End User License Agreement

This End User License Agreement ("EULA" or "Agreement") is a legally binding contract between you, the end user ("You", "User", or "Customer"), and Aikenist Technologies Private Limited (CIN: U72900KA2019PTC128949), having its registered office at 007, Pushpanjali Apartments, 1st Cross, 1st Main, Chamarajpet, Bangalore KA 560018, India ("Aikenist", "We", "Us", or "Our").

This EULA governs Your access to and use of all Aikenist software products, applications, cloud services, on-premise deployments, hardware devices, and related documentation collectively offered under the QuickSuite product line (collectively, the "Software" or "Services").

This EULA should be read together with Aikenist's Universal Terms & Conditions, Privacy Policy, Payment Terms, and Cancellation & Refund Policy, all of which are incorporated herein by reference. In the event of a conflict between this EULA and a separately executed written agreement, the written agreement shall prevail.

Effective Date: This EULA is effective as of the date You first install, access, or use the Software, whichever is earliest.

"Software" means all Aikenist software products, including but not limited to Aiken QuickFlow, Aiken QuickScan, Aiken QuickDiag (and all sub-modules including OncoSuite, StrokeSuite, XraySuite, Aiken BMD, Aiken Adipo, Calcium Scoring), Aiken QuickRad (and all sub-modules including Dental PACS, Aiken Voice, AI Reporting, 3D Workstation, Aiken Viewer, Gen AI Reporting, Aiken RIS), and Aiken AI Platform, in any version, form, or rendition, whether delivered as SaaS, on-premise, cloud-hosted, mobile application, or embedded in hardware Devices.

"Documentation" means all user manuals, technical guides, clinical validation summaries, integration guides, and other materials provided by Aikenist in connection with the Software, whether in electronic or printed form.

"Device" means any laptop, desktop, workstation, mobile phone, GPU server, edge compute unit, or other electronic device on which the Software is installed or through which the Software is accessed, whether provided by Aikenist or by You.

"User" means any individual granted access to the Software under Your account, including account administrators, radiologists, clinicians, technicians, and other authorized personnel.

"Patient Data" means any medical imaging data, diagnostic data, or health information relating to an identified or identifiable patient processed through the Software, including DICOM files, imaging studies, and clinical reports.

"De-identified Data" means Patient Data from which all direct and indirect identifiers have been removed in compliance with applicable law, such that the data cannot reasonably be used to identify the individual patient.

"AI Output" means any analysis, inference, measurement, score, report, annotation, or other result generated by the Software's artificial intelligence and machine learning models from input imaging data.

"Clinical Decision" means any diagnosis, treatment plan, therapeutic recommendation, or other medical judgment that affects patient care.

"Subscription" means the paid, time-limited right to access and use the Software as specified in the applicable order form, purchase order, or service agreement.

"Confidential Information" means all non-public information disclosed by either party in connection with this EULA that is designated as confidential or that reasonably should be understood to be confidential given the nature of the information and circumstances of disclosure.

This EULA covers the following Aikenist software products and modules:

Product	Description	Key Capabilities
Aiken QuickFlow	AI Radiology Workflow & RIS	Intelligent scheduling, worklist management, HIMS/EMR integration, patient journey tracking, TAT dashboard, automated billing
Aiken QuickScan	AI MRI/CT Acceleration	Up to 4× faster MRI, 50% CT dose reduction, 70% SNR improvement, machine-agnostic (95% scanner compatibility), zero hardware modification required
Aiken QuickDiag	AI Diagnostic Suite	OncoSuite, StrokeSuite (92% sensitivity), XraySuite, BMD analysis, fat quantification (Adipo), Calcium Scoring, structured AI reporting, <1 second inference
Aiken QuickRad	AI PACS & Radiology Platform	Cloud PACS, universal viewer, AI reporting, voice dictation, semantic search, teleradiology, Dental PACS, 3D workstation, Gen AI reporting, RIS
Aiken AI Platform	GPU-Powered AI Workstation	12+ AI models, multi-organ segmentation, 3D reconstruction, volumetric measurement, DICOM SR output, automated PACS push, sub-second inference

Aikenist may add, modify, or discontinue individual products or modules at its sole discretion. Your access to specific modules is governed by Your active Subscription and the applicable order form.

