Pretaa, Inc. Data Processing Addendum

This Data Processing Addendum (“Addendum”) is incorporated by reference into the Purchase Order, or other agreement between Customer and Pretaa, Inc. (“Pretaa”) governing Customer’s use of the Services (the “Purchase Order”) and reflects the parties’ agreement with regard to the processing of personal information in accordance with the requirements of the applicable Data Protection Legislation.  

The terms used in this Addendum shall have the meanings set forth in this Addendum. Capitalized terms not otherwise defined herein shall have the meaning given to them in the Agreement. This Addendum forms part of the Agreement and will have the same force and effect as if set out in the body of the Agreement. 

1. DEFINITIONS AND INTERPRETATIONS

1.1 The following terms shall have the following meanings: 

(a) “Applicable Law” means all applicable laws, statutes, codes, ordinances, decrees, rules, regulations, municipal by-laws, judgments, orders, decisions, rulings or awards of any government, quasi-government, statutory or regulatory body, ministry, government agency or department, court, agency or association of competent jurisdiction;

(b) “Controller” means an entity which, alone or jointly with others, determines the purposes and means of the processing of Personal Information and shall also mean a “Business”, where applicable, as defined by the CCPA;

(c) “Customer Personal Information” shall have the meaning given to it in Section 3.1;

(d) “Data Protection Legislation” means all laws and regulations, including state, federal and national laws and regulations of the European Union (“EU”), the European Economic Area (“EEA”), their Member States, the United Kingdom, Switzerland and the United States, applicable to the processing of Personal Information under the Agreement, including, as applicable, the GDPR and the California Consumer Privacy Act of 2018, Cal.  Civ.  Code §§ 1798.100 –1798.199, and its implementing regulations (the “CCPA”), each, as amended, repealed or replaced from time to time;

(e) “GDPR” means Regulation (EU) 2016/679 and also refers to the GDPR as it forms part of the law of England and Wales, Scotland and Northern Ireland by virtue of section 3 of the European Union (Withdrawal) Act 2018 (“UK GDPR”) (in this Addendum, any references to specific articles of the GDPR shall be construed as also referring to the equivalent sections of the UK GDPR, where applicable);

(f) “Personal Information” means any information relating to an identified or identifiable natural person (a “Data Subject”) and/or any such information as may be defined as constituting Personal Information, personally identifiable information or any equivalent thereof, in any applicable Data Protection Legislation;

(g) “Process” and variants of it, such as “processing” and “processed” (whether capitalized or not) means any operation or set of operations performed upon Personal Information or sets of Personal Information, whether or not by automated means, such as collection, recording, organization, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction;

(h) “Processor” means an entity which processes Personal Information on behalf of the Controller  and shall also mean a “Service Provider”, where applicable, as defined by the CCPA;

(i) “Standard Contractual Clauses” means the standard contractual clauses for the transfer of Personal Information to processors established in third countries, as approved by the European Commission in Decision (EU) 2021/914 as set out in Schedule A; 

(j) “Services” shall have the meaning set forth in the Agreement or, if the Agreement does not define “Services”, shall mean the services and other activities to be performed by Pretaa as set forth in and pursuant to the Agreement; 

(k) “Subprocessor” means any person or entity appointed by or on behalf of Pretaa (or the relevant intermediate Subprocessor) to process Personal Information as described in Section 6; and

(l) “Supervisory Authority” means a supervisory authority established by an EEA Member State or the United Kingdom, pursuant to Article 51 of the GDPR, or any other competent government authority with jurisdiction over the processing of Personal Information under the Agreement.

1.2 In this Addendum (except where the context otherwise requires any phrase introduced by the terms “including”, “include”, “in particular” or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms.

2. ROLES OF THE PARTIES 

2.1 Both parties will comply with all applicable requirements of the Data Protection Legislation. This Section 2.1 is in addition to, and does not relieve, remove or replace, either party’s obligations under the Data Protection Legislation.

2.2 The parties acknowledge and agree that for the purposes of the Data Protection Legislation, Customer is the Controller and Pretaa is the Processor.

2.3 Customer shall ensure that it has and will continue to have, the right to transfer, or provide access to, Customer Personal Information to Pretaa for processing in accordance with the Agreement. For the avoidance of doubt, Customer’s instructions for the processing of Customer Personal Information shall comply with applicable Data Protection Legislation. Pretaa will inform Customer if it considers, in its opinion, that any of Customer’s instructions infringe applicable Data Protection Legislation. Customer shall have sole responsibility for the accuracy, quality, and legality of Customer Personal Information and the means by which Customer acquires Customer Personal Information and shall be responsible for ensuring that the processing of Personal Information, which Pretaa is instructed to perform, has a valid legal basis.

3. SCOPE OF PROCESSING

3.1 Customer agrees that Pretaa may process Personal Information on behalf of Customer to perform its obligations under the Agreement for the term of the Agreement (“Customer Personal Information”) in accordance with this Addendum. A list of the categories of data subjects, types of Customer Personal Information and the processing activities are set out in Appendix I to the Standard Contractual Clauses.  The duration of the processing corresponds to the term of the Agreement, unless otherwise stated in the Agreement or this Addendum.

3.2 Pretaa shall process Customer Personal Information only on the written instructions of Customer unless Pretaa is required by Applicable Law to process such data. Where Pretaa is relying on Applicable Law as the basis for processing Customer Personal Information, Pretaa shall notify Customer of this before performing the processing required by Applicable Law unless Applicable Law prohibits Pretaa from so notifying Customer.  

3.3 The following is deemed an instruction by Customer to process Customer Personal Information, subject to Pretaa’s compliance with this Addendum and the Data Protection Legislation: (i) processing necessary to perform the Services and/or for Pretaa’s performance of its obligations under the Agreement; (ii) processing initiated by Customer, (or its authorized representative) in their use of the Services; and (iii) processing necessary to comply with other reasonable instructions provided by Customer where such instructions are consistent with the Agreement and this Addendum.

