SECTION I
Clause 1: Purpose and scope

(a) The purpose of these Standard Contractual Clauses (the Clauses) is to ensure compliance with Article 28(3) and (4) 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.

(b) The controllers and processors listed in Annex I have agreed to these Clauses in order to ensure compliance with Article 28(3) and (4) of Regulation (EU) 2016/679.

(c) These Clauses apply to the processing of personal data as specified in Annex II.

(d) Annexes I to IV are an integral part of the Clauses.

(e) These Clauses are without prejudice to obligations to which the controller is subject by virtue of Regulation (EU) 2016/679.

(f) These Clauses do not by themselves ensure compliance with obligations related to international transfers in accordance with Chapter V of Regulation (EU) 2016/679.

Clause 2: Invariability of the Clauses

(a) The Parties undertake not to modify the Clauses, except for adding information to the Annexes or updating information in them.

(b) This does not prevent the Parties from including the standard contractual clauses laid down in these Clauses in a broader contract, or from adding other clauses or additional safeguards provided that they do not directly or indirectly contradict the Clauses or detract from the fundamental rights or freedoms of data subjects.

Clause 3: Interpretation

(a) Where these Clauses use the terms 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 runs counter to the rights and obligations provided for in Regulation (EU) 2016/679 or in a way that prejudices the fundamental rights or freedoms of the data subjects.

Clause 4: Hierarchy

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

Clause 5 – Docking clause
[Intentionally omitted]

SECTION II – OBLIGATIONS OF THE PARTIES

Clause 6: Description of processing(s)

The details of the processing operations, in particular the categories of personal data and the purposes of processing for which the personal data is processed on behalf of the controller, are specified in Annex II.

Clause7: Obligations of the Parties

7.1. Instructions
(a) The processor shall process personal data only on documented instructions from the controller, unless required to do so by Union or Member State law to which the processor is subject. In this case, the processor shall inform the controller of that legal requirement before processing, unless the law prohibits this on important grounds of public interest. Subsequent instructions may also be given by the controller throughout the duration of the processing of personal data. These instructions shall always be documented.

(b) The processor shall immediately inform the controller if, in the processor’s opinion, instructions given by the controller infringe Regulation (EU) 2016/679 or the applicable Union or Member State data protection provisions.

7.2. Purpose limitation
The processor shall process the personal data only for the specific purpose(s) of the processing, as set out in Annex II, unless it receives further instructions from the controller.

7.3. Duration of the processing of personal data
Processing by the processor shall only take place for the duration specified in Annex II.

7.4. Security of processing
(a) The processor shall at least implement the technical and organisational measures specified in Annex III to ensure the security of the personal data. This includes protecting the data against a breach of security leading to accidental or unlawful destruction, loss, alteration, unauthorised disclosure or access to the data (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 purposes of processing and the risks involved for the data subjects.

(b) The processor shall grant access to the personal data undergoing processing to members of its personnel only to the extent strictly necessary for implementing, managing and monitoring of the contract. The processor shall ensure that persons authorised to process the personal data received have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality.

7.5. Sensitive data
If the processing 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 (“sensitive data”), the processor shall apply specific restrictions and/or additional safeguards.

7.6 Documentation and compliance
(a) The Parties shall be able to demonstrate compliance with these Clauses.

(b) The processor shall deal promptly and adequately with inquiries from the controller about the processing of data in accordance with these Clauses.

(c) The processor shall make available to the controller all information necessary to demonstrate compliance with the obligations that are set out in these Clauses and stem directly from Regulation (EU) 2016/679. At the controller’s request, the processor shall also permit 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 an audit, the controller may take into account relevant certifications held by the processor.

(d) The controller may choose to conduct the audit by itself or mandate an independent auditor. Audits may also include inspections at the premises or physical facilities of the processor and shall, where appropriate, be carried out with reasonable notice.

(e) The Parties shall make the information referred to in this Clause, including the results of any audits, available to the competent supervisory authority/ies on request.

