This Data Processing Addendum (“DPA”) forms a part of Customer Terms of Service found at https://www.carepatron.com/terms-of-service (the “Agreement”).
By accepting the Agreement, Customer enters into this DPA on behalf of itself and, to the extent required under applicable Data Protection Laws, in the name and on behalf of its Controller Affiliates (defined below). For the purposes of this DPA only, and except where indicated otherwise, the term “Customer” shall include Customer and Controller Affiliates. All capitalised terms not defined herein shall have the meaning set forth in the Agreement.
In the course of providing the Services under the Agreement, Carepatron may Process Customer Data (such terms defined below) on behalf of Customer and where Carepatron Processes such Customer Data on behalf of Customer, the Parties agree to comply with the terms and conditions in this DPA in connection with such Customer Data.
How this DPA applies to the Customer and its Affiliates
This DPA is an addendum to and forms part of the Agreement. In such case, the Carepatron entity that is party to the Agreement is party to this DPA.
“Affiliate” means any entity that directly or indirectly controls, is controlled by, or is under common control with the subject entity. “Control,” for purposes of this definition, means direct or indirect ownership or control of more than 50% of the voting interests of the subject entity.
“Authorised User” define as any person who is authorised by Carepatron to use the Services.
“Controller Affiliate” means any of Customer's Affiliate(s) (a) (i) that are subject to applicable Data Protection Laws, and (ii) permitted to use the Services pursuant to the Agreement between Customer and Carepatron, but are not a “Customer” as defined under the Agreement, (b) if and to the extent Carepatron processes Customer Data for which such Affiliate(s) qualify as the Controller.
“Customer” means if you are representing an entity, that entity, otherwise, means you as an individual.
“Customer Data” means all Personal Data Processed by Carepatron (or its appointed Sub-processors) on behalf of Customer, pursuant to the provision of the Services.
“Data Protection Laws” means all laws and regulations, including laws and binding regulations of the United Kingdom applicable to the Processing of Personal Data under the Agreement, and “Controller”, “Data Subject”, “Personal Data”, “Processing”, “Processor”and “Supervisory Authority” shall have the meanings set out in Data Protection Laws (and related terms such as “Processed” shall have corresponding meanings).
“Carepatron” means Care patron Ltd, a company incorporated in Tauranga, New Zealand, and constituted under the laws of New Zealand.
“Security Practices Datasheet” means Carepatron’s Security Practices Datasheet, as updated from time to time, and currently available at https://www.carepatron.com/healthcare-compliance.
“Services” means the provision of the Carepatron software application and related platform, and services related thereto (such as customer support).
“Standard Contractual Clauses” means module two of the standard contractual clauses for the transfer of personal data to third countries pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council adopted by European Commission decision of 4 June 2021 and published under document number C/2021/3972, as amended by the UK Addendum to the EU Commission Standard Contractual Clauses issued by the UK Information Commissioner under section 119A(1) Data Protection Act 2018.
“Sub-processor” means any entity engaged by Carepatron to Process Customer Data in connection with the Services.
2. Processing of personal data
2.1. Roles of the Parties. The parties acknowledge and agree that with regard to the Processing of Customer Data, Customer is the Controller, Carepatron is the Processor and that Carepatron will engage Sub-processors pursuant to the requirements set forth in Section 4 “Sub-processors” below.
2.2. Customer’s Processing of Personal Data. Customer shall, in its use of the Services and provision of instructions, Process Personal Data in accordance with the requirements of applicable Data Protection Law. Customer shall have sole responsibility for the accuracy, quality, and legality of Personal Data and the means by which Customer acquired Personal Data.
2.3. Carepatron’s Processing of Customer Data. As Customer’s Processor, Carepatron shall only Process Customer Data for the following purposes: (i) Processing in accordance with the Agreement; (ii) Processing initiated by Authorised Users in their use of the Services; and (iii) Processing to comply with other reasonable instructions provided by Customer from time to time (e.g., via email or support tickets) that are consistent with the terms of the Agreement (individually and collectively, the “Purpose”). Carepatron acts on behalf of and upon the instructions of Customer in carrying out the Purpose.
2.4. Details of the Processing. The subject-matter of Processing of Customer Data by Carepatron is as described in the Purpose in Section 2.3. The duration of the Processing, the nature and purpose of the Processing, the types of Customer Data and categories of Data Subjects Processed under this DPA are further specified in Exhibit A (Description of Processing Activities) to this DPA.
