General Terms & Conditions of Health Harmony™ For Physician Private Practice (CPT Coding)
These General Terms and Conditions of Health HarmonyTM for Physician Private Practice, are attached and incorporated into the Health Harmony™ Physician Private Practice Agreement. Any additional or contradictory terms or conditions contained on any standard Practice purchase order, invoice, order acknowledgment, or in any other form, whenever received, expressly are rejected and shall be of no force or effect. Care Innovations and Practice may be singularly referred to as a “Party” herein and collectively as the “Parties”.
Unless otherwise defined herein, defined terms in the Health Harmony™ Physician Private Practice Agreement shall apply.
“Business Associate Agreement” means the agreement to protect personal health information in accordance with Health Insurance Portability and Accountability Act guidelines, as set forth as Exhibit #2 to this Agreement.
“Care Innovations® Health HarmonyTM” or “Health HarmonyTM” consists of the Care Innovations® Health HarmonyTM Mobile, an FDA-regulated application accessed by patients or individuals to display medical device data, the Care Innovations® Health Harmony™ Maestro, a clinical data management application for remote patient monitoring, and any peripheral products used by Practice for the purpose of providing remote patient monitoring for Practice Patients.
“Care Innovations® Health HarmonyTM Maestro” or “Health HarmonyTM Maestro” or “Maestro” means Care Innovations FDA-regulated, hosted applications and data services licensed to the Practice, solely with respect to its utilization patient monitoring utilizing Care Innovations, Practice or third party hosted applications, including without limitation supporting use of the Care Innovations® Health Harmony Mobile applications that capture Patient or Individual information for integration into Practice’s electronic health records.
“Care Innovations® Health HarmonyTM Mobile” or “Health HarmonyTM Mobile” is intended as a medical display device for use by the Practice or Patient, either as a tablet or a Patient-provided “Bring Your Own Device” (“BYOD”) to transmit vital sign measurements.
“Clinical Monitoring Services” means Clinical Monitoring provided by Care Innovations to Practice or Patients.
“Confidential Information” means any non-public information disclosed by one Party to another Party that is: (a) at the time of disclosure identified or marked as confidential or proprietary information; or (b) by its nature and the circumstances should reasonably be considered to be confidential information, in all cases including, but not limited to, information regarding each Party’s technology, strategy, operations, finances, sales, supply chain, transactions, patients, customers, and information maintained in a Party’s internal-only documentation or web sites.
“CPT Codes” or “CPT Coding” means the Current Procedural Terminology Code set as a medical code set maintained by the American Medical Association through the CPT Editorial Panel. CPT Codes are used for the classification of medical, surgical, and diagnostic services for submission to payers.
“Days” means calendar days.
“Documentation” means all legends, notices, or other identifying marks and manuals, technical specifications, or user instructions regarding functionality, operation, installation, training, maintenance, and use generally made available by Care Innovations to Practice with respect to the Health Harmony™ Solution, as modified or updated by Care Innovations from time to time.
“Effective Date” of this Agreement means the date this Agreement is signed by the last signatory/Party.
“FDA” means the United States Food and Drug Administration of the United States Department of Health and Human Services and any successor agency or entity that may be established hereafter.
“Practice” means the private physician practice(s) that will provide healthcare to their patients and will submit practice-approved CPT Codes to payers.
“Patient” means a patient of the Practice.
“Pricing Schedule” means the equipment and services provided, and associated fees for the Program, as set forth as Exhibit #1 to this Agreement.
“Protocol” means a collection of one or more tasks, questions, and information that is assembled by or at the direction of Practice clinicians for use with the Clinical Monitoring Services and Health Harmony™ Solution to capture health information about a Patient. Protocols may be created by the Practice or may be obtained from Care Innovations.
“Service(s)” means the Care Innovations hosted service consisting of access to: (i) Health Harmony™ Maestro; (ii) related support services including but not limited to recommended CPT Coding; and/or (iii) Clinical Monitoring Services, as each may be updated or modified from time to time.
“Software” means (i) Care Innovations proprietary code and third-party software hosted for use by Practice or Patients, as applicable; and (ii) any Updates or Upgrades.
“Update” means a new release of the licensed software that contains bug fixes or minor software enhancements indicated by a change in the version number to the right of the first decimal point (e.g., Version 3.5 to 3.6).
“Upgrade” means a major release of the licensed software that delivers new or enhanced functionality, indicated by a change in the version number to the left of the first decimal point (e.g., Version 2.3. to 3.x).
“Vendor Product(s)” or “Products” means the product(s)or any third-party device used in connection with the Health Harmony™ Solution (e.g., for collecting patient data or measurements, or providing internet connectivity to or for the Services), or peripheral supply items to be used in connection with the Services, provided to the Practice or to the Patient pursuant to this Agreement.
“Warranty Period” means: (a) for a Vendor Product provided to the Practice or Patient, one (1) year following the start of Practice or Patient use.
- TERM AND TERMINATION.
