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Almost done. Please review the Mahana Tinnitus Dispense Agreement and accept the terms at the bottom of the document.

MAHANA TINNITUS PRODUCT DISPENSE AGREEMENT & TERMS OF USE

This Mahana Tinnitus Product Dispense Agreement (the “Agreement”) is entered into this 23rd November, 2023 (the "Effective Date"), by and between First Name of Provider, a corporate entity, having its principal place of business at address-1, city, state, zip, (“Customer”), and Mahana Therapeutics, Inc., a Delaware corporation having its principal place of business at 1534 Plaza Lane #316, Burlingame, California 94010 (“Mahana”) ( Mahana and Customer each a “Party” and together the “Parties”).  The Terms and Conditions (“Terms”) attached as Exhibit A are hereby incorporated by reference into this Agreement.  Defined terms not defined in the main body of this Agreement shall have the meaning stated in the Terms.

  1. PRODUCTS. Mahana desires that Customer help facilitate Dispensing to End Users of a digital therapeutic product known as Mahana Tinnitus™ and such other products as may be listed in Section 2, Price & Product List, below (the “Product,” as further defined in the Terms).  Customer is engaged in providing medical care and other related services to End Users and desires that End Users use the Product.  Customer agrees to help facilitate Dispensing of  the Products to End Users per the attached Terms.  Customer is assisting with the electronic Dispensing of the Product and may set the price  charged to End Users for each Product Dispensed in an amount equal to fair market value, as reasonably determined by Customer.
  2. PRICE & PRODUCT LIST. The price that Mahana charges Customer for each Product  Dispensed to End User along with a list of Products is as follows, subject to the additional terms contained in the Terms
  1. TERM.  The term of this Agreement (the “Term”) will commence as of the Effective Date and will continue for a period of two (2) years (“Initial Term”) and shall automatically renew for successive one (1) year periods (each, a “Renewal Term”), unless either Party provides notice of its intention not to renew this Agreement to the other Party at least ninety (90) days prior to the expiration of the Term or Renewal Term then in effect.  Either Party may terminate this Agreement, at any time without cause by providing the other Party with ninety (90) days prior written notice of such termination.
  2. NOTICES. All notices shall be in writing and shall be deemed to be delivered when received by certified United States mail, postage prepaid, return receipt requested, or when delivered by national carrier or courier with acknowledgment of receipt, or when delivered in person. All notices shall be directed to the Parties at the address first stated above.
  3. SEVERABILITY/ENFORCEABILITY. The provisions of this Agreement are severable. If and to the extent that any court of competent jurisdiction determines that it is impossible to construe any provision of this Agreement consistently with any Applicable Law and consequently holds that provision to be invalid, or unenforceable as written or interpreted, such holding shall in no way affect the validity of the other provisions of this Agreement, which shall remain in full force and effect.
  4. COUNTERPARTS AND ELECTRONIC SIGNATURES. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original agreement and both of which shall constitute one and the same agreement. The counterparts of this Agreement may be executed and delivered by electronic communication (e.g., pdf sent via email) or other electronic signature (including DocuSign or AdobeSign) by either of the Parties and the receiving Party may rely on the receipt of such document so executed and delivered electronically as if the original had been received.
  5. AMENDMENTS. No changes to this Agreement or waivers of a Party’s rights or obligations hereunder will be binding on any Party unless made in writing and signed by the Party to this Agreement against whom the change or waiver is to be enforced.
  6. ACKNOWLEDGMENT. The parties acknowledge and agree that they have read and understand this Agreement, which includes the Terms (and any documents referenced there), and any other Exhibit(s) attached hereto. This Agreement contains the sole and exclusive terms and conditions that will govern the rights, responsibilities, and obligations of the parties related to the Products provided by Mahana to Customer.  This Agreement supersedes all prior or contemporaneous communications between the parties including all oral or written proposals, and may be modified or amended only by written instrument signed by duly authorized representatives of Mahana and Customer. If there ever is a conflict between the terms of this Agreement, the Terms, and/or any xhibit, the order of precedence shall be this Agreement, the Terms, and the Terms of Use.

TERMS OF USE

These Terms and Conditions (“Terms”) are attached to and part of the Mahana Tinnitus Product Dispense Agreement (the “Agreement”). Any defined terms used in these Terms shall have the same meaning stated in the Agreement, unless otherwise expressly stated herein. Any reference herein to “Agreement” includes these Terms.

