Applicable to Non-U.S. Customers
1 Definitions and Interpretation
1.1 For purposes of this Agreement the following terms shall have the following meanings:
“Acceptance Criteria” have the meaning given in Section 13.10;
“Administrator Permissions” mean permissions given by the Customer to certain User allowing such User to set up and administrate access and permission management, security settings and perform similar administrative actions in relation to the Services provided to the Customer.
“Affiliates” mean an entity that owns or controls, is owned or controlled by or is under common control or ownership with a party, where control is defined as the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of an entity, whether through ownership of voting securities, by contract or otherwise;
“Agreement” means any Order Form together with these Terms and with all and any schedules and exhibits attached to the Order Form;
“Agreement Term” has the meaning given in Section 14.1 hereof,
“Agreement Effective Date” means the Order Form Effective Date on the signed Order Form referencing these Terms ;
“Application” means the PM’s mobile application connected to the Modules that may be used by Users, among other things, for upload of ECG images, view of interpretation results as well as other functionality that may become available;
“Billing Period” means a period set forth in the Order Form, with the first Billing Period starting on the Commencement Date;
“Claim” has the meaning given in Section 17.1;
“Commencement Date” means the commencement date stipulated in the Order From as of which the Services represented in that Order Form are being provided;
“Consultant” has the meaning given in Section 13.5;
“Content” has the meaning given in Section 5.4;
“Data Processing Agreement” of “DPA” means an agreement that Customer and PM in relation to processing of personal data;
“Deliverables” have the meaning given in Section 14.4;
“Dispute” has the meaning given in 1.7;
“Documentation” means user guides, Instructions for Use, technical documentation, and FAQs designed for some or all of the Services as provided to the Customer or published by PM on its website;
“ECG” means electrocardiogram – the result of a cardiovascular test that measures electrical activity of the heart;
“EULA” means end user license agreement between PM and Users concluded for the purposes of provision of the Subscription Services;
“Feedback” has the meaning given in Section 10.5 hereof;
“Fees” have the meaning given in Section 2.1.2 hereof;
“Force Majeure Event” has the meaning given in Section 16.2 hereof;
“HP User” means a User that is a healthcare professional with basic knowledge of ECG interpretation;
“Instructions for Use” mean the respective version of the instructions for use of applicable Modules available online at https://powerfulmedical.com/pmcardio-org-ifu/. Instructions for Use form an integral part of this Agreement;
“Investigational Use” means a use of the Services for purposes other than clinical diagnosis, patient management, or an investigation that is not exempt under the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices or any other purpose limited to a medical device;
“License” has the meaning given in Section 8.2 hereof;
“Medical Device Module” means a Module that is a registered medical device that has been cleared by the European Medicines Agency or another applicable authority to be marketed (for commercial purposes) within the Territory and may be used only by HP Users;
“Module” means the underlying technology package forming part of the Subscription Services. Respective Modules may, among other things, provide ECG processing, analysis and detection of certain indications, as well as other functionality that may become available;
“On-demand Services” mean additional services, other than the Subscription Services, such as consulting services, setup, technical implementation, dedicated support, dedicated consultant or similar;
“Order Form” has the meaning given in Section 2.1.1 hereof;
“Order Form Effective Date” means the effective date stipulated in the respective Order From;
“Order Form Term” means the initial term and the renewal term as stipulated in the Order Form starting as of Order Form Effective Date;
“Other Module” is any Module other than Medical Device Module or Research Module;
“Privacy Policy” means the privacy policy informing the Customer and its Users as the relevant data subjects about the processing of data and personal data in relation to the Subscription Services and their respective rights and available at https://www.powerfulmedical.com/legal/general-privacy/;
“Report” means the result of ECG digitization and interpretation consisting of diagnosis and patient management recommendations, which may be created through the Subscription Services and can be managed through the Web Platform;
“Research Module” means a Module that is for Investigational Use only and may be used only by HP Users;
“Services” mean Subscription Services and On-demand Services;
“Service Account” means Customer’s account that will be used for managing API (Application Programming Interface) access and integrations by utilization of which Customer can access the Modules;
“Site” means a specific hospital or similar site set forth in the Order Form where the Subscription Services may be used;
“SLA” means a service level agreement which might be provided by PM to the Customer for the Services;
“Subscription” means a subscription plan stipulated in the Order Form for Users to access and use of the Subscription Services;
“Subscription Services” mean the Modules provided by PM to the Customer via Web Platform, Application and/or through Service Account;
“Territory” means the geographical territory set forth in the Order Form on which the Services are being provided to the Customer;
“Usage Allowances” means any limitations that Services are or may be subject to, including, but not limited to the number of Users or specific sites set forth in the Order Form;
“User” means any individual who has access to the Subscription Services based on the License purchased by the Customer as part of the Subscription;
“Web Platform” means the web application interface connected to the Modules which the Customer and Users may use for viewing of interpretation results, User administration, Service Account administration, and general account administration.
