Business Associate Agreement

CYMEDICA PROVIDER PORTAL MASTER SERVICES AGREEMENT

This CyMedica Provider Portal Master Services Agreement (the “Agreement”), dated as of [insert date] (the “Effective Date”), is between CyMedica Orthopedics, Inc., a Delaware corporation with offices located at 2120 East 6th Street, Suite 8, Tempe, AZ 85288 (“CyMedica”), and __________________, a __________________, with offices located at ______________ (“Customer). CyMedica and Customer may each be referred to in this Agreement as a “Party” and, collectively, as the “Parties.”

BACKGROUND:

  • CyMedica’s technology platform and Medical Devices (the “CyMedica e-vive™ system” or “e-vive system” and CyMedica IntelliHab™ system) enables remote monitoring of a patient’s knee range of motion, pain, steps, and compliance with therapeutic recommendations.
  • Customer is a medical practice serving patients who may benefit from Medical Devices.
  • The Parties desire to enter into this Agreement in order to specify the terms and conditions for use of Medical Devices by Customer for the benefit of Customer’s patients.

The Parties agree as follows:

  1. DEFINITIONS
  • “Authorized User” means (a) the employees, consultants, agents and subcontractors of Customer that are authorized by Customer to access the Software or Services; and (b) any Patient User.
  • “Customer Data” means (a) all data and information Customer submits or transmits to CyMedica, including any PHI (as defined below) necessary for CyMedica to provide the Software and Services; and (b) data, records and information CyMedica generates that relates directly to Medical Devices for Customer under this Agreement, exclusive of information or documentation that CyMedica generates for use in CyMedica’s business generally or for use with multiple customers and exclusive of De-Identified Data as defined below.
  • “De-Identified Data” means personally identifiable information (PII) and PHI (defined below) that has been stripped of certain identifiable elements so as to render the individual’s data de-identified.
  • “Medical Devices” means the devices and any other equipment provided by CyMedica to Customer and identified in Exhibit A.
  • "Documentation" means user manuals for the Medical Devices and Software; all addenda, corrections, and new editions of these materials; and any other materials in any form, that CyMedica customarily provides to end users of the Medical Devices and Software.
  • “Governmental Authority” means the Federal government, any state, county, municipal or local government or any governmental department, political subdivision, agency, bureau, commission, authority, body or instrumentality or court that regulates the applicable party’s activities or operations.
  • “Intellectual Property Rights” means any patent, invention, discovery, know-how, moral, technology, software, copyright, authorship, trade secret, trademark, trade dress, service mark, confidentiality, proprietary, privacy, intellectual property or similar rights (including rights in applications, registrations, filings and renewals) that are now or hereafter protected or legally enforceable under state or Federal common laws or statutory laws or laws of foreign jurisdictions.
  • “Laws” means all applicable common law and any and all state, Federal or local statutes, ordinances, codes, rules, regulations, or requirements enacted, adopted, followed or imposed by any Governmental Authority, as amended, interpreted or enforced by any Governmental Authority, as applicable to each respective Party.
  • “Licensed Firmware” means the object code version of the computer programs incorporated, embedded, or otherwise provided by CyMedica for use in connection with the Medical Devices.
  • “Participating Patients” means those patients of Customer’s practice that Customer has determined may benefit from the Medical Devices.
  • “Patient-Generated Health Data” means physiologic data from a Patient User (as defined below), whether self-reported or detected by a Medical Device or Medical Devices.
  • “Patient User” means any patient of Customer or any duly authorized representative or agent of Patient, who has registered to use the Software and has agreed to the Terms of Use.
  • “Protected Health Information” or “PHI” shall have the meaning ascribed to such term in 45 C.F.R. 160.103.
  • “Software” means the CyMedica SaaS offerings, including the CyMedica provider portal and Patient Mobile App for use in connection with the Medical Devices.
  • “CyMedica Data” means: (a) all data, software (in any form) and information CyMedica submits or transmits to Customer regarding CyMedica; (b) all data, records and information generated in CyMedica’s business or operations, including any information relating to CyMedica’s subcontractors and/or affiliates; (c) all CyMedica Intellectual Property, together with all derivative works of the CyMedica Intellectual Property; and (d) data, records or information occurring in any form, including written, graphic, electronic, visual or fixed in any tangible medium of expression and whether developed, generated, stored, possessed or used by CyMedica, Customer, or a third party if related to the items described in (a) through (c) above. CyMedica Data does not include any data or information that relates exclusively to Customer or Customer’s business, operations or activities.
  • “Terms of Use” means the CyMedica Provider Terms of Use for Customer’s end users of the software.
  1. Medical Devices
