EM-seq datatset of primary human thymocyte subsets

Data Transfer Agreement [Transfer of pseudonymised Personal Data Non-commercial purposes / academic partner / research institution] Charité – Universitätsmedizin Berlin Charitéplatz 1 10117 Berlin, Germany Executing unit: xxx Responsible investigator: xxx – hereinafter: „PROVIDER“ – and [INSERT INSTITUTION DETAILS full legal name and address] – hereinafter: „RECIPIENT“ – – individually referred to as “PARTY” and/or together referred to as “PARTIES” – § 1 Definitions: CONFIDENTIAL INFORMATION means, including without limitation, know-how, technology, methodologies, procedures, data, business- and trade secrets, information related to the DATA, in any form whatsoever, and disclosed by the “disclosing Party” to the “receiving Party” for the purpose of this Agreement, and clearly marked as confidential or, if disclosed orally, reduced to writing and communicated to the receiving Party within 30 days from disclosure. DATA means the data as identified in Annex 1 which the PROVIDER will transfer to the RECIPIENT for the purposes set out in Annex 1. Data will contain Personal data. PERSONAL DATA means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person according to Article 4 (1) GDPR. PROJECT means the research project of the RECIPIENT as specified in Annex 1. PURPOSE means the intended use of the transferred DATA in the context of the research project as described in Annex 1. RESULTS means all work results (such as data, inventions, including, but without limitations, results of imaging and statistical analyses) generated by the RECIPIENT as a result of conducting the PROJECT. § 2 Subject of the Data Transfer Agreement (1) RECIPIENT desires to obtain the DATA from PROVIDER for use by RECIPIENT for the PURPOSE described in Annex 1 (the “PURPOSE”) under the terms and conditions of this Data Transfer Agreement (“AGREEMENT”). (2) The PROVIDER is willing to provide the RECIPIENT with the requested DATA as specified for the PURPOSE under the terms and conditions of this Agreement including its Annexes. § 3 Obligation of the RECIPIENT (1) The RECIPIENT warrants and undertakes that the Data may solely and exclusively be used within the framework of the Project for the purposes and uses described in Annex. (2) Any use of the DATA beyond the PURPOSE and/or for any commercial purpose is prohibited under this Agreement. § 4 Ownership and Intellectual property (1) The PROVIDER grants the RECIPIENT a non-exclusive, non-transferable, non-sublicensable right to use the DATA for the sole purpose and duration of performing the Project as described in Annex 1. Any other (e.g. commercial) use is strictly prohibited without the PROVIDER’s prior written consent. For the avoidance of doubts, the RECIPIENT recognises that nothing in this Agreement shall operate to transfer to the RECIPIENT any intellectual property rights in or relating to the DATA. (2) The PROVIDER has no knowledge of any conflicting property rights of third parties regarding the provided DATA. If the PROVIDER learns of potential conflicting property rights of third parties, the PROVIDER shall inform the RECIPIENT; however, no liability can be assumed for this. (3) The RECIPIENT shall be entitled to the RESULTS (excluding the DATA incorporated in the RESULTS). § 5 Publications The RECIPIENT may publish or otherwise publicly disclose its RESULTS of the Project. In all such oral presentations or written publications, the RECIPIENT agrees to provide academically and scientifically appropriate acknowledgement of the source of the DATA, PROVIDER and PROVIDER Scientist in accordance with international standards of publications such as the ICMJE, unless requested otherwise. § 6 Confidentiality (1) The PARTIES shall keep Confidential Information of the other PARTY confidential for a period of five (5) years following expiration or termination of this Agreement and use the standard of care the receiving PARTY would use for its own confidential information of like kind, but no less than reasonable standard of care, except such CONFIDENTIAL INFORMATION which: a. was in the public domain prior to being transferred to the receiving PARTY, or became part of the public domain thereafter, except by breach of this Agreement by the receiving PARTY; b. was known by the receiving PARTY prior to being transferred to the receiving PARTY as can be proved by receiving PARTY’s written records predating the date it was learned under this Agreement and without an obligation to confidentiality; c. was received by the receiving PARTY from a third party who obtained it lawfully, without a breach of this Agreement; d. was independently developed by the receiving PARTY's personnel who did not have access to CONFIDENTIAL PARTY or the DATA as demonstrated by the receiving PARTY’s written records contemporaneous with such development. The receiving PARTY bears the burden of proof for these exceptions. (2) Apart from that, the confidentiality obligation shall not apply where applicable laws or a decision by a competent authority requires disclosure, provided that the receiving PARTY shall, to the extent legally possible, first inform the disclosing PARTY and shall limit the disclosure to the content absolutely necessary. (3) For the avoidance of doubt, the confidentiality obligations arising under this Agreement shall not apply to the RESULTS to the extent the RESULTS do not incorporate the DATA. § 7 Costs/Remuneration The DATA will be provided to the RECIPIENT free of charge. § 8 Liability (1) The RECIPIENT accepts that the PROVIDER, the original data creators, depositors or copyright holders, or the funders of the DATA or any part of the DATA supplied: (i) bear no legal responsibility for the accuracy or comprehensiveness of the DATA; and (ii) accept no liability for indirect, consequential, or incidental, damages or losses arising from use of the DATA, or from the unavailability of, or break in access to, the DATA for whatever reason, except for damages caused intentionally or by gross negligence. (2) Nothing in this Agreement limits or excludes either PARTY’s liability for (i) product liability claims, (ii) death or personal injury resulting from negligence or any fraud or (iii) or in case of breaches of so called “material contractual obligations (Kardinalpflichten)”. Material contractual obligations (Kardinalpflichten) are obligations which