1.2 A statutory provision includes a reference to the statutory provision as modified or re-enacted from time to time, and any subordinate legislation made pursuant to the statutory provision, in each case whether before or after the Agreement Effective Date.
1.3 Any reference to persons or entities includes a reference to natural persons, any corporate body, unincorporated association, trust, partnership, or other entity or organization, and includes a reference to that person’s or entity’s successors or assigns.
1.4 The schedules to the Order Form form an integral part of this Agreement and have effect as if set out in full in the main body of this Agreement.
1.5 Unless the context requires otherwise, the singular includes the plural and vice versa. The headings in this Agreement shall not affect the interpretation of this Agreement. Any reference to the term “including” shall be deemed to mean “including without limitation”. Any reference to the term “execution” shall include execution by electronic signature.
2 Subject of the Agreement
2.1 The subject of this Agreement is to specify the rights and obligations of the Parties in relation to the following:
2.1.1 The obligation of PM to provide Services listed in and based on the applicable order form agreed between the Parties specifying the scope of the provided Services and referencing these Terms (the “Order Form”). To the extent there are any terms in the Order Form that are contradictory to the terms of these Terms, terms of the Order Form, shall prevail and govern.
2.1.2 The obligation of the Customer to pay to PM fees for the provided Services in accordance with Section 4 of this Agreement and the Order Form (the “Fees”).
3 Obligations of Customer
3.1 The Customer acknowledges and agrees that:
3.1.1 The Customer shall use the Services exclusively in accordance with this Agreement, Documentation and any applicable laws and regulations.
3.1.2 The Customer is fully and exclusively responsible for using the Services and for any consequences resulting from such use. The Customer must ensure that each User acts in full compliance with this Agreement.
3.1.3 The Customer shall provide the necessary cooperation that PM may require to carry out its obligations. Such cooperation may include provision of timely and accurate information and documentation and making available to PM all equipment, material, information, data, network access, or facilities that PM may reasonably require to carry out its obligations. The Customer acknowledges that any delay on its part in the performance of its obligations may have an impact on PM’s performance of its activities under the Agreement, and PM shall not be liable for any delay caused by Customer’s failure to fulfil any of its requirements under the Agreement.
4 Fees
4.1 Customer undertakes to duly and timely pay PM the Fees for provision of the Services based on price list included in the Order Form. All pre-paid Fees are non-refundable.
4.2 PM shall issue electronic invoice to the Customer for payment of Fees within 14 calendar days from the start of applicable Billing Period. Unless otherwise stipulated in the Order Form, the invoices shall be due within fourteen (14) calendar days from the delivery of the invoice to the Customer. The invoice shall meet all the requirements of legal regulations applicable to PM on its issuance, in particular it must contain all the requirements of an accounting tax document. Electronic invoices will be sent to the Customer billing e-mail address set forth in the Order Form.
4.3 If any undisputed Fee under this Agreement is not paid when due, then PM is entitled to payment of interest from the due date until payment is made in full, at 12% (twelve per cent) per annum.
4.4 Fees are exclusive of all taxes or duties that PM may be required to collect or pay in relation to delivery of the Services (other than taxes levied on PM’s income). Customer agrees to pay such taxes or duties unless the Customer is exempt from such taxes or duties. Where applicable, Customer will provide PM with an exemption resale certificate.
5 Users and Use of the Subscription Services
5.1 The Customer acknowledges, shall secure and is responsible for the following:
5.1.1 To use the Subscription Services, each User must have an account. To create such account, certain details must be provided. In setting up the accounts, Customer shall truthfully provide all required information. Each HP User must be a healthcare professional authorized to provide healthcare in the country and state where the HP User uses Medical Device Modules and Research Modules. The HP User must follow all regulatory requirements imposed on healthcare professionals by that country and state (including continuing medical education as applicable) and meet any other criteria set forth by the Instructions for Use. Users who are not healthcare professionals are not authorized to use Medical Device Modules and Research Modules regardless of the fact if such Modules are for the Investigational Use only.
5.1.2 Users must be either invited or approved by the Customer in order to access the Subscription Services.
5.1.3 Users shall at all times protect their login credentials. Users are not allowed to log in using login credentials of other Users, nor are they allowed to obtain or collect login credentials of other Users.
5.1.4 Users must not use the Subscription Services in life supporting or sustaining systems, nor in ECG-monitoring and/or alarm devices.
5.1.5 Users must use the Subscription Services in compliance with the Instructions for Use.
5.1.6 Wherever any part of the Subscription Services or its interface is labelled “investigational use only” or similar on the user interface, User may use such part of the Subscription Services strictly only for Investigational Use.
5.1.7 Users will at all times adhere to the EULA. No User may use Subscription Services before accepting the EULA.
5.2 The Customer must provide at least one User with Administrator Permissions. Such Users shall be responsible for access and permission management, security settings and performance of similar administrative actions in relation to the Subscription Services.
5.3 The Customer is solely responsible for configuring any security settings and similar settings in relation to Subscription Services correctly.
