ECG Buddy End-User License Agreement (EULA) <h1 style="text-align:center;">ECG Buddy End-User License Agreement (EULA)</h1><p style="margin-left:0px;text-align:center;">Effective Date: April 20, 2026</p><h2 style="text-align:center;"><strong>Chapter 1. General Provisions</strong></h2><p style="text-align:center;"> </p><h3><strong>Article 1 (Purpose)</strong></h3><p style="margin-left:0px;">The purpose of this Agreement is to prescribe the rights, obligations, and responsibilities between <strong>ARPI Inc.</strong> (hereinafter referred to as the "<strong>Company</strong>") and the <strong>End-User</strong> (hereinafter referred to as the "<strong>User</strong>") who intends to use <strong>ECG Buddy</strong> (hereinafter referred to as the "<strong>Software</strong>"), a standalone software medical device developed and provided by the Company. The User may use the Software by agreeing to this Agreement.</p><h3><strong>Article 2 (Definitions)</strong></h3><p style="margin-left:0px;">The definitions of the terms used in this Agreement are as follows:</p><ol><li><p style="margin-left:20px;"><strong>"Software"</strong>: Refers to ECG Buddy, developed and provided by the Company, which is an item authorized by the Ministry of Food and Drug Safety as a standalone software medical device in accordance with the Digital Medical Products Act. The Intended Use of the Software is as follows, and all functions, including the Intended Use, shall not exceed the scope authorized under Relevant Laws:</p><p style="margin-left:0px;"><strong><u>Intended Use (KR) (MFDS 24-1179)</u></strong>Software that assists a physician's diagnostic decisions by utilizing deep learning algorithms to analyze electrocardiogram (ECG) images or waveform data to aid in the diagnosis of arrhythmias and provide numerical risk scores for emergency situations and cardiac dysfunctions.</p></li><li><p style="margin-left:20px;"><strong>"Service"</strong>: Refers to the additional support and the environment provided by the Company through the Software for the User's convenience, including the receipt of AI analysis requests, data processing, visualization of analysis results, generation and management of Analysis Reports, account operation, and customer support.</p></li><li><p style="margin-left:20px;"><strong>"Company"</strong>: Refers to ARPI Inc., the developer and supplier of the Software. The detailed information of the Company is as follows:</p><ul><li><p style="margin-left:20px;"><strong>Registered Address:</strong> #1401, 8, Seongnam-daero 331beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (ARPI Inc.)</p></li><li><p style="margin-left:20px;"><strong>Representative Contact:</strong> +82-31-738-0110</p></li><li><p style="margin-left:20px;"><strong>Representative Email:</strong> [email protected] </p></li></ul></li><li><p style="margin-left:20px;"><strong>"User"</strong>: Refers to an individual or legal entity that has entered into a use agreement for the Software in accordance with this Agreement and has acquired the right to use (License) the Software according to the procedures provided by the Company. The User may only use the Software within the scope of the Intended User.</p></li><li><p style="margin-left:20px;"><strong>"Intended User"</strong>: Refers to the users specified according to the Intended Use of the Software, which includes physicians (those responsible for final diagnosis and decisions), medical professionals using the Software to convey relevant information to physicians, medical and graduate medical students, researchers, and other non-clinical users for research and educational purposes.</p></li><li><p style="margin-left:20px;"><strong>"User Manual (IFU, Instructions For Use)"</strong>: Refers to the user manual and safe use information provided by the Company for the Software, which is a document describing in detail the appropriate method of use, performance, and prohibited matters of the Software.</p></li><li><p style="margin-left:20px;"><strong>"License"</strong>: Refers to the limited, non-exclusive, and non-transferable authority granted by the Company to the User to install, access, and use the Software in accordance with this Agreement and the Subscription Plan. It has the meaning given in Chapter 3 (License) of this Agreement.</p></li><li><p style="margin-left:20px;"><strong>"Subscription Plan"</strong>: Refers to the Company's policy regarding the period and conditions for using the paid services of the Software, including the pricing method based on the number of ECG analysis requests and the membership subscription method where limited Credits are provided for monthly use during a specified period.</p></li><li><p style="margin-left:20px;"><strong>"Credit"</strong>: Refers to a limited unit of use frequency granted to the User for a fee in accordance with the Subscription Plan, which can be used for AI ECG analysis requests and result inquiries. Credits may expire upon the expiration of the use period or termination of the Agreement.</p></li><li><p style="margin-left:20px;"><strong>"Membership"</strong>: Refers to the membership status granted to use specific functions and Credits of the Software for a certain period by subscribing to the paid Subscription Plan provided by the Company.</p></li><li><p style="margin-left:20px;"><strong>"ECG"</strong>: Refers to an electrocardiogram, which is the result of a cardiovascular test measuring the electrical activity of the heart. The Software processes only standard 12-lead ECG data.</p></li><li><p style="margin-left:20px;"><strong>"Analysis Report"</strong>: Refers to the arrhythmia (heart rhythm) probability and digital biomarker risk scores quantified from 0 to 100 generated by the Software by analyzing the ECG data entered by the User. This report is used only for the purpose of assisting a physician's diagnostic decisions.