principally enable the fulfilment of the proper enforcement of the agreement and on which the other PARTY can trust and is allowed to trust for compliance (iiii) for any sort of other liability which by law cannot be limited or excluded according to applicable law. § 9 Term and termination (1) This Agreement shall begin upon signing by the PARTIES and shall expire automatically upon termination of the PROJECT, however at the latest three (3) years after its signature by both PARTIES. (2) This Agreement will terminate immediately upon any breach of the provisions of this Agreement by the RECIPIENT. (3) The RECIPIENT accepts that the changing ethical framework of human genetic research may lead to: (i) alteration to the provisions of this Agreement, in which case the RECIPIENT may accept such alterations or terminate this Agreement; or (ii) the withdrawal of this Agreement in extreme circumstances. (4) The notification of either PARTY to terminate this Agreement shall be made in writing with 30 days’ notice. (5) In the event that this Agreement is expired or terminated in accordance with this Clause 8, section (10) c) of Annex 2 Part II shall apply. § 10 General provisions (1) This Agreement, Annex 1 and 2 [if applicable: and Standard Contractual Clauses in Annex 3] attached hereto and hereby incorporated herein, contains the final, complete and exclusive agreement of the PARTIES relative to the subject matter hereof and supersedes all prior and contemporaneous understandings and agreements relating to its subject matter. This Agreement may not be changed, modified, amended or supplemented except by a written instrument signed by both PARTIES. (2) This Agreement shall be governed, construed and interpreted in accordance with the substantive laws of Germany. This Agreement shall be in the English language and the English version of this Agreement shall be deemed the official and governing instrument, notwithstanding any translations thereof. (3) The PARTIES agree to submit to the exclusive jurisdiction of the courts of Berlin, Germany, as regards any disputes, claims or matter arising under this Agreement. Annexes Annex 1 – Project description: Data request and Purposes Annex 2 – Data Protection: Description of the data transfer and Joint Controller Agreement in accordance with Article 26 GDPR Annex 3 – [if applicable] Standard Contractual Clauses of the EU Commission (Controller to Controller) On behalf of Charité Berlin, on [Name of authorised representative in block capitals] [Position] Acknowledged: Town/city, date [Name of Charité’s responsible investigator] Responsible investigator   On behalf of [Name of Contractual Partner 1] Town/city, date [Name of authorised representative in block capitals] [Position] Acknowledged: Town/city, date [Name of Contractual Partner 1’s project manager] Project manager   Annex 1 – Project description: Data request and Purposes Project title Requested Data [Please describe requested Data] (non-commercial) Purposes: Purposes/ purpose limitation Project description, Planned use of the Data, Research question [please complete] Ethical Approval Protocol [if appropriate add or refer to protocol/ project documentation] Authorized user/recipients.   Annex 2 – Data Protection: Description of the data transfer and Joint Controller Agreement according to Article 26 GDPR) Unless otherwise specified, the terms used hereafter shall have the meaning ascribed to them in Article 4 Regulation (EU) 2016/679 (hereinafter “GDPR”). [Note: please complete (select the appropriate the appropriate option and/or fill out additional information).] Annex 2: Part I - Description of the data transfer 1 PROVIDER (Data exporter) Contact person’s name, position and contact details: [please complete] … Data protection officer: [please complete] … 2 RECIPIENT (Data importer) Contact person’s name, position and contact details: [please complete] … Data protection officer: [please complete] … 3 Data subjects ☐ Patients ☐ Study participants ☐ Employees ☐ Others: … [please complete] [e.g. employees of contract processors] 4 Categories of Personal Data [please select, complete and/or adapt information] ☐ Demographics: gender, year of birth, location … ☐ … ☐ Contact information and relevant professional experience of research staff 5 Sensitive data [Please select all applicable items and complete as appropriate] ☐ Health data ☐ Genetic data ☐ Biometric data ☐ Data concerning sexuality, ethnicity, religion or belief … Including: ☐ Images, x-ray, MRT …. ☐ Photos/videos/gait patterns … ☐ Voice/audio ☐ DNA/RNA, whole genome data, RNAseq … ☐ Symptoms, diagnoses, outcomes, mortality information, treatments ☐ … ☐ … 6 Frequency of the transfer [on a one-off or continuous basis] 7 Nature of the processing [e.g. structuring, analyzing, storage, transfer, publication] 8 Purpose(s) of the data transfer conducting the research Project described under Annex 1. 9 Period of retention (or criteria) [e.g. 10 years; if not applicable e.g. period according to the ethical approval, criteria … ] … 10 Authorized sub-processors and other recipients [processor(s) and processing sub-contracted:] … [other recipients within the meaning of Art. 4 (9) GDPR, if agreed upon between by the Parties and if authorized by the consent form and/or applicable laws:] … 11 Method of data transfer … [please complete] 12 Method of data storage and/or processing … [please complete] 13 Technical and organisational measures (including pseudonymisation) [Note to RECIPIENT: please describe the technical and organizational measures implemented, including pseudonymization and other relevant measures] Pseudonymisation … 14 Transfer of Personal Data to third countries ☐ RECIPIENT(s) located in a country covered by the GDPR. ☐ RECIPIENT(s) located in… [please specify the country]. There is an adequacy decision covering the data transfer. ☐ RECIPIENT(s) located ... [please specify the country]. Since the data transfer is not covered by an adequacy decision, the Parties undertake to enter into Standard Contractual Clauses pursuant to Art. 46 (2) (c) GDPR. [Note: Please make sure to insert Annex 3 in the Agreement] Annex 2: Part II – Joint Controller Agreement in accordance with Article 26 GDPR (1) General remarks and scope of application (a) The Parties undertake to comply with all applicable data protection laws, in particular the GDPR, when processing the Data. (b) Within