3. Rights of data subjects
3.1. Data Subject Requests. Carepatron shall, to the extent legally permitted, promptly notify Customer if Carepatron receives any requests from a Data Subject to exercise the following Data Subject rights in relation to Customer Data: access, rectification, restriction of Processing, erasure (“right to be forgotten”), data portability, objection to the Processing, or to not be subject to an automated individual decision making (each, a “Data Subject Request”). Taking into account the nature of the Processing, Carepatron shall assist Customer by appropriate technical and organisational measures, insofar as this is possible, for the fulfilment of Customer’s obligation to respond to a Data Subject Request under applicable Data Protection Laws. In addition, to the extent Customer, in its use of the Services, does not have the ability to address a Data Subject Request, Carepatron shall, upon Customer’s request, provide commercially reasonable efforts to assist Customer in responding to such Data Subject Request, to the extent Carepatron is legally permitted to do so and the response to such Data Subject Request is required under applicable Data Protection Laws. To the extent legally permitted, Customer shall be responsible for any costs arising from Carepatron’s provision of such assistance, including any fees associated with provision of additional functionality.
4.1. Appointment of Sub-processors. Customer acknowledges and agrees that (a) Carepatron’s Affiliates may be retained as Sub-processors through written agreement with Carepatron and (b) Carepatron and Carepatron’s Affiliates respectively may engage third-party Sub-processors in connection with the provision of the Services. As a condition to permitting a third-party Sub-processor to Process Customer Data, Carepatron or a Carepatron Affiliate will enter into a written agreement with each Sub-processor containing data protection obligations that provide at least the same level of protection for Customer Data as those in this DPA, to the extent applicable to the nature of the Services provided by such Sub-processor. Customer acknowledges that Carepatron is located in New Zealand and is involved in providing the Services to Customer directly. Customer agrees to enter into the Standard Contractual Clauses set out in Exhibit B and acknowledges that Sub-processors may be appointed by Carepatron in accordance with Clause 9 of Exhibit B.
4.2. List of Current Sub-processors and Notification of New Sub-processors. A current list of Sub-processors for the Services, including the identities of those Sub-processors and their country of location, is accessible via https://help.carepatron.com/en/articles/8216691-carepatron-subprocessors (“Sub-processor Lists”). Customer may receive notifications of new
Sub-processors by emailing to firstname.lastname@example.org to ‘Subscribe’, and if a Customer contact subscribes, Carepatron shall provide the subscriber with notification of new Sub-processor(s) before authorising such new Sub-processor(s) to Process Customer Data in connection with the provision of the applicable Services. Customer hereby agrees that the aforementioned means of notification shall discharge Carepatron’s notification provisions under Clause 9 of Exhibit B.
4.3. Objection Right for New Sub-processors. Customer may reasonably object to Carepatron’s use of a new Sub-processor (e.g., if making Customer Data available to the Sub-processor may violate applicable Data Protection Law or weaken the protections for such Customer Data) by notifying Carepatron promptly via email to email@example.com within ten (10) business days after receipt of Carepatron’s notice in accordance with the mechanism set out in Section 4.2. Such notice shall explain the reasonable grounds for the objection. In the event Customer objects to a new Sub-processor, as permitted in the preceding sentence, Carepatron will use commercially reasonable efforts to make available to Customer a change in the Services or recommend a commercially reasonable change to Customer’s configuration or use of the Services to avoid Processing of Customer Data by the objected-to new Sub-processor without unreasonably burdening Customer. If Carepatron is unable to make available such change within a reasonable period of time, which shall not exceed thirty (30) days, either party may terminate without penalty the applicable Agreement with respect only to those Services which cannot be provided by Carepatron without the use of the objected-to new Sub-processor by providing written notice to Carepatron. Carepatron will refund Customer any prepaid fees covering the remainder of the term of such Agreement following the effective date of termination with respect to such terminated Services, without imposing a penalty for such termination on Customer.
4.4. Liability. Carepatron shall be liable for the acts and omissions of its
Sub-processors to the same extent Carepatron would be liable if performing the Services of each Sub-processor directly under the terms of this DPA.