5.4 Content. During use of the Subscription Services the Users will enter into the Services various information including upload of files (the “Content”). PM does not control, verify, monitor or endorse the Content that Users put on the Subscription Services. The Customer and/or Users, as applicable under EULA, shall be responsible for: (a) all Content Users place in or share through the Subscription Services and (b) making sure that the Customer and Users have all the rights needed to the Content. In addition, Customer shall secure that by storing, using or transmitting Content Users will not violate any law or the EULA or any rights of a third party.
5.5 The Customer acknowledges that Users may receive notifications from PM about new features or improvements to the Services directly via the Subscription Services.
5.6 The Customer is responsible and liable for actions or omissions of its Users in connections of their use of the Subscription Services.
6 Restrictions
6.1 The Customer will not disrupt or damage the operation of the Services (or attempt to do so), violate rights of third parties, or conduct any activities that may be considered unethical, illegal or contrary to good faith.
6.2 The Customer shall not (and shall not authorize any third party to): (a) modify, translate, reverse engineer, decompile, disassemble, or create any derivative works based on the Services, except to the extent that enforcement of the foregoing restrictions is prohibited by applicable legislation; (b) circumvent any user limits, Usage Allowances, or other timing, use, or functionality restrictions built into the Services; (c) remove any proprietary notices, labels, or marks from the Services; (d) frame or mirror any content forming part of the Services; (e) access the Services in order to (i) build a competitive product or service, or (ii) copy any ideas, modules, functions, or graphics of the Services; (f) use PM’s intellectual property rights (or any related or similar logos or trademarks of PM) for its benefit or (g) use the Services in a way that is prohibited by the Instructions for Use. Moreover, specifically in relation to the Service Account, Customer will not (i) “frame,” distribute, resell, or permit access to the APIs by any third party other than as allowed by the features and functionality of the Subscription Services; (ii) interfere with, disrupt, or gain unauthorized access to the Service Account or API keys; (iii) transfer to the Service Account or API or otherwise use on the API any code, exploit, or undisclosed feature that is designed to delete, disable, deactivate, interfere with or otherwise harm or provide unauthorized access to the Service Account or API.
6.3 The Customer will not make any fully automated decisions on the basis of information provided by PM during or based on the use of the Services and must always ensure appropriate human intervention by User review and verification before using such information for any purpose.
6.4 Usage Allowances. The Customer shall use the Services within the Usage Allowances set forth in the Order Form. Any warranties, including any warranties related to performance of the Services or any SLAs (if agreed), provided by PM in the Agreement shall be subject to the Customer’s compliance with the Usage Allowances and Instructions for Use.
7 Rights of PM
7.1 PM is under no circumstances responsible for the use of the Services by the Customer including the use of the Services by its Users, or consequences of such use, other than for liability set out in applicable mandatory law.
7.2 PM is entitled to change the scope of the Subscription Services unless such change would result in a substantial decrease in the quality of the Subscription Services. In such case, the Customer is not entitled to demand any compensation for damage or other compensation, unless stated otherwise herein.
7.3 If PM determines that the use of the Services by the Customer, i.e. by any Users covered by the Subscription, is in violation of this Agreement or applicable law, PM may, at its discretion, without affecting any its rights relating to the termination hereof, cancel the account of the Customer, temporarily or permanently block the access to the Services of the Customer and/or its respective Users.
7.4 The Customer acknowledges that PM may review each User´s registration to determine such User´s compliance with conditions set out in Section 5, in particular Section 5.1.2.
8 Intellectual property
8.1 The Services are subject to intellectual property rights of PM. PM shall retain all rights, including but not limited to all patent rights, trademark rights, copyright, trade secrets, and any other intellectual property rights, in and to the Services, Documentation, and any underlying structure, schema, functions, methods of operation, and ideas relating to the Services that are being developed, and any algorithms, derivative works, or any modifications, corrections, improvements, or extensions to the Services. The Customer will not obtain any further rights other than are explicitly granted to the Customer under this Agreement.
8.2 PM grants, as of the date Customer receives access to the Subscription Services, the Customer and, subject to their entry into and acceptance of the applicable EULA, its Users, in each case subject to Usage Allowances and other limitations of the Subscription, a non-exclusive, non-transferable, non-sublicensable, revocable license to use the Subscription Services in accordance with and for the purposes set forth in this Agreement (the “License”). The License is granted for the term of the Subscription i.e. for the Order Form Term or for as long as Customer duly pays all the Fees according to the Order Form and complies with the terms set forth herein.
