DMC Data Processing Addendum

DMC Member Data Protection Addendum

During the course of providing Services to, or on behalf of, Cytel Inc. or any of its affiliated companies, including Axio Research, LLC (collectively, “Cytel”) pursuant to the applicable data monitoring committeee (“DMC”) member agreement between Cytel and DMC member (collectively, the “Agreement”), DMC member may access or otherwise process personal data.  The Parties agree that with regard to the processing of personal data pursuant to the Agreement or this DPA, Cytel is the data processor (and shall hereinafter be referred to as the “Processor”), and DMC member is the data subprocessor (and shall hereinafter be referred to as the “Subprocessor”).  The Parties have agreed that the Subprocessor will provide the Services to the Processor pursuant to and in accordance with the terms and conditions of this DPA.  In the event of a conflict between the terms of this DPA and the Agreement, the terms of this DPA shall govern.

IT IS HEREBY AGREED as follows:

1. DEFINITIONS

Capitalized terms used but not defined in this DPA will have the meanings set forth in the Agreement.  The following capitalized words and expressions shall have the following meanings unless the context otherwise requires:

“Controller” means the client or customer of the Processor who determines the purposes and means of the processing of personal data.

“DPA” means this Data Protection Addendum, its schedules and any other documents attached to or referred to as forming part of this DPA, which are hereby incorporated into this DPA by reference;

“Data” means all personal data processed by (or on behalf of) the Subprocessor for the Processor under or in connection with the Agreement, including in the provision of the Services;

“Data Subjects’ Rights” means those rights of data subjects as set out in the GDPR including, without limitation, rights of access, rectification, erasure, restriction of processing, data portability, objection, and not to be subject to automated decision making (including profiling);

“EEA” means European Economic Area;

“EU” means the European Union;

“GDPR” means 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, and repealing Directive 95/46/EC;

“data subject,” “international organisation,” “personal data,” “personal data breach,” “process/processing,” “pseudonymisation,” “representative,” “special categories of personal data,” “supervisory authority,” and “third country” shall each have the meaning ascribed to them in the GDPR;

“Standard Contractual Clauses” means the European Commission approved Processor to Subprocessor Standard Contractual Clauses; and

“Third-Party Subprocessor” means any third party (i) who is engaged by a Subprocessor to carry out specific processing activities in respect of the Data for or on behalf of a Processor; or (ii) to whom the Subprocessor subcontracts any of its obligations under or in connection with this Agreement.

2. SCOPE OF PROCESSING
   • The duration of processing will be the same as the duration of the Agreement, except as otherwise agreed to in the Agreement or in writing by the Parties. The scope and further details of the processing activities to be performed by the Subprocessor under or in connection with the Agreement and this DPA are set out in Schedule 1 to this DPA (Scope of Processing) which shall be provided to you by Cytel under separate cover.
   • To the extent that any additional information is required to be included in Schedule 1 to this DPA pursuant to the GDPR or any other applicable EU or EU Member State law, or this Agreement otherwise requires updating, the Parties will work together in good faith to amend this DPA to ensure continued compliance with such legislation provided, however, that no amendment to this DPA is permitted without the prior written consent of both the Subprocessor and the Processor (such consent not to be unreasonably withheld or delayed).
3. GENERAL SubPROCESSOR OBLIGATIONS
   • The Subprocessor shall, and shall procure that each of its employees, permitted Third-Party Subprocessors and any other individual acting under its authority who has access to the Data shall:
     • only process the Data to the extent and in such a manner as is necessary for the provision of the Services and for no other purpose(s) (including but not limited to any of its own purposes);
     • only process the Data in accordance with the terms of this DPA;
     • only process the Data in accordance with the written instructions of the Processor from time to time (including in respect of transfers of Data to a third country or international organisation outside the EEA), unless otherwise required to do so by applicable EU or EU Member State law (in any such case, the Subprocessor shall promptly inform the Processor of the relevant legal requirement before processing, unless prohibited from doing so on important public interest grounds);
     • keep the Data confidential and ensure that any person authorized to process the Data for or on behalf of the Subprocessor (including but not limited to any Subprocessor employees and staff as well as permitted Third-Party Subprocessors) have agreed to keep the Data confidential, or are otherwise under an appropriate statutory obligation of confidentiality in respect of the Data; and
     • on request from the Processor, provide an up-to-date copy of the Data in the format, on the media and within any commercially reasonable time periods required by the Processor.