5.1. Controls for the Protection of Customer Data. Carepatron shall maintain appropriate technical and organisational measures for protection of the security (including protection against unauthorised or unlawful Processing and against accidental or unlawful destruction, loss or alteration or damage, unauthorised disclosure of, or access to, Customer Data), confidentiality and integrity of Customer Data, as set forth in the Security Practices Datasheet. Carepatron regularly monitors compliance with these measures. Carepatron will not materially decrease the overall security of the Services during a subscription term.
5.2. Third-Party Certifications and Audits. Carepatron has access to the third-party certifications and audits set forth in the Security Practices Datasheet. Upon Customer’s request, and subject to the confidentiality obligations set forth in the Agreement, Carepatron shall make available to Customer (or Customer’sindependent, third-party auditor) information regarding the Carepatron’s compliance with the obligations set forth in this DPA in the form of the third-party certifications and audits set forth in the Security Practices Datasheet. Customer may contact Carepatron via email to firstname.lastname@example.org to request an on-site audit of Carepatron’s procedures relevant to the protection of Customer Data, but only to the extent required under applicable Data Protection Law. Customer shall reimburse Carepatron for any time expended for any such on-site audit at Carepatron’s then-current rates, which shall be made available to Customer upon request. Before the commencement of any such on-site audit, Customer and Carepatron shall mutually agree upon the scope, timing, and duration of the audit, in addition to the reimbursement rate for which Customer shall be responsible. All reimbursement rates shall be reasonable, taking into account the resources expended by Carepatron. Customer shall promptly notify Carepatron with information regarding any non-compliance discovered during the course of an audit, and Carepatron shall use commercially reasonable efforts to address any confirmed non-compliance.
6. Personal data incident management and notification, DPIAs and prior consultation
Carepatron maintains security incident management policies and procedures specified in the Security Practices Datasheet. Carepatron shall notify Customer without undue delay of any breach relating to Customer Data (within the meaning of applicable Data Protection Law) of which Carepatron becomes aware and which may require a notification to be made to a Supervisory Authority or Data Subject under applicable Data Protection Law or which Carepatron is required to notify to Customer under applicable Data Protection Law (a “Customer Data Incident”). Carepatron shall provide commercially reasonable cooperation and assistance in identifying the cause of such Customer Data Incident and take commercially reasonable steps to remediate the cause to the extent the remediation is within Carepatron’s control. Except as required by applicable Data Protection Law, the obligations herein shall not apply to incidents that are caused by Customer, Authorised Users and/or any Non-Carepatron Products.
Upon Customer’s request, Carepatron shall provide Customer with reasonable cooperation and assistance needed to fulfil Customer’s obligation under Data Protection Laws to carry out a data protection impact assessment related to Customer’s use of the Services, to the extent Customer does not otherwise have access to the relevant information, and to the extent such information is available to Carepatron. Carepatron shall provide reasonable assistance to Customer in the cooperation or prior consultation with a Supervisory Authority, to the extent required under Data Protection Laws.
7. Return and deletion of personal data
Upon termination of the Services for which Carepatron is Processing Customer Data, Carepatron shall, upon Customer’s request, and subject to the limitations described in the Agreement and the Security Practices Datasheet, return all Customer Data in Carepatron’s possession to Customer or securely destroy such Customer Data and demonstrate to the satisfaction of Customer that it has taken such measures, unless applicable law prevents it from returning or destroying all or part of Customer Data.
8. Controller Affiliates
8.1. Contractual Relationship. The parties acknowledge and agree that, by accepting the Agreement, Customer enters into the DPA on behalf of itself and, as applicable, in the name and on behalf of its Controller Affiliates, thereby establishing a separate DPA between Carepatron and each such Controller Affiliate subject to the provisions of the Agreement and this Section 8 and Section 9. Each Controller Affiliate agrees to be bound by the obligations under this DPA and, to the extent applicable, the Agreement. For the avoidance of doubt, a Controller Affiliate is not and does not become a party to the Agreement, and is only a party to the DPA. All access to and use of the Services by Controller Affiliates must comply with the terms and conditions of the Agreement and any violation of the terms and conditions of the Agreement by a Controller Affiliate shall be deemed a violation by Customer.
8.2. Communication. The Customer that is the contracting party to the Agreement shall remain responsible for coordinating all communication with Carepatron under this DPA and be entitled to make and receive any communication in relation to this DPA on behalf of its Controller Affiliates.