9 Confidentiality
9.1 The following information is considered as confidential (the “Confidential Information”):
9.1.1 either Party’s trade secrets, know-how, procedures, ideas, proposals, proprietary technologies and techniques, details of the internal structure and personnel, information about prices and their calculation and all related information made available or disclosed, whether orally, in writing, in the form of an electronic document, visual or audio recording or by any other means;
9.1.2 information of a technical, economic and commercial character, information about products and/or related documentation and manuals, including their content, any information about research and development, including research and development plans, business and development plans, business and product marketing plans, past and present economic results, forecasts and estimates of economic results, budgets and other economic data, as well as any future strategies of PM made available or disclosed, whether orally, in writing, in the form of an electronic document, visual or audio recording or by any other means;
9.1.3 the existence and content of any discussions relating to the subject matter of hereof, unless agreed otherwise;
9.1.4 any information designated by PM as confidential regardless of the form of such designation; and
9.1.5 any notes, records or copies relating to information referred to in 9.1.1 to 9.1.4 above made by one of the Parties or one of their personnel.
9.2 Parties may provide each other with the Confidential Information. The Confidential Information made available shall be used solely for the purpose for which it was provided.
9.3 Notwithstanding Section 9.1 the information shall not be considered to be Confidential Information if it (a) is or becomes generally available to the public through no breach of this Agreement, (b) was in receiving Party’s possession or known by it prior to receipt from the disclosing Party, (c) was rightfully disclosed to either Party without restriction by a third party, (d) was independently developed without the use of any Confidential Information of other Party or (e) is required by law to be disclosed, provided that the receiving Party first provides the disclosing Party with reasonable prior notice and obtains, or provides disclosing Party with an opportunity to obtain, a protective order or confidential treatment of the Confidential Information. Notwithstanding anything to the contrary in this Agreement, the receiving Party may disclose the Confidential Information of the disclosing Party to the extent required by an information disclosure request made under applicable law, provided that the receiving Party promptly notifies the disclosing Party of the information disclosure request before disclosing the Confidential Information and comply with disclosing Party’s reasonable requests regarding its efforts to oppose the disclosure. Notwithstanding the foregoing, the receiving Party is not obliged to notify the disclosing Party of the information disclosure request if it would result in a violation of applicable law by the receiving Party.
9.4 Confidential Information that are being disclosed must be kept confidential by the receiving Party and must not be disclosed to any third parties and persons, unless agreed otherwise by the Parties or as provided in this Agreement. The receiving Party undertakes to ensure the confidentiality and protection of Confidential Information against access by unauthorized persons, and to notify the disclosing Party without undue delay of a suspicion of breach of this Section 9.
9.5 It is understood and agreed that in the event of a breach of this Section 9, damages may not be an adequate remedy and the disclosing Party shall be entitled to specific performance, injunctive relief as well as all other rights and remedies that the disclosing Party may have to restrain any such threatened or actual breach.
9.6 Either Party shall return and/or destroy the Confidential Information of the other Party upon termination or expiration of this Agreement or the Order Form. If the Confidential Information are on material documents, the receiving Party is obliged to return them physically. In the event that the Confidential Information is stored in electronic form, the receiving Party is obliged to securely delete all Confidential Information stored in electronic form and destroy any media to the extent it contains such Confidential Information subject to the restrictions imposed by mandatory applicable law. The Parties are obliged to provide each other, upon request, a written certification of deletion and destruction. The Customer further undertakes to return all Confidential Information provided, at any time upon disclosing Party’s request. However, if such request for return is not accompanied by a termination of the Agreement or is made after this Agreement has already expired, the Customer is obliged to return the requested Confidential Information only to the extent such return will not affect the provision of the Services.
9.7 All Confidential Information belonging to each Party will remain the sole property of and available to that party and the recipient does not acquire any rights related to the Confidential Information upon their provision, unless otherwise provided in this Agreement.
10 Data
10.1 The Parties understand that all processing of personal data in relation to this Agreement shall be in compliance with all applicable data protection legislation and the Privacy Policy.
10.2 Patient Data. The Parties acknowledge that no personal identifiable information or protected health information data of Customer’s patients shall be processed as part of the Services, unless the Parties agree otherwise and conclude a DPA before such processing takes place. It is the Customer’s responsibility to initiate entering a DPA.
10.3 Customer Representation. Customer represents and warrants that it owns or has obtained all rights, consents, permissions, waivers, or licenses necessary to allow PM’s access to, possession of, manipulation of, and use of the Customer’s data as contemplated or permitted hereunder.
10.4 Continuous Improvement of Services. Notwithstanding anything to the contrary in the Agreement, PM shall have the right to collect and analyze any de-identified, aggregate or anonymized data (including personal data which does no longer allow an identification of the individual, including a patient) derived from the Customer’s data and other information relating to the provision, use and performance of various aspects of the Services and related systems and technologies, and PM will be free to (i) use such information and data to improve and enhance the Services and other PM’s offerings (or offering of its Affiliates) and all their capabilities, performance and effectiveness, (ii) use such information and data for its general research and development as well as scientific research purposes, and (iii) make such data available in the aggregated and anonymized form via anonymized industry standard trends.
10.5 Customer Feedback. If the Customer (or its Users) provides PM with any reports of defects and/or suggests modifications (the “Feedback”), PM shall have the right to use such Feedback, including incorporating the Feedback into its Services or other services or products, without any obligation to the Customer or any User.