- This Agreement shall be effective on the Effective Date and shall continue for a period of one (1) year; provided that in the event of any termination or expiration of this Agreement, any outstanding Health Harmony™ Solution services will continue until completion.
- Termination for Breach. Either party may terminate this Agreement upon providing written notice if the other if a party: (a) breaches any material provision of this Agreement and fails to cure the same within thirty (30) days after receipt of written notice of breach from the other party; (b) files or has filed against it a petition in bankruptcy; (c) has a receiver appointed to handle its assets or affairs; (d) makes or attempts to make an assignment for benefit of creditors; (e) undergoes a change in control through acquisition or (f) knowingly violates any law or regulation applicable to the delivery or use of the Health Harmony™ Solution.
- Termination for Convenience. Either party may terminate this Agreement, in whole or in part, at any time upon at least ten (10) business days’ written notice to the other party. Upon the effective date of termination, Care Innovations may charge all accrued fees as identified in the Pricing Schedule or Terms and Conditions, and Practice shall be obligated to pay for services and, if applicable, program related expenses incurred, but not yet invoiced, as of the effective date of termination.
- FEES AND TERMS OF PAYMENT.
- For Practice or Patient use of the Service(s), fees are accrued and invoiced on a “per Patient per month” (“PP/PM”) on a calendar month basis, in accordance with the Pricing Schedule. Practice agrees to pay invoices within ninety (90) days of receipt from Care Innovations.
- Invoices may be delivered electronically or in any other agreed format. If Practice has a good faith dispute regarding payment of a particular invoice such dispute shall not entitle Practice to withhold payment for any other Vendor Product (or subsystem thereof) or Service.
- Post Termination Fees for Vendor Products. Practice remains liable for payment of invoices for any unreturned, lost, or damaged Vendor Products post termination period, in accordance with Care Innovations invoices for such Vendor Products.
3.0 REIMBURSEMENT REPRESENTATION. PRACTICE ACKNOWLEDGES THAT REIMBURSEMENT FOR PAYMENT FOR THE VENDOR PRODUCTS AND SERVICES IT IS OBTAINING ARE THE SOLE RESPONSIBILITY OF THE PRACTICE EVEN IF SUCH VENDOR PRODUCTS AND SERVICES ARE REIMBURSABLE UNDER MEDICARE, MEDICAID, OR ANY OTHER GOVERNMENT ENTITY OR PROGRAM.
4.0 TAXES. Prices specified in Agreement exclude taxes. Practice will pay any tax or levy, however designated, (and any related interest or penalty) imposed with respect to the Services. If Services provided hereunder are determined to be subject to transaction taxes or become taxable, and Care Innovations is required by law to pay or collect any such taxes, then Care Innovations shall state such taxes separately in its invoice. Care Innovations will not collect sales taxes from Practice if Care Innovations receives a properly executed exemption certificate from Practice and Practice assumes all liability with respect to any such uncollected taxes.
5.0 TRANSPORTATION AND RISK OF LOSS. Vendor Product shipping terms are FOB Point of Shipment. Risk of loss to the Vendor Product passes to Practice upon shipment to Patient or Practice designated location.
6.0 DAMAGE OR LOSS OF THE VENDOR PRODUCT. Practice will safeguard the Vendor Product(s) from loss or damage of any kind and will not permit anyone other than personnel authorized by Care Innovations to perform any work on the Vendor Product. If the Vendor Product is damaged, destroyed, lost, stolen, or otherwise unrecoverable while in Practice or Patient’s possession, Practice may be liable for the cost of repair or replacement of the Vendor Product. If the Vendor Product cannot be refurbished or repaired, Practice authorizes Care Innovations to dispose of the Product in Care Innovations’ sole discretion.
- WARRANTIES AND REPRESENTATIONS. Care Innovations represents and warrants to Practice that:
- Product(s) and Service(s) Rental Rights. Care Innovations owns or otherwise has the right to provide all of the Product(s) and Service(s). Care Innovations has the right to rent the Product(s) and Service(s) in connection with the transactions contemplated by this Agreement.
- Licenses and Permits and Compliance with Laws. Care Innovations has all rights, licenses, permits, and consents necessary to rent the Product(s) to Practice and to perform its obligations hereunder during the Term. Care Innovations is and will at all times during the Term be in compliance with all laws applicable to the performance of its obligations under this Agreement.
- Each Product at the time of delivery by Care Innovations is and shall be handled, stored, and
transported in accordance with all applicable laws pertaining thereto. Each Product that Care Innovations provides to Practice during the Term (i) will be manufactured in accordance with its packaging, (ii) will be manufactured, handled, stored, and transported in accordance with all applicable laws, (iii) will substantially conform to all specifications for effectiveness, safety, and reliability as required by any applicable law, including the FDA, (iv) will be fit for the indications described in its Product labeling and package inserts, and (v) will be labeled in compliance with all applicable laws. Each Product is and will substantially conform to its specifications as written or published, unless otherwise agreed to in writing by the parties hereto. In the event a Product or any component of a Product is not manufactured by Care Innovations, Care Innovations hereby assigns or agrees to assign (to the extent assignable) to Practice all such manufacturer warranties, copies of which shall be provided by Care Innovations to Practice upon request. If a Product(s) does not conform in any respect to any of the warranties provided in this Agreement, Care Innovations will be obligated, at its sole cost and expense, to replace or repair such Product(s).