4 DATA PROCESSING OBLIGATIONS

4.1 Without prejudice to the generality of Section 2.1, Pretaa shall, in relation to any Customer Personal Information processed in connection with the performance by Pretaa of its obligations under the Agreement: 

(a) maintain technical and organizational measures designed to protect against the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, Customer Personal Information in its possession or control (a “Personal Information Breach”);

(b) ensure that all personnel who have access to and/or process Customer Personal Information are obliged to keep Customer Personal Information confidential; 

(c) taking into account the nature of the processing and the information available to it, assist Customer by appropriate technical and organizational measures, insofar as this is possible, in responding to a request from a Data Subject and in ensuring compliance with its obligations under the Data Protection Legislation with respect to records of processing, security, breach notifications, impact assessments and consultations with Supervisory Authorities. To the extent legally permitted, Customer shall be responsible for any costs arising from Pretaa’s provision of such assistance; 

(d) notify Customer without undue delay on becoming aware of a Personal Information Breach and shall provide Customer with further information about the Personal Information Breach in phases as such information becomes available to Pretaa; and

(e) at the written direction of Customer, delete or return Customer Personal Information and copies thereof in its possession or control to Customer on termination of the Agreement unless required by Applicable Law to store Customer Personal Information.

4.2 Pretaa shall maintain records and information to demonstrate its compliance with this Addendum.  Customer shall, with reasonable notice to Pretaa, have the annual right (unless required more frequently by an order of a Supervisory Authority or court, or in the event of a Personal Information Breach) to review such records at Pretaa’s offices during regular business hours.

4.3 Upon Customer’s request, Pretaa shall, no more than once per calendar year (unless required more frequently by an order of a Supervisory Authority or court, or in the event of a Personal Information Breach) make available for Customer’s review copies of certifications or reports demonstrating Pretaa’s compliance with this Addendum and the prevailing data security standards applicable to the processing of Customer Personal Information. 

4.4 Where Customer reasonably believes the information provided under Section 4.2 and 4.3 above is not sufficient to demonstrate Pretaa’s compliance with this Addendum, at Customer’s expense and subject to Section 5, Pretaa shall permit Customer, or its appointed third-party auditors (collectively, “Auditor”), to audit the architecture, systems and procedures relevant to Pretaa’s compliance with this Addendum and shall make available to the Auditor all information, systems and staff necessary for the Auditor to conduct such audit. To the extent any such audit incurs in excess of 10 hours of Pretaa personnel time, Pretaa may charge Customer on a time and materials basis for any such excess hours.

4.5 To the extent Pretaa, in its role as a Service Provider (as defined by the CCPA), receives Customer Personal Information that is subject to the CCPA, Pretaa shall not (i) Sell (as defined by the CCPA) such Personal Information; (ii) retain, use, or disclose such Personal Information for any purpose other than performing its obligations under the Agreement or as otherwise permitted under the Agreement or CCPA or its underlying regulations; (iii) retain, use, or disclose the Personal Information for a commercial purpose other than performing its obligations under the Agreement or as otherwise permitted under the Agreement or CCPA or its underlying regulations; or (iv) retain, use, or disclose such Personal Information outside of the direct business relationship between Customer and Pretaa unless otherwise permitted under the Agreement.  Pretaa agrees to comply with the CCPA, as applicable to Service Providers, in performing its obligations under the Agreement and certifies its compliance with its obligations set forth in this Section 4.5.

5. AUDITS

5.1 Before the commencement of an audit described in Section 4, Pretaa and Customer will mutually agree upon the reasonable scope, start date, duration of and security and confidentiality controls applicable to the audit. Customer agrees that: 

(a) audits will be conducted during Pretaa’s normal business hours;

(b) it will not exercise its on-site audit rights more than once per calendar year, (unless required more frequently by an order of a Supervisory Authority or court, or in the event of a Personal Information Breach);

(c) it will be responsible for any fees charged by any third party auditor appointed by Customer to execute any such audit;

(d) Pretaa may object to any third-party auditor appointed by Customer to conduct an audit if the auditor is, in Pretaa’s opinion, not suitably qualified or independent, a competitor of Pretaa or otherwise manifestly unsuitable. Any such objection by Pretaa will require Customer to appoint another auditor or conduct the audit itself;

(e) nothing in this Section 5 will require Pretaa either to disclose to the Auditor, or to allow the Auditor access to (a) any data processed by the Pretaa on behalf of any other organization, (b) any Pretaa internal accounting or financial information, (c) any trade secret of Pretaa, (d) any information that, in Pretaa’s opinion, could (i) compromise the security of any Pretaa systems or premises, or (ii) cause Pretaa to breach its obligations to Customer or any third party, or (e) any information that Customer seeks to access for any reason other than the good faith fulfillment of Customer’s obligations under the Applicable Data Protection Law; and

(f) shall provide Pretaa with copies of any audit reports completed by the Auditors, which reports shall be subject to the confidentiality provisions of the Agreement.

6. APPOINTMENT OF SUBPROCESSORS

6.1 Customer authorizes Pretaa to appoint (and permit each Subprocessor appointed in accordance with this Section 6 to appoint) Subprocessors in accordance with this Section 6 and any restrictions in the Agreement. 

6.2 Pretaa may continue to use those Subprocessors already engaged by Pretaa, subject to Pretaa in each case as soon as practicable meeting the obligations set out in Section 6.4. 