  1. Additional Definitions.
  1. Applicable Laws” means all applicable federal, state, and local laws, statutes, regulations, guidelines, guidance, rules, standards, policies, and ordinances of the relevant governmental or Governmental Authorities, and binding guidance governing the Product or a Party, or the performance of any other obligations under this Agreement, whether in effect as of the Effective Date or adopted thereafter, including any successor laws, statutes, regulations, guidelines, guidance, rules, standards, policies, and ordinances.
  2. Confidential Information” means all written or oral information related to the business or operations of Mahana or a third party that has been identified as confidential or proprietary as well as all non-public data and information of Mahana, and all Mahana information that by the nature of the circumstances surrounding disclosure ought reasonably to be treated as confidential or proprietary, regardless of whether such information was disclosed intentionally or unintentionally or marked as “confidential” or “proprietary,” including, without limitation: proprietary information, Mahana IP, source and object code, technical data, trade secrets or know-how, databases, hardware, software, designs and techniques, programs, models, displays and manuals, and the selection, coordination, and arrangement of the contents of such materials, any published or unpublished information concerning research activities and plans, customers, End Users, marketing or sales plans, sales forecasts or results of marketing efforts, prices, pricing or pricing strategies, costs, operational techniques, strategic plans, and unpublished financial information, including information concerning revenues, profits, and profit margins, and the contents and substance of this Agreement.   
  3. Dispense,” “Dispensed,” “Dispensing,” means the process of making the Product available to End Users, and the issuance to End Users of a limited term right to access and use the Product.
  4. End User” means an individual patient who is authorized to access the Product.  
  5. Facilities” means the geographic locations Customer owns or operates out of in order to carry out its business, including the activities governed by this Agreement.  Facilities are listed in Section 4, Customer Facility Locations, of the main body of this Agreement (“Facility List”), as may be amended from time to time with the agreement of the Parties.  
  6. Governmental Authority” means all applicable agencies, commissions, officials, boards, courts, and other governmental, regulatory, or legislative bodies or authorities having authority to regulate or enforce regulation of the Products and/or other subject matter of this Agreement. 
  7. Intellectual Property Rights” means any and all now known or hereafter existing: (i) rights associated with works of authorship, including copyrights, mask work rights, and moral rights; (ii) trademark or service mark rights; (iii) trade secret rights; (iv) patents, patent rights, and industrial property rights; (v) layout design rights, design rights, design patents and design patent rights, (vi) other proprietary rights of every kind and nature; and (vii) all registrations, applications, renewals, extensions, or reissues of the foregoing, in each case in any jurisdiction throughout the world.
  8. Mahana IP” means all of Mahana’s intellectual property including but not limited to all scientific, technical, and other information, data, works of authorship, discoveries, concepts, technology, methods, know-how, designs, processes, procedures, compositions of matter, materials, methods, techniques, documentation, hardware, software, algorithms and inventions, whether patentable or not, together with all Intellectual Property Rights associated therewith, including, without limitation, all: (i) trade secrets rights and protections; (ii) patent applications (including, but not limited to any and all priority applications, provisionals, non-provisionals, divisionals, continuations, continuations-in-part, reissues, reexaminations, substitutions, renewals) including the right to claim the benefit of priority to any of the foregoing; (iii) patents granting on any of (ii); (iv) extensions and supplemental protection certificates based on any of (ii) and (iii); (v) trademark applications, registrations, service marks, domain names and all renewals and extensions thereto; and (vi) copyright applications and registrations and all restorations, reversions, renewals and extensions thereof.
  9. Personally Identifiable Information” means: (i) any information that relates to, is linked to, or is reasonably capable of being linked to, an individual; and (ii) any information that qualifies as “personal data,” “personal information,” “personally identifiable information,” “non-public financial information” or similar term under any Applicable Law.
  10. Product” or “Products” means Mahana’s digital health application called “Mahana Tinnitus™” in addition to any Mahana Products listed in Section, 2, Price & Product List, of the main body of this Agreement (“Product List”), which may be amended from time-to-time by written agreement of the Parties.   
  11. Providers” means the health care providers listed (by Facility and NPI) in Section 3, Customer Licensed Providers, of the main body of this Agreement (“Provider List”) whose licenses have been validated by Customer and Mahana.  Only Providers listed in the Provider List, or a written Addendum thereto signed by the Parties, are authorized to facilitate Dispensing of Product to End Users under this Agreement. Upon notice to Customer, Mahana reserves the right to remove Providers from the Provider List who are not properly licensed or are listed on the OIG’s exclusion database or for any other reason.   
  12. Upgrades” means any additional features, bug fixes, patches, or functionalities added to an existing Product. 
  1. General Terms.
  1. Product Dispensing.  Pursuant to the terms of this Agreement, Customer  agrees to log into “Mahana Direct,” which is Mahana’s provider portal, and complete the information necessary about End Users to facilitate Dispensing of Product and related license  to End Users.  
  1. Applicable Laws, Generally.  Customer hereby agrees to comply with all Applicable Laws.
  2. Provider List. Customer hereby agrees to provide Mahana with the Provider List.
  3. End User Terms. End Users will separately be required to agree to Mahana’s End User Terms and Conditions of Use that accompany the Product.
  4. Security. It shall be Customer’s obligation to secure and control access to its instance of Mahana Direct.
  1. Order Process & Procedure & Pricing.
  1. Orders.  Customer shall place orders for Product through Mahana Direct.  
  2. License Grant. During the Term, Customer shall have a limited, non-exclusive, non-sublicensable, non-transferable license to  access (i) Mahana Direct for the purpose of authorizing Dispensing, and assisting Mahana with Dispensing, of the Product to End Users and (ii) reports about the End Users as long as End User is a patient of Customer, subject to the terms of this Agreement.
  3. Invoicing, Pricing, Collection of Payment from End Users.   Mahana shall invoice Customer for each Product Dispensed at the “Price Per Product Dispensed” (“Customer Fee”) stated in Section 2 of the Agreement.  The Customer Fee shall be paid to Mahana from the End User Fees collected, as further described below. 