  • Provider Portal. The provider portal (the “Provider Portal”) may be used by Customer’s healthcare providers and clinical staff to monitor Participating Patients and determine which Patients require follow-up and/or intervention. The Provider Portal allows Customer to 1) customize the thresholds that are used for notifications; 2) view notifications for each Participating Patient; 3) review monitored physiological data for each Participating Patient; and 4) track provider/staff time spent reviewing and interacting with Participating Patient data.
  • Medical Devices. The Medical Devices include a conductive garment, worn on the knee that monitor and transmit health data. The CyMedica e-vive device also includes built-in sensors for measurement and transmission of knee range of motion data. The Medical Devices also holds electrodes that deliver electrical stimulation to the patient’s quadriceps to augment a patient’s rehabilitation before and after knee surgery, or strengthen the quadriceps, or treat knee pain. The Medical Devices also include a patient facing Mobile App where patient reported outcomes such as pain or VAS (Visual Analog Pain Scale), KOOS/ KOOS JR. (Knee Injury and Osteoarthritis Outcome Score) are collected and transmitted to the Provider Portal. When appropriate, the Medical Devices may also include a post-operative knee brace for patients recovering from a knee surgery. The Medical Devices send a portion of the collected data to the Patient Mobile App for Patient to view and to the Provider Portal where the data can be viewed by a patient’s health care provider.
  • Patient Mobile App. CyMedica will provide Customer’s Participating Patients with access to the Patient Mobile App. The Patient Mobile App has three main functionalities: 1) onboarding of Participating Patients and helping them understand how to pair and set up the Medical Device; 2) receiving data from Medical Devices and relaying it to CyMedica servers for storage/processing; and 3) displaying a portion of the data collected to patients. CyMedica’s Patient Mobile App shall be available by download via the CyMedica website at cymedicaortho.com, via the App Store, and via Google play.
  • Delivery of Medical Devices. CyMedica will deliver to Customer the Medical Devices. All Medical Devices are intended to be delivered in good working order.
  • Returns. All returns of defective Medical Devices, and the shipment of repair or replacement parts for the Medical Devices, shall be at CyMedica’s risk and expense, unless such defect, repair, or replacement occurs as a result of patient’s fault, in which case the shipment repair or replacement parts shall be patient’s responsibility.
  • Availability. CyMedica will strive to make the Medical Devices available twenty-four hours per day, seven days per week except for scheduled maintenance windows. If any service element deteriorates so much as to render the Program unusable for more than 12 hours, the situation will be escalated to CyMedica’s Head of Product Development.
  • License Grant.
  • Software. Subject to Customer’s compliance with the terms of this Agreement, CyMedica hereby grants to Customer and its Authorized Users, during the Term of this Agreement, a limited, non-exclusive, non-transferable right (a) to access and use the Software in accordance with the Documentation and subject to any applicable Terms of Use for the relevant Software, (b) to upload Customer Data by and through the Software; (c) to access and use reports generated from time to time by CyMedica; and (d) to use and reproduce the Documentation solely as necessary for Customer’s use of the Services (the “License”).
  • Customer Data. Customer hereby grants to CyMedica a limited, non-exclusive, royalty-free, worldwide license to:
  • Use, reproduce, aggregate and modify the Customer Data and to perform all acts with respect to the Customer Data as may be necessary for CyMedica to provide the Services to Customer; and
  • Use Customer’s name, logo, trademark, for marketing purposes, upon written consent of Customer; and
  • Use or modify the Customer Data for the purposes of creating De-identified Data from PII and PHI contained in the Customer Data. CyMedica intends to use De-identified Data, aggregated with the de-identified data of other CyMedica customers, to enable CyMedica to provide more targeted, accurate, and useful insights to its customers.
  • As between CyMedica and Customer, Customer is solely responsible for the accuracy, quality, integrity, legality, reliability, and appropriateness of all Customer Data. Customer Data will be included in and treated as Customer’s Confidential Information under this Agreement.
  • Intellectual Property. Except as otherwise set forth in this Agreement, all inventions, works of authorship, and developments conceived, created, written, or generated by or on behalf of CyMedica, whether solely or jointly, including without limitation, in connection with the Services, Medical Devices and Software hereunder (“CyMedica Developments”) and all Intellectual Property Rights therein, shall be the sole and exclusive property of CyMedica. Customer agrees to execute any documents or take any actions as may reasonably be necessary, or as CyMedica may reasonably request, to protect ownership of the CyMedica Developments.
  1. CUSTOMER RESPONSIBILITIES