10.6 Usage Data. The Customer acknowledges and agrees that provision of the Services involves, and the Customer authorizes PM to: (a) collect usage data in connection with Customer’s (and its Users’) use of the Services; (b) conduct Customer (and User) satisfaction surveys; and (c) use usage data, Customer satisfaction data and Feedback in connection with providing, analyzing, and improving the Services.
10.7 Return of data. Upon the request of the Customer that is made (i) any time during the Term, or (ii) within thirty (30) calendar days after the effective date of termination or the expiration of the Agreement, PM will make Customer’s data available to the Customer in a file for download in industry acceptable format. After such thirty (30) day period, PM shall have no obligation to maintain or provide any such Customer’s data and may thereafter, unless and to the extent legally prohibited from doing so, delete all Customer’s data in PM’s systems, under PM’s control or otherwise in PM’s possession. Upon instruction of the Customer, PM shall, within commercially reasonable time, unless and to the extent legally prohibited from doing so and subject to its internal data retention practices, delete all Customer’s data in PM’s system, which were requested by the Customer, in accordance with applicable law. For the avoidance of doubt, the Customer acknowledges that this clause shall not apply to the following: (a) data in audit logs; (b) de-identified or anonymized data under Section 10.4 hereof; (c) usage data, Customer satisfaction data and Feedback under Section 10.6 hereof; (d) other aggregated data; and (e) other data stored for statistical purposes.
10.8 Data Backups. The Subscription Services are not intended to, and will not, operate as a data storage or archiving service and the Customer agrees not to rely on the Subscription Services for the storage of any of its data. The Customer is solely responsible for the maintenance and backup of its data with the sole exception of backup features set forth by internal backup policies and processes of PM solely for disaster recovery purposes.
11 Warranty and Representations
11.1 Customer represents, covenants, and warrants that the Customer will use (and will cause its Users to use) the Services in compliance with the applicable law and this Agreement. PM warrants that any Services shall be provided (i) in a competent and workmanlike manner (ii) in accordance with relevant industry standards and laws applicable to PM, and (iii) in accordance with the terms of the Agreement.
11.2 Except as provided herein, or in the applicable SLA, PM MAKES NO EXPRESS REPRESENTATIONS OR WARRANTIES WITH REGARDS TO THE SERVICES, DOCUMENTATION, CONSULTATION, OR ANY CONTENT. PM does not warrant that the Services will be uninterrupted or error free; nor does it make any warranty as to the results that may be obtained from use of the Services. THE SERVICES ARE PROVIDED “AS IS” AND “AS AVAILABLE” AND PM DISCLAIMS ALL STATUTORY OR OTHERWISE CONDITIONS, REPRESENTATIONS, AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. PM IS NOT ENGAGED IN THE PROVISION OF HEALTHCARE NOR PRACTICE OF LAW. ANY STATEMENTS OR ASSISTANCE PM PROVIDES SHOULD BE INTERPRETED AS OPINIONS OR ADVICE CONCERNING ISSUES TO BE CONSIDERED IN CONNECTION WITH THE SERVICES. CUSTOMER ACKNOWLEDGES THAT NEITHER PM NOR ITS THIRD-PARTY PROVIDERS CONTROLS THE TRANSFER OF DATA OVER THE INTERNET, AND THAT THE SERVICES MAY BE SUBJECT TO LIMITATIONS, DELAYS, AND OTHER PROBLEMS INHERENT IN THE USE OF THE INTERNET. PM IS NOT RESPONSIBLE FOR ANY DELAYS, DELIVERY FAILURES OR OTHER DAMAGE RESULTING FROM SUCH PROBLEMS. PM makes no warranty regarding the quality, accuracy, timeliness, truthfulness, completeness, or reliability of the products and services provided under the Services, Documentation, or any content of PM.
11.3 Third-Party Services. The Services may be integrated with third-party applications and services (“Third Party Services”). Customer’s access to and use of any Third Party Services, if any, including any goods, software, services or information made available from those Third Party Services, is governed by the terms and conditions applicable to those Third Party Services. Third Party Services are not owned or operated by PM in any way. THE CUSTOMER SHALL USE THIRD PARTY SERVICES AT ITS OWN RISK. PM MAKES NO WARRANTIES, CONDITIONS, INDEMNITIES, REPRESENTATIONS OR TERMS, EXPRESS OR IMPLIED, WHETHER BY STATUTE, COMMON LAW, EQUITY, CUSTOM, USAGE OR OTHERWISE AS TO ANY OTHER MATTERS, INCLUDING BUT NOT LIMITED TO NON-INFRINGEMENT OF THIRD PARTY RIGHTS, TITLE, INTEGRATION, ACCURACY, SECURITY, AVAILABILITY, SATISFACTORY QUALITY, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE WITH RESPECT TO THE THIRD PARTY SERVICES. PM may share some information, in some instances including personal data, with the Third Party Services providers and such Third Party Services providers may share similar information with PM in extent necessary to provide the Services.