Customer shall establish End User pricing in an amount that represents the fair market value of the products and services offered by Customer and Mahana (“End User Fee(s)”). End User shall be required to make payment through an electronic link that Customer Dispenses to End User through Mahana Direct (the “Link”).  Mahana, through its third party payment processor, shall collect the End User Fee from End Users. Mahana’s third party payment processor shall remit to Customer the difference between the End User Fee and Customer Fee, and shall remit to Mahana the Customer Fee. Customer acknowledges that some End Users may rescind or challenge End User Fees, or otherwise not make payments, even if Customer has provided services. While Mahana shall use commercially reasonable efforts to collect End User Fees through the Link or the digital application that End User downloads to access the Product (“Application”), Mahana shall not have any obligation to pursue collection of unpaid, rescinded, or challenged End User Fees. Mahana hereby disclaims any liability for any failure of End User to make payments, whether those payments are for services procured through Mahana or  Customer. If End User rescinds a payment or otherwise challenges a payment, Mahana in its sole discretion may issue a credit or refund to End User. In which case, Mahana shall also have the right to debit any amounts paid to Customer related to the amount credited or refunded to an End User.

  1. Cash Pay. The Parties acknowledge that this is a “cash-pay” transaction. Customer represents that it will not bill any government or other payor for the Products Dispensed and that to its knowledge the fees for Products are not reimbursable by a government payor program. The foregoing shall not limit the ability of an End User to pay for, or Mahana’s ability to receive payment for, Product Dispensed through End User’s flexible spending account or health savings account or similar plan, provided that such payment is made through the Link or Application and processed by Mahana through its third party processor.
  2. Pricing Confidentiality.  For the avoidance of doubt, both Customer and End User pricing is Confidential Information. Customer shall not disclose Customer Pricing, or any related matter to End Users or others.
  3. Changes to Customer Pricing.  Pricing is subject to change at any time in Mahana’s sole discretion. Upon any changes to Product pricing, Mahana shall deliver a revised price list to Customer which the Parties agree shall, as of the date of receipt of such list by Customer, amend and supersede the prices set forth in the Product List, hereto and any subsequent amendments thereto.  Any revised pricing shall apply to any Products not yet distributed to Customer.     
  4. Discounts; Credits; Rebates. To the extent the Anti-Kickback Statute applies to the transactions undertaken in this Agreement, if and to the extent Mahana offers, extends, or applies any discount, credit, rebate or other purchase incentive to the Products purchased hereunder, such discount, credit, rebate or other purchase incentive shall constitute a "discount or other reduction in price," as such terms are defined under the  Anti-Kickback Statute. To the extent applicable to the Parties, each Party agrees to use their best efforts to comply with any and all requirements imposed on sellers and buyers, respectively, under 42 U.S.C. § 1320a-7b(b)(3)(a) and the "safe harbor" regulations regarding discounts or other reductions in price set forth in 42 C.F.R. § 1001.952(h). In this regard, Customer may hereunder have an obligation to accurately report, under any state or Federal program which provides cost or charge based reimbursement for the Products covered under this Agreement, the net cost actually paid by Customer.
  1. Payment & Invoices. Mahana shall invoice Customer monthly for Product Dispensed to End Users within the prior month. Mahana shall facilitate collection of payment of Customer Fees and End User Fees as discussed above in Section III. Any fees for products or services not covered by the Customer Fees or End Users Fees will be due to Mahana within thirty (30) days from the date of such invoice.  If any invoice is disputed by Customer, in whole or in part, a detailed notice must be provided to Mahana within fifteen (15) days from the date of such invoice. In the case of disputed invoices, Customer shall distinguish the disputed from the undisputed portion and timely pay the undisputed part. Any undisputed invoice not paid when due shall accrue interest from the date payment is due at the lower of one-and-one-half percent (1.5%) per month or the highest interest rate permitted by Applicable Law.  Payments due to Mahana shall be made without any deduction or offset for any costs, expenses or credits of any kind. 
  2. Product Upgrades. Mahana may make Product Upgrades from time-to-time in its sole discretion. Product Upgrades that are incorporated into existing Products are subject to the terms of this Agreement. Product Upgrades that have separate pricing may be added to this Agreement by a mutually-agreed upon amendment signed by both Parties. 
     