</p></li><li><p style="margin-left:20px;"><strong>"Research Use Only (RUO)"</strong>: Refers to the status where the Software is intended to be used solely for scientific research or educational purposes by non-clinical users such as medical students and researchers. It is expressly stated that RUO shall never be used for diagnosis, treatment, or other clinical applications, and functional restrictions may apply in accordance with Relevant Laws.</p></li><li><p style="margin-left:20px;"><strong>"Privacy Policy"</strong>: Refers to a separate document that notifies the User and relevant data subjects of the method, purpose, period of processing and retention, provision to third parties, entrustment of processing (if applicable), and relevant rights regarding personal information. It is based on the Personal Information Protection Act of the Republic of Korea.</p></li><li><p style="margin-left:20px;"><strong>"Relevant Laws"</strong>: Collectively refers to all domestic laws, notifications, and guidelines from regulatory authorities related to the manufacture, sale, and use of the Software, including the Digital Medical Products Act, Medical Device Act, and Personal Information Protection Act of the Republic of Korea, as well as their subordinate statutes and notifications.</p></li><li><p style="margin-left:20px;"><strong>"Effective Date"</strong>: Refers to the date on which the User agrees to this Agreement and creates a member account, upon which this Agreement becomes effective.</p></li></ol><h3><strong>Article 3 (Formation and Application of Agreement)</strong></h3><ol><li><p style="margin-left:20px;">This Agreement shall be validly formed when a person who intends to become a User agrees to this Agreement and creates a member account.</p></li><li><p style="margin-left:20px;">The Company shall post the contents of this Agreement on the initial execution screen of the Software or the service screen so that the User can easily access them.</p></li><li><p style="margin-left:20px;">This Agreement shall be interpreted and applied in accordance with the laws of the Republic of Korea (provided, however, that if a separate Appendix applies to a specific region, the provisions of such Appendix shall prevail over this Main Agreement in the event of a conflict). Separate policies and regulations concerning the Software (Privacy Policy, detailed terms of the Subscription Plan, etc.) constitute a part of this Agreement and shall be effective to the extent they do not conflict with this Agreement. In the event of a conflict between such policies/regulations and this Agreement (including its Appendices), this Agreement shall prevail.</p></li></ol><h2 style="text-align:center;"> </h2><h2 style="text-align:center;"><strong>Chapter 2. Characteristics and Use Restrictions of the Software</strong></h2><h3><strong>Article 4 (Medical Device Notice and Role of the Software)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Legal Status of the Software:</strong> The Software is a standalone software medical device under the Digital Medical Products Act, and its manufacture, quality control, authorization, and use are strictly regulated in accordance with Relevant Laws.</p></li><li><p style="margin-left:20px;"><strong>Specification of Assistive Role:</strong> The Analysis Report and all results provided by the Software are merely reference materials intended to assist a physician's diagnostic and treatment decisions. The Software does not replace final medical acts aimed at the diagnosis, treatment, prescription, prevention, or cure of a patient's disease.</p></li><li><p style="margin-left:20px;"><strong>Final Responsibility:</strong> The final responsibility for all medical acts, including patient diagnosis, treatment decisions, and medical judgment, rests entirely with the physician who is the User; the Company shall not be liable for any clinical outcomes or misdiagnoses arising from the assistive use of the Software.</p></li></ol><h3><strong>Article 5 (Definition and Scope of Use for Intended Users)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Scope of Intended Users:</strong> The primary users of the Software are physicians; medical professionals using the Software to convey relevant information under a physician's direction, as well as non-clinical users for research or educational purposes, are also included as Intended Users in an assistive capacity.</p></li><li><p style="margin-left:20px;"><strong>User Qualification Declaration and Responsibility:</strong></p><ul><li><p style="margin-left:20px;">Before commencing use of the Software, the User must directly select and declare their Occupation and purpose of use through the Company's system.</p></li><li><p style="margin-left:20px;">The User guarantees that the selected Occupation and purpose of use are true; the User shall bear full legal and clinical responsibility for any misuse of the Software arising from a false declaration of qualifications.</p></li><li><p style="margin-left:20px;">The Company permits use based on the User's qualification declaration and does not bear the obligation to directly verify the truthfulness of the content declared by the User.</p></li></ul></li><li><p style="margin-left:20px;"><strong>Use by Medical Professionals:</strong> Use of the Software by medical professionals must be conducted under the guidance and supervision of a physician, and the interpretation of analysis results and their application to patients must follow the physician's final judgment.