- Health Care Programs. Practice represents that neither it or any of its affiliates or employees is currently (a) named, or excluded, on, or from, any of the following lists: (i) HHS/OIG List of Excluded Individuals/Entities; (ii) The System for Award Management (SAM); and (iii) OFAC “SDN and Blocked Individuals”; or (b) under investigation or otherwise aware of any circumstances which would result in Care Innovation being excluded from participation in any Federal health care program, as defined under 42 U.S.C. §1320a-7b(f).
- Restrictions on Use of Health Harmony™ Private Practice Solution and Services. CARE INNOVATIONS®HEALTH HARMONY PRIVATE PRACTICE SOLUTION AND SERVICES ARE NOT INTENDED, DESIGNED, OR AUTHORIZED FOR CONTINUOUS COMMUNICATION OF REAL-TIME DATA. THE SOFTWARE IS NOT INTENDED, DESIGNED, OR AUTHORIZED FOR PROVIDING TIME-CRITICAL MEDICAL CARE, PROVIDING MEDICAL OR OTHER EMERGENCY RESPONSE ALERTS, OR ANY OTHER APPLICATIONS OUTSIDE THE INTENDED USE SPECIFIED IN THE CARE INNOVATIONS DOCUMENTATION, OR FOR USE IN ANY CIRCUMSTANCE IN WHICH THE FAILURE OF THE HEALTH HARMONY PRIVATE PRACTICE SOLUTION OR SERVICES WOULD PRESENT AN UNREASONABLE RISK OF ILLNESS, INJURY OR DEATH TO THE PATIENT OR INDIVIDUAL.
- IN NO EVENT WILL CARE INNOVATIONS BE LIABLE FOR ANY MONETARY DAMAGES OR OTHER COSTS ASSOCIATED WITH WARRANTY CLAIMS, WHETHER FOR THE REPLACEMENT OR REPAIR OF VENDOR PRODUCTS OR SERVICES, INCLUDING LABOR, INSTALLATION, ANY COSTS RELATING TO THE REMOVAL OR REPLACEMENT OF ANY SERVICES OR VENDOR PRODUCT, OR ANY OTHER COSTS INCURRED BY PRACTICE, PATIENTS OR INDIVIDUALS.
ALL SERVICES, MATERIALS AND PRODUCTS PROVIDED BY EITHER PARTY TO THE OTHER HEREUNDER ARE PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND. EACH PARTY SPECIFICALLY DISCLAIMS IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND ANY WARRANTY AGAINST INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHT OF ANY THIRD PARTY OR ANY WARRANTY ARISING OUT OF ANY PROPOSAL OR SPECIFICATION. ALL SUCH WARRANTIES ARE HEREBY DISCLAIMED.
- Returned Material Authorization (RMA) Instructions. For warranty repair of Vendor Product(s), Practice must (i) provide Care Innovations with an explanation of the defect; and (ii) return defective Vendor Product(s) to Care Innovations’ service facility in accordance with Care Innovations’ RMA instructions (as updated from time to time). Care Innovations will supply Practice with instructions for returning the defective Vendor Product(s) to Care Innovations at Care Innovations’ expense.
- Clinical Monitoring Services. Care Innovations provides Clinical Monitoring Services to Practice or Patients in accordance with the direction, control, instructions, and protocols supplied by the Practice. Practice agrees that any Clinical Monitoring Services provided by Care Innovations do not include medical advice, medical interpretation, medical diagnosis, or any other medical services other than referral to the Practice care clinician contact at such times and places as authorized by Practice. Practice agrees that CPT Codes recommended by Care Innovations in conjunction with Clinical Monitoring Services provided by Care Innovations are recommendations only and Practice is responsible for the final confirmation and submission of any CPT Codes. The foregoing is the full extent of Care Innovations’ warranty and representation to Practice with regards to the Clinical Monitoring Services provided under the Agreement.
8.0 CARE INNOVATIONS RESPONSIBILITIES.
- Delivery, Activation, and Configuration. Care Innovations or its designee shall coordinate delivery, activation, and configuration of the Product(s).
- Technical Support. Care Innovations shall provide a toll-free telephone number for Practice or Patient to call for support services for the Product and Services and for initiation of Product RMA requests for warranty repairs. Care Innovations or its designee’s help desk (“Help Desk”) will work with the caller to track, report, and prioritize a reported Error. In addition, the Help Desk will work with the caller to handle routine requests. As used herein, “Error” means a failure of the Product or Service to function, perform, or otherwise comply in accordance with the applicable end user Documentation or other requirements under this Agreement. Report of a notified Error (an “Incident Report”) will be made through Care Innovations or its designee’s Help Desk via telephone, e-mail, or Care Innovations website at numbers and addresses to be furnished by Care Innovations. Care Innovations or its designee shall provide Help Desk coverage as follows:
- Help Desk Support During Normal Support Hours. Care Innovations shall provide live answer phone support for Practice during “Normal Support Hours,” which is defined as Monday through Friday 8:00 a.m. to 8:00 p.m. Eastern Time.
