXHIBIT A. SERVICES
SALES AND MARKETING SERVICES
1. Provider Plus shall provide the sales and marketing services to promote Company’s Regenr8-ive Products and Services offering.
2. Provider Plus will be compensated as outlined in Exhibit C.
EXHIBIT B. STANDARD OPERATING PROCEDURES
l. The Target Markets for Regenr8 Products and Services shall be limited to Licensed Healthcare Professionals, as follows:
Medical Doctors (MDs) – Family Practitioner, Internal Medicine, Naturopathic Doctor (ND), Doctor of Osteopathy (DO), Nurse Practitioners (NP), Integrative Medicine, Functional Medicine, OB/GYN, Pediatricians, Psychiatrists/Psychologists
Doctors of Chiropractic (DCs)
Licensed Dieticians and Nutritionists
Infusion Centers, Medical Spas
Professionals outside the scope defined above shall be approved by Company Management.
2. Licensed Healthcare Professionals are allowed to market with Company-approved materials to their Patients and prospective Patients.
3. The Provider Plus shall not use any trademark, trade name, tagline owned or licensed by Company, without prior Company approval.
4. The Provider Plus shall not use its own promotional materials without the prior written consent of the Company.
5. To ensure continuity of messaging and compliance, for the purposes of training and equipping healthcare consultants and providers, all consultants and representatives of Company shall use only Company created and approved documentation and assets. Such materials include but are not limited to:
o Videos, PowerPoint Presentations, Digital Marketing Cards, Learning Assets, White
Papers, Invitations, Printed Materials, Product Information Cards, Documentation, Corporate Sponsored Social Media Page(s), Electronic Marketing, Customer
EXHIBIT C. COMPENSATION
Provider Plus Compensation Model:
20% of Commissionable Volume for the Provider Plus that refers the Healthcare Provider to Company
7% of Commissionable Volume for the Provider Plus whose referred Healthcare Provider refers another Healthcare Provider (2nd level commission)
3% of Commissionable Volume for the Provider Plus whose 2nd level Provider refers another Healthcare Provider (3rd level commission)
Payment to Provider Plus shall be made by the middle of the month (or first business day thereafter) following the month of payment for Products and Services by the Healthcare Provider to Company.
Payer Mix %
* Order Information
* Mandatory Fields