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Terms and Conditions of Use of PMcardio

Effective date: February 22, 2021

1

Introduction

These Terms and Conditions of Use of PMcardio (the “Terms”) cover the use of and access to the Application and the content within the Application. These Terms are a binding agreement between Powerful Medical and each registered User (as defined below). Each User of the Application must accept these Terms prior to using the Application and comply at all times with the terms and conditions provided in the Terms below. The Terms together with the Data Processing Addendum constitute the full contractual relationship between the User and Us.

2

Definitions

For the purposes of these Terms, the capitalised terms below have the following meanings:

Agreement” means the agreement for the provision of Services between User and Us stipulated in these Terms, including the Data Processing Addendum.

Application” means the mobile application called PMcardio provided by Us to registered Users. The Application is a software product providing Services outlined in these Terms, in particular ECG scanning, ECG digitization, ECG segmentation, ECG reporting, and specialized cardiologist consultation.

Data Processing Addendum” means addendum to these Terms, governing the relationship between Us and the User on processing of data.

ECG” means electrocardiogram – the result of a cardiovascular test that measures electrical activity of the heart.

Powerful Medical”, “We” or “Us” or “Our” means POWERFUL MEDICAL s. r. o., a limited liability company organized and existing under the laws of the Slovak republic, with its registered seat at Bratislavská 81/37, 931 01 Šamorín, Slovak republic, Company ID No. 50 948 431, registered with the Commercial Register maintained by District Court Trnava, section Sro, file No. 46781/T and includes any and all entities affiliated to POWERFUL MEDICAL s. r. o. by common control, management or ownership on behalf of which POWERFUL MEDICAL s. r. o. is acting.

Privacy Notice” means notice provided to the User informing him/her about the processing of personal data in relation to the Application and his/her respective rights and available at powerfulmedical.com/pmcardio/privacy-policy.

Services” means the services offered through the Application consisting of ECG scanning, ECG digitization, ECG segmentation, ECG reporting, and specialized cardiologist consultation.

Terms” means these Terms and Conditions for of Use of PMcardio and available at powerfulmedical.com/pmcardio/terms-and-conditions.

User” means the user of the Application, including the Data Processing Addendum.

3

Subject Of The Agreement

3.1

Under the Agreement, We undertake to provide the Services in the scope defined in these Terms and the User undertakes to use the Application in compliance with these Terms and, if applicable, pay the agreed price for the Services specified further in these Terms.

4

Prices And Payments

4.1

Services provided under the Agreement are free of charge. We reserve the right to amend this Section 4.1 at any time and request the payment of fees. Should any change of this Section 4.1 occur, We will inform the User in advance and provide the User with an opportunity to object. In case the User objects in accordance with the previous sentence, the User shall have no right to use the Application after the effective date of the amendment.

5

Using The Application

5.1

The User acknowledges and agrees that although We are in the process of registering the Application as a medical device, the Application is not yet a registered as a medical device. The Application is subject to improvements and may provide inaccurate or incomplete information. As a result, the User expressly confirms and agrees not use the Application as a medical device and not to rely on the Application as part of the provision of health care or any related services.

5.2

The User may use the Application only after completing the registration process and after agreeing to these Terms.

5.3

We will verify and approve each User as part of the registration. In case of interest, please reach out to Us at registration@powerfulmedical.com.

5.4

After successful approval, We will create an account for each User, using individual log-in credentials consisting of email address and password. Log-in credentials as well as as a link to download the Application will be sent via email to each User individually.

5.5

The User shall keep their log-in credentials confidential, not disclose it to any third party and ensure that it is adequately protected to avoid any access by an unauthorized party to the Application (in particular, by selecting a sufficiently secure password).

5.6

After downloading and installing the Application, the User has to log in. The User can log into the Application only with log-in credentials send to him/her under the Section 5.3 above.

5.7

Before using the Application, each User must read these Terms and explicitly confirm that he/she has read and agreed to these Terms by ticking the box: “I have read and agree to the Terms and Conditions of Use of the Application. These Terms will be further available at powerfulmedical.com/pmcardio/terms-and-conditions.

5.8

The registration is complete after the User logs in for the first time into the Application.

5.9

By registering and agreeing to these Terms, a binding contract is concluded between the User and Us. If the User does not agree to and accept all of the Terms, he/she has no right to use the Services. The Agreement is concluded the moment the User confirms his/her acceptance with these Terms, but in any case not later than when the registration is complete.

5.10

The up-to-date versions of the Terms and the Privacy Notice are available at powerfulmedical.com/pmcardio/terms-and-conditions and powerfulmedical.com/pmcardio/privacy-policy.