</p></li><li><p style="margin-left:20px;"><strong>Restrictions on Research Use Only (RUO):</strong></p><ul><li><p style="margin-left:20px;">Users who have declared themselves as research-purpose users (medical/graduate medical students, researchers, etc.) must utilize the Software only in the Research Use Only (RUO) status as defined in Article 2, Paragraph 13.</p></li><li><p style="margin-left:20px;">When using for research purposes, the results must never be used for a patient's diagnosis, treatment, prevention, or any other clinical purposes.</p></li><li><p style="margin-left:20px;">The Company bears no responsibility for any clinical or legal issues arising from the violation of restrictions on research use, and the Company may immediately terminate this Agreement upon such violation.</p></li></ul></li></ol><h3><strong>Article 6 (Obligation to Comply with User Manual (IFU))</strong></h3><ol><li><p style="margin-left:20px;"><strong>Compliance with IFU:</strong> The User must fully familiarize themselves with the contents of the IFU (User Manual) provided by the Company before using the Software and must comply with the IFU during use.</p></li><li><p style="margin-left:20px;"><strong>Prohibition of Use Outside IFU Scope:</strong> The User must not use or apply the Software outside the scope specified in the IFU, including the authorized purpose of use, methods of use, performance limitations, and contraindications.</p></li><li><p style="margin-left:20px;"><strong>Responsibility for Compliance:</strong> The User shall bear full responsibility for all damages, problems, or clinical outcomes arising from failure to familiarize themselves with the IFU, use outside the scope of the IFU, misuse, or negligent use.</p></li></ol><h2 style="text-align:center;"> </h2><h2 style="text-align:center;"><strong>Chapter 3. Grant and Restrictions of License</strong></h2><h3><strong>Article 7 (Grant of License)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Limited License:</strong> On the condition that the User creates a valid member account and complies with all terms and restrictions specified in this Agreement and the Subscription Plan, the Company grants the User a limited, non-exclusive, and non-transferable License to access and use the Software.</p></li><li><p style="margin-left:20px;"><strong>Scope and Subject of License:</strong> The License is granted only for the Object Code version of the Software, and no rights to the source code of the Software are granted to the User. This License is dependent on the member account (email address) created by the individual User, and the authority is maintained through access to the Software via said account.</p></li><li><p style="margin-left:20px;"><strong>License Period:</strong> The License begins from the Effective Date (the date of membership registration and agreement to the terms) and remains effective during the subscription period if the User uses a paid Subscription Plan, or while the member account remains valid even if a paid subscription is not used. However, the Company reserves the right to terminate the Agreement in accordance with Article 13 (Modification and Termination) of this Agreement.</p></li></ol><h3><strong>Article 8 (Restrictions on License and Prohibited Acts)</strong></h3><p style="margin-left:0px;">The User shall not engage in any of the following acts; in the event of a violation, the Company may immediately terminate the Agreement and hold the User legally liable in accordance with Relevant Laws.</p><ol><li><p style="margin-left:20px;"><strong>Prohibition of Reproduction and Distribution:</strong> Reproducing, lending, leasing, transferring, sublicensing, or distributing all or part of the Software to a third party.</p></li><li><p style="margin-left:20px;"><strong>Prohibition of Modification and Analysis:</strong> Reverse engineering, decompilation, disassembly, or any other analytical acts to extract the source code of the Software, including its artificial intelligence algorithms.</p></li><li><p style="margin-left:20px;"><strong>Prohibition of Technology Theft (AI Model Protection):</strong> Illegally reproducing or imitating technologies to which the Company's intellectual property rights apply — such as the artificial intelligence (AI) models, algorithms, training data, and analysis techniques embedded in the Software — or any attempt to copy such technology (including indirect methods).</p></li><li><p style="margin-left:20px;"><strong>Prohibition of Use Outside of Purpose:</strong> Using or applying the Software outside the scope of the Intended Use and IFU specified in Articles 4 and 5 of this Agreement.</p></li><li><p style="margin-left:20px;"><strong>Prohibition of Security Circumvention:</strong> Any attempt to bypass or neutralize the functional restrictions, Credit system, security, or license management features of the Software.</p></li><li><p style="margin-left:20px;"><strong>Prohibition of Sharing Access Rights:</strong> Sharing the granted License or Credits among multiple users or accounts, or arbitrarily transferring them to a third party.</p></li></ol><h3><strong>Article 9 (Intellectual Property Rights)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Ownership of Rights:</strong> All rights (including copyrights, patents, trademarks, trade secrets, and all other intellectual property rights) regarding the Software, Service, and information obtained through the use of the Software and Service (such as user manuals) are owned by the Company; what is granted to the User under this Agreement is limited to the right to use (License) the Software.