Subject to Your compliance with this EULA and timely payment of all applicable fees, Aikenist grants You a limited, non-exclusive, non-transferable, non-sublicensable, revocable license to:

• Access and use the Software solely for Your internal clinical and administrative operations within Your licensed facility or institution;
• Use the Software by the number of Users and for the volume of studies specified in Your Subscription;
• Access the Software via Aikenist's secure cloud infrastructure, or install and operate the Software on-premise within Your designated facility, as specified in Your order form;
• Use the Documentation solely in support of Your permitted use of the Software.

Scope of License

The license granted hereunder is strictly limited to the territory, facility, use case, number of Users, and study volume specified in the applicable agreement or order form. Any use beyond this scope requires prior written approval from Aikenist and may be subject to additional fees.

No Implied Rights

Except for the limited license expressly granted above, Aikenist reserves all rights in and to the Software. No additional rights are granted by implication, estoppel, or otherwise.

You shall not, and shall not permit any third party to:

• Reverse engineer — decompile, disassemble, sniff, peel semiconductor components, or otherwise attempt to derive the source code, underlying algorithms, AI model weights, or architecture of the Software;
• Copy or reproduce — copy, reproduce, or create derivative works of the Software or Documentation except as expressly permitted;
• Distribute or sublicense — license, sublicense, sell, resell, rent, lease, transfer, assign, distribute, time-share, or otherwise make the Software available to any third party not covered by Your Subscription;
• Modify — modify, adapt, translate, or re-engineer the Software or any component thereof;
• Circumvent — remove, disable, circumvent, or modify any technical protection measure, license enforcement mechanism, or usage monitoring feature within the Software;
• Use for unauthorized purposes — use the Software for any purpose other than the clinical and administrative purposes explicitly covered by Your Subscription, including use for competing product development, benchmarking for publication without prior written consent, or training competing AI models;
• Export outside authorized territory — use, transfer, or make accessible the Software outside the territory specified in Your agreement without prior written approval;
• Process unauthorized data — process Personal Data or protected health information through the Software without first de-identifying such data in compliance with applicable law;
• Scrape or extract — "crawl", "scrape", "spider", or systematically extract data, AI outputs, model responses, or any content from the Software through automated means;
• Use for malicious purposes — use the Software for any illegal, fraudulent, or harmful purpose, including to violate the rights of others, to threaten or harm patients, or to circumvent applicable medical device regulations.

Software as a Medical Device (SaMD)

Aikenist QuickSuite products are classified as Software as a Medical Device (SaMD) under applicable medical device regulations. These products have received the following regulatory clearances and certifications:

Certification	Jurisdiction	Details
FDA 510(k)	United States	Class II Medical Device clearance
CDSCO MD-5	India	License No. MFG/MD/2024/000597 — Schedule M III
ISO 13485:2016	International	Medical Device Quality Management System
ISO 14971	International	Medical Device Risk Management
IEC 62304	International	Medical Device Software Lifecycle
HIPAA	United States	Healthcare data privacy compliance
EU GDPR	European Union	General Data Protection Regulation compliance
ANVISA	Brazil	Brazilian regulatory clearance

General Intended Use Statement

Aikenist QuickSuite software products are intended to be used by, or under the direct supervision of, licensed and board-certified healthcare professionals only. The Software is designed as a computer-aided detection and analysis tool to assist qualified radiologists and clinicians in the review and analysis of medical imaging studies.