7.7. Use of sub-processors
(a) The processor has the controller’s general authorisation for the engagement of sub-processors. The processor shall inform the controller of any changes of that list through the addition or replacement of sub-processors. In order to access the current version of the list of the sub-processors and receive these notifications, the controller shall register here. The processor shall provide the controller with the information necessary for the controller to decide whether to exercise the right to object. Furthermore, the processor may engage sub-processors based on the specific authorisation by the controller.

(b) Where the processor engages a sub-processor for carrying out specific processing activities (on behalf of the controller), it shall do so by way of a contract which imposes on the sub-processor, in substance, the same data protection obligations as the ones imposed on the data processor in accordance with these Clauses. The processor shall ensure that the sub-processor complies with the obligations to which the processor is subject pursuant to these Clauses and to Regulation (EU) 2016/679.

(c) At the controller’s request, the processor shall provide a copy of such a sub-processor agreement and any subsequent amendments to the controller. To the extent necessary to protect business secret or other confidential information, including personal data, the processor may redact the text of the agreement prior to sharing the copy.

(d) The processor shall remain fully responsible to the controller for the performance of the sub-processor’s obligations in accordance with its contract with the processor. The processor shall notify the controller of any failure by the sub-processor to fulfil its contractual obligations.

(e) The processor shall agree a third party beneficiary clause with the sub-processor whereby – in the event the processor has factually disappeared, ceased to exist in law or has become insolvent – the controller shall have the right to terminate the sub-processor contract and to instruct the sub-processor to erase or return the personal data.

7.8. International transfers
(a) Any transfer of data to a third country or an international organisation by the processor shall be done only on the basis of documented instructions from the controller or in order to fulfil a specific requirement under Union or Member State law to which the processor is subject and shall take place in compliance with Chapter V of Regulation (EU) 2016/679.
(b) The controller agrees that where the processor engages a sub-processor in accordance with Clause 7.7. for carrying out specific processing activities (on behalf of the controller) and those processing activities involve a transfer of personal data within the meaning of Chapter V of Regulation (EU) 2016/679, the processor and the sub-processor can ensure compliance with Chapter V of Regulation (EU) 2016/679 by using standard contractual clauses adopted by the Commission in accordance with of Article 46(2) of Regulation (EU) 2016/679, provided the conditions for the use of those standard contractual clauses are met.

Clause 8: Assistance to the controller

(a) The processor shall promptly notify the controller of any request it has received from the data subject. It shall not respond to the request itself, unless authorised to do so by the controller.

(b) The processor shall assist the controller in fulfilling its obligations to respond to data subjects’ requests to exercise their rights, taking into account the nature of the processing. In fulfilling its obligations in accordance with (a) and (b), the processor shall comply with the controller’s instructions

(c) In addition to the processor’s obligation to assist the controller pursuant to Clause 8(b), the processor shall furthermore assist the controller in ensuring compliance with the following obligations, taking into account the nature of the data processing and the information available to the processor:

(1) the obligation to carry out an assessment of the impact of the envisaged processing operations on the protection of personal data (a ‘data protection impact assessment’) where a type of processing is likely to result in a high risk to the rights and freedoms of natural persons;

(2) the obligation to consult the competent supervisory authority/ies prior to processing where a data protection impact assessment indicates that the processing would result in a high risk in the absence of measures taken by the controller to mitigate the risk;

(3) the obligation to ensure that personal data is accurate and up to date, by informing the controller without delay if the processor becomes aware that the personal data it is processing is inaccurate or has become outdated;

(4) the obligations in Article 32 Regulation (EU) 2016/679.

(d) The Parties shall set out in Annex III the appropriate technical and organisational measures by which the processor is required to assist the controller in the application of this Clause as well as the scope and the extent of the assistance required.

Clause 9: Notification of personal data breach

In the event of a personal data breach, the processor shall cooperate with and assist the controller for the controller to comply with its obligations under Articles 33 and 34 Regulation (EU) 2016/679, taking into account the nature of processing and the information available to the processor.