</p></li><li><p style="margin-left:20px;"><strong>User Obligations:</strong> The User shall not remove or alter the Company's trademarks, logos, copyright notices, etc., displayed on the Software.</p></li></ol><h2 style="text-align:center;"> </h2><h2 style="text-align:center;"><strong>Chapter 4. Contract and Payment (Subscription)</strong></h2><h3><strong>Article 10 (Subscription Plan and Credit)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Free Provision and Changes:</strong></p><ul><li><p style="margin-left:20px;">The User may be granted a certain amount of Credits for free in accordance with the Company's policy during the period of membership registration and account validity to use the analysis functions of the Software.</p></li><li><p style="margin-left:20px;">The Company may change or discontinue the quantity, payment cycle, and policy of the free Credits at any time without prior notice in accordance with Relevant Laws or the Company's internal policies. Unless otherwise specified in Relevant Laws, no separate compensation will be provided to the User if the Company changes or discontinues the free Credit policy.</p></li><li><p style="margin-left:20px;">Credits refer to a limited unit of use frequency that can be used only for AI ECG analysis requests and result inquiries, and they cannot be exchanged for cash or other property values. The User may use the functions of the Software using the granted Credits in accordance with the Company's policy.</p></li><li><p style="margin-left:20px;">If the User purchases a Membership under a paid Subscription Plan, the existing free Credits will expire upon the application of said paid Membership, and no additional free Credits will be provided until the expiration of the Membership.</p></li></ul></li><li><p style="margin-left:20px;"><strong>Paid Subscription Plan:</strong> If the User requires additional analysis requests or wishes to use more functions, the User may purchase a monthly or annual Membership according to the Subscription Plan set by the Company.</p></li><li><p style="margin-left:20px;"><strong>Nature and Use of Credits:</strong></p><ul><li><p style="margin-left:20px;">Credits refer to a limited unit of use frequency that can be used only for AI ECG analysis requests and result inquiries and cannot be exchanged for cash or other property values.</p></li><li><p style="margin-left:20px;">The User may use the functions of the Software using Credits that were purchased for a fee or granted for free.</p></li></ul></li><li><p style="margin-left:20px;"><strong>Expiration of Credits:</strong></p><ul><li><p style="margin-left:20px;">Credits purchased for a fee may expire upon the lapse of the validity period specified in the Subscription Plan or upon termination of this Agreement.</p></li><li><p style="margin-left:20px;">Credits granted for free may expire on a daily or monthly basis according to the Company's policy, and notification regarding the timing of expiration will be made through the Software or announcements.</p></li><li><p style="margin-left:20px;">The Company bears no obligation for compensation or refund for Credits that have expired in accordance with the terms of this Agreement.</p></li></ul></li></ol><h3><strong>Article 11 (Fee Payment and Billing)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Payment Obligation:</strong> If the User selects a paid Subscription Plan, the User must pay the fees specified in said Subscription Plan using the designated payment method and means.</p></li><li><p style="margin-left:20px;"><strong>Fee Policy:</strong> The fees and billing cycle of the Subscription Plan shall follow the Company's Subscription Plan policy, and the Company shall notify the User in advance of any policy changes.</p></li><li><p style="margin-left:20px;"><strong>Payment Failure and Contract Termination:</strong> If the User fails to pay the subscription fee within the set period or if payment fails due to issues with the registered payment method, the Company may suspend the use of paid services or terminate this Agreement after notifying the User.</p></li></ol><h3><strong>Article 12 (Withdrawal or Termination of Subscription, and Compensation Policy)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Withdrawal of Subscription:</strong></p><ul><li><p style="margin-left:20px;">The User may request a withdrawal of subscription if they have not used any of the purchased Credits within 7 days from the date of the paid subscription payment. In this case, the Company shall refund the full subscription fee.</p></li></ul></li><li><p style="margin-left:20px;"><strong>Subscription Termination and Refund:</strong></p><ul><li><p style="margin-left:20px;">If the period in Paragraph 1 has elapsed or if the User has used the purchased Credits at least once, the User may request the termination of the subscription from the Company.</p></li><li><p style="margin-left:20px;">Upon a request for subscription termination, the Company shall refund the remaining balance after deducting (i) the portion of the subscription fee corresponding to the ratio of used Credits to the total Credits provided during the paid subscription period and (ii) an additional 10% of the balance as a termination penalty.</p></li></ul></li><li><p style="margin-left:20px;"><strong>Processing of Unused Credits:</strong> Credits provided (refilled) on a monthly basis according to the paid subscription service do not carry over to the next subscription period. Remaining unused Credits at the time of expiration of the subscription period will automatically expire, and new Credits will be provided according to the policy when the new subscription period begins. The responsibility for using the provided Credits rests entirely with the User.