Specific Clinical Limitations

• The Software's AI models are trained and validated on defined populations and imaging protocols. Performance may vary outside validated parameters, patient demographics, scanner types, or imaging conditions.
• The Software may generate false positive or false negative results. Missed detections (omission errors) and incorrect detections (commission errors) are inherent limitations of all AI-based image analysis systems.
• AI Outputs must always be interpreted in the context of the patient's full clinical history, presenting symptoms, physical examination findings, and other relevant diagnostic information.
• The Software is not validated for use in emergency triage as a standalone decision-making tool. Where the Software provides prioritization or alert features (e.g., stroke detection alerts), these are intended to supplement — not replace — established clinical triage protocols.
• Performance metrics published by Aikenist (e.g., 92% stroke sensitivity, <1 second inference time) are based on multi-centre clinical validation studies under controlled conditions and may not reflect real-world performance in all deployment environments.
• The Software processes only imaging studies that meet specified eligibility criteria (modality, resolution, patient age, body part). Studies that do not meet these criteria may produce unreliable or invalid AI Outputs.

Eligible Input Data Requirements

AI outputs are only reliable for imaging studies meeting the following minimum criteria. The Software should not be applied to studies outside these parameters:

Modality	Parameter	Requirement
Chest X-Ray	Patient Age	6 years and above
Chest X-Ray	Modality	CR / DR / DX only
Chest X-Ray	View	AP or PA projection only
Chest X-Ray	Minimum Resolution	1440 × 1440 pixels
Chest X-Ray	Format	DICOM (.dcm)
Brain CT	Series Type	Non-contrast axial, consistently spaced
Brain CT	Patient Age	Over 18 years
Brain CT	Slice Thickness	Maximum 6mm
MRI (All)	Field Strength	1.5T or 3.0T systems

User Responsibility

You are solely responsible for ensuring that all personnel accessing the Software are appropriately qualified, trained, and licensed to use AI-assisted radiology tools in your jurisdiction. Aikenist specifically disclaims all liability for outcomes arising from use of the Software by unqualified or unlicensed personnel, or from use outside the stated intended use parameters.

Aiken QuickFlow

QuickFlow is a radiology workflow management and RIS (Radiology Information System) platform intended for use by radiology departments, imaging centers, and hospitals to streamline scheduling, patient flow, worklist management, and billing processes. QuickFlow is not a diagnostic tool and does not generate clinical AI outputs. Its workflow automation and notification features are administrative aids and must be overseen by qualified radiology department personnel.

Aiken QuickScan

QuickScan is an AI-based MRI acceleration and CT dose-reduction software intended to reduce scan acquisition time (up to 4× for MRI) and radiation exposure (up to 50% dose reduction for CT) while maintaining diagnostic image quality. QuickScan is intended for use only by licensed radiologists and qualified MRI/CT technicians operating on validated scanner hardware. Image quality adequacy for diagnostic purposes must be confirmed by the responsible radiologist for each study.

Aiken QuickDiag

QuickDiag is a multi-organ AI diagnostic assistance suite providing computer-aided detection and quantitative analysis across the following sub-modules:

• OncoSuite: Tumor detection, segmentation, and RECIST lesion tracking for multi-organ oncology workflows. Intended to assist oncologists and radiologists — not to replace formal oncology assessment.
• StrokeSuite: Acute stroke detection, ASPECTS scoring, hemorrhage identification, and TBI analysis. Clinical sensitivity of approximately 92% in validation studies. Intended to assist in stroke pathway prioritization under direct neurologist or radiologist oversight.
• XraySuite: Chest X-ray analysis for pneumonia, pleural effusion, cardiomegaly, and pulmonary nodule detection. All findings require radiologist verification before clinical reporting.
• Aiken BMD: Automated bone mineral density measurement and T-score reporting from CT images. Results must be interpreted by the responsible radiologist or clinician in the context of the patient's full clinical picture.
• Aiken Adipo: Visceral and subcutaneous fat quantification for metabolic risk stratification. Intended as a quantitative aid — not a standalone clinical assessment.
• Calcium Scoring (CACS): Automated coronary artery calcium scoring with Agatston score calculation. Must be reviewed and reported by a qualified radiologist or cardiologist.

