EHR DataSync HL7 Adapter END USER LICENSE AGREEMENT

Effective as of the date of and by clicking “ACCEPT,” Customer enters into the following EHR DataSync HL7 Adapter Integration End User License Agreement (“Agreement”) with Biotronik, Inc., a Delaware corporation (“Biotronik”). 

In consideration of the mutual covenants, agreements, representations and warranties contained herein, the receipt and sufficiency of which are hereby acknowledged, Biotronik and Customer agree as follows:

1.       Background.  Biotronik’s EHR DataSync HL7 Adapter (“DataSync Adapter”) is comprised of software (“Software”) that a) installs an Application Program Interface (“API”) on Customer’s computer, allowing communication between a Customer and Biotronik’s Home Monitoring Service Center (“HMSC”) and exportation of patient and device data files from HMSC to Customer; and b) installs a program that converts patient and device data files to HL7 format for importation into a Customer’s Electronic Health Record’s (“EHR”) system. 

2.       Access and Conditions of Use.

2.1.    Access and Limited License.  Subject to the terms and conditions of this Agreement, Biotronik will: (a) permit Customer to access and use Biotronik’s DataSync Adapter during the term of this Agreement; (b) grants Customer a limited, non-exclusive, revocable, world-wide, non-transferable, non-sub-licensable license during the term of this Agreement (i) to install the Software using a Window’s executable file, including any subsequent Software updates; and (ii) to use the DataSync Adapter solely in support of Customer’s importation of Biotronik patient and device data from HMSC into Customer’s EHR system during the term of this Agreement.

2.2.    Use.  Customer will not: (a) transfer to any other person or entity any of its rights to use the DataSync Adapter; (b) sell, rent, sublicense or lease the DataSync Adapter, (c) create any derivative works based upon the DataSync Adapter ; (d) copy any feature, design or graphic in, or reverse engineer DataSync Adapter; (e) access or use the DataSync Adapter in order to compete with Biotronik or assist someone else to compete with Biotronik; or (f) use the DataSync Adapter in a way that violates any law, regulation or mandate. Customer has the sole responsibility for the accuracy, quality, integrity, legality, reliability and appropriateness of all Customer Data (defined below).

2.3.    User Information.  The DataSync Adapter may only be used by Customer’s participants (employees, contractors and/or physicians) having privileges or authorization at Customer’s facilities who are trained or training in the fields for which the DataSync Adapter is being utilized (“Authorized Users”). Customer hereby assumes fully responsibility for ensuring the appropriate use and reliance upon the DataSync Adapter in view of all attendant circumstances, indications and contraindications. Customer will not, and will not permit Authorized Users to, provide Authorized User information that: (a) violates any privacy rights, law or regulation; (b) is materially false, misleading or inaccurate; or (c) contains any viruses or programming routines intended to damage, surreptitiously intercept or expropriate any system, data or personal information.  

2.4.    Customer Responsibilities. As part of the consideration for the DataSync Adapter, and as a condition to Biotronik’s obligations hereunder, Customer shall undertake the following:

2.4.1  2.4.1 Customer must provide and maintain, at its own expense, all software, hardware and connectivity to the internet (“Information Technology”) and any and all live and test production systems, applications and/or environments, including, but not limited to the EHR system (collectively, the “Systems”). Customer expressly acknowledges that its failure to maintain the Information Technology and Systems could have an adverse effect on the performance and reliability of the DataSync Adapter and agrees that any costs of correcting any failures and or lack of performance or reliability caused, in whole or in part, by Customer’s failure to maintain the Information Technology and Systems shall be at Customer’s sole cost and expense.

2.4.2  Customer will designate an individual responsible for coordinating with Biotronik the installation of the DataSync Adapter. When necessary, Customer will permit Biotronik to connect to the Systems by remote access as may be beneficial to support the performance of maintenance or repair activities in fulfillment of Biotronik’s warranty obligations or as otherwise agreed by the parties. This may include automatic software downloads, upgrades, fixes and proactive monitoring and access to performance data related to the DataSync Adapter to gather and use data for benchmarking and quality initiatives. Customer is solely responsible to ensure compliance with any regulatory requirements related to the Customer’s use of the DataSync Adapter.