6

Rights And Obligations Of The User

6.1

The User acknowledges and agrees that:

(i) At the moment of registration he/she consents to these Terms and declares that he/she has duly read and understood them and unconditionally agrees to them;

(ii) The Application will be used exclusively in accordance with these Terms, the laws of the Slovak Republic and of the European Union, and where the User’s use of the Application is subject to any other laws, in accordance with any such applicable laws and regulations;

(iii) He/she will not do anything which might disrupt or damage the operation of the Application, violate the rights of third parties, or conduct any activities which may be considered unethical, illegal or contrary to good faith;

(iv) The User shall not make any fully automated decisions based on the information provided by Us using the Application and shall always ensure appropriate human intervention, review and verification before using the information for any purpose.

(v) The Application serves for research purposes and for improvement of the underlying technology;

(vi) The Application is made available to the User solely for personal non-commercial use;

(vii) The User must not use the specialized cardiologist consultation functionality within the Application beyond what is necessary for the specific use or to achieve a purpose as defined by the User.

(viii) The User is fully and exclusively responsible for using the Application and for any consequences of that use;

(ix) The User will not (i) make and distribute copies of the Application (ii) attempt to copy, reproduce, alter, modify, reverse engineer, disassemble, decompile, transfer, exchange or translate the Application; or (iii) create derivative works of the Application of any kind whatsoever; or that he/she will not allow any third parties to do so on his/her behalf;

(x) The User will not log in using registration data which is not his/her own, and will not obtain or collect registration data of other users;

(xi) The User will not do anything which might disrupt or damage the operation of the Application, violate the rights of third parties, or conduct any activities which may be considered is unethical, illegal or contrary to good faith in any way.

(xii) The User acknowledges that We are based within the European Economic Area and is responsible for the compliance with obligations relating to the transfer of data from the User’s country outside of European Economic Area to the European Economic Area.

6.2

The User agrees to indemnify Us for any and all damage arising as a consequence of the violation of these Terms by the User.

7

Our Rights And Obligations

7.1

We reserve the right to amend, withdraw or discontinue the Application at any time and for any reason without the need to inform the User about this in advance. We are in particular entitled to change the scope of Services provided through the Application. In such case, the User is not entitled to demand any compensation for damage or other compensation, unless stated otherwise by legal regulations.

7.2

We are under no circumstances responsible for use of the Application by the User and any consequences of that use.

7.3

We do not offer any guarantee relating to the Application. Specifically, without this list being exhaustive, We do not guarantee that the Application (i) is free from any programming or other errors, (ii) meets all the expectations of every User, (iii) will not be the subject of any malfunctions, (iv) will provide accurate or reliable results or (v) that its use will be uninterrupted.

7.4

If We consider that the use of the Application by the User is in violation with the Terms or applicable legal regulations, We may, at Our discretion, cancel the registration of the particular User, temporarily or permanently block the User’s access to the Application or terminate the Agreement between Us and the User.

8

Intellectual Property And License

8.1

The Application is subject to Our intellectual property rights, in particular copyright and trademarks.

8.2

By concluding the Agreement, We grant the User a non-exclusive, non-transferable, non-sublicensable, revocable license until this Agreement is terminated for any reason to use the Application in accordance with and for the purposes set forth in these Terms to the following extent (the “License”):

(i)

The User is entitled to use the Application to the extent and under the conditions set forth herein.

(ii)

The User is not entitled to modify the Application or its source code in any way or to update the Application or its source code in any way.

9

Content Provided by User

9.1

In connection with the use of the Application, the User may provide feedback, recommendations, contribute to improvements of the Application or participate in various surveys, by which the User will provide to Us information or materials (including documents in writing, photographs, video, or audio recording, software, statistical data, databases) which may be protected by intellectual property rights (the “User Content”).

9.2

The User agrees that Powerful Medical shall be enabled unhindered use, including commercial use, of User Content to the fullest extent possible. In order to achieve such unhindered use, the User hereby agrees to the following:

9.2.1

If User provided User Content upon request from Powerful Medical, such User Content shall be deemed “work for hire” (in Slovak: dielo na objednávku) in accordance with § 91 of act no. 185/2015 Coll. Copyright Act and Powerful Medical shall be the holder of the economic rights relating to such User Content.