6.3 Pretaa shall give Customer prior notice of any intended changes concerning the appointment or replacement of Subprocessors. If, within fourteen (14) days of receipt of that notice, Customer notifies Pretaa in writing of any objections (on reasonable grounds) to the proposed appointment:

(a) Pretaa shall work with Customer in good faith to make available a commercially reasonable change in the provision of the Services which avoids the use of that proposed Subprocessor; and

(b) where such a change cannot be made within thirty (30) days from receipt by Pretaa of Customer’s notice, notwithstanding anything in the Agreement, Customer may by written notice to Pretaa terminate those Services which cannot be provided by Pretaa without the use of the objected-to Subprocessor. This termination right is Customer’s sole and exclusive remedy if Customer objects to any proposed Subprocessor.

6.4 With respect to each Subprocessor, Pretaa shall:

(a) ensure that the arrangement between on the one hand (a) Pretaa, or (b) the relevant intermediate Subprocessor; and on the other hand the Subprocessor, is governed by a written contract including terms which offer at least the same level of protection for Customer Personal Information as those set out in this Addendum and meet the requirements of Article 28(3) of the GDPR;

(b) to the extent that Subprocessor processes Customer Personal Information to which the GDPR or UK GDPR applies outside of the EU, EEA, Switzerland and/or the United Kingdom, Pretaa will ensure that appropriate safeguards are at all relevant times incorporated into the agreement between on the one hand (a) Pretaa, or (b) the relevant intermediate Subprocessor; and on the other hand the Subprocessor, or before the Subprocessor first processes Customer Personal Information procure that it enters into an agreement incorporating appropriate safeguards; and

(c) provide to Customer for review such copies of the agreements with Subprocessors (which may be redacted to remove confidential commercial information not relevant to the requirements of this Addendum) as Customer may request from time to time.

6.5 Pretaa may replace a Subprocessor if the need for the change is urgent and necessary to provide the Services and the reason for the change is beyond Pretaa’s reasonable control.  In such instance, Pretaa shall notify Customer of the replacement as soon as reasonably practicable, and Customer shall retain the right to object to the replacement Subprocessor pursuant to Section 6.3 above.

6.6 Where the Subprocessor fails to fulfil its data protection obligations and Pretaa is the initial Processor, Pretaa shall remain fully liable to Customer for the performance of that Subprocessor’s obligations. 

7. INTERNATIONAL TRANSFERS 

7.1 The Parties hereby enter into the Standard Contractual Clauses with respect to any transfer of Customer Personal Information to which the GDPR and/or UK GDPR applies from Customer (as “data exporter”) to Pretaa (as “data importer”) where such transfer would otherwise be prohibited by Data Protection Legislation. The Standard Contractual Clauses shall come into effect on the commencement of a relevant transfer as described in this Section 7.

7.2 In case of any transfers of Customer Personal Information subject to the UK GDPR, (i) general and specific references in the Standard Contractual Clauses to GDPR or EU or Member State Law shall have the same meaning as the equivalent reference in the Data Protection Legislation of the UK including the UK GDPR (“UK Data Protection Laws”), as applicable; (ii) any other obligation in the Standard Contractual Clauses determined by the Member State in which the data exporter or Data Subject is established shall refer to an obligation under UK Data Protection Laws, as applicable, (iii) Clause 13(a) and Part C of Annex I are not used; (iv) the “competent supervisory authority” is the UK Information Commissioner’s Office; and (v) Clause 17 is replaced to state “These Clauses are governed by the laws of England and Wales” and Clause 18 is replaced to state: “Any dispute arising from these Clauses shall be resolved by the courts of England and Wales. A data subject may also bring legal proceedings against the data exporter and/or data importer before the courts of any country in the UK. The Parties agree to submit themselves to the jurisdiction of such courts.”

7.3 In case of any transfers of Customer Personal Information subject to the Data Protection Legislation or Switzerland (“Swiss Data Protection Laws”), (i) general and specific references in the Standard Contractual Clauses to GDPR or EU or Member State Law shall have the same meaning as the equivalent reference in the Swiss Data Protection Laws, as applicable; (ii) any other obligation in the Standard Contractual Clauses determined by the Member State in which the data exporter or Data Subject is established shall refer to an obligation under Swiss Data Protection Laws, as applicable, (iii) Clause 13(a) and Part C of Annex I are not used; (iv) the “competent supervisory authority” is the Swiss Federal Data Protection and Information Commissioner; and (v) Clause 17 is replaced to state “These Clauses are governed by the laws of Switzerland”.

7.4 Additional terms for Standard Contractual Clauses:

(a) For the purposes of Clause 8.1(a) of the Standard Contractual Clauses, the processing described in Section 3 of this Addendum is deemed an instruction by Customer to process Customer Personal Information, subject to Pretaa’s compliance with applicable Data Protection Legislation.

(b) Pursuant to Clause 9(a) of the Standard Contractual Clauses, Customer agrees that Pretaa may continue to use those Subprocessors already engaged by Pretaa as at the date of this Addendum, subject to Pretaa in each case as soon as practicable meeting the obligations set out in Section 6.4.

(c) Pursuant to Clause 9(a) of the Standard Contractual Clauses, Customer agrees that Pretaa may engage new Subprocessors as detailed in Section 6 of this Addendum.

(d) Customer agrees that the audits described in Clause 8.9 of the Standard Contractual Clauses shall be carried out in accordance with Sections 4 and 5 of this Addendum.

(e) In the event of any conflict or inconsistency between this Addendum and the Standard Contractual Clauses, the Standard Contractual Clauses shall prevail. The parties’ signature to the Agreement shall be considered as signature to the Standard Contractual Clauses.

7.5 Pretaa may propose variations to this Addendum and the Standard Contractual Clauses which Pretaa reasonably considers to be necessary to address the requirements of any Data Protection Legislation, and the parties shall promptly discuss the proposed variations and negotiate in good faith with a view to agreeing and implementing those or alternative variations designed to address the requirements identified in Pretaa’s notice as soon as is reasonably practicable. 