the scope of the Agreement, the Parties will process Personal data in respect of which the Parties – at least in part – jointly determine the purposes and means of the data processing and to that extent consider themselves as joint controllers within the meaning of Article 26 GDPR. (b) For the avoidance of doubt, with respect to any processing that falls outside the scope of this Agreement, each of the Parties shall remain solely responsible as controller within the meaning of Article 4 (7) GDPR. (c) Unless otherwise specified, the terms used hereafter shall have the meaning ascribed to them in Article 4 GDPR. (2) Subject-matter and purposes of processing, Article 5 GDPR (a) The Parties shall at all times ensure that they comply with the principles relating to the processing of Personal Data under Article 5 GDPR, including but not limited to lawfulness and purpose limitation. (b) The categories of Personal Data transferred, the Data Subjects concerned and other relevant information regarding the data transfer are described in Annex 2 (Part I). (c) The PROVIDER shall only provide pseudonymized Personal data and no directly identifying Personal Data. The RECIPIENT shall refrain from any attempt at de-pseudonymisation or re-identification. (c) The RECIPIENT shall process the Personal Data transferred solely and exclusively within the framework of the Project for the purposes described in Annex 1. (d) The RECIPIENT shall not disclose the Personal data for any other third parties or recipients, unless agreed upon and set out in Annex 2 (I). (3) Legal basis for processing, Article 6, 9 GDPR (a) The PROVIDER warrants and undertakes that the Personal Data have been collected and processed in accordance with all laws applicable to the PROVIDER. (b) [please select the appropriate option] ☐ [OPTION 1:] The legal basis for the processing (including the transfer) of Personal Data is the consent of the Data Subjects. The PROVIDER shall be responsible for obtaining consent from Data Subjects. The PROVIDER shall ensure that each Data Subject has been informed comprehensively prior to giving consent as described in (4). The consent and information form shall comply with the requirements of applicable laws, in particular the GDPR, and shall contain the necessary information so that Data Subject can be informed comprehensively and transparently about the planned use of their Personal Data. If required, the RECIPIENT shall assist the PROVIDER in drafting the informed consent form by providing necessary information about its processing activities as part of the Project. ☐ [OPTION 2:] The legal basis for the processing (including the transfer) of Personal Data is not the consent of Data Subjects. The PROVIDER warrants that there is a legal basis under applicable laws covering the transfer and processing of the Personal Data for the intended purpose, namely … [Please specify the legal basis]). The PROVIDER warrants that all legal requirements that apply to the further processing (transfer and secondary use) of the Personal Data under applicable laws applicable to the PROVIDER and the Data are met. (4) Informing data subjects, Article 13, 14 GDPR The PROVIDER shall provide the Data Subjects with the information required under applicable data protection laws, in particular Article 13 and 14 GDPR, by appropriate means, in a concise, transparent, intelligible and easily accessible form, using clear and plain language. This information shall also inform Data Subjects about the allocation of responsibilities between the Parties under this Agreement; the PROVIDER shall be named as the contact person for safeguarding the rights of Data Subjects. (5) Rights of Data Subjects, Article 15-22 GDPR. (a) Both Parties shall take all technical and organisational measures required to ensure that the rights of the Data Subjects under Art. 15 to 22 GDPR are guaranteed at all times within the statutory time limits. (b) The PROVIDER shall be, as the primary point of contact, responsible for responding to requests of Data Subjects for the purpose of asserting their rights under Article 15 to 22 GDPR. (c) If a Data Subject were to contact the RECIPIENT to exercise his/her rights, the RECIPIENT shall forward the request to the PROVIDER without undue delay. If necessary and requested, the RECIPIENT shall support the PROVIDER in responding to the requests of Data Subjects, in particular by providing the PROVIDER with the necessary information about its processing activities. (d) The Parties will assist each other in giving effect to Data Subjects’ rights, if necessary. The PROVIDER will inform the RECIPIENT immediately if, following a Data Subject’s request or withdrawal of consent, Personal Data has to be rectified, erased or restricted in accordance with applicable laws and provided there is no legal obligation to retain the Personal Data. The RECIPIENT agrees to support the PROVIDER in these cases to the best of its ability. This may include, upon PROVIDER’s request, the erasure of the Personal Data, to the extent required by applicable laws and as far as the data make it possible to re-identify the Data Subjects. (6) Technical and organizational measures, Article 32 GDPR. (a) The RECIPIENT shall ensure that members of staff authorised to process the Personal Data have committed themselves to confidentiality, in particular with regard to their legal duty of confidentiality, and are bound by appropriate contractual confidentiality obligations that survive the end of this Agreement. (b) The RECIPIENT shall ensure with respective delegation of roles and responsibilities matrix that only authorized staff required for the completion of a particular assigned task as described in the Protocol or Project Documentation, will have access to the Personal Data and Data. (c) Taking into account the state of the art, the costs of implementation and the nature, scope, context and purposes of processing as well as the risk of varying likelihood and severity for the rights and freedoms of natural persons, the RECIPIENT shall implement appropriate technical and organizational measures to ensure a level of security appropriate to the risk, including, as appropriate, the measures referred to in Article 32 (1) of the GDPR. (c) If required pursuant to Article 35 GDPR, the Parties carry out a Data protection impact assessment (hereinafter “DPIA”). The Parties shall assist each