9.2.2

If User provided User Content otherwise or if, for any reason, the rights granted to Powerful Medical do not allow the full and unhindered use of User Content, the User grants at the moment of disclosure of User Content an exclusive, sublicensable, perpetual, irrevocable, royalty-free, worldwide license to Powerful Medical for the full unhindered use of User Content as outlined in Section 9.2 above. For the avoidance of doubt, such use shall include but not be limited to reproduce, adapt, translate, modify, transform, and prepare derivative works of, publicly display, publicly perform, sublicense, make available and distribute User Content and any derivative works.

10

Availability

10.1

The Application is available to handheld mobile devices running operating systems specified in the Application. The User acknowledges that the Application is provided via the internet and mobile networks, and so the quality and availability of the Application may be affected by factors outside Our reasonable control.

10.2

We do not accept any responsibility for unavailability of the Application, or any other communications system failure which may result in the Application being unavailable.

11

System Requirements

11.1

In order to use the Application, the User is required to have a compatible mobile telephone or handheld device, internet access, and the necessary minimum specifications, i.e. software and hardware requirements.

11.2

The version of the Application software may be upgraded from time to time to add support for new functionality and services, to improve user experience, to remove bugs or certain features.

12

Data Protection

12.1

The parties acknowledge and agree that the Services provided by Us may involve the processing of personal data of individuals on behalf of the User and that, with respect to such personal data, We will be acting as a processor and the User will be acting as controller for such personal data. Such processing is subject to Data Processing Addendum, which forms part of these Terms. The User commits to fully comply with applicable data protection laws and regulations, in particular by providing appropriate notice and by having an appropriate legal basis for the full processing of personal data as outlined in these Terms.

12.2

The parties acknowledge and agree that the Services provided by Us may involve the processing of personal data of the User or its representatives. We will be acting as a controller in relation to such processing.

12.3

Further information relating to data protection can be found in the Privacy Notice.

13

Confidentiality of Information

13.1

The following information is considered as confidential (the “Confidential Information”):

13.1.1

all trade secrets, know-how, procedures, ideas, proposals, proprietary technologies and techniques 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;

13.1.2

information of a technical, economic and commercial character, information on prices and their calculation, information on products and/or related documentation and manuals, including their content, any information on 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, data on the internal structure of Powerful Medical and its employees, as well as any future strategies of Powerful Medical made available or disclosed, whether orally, in writing, in the form of an electronic document, visual or audio recording or by any other means;

13.1.3

the existence and content of any discussions relating to the subject matter of this Agreement, unless agreed otherwise;

13.1.4

any information designated by Powerful Medical as confidential and

13.1.5

any notes, records or copies relating to the information referred to in 1.1 and 13.1.4 above made by the Contracting Party or one of its personnel.

13.2

We may provide the User access to the Confidential Information. The Confidential Information made available shall be used only in accordance with the purpose for which it was provided, but not for any other purpose.

13.3

Disclosed Confidential Information must be kept confidential by the User and protected from disclosure to any third parties and persons, unless agreed otherwise by Powerful Medical and the User or as provided in these Terms.

13.4

The User undertakes to ensure the confidentiality and protection of Confidential Information from unauthorized persons and to notify Us without undue delay of the suspicion of breach of this section 13 and to return all provided Confidential Information at any time upon Our request. If the Confidential Information has the nature of material documents, the User is obliged to return them physically. In the event that the Confidential Information is stored in electronic form, the User is obliged to securely delete all Confidential Information stored and destroy any media to the extent it holds such Confidential Information. The User is obliged to provide Us with a written certification of deletion and destruction.

13.5

All Confidential Information shall remain the sole property of and available to Powerful Medical. By providing Confidential Information, the recipient shall not acquire any rights related to the Confidential Information.

14

Duration of the Agreement and Termination

14.1

The Agreement is concluded for a definite time starting with the conlusion of this Agreement and ending with the termination of the Agreement for any reason.

14.2

We may terminate the Agreement at any time without specifying a reason. We will aim to provide the Use with a reasonable prior notice via email.

14.3

The User may terminate the Agreement at any time without specifying a reason with a one-month notice period through the termination option in the Application. Powerful Medical may request that such termination has immediate effect and may immediately undertake the activities outlined in Section 7.4, in particular permanently block the User’s access to the Application.

 

15

Limitation of Liability

15.1

Our maximum aggregate liability under the Agreement whether in contract, tort (including negligence) or otherwise, shall in no circumstances exceed the amount of EUR 250. The parties agree that the limited liability for damages arising out of any breach of the Agreement is appropriate to the circumstances of the subject matter of the Agreement and business relations. The limitation of the extent of compensation for damages represents a foreseeable and reasonable rate of compensation for damages which on the date of concluding the Agreement the parties anticipated as the possible consequence of the breach of obligations arising out of the Agreement and which could be anticipated in connection with the given facts and objectives of the Agreement. Nothing in the Agreement shall limit or exclude Our liability caused by gross negligence or any liability which cannot be excluded by law.