  • System. Customer is responsible for (a) obtaining, deploying and maintaining the all-computer hardware, software, modems, routers and other communications equipment necessary for Customer’s Authorized Users to access and use the Software via the Internet; (b) contracting with third party ISP, telecommunications and other service providers to access and use the Software via the Internet; and (c) paying all third party fees and access charges incurred in connection with the foregoing. Except as specifically set forth in this Agreement, CyMedica will not be responsible for supplying any hardware, software or other equipment to Customer under this Agreement.
  • Consents. Customer shall obtain and document all required patient consents from Participating Patients prior to using the Software or Services in connection with the patient’s care, including without limitation consent to remote patient monitoring services. Unless otherwise agreed in writing, Customer will obtain all additional necessary consents and authorizations to enable CyMedica to use, upload, process and store Customer Data using the Software. Customer will not furnish any Customer Data that includes an individual’s PHI to CyMedica in the event such individual objects. Customer acknowledges and accepts full responsibility and liability for all Customer Data.
  • Terms of Use. Customer will be solely responsible for its actions and the actions of its Authorized Users while using the Software. As a condition to Customer’s and its Authorized Users’ use of the Software, Customer shall require its Authorized Users to review and accept the Terms of Use (“TOU”). Customer acknowledges and agrees that, from time to time, CyMedica may (in accordance with the process specified in the TOU and without the prior written consent of Customer) change, remove, add to (including without limitation by way of additional terms) or otherwise modify the TOU. In the event of a conflict between the TOU and this Agreement, the terms of this Agreement shall prevail.
  • Patient Copays and Deductibles. Customer is responsible for collecting from a Participating Patient any applicable patient copay or deductible amount as required by Participating Patient’s health insurance plan, whether commercial or government sponsored.
  1. PAYMENTS
  • Fees. As compensation for the Provider Portal access, Customer shall pay CyMedica pursuant to the fee arrangement set forth in Exhibit A.
  • Invoicing and Payment.
  • CyMedica shall invoice Customer via email to Customer’s designated contact person for fees owed to CyMedica on a monthly basis.
  • Customer shall pay CyMedica for invoiced amounts and any other amounts due under this Agreement via credit/debit card or check.
  • Customer shall pay all undisputed fees within 30 days of receipt of an invoice from CyMedica.
  • Currency. All amounts set forth in this Agreement are denominated and shall be paid in U.S. dollars.
  • Overdue Payments.
  • Any payment owed by Customer to CyMedica hereunder and not timely paid to CyMedica (an “Overdue Payment”) may accrue, at CyMedica’s discretion, late charges at the rate of one and one-half percent (1.5%) of the outstanding balance per month, or at the maximum rate permitted by law, whichever is lower, from the date such payment was due until the date paid.
  • If there are payments outstanding for more than thirty (30) days and such payments have not been disputed in good faith pursuant to Section 4.5, CyMedica will provide a ten (10) day opportunity to cure. If, after the thirty (30) day cure period, payments remain overdue, CyMedica reserves the right to suspend Authorized Users’ access to the Software until such amounts are paid in full. Customer shall continue to be obligated to pay all Fees during such suspension period.
  • Disputed Payments. Customer must indicate that they are disputing any fees or expenses, in writing, to CyMedica within ten (10) business days of receipt of the invoice specifying such fees or expenses (a “Dispute Notice”). In the event a Customer disputes any fees or expenses owed pursuant to this Agreement and withholds payment, CyMedica and Customer agree to attempt to resolve such dispute through informal meetings and discussions in good faith between appropriate representatives of said parties within forty-five (45) days of receipt of the Dispute Notice before resorting to any other dispute resolution procedure.
  • Taxes. All amounts payable by Customer to CyMedica pursuant to this Agreement are exclusive of all local, state, federal and foreign taxes, levies, or duties of any nature (“Taxes”), and all payments to CyMedica are payable in full without reduction for Taxes. Customer is responsible for payment of all Taxes, excluding taxes owed by CyMedica based on CyMedica’s net income. If CyMedica has the legal obligation to pay or collect Taxes for which Customer is responsible pursuant to this Section, the appropriate amount shall be invoiced to and paid by Customer, unless Customer provides CyMedica with a valid tax exemption certificate authorized by the appropriate taxing authority.
  1. PROPRIETARY RIGHTS
  • CyMedica Intellectual Property. As between CyMedica and Customer, all right, title and interest, including all Intellectual Property Rights, in the Services, Software, CyMedica Data, Documentation, and any other CyMedica property or materials furnished or made available hereunder, and all modifications and enhancements thereof, belong to and are retained solely by CyMedica or CyMedica’s licensors and providers, as applicable.
  • Trademarks. Nothing in this Agreement shall grant any party any ownership interest, license or other right to any other party’s trade names, trademarks or service marks. 