- After Hours Help Desk Support. Care Innovations shall provide voicemail answering service support outside of Normal Support Hours.
- ACTIVATION AND CONFIGURATION OF HEALTH HARMONY™ MAESTRO. Care Innovations or its designee shall facilitate configuration and activation of Practice’s account within Health Harmony™ Maestro (“Maestro”). The configuration and activation of Maestro is based upon information furnished to Care Innovations by Practice. Practice is responsible for required modifications to Maestro configuration due to inaccuracies or incompleteness of the information furnished by Practice, changes in Practice’s requirements, or for other reasons attributable to Practice or Practice Patient
- Deployment of Maestro. Care Innovations will create a secure account where Practice may register its Patients, develop care Protocols, and where Practice’s authorized health care professionals can manage Patient care remotely via Maestro and Care Innovations can access Patient Electronic Health Records to provide the Services.
9.0 PRACTICE RESPONSIBILITIES.
- Clinical System of Record and Backup of Practice Data and Content. Notwithstanding the data backup and recovery procedures employed by Care Innovations to provide Practice ongoing access to data within the Practice Health HarmonyTM account, Practice acknowledges that Maestro is not intended to be used as the legal system of record for Patient or Practice records or information. Practice shall maintain procedures to backup and restore damaged, lost, or stolen Patient or Practice files, data, or content in the Health Harmony™ account in its sole discretion.
- Consent and Notice. Practice is responsible for obtaining all applicable Patient or consent and providing all applicable Patient notices for activation of the Services and storage of Patient personal information as that term is used in or defined by applicable Privacy, Breach Notification, and Security Laws, including Personal Health Information and Personal Individually Identifiable Health Information as those terms are defined in the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations (“HIPAA”). Privacy, Breach Notification, and Security Laws means national and local (including in the United States federal and state and in Europe the European Union and each country and region) laws, including rules and regulations, and guidance that apply to the receipt, processing, use, disclosure, maintenance, and transmission of PII (including for example health, consumer, and financial information) as the same may hereafter be amended or changed. Upon the request of Care Innovations, Practice shall provide copies of all applicable notices and consents.
- Patient and Individual Training for Product. Practice is responsible for deploying the Product only with Patients that are capable of using the Product properly and in accordance with the Documentation.
- Practice Requirements. In order for Care Innovations and its designees to perform its obligations under the Agreement (including warranty obligations), Practice agrees to:
- Obtain and maintain all licenses, permits, and other approvals necessary for installation and use (each as applicable) of Products and the Services.
- Promptly place service calls to Care Innovations in accordance with the terms herein and designate a Practice representative with the necessary skills to assist Care Innovations in the diagnosis of service problems.
- Take possession of the Product(s) for its own or Patients use in accordance with the terms herein and not send or otherwise export the Product(s) to any other country outside the country in which Care Innovations delivers the Product(s) to Practice.
- Practice is responsible for the enrollment, recruitment, and consenting of eligible patients based upon the patient inclusion/exclusion guidance provided by Care Innovations or Practice.
- Practice agrees that any reports from Care Innovations relating to reimbursement under CPT codes, and CPT Codes recommended by Care Innovations for reimbursement are recommendations only. Practice is responsible for the final review, confirmation, and submission of any CPT Codes for reimbursement.
- Compliance with Law. Practice acknowledges that the Products and Services are or may be subject to regulation by the FDA and other federal or state agencies. Practice, and anyone acting for or on behalf of the Practice, shall comply with all applicable laws and regulations specifically relating to medical devices, including FDA regulations and federal healthcare program anti-kickback regulations, including but not limited to laws, regulations and guidance pertaining to state and federal anti-kickback statutes (42 U.S.C. §§ 1320a-7b(b), et seq. and their implementing regulations) and submission of false claims to governmental or private health care payers (31 U.S.C. §§ 3729, et seq. and its implementing regulations). Practice, and anyone acting for or on behalf of the Practice, shall also comply with The Stark Act (42 U.S.C. §1395 nn). Practice will provide Care Innovations with a copy of any notice of reportable events submitted to the FDA or CMS with respect to the Product or Service, including without limitation notices related to Product performance concerns, Product misuse leading to an adverse event, or modifications to the Product that may result in an adulterated Product.
10.0 DATA, USE AND ACCESS.
- Data Hosting and Data Retention. As between Care Innovations and Practice, all Practice and Patient data shall at all times remain solely the property of Practice. Care Innovations may maintain a copy of Practice and Patient data.