Aiken QuickRad

QuickRad is a cloud-based PACS (Picture Archiving and Communication System) and radiology reporting platform. It provides archiving, viewing, AI-assisted reporting, voice dictation, and teleradiology capabilities. All clinical reports generated through QuickRad must be reviewed, verified, and electronically signed by a licensed radiologist before being issued. The Gen AI reporting feature drafts reports from AI findings and must not be issued without radiologist review and attestation.

Aiken AI Platform

The Aiken AI Platform is a GPU-accelerated compute platform providing 12+ onboard AI models for multi-organ segmentation, 3D reconstruction, volumetric measurement, and image enhancement. All AI outputs are delivered as DICOM SR structured reports and are intended as quantitative aids for the responsible radiologist. No AI output from the Platform should be used for Clinical Decisions without radiologist review and sign-off.

Account Credentials

You are responsible for maintaining the confidentiality of all login credentials, passwords, API keys, and authentication tokens associated with Your account. You must immediately notify Aikenist at contact@aikenist.com upon becoming aware of any unauthorized access or suspected breach of account security.

Authorized Access Only

Access to the Software must be restricted to Users who are: (a) duly authorized by You; (b) appropriately qualified and licensed to perform the functions they are accessing; and (c) bound by confidentiality obligations no less protective than those in this EULA.

Device Security

You represent and warrant that all Devices used to access the Software are:

• Free from known viruses, malware, logic bombs, and unauthorized remote access software;
• Running current, supported operating system versions with security patches applied;
• Protected by appropriate access controls, including password authentication and, where feasible, multi-factor authentication;
• Used only within secure network environments with appropriate firewall and intrusion detection controls.

Audit Logging

Aikenist's Software maintains audit logs of user access, AI inference events, and report generation activities. You consent to such logging for the purposes of license compliance monitoring, security incident investigation, and quality assurance. You shall not disable, tamper with, or circumvent audit logging functionality.

Scan Count Compliance

Where Your Subscription is volume-based (e.g., scan count), Aikenist has the right to access Devices and system logs periodically to verify scan count compliance. You shall cooperate fully with such compliance verification activities.

De-identification Obligation

You are solely and exclusively responsible for de-identifying all Patient Data before it is uploaded to, transmitted to, or processed by Aikenist's cloud infrastructure. Aikenist does not accept, store, or process protected health information (PHI) or personally identifiable patient data on its cloud servers.

On-Premise Deployments

For on-premise deployments within Your facility's own IT infrastructure, Patient Data remains within Your controlled environment and is processed locally. Aikenist staff do not have access to patient-identifiable data in on-premise deployments. You remain responsible for HIPAA, GDPR, and applicable local data protection compliance for all data within Your infrastructure.

DICOM Data Handling

DICOM imaging files processed through the Software are transmitted using encrypted connections. Post-processing, DICOM files are not retained by Aikenist's cloud systems beyond the processing transaction. All AI Outputs are returned to Your PACS or storage system. Aikenist may retain de-identified, aggregated statistical metadata (e.g., scan counts, modality distribution) for quality assurance and product improvement purposes only.

Data Consent

You are solely responsible for obtaining all necessary consents, authorizations, and approvals from patients, research participants, and relevant data owners as required under applicable law before processing any data through the Software.

Privacy Policy

The collection and use of personal data relating to Your Users and account administrators is governed by Aikenist's Privacy Policy, which is incorporated herein by reference. Your Users' data subject rights (access, rectification, erasure, portability) are addressed in full in the Privacy Policy.

Data Processing Agreement

Where Aikenist processes personal data on Your behalf as a data processor (e.g., User account data for EU customers), a Data Processing Agreement (DPA) is available upon request and shall be executed prior to processing. Contact contact@aikenist.com to obtain the DPA.

The Software, including all AI models, algorithms, model weights, training methodologies, source code, object code, user interfaces, Documentation, trade names, trademarks, service marks, logos, and all other intellectual property embodied therein, is and shall remain the exclusive property of Aikenist Technologies Private Limited or its licensors.