8. GENERAL TERMS 

8.1 Termination and Survival. The parties agree that this Addendum shall terminate automatically upon termination of the Agreement.  Notwithstanding the foregoing, any obligation imposed on Pretaa under this Addendum in relation to the processing of Customer Personal Information shall survive any termination or expiration of this Addendum.

8.2 Governing Law. This Addendum shall be governed by the governing law of the Agreement.

8.3 Jurisdiction. The parties to this Addendum hereby submit to the choice of jurisdiction stipulated in the Agreement with respect to any disputes or claims howsoever arising under this Addendum.

8.4 Order of precedence. Nothing in this Addendum reduces Pretaa’s obligations under the Agreement in relation to the protection of Customer Personal Information or permits Pretaa to process (or permit the processing of) Customer Personal Information in a manner which is prohibited by the Agreement. In the event of any inconsistency between this Addendum and any other agreements between the parties, including but not limited to the Agreement, the Addendum shall prevail.

8.5 Severance. Should any provision of this Addendum be invalid or unenforceable, then the remainder of this Addendum shall remain valid and in force. The invalid or unenforceable provision shall be either (i) amended as necessary to ensure its validity and enforceability, while preserving the parties’ intentions as closely as possible or, if this is not possible, (ii) construed in a manner as if the invalid or unenforceable part had never been contained therein.

SCHEDULE A: STANDARD CONTRACTUAL CLAUSES

SCHEDULE

STANDARD CONTRACTUAL CLAUSES (CONTROLLER-TO-PROCESSOR)

SECTION I

Clause 1 

Purpose and scope 

1. The purpose of these standard contractual clauses is to ensure compliance with the requirements of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) for the transfer of personal data to a third country. 
2. The Parties: 

1. the natural or legal person(s), public authority/ies, agency/ies or other body/ies (hereinafter “entity/ies”) transferring the personal data, as listed in Annex I.A. (hereinafter each “data exporter”), and 
2. the entity/ies in a third country receiving the personal data from the data exporter, directly or indirectly via another entity also Party to these Clauses, as listed in Annex I.A. (hereinafter each “data importer”) have agreed to these standard contractual clauses (hereinafter: “Clauses”).

3. These Clauses apply with respect to the transfer of personal data as specified in Annex I.B. 
4. The Appendix to these Clauses containing the Annexes referred to therein forms an integral part of these Clauses. 

Clause 2 

Effect and invariability of the Clauses 

1. These Clauses set out appropriate safeguards, including enforceable data subject rights and effective legal remedies, pursuant to Article 46(1) and Article 46 (2)(c) of Regulation (EU) 2016/679 and, with respect to data transfers from controllers to processors and/or processors to processors, standard contractual clauses pursuant to Article 28(7) of Regulation (EU) 2016/679, provided they are not modified, except to select the appropriate Module(s) or to add or update information in the Appendix. This does not prevent the Parties from including the standard contractual clauses laid down in these Clauses in a wider contract and/or to add other clauses or additional safeguards, provided that they do not contradict, directly or indirectly, these Clauses or prejudice the fundamental rights or freedoms of data subjects. 
2. These Clauses are without prejudice to obligations to which the data exporter is subject by virtue of Regulation (EU) 2016/679. 

Clause 3 

Third-party beneficiaries 

1. Data subjects may invoke and enforce these Clauses, as third-party beneficiaries, against the data exporter and/or data importer, with the following exceptions: 

1. Clause 1, Clause 2, Clause 3, Clause 6, Clause 7; 
2. Clause 8.1(b), 8.9(a), (c), (d) and (e); 
3. Clause 9(a), (c), (d) and (e); 
4. Clause 12(a), (d) and (f); 
5. Clause 13; 
6. Clause 15.1(c), (d) and (e); 
7. Clause 16(e); 
8. Clause 18(a) and (b); 
9. Paragraph (a) is without prejudice to rights of data subjects under Regulation (EU) 2016/679. 

Clause 4 

Interpretation 

1. Where these Clauses use terms that are defined in Regulation (EU) 2016/679, those terms shall have the same meaning as in that Regulation. 
2. These Clauses shall be read and interpreted in the light of the provisions of Regulation (EU) 2016/679. 
3. These Clauses shall not be interpreted in a way that conflicts with rights and obligations provided for in Regulation (EU) 2016/679. 

Clause 5 

Hierarchy 

In the event of a contradiction between these Clauses and the provisions of related agreements between the Parties, existing at the time these Clauses are agreed or entered into thereafter, these Clauses shall prevail.

Clause 6 

Description of the transfer(s) 

The details of the transfer(s), and in particular the categories of personal data that are transferred and the purpose(s) for which they are transferred, are specified in Annex I.B. 

Clause 7 

Docking clause

[NOT USED] 

SECTION II – OBLIGATIONS OF THE PARTIES

Clause 8 

Data protection safeguards 

The data exporter warrants that it has used reasonable efforts to determine that the data importer is able, through the implementation of appropriate technical and organizational measures, to satisfy its obligations under these Clauses.

8.1 Instructions 

1. The data importer shall process the personal data only on documented instructions from the data exporter. The data exporter may give such instructions throughout the duration of the contract. 
2. The data importer shall immediately inform the data exporter if it is unable to follow those instructions. 

8.2 Purpose limitation 

The data importer shall process the personal data only for the specific purpose(s) of the transfer, as set out in Annex I.B, unless on further instructions from the data exporter. 