4. Security

In accordance with the GDPR, taking into account the state of the art, the costs of implementation and the nature, scope, context and purposes of the processing of the Data to be carried out under or in connection with the Agreement, as well as the risks of varying likelihood and severity for the rights and freedoms of natural persons and the risks that are presented by the processing, especially from accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to the Data transmitted, stored or otherwise processed, the Subprocessor agrees and warrants that it shall implement appropriate technical and organisational security measures appropriate to the risk.

5. Third-Party Subprocessors
   • The Subprocessor is not authorized to use an additional Third Party Subprocessors without the prior written consent of the Processor. If Subprocessor is provided written consent to engage a Third Party Subprocessor the following subsections of this Section 5 shall apply.
   • Before engaging new Third-Party Subprocessors, the Subprocessor will provide written notice to the Processor regarding the engagement and all intended changes regarding the replacement or addition of Third-Party Subprocessors to allow for objections.
   • Processor may object in writing to a new Third-Party Subprocessor within five (5) calendar days after receipt of this Agreement or other notice. If the Processor objects on reasonable grounds, the Subprocessor and Processor will discuss reasonable alternative solutions in good faith. If no resolution is reached, the Subprocessor will not appoint the Third-Party Subprocessor in dispute and will seek alternative Third-Party Subprocessors, or if an alternative Third-Party Subprocessor is not found, the Processor has the right to terminate its Agreement with Subprocessor in accordance with the provisions of the Agreement.
   • Regarding any permitted Third-Party Subprocessor engaged in accordance with Sections 1 through 5.3 for carrying out any specific processing activities on behalf of the Processor, the Subprocessor shall ensure that the same data protection obligations as set out in this DPA as between the Processor and the Subprocessor are imposed on that Third-Party Subprocessor by way of a written agreement. If any relevant Third-Party Subprocessor fails to fulfill its data protection obligations, the Subprocessor shall remain fully liable to the Processor for the performance of the relevant Third-Party Subprocessor’s obligations.
6. Assistance
   • The Subprocessor shall provide reasonable assistance to the Processor, and at the Processor’s request, the Controller, in ensuring compliance with the obligations referred to below as and to the extent required by the GDPR and any other applicable data protection related legislation, taking into account the nature of processing and the information available to the Subprocessor, including in respect of:
     • implementing appropriate technical and organisational security measures to ensure the security of processing in respect of the Data;
     • the notification of any personal data breaches in respect of the Data to any relevant supervisory authority and communication of personal data breaches to any relevant data subjects;
     • carrying out data protection impact assessments; and
     • any consultation with any relevant supervisory authority prior to processing where a data protection impact assessment indicates that the processing would result in a high risk if measures are not taken by the Processor to mitigate the risk.

7. Rights of Data Subjects
   • The Processor shall be responsible for providing data subjects with the information required under the GDPR at the point of collection of their personal data. If required by the Processor, the Subprocessor will provide the relevant information to data subjects on the Processor’s behalf in a form approved in advance by the Processor.
   • Taking into account the nature of the processing performed by the Subprocessor, the Subprocessor shall assist the Processor by appropriate technical and organisational measures, insofar as this is possible, for the fulfillment of the Processor’s obligations to respond to requests for exercising Data Subjects’ Rights.
   • The Subprocessor shall notify the Processor, and at the Processor’s request, the Controller, in writing (email being sufficient) of each such request that it receives. Such written notification shall be made promptly following receipt of the request, and shall include any information in the Subprocessor’s custody or control that may assist the Processor or Controller, as applicable, to respond to the request.
   • Unless otherwise required by applicable EU or EU Member State law, the Subprocessor shall not respond to any such requests or other communications which the Subprocessor receives from data subjects, without the prior written consent of and at the direction of the Processor.
8. Personal Data Breaches

In the case of any actual personal data breach in respect of the Data, the Subprocessor shall promptly notify the Processor, and at the Processor’s request, the Controller, in writing (email being sufficient) no later than 24 hours after becoming aware of such breach.