Ownership of AI Models

The proprietary AI and deep-learning models embedded in QuickScan, QuickDiag, QuickRad, and the Aiken AI Platform — including all training data, model architectures, weights, and inference pipelines — are trade secrets and proprietary intellectual property of Aikenist. You acquire no rights in or to these models beyond the limited license to use AI Outputs as expressly permitted by this EULA.

Your Data

As between You and Aikenist, You retain all rights in and to the imaging studies and clinical data You submit for processing. By submitting data to the Software, You grant Aikenist a limited, non-exclusive license to process such data solely to provide the Services to You. Aikenist does not claim ownership of Your institutional data.

Feedback

If You provide Aikenist with feedback, suggestions, or error reports regarding the Software ("Feedback"), You hereby assign to Aikenist all right, title, and interest in such Feedback. Aikenist may use Feedback freely without restriction, compensation, or attribution to You.

No IP License Beyond Scope

Nothing in this EULA grants You any right to use Aikenist's trademarks, logos, product names, or corporate identity in any marketing material, publication, or public communication without Aikenist's prior written consent.

Updates and Patches

Aikenist may release updates, patches, hotfixes, and new versions of the Software at any time ("Updates"). Updates may include security fixes, performance improvements, regulatory compliance changes, or corrections to AI model behaviour. You are required to apply Updates within five (5) business days of notification. Aikenist is not responsible for any malfunction, security incident, or adverse outcome that could have been prevented by applying a pending Update.

AI Model Updates

Aikenist may periodically update the AI models embedded in the Software to improve accuracy, expand validated use cases, or address identified clinical limitations. Updated model versions will be communicated through release notes. Where a model update changes clinical performance characteristics, Aikenist will provide at least ten (10) days' prior written notice.

Feature Upgrades

Upgrades that introduce new clinical modules, new AI capabilities, or new product features may be subject to additional licensing fees. Aikenist will notify You in writing of any such additional costs before they take effect. Upgrades to on-premise or offline deployments are provided at Aikenist's sole discretion and may require on-site service engagement.

Discontinuation

Aikenist reserves the right to discontinue any product, module, or feature with a minimum of ninety (90) days' written notice. Aikenist will provide reasonable transition assistance to help You migrate to an alternative module or product where feasible.

Standard Support

Aikenist provides standard technical support to all active Subscribers through the following channels:

• Email: support@aikenist.com
• Phone: +91 7560898983
• Business hours: Monday–Friday, 9:00 AM – 6:00 PM IST (excluding public holidays)

Support Scope

Standard support covers: Software installation and configuration issues, bug reports, general usage questions, integration assistance (DICOM/PACS connectivity), and access issues. Support does not cover issues caused by: unauthorized modification of the Software, use outside the intended use parameters, Customer-side infrastructure failures, or third-party software incompatibilities.

Maintenance Windows

Aikenist performs routine maintenance on cloud-hosted services with advance notice of not less than twenty-four (24) hours for planned maintenance windows. Emergency maintenance may be performed without advance notice where required to address critical security vulnerabilities. Aikenist will make commercially reasonable efforts to minimize downtime during maintenance activities.

On-Premise Support

For on-premise deployments, Aikenist provides remote support only. On-site visits, where required, are subject to separate engagement terms and fees. You are responsible for providing Aikenist personnel with secure remote access to the deployment environment for support purposes.

Third-Party Software

The Software may incorporate third-party software components, libraries, and tools, including proprietary components licensed from third parties and open-source software. Aikenist makes no warranties — express or implied — regarding the accuracy, reliability, security, or fitness for purpose of any third-party component embedded in the Software. Third-party components are used at Aikenist's discretion and are subject to their respective third-party license agreements.

Open-Source Software (OSS)

The Software may include components licensed under open-source licenses (e.g., MIT, Apache 2.0, GPL). Such OSS components are specifically excluded from all warranty and support obligations described in this EULA. Where required by applicable OSS license terms, Aikenist makes the relevant OSS license texts and/or source code available upon written request to contact@aikenist.com.