  3. Dispensing Limitations.
  1. Customer’s post-purchase activities with respect to Dispensing of Products shall be limited to  maintaining records, evaluating End Users, and other necessary activities contemplated by this Agreement.  
  2. The decision to evaluate an End User, recommend Product, or Dispense the Product  to an End User is solely the Provider’s decision which must be made in the Provider’s professional medical judgment.  
  3. The Product use period is three (3) months, after which time the End User will retain access to completed content for up to one (1) year.  If the End User desires to continue using the Product longer than 12 months, and if a Provider determines in their professional medical judgment that an End User requires renewed use of the Product, End User will be given the opportunity to renew its access to the Application and Product, which will require additional payment to Mahana as determined by the pricing set forth on the Product List at that time. Mahana will facilitate collection of the payment from End User through Mahana’s third party payment processor and the Parties shall otherwise follow the process described above in Section III.
  1.  Product Records, Inspections & Audits. Customer shall maintain records and books of account containing complete information concerning all Products Dispensed to End Users. Upon Mahana’s request, Customer agrees to allow Mahana to conduct an audit, inspection, examination, or evaluation, in either case for the purposes of examining the Facility’s books of account, Dispensing records and other business records, wherever located, which relate to the Products to the extent reasonably necessary to evaluate Customer’s or Facility’s compliance with Applicable Laws, and other requirements of this Agreement, or to assess Customer’s performance under this Agreement. 
  2. Product Complaints. 

Each Party shall cooperate fully with the other Party in dealing with End User complaints concerning the Products and shall take reasonable action to resolve promptly and follow up with regard to such complaints.  Customer shall provide Mahana with:

  1. All reports of death, serious injury or malfunction that could result in death or may have caused or contributed to serious injury associated with the Product as promptly as possible but in any event within three (3) business days of receipt thereof;
  2. All other adverse experience reports related to the Product including any information Customer receives regarding real or potential adverse reactions or defects of the Product or any information that might otherwise constitute a complaint about the Product to Mahana immediately but in any event within five (5) days of receipt thereof; and
  3. Copies of all Customer and End User communications that address a potential Product problem or safety issue. 
  1. Product Modifications.
  1. Except with the prior written approval of Mahana, Customer shall not in any way: (i) alter or modify any of the Products; or (ii) remove, cover, change, or add to the labels trademarks, or trade names or such labels affixed by Mahana to any of the Products.
  2. Mahana has the right to supplement, modify and update the Product specifications, or provide Upgrades from time to time without notice to Customer other than that which is contained on and within Product labels or otherwise required by Applicable Law.  
  3. In the event Mahana requests Customer’s assistance in communicating specification changes or Upgrades to End Users, Customer agrees to partake in such requested activities. 
  4. Mahana is solely responsible for making determinations of whether additional regulatory submissions pertaining to the Products are necessary to be made (and to make any such submissions) to any Governmental Authorities.
  1. Product Labeling. Mahana shall determine the contents of and affix labels to the Products, which Customer shall not alter.     
  2. Recalls, Corrections & Removals.
  1. Mahana is solely and exclusively responsible for making recall, correction, and removal decisions and notices, and implementing such actions. If Customer in good faith believes that a recall involving the Products is warranted, Customer shall immediately notify Mahana in writing and shall advise Mahana of the reasons underlying its determination that a recall is warranted.  Customer shall not take any action related to a recall, unless directed to do so by Mahana.
  2. During the Term, Customer shall maintain records of all sales of the Products and End Users sufficient to adequately administer a recall, market withdrawal or correction. Immediately upon termination or expiration of this Agreement, Customer shall provide Mahana with a copy of all Dispensing records relating to the Products. Upon Mahana’s request, Customer agrees to provide requested information to Mahana or assist with conducting a recall, correction, or removal.