</p></li><li><p style="margin-left:20px;"><strong>Compensation due to Company's Attribution:</strong></p><ul><li><p style="margin-left:20px;">If purchased Credits are incorrectly indicated or unfairly reduced due to the Company's fault, such as a system error of the Software, the Company shall restore the reduced Credits or provide equivalent additional Credits.</p></li><li><p style="margin-left:20px;">However, if the Agreement is terminated due to unavoidable reasons where the Company can no longer provide the Service (e.g., business closure), refunds for remaining unused Credits may be processed in accordance with Relevant Laws.</p></li></ul></li></ol><h2 style="text-align:center;"> </h2><h2 style="text-align:center;"><strong>Chapter 5. Rights and Responsibilities of the Company</strong></h2><h3><strong>Article 13 (Authority of the Company and Modification of Agreement)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Authority to Provide Service:</strong> The Company holds the technical and administrative authority to stably provide the Software and Service in accordance with this Agreement and Relevant Laws.</p></li><li><p style="margin-left:20px;"><strong>Modification and Improvement of the Software:</strong> The Company may update, change, or improve the Software from time to time to enhance quality, strengthen security, improve functions, and comply with relevant regulations; accordingly, some functions of the Software may be added, changed, or deleted.</p></li><li><p style="margin-left:20px;"><strong>Modification of the Agreement:</strong> The Company may modify this Agreement to the extent that it does not violate Relevant Laws. When modifying this Agreement, the Company shall notify the details of the existing and modified Agreement, specifying the effective date and reasons for the amendment, on the initial screen of the Software or the connected service screen <strong>at least 7 days prior to the effective date</strong>, and shall provide individual notice if necessary under Relevant Laws such as the Act on the Regulation of Terms and Conditions.</p></li><li><p style="margin-left:20px;"><strong>Effect of Modification:</strong></p><ul><li><p style="margin-left:20px;">When the Company modifies this Agreement, it shall confirm the User's consent to the application of the modified Agreement after notifying the modification. When providing notice under Paragraph 3, the Company shall also notify that the User's failure to express consent or rejection shall be deemed as consent; if the User does not express rejection by the effective date of the modified Agreement, the User may be deemed to have consented to the modification.</p></li><li><p style="margin-left:20px;">If the User does not agree to the modified Agreement, either the Company or the User may terminate this Agreement.</p></li></ul></li></ol><h3><strong>Article 14 (Termination and Cancellation of Agreement)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Termination by User:</strong> The User may terminate this Agreement at any time through the membership withdrawal procedure. However, if paid Credits or subscription periods remain at the time of termination, refunds shall be processed in accordance with Article 12.</p></li><li><p style="margin-left:20px;"><strong>Termination by Company:</strong> The Company may terminate this Agreement after prior notice to the User if any of the following reasons occur; in such cases, the Company may bear no refund obligation or may refund only within a limited scope:</p><ul><li><p style="margin-left:20px;">The User violates regulations regarding use restrictions and prohibited acts specified in Chapters 2 and 3 (particularly violations of research use restrictions or attempts at technology theft).</p></li><li><p style="margin-left:20px;">The User causes damage to the Company through intent or gross negligence.</p></li><li><p style="margin-left:20px;">It is confirmed that the User used the Software by submitting false qualifications or false information.</p></li></ul></li><li><p style="margin-left:20px;"><strong>General Notice of Service Termination:</strong> If the Company terminates the entire Software service due to significant reasons such as managerial or technical changes or changes in Relevant Laws, it shall notify the User <strong>at least 6 months prior to the scheduled termination date</strong> and guarantee that the User can use the service during that period. If unused Credits remain by the notified termination date, the User's rights shall be protected in accordance with Relevant Laws.</p></li><li><p style="margin-left:20px;"><strong>Emergency Termination and Immediate Recall:</strong> In any of the following cases, the Company may stop the use of or recall the Software immediately after notifying the User without applying the aforementioned 6-month notice period:</p><ul><li><p style="margin-left:20px;">An order for immediate suspension of use, recall, or destruction of the Software is issued by relevant regulatory authorities (e.g., the Ministry of Food and Drug Safety).</p></li><li><p style="margin-left:20px;">A significant safety or efficacy issue occurs in the Software, posing a risk of serious danger to Users and patients.</p></li></ul><p style="margin-left:0px;">In such cases, the Company shall immediately notify the User and fulfill obligations required under Relevant Laws, such as refunds for unused Credits.</p></li></ol><h3><strong>Article 15 (Limitation of Liability and Indemnification)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Indemnification for Medical Acts:</strong> While the Company warrants that the Software performs its authorized functions as a medical device, the Software is provided only for diagnostic assistance as specified in Article 4; the User (Physician) bears full responsibility for all medical acts, including final patient diagnosis, treatment, and medical judgment.