2.4.3  2.4.3 Customer agrees to provide all necessary resources for Biotronik to provide the DataSync Adapter validation testing (“Validation Testing”), including assigning a project manager and clinical manager who are responsible for: (a) coordination with Customer’s internal information technology personnel and third party vendors; and (b) providing written responses to Biotronik’s questionnaires within thirty (30) days of Validation Testing completion. Customer agrees that Biotronik does not agree to treat as confidential any suggestion or idea provided by Customer (“Feedback”), and nothing in this Agreement or in the parties’ dealings arising out of or related to this Agreement will restrict Biotronik’s right to use, profit from, disclose, publish or otherwise exploit any Feedback, without any compensation to Customer.    

2.4.5  To the extent Biotronik’s provision of the DataSync Adapter and associated services (“Services”) to Customer involves the receipt, disclosure, creation of, or access to, certain Protected Health Information (“PHI”) as a Business Associated as those terms as defined in the Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder (“HIPAA”), the parties agree to be bound to the terms of the Business Associate Agreement.

3.       Term and Termination

3.1.    Term.  This Agreement commences on the Effective Date and, unless earlier terminated as provided herein, terminates upon expiration of Customer’s use of the DataSync Adapter. 

3.2.    Termination Without Cause.  Either party may terminate this Agreement, without cause, by providing thirty (30) days written notice to the other party.

3.3.    Effects of Termination.  Upon termination of this Agreement, Biotronik may immediately deny Customer access to the Biotronik Remote Home Monitoring via the DataSync Adapter. 

4.       Customer Data

4.1.    Customer Data.  “Customer Data” means any electronic data provided by Customer to Biotronik for use in connection with the DataSync Adapter including, without limitation: (a) non-public information entrusted to Customer by third parties including Customer’s customers, potential customers, clients, vendors or representatives; and (b) personal or PHI entrusted to Customer by third parties including Customer’s patients, clients, vendors or representatives. Customer is solely responsible for the content and accuracy of Customer Data, and Biotronik will not modify such data or test its accuracy. Customer agrees to provide Biotronik sufficient Customer Data, from whatever source is required, including without limitation, the Systems, in order for Biotronik to verify the Interface Validation Testing is complete.

4.2.    Customer Backup.  Customer is responsible for performing a full back up of Customer Data before providing Biotronik access to Customer’s Systems. Biotronik will have no responsibility for Customer’s failure to perform a full backup or for the results of the backup, including the reliability of Customer’s backup DataSync Adapter, equipment or media. It is solely Customer’s responsibility to determine and implement all necessary steps to backup Customer Data, and Biotronik will have no responsibility for loss of or damage to Customer Data.

4.3.    Security.  Biotronik agrees to comply with Customer’s administrative, security and safety rules, policies and procedures (“Procedures”) while providing Services associated with the DataSync Adapter, provided that: (a) the Procedures do not violate any state, local or federal laws: (b) Customer makes Procedures available to Biotronik prior to commencement of installation of the DataSync Adapter; (c) Procedures do not modify or amend the terms and conditions of this Agreement; and (d) Customer provides Biotronik with any training regarding the Procedures as reasonably requested by Biotronik.  

5.       Confidentiality and Intellectual Property

5.1.    Confidential Information.  Each Party acknowledges that performance of this Agreement may give it access to information owned or controlled by the other Party or its affiliates, disclosure of which would cause substantial or irreparable harm to the other Party. As used in this Section 5.1, the term "Discloser" will mean the Party disclosing, or giving access to, Confidential Information to the other Party, and the term "Recipient" will mean the Party receiving or gaining access to such Confidential Information. The term "Confidential Information" will mean: (a) any information, ideas, plans, or strategies, in any form, relating to the Discloser's or its affiliates' business, production, marketing, sales, structure, financial affairs, research, inventions, designs, products, information systems, vendors, customers, or employees, even if disclosed prior to the Effective Date; and (b) any information relating to the business between the Discloser and the Recipient, including the subject matter of this Agreement. Notwithstanding the above, Confidential Information does not include any data, documentation, results, processes, reports, materials or other work product generated or arising during the Validation Testing. 