Cloud Infrastructure Providers

Aikenist's cloud-hosted services are delivered using infrastructure from Amazon Web Services (AWS) and Microsoft Azure, both of which support HIPAA-eligible services and healthcare data compliance programs. Use of these services is subject to their respective terms of service, which operate independently of this EULA.

Third-Party Integrations

The Software supports integration with third-party systems including PACS, RIS, HIMS, and EMR platforms. Aikenist provides standard DICOM and HL7 interfaces for such integrations. Aikenist is not responsible for the availability, performance, or security of third-party systems connected to the Software.

Export Controls

The Software may be subject to export control laws and regulations of India, the United States (EAR/ITAR), and other applicable jurisdictions. You shall not export, re-export, or transfer the Software, or any component thereof, to any country, entity, or individual in violation of applicable export control laws. You represent and warrant that You are not located in, under the control of, or a national or resident of any country subject to applicable trade embargoes, and that You are not on any government list of prohibited or restricted parties.

Medical Device Regulatory Compliance

You are responsible for ensuring that Your use of the Software complies with all applicable medical device regulations in Your jurisdiction, including but not limited to:

• CDSCO guidelines (India) — Medical Devices Rules 2017 and applicable guidance;
• FDA regulations (United States) — 21 CFR Part 820 and applicable SaMD guidance;
• MDR/IVDR (European Union) — Medical Devices Regulation (EU) 2017/745;
• Any local or national medical device registration requirements in Your country of operation.

Where local regulatory registration or approval is required for use of the Software in Your jurisdiction (in addition to Aikenist's existing approvals), You are responsible for obtaining and maintaining such approvals. Aikenist will provide reasonable cooperation and supporting documentation upon written request.

Anti-Corruption

You and Your officers, employees, and agents shall at all times comply with applicable anti-corruption laws, including the Prevention of Corruption Act 1988 (India), the U.S. Foreign Corrupt Practices Act (FCPA), and the UK Bribery Act 2010. You shall not offer, pay, or arrange for payment of any bribe or improper benefit to any public official or third party in connection with Your use of the Software or Your relationship with Aikenist.

THE SOFTWARE IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTY OF ANY KIND. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, AIKENIST EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WITHOUT LIMITATION:

• Any implied warranty of merchantability;
• Any implied warranty of fitness for a particular purpose;
• Any warranty of non-infringement of third-party rights;
• Any warranty that the Software will be uninterrupted, error-free, or secure;
• Any warranty that AI Outputs will be accurate, complete, or clinically correct;
• Any warranty that the Software will detect all pathologies or imaging findings within its scope;
• Any warranty that the Software's performance will meet the specific clinical needs of any individual patient or case;
• Any warranty that defects in the Software will be corrected within any particular timeframe.

Some jurisdictions do not allow the exclusion of implied warranties. To the extent any implied warranty cannot be excluded under applicable law, such warranty is limited in duration to the minimum period permitted by applicable law.

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL AIKENIST, ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, SUPPLIERS, OR LICENSORS BE LIABLE FOR ANY:

• Direct, indirect, incidental, special, punitive, exemplary, or consequential damages of any kind;
• Clinical misdiagnosis, missed diagnosis, or wrong diagnosis arising from reliance on AI Outputs;
• Patient harm or adverse clinical outcomes resulting from use or misuse of the Software or AI Outputs;
• Loss of profits, revenue, business, data, goodwill, or anticipated savings;
• Business interruption caused by Software unavailability, errors, or degraded performance;
• False positive or false negative AI detections (errors of omission or commission);
• Damages arising from unauthorized access to Your account or data due to Your failure to maintain adequate security;
• Any liability arising from Your use of the Software outside its stated intended use, including use by unqualified personnel, processing of data outside validated parameters, or application to patient populations outside the Software's validated scope.

These limitations apply whether the claim arises in contract, tort (including negligence), strict liability, or any other theory of liability, and regardless of whether Aikenist has been advised of the possibility of such damages.