9.1 Data breach concerning data processed by the controller
In the event of a personal data breach concerning data processed by the controller, the processor shall assist the controller:

(a) in notifying the personal data breach to the competent supervisory authority/ies, without undue delay after the controller has become aware of it, where relevant/(unless the personal data breach is unlikely to result in a risk to the rights and freedoms of natural persons);

(b) in obtaining the following information which, pursuant to Article 33(3) Regulation (EU) 2016/679, shall be stated in the controller’s notification, and must at least include:

(1) the nature of the personal data including where possible, the categories and approximate number of data subjects concerned and the categories and approximate number of personal data records concerned;

(2) the likely consequences of the personal data breach;

(3) the measures taken or proposed to be taken by the controller to address the personal data breach, including, where appropriate, measures to mitigate its possible adverse effects.
Where, and insofar as, it is not possible to provide all this 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.

(c) in complying, pursuant to Article 34 Regulation (EU) 2016/679, with the obligation to communicate without undue delay the personal data breach to the data subject, when the personal data breach is likely to result in a high risk to the rights and freedoms of natural persons.

9.2 Data breach concerning data processed by the processor

In the event of a personal data breach concerning data processed by the processor, the processor shall notify the controller without undue delay after the processor having become aware of the breach. Such notification shall contain, at least:

(a) a description of the nature of the breach (including, where possible, the categories and approximate number of data subjects and data records concerned);

(b) the details of a contact point where more information concerning the personal data breach can be obtained;

(c) its likely consequences and the measures taken or proposed to be taken to address the breach, including to mitigate its possible adverse effects.

Where, and insofar as, it is not possible to provide all this 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.

The Parties shall set out in Annex III all other elements to be provided by the processor when assisting the controller in the compliance with the controller’s obligations under Articles 33 and 34 of Regulation (EU) 2016/679.

SECTION III – FINAL PROVISIONS

Clause 10: Non-compliance with the Clauses and termination

(a) Without prejudice to any provisions of Regulation (EU) 2016/679, in the event that the processor is in breach of its obligations under these Clauses, the controller may instruct the processor to suspend the processing of personal data until the latter complies with these Clauses or the contract is terminated. The processor shall promptly inform the controller in case it is unable to comply with these Clauses, for whatever reason.

(b) The controller shall be entitled to terminate the contract insofar as it concerns processing of personal data in accordance with these Clauses if:

(1) the processing of personal data by the processor has been suspended by the controller pursuant to point (a) and if compliance with these Clauses is not restored within a reasonable time and in any event within one month following suspension;

(2) the processor is in substantial or persistent breach of these Clauses or its obligations under Regulation (EU) 2016/679;

(3) the processor fails to comply with a binding decision of a competent court or the competent supervisory authority/ies regarding its obligations pursuant to these Clauses or to Regulation (EU) 2016/679.

(c) The processor shall be entitled to terminate the contract insofar as it concerns processing of personal data under these Clauses where, after having informed the controller that its instructions infringe applicable legal requirements in accordance with Clause 7.1 (b), the controller insists on compliance with the instructions.

(d) Following termination of the contract, the processor shall, at the choice of the controller, delete all personal data processed on behalf of the controller and certify to the controller that it has done so, or, return all the personal data to the controller and delete existing copies unless Union or Member State law requires storage of the personal data. Until the data is deleted or returned, the processor shall continue to ensure compliance with these Clauses.

ANNEX I: LIST OF PARTIES

Controller: Details of the Institution (including contact details), as identified in the Cooperation Agreement
Signature and accession date: See signature in the Cooperation Agreement

Processor(s): Details of the Milestone One entity (including contact details), as identified in the Cooperation Agreement

Signature and accession date: See signature in the Cooperation Agreement

ANNEX II: DESCRIPTION OF THE PROCESSING

Advancement and implementation of the Cooperation: The following attributes equally apply to all aspects related to the Cooperation

Nature of the processing: Collection/obtainment, storage, alteration, transfer/transmission, de-identification (pseudonymisation, anonymisation, aggregation, masking, removal of data elements), deletion/destruction

Duration of the processing and the period for which the personal data will be retained, or, if that is not possible, the criteria used to determine that period: Throughout the duration of the Cooperation and validity of the Agreement. Retention determined by the applicable country-specific record keeping and/or archiving regulations applicable to the records that contain personal data, but in any case, covering the duration of the processing necessary for the Cooperation.