5.2.    Confidentiality Obligations.  Recipient will protect Discloser's Confidential Information by using the same degree of care with respect to such information that it would exercise with its own confidential information or trade secrets, but in any event no less than reasonable care. Recipient will ensure that Discloser's Confidential Information is made available only to those employees of Recipient who need to know such information in connection with performance of this Agreement. Recipient will not, without Discloser's prior written consent: (a) divulge such information to third parties; or (b) copy documents reflecting Confidential Information. Recipient will be liable for the unauthorized disclosure of Discloser's Confidential Information by Recipient's employees, agents, and contractors. The foregoing non-disclosure obligations will not apply to Confidential Information which: (x) is or later becomes part of the public domain without breach of this Agreement and through no act or omission of the Recipient; (y) the Recipient rightly receives from a third party; or (z) was developed independently by and was reduced to writing by the Recipient prior to the earlier of the date of this Agreement or the date of any access or exposure to any Confidential Information.

5.3.    Intellectual Property.  The term “Intellectual Property Rights” means the worldwide, intangible rights or interests evidenced by or embodied in: (a) any idea, design, concept, method, process, technique, apparatus, invention, discovery or improvement, including any patents, patent applications, trade secrets, and know- how; (b) any work of authorship, including any copyrights, industrial designs, registration or moral rights recognized by law; and (c) any trademarks, trade names, trade dress and associated goodwill or (d) any other proprietary technology or material in which similar rights exist. The term “Materials” means documentation, deliverables or work product, the DataSync Adapter, Biotronik software, including the Software, Biotronik Confidential Information, other inventions or materials comprising the Interface or Software and any other information or materials provided to Customer that are proprietary to Biotronik or its licensors or services providers. Except for the Customer-specific materials, including but not limited to, reports, documents, and charts generated out of the use of the DataSync Adapter, all Intellectual Property Rights in the Materials are and will remain the exclusive property of Biotronik or its licensors or suppliers, whether or not specifically recognized or perfect under applicable local law. Any rights not expressly granted herein are reserved to Biotronik or its licensors and service providers. Customer will not: (a) take any action that jeopardizes Biotronik’s or its licensor’s or service provider’s proprietary rights in any Materials or acquire any right in any Materials (b) modify, reverse engineer, decompile or create derivative works of any Materials or (c) remove or modify any proprietary markings of restrictive legends placed on any Materials.

6.       Warranties and Indemnification

6.1.    Customer Representations and Warranties.  Customer represents and warrants that: (a) Customer has full corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereunder; (b) Customer has full corporate power and authority to request and authorize the installation of the DataSync Adapter contemplated hereunder, including, but not limited to, any interface engine(s) with the Systems; (c) this Agreement has been duly and validly executed and delivered by Customer and constitutes the valid and binding agreement of Customer, enforceable against Customer in accordance with its terms; and (d) each of the Systems with which Biotronik may integrate, as part of the Services hereunder, are fully protected and have a business resumption and contingency plan (“Plan”) which ensures the continued provision of the services provided and/or performed by the applicable System and which protects all of the System’s programs and data files, including, but not limited to, the integrity and confidentiality of such program and data. 

At a minimum each Plan must provide for Customer’s responsibility for backing up and otherwise protecting program and data files, protecting equipment and maintaining disaster recovery and contingency plans. Customer agrees to hold Biotronik, its affiliates, and their directors, officers, employees and agents harmless from, for and against any and all costs, expenses, claims (third party or otherwise), demands, suits, losses, governmental fines and penalties and/or damages of every kind, nature and description (including reasonable attorneys’ fees) which are incurred by, claimed from, or otherwise asserted by or against Customer, arising out of, connected with, related to, caused by or resulting from (i) any failure of any such Plan; and (ii) the acts or omissions of Customer during installation of the Software or use of the DataSync Adapter; except in the case of an intentional and malicious act by Biotronik.

6.2.    Biotronik Representations and Warranties.  Biotronik represents and warrants that: (a) Biotronik has full corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereunder; (b) this Agreement has been duly and validly executed and delivered by Biotronik and constitutes the valid and binding Agreement of Biotronik, enforceable against Biotronik in accordance with its terms; and (c) it will provide the DataSync Adapter in a manner consistent with industry standards generally applicable to the provision thereof. Biotronik does not warrant that the DataSync Adapter is error free or that Customer will be able to access and use the DataSync Adapter without problems or interruptions. Biotronik may use such representatives and/or subcontractors as Biotronik deems necessary to carry out Biotronik’s duties under this Agreement.   Biotronik agrees to impose on its subcontractors the same obligations imposed upon Biotronik under this Agreement with regards to confidentiality and security.