</p></li><li><p style="margin-left:20px;"><strong>Indemnification for Non-compliance with IFU:</strong> The Company shall not be liable for misuse, misdiagnosis, damages, or any other consequences arising from the User's failure to comply with the IFU (User Manual).</p></li><li><p style="margin-left:20px;"><strong>Indemnification for AI and Performance Limitations:</strong></p><ul><li><p style="margin-left:20px;">As an AI technology-based statistical analysis tool, the Software does not warrant that analysis results will always be 100% accurate or error-free.</p></li><li><p style="margin-left:20px;">While the Company exerts best efforts and technical expertise to maintain the stability and accuracy of the Software, abnormal display of analysis results or temporary functional failures may occur due to technical limitations of AI models, temporary errors (bugs) in data processing, or changes in the network environment.</p></li><li><p style="margin-left:20px;">The Company shall not be liable for unpredictable results, errors, or performance degradation occurring within the aforementioned technical limitations. However, long-term suspension of service or fatal damage caused by the Company's intent or gross negligence is not subject to this provision.</p></li></ul></li><li><p style="margin-left:20px;"><strong>Limitation of Liability:</strong> If damage occurs to the User due to the Company's fault, the Company's total aggregate liability for damages shall not exceed the total subscription fees actually paid by the User to the Company during the 12 months immediately preceding the occurrence of such damage. This limitation excludes damages caused by the Company's intent or gross negligence. Furthermore, the Company is indemnified against all other damages, including consequential damages, loss of profits, and special, indirect, or incidental damages.</p></li><li><p style="margin-left:20px;"><strong>Force Majeure:</strong> The Company shall be indemnified from liability if it cannot provide the service due to force majeure events beyond its reasonable control, such as natural disasters, war, riots, government regulations, communication failures, or failures of service providers.</p></li></ol><h2 style="text-align:center;"> </h2><h2 style="text-align:center;"><strong>Chapter 6. Rights and Obligations of the End-User</strong></h2><h3><strong>Article 16 (Rights of the User)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Right to Use the Software:</strong> The User has the right to install, access, and use the Software according to the Intended Use, provided that the License remains validly in effect in accordance with this Agreement and the Subscription Plan.</p></li><li><p style="margin-left:20px;"><strong>Right to Access Analysis Reports and Restrictions:</strong></p><ul><li><p style="margin-left:20px;">The User has the right to view and use the Analysis Report, which is the result of the ECG analysis requested using Credits.</p></li><li><p style="margin-left:20px;">To ensure User data security and compliance with Relevant Laws, the Company automatically deletes the Analysis Report from the system after a maximum of six (6) hours from the time of its generation. The User agrees to this deletion policy and acknowledges the limitations regarding report retention.</p></li></ul></li><li><p style="margin-left:20px;"><strong>Right to Request Information Notification:</strong> The User has the right to request prior notification regarding matters that significantly affect the use of the Software, such as major changes in the Company's service policy, modifications to the Agreement, or temporary or permanent suspension of the Service.</p></li><li><p style="margin-left:20px;"><strong>Rights Related to Personal Information:</strong> The User has the rights guaranteed under Relevant Laws regarding the processing of their personal data, such as the right to request access, correction/deletion, and suspension of processing, in accordance with the Privacy Policy and Chapter 7 of this Agreement.</p></li></ol><h3><strong>Article 17 (Obligations of the User)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Obligation to Comply with Relevant Laws and Terms:</strong> The User shall comply with this Agreement and relevant regulations and must strictly follow the methods of use, restrictions, and contraindications specified in the Company's IFU (User Manual).</p></li><li><p style="margin-left:20px;"><strong>Obligation to Provide Information:</strong> The User warrants that all information submitted to the Company at the time of membership registration (particularly the declaration of Occupation and purpose of use) is true and consistent with facts. In the event of any changes, the User bears the obligation to update it to the latest information immediately.</p></li><li><p style="margin-left:20px;"><strong>Obligation for Account and Security Management:</strong></p><ul><li><p style="margin-left:20px;">The User must strictly manage their member account and password and must not share or transfer account information to any third party.</p></li><li><p style="margin-left:20px;">The User shall be solely responsible for any liabilities arising from the negligent management or transfer of their user account.</p></li></ul></li><li><p style="margin-left:20px;"><strong>Obligation to Refrain from Prohibited Acts:</strong> The User bears the obligation to refrain from any of the license restrictions and prohibited acts specified in Article 8 of Chapter 3 (e.g., reverse engineering, attempts at technology theft, use outside of purpose, etc.).