  • Customer Data. As between CyMedica and Customer, all right, title and interest in the Customer Data belong to and are retained solely by Customer except as set forth in Section 2.7.2. 
  • Feedback License. CyMedica owns all right, title and interest in and to any suggestion, enhancement, request, recommendation, or other feedback related to the Software provided by Customer (any “Feedback”). Feedback shall not be considered Customer’s Confidential Information pursuant to this Agreement.
  • De-identified Data. As permitted in Section 2.7.2 above, CyMedica may use PII and PHI (a subset of Customer Data) to create De-identified Data. CyMedica may use, create, modify, aggregate, and disclose De-identified Data for any purposes not prohibited by law. CyMedica owns all rights, title and interest in such De-identified Data and any data, information and material created by CyMedica with such De-identified Data, including all Intellectual Property Rights therein. De-identified Data is NOT Customer Data. For the avoidance of doubt, the second and third sentences of this Section 5.5 shall survive the expiration or earlier termination of this Agreement.
  1. REPRESENTATIONS AND WARRANTIES; DISCLAIMER
  • Mutual Representations and Warranties. Each Party represents, warrants and covenants that such Party has conducted reasonable inquiry and based thereon is informed and believes that: (a) it has the full power and authority to enter into this Agreement and to perform its obligations hereunder, without the need for any consents, approvals or immunities not yet obtained; (b) its acceptance of and performance under this Agreement will not breach any oral or written agreement with any third party or any obligation owed by it to any third party to keep any information or materials in confidence or in trust; and (c) it will comply with any and all applicable local, state, and/or national laws or regulations applicable to such party, including, without limitation, those related to PHI, Covered Entities, and Business Associates as each term is defined under HIPAA, and to any other laws or regulations regarding data privacy and transmission of personal data.
  • Device Warranty. CyMedica represents and warrants that the Medical Devices: (i) is free from defects, whether patent or latent, in design, materials or workmanship; (ii) has packaging, labeling and inserts that conform to and comply with the requirements of all applicable industry, accreditation, commission and regulatory standards, and applicable federal, state and local laws, regulations and ordinances (including those of The Joint Commission and Medicare/Medicaid conditions of participation); (iii) conforms with statements in CyMedica’s product inserts, advertising literature, user documentation, specifications, and written warranties for the products; and (iv) if the products are mains powered, the products meet all applicable standards/codes that address the safety and marking requirements of information technology equipment. If any Medical Device provided by CyMedica under this Agreement fails to function in accordance with the warranties stated in this Section 6.2, then CyMedica shall promptly repair or replace the product at no additional cost to Customer. The repair and replacement of the Medical Device is Customer’s sole and exclusive remedy for a breach of this Section 6.2.
  • Software. During the Term of this Agreement, CyMedica warrants that the Software will perform substantially in compliance with the Documentation and according to the terms of this Agreement. 
  • Practice of Medicine. CUSTOMER HEREBY AGREES AND ACKNOWLEDGES THAT CYMEDICA IS IN NO WAY ACTING AS A MEDICAL PROVIDER WITH RESPECT TO ANY PATIENT OR ANY OF CUSTOMER’S RELATED PARTIES AND PROVIDERS, NOR IS CYMEDICA PROVIDING 24/7 CONTINUOUS, SYNCHRONOUS, OR EMERGENCY ALERTING. CUSTOMER FURTHER ACKNOWLEDGES AND AGREES THAT THE TREATMENTS, PROCEDURES, WORKFLOW, INFORMATION, MEDICATIONS, PROCESSES, PRODUCTS AND OTHER ITEMS REFERENCED BY CYMEDICA OR ITS SOFTWARE ARE NOT INTENDED AS A RECOMMENDATION OR ENDORSEMENT OF ANY COURSE OF TREATMENT, PROCEDURE, INFORMATION, PRODUCT OR MEDICATION AND THAT THE ULTIMATE RESPONSIBILITY FOR DIAGNOSING AND TREATING ANY PATIENT RESTS WITH THE PHYSICIANS TREATING SUCH PATIENT.
  • Third Party Materials. CUSTOMER UNDERSTANDS AND AGREES THAT USING, ACCESSING, DOWNLOADING, OR OTHERWISE OBTAINING INFORMATION, MATERIALS, OR DATA THROUGH THE SOFTWARE FROM A SOURCE OTHER THAN CYMEDICA (“Third Party Materials”) IS AT CUSTOMER’S OWN DISCRETION AND RISK AND THAT CUSTOMER WILL BE SOLELY RESPONSIBLE FOR ANY DAMAGE TO ITS OR ITS AUTHORIZED USERS’ PROPERTY OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OR USE OF SUCH MATERIAL OR DATA.
  • Disclaimer. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS SECTION 6, THE MEDICAL DEVICES, SERVICES AND SOFTWARE ARE PROVIDED ON AN AS-IS BASIS. CUSTOMER’S USE OF THE MEDICAL DEVICES, SERVICES AND SOFTWARE IS AT ITS OWN RISK. CYMEDICA DOES NOT MAKE, AND HEREBY DISCLAIMS, ANY AND ALL OTHER EXPRESS, STATUTORY AND IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT AND ACCURACY (OF DATA OR ANY OTHER INFORMATION OR CONTENT), AND ANY WARRANTIES ARISING FROM A COURSE OF DEALING, USAGE, OR TRADE PRACTICE. ANY WARRANTIES MADE BY CYMEDICA ARE FOR THE BENEFIT OF CUSTOMER ONLY AND NOT FOR THE BENEFIT OF ANY THIRD PARTY. THE SERVICES MAY BE SUBJECT TO LIMITATIONS, DELAYS, AND OTHER PROBLEMS INHERENT IN THE USE OF THE INTERNET AND ELECTRONIC COMMUNICATIONS. CYMEDICA IS NOT RESPONSIBLE FOR ANY DELAYS, DELIVERY FAILURES, OR OTHER DAMAGES RESULTING FROM SUCH PROBLEMS.