other and provide each other with the information necessary for its preparation. Projects for which a DPIA is to be carried out may only be started once the DPIA has been completed. (7) Use of processors, Article 28 GDPR. (a) The Parties are entitled to use processors within the meaning of Article 28 GDPR for processing operations under their respective responsibility within the scope of this Agreement. In the event of a legitimate interest (e.g. monitoring compliance with the obligations under this Agreement, request from a supervisory authority or a data subject, transparency obligations), the Parties shall make the lists available to each other. (b) Processors of the RECIPIENT listed in Annex 2 (I) and processors of the PROVIDER (if applicable) already entrusted with processing operations at the time of conclusion of the Agreement (as applicable) shall be deemed to be approved by the other Parties. (b) The Parties shall inform each other in good time, and in any event at least one month in advance, of any intended changes concerning the addition or replacement of subcontracted processors for the processing operations for which the Parties are joint controllers and shall only use subcontractors that comply with the requirements of data protection law and the provisions of this Agreement. For the purposes of this provision, subcontracted services do not include services that the Parties obtain from third parties as ancillary services in support of the performance of the contract, such as telecommunications services and maintenance. However, the Parties are obliged to make appropriate and legally compliant contractual agreements and to take control measures to ensure the protection and security of Personal Data, even in the case of externally contracted ancillary services. Each Party shall have the right to object to the engagement of a specific processor for good cause within 14 days of receipt of the notification of the intended engagement. (d) The Parties undertake to conclude a contract in accordance with Article 28 GDPR when using processors within the scope of this Agreement. The Party engaging the processors shall impose obligations on these processors regarding data protection, confidentiality and data security that meet the requirements of Articles 28 and 29 GDPR and are at least as stringent as those set out in this Agreement. The subcontracting Party shall ensure that these processors impose corresponding obligations on their subcontractors, if applicable. (8) Procedure in the event of Personal Data breaches, Article 33-34 GDPR (a) In the event of a data protection breach involving Personal Data, the affected Party shall inform the other Party without delay, within a maximum of 24 hours after becoming aware of the breach, and shall provide the other Party with the information required under Article 33 (3) GDPR. (b) The Parties shall promptly take all measures necessary to address the breach and mitigate the risks within their respective area of responsibility, assist each other in implementing defensive and protective measures and in making the necessary notifications to the extent necessary and reasonable, and shall, as far as possible, coordinate the procedure before making a notification to the supervisory authority and/or to the Data Subjects. (c) The Party, under whose area of responsibility the Personal Data breach occurred, shall be responsible for the fulfilment of the notification obligations to the competent supervisory authority under Article 33 GDPR. The Parties shall comply with the statutory time limit for notification within 72 hours; any deviation from the time limit must be justified and documented. (d) If Data Subjects are to be informed pursuant to Article 34 GDPR, the Parties agree that the PROVIDER shall communicate the Personal Data breach to the Data Subjects as required by Article 34 GDPR. As applicable, the RECIPIENT shall assist the PROVIDER to the best of its abilities by forwarding the information required to fulfil the communication obligation under Article 34 GDPR to the PROVIDER without undue delay. (9) Location of data processing, Article 44 seqq. GDPR [Please select the applicable option] ☐ [OPTION 1:] The transfer and/or processing of the Personal Data outside the EU/EEA is not allowed within the framework of the Project. ☐ [OPTION 2: Data transfer and processing outside the EU/EEA is allowed:] (a) The Parties shall ensure that the requirements of Art. 44 et seqq. GDPR are met. (b) If the RECIPIENT is located in a country outside the European Economic Area (EEA), and that country has not received an adequacy decision from the European Commission or if the adequacy decision is not applicable to the data transfer in question, the Parties shall enter into the standard contractual clauses authorized by the EU Commission and set out in Article 46 (2) (c) of the GDPR in order to ensure that the RECIPIENT has adequate data protection standards in place. [If applicable: The standard contractual clauses are attached as Annex 3 and hereby incorporated herein by reference]. (c) The Paragraph above shall apply accordingly to the use of processors in accordance with (7). If applicable, the Party engaging the processor, shall ensure that the requirements of Art. 44 et seqq. GDPR are met. (10) Retention and erasure of Personal data (a) The RECIPIENT shall erase (or, if agreed upon, return) all Personal Data transferred after the retention period specified in Annex 2 Part I has ended or, if applicable, after earlier termination of the Main Agreement. All Personal Data shall be erased, at the latest, when the storage of the Personal Data is no longer necessary for the purposes of processing and when there is no legal basis for the further retention of the Personal Data. (b) Upon the PROVIDER's request, the RECIPIENT shall confirm the erasure of the Personal Data. (c) Provided they remain in possession of Personal Data upon termination of the agreement, the Parties shall observe their data protection obligations even after the Main Agreement has terminated. (11) Data protection liability (a) The Parties shall be liable to the data subjects in accordance with the statutory provisions (Article 82 GDPR). (b) The Parties shall indemnify each other from any liability to the extent that they each bear part of the responsibility for the cause giving rise to liability. This shall also apply with regard to any fine imposed on a Party for a violation of data protection laws, provided that the Party subject to the fine must first have exhausted all legal remedies against the administrative order imposing the fine. If the respective Party remains subsequently wholly or partly burdened with a fine which does not correspond to its internal share of responsibility for the infringement, the respective other Party is obliged to indemnify the first Party from the fine to the extent that the other Party has responsibility for the infringement sanctioned by the fine.   