For processing by (sub-)processors, also specify subject matter, nature and duration of the processing: Engaged in accordance with Clause 7.7, on the basis of controller’s general authorisation, with the subject matter, nature and duration of the processing specified in the respective processing agreements with these sub-processors.

1. STUDY SOURCING AND SELECTION FOR PARTICIPATION
Purpose(s) for which the personal data is processed on behalf of the controller: Processing necessary to enable provision of indicated activity subject to the Cooperation.

Categories of data subjects whose personal data is processed: Personnel of Institution, of MO1 and its affiliates, and of service providers .

Categories of processed personal data: Name, surname, work address/location; job title and job function, department, region; education, work experience, language skills, CV, former employment, certificates, licenses, professional membership, awards, publications, professional opinions; video and photographic images, voice recordings; contract terms, joint projects.

Sensitive data processed: None

2. SITE FEASABILITY, SET UP AND ACTIVATION PREPARATION
Purpose(s) for which the personal data is processed on behalf of the controller: Processing necessary to enable provision of indicated activity subject to the Cooperation.

Categories of data subjects whose personal data is processed: Personnel of Institution and of service providers.

Categories of processed personal data: Name, surname, gender, work address, work phone number, work fax number, work email address, work mobile phone number, office e-mail address, office phone number, company phone number, work address/location; job title and job function, department, region.

Sensitive data processed: None

3. SITE CONTRACTS/AMENDMENTS. BUDGET ASSISTANCE.
Purpose(s) for which the personal data is processed on behalf of the controller: Processing necessary to enable provision of indicated activity subject to the Cooperation.

Categories of data subjects whose personal data is processed: Personnel of Institution, of MO1 and its affiliates, of Study sponsors and of service providers

Categories of processed personal data: Name, surname, gender, work address, work phone number, work fax number, work email address, work mobile phone number, office e-mail address, office phone number, company phone number, work address/location; job title and job function, department, region, contractual details associated individually with data subject

Sensitive data processed: None

4. PATIENT RECRUITMENT AND ENROLLMENT SUPPORT
Purpose(s) for which the personal data is processed on behalf of the controller: Processing necessary to enable provision of indicated activity subject to the Cooperation.

Categories of data subjects whose personal data is processed: Personnel of Institution, of MO1 and its affiliates, of Study sponsors and of service providers, Study participants.

Categories of processed personal data:

• Study participants: Study participant identification code, sex, name, surname, address, email address, enrollment status, associated dates, reasons for non-eligibility
• Personnel of Institution, of MO1 and its affiliates, of Study sponsors and of service providers: Name, surname, gender, work address, work phone number, work fax number, work email address, work mobile phone number, office e-mail address, office phone number, company phone number, work address/location; job title and job function, department, region.

Sensitive data processed:
Categories of data: Study participants: Race/ethnicity, data of testing/examination of a body part or bodily substance, including from genetic data and biological samples; disease, disability, disease risk, medical history, clinical treatment or the physiological or biomedical state of the data subject independent of its source, vital signs, vital status; contraception, pregnancy.

Restrictions or safeguards: pseudonymization, data minimisation, purpose limitation, restricted access, no unauthorized onward transfers, limited retention.

5. STUDY PERFORMANCE REPORTING AND ENROLLMENT OVERSIGHT
Purpose(s) for which the personal data is processed on behalf of the controller: Processing necessary to enable provision of indicated activity subject to the Cooperation.

Categories of data subjects whose personal data is processed: Personnel of Institution, of MO1 and its affiliates, of Study sponsors and of service providers, Study participants.