THE ENTIRE RISK ARISING OUT OF USE OR PERFORMANCE OF THE MEDICAL DEVICES, SERVICES AND SOFTWARE, INCLUDING, WITHOUT LIMITATION, ANY INFORMATION, DATA, PRODUCTS, PROCESSES, AND OTHER MATTERS REFERENCED BY THE MEDICAL DEVICES, SERVICES AND SOFTWARE, REMAINS WITH THE CUSTOMER. 

EXCEPT AS EXPRESSLY PROVIDED HEREIN, CYMEDICA DOES NOT GUARANTEE CONTINUOUS, ERROR-FREE, VIRUS-FREE OR SECURE OPERATION AND ACCESS TO THE SOFTWARE.

  • Basis of the Bargain. CUSTOMER ACKNOWLEDGES AND AGREES THAT CYMEDICA HAS OFFERED ITS PRODUCTS AND SERVICES AND ENTERED INTO THIS AGREEMENT TO WHICH IT IS A PARTY IN RELIANCE UPON THE WARRANTY DISCLAIMERS AND THE LIMITATIONS OF LIABILITY SET FORTH HEREIN, THAT THE WARRANTY DISCLAIMERS AND THE LIMITATIONS OF LIABILITY SET FORTH HEREIN REFLECT A REASONABLE AND FAIR ALLOCATION OF RISK BETWEEN CUSTOMER AND CYMEDICA, AND THAT THE WARRANTY DISCLAIMERS AND THE LIMITATIONS OF LIABILITY SET FORTH HEREIN FORM AN ESSENTIAL BASIS OF THE BARGAIN BETWEEN CUSTOMER AND CYMEDICA. CUSTOMER ACKNOWLEDGES AND AGREES THAT CYMEDICA WOULD NOT BE ABLE TO PROVIDE THE MEDICAL DEVICES, SERVICES AND SOFTWARE TO CUSTOMER ON AN ECONOMICALLY REASONABLE BASIS WITHOUT THESE LIMITATIONS.
  1. CONFIDENTIALITY
  • Confidential Information Defined. “Confidential Information” means any and all non-public technical and non-technical information disclosed by one party (the “Disclosing Party”) to the other party (the “Receiving Party”) in any form or medium, whether oral, written, graphical or electronic, pursuant to this Agreement, that is marked confidential and proprietary, or that the Disclosing Party identifies as confidential and proprietary, or that by the nature of the circumstances surrounding the disclosure or receipt ought to be treated as confidential and proprietary information, including but not limited to: (a) techniques, sketches, drawings, models, inventions (whether or not patented or patentable), know-how, processes, apparatus, formulae, equipment, algorithms, software programs, software source and object codes and documents, APIs, and other creative works (whether or not copyrighted or copyrightable); (b) information concerning research, experimental work, development, design details and specifications, engineering, financial information, procurement requirements, purchasing, manufacturing, customer lists, business forecasts, sales and merchandising and marketing plans and information; (c) the business relationships and affairs of either party and its clients, patients, and referral sources; (d) the internal policies and procedures of either Party; (e) proprietary or confidential information of any third party who may disclose such information to Disclosing Party or Receiving Party in the course of Disclosing Party’s business; and (f) the terms of this Agreement. CyMedica’s Confidential Information includes the Services, Software, Documentation, and CyMedica Data. Confidential Information of Customer includes Customer Data. Confidential Information also includes all summaries and abstracts of Confidential Information. In addition, Confidential Information excludes PHI, which must be protected according to the Business Associate Agreement, and not according to Section 7.2 below.
  • Confidential Information Terms. Each Party acknowledges that, in the course of the performance of this Agreement, it may obtain the Confidential Information of the other party. The Receiving Party will, at all times, both during the term and thereafter, keep in confidence and trust all of the Disclosing Party’s Confidential Information. The Receiving Party will not use the Confidential Information of the Disclosing Party other than as necessary to fulfill the Receiving Party’s obligations or to exercise the Receiving Party’s rights under this Agreement. Notwithstanding the above, either Party may disclose the other Party’s Confidential Information upon the order of any competent court or government agency; provided that, prior to disclosure, to the extent possible, the receiving Party shall (i) assert the confidential nature of the Confidential Information to the agency; (ii) immediately notify the Disclosing Party in writing of the agency’s order or request to disclose; and (iii) cooperate fully with the Disclosing Party in protecting against any such disclosure and in obtaining a protective order narrowing the scope of the compelled disclosure and protecting its confidentiality. Each Party agrees to secure and protect the other Party’s Confidential Information with the same degree of care and in a manner consistent with the maintenance of such Party’s own Confidential Information (but in no event less than reasonable care), and to take appropriate action by instruction or agreement with its employees or other agents who are permitted access to the other Party’s Confidential Information to satisfy its obligations under this Section 7. The Receiving Party will not disclose Confidential Information of the Disclosing Party to any person or entity other than its officers, employees, affiliates and agents who need access to such Confidential Information in order to effect the intent of this Agreement and who are subject to confidentiality obligations at least as stringent as the obligations set forth in this Agreement.
  • Non-Confidential Information. The term “Confidential Information” shall not include any information which: (i) was known by the Receiving Party prior to receipt from the Disclosing Party either itself or through receipt directly or indirectly from a source other than one having an obligation of confidentiality to the Disclosing Party, as evidenced by the Receiving Party’s written records; (ii) was developed by the Receiving Party without use of the Disclosing Party’s Confidential Information, as evidenced by the Receiving Party’s written records; or (iii) becomes publicly known or otherwise ceases to be secret or confidential, except as a result of a breach of this Agreement or any obligation of confidentiality by the Receiving Party. 
  • Injunctive Relief. The Parties agree that any unauthorized disclosure of Confidential Information may cause immediate and irreparable injury to the Disclosing Party and that, in the event of such breach, the Receiving Party will be entitled, in addition to any other available remedies, to seek immediate injunctive and other equitable relief, without bond and without the necessity of showing actual monetary damage.
  • HIPAA Compliance. Each Party, to the extent applicable, will comply with laws and regulations applicable to the privacy and security of individually identifiable health information, including but not limited to state laws and regulations and the Health Insurance Portability and Accountability Act (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and/or regulations promulgated thereunder (“HIPAA Regulations”). State law, HIPAA, HITECH, HIPAA Regulations and other federal laws and regulations are hereafter referred to collectively as “Privacy Laws”. The Business Associate Agreement executed between the Parties further describes the parties’ obligations with respect to compliance with HIPAA, HITECH, and HIPAA Regulations, and is hereby incorporated into this Agreement by reference. 
  • Security. CyMedica will allow Customer to create user logins and passwords for each of its Authorized Users. Customer will be, and will ensure that its Authorized Users are, responsible for maintaining the confidentiality of all User logins and passwords and for ensuring that each User login and password is used only by the Authorized User to which it was issued. Customer shall restrict its Authorized Users from sharing passwords. Customer agrees to immediately notify CyMedica of any unauthorized use of any account or login and password issued to its Authorized Users, or any other breach of security known to Customer. CyMedica will have no liability for any loss or damage arising from Customer’s failure to comply with the Agreement set forth in this Section. Customer will ensure its Authorized Users do not circumvent or otherwise interfere with any user authentication or security of the Software.
  1. INDEMNIFICATION
  • Indemnification by Customer. Customer shall indemnify and hold harmless CyMedica and its officers, directors, employees and agents (“CyMedica Indemnified Parties”), from and against any and all damages, liabilities, penalties, interest, fines, losses, costs and expenses (including reasonable attorneys’ fees and expenses) (“Losses”), arising, directly or indirectly, out of or relating to any claim, action or proceeding (a “Claim”) brought by a third party based on (i) the improper use or operation of the Software (and any third party software provided to Customer pursuant to this Agreement) by Patients, Customer and/or the Authorized Users, including, without limitation, any non-authorized use of Customer’s user logins, provided, however, that Customer shall have no indemnification obligation for any claim for which the proximate cause was the gross negligence or willful misconduct of CyMedica; (ii) a breach of the Agreement by Customer or any of its Authorized Users, (iii) the accuracy, quality, integrity, legality, reliability or appropriateness of Customer Data or any other content or data introduced to the Software by any Authorized User; (iv) violation of any applicable law, rule or regulation by Customer or any of the Authorized Users, (v) the diagnosis and/or treatment of any of Customer’s Patients; and/or (vi) the negligent acts or willful misconduct of Customer or its personnel; (vii) the negligent and intentional acts or omissions of Customer, with unintentional or inadvertent errors of medical billing. In addition, Customer agrees to comply with all federal and state statutes, as well as all applicable third-party payer rules, and regulations applicable to billing and reimbursement activities related to remote patient monitoring, including, but not limited to, appropriate documentation of services in the medical record and coding. 