</p></li><li><p style="margin-left:20px;"><strong>Obligation to Notify Adverse Events and Feedback:</strong></p><ul><li><p style="margin-left:20px;">The User must immediately notify the Company upon becoming aware of any unexpected side effects (adverse events), serious errors in performance or analysis results (bugs), or significant opinions and feedback necessary for the improvement of the Software during its use.</p></li><li><p style="margin-left:20px;">The Company shall not be held liable for any additional damages or consequences arising from the User's failure to perform the aforementioned notification obligation.</p></li></ul></li></ol><h2 style="text-align:center;"> </h2><h2 style="text-align:center;"><strong>Chapter 7. Data Protection, Confidentiality, and Dispute Resolution</strong></h2><h3><strong>Article 18 (Personal Information and Data Protection)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Compliance with Privacy Policy:</strong> The Company shall process and protect the User's personal information in accordance with Relevant Laws and the separately posted Privacy Policy. The User must review the Privacy Policy before using the Software.</p></li><li><p style="margin-left:20px;"><strong>Anonymization and Utilization of Data:</strong> The Company does not store or utilize any Protected Health Information (PHI) of patients or any personal information contained within the original ECG data uploaded by the User.</p></li><li><p style="margin-left:20px;"><strong>Research and Improvement:</strong> The Company may utilize only non-identifiable ECG waveform data and service usage logs, processed to ensure that individuals cannot be identified, for the purposes of service improvement, AI model performance enhancement, and academic research.</p></li><li><p style="margin-left:20px;"><strong>Automatic Deletion of Analysis Reports:</strong> The User acknowledges the policy regarding the automatic deletion of Analysis Reports after six (6) hours as specified in Article 16, Paragraph 2 of Chapter 6. The Company shall not be held liable for any data loss arising from this policy.</p></li></ol><h3><strong>Article 19 (Confidentiality and Notification to Users)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Definition of Confidential Information:</strong> In this Agreement, "Confidential Information" refers to all business or technical secrets related to the Company that are provided to or recognized by the User, including but not limited to undisclosed functions, technologies, algorithms, marketing plans, and business information of the Software.</p></li><li><p style="margin-left:20px;"><strong>Confidentiality Obligation:</strong> The User shall not reproduce, use, or disclose Confidential Information to any third party without the prior written consent of the Company. This obligation shall remain in effect even after the termination of the period of Software use.</p></li><li><p style="margin-left:20px;"><strong>Notification to Users:</strong></p><ul><li><p style="margin-left:20px;">When the Company provides notice to the User, it may do so via the member's email address, text message (LMS/SMS), etc.</p></li><li><p style="margin-left:20px;">In the case of notifications directed to all Users, the Company may substitute the notice in Paragraph 1 by displaying a pop-up screen or similar notice through the Software for at least seven (7) days.</p></li><li><p style="margin-left:20px;">Where required under Relevant Laws, the Company may send relevant notices even if the User has opted out of receiving notifications.</p></li></ul></li></ol><h3><strong>Article 20 (Governing Law and Dispute Resolution)</strong></h3><ol><li><p style="margin-left:20px;"><strong>Governing Law:</strong> The interpretation and application of this Agreement shall be governed by the laws of the Republic of Korea.</p></li><li><p style="margin-left:20px;"><strong>Amicable Settlement:</strong> In the event of a dispute between the Company and the User regarding the performance or interpretation of this Agreement, both parties shall endeavor to resolve it through mutual consultation based on the principle of good faith.</p></li><li><p style="margin-left:20px;"><strong>Jurisdiction:</strong> If a dispute is not resolved despite the consultation under Paragraph 2 and a lawsuit is filed, such lawsuit shall be subject to the jurisdiction prescribed by the Civil Procedure Act.</p></li></ol><h2 style="text-align:center;"> </h2><h2 style="text-align:center;"><strong>Appendix A: EU/EEA Specific Provisions</strong></h2><h3><strong>Article A.1 Scope and Prevalence</strong></h3><p style="margin-left:0px;">This Appendix applies to Users residing in the European Union (EU) or the European Economic Area (EEA). In the event of any conflict between this Appendix and the Main Agreement, the provisions of this Appendix shall prevail.</p><h3><strong>Article A.2 Intended Use</strong></h3><ol><li><p style="margin-left:20px;"><strong>Regulatory Status:</strong> This Software is a Class IIa medical device in compliance with <strong>Regulation (EU) 2017/745 (MDR)</strong>, certified by <strong>BSI (Notified Body No. 2797, Certificate No. MDR823808 R000)</strong>.