Categories of processed personal data:

• Study participants: Study participant identification code, sex, name, surname, address, email address, enrollment status, associated dates, reasons for non-eligibility
• Personnel of Institution, of MO1 and its affiliates, of Study sponsors and of service providers: Name, surname, gender, work address, work phone number, work fax number, work email address, work mobile phone number, office e-mail address, office phone number, company phone number, work address/location; job title and job function, department, region.

Sensitive data processed:
Categories of data: Study participants: Race/ethnicity, reasons for non-eligibility, disease, medical history.
Restrictions or safeguards: pseudonymization, data minimisation, purpose limitation, restricted access, no unauthorized onward transfers, limited retention.

6. SITE (INCL. TEAM MEMBERS & PI) AND SERVICE PROVIDER MANAGEMENT (INCL. PAYMENTS)
Purpose(s) for which the personal data is processed on behalf of the controller: processing necessary to enable provision of indicated activity subject to the Cooperation.

Categories of data subjects whose personal data is processed: Personnel of Institution, Study sponsor and of service providers

Categories of processed personal data: Name, surname, gender, work address, work phone number, work fax number, work email address, work mobile phone number, office e-mail address, office phone number, company phone number, work address/location; job title and job function, department, region, credit card expenditure, expenses, benefits, travel allowances, car or commuting allowances, expenses refund and advances; compensation and remuneration received, payments, deliveries, requests, contract terms, joint projects, bank details, expenses.

Sensitive data processed: None

7. MEDIATING COLLABORATION WITH STUDY STAKEHOLDERS
Purpose(s) for which the personal data is processed on behalf of the controller: processing necessary to enable provision of indicated activity subject to the Cooperation.

Categories of data subjects whose personal data is processed: Personnel of Institution, of MO1 and its affiliates, and of service providers.
Categories of personal data processed: Name, surname, gender, work address, work phone number, work fax number, work email address, work mobile phone number, office e-mail address, office phone number, company phone number, work address/location; job title and job function, department, region; contract terms, joint project; bank details.

Sensitive data processed: None.

8. ROASTER MAINTENANCE AND MISCELLANEOUS ASSISTANCE
Purpose(s) for which the personal data is processed on behalf of the controller: processing necessary to enable provision of indicated activity subject to the Cooperation.

Categories of data subjects whose personal data is processed: Personnel of Institution, of MO1 and its affiliates

Categories of personal data processed: Name, surname, gender, work address, work phone number, work fax number, work email address, work mobile phone number, office e-mail address, office phone number, company phone number, work address/location; job title and job function, department, region; type of training, training status, quiz results.

Sensitive data processed: None.

9. STUDY INFRASTRUCTURE DEVELOPMENT AND OPERATIONALIZATION
Purpose(s) for which the personal data is processed on behalf of the controller: processing necessary to enable provision of indicated activity subject to the Cooperation.

Categories of data subjects whose personal data is processed: Personnel of Institution, of MO1 and its affiliates, and of service providers.

Categories of personal data processed: Name, surname, work address/location; job title and job function, department, region.

Sensitive data processed: None

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

1)       Measures of pseudonymisation of personal data are implemented to the personal data of Study participants via replacement of the identifying attributes with an (alpha)numeric code. MO1 (processor) commits to maintain pseudonymisation when it is instructed to disclose or/and share personal data of trial participants with authorised stakeholders, including Study sponsors, contract research organisations, specialized clinical trial service providers.

2)       Measures of encryption are implemented for personal data in transit and, where appropriate, for personal data at rest, using cryptographic techniques that are suitable to the sensitivity of the data and the risks of the processing, in order to protect personal data against unauthorised access or disclosure.

3)       Measures for ensuring ongoing confidentiality and for user identification and authorisation are implemented through imposing obligations of confidentiality on MO1’s personnel involved in the personal data processing and, where applicable, on personnel of its sub‑processors, establishing access control to information systems where data are processed. User accounts are attributed to individual users with unique identifiers, and suitable authentication methods are applied, which may include more than one authentication factor for higher‑risk access. Access rights to personal data are granted on a need‑to‑know basis in line with the least privilege principle and defined roles and responsibilities, and are subject to periodic review and adjustment.