8.3 Transparency 

On request, the data exporter shall make a copy of these Clauses, including the Appendix as completed by the Parties, available to the data subject free of charge. To the extent necessary to protect business secrets or other confidential information, including the measures described in Annex II and personal data, the data exporter may redact part of the text of the Appendix to these Clauses prior to sharing a copy, but shall provide a meaningful summary where the data subject would otherwise not be able to understand its content or exercise his/her rights. On request, the Parties shall provide the data subject with the reasons for the redactions, to the extent possible without revealing the redacted information. This Clause is without prejudice to the obligations of the data exporter under Articles 13 and 14 of Regulation (EU) 2016/679. 

8.4 Accuracy 

If the data importer becomes aware that the personal data it has received is inaccurate, or has become outdated, it shall inform the data exporter without undue delay. In this case, the data importer shall cooperate with the data exporter to erase or rectify the data.

8.5 Duration of processing and erasure or return of data 

Processing by the data importer shall only take place for the duration specified in Annex I.B. After the end of the provision of the processing services, the data importer shall, at the choice of the data exporter, delete all personal data processed on behalf of the data exporter and certify to the data exporter that it has done so, or return to the data exporter all personal data processed on its behalf and delete existing copies. Until the data is deleted or returned, the data importer shall continue to ensure compliance with these Clauses. In case of local laws applicable to the data importer that prohibit return or deletion of the personal data, the data importer warrants that it will continue to ensure compliance with these Clauses and will only process it to the extent and for as long as required under that local law. This is without prejudice to Clause 14, in particular the requirement for the data importer under Clause 14(e) to notify the data exporter throughout the duration of the contract if it has reason to believe that it is or has become subject to laws or practices not in line with the requirements under Clause 14(a). 

8.6 Security of processing 

1. The data importer and, during transmission, also the data exporter shall implement appropriate technical and organizational measures to ensure the security of the data, including protection against a breach of security leading to accidental or unlawful destruction, loss, alteration, unauthorized disclosure or access to that data (hereinafter “personal data breach”). In assessing the appropriate level of security, the Parties shall take due account of the state of the art, the costs of implementation, the nature, scope, context and purpose(s) of processing and the risks involved in the processing for the data subjects. The Parties shall in particular consider having recourse to encryption or pseudonymisation, including during transmission, where the purpose of processing can be fulfilled in that manner. In case of pseudonymisation, the additional information for attributing the personal data to a specific data subject shall, where possible, remain under the exclusive control of the data exporter. In complying with its obligations under this paragraph, the data importer shall at least implement the technical and organizational measures specified in Annex II. The data importer shall carry out regular checks to ensure that these measures continue to provide an appropriate level of security. 
2. The data importer shall grant access to the personal data to members of its personnel only to the extent strictly necessary for the implementation, management and monitoring of the contract. It shall ensure that persons authorized to process the personal data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality. 
3. In the event of a personal data breach concerning personal data processed by the data importer under these Clauses, the data importer shall take appropriate measures to address the breach, including measures to mitigate its adverse effects. The data importer shall also notify the data exporter without undue delay after having become aware of the breach. Such notification shall contain the details of a contact point where more information can be obtained, a description of the nature of the breach (including, where possible, categories and approximate number of data subjects and personal data records concerned), its likely consequences and the measures taken or proposed to address the breach including, where appropriate, measures to mitigate its possible adverse effects. Where, and in so far as, it is not possible to provide all information at the same time, the initial notification shall contain the information then available and further information shall, as it becomes available, subsequently be provided without undue delay. 
4. The data importer shall cooperate with and assist the data exporter to enable the data exporter to comply with its obligations under Regulation (EU) 2016/679, in particular to notify the competent supervisory authority and the affected data subjects, taking into account the nature of processing and the information available to the data importer. 

8.7 Sensitive data 

Where the transfer involves personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, genetic data, or biometric data for the purpose of uniquely identifying a natural person, data concerning health or a person’s sex life or sexual orientation, or data relating to criminal convictions and offenses (hereinafter “sensitive data”), the data importer shall apply the specific restrictions and/or additional safeguards described in Annex I.B. 

8.8 Onward transfers 

The data importer shall only disclose the personal data to a third party on documented instructions from the data exporter. In addition, the data may only be disclosed to a third party located outside the European Union (in the same country as the data importer or in another third country, hereinafter “onward transfer”) if the third party is or agrees to be bound by these Clauses, under the appropriate Module, or if: 

1. the onward transfer is to a country benefiting from an adequacy decision pursuant to Article 45 of Regulation (EU) 2016/679 that covers the onward transfer; 
2. the third party otherwise ensures appropriate safeguards pursuant to Articles 46 or 47 Regulation of (EU) 2016/679 with respect to the processing in question; 
3. the onward transfer is necessary for the establishment, exercise or defense of legal claims in the context of specific administrative, regulatory or judicial proceedings; or 
4. the onward transfer is necessary in order to protect the vital interests of the data subject or of another natural person.

Any onward transfer is subject to compliance by the data importer with all the other safeguards under these Clauses, in particular purpose limitation.

8.9 Documentation and compliance 

1. The data importer shall promptly and adequately deal with enquiries from the data exporter that relate to the processing under these Clauses. 
2. The Parties shall be able to demonstrate compliance with these Clauses. In particular, the data importer shall keep appropriate documentation on the processing activities carried out on behalf of the data exporter. 
3. The data importer shall make available to the data exporter all information necessary to demonstrate compliance with the obligations set out in these Clauses and at the data exporter’s request, allow for and contribute to audits of the processing activities covered by these Clauses, at reasonable intervals or if there are indications of non-compliance. In deciding on a review or audit, the data exporter may take into account relevant certifications held by the data importer. 
4. The data exporter may choose to conduct the audit by itself or mandate an independent auditor. Audits may include inspections at the premises or physical facilities of the data importer and shall, where appropriate, be carried out with reasonable notice. 
5. The Parties shall make the information referred to in paragraphs (b) and (c), including the results of any audits, available to the competent supervisory authority on request. 