8.3. Rights of Controller Affiliates. If a Controller Affiliate becomes a party to the DPA with Carepatron, it shall, to the extent required under applicable Data Protection Laws, also be entitled to exercise the rights and seek remedies under this DPA, subject to the following:
8.3.1. Except where applicable Data Protection Laws require the Controller Affiliate to exercise a right or seek any remedy under this DPA against Carepatron directly by itself, the parties agree that (i) solely the Customer that is the contracting party to the Agreement shall exercise any such right or seek any such remedy on behalf of the Controller Affiliate, and (ii) the Customer that is the contracting party to the Agreement shall exercise any such rights under this DPA not separately for each Controller Affiliate individually but in a combined manner for all of its Controller Affiliates together (as set forth, for example, in Section 8.3.2, below).
8.3.2. The parties agree that the Customer that is the contracting party to the Agreement shall, if carrying out an on-site audit of the Carepatron procedures relevant to the protection of Customer Data, take all reasonable measures to limit any impact on Carepatron by combining, to the extent reasonably possible, several audit requests carried out on behalf of different Controller Affiliates in one single audit.
9. Limitation of Liability
Each party’s and all of its Affiliates’ liability, taken together in the aggregate, arising out of or related to this DPA, and all DPAs between Controller Affiliates and Carepatron, whether in contract, tort or under any other theory of liability, is subject to the ‘Limitation of Liability’ section of the Agreement, and any reference in such section to the liability of a party means the aggregate liability of that party and all of its Affiliates under the Agreement and all DPAs together.
For the avoidance of doubt, Carepatron and its Affiliates’ total liability for all claims from the Customer and all of its Controller Affiliates arising out of or related to the Agreement and each DPA shall apply in the aggregate for all claims under both the Agreement and all DPAs established under the Agreement, including by Customer and all Controller Affiliates, and, in particular, shall not be understood to apply individually and severally to Customer and/or to any Controller Affiliate that is a contractual party to any such DPA.
10. Legal Effect
This DPA shall only become legally binding between Customer and Carepatron when Customer accepts the Agreement. If Customer has previously executed a UK Data Processing Addendum with Carepatron, this DPA supersedes and replaces such prior UK Data Processing Addendum.
11. Governing Law
This DPA and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by, and construed in accordance with, the laws of Ireland.
List of Exhibits
Exhibit A: Description of Processing Activities
Exhibit B: Standard Contractual Clauses
Description of Processing Activities
Nature and purpose of the processing
To allow Carepatron to deliver the Services to Customer, together with the Purpose.
Nature and purpose of sub-processing
To allow Carepatron to outsource certain elements of the Services, together with the Purpose.
Duration of processing
For the term of the Agreement.
Customer may submit Personal Data to the Services, the extent of which is determined and controlled by Customer and which may include, but is not limited to, Personal Data relating to the following categories of Data Subject:
- Authorised Users;
- employees of Customer;
- consultants of Customer;
- contractors of Customer;
- agents of Customer; and/or
- third parties with whom the Customer conducts business, or about whom the Customer obtains information in the course of and for the purpose of conducting business.
Categories of data
The Personal Data transferred concern the following categories of data: Any Personal Data comprised in Customer Data, as defined in the Agreement.
Special categories of data
Customer may submit Personal Data to Carepatron through the Services, the extent of which is determined and controlled by Customer in compliance with applicable Data Protection Law and which may concern the following special categories of data, if any:
- racial or ethnic origin;
- political opinions;
- religious or philosophical beliefs;
- trade-union membership
- genetic or biometric data;
- health; and
- data concerning a person’s sex life or sexual orientation.
The Personal Data transferred will be Processed in accordance with the Agreement and any Order Form and may be subject to the following Processing activities:
- storage and other Processing necessary to provide, maintain, and update the Services provided to Customer;
- to provide customer and technical support to Customer; and
- disclosures in accordance with the Agreement, as compelled by law.
Frequency of the transfer
The transfer shall be continuous and for the duration the Services are provided to Customer.
Standard Contractual Clauses
Purpose and scope
(a) 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.
(b) The Parties:
(i) 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
(ii) 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”).
(c) These Clauses apply with respect to the transfer of personal data as specified in Annex I.B.
(d) The Appendix to these Clauses containing the Annexes referred to therein forms an integral part of these Clauses.