  1. Non-Conformance & Returns
  1. Customer shall immediately, but not later than thirty (30) days after receipt of notice of any Product defect or End User complaint and state with reasonable specificity the reason for the nonconformity along with identifying information about the Product and related End User in question.
  2. Once an End User has been given a Link to the  Product, Customer shall direct the End User to Mahana to enable Mahana to work directly with that End User to provide support, troubleshooting and resolve technical issues pursuant to Mahana’s End User Terms and Conditions of Use. 
  3. Mahana does not offer refunds or replacements after an End User makes payment for the  Product. If Mahana voluntarily chooses to exercise its sole discretion on a case-by-case basis and issue a refund, any such refund will not be conditioned on Customer’s exclusive use of, or a minimum purchase of, any of Mahana’s Products or services.
  1. Governmental Inspections & Inquiries. Customer shall immediately, and in any event within three (3) business days after the date of receipt of notice, notify Mahana in writing of, and shall provide Mahana with copies of, any and all correspondence and other documentation received or prepared by Customer from or to any Governmental Authority related or pertaining to the Product. This shall include but is not limited to:  (i) Regulatory letters, warnings, recall notices, notices of inspection or similar communications from any Governmental Authority including but not limited to communications pertaining to the storage, marketing, advertisement, sale, and Dispensing of the Products; and (ii) any Governmental Authority’s comments relating to the Products that may require a response or action by Mahana.
  2. Proprietary Rights & Confidentiality.
  1. Confidential Agreement. For the avoidance of doubt, Customer shall not disclose the contents or substance of this Agreement, which are both considered Confidential Information.
  2. Proprietary Rights. Mahana owns the complete and exclusive rights, title, and interest in any and all Confidential Information and Intellectual Property Rights, including but not limited to patents, trademarks, trade names, inventions, copyrights, know-how, trade secrets and other intellectual property relating to the design, manufacture, operation or service of the Products, Mahana Direct, or the Application. 
  3. Limited Rights. Except for the limited rights expressly granted to Customer in this Agreement, this Agreement does not grant or confer any right, interest, or license to Customer in any patents or patent applications, copyrights or other proprietary rights that Mahana or any third party has, may have, or could potentially pursue in or related to the Products, Mahana Direct, or the Application, and shall not confer on Customer any right to manufacture or have manufactured, duplicated or otherwise copied or reproduced any of the Products Mahana Direct, or the Application, or any part or component thereof. 
  4. Reserved Rights. Mahana shall retain exclusive ownership of all proprietary rights including but not limited to Confidential Information and Intellectual Property Rights, as well as in and to all documentation and other data and materials pertaining to any Products, Mahana Direct, or the Application. All rights not expressly granted to Customer in this Agreement are reserved by Mahana.
  5. Software. As between the Parties, Mahana owns and shall retain all right, title and interest in the software, firmware, and computer code contained in the Products, Mahana Direct, or the Application (“Software”). End Users are granted Mahana’s permission to utilize the Product and Application as further described in  these Terms, but all rights to the Product remain with Mahana. Except where such restriction is expressly prohibited by law, Customer will not reverse engineer or otherwise attempt to derive or obtain information about the functioning, manufacture or operation of the Products, including the Software therein.
  1. Use & Handling of Confidential Information. Customer shall not request, obtain, keep, store, sell, distribute, cause or allow to be further disclosed, or utilize Confidential Information for any purpose other than Customer’s performance under this Agreement.  Mahana may disclose certain Confidential Information to Customer to permit Customer to perform its obligations under this Agreement. Customer shall not use any Confidential Information for any purposes or activities other than those specifically authorized in this Agreement and shall not disclose any Confidential Information to third parties without Mahana’s prior written approval. The foregoing use and disclosure restrictions with respect to Confidential Information shall apply during the Term and shall survive the expiration or early termination of this Agreement in perpetuity. The aforesaid prohibitions from use and obligation of confidentiality assumed by Customer hereunder shall not apply or shall cease to apply to: (i) any Confidential or Proprietary Information which was or becomes publicly available to Customer due to no fault of Customer, provided that any Personally Identifiable Information shall continue to be treated as confidential if required by Applicable Law to be kept confidential; or (ii) Confidential Information required to be disclosed pursuant to any statutory or regulatory provision or court order (provided that Customer promptly notifies Mahana of such potential required disclosure and assists Mahana in preventing or limiting such disclosure to the maximum extent permitted, or arguably permitted by Applicable Laws).  
  2. Return or Destruction of Confidential Information. Within ten (10) days after lawful termination of this Agreement for any reason, Customer shall stop use of all Confidential Information, and either return or destroy, as directed by Mahana, all copies thereof (including redaction thereof from any materials incorporating such information in whole or in part) then in its possession or control in any form stored, and certify in writing to Mahana that such activities are complete; provided, however, that Customer shall be entitled to retain a single copy of all such Confidential Information for legal compliance or dispute purposes.