Annex 3 – [if applicable] Standard Contractual Clauses – Controller to Controller [NOTE: Please make sure to insert the SCCs in the Agreement, if the data transfer is not covered by an adequacy decision of the European Commission. Please note Clause 2: The SCCs are not to be 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”. Please review Annex I and II (see pre-filled information).] 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) 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 – Module One: Clause 8.5 (e) and Clause 8.9(b); Module Two: Clause 8.1(b), 8.9(a), (c), (d) and (e); Module Three: Clause 8.1(a), (c) and (d) and Clause 8.9(a), (c), (d), (e), (f) and (g); Module Four: Clause 8.1 (b) and Clause 8.3(b); (iii) Clause 9 – Module Two: Clause 9(a), (c), (d) and (e); Module Three: Clause 9(a), (c), (d) and (e); (iv) Clause 12 – Module One: Clause 12(a) and (d); Modules Two and Three: Clause 12(a), (d) and (f); (v) Clause 13; (vi) Clause 15.1(c), (d) and (e); (vii) Clause 16(e); (viii) Clause 18 – Modules One, Two and Three: Clause 18(a) and (b); Module Four: Clause 18. (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 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. It may only process the personal data for another purpose: (i) where it has obtained the data subject’s prior consent; (ii) where necessary for the establishment, exercise or defence of legal claims in the context of specific administrative, regulatory or judicial proceedings; or (iii) where necessary in order to protect the vital interests of the data subject or of another natural person. 8.2 Transparency (a) In order to enable data subjects to effectively exercise their rights pursuant to Clause 10, the data importer shall inform them, either directly or through the data exporter: (i) of its identity and contact details; (ii) of the categories of personal data processed; (iii) of the right to obtain a copy of these Clauses; (iv) where it intends to onward transfer the personal data to any third party/ies, of the recipient or categories of recipients (as appropriate with a view to providing meaningful information), the purpose of such onward transfer and the ground therefore pursuant to Clause 8.7. (b) Paragraph (a) shall not apply where the data subject already has the information, including when such information has already been provided by the data exporter, or providing the information proves impossible or would involve a disproportionate effort for the data importer. In the latter case, the data importer shall, to the extent possible, make the information publicly available. (c) On request, the Parties shall make a copy of these Clauses, including the Appendix as completed by them, available to the Data Subject free of charge. To the extent necessary to protect business secrets or other Confidential Information, including Personal Data, the Parties 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. (d) Paragraphs (a) to (c) are without prejudice to the obligations of the data exporter under Articles 13 and 14 of Regulation (EU) 2016/679. 8.3 Accuracy and data minimisation (a) Each Party shall ensure that the Personal Data is accurate and, where necessary, kept up to date. The data importer shall take every reasonable step to ensure that Personal Data that is inaccurate, having regard to the purpose(s) of processing, is erased or rectified without delay. (b) If one of the Parties becomes aware that the Personal Data it has transferred or received is inaccurate, or has become outdated, it shall inform the other Party without undue delay. (c) The data importer shall ensure that the Personal Data is adequate, relevant and limited to what is necessary in relation to the purpose(s) of processing. 8.4 Storage limitation The data importer shall retain the personal data for no longer than necessary for the purpose(s) for which it is processed. It shall put in place appropriate technical or organisational measures to ensure compliance with this obligation, including erasure or anonymisation of the data and all back-ups at the end of the retention period. 8.5 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 personal data, including protection against a breach of security leading to accidental or unlawful destruction, loss, alteration, unauthorised disclosure or access (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. (b) The Parties have agreed on the technical and organisational measures set out in Annex II. The data importer shall carry out regular checks to ensure that these measures continue to provide an appropriate level of security. (c) The data importer shall ensure that persons authorised to process the personal data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality. (d) 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 personal data breach, including measures to mitigate its possible adverse effects. (e) In case of a personal data breach that is likely to result in a risk to the rights and freedoms of natural persons, the data importer shall without undue delay notify both the data exporter and the competent supervisory authority pursuant to Clause 13. Such notification shall contain i) a description of the nature of the breach (including, where possible, categories and approximate number of data subjects and personal data records concerned), ii) its likely consequences, iii) the measures taken or proposed to address the breach, and iv) the details of a contact point from whom more information can be obtained. To the extent it is not possible for the data importer to provide all the information at the same time, it may do so in phases without undue further delay. (f) In case of a personal data breach that is likely to result in a high risk to the rights and freedoms of natural persons, the data importer shall also notify without undue delay the data subjects concerned of the personal data breach and its nature, if necessary in cooperation with the data exporter, together with the information referred to in paragraph (e), points ii) to iv), unless the data importer has implemented measures to significantly reduce the risk to the rights or freedoms of natural persons, or notification would involve disproportionate efforts. In the latter case, the data importer shall instead issue a public communication or take a similar measure to inform the public of the personal data breach. (g) The data importer shall document all relevant facts relating to the personal data breach, including its effects and any remedial action taken, and keep a record thereof. 