6.3.    Biotronik Indemnification.  Provided Customer is in material compliance with the terms of this Agreement, and subject to the exceptions provided in Section 6.5, Biotronik will indemnify Customer against any judgments finally awarded by a court and pay any settlements approved by Biotronik with respect to any claims by a third party that the DataSync Adapter (as it stands alone) or the permitted use thereof infringes any valid and issued U.S. intellectual property rights. 

6.4.    Customer Indemnification.  Customer will defend Biotronik and its affiliates, licensors and service providers at Customer’s expense, indemnify Biotronik and its affiliates, licensors and service providers against any judgments finally awarded by a court and pay any settlements approved by Customer with respect to any claims: (a) that Customer’s data infringes any intellectual property rights of a third party; (b) arises from Customer’s non-compliance with Section 2.3; (c) arising directly or indirectly from Customer’s acts or omissions, including negligence, during installation and use of the DataSync Adapter; or (d) that the DataSync Adapter or the use thereof infringes any intellectual property rights of a third party to the extent such claim arises from any of the exceptions enumerated in Section 6.5. Customer will further indemnify Biotronik and its affiliates, licensors and service providers against cost incurred by Biotronik in complying with governmental investigations, complaints and actions relating to Customer’s use of the DataSync Adapter and any penalties, fines or other damages incurred from the use of the DataSync Adapter in a way that violates any law, regulation or mandate.

6.5.    Exceptions.  In no event will Biotronik have any warranty or indemnification obligations to the extent any claim arises from: (a) use of the Software in combination with any equipment or third party software not certified by Biotronik for use in combination with the DataSync Adapter; (b) use of an out-dated version of the DataSync Adapter; (c) Customer’s material non-compliance with this Agreement; (d) use of the DataSync Adapter with third party services, processes or materials alone or in combination with the Software or Interface; (e) accidental damage or other events beyond Biotronik’s control; (f) Customer’s failure to install and use any modifications or updates to the Software provided by Biotronik; (g) any alteration, configuration, customization or modification of the Software regardless of who performed the alteration, configuration, customization or modification; and (h) the creation of derivative works of the Software by Customer or its agents and/or contractors or Biotronik’s compliance with Customer’s request or instructions or use of materials provided by Customer.

6.6.    Indemnification Procedure.  A party who believes it is entitled to indemnification (“Indemnified Party”) will promptly notify the other party (“Indemnifying Party”) of any claim for which the Indemnified Party seeks indemnification (“Claim”) and provide reasonable assistance to the Indemnifying Party with respect to handling the Claim. The Indemnified Party’s failure to provide timely notice or reasonable assistance will relieve the Indemnifying Party of its indemnification obligations to the extent that the Indemnifying Party’s failure to provide timely notice or reasonable assistance has been actually and materially prejudiced by such failure. The Indemnifying Party will have the sole right to defend, make decisions relative to the defense, negotiate and settle any Claim provided that the Indemnifying Party obtains the prior written approval of the Indemnified Party. The Indemnified Party will be entitled to participate in the dense of a Claim and to employ legal representation at its own expense to assist in the handling of a Claim.

7.       Disclaimer and Limitation of Liability

7.1.    Disclaimer.  EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, THE DATASYNC ADAPTER AND ALL OTHER SERVICES, DELIVERABLES, PRODUCTS AND MATERIALS PROVIDED BY BIOTRONIK ARE PROVIDED “AS IS” AND BIOTRONIK AND ITS LICENSORS AND SERVICE PROVIDERS EXPRESSLY DISCLAIM ALL WARRANTIES, CONDITIONS, REPRESENTATIONS, INDEMNITIES AND GUARANTEES WHETHER EXPRESS OR IMPLIED, ARISING BY LAW, CUSTOM, PRIOR ORAL OR WRITTEN STATEMENTS OR OTHERWISE INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY, TITLE, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, COMPATIBILITY, SECURITY OR ACCURACY. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, BIOTRONIK DOES NOT WARRANT THAT ACCESS TO OR USE OF THE SAAS SERVICES WILL BE UNINTERRUPTED OR ERROR-FREE.