Effect and invariability of the Clauses
(a) 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 additionalsafeguards, provided that they do not contradict, directly or indirectly, these Clauses or prejudice the fundamental rights or freedoms of data subjects.
(e) These Clauses are without prejudice to obligations to which the data exporter is subject by virtue of Regulation (EU) 2016/679.
(a) Data subjects may invoke and enforce these Clauses, as third-party beneficiaries, against the data exporter and/or data importer, with the following exceptions:
(i) Clause 1, Clause 2, Clause 3, Clause 6, Clause 7;
(ii) Clause 8.1(b), 8.9(a), (c), (d) and (e);
(iii) Clause 9(a), (c), (d) and (e);
(iv) Clause 12(a), (d) and (f);
(v) Clause 13;
(vi) Clause 15.1(c), (d) and (e);
(vii) Clause 16(e);
(viii) Clause 18(a) and (b).
(b) Paragraph (a) is without prejudice to rights of data subjects under Regulation (EU) 2016/679.
(a) Where these Clauses use terms that are defined in Regulation (EU) 2016/679, those terms shall have the same meaning as in that Regulation.
(b) These Clauses shall be read and interpreted in the light of the provisions of Regulation (EU) 2016/679.
(c) These Clauses shall not be interpreted in a way that conflicts with rights and obligations provided for in Regulation (EU) 2016/679.Clause 5
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.
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.
(a) An entity that is not a Party to these Clauses may, with the agreement of the Parties, accede to these Clauses at any time, either as a data exporter or as a data importer, by completing the Appendix and signing Annex I.A.
(b) Once it has completed the Appendix and signed Annex I.A, the acceding entity shall become a Party to these Clauses and have the rights and obligations of a data exporter or data importer in accordance with its designation in Annex I.A.
(c) The acceding entity shall have no rights or obligations arising under these Clauses from the period prior to becoming a Party.
SECTION II – OBLIGATIONS OF THE PARTIES
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 organisational measures, to satisfy its obligations under these Clauses.
(a) 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.
(b) 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.
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 the 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.
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
(a) The data importer and, during transmission, also the data exporter shall implement appropriate technical and organisational measures to ensure the security of the data, including protection against a breach of security leading to accidental or unlawful destruction, loss, alteration, unauthorised 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 organisational 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.
(b) 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 authorised to process the personal data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality.
(c) 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.
(d) 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 offences (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:
(i) the onward transfer is to a country benefitting from an adequacy decision pursuant to Article 45 of Regulation (EU) 2016/679 that covers the onward transfer;
(ii) 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;
(iii) the onward transfer is necessary for the establishment, exercise or defence of legal claims in the context of specific administrative, regulatory or judicial proceedings; or
(iv) 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
(a) The data importer shall promptly and adequately deal with enquiries from the data exporter that relate to the processing under these Clauses.
(b) 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.
(c) 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.
(d) 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.
(e) 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.
Use of sub-processors
(a) The data importer has the data exporter’s general authorisation for the engagement of sub-processor(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 sub-processors at least thirty (30) days in advance, thereby giving the data exporter sufficient time to be able to object to such changes prior to the engagement of the sub-processor(s). The data importer shall provide the data exporter with the information necessary to enable the data exporter to exercise its right to object.
(b) Where the data importer engages a sub-processor 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 fulfils its obligations under Clause 8.8. The data importer shall ensure that the sub-processor complies with the obligations to which the data importer is subject pursuant to these Clauses.
(c) The data importer shall provide, at the data exporter’s request, a copy of such a sub-processor 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.
(d) The data importer shall remain fully responsible to the data exporter for the performance of the sub-processor’s obligations under its contract with the data importer. The data importer shall notify the data exporter of any failure by the sub-processor to fulfil its obligations under that contract.
(e) The data importer shall agree a third-party beneficiary clause with the sub-processor 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 sub-processor contract and to instruct the sub-processor to erase or return the personal data.
Data subject rights
(a) 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 authorised to do so by the data exporter.
(b) 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 organisational 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.
(c) In fulfilling its obligations under paragraphs (a) and (b), the data importer shall comply with the instructions from the data exporter.
(a) 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 authorised to handle complaints. It shall deal promptly with any complaints it receives from a data subject.
(b) 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.