9. International Transfers of Data
   • The Subprocessor shall not process in or transfer any Data to any third country or international organisation outside the EEA except on the instructions or with the prior written approval of the Processor. The Processor consents to the processing or transfer of Data to the third countries and international organisations outside the EEA set forth in Part D of Schedule 1.
   • In order to ensure compliance with the GDPR regarding any agreed transfers of personal data to third countries or international organisations outside the EEA, unless another valid transfer mechanism exists for such transfers which satisfies the GDPR’s requirements, such transfers shall be governed by the Standard Contractual Clauses set out in Schedule 2 to this DPA, which shall be deemed to be executed by the Parties and come into full force and effect upon execution of this DPA.
10. Accountability
    • Upon written request from the Processor, the Subprocessor shall make available to the Processor, and at the Processor’s request, the Controller, all information necessary to demonstrate compliance with its obligations under this DPA and allow for and contribute to audits, including inspections, conducted by the Processor, the Controller, or another auditor mandated by the Processor or Controller.
    • The Subprocessor shall immediately inform the Processor, and at the Processor’s request, the Controller, if, in the Subprocessor’s opinion, any instruction from the Processor or Controller with respect to the processing of Data under or in connection with this DPA infringes the GDPR, or other applicable EU or EU Member State data protection law or regulation.
    • The Subprocessor shall notify the Processor of all communications it receives from any third party relating to the Data, which suggest non-compliance by the Processor, the Subprocessor or any other person with the GDPR or any other law or regulation relating to privacy or the protection of personal data, including communications from data subjects and regulatory bodies, and shall not do anything or enter into any communication with such third party unless expressly authorised to do so by the Processor, unless permitted or required by law or regulation.
11. RETURN OR DISPOSAL
    • Upon completion of the Services or upon the expiry or termination of the Agreement for any reason, the Subprocessor shall (and shall procure that any permitted Third-Party Subprocessor shall), at the Processor’s or Controller’s discretion and to the extent technically feasible:
      • return all Data processed under or in connection with this Agreement (including any and all copies thereof) to the Processor or Controller, as applicable (or to any other person as directed by the Processor or Controller to the Subprocessor in writing); or
      • securely delete and destroy such Data (including any and all copies thereof) and certify to the Processor or Controller, as applicable, in writing that it has done so, in each case unless EU or EU Member State law requires the storage of such Data, in which case the Subprocessor shall promptly inform the Processor or Controller, as applicable, of such requirement.
    • The Subprocessor agrees (and shall procure that any permitted Third-Party Subprocessor shall agree) that, at the request of the Processor or any relevant supervisory authority, it will submit its data processing facilities for an audit of the measures referred to in this Section 11.
12. General
    • Additional obligations. The Subprocessor agrees to take any other actions required to be imposed upon subprocessors of the Processor under the data processing agreement between the Controller and the Processor.

This Data Protection Addendum is accepted and agreed by:

CYTEL INC.                                                 CONSULTANT

 

By:                                                                             By:

Name:                                                                       Name:

 

Title:                                                                          Title:

 

Date:                                                                          Date:

 

[END OF MAIN AGREEMENT]

 

STANDARD CONTRACTUAL CLAUSES

Processor to Processor

SECTION I

Clause 1- 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) ([i]) 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.

 

Clause 2- 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 additional safeguards, provided that they do not contradict, directly or indirectly, these Clauses or prejudice the fundamental rights or freedoms of data subjects.

(b)        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 

(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(a), (c) and (d) and Clause 8.9(a), (c), (d), (e), (f) and (g);

(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.

 

Clause 4- Interpretation

(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-  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

(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

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 organisational measures, to satisfy its obligations under these Clauses.

8.1   Instructions

(a)        The data exporter has informed the data importer that it acts as processor under the instructions of its controller(s), which the data exporter shall make available to the data importer prior to processing.

(b)        The data importer shall process the personal data only on documented instructions from the controller, as communicated to the data importer by the data exporter, and any additional documented instructions from the data exporter. Such additional instructions shall not conflict with the instructions from the controller. The controller or data exporter may give further documented instructions regarding the data processing throughout the duration of the contract.

(c)        The data importer shall immediately inform the data exporter if it is unable to follow those instructions. Where the data importer is unable to follow the instructions from the controller, the data exporter shall immediately notify the controller.

(d)       The data exporter warrants that it has imposed the same data protection obligations on the data importer as set out in the contract or other legal act under Union or Member State law between the controller and the data exporter ([ii]).

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 controller, as communicated to the data importer by the data exporter, or 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 personal data, the data exporter may redact part of the text of the Appendix 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.