11.4 The Customer specifically acknowledges and agrees that the functionality of the Subscription Services including its medical device components may be subject to errors. The Customer or the User as a healthcare professional, as applicable in the specific case, are solely responsible for their patient’s treatment. When providing treatment to a patient, the User must not solely rely on the Services, but must act with due care and evaluate the overall clinical condition of their patient, including taking into account factors which may not be incorporated within the Services (including but not limited to the patient’s condition on visual examination or the results of other examinations).
11.5 The Customer acknowledges that the Services or its parts can only be used in countries where these meet regulatory requirements for being placed on the market.
11.6 PM may pause access to the Services for a limited period of time to make necessary updates, maintenance and changes to the Services without Customer’s consent. PM shall make reasonable efforts to notify the Customer of such pause of access reasonably in advance. PM undertakes, subject to this Agreement, to make the Services available to the extent required to ensure that its performance, safety and reliability is in line with its intended use.
11.7 Provided the Parties entered into the SLA, the terms and conditions of the SLA shall prevail over Sections 11.1 and 11.2 hereof to the extent such terms are contradictory.
11.8 Each Party represents and warrants to the other Party that: (a) such Party is duly incorporated and validly existing under the laws of the jurisdiction of its incorporation; (b) the execution, delivery and performance of the Agreement constitutes the legal, valid and binding obligation of such Party; and (c) such Party has all requisite corporate power and financial capacity, and authority to execute, deliver, and perform its obligations under the Agreement.
12 System Requirements
12.1 To use the Application, the Customer and each User must have appropriate internet access and a compatible mobile phone or handheld mobile device.
12.2 The version of the Services software may be upgraded from time to time to add support for new functionality and services, to improve user experience, or to remove bugs or certain features.
12.3 To use the Web Platform, the Customer must have a device with appropriate internet access and a compatible web browser.
12.4 To use the Service Account, the Customer must have a system allowing for utilization of API and have it correctly set up to allow the necessary flow of relevant data.
13 Regulatory
13.1 PM will be solely responsible for the preparation, submission and maintenance of all regulatory filings and obtaining all regulatory clearances or approvals with respect to the Medical Device Module. PM will own all right, title and interest in and to any and all regulatory filings and regulatory clearances or approvals directed to the Medical Device Module and all related documentation. Customer will cooperate with PM, at its reasonable request, with respect to any safety or regulatory matters related to the Medical Device Module or the Services.
14 On-demand Services
14.1 Applicability. This Section 14 shall apply exclusively for the provision of the On-demand Services. Should provisions of this Section contradict any other provisions of these Terms, the provisions of this Section shall prevail exclusively in relation to On-demand Services.
14.2 Ordering On-demand Services. Any On-demand Services (including any Deliverables) to be provided by PM to the Customer must be agreed to by both Parties in writing.
14.3 Types of On-Demand Services. PM may provide the Customer in particular, but not exclusively, with the following On-Demand Services: consulting services, setup, technical implementation, dedicated support, dedicated consultant, and other services specified in the Order Form.
14.4 PM shall provide the On-demand Services and develop any related deliverables described in the respective Agreement (the “Deliverables”). PM shall provide these On-demand Services in a reasonable, professional manner in keeping with professional standards and practices. PM shall be entitled to, at its sole discretion, determine the methods and means for performing the On-demand Services and developing Deliverables.
14.5 Consultants. The Customer acknowledges and agrees that PM may utilize the services of independent consultants and third-party contractors (the “Consultants”) from time to time to perform, or to assist PM in performing the On-demand Services and develop the Deliverables. Personnel of PM and of the Consultants shall remain under the control of PM and PM’s remains liable, subject to limitations stipulated herein, for their performance of On-demand Service.
14.6 Cooperation. The Customer acknowledges and agrees that performance of the On-demand Services is heavily dependent on the information and responses to be provided by the Customer. Accordingly, Section 3.1.3 hereof shall apply to On-demand Services.
14.7 Fees and Payment for On-demand Services. The Customer shall pay the Fees for On-Demand Services as agreed in the Order Form. The Parties acknowledge that any prepaid On-demand Services shall not be repaid, even if not utilized by the Customer. The Customer shall reimburse PM for all reasonable out-of-pocket expenses incurred by PM in the performance of the On-demand Services, provided that such expenses are approved by the Customer.
14.8 Termination. If the Customer terminates the Agreement, the Customer shall pay PM the full Fee for On-demand Services performed (including all other costs for which PM has the right to reimbursement) up to the effective date of the termination of the Agreement; provided that if the Fee for Deliverables are based on identified milestones being achieved by PM, the Customer shall pay the pro-rated Fee for the next scheduled milestone with such pro-rated fee to be determined based on the percentage of time between the commencement of work on such milestone and the effective date of termination.