Customer will pay all Losses (whether by settlement or award of by a final judicial judgment) incurred by the CyMedica Indemnified Parties from any such Claim.

  • Indemnification by CyMedica. Subject to limitations of liability as set forth in Section 9, CyMedica agrees to defend Customer and its officers, directors, employees and agents (a “Customer Indemnified Party”) from and against any Claims brought by a third party resulting from or arising out of (i) the unauthorized disclosure by CyMedica of PHI in breach of the Business Associate Agreement by CyMedica; and (ii) an allegation that the Medical Devices, Services, Software or Licensed Firmware infringe or misappropriate the patent, trade secret, trademark, copyright or other Intellectual Property Rights of any third party (an “Infringement Claim”). CyMedica will pay all Losses (whether by settlement or award of by a final judicial judgment) incurred by the Customer Indemnified Parties from any such Claim.
  • In the event of an unauthorized disclosure by CyMedica of PHI in breach of the Business Associate Agreement, CyMedica shall undertake, and shall bear its own costs or third-party expenses incurred by CyMedica with respect to, providing such credit monitoring services and notice to Customer’s affected patients as are required by applicable privacy and data security laws, including, but not limited to, 45 CFR 164.400 et seq.
  • In the event of an Infringement Claim, CyMedica may, at its election, and sole expense, (i) modify the Medical Device and/or Service so that such Medical Device and/or Service is non-infringing and functionally equivalent; (ii) replace the Medical Device and/or Service with a non-infringing Medical Device and/or Service that is functionally equivalent; or (iii) obtain the right for Customer and Customer’s patients to continue using the Medical Device and/or Service at no additional cost to Customer. If none of the foregoing is commercially practicable, CyMedica may terminate this Agreement and Customer will return to CyMedica all such infringing Medical Devices. If CyMedica terminates the Agreement, CyMedica will refund all amounts Customer paid for such Medical Devices and/or for any Services not yet performed.
  • Procedure. Each Party shall provide the other Party prompt notice of any Claim for which they are seeking indemnification. The indemnified party in may have counsel reasonably acceptable to the indemnifying party observe the proceedings at the indemnified party’s expense, provided the indemnifying party retains sole control of the defense of the Claim. The indemnified party has the right to approve any settlement that affirmatively places on the indemnified party an obligation that has a material adverse effect on the indemnified party other than requiring the indemnified party to cease using the Software or to pay sums indemnified hereunder. Such approval shall not be unreasonably withheld.
  1. LIMITATIONS OF LIABILITY
  • No Consequential Damages. NEITHER PARTY WILL BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, OR ANY DAMAGES FOR LOST DATA, BUSINESS INTERRUPTION, LOST PROFITS, LOST REVENUE OR LOST BUSINESS, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, EVEN IF A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING WITHOUT LIMITATION, ANY SUCH DAMAGES ARISING OUT OF CYMEDICA’S PROVISION OR CUSTOMER’S USE OF THE MEDICAL DEVICES, SOFTWARE, OR SERVICES OR THE RESULTS THEREOF. IN NO EVENT WILL CYMEDICA BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES.
  • Limits on Liability. CYMEDICA SHALL NOT BE LIABLE FOR CUMULATIVE, AGGREGATE DAMAGES GREATER THAN THE AMOUNTS PAID AND PAYABLE BY CUSTOMER TO CYMEDICA UNDER THIS AGREEMENT DURING THE TWELVE (12) MONTH PERIOD PRECEDING THE DATE ON WHICH THE CLAIM FIRST ACCRUED, WITHOUT REGARD TO WHETHER SUCH CLAIM IS BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), PRODUCT LIABILITY OR OTHER.
  • Essential Purpose. CUSTOMER ACKNOWLEDGES THAT THE TERMS IN THIS SECTION 10 (LIMITATION OF LIABILITY) ARE A BARGAINED FOR REASONABLE ALLOCATION OF THE RISK BETWEEN THE PARTIES AND WILL APPLY (A) TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, AND (B) EVEN IF AN EXCLUSIVE OR LIMITED REMEDY STATED HEREIN FAILS OF ITS ESSENTIAL PURPOSE.
  • Exceptions. The limitations and exclusions of certain damages set forth in Section 9.1 and 9.2 will not apply to injury or damage caused by a Party’s gross negligence or willful misconduct.
  • Limitation of Action. No action (regardless of form) arising out of this Agreement may be commenced by Customer against CyMedica more than two (2) years after the cause of action arose.
  1. TERM & TERMINATION
  • Initial and Renewal Term. This Agreement shall be effective as of the Effective Date and continue for an initial term of one (1) year (“Initial Term”). Unless a Party provides the other Party with a notice of non-renewal at least sixty (60) days prior to the end of the then current term, this Agreement shall automatically renew for an additional one (1) year term (a “Renewal Term”) at the end of the Initial Term or any Renewal Term. The Initial Term and each Renewal Term are collectively, the “Term”. If a Party provides notice of non-renewal in accordance with this Section 10.1, this Agreement shall terminate effective as of the day that would have been the first day of the then-current Renewal Term.
  • Termination. This Agreement may be terminated according to the following terms:
  • Mutual Agreement. This Agreement shall terminate upon the mutual written agreement of Customer and CyMedica.
  • For Cause.
  • Material Breach. Either Party may terminate this Agreement following a material breach of this Agreement by the other Party which is not cured during the Cure Period (defined below). The non-breaching Party shall notify the breaching Party of the breach in writing and the breaching party shall have thirty (30) days (the “Cure Period”) to cure the breach following receipt of the notification. If the breaching Party fails to cure the breach within the Cure Period, then the non-breaching Party may terminate this Agreement upon written notice to the breaching party.