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 rectify or erase 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 controller 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, they 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 subject. 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 or the controller. 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 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, without undue delay, the data exporter and, where appropriate and feasible, the controller 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 data breach, including 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 its controller so that the latter may in turn 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 set out 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 controller, as communicated to the data importer by the data exporter. In addition, the data may only be disclosed to a third party located outside the European Union ([iii]) (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 of Regulation (EU) 2016/679;

(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 or the controller 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 controller.

(c)        The data importer shall make all information necessary to demonstrate compliance with the obligations set out in these Clauses available to the data exporter, which shall provide it to the controller.

(d)       The data importer shall allow for and contribute to audits by the data exporter of the processing activities covered by these Clauses, at reasonable intervals or if there are indications of non-compliance. The same shall apply where the data exporter requests an audit on instructions of the controller. In deciding on an audit, the data exporter may take into account relevant certifications held by the data importer.

(e)        Where the audit is carried out on the instructions of the controller, the data exporter shall make the results available to the controller.

(f)        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.

(g)        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 Sub-Processors

(a)        The data importer shall not sub-contract any of its processing activities performed on behalf of the data exporter under these Clauses to a sub-processor without the prior specific written authorisation of the controller. The data importer shall submit the request for specific authorisation at least [Specify time period] prior to the engagement of the sub-processor, together with the information necessary to enable the controller to decide on the authorisation. It shall inform the data exporter of such engagement. The list of sub-processors already authorised by the controller can be found in Annex III. The Parties shall keep Annex III up to date.

(b)        Where the data importer engages a sub-processor to carry out specific processing activities (on behalf of the controller), 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. ([iv]) 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 or controller’s request, a copy of such a sub-processor agreement and any subsequent amendments. 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.

Clause 10- Data Subject Rights

(a)        The data importer shall promptly notify the data exporter and, where appropriate, the controller of any request it has received from a data subject, without responding to that request unless it has been authorised to do so by the controller.

(b)        The data importer shall assist, where appropriate in cooperation with the data exporter, the controller in fulfilling its obligations to respond to data subjects’ requests for the exercise of their rights under Regulation (EU) 2016/679 or Regulation (EU) 2018/1725, as applicable. 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 controller, as communicated by the data exporter.

Clause 11– Redress

(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.

[OPTION: The data importer agrees that data subjects may also lodge a complaint with an independent dispute resolution body ([v]) at no cost to the data subject. It shall inform the data subjects, in the manner set out in paragraph (a), of such redress mechanism and that they are not required to use it, or follow a particular sequence in seeking redress.]

(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.

Clause 12- Liability

(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 sub-processor) 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.

Clause 13- Supervision

• [Where the data exporter is established in an EU Member State:] 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.

[Where the data exporter is not established in an EU Member State, but falls within the territorial scope of application of Regulation (EU) 2016/679 in accordance with its Article 3(2) and has appointed a representative pursuant to Article 27(1) of Regulation (EU) 2016/679:] The supervisory authority of the Member State in which the representative within the meaning of Article 27(1) of Regulation (EU) 2016/679 is established, as indicated in Annex I.C, shall act as competent supervisory authority.

[Where the data exporter is not established in an EU Member State, but falls within the territorial scope of application of Regulation (EU) 2016/679 in accordance with its Article 3(2) without however having to appoint a representative pursuant to Article 27(2) of Regulation (EU) 2016/679:] 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 behaviour is monitored, are located, as indicated in Annex I.C, shall act as competent supervisory authority.

• 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

(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 ([vi]);

(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). The data exporter shall forward the notification to the controller.

(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, if appropriate in consultation with the controller. 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 controller or 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

(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.

The data exporter shall forward the notification to the controller.

• 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.
• 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.). The data exporter shall forward the information to the controller.
• 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.
• 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 minimization

(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. The data exporter shall make the assessment available to the controller.

(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

Clause 16- 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 and the controller 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.

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 Germany.

Clause 18 – 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 Germany.

(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.

 

APPENDIX

EXPLANATORY NOTE: It must be possible to clearly distinguish the information applicable to each transfer or category of transfers and, in this regard, to determine the respective role(s) of the Parties as data exporter(s) and/or data importer(s). This does not necessarily require completing and signing separate appendices for each transfer/category of transfers and/or contractual relationship, where this transparency can achieved through one appendix. However, where necessary to ensure sufficient clarity, separate appendices should be used.