8.6 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 or offences (hereinafter ‘sensitive data’), the data importer shall apply specific restrictions and/or additional safeguards adapted to the specific nature of the data and the risks involved. This may include restricting the personnel permitted to access the personal data, additional security measures (such as pseudonymisation) and/or additional restrictions with respect to further disclosure. 8.7 Onward transfers The data importer shall not disclose the personal data to a third party located outside the European Union (in the same country as the data importer or in another third country, hereinafter ‘onward transfer’) unless the third party is or agrees to be bound by these Clauses, under the appropriate Module. Otherwise, an onward transfer by the data importer may only take place if: (i) it 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 with respect to the processing in question; (iii) the third party enters into a binding instrument with the data importer ensuring the same level of data protection as under these Clauses, and the data importer provides a copy of these safeguards to the data exporter; (iv) it is necessary for the establishment, exercise or defence of legal claims in the context of specific administrative, regulatory or judicial proceedings; (v) it is necessary in order to protect the vital interests of the data subject or of another natural person; or (vi) where none of the other conditions apply, the data importer has obtained the explicit consent of the data subject for an onward transfer in a specific situation, after having informed him/her of its purpose(s), the identity of the recipient and the possible risks of such transfer to him/her due to the lack of appropriate data protection safeguards. In this case, the data importer shall inform the data exporter and, at the request of the latter, shall transmit to it a copy of the information provided to the data subject. Any onward transfer is subject to compliance by the data importer with all the other safeguards under these Clauses, in particular purpose limitation. 8.8 Processing under the authority of the data importer The data importer shall ensure that any person acting under its authority, including a processor, processes the data only on its instructions. 8.9 Documentation and compliance (a) Each Party shall be able to demonstrate compliance with its obligations under these Clauses. In particular, the data importer shall keep appropriate documentation of the processing activities carried out under its responsibility. (b) The data importer shall make such documentation available to the competent supervisory authority on request. Clause 9 Use of sub-processors [not applicable. Intentionally left blank] Clause 10 Data subject rights (a) The data importer, where relevant with the assistance of the data exporter, shall deal with any enquiries and requests it receives from a data subject relating to the processing of his/her personal data and the exercise of his/her rights under these Clauses without undue delay and at the latest within one month of the receipt of the enquiry or request10. The data importer shall take appropriate measures to facilitate such enquiries, requests and the exercise of data subject rights. Any information provided to the data subject shall be in an intelligible and easily accessible form, using clear and plain language. (b) In particular, upon request by the data subject the data importer shall, free of charge: (i) provide confirmation to the data subject as to whether personal data concerning him/her is being processed and, where this is the case, a copy of the data relating to him/her and the information in Annex I; if personal data has been or will be onward transferred, provide information on recipients or categories of recipients (as appropriate with a view to providing meaningful information) to which the personal data has been or will be onward transferred, the purpose of such onward transfers and their ground pursuant to Clause 8.7; and provide information on the right to lodge a complaint with a supervisory authority in accordance with Clause 12(c)(i); (ii) rectify inaccurate or incomplete data concerning the data subject; (iii) erase personal data concerning the data subject if such data is being or has been processed in violation of any of these Clauses ensuring third-party beneficiary rights, or if the data subject withdraws the consent on which the processing is based. (c) Where the data importer processes the personal data for direct marketing purposes, it shall cease processing for such purposes if the data subject objects to it. (d) The data importer shall not make a decision based solely on the automated processing of the personal data transferred (hereinafter ‘automated decision’), which would produce legal effects concerning the data subject or similarly significantly affect him/her, unless with the explicit consent of the data subject or if authorised to do so under the laws of the country of destination, provided that such laws lays down suitable measures to safeguard the data subject’s rights and legitimate interests. In this case, the data importer shall, where necessary in cooperation with the data exporter: (i) inform the data subject about the envisaged automated decision, the envisaged consequences and the logic involved; and (ii) implement suitable safeguards, at least by enabling the data subject to contest the decision, express his/her point of view and obtain review by a human being. (e) Where requests from a data subject are excessive, in particular because of their repetitive character, the data importer may either charge a reasonable fee taking into account the administrative costs of granting the request or refuse to act on the request. (f) The data importer may refuse a data subject’s request if such refusal is allowed under the laws of the country of destination and is necessary and proportionate in a democratic society to protect one of the objectives listed in Article 23(1) of Regulation (EU) 2016/679. (g) If the data importer intends to refuse a data subject’s request, it shall inform the data subject of the reasons for the refusal and the possibility of lodging a complaint with the competent supervisory authority and/or seeking judicial redress. 