  1. Right to Market the Product.
  1. Authorized Actions. Mahana may allow Customer to advertise the Products under the trademarks, marks, logos, branding and trade names (collectively, “Trademarks”) specified in advance by Mahana, but all such advertising and use of the Trademarks shall be at Mahana’s sole discretion and subject to Mahana’s oversight and control. 
  2. Limitations. Customer shall not create new service or trademarks or trade-names based in whole or in part on Mahana Trademarks. Nothing herein shall grant to Customer or the Facilities any right, title or interest in Mahana Trademarks. Customer acknowledges Mahana’s sole ownership of and rights thereto.  
  3. Mahana Provided Materials.  Mahana reserves the right to provide Customer with training, marketing, and promotional material related to the Products and Mahana Direct to facilitate Customer’s marketing of the Product to End Users.  If Mahana chooses to make such materials available to Customer, Customer agrees to be solely responsible and liable for any and all uses of said materials, including but not limited to the obligation to ensure marketing and promotional materials comply with marketing authorizations and all Applicable Laws.  
  4. Customer Generated Materials. Any Product promotion by Customer shall be in accordance with any cleared indications for use and Mahana approved labeling.  All representations of Mahana Trademarks that Customer intends to use or publish shall use the appropriate trademark symbol and legends in conjunction therewith. 
  5. Approval of Customer Generated Materials.  Any Product promotion by Customer including materials created by Customer accompanying said promotion shall be submitted to Mahana’s Medical Marketing Review Committee for pre-approval prior to Customer’s public use of the materials.  Customer shall modify any materials and activities, including but not limited to materials that include Mahana Trademarks upon Mahana’s request.
  1. Taxes. Customer is responsible for taxes on the Products Dispensed and its use of Mahana Direct and related interest and penalties. Customer shall pay when due, or reimburse Mahana for all taxes and governmental charges of any kind (other than franchise taxes and any taxes based on Mahana’s net income) imposed as a direct or indirect result of Customer’s Dispensing of Products or use of Mahana Direct, provided however, the foregoing shall not apply to the extent Customer is and remains a tax exempt entity. Customer agrees to provide documentation to substantiate such status upon Mahana’s request.
  2. Representations & Warranties.
  1. Customer. Customer hereby represents, warrants and covenants to Mahana that:
  1. Adherence to Laws and Industry Regulations. Customer adheres to and agrees to comply with all Applicable Laws, to industry standards governing and covering its activities under this Agreement, and this Agreement. 
  2. Provider Status. All Providers listed in The Provider List, and any subsequent addendums thereto, are properly licensed to Dispense Products in the state in which they operate as of the date of that writing. Customer shall promptly notify Mahana if any Provider’s license, location, practice affiliation or right to practice status changes.
  3. Insurance. Customer, for itself and all of its Facilities and all of its employees, staff, and agents shall maintain during the Term insurance coverage consistent with industry standards for businesses engaged in the practice of medicine, evaluation of End Users, as well as the purchase, sale, and Dispensing, of digital therapeutic products, including cyber-liability and professional and general liability insurance and as consistent with the requirements set forth in this Agreement.
  4. Products for Own & End-User Use Only. Customer’s receipt and use of Mahana Direct is for its “own use” in the Facilities, and Customer may not resell Mahana Direct. Further, Customer may not Dispense the Products to anyone other than End Users with medical conditions that Providers believe after exercising reasonable medical judgment can benefit from use of the Product, and may not use any third party (aside from Mahana) to Dispense the Product.
  5. Customer Support and Training. Customer shall have the sole responsibility for (i) obtaining orders for Products from Facilities to Dispense Products, (ii) providing End User medical consultations upon request with respect to the Products Dispensed by Facilities, and (iii) handling all other interactions with End Users, and Facilities with respect to Dispensing Products to End Users, provided that any technical questions about the Product, including but not limited to installation or function of the application or iOS compatibility, shall be referred to Mahana’s Customer Service.
  6. Training; Licensure. Customer shall ensure that Facility personnel participate in standard training applicable to the Products before Dispensing any Products.
  7. Customer shall ensure that Facilities provide Product consultations upon request to all End Users, including Mahana customer and technical support contact information, and to ensure that Facilities create and maintain a record of consultations for each End User with respect to the Products.
  8. Not Excluded or Debarred. Customer has not been, and during the Term shall not be: (i) sanctioned within the meaning of Social Security Act Section 1128A or any amendments thereof; (ii) convicted of violating the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (“HIPAA”), the Federal Health Care Program Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), or the Federal civil False Claims Act, 31 U.S.C. §§ 3729-3733; or (iii) debarred, excluded, suspended or otherwise declared ineligible from participation in any federal or state health care program.
  9. Texts. Customer shall obtain written permission from End Users to send texts to End Users to receive the Link and other information related to the Products and Application and comply with Applicable Laws related to texting and otherwise communicating with End Users.
  1. Mahana. Mahana represents and warrants to Customer it is in material compliance with all Applicable Laws. 
  2. Mutual. Each Party hereby individually represents and warrants to the other Party that:
  1. Authority. Such Party has full right, power and authority to enter into and perform its obligations under and contemplated by this Agreement, the attached Schedules, and any other agreements or documents executed or delivered in connection with the consummation of the transactions contemplated hereby. Delivery and performance of this Agreement has been duly authorized by all necessary corporate action on the part of both Parties.
  2. Valid Legal Obligation.  The Agreement has been duly executed and delivered by each Party and constitutes the legal, valid, and binding obligation of each Party, enforceable against the other Party in accordance with its terms.
  1. Mahana Warranty Disclaimer.