 

ANNEX I

1. LIST OF PARTIES

Data exporter(s) as applicable: 

 

Name: Cytel Inc.

Address: 675 Massachusetts Ave., Cambridge, MA 02139 USA

Contact person’s name, position and contact details:  

Privacy Officer

Email: Privacy@Cytel.com

 

Activities relevant to the data transferred under these Clauses: As set forth in the applicable agreement.

Signature: Upon Signature of DMC Member Agreement

Date: Upon Signature of DMC Member Agreement

Role: Processor

Name: Axio Research, LLC

Address: 10202 5^th Ave NE, Seattlel, Washington 98125

Contact person’s name, position and contact details: 

Privacy Officer

Email: Privacy@Cytel.com

Activities relevant to the data transferred under these Clauses: As set forth in the applicable agreement.

Signature: Upon Signature of DMC Member Agreement

Date: Upon Signature of DMC Member Agreement

Role: Processor

 

 

 

 

Data importer(s): 

 

Name: As listed in DMC Member Agreement

 

Address: As listed in DMC Member Agreement

 

Contact person’s name, position and contact details:

 

Consultant

Email: As listed in DMC Member Agreement

Activities relevant to the data transferred under these Clauses: As set forth in the agreement with Cytel.

Signature: Upon Signature of DMC Member Agreement

Date: Upon Signature of DMC Member Agreement

Role: Processor

 

1. DESCRIPTION OF TRANSFER

Categories of data subjects whose personal data is transferred: CLINICAL TRIAL STUDY SUBJECTS

Name and contact information of the Data Controller and/or Data Exported (Processor) employees or agents

Categories of personal data transferred: PSEUDONYMIZED BIOMETRIC/HEALTH DATA FROM CLINICAL TRIALS

Sensitive data transferred (if applicable) and applied restrictions or safeguards that fully take into consideration the nature of the data and the risks involved, such as for instance strict purpose limitation, access restrictions (including access only for staff having followed specialised training), keeping a record of access to the data, restrictions for onward transfers or additional security measures: N/A

The frequency of the transfer (e.g. whether the data is transferred on a one-off or continuous basis): INTERMITTANT DURING THE DURATION OF THE RELEVANT AGREEMENT.

Nature of the processing: REVIEW AND ANALYSIS OF CLINICAL STUDY DATA

Purpose(s) of the data transfer and further processing: REVIEW AND ANALYSIS ON BEHALF OF CONTROLLER

The period for which the personal data will be retained, or, if that is not possible, the criteria used to determine that period: ACCESS TO SUCH DATA WILL END UPON END OF SERVICES UNDER THE AGREEMENT.

For transfers to (sub-) processors, also specify subject matter, nature and duration of the processing: NO FURTHER SUBPROCESSING IS PERMITTED.

1. COMPETENT SUPERVISORY AUTHORITY

Identify the competent supervisory authority/ies in accordance with Clause 13

 

 

ANNEX II

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

EXPLANATORY NOTE: The technical and organisational measures must be described in specific (and not generic) terms. See also the general comment on the first page of the Appendix, in particular on the need to clearly indicate which measures apply to each transfer/set of transfers.

 

Data

Cytel interacts with data in various ways. Regarding personal data that is received and processed in relation to business relations, such as client and vendor employee information, Cytel maintains ORG-PRIV-PR-000001 Global Privacy Program and publishes a Privacy Notice on the public website https://www.cytel.com/privacynotice.

Regarding the pseudonymized clinical research data that is received by Cytel for fulfilment of clinical research services, Cytel maintains a wealth of PD that speak to data integrity, including information systems requirements and project-specific data handling requirements. Key PD governing data integrity include, but are not limited to:

 

Information Systems

• ORG-ISMS-GEN-000001 Cytel Information System Security Management System Statement of Applicability
• ORG-ISMS-PL-000001 Cytel Information Security Policy
• ORG-ISMS-PL-000004 Cytel Information Classification Policy
• ORG-IT-GEN-000001 Business Continuity Plan
• ORG-IT-GEN-000001 Disaster Recovery Plan, supported by ORG-IT-SOP-000001 Disaster Recovery
• ORG-IT-PL-000001 User Account Access Policy
• ORG-IT-SOP-000002 Data Backup and Restore
• ORG-IT-SOP-000008 System Maintenance
• ORG-IT-SOP-000007 Cryptography Management