- Restricting Access to Maestro. Upon reasonable prior notice, Care Innovations may restrict access to Maestro if, in Care Innovations’ reasonable judgment, use of Maestro by Practice or, Patient: (i) presents a significant and material security risk; (ii) violates applicable laws, governmental regulations, or court or government agency order; (iii) violates or infringes any intellectual property right; (iv) violates or third party rights.
11.0 GOVERNMENTAL REQUIREMENTS.
11.1. Record Retention. If Section 1861(V)(1) ( I ) of the Social Security Act (pertaining to Medicare reimbursement) applies to this Agreement, subsections (i) and (ii) of such Section are made a part hereof. If applicable, Care Innovations will retain and make available, and insert the requisite clause in each applicable subcontract requiring its subcontractors to retain and make available the contracts, books, documents, and records to the persons upon the request and for the period of time as required by such subsections.
11.2 Cost Reporting. Practice, as required by applicable laws, will (i) fully and accurately account for and report in any applicable cost reports or otherwise fully disclose to government program payors and accurately reflect where and as appropriate to the applicable reimbursement methodology, and (ii) provide information upon request by federal or state agencies concerning all services and other items, including any discounts, received from Care Innovations from Practice in compliance with all applicable laws, including the federal Social Security Act and implementing regulations relating to Medicare, Medicaid, and other federal and state health care programs.
- PROPERTY OWNERSHIP. Care Innovations, its licensors, and its designees, as applicable, retain sole and exclusive ownership of, and all intellectual property rights in and to, the Software, Product(s), Service(s), Care Innovations-created Protocols and educational materials, and Documentation. Practice shall not have any ownership rights with respect to the Software, Product(s) or Service(s), or any intellectual property rights in or to the foregoing. No license or other rights are granted (whether by implied license, estoppel or otherwise) to Practice, except as specifically provided in this Agreement.
- Software License. Subject to the terms and conditions of this Agreement, during the Term, Care Innovations hereby grants to Practice a limited, nonexclusive, nontransferable, non-sublicensable, revocable license under copyrights owned or licensable by Care Innovations to use the Software provided with the Product(s) or Service(s) for the sole purpose of using the Product(s) or Service(s) strictly for remote patient monitoring and CPT coding as part of Practice’s internal business operations, and subject to any restrictions or limitations set forth herein. Without Care Innovations’ prior written consent, Practice shall not (a) copy or reproduce, modify, or translate the Software, Product(s) or Service(s), or create derivative works based thereon; (b) directly or indirectly decompile, disassemble, reverse engineer, or otherwise attempt to learn the source code, structure, algorithms, or ideas underlying the Software, Product(s) or Service(s); (c) provide service bureau, time share or subscription services, or any other third party use based on the Software, Product(s) or Service(s); (d) remove, obscure, or modify any markings, labels, or any notice of the proprietary rights, including copyright, patent, and trademark notices of Care Innovations or its licensors; (e) use any markings, labels, or any notice of the proprietary rights, including copyright, patent, and trademark notices of Care Innovations or its licensors, suppliers, or service providers for any purposes, including but not limited to marketing or publicity, other than as attached to the Product(s); (f) alter, misuse, tamper with, or remove the Product(s) packaging as provided by Care Innovations; (g) engage in or allow any action involving the Software, Product(s) or Service(s) that is inconsistent with the user Documentation as provided by Care Innovations; or (h) intentionally or negligently introduce into the Software any routine designed to permit unauthorized access, disable, erase, or otherwise harm the Software, Product(s) or Service(s), including but not limited to viruses, Trojan horses, worms, or wormholes.
Continued use of the Software, Product(s) and Service(s) is subject to Practice strict compliance with the terms herein. Practice is granted only those licenses or other rights with respect to the Software that are expressly granted herein. In the event Care Innovations provides a Software Update or Upgrade, Practice shall install the Update or Upgrade, and discontinue use of the prior version of the Software as soon as commercially reasonable. In the event that an Upgrade or Update is provided to avoid claims of infringement, Practice agrees to cease use of the prior version as soon as is reasonably possible.
Required Software Updates will be supplied at no charge to Practice. Optional Upgrades, when available, will be offered to Practice. There may be an additional charge for optional Upgrades upon mutual agreement of the Parties.
13.0 INDEMNIFICATION, RECALL AND LIMITATION OF LIABILITY.
- Liability and Indemnity. Each Party agrees to defend, indemnify, save, and hold the other Party and each of its affiliates, respective directors, officers, members, managers, partners, employees, consultants, subcontractors, agents, attorneys, advisors, or representatives (individually, an “Indemnified Party” and collectively, the “Indemnified Parties”) harmless from and against any and all causes of action (at law or in equity), actions, settlements, judgments, claims, suits, liabilities, demands, losses, damages, obligations, deficiencies, costs, fines, penalties, proceedings, or expenses of all kinds (including attorneys’ fees, witnesses’ fees, investigation expenses, or any other expenses incident thereto) (collectively, “Losses”) incurred, received or experienced by any Indemnified Party based on a third party claim for: (a) any breach of any representation or warranty made by either Care Innovations or Practice; or (b) any breach by either Party of any of its covenants, agreements, or obligations in this Agreement; or (c) resulting from third-party claims of personal injury (including death) or damage to or loss of property.