EXCEPT AS EXPRESSLY SET FORTH HEREIN, MAHANA MAKES NO WARRANTIES, GUARANTIES, OR REPRESENTATIONS WITH RESPECT TO THE PRODUCTS, MAHANA DIRECT, OR APPLICATION, OR THIS AGREEMENT, WHETHER EXPRESS OR IMPLIED. MAHANA HEREBY EXPRESSLY DISCLAIMS AND CUSTOMER HEREBY EXPRESSLY WAIVES, ANY OTHER WARRANTIES, GUARANTIES, OR REPRESENTATIONS, INCLUDING, BUT NOT LIMITED TO, ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

  1. Privacy & Security Compliance.

The Parties agree that the personal information pertaining to End Users must be protected in accordance with Applicable Laws relating to the privacy and security of Personal Information (collectively, “Privacy Laws”).  To the extent Customer provides any protected health information (“PHI”), as that term is defined under HIPAA, to Mahana, any such disclosures shall be in accordance with HIPAA’s privacy regulations, and each Party agrees to use appropriate safeguards, in accordance with the provisions of the Privacy Laws and the Party’s own policies and procedures, to protect the confidentiality and security of such information. It is the Parties’ intention that any sharing of PHI under this Agreement be in their roles as health care providers acting on their own behalf or the behalf of their common patient. See 45 CFR Sec. 164.506(c)(2), (3).

  1. Indemnification.
  1. By Mahana. Mahana hereby agrees to indemnify, defend,  and hold harmless Customer and its affiliates and their respective stockholders, directors, officers, employees, and agents (collectively, “Customer Representatives”) from and against any and all third party claims and resulting liabilities,  injuries, losses, damages, costs, and expenses (including, without limitation, reasonable attorneys' fees, court or arbitration costs, and out-of-pocket expenses) suffered or incurred which arise or result from the infringement of the Product on the intellectual property rights of any third party. 
  2. By Customer. Customer hereby agrees to indemnify, defend (using counsel selected by Mahana which is reasonably acceptable to Customer) and hold harmless Mahana and its affiliates and their respective stockholders, directors, officers, employees, agents, contractors, and suppliers (collectively, “Mahana Representatives”) from and against any and all liabilities, claims, suits, injuries, losses (inclusive of lost profits), damages, costs, and expenses (including, without limitation, reasonable attorneys' fees, court or arbitration costs, and out-of-pocket expenses) brought or incurred by any person, entity, or Governmental Authority which arise, result from or are related to Customer’s or Customer’s Representatives’: (i) marketing, promotion, sale, distribution, prescription, or Dispensing of Product governed by this Agreement;  (ii) violation of any Applicable Law; (iii) actual or alleged medical practice, negligence or other tortious conduct, intentional misconduct, professional breach of duty, or violation of any state or federal medical law or standard; or (iv) actual or alleged breach of this Agreement.
  3. Procedures. Any Party that may be entitled to indemnification under this Agreement (the “Indemnified Party”) shall give written notice to the Party obligated to indemnify it (the “Indemnifying Party”) with reasonable promptness upon becoming aware of any claim or other facts upon which it will base a claim for indemnification. The Indemnified Party shall cooperate in the defense of any such claim asserted by a third party and make available all records, materials, and witnesses reasonably requested by the Indemnifying Party in connection therewith at the Indemnifying Party’s expense. If the Indemnifying Party assumes the defense of the claim, the Indemnifying Party shall not be liable to the Indemnified Party for any legal or other expenses (other than for reasonable costs of investigation) subsequently incurred by the Indemnified Party in connection with the defense thereof. The Indemnifying Party shall not be liable for any claim settled without its consent, which consent shall not be unreasonably withheld or delayed.  
  1. Damage & Liability Limitation.

NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, MAHANA WILL NOT BE LIABLE TO CUSTOMER FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR EXEMPLARY DAMAGES OR LOST PROFITS, BUSINESS, OR DATA ARISING IN CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND WITHOUT REGARD TO THE NATURE OF THE CLAIM OR THE UNDERLYING THEORY OR CAUSE OF ACTION (E.G., CONTRACT, TORT, ETC.).  IN NO EVENT SHALL THE TOTAL LIABILITY OF MAHANA OR MAHANA’S REPRESENTATIVES, FOR ANY AND ALL CLAIMS, WHETHER IN CONTRACT, WARRANTY, TORT, OR OTHERWISE, ARISING OUT OF OR RELATED TO THIS AGREEMENT, THE PRODUCTS, MAHANA DIRECT, THE APPLICATION, OR ANY SERVICES, OR THE ACTS OR OMISSIONS OF MAHANA OR MAHANA’S REPRESENTATIVES, EXCEED THE TOTAL AMOUNTS PAID AND/OR PAYABLE BY CUSTOMER FOR ANY PRODUCTS OR SERVICES PURCHASED BY CUSTOMER IN THE 12 MONTHS PRECEDING ANY CLAIM.