Quality Assurance

• ORG-QA-GEN-000002 Good Clinical Practices Training, including Good Documentation Training (annual)
• ORG-QA-GEN-000003 Data Privacy Training (annual)
• ORG-QA-GEN-000004 21 CFR Part 11 and Annex 11 Training (annual)
• ORG-QA-SOP-000011 Good Documentation Practices
• ORG-QA-SOP-000012 Central File and Record Retention

Clinical Research Services

• CRS-BS-SOP-000006 Managing Unblinded Data
• CRS-BS-SOP-000009 External Data Transfer Receipt
• CRS-PM-SOP-000001 Project Management Planning, Conduct, and Closure Activities

Document management, retention times, storage and archival

Cytel maintains ORG-QA-SOP-000012 Central File and Record Retention, which describes requirements for Cytel’s record maintenance and archival processes.

Cytel’s primary method of record administration, including signing processes, are electronic and conducted on validated systems where relevant to regulated activity. Cytel engages Microsoft Azure for Infrastructure as a Service (IaaS), with primary server locations in MS Azure’s US East region, and backup and failover server locations in MS Azure’s US West region.

Cytel does maintain historical paper-based records in a designated secure file room with access restricted through proximity card and reader. Wet ink signatures are discouraged by Cytel. However, processes are in place, including a certified copy process, to ensure these records are maintained in accordance with regulation and best practices.

Cytel retains all project-related documents for at least five years after project completion or per contractual agreement, whichever is longer.

Vendor qualification

Documents (PD), which collectively describe requirements and processes for vendor qualification and software validation:

• ORG-QA-SOP-000008 Vendor Qualification, which includes requirements and forms for conducting and documenting Vendor Risk Assessments and Qualification and Data Privacy Questionnaires
• ORG-QA-SOP-000007 Auditing, which includes requirements and forms for conducting and documenting vendor audit planning, preparation, and conduct, as well as report issuance, response processing, follow-up, and closure.
• ORG-QA-PL-000003 Computer System Validation Policy, supported by ORG-QA-SOP-00018 Computer System Validation, which includes requirements and forms for conducting and documenting computer systems validation

Training, Skills and Competencies

Assignments to Sponsor projects are made based on project-specific requirements, including education, experience, and skill sets. Cytel has a pool of Data Managers, Biostatisticians, and Statistical Programmers to select from, ensuring that relevant knowledge, experience, and support is shared within the team. Cytel strives to keep the same resources on a study as much as possible. We realize however, that staff changes can happen for a variety of reasons, such as illness. As such, we have defined back-ups in-place for all functional leads. These back-ups are involved with the project and are able to step-in at a moment’s notice to ensure no loss of continuity. If we have to replace a resource, we have a defined handover processes in place which is thoroughly documented. Given Cytel’s focus on Biometrics, we attract staff who are passionate about biometrics and who tend to want to be involved with Cytel. We have unique training opportunities and technical career development that help us to retain staff over the course of studies and year over year.

Training is assigned in TWD, TMS module. Training Plans are created based on department and role. New hires are assigned training at hire. Training requirements are updated based on training plan update or change in role / department. All training is required to be completed within 21 days of assignment. Re-training is conducted at least every 2 years for Procedural Documents.

Cytel requires contracted personnel to train identically to Cytel employees performing the same job function. Training is assigned and completed within the Training Management System (TMS). Contracted personnel must sign off on completed trainings using a 21 CRF Part 11 compliant signature. Contracted personnel have 21 days to train. Compliance reports can be pulled from the system on all current and past contracted personnel to show training status.

IT Security

Cytel has physical and logical security procedures in place outlining how data is projected at Cytel. ORG-IT-SOP-000010 Logical Security describes appropriate logical security measures necessary to protect data of Cytel’s computerized systems. ORG-IT-SOP-000009 Physical Security describes physical security measures applied by Cytel to protect data and users.

Data is only sent using approved Secure File Transfer mechanisms. Data is stored in restricted project folders, with only authorized team members having access.