- Product Liability by Care Innovations. Subject to Section 13.4 and 13.7 below, Care Innovations will defend and hold harmless Practice against any claim arising out of, or related to: (a) the use of any Product by Practice or Patient in accordance with its labeling and instructions for use; (b) any defect in the design or manufacture of any Product resulting in claims for property damage, loss of life, or bodily injury; provided that (i) there have been no Unauthorized Modifications of the Product; (ii) the Product has been stored, maintained, and transported (if Practice is responsible for such storage, maintenance and transportation), in accordance with its Documentation and labeling, instructions, and all applicable laws; and (iii) neither Practice nor the third party claiming damages has promoted or used the device for any off-label use or in violation of the law. Notwithstanding the foregoing or any other provision in this Agreement to the contrary, Practice acknowledges and agrees that Care Innovations provides no indemnities with regard to Vendor Product(s) or services provided by third party Vendors with regard to Vendor Product(s). To the extent any problem or liability arises with respect to third-party Vendor Product(s) or such services, Practice agrees to seek recourse solely from the applicable third-party Vendor, and not from Care Innovations.
- In the event the FDA or any applicable governmental authority initiates a mandatory recall (i.e., the correction or removal of any Product(s)) or Care Innovations believes in its reasonable discretion that it may be necessary to conduct a recall (i.e., the correction or removal of any Product(s), field market withdrawal, stock recovery, or other similar action with respect to any Product(s) (each, a “Recall”), Care Innovations shall notify Practice of such Recall in accordance with applicable law and in a commercially reasonable manner. The Parties hereto agree that the final decision as to and control of the handling of any Recall shall be in Care Innovations’ sole reasonable discretion. In the event that Care Innovations does not conduct a Recall in accordance with all applicable legal requirements and general guidance issued by the FDA or any applicable governmental authority, Practice shall have the right, in its sole reasonable discretion, to take any and all actions it determines necessary to comply with all such applicable legal requirements and general guidance issued by the FDA or any applicable governmental authority. Practice shall provide all reasonable assistance requested by Care Innovations in connection with a Recall, at Care Innovations’ sole cost and expense. In the event of a Recall with respect to any Product(s), Care Innovations shall either (a) replace such Product(s) with products that have substantially similar functionality or (b) reimburse Practice for one hundred percent (100%) of the price paid by Practice for any such unused Product(s) that is subject to such Recall that Customer must return to Care Innovations or any third party designated by Care Innovations as a result of such Recall, and (c) all out-of-pocket expenses incurred by Practice in connection with the return of Product(s) related to such Recall. Practice and Care Innovations shall maintain records of each Product to the Practice so as to enable Care Innovations to adequately administer a Recall with respect to each such Product(s) in accordance with applicable legal requirements and general guidance issued by the FDA or any applicable governmental authority. Any return by Practice pursuant to this paragraph shall be sent back to Care Innovations, “FOB Point-of-Origin”, at Care Innovations’ sole cost and expense.
- Infringement Indemnity by Care Innovations. Care Innovations will defend and hold harmless Practice against any third-party claim that Practice use of Product(s) and Service(s) in accordance with this Agreement infringes a valid U.S. patent, copyright, trade secret or other intellectual property right. If a final injunction is obtained against the Practice use of any Product or Services, or if in the opinion of Care Innovations, the Product or Services is likely to become the subject of a successful claim, Care Innovations may (i) procure for Practice the right to continue using the Product or Services, (ii) replace or modify the Product or Services so that it becomes non-infringing.
- Conditions Precedent to Indemnification. An indemnifying Party’s obligations hereunder are conditioned on (i) the indemnified Party providing reasonably prompt notification in writing of a claim subject to indemnification; (ii) the indemnifying Party having sole control of the defense or settlement of the claim; (iii) the indemnified Party fully and timely cooperating and providing all requested authority, information, and assistance to the indemnifying Party to defend any such suit or proceeding properly (at the expense of the indemnifying Party). The indemnified Party may participate in any such suit or proceeding through counsel of its choice at its own expense; however, costs associated with the indemnified Party’s counsel shall not be deemed damages or costs for purposes of the indemnifying Party’s indemnity hereunder. The indemnifying Party will not be responsible for any costs or expenses of, or be bound by, any settlement or compromise incurred or made by indemnified Party, nor may such settlement or compromise be used in any way against the indemnifying Party, without the indemnifying Party’s prior written consent.