(c) 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:
(i) 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;
(ii) refer the dispute to the competent courts within the meaning of Clause 18.
(d) The Parties accept that the data subject may be represented by a not-for-profit body, organisation or association under the conditions set out in Article 80(1) of Regulation (EU) 2016/679.
(e) The data importer shall abide by a decision that is binding under the applicable EU or Member State law.
(f) 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.
(a) 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.
(b) 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 sub-processor causes the data subject by breaching the third-party beneficiary rights under these Clauses.
(c) 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.
(d) The Parties agree that if the data exporter is held liable under paragraph (c) for damages caused by the data importer (or its sub-processor), 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.
(e) 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.
(f) 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.
(g) The data importer may not invoke the conduct of a sub-processor to avoid its own liability.
(a) The supervisory authority with responsibility for ensuring compliance by the data exporter with Regulation (EU) 2016/679 as regards the data transfer, as indicated in Annex I.C, shall act as competent supervisory authority.
(b) 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
Local laws and practices affecting compliance with the Clauses
(a) 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 authorising 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.
(b) The Parties declare that in providing the warranty in paragraph (a), they have taken due account in particular of the following elements:(i) 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;
(ii) the laws and practices of the third country of destination - including those requiring the disclosure of data to public authorities or authorising access by such authorities - relevant in light of the specific circumstances of the transfer, and the applicable limitations and safeguards;
(iii) any relevant contractual, technical or organisational 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.
(c) 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.
(d) The Parties agree to document the assessment under paragraph (b) and make it available to the competent supervisory authority on request.
(e) 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).
(f) Following a notification pursuant to paragraph (e), or if the data exporter otherwise has reason to believe that the data importer can no longer fulfil its obligations under these Clauses, the data exporter shall promptly identify appropriate measures (e.g. technical or organisational 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.
Obligations of the data importer in case of access by public authorities
(a) 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:
(i) 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
(ii) 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.
(b) 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.
(c) 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.).
(d) 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.
(e) 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
(a) 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).
(b) 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.
(c) 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
Non-compliance with the Clauses and termination
(a) The data importer shall promptly inform the data exporter if it is unable to comply with these Clauses, for whatever reason.
(b) 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).
(c) The data exporter shall be entitled to terminate the contract, insofar as it concerns the processing of personal data under these Clauses, where:
(i) 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;
(ii) the data importer is in substantial or persistent breach of these Clauses; or
(iii) 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.
(d) 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.
(e) 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.
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.
Choice of forum and jurisdiction
(a) Any dispute arising from these Clauses shall be resolved by the courts of an EU Member State.
(b) The Parties agree that those shall be the courts of the Republic of Ireland.
(c) 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.
(d) The Parties agree to submit themselves to the jurisdiction of such courts.
A. LIST OF PARTIES
Data exporter(s): Customer and Controller Affiliates
Data importer(s): Carepatron and its Affiliates
B.DESCRIPTION OF TRANSFER
See Exhibit A.
ANNEX II - TECHNICAL AND ORGANISATIONAL MEASURES INCLUDING TECHNICAL AND ORGANISATIONAL MEASURES TO ENSURE THE SECURITY OF THE DATA
See the Security Practices Datasheet.
ANNEX III – LIST OF SUB-PROCESSORS
The controller has authorised the use of the following sub-processors: see the Sub-processor lists.
International Data Transfer Addendum to the EU Commission Standard Contractual Clauses
Start date: The effective date of the Services Agreement.
The Parties: Exporter (who sends the Restricted Transfer) / Importer (who receives the Restricted Transfer)
Parties’ details: Customer and Controller Affiliates / Carepatron and its Affiliates
Key Contact: Customer / Carepatron
Selected SCCs, Modules and Selected Clauses
Addendum EU SCCs: The version of the Approved EU SCCs which this Addendum is appended to, detailed below, including the Appendix Information:
Module in operation: Yes
Clause 7 (Docking Clause): Yes
Clause 11 (Option): No
Clause 9a (Prior Authorisation or General Authorisation): General
Clause 9a (Time period): 30 days
Is personal data received from the Importer combined with personal data collected by the Exporter? N/A
“Appendix Information” means the information which must be provided for the selected modules as set out in the Appendix of the Approved EU SCCs (other than the Parties), and which for this Addendum is set out in:
Annex 1A: List of Parties: See Annex I to the Appendix
Annex 1B: Description of Transfer: See Annex I to the Appendix
Annex II: Technical and organisational measures including technical and organisational measures to ensure the security of the data: Annex II to the Appendix
Annex III: List of Sub processors (Modules 2 and 3 only): See Annex III to the Appendix
Ending this Addendum when the Approved Addendum ChangesEnding this Addendum when the Approved Addendum changes: Which Parties may end this Addendum as set out in Section 19: neither Party
Part 2: Mandatory Clauses
Entering into this Addendum
1. Each Party agrees to be bound by the terms and conditions set out in this Addendum, in exchange for the other Party also agreeing to be bound by this Addendum.