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 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) Each Party shall be liable to the data subject, and the data subject shall be entitled to receive compensation, for any material or non-material damages that the Party 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 under Regulation (EU) 2016/679. (c) 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. (d) The Parties agree that if one Party is held liable under paragraph (c), 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. (e) The data importer may not invoke the conduct of a processor or sub-processor to avoid its own liability. Clause 13 Supervision (a) The supervisory authority with responsibility for ensuring compliance by the data exporter with Regulation (EU) 2016/679 as regards the data transfer, as indicated in Annex I.C, shall act as competent supervisory authority. (b) The data importer agrees to submit itself to the jurisdiction of and cooperate with the competent supervisory authority in any procedures aimed at ensuring compliance with these Clauses. In particular, the data importer agrees to respond to enquiries, submit to audits and comply with the measures adopted by the supervisory authority, including remedial and compensatory measures. It shall provide the supervisory authority with written confirmation that the necessary actions have been taken. SECTION III – LOCAL LAWS AND OBLIGATIONS IN CASE OF ACCESS BY PUBLIC AUTHORITIES 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 safeguards12https://eur-lex.europa.eu/eli/dec_impl/2021/914/oj?uri=CELEX:32021D0914&locale=en; (iii) any relevant contractual, technical or organisational safeguards put in place to supplement the safeguards under these Clauses, including measures applied during transmission and to the processing of the personal data in the country of destination. (c) The data importer warrants that, in carrying out the assessment under paragraph (b), it has made its best efforts to provide the data exporter with relevant information and agrees that it will continue to cooperate with the data exporter in ensuring compliance with these Clauses. (d) The Parties agree to document the assessment under paragraph (b) and make it available to the competent supervisory authority on request. (e) The data importer agrees to notify the data exporter promptly if, after having agreed to these Clauses and for the duration of the contract, it has reason to believe that it is or has become subject to laws or practices not in line with the requirements under paragraph (a), including following a change in the laws of the third country or a measure (such as a disclosure request) indicating an application of such laws in practice that is not in line with the requirements in paragraph (a). (f) Following a notification pursuant to paragraph (e), or if the data exporter otherwise has reason to believe that the data importer can no longer fulfil its obligations under these Clauses, the data exporter shall promptly identify appropriate measures (e.g. technical or organisational measures to ensure security and confidentiality) to be adopted by the data exporter and/or data importer to address the situation. The data exporter shall suspend the data transfer if it considers that no appropriate safeguards for such transfer can be ensured, or if instructed by the competent supervisory authority to do so. In this case, the data exporter shall be entitled to terminate the contract, insofar as it concerns the processing of personal data under these Clauses. If the contract involves more than two Parties, the data exporter may exercise this right to termination only with respect to the relevant Party, unless the Parties have agreed otherwise. Where the contract is terminated pursuant to this Clause, Clause 16(d) and (e) shall apply. 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. (b) If the data importer is prohibited from notifying the data exporter and/or the data subject under the laws of the country of destination, the data importer agrees to use its best efforts to obtain a waiver of the prohibition, with a view to communicating as much information as possible, as soon as possible. The data importer agrees to document its best efforts in order to be able to demonstrate them on request of the data exporter. (c) Where permissible under the laws of the country of destination, the data importer agrees to provide the data exporter, at regular intervals for the duration of the contract, with as much relevant information as possible on the requests received (in particular, number of requests, type of data requested, requesting authority/ies, whether requests have been challenged and the outcome of such challenges, etc.). (d) The data importer agrees to preserve the information pursuant to paragraphs (a) to (c) for the duration of the contract and make it available to the competent supervisory authority on request. (e) Paragraphs (a) to (c) are without prejudice to the obligation of the data importer pursuant to Clause 14(e) and Clause 16 to inform the data exporter promptly where it is unable to comply with these Clauses. 