- Apportionment of Damages and Costs. Subject to Section 13.7 below, in the event of a lawsuit or other proceeding subject to indemnification under this Agreement, each Party reserves the right to seek apportionment or reimbursement of defense costs and expenses incurred defending against a claim based on the acts, omissions, negligence, professional malpractice, infringement, or other fault of the other Party or its officers, directors, employees, members, agents, or representatives, and each Party’s obligation to pay any damages or costs finally awarded against the other Party, its officers, directors, employees, members, agents, or representatives under such circumstances shall be limited to those damages and costs allocated to the other Party in accordance with the apportionment of fault between the Parties in the lawsuit.
- Aggregate Liability. Except for the Exclusions to Limitation of Liability in Section 13.9 below, and to the full extent permitted by applicable law, each Party’s maximum aggregate liability for all claims hereunder, whether for breach of contract, breach of warranty or in tort, including negligence, will be limited to two times (2x) the total amounts paid and payable by Practice under this Agreement.
- LIMITATION OF LIABILITY. NEITHER PARTY WILL BE LIABLE FOR ANY LOSS OF PROFITS, LOSS OF USE, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF ANY BREACH OR FAILURE UNDER THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE PARTIES ACKNOWLEDGE THAT THESE LIMITATIONS ON POTENTIAL LIABILITIES ARE AN ESSENTIAL AND BARGAINED FOR ELEMENT IN THIS AGREEMENT. PRACTICE AGREES THE LIMITATION OF LIABILITY FOR THE HEALTH HARMONYTM SOLUTION PRODUCTS AND SERVICES AS SET FORTH IN THESE TERMS AND CONDITIONS OF USE SHALL APPLY TO THIS AGREEMENT.
- Exclusions to Limitation of Liability. The limitations of liability set forth above will not apply to breach of a Party’s confidentiality obligations hereunder, Practice’s breach of Section 8.5, Compliance with Law, as set forth in this Agreement or the terms of a Business Associates Agreement to be entered into between the Parties.
- Confidentiality Obligations. Confidential Information of a Party (“Disclosing Party”) will be held in confidence by the other Party (“Recipient”) and, except as otherwise provided herein or with the Disclosing Party’s prior written consent, will not be disclosed to any third party other than: i) a third party with a need to know, to support invoicing and billing purposes; or ii) Recipient’s employees, contractors or representatives who have a need to know and who are bound by obligations of confidentiality at least as protective of the Disclosing Party’s Confidential Information as those herein (“Representatives”). To the extent necessary for Practice’s full and unrestricted use of any Products, Care Innovations consents to disclosure of its Confidential Information by Practice, to Practice employees, contractors, agents, representatives, outsourcing services providers, and other third parties performing services for or on behalf of Practice, subject to appropriate confidentiality obligations.
- Restrictions on Use of Confidential Information. The Recipient will: (a) not use the Confidential Information for any purpose other than in the performance and fulfillment of the Recipient’s obligations or in the exercise of the Recipient’s rights under this Agreement.; (b) take all reasonable and necessary steps to ensure that its employees, principals, officers, agents, contractors, representatives, affiliates, and any and all other persons or entities who have access to Confidential Information through Recipient, comply with the Recipient’s obligations pursuant to this Section; (c) disclose any of the Disclosing Party’s Confidential Information in response to a valid court order or other legal process, only to the extent required by that order or process and only after the Recipient has given the Disclosing Party written notice, if permitted, promptly after receipt thereof and the opportunity for the Disclosing Party to seek a protective order or confidential treatment of such Confidential Information (with the reasonable assistance of Recipient, if the Disclosing Party so requests); and (d) return all the Disclosing Party’s Confidential Information to the Disclosing Party or destroy the same, at the Disclosing Party’s request, by no later than fifteen (15) Days after such request or when Recipient no longer needs Confidential Information for its authorized purposes.
- The foregoing obligations apply to all Confidential Information of the Disclosing Party, unless and until such time as the Recipient can demonstrate with competent evidence that: (a) such Confidential Information is or became generally available to the public, through no fault of the Recipient and without breach of this Agreement; (b) such Confidential Information is or was already in the possession of the Recipient without restriction and prior to any disclosure by the Disclosing Party; (c) such Confidential Information is or has been lawfully disclosed to the Recipient by a third party without an obligation of confidentiality upon the Recipient; or (d) the Recipient can prove that such Confidential Information was developed independently by the Recipient without access to, use of or reference to the Confidential Information disclosed by the Disclosing Party.
15.0 AUDIT. During the Term of this Agreement and for a period of three (3) years thereafter: (a) Care Innovations will keep proper documentation of all transactions related to this Agreement, including keeping books of record and account in accordance with generally accepted accounting practices; and (b) upon reasonable notice, Care Innovations will permit Practice or an independent accounting firm to examine and inspect, at Care Innovations’ facility and during normal business hours, to make copies therefrom for the purpose of determining Care Innovations’ compliance with the terms of this Agreement.
16.1 Dispute Resolution and Governing Law. Any claim arising under or relating to this Agreement shall be governed by the laws of the State of California, without regard to principles of conflict of laws. Each party hereby agrees that any disputes under this Agreement shall be referred to mediation or arbitration in accordance with the Rules of Procedure for Arbitration of the American Health Lawyers Association Alternative Dispute Resolution Service. The parties agree that the findings of the arbitrator shall be final and binding. The parties further agree that the party initiating the mediation or arbitration shall be responsible for all fees and deposits required for the initiation of the mediation or arbitration and the retention of the mediator or arbitrator.