14.9 Intellectual Property Rights. PM shall own all right, title and interest to all Deliverables. PM shall retain all right, title and interest to all of PM’s proprietary information and software (including but not limited to any modifications to the Services). Subject to the payment of the applicable Fees set forth in the Agreement, PM grants to the Customer a worldwide, fully-paid up (such payment is already included in the Fees), non-exclusive, non-transferable license to use the Deliverables for the intended purposes.
14.10 Acceptance and Takeover. Takeover of the On-demand Services by the Customer shall follow the acceptance procedure. The acceptance procedure involves comparing the basic properties of the respective On-demand Services with the criteria specified in the Order Form (the “Acceptance Criteria“). If no such Acceptance Criteria are agreed, then the respective On-demand Services are deemed to be accepted by the Customer immediately following their delivery. If the On-demand Services do not satisfy the Acceptance Criteria, then: (a) the Customer shall itemize in writing each failure to satisfy the Acceptance Criteria no more than five (5) Business Days after delivery of such On-demand Services or their part (otherwise such On-demand Services are deemed to be accepted by the Customer) specifying at least the following elements: (i) the name of the output (whether Deliverables or otherwise) to which the comment applies; (ii) proposed corrections specific enough to be able to incorporate them within such On-demand Services; (b) PM shall use its best efforts to correct the On-demand Services and to deliver the On-demand Services to the Customer for re-testing and acceptance; and (c) the acceptance period shall be halted while PM is working on the corrections to the On-demand Services as part of the acceptance procedure. The period shall continue after the failure specified by Customer is corrected by PM. For the avoidance of doubt, (i) if at any time the Customer commences with the live operation of the whole or any part of the respective On-demand Services, then Customer shall be deemed to have accepted such On-demand Services; and (ii) any shortcomings that have no material effect on the standard functionality of the On-demand Services do not impede the delivery thereof and the deemed acceptance of the On-demand Services.
15 Term and Termination
15.1 Agreement Term. This Agreement shall commence on the Agreement Effective Date and shall remain in effect until expired or terminated in accordance with Section 15.2 (“Agreement Term”).
15.2 Termination For Cause. In addition to any other remedies it may have, either Party may terminate this Agreement and the underlying Order Form(s): upon 30 calendar days’ written notice if (a) the other Party materially breaches any of the terms or conditions of this Agreement and such breach is not cured within the notice period; (b) if either Party becomes insolvent on the basis of a respective court order immediately upon written notice. If the Customer breaches the Instructions for Use, PM may terminate the Agreement immediately upon notice.
15.3 Effect of Termination. Upon termination Customer will cease using the Services and if applicable shall promptly return all copies of the Documentation to PM or otherwise destroy those copies and provide written confirmation that it has done so if requested. If Customer terminates this Agreement due to PM’s uncured material breach, PM will refund any prepaid Fees covering the remainder of the Term of the affected Order Form after the effective date of the termination on a pro-rata basis.
16 Limitation Of Liability
16.1 Neither Party shall be liable hereunder for any loss of profits, business, revenues, savings, reputation, production, goodwill, use or data, or for interruption of business, or any other indirect, incidental, special, exemplary, consequential or punitive damages even if advised of the possibility of such damages, regardless of the form of action. Except for PM’s indemnification obligations in Section 16 herein, PM’s aggregate, cumulative liability for any damages arising from or related to this Agreement, whether in contract or in tort or under any other legal theory, shall not exceed the Fees paid by Customer to PM for the Services under this Agreement in the last 12 months prior to the act that gave rise to the liability. The Parties agree that this clause represents a reasonable allocation of risks. THE FOREGOING EXCLUSIONS AND LIMITATIONS SHALL BE ENFORCED TO THE GREATEST EXTENT PERMITTED BY SLOVAK LAW.
16.2 Force Majeure. Neither Party shall be liable for any failure or delay in performing its obligations under this Agreement if such failure or delay is caused by circumstances beyond its reasonable control, including, but not limited to, acts of God, war, terrorism, fire, flood, natural disaster, governmental actions, pandemics, or any other similar event (the “Force Majeure Event”). During the period of any such delay or failure to perform by the affected Party, the obligations of the other Party shall be suspended to the extent necessary to accommodate the effects of the Force Majeure Event. Notwithstanding anything to the contrary herein, neither Party shall be excused from performing its obligations under this Agreement due to financial hardship or inability to meet financial obligations.
17 Indemnity
17.1 PM shall indemnify and defend Customer against any third-party action, claim, or suit (the “Claim”) to the extent such Claim alleges that the Services infringe any United States, United Kingdom or European Union patent right or trademark of a third party. The foregoing obligation shall not apply with respect to any Claim arising from or relating to (i) Customer’s use of the Services other than in accordance with and as contemplated by this Agreement or other breach of this Agreement by Customer; (ii) the combination of the Services with any other products, services, materials or technology, if the Services would not be infringing without such combination; (iii) any open source software; or (iv) modifications to the Services not specifically authorized in writing by PM. If the Services become the subject of an intellectual property infringement Claim, PM may, at its sole option, (1) procure for Customer a license to continue using the Services in accordance with this Agreement; (2) replace or modify the allegedly infringing portion of the Services to avoid the infringement, or (3) terminate this Agreement and refund any prepaid unused Fees as of the date of the termination. This Section 17.1 sets forth Customer’s sole remedy in the event of any third-party infringement Claim regarding the Services.