2. Although Annex 1A and Clause 7 of the Approved EU SCCs require signature by the Parties, for the purpose of making Restricted Transfers, the Parties may enter into this Addendum in any way that makes them legally binding on the Parties and allows data subjects to enforce their rights as set out in this Addendum. Entering into this Addendum will have the same effect as signing the Approved EU SCCs and any part of the Approved EU SCCs.
Interpretation of this Addendum
3. Where this Addendum uses terms that are defined in the Approved EU SCCs those terms shall have the same meaning as in the Approved EU SCCs. In addition, the following terms have the following meanings:
Addendum: This International Data Transfer Addendum which is made up of this Addendum incorporating the Addendum EU SCCs.
Addendum EU SCCs: The version(s) of the Approved EU SCCs which this Addendum is appended to, as set out in Table 2, including the Appendix Information.
Appendix Information: As set out
Appropriate Safeguards: The standard of protection over the personal data and of data subjects’ rights, which is required by UK Data Protection Laws when you are making a Restricted Transfer relying on standard data protection clauses under Article 46(2)(d) UK GDPR.
Approved Addendum: The template Addendum issued by the ICO and laid before Parliament in accordance with s119A of the Data Protection Act 2018 on 2 February 2022, as it is revised under Section 18.
Approved EU SCCs: The Standard Contractual Clauses set out in the Annex of Commission Implementing Decision (EU) 2021/914 of 4 June 2021.
ICO: The Information Commissioner.
Restricted Transfer: A transfer which is covered by Chapter V of the UK GDPR.
UK: The United Kingdom of Great Britain and Northern Ireland.
UK Data Protection Laws: All laws relating to data protection, the processing of personal data, privacy and/or electronic communications in force from time to time in the UK, including the UK GDPR and the Data Protection Act 2018.
UK GDPR: As defined in section 3 of the Data Protection Act 2018.
4. This Addendum must always be interpreted in a manner that is consistent with UK Data Protection Laws and so that it fulfils the Parties’ obligation to provide the Appropriate Safeguards.
5. If the provisions included in the Addendum EU SCCs amend the Approved EU SCCs in any way which is not permitted under the Approved EU SCCs or the Approved Addendum, such amendment(s) will not be incorporated in this Addendum and the equivalent provision of the Approved EU SCCs will take their place.
6. If there is any inconsistency or conflict between UK Data Protection Laws and this Addendum, UK Data Protection Laws applies.7. If the meaning of this Addendum is unclear or there is more than one meaning, the meaning which most closely aligns with UK Data Protection Laws applies.
8. Any references to legislation (or specific provisions of legislation) means that legislation (or specific provision) as it may change over time. This includes where that legislation (or specific provision) has been consolidated, re-enacted and/or replaced after this Addendum has been entered into.
9. Although Clause 5 of the Approved EU SCCs sets out that the Approved EU SCCs prevail over all related agreements between the parties, the parties agree that, for Restricted Transfers, the hierarchy in Section 10 will prevail.
10. Where there is any inconsistency or conflict between the Approved Addendum and the Addendum EU SCCs (as applicable), the Approved Addendum overrides the Addendum EU SCCs, except where (and in so far as) the inconsistent or conflicting terms of the Addendum EU SCCs provides greater protection for data subjects, in which case those terms will override the Approved Addendum.
11. Where this Addendum incorporates Addendum EU SCCs which have been entered into to protect transfers subject to the General Data Protection Regulation (EU) 2016/679 then the Parties acknowledge that nothing in this Addendum impacts those Addendum EU SCCs.