15.2 Review of legality and data minimisation (a) The data importer agrees to review the legality of the request for disclosure, in particular whether it remains within the powers granted to the requesting public authority, and to challenge the request if, after careful assessment, it concludes that there are reasonable grounds to consider that the request is unlawful under the laws of the country of destination, applicable obligations under international law and principles of international comity. The data importer shall, under the same conditions, pursue possibilities of appeal. When challenging a request, the data importer shall seek interim measures with a view to suspending the effects of the request until the competent judicial authority has decided on its merits. It shall not disclose the personal data requested until required to do so under the applicable procedural rules. These requirements are without prejudice to the obligations of the data importer under Clause 14(e). (b) The data importer agrees to document its legal assessment and any challenge to the request for disclosure and, to the extent permissible under the laws of the country of destination, make the documentation available to the data exporter. It shall also make it available to the competent supervisory authority on request. (c) The data importer agrees to provide the minimum amount of information permissible when responding to a request for disclosure, based on a reasonable interpretation of the request. SECTION IV – FINAL PROVISIONS 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 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 Berlin, 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 A. LIST OF PARTIES Data exporter(s): [Identity and contact details of the data exporter(s) and, where applicable, of its/their data protection officer and/or representative in the European Union] 1. Name: Charité – Universitätsmedizin Berlin Address: Charitéplatz 1, 10117 Berlin, Germany Contact person’s name, position and contact details: Project manager: see Rubrum/Preambel. Data Protection Officer: see Annex 2 (I) (1) Activities relevant to the data transferred under these Clauses: performance of a research Project as described in Annex 1 (PROVIDER) Signature and date: … Role (controller/processor): controller Data importer(s): [Identity and contact details of the data importer(s), including any contact person with responsibility for data protection] 2. Name: see Annex 2 (I) (2) Address: : see Annex 2 (I) (2) Contact person’s name, position and contact details: Project manager: : see Annex 2 (I) (2) . Data Protection Officer/ Contact for data protection inquiries: see Annex 2 (I) (2). Activities relevant to the data transferred under these Clauses: performance of a research Project as described in Annex 1 (RECIPIENT) Signature and date: ... Role (controller/processor): controller B. DESCRIPTION OF TRANSFER Categories of data subjects whose personal data is transferred Donors as described in Appendix 1; [if applicable] Research Staff performing the Project as described in Annex 2 (I) (3). Categories of personal data transferred Personal data transferred listed in Annex 2 (I) (4). 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. Sensitive data transferred listed in Annex 2 (I) (5). The frequency of the transfer (e.g. whether the data is transferred on a one-off or continuous basis). One-off. Nature of the processing structuring, analyzing, storage, transfer, publication. Purpose(s) of the data transfer and further processing To perform scientific research as described in Annex 1; to comply with legal obligations related to the research Project The period for which the personal data will be retained, or, if that is not possible, the criteria used to determine that period Relevant personal data will be kept for as long as necessary for the purposes mentioned above for which it has been transferred in accordance with the Protocol (if applicable), the DTA (Annex 2 (I) (9) and with applicable regulations and legal obligations. For transfers to (sub-) processors, also specify subject matter, nature and duration of the processing [Only if applicable and agreed upon as set out in Annex 2 (I) (10) (“Sub-processors/other recipients”): All of the above is applicable to entities and individuals working with and/or for the data importer to conduct the Project described in Annex 2 (10), including central laboratories, safety review boards, data management and statistical analysis suppliers, medical monitors, clinical trial auditors; regulatory authorities]. C. COMPETENT SUPERVISORY AUTHORITY Identify the competent supervisory authority/ies in accordance with Clause 13 Berliner Beauftragte für Datenschutz und Informationsfreiheit Berlin Commissioner for Data Protection and Freedom of Information Alt-Moabit 59-61 10555 Berlin, Germany Telefon: 030 13889-0 Telefax: 030 2155050 E-Mail: mailbox@datenschutz-berlin.de ________________________________________   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. [Note to RECIPIENT: Please review; refer to Annex 2 (I) (13) and/or add measures if necessary]. Personal Data of Donors is pseudonymized. Data importer (RECIPIENT) receives the pseudonymized personal data but does not hold the pseudonymization key. The key is held by the data exporter (PROVIDER) and is not provided to the data importer. Personal Data of personnel performing the Project is not pseudonymized, but such data consists of the personnel’s name, professional qualifications and professional contact information. Data importer uses measures to encrypt data during transit. Data retained on data importer hard drives is encrypted. Data importer personnel and partners are subject to confidentiality obligations. [Examples of possible measures: Measures of pseudonymisation and encryption of personal data Measures for ensuring ongoing confidentiality, integrity, availability and resilience of processing systems and services 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 Processes for regularly testing, assessing and evaluating the effectiveness of technical and organisational measures in order to ensure the security of the processing Measures for user identification and authorisation Measures for the protection of data during transmission Measures for the protection of data during storage Measures for ensuring physical security of locations at which personal data are processed Measures for ensuring events logging Measures for ensuring system configuration, including default configuration Measures for internal IT and IT security governance and management Measures for certification/assurance of processes and products Measures for ensuring data minimisation Measures for ensuring data quality Measures for ensuring limited data retention Measures for ensuring accountability Measures for allowing data portability and ensuring erasure] 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.]