17.2 Customer shall indemnify and defend PM against any Claim to the extent such claim is arising from Customer’s or any of its Users’ breach of the Instructions for Use or other misuse of the Services.
17.3 Each Party’s obligations under this Section 17 shall be conditioned on the Party seeking indemnification providing the indemnifying Party with (i) prompt notice of any Claim, (ii) sole control of the defense and settlement of any such Claim and (iii) reasonable cooperation in such defense and settlement. The indemnifying Party will not enter into any settlement or compromise of any such claim without the indemnified Party’s prior written consent provided the settlement would require admission of fault or payment by the indemnified Party. Subject to the requirements set forth herein, the indemnifying Party shall pay reasonable costs incurred by the indemnified Party directly related to the Claim.
18 Notices
18.1 The Customer consents to any communication sent by PM or any notifications anticipated under the Agreement being sent to the Customer via email to the e-mail address provided in the Customer’s account or set forth in the Order Form.
18.2 Any notices, comments, feedback or any questions shall be sent to PM to the following e-mail address: legal@powerfulmedical.com.
19 Modification of the Terms
19.1 PM may, at its sole discretion, issue new versions of the Terms and notify the Customer without undue delay to its email address. If the Customer does not agree with a new version of the Terms, the Customer shall notify PM within thirty (30) calendar days of being notified by PM about the new version of the Terms, that it does not wish to be bound by the new version of the General Terms and Conditions. In such a case, the Agreement remains to be governed by the then current version of the Terms until the end of the then-current Order Form Term. Once a new Renewal Term commences, the Agreement shall be governed by the new version of the Terms regardless of any objection given by the Customer against the new version of the Terms.
20 Marketing
20.1 PM may reference the Customer and the contractual relationship in press releases, on websites (including social media), and in other marketing or advertising materials. The Customer hereby grants to PM the right to use Customer’s name, logo and trademarks in connection therewith.
20.2 With Customer’s prior consent, PM may develop and publish case studies based upon Customer’s use of the Services, which include but are not limited to video testimonials webinars.
21 General
21.1 Unless the Agreement provides otherwise, neither Party shall assign or transfer any of its rights or obligations under this Agreement without the prior written consent of the other Party except that, subject to the limitations stipulated herein, PM may assign or transfer any of its rights or obligations this Agreement to any of its Affiliates. Any actual or proposed change in control of the Customer that results or would result in a direct or indirect competitor of PM directly or indirectly owning or controlling 50% or more of the Customer (regardless of whether in economic benefit or voting rights) shall entitle PM to terminate this Agreement immediately upon written notice.
21.2 This Agreement together with all the schedules and other attachments hereto, supersedes all prior agreements and understandings between the Parties, with respect to the subject matter hereof and constitute the complete agreement and understanding between the Parties with respect to the subject matter hereof unless modified, amended, supplemented or waived in a writing signed by both Parties.
21.3 The failure or delay of either Party to this Agreement to insist upon strict performance of any of the provisions contained in this Agreement will in no way constitute a waiver of its rights as set forth in this Agreement, at law or a waiver of any other provisions or subsequent default by the other Party in the performance or compliance with any of the terms and conditions set forth in this Agreement.
21.4 If any provision of this Agreement (or any portion thereof) is determined to be invalid or unenforceable the remaining provisions of this Agreement will not be affected thereby and will be binding upon Parties and will be enforceable as though said invalid or unenforceable provision (or portion thereof) were not contained in this Agreement.
21.5 The provisions of Sections 8, 9, 10, 15 and 16 shall survive the termination or expiration of this Agreement or any portion thereof.
21.6 This Agreement will be governed and construed in all respects by the laws of the Slovak Republic.
21.7 In the event of a dispute between the Parties hereunder (each, a “Dispute”), prior to commencing legal proceedings (other than an action for interim injunctive relief pending final resolution of the Dispute), each Party will refer the Dispute to its designated representative to work in good faith to attempt to resolve the Dispute amicably for a thirty (30) calendar days from the date of written notice of such Dispute from one Party to the other; provided, however, that all Fees due not in dispute shall be promptly paid by the Customer. If the Dispute is not resolved by the amicable negotiations within thirty (30) calendar days, such Dispute shall be finally settled under the Rules of Arbitration (Vienna Rules) of the Vienna International Arbitral Centre (VIAC) of the Austrian Federal Economic Chamber by one or three arbitrators appointed in accordance with the said Rules. The place of arbitration shall be Vienna, Austria and language of the proceedings shall be English. This clause shall be governed by and construed exclusively in accordance with the laws of the Slovak Republic.