</p></li><li><p style="margin-left:20px;">Notwithstanding Article 2.1 of the Main Agreement, <strong>the following Intended Use shall apply to Users in the EU:</strong></p><p style="margin-left:0px;">ECG Buddy is an AI-based software intended for use by qualified healthcare professionals for the review and interpretation of 12-lead ECG images acquired from patients. The software generates automated analysis results that are presented in a standardized report format, which may be printed or stored for reference. ECG Buddy is not intended for use in life-supporting or life-sustaining systems, nor does it function as a real-time ECG monitoring or alarm device. The automated outputs provided by ECG Buddy are not intended to be used as the sole basis for clinical diagnosis. ECG Buddy is not intended as the sole diagnostic tool in critical emergency care settings or for use in patients requiring immediate life-saving medical interventions. It is intended primarily for use in routine clinical evaluations, outpatient clinic assessments, or health screening purposes for non-acute conditions. The ECG Buddy report is designed to support clinical decision-making and must be interpreted in conjunction with the clinician's expertise, the patient's clinical history, presenting symptoms, and other relevant diagnostic findings.</p></li></ol><h3><strong>Article A.3 Intended User and Research Use</strong></h3><ol><li><p style="margin-left:20px;"><strong>User Qualification:</strong> The Software is intended for use by qualified healthcare professionals, specifically <strong>Physicians</strong> and <strong>Nurses</strong>, who are licensed to provide medical services in their respective jurisdictions.</p></li><li><p style="margin-left:20px;"><strong>Research Use Only (RUO):</strong> In accordance with Article 2.13 and Article 5 of the Main Agreement, if a user without clinical qualifications (such as researchers or students) uses the Software, such use is strictly limited to <strong>Research and Educational Purposes (RUO)</strong>.</p></li><li><p style="margin-left:20px;"><strong>Prohibition of Clinical Use for RUO:</strong> Under RUO status, the results must never be used for diagnosis, treatment, or any other clinical purposes, and certain functionalities of the Application may be restricted in accordance with applicable regulations.</p></li><li><p style="margin-left:20px;"><strong>User Responsibility:</strong> The Company provides the Service based on the regulatory scope of the EU, and the Company shall not be held liable for any consequences arising from a User's false declaration of their qualifications or intended purpose.</p></li></ol><h3><strong>Article A.4 Data Protection and International Transfer</strong></h3><ol><li><p style="margin-left:20px;"><strong>GDPR Compliance:</strong> The Company complies with Regulation (EU) 2016/679 (GDPR), and detailed information regarding data processing is governed by the separate Privacy Policy.</p></li><li><p style="margin-left:20px;"><strong>Data Residency:</strong> Primary processing and storage of EU User data (including anonymized ECG data) are conducted within AWS regions located in the European Union.</p></li><li><p style="margin-left:20px;"><strong>Data Transfer:</strong> Minimal personal data required for account management (e.g., email address) may be transferred to the Company's headquarters in the Republic of Korea, safeguarded by the Standard Contractual Clauses (SCCs) or the EU-Korea Adequacy Decision.</p></li></ol><h3><strong>Article A.5 Limitation of Liability</strong></h3><ol><li><p style="margin-left:20px;"><strong>Liability Cap:</strong> Notwithstanding Article 15.4 (or Article 12.1) of the Main Agreement, the Company's total aggregate liability shall not exceed the total fees paid by the User during the twelve (12) months immediately preceding the event, or USD 50,000, whichever is lower.</p></li><li><p style="margin-left:20px;"><strong>Exclusion of Liability for Clinical Outcomes:</strong> Any death, serious injury, or health complications shall be deemed results of clinical decisions made by the User based on their independent professional judgment. The Company shall not be held liable for such outcomes unless a technical defect in the Software is proven to be the sole and direct cause of the damage.</p></li></ol><h3><strong>Article A.6 Adverse Event Reporting</strong></h3><ol><li><p style="margin-left:20px;"><strong>Reporting Obligation:</strong> In accordance with Article 17.5 of the Main Agreement, Users must immediately notify the Company of any unexpected side effects (adverse events) or serious performance errors via the contact information specified in the Emergency Contact section of the IFU (Instructions For Use) or through the official support channel ([email protected] ).</p></li><li><p style="margin-left:20px;"><strong>Regulatory Compliance:</strong> This reporting supports the Company's post-market surveillance obligations under EU MDR regulations.</p></li></ol><h3><strong>Article A.7 Termination of Service</strong></h3><ol><li><p style="margin-left:20px;"><strong>Notice and Procedure:</strong> The notice period and procedures for service termination are governed by Article 14.3 of the Main Agreement.</p></li><li><p style="margin-left:20px;"><strong>Data Erasure:</strong> Upon termination, all customer-related data will be securely and permanently deleted in accordance with the GDPR and applicable data protection laws.</p></li></ol><h3><strong>Article A.8 Regulatory Scope and Jurisdiction</strong></h3><ol><li><p style="margin-left:20px;"><strong>Applicable Laws:</strong> For EU Users, "Relevant Laws" includes Regulation (EU) 2017/745 (MDR) and the GDPR.</p></li><li><p style="margin-left:20px;"><strong>Jurisdiction:</strong> This Agreement is governed by the laws of the Republic of Korea; however, this shall not deprive the User of the protection afforded by mandatory consumer protection laws of the Member State in which the User resides.</p></li></ol>
Published: 2026-04-06 Read more