7.2.    Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE UNDER THIS AGREEMENT FOR ANY INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE ORCONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATIONDAMAGES FOR LOSS OF GOODWILL, WORK STOPPAGE, COMPUTER FAILURE OR MALFUNCTION, LOST OR CORRUPTED DATA, LOST PROFITS, LOST BUSINESS OR LOST OPPORTUNITY) OR ANY OTHER SIMILAR DAMAGES UNDER ANY THEORY OF LIABILITY(WHETHER IN CONTRACT, WARRANTY, TORT (INCLUDING NEGLIGENCE) PRODUCT LIABILITY, STRICT LIABILITY OR ANY OTHER THEORY, EVEN IF INFORMED OF THIS POSSIBLITY AND EVEN IF A REMEDY IS FOUND TO HAVE FAILED OF ITS ESSENTIAL PURPOSE. EITHER PARTY’S TOTAL LIABILITY FOR ANY LOSS, COST OR DAMAGES OF ANY KIND RELATED TO THIS AGREEMENT WILL NOT EXCEED THE AMOUNT OF THE FEES PAID OR PAYABLE BY CUSTOMER TO BIOTRONIK DURING THE TWELVE (12) MONTHS BEFORE THE EVENT GIVING RISE TO SUCH LOSS, COST, CLAIM OR DAMAGES.

8.       General

8.1.    Independent Contractors.  The parties further agree that Biotronik is an independent contractor and not an employee, agent or partner of, or in a joint venture with, Customer.

8.2.    Entire Agreement.  This Agreement constitutes the parties’ complete understanding with regard to the subject matter of this Agreement and supersedes all prior written or oral agreements or understandings with respect thereto. 

8.3.    Force Majeure. Biotronik will not be liable for any delay or failure in performance of any of its obligations under this Agreement due to unforeseen circumstances or cause beyond Biotronik’s control, including, but not limited to, acts of God, war, terrorism, riot, embargoes, acts of civil or military authorities, delay or disruption of service providers or acts of licensors.

8.4.    Arm’s Length Transaction.  The parties hereto represent and warrant that any compensation provided under the terms of this Agreement shall be consistent with fair market value in arm’s length transactions, and has not been determined in any manner with regard to, or has been given in exchange for, any implicit or explicit agreement to provide favorable procurement decisions with regard to Biotronik's products, or to the value or volume of any business generated between the parties.

8.5.    No Government Health Programs Sanctions.  Each party represents and warrants that it is not and at no time has been excluded from participation in any federally- funded healthcare program, including, but not limited to, Medicare and Medicaid. Each party shall notify the other party promptly after it becomes aware of its suspension or exclusion from participation in any state or federally-funded healthcare program. If either party is excluded from participation in any state or federally-funded healthcare program, this Agreement shall terminate automatically effective as of the date of commencement of such exclusion.

8.6.    Publicity.  Biotronik may use Customer’s name, tradename or trademark in a press release or other publication so long as the information provided is correct and contains no misrepresentations of fact. 

8.7.    Construction.  This Agreement has been negotiated at arm’s length and has been entered into for the sole benefit of the parties to this Agreement. The parties agree that no benefit accruing to either party to this Agreement shall be conditioned upon, or granted, in consideration of the referral of any patient or business to either party. This Agreement shall inure to the benefit and shall be binding on the parties thereto, and their respective successors and assigns. The subject headings of the sections of this Agreement are included for purposes of convenience only and shall not affect the construction or interpretation of any of its provisions. All schedules and exhibits to this Agreement are incorporated into and made part of this Agreement by this reference as if set forth in their entirety herein.

8.8.    Governing Law.  This Agreement will be governed by the laws of the State of Oregon without giving effect to the principles of conflict of laws of any jurisdiction.

8.9.    Waiver/Severability.  No waiver of any violation or nonperformance of this Agreement in one instance shall be deemed to be a waiver of any violation or nonperformance in any other instance. All waivers must be in writing. In the event any portion of this Agreement is declared void by a court or arbitrator, such portion shall be severed from this Agreement, and the remaining provisions shall remain in effect, unless the effect of such severance would be to alter substantially this Agreement or the obligations of the parties, in which case this Agreement may be immediately terminated.