15.2

We are not liable to the User for any damage or alteration to his/her equipment including but not limited to handheld devices or mobile telephones as a result of the installation or use of the Application or by any use of the Application of the User in violation of these Terms.

16

Modification Of These Terms

16.1

We reserve the right to amend and supplement any part of these Terms at any time. This provision is without prejudice to the rights and obligations that have already arisen during the effective period of the previous version of the Terms.

16.2

In the event of any modification or update of these Terms, We will notify the User via email reasonably in advance before any such modification becomes effective to the email address indicated in the User’s account.

16.3

In the event of any modification of these Terms, except for any modification merely reflecting changes in applicable legislation, the User has the right to reject the planned changes to these Terms and terminate the Agreement without stating any reason in accordance with Section 12 of these Terms.

17

Applicable Laws And Jurisdiction

17.1

The Agreement and any dispute or claim arising thereof or in connection with it shall be governed by and construed in accordance with the laws of the Slovak Republic and the parties jointly agree that act no. 513/1991 Coll. Commercial Code shall govern this Agreement.

17.2

Should any dispute arise in connection with the Agreement, these Terms, Data Processing Addendum or with the provision of the Services described herein, the parties will attempt to settle any such dispute amicably without pursuing legal action.

17.3

The courts of the Slovak Republic shall have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with the Agreement, these Terms, Data Processing Addendum or the provision of the Services described therein.

18

Notifications And Communication

18.1

The User consents to any communication sent by Us or any notifications anticipated under the Agreement or these Terms being sent to the User via email to the email address provided in the User’s account.

18.2

Any notifications, comments, feedback or any questions shall be sent to Us in accordance with these Terms using the following email address: feedback@powerfulmedical.com.

19

Final Provisions

19.1

The User declares that he/she considers the rights and obligations set forth in these Terms to be fair, comprehensible and fully agrees to them.

1.92

These Terms constitute the entire agreement between the parties and supersedes and extinguishes all previous agreements, promises, assurances, warranties, representations and understandings between them, whether written or oral, relating to the Agreement’s subject matter.

19.3

These Terms and Data Processing Addendum comprise an inseparable and integral part of the Agreement between the User and Us.

19.4

If any provision or part-provision of the Agreement, these Terms or Data Processing Addendum is or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such a modification is not possible, the relevant provision or part-provision shall be deemed deleted without affecting the remainder of the Agreement.

These Terms are effective as of February 22, 2021.

DATA PROCESSING ADDENDUM

(the “Addendum”)

1

Introduction

1.1

This Addendum describes Our privacy practices regarding the Processing of Personal Data on behalf of the User, to the extent applicable, as part of the provision of Services provided to the Users. Where We provide Services to the Users, We act as a Processor and the User acts as a Controller. This Addendum applies globally to any and all Services provided by Us to the User, unless otherwise agreed by the parties.

1.2

For the avoidance of doubt, this Addendum does not apply to such processing where We act as a Controller. We refer to Our separate Privacy Notice for more information about what specific activities are conducted by Us as Controllers.

1.3

We reserve the right to update this Addendum in accordance with the Section 14 of the Terms.

2

Definitions

Act” means the Act no. 18/2018 Coll. on Personal Data Protection.

Controller” means the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the Processing of Personal Data.

Data Protection Legislation” means the Act and the Regulation.

Personal Data” mean any information about an identified or identifiable natural person or which may directly or indirectly identify a natural person processed by Powerful Medical as Processor in accordance with Section 3.1 of this Addendum.

Processing” means any operation or set of operations which is performed upon Personal Data or on sets of Personal Data, whether or not by automated means, such as collection, recording, organization, structuring, storage, adaption or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.

Processor” means the party, which Processes Personal Data on behalf of the Controller.

Regulation” means Regulation (EU) 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC.

3

Processing Of Personal Data

3.1

We will process (i) data provided by the User, in particular ECG image, comorbidities, age, sex, height, smoking / alcohol / medication used about those individuals that the User determines (e.g. volunteers, patients) and (ii) identification, contact details, workplace, specialization about the User or its representatives who use the Application in relation to the operation and administration of the Application (Scanning / Digitization / Segmentation / Reporting). The data processed may include information about the ECG device used, such as the manufacturer, model, paper speed, voltage gain and similar.