Clause 9 

Use of Subprocessors

1. The data importer has the data exporter’s general authorisation for the engagement of Subprocessor(s) from an agreed list. The data importer shall specifically inform the data exporter in writing of any intended changes to that list through the addition or replacement of Subprocessors at least 14 days in advance, thereby giving the data exporter sufficient time to be able to object to such changes prior to the engagement of the Subprocessor(s). The data importer shall provide the data exporter with the information necessary to enable the data exporter to exercise its right to object. 
2. Where the data importer engages a Subprocessor to carry out specific processing activities (on behalf of the data exporter), it shall do so by way of a written contract that provides for, in substance, the same data protection obligations as those binding the data importer under these Clauses, including in terms of third-party beneficiary rights for data subjects. The Parties agree that, by complying with this Clause, the data importer fulfills its obligations under Clause 8.8. The data importer shall ensure that the Subprocessor complies with the obligations to which the data importer is subject pursuant to these Clauses. 
3. The data importer shall provide, at the data exporter’s request, a copy of such a Subprocessor agreement and any subsequent amendments to the data exporter. To the extent necessary to protect business secrets or other confidential information, including personal data, the data importer may redact the text of the agreement prior to sharing a copy. 
4. The data importer shall remain fully responsible to the data exporter for the performance of the Subprocessor’s obligations under its contract with the data importer. The data importer shall notify the data exporter of any failure by the Subprocessor to fulfill its obligations under that contract. 
5. The data importer shall agree a third-party beneficiary clause with the Subprocessor whereby – in the event the data importer has factually disappeared, ceased to exist in law or has become insolvent – the data exporter shall have the right to terminate the Subprocessor contract and to instruct the Subprocessor to erase or return the personal data. 

Clause 10 

Data subject rights

1. The data importer shall promptly notify the data exporter of any request it has received from a data subject. It shall not respond to that request itself unless it has been authorized to do so by the data exporter. 
2. The data importer shall assist the data exporter in fulfilling its obligations to respond to data subjects’ requests for the exercise of their rights under Regulation (EU) 2016/679. In this regard, the Parties shall set out in Annex II the appropriate technical and organizational measures, taking into account the nature of the processing, by which the assistance shall be provided, as well as the scope and the extent of the assistance required. 
3. In fulfilling its obligations under paragraphs (a) and (b), the data importer shall comply with the instructions from the data exporter. 

Clause 11 

Redress 

1. The data importer shall inform data subjects in a transparent and easily accessible format, through individual notice or on its website, of a contact point authorized to handle complaints. It shall deal promptly with any complaints it receives from a data subject. 
2. In case of a dispute between a data subject and one of the Parties as regards compliance with these Clauses, that Party shall use its best efforts to resolve the issue amicably in a timely fashion. The Parties shall keep each other informed about such disputes and, where appropriate, cooperate in resolving them. 
3. Where the data subject invokes a third-party beneficiary right pursuant to Clause 3, the data importer shall accept the decision of the data subject to: 

1. lodge a complaint with the supervisory authority in the Member State of his/her habitual residence or place of work, or the competent supervisory authority pursuant to Clause 13; 
2. refer the dispute to the competent courts within the meaning of Clause 18. 

4. The Parties accept that the data subject may be represented by a not-for-profit body, organization or association under the conditions set out in Article 80(1) of Regulation (EU) 2016/679. 
5. The data importer shall abide by a decision that is binding under the applicable EU or Member State law. 
6. The data importer agrees that the choice made by the data subject will not prejudice his/her substantive and procedural rights to seek remedies in accordance with applicable laws. 

Clause 12 

Liability

1. Each Party shall be liable to the other Party/ies for any damages it causes the other Party/ies by any breach of these Clauses. 
2. The data importer shall be liable to the data subject, and the data subject shall be entitled to receive compensation, for any material or non-material damages the data importer or its Subprocessor causes the data subject by breaching the third-party beneficiary rights under these Clauses. 
3. Notwithstanding paragraph (b), the data exporter shall be liable to the data subject, and the data subject shall be entitled to receive compensation, for any material or non-material damages the data exporter or the data importer (or its Subprocessor) causes the data subject by breaching the third-party beneficiary rights under these Clauses. This is without prejudice to the liability of the data exporter and, where the data exporter is a processor acting on behalf of a controller, to the liability of the controller under Regulation (EU) 2016/679 or Regulation (EU) 2018/1725, as applicable. 
4. The Parties agree that if the data exporter is held liable under paragraph (c) for damages caused by the data importer (or its Subprocessor), it shall be entitled to claim back from the data importer that part of the compensation corresponding to the data importer’s responsibility for the damage. 
5. Where more than one Party is responsible for any damage caused to the data subject as a result of a breach of these Clauses, all responsible Parties shall be jointly and severally liable and the data subject is entitled to bring an action in court against any of these Parties. 
6. The Parties agree that if one Party is held liable under paragraph (e), it shall be entitled to claim back from the other Party/ies that part of the compensation corresponding to its / their responsibility for the damage. 
7. The data importer may not invoke the conduct of a Subprocessor to avoid its own liability. 

Clause 13 

Supervision

1. The supervisory authority of one of the Member States in which the data subjects whose personal data is transferred under these Clauses in relation to the offering of goods or services to them, or whose behavior is monitored, are located, as indicated in Annex I.C, shall act as competent supervisory authority. 
2. The data importer agrees to submit itself to the jurisdiction of and cooperate with the competent supervisory authority in any procedures aimed at ensuring compliance with these Clauses. In particular, the data importer agrees to respond to enquiries, submit to audits and comply with the measures adopted by the supervisory authority, including remedial and compensatory measures. It shall provide the supervisory authority with written confirmation that the necessary actions have been taken. 