Incorporation of and changes to the Approved EU SCCs
12. This Addendum incorporates the Addendum EU SCCs which are amended to the extent necessary so that:
a. together they operate for data transfers made by the data exporter to the data importer, to the extent that UK Data Protection Laws apply to the data exporter’s processing when making that data transfer, and they provide Appropriate Safeguards for those data transfers;
b. Sections 9 to 11 override Clause 5 (Hierarchy) of the Addendum EU SCCs; and
c. this Addendum (including the Addendum EU SCCs incorporated into it) is (1) governed by the laws of England and Wales and (2) any dispute arising from it is resolved by the courts of England and Wales, in each case unless the laws and/or courts of Scotland or Northern Ireland have been expressly selected by the Parties.
13. Unless the Parties have agreed alternative amendments which meet the requirements of Section 12, the provisions of Section 15 will apply.
14. No amendments to the Approved EU SCCs other than to meet the requirements of Section 12 may be made.
15. The following amendments to the Addendum EU SCCs (for the purpose of Section 12) are made:
a. References to the “Clauses” means this Addendum, incorporating the Addendum EU SCCs;
b. In Clause 2, delete the words: “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”;
c. Clause 6 (Description of the transfer(s)) is replaced with: “The details of the transfers(s) and in particular the categories of personal data that are transferred and the purpose(s) for which they are transferred) are those specified in Annex I.B where UK Data Protection Laws apply to the data exporter’s processing when making that transfer.”;
d. Clause 8.8(i) of Modules 2 and 3 is replaced with: “the onward transfer is to a country benefitting from adequacy regulations pursuant to Section 17A of the UK GDPR that covers the onward transfer;”
e. References to “Regulation (EU) 2016/679”, “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)” and “that Regulation” are all replaced by “UK Data Protection Laws”. References to specific Article(s) of “Regulation (EU) 2016/679” are replaced with the equivalent Article or Section of UK Data Protection Laws;
f. References to Regulation (EU) 2018/1725 are removed;
g. References to the “European Union”, “Union”, “EU”, “EU Member State”, “Member State” and “EU or Member State” are all replaced with the “UK”;
h. The reference to “Clause 12(c)(i)” at Clause 10(b)(i) of Module one, is replaced with “Clause 11(c)(i)”;
i. Clause 13(a) and Part C of Annex I are not used;
j. The “competent supervisory authority” and “supervisory authority” are both replaced with the “Information Commissioner”;
k. In Clause 16(e), subsection (i) is replaced with: “the Secretary of State makes regulations pursuant to Section 17A of the Data Protection Act 2018 that cover the transfer of personal data to which these clauses apply;”;
l.Clause 17 is replaced with:
“These Clauses are governed by the laws of England and Wales.”;
m. Clause 18 is replaced with: “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.”; and
n. The footnotes to the Approved EU SCCs do not form part of the Addendum, except for footnotes 8, 9, 10 and 11.
Amendments to this Addendum
16. The Parties may agree to change Clauses 17 and/or 18 of the Addendum EU SCCs to refer to the laws and/or courts of Scotland or Northern Ireland.
17. If the Parties wish to change the format of the information included in Part 1: Tables of the Approved Addendum, they may do so by agreeing to the change in writing, provided that the change does not reduce the Appropriate Safeguards.
18. From time to time, the ICO may issue a revised Approved Addendum which:
a. makes reasonable and proportionate changes to the Approved Addendum, including correcting errors in the Approved Addendum; and/or
b. reflects changes to UK Data Protection Laws;
The revised Approved Addendum will specify the start date from which the changes to the Approved Addendum are effective and whether the Parties need to review this Addendum including the Appendix Information. This Addendum is automatically amended as set out in the revised Approved Addendum from the start date specified.
19. If the ICO issues a revised Approved Addendum under Section 18, if any Party selected in Table 4 “Ending the Addendum when the Approved Addendum changes”, will as a direct result of the changes in the Approved Addendum have a substantial, disproportionate and demonstrable increase in:
a its direct costs of performing its obligations under the Addendum;
and/or b its risk under the Addendum,
and in either case it has first taken reasonable steps to reduce those costs or risks so that it is not substantial and disproportionate, then that Party may end this Addendum at the end of a reasonable notice period, by providing written notice for that period to the other Party before the start date of the revised Approved Addendum.
20. The Parties do not need the consent of any third party to make changes to this Addendum, but any changes must be made in accordance with its terms.