  1. Termination.   Either Party shall have the right to immediately terminate this Agreement if (i) the other Party files a petition in bankruptcy, or enters into an agreement with its creditors, or applies for or consents to the appointment of a receiver or trustee, or makes an assignment for the benefit of creditors, or suffers or permits the entry of any order adjudicating it to be bankrupt or insolvent and such order is not discharged within thirty (30) days; or (ii) if the other Party materially breaches any of the provisions of this Agreement, and such breach is not cured within thirty (30) days after the giving of written notice. Upon termination of this Agreement: (i) all amounts owing to either Party shall become immediately due and payable; (ii) Mahana and any persons designated by Mahana shall have the right to remove any Products or digital footprints thereof from Customer’s servers or require Customer to do the same, and Customer hereby irrevocably authorizes Mahana to do so or at Mahana’s direction and in its discretion to have Customer certify that Customer has done the same; and (iii) Mahana may exercise, with respect to the Products, all rights and remedies under this Agreement or otherwise available to Mahana.  
  2.  Disputes. 
  1. Arbitration. Each Party irrevocably and unconditionally agrees that it shall not commence any action, litigation, or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims, in any forum other than American Arbitration Association (“AAA”), which shall finally dispose of all disputes, controversies, or claims out of or in connection with the existence, validity, interpretation, or performance of this Agreement. All disputes arising out of or in relation to this Agreement shall be exclusively and finally settled, disposed of, and resolved by the arbitration, and the Parties hereby and expressly agree to refrain from using any principal of law or equity, or any application of any Applicable Laws to set aside the arbitration award.   Each Party agrees that the arbiter’s final judgment or decision in any such proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Applicable Laws.  The Parties hereby acknowledge this Agreement’s arbitration provisions and consent to them. Three arbitrators shall be selected.  The Mahana and Customer shall each select one arbitrator and the two chosen arbitrators shall select the third arbitrator, or failing agreement on the selection of the third arbitrator, AAA shall select the third arbitrator.  Unless otherwise agreed by the Parties, arbitration will take place a U.S. city of Mahana’s choice.  The fees and expenses of the arbitration panel and the cost of the arbitration (including lawyers’ fees) shall be borne by the Party against whom the arbitration award rules or, to the extent a Party is only partially successful, on a pro-rata- basis in proportion to the amount awarded by the arbitration panel compared to the total amount of the claim.
  2. Governing Law.  In the arbitration or in any other legal proceeding, this Agreement shall be governed by and interpreted in accordance with the laws of the State of Delaware without regard to conflicts of law principles, and the laws of the State of Delaware shall govern the Party’s disputes.
  3. Injunctive Relief. Notwithstanding the foregoing, Mahana may pursue injunctive relief in a court of law to enforce any obligations Customer has under this Agreement, and either party may seek judicial enforcement of an arbitrator’s judgment or award.
  1. Survival.  The following Sections of this Agreement along with any other terms that by their nature should survive the expiration or termination of this Agreement shall survive the expiration or termination of this Agreement in perpetuity: Sections 1, 3 through 16, and 18 through 28 of these Terms and Sections 6, 7, 9 and 10 of the main body of the Agreement. All payment obligations incurred prior to the effective date of the expiration or termination, will be deemed to survive such expiration or termination.
  2. Assignment & Successors. Customer shall not transfer or assign this Agreement or any of its rights or delegate its obligations under this Agreement in whole or in part without the prior written consent of Mahana, with Customer remaining jointly and severally liable with any such assignee for the performance of its assigned obligations hereunder. Any attempted assignment by Customer in violation hereof shall be void.  Subject to the preceding sentences, this Agreement shall be binding upon, insure to the benefit of, and be enforceable by and against the respective successors and assigns of the Parties.
  3. Force Majeure. Neither Party will be liable for any failure to perform or for delay in performance resulting from any cause beyond its reasonable control, including without limitation acts of God, fires, floods or weather, epidemics, pandemics (including that arising in connection with COVID-19 and its variants), strikes, lockouts, labor troubles, factory shutdowns, embargoes, accidents, wars, armed conflicts, hostilities, riots, insurrection, terrorist acts, shortages of power or material and natural resources of any kind, disruptions in transportation, governmental laws, orders, or other regulations.  Each Party agrees to promptly notify the other Party of the occurrence of any event beyond its reasonable control that affects the fulfillment of its obligations under this Agreement if the cause continues unabated for 90 days. 

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