4)       Measures for ensuring events logging are implemented within computer systems and applications used to process personal data, through registering the relevant events relating to access and use of such systems that occur during a login session, e.g., log-in, log-out, session termination, a change of application and/or context parameters, session errors, etc. Such logs are retained and protected in a manner appropriate to their sensitivity and purpose.

5)       Measures for ensuring system configuration, including default configuration, are implemented through ensuring that the security measures are applied when setting up and operating systems and services used to process personal data, in order to reduce unnecessary cyber vulnerabilities. Configurations are based on suitably secure settings, with default options reviewed and adjusted where appropriate, and material changes to configurations are managed in a controlled manner so that they can be monitored and, where reasonably required, reversed.

6)       Measures for managing technical vulnerabilities are implemented through processes for identifying, assessing and addressing security vulnerabilities in systems and software used to process personal data, and for applying software updates and patches in an organised and timely manner, taking into account the risks associated with the relevant systems and services and the state of the art. Such processes may include, as appropriate, the use of automated vulnerability scanning tools, security testing activities such as penetration testing, and other methods aimed at detecting weaknesses that could affect the security of personal data.

7)       Measures for endpoint protection are implemented through ensuring that devices used to process personal data (such as laptops, workstations and, where applicable, mobile devices) are protected by appropriate technical safeguards, such as centrally managed antivirus/anti‑malware solutions, host‑based firewalls and security configuration standards, and are kept reasonably up to date through the application of relevant security updates and patches.

8)       Measures for ensuring physical security of locations at which personal data are processed are implemented through restricting physical access to the offices and information processing facilities to personnel and approved visitors; monitoring of the reception areas by a receptionist or security guard; provision of access cards and keys to data centres, server and back-up rooms to authorized persons only; performing reviews of access rights.

9)       Availability and resilience of processing systems and services are ensured through implementation of business continuity and disaster recovery arrangements that are appropriate to the nature of the services and the risks of the processing, which may include documented continuity and recovery plans and, where relevant, systems redundancy and periodic testing of such arrangements.

10)     Measures for ensuring the ability to restore the availability and access to personal data in a timely manner in the event of a physical or technical incident are implemented through the use of regular data backups performed in accordance with MO1’s policies; storage of backups at separate or external locations or services; where backup services are outsourced, inclusion of appropriate security and confidentiality obligations in the contracts; and periodic verification that backup and restoration procedures function as intended.

11)     Measures for handling personal data breaches and other security incidents are implemented through maintaining procedures for detection, reporting and investigation of such events. MO1 requires its personnel and, where applicable, its sub‑processors, to report suspected or actual security incidents without undue delay, and takes appropriate steps to contain, assess and mitigate incidents affecting personal data, as well as to support the controller in meeting any legal notification obligations.

12)     Measures for internal IT and IT security governance and management are ensured through (i) the engagement of appropriately skilled and qualified personnel and (ii) the provision, where relevant, of training on information security and secure software development and on the procedures applicable to the processing of personal data.

13)     Measures for certification/assurance of processes and products are implemented through the engagement, whenever possible, of service providers that maintain current ISO certifications and demonstrate adherence to similar standards.

14)     Measures for ensuring data minimisation are implemented through developing processes that incorporate the rule of data collection strictly necessary for the purpose of a business activity; MO1 performs regular assessments of data processing instructions to continuously supervise accurate implementation of data minimisation principle.

15)     Measures for ensuring data quality through establishing data collection tools that enable data accuracy and data quality verification; through documenting the processes implemented to ensure accuracy during data obtainment and verifying that no tampering that might distort data accuracy during further processing, in particular storage/archiving, is possible.

16)     Measures for ensuring limited data retention are implemented through inclusion of data retention provisions in the Clauses; through compliance with the corporate policies, procedures, business process descriptions, etc., developed with the consideration of the principle of limited data retention.

17)     Measures for ensuring accountability are implemented through development and maintenance of appropriate documentation; through making the necessary information and facilities available for internal quality control audits, regulatory inspections, and audits required by business partners.