SECTION III – LOCAL LAWS AND OBLIGATIONS IN CASE OF ACCESS BY PUBLIC AUTHORITIES

Clause 14 

Local laws and practices affecting compliance with the Clauses

1. The Parties warrant that they have no reason to believe that the laws and practices in the third country of destination applicable to the processing of the personal data by the data importer, including any requirements to disclose personal data or measures authorizing access by public authorities, prevent the data importer from fulfilling its obligations under these Clauses. This is based on the understanding that laws and practices that respect the essence of the fundamental rights and freedoms and do not exceed what is necessary and proportionate in a democratic society to safeguard one of the objectives listed in Article 23(1) of Regulation (EU) 2016/679, are not in contradiction with these Clauses. 
2. The Parties declare that in providing the warranty in paragraph (a), they have taken due account in particular of the following elements: 

1. the specific circumstances of the transfer, including the length of the processing chain, the number of actors involved and the transmission channels used; intended onward transfers; the type of recipient; the purpose of processing; the categories and format of the transferred personal data; the economic sector in which the transfer occurs; the storage location of the data transferred; 
2. the laws and practices of the third country of destination– including those requiring the disclosure of data to public authorities or authorizing access by such authorities – relevant in light of the specific circumstances of the transfer, and the applicable limitations and safeguards;
3. any relevant contractual, technical or organizational safeguards put in place to supplement the safeguards under these Clauses, including measures applied during transmission and to the processing of the personal data in the country of destination. 

3. The data importer warrants that, in carrying out the assessment under paragraph (b), it has made its best efforts to provide the data exporter with relevant information and agrees that it will continue to cooperate with the data exporter in ensuring compliance with these Clauses. 
4. The Parties agree to document the assessment under paragraph (b) and make it available to the competent supervisory authority on request. 
5. The data importer agrees to notify the data exporter promptly if, after having agreed to these Clauses and for the duration of the contract, it has reason to believe that it is or has become subject to laws or practices not in line with the requirements under paragraph (a), including following a change in the laws of the third country or a measure (such as a disclosure request) indicating an application of such laws in practice that is not in line with the requirements in paragraph (a). 
6. Following a notification pursuant to paragraph (e), or if the data exporter otherwise has reason to believe that the data importer can no longer fulfill its obligations under these Clauses, the data exporter shall promptly identify appropriate measures (e.g. technical or organizational measures to ensure security and confidentiality) to be adopted by the data exporter and/or data importer to address the situation. The data exporter shall suspend the data transfer if it considers that no appropriate safeguards for such transfer can be ensured, or if instructed by the competent supervisory authority to do so. In this case, the data exporter shall be entitled to terminate the contract, insofar as it concerns the processing of personal data under these Clauses. If the contract involves more than two Parties, the data exporter may exercise this right to termination only with respect to the relevant Party, unless the Parties have agreed otherwise. Where the contract is terminated pursuant to this Clause, Clause 16(d) and (e) shall apply. 

Clause 15 

Obligations of the data importer in case of access by public authorities

15.1 Notification 

1. The data importer agrees to notify the data exporter and, where possible, the data subject promptly (if necessary with the help of the data exporter) if it: 

1. receives a legally binding request from a public authority, including judicial authorities, under the laws of the country of destination for the disclosure of personal data transferred pursuant to these Clauses; such notification shall include information about the personal data requested, the requesting authority, the legal basis for the request and the response provided; or 
2. becomes aware of any direct access by public authorities to personal data transferred pursuant to these Clauses in accordance with the laws of the country of destination; such notification shall include all information available to the importer. 

2. If the data importer is prohibited from notifying the data exporter and/or the data subject under the laws of the country of destination, the data importer agrees to use its best efforts to obtain a waiver of the prohibition, with a view to communicating as much information as possible, as soon as possible. The data importer agrees to document its best efforts in order to be able to demonstrate them on request of the data exporter. 
3. Where permissible under the laws of the country of destination, the data importer agrees to provide the data exporter, at regular intervals for the duration of the contract, with as much relevant information as possible on the requests received (in particular, number of requests, type of data requested, requesting authority/ies, whether requests have been challenged and the outcome of such challenges, etc.).
4. The data importer agrees to preserve the information pursuant to paragraphs (a) to (c) for the duration of the contract and make it available to the competent supervisory authority on request. 
5. Paragraphs (a) to (c) are without prejudice to the obligation of the data importer pursuant to Clause 14(e) and Clause 16 to inform the data exporter promptly where it is unable to comply with these Clauses. 

15.2 Review of legality and data minimisation 

1. The data importer agrees to review the legality of the request for disclosure, in particular whether it remains within the powers granted to the requesting public authority, and to challenge the request if, after careful assessment, it concludes that there are reasonable grounds to consider that the request is unlawful under the laws of the country of destination, applicable obligations under international law and principles of international comity. The data importer shall, under the same conditions, pursue possibilities of appeal. When challenging a request, the data importer shall seek interim measures with a view to suspending the effects of the request until the competent judicial authority has decided on its merits. It shall not disclose the personal data requested until required to do so under the applicable procedural rules. These requirements are without prejudice to the obligations of the data importer under Clause 14(e). 
2. The data importer agrees to document its legal assessment and any challenge to the request for disclosure and, to the extent permissible under the laws of the country of destination, make the documentation available to the data exporter. It shall also make it available to the competent supervisory authority on request. 
3. The data importer agrees to provide the minimum amount of information permissible when responding to a request for disclosure, based on a reasonable interpretation of the request. 