Aggregate Liability Cap

Notwithstanding the foregoing, in jurisdictions where limitation of consequential damages is not fully enforceable, Aikenist's total aggregate liability to You under or in connection with this EULA, regardless of the form of action, shall not exceed the total fees paid by You to Aikenist in the twelve (12) month period immediately preceding the event giving rise to the claim.

You agree to indemnify, defend, and hold harmless Aikenist, its affiliates, officers, directors, employees, and agents from and against any and all claims, damages, losses, liabilities, costs, and expenses (including reasonable attorneys' fees) arising out of or in connection with:

• Your use or misuse of the Software in violation of this EULA;
• Your use of the Software outside its stated intended use parameters or regulatory clearance scope;
• Your failure to de-identify Patient Data before processing through Aikenist's cloud services;
• Any Clinical Decision made in reliance on AI Outputs without appropriate radiologist or clinician review and independent professional judgment;
• Your breach of any representation, warranty, or obligation under this EULA;
• Your violation of any applicable law, regulation, or third-party right in connection with Your use of the Software;
• Any claim by a patient, healthcare authority, or regulatory body arising from Your deployment or use of the Software.

Each party agrees to maintain the confidentiality of the other party's Confidential Information and to use such information only as permitted under this EULA. Confidential Information shall not include information that: (a) is or becomes publicly known through no breach of this EULA; (b) was rightfully known to the receiving party before disclosure; (c) is rightfully received from a third party without restriction; or (d) is independently developed by the receiving party without use of the disclosing party's Confidential Information.

Specific Confidentiality Obligations

You shall not disclose: (a) the Software's underlying technology, AI model architectures, performance benchmarks, or proprietary algorithms; (b) Aikenist's pricing, commercial terms, or business plans; or (c) any non-public information about Aikenist's products, roadmap, or regulatory submissions — to any third party without Aikenist's prior written consent.

Return and Destruction

Upon termination of this EULA, You shall promptly return or destroy all Confidential Information of Aikenist in Your possession within seven (7) calendar days and provide written certification of such destruction upon request.

Injunctive Relief

You acknowledge that breach of the confidentiality obligations in this section would cause irreparable harm to Aikenist that cannot adequately be compensated by monetary damages. Aikenist shall be entitled to seek injunctive or other equitable relief without the necessity of proving actual damages or posting bond.

Neither party shall be liable for any delay or failure in performance under this EULA to the extent such delay or failure is caused by circumstances beyond that party's reasonable control, including but not limited to: acts of God, natural disasters, pandemics, epidemics, war, terrorism, civil disturbance, government action, cyberattacks originating from nation-state actors, Internet infrastructure failures, or failure of third-party cloud infrastructure providers (e.g., AWS, Microsoft Azure).

The party affected by a force majeure event shall: (a) promptly notify the other party in writing; (b) use commercially reasonable efforts to mitigate the effects of and overcome the force majeure event; and (c) resume performance as soon as reasonably practicable. If a force majeure event prevents performance for more than sixty (60) consecutive days, either party may terminate the relevant Subscription upon written notice without penalty, and Aikenist will issue a pro-rated refund for any prepaid, unused portion of the affected Subscription term.

Term

This EULA is effective from the date You first access or use the Software and remains in effect for the duration of Your active Subscription, unless earlier terminated in accordance with this section.

Termination by You

You may terminate Your Subscription and this EULA by following the cancellation procedure described in Aikenist's Cancellation & Refund Policy. Cancellation requires a minimum of thirty (30) days' written notice to contact@aikenist.com.

Termination by Aikenist

Aikenist may terminate this EULA immediately upon written notice if You:

• Materially breach any provision of this EULA and fail to cure such breach within fourteen (14) days of written notice;
• Become insolvent, make an assignment for the benefit of creditors, or become subject to bankruptcy, liquidation, or similar proceedings;
• Use the Software in a manner that poses a risk to patient safety, clinical outcomes, or public health;
• Violate any applicable law, regulation, or medical device regulatory requirement in connection with Your use of the Software;
• Fail to pay any amounts due under this EULA or the applicable payment terms for more than thirty (30) days after the due date.