Cytel maintains a wealth of PD that speak to data security. Key PD governing data security include, but are not limited to:

• ORG-ISMS-GEN-000001 Cytel Information System Security Management System Statement of Applicability
• ORG-ISMS-PL-000001 Cytel Information Security Policy
• ORG-ISMS-PL-000005 Cytel Network Security Policy
• ORG-ISMS-PL-000006 Cytel Technical Vulnerability Management Policy
• ORG-ISMS-PL-000010 Cytel Information Security Management System Scope
• ORG-ISMS-SOP-000002 Cytel Information Security Objectives
• ORG-IT-SOP-000007 Cryptography Management
• ORG-IT-SOP-000010 Logical Security

Data Backups

In line with ORG-IT-SOP-000002 Data Backup and Restore the data backup and restoration process is managed by Cytel. Backup and restore is the activity to ensure that the data is backed up and can be recovered in the event of hardware or software failure in order to protect against loss of integrity or availability of the original data. Cytel utilizes Microsoft Azure as our cloud storage vendor

Business Continuity and Disaster Recovery

Cytel has a documented procedure called ORG-IT-GEN-000001 Business Continuity Plan and ORG-IT-SOP-000001 Disaster Recovery. We are performing DR test once in a year.

Risk Management

ORG-QA_PL-000002 Risk Management Policy outlines Cytel’s approach to managing risks to support the achievement of corporate objectives and protection of staff and business assets.

ORG-QA-SOP-000017 Risk Management is followed to create a risk management plan at the project level.

For transfers to (sub-) processors, also describe the specific technical and organisational measures to be taken by the (sub-) processor to be able to provide assistance to the controller and, for transfers from a processor to a sub-processor, to the data exporter

Not applicable as no further subprocessing is permitted. …

List Of Sub-Processors

EXPLANATORY NOTE: This Annex must be completed in case of the specific authorisation of sub-processors (Clause 9(a), Option 1).

The controller has authorised the use of the following sub-processors:

1. Name: N/A

Address: N/A

Contact person’s name, position and contact details: N/A

Description of processing (including a clear delimitation of responsibilities in case several sub-processors are authorised): N/A

[i] Where the data exporter is a processor subject to Regulation (EU) 2016/679 acting on behalf of a Union institution or body as controller, reliance on these Clauses when engaging another processor (sub-processing) not subject to Regulation (EU) 2016/679 also ensures compliance with Article 29(4) of Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39), to the extent these Clauses and the data protection obligations as set out in the contract or other legal act between the controller and the processor pursuant to Article 29(3) of Regulation (EU) 2018/1725 are aligned. This will in particular be the case where the controller and processor rely on the standard contractual clauses included in Decision 2021/915.

 

[ii] See Article 28(4) of Regulation (EU) 2016/679 and, where the controller is an EU institution or body, Article 29(4) of Regulation (EU) 2018/1725.

[iii]  The Agreement on the European Economic Area (EEA Agreement) provides for the extension of the European Union’s internal market to the three EEA States Iceland, Liechtenstein and Norway. The Union data protection legislation, including Regulation (EU) 2016/679, is covered by the EEA Agreement and has been incorporated into Annex XI thereto. Therefore, any disclosure by the data importer to a third party located in the EEA does not qualify as an onward transfer for the purposes of these Clauses.

[iv] This requirement may be satisfied by the sub-processor acceding to these Clauses under the appropriate Module, in accordance with Clause 7.

[v] The data importer may offer independent dispute resolution through an arbitration body only if it is established in a country that has ratified the New York Convention on Enforcement of Arbitration Awards.

[vi] As regards the impact of such laws and practices on compliance with these Clauses, different elements may be considered as part of an overall assessment. Such elements may include relevant and documented practical experience with prior instances of requests for disclosure from public authorities, or the absence of such requests, covering a sufficiently representative time-frame. This refers in particular to internal records or other documentation, drawn up on a continuous basis in accordance with due diligence and certified at senior management level, provided that this information can be lawfully shared with third parties. Where this practical experience is relied upon to conclude that the data importer will not be prevented from complying with these Clauses, it needs to be supported by other relevant, objective elements, and it is for the Parties to consider carefully whether these elements together carry sufficient weight, in terms of their reliability and representativeness, to support this conclusion. In particular, the Parties have to take into account whether their practical experience is corroborated and not contradicted by publicly available or otherwise accessible, reliable information on the existence or absence of requests within the same sector and/or the application of the law in practice, such as case law and reports by independent oversight bodies.