SECTION IV – FINAL PROVISIONS

Clause 16 

Non-compliance with the Clauses and termination 

1. The data importer shall promptly inform the data exporter if it is unable to comply with these Clauses, for whatever reason. 
2. In the event that the data importer is in breach of these Clauses or unable to comply with these Clauses, the data exporter shall suspend the transfer of personal data to the data importer until compliance is again ensured or the contract is terminated. This is without prejudice to Clause 14(f). 
3. The data exporter shall be entitled to terminate the contract, insofar as it concerns the processing of personal data under these Clauses, where: 

1. the data exporter has suspended the transfer of personal data to the data importer pursuant to paragraph (b) and compliance with these Clauses is not restored within a reasonable time and in any event within one month of suspension; 
2. the data importer is in substantial or persistent breach of these Clauses; or 
3. the data importer fails to comply with a binding decision of a competent court or supervisory authority regarding its obligations under these Clauses. 

In these cases, it shall inform the competent supervisory authority of such non-compliance. Where the contract involves more than two Parties, the data exporter may exercise this right to termination only with respect to the relevant Party, unless the Parties have agreed otherwise. 

4. Personal data that has been transferred prior to the termination of the contract pursuant to paragraph (c) shall at the choice of the data exporter immediately be returned to the data exporter or deleted in its entirety. The same shall apply to any copies of the Data. The data importer shall certify the deletion of the data to the data exporter. Until the data is deleted or returned, the data importer shall continue to ensure compliance with these Clauses. In case of local laws applicable to the data importer that prohibit the return or deletion of the transferred personal data, the data importer warrants that it will continue to ensure compliance with these Clauses and will only process the data to the extent and for as long as required under that local law. 
5. Either Party may revoke its agreement to be bound by these Clauses where (i) the European Commission adopts a decision pursuant to Article 45(3) of Regulation (EU) 2016/679 that covers the transfer of personal data to which these Clauses apply; or (ii) Regulation (EU) 2016/679 becomes part of the legal framework of the country to which the personal data is transferred. This is without prejudice to other obligations applying to the processing in question under Regulation (EU) 2016/679. 

Clause 17 

Governing law

These Clauses shall be governed by the law of one of the EU Member States, provided such law allows for third-party beneficiary rights. The Parties agree that this shall be the law of the Republic of Ireland.

Clause 18

Choice of forum and jurisdiction

1. Any dispute arising from these Clauses shall be resolved by the courts of an EU Member State.   
2. The Parties agree that those shall be the courts of the Republic of Ireland.
3. A data subject may also bring legal proceedings against the data exporter and/or data importer before the courts of the Member State in which he/she has his/her habitual residence. 
4. The Parties agree to submit themselves to the jurisdiction of such courts. 

APPENDIX TO THE STANDARD CONTRACTUAL CLAUSES

This Appendix forms part of the Standard Contractual Clauses and must be completed by the parties.

ANNEX I

ANNEX II

TECHNICAL AND ORGANIZATIONAL MEASURES INCLUDING TECHNICAL AND ORGANIZATIONAL MEASURES TO ENSURE THE SECURITY OF THE DATA

Description of the technical and organizational security measures implemented by the data importer:

Infrastructure Level

1. For all its infrastructure services, Pretaa uses Amazon’s Web Service (AWS) Infrastructure employed as either PaaS (Platform as a Service) or IaaS (Infrastructure as a Service) and all data is stored in highly secure AWS data centers. It is standard policy for data to be encrypted at rest.

2. Pretaa platform is only accessible over a TLS (Transport Layer Security) connection which is used to establish an encrypted link between our application and front-end clients. All services inside the AWS infrastructure also use TLS.

3. Pretaa Platform employs a standard three-tier architecture with functions distributed across Presentation, Application and Datastore tiers. The front-end that runs in the browser is coded in React (front-end web application framework mainly maintained by Facebook and the community). We use Node.JS for the backend application framework, which in turn interfaces with Amazon’s AWS infrastructure and database.

4. The application server and database run in a secured private environment behind a load balancer. A security policy is established so the Application server can perform read/write operations on the database. Port 443 for HTTPS is the only external-facing port that is open on the load balancer. 

5. All patient’s data of a facility is stored in databases with very strict access controls, ensuring the isolation and safety of your data. 
6. There is no public-facing API and therefore does not introduce any vulnerabilities associated with it.

Application Level

1. Pretaa platform provides partitioned access to data based on the user’s roles. We limit access to information and application functionality based on user roles and default access. We do not allow the elevation of privileges unless designated by the customer. 
   
2. Access to the platform is always protected by authentication. This is done using a password. Pretaa stores only hashed passwords. At no point is Pretaa privy to a customer’s password.
   
3. We make use of cookies to keep track of the user’s session. Our cookies are signed (to prevent tampering) and are set to expire after 1 hour of inactivity – upon expiry, the user is forced to perform authentication again
   
4. API parameters passed to the backend are validated against expected fields and their ranges. 
   
5. Pretaa platform stores your patient’’s health information from smart device providers like FitBit, on our servers in a secure fashion. A patient always has the ability to download or delete all the data we collect. This data is used for health analysis and deductions that the platform makes.
   
6. Pretaa only consumes what is needed from your EHR systems for us to derive value. We never write to or pollute your EHR system. We have an option to upload our analysis reports to the facility’s EHR if they apply for it.
   
7. Pretaa mobile application will require access to ‘Push Notifications’, ‘Face Id’ and ‘Geolocation’.
   
8. Whenever we are sending out patient names outside the system, for things like emails, push notifications etc; we only show the first 2 characters of the last name. This ensure patient privacy outside of the Pretaa application.
   
9. Pretaa’s mobile applications have all passed their respective stores’ security requirements and data privacy requirements.
   
10. All Pretaa applications have been penetration tested, with particular attention being paid to the Open Web Application Security Project (OWASP) “Top 10” web application security risks. These risks are kept current annually and are considered an industry standard list upon which to guard against.