  • Other Cause. CyMedica may terminate this Agreement immediately by providing written notice to Customer upon the occurrence of any of the following events:
  • CyMedica reasonably determines that Customer and/or its Authorized User(s) have been or are engaged in unlawful activity associated with the use of the Software and/or the Services;
  • The indictment or conviction of Customer or its principals, employees, or agents for any felony or misdemeanor involving moral turpitude;
  • The filing, with respect to Customer, of a voluntary or involuntary petition in bankruptcy if such petition is not dismissed within thirty (30) days of such filing;
  • Upon the appointment of a receiver or trustee to take possession of all, or substantially all, of Customer’s assets, if such appointment is not terminated within thirty (30) days;
  • Customer’s exclusion from participation in Medicare; and/or
  • For any other reason CyMedica feels could reasonably jeopardize the integrity or reputation of its operations or systems.
  • Without Cause. Either Party may terminate this Agreement without cause provided that the terminating Party provides ninety (90) days’ written notice of termination.
  • Effect of Termination.
  • Unless otherwise stated below, upon expiration or termination of this Agreement for any reason, (a) the License shall terminate and the Customer shall not use or access, directly or indirectly, the Software or Documentation; (b) CyMedica’s obligation to perform support Services shall cease; and (c) all fees and other amounts owed to CyMedica will be immediately due and payable by Customer. If Customer has made any copies of any Software, Documentation, or any other CyMedica property or materials furnished or made available hereunder, Customer shall either destroy or return to CyMedica all such copies along with a certificate signed by Customer that all such copies have been either destroyed or returned, respectively, and that no copy or any part of the aforementioned software, data or materials has been retained by Customer in any form.
  • Within thirty (30) days after the effective date of applicable termination or expiration, CyMedica will make any Customer Data stored on the Software available for download by Customer for a period of thirty (30) days in the format in which it is stored in the Software. Except as required by law or under the Business Associate Agreement, after such 30-day period, CyMedica will have no obligation to maintain or provide any Customer Data and may thereafter delete (in accordance with the Business Associate Agreement) all Customer Data in its systems or otherwise in its possession or under its control. 
  • Upon any termination For Cause by CyMedica, Customer will pay any unpaid fees earned up to the effective date of termination. In no event will any termination relieve Customer of the obligation to pay any fees payable to CyMedica for the period prior to the effective date of termination.
  • Upon termination without cause by CyMedica, or termination for just cause by Customer, Customer shall be entitled to a refund of any fees pre-paid but unearned as of the effective date of termination.
  1. MISCELLANEOUS
  • Records. The Parties will each retain books and records directly related to the performance of the Medical Devices Services for a period of seven (7) years following the date of their creation or for a longer time period, if required by applicable laws.
  • Insurance. CyMedica shall maintain, at its own expense and in the minimum amounts specified herein:
  • Commercial General Liability insurance with limits of One Million Dollars ($1,000,000) per occurrence and Two Million Dollars ($2,000,000) in the aggregate (including coverages for product liability, completed operations, contractual liability and personal injury liability) on an occurrence or claims-made basis. If such coverage is provided on a claims-made basis, such insurance shall continue throughout the term, and upon the termination, expiration or nonrenewal of this Agreement, or the expiration or cancellation of the insurance, CyMedica shall: (i) renew the existing coverage, maintaining the expiring policy’s retroactive date; or (ii) purchase or arrange for the purchase of either an extended reporting endorsement (“Tail” coverage) from the prior insurer, or “Prior Acts” coverage from the subsequent insurer, with a retroactive date on or prior to the Effective Date and, in either event, for a period of three (3) years following the termination or expiration of this Agreement.
  • Cyber Liability insurance (including privacy), with minimum limits of Two Million Dollars ($2,000,000) per claim and Two Million Dollars ($2,000,000), in the aggregate.
  • Worker’s Compensation insurance, if applicable, with applicable statutory limits, and Employer’s Liability insurance with limits of One Million Dollars ($1,000,000).
  • Subcontractors. CyMedica may use its affiliates or subcontractors to perform the Services. CyMedica will be responsible for the Services provided that CyMedica’s obligations under this Agreement and under any BAA between CyMedica and Customer will apply to the same extent had CyMedica performed those services without the use of an affiliate or subcontractor.
  • Notices. Any notices, requests, consents, demands or other communications required or permitted under this Agreement will be in writing and deemed to have been duly given either: (a) when delivered, if delivered by hand, sent by United States registered or certified mail (return receipt requested), delivered personally by commercial courier, or (b) on the second following business day, if sent by United States Express Mail or a nationally recognized commercial overnight courier; and in each case to the parties at the following addresses (or at other addresses as specified by a notice) with applicable postage or delivery charges prepaid.