16.2 Assignment. This Agreement may not be assigned or otherwise transferred by Practice, nor, except as expressly provided herein, may any right or obligation hereunder be assigned or transferred to a third party by Practice, expressly, through merger or acquisition, by operation of law or otherwise, without the prior written consent of Care Innovations. Practice agrees that Care Innovations may assign or otherwise transfer this Agreement and the rights and obligations of Care Innovations hereunder without the written consent of Practice to one or more affiliates of Care Innovations under common control or ownership, or to a successor entity as part of a merger, sale, transfer, reconstruction or consolidation involving the ownership interests of Care Innovations or its assets.
16.3 Relationship of Parties. The parties hereto are independent contractors. Neither party has any express or implied right or authority to assume or create any obligations on behalf of the other or to bind the other party to any contract, agreement or undertaking with any third party. Nothing in this Agreement shall be construed to create a partnership, joint venture, employment or agency relationship between the parties, nor shall it be construed to reflect any intent to create third party beneficiary rights in another entity.
16.4 Notices. All notices required or permitted to be given hereunder shall be in writing, shall make reference to this Agreement, and shall be delivered by hand, or dispatched by prepaid air courier or by registered or certified airmail, postage prepaid, to the address specified on the first page of these Terms and Conditions of Use. Such notices shall be deemed served when received by addressee or, if delivery is not accomplished by reason of some fault or omission of the addressee, when tendered for delivery. Either party may give written notice of a change of address, and, after notice of such change has been received, any notice or request shall thereafter be given to such party at such changed address.
16.5 Waiver. Failure by any party to enforce any term of this Agreement shall not be deemed a waiver of future enforcement of that or any other term in this Agreement or any other agreement that may be in place between the parties. No waiver of any breach of the Agreement or the Pricing Schedule shall be held to be a waiver of any other or subsequent breach.
16.6 Force Majeure. Neither party will be liable for any failure to perform due to reasonably unforeseen circumstances or causes beyond the parties reasonable control, including, but not limited to, acts of God, war, riot, embargoes, acts of civil or military authorities, fire, flood, disease, pandemic, accident, strikes, inability to secure transportation, facilities, fuel, energy, or materials. The nonperforming party may defer performance until the duration of the contingency is over. If the contingency lasts more than thirty (30) days, the non-affected party may terminate in writing all or any portion of this Agreement or the Pricing Schedule without obligation or liability.
16.7 Severability. If any provision of this Agreement is determined by a court or arbitrator to be unenforceable, the parties agree to re-negotiate such provision in good faith. If the parties cannot agree to the terms of the determined unenforceable provision, then such provision shall be struck from the Agreement.
16.8 Injunctive Relief. It is understood and agreed that money damages might not be a sufficient remedy for a breach of the confidentiality obligations forth in this Agreement and that either party may be entitled to seek equitable relief, including injunction and specific performance as a remedy of such breach.
16.9 Merger and Modification. This Agreement consisting of the Pricing Schedule incorporated as Exhibit #1, the Health HarmonyTM terms and conditions, and the Business Associate Agreement incorporated as Exhibit #2 constitute the entire agreement between the parties with respect to the subject matter hereof, supersedes all prior and contemporaneous agreements and negotiations, and may only be modified in a writing signed by authorized representatives of both parties.
16.10 Conflict. In the event of a conflict between this Private Practice Agreement and the incorporated Pricing Schedule, Health HarmonyTM Terms and Conditions for Private Practice, and the incorporated Business Associate Agreement, the following documents shall take precedence: 1) the Health HarmonyTM Terms and Conditions for Physician Private Practice; 2) the Pricing Schedule; and 3) the Business Associate Agreement.
17.0 MODIFICATIONS TO THESE TERMS AND CONDITIONS.
We reserve the right, at our discretion, to make changes to these Terms and Conditions at any time. It is your responsibility to check our website periodically for changes to these Terms and Conditions.
18.0 ADDITIONAL PROVISIONS.
Any provisions that, expressly or by their nature are intended to survive the termination or expiration of this Agreement, will survive its termination or expiration. The United Nations Convention for International Sale of Goods shall not govern this Agreement. All rights and remedies, whether conferred hereunder or by any other instrument or law, will be cumulative and may be exercised singularly or concurrently. Deviations from these terms and conditions are not valid unless agreed to in writing by an authorized representative of Care Innovations. The Parties agree that they have not relied on any oral or written terms, conditions, representations, or warranties outside those expressly stated or incorporated by reference in this Agreement in making their decision to enter into this Agreement. Headings are for convenience only and shall not be used in the interpretation of this Agreement. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective officers, directors, employees, successors, and assigns. Care Innovations may use subcontractors without Practice prior approval.