3.2

We will not provide Personal Data to any third party other than (i) as necessary to perform activities and Services outlined in the Terms; (ii) in accordance with the documented instructions of the User; (iii) within entities affiliated to Powerful Medical by common control, management or ownership, (iv) as part of a merger, acquisition or other investment by a third party into Powerful Medical, or (v) as required to comply with Data Protection Legislation or other laws to which We are subject, in which case We shall (to the extent permitted by law) inform the User of that legal requirement before Processing Personal Data.

3.3

In addition, We are allowed to use (i) aggregated data – to the extent this can no longer be considered personal data – or (ii) de-identified data (i.e. data which does not allow an identification of the patient) for scientific research purposes, for internal operations, including troubleshooting, data analysis, testing, research, for statistical purposes and for improving the quality of the Services.

4

Our Obligations

4.1

We shall:

(i)

At the moment of registration he/she consents to these Terms and declares that he/she has duly read and understood them and unconditionally agrees to them;

(ii)

apply all commercially reasonable technical and organizational measures to protect the Personal Data in conformity with the provisions of Art. 32 of the Regulation;

(iii)

assist the User, as the Controller, to perform his/her obligations resulting from Art. 32-36 of the Regulation taking into account the nature of processing and the information available to the processor;

(iv)

taking into account the nature of the processing, assists the Controller by appropriate technical and organisational measures, insofar as this is possible, for the fulfilment of the Controller’s obligation to respond to requests for exercising the data subject’s rights laid down in Chapter III of the Regulation;

(v)

ensure that the persons authorized to process the Personal Data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality;

(vi)

inform the User about a Personal Data breach without undue delay after We become aware of it, specifying (1) the nature of the Personal Data breach, (2) the likely consequences and (3) the measures taken to address the Personal Data breach; such information may be provided gradually, in case not readily available. We shall provide full cooperation to the User and act as instructed by the User to assist in the investigation and remediation of such Personal Data breach;

(vii)

at the choice of the User, delete or return all Personal Data without undue delay after the termination of the Agreement, delete existing copies of Personal Data, unless otherwise provided by law or agreed by the parties;

(viii)

make available to the User upon reasonable request all information necessary to demonstrate compliance with the obligations laid down in Article 28 of the Regulation and allow for and upon reasonable prior notice not shorter than 2 weeks contribute to audits, including inspections where provision of documents is not sufficient to demonstrate compliance, conducted during regular business hours, not more often than once per year by an independent third party expert auditor mandated by the User at the expense of the User.

5

Limitation of Liability

5.1

We may appoint certain third parties to provide parts of the Services or assist with providing technical or professional support. By accepting the Terms, the User authorizes Us to subcontract the Processing of Personal Data to subprocessors. Subprocessors are in each case subject to binding obligations between Us and the subprocessor which contain substantially similar provisions as those set out in this Addendum. We will inform the User of the details of such subprocessor(s) upon written request from the User.

6

International Data Transfers

6.1

We shall not transfer Personal Data to countries outside the European Economic Area, with the exception of countries recognized by the European Commission as providing adequate protection. A full list of such countries is accessible here.

6.2

If the User resides, is based or operates the Application from a country outside of the EEA, the Personal Data from such use will be transferred to the EEA.

7

Liability

7.1

The User commits to Process all Personal Data, in particular the provision of Personal Data to Us, in accordance with Data Protection Legislation including without limitation:

(i)

ensuring that all notifications to and approvals from regulators which are required by Data Protection Legislation are made and maintained by the User; and

(ii)

ensuring that all Personal Data is Processed fairly and lawfully (in particular, the User has a valid legal basis for any Processing necessary in accordance with the Terms and this Addendum), in a transparent manner (in particular, the User has provided appropriate privacy notices to the data subjects), is accurate and up to date.

7.2

The User shall indemnify and hold Us harmless from and against any losses, fines, damage, fees or any additional expenses (including reasonable attorneys’ fees and other reasonable costs of litigation), due from or incurred in relation to a breach of this Addendum or non-compliance with Data Protection Legislation by the User. In accordance with Art. 82(2) of the Regulation, We, as a Processor, shall be liable for the damage caused by Processing only where it has not complied with obligations of the Regulation specifically directed to processors or where We have acted outside or contrary to lawful instructions of the Controller.

8

Final Provisions

8.1

We may charge reasonable fees for any activites or assistance undertaken upon request by the User which go beyond the scope of Services.

8.2

This Addendum has been concluded for the duration of the Agreement (as defined in the Terms) and shall be governed and subject to the same laws and jurisdiction as the Terms.