Effect of Termination

Upon termination of this EULA for any reason: (a) all licenses granted to You hereunder immediately cease; (b) You must uninstall and delete all copies of the Software from Your Devices; (c) You must return all Aikenist-owned hardware Devices within thirty (30) days; (d) Aikenist will provide a data export window of thirty (30) days for You to retrieve Your data. Sections 9 (Data), 10 (IP), 15 (Warranty Disclaimer), 16 (Liability), 17 (Indemnification), 18 (Confidentiality), and 21 (Governing Law) shall survive termination of this EULA.

Governing Law

This EULA and any dispute arising out of or in connection with it shall be governed by and construed in accordance with the laws of India, without regard to its conflict of law principles.

Dispute Resolution

The parties shall attempt to resolve any dispute arising under this EULA through good-faith negotiation for a period of thirty (30) days following written notice of the dispute. If the dispute cannot be resolved through negotiation, it shall be submitted to mediation before a mutually agreed mediator. If mediation fails within sixty (60) days, the dispute shall be finally resolved by binding arbitration conducted in accordance with the rules of the Mumbai Centre for International Arbitration (MCIA). The seat and venue of arbitration shall be Mumbai, India. The language of the proceedings shall be English. The arbitral award shall be final and binding on both parties.

Class Action Waiver

Any claim brought by You or Your Users against Aikenist shall be on an individual basis only. You waive any right to bring or participate in any class action, collective, representative, or multi-plaintiff proceeding against Aikenist.

Jurisdiction for Interim Relief

Notwithstanding the above, either party may seek interim or emergency injunctive relief in the courts of Mumbai to prevent irreparable harm pending the outcome of arbitration, particularly with respect to intellectual property violations or confidentiality breaches.

Entire Agreement

This EULA, together with the Universal Terms, Privacy Policy, Payment Terms, Cancellation & Refund Policy, and any applicable order form or service agreement, constitutes the entire agreement between You and Aikenist with respect to the Software and supersedes all prior discussions, representations, and agreements.

Amendment

Aikenist may amend this EULA from time to time. Material changes will be communicated by email to Your registered account address and/or by notice through the Software at least ten (10) days prior to the effective date. Your continued use of the Software after such notice constitutes acceptance of the amended EULA.

Assignment

You may not assign this EULA or any of Your rights or obligations hereunder without Aikenist's prior written consent. Aikenist may assign this EULA freely, including in connection with a merger, acquisition, or sale of all or substantially all of its assets, without requiring Your consent.

Severability

If any provision of this EULA is held invalid, illegal, or unenforceable by a court of competent jurisdiction, such provision shall be modified to the minimum extent necessary to make it enforceable, and the remaining provisions shall continue in full force and effect.

No Waiver

Failure by either party to exercise or enforce any right or remedy under this EULA shall not constitute a waiver of such right or remedy. Any waiver must be in writing to be effective.

Relationship of the Parties

The parties are independent contractors. This EULA does not create any partnership, franchise, joint venture, employment, or agency relationship between the parties.

Notices

All formal notices under this EULA shall be in writing and delivered by email with read-receipt confirmation or by nationally recognized overnight courier to:

• Aikenist: 7th Floor, Oberoi Commerz-II, International Business Park, Goregaon East, Mumbai, Maharashtra 400063, India — contact@aikenist.com
• You: The address and email specified in Your account registration or service agreement.

Publicity

You grant Aikenist the right to identify You as a customer on Aikenist's website and in marketing materials, and to reference Your use of the Software in anonymized or with-permission case studies. If You wish to opt out of this publicity right, notify Aikenist in writing at contact@aikenist.com.

Applicable Regulatory Standards

This EULA and the Software have been developed in accordance with IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Medical Device Risk Management), ISO 13485:2016 (Medical Device Quality Management), and applicable FDA and CDSCO guidance on Software as a Medical Device (SaMD).

Last updated: May 2025  |  Version: 1.0