If to CyMedica:

CyMedica Orthopedics, Inc.

2120 East 6th Street, Suite 8

Tempe, AZ 85288

If to Customer:

__________________

__________________

__________________

11.5 Amendment. Except as may otherwise be specified in this Agreement, this Agreement may be modified, changed or amended only by a dated written instrument executed by a duly authorized person of each party.

11.6 Waiver; Severability. The failure of any Party to insist in any one or more instances upon performance of any term of this Agreement will not be construed as a waiver of future performance of the term, and the Party’s obligations for the term will continue in full force and effect. The provisions of this Agreement are severable. The invalidity or unenforceability of any term or provision in any jurisdiction will be construed and enforced as if it has been narrowly drawn so as not to be invalid, illegal or unenforceable to the extent possible and will in no way affect the validity or enforceability of any other terms or provisions in that jurisdiction or of this entire Agreement in that jurisdiction.

11.7 Governing Law. This Agreement and each Party’s rights and obligations under it will be governed by and construed in accordance with the laws of the State of Arizona, without giving effect to conflicts of law principles. The venue for any dispute shall be the state or federal courts presiding over [insert county] County, Arizona.

11.8 Assignment. Neither Party may assign or transfer this Agreement without the prior written consent of the other Party; provided, however, that CyMedica may assign or transfer this Agreement, without the consent of the Customer, to any of affiliates, subsidiaries, entities controlled by or under common control with CyMedica, or in the event of a merger, change of control or sale of substantially all of its assets. This Agreement will bind the Parties and their respective successors and assigns and will inure to the benefit of the Parties and their respective permitted successors and assigns.

11.9 Force Majeure. If any Party is unable to perform any of its obligations under this Agreement (other than payment obligations) because of any cause beyond the reasonable control of and not the fault of the party invoking this section, including any act of God, fire, casualty, flood, earthquake, war, strike, lockout, epidemic, destruction of production facilities, riot, insurrection or material unavailability, and if the non-performing Party has been unable to avoid or overcome its effects through the exercise of commercially reasonable efforts, such non-performing Party will give prompt notice to the other Party, its performance will be excused, and the time for its performance will be extended for the period of delay or inability to perform due to such occurrences. If performance is extended under this section for more than sixty (60) days, then at any time before reinstatement of the performance, the other Party may terminate this Agreement upon notice to the non-performing Party. CyMedica will maintain commercially reasonable business continuity and disaster recovery plans.

11.10 Relationship of the Parties. The sole relationship between the Parties is that of independent contractors. This Agreement will not create a joint venture, partnership, agency, employment or other relationship between the Parties. Nothing in this Agreement will be construed to create any rights or obligations except among the Parties; and no person or entity will be regarded as a third-party beneficiary of this Agreement, except as otherwise provided in this Agreement.

11.11 Survival. Any term of this Agreement that contemplates performance after termination of this Agreement will survive expiration or termination and continue until fully satisfied.

11.12 Dispute Resolution. In case of disputes in connection with the negotiation, execution, interpretation, performance or non-performance of this Agreement, Parties agree to seek non-binding mediation, which shall be conducted remotely by a single mediator selected by the Parties. The mediator shall conduct the proceedings pursuant to the rules of the American Arbitration Association, as now or hereafter amended. In the event that any such mediation does not produce a settlement, unless the dispute is otherwise settled, the dispute shall be determined by binding and final arbitration in Tempe, Arizona, by three (3) arbitrators selected by the Parties (or by the American Arbitration Association if the Parties cannot agree) in accordance with the law of the State of Arizona and the rules of the American Arbitration Association. If the Parties fail to agree on the mediator within thirty (30) days of the date one of them invokes this mediation provision, either Party may apply to the American Arbitration Association to make the appointment.

11.13 Entire Agreement. This Agreement, including all applicable Attachments, constitutes the entire agreement between the Parties relating to this subject matter and supersedes all prior or simultaneous understandings, representations, discussions, negotiations, and agreements, whether written or oral.

11.14 Counterparts. This Agreement may be executed in one or more counterparts. Each counterpart will be an original, but all such counterparts will constitute a single instrument.

IN WITNESS WHEREOF, the Parties, by their duly authorized representatives, have executed this Agreement effective as of the Effective Date.

CYMEDICA ORHTOPEDICS, INC. [CUSTOMER]

Signed: ____________________ Signed: _______________________

By: _______________________ By: __________________________

Title: _____________________ Title: _________________________

Date: _____________________ Date: _________________________

EXHIBIT A

FEE SCHEDULE FOR PROVIDER PPRTAL ACCESS

During the term of the Agreement, as total compensation the Provider Portal provided by CyMedica under this Agreement, Customer agrees to pay CyMedica the following fees:

This fee will include:



CY-0300-026, Rev. C